EPA’s Approach to Pharmaceutical Waste

Vol. 28 No. 3

Mr. Zywno is a recent Vermont Law School graduate, having received both juris doctor and master of Environmental Law & Policy degrees. He currently resides in Northampton, Massachusetts.

Many states are giving increased attention to pharmaceutical waste, and for good reason: America generates a lot of it. According to a May 2012 report from the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG), EPA estimates that hospitals and reverse distributors (i.e., pharmaceutical manufacturers that accept returns of expired or unused pharmaceuticals) generate roughly 15,000 tons of hazardous waste pharmaceuticals (HWPs) every year. However, OIG states that, for various reasons, the figure is likely a great underestimation. Moreover, hospitals and reverse distributors are clearly not the only generators of HWPs. Pharmacies, other healthcare-related facilities, and community residents also contribute significantly to the total HWPs generated nationally.

Of course, mere generation of HWPs is not the main cause for concern; of main concern is that these wastes are migrating into our waters. A 2002 U.S. Geological Service (USGS) report states that among 139 streams ranging across thirty different states, 80 percent contained one or more pharmaceutical compounds, while 50 percent contained at least seven. Overall, these compounds were found at very low levels, but serious questions remain as to what effects prolonged low-level exposure might have to humans and wildlife. Endocrine disrupters serve as just one concerning example, having the potential to alter hormonal activity at concentrations even in the parts per trillion. Further adding to concerns are recent studies finding that excessive hormone levels in some waters are likely skewing sex ratios among fish toward increasingly male-dominated populations.

Unfortunately, the Resource Conservation and Recovery Act (RCRA)—under which the EPA regulates the “cradle to grave” handling of hazardous waste—is failing to address the problem under EPA’s current administration of the act. RCRA tasks EPA with researching, listing, and regulating substances that constitute “hazardous wastes,” as defined under the act. Even though increasingly more new drugs enter the pharmaceutical market every year, EPA has only listed roughly thirty-one pharmaceuticals as hazardous waste, all of which were listed in 1980. No pharmaceuticals have been listed as a RCRA hazardous waste since. According to its report, OIG found at least eight pharmaceutical compounds that very likely qualify as RCRA hazardous wastes but are not listed. The National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) have also identified more than 100 pharmaceuticals as hazardous.

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