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Pharmaceuticals and Personal Care Products in Drinking Water


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This UL white paper provides an overview of the issues related to the presence of …

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.

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  • 1. Pharmaceuticals andPersonal Care Productsin Drinking Water
  • 2. Pharmaceuticals and Personal Care Products in Drinking WaterPharmaceuticals and Personal Care Productsin Drinking WaterScientific advances in pharmaceutical therapies and the growing availability ofpharmaceutical drugs has done much to improve the overall health of the world’spopulation. But the widespread use of pharmaceuticals and other personal careproducts has increased concerns about concentrations of these substances throughoutthe water cycle, including surface and ground waters, wastewater, and drinking water.Despite seemingly small concentrations, the presence of pharmaceuticals in drinkingwater has raised concerns about the potential risks to human health from exposure towater-borne pharmaceuticals.In part, the increased detection of pharmaceuticals in drinking water is due to advancesin analytical technology that support the measurement of concentrations to levelsas low as the nanogram per liter range. However, the effects of prolonged exposureto even small concentrations of pharmaceuticals in water are not well understood.Further, since the use of pharmaceuticals and other personal care products is expectedto increase, the risk from their introduction into the water system will also rise. Assuch, water supply stakeholders, including government officials, drinking waterregulators, water suppliers and the general public, are focusing increased attention onpharmaceutical concentration levels in drinking water.This UL white paper provides an overview of the issues related to the presence ofpharmaceuticals and personal care products (PPCPs) in drinking water. The paperdiscusses the possible effects of PPCPs on humans and on the environment andsummarizes recent research conducted by U.S. government agencies, UL and others onPPCP concentrations found in public drinking water supplies and wastewater facilities.The white paper also discusses available water treatment options for reducing PPCPconcentrations and their relative effectiveness. The paper concludes with areas forfurther research and a preview of possible future regulatory 2
  • 3. Pharmaceuticals and Personal Care Products in Drinking WaterTypes and Sources of PPCPs through bathing or showering, when treated water. In addition, prolongedin 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. 4In general, the term PPCP refers to any water system.product used for either personal health Research on PPCPs in Wateror cosmetic reasons as well as any The Impact of PPCPs in Research on PPCPs in water has beenproduct used in the agricultural industry Drinking Water ongoing for nearly 20 years, withto maintain the health or enhance While there are no confirmed adverse the first Environmental Protectionthe 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 inof thousands of chemical substances, contamination remains a significant water dating to 1982. The EPA web-siteincluding prescription and over-the- concern. For example, pharmaceuticals lists more than 100 separate researchcounter therapeutic drugs for humans are designed to interact with cellular-level projects related to PPCPs in which theand animals, biopharmaceuticals, EPA has been or is currently involved,5 receptors at low concentrations todiagnostic agents, vitamins and other and the agency maintains an extensive induce specific biological effects, and thenutritional supplements, cosmetics database of published literature on side effects caused by interaction withand fragrances, and growth-enhancing PPCPs as environmental contaminants.6 nonreceptor targets are unpredictablechemicals used in livestock operations.1 Here is a brief summary of some of the and poorly understood. Further, certainPPCPs enter the water supply as a result key research that has been conducted strains of bacteria subject to prolongedof multiple industrial, commercial and concerning PPCPs in water. exposure to antibiotics can developagricultural activities and pharmaceutical National Reconnaissance of resistance to those antibiotics, resultingmanufacturing (although the latter is Pharmaceuticals, Hormones and Other in strains of drug-resistant bacteria.tightly regulated2). PPCPs also enter the Organic Wastewater Contaminants inwater supply in the form of residue from Other PPCPs, such as steroid hormones Streams of the U.S., 1999-2000hospitals and other healthcare facilities like estrone, progesterone and testosterone and fragrance additives This important field study 7 was conductedand as a byproduct of veterinary drug use, like galaxolide, have been identified as by researchers at the U.S. Geologicalmost notably antibiotics and steroids. endocrine-disrupting compounds (EDCs). Survey in 1999 and 2000 to provideWater-born PPCPs can also result from EDCs are synthetic chemicals that block baseline information on the occurrencesthe surreptitious disposal of illegal drugs. or mimic natural hormones in the body, of pharmaceuticals, hormones and otherIndividual consumers are also an wastewater contaminants in water disrupting normal organ function. It isimportant source, both intentionally resources. Concentrations of 95 separate important to note that EDCs, even atand unintentionally, of PPCPs found organic wastewater contaminants extremely low concentrations, can havein water. Consumers often dispose of (OWCs) were measured in water samples effects on the human endocrine system.3unused prescription medications by taken from 139 streams in 30 states acrossincluding them with household refuse Beyond potential effects on human the United States. Researchers foundor 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 detergentfrom the body, since drugs are not always exposure to PPCP concentrations, often metabolite) and caffeine as the mostfully metabolized by the body, and also at higher concentrations than found in frequently detected 3
  • 4. Pharmaceuticals and Personal Care Products in Drinking WaterAccording to the results of this field study, the measured concentrations of OWCs foundwere low - generally, less than one part per billion - and rarely in excess of drinkingwater guidelines or health advisories. However, researchers noted that concentrationguidelines have been established for only 14 of the 95 identified compounds. Thestudy’s report recommended further research to “fully understand not only the fateand transport of OWCs in the hydrologic system but also their ultimate overall effect onhuman health and the environment.”Study of Occurrence of Contaminants of Emerging Concern in WastewaterThis 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 treatmentfacilities in the United States. The CECs evaluated in this study included PPCPs, steroidsand hormones, bisphenol A (BPA), commercial flame retardants, and pesticides. A totalof 72 different PPCPs were tested in both influent and effluent samples.According to the final report issued in August 2009, detectible amounts of 44 differentPPCPs were identified in at least one influent sample collected, and 27 different PPCPswere 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 lessthan 25% of the effluent samples analyzed. Pharmaceutical antibiotics represented thecategory of PPCPs most frequently identified, accounting for half of the total PPCPsidentified in both influent and effluent samples.EPA researchers cautioned that the results of this study were not statisticallyrepresentative of all public-owned treatment works. Further, although the studymeasured PPCP concentrations in both influent and effluent samples from watertreatment facilities, researchers noted that the data were insufficient to draw anyconclusions about the effectiveness of various treatment methods.An important byproduct of this EPA study was the development of new analyticalmethods for detecting the occurrence of PPCPs and other contaminants in untreatedand fully treated wastewater and sludge. These methods include “Method 1694:Pharmaceuticals and Personal Care Products in Water, Soil, Sediment, and Biosolids byHPLC/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), thistechnical report11 is based on work conducted by a WHO working group that includedexperts in water quality and health, water treatment, drinking water regulation andpolicy, and water quality and health. The chief goal of the working group was to reviewand summarize available scientific knowledge about pharmaceuticals in drinking water,and recommend steps for managing the 4
  • 5. Pharmaceuticals and Personal Care Products in Drinking WaterThe WHO report determined that least 41 million Americans. Specifically, sensitivity when compared with theconcentration levels of pharmaceuticals pharmaceuticals were found in the parts per billion (ppb) concentrationin drinking water fall outside the drinking water supplies of 24 major U.S. range available with standard analyticalscope 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 advancedfor compliance analysis of drinking of 35 of the 62 major providers and found analytical technologies to enablewater. However, WHO experts pharmaceutical concentrations in 28 of increased understanding of theacknowledged that there are “very few those watersheds. occurrence of PPCPs and EDCs in drinkingsystematic monitoring programmes water. Table 1 lists the 10 most frequentlyor comprehensive, systematic studies Research by UL detected PPCPs submitted to UL fromon the occurrence of pharmaceuticals As noted in the WHO technical study various cities in 30 states between 2008in drinking-water.” Further, according discussed above, concentrations of and 2009. A total of 57 different PPCPsto the report, the “limited occurrence pharmaceuticals in drinking water have and 17 different EDCs were present one of the key challenges often been below levels detectable with most analytical testing equipment. But While the concentrations of PPCPs foundin assessing the potential risks most studies on PPCPs also concede that in drinking water supplies sampled byassociated with trace concentrations of the effects of prolonged exposure to even UL were millions of times lower than thepharmaceuticals in drinking-water.” The small concentrations of pharmaceuticals concentrations prescribed for therapeuticreport concluded that “future research … in water are not well understood. effect, additional research by the EPAmay be beneficial to better characterize Although the increased detection of and others is underway to determinepotential health risks from long-term, PPCPs in drinking water in recent years the potential health risk to humans andlow-level exposure to pharmaceuticals.” is due, in part, to advances in analytical ecological systems of PPCPs at theseResearch by the Associated Press technology, continued technological concentration levels.Research into the presence of advances along with routine monitoring More recently, UL has continued itspharmaceuticals and other personal care are necessary to fully understand the efforts to further develop its own testingproducts in drinking water has not been occurrence of these contaminants and methods for identifying PPCPs and otherlimited 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 theby the Associated Press (AP) 12 analyzed UL has a long history of developing analysis of PPCPs and EDCs based on priorfederal drinking water databases, analytical technologies for emerging proprietary testing methods. The newreviewed hundreds of scientific reports, contaminants in drinking water. During method, L222, focuses on the detectionand interviewed more than 230 the past decade UL has invested in and analysis of almost 30 of the mostofficials, scientists and academics. AP’s advanced analytical equipment such as frequently detected and studied PPCPinvestigatory 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 small community water providers in all various sample preparation techniques, UL also created method S190, which50 states. this technology has enabled UL to develop streamlined the analysis of selectedAP’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 flameantibiotics, anti-convulsant drugs and the parts per trillion (ppt) concentration retardants, fragrances, polyaromaticmood stabilizers, were found in the range. This level of detection represents hydrocarbons (PAHs), phenolsdrinking water supplies that serve at a thousand-fold increase in measurement and 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 104Table 1: Top ten PPCPs found in drinking water samples tested at ULTreatment Methods for PPCPs of success in removing PPCPs in several •  More than 90% of lipid regulatorsin Drinking Water classifications, as follows: can be removed using activatedMost conventional water treatment carbon, biologically activated •  More than 90% of steroids cansystems are not specifically engineered or be removed from drinking water carbon, ozone/advanced oxidationequipped to remove PPCPs from drinking using activated sludge, activated processes, nanofiltration andwater. However, depending on the specific carbon, biologically activated reverse osmosischemical class of the contaminant, there carbon, ozone/advanced oxidation •  Less than 40% of listed PPCPsis a range of treatment methodologies processes, UV treatments and can be removed through the usethat have proven effective for removing reverse osmosis of coagulation/flocculation andPPCPs or reducing their concentration. •  More than 90% of antibiotics, softening/metal oxidesSuch 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 variousAccording to some researchers, a 13 advanced oxidation processes, UV types of treatment methodologies, basednumber of individual water treatment treatments, nanofiltration and on compiled data from a subset of themethods have demonstrated high levels reverse osmosis EPA’s research document 6
  • 7. Pharmaceuticals and Personal Care Products in Drinking WaterAreas for Future Research and needed to understand both the scope of Rule (UCMR 3). UCMR 3 will require allPossible 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 representativeAs authorized under the U.S. Safe has several research efforts currently sample of the 800 systems servingDrinking Water Act (SDWA), the EPA underway to strengthen the science for 10,000 or fewer people, to conductsets drinking water standards to control understanding the behavior of PPCPs assessment monitoring for the presencecontaminants in the public drinking water in drinking water, including research, of 28 separate chemicals during asupply, and currently has drinking water methods development and occurrence 12-month period. The rule will requireregulations for more than 90 separate studies. Data from this research will public water systems (PWS) to conductcontaminants. To determine whether this occurrence monitoring from Januarya contaminant should be regulated, assist the agency in determining whether 2013 through December 2015. Includedthe 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 inincluding the occurrence levels of a and the testing of public drinking water estrogen replacement therapies) andcontaminant in the environment, routes systems should be considered, even in the testosterone. Although these substancesof human exposure and the health effects absence of health-based standards. are not currently regulated by nationalof exposure, particularly the effects on As part of its ongoing research primary drinking water regulations, thevulnerable subpopulations. to determine the occurrence of EPA will use the data from this and priorThe fact that contaminants are detected contaminants of emerging concern, UCMR assessment phases to determinein trace amounts does not alone imply the EPA has recently proposed the whether further regulations are in therisk to humans. Significant research is still Unregulated Contaminant Monitoring interest of public health.15page 7
  • 8. Pharmaceuticals and Personal Care Products in Drinking WaterConclusionThe presence of PPCPs and other emerging contaminants in drinking water is not anew issue, and significant research is still required to understand both the scope of theproblem 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 rangeof contaminants in drinking water with greater specificity and sensitivity than at anytime in the past. Only a few laboratories, including UL, have developed methods todetect pharmaceuticals and other compounds at ultralow levels.UL is a recognized leader in drinking water analysis and has analyzed over 2.5 millionsamples 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. ULis one of only a few laboratories in the United States that can analyze a wide varietyof emerging contaminants in drinking water, including PPCPs, estrogens and otherhormones, 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 mostefficient methods available, thereby streamlining the testing process and reducingtesting costs.For more information about the “Pharmaceuticals and Personal Care Products inDrinking Water” white paper, please contact Laura Snell, marketing manager –Food & Water, at Laura.J.Snell@ul.comTHIS DOCUMENT IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED TO CONVEY ANY LEGAL ADVICE. USE OFTHE INFORMATION IN THIS DOCUMENT IS AT YOUR OWN RISK. PLEASE CONSULT WITH LEGAL COUNSEL FOR ADVICE ON COMPLYINGWITH THE REGULATIONS DESCRIBED ABOVE.Copyright©2011 Underwriters Laboratories Inc. All rights reserved. No part of this document may be copied or distributed without theprior written consent of Underwriters Laboratories Inc. 12/11page 8
  • 9. Pharmaceuticals and Personal Care Products in Drinking Water1 “Pharmaceuticals and Personal Care Products (PPCPs).” U.S. Environmental Protection Agency. Web. 4 Nov. 2011 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. Day, Rhonda, “Managing Micro-Pollutants.” Water and Wastewater International, Dec/Jan 2010-2011. Web. 21 Nov 2011. “Frequent Questions: Pharmaceuticals and Personal Care Products (PPCPs).” U.S. Environmental Protection Agency. 4 Nov 2011. “EPA PPCP Research Areas.” U.S. Environmental Protection Agency. Web. 7 Nov 2011. “Published Literature Relevant to Issues Surrounding PPCPs as Environmental Contaminants.” U.S. Environmental Protection Agency. Web. 7 Nov 2011. 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 Additional information about this study, as well as study data, is available at “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. “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. “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. “Pharmaceuticals in drinking-water: Technical report.” World Health Organization. June 2011. Web. 4 Nov 2011. 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. 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 “Treating Contaminants of Emerging Concern.” U.S. Environmental Protection Agency. Aug. 2010. Web. 10 Nov 2011. “Basic Information about the Unregulated Contaminant Monitoring Rule 3 (UCMR 3).” U.S. Environmental Protection Agency. Web. 23 Nov 2011. 9