Daughton CG. Published literature relevant to the issues surrounding PPCPs as environmental contaminants. In: EPA US (eds). http://www.epa.gov/ppcp/lit.html. 2012 .
Brooks BW, Berninger JP, Kristofco LA, Ramirez AJ, Stanley JK, Valenti TW. Pharmaceuticals in the environment: lessons learned for reducing uncertainties in environmental risk assessment. Prog Mol Biol Transcl Sci. 2012;112:231–58.
UNEP. State of the science of endocrine disrupting chemicals examined in landmark UN report. UNEP News Centre. 2013. http://www.unep.org/newscentre/Default.aspx?DocumentID=2704&ArticleID=9403&l=en; http://unep.org/pdf/9789241505031_eng.pdf.
USFDA. National Environmental Policy Act; Revision of Policies and Procedures; final rule. Federal Register; 1997.
Wise A, O’Brien K, Woodruff T. Are oral contraceptives a significant contributor to the estrogenicity of drinking water? Environ Sci Technol. 2011;45(1):51–60.
Anderson PD, Johnson AC, Pfeiffer D, Caldwell DJ, Hannah R, Mastrocco F, et al. Endocrine disruption due to estrogens derived from humans predicted to be low in the majority of U.S. surface waters. Environ Toxicol Chem. 2012;31(6):1407–15.
Caldwell DJ, Mastrocco F, Anderson PD, Lange R, Sumpter JP. Predicted-no-effect concentrations for the steroid estrogens estrone, 17 beta-estradiol, estriol, and 17 alpha-ethinylestradiol. Environ Toxicol Chem. 2012;31(6):1396–406.
Caldwell DJ, Mastrocco F, Nowak E, Johnston J, Yekel H, Pfeiffer D, et al. An assessment of potential exposure and risk from estrogens in drinking water. Environ Health Perspect. 2010;118(3):338–44.
Diamanti-Kandarakis E, Bourguignon JP, Giudice LC, Hauser R, Prins GS, Soto AM, et al. Endocrine-disrupting chemicals: an endocrine society scientific statement. Endocr Rev. 2009;30(4):293–342.
USEPA. Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR 3) for Public Water Systems. 77 Federal Register 26071; 2012.
European Parliament. Surface waters: 12 new controlled chemicals, three pharmaceuticals on watch list. 2013. http://www.europarl.europa.eu/news/en/pressroom/content/20130701IPR14760/.
Endocrine Screening Program (EDSP). Washington (DC): Office of Chemical Safety and Pollution Prevention, US Environmental Protection Agency 2012. http://www.epa.gov/endo/. Accessed 1 Aug 2012
USEPA. Amendment to the universal waste rule: addition of pharmaceuticals. In: USEPA, editor. Federal register, 73(232). Washington, DC: US Environmental Protection Agency; 2008. p. 26.
Ankley G, Erickson R, Hoff D, Mount D, Lazorchak J, Beaman J, et al. Draft white paper: aquatic life criteria for contaminants of emerging concern, part i, general challenges and recommendations. Prepared by the Office of Water and Office of Research and Development Emerging Contaminants Workgroup. Washington, DC: U.S. Environmental Protection Agency; 2008.
USEPA. Science advisory board: aquatic life water quality criteria for contaminants of emerging concern. Washington, DC: U.S. Environmental Protection Agency; 2008.
Kostich MS, Lazorchak JM. Risks to aquatic organisms posed by human pharmaceutical use. Sci Total Environ. 2008;389(2–3):329–39.
Snyder SA. Occurrence, treatment, and toxicological relevance of EDCs and pharmaceuticals in water. Ozone Sci Eng. 2008;30(1):65–9.
Debroux J-F, Soller JA, Plumlee MH, Kennedy LJ. Human health risk assessment of non-regulated xenobiotics in recycled water: a review. Hum Ecol Risk Assess Int J. 2012;18(3):517–46.
Grzybowski W. Comment on “Are oral contraceptives a significant contributor to the estrogenicity of drinking water?”. Environ Sci Technol. 2011;45(17):7605.
Daughton C. Pharmaceutical ingredients in drinking water: overview of occurrence and significance of human exposure. Washington DC: American Chemical Society; 2010.
USFDA. Response to citizen petition to the FDA commissioner under the national environmental policy act and administrative procedure act requesting an amendment to a FDA rule regarding human drugs and biologics. 2013. p. 16.
Committee on the Assessment of Water Reuse as an Approach to Meeting Future Water Supply Needs; National Research Council. Water reuse: potential for expanding the nation’s water supply through reuse of municipal wastewater. Washington, DC: The National Academies Press; 2012.
Jelić A, Petrović M, Barceló D. Pharmaceuticals in drinking water. In: Barceló D, editor. Emerging organic contaminants and human health. Berlin: Springer; 2012. p. 47–70.
USFDA. In: Center for Biologics Evaluation and Research, editor. Guidance for industry: environmental assessment of human drug and biologics application. Rockville: US Food and Drug Administration; 1998. p. 39.
USEPA. Guidelines for ecological risk assessment. Fed Regist. 1998;63:26846–924.
Stephan CE, Mount DI, Hansen DJ, Gentile JH, Chapman GA, Brungs WA. Guidelines for deriving numerical national water quality criteria for the protection of aquatic organisms and their uses. Washington, D.C.: U.S. EPA; 1985.
Jobling S, Nolan M, Tyler CR, Brighty G, Sumpter JP. Widespread sexual disruption in wild fish. Environ Sci Technol. 1998;32(17):2498–506.
Vajda AM, Barber LB, Gray JL, Lopez EM, Woodling JD, Norris DO. Reproductive disruption in fish downstream from an estrogenic wastewater effluent. Environ Sci Technol. 2008;42(9):3407–14.
USFDA. Drugs@FDA. 2011. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
Mosher W, Jones J. Use of contraception in the United States: 1982–2008. National Center for Health Statistics. Vital Health Stat. 2010;23:29.
IMS. IMS national sales perspectives, year 2007–2011. Parsippany: IMS Health; 2012. Extracted April 2012.
Chlebowski RT, Kuller LH, Prentice RL, Stefanick ML, Manson JE, Gass M, et al. Breast cancer after use of estrogen plus progestin in postmenopausal women. New Engl J Med. 2009;360(6):573–87.
de Mes TZD, Zeeman G, Lettinga G. Occurrence and fate of estrone, 17β-estradiol and 17α-ethynylestradiol in STPs for domestic wastewater. Rev Environ Sci Biotechnol. 2005;4(4):275–311.
Gutendorf B, Westendorf J. Comparison of an array of in vitro assays for the assessment of the estrogenic potential of natural and synthetic estrogens, phytoestrogens and xenoestrogens. Toxicology. 2001;166(1–2):79–89.
Céspedes R, Petrovic M, Raldúa D, Saura Ú, Piña B, Lacorte S, et al. Integrated procedure for determination of endocrine-disrupting activity in surface waters and sediments by use of the biological technique recombinant yeast assay and chemical analysis by LC–ESI-MS. Anal Bioanal Chem. 2004;378(3):697–708.
Endocrine Disruptors Research. U.S. Environmental Protection Agency; 2012. http://www.epa.gov/endocrine/. Accessed 7 Aug 2012.
Hyder SM, Chiappetta C, Stancel GM. Synthetic estrogen 17 alpha-ethinyl estradiol induces pattern of uterine gene expression similar to endogenous estrogen 17 beta-estradiol. J Pharmacol Exp Ther. 1999;290(2):740–7.
Islinger M, Willimski D, Volkl A, Braunbeck T. Effects of 17a-ethinylestradiol on the expression of three estrogen-responsive genes and cellular ultrastructure of liver and testes in male zebrafish. Aquat Toxicol. 2003;62(2):85–103.
Urbatzka R, Rocha E, Reis B, Cruzeiro C, Monteiro RAF, Rocha MJ. Effects of ethinylestradiol and of an environmentally relevant mixture of xenoestrogens on steroidogenic gene expression and specific transcription factors in zebrafish. Environ Pollut. 2012;164:28–35.
Albero B, Sánchez-Brunete C, Miguel E, Pérez RA, Tadeo JL. Analysis of natural-occurring and synthetic sexual hormones in sludge-amended soils by matrix solid-phase dispersion and isotope dilution gas chromatography-tandem mass spectrometry. J Chromatogr. 2013;1283:39–45.
ECOTOXicology Database. 2011. http://cfpub.epa.gov/ecotox/. Accessed 29 March 2011
Nagpal NK, Meays CL. Water quality guidelines for pharmaceutically-active compounds (PhACs): 17α-ethinylestradiol (EE2), technical appendix. Province of British Columbia: Ministry of Environment; 2009. p. 27.
Caldwell DJ, Mastrocco F, Hutchinson TH, Lange R, Heijerick D, Janssen C, et al. Derivation of an aquatic predicted no-effect concentration for the synthetic hormone, 17 alpha-ethinyl estradiol. Environ Sci Technol. 2008;42(19):7046–54.
Soares J, Coimbra AM, Reis-Henriques MA, Monteiro NM, Vieira MN, Oliveira JMA, et al. Disruption of zebrafish (Danio rerio) embryonic development after full life-cycle parental exposure to low levels of ethinylestradiol. Aquat Toxicol. 2009;95(4):330–8.
Chemicals and the Water Framework Directive: Draft Environmental Quality Standards, Ethinylestradiol (EE2). European Commission, Scientific Committee on Health and Environmental Risks; 2011.
Nagpal NK, Meays CL. Water quality guidelines for pharmaceutically-active compounds (PhACs): 17α-ethinylestradiol (EE2). Province of British Columbia: Ministry of Environment; 2009. p. 8.
Surface waters: new chemicals added to EU risk list (press release). European Parliment; 2012.
Hannah R, D’Aco VJ, Anderson PD, Buzby ME, Caldwell DJ, Cunningham VL, et al. Exposure assessment of 17 alpha-ethinylestradiol in surface waters of the United States and Europe. Environ Toxicol Chem. 2009;28(12):2725–32.
Barber LB, Furlong ET, Keefe SH, Brown GK, Cahill J. Natural and contaminant organic compounds in the Boulder Creek watershed, Colorado, during high-flow and low-flow conditions, 2000. Chapter 5 in Murphy, S.F., Verplanck, P.L., and Barber, L.B., eds., Comprehensive water quality of the Boulder Creek Watershed, Colorado, during high-flow and low-flow conditions. 2000. U.S. Geological Survey Water-Resources Investigations Report 03-4045, p. 103–44.
Huang CH, Sedlak DL. Analysis of estrogenic hormones in municipal wastewater effluent and surface water using enzyme-linked immunosorbent assay and gas chromatography/tandem mass spectrometry. Environ Toxicol Chem. 2001;20(1):133–9.
Benotti MJ, Trenholm RA, Vanderford BJ, Holady JC, Stanford BD, Snyder SA. Pharmaceuticals and endocrine disrupting compounds in US drinking water. Environ Sci Technol. 2009;43(3):597–603.
Survey of Endocrine Disruptors in King County Surface Waters. Washington State Department of Natural Resources and Parks: Prepared by R. Jack and D. Lester, DNRP Water and Land Resources Division, Seattle, WA, 2007.
STOrage and RETrieval (STORET). Repository for water quality, biological, and physical data. Washington, D.C: U.S. Environmental Protection Agency; 2011.
National Water Information System (NWIS). U.S. Geographical Survey; 2011. http://waterdata.usgs.gov/nwis.
Cunningham VL, Buzby M, Hutchinson T, Mastrocco F, Parke N, Roden N. Effects of human pharmaceuticals on aquatic life: next steps. Environ Sci Technol. 2006;40(11):3456–62.
Anderson PD, D’Aco VJ, Shanahan P, Chapra SC, Buzby ME, Cunningham VL, et al. Screening analysis of human pharmaceutical compounds in US surface waters. Environ Sci Technol. 2004;38(3):838–49.
Kostich M, Flick R, Martinson J. Comparing predicted estrogen concentrations with measurements in US waters. Environ Pollut. 2013;178:271–7.
GREAT-ER. European Chemical Industry (CEFIC); 2012. http://www.great-er.org/pages/GenericSubPage.cfm?pageId = 31&parentPgId = 2.
Aronson D, Weeks J, Meylan B, Guiney PD, Howard PH. Environmental release, environmental concentrations, and ecological risk of N,N-diethyl-m-toluamide (DEET). Integr Environ Assess Manag. 2012;8(1):135–66.
Exposure and fate assessment screening tool (E-FAST), Version 2.0, Documentation manual. Washington (DC): Exposure Assessment Branch, Office of Pollution Prevention and Treatment: U.S. Environmental Protection Agency; 2012. http://onlinelibrary.wiley.com/doi/10.1002/ieam.271/pdf. Accessed 31 July 2012
Johnson AC, Williams RJ, Matthiessen P. The potential steroid hormone contribution of farm animals to freshwaters, the United Kingdom as a case study. Sci Total Environ. 2006;362(1–3):166–78.
Lange IG, Daxenberger A, Schiffer B, Witters H, Ibarreta D, Meyer HHD. Sex hormones originating from different livestock production systems: fate and potential disrupting activity in the environment. Anal Chim Acta. 2002;473(1–2):27–37.
Combalbert S, Hernandez-Raquet G. Occurrence, fate, and biodegradation of estrogens in sewage and manure. Appl Microbiol Biotechnol. 2010;86(6):1671–92.
Kolodziej EP, Harter T, Sedlak DL. Dairy wastewater, aquaculture, and spawning fish as sources of steroid hormones in the aquatic environment. Environ Sci Technol. 2004;38(23):6377–84.
Rodriguez-Rojas A, Rodriguez-Beltran J, Couce A, Blazquez J. Antibiotics and antibiotic resistance: a bitter fight against evolution. Int J Med Microbiol. 2013;303(6–7):293–7.
Rajapakse N, Silva E, Kortenkamp A. Combining xenoestrogens at levels below individual no-observed-effect concentrations dramatically enhances steroid hormone action. Environ Health Perspect. 2002;110(9):917–21.
Silva E, Rajapakse N, Kortenkamp A. Something from “Nothing”—eight weak estrogenic chemicals combined at concentrations below NOECs produce significant mixture effects. Environ Sci Technol. 2002;36(8):1751–6.
Carpenter DO, Arcaro K, Spink DC. Understanding the human health effects of chemical mixtures. Environ Health Perspect. 2002;110(S1):25–42.
Park JY, Lee BC, Ra JS, Lee J, Kim SD. Effect of copper complexation on the estrogenic activities of endocrine-disrupting compounds using e-screen bioassay. Environ Toxicol Chem. 2008;27(3):535–41.
Birnbaum LS. Environmental chemicals: evaluating low-dose effects. Environ Health Perspect. 2012;120(4):A143–4.
Vandenberg LN, Colborn T, Hayes TB, Heindel JJ, Jacobs Jr DR, Lee D-H, et al. Regulatory decisions on endocrine disrupting chemicals should be based on the principles of endocrinology. Reprod Toxicol. 2013;38:1–15.
USEPA. State of the science evaluation: nonmonotonic dose responses as they apply to estrogen, androgen, and thyroid pathways and EPA testing and assessment procedures. Washington, D.C.: USEPA; 2013.
Rhomberg LR, Goodman JE. Low-dose effects and nonmonotonic dose–responses of endocrine disrupting chemicals: has the case been made? Regul Toxicol Pharmacol. 2012;64(1):130–3.
Dekant W, Colnot T. Endocrine effects of chemicals: aspects of hazard identification and human health risk assessment. Toxicol Lett. 2013;223(3):280–6.
Zoeller RT, Brown TR, Doan LL, Gore AC, Skakkebaek NE, Soto AM, et al. Endocrine-disrupting chemicals and public health protection: a statement of principles from the endocrine society. Endocrinology. 2012;153(9):4097–110.
U.S. Environmental Protection Agency. Non-monotonic dose response curves research. 2012. http://epa.gov/ncct/edr/non-monotonic.html.
EMEA. Guidelines on the environmental risk assessment of medicinal products for human use. London: European Medicine Agency (EMEA); 2006. Contract no.: EMEA/CHMP/SWP/4447/00.
Connon RE, Geist J, Werner I. Effect-based tools for monitoring and predicting the ecotoxicological effects of chemicals in the aquatic environment. Sensors. 2012;12(9):12741–71.
Sun H, Xia M, Austin C, Huang R. Paradigm shift in toxicity testing and modeling. AAPS J. 2012;14(3):473–80.
Brausch JM, Connors KA, Brooks BW, Rand GM. Human pharmaceuticals in the aquatic environment: a review of recent toxicological studies and considerations for toxicity testing. Rev Environ Contam Toxicol. 2012;218:1–99.
Schmidt CW. TOX 21: new dimensions of toxicity testing. Environ Health Perspect. 2009;117(8):A348–53.
Huang R, Xia M, Cho M-H, Sakamuru S, Shinn P, Houck KA, et al. Chemical genomics profiling of environmental chemical modulation of human nuclear receptors. Environ Health Perspect. 2011;119(8):1142–8.
Stanczyk FZ, Archer DF, Bhavnani BR. Ethinyl estradiol and 17β-estradiol in combined oral contraceptives: pharmacokinetics, pharmacodynamics and risk assessment. Contraception. 2013;87:706–27.
USEPA, USDA, USHHS, USDOI. Memorandum of understanding on Sustainability of Federal Collaboration on Pharmaceuticals in Drinking Water. U.S. Environmental Protection Agency, U.S. Department of Agriculture, U.S. Department of Health and Human Services, and U.S. Department of Interior, 2012.
USFDA. In: Consumer Health Information, editor. How to dispose of unused medicines. Rockville: US Food and Drug Administration; 2012. p. 2.
Kostich MS, Batt AL, Lazorchak JM. Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environ Pollut. 2014;184:354–9.
USFDA. Endocrine disruption potential of drugs: nonclinical evaluation (draft). Rockville: US Food and Drug Administration; 2013.
Boxall ABA, Rudd MA, Brooks BW, Caldwell DJ, Choi K, Hickmann S, et al. Pharmaceuticals and personal care products in the environment: what are the big questions? Environ Health Perspect. 2012;120(9):1221–9.
Gao P, Shi Y. Characterization of supersaturatable formulations for improved absorption of poorly soluble drugs. AAPS J. 2012;14(4):703–13.
Daughton CG, Ruhoy IS. Lower-dose prescribing: minimizing “side effects” of pharmaceuticals on society and the environment. Sci Total Environ. 2013;443:324–37.
Keil F. Pharmaceuticals for human use: an integrated strategy for reducing the contamination of water bodies. In: Kümmerer K, Hempel M, editors. Green and sustainable pharmacy. Berlin: Springer; 2010. p. 225–41.
Hamburg MA, Collins FS. The path to personalized medicine. New Engl J Med. 2010;363(4):301–4.
Woodcock J. The prospects for personalized medicine in drug development and drug therapy. Clin Pharmacol Ther. 2007;81(2):164–9.
Daughton CG, Ruhoy IS. Green pharmacy and pharmecovigilance: prescribing and the planet. Expert Rev Clin Pharmacol. 2011;4(2):211–32.
Daughton CG, Ruhoy IS. Reducing the ecological footprint of pharmaceutical usage: linkages between healthcare practices and the environment. In: Kümmerer K, Hempel M, editors. Green and sustainable pharmacy. Berlin: Springer; 2010. p. 77–102.
Diab R, Jaafar-Maalej C, Fessi H, Maincent P. Engineered nanoparticulate drug delivery systems: the next frontier for oral administration? AAPS J. 2012;14(4):688–702.
Moore K, Townsend J, Spieler J, Coffey PS, Blithe D, Arndorfer E, et al. A greenprint for sustainable contraceptive research and development. Contraception. 2013;98(3):347–51.
Barber LB, Vajda AM, Douville C, Norris DO, Writer JH. Fish endocrine disruption responses to a major wastewater treatment facility upgrade. Environ Sci Technol. 2012;46(4):2121–31.
Marfil-Vega R, Suidan MT, Mills MA. Assessment of the abiotic transformation of 17β-estradiol in the presence of vegetable matter–II: the role of molecular oxygen. Chemosphere. 2012;87(5):521–6.
Marfil-Vega R, Suidan MT, Mills MA. Abiotic transformation of estrogens in synthetic municipal wastewater: an alternative for treatment? Environ Pollut. 2010;158(11):3372–7.