2. OVERVIEW of TODAY’S PRESENTATION 1.RCRA for healthcare 2.Discuss specific requirements for proper management and disposal of RCRA hazardous waste 3.What to expect during a hazardous waste inspection 4.Frequently Asked Questions!

3. Definitions 1.RCRA – Resource Conservation Recovery Act Regulations that govern hazardous waste Created by Congress in 1976 EPA rolled out RCRA in early 1980’s EPA is governing agency, states can be authorized. Colorado is an authorized state which administers RCRA with EPA oversight. Designed for industry 2.Solid Waste, Medical Waste, Hazardous Waste, Household Waste Specific definitions Different regulatory disposal requirements 3.Hazardous – RCRA? OSHA? Bio-hazardous? Dangerous?

4. Typical Healthcare Waste Streams Solid waste – waste or product? Medical waste/sharps/bio-hazardous Medications Healthcare Laboratories (solvents) pH adjusters Acids/bases Reagents Stain/staining lines Test kits Aerosols Hand sanitizers/lotions/select shampoos Cleaning supplies Light bulbs/batteries/electronics

5. CATAGORIES OF MEDICAL WASTE Sharps Blood and body fluids Pathological waste Trauma scene waste Non-RCRA waste pharmaceuticals and vaccines Other as determined by the Department

6. Urine or feces Lightly to moderately contaminated bandages Garments or disposable bedding RCRA pharmaceuticals

7. Regulation/AgencyPrimary Concern CDPHE, Hazardous Waste Regulations Disposal at hazardous waste facility CDPHE, Solid Waste Regulations Non acceptance of hazardous waste; landfill suitability for medication waste CDPHE, Health Facilities Division Proper dispensing of medication to patients; safety DEAPrevention of diversion, drug abuse, accidental poisonings State Board of PharmacyProper dispensing of medication; safety Local POTW, local landfill, OSHAVarious!

8. Household wastes are exempt from regulation as medical waste

9. Multiple sets of regulations yields multiple definitions for waste Healthcare manages multiple types of waste streams Medical waste is typically the largest category of waste medical facilities manage Is it a waste or is it still product? All waste starts off as a solid waste! Households are exempt from some regulations, including RCRA.

10. Typical Pharmaceutical Waste that could be RCRA Hazardous Waste in Healthcare -Partial vials -Un-dispensed medications -Un-administered medications -Discontinued medications -Patient prescriptions -Physician Rx samples -Pre-instilled IVs -Hospital re-packs -Pre-filled syringes -Partial syringes -Certain empty packages/containers (P- listed)

11. WHERE HAS RCRA HAZARDSOUS HEALTHCARE WASTE HISTORICALLY BEEN DISPOSED?  DRAIN  RED BAGS  SHARPS CONTAINERS  DIRECT TO THE LANDFILL  LOCAL INCINTERATORS

12. A hazardous waste is a solid, a liquid or a contained gaseous material that is no longer used and that no longer serves the purpose for which it was produced, and could pose dangers to human health and the environment after it is discarded.

13.  Any business that produces a RCRA hazardous waste is called a “generator” in RCRA regulations.  Must determine what wastes are RCRA hazardous wastes.  Must ensure that RCRA hazardous waste is disposed of at a permitted hazardous waste disposal facility.  Other requirements apply depending on the generator category.

14.  Requirements apply as soon as waste is generated, not in a few months after a pile has accumulated!

15.  Conditionally Exempt Small Quantity Generators (CESQG) (6 CCR 1007-3, Section 261.5) (less than 220 pounds per month of RCRA haz waste and less than 2.2 pounds per month or onsite at any one time of P-listed RCRA haz waste)  Small Quantity Generators (SQG) (6 CCR 1007-3, Section 262.34) (between 220 and 2200 pounds per month of RCRA haz waste and less than 2.2 pounds per month or any one time of P-listed RCRA haz waste)  Large Quantity Generators (LQG) (6 CCR 1007-3, Section 262.34) (greater than 2200 pounds per month and/or more than 2.2 pounds per month or any one time of P- listed RCRA haz waste)

16. Two sides to RCRA hazardous waste determination – listed and characteristic 1. Listed waste – on a list due to it’s pedigree (historical use, background, derivation) P-List (acute), U-List (toxic), F-List (typically solvents) 2. Characteristic waste – based on chemistry (physcial properties) Ignitable, corrosive, reactive, toxic

17.  P and U lists are for unused commercial chemical products. If the product was used, it will not be a P or U listed waste but it still may be a characteristic hazardous waste (nicotine patches as an example).  For P-listed hazardous waste, 2.2 lbs or more per month or stored onsite at any one time of acute (P listed) hazardous waste means you operate as an LQG. Tracking weights on a monthly basis is important here for this very reason!  Empty containers that held “P” listed drugs are hazardous wastes (with exceptions) but you do not count the weight of those containers toward your 2.2 pound threshold. It’s the residual inside the container that counts toward your generation rate! (no need to calculate residual).

18. Arsenic trioxide P012 ƒ Nicotine P075 Phentermine (CIV) P046 ƒ Physostigmine P204 ƒ Physostigmine Salicylate P188 ƒ Warfarin >0.3% P001 Note: Epinephrine P042 and Nitroglycerin P081 are not regulated as P-listed hazardous waste in Colorado.

19.  P and U lists are for unused commercial chemical products. If the product was used, it will not be a P or U listed waste but it still may be a characteristic hazardous waste (nicotine patches as an example).  For u-listed hazardous waste or any other hazardous waste category (other than P-listed waste) there is no specific weight threshold other than the generator category thresholds.  Typical u-listed waste in health care includes chemotherapy drugs.

20. Chloral Hydrate (CIV) U034 ƒ Chlorambucil (chemo) U035 ƒ Chloroform U044 ƒ Cyclophosphamide (chemo) U058 ƒ Daunomycin (chemo) U059 ƒ Dichlorodifluromethane U075 ƒ Diethylstilbestrol(chemo) U089 ƒ Formaldehyde U122 ƒ Hexachlorophene U132 ƒ Lindane U129 ƒ Melphalan (chemo) U150 ƒ Mercury U151 Mitomycin C (chemo) U010 ƒ Paraldehyde (CIV) U182 ƒ Phenacetin U187 ƒ Phenol U188 ƒ Reserpine U200 ƒ Resorcinol U201 ƒ Saccharin U202 ƒ Selenium sulfide U205 ƒ Streptozotocin (chemo)U206 ƒ Trichloromonofluromethane U121 ƒ Uracil mustard (chemo)U237 ƒ Warfarin <0.3% U248

21.  Do an internet search for RCRA P-list, U-list, or F-list.  Visit EPA’s website and search for the list on their website.  Refer to the regulations 6 CCR 1007- 3 261.33 for a listing.

22. Display one or more of the four generic hazardous properties  Ignitable, D001  Corrosive, D002  Reactive, D003  Toxic, D004  D043

23. Hazardous Waste Code – D001 Characteristics of Ignitability include anƒ aqueous solution (defined as greater than 50% water) containing 24% alcohol or more by volume and a flash point of <140 degrees Fahrenheit. Examples include rubbing alcohol, topical preparations, some cancer drugs (eg. Paclitaxel)

24. Hazardous Waste Code – D002 Characteristics of corrosivity include a pH 12.5. Examples include primarily compounding chemicals such as glacial acetic acid and sodium hydroxide.

25. Hazardous Waste Code – D003 Characteristic of Reactivity ƒ - explosive and water reactive wastes ƒ Nitroglycerin formulations are exempted federally as of 2001 which was adopted by Colorado. Must still be evaluated for ignitability.

26. Waste Code Contaminant Maximum Concentration  D004 Arsenic 5 mg/L  D005 Barium 100 mg/L  D007 Chromium 5 mg/L  D013 Lindane 0.4 mg/L  D009 Mercury 0.2 mg/L  D010 Selenium 1 mg/L  D011 Silver 5 mg/L The entire list of characteristic hazardous waste can be found in the Colorado Hazardous Waste Regulations, 6 CCR 1007.3 Section 261.24.

27.  D009-Mercury (0.2 mg/L) › products w/thimerosal or phenyl- mercuric acetate (eye drops, nasal spray, some multi dose vaccines) D024-M-cresol (200 mg/L) - Insulin w/cresol Also may be U-listed

28. Definition of a RCRA hazardous waste Regulations apply to businesses Regulatory requirements kick in as soon as the waste is generated – not “later” Generator categories based on volume generated Listed and characteristic RCRA waste

29. 1. Hazardous waste determination – you must know what RCRA hazardous wastes you generate. 2. Track your monthly hazardous waste volume (P- listed and characteristic) to prove generator status. 3. Send waste to a disposal facility that is authorized to accept RCRA hazardous wastes from CESQGs. Ensuring proper disposal is the generators responsibility. 4. Minimize potential for release to people and environment. If your business generates less than 220 pounds of hazardous waste (total) AND less than 2.2 pounds of P-listed hazardous waste on a monthly basis, then your facility is a conditionally exempt small quantity generator (CESQG) subject to the following requirements.

30.  Determine what RCRA hazardous wastes you generate.  How do I do that?

31.  When a material is no longer needed or usable for it’s intended purpose, it becomes a waste and you need to ask yourself “is this a haz waste when I go to dispose?”  Use this resource as a starting point: https://www.colorado.gov/pacific/sites/default/files/HM_ mw-evaluating-health-care-waste-including- pharmaceuticals.pdf https://www.colorado.gov/pacific/sites/default/files/HM_ mw-evaluating-health-care-waste-including- pharmaceuticals.pdf  Utilize the lists provided by CDPHE during training and outreach and posted online here: https://www.colorado.gov/pacific/sites/default/files/HM_ mw-examples-of-hw-pharmaceuticals.pdf https://www.colorado.gov/pacific/sites/default/files/HM_ mw-examples-of-hw-pharmaceuticals.pdf  Ask your pharmacist(s) for assistance;  Ask your disposal company for assistance. A list of potential disposal companies serving Colorado is on our website located here: https://www.colorado.gov/pacific/sites/default/files/HM_ mw-service-providers-list.pdf https://www.colorado.gov/pacific/sites/default/files/HM_ mw-service-providers-list.pdf

32.  Contact the manufacturer (for instance, Pfizer has a website where you can type in the name of their medication and find out whether it is a hazardous waste on disposal or not) located here: http://www1.pfizerpro.com/professional_resources/responsible_d isposal http://www1.pfizerpro.com/professional_resources/responsible_d isposal  Review the insert for that specific medication to find the active ingredients in the medication and compare that to RCRA P and U lists which are located here: http://www.epa.gov/wastes/hazard/wastetypes/pdfs/listing- ref.pdf (scroll down the page to find the p and u listings). http://www.epa.gov/wastes/hazard/wastetypes/pdfs/listing- ref.pdf  Review the safety data sheet (SDS) or equivalent to see if it identifies whether it's a RCRA hazardous waste when disposed (or not) or whether the SDS provides characteristic information on the active ingredients;  Regulations and regulatory guidance for health care facilities in Colorado is included here: https://www.colorado.gov/pacific/cdphe/medicalwaste https://www.colorado.gov/pacific/cdphe/medicalwaste

33.  The P and U listings are based on the active ingredient associated with the Chemical Abstract Number (CAS)  If you use the National Drug Code (NDC) instead of the Chemical Abstract Number, make sure to cross reference the NDC with the CAS Number

34.  All non RCRA- hazardous pharmaceuticals should be sent to an authorized facility for incineration or other adequate treatment (autoclaving is not an option for any pharmaceutical waste). No drain!  There are landfills (those owned by Waste Management) in Colorado that have been recently permitted to accept non-hazardous pharmaceutical waste – talk with your disposal company and consider the issues on how to store and get the material safely to the landfill. Beware of the unlocked trash receptacle!!  Consider whether the waste must be specially managed according to other rules as: › DEA-controlled substances; › OSHA-chemotherapy drugs; › US Nuclear Regulatory Commission.

35.  Stay below the volume thresholds for CESQG status. › <220 lbs hazardous non-acutely hazardous waste per month; › <2.2 lbs p-listed waste  How has it been done? › Weigh your waste monthly and document the weights OR › Add up the weights on your disposal log OR › Devise another accurate way.

36. P-LISTED HAZARDOUS WASTE GENERATION RATE TRACKING LOG NAME OF WASTE MEDICATIONDATE PLACED INTO CONTAINERMONTHLY WEIGHTCumulative Weight Coumadin 1/1/2015 nicotine 1/15/2015 total1 pound Coumadin 2/5/2015 nicotine 2/11/2015 total2.5 pounds 3.5 pounds Coumadin 3/2/2015 nicotine 3/12/2015 total1.5 pounds 5 pounds

37.  Send waste to a disposal facility that is authorized to accept RCRA hazardous wastes from CESQGs.  Ensure proper disposal. › Ask your disposal company for documentation that they can accept RCRA hazardous waste from CESQGs; › The verification should include the name, address, EPA ID # and type of RCRA permit held by the facility that accepts the waste. › Recommend using the manifest!

38. Healthcare Waste Landfill Incinerator Tissue Pharmaceuticals Chemo (trace and bulk) Hazardous Waste (if RCRA incinerator) “Red bag” waste or sharps NO recognizable body parts NO Pharmaceuticals NO radioactive waste NO chemo waste Disposal Scenarios Autoclave

39.  Minimize releases.  How has it been done? › Make sure waste is properly containerized at all times. › If you are shredding waste, use a unit that effectively contains dust or discontinue shredding. Shredded waste should not be left open to the environment.

40.  New rule issued by DEA on September 9, 2014 in effect as of October 9, 2014.  Once a controlled substance is rendered non- retrievable the DEA and CDPHE Health Facilities no longer consider that drug a controlled substance and can be properly disposed using the processes outlined herein.  Work with your pharmacist (DEA registrant) on the proper management of controlled substances.  http://www.deadiversion.usdoj.gov/fed_regs/r ules/2014/2014-20926.pdf http://www.deadiversion.usdoj.gov/fed_regs/r ules/2014/2014-20926.pdf http://www.deadiversion.usdoj.gov/fed_regs/r ules/2014/2014-20926.pdf

41.  How will you make your hazardous waste determinations?  Will you sort RCRA hazardous from non- RCRA hazardous?  How will you keep track of the amount of hazardous waste you generate?  Who will you use to properly dispose of your pharmaceutical waste?

42. Waste Cleaners or Sanitizers Mercury–containing Lighting Waste Sharps and Infectious Waste Used Electronics Used Batteries

43.  Label what it is – “waste bulbs”, “waste batteries”, “waste lighting”, “waste electronics”  Date the container once the first piece of waste is placed inside (you can hold this waste for up to one year before you have to dispose of it)  Keep the container closed (watch out for those bulbs and box sizes)