Chapter NR 526

NR 526.11(1)(a) (a) Incineration. Treatment by incineration shall consist of incineration in a controlled air, multi-chambered incinerator which provides complete combustion of the waste to carbonized or mineralized ash. The incinerator shall be one that is regulated by the department under s. NR 502.09 or 502.13.

NR 526.11(1)(b) (b) Steam disinfection. Treatment by steam disinfection, including but not limited to autoclaving, shall subject all the waste to a combination of operational temperature, pressure (if applicable) and time proven to render the waste non-infectious at the design capacity of the installed equipment.

NR 526.11(1)(c) (c) Chemical disinfection. Treatment by chemical disinfection shall expose the infectious waste to an appropriate type and concentration of disinfectant for a period of time sufficient to render the waste non-infectious. The chemical disinfectant shall be chosen based on the manufacturer’s recommended use of the disinfectant, the cleanliness of the surface of the waste, the contact time, the physical and chemical properties of the waste, the concentration of the disinfectant and the degree of microbial contamination.

NR 526.11(1)(d) (d) Mechanical grinding and chemical disinfection. Treatment by mechanical grinding and chemical disinfection shall expose all of the waste to the chemical disinfectant for a period of time sufficient to render the waste non-infectious. The chemical disinfectant shall be chosen based on the use of the disinfectant in medical situations, the cleanliness of the surface of the waste, the contact time, the physical and chemical properties of the waste, the concentration of the disinfectant and the degree of microbial contamination. Treatment by mechanical grinding and chemical disinfection shall prevent the release of infectious liquid or infectious gaseous discharges into the environment.

NR 526.11(1)(e) (e) Mechanical grinding and heat disinfection. Treatment by mechanical grinding and heat disinfection, including but not limited to low frequency wave radiation and microwave radiation, shall expose all of the waste to heat for a period of time sufficient to render the waste non-infectious. Treatment by mechanical grinding and heat disinfection shall prevent the release of infectious liquid or infectious gaseous discharges into the environment.

NR 526.11(1)(f) (f) Gas disinfection. Treatment by gas disinfection shall allow gas to penetrate all the infectious waste and shall render the waste non-infectious. The unit shall be operated in a manner that does not pose an occupational risk of exposure to the gas.

NR 526.11 Note Note: For ethylene oxide sterilizers, refer to OSHA regulations in 29 CFR 1910.1047. Air toxic rules in ch. NR 445 may also apply.

NR 526.11(1)(g) (g) Other methods. Treatment by other treatment methods and processes shall render the waste non-infectious and shall be appropriate with respect to all of the following: the properties of the waste being disinfected, the manufacturer’s recommended use of the disinfectant, the cleanliness of the surface of the waste, the contact time, the physical properties of the waste, the concentration of the disinfectant and the degree of microbial contamination.

NR 526.11(2) (2) Special considerations. No person may treat the following categories of infectious waste except as follows:

NR 526.11(2)(a) (a) Human tissue. Human tissue, except teeth containing mercury amalgam treated according to par. (f), shall be treated by any of the following methods:

NR 526.11(2)(a)1. 1. Methods which render the tissue both non-infectious and unrecognizable as human tissue.

NR 526.11(2)(a)2. 2. Incineration where the tissue is transformed into an ash which would not be recognized as being from a human being.

NR 526.11(2)(b) (b) Animal tissue. Animal tissue known to be carrying or experimentally infected with a zoonotic infectious agent shall be treated by any of the following methods:

NR 526.11(2)(b)1. 1. Methods which render the tissue non-infectious.

NR 526.11(2)(b)2. 2. Incineration.

NR 526.11(2)(b)3. 3. Burial on the land on which the animal was kept, in accordance with s. 289.43 (9), Stats., for animals infected with scrapie or s. 289.43 (8), Stats., or s. NR 503.08 for other animals.

NR 526.11(2)(b)4. 4. Rendering or other methods which incorporate the animal into a consumer product in accordance with all other applicable state and federal regulations.

NR 526.11 Note Note: For animals and animal waste used in HIV and HbV research, refer to OSHA blood-borne pathogen standard 29 CFR 1910.1030 (e).

NR 526.11(2)(c) (c) Sharps. Sharps shall be treated by any of the following methods:

NR 526.11(2)(c)1. 1. A method which both renders the sharp non-infectious and renders the sharp broken and not able to be reused, such as by a grinding or shredding process.

NR 526.11(2)(c)2. 2. Incineration.

NR 526.11(2)(d) (d) Bulk blood. Bulk blood shall be treated by any of the following methods:

NR 526.11(2)(d)1. 1. Biological treatment in a municipal or industrial wastewater treatment facility which has been approved under s. 281.41, Stats., or permitted under ch. 283, Stats. Bulk blood may be transported to the wastewater treatment facility through the sewer system.

NR 526.11(2)(d)2. 2. Methods which render the blood non-infectious.

NR 526.11(2)(d)3. 3. Incineration.

NR 526.11(2)(e) (e) Body fluids and blood-contaminated urine and feces. Body fluids and blood-contaminated urine and feces shall be treated by any of the methods listed in par. (d) or by disposal in a septic system.

NR 526.11(2)(f) (f) Teeth containing mercury amalgam. Infectious waste generators shall disinfect a tooth containing mercury amalgam using procedures allowed under sub. (1) (c), except bleach, which leaches mercury, and shall manage the disinfected tooth in one of the following ways:

NR 526.11(2)(f)1. 1. Recycle the disinfected tooth containing mercury amalgam with other mercury-containing wastes.

NR 526.11(2)(f)2. 2. Dispose of the disinfected tooth containing mercury amalgam as a hazardous waste.

NR 526.11(2)(f)3. 3. Remove the mercury amalgam from the disinfected tooth and either recycle the mercury amalgam or dispose of the mercury amalgam as a hazardous waste. The disinfected tooth may be discarded as solid waste.

NR 526.11 Note Note: See the American Dental Association’s website at www.ada.org for recommended procedures for disinfecting teeth containing mercury amalgam.

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 NR 526.12 Treatment facilities.

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)(b) (b) Prepare a plan of operation as described in sub. (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)1. 1. Date.

NR 526.12(4)(c)2. 2. Clock time of start of cycle.

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)(c)6. 6. Results of any tests run to verify disinfection.

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)1. 1. The operator shall sign the infectious waste manifest according to s. NR 526.14 (1) (b).

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 526.13 History History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; CR 05-020: am. Register January 2006 No. 601, eff. 2-1-06.

NR 526.14 NR 526.14 Records and infectious waste manifests.

NR 526.14(1) (1) Activities.

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) (2) Exemptions.

NR 526.14(2)(a) (a) The following persons are exempt from all the requirements of this section:

NR 526.14(2)(a)1. 1. Home generators of infectious waste.

NR 526.14(2)(a)2. 2. Owners and operators of sharps collection stations.

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)(d) (d) The composition of the infectious waste, including the type or types of infectious waste listed in s. NR 526.05 (1).

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.