Section 2: Scientific Explanation of Pharmaceutical Contamination

B. Environmental Impact

              While the link between the consumption of pharmaceutically contaminated water and ill health effects in humans has been insufficiently studied, there is no shortage of studies establishing deleterious effects to animals living in environments with pharmaceutically contaminated waters.  Such effects include the following: “abnormal thyroid function and development in fish and birds; decreased fertility in fish, shellfish, birds, and mammals; decreased hatching success in fish, birds, and reptiles; demasculinization and feminization of fish, birds, reptiles, and mammals; defeminization and masculinization of gastropods, fish, and birds; decreased offspring survival; and alteration of immune and behavioral function in birds and mammals.”[23]

              Of particular note is the effect that pharmaceutical estrogens and antidepressants have on aquatic life. In a Canadian study, scientists polluted a lake with estrogens in concentrations similar to that found in a local municipal water supply.[24] Scientists observed the fathead minnow present in the lake and after four years, “the fish had all but disappeared from the lake.”[25] The male fish had become sterile or transformed into female fish and the female fish essentially received a low dose administration of birth control (which is essentially estrogen).[26] Three years after the scientists ceased the estrogen treatment, the fish population returned to normal.[27]  A different study found that when male fathead minnows are exposed to birth control for a majority of their life, they become female and are unable to reproduce.[28]  Such gender-swapping effects have been observed in fish at estrogen concentrations as low as three parts per billion.[29]  For reference, this concentration can be achieved by dissolving one birth control pill into 2,641 gallons of water.  “[A] human female using the birth control pill will excrete this amount in her urine over the course of a single day.”[30]  In addition to estrogens, the presence of antidepressants has ill effects on aquatic life including the triggering of spawning in bivalves and crustaceans, decrease in prey capture ability, and reduced predator avoidance.[31]

[23] Thomas M. Crisp et al., Environmental Endocrine Disruption: An Effects Assessment and Analysis, 106 Envtl. Health Persp. 11, 11 (Supp. 1998).

[24] Halford, supra note 2.

[25] Id.

[26] Id.

[27] Id.

<p

[28] Id.

<

[29] Id.

[30] Id.

[31] Melissa M. Schultz et al., Antidepressant Pharmaceuticals in Two U.S. Effluent- Impacted Streams: Occurrence and Fate in Water and Sediment, and Selective Uptake in Fish Neural Tissue, 44 Envtl. Sci. & Tech. 1918 (2010).

Section 2: Scientific Explanation of Pharmaceutical Contamination

A.   Human Impact

              Most pharmaceuticals in the water occur in concentrations far below prescribed dosages.  Nevertheless, micro-dose exposure to many drugs over a long period poses great human health risk.[8] Pharmaceuticals are designed to effect biological change, and thus these compounds pose a greater risk to human health than other anthropogenically- originating chemicals in the environment.[9] Additionally, human exposure to pharmaceuticals in water is not limited to the water humans consume.  Exposure also occurs through the consumption of fish and shellfish that have bioaccumulated pharmaceuticals or have been in contact with contaminated water.[10] The most studied side effect of consuming pharmaceutically contaminated water is endocrine system disruption.[11]  Endocrine resistance occurs when drugs that mimic naturally occurring hormones or drugs that are exogenous forms of hormones produced in the body are consumed and cause the endocrine system to stop producing its own hormones.[12] Such endocrine disrupting affects can “include breast cancer and endometriosis in women, testicular and prostate cancers in men, abnormal sexual development, reduced male fertility, alteration in pituitary and thyroid gland functions, immune suppression and neurobehavioral effects.”[13]  There is a direct relationship between the generational decline in men’s testosterone and luteinizing hormone levels and the amount of birth control prescribed for and consumed by women.[14]

              Pharmaceuticals in the water also contribute to antimicrobial resistance, which occurs when microbes that adapt to antimicrobial agents reproduce and then pass on that resistance gene.[15] Such resistance poses serious public health risks, such as the need for\multiple rounds of antibiotics to kill bacteria or the inability to fight infections altogether.[16]

              While antimicrobial resistance of the endocrine system and to antibiotics is an indisputable effect of consuming pharmaceutically contaminated water, some scientists argue that there are few other side effects to human consumption of such water.[17] This camp believes that new sewage treatment mechanisms are not necessary. But there is a large group of scientists who disagree. They argue that there have not been enough studies conducted and that presently there are inefficient means to detect the threats that long term, low dose consumption of many pharmaceuticals pose.[18]

              Despite the lack of human studies, there have been many studies on how pharmaceutically contaminated water impacts individual human cells. In one study, scientists exposed healthy cells to a dosage of pharmaceuticals similar to that found in Italian rivers – the result was that cells grew a third as fast as they did prior to exposure.[19] Another study found that breast cancer cells exposed to estrogens taken fromfish that were caught near sewage plants grew twice as quickly as unexposed cells.[20]  Other studies have found that individual drugs can cause cell growth, but when drugs that cause growth are combined with other drugs, growth can actually be slowed.[21] Such effects prove that pharmaceuticals have synergistic effects. Yet in the lab and in testing for humans, such effects are not studied because most drugs are not designed to be stacked with other compounds.[22]

[8] Kolpin, supra note 1.

[9] Halford, supra note 2.

[10] GLOBAL WATER RESEARCH COALITION, OCCURRENCE AND POTENTIAL FOR HUMAN HEALTH IMPACTS OF PHARMACEUTICALS IN THE WATER SYSTEM 2 (2009).

[11] Karyn Feiden, Pharmaceuticals Are in the Drinking Water: What Does It Mean?, Rapid Pub. Health Pol’y Response Project: Geo. Wash. Sch. of Pub. Health & Health Serv., 3 (April 2008)

[12] Thomas M. Crisp et al., Environmental Endocrine Disruption: An Effects Assessment and Analysis, 106 Envtl. Health Persp. 11, 11 (Supp. 1998).

[13] Tanya Tillett, Summit Focuses on Pharmaceuticals in Drinking Water, 117 Envtl. Health Persp. A16, A16 (2009).

[14] Id.

[15] Antimicrobial Resistance, World Health Org. (Mar. 2016), http:// www.who.int/ mediacentre/factsheets/fs194/en/.

[16] Christopher T. Nidel, Regulating the Fate of Pharmaceutical Drugs: A New Prescription for the Environment, 58 Food & Drug L.J. 81, 83-84 (2003).

[17] Halford, supra note ii.

[18] Id.

[19] How Meds in Water Could Impact Human Cells, MSNBC (Feb. 16, 2010), http:// www.msnbc.msn.com/id/23558785.

[20] Id.

[21] Id.

[22] Francisco Pomati et al., Effects and Interactions in an Environmentally Relevant Mixture of Pharmaceuticals, 102 Toxicology Sci. 129, 129 (2008).

Section 1: Introduction

              Pharmaceuticals are in our rivers, streams, lakes, oceans, and ground and soil waters.  A U.S. Geological survey conducted from 1999-2000, found at least one of ninety-five organic wastewater contaminants, such as “antibiotics, other prescription drugs, non-prescription drugs, steroids [and] reproductive hormones” in eighty percent of the one-hundred and thirty-nine streams sampled.[1] A 2008 Associated Press investigation revealed “[a] vast array of pharmaceuticals including antibiotics, anti-convulsants, mood stabilizers and sex hormones […] in the drinking water supplies of at least 41 million Americans” in twenty-four major metropolitan areas.[2] In 2013[3], the U.S. Environmental Protection Agency found that there were at least twenty-five different active pharmaceutical ingredients in the water at fifty large wastewater treatment plants across the United States.[4]

              Despite the pervasiveness of pharmaceuticals in our nation’s waters, authorities have taken little action to prevent further contamination or to address existing contamination.  Federal environmental statutes do not directly address the discharge of pharmaceuticals into water.  As a result, most wastewater processes do not target pharmaceutical contaminants[5];nor could they due to lack of capacity and technology.[6] Many believe that regulating pharmaceutical discharge is a futile exercise.  Christian Daughton of the EPA noted that “[g]iven the vast array of mechanisms of drug action and side effects, the total number of different toxicity tests possibly required to screen the effluent from a typical [sewage treatment plant] could be impractically large.”[7]

              The discussion that follows includes a scientific explanation of the human and environmental impacts of pharmaceutical discharges and the sources of such discharges (as Section 2); the current legislation that regulates pharmaceutical discharges (as section 3); the scientific solution to preventing pharmaceuticals from entering waters (as part of section 4); and a feasible legal remedy to pharmaceutical discharges (as part of section 4). Additionally, the discussion as a whole makes the case that unregulated pharmaceutical discharges present serious environmental and human health risks that demand statutory directive.

[1] Dana W. Kolpin et al., Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999–2000: A National Reconnaissance, 35 ENVTL. SCI. & TECH. 1202, 1203 (2002).

[2] WORLD HEALTH ORG., PHARMACEUTICALS IN DRINKING WATER 15 (2012); Jeff Donn et al., Pharmawater I: Pharmaceuticals Found in Drinking Water, Affecting Wildlife and Maybe Humans, ASSOCIATED PRESS (Mar. 9, 2008), http://hosted.ap.org/ specials/interactives/pharmawater_site/day1_01.html; Matt Harvey, Your Tap Water Is Probably Laced with Antidepressants, SALON (Mar. 14, 2013), http://www.salon.com/ 2013/03/14/your_tap_water_is_probably_laced_with_anti_depressants_partner/; David Noble, Trouble at the Tap, WATER QUALITY PRODUCTS.

[3] That year Americans filled nearly four billion prescriptions.

[4] M.S. Kostich et al., Concentrations of Prioritized Pharmaceuticals in Effluents from 50 Large Wastewater Treatment Plants in the U.S. and Implications for Risk Estimation, 184 ENVTL. POLLUTION 354 (2014)

[5] See Staffan Castensson, Pharmaceutical Waste, in PHARMACEUTICALS IN THE ENVIRONMENT: SOURCES, FATE, EFFECTS AND RISK 489, 497 (Klaus Kümmerer ed., 2008) (“Pharmaceuticals are designed to be resistant to biological degredation”)

[6] Id.

[7] Christian G. Daughton & Thomas A. Ternes, Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?, 107 ENVTL. HEALTH PERSP. 907, 908 (1999).