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58052 Federal Register/Vol. 80, No. 186/Friday, September 25, 2015/Proposed Rules practice and either have one inch or less of residue remaining, or 3 percent or less of weight of the total capacity of the container remaining, then the container is considered "RCRA empty," and may be managed as non -hazardous waste. Likewise, according to § 261.7(b)(3), there are three ways that a container that held an acute hazardous waste can be considered "empty": A container or an inner liner removed from a container that has held an acute hazardous waste listed in §§ 261.31 or 261.33(e) is "empty" if: (i) The container or inner liner has been triple rinsed using a solvent capable of removing the commercial chemical product or manufacturing chemical intermediate; (ii) The container or inner liner has been cleaned by another method that has been shown in the scientific literature, or by tests conducted by the generator, to achieve equivalent removal; or (iii) In the case of a container, the inner liner that prevented contact of the commercial chemical product or manufacturing chemical intermediate with the container, has been removed. Therefore, if the container that held the P -listed pharmaceutical is not triple rinsed, or cleaned by another method that has been demonstrated to achieve equivalent removal, or had the inner liner removed, the container is not considered "RCRA empty," even though the pharmaceutical may have been fully dispensed. If the container is not "RCRA empty," then the residues are regulated as acute hazardous waste. In November 2011, EPA issued guidance about containers that once held P -listed pharmaceuticals 129 that provides three possible regulatory approaches for generators: (1) Count only the weight of the residue toward generator category (2) Demonstrate an equivalent removal method to render containers RCRA empty (3) In the case of warfarin, show that the concentration in the residue is below the P -listed concentration. This guidance was intended as a short-term solution that worked within the confines of the existing RCRA hazardous waste regulations and EPA indicated at the time that a more comprehensive solution would require notice and public comment that occurs during a rulemaking. We are proposing to amend the regulations that pertain to containers that once held pharmaceuticals that are RCRA hazardous wastes. We are proposing different regulatory solutions for different types of containers found in healthcare settings. Specifically, we address the following three types of containers: (1) Unit -dose containers (e.g., packets, cups, wrappers, blister packs, and delivery devices) and dispensing bottles and vials; (2) dispensed syringes; and (3) other containers, including delivery devices. If finalized, these new regulations for pharmaceutical containers would replace the November 2011 guidance; however, in the meantime, the guidance remains in effect. b. Unit -dose containers. First, with regard to unit -dose containers and dispensing bottles and vials up to 1 liter or 1000 pills, we are proposing a conditional exemption from the empty container regulations of § 261.7 for containers from which the pharmaceuticals have been fully dispensed. Specifically, we are proposing that the removal of the pharmaceuticals from the unit -dose containers, and dispensing bottles and vials (up to 1 liter or 1000 pills), is equivalent to rendering the container "RCRA empty." Therefore, for containers that once held non-acute hazardous wastes, it will not be necessary to measure the remaining wit ctents, and for containers that once held acute hazardous wastes, it will not be necessary to triple -rinse the containers or demonstrate an equivalent removal method. Rather, if the contents of the container have been fully dispensed by removing all pharmaceuticals that can be removed using the practices commonly employed to remove materials from that type of container, the residues (and therefore the container) may be disposed of as non -hazardous waste. We are proposing this conditional exemption for two reasons. First, we want to eliminate the sewering of pharmaceuticals. We are particularly concerned that in a healthcare setting, when containers are triple rinsed, the rinsate will be poured down the drain which is not a good environmental practice. We think it is important that the residues be managed in a more controlled manner—such as municipal solid waste management—rather than poured down the drain. Second, although the "empty container" regulations of § 261.7 apply to all sizes of containers, they were developed with larger, industrial -sized containers in mind. For the most part, the containers that hold pharmaceuticals range in size from a few milliliters (e.g., packaging for nicotine gum, paper cups used to dispense pharmaceuticals to in -patients) to a liter (e.g., bottles that hold bulk quantities of pills). In rare circumstances, containers with pharmaceuticals are as large as two or three liters (e.g., powders that are reconstituted with water). This differs significantly from the 55 -gallon drums that are typically used in other sectors that generate hazardous waste. Consequently, the amount of residues in the containers was anticipated to be much more substantial than is the case for containers typically used for pharmaceuticals. EPA has received data from three stakeholders demonstrating that there is very little residue remaining in fully dispensed containers of pharmaceuticals. In addition, EPA's ORD conducted similar research. The results from each of the four sources are SL below; the full results are in in the docket for this proposed rulemaking (EPA–HQ–RCRA-2007– 0932). i. Consulting Firm. One stakeholder, onh a hazardous medical materials C( firm, provided some I testing. They had the residues from single -unit dose packaging of four different P -listed pharmaceuticals tested using gas chromatography/mass spectrometry (GC/MS) and high performance liquid chromatography/ultraviolet detector (HPLC/UV). The amount of active pharmaceutical ingredient in the residues remaining in containers was quantified and the results from containers that had been triple rinsed were compared with containers that had not been triple rinsed. For the containers that were triple rinsed, the active ingredient in the residues was non -detect in all cases. For the containers that were not triple rinsed, the highest level detected was 35.8 µg (or 0.0358 mg). The laboratory results submitted to EPA are summarized in Table 9; the full laboratory results are included in the docket for this rulemaking (EPA—HQ—RCRA-2007— 0932). izsRudzinski to RCRA Division Directors, yosemite.epa.gov/osty/rcra.nsf/ 57B21F2FE33735128525795F00610FOF/$file/ November 11, 2011, RCRA Online #14827 http:// Oc994248c239947e85256d090071175f/ 14827.pdf.