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.