### 1 **Waste	Management	Recommendations	on Disposal	of	Consumer	Unused	Medications** 

February 11, 2011 **Goals	of	a	Comprehensive	Consumer	Pharmaceutical	Take -**  **back	Program** The ideal program will be: 1. Convenient 2. Safe (both from a physical and a diversion perspective) 3. Cost - effective 4. Widely Available Key program elements :  **Multiple drug return options**, such as kiosk drop boxes in pharmacies and other convenient locations, mail - back conta iners, and community events for scheduled drop off;  **Use of existing transportation infrastructure**, such as USPS, FedEx, and UPS to provide cost - effective logistics;  **Flexible disposal options** that are compliant with federal and state regulatory requirement s;  **Disposal** of returned household pharmaceuticals by incineration at a permitted **medical waste incinerator or MSW waste**  **- to**  **- energy facility**  will be significantly less costly than disposal at a hazardous waste incinerator;  **Appropriate state agencies** should be tasked with development of **regulatory criteria for program approval, performance and oversight**  to ensure that ultimate disposal is secure and environmentally protective; and  Return options **compliant with Federal Controlled Substances Act;** 

### WM	ha**s	recommended	safe	destruction	of	consumer	pharmaceutical discards	using	permitted	waste**  **- to**  **- energy	or	medical	waste	incineration**  . These methods are environmentally protective, ensure complete destruction, and are cost effective. 

### T **ake -**  **back programs	will	only	be	successful	if	they	are	cost** **- effective** **, as**  **funding	sources	are	limited.** Hazardous w aste incineration will be significantly more costly and may discourage or impede the nascent consumer take - back or mail - back programs. Hazardous wast e incineration is about five times more expensive than waste -to - energy and about three times more expensive than medical waste incineration. (See Table of Comparative Costs on pg 4) Since only 8 hazardous waste incinerators are available, compared with 8 6 waste -to - energy facilities and 22 regulated medical waste incinerators, transportation and logistics costs are also higher for hazardous waste treatment.

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If pharmaceutical take - back/mail
- back programs are expensive, fewer consumers will participate and will continue to either drain dispose or stockpile unused medications. 

### Only	a	tiny	percentage	of	consumer	pharmaceutical	discards	would	even **trigger	the	household	hazardous	waste	exclusion.** Most materials in consumers’ possession are not hazardous wastes . Only about 5% of the drugs on the market meet the criteria for hazardous waste and a number of those, such as physostigmine, are only used in healthcare settings and not by consumers. Among controlled substances , the only drugs over which DEA has regula tory authority, only 2.6% are hazardous waste . Of these , two are listed, chloral hydrate, U034, used only in p ediatrics in hospitals, and phentermine, P046, one of the diet drugs used in Fen - Phen, which is now seldom prescribed. The remaining drugs that b ecome hazardous waste are D001 for alcohol content and include Paregoric, (camphorated tincture of opium) and two drugs in alcoholic preparation, diazepam (Valium) and testosterone . In a review of data documented by the Texas Tech UHSC School of Pharmacy at an actual “take back” community event, 646 lines of controlled substances were recorded, with 7 being hazardous waste (1.08%). For non - controlled prescription drugs, of 4571 recorded lines, 42 were warfarin (.9%), 69 pressurized inhalers were counted (most were non -flammable) (1.6%), and 11 vials of human insulin were noted (.2%). In total 136 lines of potentially hazardous waste (including the non -flammable aerosols) was collected or 2.9% of the total non - controlled prescription drugs. Separating pharmaceutical discards to identify the tiny percentage that designate as hazardous waste would significantly increase the risk of th eft and diversion as sealed containers would need to be opened and the contents handled by program staff. Importantly, increased handling of discards poses occupational hazards , particularly if the contents of individual medicine containers are not well - l abeled. 

### There	are	significant	differences	in	the	design	and	implementation	of **pharmaceutical	take -**  **back/mail -**  **back	programs	and	household hazardous	waste	(HHW)	collection	programs.**  The vast majority of pharmaceutical take - back programs being piloted or und er development do not envision accepting household hazardous wastes. In fact, many pharmaceutical collection program designs would utilize mail - back containers or locked kiosks in retail or office locations that are unsuitable for HHW. Each year, there a re approximately 3,000 HHW programs operating in the US either as limited events or as permanent collection programs. It is estimated that only a small portion of these programs accept pharmaceuticals. The small portion of household hazardous waste (HHW) collection programs that do accept consumer discarded medications in many cases segregate pharmaceutical waste from HHW. The segregation allows the waste to be treated at a lower cost incinerator. A few HHW programs that collect pharmaceuticals from res idents combine

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the waste with flammable or toxic waste steams. Most HHW programs may not a ccept controlled substances because they typically do not involve law enforcement officers. Though less mature than HHW programs, the number of pharmaceutical coll ection events or take - back programs is increasing. The DEA sponsored with local law enforcement a national, one - day consumer pharmaceutical collection event in September of 2010 with participation from over 3,000 locations. The typical pharmaceutical tak e - back program or event collects and segregates only prescription and over the counter (OTC) medications. Many of these programs involve law enforcement and are able to accept controlled substances. Forty-three U.S. states do not regulate the prescripti on and OTC discarded material collected by these programs as hazardous waste. Of the seven states that do, at least two of the states (NH, WA) are considering a change that would exempt the waste stream from management as a state hazardous waste. A non - h azardous classification allows additional options for storage, transportation, and treatment of the waste lowering c ost s for program operators. 

### WM	believes	consumer	pharmaceutical	take **- back/mail**  **- back	programs**  **are	sufficiently	different	from	household	ha zardous	waste	collection**  **programs	that	they	warrant	EPA’s	consideration	of	different	disposal and	management	recommendations.** 

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**PHA RM**  **ACEUTICAL W AS**  **TE DISPOSA LCOMPA** **RISION Ty**  **pe of Facility Waste**  **- To**  **- Energy Plant**  **Hazardous Waste Incinerator**  **Regulated Medical Waste**  **Incinerator Number of Facilities Nationwide**  86 8 22 **Ty pes of**  **Pharmaceutic al Wastes**  **Handled** Non - Hazardous Yes Yes Yes

Hazardous No Yes (permit dependent) No Controlled Yes (non - RCRA C only) Yes (permit dependent) Yes Regulated Medical No ? Yes **Cost For Disposal**  **(per ton)** Non - Hazardous $200 - $300 $1,200 - $1,600 $500

Hazardous Not Applicable $2,000 and up Controlled $300 - $400 $2,000 and up $500 Regulated Not Applicable Not Obtained Not Obtained
**Comments Concerning Costs** Costs are for typical pit feed. If hopper feed (regulated flow rate) is required, cost is $350 - $800/per ton Costs do not include EIS fees (typically 10%) or incineration taxes ($2 - $5 per ton) Additional costs applicable for special handling labor or destruction witnesses Additional costs applicable for special handling labor or destruction witnesses Additional costs applicable for special handling labor or destruction witnesses Minimum per load cost = $500 **Acceptable Packaging** Cardboard boxes shrink wrapped and palletized, gaylords, poly drums, fiber drums, bulk. **No metal drums**  Cardboard boxes shrink wrapped and palletized, gaylords, metal drums, poly drums, fiber drums, some bulk containers.

**Pharmaceutic al Waste**  **Definitions (used in cost**  **section above) Non**  **- Hazardous**  - Include pharmaceutical packaged products, as well as, raw

materials and waste from production of these products **Hazardous** - Typically include listed (P & U listed) and characteristic (ignitability, corrosivity, reactivity, toxicity) waste **Controlled substances** - Drugs (divided into 5 schedules based on potential for abuse) regulated by the Drug Enforcement Administration **Regulated** - Liquid or semi - liquid blood or other potentially infectious materials; contaminated items that would release blood