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VCVSHealth Ms. Flondo March 20, 2019 Page 3 is important that the residues be managed in a more controlled manner—such as in municipal solid waste landfills—rather than poured down the drain. 3. EPA carefully assessed whether destruction of empty warfarin containers is warranted and ultimately determined that destruction is not necessary. Although EPA's proposed rule would have required destruction of empty containers, EPA ultimately did not finalize the requirement to destroy the empty containers prior to disposal, given the potential for worker safety concerns if required to crush or shred the containers. We emphasize the above points from the Pharm Rule because EPA carefully considered whether residue and empty containers should be managed as hazardous (or acute hazardous) waste. Based on (i) data (such as the studies that EPA reviewed) supporting the conclusion that very little residue remains in containers after the pharmaceuticals are dispensed, and (ii) for policy reasons (such as avoiding sewering of residues after triple -rinsing), EPA determined that it is not appropriate to manage the residues or containers as hazardous (or acute) hazardous waste. California. We are aware that prior to EPA's publication of the Pharm Rule, DTSC issued a December 24, 2015 interpretation rejecting EPAs November 4, 2011 memorandum regarding empty containers. DTSC interpreted California's regulations as more stringent than federal regulations and stated: "The distinction between the regulations is that the federal regulation specifically addresses the `Residues of hazardous waste in empty containers' ... and California's regulation addresses the `Contaminated Containers' as whole entities." The DTSC letter quoted California Code of Regulations, title 22, section 66261.7(r): 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 subsection [...](d) of this section, ... shall be manamed 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). (Emphasis added). DTSC furt her stated: When DTSC observes a hazardous waste that is comprised of non -empty containers having RCRA P -listed hazardous waste residues inside them, DTSC considers the entire container and residue combination as "the hazardous waste" that must be properly managed to protect human health and the environment. Accordingly, generators must include the weight of the container and not just the mass of container residue when computing the amount of acute hazardous waste generated (i.e. handling each residue and its associated container as a whole entity of hazardous waste). (Cal. Code Regs., tit. 22, § 66261.100, subd. (a)(2).) �S pharmacy / Caremark /minute clinic /specialty 36482763v1