Standards for health care facilities managing noncreditable hazardous waste pharmaceuticals

1. Notification and withdrawal from sections 33.1-24-05-310 through 33.1-24-05-320 for health care facilities managing hazardous waste pharmaceuticals. a. Notification. A health care facility must notify the department using the site identification form (environmental protection agency form 8700-12), that it is a health care facility operating under sections 33.1-24-05-310 through 33.1-24-05-320. A health care facility is not required to fill out box 10.B. (waste codes for federally regulated hazardous waste) of the site identification form with respect to its hazardous waste pharmaceuticals. A health care facility must submit a separate notification (site identification form) for each site or environmental protection agency identification number. (1) A health care facility that already has an environmental protection agency identification number shall notify the department using the site identification form (environmental protection agency form 8700-12) that it is a health care facility as part of its next biennial report, if it is required to submit one; or if not required to submit a biennial report, within sixty days of July 1, 2021, or within sixty days of becoming subject to this subpart. (2) A health care facility that does not have an environmental protection agency identification number shall obtain one by notifying the department, using the site identification form (environmental protection agency form 8700-12), that it is a health care facility as part of its next biennial report, if it is required to submit one; or if not required to submit a biennial report, within sixty days of July 1, 2021, or within sixty days of becoming subject to this subpart. (3) A health care facility must keep a copy of its notification on file for as long as the health care facility is subject to sections 33.1-24-05-310 through 33.1-24-05-320. b. Withdrawal. A health care facility that operated under sections 33.1-24-05-310 through 33.1-24-05-320, but is no longer subject to these requirements, because it is a very small quantity generator operating under section 33.1-24-03-26 and elects to withdraw from this subpart, shall notify the department using the site identification form (environmental protection agency form 8700-12) that it is no longer operating under these sections. A health care facility is not required to fill out box 10.B. (waste codes for federally regulated hazardous waste) of the site identification form with respect to its hazardous waste pharmaceuticals. A health care facility shall submit a separate notification (site identification form) for each environmental protection agency identification number. (1) A health care facility must submit the site identification form notifying that it is withdrawing from these requirements before it begins operating under the conditions for exemption in section 33.1-24-03-26. (2) A health care facility shall keep a copy of its withdrawal on file for three years from the date of signature on the notification of its withdrawal. 2. Training of personnel managing noncreditable hazardous waste pharmaceuticals at health care facilities. A health care facility shall ensure all personnel that manage noncreditable hazardous waste pharmaceuticals are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies. 3. Hazardous waste determination for noncreditable pharmaceuticals. A health care facility that generates a solid waste that is a noncreditable pharmaceutical shall determine whether that pharmaceutical is a hazardous waste pharmaceutical (i.e., it exhibits a characteristic identified in sections 33.1-24-02-10 through 33.1-24-02-14 or is listed in sections 33.1-24-02-15 through 33.1-24-02-19) to determine whether the waste is subject to the requirements in sections 33.1-24-05-310 through 33.1-24-05-320. A health care facility may choose to manage its nonhazardous waste pharmaceuticals as noncreditable hazardous waste pharmaceuticals under these requirements. 4. Standards for containers used to accumulate noncreditable hazardous waste pharmaceuticals at health care facilities. a. A health care facility shall place noncreditable hazardous waste pharmaceuticals in a container that is structurally sound, compatible with its contents, and that lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. b. A health care facility that manages ignitable or reactive noncreditable hazardous waste pharmaceuticals, or that mixes or commingles incompatible noncreditable hazardous waste pharmaceuticals shall manage the container so that it does not have the potential to: (1) Generate extreme heat or pressure, fire or explosion, or violent reaction; (2) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health; (3) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions; (4) Damage the structural integrity of the container of noncreditable hazardous waste pharmaceuticals; or (5) Through other like means threaten human health or the environment. c. A health care facility shall keep containers of noncreditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents. d. A health care facility may accumulate noncreditable hazardous waste pharmaceuticals and nonhazardous noncreditable waste pharmaceuticals in the same container, except that noncreditable hazardous waste pharmaceuticals prohibited from being combusted because of the dilution prohibition of section 33.1-24-05-252 must be accumulated in separate containers and labeled with all applicable hazardous waste numbers, i.e., hazardous waste codes. 5. Labeling containers used to accumulate noncreditable hazardous waste pharmaceuticals at health care facilities. A health care facility shall label or clearly mark each container of noncreditable hazardous waste pharmaceuticals with the phrase "Hazardous Waste Pharmaceuticals". 6. Maximum accumulation time for noncreditable hazardous waste pharmaceuticals at health care facilities. a. A health care facility may accumulate noncreditable hazardous waste pharmaceuticals on site for one year or less without a permit. b. A health care facility that accumulates noncreditable hazardous waste pharmaceuticals onsite shall demonstrate the length of time that the noncreditable hazardous waste pharmaceuticals have been accumulating, starting from the date it first becomes a waste. A health care facility may make this demonstration by any of the following methods: (1) Making or labeling the container of noncreditable hazardous waste pharmaceuticals with the date that the noncreditable hazardous waste pharmaceuticals became a waste; (2) Maintaining an inventory system that identifies the date the noncreditable hazardous waste pharmaceuticals being accumulated first became a waste; or (3) Placing the noncreditable hazardous waste pharmaceuticals in a specific area and identifying the earliest date any of the noncreditable hazardous waste pharmaceuticals in the area became a waste. 7. Land disposal restrictions for noncreditable hazardous waste pharmaceuticals. The noncreditable hazardous waste pharmaceuticals generated by a health care facility are subject to the land disposal restrictions of sections 33.1-24-05-250 through 33.1-24-05-309. A health care facility that generates noncreditable hazardous waste pharmaceuticals shall comply with the land disposal restrictions in accordance with subsection 1 of section 33.1-24-05-256 requirements, except that it is not required to identify the hazardous waste numbers (i.e., hazardous waste codes) on the land disposal restrictions notification. 8. Procedures for health care facilities for managing rejected shipments of noncreditable hazardous waste pharmaceuticals. A health care facility that sends a shipment of noncreditable hazardous waste pharmaceuticals to a designated facility with the understanding that the designated facility can accept and manage the waste, and later receives that shipment back as a rejected load in accordance with the manifest discrepancy provisions of section 33.1-24-05-39 may accumulate the returned noncreditable hazardous waste pharmaceuticals onsite for up to an additional ninety days provided the rejected or returned shipment is managed in accordance with subsections 4 and 5. Upon receipt of the returned shipment, the health care facility shall: a. Sign either: (1) Item 18c of the original manifest, if the original manifest was used for the return shipment; or (2) Item 20 of the new manifest, if a new manifest was used for the returned shipment. b. Provide the transporter a copy of the manifest; c. Within thirty days of receipt of the rejected shipment, send a copy of the manifest to the designated facility that returned the shipment to the health care facility; and d. Within ninety days of receipt of the rejected shipment, transport or offer for transport the returned shipment in accordance with the shipping standards of subsection 1 of section 33.1-24-05-318. 9. Reporting by health care facilities for noncreditable hazardous waste pharmaceuticals. a. Biennial reporting by health care facilities. Health care facilities are not subject to biennial reporting requirements under section 33.1-24-03-14, with respect to noncreditable hazardous waste pharmaceuticals managed under sections 33.1-24-05-310 through 33.1-24-05-320. b. Exception reporting by health care facilities for a missing copy of the manifest. (1) For shipments from a health care facility to a designated facility, if a health care facility does not receive a copy of the manifest with the signature of the owner or operator of the designated facility within sixty days of the date of the noncreditable hazardous waste pharmaceuticals were accepted by the initial transporter, the health care facility shall submit: (a) A legible copy of the original manifest, indicating the health care facility has not received confirmation of delivery, to the department; and (b) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, stating the return copy was not received and explaining the efforts taken to locate the noncreditable hazardous waste pharmaceuticals and the results of those efforts. (2) For shipments rejected by the designated facility and shipped to an alternate facility, if a health care facility does not receive a copy of the manifest for a rejected shipment of the noncreditable hazardous waste pharmaceuticals that is forwarded by the designated facility to an alternate facility using appropriate manifest procedures, with the signature of the owner or operator of the alternate facility, within sixty days of the date the noncreditable hazardous waste was accepted by the initial transporter forwarding the shipment of noncreditable hazardous waste pharmaceuticals from the designated facility to the alternate facility, the health care facility shall submit: (a) A legible copy of the original manifest, indicating the health care facility has not received confirmation of delivery, to the department; and (b) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, stating the return copy was not received and explaining the efforts taken to locate the noncreditable hazardous waste pharmaceuticals and the results of those efforts. c. Additional reports. The department may require health care facilities to furnish additional reports concerning the quantities and disposition of noncreditable hazardous waste pharmaceuticals. 10. Recordkeeping by health care facilities for noncreditable hazardous waste pharmaceuticals. a. A health care facility shall keep a copy of each manifest signed in accordance with subsection 1 of section 33.1-24-03-07 for three years or until it receives a signed copy from the designated facility which received the noncreditable hazardous waste pharmaceuticals. This signed copy must be retained as a record for at least three years from the date the waste was accepted by the initial transporter. b. A health care facility shall keep a copy of each exception report for a period of at least three years from the date of the report. c. A health care facility shall keep records of any test results, waste analyses, or other determinations made to support its hazardous waste determination consistent with subsection 6 of section 33.1-24-03-02 for at least three years from the date the waste was last sent to an onsite or offsite treatment, storage, or disposal. A health care facility that manages all of its noncreditable nonhazardous waste pharmaceuticals as noncreditable hazardous waste pharmaceuticals is not required to keep documentation of hazardous waste determinations. d. The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the department. e. All records must be readily available upon request by an inspector. 11. Response to spills of noncreditable hazardous waste pharmaceuticals at health care facilities. A health care facility immediately shall contain all spills of noncreditable hazardous waste pharmaceuticals and manage the spill cleanup materials as noncreditable hazardous waste pharmaceuticals in accordance with the requirements in sections 33.1-24-05-310 through 33.1-24-05-320. 12. Accepting noncreditable hazardous waste pharmaceuticals from an offsite health care facility that is a very small quantity generator. A health care facility may accept noncreditable hazardous waste pharmaceuticals from an offsite health care facility that is a very small quantity generator under section 33.1-24-03-26 without a permit or without having interim status, provided the receiving health care facility: a. Is under the control of the same person, as defined in section 33.1-24-03-26, as the very small quantity generator health care facility that is sending the noncreditable hazardous waste pharmaceuticals offsite ("control", for the purposes of this section means the power to direct the policies of the health care facility, whether by the ownership of stock, voting rights, or otherwise, except that contractors who operate health care facilities on behalf of a different person as defined in section 33.1-24-03-26 may not be deemed to "control" such health care facilities) or has a contractual or other documented business relationship whereby the receiving health care facility supplies pharmaceuticals to the very small quantity generator health care facility; b. Is operating under this section for the management of its noncreditable hazardous waste pharmaceuticals; c. Manages the noncreditable hazardous waste pharmaceuticals that it receives from offsite in compliance with sections 33.1-24-05-310 through 33.1-24-05-320; and d. Keeps records of the noncreditable hazardous waste pharmaceuticals shipments it receives from offsite for three years from the date that the shipment is received.