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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 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 waste. healthcare settings.Specifically,we from a few milliliters(e.g,,packaging for Likewise,according to§261.7(b)(3), address the followingthreetypes of YP 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 liner 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( g''e. owders that are 261.33(e)is"empty"if: If finalized,these new regulations for P reconstituted with water).This differs (i)The container or inner liner has pharmaceutical containers would been triple rinsed using a solvent replace the November 2011 guidance; significantly from the 55-gallon drums capable of removing the commercial however,in the meantime,the guidance that are typically used in other sectors chemical product or manufacturing remains in effect. that generate hazardous waste. chemical intermediate; b. Unit-dose containers.First,with Consequently,the amount ofresidues in (ii)The container or inner liner has regard to unit-dose containers and the containers was anticipated to be been cleaned by another method that dispensing bottles and vials up to 1 liter much more substantial than is the case has been shown in the scientific or 1000 pills,we are proposing a for containers typically used for literature,or by tests conducted by the conditional exemption from the empty Pharmaceuticals. 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). 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 the pharmaceutical may have been fully held acute hazardous wastes,it will not consulting firm,provided some dispensed.If the container is not"RCRA be necessary to triple-rinse the laboratory testing.They had the empty,"then the residues are regulated containers or demonstrate an equivalent residues from single-unit dose as acute hazardous waste. removal method.Rather,if the contents packaging of four different P-listed In November 2011,EPA issued of the container have been fully pharmaceuticals tested using gas guidance about containers that once dispensed by removing all chromatography/mass spectrometry held P-listed pharmaceuticals 12a that pharmaceuticals that can be removed (GC/MS)and high performance liquid provides three possible regulatory using the practices commonly employed chromatography/ultraviolet detector approaches for generators: to remove materials from that type of (HPLC/UV).The amount of active (1)Count only the weight of the container,the residues(and therefore pharmaceutical ingredient in the residue toward generator category the container)may be disposed of as residues remaining in containers was (2)Demonstrate an equivalent non-hazardous waste, quantified and the results from removal method to render containers We are proposing this conditional containers that had been triple rinsed RCRA empty exemption for two reasons.First,we were compared with containers that had (3)In the case of warfarin,show that want to eliminate the sewering of not been triple rinsed.For the the concentration in the residue is pharmaceuticals.We are particularly containers that were triple rinsed,the 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 containers that were not triple rinsed, the confines of the existing RCRA which is not a good environmental the highest level detected was 35.8 gg hazardous waste regulations and EPA practice.We think it is important that (or 0.0358 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 Table 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,We are proposing poured down the drain.Second, rulemaking(FPA–HQ–RCRA-2007– to amend the regulations that pertain to although the"empty container" 0932). 1211Rudzinski to RCRA Division DIrectors, yosemi1r,.epo.gov/oscv/rcra.nsf1 57A21MR33735128525795F000]OFOFISfilet November 11,2011,RCRA Online#14827 http:11 Oc994248c239947e85256d090071175f/ 14a27.pdf.