EPA’s New Pharmaceutical Rule: Relief for Healthcare Facilities and Our Water Sources

Background When initially written, RCRA hazardous waste provisions were almost entirely focused on wastes generated by industrial facilities. These waste streams are few in number when compared to healthcare facilities, which could have thousands of medications on hand at any one time. Certain pharmaceuticals are regulated as hazardous waste under RCRA when discarded. The EPA has long been aware that the method for managing used or unused pharmaceuticals has been to flush them down the sewer. RCRA, in fact, has permitted such disposal, with some exceptions. Although most pharmaceutical contamination in our waters comes from secretions, disposal of pharmaceuticals into sewers is as a cause for concern. These circumstances created a clear need for a separate RCRA program for management of pharmaceutical waste generated by healthcare facilities. The EPA published their final rule, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” on February 22, 2019. According to the EPA’s Rule Summary:
  • “This final rule establishes cost- saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.
  • Importantly, this final rule will make our drinking and surface water safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering our waterways by 1,644 to 2,300 tons on an annual basis by prohibiting all facilities subject to the rule from sewering them. This action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.”
Who is Affected?
  • Healthcare facilities (human or animal)
  • Reverse distributors
Who is Not Affected?
  • Pharmaceutical manufacturers
  • Households
  • Farmers, Ranchers, Fisheries
  • RCRA-Permitted TSDFs
Highlights of the Final Rule Healthcare facilities and reverse distributors will manage their hazardous waste pharmaceuticals (HWPs) under this new set of standards in lieu of the existing hazardous waste generator regulations. Here are a few examples of changes under the new rule:
  • Sewering Ban: health care facilities covered by the rule are prohibited from discharging HWPs to a sewer system that passes through a POTW. This will go into effect August 21, 2019 regardless of a state’s RCRA status.
  • Empty Containers: under the new regulations, certain stock, dispensing and unit-dose containers including syringes and IV bags are considered “empty” and therefore not regulated as hazardous waste under RCRA, even if minor pharmaceutical residue remains, provided they have been emptied using the practices commonly employed to remove materials from that type of container or have been fully administered to a patient.
  • OTC Nicotine Replacement Therapies: Under the new rule, over the counter Nicotine replacement therapies, including lozenges, gum and patches, are exempt from the P075 waste code.
  • Overlapping regulations for wastes that carry additional hazards are addressed in the final rule. Examples include DEA-regulated HWPs, “dual waste” (i.e., HWP and medical) and “mixed waste,” or HWPs with a radioactive component.
  • Definitions for Subpart P: Some RCRA definitions have been added, including these: healthcare facility, long-term care facility, reverse distributor, noncreditable hazardous waste pharmaceutical, and potentially creditable hazardous waste pharmaceutical.
Waste Pharmaceuticals in California Note that many of these provisions do not apply to waste pharmaceuticals at California facilities. In California, pharmaceutical wastes that meet California’s definition of hazardous waste (“non-RCRA hazardous waste”) are subject to the Medical Waste Management Act (“MWMA” – Division 104, Part 14 California Health and Safety Code). Pharmaceutical wastes that are regulated under RCRA, such as bulk chemotherapy drugs, P-listed waste (nicotine, Coumadin/warfarin, arsenic trioxide, etc.), U-listed waste (mercury, chloroform, etc.) and characteristic hazardous waste (aerosol propellants, M-Cresol, etc. are excluded from the MWMA regulations and must be managed as hazardous waste. The MWMA establishes specific requirements for storage, management and disposal of medical waste pharmaceuticals from California facilities. Implementation of the EPA Pharmaceutical Rules The prohibition on disposing of HWPs via sewer is effective in ALL states beginning August 21, 2019. The amendment to the Nicotine listing only applies to unauthorized states effective August 21,2019. Since it is less stringent, authorized states are not required to adopt the amendment. Subpart P: authorized states have until July 1, 2021 to adopt. If a state requires a statutory amendment, it has until July 1, 2022 to adopt. For more information: View the Federal Register’s published rule here: https://www.federalregister.gov/documents/2019/02/22/2019-01298/management-standards-for-hazardous-waste-pharmaceuticals-and-amendment-to-the-p075-listing-for View the California Medical Waste Management Act here: https://www.cdph.ca.gov/Programs/CEH/DRSEM/CDPH%20Document%20Library/EMB/MedicalWaste/ MedicalWasteManagementAct.pdf The EPA has also posted a Webinar, which can be viewed here: https://clu-in.org/conf/tio/HazWastePharmaceuticals_040219/ Should you need more information on this new rule or help in disposing of any regulated waste in the safest, most sustainability-minded way, please reach out to me or any of my colleagues. We will be glad to assist. – Vanessa Clark, Strategic Account Manager
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