NR 526.11 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94; am. (1) (a), (2) (b) 3., (e),
Register, June, 1996, No. 486, eff. 7-1-96;
CR 05-020: am. (2) (a) (intro.), cr. (2) (f)
Register January 2006 No. 601, eff. 2-1-06.
NR 526.12(1)(1)
Licenses. Except as provided in sub.
(2), no person may operate or maintain an infectious waste treatment facility unless the person has obtained an operating license from the department under s.
NR 502.08 as a solid waste processing facility and the facility meets all the requirements in this chapter for containing, handling, storing and treating infectious waste. To apply for an operating license, the applicant shall do all of the following:
NR 526.12(1)(a)
(a) Contact the department's district or area office as appropriate to arrange an initial site inspection for the purpose of evaluating compliance with the requirements of s.
NR 502.08 (3).
NR 526.12(1)(c)
(c) Submit the plan of operation to the department for approval, according to the requirements in s.
NR 500.05. Upon receipt of the plan of operation, the department shall send an invoice for the plan review fee for solid waste processing facilities, as specified in s.
NR 520.04, Table 2.
NR 526.12(1)(d)
(d) After obtaining a plan of operation approval from the department, submit an application form for the operating license and the license fee for a solid waste processing facility, according to ss.
NR 500.06 and
520.04, Table 2.
NR 526.12(2)
(2)
Exemptions. Persons who operate the following infectious waste treatment facilities are exempt from the requirements for obtaining an operating license and submitting a plan of operation for a solid waste processing facility, but shall comply with the following specified requirements:
NR 526.12(2)(a)
(a) Individual infectious waste treatment facilities which are located on the property where the infectious waste was generated and which treat less than 500 pounds of infectious waste per day. These treatment facilities may accept infectious waste from other infectious waste generators if the waste is accepted on a not-for-profit and cost-only basis. Persons operating these infectious waste treatment facilities shall follow all the requirements in sub.
(4) for operating and testing the treatment unit and for keeping records.
NR 526.12(2)(b)
(b) Incinerators and municipal solid waste combustors, which are regulated under s.
NR 502.09 or
502.13. In addition to what is required under those sections, persons operating incinerators and municipal solid waste combustors shall follow the requirements in sub.
(4) (a) and
(c) for operating an infectious waste treatment unit and for keeping records.
NR 526.12(3)
(3)
Plan of operation. Except as provided in sub.
(2), no person may establish or construct an infectious waste treatment facility or expand an existing facility unless the person has met the applicable requirements of s.
NR 502.08 for solid waste processing facilities and has obtained from the department a plan of operation approval and applied for an operating license as a solid waste processing facility. The plan of operation shall specify the intent and objectives of the proposal and indicate methods and procedures to prevent and minimize adverse environmental and health impacts. Unless otherwise approved by the department in writing, the plan shall be submitted in accordance with s.
NR 500.05 and shall contain, at a minimum, the information listed in s.
NR 502.08 (3) to
(5) and any other details necessary to address the requirements in this chapter, including but not limited to requirements for handling, containment and storage and the requirements in subs.
(4) and
(5).
NR 526.12(4)
(4)
Minimum requirements for all treatment facilities. No person may operate or maintain an infectious waste treatment facility unless all of the following requirements are met:
NR 526.12(4)(a)
(a) Operating. The person shall demonstrate that the treatment unit renders infectious waste non-infectious. The operator shall follow a written operational manual or documented quality assurance procedures for operating the treatment unit. The operational procedures shall be available to the operator at all times the treatment unit is in operation.
NR 526.12(4)(b)
(b) Testing. At a minimum, the person shall ensure that a qualified person tests the treatment unit at the frequency specified by the manufacturer's instructions or after every 100 hours of operation, whichever is more frequent. Test methods shall be appropriate for the treatment method and shall be based on medically-accepted procedures and the manufacturer's instructions. Acceptable test methods may be physical, chemical or microbiological in nature, as appropriate for the treatment method.
NR 526.12(4)(c)
(c) Keeping records. The person shall maintain an operating log for each treatment unit in the treatment facility and retain the operating log for at least 3 years. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action. For treatment units treating 50 pounds or more of infectious waste per month, the operating log shall be kept for all test cycles and treatment cycles. For treatment units treating less than 50 pounds of infectious waste per month, the operating log shall be kept for test cycles only. The operating log shall contain all of the following information for all test cycles and, if required, treatment cycles:
NR 526.12(4)(c)3.
3. Operating parameters, including any of the following that apply to the treatment method being used: temperature, pressure, type of disinfectant, concentration of disinfectant, duration of treatment cycle and contact time.
NR 526.12(4)(c)4.
4. Approximate amount of waste treated by weight, unless this information has already been recorded on an infectious waste manifest or USDOT shipping paper.
NR 526.12(4)(c)5.
5. Generator of waste treated, if other than the owner or operator of the treatment facility, unless the waste is accompanied by an infectious waste manifest or USDOT shipping paper.
NR 526.12(4)(d)
(d) Using manifests. Unless USDOT regulations apply, when treating infectious waste which is accompanied by an infectious waste manifest, the operator of an infectious waste treatment facility shall certify that the infectious waste has been treated according to s.
NR 526.11 by doing all of the following:
NR 526.12(4)(d)2.
2. The operator shall send a copy of the signed infectious waste manifest form along with the treated infectious waste to the solid waste disposal facility where the waste is disposed. The department may approve alternative procedures for certifying that waste has undergone infectious waste treatment before being disposed.
NR 526.12(4)(d)3.
3. Within 30 days of when the infectious waste was treated, the operator shall return to the generator the signed original infectious waste manifest form which certifies to the infectious waste generator that the infectious waste has been treated according to s.
NR 526.11. The department may approve alternative procedures for certifying that waste has undergone infectious waste treatment.
NR 526.12(5)
(5)
Operating requirements for licensed treatment facilities. In addition to the requirements in sub.
(4), persons who operate infectious waste treatment facilities which are required to be licensed as solid waste processing facilities under sub.
(1) shall meet the requirements in ss.
NR 502.08 (6) to
(8),
502.04 and
502.05.
NR 526.12 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94; am. (1) (a), (c), (d), (2) (b), (3), (5),
Register, June, 1996, No. 486, eff. 7-1-96;
CR 05-020: am. (1) (c), (4) (c) 4. and 5., (d) (intro.) and 2.
Register January 2006 No. 601, eff. 2-1-05.
NR 526.13
NR 526.13 Disposal. No person may dispose of infectious waste in a solid waste disposal facility unless the infectious waste has undergone infectious waste treatment and is otherwise managed according to s.
NR 526.11. Infectious waste generators shall ensure that infectious waste generated by them has undergone infectious waste treatment before disposal.
NR 526.14
NR 526.14 Records and infectious waste manifests. NR 526.14(1)(a)(a) Records. Except as provided in sub.
(2), all infectious waste generators shall keep records of the amount of infectious waste sent off-site for treatment. Records shall include all the information listed under sub.
(3) and retained as provided in sub.
(4). Records may consist of any of the following: originals or copies of infectious waste manifests, USDOT shipping papers, invoices or records received from the infectious waste treatment facility, logs or other written documentation of the amount of infectious waste sent off-site for treatment. If USDOT shipping papers are used as records, infectious waste generators shall keep separate records of information required under sub.
(3) which is not written on their USDOT shipping papers.
NR 526.14(1)(b)
(b) Manifests. When USDOT regulations apply, the generator shall use a USDOT shipping paper instead of an infectious waste manifest prepared in accordance with this paragraph. Unless USDOT regulations apply or as provided in sub.
(2), no person may store, transfer, transport or treat infectious waste beyond the property where the waste was generated unless the waste is accompanied by an infectious waste manifest. The infectious waste manifest may either be a Wisconsin infectious waste manifest form supplied by the department or an alternative manifest form which includes all the information required in sub.
(3).
After an infectious waste manifest has been initiated, all persons who store, transfer, transport or treat the waste shall sign the infectious waste manifest form, even if the infectious waste generator is exempt from manifesting under sub.
(2), and shall deliver the infectious waste manifest form to the next person who handles the waste. The infectious waste transporter shall leave a copy of the manifest with the infectious waste generator at the time that the waste is removed from the generator's facility.
NR 526.14 Note
Note: Wisconsin infectious waste manifest forms (DNR form 4400-176) may be obtained from the department of natural resources by writing to Wisconsin Department of Natural Resources, Bureau of Waste Management, P. O. Box 7921, Madison, Wisconsin, 53707-7921 or by calling 608-266-2111. For more information about USDOT regulations contact USDOT helpline at 1-800-467-4922.
NR 526.14(2)(a)(a) The following persons are exempt from all the requirements of this section:
NR 526.14(2)(b)
(b) The following persons are exempt from the requirements to use infectious waste manifests under this section, but shall follow the requirement for keeping records under sub.
(1) (a):
NR 526.14(2)(b)1.
1. An infectious waste generator transporting infectious waste only on private roads on the same property where the infectious waste was generated and using vehicles owned or leased by the infectious waste generator or by one of the generators in the group.
NR 526.14(2)(b)2.
2. An infectious waste generator transporting less than 50 pounds per calendar month of untreated infectious waste away from the property where the waste was initially generated, including items which are mixed with the infectious waste.
NR 526.14(2)(b)3.
3. Infectious waste generators located on the same property who manage their infectious waste together and who, as a group, transport less than 50 pounds per calendar month of untreated infectious waste away from the property.
NR 526.14(3)
(3)
Format. The infectious waste manifest form shall include all of the following information:
NR 526.14(3)(a)
(a) The place of origin of the infectious waste, including the name, address, telephone number, and name of contact person and type of facility where the infectious waste was generated, including but not limited to: hospitals, clinics, nursing homes, sharps collection stations and other facilities.
NR 526.14(3)(b)
(b) The route for the infectious waste, including the name, address, telephone number, license number and name of contact person for any and all persons storing, transporting or treating the infectious waste beyond the location where the infectious waste was generated.
NR 526.14(3)(c)
(c) The destination for disposal of the treated infectious waste, including the name, address, telephone number, solid waste disposal facility license number and name of a contact person.
NR 526.14(3)(e)
(e) The quantity of the infectious waste, including both the number of containers and the total weight, whether known or estimated, of infectious waste including waste which is mixed with the infectious waste.
NR 526.14(3)(f)
(f) The signature of an authorized representative of each facility or licensed transporter handling the waste from generation through treatment.
NR 526.14(4)
(4)
Retention. Infectious waste manifests and records documenting the information required under sub.
(3) shall be retained as follows:
NR 526.14(4)(a)
(a) The infectious waste generator shall retain the copy of the infectious waste manifest received when the waste was removed from the generator's facility and the records that certify their infectious waste was treated, as required in s.
NR 526.12 (4) (d) 3. The infectious waste generator shall retain these records for at least 3 years after the waste has been treated and provide the department copies of manifests and the records documenting the information required in sub.
(3) upon request. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action.
NR 526.14 Note
Note: Hospitals, clinics and nursing homes should keep records for at least 5 years to comply with s.
NR 526.19 (9) (a) and
(g).
NR 526.14(4)(b)
(b) Each licensed infectious waste transporter and each owner or operator of a storage or transfer facility, combustor, incinerator or infectious waste treatment facility which handles or disinfects infectious waste shall retain a copy of each manifest, certification of infectious waste treatment according to s.
NR 526.11 and records documenting the information required in sub.
(3) for at least 3 years after delivering the waste to the next destination and shall provide the department copies of these documents upon request. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action.
NR 526.14(4)(c)
(c) The owner or operator of a solid waste disposal facility which receives treated infectious waste shall retain a copy of the infectious waste manifest and certification of infectious waste treatment under s.
NR 526.12 (4) (d) 2. for at least 3 years after disposal of the waste and shall provide the department copies of these documents upon request. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action.
NR 526.14 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94; am. (2) (b) 2.,
Register, June, 1996, No. 486, eff. 7-1-96;
CR 05-020: am. (1) (a), (b) and (4)
Register January 2006 No. 601, eff. 2-1-06.
NR 526.15
NR 526.15 Infectious waste annual reports. An infectious waste generator which is either required to use manifests under s.
NR 526.14 or to submit progress reports on medical waste reduction under s.
NR 526.21 shall submit an annual report to the department on a form supplied by the department and the annual filing fee for the infectious waste annual report, as specified in s.
NR 520.04, Table 2. An annual report form submitted by a medical facility shall be signed by the director of the facility. An annual report form submitted by other infectious waste generators shall be signed by the administrator, chief executive officer or board of directors.
NR 526.15(1)
(1)
Groups of generators. Infectious waste generators who manifest infectious waste as a group may choose to submit a single annual report on behalf of the group and which is signed by the director of each generator in the group. Except as required under s.
NR 526.21 (1), the annual report shall be submitted by March 1 for activities performed during the preceding calendar year.
NR 526.15(2)
(2)
Generators of mass vaccination waste. This subsection applies to persons generating infectious waste during emergency mass vaccinations, including but not limited to smallpox and excluding routine vaccinations. The filing status of these generators is based on their non-mass vaccination waste, that is, the total amount of waste generated in the year minus the amount of waste generated at mass vaccination clinic or clinics. These generators are required to file an annual report only if they are required to file an annual report under this section based on their non-mass vaccination waste. Their annual report shall include the amount of the infectious waste generated at the mass vaccination clinic or clinics. Conversely, if generators of infectious waste from emergency mass vaccinations are not required to file an annual report under this section, based on their non-mass vaccination waste, they do not need to file the annual report or report the amount of their mass vaccination waste.
NR 526.15 Note
Note: Infectious waste annual report forms (DNR form 4400-177) may be obtained from the Department of Natural Resources, Bureau of Waste Management, 101 S. Webster Street, P.O. Box 7921, Madison, WI 52707-7921. Phone number 608-266-2111. The forms are also available on DNR's website,
http://dnr.wi.gov.
NR 526.15 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94; am.,
Register, June, 1996, No. 486, eff. 7-1-96;
CR 05-020: r. and recr.
Register January 2006 No. 601, eff. 2-1-06.
NR 526.16(1)(1)
Purpose. The purpose of this subchapter is to require medical facilities, except those exempted under sub.
(2), to implement policies which will do all of the following: reduce the amount of medical waste generated by medical facilities, prevent the mixing of infectious waste with non- infectious waste, promote practical alternatives to disposable items in medical facilities, and maintain effective waste reduction programs. Waste reduction efforts initiated prior to November 1, 1994 may be incorporated into the policy and plan.
NR 526.16 Note
Note: Medical waste does not mean all of the waste produced in a medical setting. Waste materials from a medical setting which do not meet the definition of “infectious waste" in statutes are considered to be “medical waste" only if the generator mixes them with infectious waste or manages them as though they are infectious waste.
NR 526.16(2)
(2)
Exemptions. Directors of all medical facilities are encouraged to audit their waste management practices and to reduce medical waste whenever possible. The following directors of medical facilities are exempt from the requirements of this subchapter, provided they keep records of the amount of medical waste generated in order to verify whether or not they are exempt from the requirements of this subchapter and they retain the records for 5 years:
NR 526.16(2)(a)
(a) Directors of medical facilities which generate less than 50 pounds of medical waste per calendar month, regardless of where the waste is treated.
NR 526.16(2)(b)
(b) Directors of medical facilities which generate more than 50 pounds of medical waste during only one calendar month of a calendar year, regardless of where the waste is treated, and which average less than 50 pounds of medical waste per month for the same calendar year.
NR 526.16 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94.
NR 526.17
NR 526.17 Medical waste reduction policy. Except as provided in s.
NR 526.16 (2), each director shall adopt a written medical waste reduction policy which commits the medical facility to the process of reducing the amount of medical waste generated at the source. A group of directors may work together to develop a policy which each individual director will subsequently adopt. The director shall review and update the medical waste reduction policy as necessary or at least every 5 years. The medical waste reduction policy shall, at a minimum, commit the medical facility to the process of waste reduction, which consists of all of the following:
NR 526.17(1)
(1) Auditing current practices for managing solid waste generated by the medical facility and repeating the waste audit as necessary, according to s.
NR 526.18.
NR 526.17(2)
(2) Preparing a medical waste reduction plan and updating the plan as necessary, according to s.
NR 526.19.
NR 526.17(4)
(4) Assessing the medical waste reduction plan and the progress toward goals annually, according to s.
NR 526.20 (2), and submitting progress reports to the department, according to s.
NR 526.21.
NR 526.17 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94.
NR 526.18
NR 526.18 Waste audit. Before completing or updating the medical waste reduction plan required in s.
NR 526.19, each director or director's designee shall audit the medical facility's current solid waste management practices. Each director or director's designee shall repeat the audit at least every 5 years for the whole medical facility or more frequently for any part of the facility where there has been a significant change in solid waste characteristics or amounts of solid waste due to major remodeling, expansion of service or other factors. Each director or director's designee shall keep a copy of the results of the initial audit and all subsequent audits at the medical facility. The department may review these records upon request. The waste audit shall address all of the following:
NR 526.18(1)
(1)
Source areas. The waste audit shall identify all areas within the medical facility where solid waste, not just medical waste, is generated.
NR 526.18(2)
(2)
Waste types. The waste audit shall identify the types of waste that are generated within each source area. It is not necessary to determine how much of each waste type is generated in each source area. The waste types are: medical waste, including infectious waste items listed in s.
NR 526.05 and items which are either being mixed with infectious waste or handled as infectious waste; hazardous waste, including but not limited to hazardous chemotherapy waste; radioactive waste; trace chemotherapy waste; recyclable materials; wastes which may have to be managed separately because they are any combination of infectious, hazardous or radioactive waste; and other solid waste.
NR 526.18 Note
Note: Infectious waste which is also hazardous may also be regulated by the department under hazardous waste rules. See chs.
NR 660 to
670 and s.
NR 526.11 (2) (f). Infectious waste which is also radioactive is regulated by the department of health services under ch.
DHS 157 and the federal government under Title 10 CFR until no longer regulated as radioactive material, as provided in s.
NR 526.02 (6).
NR 526.18(3)
(3)
Quantity of medical waste. The waste audit shall identify how many pounds of medical waste the medical facility, as a whole, generated during the previous 12 months.
NR 526.18(4)
(4)
Medical waste generation rate. The waste audit shall identify the rate at which the medical facility generated medical waste during the 12 months covered by the audit. The waste generation rate shall be calculated according to the appropriate formula in s.
NR 526.21 (1).
NR 526.18(5)
(5)
Waste management practices. The waste audit shall identify how medical waste is collected, stored, transported and treated from the point of generation to the point of final disposal, including any medical waste discharged to a publicly-owned wastewater treatment system. The audit shall identify how non-infectious waste is prevented from being mixed with infectious waste. The audit shall include any waste types that are currently mixed with or may be mixed with infectious waste. The audit may also identify waste management practices for waste types that are not mixed with medical waste.
NR 526.18 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94;
CR 05-020: am. (2)
Register January 2006 No. 601, eff. 2-1-06.
NR 526.19
NR 526.19 Medical waste reduction plan. NR 526.19(1)(1)
General provisions. Unless exempt under s.
NR 526.16 (2), each director or director's designee shall prepare a medical waste reduction plan for separating, reducing and managing the medical waste generated, for evaluating alternatives to disposable products and for maintaining waste reduction efforts. The director or director's designee shall do all of the following when preparing the medical waste reduction plan:
NR 526.19(1)(a)
(a) Include all of the information required in subs.
(3) to
(10) in the medical waste reduction plan.
NR 526.19(1)(b)
(b) Assess the medical waste reduction plan and its results annually and update the plan at least every 5 years.
NR 526.19(1)(c)
(c) Keep a copy of the most recent medical waste reduction plan and make it available for the department to review upon request according to s.
NR 526.22 (2). The department may require the director to submit a copy of the plan and related materials to the department for its review and approval. The department may approve the plan with conditions, including but not limited to specifying goals, objectives and schedules.
NR 526.19(1)(d)
(d) Consider the following priorities in developing the medical waste reduction plan:
NR 526.19(1)(d)1.
1. Waste reduction, including but not limited to: reducing the amount of packaging and the use of disposable items, substituting other products and materials, changing or modifying equipment, changing purchasing policies or procedures, changing housekeeping practices, providing more effective ways to separate infectious wastes from all other waste types, and selling or donating unused items and equipment to others.
