NR 526.04(1)(1)
General exemptions. In special cases, the department may grant exemptions in writing from non-statutory requirements of this chapter. A person may apply for an exemption under this section by providing the department with a written request along with appropriate documentation which demonstrates to the satisfaction of the department that the proposal will not cause environmental pollution as defined in s.
299.01 (4), Stats., and will protect waste handlers and other persons from exposure to infectious waste. The department will send an invoice for the exemption request fee specified in s.
NR 520.04, Table 2, upon receipt of the exemption request. In making its decision, the department shall take into account factors such as the population of the area being served, the amount of waste being generated, the design of the facility, the operational history of the facility, the physical and chemical characteristics of the waste and any other information which may be appropriate. The department may grant exemptions under this section if the department finds that granting the exemption will not cause environmental pollution as defined in s.
299.01 (4), Stats., and that the exemption will protect waste handlers and other persons from exposure to infectious waste.
NR 526.04(3)
(3)
Sharps collection station exemptions. Persons who operate sharps collection stations are exempt from the requirements of this chapter except the requirements under s.
NR 526.09 (5).
NR 526.04(4)
(4)
Emergency response exemptions. Persons, including but not limited to law enforcement personnel, emergency medical personnel and fire fighters, who are responding to an emergency not occurring at a medical facility, including but not limited to vehicle accidents, fires and natural disasters, are exempt from the requirements of this chapter except the requirements under ss.
NR 526.06 to
526.08,
526.09 (4),
526.10 (3) and
526.13.
NR 526.04(5)
(5)
Funeral director exemptions. Human tissue which is to be interred or cremated under the direction of a funeral director licensed under ch.
445, Stats., the university of Wisconsin medical school or the medical school of Wisconsin, is exempt from the requirements of this chapter.
NR 526.04(6)
(6)
Research exemptions. Human tissue or animal tissue carrying an infectious agent which is used in research is exempt from the requirements of this chapter until it is no longer being used for research.
NR 526.04(7)
(7)
Animal product exemptions. Animal tissue which is processed by a rendering plant or incorporated into a consumer product is exempt from the requirements of this chapter.
NR 526.04(8)
(8)
Wastewater treatment plant exemptions. Any mixture of domestic sewage and other wastes that passes through a sewer system to a publicly-owned treatment works for treatment is exempt from the requirements of this chapter.
NR 526.04 Note
Note: Persons who generate or manage small quantities of infectious waste must follow all safety-related requirements found in this rule, but may be exempt from administrative requirements such as licensing and paperwork. Safety requirements are found in the following sections:
Section
NR 526.06 for separating waste.
Section
NR 526.07 for containing infectious waste.
Section
NR 526.08 for handling infectious waste.
Section
NR 526.09 (4) for storing and transferring infectious waste.
Section
NR 526.10 (3) for transporting and shipping infectious waste.
Sections
NR 526.11 and
526.12 (4) for treating infectious waste.
Section
NR 526.13 for disposing of infectious waste.
Exemptions from administrative requirements are found in the following sections:
Section
NR 526.09 (2) for storage and transfer licenses.
Section
NR 526.10 (2) for transportation licenses.
Section
NR 526.12 (2) for treatment licenses.
Section
NR 526.14 (2) for infectious waste manifests and keeping records of amounts generated.
Section
NR 526.15 (2) for infectious waste annual reports.
NR 526.04(9)
(9)
Blood collection vehicle exemptions. Persons, including but not limited to the American Red Cross, who are transporting whole blood or blood components from temporary locations where blood is collected back to the collector's permanent location are exempt from the requirements of this chapter except the requirements under ss.
NR 526.06 to
526.08,
526.09 (4),
526.10 (3) and
526.13.
NR 526.04(10)
(10)
Mass vaccination waste exemptions. Persons who are transporting infectious waste from emergency mass vaccinations, including but not limited to smallpox and excluding routine vaccinations, are exempt from the requirements of this chapter except the requirements under ss.
NR 526.06 to
526.08,
526.09 (4),
526.10 (3),
526.11,
526.12 (4),
526.13 and
526.14 (1) (a). Persons transporting waste from emergency mass vaccinations may be required to file annual reports under s.
NR 526.15.
NR 526.04 Note
Note: USDOT requirements may apply to hazardous materials transported by researchers, emergency response personnel and blood collection vehicles. For more information, contact the USDOT helpline at 1-800-467-4922.
NR 526.04 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94; am. (1),
Register, June, 1996, No. 486, eff. 7-1-96;
CR 05-020: cr. (9) and (10)
Register January 2006 No. 601, eff. 2-1-06.
NR 526.05
NR 526.05 Infectious waste categories. NR 526.05(1)(1)
A solid waste which is included in any of the following categories is presumed to be infectious waste unless methods of testing which are generally accepted by the medical profession demonstrate that the waste is not infectious:
NR 526.05(1)(a)1.
1. Contaminated sharps which are both infectious and may easily cause punctures or cuts in the skin, including but not limited to: hypodermic needles, syringes with needles attached, scalpel blades, lancets, broken glass vials, broken rigid plastic vials and laboratory slides.
NR 526.05(1)(a)2.
2. Unused or disinfected sharps which are being discarded, including hypodermic needles, scalpel blades, lancets and syringes with needles attached.
NR 526.05 Note
Note: A tooth containing mercury amalgam may be both an infectious waste and a hazardous waste. See s.
NR 526.11 (2) (f) for how to manage teeth containing mercury amalgam.
NR 526.05(1)(e)
(e) Tissue, bulk blood or body fluids from an animal which is carrying a zoonotic infectious agent.
NR 526.05(2)
(2) A solid waste which is not included in the definition of infectious waste, which is not mixed with infectious waste and which does not fall under one of the categories in sub.
(1) is presumed not to be an infectious waste. Solid wastes presumed not to be infectious wastes include all of the following:
NR 526.05(2)(a)
(a) Items soiled but not saturated with blood or body fluids from humans included in the definition of “bulk blood and body fluids".
NR 526.05(2)(b)
(b) Items soiled with body fluids from humans not included in the definition of “bulk blood and body fluids".
NR 526.05(2)(d)
(d) Tissue, blood, body fluids or cultures from an animal which is not known to be carrying or experimentally infected with a zoonotic infectious agent.
NR 526.05(2)(f)
(f) Other solid wastes, including but not limited to containers, packages, waste glass, laboratory equipment and other materials which have had no contact with blood, body fluids, clinical cultures or infectious agents. When possible, use of these items shall be reduced, and the items shall be reused or recycled.
NR 526.05(3)
(3) An item which is trace chemotherapy waste and is also considered to be infectious waste either by being included in the definition of infectious waste or by falling under one of the categories in sub.
(1), is regulated only according to s.
NR 526.055. However, if that item is mixed with bulk amounts of chemotherapy waste which is a hazardous waste, the item is regulated according to chs.
NR 660 to
670.
NR 526.05 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94; cr. (2) (g),
Register, June, 1996, No. 486, eff. 7-1-96;
CR 05-020: am. (3)
Register January 2006 No. 601, eff. 2-1-06; correction in (3) made under s. 13.93 (2m) (b) 7., Stats.,
Register April 2013 No. 688.
NR 526.055(1)(a)
(a) No person may mix trace chemotherapy waste in the same bag or waste receptacle with infectious waste or with non-hazardous solid waste, unless mixing the wastes is necessary to protect the health or safety of patients, employees or other persons.
NR 526.055(1)(b)
(b) If infectious waste or non-hazardous solid waste is mixed with trace chemotherapy waste, the mixture shall be managed according to subs.
(2) and
(3).
NR 526.055(1)(c)
(c) If trace chemotherapy waste is mixed with other chemotherapy waste, the mixture shall be managed according to chs.
NR 660 to
670.
NR 526.055(2)
(2)
Containment. No person may transport trace chemotherapy waste from the property where the waste was generated unless the person puts the waste in a container which protects waste handlers and other persons from exposure to the trace chemotherapy waste and all of the following requirements are met:
NR 526.055(2)(a)
(a) Hard trace chemotherapy waste, including but not limited to syringes, drug dispensing devices and broken or empty chemotherapy drug vials, shall be contained in rigid, puncture-resistant labeled plastic containers designed to prevent the loss of the contents and labeled with the visible words “Trace chemotherapy waste" and “Incinerate only".
NR 526.055(2)(b)
(b) Soft chemotherapy waste, including but not limited to gloves, disposable gowns, towels, empty intravenous solution bags and empty tubing, may be contained in containers meeting the requirements of par.
(a) or in a bag meeting the requirements of s.
NR 526.07 (2) (a) and
(b).
NR 526.055 Note
Note: “Empty" has the meaning in s.
NR 661.0007.
NR 526.055(3)
(3)
Treatment. Trace chemotherapy waste shall be treated by incineration or other method approved by the department. An incinerator used to treat trace chemotherapy waste may be one of the following:
NR 526.055(3)(a)
(a) An incinerator regulated by the department under s.
NR 502.09 or
502.13 or regulated by another state as an incinerator that burns medical waste.
NR 526.055(3)(b)
(b) An incinerator regulated by the department under chs.
NR 664 and
665 or regulated by another state as an incinerator that burns hazardous waste.
NR 526.055 Note
Note: The NIOSH “Hazardous Drug Alert" lists hazardous drugs, including chemotherapy drugs, by name and gives guidance on containment, labeling, handling, storage and disposal.
NR 526.055 History
History: CR 05-020: cr.
Register January 2006 No. 601, eff. 2-1-05; correction in (1) (c), (3) (b) made under s. 13.93 (2m) (b) 7., Stats.,
Register April 2013 No. 688.
NR 526.06(1)(1)
No person may mix infectious waste in the same bag or waste receptacle with solid waste which is not infectious waste, unless mixing the wastes is necessary to protect the health or safety of patients, employees or other persons.
NR 526.06(2)
(2) No person may separate infectious waste from solid waste which is not infectious waste unless adequate measures are taken to protect waste handlers and other persons from exposure. After separation, solid waste previously mixed in the same bag or waste receptacle with infectious waste shall be managed as infectious waste.
NR 526.06(3)
(3) No person may remove solid waste or infectious waste that has been placed in a bag or waste container labeled with the biohazard symbol or fail to manage the waste as infectious waste from the time of generation until the waste has been treated according to s.
NR 526.11, unless the person follows waste management procedures which will protect waste handlers and other persons from exposure.
NR 526.06(4)
(4) No person may transport solid waste and infectious waste on the same cart or vehicle unless the wastes are in separate and identifiable bags or waste containers. If the wastes are transported on any roads, the requirements of ss.
NR 502.06 and
526.10 shall also be met.
NR 526.06 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94.
NR 526.07
NR 526.07 Containment. No person may transport infectious waste from the property where the waste was generated unless the person puts the waste in a container which protects waste handlers and other persons from exposure to the infectious waste and the person meets all of the following requirements:
NR 526.07(1)
(1) Sharps shall be contained in rigid, puncture-resistant labeled containers made of materials including but not limited to metal or rigid plastic, designed to prevent the loss of the contents and labeled with a visible bio- hazard emblem or with the visible words “bio-hazard", “sharps" or “infectious waste".
NR 526.07(2)
(2) Infectious waste other than sharps shall be contained according to all of the following:
NR 526.07(2)(a)
(a) The waste shall be placed in a single plastic bag that meets or exceeds 165 grams resistance by the ASTM method D1709-04 and is tear resistant using method ASTM method D1922-03a, or, if necessary, a double bag that meets the same standards, or a rigid reusable container.
NR 526.07 Note
Note: These testing methods are entitled “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method" and “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method" respectively. Copies are available for inspection at the central office of the department of natural resources and the offices of the secretary of state and the legislative reference bureau. Copies may be obtained from ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA, 19428-2959 USA,
www.astm.org, phone number 610-832-9585.
NR 526.07(2)(b)
(b) The bag or rigid reusable container shall be securely sealed to prevent leakage or expulsion of the contents under normal handling.
NR 526.07(2)(c)
(c) Any bag containing infectious waste shall be placed in a rigid container, including but not limited to a corrugated cardboard container, a covered reusable container or a covered cart. The rigid container shall be labeled with a visible bio-hazard emblem and the word “bio-hazard". Bulk containers shall be small enough to be handled by a single person.
NR 526.07(3)
(3) No person may open a secured container of infectious waste which is ready for transportation until immediately before treating the waste, unless repacking is necessary to prevent spills or leakage, or the person is conducting a waste audit or training session.
NR 526.07(4)
(4) All reusable containers shall be disinfected after being emptied. No person may open, empty or clean a reusable sharps container by hand.
NR 526.07 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94; am. (intro.),
Register, June, 1996, No. 486, eff. 7-1-96;
CR 05-020: am. (2) (a) and (c), r. (2) (d), cr. (4)
Register January 2006 No. 601, eff. 2-1-06.
NR 526.08
NR 526.08 Handling. No person may handle, load, unload, process or treat infectious wastes unless adequate measures are taken to protect waste handlers and other persons from exposure to the infectious wastes and unless all of the following requirements are met:
NR 526.08(1)
(1) All containers shall be handled and transported to prevent the loss or spilling of the contents.
NR 526.08(2)
(2) Nuisance conditions shall be prevented from developing. Appropriate measures shall be taken to prevent odors, including but not limited to refrigerating the infectious waste below 42
° Fahrenheit until treated.
NR 526.08(3)
(3) All infectious waste shall be loaded and unloaded by hand or by a safe mechanical method which does not damage containers or spill their contents.
NR 526.08(4)
(4) Untreated infectious waste may not be compacted.
NR 526.08 History
History: Cr.
Register, October, 1994, No. 466, eff. 11-1-94; am. (2),
Register, June, 1996, No. 486, eff. 7-1-96.
NR 526.09
NR 526.09 Storage and transfer. No person may store infectious wastes unless the person protects waste handlers and other persons from exposure to the infectious waste and unless the requirements of this section are met. For the purposes of this chapter, storage also includes, but is not limited to the transfer of infectious waste. Infectious waste generators may temporarily accumulate infectious waste in individual containers near the place where the waste was generated, prior to moving the waste to an on-site infectious waste storage facility.
NR 526.09(1)
(1)
Licensing. Except as provided in sub.
(2), no person may operate or maintain an infectious waste storage facility unless the person has obtained an operating license for storing solid waste under s.
NR 502.05 and the storage facility meets all the requirements for handling infectious waste under s.
NR 526.08 and storing infectious waste under this section. The department may require that the owner or operator provide proof of financial responsibility for the removal, transportation, treatment and ultimate disposal of the stored material. To apply for an operating license for an infectious waste storage facility, the applicant shall take all of the following actions:
NR 526.09(1)(a)
(a) Contact the department to arrange an initial inspection.
NR 526.09(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 will send an invoice for the plan review fee for infectious waste storage facilities, as specified in s.
NR 520.04, Table 2.
NR 526.09(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, according to ss.
NR 500.06 and
520.04, Table 2.
NR 526.09(2)
(2)
Exemptions. Infectious waste storage facilities which meet any of the following conditions are exempt from the requirement to obtain an operating license under sub.
(1) and preparing a plan of operation under sub.
(3) for storing infectious waste, but shall meet the minimum operating requirements for storing infectious waste under sub.
(4).
NR 526.09(2)(a)
(a) Storage facilities which are located on the property where the infectious waste is generated.
NR 526.09(2)(b)
(b) Storage facilities which are located on the property where the infectious waste is generated and which accept infectious waste from off-site generators, if the total quantity of infectious waste, including items mixed with infectious waste, accepted from off-site is less than the quantity generated on- site or less than 500 pounds per month, whichever is less and if the waste is accepted on a not-for-profit and cost-only basis.
NR 526.09(2)(c)
(c) Sharps collection stations which comply with all of the requirements under sub.
(5).
NR 526.09(2)(d)
(d) Storage facilities for infectious waste which also is hazardous waste under s.
291.01 (7), Stats., provided that the storage facility is regulated under ch.
NR 664.
NR 526.09(3)
(3)
Plan of operation. No person may establish or construct an infectious waste storage facility or expand an existing facility unless the person has obtained a plan of operation approval from the department or unless the facility is exempt from licensing under sub.
(2). 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 502.05 (8), except s.
NR 502.05 (8) (e), and any other details necessary to address the requirements in this chapter, including but not limited to requirements for handling and containment and the requirements of sub.
(4).
NR 526.09(4)
(4)
Minimum requirements for all persons storing infectious waste. No person may operate or maintain an infectious waste storage facility unless the storage area meets all of the following requirements:
NR 526.09(4)(a)
(a) The storage area shall be kept clean and be impermeable to liquids. Carpeted areas or wooden floors may not be used in storage areas.
NR 526.09(4)(b)
(b) The storage area designated for infectious waste may contain only infectious wastes and their containers. The storage area may be an area designated within a room.
NR 526.09(4)(c)
(c) The storage area shall be in an enclosed building, container or vehicle so that the infectious waste is not exposed to weather.
NR 526.09(4)(d)
(d) Access to the storage area shall be limited to authorized personnel.
NR 526.09(4)(e)
(e) Nuisance conditions shall be prevented from developing. Appropriate measures shall be taken to prevent odors, including but not limited to refrigerating the infectious waste below 42
° Fahrenheit until treated.
NR 526.09(4)(f)
(f) If the infectious waste is to be treated off-site, the operator of the infectious waste storage facility shall relinquish the infectious waste only to an infectious waste transporter licensed by the department or to a person exempt from licensing under s.
NR 526.10 (2).
