INTRODUCTION II. SOURCES AND IMPACTS OF PHARMACEUTICALS IN THE WATER A. Sources B. Impacts III. CURRENT STATE OF THE LAW A. The FDA's Regulatory Approach to Pharmaceuticals in the Environment 1. Federal Food, Drug, and Cosmetic Act 2. National Environmental Policy Act B. The EPA's Regulatory Approach to Pharmaceuticals in the Environment 1. Clean Water Act 2. Safe Drinking Water Act 3. Resource Conservation and Recovery Act. 4. Toxic Substances Control Act IV. A LOOK INTO THE FUTURE A. Interagency Workgroup B. Pharmaceutical Take-Back Programs C. Potential Litigation D. Other Countries" Approaches V. PROPOSALS FOR IMPROVEMENT IN THE U.S A. Source-based Protections B. Treatment-based Protections VI. CONCLUSION I. INTRODUCTION
In one stream in Boulder, Colorado, female white sucker fish outnumber males of the same species by a ratio of greater than five to one, and half of the males have female sex tissue. (1) Although this may seem to be a strange and possibly isolated occurrence, this situation is not restricted to Colorado, nor is it exclusive to the white sucker fish. (2) Streams all over the United States and the rest of the world are experiencing the feminization of male organisms or masculinization of female organisms. (3) Scientists are pointing to birth control and other pharmaceuticals as the culprit, and not because the fish are concerned with family planning. (4) Humans are the source of these compounds, and they enter the environment through many different routes. (5)
The effect of pharmaceuticals (6) on both the water supply for human consumption and the aquatic environment is increasingly drawing the attention of regulators. Although this problem is not a new one--the general consensus is that pharmaceuticals as a class of contaminants have been present in water since their inception--new detection technologies, allowing us to detect concentrations as low as parts per trillion, have brought this contamination to the forefront of scientific concern. (7) But even so, scientists still know very little about the effects of pharmaceuticals in low concentrations on humans and the environment. (8)
This comment addresses the growing problem of pharmaceuticals in the water. Part I discusses some of the different pathways through which pharmaceuticals enter the water. Part I also reviews what is known about the effects of these pharmaceuticals on humans and the environment. Part II presents an overview of the current state of the law. Part III examines proposed legislation addressing pharmaceuticals in the water. Part IV concludes with proposals for where to go from here.
SOURCES AND IMPACTS OF PHARMACEUTICALS IN THE WATER
Considering the prevalence of pharmaceuticals in modern society, (9) it is no wonder that some of these compounds find their way into our drinking water systems and the environment. As of 2007, scientists had identified more than 100 different pharmaceuticals or personal care products in the environment, (10) and researchers estimate that approximately forty one million Americans face exposure to pharmaceuticals through their drinking water. (11) In fact, a study examining the fifty largest cities in the United States found that at least twenty four of them had pharmaceuticals in their municipal water supply. (12) Similarly, a 2002 study by the United States Geological Survey found pharmaceutical contamination in more than eighty percent of the streams surveyed. (13)
Pharmaceuticals enter the environment through many different avenues. This comment examines the following pathways: improper disposal; human consumption and excretion; livestock and aquaculture operations; and intentional addition. Compounding the problem of many pathways and sources of contamination, most of these pharmaceuticals are highly water soluble (14) and do not "evaporate at normal temperature and pressures," (15) thereby facilitating thorough contamination.
Perhaps the most preventable conduit of contamination is improper disposal. For many years, hospitals and nursing homes disposed of their excess pharmaceuticals by flushing them down the drain. (16) In fact, until as recently as 2002 this was the recommended method for disposing of unwanted pharmaceuticals (17) because it ensured that the pharmaceuticals did not end up in the wrong hands (i.e. children or the illicit drug trade). (18) State and local governments recently began to launch massive informational campaigns in an effort to minimize or eliminate this method of pharmaceutical disposal. (19) But old habits die hard, and many people still believe that flushing is the best method of disposal for unwanted pharmaceuticals. (20)
Pharmaceuticals also enter the water through human consumption and excretion. (2l) Humans do not fully metabolize ingested pharmaceuticals and thus excrete the unmetabolized compounds in urine or feces. (22) A person's age and health can impact how much of a given drug that person metabolizes, as can timing of dose and formulation of the drug itself. (23) Federal law does not impose any monitoring requirements upon sewage treatment facilities that receive pharmaceutical-contaminated excrement. (24) Furthermore, municipalities do not design municipal sewage treatment plants to remove these unregulated pharmaceutical contaminants, (25) thus complicating any attempts to control. In fact, one study found that the treatment processes examined eliminated as little as seven percent of active drug compounds from the wastewater, (26) meaning that the vast majority of these excreted compounds remain in the "treated" water. This treated water is discharged and eventually reprocessed into drinking water. (27)
Unfortunately, in most cases, the drinking water treatment processes also fail to remove these compounds. (28) Most drinking water treatment plants rely on absorptive and oxidative processes for removal of organic materials from the water, (29) but these methods are relatively ineffective at removing pharmaceuticals and other synthetic contaminants. (30) Ozonation is one of the more effective methods for removing pharmaceuticals, although its usefulness is limited to estrogens and a small number of other pharmaceuticals. (31) It is not very effective at removing non-estrogen compounds or many other pharmaceuticals. (32)
Another source of pharmaceutical ground and surface water pollution is the intentional disposal of unwanted drugs into municipal solid waste systems. (33) Disposed pharmaceuticals often end up in landfill leachate, which can percolate into the ground water. (34) This contamination source has the potential to eclipse sewage disposal as a source of contamination because federal and state policymakers are beginning to recommend solid waste disposal of pharmaceuticals as an alternative to sewage disposal. (35)
Livestock and aquaculture operations also contribute to pharmaceutical contamination of ground and surface water. (36) Both livestock and aquaculture operations administer regular doses of antibiotics and hormones to animals in order to speed growth and to prevent the spread of disease and infection. (37) Like humans, animals do not fully metabolize the drugs and excrete them in manure and urine. (38) One major difference between veterinary and human pharmaceutical contamination is that excreted human waste generally passes through some form of treatment prior to entering surface water, whereas animals deposit their manure directly onto the ground or into the water and are thus a more direct source of pharmaceutical contamination. (39) Farmers often use both human and animal manure for crop fertilization, which provides additional opportunity for the pharmaceutical-contaminated excrement to leach and/or run off into ground and surface water. (40) Some studies have shown that crops fertilized in this manner can even uptake the pharmaceuticals. (41) Thus, crop uptake followed by human consumption may be another route of exposure. (42) Adding to the sheer quantity of contamination from farms and aquaculture operations is the fact that regulatory agencies do not usually consider these sources to be point sources, meaning that the Clean Water Act does not even govern their disposal practices. (43)
Medication of pets represents another source of contamination. This source is not as significant as livestock operations, in part because the living conditions of domestic animals are generally not as concentrated as those of livestock. (44) Like humans and livestock, domestic animals that receive pharmaceutical medication also tend not to fully metabolize it. (45) Thus, when medicated pets relieve themselves outside, their pharmaceutical contaminated excrement has the potential to leach into the ground water or contribute to contamination of urban runoff.
Of possibly even more concern than the aforementioned pathways through which pharmaceuticals unintentionally enter the water is the fact that many municipalities and businesses are intentionally adding pharmaceuticals and other personal care products to the water. One recent news article reported that companies, including pharmaceutical manufacturers, have legally released 271 million pounds of pharmaceuticals into various water bodies, and that some of these water bodies serve as drinking water sources. (46) Furthermore, municipalities in the United States and abroad already add fluoride to the drinking water supply and have done so for over fifty years. (47) One recent article even proposed adding lithium to the drinking water after areas with increased levels of naturally occurring lithium in the water reported lower than usual rates of suicide and violent crime. (48) In addition to ethical and human rights concerns, the intentional addition of pharmaceuticals and similar products creates further environmental and human health problems.
To make matters worse, the actual quantities of pharmaceuticals entering the environment are unknown. (49) Thus...
Water (R.sub.x): the problem of pharmaceuticals in our nation's waters.
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