NR 666.345(2)(g)(g) A certification that all the information provided is true, complete and accurate. Your authorized representative shall sign the statement. NR 666.345 HistoryHistory: CR 05-032: cr. Register July 2006 No. 607, eff. 8-1-06. General, Transportation and Disposal
Recordkeeping
NR 666.350NR 666.350 What general, transportation and disposal records must you keep at your facility and for how long? In addition to those records required by your NRC or NRC agreement state license, you shall keep records according to all of the following: NR 666.350(1)(1) You shall follow the applicable existing recordkeeping requirements under ss. NR 664.0073, 665.0073 and 668.07 to demonstrate that your waste has met LDR treatment standards prior to your claiming the exemption. NR 666.350(2)(2) You shall keep a copy of all notifications and return receipts required under ss. NR 666.355 and 666.360 for 3 years after the exempted waste is sent for disposal. NR 666.350(3)(3) You shall keep a copy of all notifications and return receipts required under s. NR 666.345 (1) for 3 years after the last exempted waste is sent for disposal. NR 666.350(4)(4) You shall keep a copy of the notification and return receipt required under s. NR 666.345 (2) for 3 years after the exempted waste is sent for disposal. NR 666.350(5)(5) If you are not already subject to NRC, or NRC agreement state equivalent manifest and transportation rules for the shipment of your waste, you shall also keep all other documents related to tracking the exempted waste as required under 10 CFR 20.2006 or NRC agreement state equivalent rules, including applicable NARM requirements, in addition to the records specified in subs. (1) to (4). NR 666.350 HistoryHistory: CR 05-032: cr. Register July 2006 No. 607, eff. 8-1-06. Loss of Transportation and Disposal
Conditional Exemption
NR 666.355NR 666.355 How could you lose the transportation and disposal conditional exemption for your waste and what actions must you take? NR 666.355(1)(1) Any waste will automatically lose the transportation and disposal exemption if you fail to manage it in accordance with all of the conditions specified in s. NR 666.315. NR 666.355(1)(a)(a) When you fail to meet any of the conditions specified in s. NR 666.315 for any of your wastes, you shall report to us, in writing by certified delivery, within 30 days of learning of the failure. Your report shall be signed by your authorized representative certifying that the information provided is true, accurate and complete. This report shall include all of the following: NR 666.355(1)(a)2.2. A description of the waste (including the waste name, hazardous waste codes and quantity) that lost the exemption. NR 666.355(1)(b)(b) If the failure to meet any of the conditions may endanger human health or the environment, you shall also immediately notify us orally within 24 hours and follow up with a written notification within 5 days. NR 666.355(2)(2) We may terminate your ability to claim a conditional exemption for your waste, or require you to meet additional conditions to claim a conditional exemption, for serious or repeated noncompliance with any requirements of this subchapter. NR 666.355 HistoryHistory: CR 05-032: cr. Register July 2006 No. 607, eff. 8-1-06. NR 666.360NR 666.360 If you lose the transportation and disposal conditional exemption for a waste, can the exemption be reclaimed? NR 666.360(1)(1) You may reclaim the transportation and disposal exemption for a waste after you have received a return receipt confirming that we have received your notification of the loss of the exemption specified in s. NR 666.355 (1) if both of the following apply: NR 666.360(1)(b)(b) You send a notice, by certified delivery, to us that you are reclaiming the exemption for the waste. Your notice shall be signed by your authorized representative certifying that the information provided is true, accurate and complete. The notice shall do all of the following: NR 666.360(1)(b)2.2. Certify that each failure that caused you to lose the exemption for the waste has been corrected and that you again meet all conditions for the waste as of the date you specify. NR 666.360(1)(b)3.3. Describe plans you have implemented, listing the specific steps that you have taken, to ensure that conditions will be met in the future. NR 666.360(1)(b)4.4. Include any other information you want us to consider when we review your notice reclaiming the exemption. NR 666.360(2)(2) We may terminate a reclaimed conditional exemption if we find that your claim is inappropriate based on factors including, but not limited to, your failure to correct the problem, to provide a satisfactory explanation of the circumstances of the failure or to implement a plan with steps to prevent another failure to meet the conditions of s. NR 666.315. In reviewing a reclaimed conditional exemption under this section, we may add conditions to the exemption to ensure that transportation and disposal activities will protect human health and the environment. NR 666.360 HistoryHistory: CR 05-032: cr. Register July 2006 No. 607, eff. 8-1-06. NR 666.500NR 666.500 Definitions. The following definitions apply to this subchapter: NR 666.500(1)(1) “Evaluated hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor in accordance with s. NR 666.510 (1) (c) and will not be sent to another reverse distributor for further evaluation or verification of manufacture credit. NR 666.500(2)(2) “Hazardous waste pharmaceutical” means a pharmaceutical that is a solid waste, as defined in s. NR 661.0002, and exhibits one or more characteristics identified in subch. C of ch. NR 661 or is listed in subch. D of ch. NR 661. A pharmaceutical is not a solid waste, as defined in s. NR 661.0002, and therefore not a hazardous waste pharmaceutical, if it is legitimately used, reused, for example lawfully donated for its intended purpose, or reclaimed. An over-the-counter pharmaceutical, dietary supplement, or homeopathic drug is not a solid waste, as defined in s. NR 661.0002, and therefore not a hazardous waste pharmaceutical, if it has a reasonable expectation of being legitimately used, reused, for example lawfully redistributed for its intended purpose, or reclaimed. NR 666.500(3)(3) “Healthcare facility” means any person that is lawfully authorized to do any of the following: NR 666.500(3)(a)(a) Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body. NR 666.500(3)(b)(b) Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. Including wholesale distribution, third-party logistics that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals. This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers. NR 666.500(5)(5) “Long-term care facility” means a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. Not included within the scope of this definition are group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities. NR 666.500(6)(6) “Non-creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimately used, reused, or reclaimed. This includes investigational drugs, free samples of pharmaceuticals received by healthcare facilities, residues of pharmaceuticals remaining in empty containers, contaminated personal protective equipment, floor sweepings, and clean-up material from the spills of pharmaceuticals. NR 666.500(8)(8) “Non-pharmaceutical hazardous waste” means a solid waste, as defined in s. NR 661.0002, that is listed in subch. D of ch. NR 661, or exhibits one or more characteristics identified in subch. C of ch. NR 661, but is not a pharmaceutical, as defined in this section. NR 666.500(9)(9) “Pharmaceutical” means any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system, for example electronic cigarette or vaping pen; or any liquid nicotine, or e-liquid, packaged for retail sale for use in electronic nicotine delivery systems, such pre-filled cartridges or vials. This definition includes dietary supplements, as defined by the federal food, drug and cosmetic act; prescription drugs, as defined by 21 CFR 203.3 (y); over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in non-empty containers; personal protective equipment contaminated with pharmaceuticals; and clean-up material from spills of pharmaceuticals. This definition does not include dental amalgam or sharps. NR 666.500(10)(10) “Potentially creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that is all of the following: NR 666.500(10)(b)(b) Is in original manufacturer packaging, except pharmaceuticals that were subject to a recall. NR 666.500(10)(e)(e) The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals including over-the-counter drugs, homeopathic drugs, and dietary supplements. NR 666.500(11)(11) “Reverse distributor” means any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor. NR 666.500 HistoryHistory: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20. NR 666.501(1)(1) A healthcare facility that is a very small quantity generator when counting all of its hazardous waste, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, remains subject to s. NR 662.014 and is not subject to this subchapter, except for ss. NR 666.505 and NR 666.507 and the optional provisions under s. NR 666.504. NR 666.501(2)(2) A healthcare facility that is a very small quantity generator when counting all of its hazardous waste, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, has the option of complying with sub. (4) for the management of its hazardous waste pharmaceuticals as an alternative to complying with s. NR 662.014 and the optional provisions under s. NR 666.504. NR 666.501(3)(3) A healthcare facility or reverse distributor remains subject to all applicable hazardous waste regulations with respect to the management of its non-pharmaceutical hazardous waste. NR 666.501(4)(4) With the exception of healthcare facilities identified in sub. (1), a healthcare facility is subject to the all of the following in lieu of chs. NR 662 to 665: NR 666.501(4)(a)2.2. Potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor. NR 666.501(6)(6) Hazardous waste pharmaceuticals generated or managed by entities other than healthcare facilities and reverse distributors, for example pharmaceutical manufacturers and reverse logistics centers, are not subject to this subchapter. Other generators are subject to ch. NR 662 for the generation and accumulation of hazardous wastes, including hazardous waste pharmaceuticals. NR 666.501(7)(a)(a) Pharmaceuticals that are not solid waste, as defined in s. NR 661.0002, because they are legitimately used or reused (e.g., lawfully donated for their intended purpose) or reclaimed. NR 666.501(7)(b)(b) Over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs that are not solid wastes, as defined in s. NR 661.0002, because they have a reasonable expectation of being legitimately used or reused (e.g., lawfully redistributed for their intended purpose) or reclaimed. NR 666.501(7)(c)(c) Pharmaceuticals being managed in accordance with a recall strategy that has been approved by the food and drug administration in accordance with 21 CFR part 7 subpart C. This subchapter does apply to the management of the recalled hazardous waste pharmaceuticals after the food and drug administration approves the destruction of the recalled items. NR 666.501(7)(d)(d) Pharmaceuticals being managed in accordance with a recall corrective action plan that has been accepted by the consumer product safety commission in accordance with 16 CFR part 1115. This subchapter does apply to the management of the recalled hazardous waste pharmaceuticals after the consumer product safety commission approves the destruction of the recalled items. NR 666.501(7)(e)(e) Pharmaceuticals stored according to a preservation order, or during an investigation or judicial proceeding until after the preservation order, investigation, or judicial proceeding has concluded or a decision is made to discard the pharmaceuticals. NR 666.501(7)(f)(f) Investigational new drugs for which an investigational new drug application is in effect in accordance with the food and drug administration’s regulations in 21 CFR part 312. This subchapter does apply to the management of the investigational new drug after the decision is made to discard the investigational new drug or the food and drug administration approves the destruction of the investigational new drug, if the investigational new drug is a hazardous waste. NR 666.501(7)(g)(g) Household waste pharmaceuticals, including those that have been collected by an authorized collector, as defined by the drug enforcement administration, provided the authorized collector complies with the conditional exemption under s. NR 666.506 (1) (b) and (2). NR 666.501 HistoryHistory: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20; correction in (4) (b) made under s. 13.92 (4) (b) 7., Stats., Register April 2021 No. 784. NR 666.502NR 666.502 Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals. NR 666.502(1)(1) Notification and withdrawal from this subchapter for healthcare facilities managing hazardous waste pharmaceuticals. NR 666.502(1)(a)(a) Notification. A healthcare facility shall notify the department, using the site identification form, EPA form 8700-12, that it is a healthcare facility operating under this subchapter. A healthcare 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 healthcare facility shall submit a separate notification, using a site identification form, for each site or EPA identification number. NR 666.502(1)(a)1.1. A healthcare facility that already has an EPA identification number shall notify the department, using the site identification form EPA form 8700-12, that it is a healthcare facility as part of its next annual report, if it is required to submit one; or if not required to submit an annual report, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter. NR 666.502(1)(a)2.2. A healthcare facility that does not have an EPA identification number shall obtain one by notifying the department, using the site identification form EPA form 8700-12, that it is a healthcare facility as part of its next annual report, if it is required to submit one; or if not required to submit an annual report, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter. NR 666.502(1)(a)3.3. A healthcare facility shall keep a copy of its notification on file for as long as the healthcare facility is subject to this subchapter. NR 666.502(1)(b)(b) Withdrawal. A healthcare facility that operated under this subchapter but is no longer subject to this subchapter, because it is a very small quantity generator under s. NR 662.014, and elects to withdraw from this subchapter, shall notify the department using the site identification form EPA form 8700-12 that it is no longer operating under this subchapter. A healthcare 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 healthcare facility shall submit a separate notification, using a site identification form, for each EPA identification number. NR 666.502(1)(b)1.1. A healthcare facility shall submit the site identification form notifying that it is withdrawing from this subchapter before it begins operating under the conditional exemption under s. NR 662.014. NR 666.502(1)(b)2.2. A healthcare facility shall keep a copy of its withdrawal on file for 3 years from the date of signature on the notification of its withdrawal. NR 666.502(2)(2) Training of personnel managing non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility shall 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. NR 666.502(3)(3) Hazardous waste determination for non-creditable pharmaceuticals. A healthcare facility that generates a solid waste that is a non-creditable pharmaceutical shall determine whether that pharmaceutical is a hazardous waste pharmaceutical, because it exhibits a characteristic identified in ch. NR 661 subchapter C or is listed in ch. NR 661 subchapter D, in order to determine whether the waste is subject to this subchapter. A healthcare facility may choose to manage its non-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals under this subchapter. NR 666.502(4)(4) Standards for containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities. NR 666.502(4)(a)(a) A healthcare facility shall 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. NR 666.502(4)(b)(b) A healthcare facility that manages ignitable or reactive non-creditable hazardous waste pharmaceuticals, or that mixes or commingles incompatible non-creditable hazardous waste pharmaceuticals shall manage the container so that it does not have the potential to do any of the following: NR 666.502(4)(b)1.1. Generate extreme heat or pressure, fire or explosion, or violent reaction. 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.
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