EPA Proposes Long-Awaited Hazardous Waste Pharmaceuticals Rule: Implications To Healthcare Facilities

For the better part of a decade, the regulated community, policymakers, and regulators have grappled with how best to manage hazardous waste pharmaceuticals. On August 31, 2015, the curtain rose on a new era with the pre-publication of a new proposed standard for stemming the flood of pharmaceuticals entering our water supply and streamlining waste management practices to protect our nation's drug supply. On one hand, pharmaceutical waste falls squarely within the scope of the Federal Resource Conservation and Recovery Act (RCRA).1 On the other hand, the U.S. Environmental Protection Agency regulations implementing RCRA were clearly designed to apply to industrial facilities, and thus regulating hazardous pharmaceutical waste within RCRA's framework often seems like fitting a square peg into a round hole. Complicating the issue is that many states have issued their own policies related to managing hazardous pharmaceutical waste, and thus the regulated community has struggled to implement consistent, national programs under this patchwork of federal and state-specific requirements. In its pre-publication proposed rule, EPA has tried to strike a balance that is long overdue.

1. Regulatory Background.

   Recognizing the need for a separate management structure for hazardous pharmaceutical waste, on December 2, 2008 EPA proposed a Universal Pharmaceutical Waste rule,2 which called for the management of hazardous waste pharmaceuticals through a simplified, streamlined alternate system like the one used for florescent light bulbs and waste batteries, rather than via the traditional RCRA Subtitle C requirements.3 Due to an abundance of negative public comments, EPA formally withdrew the proposed rule in 2012. Over the past several years, the regulated community has provided EPA with feedback on the challenges faced in managing hazardous waste pharmaceuticals in order to aid EPA in drafting a rule specific to healthcare facilities. EPA has listened attentively, and, in response, the pre-publication version of the proposed rule, Management Standards for Hazardous Waste Pharmaceuticals, was posted online by EPA on Monday, August 31, 2015.4

2. Proposed Rule – Generally.

   In the rulemaking, EPA has proposed to add new subpart P under 40 C.F.R. Part 266, "Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities," which would create exclusive sector-specific regulations for managing hazardous waste pharmaceuticals5 by healthcare facilities6 and pharmaceutical reverse distributors. Under the proposed rule, all hazardous waste generators would be required to manage pharmaceuticals in accordance with the new subpart P regulations, rather than 40 C.F.R Part 262.7 The management requirements would not change when hazardous waste pharmaceutical generation varies from month to month.8 This is a significant change that greatly simplifies generator requirements. As noted below, many retail pharmacies have been required to register as Large Quantity Generators of hazardous waste (LQGs) based on their accumulation of greater than 2.2 pounds of nicotine cessation products.

   The proposed rule creates separate management standards for creditable and non-creditable hazardous waste pharmaceuticals—termed "potentially creditable hazardous waste pharmaceuticals"9 and "non-creditable hazardous waste pharmaceuticals."10 "Potentially creditable hazardous waste pharmaceuticals" are subject to relaxed standards compared to the current LQG and Small Quantity Generator (SQG) regulatory requirements, and EPA directly indicates its acceptance of the practice of over-managing potentially creditable non-hazardous waste pharmaceuticals with the potentially creditable hazardous waste pharmaceuticals at the healthcare facility.11 For example, while a healthcare facility is subject to new notification and tracking requirements for shipments of potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor,12 manifesting requirements are eliminated and shipments may be made by common carrier.13 Potentially creditable hazardous waste pharmaceuticals are subject to very few onsite management requirements at the healthcare facility, and biennial reporting requirements are eliminated.14

   "Non-creditable hazardous waste pharmaceuticals" are generally managed onsite similarly to current hazardous waste SQG requirements. When shipped offsite, non-creditable hazardous waste pharmaceuticals must be manifested and transported as hazardous waste, and sent to a RCRA interim status or permitted facility.15 Many requirements for non-creditable hazardous waste pharmaceuticals, however, are relaxed compared to current hazardous waste management standards, particularly compared to existing LQG requirements. For example, whereas LQGs and SQGs are only allowed to accumulate hazardous waste onsite for 90 days and 180 days, respectively, non-creditable hazardous waste pharmaceuticals may be accumulated onsite for up to one year. Biennial reporting requirements are also eliminated.16

   While healthcare facilities generally would be subject to fewer requirements than under current LQG and SQG regulations, the new pharmaceutical reverse distributor requirements are similar to current LQG standards, with added inventory and tracking requirements. This article, however, focuses primarily on the proposed rule's effect on healthcare facilities.

3. EPA Goals

   The proposed rule addresses two EPA goals, in addition to addressing stakeholder concerns regarding the current challenges of hazardous pharmaceutical waste management.

   1. Sewer Ban

      EPA intends to restrict the currently acceptable and common practice used by healthcare facilities of disposing of pharmaceuticals down the drain.17 If finalized, the proposed rule would prohibit the discharge of all hazardous waste pharmaceuticals. Specifically, the proposed rule states: "All healthcare facilities and pharmaceutical reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly-owned treatment works."18 EPA identifies this prohibition as the largest quantified benefit of the proposed rule, and EPA anticipates a reduction of approximately 6,400 tons in the volume of hazardous waste pharmaceuticals discharged annually into waterways as a result of the sewering ban. EPA estimates cost savings of eliminated wastewater treatment to be $4.3 million annually.

      While CESQGs are generally exempt from proposed subpart P of 40 C.F.R Part 266, the prohibition against sewering equally applies to CESQG healthcare facilities. EPA is particularly concerned that CESQG healthcare facilities are more likely to dispose of hazardous waste pharmaceuticals in the sewer.19 The rule would not prohibit discharge of non-hazardous pharmaceuticals, but EPA strongly recommends not sewering any waste pharmaceuticals.20 As discussed below, controlled substances are also prohibited from being sewered.

   2. EPA and DEA Intersection

      EPA also intends to clarify the intersection between RCRA hazardous waste regulations and the federal Drug Enforcement Administration (DEA) regulations for controlled substances. For any hazardous waste pharmaceutical that is also a controlled substance, a healthcare facility must currently manage the waste in compliance with both RCRA hazardous waste requirements and requirements of the Controlled Substances Act and DEA regulations. EPA believes that the duplicative regulation often incentivizes sewering hazardous waste pharmaceuticals that are also controlled substances.

      Due to challenges associated with managing these wastes, EPA is proposing to conditionally exempt from RCRA regulatory requirements those pharmaceuticals that are both a RCRA hazardous waste and a DEA controlled substance, so long as the waste is collected, stored, transported, destroyed and disposed in compliance with all DEA requirements for controlled substances.21 Although DEA regulations alone would allow the use of other disposal technologies, the conditional exemption...