UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C SEP

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1 UNITED STATES ENVIRONMENTA PROTEION AGENCY WASHINGTON, D.C SEP OFFICE OF SOID WASTE AND EMERGENCY RESPONSE MEMORANDUM SUBJE: TO: FROM: Recommendation on the Dipoal of Houehold Pharmaceutical Collected by Take-Back Event, Mail-Back, and Other Collection Program RCRA Diviion Director EPA Region I to X Suzanne Rudzinki, Director ~ ~~~ Office of Reource Conervation and Recovery (ORCR) Office of Solid Wate and Emergency Repone Many tate and local law enforcement agencie, communitie, and organization have etablihed take-back event, mail-back, and other collection program to collect old, expired, or imply unwanted precription and over-the-counter pharmaceutical from houehold. Thee program for houehold pharmaceutical have become more prevalent throughout communitie that want to reduce the miue and abue of drug, while at the ame time topping the practice of fluhing conumer pharmaceutical which may reult in their entry into the environment. Organizer of thee houehold pharmaceutical take-back program have aked for the Environmental Protection Agency' (EPA) recommendation on how to dipoe of and detroy collected houehold pharmaceutical. The purpoe of thi memorandum i to communicate EPA' recommendation that houehold pharmaceutical collected by thee program be incinerated. Our preference i that they be ent to a permitted hazardou wate combutor, but when that i not feaible, at a minimum, they hould be ent to a large or mall municipal wate combutor. Thi guidance only applie to the collection and management of houehold pharmaceutical and doe not apply to pharmaceutical that are generated at non-houehold, uch a healthcare facilitie. Background - RCRA Regulation Pharmaceutical that are unwanted (e.g., expired or unued) by conumer (houehold) are not regulated a hazardou wate and are generally conidered municipal olid wate. While there i a mall percentage of pharmaceutical on the market that meet the definition of hazardou wate under the Reource Conervation and Recovery Act (RCRA), the federal RCRA hazardou wate regulation include an exemption for all hazardou wate generated by houehold (ee the "houehold hazardou wate" exemption at 40 CFR 261.4(b)(l)). Thu, houehold pharmaceutical wate -like other houehold hazardou wate - are not ubj ect to the federal RCRA hazardou wate regulation, even when collected at a take-back event or

2 program. However, the Agency ha hitorically recommended that houehold hazardou wate collection program manage their collected wate a hazardou wate, even though it i not required (ee memo dated November 1, 1988, from Porter to Region, RCRA Online #11377). In today' memo, the Agency i clarifying thi recommendation a it pertain to pharmaceutical collection program, ince houehold pharmaceutical wate are typically collected eparately from other houehold hazardou wate. Note that houehold pharmaceutical collection program are not required to manage collected houehold pharmaceutical in accordance with thi or earlier Agency recommendation; however, if they chooe not to, they mut manage the collected pharmaceutical in accordance with tate and/or local environmental regulation for municipal olid wate, a well a applicable federal Clean Air Act (CAA) regulation if they are incinerated. Background - Controlled Subtance Act A portion of houehold pharmaceutical that are collected through take-back event and program are controlled ubtance. Controlled ubtance are drug or other ubtance that have the potential for abue and dependence and are controlled by the Drug Enforcement Adminitration (DEA) to protect public health and afety. In addition to federal, tate and/or local environmental regulatory requirement, collection of pharmaceutical controlled ubtance through take-back event and program mut be in compliance with the requirement of the Controlled Subtance Act (CSA) and it implementing regulation publihed by DEA (21 U.S.C and 21 CFR part ). In general, only peron regitered with DEA are permitted to poe controlled ubtance a authorized by their regitration and mut comply with the applicable requirement aociated with their regitration. There are exception, however; for example, a patient who receive a controlled ubtance puruant to a lawful precription- alo known a an ultimate uer- i not required to regiter with DEA in order to receive and poe that controlled ubtance. Until recently, the CSA did not addre dipoal of controlled ubtance by ultimate uer. To dipoe of their controlled ubtance, ultimate uer were permitted to detroy the ubtance themelve (e.g., mix the ubtance with coffee ground, place in a platic bag, and throw into the garbage) or urrender the ubtance to law enforcement, including DEA. In October 201 0, however, the Secure and Reponible Drug Dipoal Act of 2010 wa enacted. DEA i currently drafting the implementing regulation. The Act and implementing regulation will provide the baic framework to allow the public (i.e., the ultimate uer) to dipoe of their unwanted or expired controlled ubtance pharmaceutical in a ecure and reponible manner. Until DEA finalize the implementing regulation for the Act, however, the ultimate uer may not deliver their controlled ubtance pharmaceutical to any other peron for the purpoe of dipoal other than by urrender to law enforcement, including DEA, for example, through a law enforcement take-back event. A dicued above, after pharmaceutical are collected from ultimate uer in a takeback event, they mut be dipoed of in accordance with federal, tate and/or local environmental regulation. In addition, DEA or other law enforcement agencie that collect controlled ubtance during an event are reponible for dipoing of the controlled ubtance they collect. Currently, mot, if not all, controlled ubtance that are collected by take-back program are detroyed by incineration. 2

3 Recommendation for Dipoal of Pharmaceutical from Take-Back Event or Program EPA i currently recommending incineration a the preferred dipoal method for houehold drug take-back program becaue we believe that incineration will addre both environmental and diverion concern. With regard to environmental concern, tudie have hown active pharmaceutical ingredient are preent in ome groundwater and drinking water, ome portion of which i likely due to fluhing. Further, ome limited tudie have hown active pharmaceutical ingredient preent in landfill leachate that i collected in municipal olid wate landfill leachate ytem. Incineration of unwanted houehold pharmaceutical will reduce the amount of houehold pharmaceutical that are dipoed by both fluhing and land filling. With regard to diverion, incineration hould alo addre DEA concern about the diverion of controlled ubtance by detroying them and thu making them unavailable for diverion. The recommendation to incinerate all collected houehold pharmaceutical further reduce diverion concern by eliminating the need for collection program peronnel to ort controlled ubtance from non-controlled ubtance. Managing all collected pharmaceutical together will alo reduce collection program cot by eliminating labor cot aociated with orting the controlled ubtance from non-controlled ubtance. Pleae note that until the implementing regulation for the Secure and Reponible Drug Dipoal Act of 2010 are finalized, the public may not deliver their controlled ubtance to any peron for the purpoe of dipoal other than by urrender to law enforcement, including DEA (e.g., a collection program run by law enforcement, including DEA). EPA ha conulted takeholder, and we are not currently aware of data documenting whether active pharmaceutical ingredient are emitted from combution unit, either hazardou wate combutor or municipal olid wate combutor. We do know, however, baed on data from DEA regarding the amount of pharmaceutical collected during it nation-wide collection day (National Take Back Initiative), that the amount of collected houehold pharmaceutical are extremely mall compared to the wate amount thee type of combutor typically burn each day. In addition, thee combution unit are ubject to carbon monoxide or total hydrocarbon tandard, which are widely accepted indicator of combution condition in the unit. EPA believe that the combution condition preent in thee regulated unit will detroy the organic compound in collected pharmaceutical. Given the lack of emiion data from burning pharmaceutical and becaue hazardou wate incinerator and cement kiln are ubject to comprehenive operating and monitoring control ( 40 CFR part 63 ubpart EEE), EPA i erring on the ide of caution in etablihing combution in a permitted hazardou wate incinerator or cement kiln a the recommended practice for detruction of collected houehold pharmaceutical. However, there are roughly 10 commercial hazardou wate incinerator in the U.S. that accept wate from off-ite ource and 12 cement manufacturing plant that have a permit to burn hazardou wate (ee attached lit of RCRA-permitted commercial hazardou wate incinerator and RCRA-permitted cement kiln) 1 EPA recognize that due to the limited number of permitted hazardou wate combutor, it may be prohibitively cotly to dipoe of houehold pharmaceutical at hazardou wate combutor; and we do not want that cot to dicourage take-back event. Therefore, the Agency i 1 Note that not all of thee permitted hazardou wate incinerator and cement kiln may be permitted to or may chooe to accept collected houehold pharmaceutical. Contact the individual facility about it policy. 3

4 recommending that when hazardou wate combution i not feaible, at a minimum, collected houehold pharmaceutical hould be incinerated at a facility that meet EPA': arge Municipal Wate Combutor (MWC) tandard: o 40 CFR part 62 ubpart FFF for exiting MWC o 40 CFR part 60 ubpart Ea and Eb for new MWC, or Small Municipal Wate Combutor (SMWC) tandard: o 40 CFR part 62 ubpart JJJ for exiting SMWC o 40 CFR part 60 ubpart AAAA and BBBB for new SMWC. There are approximately 85 facilitie with MWC and SMWC in 23 tate (ee attached lit of MWC and SMWC facilitie)? The Agency believe that by recommending hazardou wate combution a the preferred option for dipoal and detruction of collected houehold pharmaceutical, including controlled ubtance, and, if not feaible, combution by mall or large municipal wate combutor, a a minimum tandard, collection program organizer will have multiple option for dipoing and detroying unued, expired, and unwanted pharmaceutical that will meet both DEA' goal of preventing diverion of controlled ubtance and EPA' goal of protecting the environment. The "Contraband Excluion" Doe Not Apply to Burning Pharmaceutical from Take-Back Program EPA ha alo received a number of inquirie aking whether the excluion from the Other Solid Wate Incinerator (OSWI) regulation for "unit that combut contraband or prohibited good" (ee the excluion at 40 CFR (p) for new OSWi and 40 CFR (p) for exiting OSWi) can be applied to unit that combut pharmaceutical collected in take-back program. In repone, EPA doe not conider pharmaceutical, voluntarily collected from houehold in a take-back program, to be contraband or prohibited good. Therefore, if OSWI unit are ued to combut collected pharmaceutical, the excluion doe not apply, and the OSWI unit would be ubject to 40 CFR part 60 ubpart EEEE for new OSWi or 40 CFR part 60 ubpart FFFF for exiting OSWi. However, a dicued above, EPA recommend that pharmaceutical collected in take-back program be combuted in either a hazardou wate combutor or a large or mall municipal wate combutor, not OSWI unit. Crematoria Finally, we have received inquirie about burning pharmaceutical from take-back event in crematorium. Becaue crematorium currently are not regulated unit under the Clean Air Act regulation, we recommend that pharmaceutical from take-back event not be burned in thee unit. We believe that becaue they are not regulated unit, they may not provide adequate environmental protection when burning pharmaceutical wate. 2 Note that not all of thee permitted large or mall municipal wate combutor may be permitted to or may chooe to accept collected houehold pharmaceutical. Contact the individual facility about it policy. 4

5 Additional Information & Contact Pleae note that when thi letter dicue RCRA hazardou wate regulation, it i in reference to the federal hazardou wate regulation. State that are authorized to implement the RCRA program may have regulation that are different than the federal regulation, provided they are not le tringent than the federal program. Pleae conult your tate regulatory hazardou wate requirement in addition to thi memo. For quetion about the hazardou wate regulation dicued in thi memo, pleae contact Kritin Fitzgerald of the Office of Reource Conervation and Recovery at (703) or For quetion about the Clean Air Act regulation dicued in thi memo, pleae contact Charlene Spell of the Office of Air Quality Planning and Standard at (919) or Attachment: it ofrcra-permitted Hazardou Wate Incinerator & Cement Kiln it of Wate-to-Energy Plant for Municipal Wate Combution 5

6 Wate-to-Energy Plant for Municipal Wate Combution* A of2010 State A CA CA CA F F F F F F F F F F F HI IA IN ME ME ME ME MD MD MD Site Name Huntville Solid Wate-to-Energy Facility Commerce Refue-to-Energy Facility Southeat Reource Recovery Facility (SERRF) Stanilau County Reource Recovery Facility Britol Reource Recovery Facility Mid-Connecticut Reource Recovery Facility Riley Energy Sytem of ibon Connecticut Corp. Southeatern Connecticut Reource Recovery Facility Wallingford Reource Recovery Facility Wheelabrator Bridgeport Company,.P. Bay County Reource Recovery Center Miami-Dade County Reource Recovery Facility Hillborough County Reource Recovery Facility ake County Reource Recovery Facility ee County Reource Recovery Facility McKay Bay Refue-to-Energy Facility North County Reource Recovery Facility Paco County Reource Recovery Facility Pinella County Reource Recovery Facility Wheelabrator North Broward, Inc. Wheelabrator South Broward, Inc. Honolulu Reource Recover Venture (HPOWER) Ame Municipal Electric Utility Indianapoli Reource Recovery Facility Maine Energy Recovery Company Mid-Maine Wate Action Corporation Penobcot Energy Recovery Corp. Greater Portland Reource Recovery Facility Harford Wate-to-Energy Facility Montgomery County Reource Recovery Facility Baltimore Refue Energy Sytem Company (BRESCO) Haverhill Reource Recovery Facility Pioneer Valley Reource Recovery Facility Pittfield Reource Recovery Facility SESS Reource Recovery Facility Wheelabrator Millbury Inc. Wheelabrator North Andover Inc. ocation Huntville Commerce ong Beach Crow' anding Britol Hartford ibon Preton Wallingford Bridgeport Panama City Miami Tampa Okahumpka Fort Myer Tampa Wet Palm Beach Spring_ Hill St. Peterburg Pompano Beach Ft. auderdale Honolulu Ame Indianapoli Biddeford Auburn Orrington Portland Joppa Dickeron Baltimore Haverhill Agawam Pittfield Wet Ware ham Millbury North Andover *Source: Energy Recovery Council: The 2010 ERC Directory of Wate-to-Energy Plant; I energyrecoverycouncil. org/wate-energy-reource-a298 5 arge or Small

7 State Site Name ocation Wheelabrator Saugu, J.V. Saugu MI Greater Detroit Reource Recovery Facility Detroit MI Jackon County Reource Recovery Facility Jackon MI Kent County Wate-to-Energy Facility Grand Rapid MN Great River Energy - Elk River Station Elk River MN Hennepin Energy Reource Co. Minneapoli MN Olmtead Wate-to-Energy Facility Rocheter MN Perham Reource Recovery Facility Perham MN Polk County Solid Wate Reource Recovery Plant Foton MN Pope/Dougla Solid Wate Management Alexandria MN Red Wing Reource Recovery Facility Red Wing MN Xcel Energy - Red Wing Steam Plant Red Wing MN Xcel Energy - Wilmarth Plant Mankato NH Wheelabrator Clarement Co,.P. Claremont NH Wheelabrator Concord Company,.P. Penacock NJ Camden Reource Recovery Facility Camden NJ Eex County Reource Recovery Facility Newark NJ Union County Reource Recovery Facility Rahway NJ Warren Energy Reource Company Oxford Townhip NJ Wheelabrator Glouceter Company,.P. Wetville NY Babylon Reource Recovery Facility Babylon NY Dutche County Reource Recovery Facility Poughkeepie NY Hemptead Reource Recovery Facility Wetbury NY Huntington Reource Recovery Facility Eat Northport NY MacArthur Wate-to-Energy Facility Ronkonkoma NY Niagara Fall Reource Recovery Facility Niagara Fall NY Onondaga County Reource Recovery Facility Jameville NY Owego County Energy Recovery Facility Fulton NY Wheelabrator Hudon Fall Inc. Hudon Fall NY Wheelabrator Wetcheter Company,.P. Peekkill NC New Hanover County - Watec Wilmington OK Warren B. Hall Reource Recovery Facility Tula OR Marion County Solid Wate-to-Energy Facility Brook PA Delaware Valley Reource Recovery Facility Cheter PA Harriburg Reource Recovery Facility Harriburg PA ancater County Reource Recovery Facility Bainbridge PA Covanta Plymouth Renewable Energy Conhohocken PA Wheelabrator Fall Inc. Morriville PA York Reource Recovery Center York UT Waatch Integrated Wate Management Ditrict ayton VA Alexandria/Arlington Reource Recovery Facility Alexandria *Source: Energy Recovery Council: The 2010 ERC Directory of Wate-to-Energy Plant; arge or Small IS IS

8 State Site Name ocation VA Hampton-NASA Steam Plant Hampton VA Harrionburg Reource Recovery Facility Harrionburg VA I-95 Energy-Reource Recovery Facility (Fairfax) orton VA Wheelabrator Portmouth, Inc. Portmouth WA Spokane Regional Solid Wate Dipoal Facility Spokane WI Barron County Wate-to-Energy & Recycling Facility Almena WI Xcel Energy French Iland Generating Plant acroe arge or Small Note that not all of thee permitted hazardou wate incinerator and cement kiln may be permitted to or may chooe to accept collected houehold pharmaceutical. Contact the individual facility about it policy. Diclaimer: Thi i a lit of all Wate-to-Energy plant in the U.S. that are regulated a either arge or Small Municipal Solid Wate Combutor under the Clean Air Act. Incluion on thi lit doe not imply endorement or recommendation to ue any particular facility. *Source: Energy Recovery Council: The 2010 ERC Directory of Wate-to-Energy Plant;

9 RCRA-Permitted Commercial Hazardou Wate Incinerator State AR AR I MO NE OH OH TX TX UT Site Name Reynold Metal Company Clean Harbor El Dorado, C Veolia ES Technical Solution C General Dynamic Ordnance and Tactical Sytem, Joplin Operation Clean Harbor Environmental Service Ro Incineration Service, Inc. Heritage - WTI, Inc. Veolia ES Technical Solution C Clean Harbor Deer Park P Clean Harbor Aragonite C RCRA-Permitted Cement Kiln that Burn Hazardou Wate State AR IN IN KS MO MO OH OK PA c c Site Name Ah Grove Cement Co. Buzzi Unicem USA ESSROC Corporation Ah Grove Cement Co. Buzzi Unicem USA Continental Cement Company afarge North America, Inc. a farge North America, Inc. Giant Cement Holding Inc. Giant Cement Holding Inc. Holcim (US) Inc. Note that not all of thee permitted hazardou wate incinerator and cement kiln may be permitted or may chooe to accept collected houehold pharmaceutical. Contact the individual facility about it policy. Diclaimer: Thi i a lit of commercial hazardou wate incinerator that are permitted under RCRA and a lit of cement kiln that burn hazardou wate a fuel that are permitted under RCRA. Incluion on thi lit doe not imply endorement or recommendation to ue any particular facility.

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