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58052 Federal Register / Vol , 809 No. 186 / Friday, September 25 , 2015 / Proposed Rules practice and either have one inch or less containers that once held regulations of § 261 . 7 apply to all sizes of residue remaining , or 3 percent or pharmaceuticals that are RCRA of containers, they were developed with less of weight of the total capacity of the hazardous wastes . We are proposing larger, industrial-sized containers in container remaining, then the container different regulatory solutions for mind. For the most part, the containers is considered " RCRA empty ," and may different types of containers found in that hold pharmaceuticals range in size be managed as non-hazardous wastea healthcare settings. Specifically , we from a few milliliters (e.g, , packaging for Likewise, according to § 261 . 7 (b) (3) , address the following three types of nicotine gum , paper cups used to there are three ways that a container containers : (1 ) Unit-dose containers dispense pharmaceuticals to in-patients) that held an acute hazardous waste can (e.g. , packets , cups, wrappers , blister to a liter (e.g. , bottles that hold bulk be considered " empty" : packs , and delivery devices) and quantities of pills). In rare A container or an inner Iiner removed dispensing bottles and vials ; (2) circumstances, containers with from a container that has held an acute dispensed syringes; and (3) other pharmaceuticals are as large as two or hazardous waste listed in §§ 261 . 31 or containers , including delivery devices . three liters (e.g., powders that are 261 . 33 (e) is "empty" if: If finalized, these new regulations for reconstituted with water) . This differs ( 1 ) The container or inner liner has pharmaceutical containers would significantly from the 55-gallon drums been triple rinsed using a solvent replace the November 2011 guidance : that are typically used in other sectors capable of removing the commercial however, in the meantime , the guidance that generate hazardous waste. chemical product or manufacturing remains in effect . Consequently , the amount Of residues in chemical intermediate; b . Unit-dose containers. First , with the containers was anticipated to be (ii) The container or inner liner has regard to unit-dose containers and much more substantial than is the case been cleaned by another method that dispensing bottles and vials up to 1 liter for containers typically used for has been shown in the scientific or 1000 pills , we are proposing a pharmaceuticals . literature , or by tests conducted by the conditional exemption from the empty generator, to achieve equivalent container regulations of § 261 . 7 for EPA has received data from three removal ; or containers from which the stakeholders demonstrating that there is (iii ) In the case of a container, the pharmaceuticals have been fully very little residue remaining in fully inner liner that prevented contact of the dispensed . Specifically, we are dispensed containers of commercial chemical product or proposing that the removal of the pharmaceuticals . In addition , EPA's manufacturing chemical intermediate pharmaceuticals from the unit-dose ORD conducted similar research . The with the container , has been removed. containers, and dispensing bottles and results from each of the four sources are Therefore , if the container that held vials (up to 1 liter or 1000 pills) , is summarized below ; the full results are the P-listed pharmaceutical is not triple equivalent to rendering the container included in the docket for this proposed rinsed , or cleaned by another method "RCRA empty. " Therefore , for rulemaking (EPA–HQ–RCRA-2007– that has been demonstrated to achieve containers that once held non-acute 0932 ) o equivalent removal , or had the inner hazardous wastes , it will not be i . Consulting Firm . One stakeholder, liner removed , the container is not necessary to measure the remaining with a hazardous medical materials considered " RCRA empty, " even though contents , and for containers that once consulting firm , provided some the pharmaceutical may have been fully held acute hazardous wastes , it will not laboratory testing. They bad the dispensed. If the container is not " RCRA be necessary to triple-rinse the residues from single-unit dose empty , " then the residues are regulated containers or demonstrate an equivalent packaging of four different P-listed as acute hazardous waste. removal method. Rather , if the contents pharmaceuticals tested using gas In November 2011 , EPA issued of the container have been fully chromatography/mass spectrometry guidance about containers that; once dispensed b call that can be removed all (GC/MS) and high performance liquid held P-listed pharmaceuticals that p chromatography/ultraviolet detector provides three possible regulatory using the practices commonly employed (I-1PLC/UV). The amount of active ap roaches for generators: to remove materials from that type of pharmaceutical ingredient in the r1 ) Count onlythe weight of the container, the residues (and therefore P g g residues remaining in containers was residue toward generator category the container) may be disposed of as quantified and the results from (2 ) Demonstrate an equivalent non-hazardous waste, containers that had been triple rinsed removal method to render containers We are proposing this conditional RCRA empty exemption for two reasons . First , we were compared with containers that had not been triple rinsed. For the (3 ) In the case of warfarin , show that want to eliminate the sewering of containers that were triple rinsed , the the concentration in the residue is pharmaceuticals. We are particularly P below the P-listed concentration. concerned that in a healthcare setting , active ingredient in the residues was This guidance was intended as a when containers are triple rinsed, the non-detect in all cases . For the short-term solution that worked within rinsate will be poured down the drain the containers hest level detected was rine d , the confines of the existing RCRA which is not a good environmental g gg hazardous waste regulations and EPA practice , We think it is important that (or 0. 0356 mg) . The laboratory results indicated at the time that a more the residues be managed in a more submitted to EPA are summarized in comprehensive solution would require controlled manner—such as municipal 'fable 9 ; the full laboratory results are notice and public comment that occurs solid waste management rather than included in the docket for this during a rulemaking" Weare proposing poured down the drain. Second, rulemaking (EPA–HQ–RCRA- 2007– to amend the regulations that pertain to although the "empty container" 0932) . G33735129525 795FOO6ioroF/sfile/ mitr, zeRudxinski to RCRA Division Directors, yose .epn. ov/oswlrera. ns/l 57B27F2F November 11 . 2011 , RCRA Online #14827 http:// Or,994248c239947e85256do9OO71175f/ 14827•pdf,,