Wisconsin Legislature: NR 666.502(9)(b)2.a.

NR 666.502(4)(b)2. 2. Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health.

NR 666.502(4)(b)3. 3. Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions.

NR 666.502(4)(b)4. 4. Damage the structural integrity of the container of non-creditable hazardous waste pharmaceuticals.

NR 666.502(4)(b)5. 5. Threaten human health or the environment through other like means.

NR 666.502(4)(c) (c) A healthcare facility shall keep containers of non-creditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents.

NR 666.502(4)(d) (d) A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals and non-hazardous non-creditable waste pharmaceuticals in the same container, except that non-creditable hazardous waste pharmaceuticals prohibited from being combusted because of the dilution prohibition under s. NR 668.03 (3) shall be accumulated in separate containers and labeled with all applicable hazardous waste numbers, or hazardous waste codes.

NR 666.502(5) (5) Labeling containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility shall label or clearly mark each container of non-creditable hazardous waste pharmaceuticals with the phrase “Hazardous Waste Pharmaceuticals.”

NR 666.502(6) (6) Maximum accumulation time for non-creditable hazardous waste pharmaceuticals at healthcare facilities.

NR 666.502(6)(a)(a) A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals on-site for one year or less without a license or having interim status.

NR 666.502(6)(b) (b) A healthcare facility that accumulates non-creditable hazardous waste pharmaceuticals on-site shall demonstrate the length of time that the non-creditable hazardous waste pharmaceuticals have been accumulating, starting from the date the pharmaceuticals first become a waste. A healthcare facility may make this demonstration by any of the following methods:

NR 666.502(6)(b)1. 1. Marking or labeling the container of non-creditable hazardous waste pharmaceuticals with the date that the non-creditable hazardous waste pharmaceuticals became a waste.

NR 666.502(6)(b)2. 2. Maintaining an inventory system that identifies the date the non-creditable hazardous waste pharmaceuticals being accumulated first became a waste.

NR 666.502(6)(b)3. 3. 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.

NR 666.502(7) (7) 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 under ch. NR 668. A healthcare facility that generates non-creditable hazardous waste pharmaceuticals shall comply with the land disposal restrictions in accordance with s. NR 668.07 (1) requirements, except that it is not required to identify the hazardous waste numbers or hazardous waste codes on the land disposal restrictions notification.

NR 666.502(8) (8) 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 under s. NR 664.0072 or 665.0072 may accumulate the returned non-creditable hazardous waste pharmaceuticals on-site for up to an additional 90 calendar days provided the rejected or returned shipment is managed in accordance with subs. (4) and (5). Upon receipt of the returned shipment, the healthcare facility shall do all of the following:

NR 666.502(8)(a) (a) Sign one of the following:

NR 666.502(8)(a)1. 1. Item 18c of the original manifest, if the original manifest was used for the returned shipment.

NR 666.502(8)(a)2. 2. Item 20 of the new manifest, if a new manifest was used for the returned shipment.

NR 666.502(8)(b) (b) Provide the transporter a copy of the manifest.

NR 666.502(8)(c) (c) Within 30 calendar days of receipt of the rejected shipment, send a copy of the manifest to the designated facility that returned the shipment to the healthcare facility.

NR 666.502(8)(d) (d) Within 90 calendar days of receipt of the rejected shipment, transport or offer for transport the returned shipment in accordance with the shipping standards under s. NR 666.508 (1).

NR 666.502(9) (9) Reporting by healthcare facilities for non-creditable hazardous waste pharmaceuticals.

NR 666.502(9)(a) (a) Annual reporting by healthcare facilities. A healthcare facility is not subject to annual reporting requirements under s. NR 662.041 with respect to non-creditable hazardous waste pharmaceuticals managed under this subchapter.

NR 666.502(9)(b) (b) Exception reporting by healthcare facilities for a missing copy of the manifest.

NR 666.502(9)(b)1. 1. `Shipments from a healthcare facility to a designated facility.' For shipments from a healthcare facility to a designated facility, all of the following exception reporting requirements apply:

NR 666.502(9)(b)1.a. a. 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 calendar days of the date the non-creditable hazardous waste pharmaceuticals were accepted by the initial transporter, the healthcare facility shall submit all of the following to the department:

1) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery.

2) A handwritten or typed note on the original 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.

NR 666.502(9)(b)2. 2. `Shipments rejected by the designated facility and shipped to an alternate facility.' For shipments rejected by the designated facility and shipped to an alternate facility, all of the following exception reporting requirements apply:

NR 666.502(9)(b)2.a. a. 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 calendar 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 facilit y, the healthcare facility shall submit all of the following to the department:

1) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery.

NR 666.502(9)(c) (c) Additional reports. The department may require healthcare facilities to furnish additional reports concerning the quantities and disposition of non-creditable hazardous waste pharmaceuticals.

NR 666.502(10) (10) Recordkeeping by healthcare facilities for non-creditable hazardous waste pharmaceuticals.

NR 666.502(10)(a) (a) A healthcare facility shall keep a copy of each manifest signed in accordance with s. NR 662.023 (1) for 3 years or until it receives a signed copy from the designated facility that received the non-creditable hazardous waste pharmaceuticals. This signed copy shall be retained as a record for at least 3 years from the date the waste was accepted by the initial transporter.

NR 666.502(10)(b) (b) A healthcare facility shall keep a copy of each exception report for a period of at least 3 years from the date of the report.

NR 666.502(10)(c) (c) A healthcare facility shall keep records of any test results, waste analyses, or other determinations made to support its hazardous waste determination consistent with s. NR 662.011 (6), for at least 3 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 of its non-creditable non-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals is not required to keep documentation of hazardous waste determinations.

NR 666.502(10)(d) (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.

NR 666.502(10)(e) (e) All records shall be readily available upon request by the department.

NR 666.502(11) (11) Response to spills of non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility shall 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.

NR 666.502(12) (12) 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 s. NR 662.014, without a license or without having interim status, provided the receiving healthcare facility meets all of the following:

NR 666.502(12)(a) (a) Is under the control of the same person, as defined in s. NR 660.10 (90), 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 facilit y, whether by the ownership of stock, voting rights, or otherwise, except that contractors who operate healthcare facilities on behalf of a different person as defined in s. NR 660.10 may not be deemed to “control” such healthcare facilities.

NR 666.502(12)(b) (b) Is operating under this subchapter for the management of its non-creditable hazardous waste pharmaceuticals.

NR 666.502(12)(c) (c) Manages the non-creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with this subchapter.

NR 666.502(12)(d) (d) Keeps records of the non-creditable hazardous waste pharmaceuticals shipments it receives from off-site for 3 years from the date that the shipment is received.

NR 666.502 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20; correction in (6) (b) (intro.) made under s. 35.17, Stats., and renumbering in (8) made under s. 13.92 (4) (b) 2., Stats., Register August 2020 No. 776.

NR 666.503 NR 666.503 Standards for healthcare facilities managing potentially creditable hazardous waste pharmaceuticals.

NR 666.503(1)(1) Hazardous waste determination for potentially creditable pharmaceuticals. A healthcare facility that generates a solid waste that is a potentially creditable pharmaceutical shall determine whether the potentially creditable pharmaceutical is a potentially creditable hazardous waste pharmaceutical that is listed in subch. D of ch. NR 661 or exhibits a characteristic identified in subch. C of ch. NR 661. A healthcare facility may choose to manage its potentially creditable non-hazardous waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals under this subchapter.

NR 666.503(2) (2) Accepting potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator. A healthcare facility may accept potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator under s. NR 662.014, without a license or without having interim status, provided the receiving healthcare facilit y meets all of the following:

NR 666.503(2)(a) (a) Is under the control of the same person, as defined in s. NR 660.10 (90), as the very small quantity generator healthcare facility that is sending the potentially 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 facilit y, whether by the ownership of stock, voting rights, or otherwise, except that contractors who operate healthcare facilities on behalf of a different person as defined in s. NR 660.10 may not be deemed to “control” such healthcare facilities.

NR 666.503(2)(b) (b) Is operating under this subchapter for the management of its potentially creditable hazardous waste pharmaceuticals.

NR 666.503(2)(c) (c) Manages the potentially creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with this subchapter.

NR 666.503(2)(d) (d) Keeps records of the potentially creditable hazardous waste pharmaceuticals shipments it receives from off-site for 3 years from the date that the shipment is received.

NR 666.503(3) (3) Prohibition. A healthcare facility is prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to a reverse distributor.

NR 666.503(4) (4) Annual reporting by healthcare facilities. A healthcare facility is not subject to annual reporting requirements under s. NR 662.041 with respect to potentially creditable hazardous waste pharmaceuticals managed under this subchapter.

NR 666.503(5) (5) Recordkeeping by healthcare facilities.

NR 666.503(5)(a) (a) A healthcare facility that initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor shall keep all of the following records, paper or electronic, for each shipment of potentially creditable hazardous waste pharmaceuticals for 3 years from the date of shipment:

NR 666.503(5)(a)1. 1. The confirmation of delivery.

NR 666.503(5)(a)2. 2. The shipping papers prepared in accordance with 49 CFR part 172 subpart C, if applicable.

NR 666.503(5)(b) (b) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activit y, or as requested by the department.

NR 666.503(5)(c) (c) All records shall be readily available upon request by the department.

NR 666.503(6) (6) Response to spills of potentially creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility shall immediately contain all spills of potentially creditable hazardous waste pharmaceuticals and manage the spill clean-up materials as non-creditable hazardous waste pharmaceuticals in accordance with this subchapter.

NR 666.503 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20; correction in (1) made under s. 35.17, Stats., Register August 2020 No. 776.

NR 666.504 NR 666.504 Healthcare facilities that are very small quantity generators for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste.

NR 666.504(1)(1) Potentially creditable hazardous waste pharmaceuticals. A healthcare facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may send its potentially creditable hazardous waste pharmaceuticals to a reverse distributor.

NR 666.504(2) (2) Off-site collection of hazardous waste pharmaceuticals generated by a healthcare facility that is a very small quantity generator. A healthcare facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may send its hazardous waste pharmaceuticals off-site to another healthcare facility, provided one of the following is met:

NR 666.504(2)(a) (a) The receiving healthcare facility meets the conditions specified in ss. NR 666.502 (a) and 666.503 (2), as applicable.

NR 666.504(2)(b) (b) The very small quantity generator healthcare facility meets the conditions specified in s. NR 662.014 (1) (e) 8. and the receiving large quantity generator meets the conditions specified in s. NR 662.017 (6).

NR 666.504(3) (3) Long-term care facilities that are very small quantity generators. A long-term care facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may dispose of its hazardous waste pharmaceuticals, excluding contaminated personal protective equipment or clean-up materials, in an on-site collection receptacle of an authorized collector, as defined by the drug enforcement administration, that is registered with the drug enforcement administration provided the contents are collected, stored, transported, destroyed and disposed of in compliance with all applicable drug enforcement administration regulations for controlled substances.

NR 666.504(4) (4) Long-term care facilities with 20 beds or fewer. A long-term care facility with 20 beds or fewer is presumed to be a very small quantity generator subject to s. NR 662.014 for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste and not subject to this subchapter, except for ss. NR 666.505 and 666.507 and the other optional provisions of this section. The department has the responsibility to demonstrate that a long-term care facility with 20 beds or fewer generates quantities of hazardous waste that are in excess of the very small quantity generator limits as defined in s. NR 660.10 (139). A long-term care facility with more than 20 beds that operates as a very small quantity generator under s. NR 662.014 shall demonstrate that it generates quantities of hazardous waste that are within the very small quantity generator limits as defined in s. NR 660.10.

NR 666.504 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.

NR 666.505 NR 666.505 Prohibition of sewering hazardous waste pharmaceuticals. All healthcare facilities, including very small quantity generators operating under s. NR 662.014 in lieu of this subchapter, and reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly-owned treatment works. Healthcare facilities and reverse distributors remain subject to the prohibitions in 40 CFR 403.5 (b) (1).

NR 666.505 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.

NR 666.506 NR 666.506 Conditional exemptions for hazardous waste pharmaceuticals that are also controlled substances and household waste pharmaceuticals collected in a take-back event or program.

NR 666.506(1)(1) Conditional exemptions. Provided the conditions of sub. (2) are met, all of the following are exempt from the requirements under chs. NR 662 to 673:

NR 666.506(1)(a) (a) Hazardous waste pharmaceuticals that are also listed on a schedule of controlled substances by the drug enforcement administration in 21 CFR part 1308.

NR 666.506(1)(b) (b) Household waste pharmaceuticals that are collected in a take-back event or program, including those that are collected by an authorized collector, as defined by the drug enforcement administration, registered with the drug enforcement administration that commingles the household waste pharmaceuticals with controlled substances from an ultimate user, as defined by the drug enforcement administration.

NR 666.506(2) (2) Conditions for exemption. The hazardous waste pharmaceuticals shall be all of the following:

NR 666.506(2)(a) (a) Managed in compliance with the sewer prohibition under s. NR 666.505.

NR 666.506(2)(b) (b) Collected, stored, transported, and disposed of in compliance with all applicable drug enforcement administration regulations for controlled substances.

NR 666.506(2)(c) (c) Destr oyed by a method that the drug enforcement administration has publicly deemed in writing to meet its non-retrievable standard of destruction or combusted at one of the following:

NR 666.506(2)(c)1. 1. A permitted large municipal waste combustor, subject to 40 CFR part 62 subpart FFF or applicable state plan for existing large municipal waste combustors, or 40 CFR part 60 subpart Eb for new large municipal waste combustors.

NR 666.506(2)(c)2. 2. A permitted small municipal waste combustor, subject to 40 CFR part 62 subpart JJJ or applicable state plan for existing small municipal waste combustors, or 40 CFR part 60 subpart AAAA for new small municipal waste combustors.

NR 666.506(2)(c)3. 3. A permitted hospital, medical and infectious waste incinerator, subject to 40 CFR part 62 subpart HHH or applicable state plan for existing hospital, medical and infectious waste incinerators, or 40 CFR part 60 subpart Ec for new hospital, medical and infectious waste incinerators.

NR 666.506(2)(c)4. 4. A permitted commercial and industrial solid waste incinerator, subject to 40 CFR part 62 subpart III or applicable state plan for existing commercial and industrial solid waste incinerators, or 40 CFR part 60 subpart CCCC for new commercial and industrial solid waste incinerators.

NR 666.506(2)(c)5. 5. A permitted hazardous waste combustor subject to 40 CFR part 63 subpart EEE.

NR 666.506 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.

NR 666.507 NR 666.507 Residues of hazardous waste pharmaceuticals in empty containers.

NR 666.507(1)(1) Stock, dispensing and unit-dose containers. A stock bottle, dispensing bottle, vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose container (e.g., a unit-dose packet, cup, wrapper, blister pack, or delivery device) is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals have been removed from the stock bottle, dispensing bottle, vial, ampule, or the unit-dose container using the practices commonly employed to remove materials from that type of container.