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Hazardous Waste Pharmaceuticals Sewer Prohibition Kristie Shipley - - PowerPoint PPT Presentation
Hazardous Waste Pharmaceuticals Sewer Prohibition Kristie Shipley - - PowerPoint PPT Presentation
Hazardous Waste Pharmaceuticals Sewer Prohibition Kristie Shipley Hazardous Waste Program Division of Environmental Response & Revitalization Agenda Introduction Background Applicability/Definitions Management Questions
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US EPA Final Rule
Final Rule: Management Standards for Hazardous Waste Pharmaceuticals
▪ § 266.505 Sewer Prohibition- August 21, 2019
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Background
RCRA domestic sewage exclusion in § 261.4(a)(1)(ii)
▪ Any mixture of domestic sewage and other wastes that passes through a sewer system to a publicly-
- wned treatment works for treatment.
▪ Not considered solid wastes up to this point
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Clean Water Act
Ignitable and some reactive and corrosive wastes are already prohibited from being discharged to the sewer system under the Clean Water Act § 403.5(b)
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Authority
Hazardous and Solid Waste Amendments (HSWA) 1984
▪ Allows for revision of regulations to ensure substances which pass through a sewer system to POTW are adequately controlled
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Background
▪ No pollutant discharge limits that apply to healthcare facilities discharging pharmaceuticals to POTWs ▪ Wastewater treatment is not designed to remove pharmaceuticals
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Background
Projected to prevent the flushing of 1,644 to 2,300 tons of hazardous waste pharmaceuticals annually
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Applicability
▪ All healthcare facilities that generate, accumulate, or otherwise handle hazardous waste pharmaceuticals
▪ Including CESQGs
▪ Reverse distributors engaged in the management of prescription hazardous waste pharmaceuticals
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Definition
Healthcare facility: (1) provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body
- any drug or dietary supplement for use by humans or
- ther animals; any electronic nicotine delivery system, or any liquid nicotine packaged for
retail for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).
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Definition
Healthcare facility: (2) distribute, sell, or dispense pharmaceuticals, including OTC pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals
- any drug or dietary supplement for use by humans or
- ther animals; any electronic nicotine delivery system, or any liquid nicotine packaged for
retail for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).
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Healthcare Facilities
Hospitals Psychiatric hospitals Ambulatory surgical centers Health clinics Physicians’
- ffices
Optical & dental providers Chiropractors Long term care facilities Ambulance services Pharmacies Retailers of OTC medications Veterinary clinics/hospitals
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Definition
Reverse distributor: Any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit
- any drug or dietary supplement for use by humans or
- ther animals; any electronic nicotine delivery system, or any liquid nicotine packaged for
retail for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).
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Definition
Pharmaceutical:
Any drug or dietary supplement for use by humans or other animals, any electronic nicotine delivery system, or any liquid nicotine packaged for retail for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).
- any drug or dietary supplement for use by humans
- r other animals; any electronic nicotine delivery system, or any liquid nicotine
packaged for retail for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).
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Pharmaceuticals
Dietary supplements Prescription drugs OTC drugs Homeopathic drugs Compounded drugs Investigational drugs Pharmaceuticals remaining in containers Personal protective equipment (contaminated) Clean-up material (pharmaceutical spills)
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Hazardous Waste Pharmaceutical
▪ Listed hazardous waste
– Approximately 30 products listed on the P and U lists with pharmaceutical uses
▪ Characteristic hazardous waste
– Ignitable, corrosive, reactive or toxic
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DEA Controlled Substances
Name of Drug Other Name(s) Medical Uses RCRA HW Code DEA CS Schedule Chloral/ Chloral hydrate
Acetaldehyde, trichloro; Aquachloral Noctec, Somnote, Supprettes
Sedative U034 T
- xic
IV Fentanyl sublingual spray Subsys Analgesic D001 ignitable II Phenobarbital Bellergal-S Donnatal Luminal Anticonvulsant D001 ignitable IV T estosterone gels/solutions Androgel Axiron Fortesta,T estim Hormone D001 ignitable III Valium injectable/gel Diazepam Diastat Anti-anxiety D001 ignitable IV
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Applicability Summary
Are you a healthcare facility
- f reverse distributor?
Do you generate pharmaceutical waste? Is it a hazardous waste?
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Management
Need to manage as hazardous waste
▪ Chapter 3745-52 Generator Standards
Generator categories:
▪ CESQG: ≤ 1 kg acute, ≤ 100 kg hazardous ▪ SQG: > 100 kg and < 1,000 kg hazardous ▪ LQG: > 1 kg acute, ≥ 1,000 kg hazardous
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Management
Satellite accumulation (SQG/LQG)
▪ 55 gallons of non-acute ▪ 1 quart of acute ▪ At or near the point of generation
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Management
Container management (SQG/LQG)
▪ Good condition ▪ Compatible with waste ▪ Labeled as hazardous waste ▪ Maintain aisle space and lids ▪ Conduct weekly inspections ▪ Label accumulation start date (unless a satellite accumulation area)
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Management
Training (SQG/LQG)
▪ All employees must be thoroughly familiar with proper waste handling and emergency procedures, relevant to their responsibilities
Emergency equipment (SQG/LQG)
▪ Internal communication or alarm system ▪ Telephone or two-way radio ▪ Fire, spill control and decontamination equipment
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Management
▪ 180-day storage limit SQG ▪ 90-day storage limit LQG
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Management
Emergency procedures:
▪ (SQG) Emergency Coordinator’s response required ▪ (LQG) Written contingency plan and emergency procedures required
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Management
Land Disposal Restriction (SQG/LQG)
▪ Determine if waste must be treated before it can be land disposed (or write on manifest that a determination has not been made) ▪ One-time written notice to each treatment storage disposal facility receiving your hazardous waste
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Management
Reporting ▪ (LQG) Biennial report due March 1st in even numbered years for previous year
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Management
Recordkeeping (SQG/LQG)
▪ Manifests ▪ LDR notification ▪ Exception reports ▪ Waste evaluation ▪ Training ▪ Biennial Report ▪ (kept on-site for at least 3 years)
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Management
Hazardous waste pharmaceuticals should NOT be placed in red sharps containers
▪ Biohazardous waste/infectious waste
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Summary
August 21st-Hazardous waste pharmaceuticals may not be sewered (drain / flushing) Sewering of any pharmaceuticals is highly discouraged
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