Published Ahead of Print on March 8, 2010 as 10.1200/JCO.2009.24.4798 JOURNAL OF CLINICAL ONCOLOGY Prediction of Risk of Distant Recurrence Using the 21-GeneRecurrence Score in Node-Negative and Node-PositivePostmenopausal Patients With Breast Cancer Treated WithAnastrozole or Tamoxifen: A TransATAC StudyMitch Dowsett, Jack Cuzick, Christopher Wale, John Forbes, Elizabeth A. Mallon, Janine Salter, Emma Quinn,Anita Dunbier, Michael Baum, Aman Buzdar, Anthony Howell, Roberto Bugarini, Frederick L. Baehner,and Steven Shak
Alternative strategies for managing pharmaceutical and personal care products in water resources (2011)Alternative Strategies for Managing
Pharmaceutical and Personal Care Products in Water Resources TEXAS TECH UNIVERSITY School of Law™ Alternative Strategies for Managing
Pharmaceutical and Personal Care Products in Water Resources Prepared by: Gabriel Eckstein & George William Sherk TEXAS TECH UNIVERSITY School of Law™ Texas Tech University Center for Water Law & Policy
Project funded by U.S. Environmental Protection Agency
About the Texas Tech University Center for Water Law & Policy The Center for Water Law & Policy at Texas Tech University was created in 2005 in response to the growing need for research into and information about global water issues. It was designed to create and nurture opportunities for interdisciplinary collaboration on legal and policy issues related to the use, allocation, management, regulation, and conservation of fresh water resources at all levels of civil society – from the purely local to the decisively global. The Center is part of the Texas Tech University interdisciplinary water initiative, which involves faculty and students representing the disciplines of law, public policy, economics, agriculture, geosciences, engineering, biological sciences, and health sciences.
Texas Tech University Center for Water Law & Policy
Texas Tech University School of Law 1802 Hartford Avenue, Lubbock, TX 79409 (806) 742-3990 • www.law.ttu.edu/waterlaw • [email protected] This report, as well as the related Micropollutants Clearinghouse (www.micropollutants.org), could not have been completed without the dedicated support of the following students who toiled long hours on this project: Paul Cash, Brandon Durrett, Brandon Dyson, Elissa Fitzgerald, Courtney Hamilton, Matt Hardin, Sarah Hegi, Emily Howell, Christopher Jackson, Charles Jones, and Matthew Lopez at Texas Tech University School of Law, and Elizabeth Miller at Texas Wesleyan University School of Law.
In addition, special thanks is due to: Dr. Deborah Carr, Research Assistant Professor at Texas Tech University, for her invaluable assistance with generating material for the Micropollutants Clearinghouse; Peter Hall for his excellent project management support and copyright research; Pam Tarver and Robyn Lamb for their stellar accounting skills and administration of the award; Paul Aguilar, Uwe Beltz, Chad Covey, Daniel Dean, Randy Norwood and the entire Texas Tech University School of Law technology staff for their wonderful technical and Internet wizardries; the Texas Tech University School of Law faculty and administration, which facilitated this endeavor as well as the creation of the Center. A special thank you is also due to Bill Jeffrey who first conceptualized the project and guided it in its earliest phases.
We also wish to acknowledge the wonderful work done on the field study component of the project (see the case study discussed in Chapter E) that was led by Texas Tech University's Dr. Audra N. Morse, Department of Civil and Environmental Engineering, and Dr. Todd Anderson, Department of Environmental Toxicology, and their various graduate students.
Lastly, we wish to thank the U.S. Environmental Protection Agency for funding this project.
Copyright 2011 by the Texas Tech University Center for Water Law & Policy. All rights reserved.
Table of Contents About the Authors .iExecutive Summary . iiA. Introduction: .1 A.1. Methodology .3A.2. Organization of the Report .3 B. Summary of the Scientific Research: .3 B.1. Pathways .8B.2. Effects of PPCPs in Water .10 B.2.1. Long-term Low-dose Exposures .11 B.2.2. Cumulative or Synergistic Effects .11 B.2.3. Susceptible Groups .12 B.2.4. Environmental Health Impacts .12 B.3. Sources of PPCPs in Water .14B.4. Processes or Mechanisms by Which PPCPs are Introduced Into Water Supplies .15 C. Current Means of Protecting Water Supplies: .17 C.1. Common Law Remedies Sounding in Tort .17 C.1.1. Trespass .18 C.1.2. Nuisance .18 C.1.3. Negligence .18 C.1.4. Strict Liability .19 C.2. Protection of Surface Water Quality: The Clean Water Act .19C.3. Protection of Groundwater and Surface Water Quality: The Safe Drinking Water Act .20 C.3.1. National Primary Drinking Water Regulations.20 C.3.2. The Unregulated Contaminant Monitoring Rule.21 C.3.3. The Contaminant Candidate List .22 C.3.4. The Surface Water Treatment Rule .22 C.3.5. The Wellhead Protection Program .22 C.3.6. The Underground Injection Control Program .23 C.3.7. The Biosolids Rule .23 C.4. Protection of Groundwater and Surface Water Quality by Regulating Hazardous Substances and Wastes: The Resource Conservation and Recovery Act .24 C.4.1. The Mixture Rule .25 C.4.2. Categories of Generators .26 C.4.3. The Uniform Hazardous Waste Manifest System .26 C.4.4. Treatment, Storage and Disposal Facilities .26 C.4.5. The Universal Waste Rule .27 C.4.6. State Implementation .27 C.5. Protection of Groundwater and Surface Water Quality by Regulating Toxic Substances: The Toxic Substance Control Act .27 C.5.1. The Inventory .28 C.5.2. Pre-Manufacture Notification .28 C.5.3. Regulatory Controls .28 C.5.4. Imminent Hazards .29 C.6. Protection of Species: The Endangered Species Act .29 C.6.1. "Taking" Endangered Species .29 C.6.2. Interagency Coordination .30 D. Alternative Strategies: .30 D.1. Drug Design .31D.2. Drug Delivery .32D.3. Drug Marketing .33D.4. Drug Dispensing .33D.5. Drug Disposal/Recycling .34D.6. Drug Alternatives .37 E. Case Study Based on Project 2 Results: .37 E.1. Sorption of Estrogens, Triclosan, and Caffeine in a Sandy Loam and a Silt Loam Soil .38E.2. Microbially Mediated Degradation of Common Pharmaceuticals and Personal Care Products in Soil Under Aerobic and Anaerobic Conditions .38E.3. Biological Degradation of Common Pharmaceuticals and Personal Care Products in Soils39with High Water Content .39E.4. Occurrence of PPCPs at a Wastewater Treatment Plant and in Soil and Groundwater at a Land Application Site .39E.5. Conclusions from the Case Study .40 F. Strengths and Weaknesses of the Statutory, Regulatory and Alternative Strategies: .41 F.1. Statutory and Regulatory .41 F.1.1. Common Law Remedies Sounding in Tort .42 F.1.2. The Clean Water Act .43 F.1.3. The Safe Drinking Water Act .44 F.1.4. The Resource Conservation and Recovery Act .46 F.1.5. The Toxic Substance Control Act .47 F.1.6. The Endangered Species Act .47 F.2. Alternative Strategies .48 F.2.1. Drug Design .48 F.2.2. Drug Delivery .49 F.2.3. Drug Marketing .49 F.2.4. Drug Dispensing .49 F.2.5. Drug Disposal/Recycling .49 F.2.6. Drug Alternatives .50 G. Conclusions: .50H. Bibliography: Figure 1: Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams .5 Table 1: Principal Emerging PPCP Compounds and Their Uses .7 Figure 2: Sources and Pathways of PPCPs in the Urban Water Cycle .9 About the Authors Professor Gabriel Eckstein is a Professor of Law at Texas Wesleyan University School of Law. He is also Director of the International Water Law Project (www.internationalwaterlaw.org) and Senior Fellow with the Texas Tech Center for Water Law & Policy. He received his LL.M. and J.D. degrees from American University's Washington College of Law, an M.S. in International Affairs from Florida State University, and a B.S. in Geology from Kent State University. Prior to joining the law faculty of Texas Wesleyan, Prof. Eckstein held the George W. McCleskey Chair in Water Law at the Texas Tech University School of Law where he also served as the first Director of the Center for Water Law & Policy. In addition to his academic appointments, Prof. Eckstein has served as Senior Counsel for CropLife America, an agrichemical trade association, advising on matters of U.S. and international regulatory and environmental law and compliance issues related to agricultural chemicals and biotechnology, air and water pollution, endangered species, and intellectual property. Prior to that, he worked as a litigator in private practice on environmental, toxic tort, and asbestos cases. E-mail:[email protected] Dr. Sherk is Chief Operating Officer of the International Performance Assessment Centre for Geologic Storage of Carbon Dioxide (IPAC-CO2) in Regina, Saskatchewan. He is also Of Counsel to the law firm of Sullivan & Worcester in Washington, DC and an Honorary Associate at the UNESCO Centre for Water Law, Policy and Science at the University of Dundee in Scotland. Prior to joining IPAC-CO2, Dr. Sherk was Managing Director of the Colorado Energy Research Institute at the Colorado School of Mines in Golden, Colorado and an Adjunct Professor at the University of Denver Sturm College of Law. He received his D.Sc. from The George Washington University with a major in environmental and energy management (Department of Engineering Management and Systems Engineering, School of Engineering and Applied Science) and a minor in environmental health (Department of Environmental and Occupational Health, School of Public Health and Health Services). He received his J.D. from the University of Denver after completing undergraduate and graduate studies at Colorado State University. Prior to his doctoral program, he served as a Visiting Scholar at the University of Wyoming College of Law and as a Visiting Professor at Georgia State University. In addition to his career in academia, he has maintained a private law practice since 1990 after having served for several years as a Trial Attorney with the Environment and Natural Resources Division of the U.S. Department of Justice. E-mail: [email protected] or [email protected] Executive Summary (ESA). States and tribes have enacted similar legislation. While In recent decades, concern has grown over the presence of these strategies may prove to be important, their implementation pharmaceutical and personal care products (PPCPs) in water. This can be expensive and politically unpopular.
concern stems from the possibility that the presence of PPCPs in water supplies may pose a threat to both human and environmental A more effective route for responding to PPCPs in drinking health. Such threats may be both direct (e.g., exposure to water supplies may be to focus on alternative strategies that endocrine disrupting compounds) and indirect (e.g., emergence of focus on removing PPCPs from the source. These alternative antibiotic resistant bacteria). The water treatment and wastewater strategies include designing drugs and personal care products treatment community has been especially concerned over PPCPs that minimize the human and animal excretion of wastes, which because of PPCPs ubiquitous nature and their ability to persist or would then minimize the volume of PPCPs that enter the water only partially degrade in water and during wastewater treatment. system. Changing the delivery mechanisms may also be successful Studies done over the past several decades have indicated that in addressing PPCPs in water systems. This strategy relies on wastewater contaminants including antibiotics, other prescription better informing doctors and patients about the effects of PPCPs drugs, non-prescription drugs, steroids, reproductive hormones, on the environment, and educating doctors and other professionals and personal care products have been found in both surface water on how to individualize or tailor doses to the individual user and ground water in the United States.
rather than prescribing the manufacturers' recommended dose. Informing users on how to dispose of unused drugs and personal Sources of PPCPs include human & animal feces and urine, care products and producing a variety of package sizes to reduce hospital/medical wastes, wastes from industrial and agricultural the amount of unused drugs could also be an essential PPCP processes, pharmaceuticals and personal care products that are reducing mechanism.
disposed of inappropriately, urban runoff, and leachate from landfills. These contaminants are rarely treated or removed in In addition, encouraging states or manufacturers of the wastewater treatment process and typically remain in waters pharmaceuticals and personal care products to develop take-back discharged from wastewater treatment plants into receiving streams programs could also lead to the reduction of PPCPs in the water and lakes, as well as in solid and liquid wastes applied to lands supplies. Unfortunately, institutional and financial barriers may designated as application sites.
make implementing of many of these programs difficult. For take-back programs to be successful, these institutional barriers Various common law remedies, such as trespass, nuisance, need to be revised. Nutrition and health maintenance programs negligence, and strict liability, may be relevant to concerns over that reduce illness and the need for PPCPs, as well as the use of PPCPs in water supplies. However, these remedies rely on success alternative products that do not contain PPCPs, such as probiotics, in litigation. Litigation is often expensive, time consuming, and also could reduce the amount of PPCPs entering the water supply. very case specific. Additionally, success in litigation requires This alternative, however, could also be costly to the patient.
plaintiffs to prove causation – which manufacturer produced the PPCP involved in the suit, and which PPCPs resulted in the harm The issue of PPCPs in water supplies is a complex problem alleged in the suit – hurdles that may be difficult to overcome.
that will require more than one simple solution. It will require reducing the source of PPCPs and monitoring and regulating the An alternative to common law remedies may be found under PPCPs that enter the water supply. New monitoring, detection, federal, state, and tribal laws and regulations where a number of and analysis methods are needed. New drinking water treatment agencies and statutes may be relevant. Federal agencies that have processes will need to be developed. Regulatory and statutory the potential to be involved in various aspects of the management approaches need to be tailored to reducing the amount of PPCPs of PPCPs include the Environmental Protection Agency (EPA), in water supplies. The alternative strategies discussed here will be the Food and Drug Administration (FDA), the U.S. Department needed to protect human and environmental health.
of Agriculture (USDA), the U.S. Geological Survey (USGS), and the Centers for Disease Control and Prevention (CDC). In addition, numerous units of state, tribal, and local governments may be involved in implementing environmental programs that are relevant to the management of PPCPs. Existing federal statutory regimes that may be relevant to PPCPs include: Clean Water Act; Safe Drinking Water Act; Resource Conservation and Recovery Act; Toxic Substance Control Act; and Endangered Species Act In the nearly forty years since the adoption of the Federal compounds (EDCs) have received growing attention from the Water Pollution Control Act Amendments in 19721 and water treatment and wastewater treatment community because of the Safe Drinking Water Act in 1974,2 the United States the ability of PPCPs to persist or only partially degrade in water has seen dramatic improvement in the quality of both and during wastewater treatment.4 surface and drinking water. Despite these improvements, Several federal agencies, including the Environmental serious problems and questions remain.
Protection Agency (EPA), the Food and Drug Administration Chemicals occur in the environment through a wide variety (FDA), the U.S. Department of Agriculture (USDA), the U.S. of natural processes and human actions. The various federal and Geological Survey (USGS), and the Centers for Disease Control state programs implementing the Clean Water Act, the Safe and Prevention (CDC), have the potential to be involved in various Drinking Water Act and other environmental laws regulate only aspects of the management of PPCPs. In addition to these federal a small portion of these chemicals. Although the number of agencies, numerous units of state, tribal, and local governments regulated chemicals is very small when compared to the universe of are (or could be) involved in implementing federal, state, and tribal chemicals in the environment, an implicit assumption underlying environmental programs that are relevant to the management of this regulatory approach is that "these selective lists of chemicals PPCPs. Industry stakeholders also play signiﬁcant roles, both are responsible for the most signiﬁcant share of risk with respect to directly and indirectly, in the management of PPCPs.
environmental or economic impairment or to human health."3 PPCPs are an extremely diverse group of chemicals used In recent years, this assumption has been challenged. in human health care, cosmetic care, veterinary medicine, Chemicals from a wide variety of pharmaceutical and personal and agriculture. They also are ubiquitous pollutants, entering care products (PPCPs), their byproducts and endocrine disrupting the environment worldwide due to widely dispersed usage by 1 Pub. L. No. 92-500, 86 Stat. 816 (1972) (codiﬁed as amended at 33 U.S.C. § 1251 et seq. (2006)) (with subsequent amendments, now known as the Clean Water Act).
2 Safe Drinking Water Act, Public Law No. 93-523, 88 Statutes at Large 1661.
3 Christian G. Daughton, Non-Regulated Contaminants Emerging Research, Existing and Future Pollutants in Water Supplies: Old Pollutants, New Concerns - New Pollutants, Unknown Issues. Paper presented at the Presented at National Academies, Institute of Medicine: Roundtable on Environmental Health Science, Research, and Medicine (EHSRT) (Oct. 16, 2003).
4 For the purposes of this report, the term "PPCPs" includes a diverse group of chemicals that include pharmaceutical, such as prescription and over-the-counter human drugs, veterinary drugs, and diagnostic agents, and personal care products, including fragrances, lotions, cosmetics, and nutritional supplements. PPCPs also comprise the various byproducts of these substances as well as related endocrine disrupting compounds (EDCs). Concern regarding the presence of such compounds in water supplies was expressed by Masters: [These] are compounds that interfere with natural production, release, transport, metabolism, binding, action, or elimination of hormones in the body. We know that the normal functions of all organ systems are regulated by endocrine factors. Small disturbances in endocrine function, especially during certain stages of the life cycle, can lead to profound and lasting effects. There is evidence that speciﬁc populations of invertebrate, ﬁsh, avian, reptilian, and mammalian species have been, or currently are being, adversely affected by exposure to environmental contaminants that effect the endocrine systems. … The major groups of animals potentially at risk include ﬁsh, birds, reptiles, marine mammals, and invertebrates.
Robert W. Masters, Pharmaceuticals and Endocrine Disruptors in Rivers and On Tap, Water Resources Update, no. 120, 1, 1 (2001) (citing Gerald Ankley et al., Ofﬁce of Research and Development, Environmental Protection Agency, Research Plan for Endocrine Disruptors. (1998)). See also K. Xia et al., Occurrence, Distribution, and Fate of 4-Nonylphenol in Kansas Domestic Wastewater Treatment Plants, 120 WATER RESOURCES UPDATE 41 (2001).
5 Christian G. Daughton, Chapter 33: PPCPs in the Environment: Future Research – Beginning with the End Always in Mind, in Pharmaceuticals in the Environment: Sources, Fate, Effects and Risks 463 (Klaus Kümmerer ed., 2d ed. Springer 2004).
individuals and in both industry and agriculture.5 Recent reports in Project 2 focused on primary research to improve the popular media regarding pharmaceuticals in drinking water have understanding of the presence and fate of mixtures of contributed to increasing public awareness of and concern about micropollutants in the environment. This research, which was based on ﬁeld studies conducted on discharges from a wastewater treatment facility in West Texas, forms the basis for the case study noted below.
In 2006, the Center for Water Law & Policy at Texas Tech University (the "Center") was awarded funding by the Project 3 focused on an analysis of alternative strategies for Environmental Protection Agency to conduct a study related to addressing the presence and effects of PPCPs in water supplies. micropollutants (including PPCPs) in the natural environment. Statutory and regulatory approaches that are (or could be) utilized This study was divided into three speciﬁc projects.
to prevent PPCPs from entering the aquatic environment in concentrations that would exceed concentrations determined to be Project 1 focused on the development of a PPCP database appropriate for protection of human health and the environment containing documents, reports, publications, and other material were identiﬁed and evaluated.7 Potential alternative strategies related to PPCPs. While information in the database was designed were also identiﬁed and evaluated. Project 3 addressed three basic for use in Project 3 (discussed below), the information was also questions: First, can existing statutory and regulatory authorities intended to be made available to those interested in understanding be utilized to collect information about and/or effectively manage water law and policy issues, including researchers, decision-makers PPCPs entering the environment? Second, are there other in the public and private sectors, stakeholders, interest groups, alternative strategies that should be considered? Third, what are and the general public. This latter objective was achieved by the the relative strengths and weaknesses of the existing authorities creation of the Micropollutants Clearinghouse and alternative strategies? The results of Project 3 as well as answers to these three questions are contained herein. 6 For example, in 2008, the Associated Press released a series of investigative reports entitled An AP Investigation: Pharmaceuticals found in Drinking Water. These reports, which were distributed by both print and electronic media worldwide, included: Jeff Donn, PharmaWater – NYC Water: Drug Traces Turn Up in Source Waters for Nation's Biggest City; Jeff Donn, PharmaWater – Philadelphia Drugs: Tests of Philadelphia's Drinking Water Reveal 56 Drugs; Jeff Donn, PharmaWater – Research: Research Shows Pharmaceuticals in Water Could Impact Human Cells; Jeff Donn, House Panel Pressed to Consider More Tracking of Pharmaceuticals, Contaminants in US Waters; Jeff Donn, Medical Facilities Making Uncontrolled Releases of Controlled Drugs into Water; Jeff Donn, Philadelphia City Council Wants Local and Federal Action to Curb Drugs in Drinking Water Jeff Donn, Philadelphia Water Officials to Address Worries over Drugs in Water and Corrected Data; Jeff Donn, Martha Mendoza & Justin Pritchard, Pharmawater I: Pharmaceuticals Found in Drinking Water, Affecting Wildlife and Maybe Humans; Jeff Donn, Martha Mendoza & Justin Pritchard, Pharmawater II: Fish, Wildlife Affected by Drug Contamination in Water; Jeff Donn, Martha Mendoza & Justin Pritchard, Pharmawater III: No Standards to Handle Pharmaceuticals in Water; Jeff Donn, Martha Mendoza & Justin Pritchard, AP Impact: Health Care Industry Sends Tons of Drugs into Nation's Wastewater System; Jeff Donn, Martha Mendoza & Justin Pritchard, AP Investigation: Scant Advice on Disposal of Meds; Tom Hester, Jr., NJ Lawmakers Told Effects of Drugs in Water Unknown; Steve LeBlanc, Mass. Officials Detail Steps to Keep Pharmaceuticals from Water Supply, Call for Federal Help; Colleen Long, NYC Leaders Say City Must Test Drinking Water, Responding to AP Report on Drugs; Martha Mendoza, PharmaWater-Secrecy: Water Providers, Researchers Rarely Release Full Test Results; Martha Mendoza, AP Enterprise: Recent Tests Detect Pharmaceuticals in Drinking Water of 46 Million Americans; Martha Mendoza, Communities Prevent Pharmaceutical Contamination with Drug Takeback Programs; Martha Mendoza, Ill. Orders Water Testing in Reax to AP Series; Providers Elsewhere Assure Supplies are OK; Martha Mendoza, On Eve of Hearings, White House Documents Show Feds Failing to Take Action on Drugs in Water; Martha Mendoza, Scientists, Environmentalists, Utilities Agree: More Testing Needed on Drugs in Drinking Water; Martha Mendoza, Senators Rip EPA Over Lack of Knowledge on Drugs in Water; Martha Mendoza, Texas Town Releases Name of Drug Found in Water; Mayor Cited Terrorism as Reason for Secrecy; Justin Pritchard, PharmaWater – Bottled Water: Bottled Water Industry Faces Same Federal Standards for Pharmaceuticals as Tap Water; Justin Pritchard, PharmaWater – Treatments: Water Cleaning Technologies Present Challenges; Carolyn Thompson, EPA Urges Great Lakes Residents Not to Flush Old Meds.
7 The alternatives analysis contained in Project 3 was not designed to determine whether human health and environmental hazards presented by PPCPs and their byproducts warrant speciﬁc regulatory activities. Instead, Project 3 was intended to evaluate alternative strategies that could be utilized should scientiﬁc research determine that PPCPs or their byproducts are hazardous to human health or the environment.
A.2. Organization of the Report
Preparation of this report relied on both the outputs of Projects The following section provides a brief summary of current 1 and 2 and on the collective expertise of the authors. As noted scientiﬁc research regarding sources of PPCPs in water supplies. above, the output of Project 1 (the Micropollutants Clearinghouse) Processes or mechanisms by which PPCPs get into water supplies contained an extended collection of materials relating to PPCPs are described. Both short- and long-term impacts on human and in water supplies. The following section summarizes the current environmental health resulting from the presence of PPCPs in scientiﬁc research. Both this summary and Section IV regarding water supplies are reviewed.
alternative strategies were prepared after the authors had Section III describes current legal mechanisms by which water reviewed a large number of articles and reports contained in the Clearinghouse. supplies are protected, both directly and indirectly. The requirements of the Clean Water Act and the Safe Drinking Water Act are To ensure comprehensiveness, and as a quality control measure, reviewed. The management of hazardous substances and wastes, the authors also undertook an independent review of the literature. as mandated by the Resource Conservation and Recovery Act, is This review utilized a variety of online data retrieval systems. reviewed as is the regulation of toxic substances under the Toxic The results of this independent review were then compared to Substances Control Act. Of particular relevance to the aquatic the contents of the Clearinghouse. Any items not already in the environment is the Endangered Species Act, which is also reviewed.
Clearinghouse were added following this review.8 Potential alternative strategies leading to the minimization or Project 2 provided the information contained in the case elimination of PPCPs in water supplies are discussed in Section study discussed below. This research, which focused on the IV. This discussion, which addresses the reduction or elimination presence of PPCPs in soil and groundwater in West Texas, was of anthropogenic sources of PPCPs, as well as the regulation and initiated by researchers at Texas Tech University, speciﬁcally management of such sources, sets the stage for the aforementioned Dr. Todd A. Anderson, Dr. Deborah L. Carr, Dr. Adcharee case study contained in Section V. As noted above, this case study Karnjanapiboonwong, Dr. Jonathan D. Maul, Dr. Audra N. is based on Project 2 results.
Morse, and Dr. John C. Zak.9 Meetings were held with one or more of these researchers during the course of this project. Copies Strengths and weaknesses of the statutory, regulatory, and of research presentations and drafts of ﬁnal reports were provided alternative strategies are discussed in Section VI. Conclusions to the authors. The cooperation and assistance of Dr. Anderson, are presented in Section VII. Section VIII contains the Project 3 Dr. Carr, Dr. Karnjanapiboonwong, Dr. Maul, Dr. Morse, and Dr. Zak are both acknowledged and very much appreciated.
The legal review contained in Section IV and the analysis of B. Summary of the Scientific Research: the strengths and weaknesses of a variety of statutory and regulatory alternatives contained in Section VI are based primarily on the Concern over the presence of PPCPs in water supplies has expertise of the authors, both of whom have taught environmental, increased signiﬁcantly since 1965 when researchers at Harvard natural resources, and water law for many years. This expertise University ﬁrst determined that efﬂuent from wastewater treatment was supplemented by additional legal research regarding recent plants contained both natural and synthetic estrogens.11 By the initiatives unique to the issue of PPCPs in water supplies.10
8 The comprehensiveness of the research upon which the Clearinghouse was based is revealed by the fact that relatively few new references
were added following the authors' independent review of the literature.
9 Dr. Anderson, Dr. Carr, Dr. Karnjanapiboonwong and Dr. Maul are with the Institute of Environmental and Human Health, Department of Environmental Toxicology. Dr. Morse is with the Department of Civil and Environmental Engineering. Dr. Zak is with the Department of Biological Sciences.
10 The authors would like to express their appreciation to Mr. Christopher R. Jackson, Class of 2011, Texas Tech University School of Law, and Ms. Elizabeth Miller, Class of 2011, Texas Wesleyan University School of Law, for their invaluable assistance in the preparation of this portion of the report.
11 Benjamin D. Stanford et al.,.Estrogenic Activity of US drinking waters: A relative exposure comparison, 102 Journal of the American Water Works Association 55, 55 (2010) (citing Elisabeth Stumm-Zollinger & Gordon M. Fair, Biodegradation of Steroid Hormones, 37 Journal of the Water Pollution Control Federation 1506 (1965)).
1970s, the subject was being studied in both the United States12 into which wastewater had been discharged.15 In large measure, the growing concern over the presence of PPCPs in water supplies has been based on an increasing number of occurrence studies However, as noted by Stanford, et al., after these initial studies that have identiﬁed speciﬁc PPCPs in drinking water.16 While it "only sparse attention was paid to hormones and pharmaceuticals is beyond the scope of the present study to review each of these in the environment until reproductive effects in ﬁsh were shown studies, certain studies should be noted. to be directly inﬂuenced by estrogens in wastewater outfalls."14 By the early 1990s, researchers in Germany and Switzerland had identiﬁed multiple PPCPs in both wastewater and surface waters 12 Id. at 55 (citing A.W. Garrison et al., GC/MS Analysis of Organic Compounds in Domestic Wastewaters, in First Chemical congress of the North American Continent 517 (1975)).
13 Lisa J. Schulman et al., A Human Health Risk Assessment of Pharmaceuticals in the Aquatic Environment, 8 Human & Ecological Risk Assessment 657, 658 (2002).
14 Stanford et al., supra note 11, at 55-56 (citing Shane A. Snyder et al., Identification and Quantification of Estrogen Receptor Agonists in Wastewater Effluents, 35 Environmental Science & Technology 3620 (2001); C. Desbrow et al., Identification of Estrogenic Chemicals in STW Effluent. 1. Chemical Fractionation and in Vitro Biological Screening, 32 Environmental Science & Technology 1549 (1998)).
15 David L. Sedlak, & Karen E. Pinkston, Factors Affecting the Concentrations of Pharmaceuticals Released to the Aquatic Environment, 120 Water Resources Update 56 (2001) (citing H.J. Stan et al., Occurrence of Clofibric Acid in the Aquatic System – Is the Use in Human Medical Care the Source of the Contamination of Surface, Ground, and Drinking Water? 83 Vom Wasser 57 (1994); R. Hirsch et al., Determination of Betablockers and ß-Sympathomimetrics in the Aquatic Environment, 87 Vom Wasser 263 (1996); H. Stan & T. Heberer, Occurrence of Polar Organic Contaminants in Berlin Drinking Water, 86 Vom Wasser 19 (1996); Marcus Stumpf et al., Polar Drug Residues in Sewage and Natural Waters in the State of Rio de Janeiro, Brazil, 225 The Science of the Total Environment 135 (1999); Hans-Rudolf Buser et al., Occurrence of the Pharmaceutical Drug Clofibric Acid and the Herbicide Mecoprop in Various Swiss Lakes and in the North Sea, 32 Environmental Science & Technology 188 (1998); Hans-Rudolf Buser et al., Occurrence and Fate of the Pharmaceutical Drug Diclofenac in Surface Waters: Rapid Photodegradation in a Lake, 32 Environmental Science & Technology 3449 (1998); Andreas Hartmann et al., Identification of fluoroquinolone antibiotics as the main source of umuC genotoxicity in native hospital wastewater, 17 Environmental Toxicology and Chemistry 377 (1998); Thomas A. Ternes, Occurrence of Drugs in German Sewage Treatment Plants and Rivers, 32 Water Research 3245 (1998); Hans-Rudolf Buser et al., Occurrence and Environmental Behavior of the Chiral Pharmaceutical Drug Ibuprofen In Surface Waters and in Wastewater, 33 Environmental Science & Technology 2529 (1999); C. Hartig, Detection and Identification of Sulphonamide Drugs in Municipal Waste Water by Liquid Chromatography Coupled with Electrospray Ionisation Tandem Mass Spectrometry, 854 Journal of Chromatography A 163 (1999); Roman Hirsch, Occurrence of Antibiotics in the Aquatic Environment, 225 The Science of the Total Environment 109 (1999); Thomas A. Ternes & Roman Hirsch, Occurrence and Behavior of X-ray Contrast Media in Sewage Facilities and the Aquatic Environment, 34 Environmental Science & Technology 2741 (2000)). Schulman, et al., have noted that these studies "identiﬁed and measured a variety of human pharmaceuticals including hormones, lipid regulators, pain killers, antibiotics, anticancer drugs, anti-epileptic drugs, and blood pressure drugs at a range of concentrations, most below 1 µ/l." Schulman et al., supra note 13, at 658.
16 However, as noted by the American Water Works Association Research Foundation (AwwaRF), "[i]f water utilities choose to (or are compelled to) implement additional treatment measures for these compounds based solely on occurrence data, without regard to toxicological signiﬁcance, there is a risk of spending tremendous amounts of public funds for very little public health beneﬁt." Djanette Khiari, Endocrine Disruptors, Pharmaceuticals, and Personal Care Products in Drinking Water: An Overview of AwwaRF Research to Date, 17 Drinking Water Research 1, 6 (2007) (emphasis added). The AwwaRF has also noted: If presence/absence becomes our litmus test for risk and subsequent actions, treatment technology will be increasingly, and perhaps unnecessarily, costly and energy intensive. This is an especially important consideration due to the energy cost and greenhouse gas emissions of advanced treatment. American Water Works Association Research Foundation, Toxicological Relevance of EDCs and Pharmaceuticals in Drinking Water, at xix (2008).
In 1999-2000, the U.S. Geological Survey sampled surface Figure 1: Pharmaceuticals, Hormones, and Other and groundwater throughout the United States.17 The study Organic Wastewater Contaminants in U.S. Streams21 focused on the presence in U.S. water supplies of 95 organic wastewater contaminants including "antibiotics, other prescription DETECTION FREQUENCY, IN PERCENT drugs, nonprescription drugs, steroids, reproductive hormones, personal care products, products of oil use and combustion, and other extensively used chemicals."18 At least one of the 95 organic wastewater contaminants was found in 80% of stream samples and in 93% of groundwater samples. As noted in the study, the environmental presence of these compounds raises concerns regarding potential consequences, including "abnormal physiological processes and reproductive impairment, increased incidences of cancer, the development of antibiotic-resistant bacteria, and the potential increased toxicity of chemical mixtures."19 The results of the study are summarized below and , IN MICROGRAMS PER LITER* depicted in Figure 1.
The most frequently detected chemicals (found in more than half of the streams) were coprostanol (fecal steroid), cholesterol (plant and animal steroid), N-Ndiethyltoluamide (insect repellent), caffeine (stimulant), triclosan (antimicrobial disinfectant), tri (2-chloroethyl) phosphate (ﬁre retardant), and 4-nonylphenol (nonionic detergent metabolite). Steroids, nonprescription drugs, and insect repellent were the chemical groups most frequently detected. Detergent metabolites, steroids, and plasticizers generally were measured at the highest concentrations.20 *Maximum values not shown: 17 Dana W. Kolpin et al., Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A National Reconnaissance, 35 Environmental Science & Technology 1202, (2002). The results of this study are summarized in Kimberlee K. Barnes et al., Water-Quality Data for Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999- 2000, U.S. Geological Survey, U.S. Dep't of the Interior, No. Open-File Report 02-94 (2002), available at http://toxics.
18 Kolpin et al., supra note 17, at 1203.
19 Id. at 1202 (citations omitted).
20 Herbert T. Buxton & Dana W. Kolpin, Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, United States Geological Society, Dep't of the Interior, FS-027-02, at 2 (2002), available at http://toxics.usgs.gov/pubs/FS-027-02/.
In 2001, Sedlak and Pinkston identiﬁed multiple prescription supplies "because antibiotic contaminants could perturb microbial drugs in wastewater.22 They estimated concentrations of such drugs in ecology, increase the proliferation of antibiotic-resistant pathogens, wastewater, concluding that the concentrations ranged from "less than and could pose threats to human health."25 Masters summarized 1 ng/L to approximately 133,000 ng/L."23 They went on to note: The estimated concentrations are distributed over a One of the dominating concerns is the creation of wide range with the majority of compounds estimated "Superbugs." New strains of bacteria which are resistant to be present at concentrations between 100 and 1,000 to antibiotics are common near major cities and in rural ng/L. In general, the compounds expected to be present areas and have been found in all 15 rivers from one study, at the highest concentrations consisted of analgesics including the Mississippi, the Ohio, and the Colorado. (e.g., acetominophen, ibuprofen) and antibiotics (e.g., As bacteria is exposed to antibiotics they begin to adapt amoxicillin, cephalexin). Because some of the analgesics in order to survive, not unlike some of the drug resistant . also are available as over-the-counter products, their staph infections which have developed in hospitals. This concentrations in wastewater could be considerably is a concern, but like so many of today's environmental higher. Compounds estimated to be present at the issues, more research is needed.26 lowest concentrations tended to be potent drugs such as Also, in 2001, Huang, et al., noted the presence in water supplies e.g., medroxyprogresterone, equilin).24 of antibiotics used in both human therapy27 and also in animal Of particular concern is the presence of antibiotics in water husbandry, speciﬁcally beef, swine, and poultry production.28 22 Sedlak & Pinkston, supra note 15.
23 Id. at 57. 24 Id. The pharmaceuticals that were identiﬁed suggest that a "larger suite of pharmaceuticals" may be present in water supplies. Id. 25 Ching-Hua Huang et al., Assessment of Potential Antibiotic Contaminants in Water and Preliminary Occurrence Analysis, 120 Water Resources Update 30, 31 (2001), (citing Christian G. Daughton & Thomas A. Ternes, Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change? 107 Environmental Health Perspectives 1 (1999)). Accord Elizabeth A. Frick et al., Presence of Pharmaceuticals in Wastewater Effluent and Drinking Water, Metropolitan Atlanta, Georgia, July-September 1999, in Proceedings of the Waer Resources Conference (Kathryn J. Hatcher ed.) (2001); Kelly A. Reynolds, Pharmaceuticals in Drinking Water Supplies, 45 Water Conditioning and Purification (2003), available at http://www.wcponline.com/column.cfm?T=T&ID=2199 [hereinafter Reynolds, Pharmaceuticals in Drinking Water Supplies].
26 Masters, supra note 6, at 1. Furthermore, "higher levels of antibiotic resistant bacterial strains [have been detected] downstream from a swine-feed facility, compared with upstream levels." Rapid Public Health Policy Response Project, School of Public Health and Health Services, The George Washington University, Pharmaceuticals are in the Drinking Water: What Does it Mean? 4 (2008) (citing Amy R. Sapkota et al., Antibiotic-Resistant Enterococci and Fecal Indicators in Surface Water and Groundwater Impacted by a Concentrated Swine Feeding Operation, 115 Environmental Health Perspectives 1040 (2007)). "Evidence suggests that exposure to subtherapeutic doses of antibiotics has resulted in a detectable increase in antibiotic resistance in some bacteria." Chad A. Kinney et al., Presence and Distribution of Wastewater-Derived Pharmaceuticals in Soil Irrigated with Reclaimed Water, 25 Environmental Toxicology and Chemistry 317, 323 (2006) (citing Rosamund J. Williams, & David L. Heymann, Containment of Antibiotic Resistance, 279 Science 1153 (1998); Wolfgang Witte, Medical Consequences of Antibiotic Use in Agriculture, 279 Science 996 (1998)). Accord Ken Carlson et al., Antibiotics in the Cache la Poudre River, Agronomy News, Dec. 2004, at 4.
27 "Antibiotics that are likely to be present in discharged municipal wastewater are primarily antibiotics used in human therapy." Huang et al., supra note 25, at 32.
28 As discussed in greater detail in Section VI, one of the challenges facing the use of statutory and regulatory mechanisms to address PPCPs in water supplies is the fact that both the presence of PPCPs and their concentrations vary substantially. With regard to the use of antibiotics in animal husbandry, this variability was noted by Huang, et al.: [C]onsiderable differences in antibiotic usage exist among different food animal species (beef vs. swine vs. poultry). Therefore, the types of antibiotic compounds that are likely to be found in surface water will strongly depend upon the types of livestock operations within the watershed.
Id. at 33. By 2002, it had been determined that "the amount of pesticides used each year."29 The principal emerging PPCPs and pharmaceuticals and personal care products (PPCPs) released their uses were summarized by Ellis:30 into the environment each year is tantamount to the amount of Table 1: Principal Emerging PPCP Compounds and Their Uses Pharmaceuticals Veterinary & human Trimethoprim, erytromycine, lincomycin, sultamethaxole, chloramphenicol, amoxycillin Analgesics & anti- Ibuprofen, diclofenac, fenoprofen, inflammatory drugs acetaminophen, naproxen, acetylsalicylic acid, fluoxetine, ketoprofen, indometacine, paracetamol Psychiatric drugs Diazepam, carbamazepine, primidone, salbutamol Clofibric acid, bezafibrate, fenofibric acid, etofibrate, gemfibrozil Metoprolol, propranolol, timolol, sotalol, atenolol Iopromide, iopamidol, diatrizoate Steroids & hormones Estradiol, estrone, estriol, diethylstilbestrol (DES) Personal care products Fragrances Nitro, polycyclic and macrocyclic musks; phthalates Sun-screen agents Benzophenone, methylbenzylidene camphor Insect repellents Triclosan, chlorophene It is quite probable that the speciﬁc PPCPs identiﬁed in these hydrologic systems.32 Furthermore, certain PPCPs (e.g., antibiotics occurrence studies have been in drinking water supplies for years.31 and estrogens) may "persist in the environment either due to their PPCPs, which are manufactured in large quantities, have chemical inability to biodegrade naturally or to their constant use keeping and physical properties that make it likely for them to end up in them ever present."33 29 Reynolds, Pharmaceuticals in Drinking Water Supplies, supra note 25.
30 J.B. Ellis, Pharmaceutical and Personal Care Products (PPCPs) in Urban Receiving Waters, 144 Environmental Pollution 184, 185 (2006).
31 "As long as humans use prescription medicines and over-the-counter drugs, we will ﬁnd trace amounts in wastewater, surface water, groundwater and drinking water." Global Water Research Coalition, GWRC Science Brief: Occurrence and Potential for Human Health Impacts of Pharmaceuticals in the Water System 1 (2009). Accord Reynolds, Pharmaceuticals in Drinking Water Supplies, supra note 25 ("it's reasonable to assume that as long as pharmaceuticals have been in use, they, and their metabolites, have contributed to the overall environmental contamination load").
32 Frick et al., supra note 25, at 282.
33 Kelly A. Reynolds, Concern of Pharmaceuticals in Drinking Water, 50 Water Conditioning & Purification (2008), available at The increased detection of PPCPs may be the result of them to occur at very low levels, frequently at parts per trillion dramatically improved testing equipment and procedures rather (picogram) or parts per billion (nanogram) levels.
than the result of any recent introduction of PPCPs into drinking water supplies.34 Such new testing equipment and procedures now allow for the detection of PPCPs at the nanogram,35 or even picogram,36 level. Until fairly recently, detection levels were at the microgram level.37 Furthermore, as noted by Schulman, There are any number of pathways by which humans can be exposed to PPCPs contained in water supplies. The most obvious al., "detection limits are likely to decrease in the future, as more sensitive analytical detection techniques become available."38 In means is the consumption of water containing PPCPs. Other types essence, while the detection of PPCPs has increased in frequency of water exposures (e.g., swimming, bathing, showering) may also as testing equipment and procedures have improved, the actual provide an exposure pathway.
presence of PPCPs may not have changed signiﬁcantly.39 Other exposure pathways are more indirect. Schulman, et al., Most of the occurrence studies that have detected PPCPs found note that certain PPCPs bioaccumulate in ﬁsh.40 The exposure http://www.wcponline.com/pdf/0804On_Tap.pdf [hereinafter Reynolds, Concern of Pharmaceuticals in Drinking Water]. In fact, the presence of PPCPs in water supplies has been suggested as a possible indicator of human fecal contamination of those water supplies. Susan T. Glassmeyer et al., Transport of Chemical and Microbial Compounds from Known Wastewater Discharges – Potential for Use as Indicators of Human Fecal Contamination, 39 Environmental Science & Technology 5157 (2005). Accord Y. Carrie Guo & Stuart Krasner, Occurrence of Primidone, Carbamazepine, Caffeine, and Precursors for N-Nitrosodimethylamine in Drinking Water Sources Impacted by Wastewater, 45 Journal of the American Water Resources Association, 58, (2009).
34 "[A]s analytical techniques grew more sensitive over the years, many more pharmaceuticals have been detected in ambient water, wastewater, and drinking water." ToxServices LLC, Approaches to screening for risk from Pharmaceuticals in Drinking Water and Prioritization for Further Evaluation 1 (2008). Accord American Water Works Association Research Foundation, supra note 16, at xxii ("The reality is that nearly any chemical known to man could be detected in water using the most modern and sensitive of analytical instrumentation"). See also Helen C. Poynton, & Chris D. Vulpe, Ecotoxicogenomics: Emerging Technologies for Emerging Contaminants, 45 Journal of the American Water Resources Association 83 (2009) (advances in analytical techniques).
35 A nanogram (ng) is one billionth of a gram (1 x 10-9). The detection level of such tests is expressed as parts per billion (ppb). One ppb is roughly equivalent to "one drop of water in an Olympic-sized swimming pool, or a single blade of grass in a football ﬁeld[.]" Rapid Public Health Policy Response Project, supra note 26, at 1.
36 A picogram (pg) is one trillionth of a gram (1 x 10-12). The detection level of such tests is expressed as parts per trillion (ppt). One ppt is roughly equivalent to one "drop of water in one thousand pools" or one "blade of grass in one thousand football ﬁelds". Rapid Public Health Policy Response Project, supra note 26, at 1.
37 A microgram (µg) is one millionth of a gram (1 x 10-6). The detection level of such tests is expressed as parts per million (ppm).
38 Schulman et al., supra note 13, at 669. Accord American Water Works Association Research Foundation, supra note 16, at xix ("considering the continued advancements in analytical technologies, today's non-detectable contaminants will be tomorrow's emerging contaminants").
39 As noted by the Global Water Research Coalition: We hear more reports about the presence of pharmaceuticals in water mainly because of improvements of the analytical methods of detection. What was not detectable in the past has become detectable today, even at very low concentrations. Global Water Research Coalition, supra note 31, at 1.
40 Schulman et al., supra note 13, at 659.
pathway, therefore, would be the human consumption of ﬁsh or of both "major and minor exposure pathways" and concluding that shellﬁsh containing PPCPs.41 future risk assessments for PPCPs aggregate exposure assessments across multiple pathways.42 This recognition was depicted In reality, there is seldom a single exposure pathway. The graphically by Ellis:43 National Research Council recognized this, noting the existence Figure 2: Sources and Pathways of PPCPs in the Urban Water Cycle : YMHJL>H[LY 41 Virginia L. Cunningham, Stephen P. Binks & Michael J. Olson, Human Health Risk Assessment from the Presence of Human Pharmaceuticals in the Aquatic Environment, 53 Regulatory Toxicology & Pharmacology 39, 43 (2009).; Ellis, supra note 30, at 185 (citing Betty Bridges, Fragrance: emerging health and environmental concerns, 17 Flavour & Fragrance Journal 361 (2002)); Ake Wennmalm & Bo Gunnarsson, Public Health Care Management of Water Pollution with Pharmaceuticals: Environmental Classification and Analysis of Pharmaceutical Residues in Sewage Water, 39 Drug Information Journal 291, 296 (2005).
42 Committee on Toxicants and Pathogens in Biosolids Applied to Land, Board on Environmental Studies and Toxicology, Division on Earth and Life Studies, National Research Council, Biosolids Applied to Land: Advancing Standards and Practices 13 (National Academies Press 2002). Accord Kolpin et al., supra note 17, at 1202 ("there are a wide variety of transport pathways for many different chemicals to energy and persist in environmental waters").
43 Ellis, supra note 30, at 186. It should not be assumed that these are the only pathways by which exposure to PPCPs occurs. With regard to estrogenicity, for example, the AwwaRF has noted: [V]egetable juice had observed EEq [estradiol equivalent] values from 1.9 to 3.3 ng/L, while coffee ranged from 11 to 17 ng/L. Various brands of beer exhibited a broad range of results with EEq values ranging from 0.8 to 140 ng/L. The highest estrogenicity was observed in soy-based food and beverage items such as soy sauce (28 – 510 ng/L), soy baby formula (1,500 – 1,900 ng/L) and soy milk (1,900 – 4,200 ng/L). *** Considering that food items are not labeled, or often even tested, for emerging contaminants, it is difﬁcult to argue that the choice of exposure from food is any less involuntary than would be exposure from tap water. … [F]or the pharmaceuticals and potential EDCs detected in water, exposure to people through water is expected to be small compared to exposures to potentially hazardous B.2. Effects of PPCPs in Water
been documented in the literature. In addition, because antibiotics are speciﬁcally designed to reduce bacterial Though research is ongoing, it does not appear that short-term populations in animals, even low-level concentrations in the exposure to speciﬁc PPCPs at the low levels noted above results in environment could increase the rate at which pathogenic adverse human health impacts.44 Unfortunately, the question of adverse bacteria develop resistance to these compounds.45 human or environmental health impacts resulting from PPCPs in water is not as simple as the foregoing conclusion might suggest.
Furthermore, Reynolds has observed that "[t]rends of increased testicular cancer, reproductive abnormalities, breast cancer, early puberty and decreased sperm count have all been suggested as B.2.1. Long-term Low-dose Exposures
problems possibly related to low-level exposure to chemicals As noted above, short-term exposure to low levels of speciﬁc (pharmaceuticals and EDCs) in the environment."46 Additional PPCPs does not appear to result in adverse human health impacts. research is needed regarding the effects of long-term, low-dose However, as Kolpin, et al., have noted: exposure to PPCPs.47 For many [organic wastewater contaminants], acute effects to aquatic biota appear limited because of the low B.2.2. Cumulative or Synergistic Effects
concentrations generally occurring in the environment. More subtle, chronic effects from low-level environmental Human and environmental exposures to PPCPs are never to exposure to select [organic wastewater contaminants] appear a speciﬁc PPCP. Such exposures are always to combinations of to be of much greater concern. Such chronic effects have compounds through prescription and nonprescription medications, food and beverages, occupational exposures, and residential activities (e.g., cleaning products, personal care products, hobby chemicals, pesticides). Moreover, the concentrations of some potential EDCs (e.g., plasticizers) are orders of magnitude greater in food products than in drinking waters[.] American Water Works Association Research Foundation, supra note 16, at xxii-xxiii. As Stanford, et al. have concluded, "the exposure to natural estrogens and other suspected EDCs from drinking water pales in comparison to exposure through other dietary routes. … [Furthermore,] compared with air exposure, water consumption by humans may represent only a small fraction of pharmaceutical, personal care products, and EDC exposure." Stanford et al., supra note 11, at 61, 63.
44 See, e.g., Schulman et al., supra note 13, at 669: The main ﬁnding of this study was that detected levels of the compounds of interest (parent compounds, acetylsalicylic acid, cloﬁbrate, cyclophosphamide, and indomethacin, as well as the metabolites, salicylic acid and cloﬁbric acid) in surface waters and drinking water, do not pose a risk to human health. The concentrations of each of these pharmaceuticals found in various environmental media to date, fall well below the provisional safe water quality limits derived, according to the [U.S. Environmental Protection Agency's Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000)]. Thus, no adverse health effects for humans are anticipated from the levels measured.
Accord Global Water Research Coalition, supra note 31, at 2 ("to date no deﬁnitive link between pharmaceutical exposure in drinking water and human health risk has been reported nor established"); Rapid Public Health Policy Response Project, supra note 26, at 1 ("At current levels, pharmaceutical residues are unlikely to pose an immediate risk to human health, but the long-term consequences of individual chemicals, and combinations of chemicals, are unknown, especially as concentrations rise.").
45 Kolpin et al., supra note 17, at 1208 (citations omitted).
46 Reynolds, Concern of Pharmaceuticals in Drinking Water, supra note 33, at 2.
47 "Although a wealth of toxicological information may be available for pharmaceuticals, the effects of unintended chronic exposure to subtherapeutic doses that could occur via consumption of drinking water are often not known." Erin M. Snyder et al., Pharmaceuticals and EDCS in the US Water Industry – An Update, 97 Journal of the American Water Works Association 32, 33 (2005). Accord Ellis, supra note 30, at 186. PPCPs, the impacts of which are relatively unknown.48 The issue of mixtures, that is the simultaneous presence of multiple pharmaceuticals, is an ever present question Combinations of PPCPs may have cumulative or synergistic for trace residual compounds of all types in drinking effects that go beyond the effects of any single PPCP. This led water supplies. The guidelines for "provisionally safe" Kolpin, et al., to conclude: or "acceptable intake" levels are calculated separately [A]dditional research on the toxicity of the target for individual compounds. However, the "worst case compounds should include not only the individual scenario" approach used in screening risk assessment [organic wastewater contaminants] but also mixtures of includes large uncertainty factors and safety factors these compounds. The prevalence of multiple compounds and is considered by regulatory and health authorities in water resources has been previously documented for (e.g., the World Health Organization in their Drinking other contaminants. In addition, research has shown Water Quality Guidelines) to be sufﬁcient to account for that select chemical combinations can exhibit additive or possible interactions among compounds a person might synergistic toxic effects, with even compounds of different be exposed to simultaneously.52 modes of action having interactive toxicological effects.49 Nevertheless, in addition to cumulative or synergistic effects, For example, in a study of the role of steroidal estrogens recent research suggests that PPCPs may become more persistent if in determining sex, the researchers noted that "strong natural they are combined. As Monteiro and Boxall have observed: estrogens at low doses may synergize with low doses of weak As pharmaceuticals will never be in the environment natural and man-made estrogens."50 This combination of low doses as single compounds, a consideration of the impacts of estrogen "may act synergistically to produce a strong estrogenic of mixtures of different pharmaceuticals and pharmaceuticals and other compounds needs to be Other research suggests that cumulative or synergistic effects assessed. Our preliminary data demonstrate that may not be a threat to human health: degradation may be signiﬁcantly slower in mixtures[.]53 48 "In ﬁeld situations, organisms are exposed to not just one compound but a mélange of contaminants, which can interact within the environment and individual organisms." Poynton & Vulpe, supra note 34, at 91. "[I]t is not clear what toxicological implications chronic exposure to suites of trace contaminants may pose." Mark J. Benotti et al., Pharmaceuticals and Endocrine Disrupting Compounds in U.S. Drinking Water, 43 Environmental Science & Technology 597 (2009) (emphasis added) (citing Oliver A. Jones et al., Pharmaceuticals: a Threat to Drinking Water, 23 Trends in Biotechnology 163 (2005); Shane A. Snyder et al., Pharmaceuticals, Personal Care Products, and Endocrine Disruptors in Water: Implications for the Water Industry, 20 Environmental Engineering Science 449 (2003)). "A limited body of research … suggests an additive effect when a mixture of pharmaceuticals is present." Rapid Public Health Policy Response Project, supra note 26, at 4 (citing Francesco Pomati et al., Effects and Interactions in an Environmentally Relevant Mixture of Pharmaceuticals, 102 Toxicological Sciences 129 (2008)).
49 Kolpin et al., supra note 17, at 1210. In a study of the effect on aquatic and terrestrial species of exposure to tricolsan and tricolcarban, Chalew and Halden concluded that "it appears prudent to consider the possibility of additive, antagonistic or synergistic effects from exposure to mixtures of the two." Talia E. Chalew & Rolf U. Halden, Environmental Exposure of Aquatic and Terrestrial Biota to Triclosan and Triclocarban, 45 Journal of the American Resources Association 4, 11 (2009). It has also been noted that "[m]ixtures of pharmaceuticals, which commonly occur in surface waters where discharges from municipal wastewater treatment plants ﬂow, may have cumulative effects on organisms." TDC Environmental, Household Pharmaeutical Waste: Regulatory and Management Issues 2 (2004) (citing S.M. Richards et al., Effects of pharmaceutical mixtures in aquatic microcosms, 23 Environmental Toxicology and Chemistry 1035 (2004)). See also Jessica G. Davis, Antibiotics in the Environment, 24(3) Agronomy News 1, 2 (2004) ("Degradation products and interactions among compounds have not been adequately evaluated and could result in synergistic toxic effects").
50 Judith M. Bergeron et al., Developmental Synergism of Steroidal Estrogens in Sex Determination, 107 Environmental Health Perspectives 93, 96 (1999).
52 Global Water Research Coalition, supra note 31, at 2. 53 Sarah C. Monteiro, & Alistair A.B. Boxall, Pharmaceuticals and Personal Care Products in the Environment: Factors Affecting the Degradation of Pharmaceuticals in Agricultural Soils, 28 Environmental Toxicology and Chemistry 2546, 2553 (2009).
For example, while the degradation of individual PPCPs Other groups such as the elderly, the inﬁrm, or the identiﬁed in Project 2 was relatively fast (half-lives of less than 30 immunocompromised may also be unusually susceptible.57 days), the presence of two PPCPs in a simple mixture increased the Research regarding the impacts of exposure to PPCPs on these and persistence of both PPCPs.54 other population segments or groups is ongoing.
B.2.3. Susceptible Groups
B.2.4. Environmental Health Impacts
Speciﬁc population segments or groups may be unusually Human beings are not exposed continuously to water susceptible to adverse effects from exposure to PPCPs. Children, supplies containing PPCPs. The same cannot be said for aquatic for example, are thought to be particularly susceptible as are species, which by their very nature are continuously exposed to pregnant women.55 As Collier has noted: water supplies containing PPCPs.58 Such species "are exposed continually, over many generations, to the higher concentrations [L]ong-term exposure to such chemicals, for example of pharmaceuticals that linger in surface water."59 This exposure in children, could potentially cause long-term changes may result in "endocrine disruptions, reproductive effects and renal affecting organ systems and/or structural function. In deterioration in ﬁsh, among other damage."60 addition, exposure to pharmaceuticals during the fetal period when many of the growth and development patterns For example, with regard to both ﬁsh and other aquatic for later life are laid down, may induce subtle changes that vertebrates, the low-level presence of pharmaceutical estrogens61 take years to manifest, but eventually have measurable leads to "a suite of adverse effects" including: physiological, morphological, or cognitive effects.56 • Feminization of males62 54 These results are discussed in greater detail in Section V.
55 Abby C. Collier, Pharmaceutical Contaminants in Potable Water: Potential Concerns for Pregnant Women and Children, 4 EcoHealth 164, 170 (2007). Collier makes reference to "the special populations of pregnant and pediatric individuals, where there is elevated risk from exposure to several drugs that are contraindicated and to which exposure should, ideally, be nil." Id. See also, Cunningham, Binks, & Olson, supra note 41, at 40; Reynolds, Pharmaceuticals in Drinking Water Supplies, supra note 25.
56 Collier, supra note 55, at 170.
57 Cunningham, Binks, & Olson, supra note 41, at 40.
58 "Exposure risks for aquatic organisms are much larger than those for humans[.]" Rapid Public Health Policy Response Project, supra note 26, at 4 (citing Environmental Protection Agency, Pharmaceuticals and Personal Care Products (PPCPS)).
59 Id. at 4 (citing Environmental Protection Agency, Pharmaceuticals and Personal Care Products (PPCPS)).
60 Id. at 4 (citing Larry B. Barber et al., Chemical Loading into Surface Water Along a Hydrological, Biogeochemical, and Land Use Gradient: A Holistic Watershed Approach, 40 Environmental Science & Technology 475 (2006); S.D. Richardson, Water Analysis: Emerging Contaminants and Current Issues," 79 Analytical Chemistry 4295 (2007); R. Triebskorn, Toxic Effects of the Non-Steroidal Anti-Inflammatory Drug Diclofenac Part II. Cytological Effects in Liver, Kidney, Gills and Intestine of Rainbow Trout (Oncorhynchus mykiss), 68 Journal of Aquatic Toxicology 151 (2004)).
61 Speciﬁcally, estrone (E1), 17-estradiol (E2), estriol (E3) and the synthetic estrogen, 17 ethinylestradiol.
62 Marlo K. Sellin et al., Estrogenic Compounds Downstream from Three Small Cities in Eastern Nebraska: Occurrence and Biological Effect, 45 Journal of the American Water Resources Associaton 14 (2009) (citing Gordon C. Balch et al., Feminization of Female Leukophore-Free Strain of Japanese Medaka (Oryzias latipes) Exposed to 17ß-Estradiol, 23 Environmental Toxicology and Chemistry 2763 (2004); F. Brion et al., Impacts of 17ß-Estradiol, Including Environmentally Relevant Concentrations, on Reproduction After Exposure During Embryo-Larval-, Juvenile- and Adult-Life Stages in Zebrafish (Danio rerio), 68 Aquatic Toxicology 193 (2004); G.H. Panter et al., Adverse Reproductive Effects in Male Fathead Minnows (Pimephales promelas) Exposed to Environmentally Relevant Concentrations of the Natural Oestrogens, Oestradiol and Oestrone, 42 Aquatic Toxicology 243 (1998)).
• Impaired reproductive capacity63 The effects of PPCPs in water resources may be felt throughout • Abnormal sexual development64 the food web. Chalew and Halden note that "[m]any of the investigated organisms are at the bottom of the food chain; These observations led Sellin, et al. to conclude that "the therefore, impacts to their populations, due to either die-off presence of estrogens in the aquatic environment, even at low from acute toxic exposures or failure to reproduce successfully as concentrations, is likely to pose a signiﬁcant threat to the health of a result of chronic exposures, may lead to adverse consequences aquatic organisms."65 throughout the ecosystem and food chain."67 However, they also note that "such a scenario at present is entirely speculative, since Such threats are not limited to the presence of low-levels of studies appropriate to probe for this outcome have not yet been pharmaceutical estrogens. Antidepressants, for example, may "trigger premature spawning in shellﬁsh while drugs designed to treat heart ailments block the ability of ﬁsh to repair damaged ﬁns."66 63 Sellin et al., supra note 62, at 14-15 (citing Shoko Imai et al. Effects of 17ß-Estradiol on the Reproduction of Java-Medaka (Oryzias Javanicus), a New Test Fish Species, 51 Marine Pollution Bulletin 708 (2005); F. Brion et al., Impacts of 17ß-Estradiol, Including Environmentally Relevant Concentrations, on Reproduction After Exposure During Embryo-Larval-, Juvenile- and Adult-Life Stages in Zebrafish (Danio rerio), 68 Aquatic Toxicology 193 (2004); Tsutomu Shioda & Meiko Wakabayashi, Effect of Certain Chemicals on the Reproduction of Medaka (Oryzias latipes), 40 Chemosphere 239 (2000); V.J. Kramer et al., Reproductive Impairment and Induction of Alkaline-Labile Phosphate, a Biomarker of Estrogen Exposure, in Fathead Minnows (Pimephales Promelas) Exposed to Waterborne 17ß-Estradiol, 40 Aquatic Toxicology 335 (1998)). Accord Poynton & Vulpe, supra note 34 (citing Karen A. Kidd et al., Collapse of a Fish Population After Exposure to a Synthetic Estrogen, 104 Proceedings of the National Academy of Sciences of the United States of America 8897 (2007) (17 ethynylestradiol has been shown "to cause sublethal effects in fathead minnow leading to population decline at very low concentrations")); Heiko L. Schoenfuss et al., Effects of Exposure to Low Levels of Water-Borne 17-Estradiol on Nest Holding Ability and Sperm Quality in Fathead Minnows, 120 Water Resources Update 49 (2001). While exposure to 17ß-estradiol did not result in long-term changes in sperm quality, the authors noted that 17-estradiol "is but one of many estrogenic compounds that have been found in [sewage treatment plant] efﬂuent, and the overall estrogenic potency of the efﬂuent could be much greater than simulated in this experiment." Id. at 52. See also Schulman et al., supra note 13, at 676.
64 Sellin et al., supra note 62, at 15 (citing Narisato Hirai et al., Feminization of Japanese Medaka (Oryzias latipes) Exposed to 17beta-Estradiol: Formation of Testis-Ova and Sex-Transformation During Early-Ontogeny, 77 Aquatic Toxicology 78 (2006); Henrik Holbech et al., Detection of Endocrine Disrupters: Evaluation of a Fish Sexual Development Test (FSDT), 144C Comparative Biochemistry and Physiology 57 (2006); W.R. Hartley et al., Gonadal Development in Japanese Medaka (Oryzias latipes) Exposed to 17ß-Estradiol, 46 Marine Environmental Research 145 (1998)).
66 Reynolds, Pharmaceuticals in Drinking Water Supplies, supra note 25.
67 Chalew & Halden, supra note 49, at 10.
68 Id. The need for "appropriate" studies has been noted frequently. For example, Poynton & Vulpe have observed: For many emerging contaminants, their toxicity to aquatic organisms is largely unknown. Even pharmaceuticals, which undergo extensive testing in mammalian models, may exhibit different toxicity on aquatic species. In addition, many pharmaceuticals and EDCs are not responsive to traditional toxicity assays that measure lethality or reproduction over a single generation and are requiring regulatory agencies to rethink testing requirements. This could also be true for other emerging chemicals including PBDEs [polybrominated diphenyl ethers] and nanomaterials whose mechanism of action is not known. Poynton & Vulpe, supra note 34, at 84 (citing Mark C. Crane et al., Chronic Aquatic Environmental Risks From Exposure to Human Pharmaceuticals, 367 Science of the Total Environment 23 (2006); Leon E. Gray, Jr. Tiered Screening and Testing Strategy for Xenoestrogens and Antiandrogens, 102-103 Toxicology Letters 677 (1998); John P. Sumpter, & Andrew C. Johnson, Lessons From Endocrine Disruption and Their Application to Other Issues Concerning Trace Organics in the Aquatic Environment, 39 Environmental Science & Technology 4321 (2005)).
The presence of antibiotics in water supplies may also reduce There are, of course, some naturally occurring sources of the growth of aquatic plants.69 In essence, "since pharmaceuticals PPCPs. These sources appear as background amounts, not as major is one of the few chemical classes intended to be bioactive, they are PPCP sources. The major sources of PPCPs are anthropogenic.71 potentially harmful to the aquatic ﬂora and fauna."70 Assuming the use of pharmaceuticals, personal care products, dietary supplements, and other consumer products, PPCPs are contained in human and animal feces and urine. They are B.3. Sources of PPCPs in Water
also commonly contained in hospital or medical wastes and in the wastes from industrial and agricultural processes. Another An understanding of the sources of PPCPs in water is essential for common source of PPCPs is unwanted pharmaceuticals and two reasons. First, as discussed in greater detail in the following personal care products that are disposed of inappropriately (i.e., section, different statutory and regulatory requirements apply to by being ﬂushed down toilets.)72 Pharmaceuticals used in the different sources of PPCPs. Second, as discussed in greater detail in fruit production industry are yet another source of PPCPs,73 as is Section IV, potential alternative strategies leading to the minimization leachate from landﬁlls74 and urban runoff.75 PPCPs may also be or elimination of PPCPs in water may be source-speciﬁc.
rinsed from a person's body during bathing.76 69 TDC Environmental, supra note 49, at 2 (citing Richard A. Brain et al., Effects of 25 pharmaceutical compounds to Lemna gibba using a seven-day static-renewal test, 23 Environmental Toxicology and Chemistry 371 (2004)).
70 Wennmalm & Gunnarsson, supra note 41, at 291. Accord Ellis, supra note 30, at 188 ("The persistent, long-term chronic exposure of aquatic organisms to low-dose PPCP concentrations although individually at or below the [Probable No-Effects Concentration] level, may well lead to cumulative stress and toxicity which could be a catalyst for subtle endpoint ecological changes.").
71 With regard to EDCs, for example, see Ed Means, Amlan Ghosh & Zaid Chowdhury, Endocrine Disruptors and Pharmaeceuticals Strategic Initiative Expert Workshop Report (Awwa Research Foundation 2007), ("while some estrogenic compounds occur naturally, nost of the detected estrogenic compounds are introduced from man-made sources"). See also Dore Hollander, Environmental Effects on Reproductive Health: The Endocrine Disruption Hypothesis, 29 Family Planning Perspectives 82, 83 (2007): Endocrine disrupters, some of which occur naturally (phytoestrogens) and some of which are man-made, are ubiquitous: They can be found in soil, water, air and food, as well as in commonly used industrial and household products. Phytoestrogens are present in grains, legumes, grasses, herbs, nuts and a variety of fruits and vegetables; some fungi also produce compounds that may interfere with hormonal function. Phytoestrogens are weaker than endogenous estrogen (i.e., they do not bind as well to hormone receptors) and are quickly excreted or broken down into other compounds; they do not accumulate in body tissue.
72 Paul D. Anderson et al., Screening Analysis of Human Pharmaceutical Compounds in U.S. Surface Waters, 38 Environmental Science & Technology 838 (2004). Accord Ellis, supra note 30, at 185.
73 Thomas Heberer et al., Occurrence and Fate of Pharmaceuticals During Bank Filtration - Preliminary Results From Investigations in Germany and the United States, 120 Water Resources Update 4, 5 (2001) [hereinafter Heberer et al., Pharmaceuticals During Bank Filtration].
74 Benotti et al., supra note 48. Accord Reynolds, Pharmaceuticals in Drinking Water Supplies, supra note 25.
75 Juliane B. Brown, William A. Battaglin & Robert E. Zuellig, Lagrangian Sampling for Emerging Contaminants Through an Urban Stream Corridor in Colorado, 45 Journal of the American Water Resources Association 68 (2009); Benotti et al., supra note 48.
76 Snyder et al., supra note 47, at 32. B.4. Processes or Mechanisms by Which PPCPs are
the treated water discharged into a receiving stream or lake78 Introduced Into Water Supplies
and the residual sludge79 will contain varying levels of PPCPs. Consequently, it is not surprising that a number of studies have There are numerous processes or mechanisms by which PPCPs noted the increased presence of PPCPs in receiving waters are introduced into water supplies.77 With regard to the sources downstream of wastewater treatment plants.80 As discussed in of PPCPs noted above, a substantial portion of human wastes greater detail in Section V, treated wastewater used for agricultural are treated at wastewater treatment plants. Following wastewater and landscape irrigation may also contain PPCPs.81 treatment plant processing, treated water may be discharged into a receiving stream or lake.
In fact, only a portion of the wastes collected by sanitary sewers may actually be treated at wastewater treatment plants. Typically, residual sludge contained in the processing tanks Depending on the condition of the sewer system, a signiﬁcant of the wastewater treatment plant is removed and disposed portion of collected wastes may be lost through cracks or breaks of pursuant to the regulations discussed in Section III. Both in sewer lines. In areas where storm drains and sanitary sewers 77 "Pharmaceutical compounds are introduced into the environment through a number of different pathways, including excretion of the parent compound, active ingredients, water soluble conjugates, or metabolites via urine and feces after therapeutic home and hospital use, and through disposal of unused pharmaceuticals by patients or providers via landﬁlls and sewers." Schulman et al., supra note 13, at 658 (citing N.J. Ayscough et al., The Environment Agency Research and Development Dissemination Centre, Review of Human Pharmaeuticals in the Environment 106 (2000)). Accord Janice M. Skadsen et al., The Occurrence and Fate of Pharmaceuticals, Personal Care Products and Endocrine Disruption Compounds in a Municipal Water Use Cycle: Case Study in the City of Ann Arbor 2 (2004), available at http://www.a2gov.org/government/publicservices/water_treatment/Documents/EndocrineDisruptors.pdf ("the potential exists for PPCPs to enter the environment from multiple routes, such as, wastewater treatment discharge, industrial discharge, runoff from conﬁned animal feeding operations, and treated sludge applied to agricultural land…PPCPs may enter the treatment process in a reduced form (after passing through body) or by direct discharge of discarded PPCPs") (citing Christian G. Daughton & Thomas A. Ternes, Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change? 107 Environmental Health Perspectives 1 (1999)).
78 Treated wastewater frequently contains "antioxidants, detergents and detergent metabolites, disinfectants, ﬁre retardants, fragrances, insect repellants, pharmaceuticals (prescription and nonprescription drugs), pesticides, plasticizers, polycyclic aromatic hydrocarbons, and steroidal compounds[.]" Brown, Battaglin, & Zuellig, supra note 75, at 69-70. Such wastewater "has been shown to contain low, yet biologically active, concentrations of estrogenic compounds." Sellin et al., supra note 62, at 15 (citing Marta Carballa et al., Behavior of Pharmaceuticals, Cosmetics and Hormones in a Sewage Treatment Plant, 38 Water Research 2918 (2004); Andrew C. Johnson & John P. Sumpter, Removal of Endocrine-Disrupting Chemicals in Activated Sludge Treatment Works, 35 Environmental Science & Technology 4697 (2001); Chiara Baronti et al., Monitoring Natural and Synthetic Estrogens at Activated Sludge Sewage Treatment Plants and in a Receiving River Water, 34 Environmental Science & Technology 5059 (2000)). See also Chalew & Halden, supra note 49, at 7; Kinney et al., supra note 26, at 317 (citing Christian G. Daughton, & Thomas A. Ternes, Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change? 107 Environmental Health Perspectives 907 (1999)).
79 "In biosolids destined for land application, a number of pharmaceuticals and personal care products have been detected." Monteiro & Boxall, supra note 53, at 2546 (citing Chad A. Kinney et al., Survey of Organic Wastewater Contaminants in Biosolids Destined for Land Application, 40 Environmental Science & Technology 7207 (2006); Chris D. Metcalfe, Distribution of Acidic and Neutral Drugs in Surface Waters Near Sewage Treatment Plants in the Lower Great Lakes, Canada, 22 Environmental Toxicology and Chemistry 2881 (2003)). See also M. Silvia Diaz-Cruz et al., Environmental Behavior andAanalysis of Veterinary and Human Drugs in Soils, Sediments, and Sludge, 22 Trends in Analytical Chemistry 340 (2003).
80 Sellin et al., supra note 62, at 18 (greatest quantities of estrogens found in surface water downstream of wastewater treatment plants). "[P]harmaceutical and PPCP residues have been detected in ﬁsh tissues downstream of wastewater treatment facilities leading to bioaccumulation in muscles and critical organs." Poynton & Vulpe, supra note 34, at 84 (citing Bryan W. Brooks et al., Determination of Select Antidepressants in Fish From an Effluent-Dominated Stream, 24 Environmental Toxicology and Chemistry 464 (2005); J. Schwaiger et al., Toxic Effects of the Non-steroidal Anti-inflammatory Drug Diclofenac. Part 1: Histopathological Alterations and Bioaccumulation in Rainbow Trout, 68 Aquatic Toxicology 141 (2004)). Accord Brown, Battaglin, & Zuellig, supra note 75.
81 Kinney et al., supra note 26. Accord Benotti et al., supra note 48.
are combined, signiﬁcant rainfall events may produce quantities If the surface water is diverted subsequently for use as water of wastes that exceed the capacity of the wastewater treatment supply, a portion of the PPCPs contained in the raw water supply plant.82 These "combined sewer overﬂows" (CSOs) are frequently will end up in the drinking water supply. If surface water is used to discharged into surface waters with little or no treatment, resulting recharge groundwater, or if the surface stream is a "losing" stream in "elevated concentrations of bacteria, nutrients, and OWCs that recharges groundwater, PPCPs in the surface stream may end [organic wastewater compounds] in receiving waters."83 As a up in the groundwater.85 If the sludge from the processing tanks is result, untreated sewage "derived from leaky sewers and CSOs applied to land, a common disposal method in the United States . . may have a disproportionately large effect on concentrations for wastewater treatment plant sludge,86 then rain or melting snow of compounds that are well removed by wastewater treatment will allow the PPCPs to be absorbed into soils87 and to inﬁltrate processes (such as caffeine and ibuprofen)."84 82 With regard to such weather events, Wu et al. have noted that the release of bacteria (and presumably PPCPs) trapped in sediments may result from "sediment resuspension caused by storms, ﬂood, tides, or strong winds[.]" Jianyong Wu et al., Fate and Transport Modeling of Potential Pathogens: The Contribution from Sediments, 45 Journal of the American Water Resources Association 35, 36 (2009) (citing R.W. Muirhead et al., Faecal Bacteria Yields in Artificial Flood Events: Quantifying In- Stream Stores, 38 Water Research 1215 (2004); R.C. Jamieson et al., Resuspension of Sediment- Associated Escherichia Coli in a Natural Stream, 34 Journal of Environmental Quality 581 (2005)). On a related point, Guo and Krasner have noted a relationship between climatic variability and the variable presence of PPCPs in water resources. Guo & Krasner, supra note 33, at 64 (reduced instream ﬂow during dry years resulting in less dilution of wastewater treatment plant outﬂows).
83 P. Phillips, & A. Chalmers, Wastewater Effluent, Combined Sewer Overflows, and Other Sources of Organic Compounds to Lake Champlain, 45 Journal of the American Water Resources Association 45, 46 (2009). Accord Brown, Battaglin, & Zuellig, supra note 75, at 70 (storm drains as a source of PPCPs).
84 Phillips & Chalmers, supra note 83, at 46 (citing Lorien J. Fono, & David L. Sedlak, Use of the Chiral Pharmaceutical Propranol to Identify Sewage Discharges Into Surface Waters, 39 Environmental Science & Technology 9244 (2005)).
85 Thomas Heberer et al., Removal of Pharmaceutical Residues and Other Persistent Organics From Municipal Sewage and Surface Waters Applying Membrane Filtration, 120 Water Resources Update 18, 19 (2001) [hereinafter Heberer et al., Removal of Pharmaceutical Residues] (citations omitted).
86 See Committee on Toxicants and Pathogens in Biosolids Applied to Land, supra note 42, at 1 ("Approximately 5.6 million dry tons of sewage sludge are used or disposed of annually in the United States; approximately 60% of that is used for land application."). See also Xia et al., supra note 4, at 47 ("Biosolids land application is becoming the most common means of biosolids disposal as other disposal options become cost prohibitive or heavily regulated").
87 Lozano, et al., have observed that tricolsan (TCS, "an antimicrobial compound that is added to a wide variety of household and personal care products") "may be accumulated by earthworms after land application of biosolids." Nuria Lozano et al., Fate of Triclosan in Agricultural Soils After Biosolid Applications, 78 Chemosphere 760 (2010) (citing Chad A. Kinney et al. Bioaccumulation of Pharmaceuticals and Other Anthropogenic Waste Indicators in Earthworms from Agricultural Soil Amended with Biosolid or Swine Manure, 42 Environmental Science & Technology 1863 (2008)). The potential consequences of such bioaccumulation are of note: Since TCS is a bacteriostat, there is a real potential that concentrations in soils resulting from biosolid applications might affect bacterial ecology of these systems. Especially since the ecological balance and competitive advantages of the multiple species inhabiting any soil environment are very complex and any small advantage one microbe might achieve due to exposure to these known bacteriostat could be ampliﬁed under these conditions. Id. at 764 (2010). The sorption and degradation of PPCPs in soil is discussed in greater detail in Section V.
88 Concluding that several pharmaceutically active compounds "can be transported through the subsoil without any substantial attenuation[,]" Heberer et al. focused on cloﬁbric acid, "the pharmacologically active metabolite of the drugs cloﬁbrate, etofyllin cloﬁbrate, and etoﬁbrate, used as blood-lipid regulators in human health care." Heberer et al., Pharmaceuticals During Bank Filtration, supra note 73, at 6-7. [B]etween 1992 and 1995, cloﬁbric acid … was detected at concentrations at the µg/Llevel in ground water samples collected The presence of PPCPs in groundwater has also been detected way into groundwater.93 Of particular concern are both the land in areas where human wastes are treated using septic tank application of manure and the collection of liquid wastes in lagoons systems.89 Human wastes containing PPCPs that ﬂow into septic or ponds associated with Conﬁned Animal Feeding Operations.94 tanks will eventually ﬂow into groundwater.
Because of the widespread use of antibiotics in animal husbandry,90 PPCPS are also present in the feces and urine of a C. Current Means of Protecting Water wide variety of domesticated animals. Manure produced by such animals will contain PPCPs. As with the sludge from wastewater C.1. Common Law Remedies Sounding in Tort
treatment plants, manure is frequently applied to land as a waste The word "tort" is derived from the Latin disposal mechanism. Also as with wastewater treatment plant tortus meaning bent or crooked. Torts are private acts of civil wrongs in which an sludge, rain or melting snow will cause PPCPs contained in injured plaintiff seeks compensation from an allegedly responsible manure to ﬂow into groundwater.91 defendant. There are four tort theories, each of which is potentially Much like septic tank systems but on a larger scale, liquid applicable to injuries allegedly relating to exposure to PPCPs. wastes from domesticated animals may be collected in lagoons or It should be noted, however, that application of any of the four ponds.92 These impoundments are quite effective in providing a theories, either individually or in combination with one another, means by which PPCPs contained in liquid wastes can ﬁnd their will be dependent on the facts of a speciﬁc case.
from former sewage irrigation ﬁelds near Berlin and in Berlin tap-water samples. It became evident that these residues were caused by the inﬁltration of sewage efﬂuents into the soil and that cloﬁbric acid is a very mobilecompound that is not substantially adsorbed in the subsoil and is leached easily into the aquifer. … In Germany, the ﬁrst detections of cloﬁbric acid in ground water put focus on the presence of drug residues in the aquatic system as a new emerging issue andresearchers began to investigate the occurrence and fate of pharmaceutical residues in the aquatic environment, during drinking-water puriﬁcation, and in drinking water samples. Id. at 6 (citing T. Heberer & H.J. Stan, Vorkommen von polaren organischen Kontaminanten im Berliner Trinkwasser, 86 Vom Wasser 19 (1997); T. Heberer & H. J. Stan, Determination of Clofibric Acid and N-(Phenylsulfonyl)-sarcosine in Sewage, River and Drinking Water, 67 International Journal of Analytical Chemistry 113 (1996); Umweltbundesamt, Sachstandsbericht ZU Auswirkungen der Anwendung von ClofibrinsÄure und anderen Arzneimitteln auf die Umwelt und die Trinkwasserversorgung. (Umweltbundesamt 1996)). See also Huang et al., supra note 25, at 33 ("Land application of animal waste provides routes for agricultural antibiotics to enter the aquatic environments, which may eventually reach drinking water supplies").
89 Rapid Public Health Policy Response Project, supra note 26, at 1. Accord Kinney et al., supra note 26.
90 "About 90 percent of the approximately 2.5 million kg of antibiotics sold in the United States are given as growth-promoting and prophylactic agents in sub-therapeutic doses instead of being used to treat active infections, thereby lowering the cost of animal care." Heberer et al., Pharmaceuticals During Bank Filtration, supra note 73, at 10 (citing Dana Kolpin et al., Pharm-Chemical Contamination – Reconnaissance for Antibiotics in Iowa Streams, 1999, in Effects of Animal Feeding Operations on Water Resources and the Environment. Proceedings of the Technical Meeting, Fort Collins, Colorado, August 30-September 1, 1999 (Franceska D. Wilde et al. eds., U.S. Geological Survey 2000)). Accord Reynolds, Concern of Pharmaceuticals in Drinking Water, supra note 33, at 1 ("40 percent of antibiotics manufactured are fed to livestock as growth enhancers").
91 Heberer et al., Pharmaceuticals During Bank Filtration, supra note 73, at 6. Accord Davis, supra note 49.
92 "Researchers have shown that several classes of antibiotics (e.g., tetracyclines, sulfonamides, macrolides and ionophores) are present in hog waste lagoons at concentrations as high as 0.7 mg/L." Carlson et al., supra note 26, at 4. 93 Heberer et al., Pharmaceuticals During Bank Filtration, supra note 73, at 10.
94 Benotti et al., supra note 48. See also, Ken Carlson et al., Antibiotics in Animal Waste Lagoons and Manure Stockpiles, Agronomy News, Dec. 2004, at 7 ("a wide range of antibiotics is present in most animal waste streams, either runoff ponds, waste lagoons or manure stockpiles"); Heberer et al., Pharmaceuticals During Bank Filtration, supra note 73, at 10; Masters, supra note 6. Public nuisances result where a defendant (a) offended accepted community principles of decency or (b) interfered with the use There are three elements for establishing a claim under the of public highways, streams, parks, beaches or other facilities.99 theory of trespass. First, the plaintiff must have been harmed.95 Private nuisances result where the defendant (a) substantially Second, the defendant's conduct must be shown to have been interfered with the plaintiff 's use and enjoyment of property or (b) the cause of the plaintiff 's harm. Third, it must be proven that injured the plaintiff.100 the defendant intentionally (a) entered land in the possession of the plaintiff (or caused something or someone else to do so); (b) remained on the plaintiff 's land; or (c) failed to remove from the plaintiff 's land "a thing which he is under a duty to remove."96 In the case of personal property (trespass to chattels), an alternative There are ﬁve elements to the theory of negligence, all of which third element is applicable where it can be shown that the must be established to raise a claim against a defendant. First, defendant intentionally interfered with the plaintiff 's personal the plaintiff must have been harmed. Second, the evidence must property by (a) damaging the personal property; (b) depriving the show that the defendant's conduct was the cause of the plaintiff 's plaintiff of the use of the property for a substantial period of time; harm. Third, it must be established that the defendant owed a duty or (c) "dispossessing" the property from the plaintiff.97 With regard of reasonable care to the plaintiff.101 Fourth, the plaintiff must to the requirement of intentionality, individuals are generally evidence that the defendant breached the duty of reasonable care. presumed to know the "natural consequences" of their actions.98 Fifth, the harm to the plaintiff resulting from the breach must be shown to have been foreseeable.102 Of particular relevance is the duty of reasonable care. The standard of care is frequently expressed as the question: What As with the theory of trespass, there are three elements would a reasonably prudent person have done? It is noteworthy necessary to raise a claim under the theory of nuisance. First, the that professionals, because of both education and licensing plaintiff must establish that she was harmed. Second, the evidence requirements, are usually held to a higher standard of care than must show that the defendant's conduct was the cause of the non-professionals.103 Corporations, because of superior knowledge plaintiff 's harm. Third, it must be established that the defendant's regarding speciﬁc products, may also be held to a higher standard intentional actions constituted either a public or a private nuisance. of care than the general citizenry.104 95 Restatement (Second) of Torts §§ 158, 162, 901, 907 (1979). The plaintiff does not have to show harm for the defendant to be liable for trespass. However, the plaintiff would have to show harm to receive compensatory damages, though there are other remedies, such as nominal damages, that do not require a showing of harm.
96 Id. §158 . As noted in the Restatement, the protected property interest of the plaintiff is the right of "exclusive possession and physical condition of land." Id. § 157.
97 Id. §§ 217-18.
98 Francis v. Franklin, 471 U.S. 307, 311 (1985) ("A person of sound mind and discretion is presumed to intend the natural and probable consequences of his acts …").
99 See State v. H. Samuels Co., 211 N.W.2d 417 (Wis. 1973) (holding that a violation of a noise ordinance may constitute nuisance).
100 Restatement (Second) of Torts, supra note 96, at § 821D.
101 Reasonableness may be deﬁned in permit conditions or by industry custom/practice. Violation of permit conditions or other statutory or regulatory requirements is almost always negligence per se. See, e.g., Sammons v. Ridgeway, 293 A.2d 547 (Del. 1972) (holding that the violation of a statute is negligence per se).
102 See, e.g., Palsgraf v. Long Island R.R. Co., 162 N.E. 99 (N.Y. 1928).
103 See, e.g., Blair v. Eblen, 461 S.W.2d 370 (Ky. 1970) (holding that a doctor is under a duty to use that degree of care and skill which is expected of a reasonably competent doctor in the same class to which he belongs).
104 See, e.g., Binder v. Jones & Laughlin Steel Corp., 520 A.2d 863 (Pa. Super. Ct. 1987) (holding that manufacturer had an afﬁrmative duty to warn of risk due to its knowledge of the product's properties).
C.1.4. Strict Liability
C.2. Protection of Surface Water Quality: The
There are three elements to the theory of strict liability. The Clean Water Act
ﬁrst two are the same as for negligence, namely that the evidence The Clean Water Act (CWA) was intended to restore and show that the plaintiff was harmed, and the defendant's conduct maintain the chemical, physical and biological integrity of the was the cause of plaintiff 's harm. The third element requires a nation's water resources. 109 As enacted by Congress, the CWA showing that the defendant either engaged in an "abnormally imposes a number of requirements intended to achieve these dangerous activity" or manufactured an inherently dangerous objectives. Initially, states are authorized to designate water quality standards or allowable uses of rivers located within the state.110 This designation may be in terms of water quality standards to A number of factors must be considered in determining whether be maintained in the river, in terms of allowable uses, or both.111 the defendant's activities are abnormally dangerous. These include However, these standards or designated uses, which are subject to (a) a high degree of risk or harm; (b) the gravity of the harm; (c) EPA approval, 112 must be based on the National Recommended the possibility of eliminating the risk with reasonable care; (d) Water Quality Criteria.113 whether the activity is in common usage; (e) the appropriateness of the activity for the location where it occurred; and (f) the value of If a state chooses to utilize water quality standards, the standards the activity to the community. 106 If the defendant is engaged in an must include total maximum daily loads (TMDLs) for those pollutants abnormally dangerous activity, the defendant may be held strictly that are amenable to maximum daily load measurement.114 As discussed liable for injuries resulting to the plaintiff irrespective of the degree below, TMDLs are to be a part of state water quality standards of care exercised by the defendant. 107 applicable to the issuance of discharge permits.
As suggested above, the defendant may also be strictly liable Once water quality standards or designated uses have been for injuries to the plaintiff resulting from an inherently dangerous approved, implementation is carried out through the National product manufactured by the defendant. Products may be Pollutant Discharge Elimination System (NPDES) permit inherently dangerous due to design defects, manufacturing defects, system.115 This system allows companies, governmental units, or marketing defects. 108 and other entities to obtain an NPDES permit for the discharge 105 See Caporale v. C.W. Blakeslee & Sons, Inc., 175 A.2d 561 (Conn. 1961) (holding that construction under the circumstances was "intrinsically dangerous").
106 See RESTATEMENT (SECOND) OF TORTS, supra note 96, at § 402A.
107 See Rylands v. Fletcher, UKHL 1 (United Kingdom House of Lords Decisions, 1868) (mill owner who constructed a reservoir was liable without fault when the reservoir failed and ﬂooded an adjoining mine; mill owner was liability without fault for collecting "anything likely to do mischief if it escapes"). See also Caporale, 175 A.2d at 564.
108 See Saupitty v. Yazoo Mfg. Co., 726 F.2d 657 (10th Cir. 1984) (holding that a lawnmower as designed was inherently dangerous); MacPherson v. Buick Motor Co., 111 N.E. 1050 (N.Y. 1916) (ﬁnding that defects in the manufacture of a motor vehicle rendered it inherently dangerous); Dunham v. Vaughn & Bushnell Mfg. Co., 247 N.E.2d 401 (Ill. 1969) (holding that a hammer was inherently dangerous when used as advertised).
109 Clean Water Act, Pub. L. No. 92-500, 86 Stat. 816 (1972) (codiﬁed as amended at 33 U.S.C. § 1251 et seq. (2006)).
110 See 40 C.F.R. § 130.0 (2010).
111 PUD No. 1 of Jefferson County v. Washington Dep't of Ecology, 511 U.S. 700 (1994).
112 See WESTVACO v. EPA, 899 F.2d 1383 (4th Cir. 1990). Such standards or designated uses may also be subject to EPA disapproval. Id.
113 33 U.S.C. §§ 1313-1314.
114 § 130.4.
115 CWA § 1342. 116 40 C.F.R. § 230.3(s) (2010).
of efﬂuent from a point source into "waters of the United on public water systems. The National Primary Drinking Water States."116 Absent an NPDES permit, such discharges are strictly Regulations, one of the primary enforcement mechanisms of the SDWA, apply to community water systems.124 Noncommunity or transient water systems are smaller systems that usually rely on NPDES permits contain speciﬁc provisions regarding the type of waste treatment technology required and the type and concentration of materials to be discharged.118 For existing facilities, the general requirement is Best Cost-Reasonable C.3.1. National Primary Drinking Water
Technology (BCT).119 For new facilities, the requirement is Best Available Technology.120 The National Primary Drinking Water Regulations are health-based standards for drinking water supplied by public water systems.125 These regulations are without exceptions. They apply C.3. Protection of Groundwater and Surface Water
to contaminants that have been determined to pose public health Quality: The Safe Drinking Water Act
risks and are expressed in terms of Maximum Contaminant Levels The primary objective of the Safe Drinking Water Act (MCLs).126 In general, "Best Available Technology" is required, (SDWA) is to identify, monitor, and control contaminants though cost is taken into consideration. 127 The technology in drinking water.121 The SDWA is also intended to provide should result in a discharge as close as possible to the Maximum an enforcement mechanism, provide for the collection and Contaminant Level Goal (MCLG).128 dissemination of water-related information, and provide funding mechanisms to upgrade water supply systems.122 Both MCLs and MCLGs are to be based on human health effects. Risk assessments are to be used to determine these effects. As with many environmental statutes, implementation of In conducting such assessments, EPA is to utilize "the best the SDWA is an example of cooperative federalism. States have available, peer-reviewed science and supporting studies conducted primary enforcement authority once the state SDWA program has in accordance with sound and objective scientiﬁc practices"129 and been approved by the EPA.123 SDWA requirements focus primarily "data collected by accepted methods or best available methods (if 117 See id.
118 Id. § 1342(p)(3).
119 40 C.F.R. § 125.3.
120 Id. EPA has issued New Source Performance Standards mandating the use of "best available demonstrated control technology" for a number of industrial categories.
121 Safe Drinking Water Act (SDWA), Pub. L. No. 93-523, 88 Stat. 1660 (codiﬁed as amended at 42 U.S.C. § 300f (2006)); Daniel J. Kucera, Safe Drinking Water Act, in Environmental Law Handbook 437, 439 (Thomas F.P. Sullivan ed., Government Institutes 19th ed. 2007).
122 Kucera, supra note 121, at 439-40.
123 Id. at 440.
124 Community water systems are systems having at least 15 taps or providing service to at least 25 individuals. SDWA § 300f(15).
125 40 C.F.R. § 141.1 et seq .(2010). The National Primary Drinking Water Standards include 85 standards divided into six categories: disinfectants, disinfection byproducts, inorganic chemicals, microorganisms, organic chemical, and radionuclides. Id.
126 SDWA § 300g-1(b)(1). MCLs may also be expressed in terms of treatment techniques if it is impossible to establish an MCL (i.e., difﬁculty in measuring or uncertainty regarding appropriate exposure limits). Id. § 300g-1(b)(7).
127 See id. § 300g-1(b)(4).
128 Id. § 300g-1(b)(4). MCLGs are health-based goals that do not take cost into consideration. See id. §§ 300g-1(b)(1), (4).
129 42 U.S.C. § 300g-1(b)(3)(A)(i).
the reliability of the method and the nature of the decision justiﬁes color, taste, odor), rather than its safety.137 The National Secondary use of the data)."130 Drinking Water Regulations are not enforceable.138 The process for establishing MCLGs is relevant vis-à-vis the PPCP control options discussed in Section VI.131 With regard to MCLGs for non-carcinogens, using the methodology noted above, C.3.2. The Unregulated Contaminant Monitoring
a substance-speciﬁc Reference Dose (RfD) is determined.132 In general, depending on the availability of information about a speciﬁc The SDWA requires the EPA to both: (a) establish criteria substance, the RfD is calculated by dividing Lowest-Observed- for a monitoring program for unregulated contaminants; and Adverse-Effect Level (LOAEL)133 or No-Observed-Adverse-Effect (b) publish a list of contaminants to be monitored. 139 Based on Level (NOAEL)134 by an Uncertainty Factor (UF).135 The MCLG information developed through the monitoring program, the is then determined by (a) multiplying the RfD by an assumed EPA is to evaluate and prioritize unregulated contaminants for body weight of 70 kg, (b) dividing by an assumed daily water potential inclusion on the Contaminant Candidate List discussed consumption of 2 liters to determine Drinking Water Equivalent below. 140 The Unregulated Contaminant Monitoring Rule 141 lists Level (DWEL) and (c) multiplying DWEL by an assumed daily contaminants that must be monitored by public water systems, exposure attributed to the consumption of water.136 describes analytical methods of assessing these contaminants, and requires the monitoring and analysis results to be submitted to the The SDWA also authorizes National Secondary Drinking EPA for inclusion in the National Drinking Water Contaminant Water Regulations which relate to the aesthetics of water (i.e., 130 Id. § 300g-1(b)(3)(A)(ii).
131 Infra, note 229 and associated text.
132 Reference Dose is deﬁned as "[a]n estimate of a daily oral exposure for a given duration to the human population (including susceptible subgroups) that is likely to be without an appreciable risk of adverse health effects over a lifetime. It is derived from a BMDL [Benchmark Dose Level], a NOAEL [No- Observed-Adverse-Effect Level], a LOAEL [Lowest-Observed-Adverse-Effect Level], or another suitable point of departure, with uncertainty/variability factors applied to reﬂect limitations of the data used." Environmental Protection Agency, Integrated Risk Information System (IRIS), http://www.epa.gov/iris/gloss8_arch.htm (last visited Feb. 9, 2011).
133 Lowest-Observed-Adverse-Effect Level is deﬁned as "[t]he lowest exposure level at which there are statistically or biologically signiﬁcant increases in frequency or severity of adverse effects between the exposed population and its appropriate control group." Id.
134 No-Observed-Adverse-Effect Level is deﬁned as the "highest exposure level at which there are no statistically or biologically signiﬁcant increases in the frequency or severity of adverse effect between the exposed population and its appropriate control; some effects may be produced at this level, but they are not considered adverse, nor precursors to adverse effects." Id.
135 "Uncertainty Factor" is deﬁned as "[o]ne of several, generally 10-fold factors, used in operationally deriving the RfD [Reference Dose] and RfC [Reference Concentration] from experimental data. UFs are intended to account for (1) the variation in sensitivity among the members of the human population, i.e., interhuman or intraspecies variability; (2) the uncertainty in extrapolating animal data to humans, i.e., interspecies variability; (3) the uncertainty in extrapolating from data obtained in a study with less-thanlifetime exposure to lifetime exposure, i.e., extrapolating from subchronic to chronic exposure; (4) the uncertainty in extrapolating from a LOAEL rather than from a NOAEL; and (5) the uncertainty associated with extrapolation from animal data when the database is incomplete." Id.
136 Environmental Protection Agency, Regulating Public Water Systems and Contaminants Under the Safe Drinking Water Act, http://water.epa.gov/lawsregs/rulesregs/regulatingcontaminants/basicinformation.cfm (last visited Feb. 9, 2011).
137 Kucera, supra note 121, at 445.
138 40 C.F.R. § 143.1 (2010).
139 Kucera, supra note 121, at 477.
141 Unregulated Contaminant Monitoring Rule, 64 Fed. Reg. 50,556 (Sept. 17, 1999) (codiﬁed at 40 C.F.R. §§ 9, 141-42).
Occurrence Database. Public water systems are also required Cryptosporidium (99% removal), Giardia lamblia (99.9% removal or to notify their consumers of the results of the monitoring and inactivation), and viruses (99.99% removal or inactivation).147 analysis. 142 The goal of the Unregulated Contaminant Monitoring Rule is to ensure that decisions regarding the regulation of speciﬁc contaminants are based on sound science, not political inﬂuence.143 C.3.5. The Wellhead Protection Program
Amendments to the SDWA in 1986 enhanced the protection of underground sources of drinking water by authorizing the wellhead C.3.3. The Contaminant Candidate List
protection program. 148 Under the SDWA as amended, states The SDWA 144 also requires the EPA to publish a Contaminant were required to develop wellhead protection programs within Candidate List every ﬁve years. This list must include contaminants three years and submit them to the Administrator of the EPA for that are not currently subject to National Primary Drinking Water approval. 149 The goal of the wellhead protection program was to Regulations but are known or anticipated to occur in public water "protect wellhead areas . . from contaminants which may have any systems. 145 The SDWA speciﬁes three criteria to be utilized adverse effect on the health of persons[.]" 150 in determining whether a contaminant may be a candidate for To encourage the states to develop wellhead protection regulation: (1) The contaminant may have an adverse effect on the programs, Congress provided both an incentive and a disincentive. health of persons; (2) The contaminant is known to occur, or there As an incentive, the SDWA provided that the activities of federal is a substantial likelihood that the contaminant will occur in public agencies having an effect on the wellhead protection area must water systems with a frequency and at levels of public health concern; be consistent with the states' wellhead protection programs. 151 and (3) In the sole judgment of the Administrator, regulation of As a disincentive, the SDWA provided that failure to develop such contaminant presents a meaningful opportunity for health risk an acceptable wellhead protection program would result in state reduction for persons served by public water systems.146 ineligibility for certain federal funding to implement the wellhead protection program.152 C.3.4. The Surface Water Treatment Rule
The SDWA also contains a Surface Water Treatment Rule which C.3.6. The Underground Injection Control Program
requires systems using surface water or groundwater under the direct inﬂuence of surface water to disinfect and ﬁlter their water so that Protection of underground sources of drinking water also the following contaminants are controlled at the following levels: occurs through the SDWA's Underground Injection Control 142 Kucera, supra note 121, at 457.
143 See SDWA § 300g-1(b).
146 SDWA § 300g-1(b)(1)(A); see Kucera, supra note 121, at 447.
147 Surface Water Treatment Rule, 40 C.F.R. § 141.70 (2010); see SDWA § 300g-1(b)(2)(C).
148 SDWA § 300h-7.
149 Id. § 300h-7(a).
150 "Wellhead protection areas" were deﬁned as "the surface and subsurface area surrounding a water well or wellﬁeld, supplying a public water system, through which contaminants are reasonably likely to move toward and reach such water well or wellﬁeld[.]" Id. § 300h-7(e).
151 Id. § 300h-7(h).
152 Id. § 300h-7(d). Program (UICP). 153 The UICP was mandated by ongoing reliance • Class V wells include all injection wells that are not on groundwater as a source of drinking water supplies. 154 Over included in Classes I-IV.
80% of community water systems rely on groundwater for all or • Class VI wells are used for injection of carbon dioxide.
part of their water supply. 155 With regard to well construction, the UICP both required permits and established standards based on different classes of wells: 156 C.3.7. The Biosolids Rule
• Class I wells are used for injection of industrial non- The Clean Water Act Amendments of 1987 required EPA hazardous liquids, municipal wastewaters, or hazardous to promulgate regulations to protect public health and the wastes beneath the lowermost underground source of environment from adverse impacts associated with the disposal drinking water.
of biosolids (i.e., the sludge from wastewater treatment plants). These regulations were published in 1993 157 and became Title 40, • Class II wells are used for injection of ﬂuids in Part 503 of the Code of Federal Regulations. As a result, they are connection with conventional oil or natural gas commonly known as the "Part 503 Biosolids Rule." production, enhanced oil and gas production, and the storage of hydrocarbons which are liquid at standard Of particular relevance to the issue of PPCPs in water supplies temperature and pressure.
is that portion of the Biosolids Rule relating to the application of biosolids to land. 158 Four general requirements are established • Class III wells are used for injection of ﬂuids associated under the Biosolids Rule. First, ceiling concentration limits were with the extraction of minerals or energy, including the established for heavy metals. 159 Second, pollutant loading rate mining of sulfur and solution mining of minerals. limits were formulated. Third, pathogen control requirements were • Class IV wells are used for injection of hazardous or radioactive wastes into or above underground source of drinking waters.
153 Id. § 300h.
154 Kucera, supra note 121, at 474.
155 See id.
156 40 C.F.R. § 146.5 (2010). With regard to Class VI wells, see Federal Requirements Under the Underground Injection Control (UIC) Program for Carbon Dioxide (CO2) Geologic Sequestration (GS) Wells, 75 Fed. Reg. 77,230 (December 10, 2010).
157 58 Fed. Reg. 9348 (February 19, 1993).
158 Other portions of Part 503 apply to a variety of different uses and disposal techniques for biosolids. See generally Ofﬁce of Wastewater Management, Environmental Protection Agency, A Plain English Guide to the EPA Part 503 Biosolids Rule (1994) [hereinafter EPA Guide to Part 503 Biosolids Rule].
159 Ceiling concentration limits were established for arsenic, cadmium, chromium, copper, lead, mercury, molybdenum, nickel, selenium and zinc. See Environmental Protection Agency, Chapter 2: Land Application of Biosolids in EPA Guide to Part 503 Biosolids Rule, supra note 158, at 29. To establish these limits: EPA conducted extensive risk assessments that involved identifying the chemical constituents in biosolids judged likely to pose the greatest hazard, characterizing the most likely exposure scenarios, and using scientiﬁc information and assumptions to calculate concentration limits and loading rates (amount of chemical that can be applied to a unit area of land). [However, there] have been substantial advances in risk assessment since then, and there are new concerns about some adverse health outcomes and chemicals not originally considered. Because of the diversity of exposed populations, environmental conditions, and agricultural practices in the United States, it is important that nationwide chemical regulations be based on the full range of exposure conditions that might occur. Furthermore, there is a need to investigate whether the biosolids produced today are similar in composition to those used in the original assessments. ascertained. 160 Fourth, vector-attraction reduction requirements One of the primary statutes dealing with hazardous substances were mandated. 161 and wastes is the Resource Conservation and Recovery Act (RCRA), which was enacted to establish a program for the "cradle- For land disposal to be permitted, all biosolids must comply to-grave" management of hazardous substances and waste. 164 One with the ceiling concentration limits for heavy metals. There are a of the goals of RCRA, as expressed in Subtitle A, is to protect number of options available to fulﬁll the other three requirements. human health and the environment from the hazards posed by These options are based on the characteristics of both the biosolids waste disposal. 165 Other goals include the reduction or elimination and the land to which the biosolids are to be applied. 162 Once of the amount of waste generated (including hazardous waste) and biosolids have been applied to land, an ongoing monitoring the proper management of such waste to protect human health and program is required. 163 the environment. 166 Subtitle C of RCRA created a hazardous waste management C.4. Protection of Groundwater and Surface Water
program. 167 A waste is considered "hazardous" if it is a solid waste, Quality by Regulating Hazardous Substances and
Wastes: The Resource Conservation and Recovery Act
Committee on Toxicants and Pathogens in Biosolids Applied to Land, supra note 42, at 2, 12. This led the National Research Council to recommend: [A] new national survey of chemicals in biosolids should be conducted. EPA should review available databases from state programs in designing a new survey. Other elements that should be included in the survey are an evaluation of the adequacy of detection methods and limits to support risk assessment; consideration of chemical categories, such as odorants and pharmaceuticals, that were not previously evaluated[.] Id. at 12 (emphasis added).
160 "In contrast to the chemical standards, the pathogen standards are not risk-based concentration limits for individual pathogens but are technologically based requirements aimed at reducing the presence of pathogens and potential exposures to them by treatment or a combination of treatment and use restrictions." Committee on Toxicants and Pathogens in Biosolids Applied to Land, supra note 42, at 2. In fact, with regard to pathogens, the National Research Council has recommended use of improved risk assessment method: "Risk-assessment methods for chemicals and pathogens have advanced over the past decade to the extent that (1) new risk assessments should be conducted to update the scientiﬁc basis of the chemical limits, and (2) risk assessments should be used to supplement technological approaches to establishing regulatory criteria for pathogens in biosolids." Id. at 4.
161 Vectors are typically ﬂies and rodents.
162 See Ofﬁce of Wastewater Management, Environmental Protection Agency, A Guide to the Biosolids Risk Assessments for the EPA Part 503 Rule (1995).The options include the Exceptional Quality option, the Pollutant Concentration option, the Cumulative Pollutant Loading Rule option and the Annual Pollutant Loading Rate option. The requirements applicable to each option are discussed in Chapter 2: Land Application of Biosolids, in EPA Guide to Part 503 Biosolids Rule, supra note 158, at 30-40. These requirements were based on a comprehensive risk assessment.
163 Monitoring must include pollutants, pathogen densities (fecal coliform, salmonella, viable helminth ova and enteric virus) and vector attraction reduction. See Chapter 2: Land Application of Biosolids, in EPA Guide to Part 503 Biosolids Rule, supra note 158, at 47-49; Chapter 6: Sampling and Analysis, in EPA Guide to Part 503 Biosolids Rule, supra note 158, at 129-51.
164 Resource Conservation and Recovery Act of 1976 (RCRA; Solid Waste Disposal Act), Pub. L. No. 94- 580, 90 Stat. 2795 (codiﬁed as amended at 42 U.S.C. §§ 6901-6992k (2006)); David R. Case, Resource Conservation and Recovery Act, in Environmental Law Handbook 133, 134 (Thomas F.P. Sullivan ed., Government Institutes 19th ed. 2007).
165 RCRA § 6902(a).
[A]ny garbage, refuse, sludge from a waste treatment • The "F" list – hazardous wastes from nonspeciﬁc plant, water supply treatment plant or air pollution control sources (e.g., spent nonhalogenated solvents, such as facility and other discarded material, including solid, toluene or methyl ethyl ketone).
liquid, semisolid, or contained gaseous materials resulting • The "K" list – hazardous wastes from speciﬁc sources from industrial, commercial, mining and agriculture activities and from community activities but does not e.g., petroleum reﬁning wastes or bottom sediment sludge from the treatment of wastewaters by the wood include solid or dissolved material in domestic sewage, or solid or dissolved materials in irrigation return ﬂows or industrial discharges which are point sources subject to • The "P" list – chemicals considered "acutely" hazardous permits under section 402 of the Federal Water Pollution irrespective of concentration (e.g., nitric oxide).
Control Act, as amended, or source, special nuclear, or byproduct material as deﬁned by the Atomic Energy Act • The "U" list – chemicals considered hazardous at higher of 1954, as amended (68 Stat. 923). 168 concentrations (e.g., acetone) Christenson notes that, "[s]ince most hazardous pharmaceuticals are on the P-list or Certain wastes are speciﬁcally excluded from the deﬁnition Ulist, health-care facilities focus primarily on these lists."172 of solid waste, including "(a) any mixture of domestic sewage and other wastes that passes through a sewer system to a publicly owned treatment works and (b) industrial wastewater discharges C.4.1. The Mixture Rule
that are point source discharges under the Clean Water Act." 169 In addition, the "mixture rule" provides that a mixture of a Waste is considered hazardous if it is: listed hazardous waste and a solid waste must also be considered a any solid waste, or combination of solid wastes, which hazardous waste. 173 This rule may not apply if (a) the mixture does because of its quantity, concentration, or physical, not exhibit the characteristics for which the waste was considered chemical, or infectious characteristics may (A) Cause, or hazardous (ignitability, corrosivity, reactivity or toxicity), (b) the signiﬁcantly contribute to an increase in mortality or an mixture is regulated under the Clean Water Act, or (c) the mixture increase in serious irreversible, or incapacitating reversible contains only de minimis quantities of hazardous wastes. 174 illness; or (B) Pose a substantial present or potential hazard to human health or the environment when C.4.2. Categories of Generators
improperly treated, stored, transported, or disposed of, or Hazardous waste generators are regulated depending on the otherwise managed. 170 amount of waste they generate each month. 175 There are three This statutory language gives the EPA broad authority to deﬁne hazardous wastes through regulation. Applicable regulations • Large quantity generators (LQG, generators of more the establish several lists of hazardous wastes: 171 1,000 kilograms of hazardous waste per month) 168 Id. § 6903(27).
169 Case, supra note 164, at 138.
170 RCRA § 6903(5).
171 40 C.F.R. § 261.31, 261.32, Part 273 (2010); Case, supra note 164, at 141-42.
172 Teirney Christenson, Comment, Fish on Morphine: Protecting Wisconsin's Natural Resources Through a Comprehensive Plan for Proper Disposal of Pharmaceuticals, 2008 Wisconsin Law Review 141, 149 (2008) (citing Christian G. Daughton, Cradle-to-Cradle Stewardship of Drugs for Minimizing Their Environmental Disposition While Promoting Human Health. II. Drug Disposal, Waste Reduction, and Future Directions, 111 Environmental Health Perspectives 775, 782 (2003)) 173 § 261.3(a)(2); Case, supra note 164, at 145.
174 40 C.F.R. § 261.3 (2010).
175 40 C.F.R. Part 260 (2010); see Case, supra note 164, at 152-53. • Small quantity generators (SQG, generators of between C.4.4. Treatment, Storage and Disposal Facilities
100 and 1,000 kilograms of hazardous waste per month) Requirements for TSDFs are also established under RCRA. A • Conditionally exempt small quantity generators permit is required to construct and operate a TSDF. 181 The permit (CESQGs, generators of less than 100 kilograms of contains speciﬁc operating standards and requirements applicable to hazardous waste per month) the TSDF. 182 The operator of a TSDF must demonstrate ﬁnancial responsibility (in case of accidents) as well as the capability to Under RCRA, hazardous waste generators must comply with close the TSDF in accordance with EPA regulations. 183 In terms regulations concerning record keeping and reporting, must observe of remediation and corrective actions that might be required at a waste accumulation time limits, and must comply with storage TSDF, the owner or operator is responsible for investigating and, requirements. 176 when necessary, remediating releases from their facilities. 184 A number of speciﬁc limitations and prohibitions are contained in RCRA. Bulk (noncontainerized) hazardous liquid waste is C.4.3. The Uniform Hazardous Waste Manifest
prohibited from disposal in any landﬁll. 185 There are also severe restrictions on the disposal of containerized hazardous liquid Generators of hazardous wastes; transporters of such wastes; waste. 186 Land disposal of speciﬁc highly hazardous waste was and operators of treatment, storage, and disposal facilities (TSDFs) phased out between 1986 and 1990. 187 must also comply with the Uniform Hazardous Waste Manifest System. 177 This System requires the use of a manifest process to RCRA also establishes minimum technological standards for track hazardous waste from its point of origin to its ultimate point new landﬁlls and surface impoundments. Requirements include: of treatment or disposal (i.e., "cradle to grave"). 178 Transporters (a) double liners, (b) a leachate collection and treatment system, of hazardous waste must also meet requirements established by (c) groundwater monitoring, and (d) in general, the use of "Best the Department of Transportation. 179 For example, regulations Demonstrated Available Technology." 188 implementing the Hazardous Materials Transportation Act require (a) labeling, (b) placarding, (c) proper containers for hazardous materials, and (d) the development of emergency (spill) response C.4.5. The Universal Waste Rule
In 1995, EPA promulgated regulations to streamline the management of certain types of commonly occurring hazardous 176 Case, supra note 164, at 150.
177 § 262.20; Case, supra note 164, at 150.
178 Case, supra note 164, at 150.
179 Id. at 134.
181 40 C.F.R. § 264.1 (2010).
183 See § 264.145; see also Case, supra note 164, at 161.
184 Case, supra note 164, at 170.
185 § 264.314.
187 Case, supra note 164, at 164-65.
188 § 264.301; Case, supra note 164, at 164-65. wastes.189 These wastes (known as "universal wastes") included C.5. Protection of Groundwater and Surface Water
batteries, certain types of lamps (e.g., containing mercury), Quality by Regulating Toxic Substances: The Toxic
mercury-containing equipment (e.g., thermostats) and certain types Substance Control Act
of pesticides. Concluding that the "current RCRA regulations In 1971, the Council on Environmental Quality (CEQ ) have been a major impediment to national collection and recycling campaigns for these wastes," 190 the Universal Waste Rule recommended comprehensive legislation to identify and control (UWR)191 was promulgated to "facilitate [their] environmentally chemicals whose manufacture, processing, distribution, use, sound collection and increase the proper recycling or treatment" of and/or disposal was potentially dangerous and not adequately regulated under other environmental statutes. 195 The result, the Toxic Substances Control Act (TSCA), was To achieve these goals, the UWR allowed for longer storage signed into law by President Ford on October 11, 1976. 196 of covered wastes, reduced record keeping requirements and simpliﬁed the procedure for recycling such wastes. Transportation Title I of TSCA focuses on the control of toxic substances. was facilitated by exempting the transport of wastes included Manufacturers and processors are required to conduct tests of within the UWR from the manifest requirements discussed above.
existing chemicals if (a) the manufacture, distribution, processing, use or disposal of the chemicals may present an unreasonable risk of injury to health or the environment; (b) the chemicals are C.4.6. State Implementation
or will be produced in substantial quantities and the potential The EPA encouraged states to assume responsibility for for environmental release or human exposure is substantial or RCRA's hazardous waste program in part by providing ﬁnancial signiﬁcant; and (c) existing data are inadequate to predict the assistance. 193 At the present time, all but two of the states have effects of human exposure and environmental releases. 197 The been granted authority to implement the RCRA program. 194 required testing may be based on risk triggers (chemical toxicity, etc.), exposure triggers (long-term, low-level exposure) or both. 198 Chemicals known or suspected to be carcinogenic, mutagenic or teratogenic are to be assigned a higher priority for testing. 199 189 Universal Waste Rule (Hazardous Waste Management System; Modiﬁcation of the Hazardous Waste Recycling Regulatory Program); 60 Fed. Reg. 25492 (May 11, 1995).
190 Id. at 25492.
191 40 C.F.R. Part 273.
192 60 Fed. Reg. at 25492.
193 RCRA § 6947.
194 It appears that Alaska and Iowa have not been granted authority to implement the RCRA program. See Environmental Protection Agency, Wastes-Laws & Regulations-RCRA State Authorization: State Authorization Federal Register Notices and Authorization Activity, http://www.epa.gov/osw/lawsregs/ state/stats/stats_safrn.htm (last visited Sept. 10, 2010).
195 This recommendation was contained in the CEQ report Toxic Substances (1971). Linda Schierow, Congressional Research Services, Summary of Environmental Laws Adminstered by the EPA, available at http://ncseonline.org/nle/crsreports/brieﬁngbooks/laws/k.
cfm (last visited July 18, 2010).
196 Toxic Substance Control Act (TSCA), Pub. L. No. 94-469, 90 Stat. 2003 (codiﬁed as amended at 15 U.S.C. §§ 2601-1692(2006)); Stanley W. Landfair, Toxic Substance Control Act, in Environmental Law Handbook 607, 607 (Thomas F.P. Sullivan ed., Government Institutes 19th ed. 2007). 197 TSCA § 2603; Landfair, supra note 196, at 644. 198 Landfair, supra note 196, at 644.
199 See id. at 643.
C.5.1. The Inventory
C.5.3. Regulatory Controls
The EPA is required to develop and maintain an inventory The TSCA requires the EPA to regulate the manufacturing, of all chemicals, or categories of chemicals, manufactured or processing, distribution, use, and disposal of a chemical if it processed in the United States. 200 All chemicals not on the will present an unreasonable risk of injury to health or the Inventory are, by deﬁnition, "new" and are subject to the Pre- environment. 207 This authority allows EPA to: (a) prohibit or Manufacture Notiﬁcation requirements. 201 limit the amount of production or distribution of a chemical; In 2008, the EPA initiated a phased, multi-year program to (b) prohibit or limit the production or distribution of a chemical obtain health and safety information from manufacturers and for a particular use; (c) limit the volume or concentration of processors of inorganic, high-production volume (HPV) chemicals. the chemical produced; (d) prohibit or regulate the manner or 202 Such information on 2,200 organic chemical HPV chemicals method of commercial use; (e) require warning labels and/or has already been obtained by the EPA. 203 instructions on containers or products; (f) require notiﬁcation of the risk of injury to distributors and (to the extent possible) consumers; (g) require record-keeping by producers; (h) specify disposal methods; and (i) require replacement or repurchase With limited exceptions, manufacturers, importers, and of products already distributed. 208 However, the EPA is to processors of chemicals not listed in the inventory are required to exercise this authority only "to the extent necessary to protect notify the EPA at least 90 days prior to producing a new chemical adequately" against a risk. Furthermore, the EPA is to use product into the United States. 204 The EPA then has 45 days to the "least burdensome" regulatory approach, even when evaluate the potential risk posed by the new chemical product. 205 unreasonable risks are being controlled. 209 If the EPA determines that the new chemical product presents or will present an unreasonable risk of injury to human health or the environment, then requirements to protect against such risks C.5.4. Imminent Hazards
must be promulgated. If data are inadequate to make an informed The TSCA also authorizes the EPA to take emergency action judgment, the EPA may prohibit or limit the use of the new through federal courts to control a chemical substance or mixture chemical product until sufﬁcient information has been submitted. 206 which presents an imminent and unreasonable risk of serious, widespread injury to human health or the environment 210 200 TSCA § 2607(b)(1).
201 See id. §2607(b); see also Landfair, supra note 196, at 611.
202 High Production Volume (HPV) Challenge Program, http://www.epa.gov/hpv (last visited Sept. 9, 2010).
204 TSCA § 2604(a)(1)(B).
205 Id. §2604(e)(1)(B).
206 Id. §2604(e)(1)(A).
207 Id. §2605(a).
210 Id. § 2606(b)(1).
C.6. Protection of Species: The Endangered Species Act
endangered species and threatened species and shall utilize their authorities in furtherance of the purposes of this chapter." 214 In Perhaps the best known of the federal species protection essence, the ESA was intended to protect threatened and endangered statutes, the Endangered Species Act (ESA) 211 essentially prohibits species virtually irrespective of the cost of the protection. 215 any federal agency from taking any action (including destruction of "critical habitat") that would jeopardize the continued existence of a threatened or endangered plant or animal species. As more fully discussed below, the ESA also prohibits all parties (both public and C.6.1. "Taking" Endangered Species
private) from undertaking actions that would result in the "taking" With only limited exceptions, Congress prohibited the "taking" of a threatened or endangered species. 212 of an "endangered"216 plant or animal species. 217 Fish and Wildlife Service regulations extending these provisions to "threatened" 218 The purposes of the ESA are "to provide a means whereby the species were sustained when challenged as a reasonable and ecosystems upon which endangered species and threatened species permissible interpretation of the ESA. 219 depend may be conserved, [and] to provide a program for the conservation of such endangered species and threatened species[.]" Concurrent with the determination that a species is endangered 213 In order to achieve these goals, Congress established the policy or threatened, the Secretary of the Interior must designate critical that "all Federal departments and agencies shall seek to conserve 211 See generally Endangered Species Act (ESA), Pub. L. No. 93-205, 87 Stat. 884 (codiﬁed as amended at 16 U.S.C. §§ 1531-1544 (2006)).
212 ESA § 1538(a)(1).
213 Id. § 1531(b).
214 Id. § 1531(c)(1).
215 See Tennessee Valley Authority v. Hill, 437 U.S. 153 (1978) (holding that the protection of the endangered snail darter under the ESA could preclude completion of a water project). 216 Endangered species are deﬁned as "any species which is in danger of extinction throughout all or a signiﬁcant portion of its range other than a species of the Class Insecta determined by the Secretary to constitute a pest whose protection under the provisions of this chapter would present an overwhelming and overriding risk to man." ESA §1532(6).
217 In relevant part, the ESA provides that "with respect to any endangered species of ﬁsh or wildlife listed pursuant to . this title it is unlawful for any person subject to the jurisdiction of the United States to . (B) take any such species within the United States or the territorial sea of the United States . or (G) violate any regulation pertaining to such species or to any threatened species of ﬁsh or wildlife listed pursuant to . this title." ESA § 1538(a)(1). Furthermore, "with respect to any endangered species of plants listed pursuant to . this title, it is unlawful for any person subject to the jurisdiction of the United States to . (B) remove and reduce to possession any such species from areas under Federal jurisdiction; maliciously damage or destroy any such species on any such area; or remove, cut, dig up, or damage or destroy any such species on any other area in knowing violation of any law or regulation of any State or in the course of any violation of a State criminal trespass law . or (E) violate any regulation pertaining to such species or to any threatened species of plants listed pursuant to . this title…." Id. § 1538(a)(2).
218 Threatened species are deﬁned as "any species which is likely to become an endangered species within the foreseeable future throughout all or a signiﬁcant portion of its range." Id. § 1532(20).
219 Sweet Home Chapter of Communities for a Great Oregon v. Lujan, 806 F. Supp. 279 (D.D.C. 1992), aff 'd sub nom Sweet Home Chapter of Communities for a Great Oregon v. Babbitt, 1 F.3d 1 (D.C. Cir. 1993), modified, 17 F.3d 1463 (D.C. Cir. 1994), rev'd, 515 U.S. 687 (1995).
220 In making a determination regarding the designation of critical habitat, the Secretary shall designate critical habitat . on the basis of the best scientiﬁc data available and after taking into consideration the economic impact, and any other relevant impact, of specifying any particular area as critical habitat. The Secretary may exclude any area from critical habitat if he determines that the beneﬁts of such exclusion outweigh the beneﬁts of specifying such area as part of the critical habitat, unless he determines, based on the best scientiﬁc and commercial data available, that the failure to designate such With regard to the "taking" of an endangered or threatened includes: (a) actions authorized by a federal agency (e.g., through species, the deﬁnition of "take" is noteworthy: "The term ‘take' the issuance of permits or licenses); (b) actions funded by federal means to harass, harm, pursue, hunt, shoot, wound, kill, trap, agencies; and (c) actions undertaken by the agency itself. 226 capture, or collect, or to attempt to engage in any such conduct." 221 In order to fulﬁll this requirement, agencies are required To conclude that the deﬁnition of "take" is quite broad would be to "use the best scientiﬁc and commercial data available." 227 an understatement. Registration of a pesticide by the EPA, for Agencies are also required to act "in consultation with and with the example, was considered a "taking" since endangered species were assistance of " the Secretary of the Interior. 228 poisoned by the pesticide. 222 Forest management practices of the Forest Service, which resulted in harm to an endangered species, constituted a "taking" in Sierra Club v. Lyng. 223 D. Alternative Strategies: As an alternative to a regulatory approach, there are a number of possibilities that could be utilized to address the presence Federal agencies are required to insure that agency actions are of PPCPs in water supplies through source control.229 These not likely to jeopardize the continued existence of a threatened or possibilities fall generally into six categories: drug design, drug endangered species. 224 Such agencies are also required to insure delivery, drug marketing, drug dispensing, drug disposal/recycling, that agency actions do not result in the destruction or adverse and drug alternatives.230 While these categories focus primarily on modiﬁcation of critical habitat. 225 In this context, "agency action" pharmaceuticals, they apply equally to personal care products and area as critical habitat will result in the extinction of the species concerned. ESA § 1533(b)(2).
221 Id. §1532(19).
222 Defenders of Wildlife v. Administrator, EPA, 882 F.2d 1294 (8th Cir. 1989).
223 Sierra Club v. Lyng, 694 F. Supp. 1260 (E.D. Tex. 1988), aff 'd in part, vacated in part, 926 F.2d 429 (5th Cir. 1991).
224 ESA § 1536(a)(2).
229 The need for source control has been stressed in a number of studies. See, e.g., the recommendations of a 2008 study by the School of Public Health and Health Services at The George Washington University included: An emphasis on controlling the discharge of contaminated water at the source, rather than treatment at the point of use. This would be safer for the environment, while reducing the burden on downstream drinking water treatment plants. Rapid Public Health Policy Response Project, supra note 26, at 6 (citing U.S. Environmental Protection Agency, Source Water Protection). See also Keith J. Jones, Endocrine Disruptors and Risk Assessment: Potential for a Big Mistake, 17 Villanoval Environmental Law Journal 357, 386 (2006) ("It might be more feasible to ban the use of an endocrine disruptor or otherwise prevent it from reaching source water (e.g., source water protection programs) rather than try to remove it from drinking water.").
230 The structure of this section and the concepts described herein are based on Christian G. Daughton, Cradle-to-Cradle Stewardship of Drugs for Minimizing Their Environmental Disposition While Promoting Human Health. II. Drug Disposal, Waste Reduction, and Future Directions, 111 Environmental Health Perspectives 775 (2003) [hereinafter Daughton, Drug Disposal, Waste Reduction, and Future Directions]. See also the section on "source water protection" in Snyder et al., supra note 47, at 34.
the full array of PPCPs previously identiﬁed in footnote 6.231 In this context, it should be noted that the U.S. Food and Drug Administration mandates environmental risk assessments for new pharmaceuticals having a predicted environmental concentration of D.1. Drug Design
more than 1 µg/L. 234 The environmental impacts of drug use, such as the excretion of It would be possible to design drugs to improve the physiologic PPCPs in both human and animal wastes, should be considered as sorption characteristics of the drug. This would result in a new drugs are being designed or formulated. While maintaining or reduction in the amount of the drug ultimately excreted. This improving therapeutic efﬁcacy, the chemical structure, properties, possibility is "being pursued on many fronts[.]" 235 and formulation (combinations of active and inactive ingredients) of new drugs could focus on "maximizing their susceptibility to Daughton notes that the "advancing ‘omnics' revolution" 236 biodegradation, photolysis, or other physicochemical alterations to could lead to the design of drugs that speciﬁcally target certain yield innocuous end products." 232 The need for such an approach groups of patients. This could have the effect of reducing the was described by Wennmalm and Gunnarsson: use of drugs having similar therapeutic effects by the general population. 237 If use of drugs resulting in the excretion of PPCPs [I]t appears urgent that future drugs not be persistent. by the general population was reduced, then the quantity of PPCPs Presently, several frequently used drugs have half-lives entering water supplies would also be reduced.
in surface water exceeding one year or more. Residues of such drugs may reach concentrations in surface or Other drug design possibilities could include the development ground water near urban areas of 100 nanograms/litre of drugs that maintain their therapeutic effectiveness despite or more before a kinetic balance between supply of new substantially reduced dosage levels 238 as well as the development of drug residues from sewage treatment plant efﬂuents and "smart" drugs that "better emulate the nonanthropocentric, native biodegradation in the aquatic medium has been reached. chemistries of natural products." 239 Such high concentrations are not readily eliminated in processes aimed at purifying the water to be drinkable. Thus, signiﬁcant concentrations of bioactive drug residues may appear in drinking water.233 231 See supra note 6.
232 Daughton, Rationale for and Avenues toward a Green Pharmacy, supra note 230, at 765. 233 Wennmalm & Gunnarsson, supra note 41, at 295-296 (citing Ettore Zuccato et al., Environmental loads and detection of pharmaceuticals in Italy, in Pharmaceuticals in the Environment 23-24 (K. Kümmerer ed., Springer Verlag 2001)).
234 Snyder et al., supra note 47, at 34.
235 Daughton, Rationale for and Avenues toward a Green Pharmacy, supra note 230, at 765 (citing Joe Alper, Breaching membranes, 296 SCIENCE 838 (2002)) (regarding the creation of in situ synthetic transporters as well as work by XenoPort, Inc. of Santa Clara, California regarding "better drug design to accommodate existing membrane transporters[.]").
236 This would include genomics (the study of genes and their functions), proteomics (the study of proteins and their functions), glycomics (study of the structure and function of sugars and saccharides) and metabolomics (the study of metabolites and their functions). See generally Cambridge Healthtech Institute, -Omes and -omics Glossary & Taxonomy: Evolving Terminology for Emerging Technologies, http://www.genomicglossaries.com/content/omes.asp (last visited Mar. 1, 2011).
237 Daughton, Rationale for and Avenues toward a Green Pharmacy, supra note 230, at 765.
238 Id. at 766.
D.2. Drug Delivery
The same result could be achieved through more precise formulation and dosing of drugs. 245 Related to this would The ﬁrst step in the drug delivery system identiﬁed by be "individualization of therapy," which would require drug Daughton as playing a role vis-àvis PPCPs in water supplies is manufacturers to "provide the medical community with more easily the prescribing of drugs. Both physicians and patients need to be implementable information (and requisite unit doses) to tailor drug better informed of the consequences of using speciﬁc drugs, 240 dosages for the individual." 246 particularly both the "medical and environmental consequences of overprescribing medications."241 The development of alternative drug delivery mechanisms is another suggested means of improving the efﬁciency of drug use. Numerous studies have shown that "the therapeutically This could include "better targeted delivery routes (e.g., expanding effective dose for many drugs can be signiﬁcantly lower than the utility of pulmonary and transdermal/mucosal delivery), that initially recommended by the manufacturer." 242 In fact, mechanisms of release (e.g., rapid-dissolving formulations, Cunningham, et al., have noted, "[t]he preferred safety proﬁle for controlled release), and mechanisms for delivery of drugs to the human pharmaceuticals is that the desired therapeutic response is target (e.g., antibody-linked drugs; in situ implants)." 247 the lowest effect observed (i.e., at the lowest dose)." 243 With regard to drugs whose use results in the excretion of PPCPs, lowering With regard to the delivery of drugs, the role of patient the dosage to the therapeutically effective level, rather than the education cannot be overstated. As noted by Daughton, it is level recommended by the manufacturer, could have the result of quite common for patients to "fail to ﬁnish their courses of reducing the quantity of PPCPs entering water supplies. 244 medication[.]" 248 As a result, unused (and perhaps outdated) drugs accumulate and eventually require disposal. If patients completed 240 Wennmalm and Gunnarsson describe such an approach in Sweden as well as actions taken by the Stockholm County Council to implement it: Despite the fact that pharmaceuticals may have adverse environmental effects, no information on such effects is easily available to prescribing doctors. We have developed a model for easy but accurate evaluation of the environmental effects of drugs, aimed at helping doctors to make an environmentally-conscious selection between medicallyequivalent drugs with different environmental impacts. Health care professionals have expressed much interest in the classiﬁcation system and the Stockholm County Council has decided that the environmental score of each pharmaceutical obtained in the classiﬁcation shall be one variable for consideration when its list of recommended pharmaceuticals is revised. Wennmalm, & Gunnarsson, supra note 41, at 294-295.
241 Daughton, Rationale for and Avenues toward a Green Pharmacy, supra note 232, at 766.
242 Id. at 767.
243 Cunningham, Binks, & Olson, supra note 41, at 43.
For a given use rate by the population, only low production volumes are needed for potent pharmaceuticals. For the same population use rate, a high therapeutic dose requires more production. So, the total amount of an API [active pharmaceutical ingredient] entering the environment is generally inversely correlated to its potency. Id. at 44.
245 Daughton, Rationale for and Avenues toward a Green Pharmacy, supra note 230, at 767.
246 Daughton notes that "individualization of therapy" is particularly relevant with regard to long-term maintenance drugs. Id. 247 Id. (citing Mona Mort, Multiple Modes of Drug Delivery," 3 Modern Drug Discovery 30 (2000)).
248 Id. at 768 (citing Daughton, Drug Disposal, Waste Reduction, and Future Directions, supra note 230).
courses of medication as prescribed, the quantity of drugs 253 This quantity could also be reduced if improved packaging inappropriately disposed of would be reduced. This could reduce extended the shelf-life of drugs. 254 the quantity of PPCPs entering water supplies.
Finally, the role of drug advertising must be considered. Such Of equal importance is education of the medical community advertising substantially inﬂuences consumer decisions regarding regarding both appropriate dosages of speciﬁc drugs and the use of both over-the-counter (nonprescription) and prescription appropriate disposal mechanisms. Daughton advocates the use of drugs. Different types of advertising may also inﬂuence the continuing education programs involving both the medicine and medical community. Because of this, Daughton argues that such environmental science to teach the importance of "cradle-to-cradle advertising should "include information for the public regarding stewardship" of medications. 249 the proper disposition of unused products and the imperative for environmental stewardship."255 D.3. Drug Marketing
As noted above, patient education is a critical factor. The D.4. Drug Dispensing
importance of the role of drug marketing in educating both There are any number of means by which both legal and illegal the patient and the public cannot be overstated. For example, drugs are dispensed. Sale of drugs via the Internet, for example, Daughton notes that the packaging of both over-the-counter will "undoubtedly [lead] to overdispensing and dispensing without (nonprescription) and prescription drugs in the United States does a prescription[,]" which could have the effect of contributing to the not provide guidance for the disposal of any unused portion of overall environmental exposure burden caused by such drug use.256 the medication. 250 Guidance may also be missing regarding the ingestion of different drugs having the same mechanism of action This is particularly true with regard to the distribution of black- or the same drug from different sources, both of which may result market and counterfeit drugs, some 25% of which are sold via the in a cumulative dose in excess of therapeutic requirements. 251 This Internet.257 In addition to potential health beneﬁts, reducing the problem may be exacerbated by different drugs having a similar quantity of such drugs sold online would also reduce the quantity name or appearance. 252 of such drugs entering the environment either through excretion or disposal. With regard to the disposal of drugs, both the size and integrity of drug packaging may play a role. Daughton notes, for With regard to the disposal of drugs, a number of issues relate example, that a broader selection of package sizes could result in to expiration dates, after which drugs are no longer considered a reduction in the quantity of drugs that are ultimately discarded. effective. Daughton notes that expiration dates should be based on actual, empirical data regarding stability duration rather than on 249 Daughton, Rationale for and Avenues toward a Green Pharmacy, supra note 230, at 768.
251 "This multiple-exposure pathway scenario is especially problematic when patients are prescribed medications by multiple physicians; for patients with multiple health care providers, poor communication can also lead to represcribing of medication that has already been shown for the patient to be nonefﬁcacious." Id.
252 Id. at 768-769 (citing Committee on Quality of Health Care in America, Institute of Medicine, To Err is Human: Building a Safer Health System (Linda T. Kohn, Janet M. Corrigan, & Molla S. Donaldson eds., National Academy Press 2000)). "Although these problems can jeopardize patient safety, they also lead to unnecessary (and inappropriate) use of drugs and their eventual discharge to the environment, as well as to the purchase of medications that might not have been made by a betterinformed consumer." Id. at 769.
253 Id. at 769.
256 Id. (citing U.S. Food and Drug Administration, Buying Medicines and Medical Products Online (2002)). 257 Daughton, Rationale for and Avenues toward a Green Pharmacy, supra note 230, at 769 (citing Cyveillance, Cyveillance Partners with Biocode to Serve Pharmaceutical Industry [press release] (2001)).
the recommendations of speciﬁc drug manufacturers.258 the sale and use of both over-the-counter (nonprescription) and prescription drugs. Daughton concludes that such a database The need to dispose of unwanted drugs could also be reduced "would be extremely useful for predicting the actual quantities if more disciplined dispensing and inventory control protocols were of drugs that could be entering the environment (by using developed. Both pharmacies and consumers could be encouraged pharmacokinetic models based on ADME/Tox – adsorption, to minimize their drug inventories in order to minimize the distribution, metabolism, excretion, and toxicity)." 262 quantity of unwanted or unneeded drugs needing disposal. 259 For example, the need to dispose of speciﬁc drugs would be reduced if the quantity either purchased or prescribed could be utilized D.5. Drug Disposal/Recycling
completely prior to the expiration date of the drug. The disposal need could also be reduced if "[r]easonable, minimal quantities of The need for appropriate disposal or recycling of pharmaceuticals medication could be purchased or prescribed until the effects of the has been noted repeatedly. 263 A number of suggestions have been medication and its therapeutic effectiveness are understood by both offered to encourage such disposal or recycling programs. Daughton, the physician and patient." 260 for example, has suggested that an appropriate incentive for drug companies to implement drug disposal/recycling programs "would Daughton makes two additional points regarding drug be to offer patent extensions to companies that formulate vibrant, dispensing vis-à-vis PPCPs in water supplies. First, the use comprehensive stewardship programs tailored for each particular of drugs for purposes not originally intended requires both drug." 264 Daughton has also suggested that the role of "reverse vigilance and ongoing review, particularly if such use results distributors" currently being used by pharmacies in the United States in the introduction of PPCPs into water supplies. 261 Second, for the return of unsold or expired drugs be expanded "into a larger, a nationwide database of drug sales is needed. This database, comprehensive disposal/recycling program, one that accommodates which should be publically accessible, would compile and track the consumer sector." 265 Such an expansion might also include drug 258 "Scientiﬁcally sound protocols need to be implemented for the public sector to deﬁne, determine, predict, and/or monitor actual expiration periods for both factory-sealed and unsealed drugs." Daughton, Rationale for and Avenues toward a Green Pharmacy, supra note 230 at 770.
261 For example, "[t]he long-running debates regarding the use of subtherapeutic antibiotics and of anabolic steroids in animal feed have resulted in a number of actions in certain countries to reduce or abolish their use." Id. at 771.
262 Id. (citing Christian G. Daughton, U.S. Environmental Protection Agency, Factors Complicating Prediction of Drug Elimination from the Body (2002)).
263 See, e.g., TDC Environmental, supra note 49, at 2; Christenson, supra note 172, at 164-166 (reviewing programs in Arizona, Arkansas and Wisconsin).
264 Daughton, Drug Disposal, Waste Reduction, and Future Directions, supra note 230, at 776.
265 Id. See also TDC Environmental, supra note 49: U.S. EPA has authorized reverse distribution of pharmaceuticals without hazardous waste management permits. The U.S. EPA authorization speciﬁcally requires the returns industry not to be used as a "waste management system" (U.S. EPA, 1981; U.S. EPA, 1991). Any items that are inherently "waste-like" (like a broken container or contaminated prescription) cannot be shipped as products to a reverse distributor. TDC Environmental, supra note 49, at 4-5 (citing Letter from Alan S. Corson, Chief, Waste Characterization Branch, Hazardous and Industrial Waste Division, U.S. EPA, to Steven Wittmer, Merck, Sharp & Dohme (May 13, 1981), available at http://yosemite.epa.gov/OSW/rcra.nsf/Documents/F3001B817EF4265885256611005156D2; Letter from Sylvia K. Lowrance, Director, Ofﬁce of Solid Waste, U.S. EPA, to Mark J. Schulz, Browning-Ferris Industries (May 16, 1991) available at http://yosemite.epa.gov/OSW/rcra.nsf/Documents/354FE6A290ED95E1852565DA006F04A1). Accord Christenson, supra note 172, at 165-166. However, it should be noted that any consumer "reverse distribution" program would have to comply with the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA), 42 U.S.C. §201, et seq. TDC Environmental, supra note 49, at 6.
samples given to physicians because the "distributors of physician ensure that pharmaceuticals provided to patients are pure samples often instruct physicians to dispose of outdated samples to and safe. Once a drug has left the control of a pharmacy, the sewage system." 266 its storage, handling, and condition are uncertain – and therefore it cannot be assured to be pure and safe. Minimization of waste ﬂows into the environment should have Because there is no viable reuse for unwanted residential the effect of reducing the presence of PPCPs in water supplies. pharmaceuticals, they are – by deﬁnition – waste.269 One approach could be re-engineered toilets to separate liquid and solid wastes. This could have the effect of both minimizing waste Development of water recycling systems that allow wastewater to ﬂows and reducing water supply requirements. 267 be upgraded for both potable and non-potable uses provides another approach to minimization of waste ﬂows. 270 As Daughton notes: Another approach could be "drug mining" (i.e., recovery of "By use of advanced water treatment technology such as reverse highly toxic drugs from excreta and other hospital wastes).268 osmosis, nearly complete removal of all PPCPs can be achieved." However, with only limited exceptions, any subsequent use of 271 This is an issue of particular concern in arid regions, particularly reclaimed or recycled drugs is prohibited: the southwestern United States, where limited water supplies and Once prescribed and given to patients, pharmaceuticals growing populations virtually mandate the reuse of water. 272 cannot be reused. State [California] and Federal law Improvements to wastewater collection273 and treatment274 require pharmacists and pharmaceutical manufacturers to systems are closely associated with the development of water 266 Daughton, Drug Disposal, Waste Reduction, and Future Directions, supra note 230, at 776.
267 Id. (citing Tove A. Larsen et al., Re-engineering the Toilet for Sustainable Wastewater Management, 35 Environmental Science & Technology 192A (2001); Novaquatis, EAWAG (Swiss Federal Institute for Environmental Science and Technology), Innovative Management of Anthropogenic Nutrients in Urban Water Management and Agriculture (2002); R. Otterpohl, Options for Alternative Types of Sewerage and Treatment Systems Directed to Improvement of the Overall Performance, 45 Water Science & Technology 149 (2002)) 268 Id. at 776 (referring to a prototype of such a system developed by Pharmaceuticals.org). See Pharmaceuticals.org, Pharmaceuticals from Human System to Human System, http://www.toilets.com/pharmaceuticals.htm (last visited March 1, 2011).
269 TDC Environmental, supra note 49, at 8.
270 Daughton, Drug Disposal, Waste Reduction, and Future Directions, supra note 232, at 776 (citing Jorge E. Drewes & Laurence S. Shore, Concerns About Pharmaceuticals in Water Reuse, Groundwater Recharge, and Animal Waste, in Pharmaceuticals and Personal Care Products in the Environment: Scientific and Regulatory Issues 206 (Christian G. Daughton & Tammy L. Jones- Lepp eds., American Chemical Society 2002); Lindsey A. Greene, Controversy Swirls Around Toilet-to- Tap Project, 108 Environmental Health Perspectives A447 (2000)).
271 Id. It should be noted, however, that "all the solutes removed by reverse osmosis are concentrated inthe rejected "brine" – a waste stream that must be disposed itself." Id.
272 Snyder et al., supra note 47, at 34.
273 Collection system improvements need to address both combined sewer overﬂows and urban streamstormﬂows as these are "signiﬁcant contributors of OWCs [organic water compounds] to receiving waters[.]" Phillips & Chalmers, supra note 86, at 56. This in turn indicates that efforts to decrease the amounts of OWCs entering large receiving waters need to identify and treat waters that bypass normal wastewatertreatment processes. Future evaluations of the annual contributions from these sources will require sampling of WWTP efﬂuents, CSO efﬂuents, and urban streams under differing seasons and ﬂow conditions. 274 With regard to the control of PPCPs in water supplies, development of advanced wastewater treatment systems "could have the greatest potential beneﬁt, as it would remove not only intentionally ﬂushed drugs but also drugs that pass through the body naturally." Christenson, supra note 172, at 159 (citing George J. Mannina, Jr., Medicines and the Environment: Legal and Regulatory Storms Ahead?, 21 Legal Backgrounder, no. 11, 2 (March 26, 2006)).
recycling systems. Advanced wastewater treatment systems using "pose problems with respect to groundwater pollution if they have reverse osmosis have the capability to remove PPCPs through a not been properly engineered and sited with local hydrogeologic physical separation process. 275 Utilization of granular activated processes in mind," 283 but the presence of PPCPs in the bodies of charcoal systems, as well as ozonation, has been effective in the deceased "could be expected to be extensive as a result of long- removing antibiotics from wastewater. 276 Engineered wetlands term medication and heroic treatment measures." 284 and groundwater inﬁltration basins have been suggested as Once again, the role of public education needs to be stressed, mechanisms to attenuate PPCPs 277 as has phytoremediation. 278 this time in the context of drug disposal/recycling. Daughton At a more basic level, Daughton recommends both that "[s]traight- emphasizes the importance of public outreach programs: piping of sewage to surface waters . continue to be identiﬁed and eliminated" 279 and that "[p]rivies and septic systems . be A well-designed, concerted public outreach program converted to municipal systems when feasible." 280 for communicating the issues associated with PPCPs as environmental pollutants could accomplish dual aims: With regard to reducing the environmental burden caused by (a) enhance the public's appreciation and understanding both the legal and illegal disposal of drugs, Daughton notes the need of a wide range of principles associated with to revise state laws that either (a) restrict the donation of prescription environmental science, and (b) increase the public's sense drugs to charity (e.g., Oklahoma) 281 or (b) restrict or limit the of environmental responsibility by showing how their authority of pharmacies to accept returns of unused drugs. 282 actions as individuals collectively contribute to the burden The complexity of issues relating to PPCPs in water supplies of PPCPs in the environment, how PPCPs can possibly is illustrated by Daughton's observation that funeral practices affect environmental processes (e.g., aquatic biota), and need to be environmentally sound. Not only can burial practices the collateral advantages (human health and economic) accrued by conscientious/responsible disposal and use of PPCPs.285 275 Sedlak and Pinkston, supra note 15, at 56. Accord Reynolds, Pharmaceuticals in Drinking Water Supplies, supra note 25; Heberer et al., Removal of Pharmaceutical Residues, supra note 85, at 28.
276 Huang et al., supra note 25, at 37. Accord Reynolds, Pharmaceuticals in Drinking Water Supplies, supra note 25, (citing Marc M. Huber et al., Oxidation of pharmaceuticals during ozonation and advanced oxidation processes, 36 Environmental Science & Technology 1202 (2003)).
277 Sedlak and Pinkston, supra note 15, at 65.
278 N. Gujarathi & J. Linden, Potential for Phytoremediation of Antibiotic-Contaminated Water, 24 Agronomy News 9 (2004).
279 Daughton, Drug Disposal, Waste Reduction, and Future Directions, supra note 230, at 776 (citing Sue Anne Pressley, North Carolina Effort Seeks to Wipe Out Outhouses, Washington Post, Apr. 25, 1999, at A3).
281 Id. at 776-77 (citing College of Osteopathic Medicine, Oklahoma State University, Prescription Medicines and Nursing Home: A Problem . A Solution, Health and Medicine Issue Paper (2000); and College of Osteopathic Medicine, Oklahoma State University, Prescription Medicines and Nursing Homes: Laws - Letters - Reports - Policies. An Issue Paper Resource Supplement (2000)).
282 Id. at 777.
283 Id. (citing Croukamp, Environmental-, Engineering- and Marine-Geoscience Division, Council forGeoscience, Cemetery Site Investigations (1999)).
D.6. Drug Alternatives
E. Case Study Based on Project 2 Results: A condition precedent to the release of PPCPs into water The Project 2 research focused on the presence of PPCPs supplies is the use of PPCPs. It is both obvious and frequently in soil and groundwater in West Texas.289 As more thoroughly overlooked that a reduction in the use of PPCPs would also reduce discussed below, this research focused on four inter-related research the quantity of PPCPs released into water supplies. Daughton notes, topics: (a) the sorption of PPCPs in different types of soils; (b) for example, that nutrition and health maintenance programs, by the degradation of PPCPs in soil under aerobic and anaerobic reducing the incidence of diseases requiring treatment, also reduce conditions; (c) the degradation of PPCPs in soil with high water the release of PPCPs associated with such treatment. 286 content; and (d) the presence of PPCPs in a wastewater treatment When treatment is required, use of alternative drugs (i.e., plant and in both soil and groundwater at sites to which treated drugs not containing PPCPs) should be considered. As an wastewater had been applied.290 example, Daughton notes that there is a "wide range of medical As noted in Section II, the research is relevant to the issue uses of probiotics" (beneﬁcial, endogenous microﬂora). 287 Such of PPCPs in water supplies because of disposal methods used by "bacteriotherapy" may achieve the same results as the use of drugs wastewater treatment plants for both solid and liquid wastes.291 containing PPCPs but without the attendant execration or disposal Solid wastes (sludge or biosolids) and liquid wastes are applied to 286 Id. In terms of reducing the use of PPCPs, Daughton suggest that "more research could be directed at reducing (or eliminating) drug dosages via the use of placebos." Id. (citing Damaris Christensen, Medicinal Mimicry: Sometimes, Placebos Work – But How? 159 Science News 74 (2001); Andrew F. Leuchter et al., Changes in Brain Function of Depressed Subjects During Treatment with Placebo, 159 American Journal of Psychiatry 122 (2002)). 287 Id. (citing Bob Beale, Probiotics: Their Tiny Worlds are Under Scrutiny, 16 Scientist 20 (2002)).
288 As an example, Daughton notes that probiotics "have long been used and studied for the protection of the gut" because of the capability of probiotics to block pathogen adhesion. Id. (citing Indu Pal Kaur et al., Probiotics: Potential Pharmaceutical Applications, 15 European Journal of Pharmaceutical Sciences 1 (2002)).
289 All of the sites involved in this research had been subjected to disposal of treated waste water efﬂuent through land application by the City of Lubbock's municipal waste water treatment facility, in some cases, for the past 70 years. These sites were ideal for this type of study, in part, because there are very few discharges of treated waste water efﬂuent "upstream" of the City of Lubbock's chief sources of municipal fresh water, which include Lake Meredith on the Canadian River and the Ogallala Aquifer. The effects of being located downstream of a waste water treatment are discussed supra note 80, and accompanying text.
290 Monteiro & Boxall express concern "over the potential impacts of biosolid-associated pharmaceuticals on terrestrial systems and associated groundwaters and surface waters[,]" Monteiro & Boxall, supra note 53, at 2546, noting: • "In biosolids destined for land application, a number of pharmaceuticals and personal care products have been detected." Id. (citing Chad A. Kinney et al., Survey ofOorganic Wastewater Contaminants in Biosolids Destined for Land Application, 40 Environmental Science & Technology 7207 (2006); Chris D. Metcalfe et al., Distribution of Acidic and Neutral Drugs in Surface Waters Near Sewage Treatment Plants in the Lower Great Lakes, Canada, 22 Environmental Toxicology & Chemistry 2881 (2003)).
• "Other studies have detected pharmaceuticals in biosolid-amended soils." Id. (citing Chad A. Kinney et al., Bioaccumulation of Pharmaceuticals and Other Anthropogenic Waste Indicators in Earthworms from Agricultural Soil Amended with Biosolid or Swine Manure, 42 Environmental Science & Technology 1863 (2008); Eva M. Golet et al., Determination of Fluoroquinolone Antibacterial Agents in Sewage Sludge and Sludge-treated Soil Using Accelerated Solvent Extraction Followed by Solid-phase Extraction, 64 Analytical Chemistry (2002)).
291 As noted previously, this is an increasing concern in areas of the world where reclaimed wastewater is being used for irrigation. Kinney et al. addressed this issue: As the range of uses and number of demands for potable water has increased, alternatives to using drinking water for agricultural and landscape irrigation have been of increasing interest. Reclaimed water is gaining use for irrigation; however, little is known lands that have been designated as application sites. The waste collected in Terry County, Texas and a silt loam collected in products then are degraded by natural processes.
Harlan County, Nebraska. As a control, laboratory sand was used.
An emerging concern is the sufﬁciency of natural processes The results of the study indicated that sorption capacity was a to degrade PPCPs before they migrate through the soils into function of the organic carbon content of the soils. The silt loam, groundwater or bioaccumulate in species inhabiting the soil having the highest organic carbon content, also had the greatest environment.292 With regard to the effects of bioaccumulation of sorption capacity. The laboratory sand, having the lowest organic PPCPs, speciﬁcally triclosan (TCS), Lozano et al. concluded: carbon content, also had the least sorption capacity.
Since TCS is a bacteriostat, there is a real potential that In terms of the sample PPCPs, estrone, 17-estradiol, concentrations in soils resulting from biosolid applications 17-ethynylestradiol, and triclosan had a strong tendency to sorb might affect bacterial ecology of these systems. Especially to the test soils. Once sorbed, the tendency of these substances since the ecological balance and competitive advantages of to desorb and migrate into groundwater was minimal. The same the multiple species inhabiting any soil environment are could not be said for estriol and caffeine, both of which had the very complex and any small advantage one microbe might potential to migrate into groundwater if soil leaching occurred.
achieve due to exposure to these known bacteriostat could be ampliﬁed under these conditions.293 E.2. Microbially Mediated Degradation of
Common Pharmaceuticals and Personal Care
E.1. Sorption of Estrogens, Triclosan, and Caffeine
Products in Soil Under Aerobic and Anaerobic
in a Sandy Loam and a Silt Loam Soil 294
Simply stated, sorption is the process by which one substance The City of Lubbock, Texas, disposes of treated efﬂuent from attaches to or holds another substance. Karnjanapiboonwong et its municipal wastewater treatment plant by applying it to lands al.'s research focused on the sorption of sample PPCPs in different designated a land application site. This site received an average of types of soil.
13 million gallons per day of efﬂuent, which was applied to the land using 31 center pivot sprinklers. Soil samples were collected The sample PPCPs were estrogens (estrone, 17-estradiol, from areas irrigated by the sprinklers (exposed soils) and from estriol and 17- ethynylestradiol)295 triclosan,296 and caffeine.297 The adjacent areas that had not been exposed to the treated efﬂuent PPCPs were contained in biosolids produced from a municipal (unexposed soils).
wastewater treatment plant. The soil types were a sandy loam about the potential for contamination of surface water and groundwater by use of this source. Kinney et al., supra note 26 (citing H. Bouwer et al., Integrating Water Management and Re-use: Causes for Concern? 1-2 Water Quality International 19 (1999)). 292 Id. (organic wastewater contaminants "might accumulate in soil if introduced through irrigation water").
293 Lozano et al., supra note 87, at 764.
294 Adcharee Karnjanapiboonwong et al., Sorption of Estrogens, Triclosan, and Caffeine in a Sandy Loam and a Silt Loam Soil, 10 Journal of Soils and Sediments 1300 (2010).
295 Estrone, 17-estradiol and estriol are naturally-occurring estrogens while 17 -ethynylestradiol is a synthetic estrogen commonly used in birth control pills. Research has indicated that 17 -ethynylestradiol may disrupt the reproductive capabilities of a number of different species. Id.
296 Triclosan is an antibacterial agent found in a number of consumer products such as soaps and cleaning supplies. Concern has been expressed that the presence of triclosan in water supplies may be causing bacteria to develop immunities to antibiotics. It has also been suggested that triclosan in combination with chlorine may form chloroform, a known carcinogen. Id.
297 The presence of caffeine usually indicates the presence of human waste products as no other animal consumes or excretes caffeine. Id. 298 Deborah L. Carr, Audra N. Morse, John C. Zak & Todd A. Anderson, Biological Degradation of Common Pharmaceuticals and Personal Care Products in Soils with High Water Content, Water, Air & Soil Pollution (forthcoming).
The researchers identiﬁed numerous PPCPs in the treated substance previously (as was the case at the land application site) as efﬂuent, including estrogens (estrone, 17-estradiol, estriol and compared to soils that had not been previously exposed.
17-ethynylestradiol), triclosan, ibuprofen,299 and ciproﬂoxacin.300 The rate of degradation of these PPCPs was calculated under aerobic and anaerobic conditions for PPCPs introduced into both E.4. Occurrence of PPCPs at a Wastewater
exposed and unexposed soils.
Treatment Plant and in Soil and Groundwater at a
The degradation rates for speciﬁc substances varied with soil Land Application Site 303
type and with aerobic/anaerobic condition. The most notable The aforementioned Lubbock, Texas wastewater treatment ﬁnding was that, under anaerobic conditions, the degradation rate plant and land application site were also involved in this component increased in exposed soils.
of the research. Water and sludge samples were obtained from the wastewater treatment plant with soil and groundwater samples being obtained from the land application site. As noted above, the E.3. Biological Degradation of Common
treated efﬂuent was distributed through the use of 31 center pivot Pharmaceuticals and Personal Care Products in
irrigation sprinklers. Samples were also obtained from adjacent Soils with High Water Content301
areas that were not irrigated with this efﬂuent.
This element of this case study addressed the movement of The target PPCPs, all of which were present in the water through soils. As noted by the researchers, soil texture affects wastewater efﬂuent,304 were estrogens (estrone, 17-estradiol, the movement of water, with more ﬁnely textured soils holding estriol and 17Ȑ-ethynylestradiol), triclosan, caffeine, ibuprofen water in pore space. The researchers also noted that oxygen and ciproﬂoxacin. The research question was whether these availability is limited in submerged soils and that this slows the PPCPs biodegraded, accumulated in the soils, or migrated into process of biological decay.
Soil samples were collected from the aforementioned site used The research results are illustrative of the difﬁculties inherent by the City of Lubbock, Texas for land disposal of treated efﬂuent. in the management of PPCPs. The presence of PPCPs in both the This efﬂuent contained multiple PPCPs, including estrogens sludge and efﬂuent from the wastewater treatment plant varied over (estrone, 17 -estradiol, estriol and 17 -ethynylestradiol), triclosan, time. PPCPs may sorb to the wastewater treatment plant sludge, and ibprofen. The research focused on the extent to which which could complicate land disposal of such sludge.
biological decay of these PPCPs was affected by the moisture With regard to the land application site, PPCPs were detected content of the soils at the land application site.
within the areas receiving efﬂuent from the center pivot sprinklers In general, the research demonstrated that the time needed as well as from adjacent areas that had not been irrigated but for biological decay to occur increased in soils with high water apparently were receiving runoff from the areas that had been content.302 The extent of this increase varied with both the speciﬁc irrigated. The presence of PPCPs in both areas varied over time. substance and the duration of the high water content. Another This variability was most likely a function of the variable presence variable was the extent to which the soils had been exposed to the of PPCPs in the efﬂuent from the wastewater treatment plant.
299 Ibprofen is a non-steroidal anti-inﬂammatory drug that is marketed for pain relief under a variety of different names (e.g., Motrin, Advil, etc.). 300 Ciproﬂoxacin is a common antibiotic that is sold worldwide for both human and veterinary use.
301 Deborah L. Carr et al., Microbially Mediated Degradation of Common Pharmaceuticals and Personal Care Products in Soil Under Aerobic and Anaerobic Conditions, 216 Water, Air & Soil Pollution 633 (2011).
302 The only exception was ibuprofen which appeared to demonstrate increased degradation in soils with high water content. 303 Adcharee Karnjanapiboonwong et al., Occurrence of PPCPs at a Wastewater Treatment Plant and in Soil and Groundwater at a Land Application Site, 216 Water, Air, & Soil Pollution 257 (2010) [hereinafter Karnjanapiboonwong, Occurrence of PPCPs].
304 Interestingly, 17ᾰ-ethynylestradiol was not detected in the sludge from the wastewater treatment plant. All the other target PPCPs were
The presence of PPCPs also varied with the depth of the evaluating the potential long-term effects of PPCPs from soil from which samples were taken. This led the researchers to contamination of soil and eventually groundwater if that conclude: "Any trend in target PPCP concentrations with soil water is to be used for drinking-water purposes.306 depth was difﬁcult to discern and is likely due to the various biodegradation rates of PPCPs with soil depth; degradation of PPCPs can be affected by environmental conditions such as E.5. Conclusions from the Case Study
temperature, pH, moisture content, organic carbon, presence of speciﬁc microorganisms, and presence/absence of oxygen."305 The research results summarized above relate to a series of studies involving the presence of a fairly limited number of PPCPs Of all of the PPCPs included in the study, only ibuprofen at a relatively small number of sites. With one exception (soil was not detected in the groundwater samples. This was true samples from Harlan County, Nebraska), all of the sampling was irrespective of whether the groundwater samples were drawn from done at the Lubbock, Texas wastewater treatment plant, the land the areas irrigated with the wastewater efﬂuent or from adjacent application site for efﬂuent from the plant, or lands adjacent to the areas that had not been irrigated. The research concluded: land application site.
PPCPs in the efﬂuent from a wastewater treatment Nonetheless, a signiﬁcant amount of variability was noted. plant can eventually move to groundwater via land Degradation of PPCPs was seen to be affected by: (a) soil type and application of the efﬂuent. However, PPCPs detected in organic content; (b) soil moisture content (including variation in groundwater at the study site were at low concentrations rainfall); (c) soil oxygen content; and (d) prior exposure to PPCPs. which are not likely to represent a concern and indicate As noted above with regard to the presence of PPCPs in soils, that the land application process is reasonably effective at additional variables could include temperature, acidity/alkalinity PPCP removal[.] … Our ﬁndings may be important for and the presence of speciﬁc microorganisms.307 305 Id. (citing Monteiro,supra note 56; Alistair B.A. Boxall, Fate and Transport of Veterinary Medicines in the Soil Environment, in Fate of Pharmaceuticals in the Environment and in Water Treatment Systems (Diana S. Aga ed., CRC Press 2008); Michael S. Colucci, Henry Bork, & Edward Topp, Persistence of Estrogenic Hormones in Agricultural Soils: I. 17ß-Estradiol and Estrone, 30 Journal of Environmental Quality 2070 (2001)).
307 With regard to temperature, Kinney et al., have noted seasonal variability: Down-core migration of pharmaceuticals may occur from either the reclaimed-water irrigation or from pharmaceutical-free precipitation. This result also could be explained by variations in the concentration of these compounds in the reclaimed water or a change in removal/degradation rate. The latter could be accounted for by differences in soil microbial population dynamics. Higher soil temperatures, consistent soil moisture, and perhaps, a steady supply of substrate and nutrients in the reclaimed water could result in greater degradation of the compounds by soil microbes during the summer irrigation period compared to that during the winter months. Kinney et al. supra note 26, at 322 (emphasis added). Lozano, et al., noting that soil concentrations of triclosan (TCS) were quite variable, concluded: "Our data suggests that the two most important parameters controlling TCS top soil concentrations are the biosolids application rate and the time between application and sampling." Lozano et al., supra note 90, at 762. This variability was also addressed in Monteiro & Boxall, supra note 53, at 2546: • "Laboratory studies show that degradation rates of pharmaceutical compounds in soils vary widely, with half-lives ranging from days to years." Id. (citing Alistair B.A. Boxall, Fate and Transport of Veterinary Medicines in the Soil Environment, in Fate of Pharmaceuticals in the Environment an in Water Treatment Systems 123 (Diana S. Aga ed., CRC Press 2008)). • "Within the same therapeutic class, half-lives can still be signiﬁcantly different ." Id.(citing Michael P. Schlüsener & Kai Bester, Persistence of Antibiotics Such as Macrolides, Tiamulin and Salinomycin in Soil, 143 Environmental Pollution 565 (2006)). • "These differences are probably explained by differences in soil properties such as moisture content, organic carbon, pH, and soil bioactivity; climate (temperature); and physicochemical properties of the compound such as degree of dissociation and This variability, especially when considered over a national statute-speciﬁc strengths and weaknesses are discussed below, scale, points to the difﬁculty of controlling or managing PPCPs many of the beneﬁts and costs of a statutory or regulatory approach once they have been introduced into the environment.308 Different are not statute speciﬁc.
PPCPs degrade at different rates and under different conditions Any regulatory program must be authorized by statute. Such at different locations. Given the complexity of the problem, it is enabling legislation deﬁnes the scope of an agency's regulatory highly likely that post-release solutions will be inadequate.
authority. Existing environmental statutes have vested substantial Consequently, as discussed in greater detail below, eliminating authority in the Environmental Protection Agency (EPA). Similar or reducing PPCPs in the waste stream is much more likely to legislation at the state, territorial and tribal levels has vested reduce both human and environmental risks than any postrelease authority in entities whose functions mirror those of the EPA.309 alternatives. In essence, it is much easier to keep PPCPs out of The result has been the development of substantial agency waste stream than to safely dispose of waste containing PPCPs.
expertise regarding speciﬁc issues. This is one of the major strengths of the existing statutory/regulatory approach to environmental regulation.
F. Strengths and Weaknesses of the Statutory, Regulatory and Alternative Agency expertise has developed as environmental law in the United States has matured. At this point in the history of environmental law, the requirements of the statutes are fairly well F.1. Statutory and Regulatory
known and understood, and the scope of EPA authority has been Statutory and regulatory approaches to the control of PPCPs established. The result is a fairly complete understanding of the may have both substantial beneﬁts and signiﬁcant costs. Though requirements of different statutes and regulations. As with the lipophilicity." Id. (citing Edward Topp et al., Fate of the Nonsteroidal Anti-inflammatory Drug Naproxen in Agricultural Soil Receiving Liquid Municipal Biosolids, 27 Environmental Toxicology and Chemistry 2005 (2008); Melanie Kah et al., Factors Influencing Degradation of Pesticides in Soils, 55 Journal of Agriculture and Food Chemistry 4487 (2007); Edward Topp et al., Biodegradation of Caffeine in Agricultural Soils, 86 Canadian Journal of Soil Science 533 (2006); and M.S. Collucci et al., Persistence of Estrogenic Hormones in Agricultural Soils (I. 17-beta Estradiol and Estrone), 30 Journal of Environmental Quality 2070 (2001)).
308 Such variability is not conﬁned to the case study. A study of PPCPs in the Ann Arbor, Michigan water use cycle identiﬁed a number of antibiotics, analgesics, antiepileptics, steroids and hormones in raw wastewater inﬂuent over a number of months. Variability in the presence of these substances can be seen by comparing the mean concentrations with the standard deviation (a measure of variance): Mean concentration
Coprostanol (steroid/hormone) Cholesterol (steroid/hormone) Sitosterol (steroid/hormone) Dihydrocholesterol (steroid/hormone) Stigmasterol (steroid/hormone) Acetaminophen (analgesic) Ibuprofen (analgesic) Skadsen et al., supra note 77 at 4, Table 4.
309 The Food and Drug Administration also has substantial authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. This authority, which includes the responsibility to ensure the safety and efﬁcacy of both human and animal drugs (21 U.S.C. § 355), was expanded with enactment of the Food Quality Protection Act of 1996. The 1996 amendments authorized the Environmental Protection Agency "to screen substances that may be found in sources of drinking water for endocrine disruption potential." Keith A. development of agency expertise, this is also one of the strengths of Likewise, any remedy provided by the court is limited to the the current statutory/regulatory system.
parties before the court. The outcome of litigation is inﬂuenced frequently by the resources available to the parties. Any potential However, a weakness associated with this system is the limited outcome may change dramatically if the parties, for whatever ability of the system to respond to site-speciﬁc issues. If PPCPs are reason, choose to settle the litigation. determined to be a threat to human health and the environment, for example, a national regulatory program could be implemented based In general, litigation has not proven to be an effective means of on one of the statutes discussed herein. Unfortunately, the problem protecting public health and the environment. That said, litigation of PPCPs may be localized as the number of variables identiﬁed in will certainly continue based both on common law tort theories the Section V case study would appear to indicate. The response and the statutes discussed in Section III.
could be the proverbial use of a sledgehammer to kill a gnat.
It is at least theoretically possible that a trespass action could be brought involving PPCPs. In the Section V case study, for example, treated efﬂuent containing PPCPs was applied to lands F.1.1. Common Law Remedies Sounding in Tort
using center pivot irrigation systems. The researchers noted that Entitlement to relief under the common law remedies is based PPCPs were also found in soil samples taken from lands adjacent on success in litigation. Since the common law tort theories to the areas where the treated efﬂuent had been sprayed. It was apply to disputes between individuals (civil wrongs as opposed to speculated that PPCPs were found on adjacent lands because of criminal or societal wrongs), application of the theories arises in run-off from the irrigated areas. On these facts, a trespass action the context of litigation between such individuals. might be feasible. However, in order to recover more than merely nominal damages, the plaintiff would have to prove that the Consequently, all of the weaknesses of litigation as a means conduct of the defendant resulted in damage to the plaintiff. Given of environmental regulation would be applicable to litigation the low levels of PPCPs noted in the case study, fulﬁlling the involving potential PPCP liability. Litigation is expensive and burden of proof regarding damages may be difﬁcult. time-consuming. Assuming that the party bringing the action has the requisite legal standing, the scope of issues before the court is A public nuisance action might be possible if it could be limited to the issues raised by the parties which are almost always shown that the use of public "streams, parks, beaches and other unique to a speciﬁc case.
Johnston & Kristine Sendek-Smith, Muddy Waters: Recent Developments Under the Clean Water Act, 24-Winter Natural Resources and Environment 31, 37 (2010): Through what has been a long and contentious process, the EPA's Endocrine Disruptor Screening Program is ﬁnally making progress in helping identify endocrine disruptors from the tens of thousands of chemicals currently in use, and it will eventually study the effects of those chemicals and compounds on humans and wildlife. EPA is near publication of the results of its sampling performed in 2007 to determine the prevalenceof certain chemicals in drinking water and is also set to expand sampling this year to obtain water samples from up to ﬁfty drinking water treatment plants to help analyze the prevalence of about 200 emerging contaminants in drinking water. Id. at 37-38 (citing Alan Kovski, Drinking Water: EPA Details Emerging Contaminants Survey, Responds to Questions about Its Usefulness, 40 Environment Reporter 2361 (Oct. 9, 2009)). Johnston and Sendek-Smith also note that the U.S. Geological Survey is in the process of developing a national reconnaissance program for emerging contaminants. This program is to focus "on four groups of compounds: veterinary and human antibiotics, human drugs, industrial and household products (such as insecticides, detergents, ﬁre retardants, and fuels), and sex and steroidal hormones." Id. at 38 (citation omitted). Authority for such a program, they note, is provided by the Safe Drinking Water Act (42 U.S.C. § 300j-17), the Toxic Substances Control Act (15 U.S.C. § 2603), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 346(a)(p), 408(p)) and the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. § 136(c)(2)(B)). Id. In addition, Nidel has noted that the authority of the Food and Drug Administration "was expanded into the environmental realm by enactment of the National Environmental Policy Act (NEPA), which not only provides FDA with the authority to bring environmental considerations into its decisionmaking, but also requires that it take these considerations into account." Christopher T. Nidel, Regulating the Fate of Pharmaceutical Drugs: A New Prescription for the Environment, 58 Food & Drug Law Journal 81, 92 (2003) (citing 42 U.S.C.S. §§ 4321 et seq.). Accord Christenson, supra note 172, at 156; George J. Mannina, Jr., Medicines and the Environment: Legal and Regulatory Storms Ahead?, 21 Legal Backgrounder, no. 11, 1, 3 (March 26, 2006). facilities"310 was adversely affected by water supplies contained However, as noted above, litigation is always fact-speciﬁc. Given PPCPs. Again, it would be the plaintiff 's burden to show harm. As an appropriate set of circumstances, application of one of the common noted above, given the low levels of PPCPs noted in the case study, law tort theories might be an appropriate response to human and fulﬁlling this burden of proof requirement may be difﬁcult.
environmental health injuries resulting from the release of PPCPs.313 Application of the theory of negligence might be appropriate when it could be documented that a speciﬁc plaintiff was injured by PPCPs released into the environment by a speciﬁc defendant. F.1.2. The Clean Water Act
However, this assumes that the appropriate chain of causation As noted in Section III, states are authorized to promulgate could be established. This is not a safe assumption given the water quality standards based on the National Recommended ubiquitous nature of PPCPs. There is no question that the Water Quality Criteria ("Criteria"). The state standards are then manufacturers of PPCPs owe a duty of due care to prevent adverse subject to EPA approval. Lopez has argued that the Environmental public and environmental health impacts. The weakness in trying Protection Agency has a mandatory duty to revise the Criteria to apply the theory of negligence to such manufacturers is the great "to establish limitations for EDCs [and other PPCPs] to protect degree of difﬁculty in determining the manufacturer of any speciﬁc against endocrine disruption."314 Should this occur, National PPCP alleged to have caused harm.
Pollutant Discharge Elimination System (NPDES) permits ultimately would have to include appropriate measures to eliminate Applying the theory of strict liability would be predicated or control PPCPs. Absent such an NPDES permit, discharges of on the averment that PPCPs are inherently dangerous products PPCPs from point sources into "waters of the United States" would for which the manufacturers should be strictly liable. Given the "value of the activity to the community"311 (i.e., the prevention or treatment of disease), it would be exceptionally difﬁcult, if not The wastewater treatment industry is familiar with both the impossible, for a plaintiff to demonstrate that PPCPs are inherently Clean Water Act and the use of NPDES permits. While this may be one of the strengths of this approach to the control of PPCPs in 310 Restatement (Second) of Torts, supra note 96, at § 821D and related text.
311 Id. at § 402A.
312 For example, acetylsalicylic acid is used for both human therapy and in animal husbandry. It is "a nonsteroidal anti-inﬂammatory" that is "also used for its analgesic, antipyretic and anti-coagulating properties." Acetylsalicylic acid "is known to cause skin, eye and upper respiratory tract irritation upon direct contact and gastrointestinal bleeding following chronic ingestion." It is "a known systemic allergen and can produce anaphylaxis at doses in the lowest end of the therapeutic range (10 mg/kg)." However, there is "strong epidemiological evidence" that acetylsalicylic acid may also afford protection from some cancers. When used for both human therapy and in animal husbandry, salicylic acid and other metabolites are excreted in urine and may end up in water supplies. On these facts, it would be difﬁcult to argue that acetylsalicylic acid is an inherently dangerous product, especially since its commonly used name is aspirin. Schulman et al., supra note 13, at 660 (citation omitted).
313 In fact, Mannina provides an example of such circumstances: [A]n Illinois municipal water district which owns and operates a plant providing water to municipal residents and businesses has sued the manufacturers of certain herbicides demanding that the manufacturers clean up all residue from a substance which has found its way into the source of the drinking water and also pay for the costs of installing and operating additional water treatment systems to guarantee the removal of any residue from this herbicide. What makes this case signiﬁcant is that the plaintiff does not allege the herbicide is being used unlawfully or contrary to the manufacturer's instructions. Nor are there any allegations of a violation of the safe drinking water standards established by EPA or the State of Illinois. Rather, the plaintiff, citing various studies allegedly demonstrating adverse human health impacts of herbicide residue at concentrations less than the existing safe drinking water standards, asserts that the federal and state standards are not protective of human health. The plaintiff then asserts that the herbicide manufacturers are guilty under state law of trespass, nuisance, negligence, and releasing "contaminants" into the environment solely because residue from the herbicide has come to be located in water owned and used by the plaintiff. While this case does not involve pharmaceuticals or personal care products, one can imagine creative attorneys using similar and related theories. Mannina, supra note 309, at 3 (emphasis added).
water supplies, it is also one of the weaknesses. If PPCPs are to be publically-owned treatment works may be both ﬁnancially and controlled through the use of NPDES permits, which PPCPs should politically impossible. As Jones has noted: "Although the public the regulation target and using what technology? The plethora of may want pure water, people are not prepared to pay what it would PPCPs would appear to require a plethora of control technologies.
actually cost even if sufﬁcient technology did exist."321 A directly related question, assuming that control of PPCPs Finally, perhaps the most signiﬁcant limitation regarding use is mandated at wastewater treatment plants, focuses on treatment of the Clean Water Act as a means of preventing the introduction techniques and systems. As noted in Section IV, new water of PPCPs into water supplies is the fact that the statutory treatment systems have been (and are being) developed.315 A requirements do not apply to nonpoint sources of wastes. Such number of authors have noted the need for these technological nonpoint sources (e.g., runoff from farms) are "a signiﬁcant sources developments to continue. Nidel, for example, notes the of the pharmaceuticals found in surface water[.]"322 need to development new wastewater treatment systems that "more effectively break down these compounds leaving only environmentally inert efﬂuents."316 The related question, therefore, F.1.3. The Safe Drinking Water Act
is whether the development and use of new wastewater treatment technology should be a condition precedent to the issuance of Inclusion of PPCPs in the National Primary Drinking Water NPDES permits.
Regulations would be one means of limiting human exposure to PPCPs. Maximum Contaminant Level Goals (MCLGs) and Maximum Requiring pretreatment of wastes containing PPCPs has been Contaminant Levels (MCLs) could be established for PPCPs.
suggested.317 Such requirements would be applicable to a variety of entities (i.e., manufacturing facilities, health care facilities) that In fact, such an approach is being considered by EPA. As discharge wastes containing PPCPs.318 The goal of such requirements indicated in Section III, the Contaminant Candidate List (CCL) would be to mandate the pretreatment of wastes that would either includes contaminants not presently subject to the National interfere with the operation of a wastewater treatment plant or that Primary Drinking Water Regulations but which may have an would pass through a wastewater treatment plant untreated.319 adverse impact on human health and is known to occur in water supply systems. If so, the EPA Administrator may subject the Assuming that wastewater treatment techniques and systems contaminant to the National Primary Drinking Water Regulations. can be developed to control the plethora of PPCPs, the cost The current CCL, which was published on 21 August 2008, lists could be staggering.320 Imposing such costs on the operators of 104 contaminants.323 Unfortunately, virtually all of the PPCPs that 314 Jacki Lopez, Endocrine-Disrupting Chemical Pollution: Why the EPA Should Regulate These Chemicals Under the Clean Water Act, Spring Sustainable Development Law and Policy 19, 22 (2010). 315 Supra, notes 268 to 280 and associated text.
316 Nidel, supra note 309, at 82. However, "this solution is under-inclusive [in that it] does not address the large amounts of animal drugs that make their way directly into the environment." Id. at 91.
317 Christenson, supra note 172, at 163 (citing P.G. Kent & T.A. Dudiak, WISCONSIN WATER LAW: A GUIDE TO WATER RIGHTS AND REGULATIONS 104 (2d ed. 2001)).
320 "The total costs of removing every possible endocrine disrupting compound could quickly become astronomical." Jones, supra note 229, at 385-386. 321 Id. at 386.
322 Christenson, supra note 172, at 148 (citing P.G. Kent & T.A. Dudiak, Wisconsin Water Law: A Guide to Water Rights and Regulations 107 (2d ed. 2001)).
323 Notice, Drinking Water Contaminant Candidate List 3, 73 Fed. Reg. 9628 (2008).
were proposed for inclusion on the CCL were not included.324 or the general environment. The current CCL process for chemicals would not identify this as an adverse effect.325 Perhaps because of this outcome, the Science Advisory Board Drinking Water Committee of the EPA Ofﬁce of Ground Water A ﬁnal decision regarding "whether to regulate ﬁve of more and Drinking Water recommended changes to the CCL selection of the contaminants from this list" is expected by 2013.326 If PPCPs are included within the regulatory scope of the Safe Drinking Water Act, it has been suggested that a "No Observed The Committee recommends consideration of emerging Transcriptional Effect Level" (NOTEL, deﬁned as "the dose issues and on-going research when selecting chemicals. of chemical which results in no signiﬁcant changes to gene There are also some clear categories of contaminants that expression") should be the regulatory limit.327 need special attention in selecting the CCL including pharmaceuticals, personal care products, endocrine The weakness of this approach has been noted already: the disruptors, antibiotics, and algal toxins. Such contaminants ubiquitous nature of PPCPs. As with alternatives under the Clean may warrant changes in the CCL selection processes. Water Act, requiring public water supply systems to address all General exposure to even low levels of antibiotics in PPCPs could impose ﬁnancial burdens that are neither ﬁnancially drinking water, for example, may lead to antibiotic- nor politically feasible.
resistant pathogens either in a person drinking the water 324 The process that preceded the current Contaminant List was described by ToxServices LLC: EPA identiﬁed 287 pharmaceuticals in its initial listing of a broad range of potential drinking water contaminants in the draft CCL3 [Drinking Water Contaminant Candidate List 3] that had data to indicate a potential to occur in drinking water and health effects. The health data used was primarily from the FDA's Database on Maximum Recommended Daily Doses and the occurrence data was from the U.S. Geological Survey's Toxic Substances Hydrology Program's National Reconnaissance of Emerging Contaminants, and TRI [Toxic Release Inventory] and high production volume chemical data. Further screening moved approximately 10 percent of the pharmaceuticals to the preliminary CCL. Only one of the pharmaceuticals, nitroglycerin, was included in the draft CCL3. ToxServices LLC, supra note 34, at 12.
325 EPA Science Advisory Board Drinking Water Committee, Environmental Protection Agency, Sab Advisory on EPA's Draft Third Drinking Water Contamination Candidate List (CCL 3) 7 (2009). The Committee also addressed PPCPs in the context of contaminants that were not included on the draft CLL. With regard to concentrations of contaminants in wastewater and the potential reuse of such water supplies, the Committee concluded: The Committee concludes that it will be important to consider information regarding wastewater concentrations when evaluating potential exposure in the CCL process. In some areas of the country, wastewater discharges are increasingly a greater percentage of water supplies, and they are being processed into potable water. Wastewater contains a wide variety of contaminants including pharmaceuticals, personal care products, enteric pathogens, and other emerging contaminants. In the case of pharmaceuticals, perﬂourinated surfactants, and other contaminants that are prevalent in wastewater efﬂuent, EPA may want to consider using data obtained in specialized wastewater efﬂuent monitoring programs for the CCL screening process. Id. at 14. In terms of chemical contaminants, the Committee noted the absence of data: The absence of data on the occurrence of pharmaceuticals in surface waters was also noted. The Committee recommends use of the data from the USGS, or any of the numerous studies in the peer-reviewed literature, to include these chemicals. 326 Johnston & Sendek-Smith, supra note 309, at 38 (citing Alan Kovski, Drinking Water: EPA Completes List of Water Contaminants to Consider as Candidates for Regulation, 40 Environment Reporter 2246 (Sept. 25, 2009)). EPA has also considered inclusion of PPCPs within the Unregulated Contaminant Monitoring Rule.
The Surface Water Treatment Rule could be amended to F.1.4. The Resource Conservation and Recovery Act
require removal of PPCPs in addition to the contaminants already The deﬁnition of a "hazardous" waste contained in the subject to the Rule. Again, the cost of such an approach may not Resource Conservation and Recovery Act (RCRA) could be make it ﬁnancially or politically opportune.
expanded to include additional wastes containing PPCPs.328 At the present time, for example, wastes discharged pursuant to a An alternative that may not face the twin roadblocks of National Pollutant Discharge Elimination System Permit are not ﬁnancial and political feasibility would be to amend the Wellhead subject to the requirements of RCRA.
Protection Program to preclude the discharge of wastes containing PPCPs in wellhead protection areas. For example, prohibiting Inclusion of wastes containing PPCPs within the deﬁnition either (a) the installation or use of septic tanks in wellhead of a "hazardous" waste would subject the waste stream to the protection areas or (b) the land application of wastewater treatment requirements of RCRA.329 Generators and transporters of wastes plant residues (biosolids) in such areas could protect groundwater containing PPCPs, as well as operators of treatment, storage and from wastes containing PPCPs.
disposal facilities (TSDF) for such wastes, would have to comply with the requirements of RCRA, including use of the Uniform A similar amendment could be implemented regarding the Hazardous Waste Manifest System and permit requirements to Underground Injection Control Program. Injection of wastes construct and operate a TSDF.
containing PPCPs could be restricted to Class I injection wells. As with the possible amendment to the Wellhead Protection However, because of the limited number of TSDFs and the Program, the goal would be to prevent the migration of PPCPs difﬁculty of establishing new TSDFs, imposing such requirements into groundwater resources.
could be both costly and burdensome to the waste management community. The volume of waste subject to RCRA requirements Sludge or biosolids containing PPCPs from water treatment would increase dramatically. The cost of disposing such waste plants could be subject to the Part 503 Biosolids Rule. The Rule could increase in proportion to the quantity of wastes generated.
would have to be amended to establish both ceiling and loading rate limits for PPCPs. As noted in the case study, liquid wastes containing One result seen repeatedly when disposal costs are excessive PPCPs were used to irrigate a waste disposal site. It may be necessary is an increase in illegal dumping of hazardous wastes. If costs to expand the Biosolids Rule to apply to such situations.
increase because of an imposition of RCRA requirements on wastes containing PPCPs, the resultant illegal dumping would most likely include a wide variety of hazardous wastes that previously would have gone to an approved TSDF.
327 Poynton & Vulpe, supra note 34, at 91 (citing E.K. Lobenhofer et al., Exploration of Low-Dose Estrogen Effects: Identification of No Observed Transcriptional MAQC Effect Level (NOTEL), 32 Toxicologic Pathology 482 (2004); Gerald T. Ankley et al., Toxicogenomics in Regulatory Ecotoxicology, 40 Environmental Science & Technology 4055 (2006)). As Poynton and Vulpe concluded, "[a]ny signiﬁcant cellular perturbation should cause some change in gene expression; therefore, the NOTEL represents a true No Observed Effect Concentration." Id. at 91. 328 Christenson addressed this approach in the context of health-care facilities, concluding: [T]he list of hazardous drugs "has not been substantially updated since the rules went into effect in 1976." For example, only eight out of 100 different chemotherapy drugs are currently on the list of hazardous wastes. In fact, health-care facilities have an extremely difﬁcult time dealing with the RCRA because the regulations were not designed for the health-care industry. Thus, when there are regulations, they are complicated and expensive to follow, and when there are not regulations, hospitals are left in the unenviable position of developing their own disposal programs or ﬂushing drugs down the toilet. Christenson, supra note 172, at 150 (citing R. Seely, Flushed Drugs Polluting Water; Complicated Rules for Disposal Result in Most Hospitals Taking Easy Way Out, Wisconsin State Journal, Dec. 10, 2006, at A1.). See also, Mannina, supra note 309, at 4 ("Provisions in RCRA and in Drug Enforcement Administration regulations which are designed to protect the public from the improper discharge or disposal of medical waste and controlled substances may, in reality, be encouraging medical professionals and the public to ﬂush unused pharmaceuticals in toilets or drains."). 329 As noted by Mannina: An alternative could be to revise the Universal Waste Rule to However, concerns have been expressed regarding the inclusion include PPCPs. In fact, on December 2, 2008, the EPA proposed of PPCPs on the Universal Waste list. These concerns focus on adding PPCPs to the Universal Waste list.330 The proposed the contention that the regulation of PPCPs under the Universal revisions would add hazardous pharmaceuticals to the list. The Waste Rule "may be less stringent than the rules for hazardous rule, as amended, would apply to pharmacies, hospitals, physicians' wastes under RCRA."336 ofﬁces, dentists' ofﬁces, outpatient care centers, ambulatory health care services, residential care facilities and veterinary clinics as well as other facilities that produce hazardous pharmaceutical wastes.331 F.1.5. The Toxic Substance Control Act
EPA has estimated that the proposed revision would affect up to Solid and liquid wastes containing PPCPs could also be subject 634,552 entities, of which approximately 181 are large quantity to the requirements of the Toxic Substances Control Act (TSCA). generators of hazardous waste.332 The amendments would allow If so, Title I of TSCA would require manufacturers and processors producers of hazardous pharmaceutical wastes to choose whether of such wastes to conduct a testing program "to predict the effects (a) to continue to have their wastes regulated under the current of human exposure and environmental releases."337 RCRA regulations or (b) to manage their hazardous wastes under the Universal Waste Rule.333 Regulatory controls are available under TSCA regarding the processing, distribution, use or disposal of a chemical presenting The proposed revision is also intended to facilitate the an unreasonable risk of injury to health or the environment.338 If collection of pharmaceutical wastes from households, including wastes containing PPCPs fall within the purview of TSCA, then non-hazardous pharmaceutical wastes.334 Of relevance to the this provision, as well as all of the regulatory controls authorized by source control options discussed below, EPA believes that the TSCA, could be applicable. If so, given the wide variety of PPCPs, amendments will simplify pharmaceutical take-back programs the potential scope and cost of complying with these requirements by "streamlining the requirements for handling hazardous could make compliance problematic.
pharmaceutical wastes received as part of a take-back program."335 EPA has listed several common medications and nine chemotherapy agents as hazardous waste if discarded. But there are more than 100 toxic chemotherapy agents which are not yet RCRA regulated. Mannina, surpa note 309, at 2. Regulation of these wastes could have unintended consequences: If regulated substances are released into the environment, as those terms are understood under Superfund [the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq.] and the Clean Water Act, can we look forward to cleanup orders and claims for natural resource damages under those laws? The answer is probably yes.
330 Amendment to the Universal Waste Rule: Addition of Pharmaceuticals, 73 Fed. Reg. 73520 (Dec. 2, 2008) (to be codiﬁed at 40 C.F.R. pt. 260, 261, 264, 265, 268, 270 and 273).
331 Environmental Protection Agency, EPA Proposes Streamlined Disposal of Hazardous Pharmaceutical Waste (Nov. 2008), available at http://www.epa.gov/osw/hazard/wastetypes/universal/pharm-fs.pdf.
332 Amendment to the Universal Waste Rule: Addition of Pharmaceuticals, 73 Fed. Reg. at 73520.
335 Id. at 73526.
336 Johnston & Sendek-Smith, supra note 309, at 38 (citing Environmental News Stand, EPA Urged to Up RCRA Pharmaceuticals Enforcement at Hospitals, INSIDE EPA (July 1, 2009). 337 TSCA, § 2603, supra note 196 and associated text.
338 Id. at § 2605(a).
F.1.6. The Endangered Species Act
case, a federal judge upheld a ﬁnding that ﬁshing was adversely affecting an ESA-protected species even though The ﬁnancial and political burdens confronting use of the there was no evidence that ﬁshing was causing any impact. aforementioned statutes would cease to be a threshold issue if The logic, using the ESA's insure no harm standard, was wastes containing PPCPs led to the "taking" of a threatened or that ﬁshermen catch ﬁsh, the listed species eat ﬁsh, and, endangered species. As discussed in Section II, the impacts of therefore, there must be an adverse impact from ﬁshing. PPCPs in water supplies have been observed in a wide variety Apply that reasoning to pharmaceuticals in the environment of aquatic species. At some point, a cause of action will arise and it is not a very long leap before the ESA can be brought when PPCPs in water supplies result in the "taking" of a species to bear on protected species such as the razorback sucker and protected by the ESA or similar legislation enacted by state, local other listed species of fish, including virtually all the salmon or Tribal governments.339 and steelhead species in the Pacific northwest.343 In fact, these causes of action may already have ripened. Implementing a recovery plan under the ESA can be both Lopez notes that "[t]here is evidence that EDCs are signiﬁcantly socially disruptive and expensive. The preferred alternative is to degrading habitat, including federally designated critical habitat, take whatever steps might be needed to preclude the need to list a and are likely injuring ﬁsh and wildlife by disrupting behavior species as threatened or endangered. This could include regulating patterns such as breeding ability."340 This could give rise to a or prohibiting the discharge of wastes containing PPCPs, "taking" cause of action regarding a number of threatened or especially if the cause of the "taking" is related to the discharge endangered species including the Razorback Sucker (Xyrauchen of such wastes. While such an approach may not be politically texanus), the Desert Pupﬁsh (Cyprinodon macularius) and the popular, the alternatives (listing a species and implementing a Santa Ana Sucker (Catostomus santaanae).341 recovery plan) are substantially less popular.
An alternative cause of action noted by Mannina is based on the ESA requirement that "federal agencies (including agencies approving the use of pharmaceuticals and hormones) ‘insure' that F.2. Alternative Strategies
any action they take or authorize is not likely to adversely affect The source control alternative strategies discussed in Section IV species protected by the ESA.342 Based on this requirement, may be more effective in reducing or eliminating PPCPs in water Mannina concluded: supplies than the imposition of a statutory or regulatory approach. Experienced ESA attorneys are all too well aware of how The approaches advocated by Daughton and others focus on little proof of impact is required before the ESA's "insure" minimizing or eliminating sources of PPCPs.344 no harm standard triggers regulatory controls. In one ESA 339 The Endangered Species Act is not the only federal species protection statute that might provide a cause of action should protected species be affected adversely by PPCPs. See, e.g., the Bald and Golden Eagle Protection Act, 16 U.S.C. §§ 668-668d; the Marine Mammal Protection Act, 16 U.S.C. §§ 1361- 1421h; the Migratory Bird Treaty Act, 16 U.S.C. §§703-712. Similar species protection legislation enacted by state, local and Tribal governments might provide additional causes of action.
340 Lopez, supra note 314, at 20 (citing Susan Jobling et al., Wild Intersex Roach (Rutilus rutilus) Have Reduced Fertility, 67 Biology of Reproduction 515 (2002) (ﬁnding that EDC-caused altering of sex characteristics leads to reduced reproductive ability)).
341 Id. at 21. See also, Mannina, supra note 309, at 2 ("ESA issues may already be present in Nevada where a USGS toxicologist detected elevated levels of pharmaceuticals and hormones in waterways downstream from Las Vegas and a very large decrease in sperm production in three species of ﬁsh, including the endangered razorback sucker.").
342 Mannina, supra note 309, at 2.
343 Id. (emphasis added).
344 As in Section IV, the discussion in this Section focuses primarily on pharmaceuticals. Nevertheless, the analysis is equally applicable to personal care products and the full array of PPCPs previously identiﬁed in footnote 6. See supra note 4.
F.2.1. Drug Design
F.2.2. Drug Delivery
Designing drugs to minimize the human and animal The drug delivery alternatives suggested by Daughton are excretion of wastes containing PPCPs would have the effect of predicated in part on voluntary participation by physicians, patients, reducing the volume of PPCPs entering water supplies. Any pharmacies and drug manufacturers. Despite Daughton's faith in number of commentators have argued that the Food and Drug public education programs, such appeals to conscience have not been Administration (FDA) needs to assess the PPCP discharge an effective means of addressing environmental health problems. 350 potential as a component of the FDA's drug approval process.345 Such an assessment could be undertaken in the context of the Environmental Assessment process mandated by the National F.2.3. Drug Marketing
Environmental Policy Act.346 "The hope," observed Nidel, "is that with an adequately informed FDA sitting as gatekeeper to The cost of informing consumers of appropriate means of this highly proﬁtable market, drug design will evolve. This will discarding unused drugs should be minimal vis-à-vis the beneﬁt of lead drug companies to internalize the external impacts of their reducing PPCPs in water supplies. However, the cost of producing products and, where feasible, design drugs of the future that are a variety of package sizes in order to minimize the quantity of noted for their minimal impact on the environment as well as for unused drugs needing disposal could be substantial. Given the their therapeutic effectiveness."347 sensitivity of consumers to drug prices, those alternatives with the least costs are more than likely the most feasible.
As noted below,348 Daughton has suggested that patent extension be used as an incentive to encourage drug companies to implement alternative source control strategies. Others have F.2.4. Drug Dispensing
suggested the need for ﬁnancial incentives or other types of ﬁnancial support, particularly with regard to drug design.349 McGrath notes that the State of Maine has limited the quantity of drugs that physicians may "prescribe for ﬁrst-time users of Despite the provision of such ﬁnancial support, a restraint certain medications."351 The political feasibility of such an approach on the feasibility of this alternative could be the need for drug raises issues regarding both the social responsibility of physicians manufacturers to pass the cost of drug development to the and the role of the state in the doctor-patient relationship.
general public. Absent a deﬁnitive showing of adverse human or environmental health impacts resulting from exposure to PPCPs, Dispensing the correct quantity of a drug with an appropriate the political feasibility of increasing the cost of drugs in order to expiration date (i.e., the drugs will not expire before the course limit PPCPs in water supplies is an open question.
of treatment has been completed) could be a win-win situation, at least for the patient and the environment. Whether such an approach would be considered a "win" for drug manufacturers is an open question.
345 As Nidel has noted, "[r]equring a more rigorous assessment when applying for new drug approval would shift the focus of the root-cause of the problem." Nidel, supra note 309, at 82.
346 Id. at 92-93.
347 Id. at 100.
348 Infra, note 360 and associated text.
349 Christenson, supra note 172, at 169 (citing Nidel, supra note 309, at 94 for the proposition that the Food and Drug Administration "already has the necessary authority" to "increase environmental review of the design of new drugs or offer intellectual-property or tax-based incentives to those manufacturers who voluntarily test for environmental effects.").
350 See, e.g., Garrett Hardin, The Tragedy of the Commons, 162 Science 1243, 1246-1247 (the "tragedy of the commons" cannot be remedied by appeals to conscience). 351 Neal McGrath, Water Pollution: Pharma's Next Big Headache?, Greenbiz.com Blogs (August 31, 2009), http://www.greenbiz.com/blog/2009/08/28/water-pollution-pharmas-next-big-headache. F.2.5. Drug Disposal/Recycling
impediment to takeback programs, that "the same pharmacist who is authorized to distribute medications … is not authorized to Existing institutional barriers to drug disposal and recycling take the medication back without prior approval by a DEA [Drug need to be revised. While there may be good reasons for some of Enforcement Administration] agent." 353 these barriers to continue (e.g., prevention of theft of discarded pharmaceuticals), blanket prohibitions encourage the inappropriate Despite such impediments, a number of states have sought to disposal of unused or unwanted drugs.
develop drug take-back programs. For example, legislation enacted in Maine authorized a drug mail-back program. 354 The program One approach to a drug disposal and recycling program would was summarized by Christensen: be a "take-back" program such as the one described by Christensen: Consumers mail unused or expired drugs in these Take-back events, typically organized by hospitals, packages to a single collection location run by the Maine pharmacies, or environmental groups, create a place for Drug Enforcement Agency (MDEA). The MDEA then consumers to bring their unused pharmaceuticals. With disposes of all returned drugs in an environmentally proper personnel available to sort pharmaceuticals and sound manner. A fund established and maintained by law enforcement available to handle controlled substances, the MDEA and funded by private contributions pays the these events are often extremely successful, resulting costs of the program. 355 in hundreds of gallons of pharmaceuticals collected in single-day events. 352 Implementation of the Maine program encountered two problems. First, "although manufacturers regularly package and ship The successful implementation of drug take-back programs prescription drugs for consumption, it is much more difﬁcult to have has been challenging. As noted above, having "law enforcement them shipped for disposal." 356 Second, "due to the potentially high available to handle controlled substances" may be a condition costs involved, it is unlikely that pharmaceutical companies would precedent to a successful program. This statement masks a serious provide the necessary funds to run the entire program." 357 352 Christenson, supra note 172 at 157 (citing R. Seely, Flushed Drugs Polluting Water; Complicated Rules for Disposal Result in Most Hospitals Taking Easy Way Out, Wisconsin State Journal, Dec. 10, 2006, at A1; R. Dickrell, Pharmaceutical Take-Back A Community's Success Story, 167 The Clarifier 48 (2006)).
353 Id. at 151 (citing Juliet Eilperin, Pharmaceuticals in Waterways Raise Concern: Effect on Wildlife, Humans Questioned, Washington Post, June 23, 2005, at A3). For the health-care industry and consumers, "DEA laws are one of the biggest stumbling blocks" on the road toward proper disposal. This is largely due to the DEA's strict control of controlled substances, under which disposal becomes quite complicated. When an individual is unsure how to dispose of a controlled substance, that individual may contact an authorized DEA agent, who will then instruct the individual to dispose of the controlled substance in one of the following manners: (1) by transfer to a person authorized to possess controlled substances (likely a law-enforcement ofﬁcer), (2) by delivery to a DEA agent, (3) by destruction in the presence of a DEA agent, or (4) by some other means determined by a DEA agent. In other words, the only persons who can possess a controlled substance that is prescribed to an individual are that individual, a law-enforcement ofﬁcer, or a DEA agent. Id. at 151-152 (citing R. Seely, Flushed Drugs Polluting Water; Complicated Rules for Disposal Result in Most Hospitals Taking Easy Way Out, Wisconsin State Journal, Dec. 10, 2006, at A1; 21 C.F.R. § 1307.21 (Drug Enforcement Administration, Ofﬁce of Diversion Control, Procedure for disposing of controlled substances)).
354 As opposed to a take-back event as described above, a "statewide mail-back model offers a centralized coordination component, adds an element of conﬁdentiality and anonymity not found with in-person take back programs and is the least burdensome of all models in terms of consumer access and utilization." Lenard Kaye, Jennifer Crittenden, & Stevan Gressitt, Executive Summary: Reducing Prescription Drug Misuse Through the Use of a Citizen Mail-Back Program in Maine (2010), available at http://www.epa.gov/aging/RX-report-Exe-Sum/.
355 Christenson, supra note 172, at 154 (citing Me. Rev. Stat. Ann. tit. 22 §§ 2700(3)-(5)).
356 Id. (citing Me. Rev. Stat. Ann. tit. 22 § 2700(4)).
357 Id. at 155 (citing Juliet Eilperin, Pharmaceuticals in Waterways Raise Concern: Effect on Wildlife, Humans Questioned, Washington McGrath notes that seven states have considered legislation to "mandate take-back programs" and that a mandatory system, funded by the drug companies, has been implemented in France. The words of H.L. Mencken ring true: "For every complex 358 Alternative programs would include the Canadian Medications problem, there is a solution that is simple, neat, and wrong." Return Program 35 Daughton's suggestion to extend the patents Mencken's conclusion appears to be particularly appropriate of drug companies implementing "vibrant, comprehensive regarding PPCPs in water supplies.
stewardship programs tailored for each particular drug" 360 has The general conclusions are deceptively simple: The merit, but it also could mean that consumers could pay higher drug anthropogenic sources of PPCPs identiﬁed in Section II need to prices over time because the introduction of alternative generic be reduced or eliminated. As discussed in Section III, such sources drugs could be delayed by the patent extensions. 361 of PPCPs may be subject to regulation. As discussed in Section IV, source control alternatives exist that could have the effect of reducing or eliminating some sources of PPCPs without the costs F.2.6. Drug Alternatives
associated with statutory or regulatory programs.
The beneﬁt of drug alternatives is a reduction in the discharge of PPCPs associated with the use of such products. The burden The devil, however, is in the details. As noted by Wennmalm has been stated already: potential cost to the patient. The use of and Gunnarsson, "The consumption of pharmaceuticals is "bacteriotherapy" may be as effective as the use of a drug resulting increasing worldwide, due both to continued population growth and in the discharge of PPCPs, but at what cost? Perhaps more increased consumption of pharmaceuticals per capita."362 The ever- importantly, does the reduction in PPCPs discharged into water increasing number of PPCPs363 combined with the concentration supplies justify the cost? variability discussed in Section V precludes any single approach to Post, June 23, 2005, at A3). Christenson notes the issue of political feasibility: Maine's government could consider legislation that would require pharmaceutical companies to signiﬁcantly contribute to the fund. However, given that the pharmaceutical industry is one of the leading lobbyists in the United States, any proposed legislation that would force manufacturers to signiﬁcantly contribute to the fund would likely meet signiﬁcant opposition. Id. (citing Jim Drinkard, Drugmakers Go Furthest to Sway Congress," USA Today, Apr. 26, 2005, at B1 (drug companies spent more on lobbying than any other industry from 1998 to 2004)).
358 McGrath, supra note 350.
359 Christenson, supra note 172, at 157-158 (citing Daughton, "Drug Disposal, Waste Reduction, and Future Directions," supra note 232 at 780).
360 Daughton, Drug Disposal, Waste Reduction, and Future Directions, supra note 230, at 776. The concept of stewardship underlay the Maine mail-back program. "Product stewardship is a concept that recognizes the responsibility of the manufacturer of a product from the manufacturing process through ﬁnal disposal in an environmentally sound manner." State of Maine Final Report of the Maine Drug Return Implementation Group, 122nd Legis., 1st Reg. Sess. at 7 (2005), available at http://www.maine.gov/legis/opla/drugrpt.pdf, (quoted in Christenson, supra note 172, at 154).
361 As noted by Christenson, "[i]f the scheme places the ﬁnancial burden on consumers, it fails to follow the product-stewardship model that underlies this solution." Christenson, supra note 172, at 155.
362 Wennmalm & Gunnarsson, supra note 41, at 291 (citing European Federation of Pharmaceutical Industries and Associations. The Pharmaceutical Industry in Figures (2002)). Consumption of pharmaceuticals is increasing 3-4% by weight per year. Ellis, supra note 30, at 185 (citing Christian G. Daughton, Non-regulated Water Contaminants: Emerging Research, 24 Environmental Impact Assessment Review 711 (2004)). Accord Reynolds, Concern of Pharmaceuticals in Drinking Water, supra note 33, at 2.
363 "[T]here may be as many as 6 million PPCP substances commercially available worldwide[.]" Ellis, supra note 30, at 185 (citing Christian G. Daughton, Non-regulated Water Contaminants: Emerging Research, 24 Environmental Impact Assessment Review 711 (2004)).
their regulation or management.364 New monitoring,365 detection366 process will be capable of reducing all trace organic contaminants to and analysis367 methods are needed. New management alternatives below increasingly sensitive analytical detection limits."371 need to be developed. New statutory or regulatory approaches As noted in the Introduction, this report is predicated on embodying the Precautionary Principle368 need to be tailored to the the assumption that the ongoing scientiﬁc inquiry regarding the goal of reducing PPCPs in water supplies.369 effects of PPCPs in water supplies produces evidence of risks to It is quite possible that new drinking water treatment processes human and environmental health. If so, then all of the alternatives will need to be developed. However, while such processes might discussed herein, as well as any number of additional alternatives protect human health, they would "provide no protection for aquatic that have yet to emerge, will be needed if both human and life."370 Furthermore, it is unlikely that any "single water treatment environmental health are to be protected.
364 "The aging population and more pharmaceutical development are two driving factors behind an expectation that increased pharmaceutical use will result in higher levels of trace residues in water." Global Water Research Coalition, supra note 31, at 2. Accord Reynolds, Pharmaceuticals in Drinking Water Supplies, supra note 25 ("a growing and aging population as well as increased reliance on drug treatments, and development of new drugs, the problem with pharmaceutical contamination promises to also increase").
365 G. Tracy Mehan, III, Water Data and Monitoring as Indispensable Tools to Manage Water Quality, Daily Environment Report, August 4, 2010, at 4.
366 "Methods of detection are not available for all pharmaceuticals, and new pharmaceuticals are developed every year, which may require new methodologies to enable their detection in water." Global Water Research Coalition, supra note 31, at 1.
367 Poynton & Vulpe, supra note 34, at 92: New chemicals and drugs are continuously developed and released in the environment. New approaches are needed for environmental risk assessment to catch up with the backlog of contaminants and keep pace with the increasing surge of new potential risks. Accord Rapid Public Health Policy Response Project. supra note 26, at 3-4 (need for human health assessments of low-level, chronic exposure to PPCPs); Jones, supra note 231, at 385 (need for new risk assessment models that account for synergistic effects).
368 "Irrespective of any risks, the precautionary principle should apply and micropollutants from wastewater should not be present in drinking water." C. Zwiener, Occurrence and Analysis of Pharmaceuticals and their Transformation Products in Drinking Water Treatment, 387 Analytical and Bioanalytical Chemistry 1159 (2007) (quoted in Rapid Public Health Policy Response Project, supra note 26, at 6. Among the various deﬁnitions of the Precautionary Principle, perhaps the one most applicable to PPCPs is the deﬁnition resulting from the Wingspread Conference on the Precautionary Principle (26 January 1998): "When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientiﬁcally." The conferees went on to explain that the "precautionary principle shifts the burden of proof, insisting that those responsible for an activity must vouch for its harmlessness and be held responsible if damage occurs." Science and Environmental Health Network, http://www.sehn.org/wing.html (last visited Jan. 30, 2011).
369 See, e.g., Heberer et al., Removal of Pharmaceutical Residues, supra note 85, at 19 (citing T. Heberer & H.-J. Stan, Arzneimittelrückstände im Aquatischen System, 50 Wasser und Boden 20 (1998); Umweltbundesamt, Annual Report 1999 (2000)): [L]ow concentrations [of pharmaceutically active compounds] may, from a toxicological point of view, not be harmful to humans but their occurrence in ground or drinking water is also not desirable from a hygienic point of view or with regard to the precautionary principle. Thus, there is a need to develop and study new drinking water treatment technologies to remove such organic contaminants from drinking water. Accord Wennmalm & Gunnarsson, supra note 41, at 296 ("in line with the precautionary principle, measures should be taken by public health authorities to avoid contamination of drinking water with … low concentrations of bioactive chemicals such as pharmaceuticals").
370 Snyder et al., supra note 47, at 34.
371 Stanford et al., supra note 11, at 56 (citing Benotti et al., supra note 48; Shane A. Snyder et al., American Water Works Association, Removal of EDCs and Pharmaceuticals in Drinking and Reuse Treatment Processes (2007) ; Brett J. Vanderford & Shane A. Snyder, Analysis of Pharmaceuticals in Water by Isotope Dilution Liquid Chromatography/Tandem Mass Spectrometry, 40 environmental Science & Technology 7312 (2006)).
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TEXAS TECH UNIVERSITY School of Law™ Texas Tech University Center for Water Law & Policy
Project funded by U.S. Environmental Protection Agency
Date: November 2010 Land East of Watmore Lane, Ecological Appraisal CSa Environmental Planning Taylor Wimpey UK Ltd Report No. CSA/1668/01 Land East of Watmore Lane, Winnersh Ecological Appraisal Contents 1.0 Methodology Desktop Biological Records Search Evaluation and Assessment Ecological Context Designated Sites