Regulated Medical Waste

Wisconsin

Medical/Infectious Waste

Background Information
Definition of Infectious Medical Waste
Managing Regulated Medical Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information

Background Information

Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Definition of Infectious Medical Waste

The following solid wastes are presumed to be infectious waste unless methods of testing which are generally accepted by the medical profession demonstrate that the waste is not infectious:

Sharps, including 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, and unused or disinfected sharps which are being discarded, including hypodermic needles, scalpel blades, lancets and syringes with needles attached;
Bulk blood and body fluids from humans;
Human tissue;
Microbiological laboratory waste; and
Tissue, bulk blood or body fluids from an animal, which is carrying a zoonotic infectious agent.

Solid wastes presumed not to be infectious wastes include the following:

Items soiled but not saturated with blood or body fluids from humans included in the definition of "bulk blood and body fluids";
Items soiled with body fluids from humans not included in the definition of "bulk blood and body fluids";
Intravenous tubing after needles have been detached;
Tissue, blood, body fluids or cultures from an animal which is not known to be carrying or experimentally infected with a zoonotic infectious agent;
Animal manure and bedding;
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; and
Formerly infectious waste, after it has been treated according to the regulations.

Managing Infectious Medical Waste

Source separation

Infectious waste may not be mixed 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.
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.
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, unless the person follows waste management procedures which will protect waste handlers and other persons from exposure.
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, transporter requirements apply.

Containment

No person may transport infectious waste from the property where the waste was generated unless the waste is put 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:

Sharps shall be contained in rigid, punctureresistant 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 "biohazard", "sharps" or "infectious waste".
Infectious waste other than sharps shall be contained according to all of the following:
- The waste shall be placed in a single plastic bag that meets or exceeds 165 grams resistance by the ASTM method D170991 and is tear resistant using method ASTM method D192289, or, if necessary, a double bag that meets the same standards, or a rigid reusable container. Copies of the testing methods are available for inspection at Department of Natural Resources, the Secretary of State, or the American Society for Testing and Materials.
- The bag or rigid reusable container shall be securely sealed to prevent leakage or expulsion of the contents under normal handling.
- 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 cart. The rigid container shall be labeled with a visible biohazard emblem and the word "biohazard". Bulk containers shall be small enough to be handled by a single person.
- All reusable containers shall be disinfected after being emptied.
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.

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:

All containers shall be handled and transported to prevent the loss or spilling of the contents.
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 degrees Fahrenheit until treated.
All infectious waste shall be loaded and unloaded by hand or by a safe mechanical method that does not damage containers or spill their contents.
Untreated infectious waste may not be compacted.

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 following requirements are met:

Storage 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 onsite infectious waste storage facility.
No person may operate or maintain an infectious waste storage facility unless the person has obtained an operating license for storing solid waste and the storage facility meets all the requirements for handling and storing infectious waste.

Infectious waste storage facilities that which meet any of the following conditions are exempt from the requirement to obtain an operating license and preparing a plan of operation, but shall meet the minimum operating requirements for storing infectious waste:

Storage facilities that are located on the property where the infectious waste is generated.
Storage facilities which are located on the property where the infectious waste is generated and which accept infectious waste from offsite generators, if the total quantity of infectious waste, including items mixed with infectious waste, accepted from offsite is less than the quantity generated onsite or less than 500 pounds per month, whichever is less and if the waste is accepted on a notforprofit and costonly basis.
Sharps collection stations which comply with all requirements.
Storage facilities for infectious waste, which is also, is hazardous waste, provided that the storage facility is regulated.

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 requirement.

Minimum Requirements for the Storage of Infectious Waste

No person may operate or maintain an infectious waste storage facility unless the storage area meets all of the following requirements:

The storage area shall be kept clean and be impermeable to liquids. Carpeted areas or wooden floors may not be used in storage areas.
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.
The storage area is in an enclosed building, container or vehicle so that the infectious waste is not exposed to weather.
Access to the storage area shall be limited to authorized personnel.
Nuisance conditions shall be prevented from developing.
If the infectious waste is to be treated offsite, the operator of the infectious waste storage facility shall relinquish the infectious waste only to a licensed infectious waste transporter or to a person exempt from licensing.
The containers of infectious waste shall be removed and emptied as necessary, but at least every 90 days.
The operator of the infectious waste storage facility shall keep records of how much and where the infectious waste has been sent offsite. Records may consist of any of the following: copies of infectious waste manifests, invoices, logs or other written documentation of the amount of infectious waste sent offsite for treatment.

Requirements for Sharps Collection Stations

No person may operate or maintain a sharps collection station unless the person complies with all of the following requirements:

Sharps and sharps containers are only accepted from infectious waste generators, each of which generates less than 50 pounds of sharps per month, including items that may be mixed with the sharps.
The service is provided on a notforprofit and costonly basis.
No more than 500 pounds of infectious waste in the sharps collection station is stored at any one time.
All applicable requirements are complied with.
The sharps collection station is registered with the department
The department is immediately notified in writing if the sharps collection station moves or ceases to operate.

Transportation and Shipping

No person may transport or ship infectious waste in Wisconsin unless adequate measures are taken to protect waste handlers, the public and the environment from exposure to the infectious waste, and all of the following requirements are met:

No person may transport infectious waste or operate or maintain an infectious waste transportation service unless the person has obtained an infectious waste transportation license for each vehicle and complies with both the minimum transportation and operating requirements for licensed infectious waste transporters.
Persons who meet any of the following conditions are exempt from licensing under this section, but shall meet the minimum requirements for transporting infectious waste:
- Infectious waste is transported 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.
- Less than 50 pounds of infectious is transported per calendar month.
- Persons operating vehicles owned or leased by the United States postal service and handling infectious waste sent through the mail.
- Persons operating vehicles owned by a parcel carrier service for which infectious waste constitutes an incidental portion of the carrier's business, if the infectious waste is handled in accordance with all applicable state and federal regulations.
- Persons transporting infectious waste through Wisconsin who are not stopping to collect, drop off or transfer the infectious waste, and who handle the infectious waste in accordance with all applicable state and federal regulations.
- Persons transporting infectious waste that is also a hazardous waste, provided that the transportation is regulated.

Minimum Requirements for Transporting Infectious Waste

No person may transport infectious waste unless all of the following minimum requirements are met:

The infectious waste shall be contained and handled according to all applicable requirements.
The vehicle used to transport the infectious waste shall meet all of the following requirements:
- The portion of the vehicle where the infectious waste is contained shall be completely enclosed to prevent littering, spillage or leakage. The enclosed portion shall be leakresistant, if necessary, considering the type of waste and its moisture content. Rolloff boxes or dumpsters may not be used to transport infectious waste.
- The vehicle shall be maintained in good repair.
- The vehicle shall be cleaned as frequently as necessary to prevent nuisances.
- Nuisance conditions shall be prevented from developing.

The person shall transport the infectious waste only to licensed solid waste facilities that store or treat infectious waste, or exempt from licensing or other requirements. Other transportation regulations, such as federal department of transportation standards, may also apply.

Operating Requirements for Licensed Infectious Waste Transporters

Infectious waste transporters that are required to be licensed shall comply with all the following requirements, in addition to other applicable rules:

Each vehicle shall have "WDNR" followed by the infectious waste transportation license number lettered on the driver's and passenger's doors. The letters shall be at least 2 inches high with a minimum of 1/2 inch brush stroke. The lettering shall contrast with the background so it is easy to read.
Vehicles or containers used for the collection or transportation of infectious waste shall be durable and easy to clean.
Each vehicle hauling infectious waste shall carry a written contingency plan for spills and accidents and shall carry tools and materials sufficient to implement the contingency plan. In case of spill or accident, the driver shall implement the contingency plan immediately after spillage occurs.
The portion of the vehicle where the infectious waste is placed shall be cleaned and disinfected before hauling materials other than infectious waste, solid waste or supplies related to managing waste.
The person transporting the infectious waste shall sign all manifests which accompany the infectious waste, even if the waste is exempt from manifesting, and deliver the manifests to the next person who handles the waste.
If infectious waste is not accompanied by an infectious waste manifest, the person transporting the waste shall initiate an infectious waste manifest for that waste, unless the person transporting the waste hauls less than 50 pounds of unmanifested infectious waste per month.

Licensed infectious waste transporters shall notify the department in writing of all significant changes in service, including adding or replacing a vehicle, changing the destination to which the infectious waste is hauled, expanding the service area into another county, or terminating service.

Treatment Methods

No person may dispose of infectious waste in a solid waste disposal facility unless the infectious waste has undergone treatment that effectively renders the waste noninfectious. The treatment method shall be chosen by considering the properties of the waste being treated and the degree of microbial contamination.

The treatment method may also need to comply with air standards for control of hazardous pollutants, and with state or federal regulations for wastewater and occupational health and safety. All infectious waste shall be treated by one or more of the following infectious waste treatment methods:

Incineration;
Steam disinfection;
Chemical disinfection;
Mechanical grinding and chemical disinfection;
Mechanical grinding and heat disinfection;
Gas disinfection; and
Other treatment methods and processes that render the waste noninfectious 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.

The following infectious wastes must be treated as follows:

Human tissue shall be treated by methods which render the tissue both noninfectious and unrecognizable as human tissue, or incineration, where the tissue is transformed into an ash which would not be recognized as being from a human being.
Animal tissue known to be carrying or experimentally infected with a zoonotic infectious agent shall be treated by methods which render the tissue noninfectious, incineration, burial on the land on which the animal was kept, or rendering or other methods which incorporate the animal into a consumer product in accordance with all other applicable state and federal regulations. Note: For animals and animal waste used in HIV and HbV research, refer to OSHA bloodborne pathogen standard.
Sharps shall be treated by a method which both renders the sharp noninfectious and renders the sharp broken and not able to be reused, such as by a grinding or shredding process, or incineration.
Bulk blood shall be treated by biological treatment in an approved or permitted municipal or industrial wastewater treatment facility (bulk blood may be transported to the wastewater treatment facility through the sewer system), methods which render the blood noninfectious, or incineration.
Body fluids and bloodcontaminated urine and feces shall be treated by any approved methods or by disposal in a septic system.

Treatment Facilities

No person may operate or maintain an infectious waste treatment facility unless they have obtained an operating license as a solid waste processing facility and the facility meets all applicable requirements for containing, handling, storing and treating infectious waste.

Records and Infectious Waste Manifests

All infectious waste generators shall keep records of the amount of infectious waste sent offsite for treatment. Records may consist of any of the following: copies of infectious waste manifests, invoices or records received from the infectious waste treatment facility, logs or other written documentation of the amount of infectious waste sent offsite for treatment. These records shall be kept for at least 3 years after they were created. If the 3year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action.

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.

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 provided by the DNR, even if the infectious waste generator is exempt from manifesting, and shall deliver the infectious waste manifest form to the next person who handles the waste.

The following persons are exempt from record keeping and manifest requirements:

Home generators of infectious waste; and
Owners and operators of sharps collection stations.

The following persons are exempt from the requirements to use infectious waste manifests, but shall follow the requirement for keeping records:

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.
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.
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.

The infectious waste manifest form shall include all of the following information:

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.
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.
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.
The composition of the infectious waste, including the type or types of infectious waste.
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.
The signature of an authorized representative of each facility or licensed transporter handling the waste from generation through treatment.

Retention of Infectious Waste Manifests and Related Records

Infectious waste manifests and related records shall be retained as follows:

The infectious waste generator shall retain the original infectious waste manifest, and the certification of infectious waste treatment for at least 3 years after the waste has been treated, and provide the department copies of manifests upon request. If the 3year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action. Note: Hospitals, clinics and nursing homes should keep records for at least 5 years.
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 for at least 3 years.

Infectious Waste Annual Reports

An infectious waste generator who is either required to use manifests under or to submit progress reports on medical waste reduction shall submit an annual report to the department on a form supplied by the department and the annual filing fee for the report

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 a representative of each generator in the group.

Except as required, the annual report shall be submitted by March 1 foractivities performed during the preceding calendar year. The annual report shall contain the information on the department's form and shall be signed by the administrator or chief executive officer of the infectious waste generator.

Medical Waste Reduction Plan

Unless exempt, medical facilities are required to prepare a medical waste reduction plan and 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.

The medical waste generator must ensure the medical waste reduction plan is prepared property, annually assess the plan and results annually, update the plan at least every 5 years, and keep a copy of the current plan and have it available for DNR review upon request.

The plan must include training of employees in waste management policies, practices and procedures for medical and other wastes generated, and an audit of the medical facility's current solid waste management practices.

OSHA Regulations HERC OSHA State Page

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste. Wisconsin is one of 26 states covered entirely by the federal OSHA program. This program is operated by the Occupational Safety and Health Administration. OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training.