EPA plans to propose new regulations this year to address the management of hazardous waste pharmaceuticals under the Resource Conservation and Recovery Act (RCRA). The agency anticipates issuing a notice of proposed rulemaking on this issue in June 2015, according to its updated regulatory agenda, the availability of which was announced in the Federal Register on December 22, 2014 (79 Fed. Reg. 76,772).
EPA previously issued a notice of proposed rulemaking on this topic in December 2008 (73 Fed. Reg. 73,520). Its 2008 proposal would have added hazardous waste pharmaceuticals to the Universal Waste Rule, which modifies RCRA’s hazardous waste regulations to streamline the management of certain hazardous wastes. EPA explained at the time that it hoped the approach would facilitate the implementation of pharmaceutical take-back programs. But after receiving adverse public comment on the proposal, EPA did not follow up with a final rule. In its online discussion “Management of Hazardous Waste Pharmaceuticals,” EPA explains that “comment on the December 2008 proposal revealed numerous concerns over the lack of notification requirements for those facilities that generate, handle or transport ‘universal waste’ pharmaceuticals as well as for the lack of tracking requirements for the shipment of these wastes.”
Now, six years later, EPA is gearing up for a second attempt to promulgate new regulations for hazardous waste pharmaceuticals. It appears that EPA will be taking a different approach than it did in 2008 when its proposal focused on adding pharmaceutical hazardous wastes to the Universal Waste Rule. According to its regulatory agenda, EPA is now considering “health care facility-specific regulations for the management of hazardous waste pharmaceuticals in order to provide a regulatory scheme that is adapted to the unique issues that hospitals, pharmacies and other health care-related facilities face.” On its website, EPA states that its new proposal will also address “the concerns raised by the public comments regarding notification and tracking issues[.]”
As with the 2008 proposed rule, the publication of the new proposed rule later this year will likely garner extensive public comments. Unless and until new final regulations are promulgated, generators of hazardous waste pharmaceuticals will continue to be subject to the RCRA Subtitle C generator requirements.