Section 335.755 - Standards for Healthcare Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals(a) Notification and withdrawal from this subchapter for healthcare facilities managing hazardous waste pharmaceuticals. A healthcare facility must notify the executive director that it is either subject to this subchapter, or is withdrawing from regulation under this subchapter, using the following procedures. (1) Notification. A healthcare facility must notify the executive director that it is a healthcare facility operating under this subchapter using a method approved by the executive director within 60 days of becoming subject to this chapter. The method approved by the executive director collects the information required by the United States Environmental Protection Agency (EPA) Site Identification Form. (A) A healthcare facility must submit a separate notification for each site or EPA identification number.(B) A healthcare facility is not required to submit EPA hazardous waste numbers with this notification.(C) A healthcare facility must retain a copy of a notification as long as the healthcare facility is subject to this subchapter.(2) Withdrawal. A healthcare facility that elects to withdraw from this subchapter because it is a very small quantity generator that meets the conditions for exemption for a very small quantity generator under 40 Code of Federal Regulations (CFR) §262.14 as adopted under § 335.53 of this title (relating to General Standards Applicable to Generators of Hazardous Waste) must notify the executive director that it elects to withdraw from this subchapter using a method approved by the executive director. A healthcare facility is not required to submit any EPA hazardous waste numbers with this notification. A healthcare facility must submit a separate notification for each site or EPA identification number.(A) A healthcare facility must submit the notification that it is withdrawing from this subchapter in accordance with this paragraph before it begins operating under the conditions for exemption of a very small quantity generator in 40 CFR § 262.14 as adopted under § 335.53 of this title.(B) A healthcare facility must retain a copy of a notification of withdrawal for three years from the date of the signature on the notification of withdrawal.(b) Training of personnel managing non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must ensure that all personnel that manage non-creditable hazardous waste pharmaceuticals are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies.(c) Hazardous waste determination for non-creditable pharmaceuticals. A healthcare facility that generates a solid waste that is a non-creditable pharmaceutical must determine whether that pharmaceutical is a hazardous waste pharmaceutical by determining if it exhibits a characteristic identified in 40 CFR Part 261 , Subpart C or is listed in 40 CFR Part 261, Subpart D as adopted under § 335.504 of this title (relating to Hazardous Waste Determination) in order to determine whether the waste is subject to this subchapter. A healthcare facility may elect to manage its nonhazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals under this subchapter.(d) Standards for containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must store containers containing non-creditable hazardous waste pharmaceuticals in accordance with the following container management standards.(1) Container requirements. A healthcare facility must place non-creditable 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.(2) Ignitable, reactive, or incompatible wastes. A healthcare facility that manages ignitable or reactive non-creditable hazardous waste pharmaceuticals, or that mixes or commingles incompatible non-creditable hazardous waste pharmaceuticals must manage the container so that it does not have the potential to:(A) generate extreme heat or pressure, fire or explosion, or violent reaction;(B) produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health;(C) produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions;(D) damage the structural integrity of the container of non-creditable hazardous waste pharmaceuticals; or(E) through other like means threaten human health or the environment.(3) Container security. A healthcare facility must keep containers of non-creditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents.(4) Accumulating non-creditable waste pharmaceuticals in the same container. A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals and nonhazardous non-creditable waste pharmaceuticals in the same container, except that non-creditable hazardous waste pharmaceuticals prohibited from being combusted because of the dilution prohibition of 40 CFR § 268.3(c) as adopted under § 335.431 of this title (relating to Purpose, Scope, and Applicability) must be accumulated in separate containers and labeled with all applicable EPA hazardous waste numbers.(e) Labeling containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must label or clearly mark each container of non-creditable hazardous waste pharmaceuticals with the phrase "Hazardous Waste Pharmaceuticals."(f) Maximum accumulation time for non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must observe the following standards for on-site accumulation time of non-creditable hazardous waste pharmaceuticals.(1) Maximum accumulation time. A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals on-site for one year or less without a permit or having interim status.(2) Accumulation start date. A healthcare facility that accumulates non-creditable hazardous waste pharmaceuticals on-site must demonstrate the length of time that the non-creditable hazardous waste pharmaceuticals have been accumulating, starting from the date it first becomes a waste. A healthcare facility may make this demonstration by any of the following methods: (A) marking or labeling the container of non-creditable hazardous waste pharmaceuticals with the date that the non-creditable hazardous waste pharmaceuticals became a waste;(B) maintaining an inventory system that identifies the date the non-creditable hazardous waste pharmaceuticals 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 non-creditable hazardous waste pharmaceuticals in the area became a waste.(g) Land disposal restrictions for non-creditable hazardous waste pharmaceuticals. The non-creditable hazardous waste pharmaceuticals generated by a healthcare facility are subject to the land disposal restrictions of 40 CFR Part 268 as adopted under Subchapter O of this chapter (relating to Land Disposal Restrictions). A healthcare facility that generates non-creditable hazardous waste pharmaceuticals must comply with the land disposal restrictions in accordance with 40 CFR § 268.7(a) requirements as adopted under § 335.431 of this title, except that it is not required to include the EPA hazardous waste numbers on the land disposal restrictions notification.(h) Procedures for healthcare facilities for managing rejected shipments of non-creditable hazardous waste pharmaceuticals. A healthcare facility that sends a shipment of non-creditable 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 40 CFR § 264.72 as adopted under § 335.152 of this title (relating to Standards) or 40 CFR § 265.72 as adopted under § 335.112 of this title (relating to Standards) may accumulate the returned non-creditable hazardous waste pharmaceuticals on-site for up to an additional 90 days provided the rejected or returned shipment is managed in accordance with subsections (d) and (e) of this section. Upon receipt of the returned shipment, the healthcare facility must complete the following. (1) Healthcare facility manifest signature. The healthcare facility must sign either: (A) item 18c of the original manifest, if the original manifest was used for the returned shipment; or(B) item 20 of the new manifest, if a new manifest was used for the returned shipment.(2) Transporter manifest copy. The healthcare facility must provide the transporter a copy of the manifest used for the returned shipment.(3) Designated facility manifest copy. Within 30 days of receipt of the rejected shipment, the healthcare facility must send a copy of the manifest to the designated facility that returned the shipment to the healthcare facility; and(4) Maximum time to re-ship a rejected shipment. Within 90 days of receipt of the rejected shipment, the healthcare facility must transport or offer for transport the returned shipment in accordance with the shipping standards of § 335.767(a) of this title (relating to Shipping Non-Creditable Hazardous Waste Pharmaceuticals from a Healthcare Facility or Evaluated Hazardous Waste Pharmaceuticals from a Reverse Distributor).(i) Reporting by healthcare facilities for non-creditable hazardous waste pharmaceuticals. A healthcare facility must comply with the following reporting requirements. (1) Biennial and annual waste reporting by healthcare facilities. A healthcare facility is not subject to the Annual Waste Summary reporting requirements under § 335.9 of this title (relating to Recordkeeping and Annual Reporting Procedures Applicable to Generators) or the biennial reporting requirements under 40 CFR § 262.41 as adopted under § 335.56 of this title (relating to Recordkeeping and Reporting Applicable to Small and Large Quantity Generators) for non-creditable hazardous waste pharmaceuticals managed under this subchapter.(2) Exception reporting by healthcare facilities for a missing copy of the manifest. A healthcare facility must submit an exception report to the executive director in the following situations. (A) For shipments from a healthcare facility to a designated facility, if a healthcare facility 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 were accepted by the initial transporter, the healthcare facility must submit:(i) a legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery, to the executive director; and(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 and the results of those efforts.(B) For shipments rejected by the designated facility and shipped to an alternate facility, if a healthcare facility does not receive a copy of the manifest for a rejected shipment of the non-creditable 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 60 days of the date the non-creditable hazardous waste was accepted by the initial transporter forwarding the shipment of non-creditable hazardous waste pharmaceuticals from the designated facility to the alternate facility, the healthcare facility must submit: (i) a legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery, to the executive director; and(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 and the results of those efforts.(3) Additional reports. The executive director may require a healthcare facility to furnish additional reports concerning the quantities and disposition of non-creditable hazardous waste pharmaceuticals.(j) Recordkeeping by healthcare facilities for non-creditable hazardous waste pharmaceuticals. A healthcare facility is subject to the following recordkeeping requirements. (1) Signed manifest retention. A healthcare facility must keep a copy of each manifest signed in accordance with 40 CFR § 262.23(a) as adopted under § 335.54 of this title (relating to Hazardous Waste Manifest) for three years or until it receives a signed copy from the designated facility which received the non-creditable 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.(2) Exception report retention. A healthcare facility must keep a copy of each exception report for a period of at least three years from the date of the report.(3) Waste determination documentation retention. A healthcare facility must keep records of any test results, waste analyses, or other determinations made to support its hazardous waste determination(s) consistent with 40 CFR § 262.11(f) as adopted under § 335.53 of this title, for at least three years from the date the waste was last sent to on-site or off-site treatment, storage or disposal. A healthcare facility that manages all its non-creditable nonhazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals is not required to keep documentation of hazardous waste determinations.(4) Documentation retention extension. 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 executive director.(5) Record inspections. All records must be readily available upon request by an inspector.(k) Response to spills of non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must immediately contain all spills of non-creditable hazardous waste pharmaceuticals and manage the spill clean-up materials as non-creditable hazardous waste pharmaceuticals in accordance with the requirements of this subchapter.(l) Accepting non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator. A healthcare facility may accept non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator under 40 CFR § 262.14 as adopted under § 335.53 of this title, without a permit or without having interim status, if the receiving healthcare facility complies with the following. (1) Consolidating waste pharmaceuticals at another healthcare facility under the control of the same person. The healthcare facility must be under the control of the same person as the very small quantity generator healthcare facility that is sending the non-creditable hazardous waste pharmaceuticals off-site or has a contractual or other documented business relationship whereby the receiving healthcare facility supplies pharmaceuticals to the very small quantity generator healthcare facility. "Control," for the purposes of this section, means the power to direct the policies of the healthcare facility, whether by the ownership of stock, voting rights, or otherwise, except that contractors who operate healthcare facilities on behalf of a different person shall not be deemed to "control" such healthcare facilities.(2) Operating under this subchapter. The healthcare facility must be operating under this subchapter for the management of its non-creditable hazardous waste pharmaceuticals.(3) Compliance with this subchapter. The healthcare facility must manage the non-creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with this subchapter.(4) Recordkeeping requirements. The healthcare facility must keep records of the non-creditable hazardous waste pharmaceuticals shipments it receives from off-site for three years from the date that the shipment is received.30 Tex. Admin. Code § 335.755
Adopted by Texas Register, Volume 47, Number 04, January 28, 2022, TexReg 0346, eff. 2/3/2022