Hazardous Waste Pharmaceutical Rule
Prohibition on Sewer Disposal of Hazardous Waste Pharmaceuticals by Healthcare Facilities and Reverse Distributors
On February 22, 2019, the United States Environmental Protection Agency, (EPA) published in the Federal Register (84 FR 5816) a Final Rule entitled Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine (Pharmaceutical Waste Rule). This final rule adds regulations for the management of hazardous waste pharmaceuticals by healthcare facilities (for both humans and animals) and reverse distributors. Among other things, these new regulations prohibit all healthcare facilities, including those operating under the regulations for very small quantity generators of hazardous waste, and reverse distributors from discharging hazardous waste pharmaceuticals to a sewer system that passes through a publicly owned treatment works.
As applied to Pretreatment Standards and Regulations, 40 Code of Federal Regulations (CFR) 403.8 (f)(1)(iii); the State of Utah, Department of Environmental Quality (DEQ) has required the St. George Regional Water Reclamation Facility, (SGRWRF) Pretreatment Program to generate an Industrial Waste Survey, (IWS). This IWS has been required to enable the SGRWRF Pretreatment Program to identify, list and generate notifications, (informing identified locations of applicable Pretreatment Standards and Requirements, including the requirements for Hazardous Waste, 40 CFR 403 (f)(1)(iii) and 2019 HW Phar Rule) to all new and existing commercial/industrial users within the SGRWRF Pretreatment Programs Jurisdictional boundaries i.e. St. George, Washington City, City of Santa Clara, and Ivins City. Generally, the SGRWRF is designed to treat domestic sewage and biodegradable commercial/industrial waste or conventional pollutants. However, non-domestic sources, commercial/industrial facilities, may also discharge toxic or non-conventional pollutants that may cause problems in the sewer collection system or at the SGRWRF.
The National Pretreatment Program is charged with controlling toxic, conventional, and nonconventional pollutants from non-domestic sources that discharge into the sewer collection system and SGRWRF. The Pretreatment Standards and Regulations found in 40 CFR Part 403 provide the SGRWRF Pretreatment Program with the necessary controls to protect the SGRWRF from the impacts of pollutants of non-domestic wastewater, including but not limited to interference with the operation of the SGRWRF, obstructions in the sewer collection system, (that cause sanitary sewer overflows) pass-through of pollutants that cause National Pollutant Discharge Elimination System, (NPDES) permit violations, worker health and safety impacts, degradation in the quality of the SGRWRF biosolids, and explosive or corrosive conditions in the sewer collection system.
The Pharmaceutical Waste Rule falls under the Resource Conservation and Recovery Act (RCRA). The Division of Waste Management and Radiation Control (DWMRC) in the Department of Environmental Quality (DEQ) is responsible for overseeing RCRA in the State of Utah and is therefore responsible for overseeing the prohibition on sewer disposal of hazardous waste pharmaceuticals. For a list of pharmaceuticals that may be considered hazardous waste when discarded or for more information on the Pharmaceutical Waste Rule, please contact Tom Ball at the DWMRC at 801-536-0251 or by email at tball@utah.gov.
Facilities following under the pharmaceutical rule are Drug Wholesalers, Supermarkets and Other Grocery (except convenience) stores, Pharmacies and Drug Stores, Warehouse Clubs and Supercenters, Veterinary Services, Physicians Offices, Dentists' Offices, Medical Labs, Chiropractors, Jails or Dentation Centers, Clinics, Mental and/or Behavioral Health Services, Outpatient Care Centers (e.g., Dialysis center, Cancer Treatment, Diabetes clinic), Other Ambulatory Health Care Services (Orthopedic services), Hospitals, Nursing Care Facilities (e.g., Assisted living facilities, Nursing Homes, Rehabilitation Services, Addiction Treatment Centers, Group Homes, Women/Children Shelters), Continuing Care Retirement Communities, (e.g., Assisted living facilities with on-site nursing facilities), Reverse Distributors.
Notification of the Discharge of Hazardous Waste
A. Any User who commences the discharge of hazardous waste shall notify the POTW, the EPA Regional Waste Management Division Director, and State hazardous waste authorities, in writing, of any discharge into the POTW of a substance which, if otherwise disposed of, would be a hazardous waste under 40 CFR Part 261. Such notification must include the name of the hazardous waste as set forth in 40 CFR Part 261, the EPA hazardous waste number, and the type of discharge (continuous, batch, or other). If the User discharges more than one hundred (100) kilograms of such waste per calendar month to the POTW, the notification also shall contain the following information: 1) an identification of the hazardous constituents contained in the wastes; 2) an estimation of the mass and concentration of such constituents in the wastestream discharged during that calendar month; and 3) an estimation of the mass of constituents in the wastestream expected to be discharged during the following twelve (12) months. All notifications must take place no later than one hundred and eighty (180) days after the discharge commences. Any notification under this paragraph need be submitted only once for each hazardous waste discharged. However, notifications of changed conditions must be submitted under Section 8-4-6.5 of this ordinance. The notification requirement in this Section does not apply to pollutants already reported by Users subject to categorical Pretreatment Standards under the self‑monitoring requirements of Sections 8-4-6.1, 8-4-6.3, and 8-4-6.4 of this ordinance.
B. Dischargers are exempt from the requirements of paragraph A, above, during a calendar month in which they discharge no more than fifteen (15) kilograms of hazardous wastes, unless the wastes are acute hazardous wastes as specified in 40 CFR 261.30(d) and 261.33(e). Discharge of more than fifteen (15) kilograms of non-acute hazardous wastes in a calendar month, or of any quantity of acute hazardous wastes as specified in 40 CFR 261.30(d) and 261.33(e), requires a one‑time notification. Subsequent months during which the User discharges more than such quantities of any hazardous waste do not require additional notification.
C. In the case of any new regulations under section 3001 of RCRA, identifying additional characteristics of hazardous waste or listing any additional substance as a hazardous waste, the User shall notify the Manager, the EPA Regional Waste Management Waste Division Director, and State hazardous waste authorities of the discharge of such substance within ninety (90) days of the effective date of such regulations.
D. In the case of any notification made under this Section, the User shall certify that it has a program in place to reduce the volume and toxicity of hazardous wastes generated.
E. This provision does not create a right to discharge any substance not otherwise permitted to be discharged by this ordinance, a permit issued thereunder, or any applicable Federal, State, or local law.
Definitions: (Ord. 8-4-1.4)(T)
Hazardous Waste. Waste as defined in 40 CFR 261.3, incorporated herein and made a part hereof.
Prohibited Discharge Standards: (Ord. 8-4-2.1)
A. General Prohibitions. No User shall introduce or cause to be introduced into the POTW any pollutant or wastewater which causes Pass Through or Interference. These general prohibitions apply to all Users of the POTW whether or not they are subject to categorical Pretreatment Standards or any other National, State, or local Pretreatment Standards or Requirements.
If you have any questions, please contact the St. George Pretreatment Department at 435-627-4273.