In 2011, U.S. EPA issued guidance concluding that generators of p-listed pharmaceutical wastes did not need to count the weight of non-RCRA empty containers in determining their generator status. Instead, EPA determined that “it is only the residue in the non-RCRA empty container that is considered a p-listed hazardous waste; the container itself is not a hazardous waste.” Containers that Once Held P Listed Pharmaceuticals, November 4, 2011. This EPA memo was long-awaited by retail pharmacies and other healthcare facilities, as it provided a mechanism to forego counting containers that previously held warfarin-family pharmaceuticals toward generator status. This was particularly helpful, given that where a facility accumulates more than 1 kilogram (2.2 pounds) of acute hazardous waste at any one time, the facility is subject to stringent Large Quantity Generator of hazardous waste (LQG) regulations. While such generators may still be subject to LQG requirements based on generation of other p-listed waste such as nicotine replacement therapy products, EPA’s November 4, 2011 memo significantly reduced the likelihood that retail pharmacies and other healthcare facilities would be subject to LQG regulation.
In a December 23, 2015 letter to Charlotte Smith of PharmEcology (attached), the California Department of Toxic Substances Control (DTSC) became only the second known state (after Hawaii) to reject the U.S. EPA’s November 4, 2011 memo. In its letter, DTSC concludes that based on differences between California and federal regulations, “California healthcare facilities should include the total weight (of the container and the residues) on the hazardous waste manifests” and that the weight would count toward the generator’s monthly totals for purposes of LQG status. DTSC explains that like federal regulations, California considers RCRA p-listed hazardous waste residue remaining in a container to be hazardous waste (Cal. Code of Regs., tit. 22 66261.7). However, while federal regulations specifically addresses “Residues of hazardous waste in empty containers” (40 CFR 261.7), California’s regulation address the “Contaminated Containers” in their entirety (Cal. Code of Regs., tit. 22 66261.7.). DTSC points specifically to Cal. Code of Regs., tit. 22 66261.7(r), which states:
Any container, or inner liner removed from a container, which previously held a hazardous material, including but not limited to hazardous waste, and which is not empty as defined in subsections (b) or (d) of this section, . . . shall be managed as a hazardous waste in accordance with this division and Chapter 6.5 of Division 20 of the Health and Safety Code (commencing with Section 25100).
DTSC acknowledges, however, that it may revisit the issue when U.S. EPA issues its final hazardous waste pharmaceuticals rule (Management Standards for Hazardous Waste Pharmaceuticals, 80 Fed. Reg. 58014). Public comments on the proposed hazardous waste pharmaceuticals rule were due to U.S. EPA on December 24, 2015.
The December 23, 2015 DTSC letter may require pharmacies and other healthcare facilities located in California to modify their current processes for calculating generator status with respect to p-listed wastes, such as warfarin-family pharmaceuticals. Such a change in process may well mean that a retail pharmacy or other healthcare facility is pushed into LQG status, potentially triggering additional changes to the facility’s hazardous waste management program. Furthermore, given the history of legal actions brought by governmental entities in California regarding retail hazardous waste management, healthcare facilities should expect heightened scrutiny regarding management of containers that previously held warfarin-family pharmaceuticals. Healthcare facilities should carefully review current processes in light of the December 23, 2015 DTSC letter and make any necessary modifications to their current processes.
For additional information related to pharmaceuticals management, including management of containers that previously held pharmaceuticals, please contact the post’s authors.