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Federal Register/Vol. 80, No. 186/Friday, September 25, 2015/Proposed Rules 58051 <br /> §261.4(b)(1)because the exclusion where they may be co-mingled 125 with residues remaining in a container are <br /> applies even when the household controlled substances continue to be specifically addressed in§261.33: <br /> hazardous wastes are collected.It is excluded from RCRA regulation, The following materials or items are <br /> important to note that in order to provided they are: hazardous wastes if and when they are <br /> maintain the exclusion,a retail (1)Combusted at a municipal solid discarded or intended to be discarded <br /> pharmacy(or other DEA authorized waste or hazardous waste combustor, <br /> collector pharmacy)can use the DEA and (c)Any residue remaining in a <br /> authorized collection receptacle to (2)managed in accordance with all container or in an inner liner removed <br /> collect waste generated only at applicable DEA regulations(see from a container that has held any <br /> households and brought to the store for §266.506(a)(2)).The Agency solicits commercial chemical product or <br /> collection.The hazardous waste comments on all these provisions, manufacturing chemical intermediate <br /> generated by the retail pharmacy and On a separate,but related matter,EPA having the generic name listed in <br /> store,including hazardous waste has received a number of inquiries paragraphs(e)or(f)of this section, <br /> pharmaceuticals,are not excluded about the exemption in the Clean Air unless the container is empty as defined <br /> household wastes under RCRA and may Act regulations for Other Solid Waste in§261.7(b).[emphasis added] <br /> not be placed in the DEA authorized Incinerator(OSWI)"units that combust According to§261.7(b)(1),there are <br /> receptacle.724 Furthermore,states contraband or prohibited goods"(see two ways a container that held a non- <br /> generally regulate non-hazardous waste the exemption at 40 CFR 60.2887(p)for acute hazardous waste can be <br /> and they may have licensing or new OSWIs and 40 CFR 60.2993(p)for considered"empty": <br /> permitting requirements for the existing OSWIs).As indicated in a A container or an inner liner removed <br /> collection of solid waste.Because EPA previous guidance memo,EPA does not from a container that has held any <br /> would like to see the use of DEA consider pharmaceuticals,voluntarily hazardous waste,except a waste that is <br /> authorized collection receptacles collected from ultimate users in a take- a compressed gas or that is identified as <br /> become widespread,we encourage back program,to be contraband or an acute hazardous waste listed in <br /> states to streamline any requirements prohibited goods.125 Likewise,EPA will §261.31 or§261.33(e)of this chapter is <br /> that may create a barrier to the use of not consider pharmaceuticals that are empty if: <br /> the collection receptacles. voluntarily dropped off at collection (i)All wastes have been removed that <br /> Under this proposal,pharmaceuticals receptacles to be contraband or can be removed using the practices <br /> collected in DEA authorized collection prohibited goods.Therefore,the OSWI commonly employed to remove <br /> receptacles will continue to be excluded exemption does not apply and law materials from that type of container, <br /> from regulation as household hazardous enforcement may not destroy e.g.,pouring,pumping,aspirating,and <br /> waste,with some conditions.The voluntarily collected pharmaceuticals in (ii)No more than 2.5 centimeters(one <br /> Agency has a long-standing the same way that it is allowed to inch)of residue remain on the bottom <br /> recommendation that household destroy contraband or prohibited goods, of the container or inner liner,or <br /> hazardous waste collection programs 3.Management of Residues in (iii) <br /> manage the collected waste as Pharmaceutical Containers (A)No more than 3 percent by weight <br /> hazardous waste..We strongly believe of the total capacity of the container <br /> that if a program goes to the expense of a•Regulatory background.Over the remains in the container or inner liner <br /> collecting the waste,including waste years,EPA has received numerous if the container is less than or equal to <br /> pharmaceuticals,it should manage the inquiries regarding the regulatory status 119 gallons in size;or <br /> waste as hazardous waste,rather than of various types of containers that once (B)No more than 0.3 percent by <br /> manage it as municipal solid waste, hold pharmaceuticals that are weight of the total capacity of the <br /> which the household could do absent considered hazardous waste when container remains in the container or <br /> the collection program.However,the discarded because of the hazardous inner liner if the container is greater <br /> current household waste exemption waste residue in the containers. than 11.9 gallons in size. <br /> Stakeholders have been particularly Therefore,if the container that held <br /> does not require an entity that hosts a <br /> concerned about containers that once the non-acute hazardous waste <br /> household hazardous waste collection <br /> held pharmaceuticals that are on the""P- Pharmaceutical does not have its <br /> event to manage the collected waste as <br /> list of acutely hazardous commercial contents removed by a commonly <br /> hazardous waste.Typically,the parties <br /> conducting household hazardous waste chemical products in§261.33(e) employed practice and either has one <br /> conducts events have been government because a generator becomes an LQG if inch or less of residue remaining or has <br /> g it generates more than 1 kg of acute 3 percent or less by weight of the total <br /> entities—municipalities and counties.It hazardous waste per calendar month or capacity of the container remaining,128 <br /> is relatively new that retail pharmacies accumulates more than 1 kg of acute then the container is not considered <br /> and others are becoming interested in hazardous waste at any time.127 The "RCRA empty,"even though the <br /> performing this function.To encourage current regulatory status of acute and pharmaceutical may have been fully <br /> this practice,while at the same time non-acute commercial chil product dispensed.If the container is not"RCRA <br /> emca <br /> ensuring that collection programs are empty,"then the residues are regulated <br /> managing the collected waste properly, 72� as hazardous waste(since the residues <br /> we are proposing that pharmaceuticals DEA does riot prohibit co-mingling of <br /> controlled substances with non-controlled are within the container,the container <br /> that are household hazardous waste substances provided they are all then managed as must be managed as hazardous waste,as <br /> (i.e.,"household waste controlled substances. well,even if it is not itself hazardous <br /> pharmaceuticals")and are collected in ''-aRudzinski to RCRA Division Directors, waste).On the other hand,if the <br /> DEA authorized collection receptacles September 26,2012.RCRA Online 1114633 hlip:// contents of the container have been <br /> yosem i l e.e p a.�o vlos w/rcfa.cls f/Oc994248c23999 <br /> 7e85256do90071175f1fcbiidd6f6id4 removed by a commonly employed <br /> 124 DEA regulations also prohibits retail pharmacy b1685257afeooSob5ce!OpenDocumeni. <br /> stock/inventory from being placed in the collection 121 Additionally,acute hazardous wastes are 120 We are assuming that containers that hold <br /> receptacle or mail-back envelopes(see 21 CFR included on the if-list of§261.31:however none of pharmaceuticals are in containers less than 119 <br /> 1317.05(a)). those acute hazardous wastes are pharmaceuticals, gallons in size. <br />