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Illinois

Regulated
Medical Waste

Background Information
Waste Categories
Managing Potentially Infectious Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts

 


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.

Waste Categories

Illinois classifies solid wastes into two main categories: nonspecial waste and special waste. Special wastes are further divided into four subcategories. Below is a summary of the categorization scheme.

Nonspecial Waste. Nonspecial wastes are generally not as harmful to people or the environment, so they are not regulated as special waste. Nonspecial wastes include garbage and commercial waste. These types of wastes are generally associated with offices, homes and restaurants, but also include clean packaging, landscape waste, clean machinery components and construction or demolition debris.

Special Waste. Special waste includes potentially infectious medical waste (PIMW), industrial process waste, pollution control waste and hazardous waste. Because the mismanagement of these wastes may cause serious health or environmental problems, special waste may be regulated under one or more sets of regulations in addition to the regulations for nonspecial waste. Special permitting requirements may also apply.

  • Potentially infectious medical waste (PIMW) - includes most medical waste generated by health care professionals or medical research that may be infectious to humans. It does not include medical waste generated at a household.
  • Industrial process waste - includes waste generated by industry or commercial services such as gas stations or painting contractors. Industrial process waste does not include clean packaging materials, office or food waste.
  • Pollution control waste - is generated by the treatment or cleanup of other wastes. Treatment residues from wastewater treatment, air scrubbing and spill cleanups are all pollution control waste.
  • Hazardous waste - is the most highly regulated category of waste. Some wastes are hazardous because of their ignitable, corrosive, reactive or toxic properties. These are called characteristically hazardous wastes. In other instances, U.S.EPA has decided that the waste produced by certain industrial activities will always be a hazardous waste. These are called listed hazardous wastes.

Definition of Potentially Infectious Medical Waste (PIMW)

Potentially Infectious Medical Waste (PIMW) is waste generated in connection with the diagnosis, treatment (i.e., provision of medical services), or immunization of human beings or animals; research pertaining to the provision of medical services; or the provision or testing of biologicals.

Managing Potentially Infectious Medical Waste

Segregation. Generators must segregate potentially infectious medical waste (PIMW) as follows:

  • Sharps,
  • Oversized PIMW, and
  • All other PIMW.

PIMW mixed with other waste is regulated as PIMW.

Packaging. PIMW, except for oversized PIMW, must be placed in a container, or a combination of containers. Such container must be:

  • rigid;
  • leak-resistant;
  • impervious to moisture;
  • of a strength sufficient to prevent tearing or bursting under normal conditions of use and handling; and
  • sealed to prevent leakage during transport

Sharps, unless rendered unrecognizable, must be packaged in a container, or a combination of containers, that is puncture-resistant.

Oversized PIMW must be covered or packaged in a manner that minimizes contact with transport workers and the public. Sharps must not be packaged with oversized PIMW in the same container.

If the outside of a container is contaminated by PIMW, a person must place the container inside another container, or clean and disinfect the container.

Once a reusable container has been cleaned and disinfected, it can be used for only waste. If a reusable container is not or cannot be cleaned and disinfected, it must be regulated as PIMW pursuant to this Subtitle.

PIMW packages must not be compacted or subjected to stress that compromises the integrity of the container.

Labeling. The following rules apply to healthcare facilities who package PIMW for off-site transportation.

The generator must mark the exterior of the outer package as follows prior to shipment:

  • Mark on two opposite sides of the outer package in lettering that is readable at a minimum distance of five (5) feet:
    • The International Biohazard Symbol as shown in Illustration A of this Part and the word "Biohazard"; and
    • The word "sharps", if the package contains sharps.
  • Mark with indelible ink in lettering that is legible on a water-resistant label or tag securely attached to or marked on the outer package:
    • The generator's name,
    • The generator's address, and
    • The generator's phone number (a 24-hour phone number, if available).

The transporter shall mark with indelible ink in lettering that is legible on a water-resistant label or tag securely attached to or marked on the outer package:

  • The transporter's name,
  • The transporter's permit number,
  • The transporter's address,
  • The transporter's phone number (a 24-hour phone number, if available), and
  • For each PIMW package, the shipment date when PIMW initially left the generator's site; or for each shipment, a unique identification number which directly corresponds to the initial date of shipment.

If a sharps container is packaged within an outer container, the inner sharps container must be marked with indelible ink in lettering that is legible as follows:

  • The International Biohazard Symbol as shown in Illustration A of this Part and the word "biohazard"; and
  • The word "sharps".

Containers which are not the inner or outer containers are exempt from the labeling requirements. Packages may be placed in a transparent container provided that all required markings are legible through the transparent container. A non-rigid transparent container cannot be used as an outer container.

For oversized PIMW, the following requirements must be met prior to shipment.

  • The generator must mark on one side of the outer package in lettering that is readable at a minimum distance of five (5) feet the International Biohazard Symbol as shown in Illustration A of this Part and the word "biohazard".
  • The generator must mark with indelible ink in lettering that is legible on a water-resistant label or tag securely attached to or marked on the outer package:
    • The generator's name,
    • The generator's address, and
    • The generator's phone number (a 24-hour phone number, if available).

The transporter must mark with indelible ink in lettering that is legible on a water-resistant label or tag securely attached to or marked on the outer package:

  • The transporter's name,
  • The transporter's permit number,
  • The transporter's address,
  • The transporter's phone number (a 24-hour phone number, if available), and
  • For each PIMW package, the shipment date when PIMW initially left the generator's site; or for each shipment, a unique identification number which directly corresponds to the initial date of shipment.

Storage. The following rules are applicable to on-site storage of PIMW at healthcare facilities. The storage requirements include:

  • Store the PIMW in a manner and location that maintains the integrity of the packaging and provides protection from water, rain, and wind.
  • Maintain the PIMW in a nonputrescent state, using refrigeration when necessary.
  • Limit access to on-site storage areas to authorized employees.
  • Store the PIMW in a manner that affords protection from animals and does not provide a breeding place or food source for vectors.
  • Multiple generators in the same building may store their PIMW packages in a common storage area.
  • Reusable PIMW containers or facility equipment (e.g., carts, squeegees or shovels) which are visually contaminated with PIMW must be cleaned in a designated area.

Transportation. PIMW can only be transported by a licensed PIMW hauler to a permitted transfer, storage, or treatment facility. Once the PIMW has been treated and the sharps have been packaged properly, it can be placed in a landfill.

A special manifest must accompany all PIMW shipments coming into Illinois, within Illinois, and from Illinois to states not providing their own manifests. The cost is $4.00 per manifest and must be paid by check, cashier’s check, or money order made payable to Treasurer, State of Illinois. Any questions should be directed to 217/782-9293 or 217/785-8604. A manifest request form can be found below under “More information”. Allow 2 weeks for processing.

Treatment

Treatment facilities are those facilities designed and operated to treat PIMW to eliminate its infectious potential. Hospitals which treat only their own PIMW or that of their medical staff are not required to be permitted by the Illinois EPA. Treatment of PIMW must be conducted in a manner that:

  • Eliminates the infectious potential of the waste. A treatment process eliminates the infectious potential of PIMW if the manufacturer/owner/operator demonstrates that an Initial Efficacy Test (IET) and Periodic Verification Test (PVT) have been completed successfully. Refer to Sections 1422.124 and 1422.125 of the Act or the Fact Sheet on Testing Requirements for details on these tests.
  • Prevents compaction and rupture of containers during handling operations, except when this is an integral part of the treatment process;
  • Disposes of treatment residuals in accordance with all applicable regulations;
  • Provides for quality assurance programs that must include a written plan;
  • Provides for periodic testing using biological testing;
  • Provides for assurances that clearly demonstrate that PIMW has been properly treated; and is in compliance with all Federal and State laws and regulations pertaining to environmental protection.

Disposal

Untreated medical waste cannot be disposed of into any landfill. Untreated PIMW is banned from all landfills in Illinois. Once PIMW has been properly treated to eliminate its infectious potential, it is no longer PIMW (except in the case of sharps) and may be disposed of into any landfill permitted by the Illinois EPA to accept municipal waste. For sharps, both the infectious nature must be eliminated and the sharps must either be rendered unrecognizable or packaged in accordance with the regulations prior to disposal.

OSHA Regulations

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. Illinois 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. These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

Statutes, Regulations and Guidelines

Title 35, Part 1420 - Potentially Infectious Medical Waste - General Provisions

Title 35, Part 1421 - Potentially Infectious Medical Waste - Activity Standards

Title 35, Part 1422 - Potentially Infectious Medical Waste - Design and Operation of Facilities

Contacts

For additional information, contact Beverly Albarracin at 217/524-3289.

More Information

PIMW Fact Sheet

PIMW Fact Sheet: General Requirements

PIMW Fact Sheet: Hospitals

PIMW Fact Sheet: Landfills

PIMW Fact Sheet: Storage

PIMW Fact Sheet: Testing

PIMW Fact Sheet: Transporters

PIMW Fact Sheet: Treatment Facilities

PIMW: Manifest Request Form