On August 31, 2015, the U.S. Environmental Protection Agency (EPA) proposed an important rule under the Resource Conservation and Recovery Act (RCRA) that would ease the standards for healthcare facilities that dispose of hazardous waste pharmaceuticals. The proposal is of interest to all participants in the pharmaceutical value chain, from manufacturers to health care providers to end users. This column explains why.
The Proposed Rule
Some pharmaceuticals when discarded are regulated as hazardous waste under RCRA. This is neither new nor surprising given the inherent toxicity of certain pharmaceuticals. The EPA has long recognized that only approximately 5% of drugs are regulated under RCRA, while the remaining 95% may be “hazardous” using the traditional criteria for measuring toxicity and “new” measures including antibiotic resistance, endocrine disruption and related metrics.
Healthcare and associated facilities that generate hazardous waste pharmaceuticals have long reported difficulties complying with the RCRA Subtitle C hazardous waste regulations. Healthcare workers may not be knowledgeable about RCRA regulations, but often are involved in their implementation. Healthcare facilities can have thousands of items at its disposal, making it difficult to ascertain which are hazardous wastes and which are not.
To facilitate compliance and respond to these concerns, the EPA proposes revising the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions also are intended to clarify regulation of the reverse distribution mechanism used by healthcare facilities for managing unused or expired pharmaceuticals. The EPA proposes adding a new Subpart P under 40 C.F.R. Part 266, and requiring healthcare facilities that are currently small quantity generators (SQG) or large quantity generators (LQG) and all pharmaceutical reverse distributors, regardless of their RCRA generator category, to manage their hazardous waste pharmaceuticals under Subpart P of 40 C.F.R. Part 266, instead of 40 C.F.R. Part 262. That is, the proposed standards are not an optional alternative to managing hazardous waste pharmaceuticals under 40 C.F.R. Part 262; they are mandatory standards.
Under the proposal, healthcare facilities will have different management standards for their non-creditable and creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste pharmaceuticals (those not expected to be eligible to receive manufacturer’s credit) will be managed on-site, similar to how they would have been under a previous proposal for managing these wastes: the 2008 Universal Waste proposal for pharmaceutical waste. When shipped off-site, they must be transported as hazardous wastes, including the use of the hazardous waste manifest, and sent to an RCRA hazardous waste treatment, storage and disposal facility (TSDF). However, healthcare facilities will be allowed to send potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors for processing manufacturers’ credit. The EPA is proposing standards to ensure safe delivery of the creditable hazardous waste pharmaceuticals to these distributors. The EPA also proposes standards for the accumulation of creditable hazardous waste pharmaceuticals at pharmaceutical reverse distributors.
Like healthcare facilities, pharmaceutical reverse distributors won’t be regulated under 40 C.F.R. Part 262 as hazardous waste generators, nor will they be regulated as TSDFs. Rather, the proposal establishes a new category of hazardous waste entity, called pharmaceutical reverse distributors, with standards similar to the LQGs standards, with supplementary standards added to respond to commenters’ concerns.
One of the EPA’s long-term goals is to minimize pharmaceutical waste. While this specific proposal applies generally to health care facilities and other users of pharmaceuticals, the initiative should be viewed in the context of a broader agency push to regulate pharmaceutical waste in new ways to reflect changed industry practices and developments in drug manufacture. The presence of pharmaceutical chemicals in drinking water samples and other media remains an issue, so the pressure to regulate more stringently the release of pharmaceuticals into the environment will continue. While RCRA is the logical federal law to address these releases, it is not the only recourse available to the EPA; the Clean Water Act and the Clean Air Act are also tools at the agency’s disposal.
Many believe the proposal will address how best to regulate the disposal of pharmaceutical waste without inviting a burdensome new infrastructure. Whether everyone agrees will be known soon when comments are submitted on the proposal. Pharmaceutical product manufacturers and others along the drug value chain should monitor and participate in this initiative, as its success will influence how and whether additional measures will be needed to minimize the environmental release of drugs that are thought to be hazardous under a growing list of criteria to measure new standards.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at email@example.com
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).