R 299.9825 Hazardous waste pharmaceuticals and hazardous waste ENDS; standards for healthcare facilities and ENDS retailers managing non-creditable hazardous waste pharmaceuticals and hazardous waste ENDS.

Rule 825. (1) The requirements of this rule apply to healthcare facilities managing non-creditable hazardous waste pharmaceuticals and ENDS retailers managing hazardous waste ENDS under R 299.9824 to R 288.9833. Healthcare facilities and ENDS retailers shall determine if their non-creditable pharmaceutical wastes or ENDS are a hazardous waste. The healthcare facility or ENDS retailer may choose to manage its non-hazardous waste pharmaceuticals or ENDS as non--creditable hazardous wastes. (2) Healthcare facilities or ENDS retailers shall notify the director that they are a healthcare facility or ENDS retailer operating under R 299.9824 to R 299.9833, using Michigan site identification form EQP5150, and obtain a site identification number if they do not already have one. The healthcare facility or ENDS retailer is not required to complete the portion of item 12 of the form on hazardous waste numbers for regulated hazardous waste for hazardous waste pharmaceuticals or hazardous waste ENDS. Separate notifications are required for each location or site identification number. The healthcare facility or ENDS retailer shall keep a copy of each notification on file for as long as the healthcare facility or ENDS retailer is subject to R 299.9824 to R 299.9833. (3) The notification required in subrule (2) of this rule must be submitted as follows: (a) As part of the healthcare facility or ENDS retailer’s next biennial report if it is required to submit one. Healthcare facilities and ENDS retailers are not subject to the biennial reporting requirements under R 299.9312, with respect to non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS managed under R 299.9824 to R 299.9833. (b) If not required to submit a biennial report, within 60 days after the effective date of R 299.9824 to R 299.9833 or within 60 days after becoming subject to R 299.9824 to R 299.9833. (4) A healthcare facility or ENDS retailer that operated under R 299.9824 to R 299.9833 but is no longer subject to those rules because it is a very small quantity generator under R 299.9304 and elects to withdraw from regulation under R 299.9824 to R 299.9833, shall notify the director, using the Michigan site identification form EQP5150, that it is no longer operating under R 299.9824 to R 299.9833. Withdraw notifications do not require completion of the portion of item 12 of the form on hazardous waste numbers for regulated hazardous waste for hazardous waste pharmaceuticals or hazardous waste ENDS. Separate notifications are required for each location or site identification number. Withdraw notifications must be submitted before beginning operation under the conditional exemption in R 299.9304. The healthcare facility or ENDS retailer shall keep a copy of each withdraw notification on file for 3 years from the date of signature on the notification. (5) The healthcare facility or ENDS retailer shall ensure that all personnel that manage non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies. (6) A healthcare facility or ENDS retailer accumulating non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS shall comply with all the following container management requirements: (a) Non-creditable hazardous waste pharmaceuticals and hazardous waste ENDS must be placed in containers that are structurally sound, compatible with their contents, and lack evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. (b) Manage containers of ignitable or reactive non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS or mixed or commingled incompatible non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS in a manner that does not have the potential to do any of the following: (i) Generate extreme heat or pressure, fire or explosion, or violent reaction. (ii) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health. (iii) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosion. (iv) Damage the structural integrity of the container. (v) Otherwise threaten human health or the environment. (c) Keep each container closed and secured in a manner that prevents unauthorized access to its contents. (d) Accumulate non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS that are prohibited from being combusted because of the dilution prohibition under 40 CFR 268.3(c) and non-hazardous non-creditable waste pharmaceuticals in separate containers. (e) Label or clearly mark each container of non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS with the phrase "Hazardous Waste Pharmaceuticals" or “Hazardous Waste Electronic Nicotine Delivery Systems”, respectively, and all applicable hazardous waste numbers. (7) A healthcare facility or ENDS retailer may accumulate non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS on-site for 1 year or less without an operating license or having interim status under these rules. The healthcare facility or ENDS retailer shall demonstrate the length of time the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS have been accumulating, starting from the date the pharmaceuticals or ENDS first become a waste. A healthcare facility or ENDS retailer may make this demonstration by any of the following methods: (a) Marking or labeling containers of non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS with the date that the pharmaceuticals or ENDS became a waste. (b) Maintaining an inventory system that identifies the date the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS being accumulated first became a waste. (c) Placing the non-creditable hazardous waste pharmaceuticals in a specific area and identifying the earliest date that any of the pharmaceuticals in the area became a waste. (d) Placing the hazardous waste ENDS in a specific area and identifying the earlier date that any of the systems in the area became a waste. (8) A healthcare facility accumulating non-creditable hazardous waste pharmaceuticals or an ENDS retailer accumulating hazardous waste ENDS shall comply with the requirements of 40 CFR part 268, except that the facility or retailer is not required to identify the hazardous waste numbers on the land disposal restrictions notification. (9) A healthcare facility that sends a shipment of non-creditable hazardous waste pharmaceuticals or an ENDS retailer that sends a shipment of hazardous waste ENDS to a designated facility with the understanding that the designated facility can accept and manage the waste, shall comply with the following requirements: (a) If the healthcare facility or ENDS retailer later receives that shipment back as a rejected load under the manifest discrepancy provisions of R 299.9608, accumulate the returned non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS on-site for up to an additional 90 days if the returned shipment is managed in accordance with subrule (6) of this rule. On receipt of the returned shipment, the healthcare facility or ENDS retailer shall do all the following: (i) Sign either item 18c of the original manifest if the original manifest was used for the returned shipment or item 20 of the new manifest if a new manifest was used for the returned shipment. (ii) Provide the transporter with a copy of the manifest. (iii) Within 30 days of receipt of the rejected shipment, send a copy of the manifest to the designated facility that returned the shipment. (iv) Within 90 days of receipt of the rejected shipment, transport or offer for transport the returned shipment in accordance with R 299.9831(1). (b) If the healthcare facility or ENDS retailer does not receive a copy of the manifest with the signature of the owner or operator of the designated facility within 60 days of the date the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS were accepted by the initial transporter, the healthcare facility or ENDS retailer shall submit to the director both of the following: (i) A legible copy of the original manifest, indicating that the healthcare facility or ENDS retailer has not received confirmation of delivery. (ii) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS and the results of those efforts. (c) If the healthcare facility or ENDS retailer does not receive a copy of the manifest for a rejected shipment of the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS that is forwarded by the designated facility to an alternate facility, with the signature of the owner or operator of the alternate facility within 60 days of the date the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS were accepted by the initial transporter forwarding the shipment from the designated facility to the alternate facility, the healthcare facility or ENDS retailer shall submit to the director both of the following: (i) A legible copy of the original manifest, indicating that the healthcare facility or has not received confirmation of delivery. (ii) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS and the results of those efforts. (10) The director may require healthcare facilities or ENDS retailers to furnish additional reports on the quantities and disposition of non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS. (11) A healthcare facility or ENDS retailer shall keep the following records for the specified time periods, unless automatically extended during any unresolved enforcement action regarding the regulated activity or requested by the director, and make them readily available to the department up request: (a) A copy of each manifest signed in accordance with R 299.9309 for 3 years or until it receives a signed copy from the designated facility that received the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS. This signed copy must be retained for not less than 3 years from the date the waste was accepted by the initial transporter. (b) Each report submitted under subrule (9) of this rule for a period of not less than 3 years from the date of the report. (c) Any test results, waste analyses, or other determinations made to support its hazardous waste determinations consistent with R 299.9302, for not less than 3 years from the date the waste was last sent to on-site or off-site treatment, storage, or disposal. A facility that manages all its non-creditable non-hazardous waste pharmaceuticals as non- creditable hazardous waste pharmaceuticals or an ENDS retailer that manages all its non-hazardous waste ENDS as hazardous waste ENDS is not required to keep documentation of hazardous waste determinations. (12) Healthcare facilities and ENDS retailers shall immediately contain all spills of non-creditable hazardous waste pharmaceuticals and hazardous waste ENDS and manage the spill clean-up materials as non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS in accordance with the requirements of R 299.9824 to R 299.9833. (13) A healthcare facility or ENDS retailer may accept noncreditable hazardous waste pharmaceuticals or hazardous waste ENDS from an offsite healthcare facility or ENDS retailer that is a very small quantity generator, without an operating license or having interim status under these rules, if the receiving healthcare facility or ENDS retailer meets the following requirements: (a) Is under the control of the same person as the very small quantity generator healthcare facility or ENDS retailer that is sending the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS off-site or has a contractual or other documented business relationship whereby the receiving healthcare facility or ENDS retailer supplies pharmaceuticals or ENDS to the very small quantity generator healthcare facility or ENDS retailer. As used in this subdivision, "control" means the power to direct the policies of the healthcare facility or ENDS retailer, whether by the ownership of stock, voting rights, or otherwise, except contractors that operate healthcare facilities or ENDS retailers on behalf of a different person do not control the healthcare facilities or ENDS retailers management of its non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS. (b) Manages the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS that it receives from off-site in compliance with R 299.9824 to R 299.9833. (c) Keeps records of the non-creditable hazardous waste pharmaceuticals or hazardous waste ENDS shipments it receives from off-site for 3 years from the date that the shipment is received. This period of retention is extended automatically during any unresolved enforcement action regarding the regulated activity or as requested by the director. Editor's note: An obvious error in R 299.9825 was corrected at the request of the promulgating agency, pursuant to section 56 of 1969 pa 306, as amended by 2000 pa 262, mcl 24.256. The rule containing the error was published in Michigan Register, 2025 MR 8. The memorandum requesting the correction was published in Michigan Register, 2025 MR 13.