January 01, 2014

EPA’s Approach to Pharmaceutical Waste

Robert Zywno

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.

 

Further demonstrating RCRA’s current failure, many establishments that generate HWPs (i.e., hospitals, pharmacies, and other healthcare-related facilities) are very often unaware of their RCRA obligations. Even those facilities that are aware of their obligations often have trouble conforming to them, further leading to improper disposal of pharmaceutical waste. Such improper means of disposal include disposal by toilet or into municipal solid waste streams.

At the heart of the problem is that Congress created RCRA with industrial and manufacturing wastes in mind. Unlike industrial wastes, pharmaceuticals and similar wastes such as batteries, pesticides, and mercury-containing products are widely generated in various different settings and therefore easily escape RCRA’s regulatory framework. To address these widely dispersed hazardous wastes, EPA created the Universal Waste Program, through which it streamlined RCRA’s typical collection and transportation requirements. This streamlining eases otherwise burdensome requirements, encouraging generators to dispose universal wastes through proper channels and to keep them out of municipal waste streams, where they could potentially migrate into the environment.

In 2008, EPA proposed regulating pharmaceutical waste under its Universal Waste Program. Under the proposed regulations, HWPs could be stored in greater quantities and for longer duration, labeling standards would be relaxed, waste tracking would not be required, and perhaps most importantly, generators could dispose nonhazardous pharmaceutical wastes alongside hazardous ones. This would eliminate the need for healthcare and pharmacy personnel to differentiate between hazardous and nonhazardous forms of pharmaceutical waste. Moreover, EPA thought relaxed standards would promote take-back programs through which community residents could properly dispose of their pharmaceutical wastes.

After receiving critical public comments, however, EPA abandoned the proposed regulations. On its webpage, EPA cites concerns regarding lack of tracking and notification. Many comments point out the rule’s great contrast to the highly regulated nature of pharmaceutical supply chains as imposed by the Drug Enforcement Administration (DEA), the Federal Drug Administration (FDA), and local authorities, which are meant to ensure secure transport and prevent illegal use of pharmaceuticals. The comments state that despite being labeled as “wastes,” unused and expired pharmaceuticals still have street value and, in the absence of tracking and notification requirements, could easily end up in the wrong hands. These comments also recommend that EPA collaborate with DEA and other agencies when rulemaking on the issue.

EPA now intends to publish a wholly new set of proposed regulations on HWPs. Disappointingly, EPA seems to be taking a piecemeal approach, stating these proposed regulations will only pertain to healthcare facilities and those pharmaceutical wastes currently qualifying as RCRA hazardous wastes. EPA intended to publish the regulations in August 2013 but has since moved the deadline to March 2014.

Limiting the scope of regulations to only those pharmaceuticals currently qualifying as HWPs plainly will not address the environmental issue at hand. In their comments to the 2008 proposed universal waste regulations, states like Massachusetts and Wisconsin questioned the rule’s effectiveness, citing that only 5 to 10 percent of pharmaceutical wastes qualify as HWPs. EPA needs to expand its HWP list vastly beyond 5 to 10 percent if such regulations are going to have any meaningful environmental benefit. OIG recommended this in its 2012 report, with which EPA later agreed in a subsequent response, but EPA has not announced any efforts to list additional pharmaceuticals as RCRA hazardous wastes since.

As an alternative to focusing only on those pharmaceuticals qualifying as HWPs, EPA could follow the advice of the Association of State and Territorial Solid Waste Management Officials (ASTSWMO). In its April 2013 position paper, ASTSWMO recommended that EPA exempt all collected “post-manufacturing” pharmaceutical waste from standard hazardous waste requirements and regulate it as a separate category as long as three requirements are met: (1) collection occurs in a manner protective of human health and the environment; (2) security and tracking measures are implemented, ensuring the pharmaceuticals are not diverted to illicit uses; and (3) the drugs are destroyed in high-temperature combustion incinerators, equipped with controls that prevent releases into the environment. The proposal eases regulatory burdens much like EPA’s 2008 universal waste proposal but heeds notification and tracking concerns. Unfortunately, EPA declined to incorporate ASTSWMO’s recommendation into future rulemakings in June.

However if EPA ultimately decides to regulate pharmaceutical wastes, it seems clear that it should do so with the following goals in mind: Ensuring ease of compliance for healthcare and pharmacy personnel, requiring tracking and notification sufficient to prevent diversion to illicit uses, ensuring compatibility with regulations from DEA and other agencies, and most importantly, encouraging proper disposal of both hazardous and nonhazardous pharmaceutical wastes.

Robert Zywno

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.