Pat Quinn, Governor
Potentially Infectious Medical Waste
A Summary of Regulatory Requirements
Treatment Facilities Requirements
Title XV of the Illinois Environmental Protection Act (Act) establishes statutory requirements to ensure that Potentially Infectious Medical Waste (PIMW) will be handled in a safe and responsible manner. On June 17, 1993, the Illinois Pollution Control Board (Board), in accordance with Title VII of the Act, adopted regulations prescribing the standards and criteria for the handling of PIMW. These regulations became effective June 21, 1993. The requirements found in the Act and the Board’s regulations are intended to reduce the occupational and environmental health risks that occur during the storage, treatment, transport, transfer, and disposal of PIMW.
The information presented in this fact sheet does not eliminate any person’s responsibility to fulfill any legal obligation under the Act or regulations promulgated thereunder.
The purpose of this fact sheet is to provide some of the PIMW requirements, found in both the Act and the Board’s regulations. For the complete requirements, please see Title XV of the Act and 35 Illinois Administrative Code (Ill. Adm. Code): Subtitle M.
For additional information on PIMW regulations in Illinois, contact the PIMW Coordinator at the Illinois Environmental Protection Agency; Bureau of Land #33; 1021 North Grand Avenue East; P.O. Box 19276; Springfield, Illinois 62794-9276, or call (217) 524-3289.
What is a Treatment Facility and do I need a permit?
Treatment facilities are those designed and operated to treat potentially infectious medical waste (PIMW) to eliminate its infectious potential. This includes facilities designed and operated to treat PIMW commercially and those facilities which treat only their own PIMW.
Any treatment facility designed and operated to eliminate the infectious potential of PIMW will require a permit EXCEPT:
Please refer to Sections 1422.105, 1422.106, and 1422.107 of Subtitle M for details concerning permit applications, including documentation required and certifications necessary. Permit applications may be obtained from the Illinois EPA.
For treatment facilities required to have a permit, the permit application must include the following information regarding the treatment unit:
How should PIMW be segregated and packaged?
Before medical waste can be accepted for off-site treatment, the PIMW must be packaged in accordance with the regulations. First, generators must separate the PIMW into the following groups: (1) sharps, (2) oversized, and (3) all other PIMW. Next, the segregated PIMW should be packaged in containers that are: (1) rigid, (2) leak-resistant, (3) impervious to moisture, (4) of sufficient strength to prevent tearing or bursting under normal conditions of use and handling, and (5) sealed to prevent leakage. In addition to the above requirements, the sharps containers must also be puncture-resistant. Oversized PIMW must be covered or packaged so that contact with transport workers and the public is minimized. Sharps may not be packaged with oversized PIMW.
How should PIMW packages be labeled?
Facilities which accept PIMW packages from off-site should make sure that the PIMW packages are labeled as follows:
The generator must mark on two opposite sides of the exterior of the PIMW package (on one side of oversized PIMW), in lettering that is readable at a minimum distance of five feet: (1) the word 'BIOHAZARD', (2) the word 'Sharps' if the package contains sharps, and (3) the International Biohazard Symbol.
In addition, the generator must securely attach a water-resistant label or tag to each package and write in indelible ink: (1) Generator's name, (2) Generator's address, and (3) Generator's phone number (24-hour number, if available).
The transporter must also affix a label to each package in the same manner: (1) Transporter's name, (2) Transporter's permit number, (3) Transporter's address, (4) Transporter's phone number (24-hour number, if available), and (5) For each package, the date when PIMW initially left the generator's site, or a unique ID number giving that information. When there is more than one transporter, each transporter must label each PIMW package in this manner. Tags must not obscure any previous information on the package.
Inner packages must be marked with the word 'BIOHAZARD', the word 'SHARPS' if they contain sharps, and the International Biohazard Symbol.
What should a transporter have to bring PIMW to my facility?
Transporters of PIMW are required to have:
How should I store PIMW before treatment?
Any person who stores PIMW prior to treatment must comply with the following:
In addition, facilities which are required to have a storage/transfer permit must comply with the following:
Are there standards for treating PIMW?
Treatment of PIMW must be conducted in a manner that:
In addition, those treatment facilities required to have a permit must comply with the following:
How should I handle treatment or cleaning residues?
Treatment residuals must be disposed of in accordance with all applicable regulations.
Residues from cleaning and disinfecting anything contaminated with PIMW are regulated as PIMW, except when discharged directly into a sanitary or combined sewer in accordance with 35 Illinois Adm. Code: Subtitle C (Water Pollution Control). Please note: Local government or sanitary districts may have requirements that are more restrictive than these regulations. The generator of any residue is responsible for checking with the local sanitary district before disposing of any liquid PIMW into the sewer system. Solids are prohibited from disposal into any sewer system.
Residues which have been treated as PIMW in accordance with these regulations are no longer considered PIMW and may go to any municipal landfill, EXCEPT:
Are there standards for my treatment unit?
All treatment units must be:
A treatment unit may be used by a treatment facility not required to have a permit under Subtitle M if one of the following is met:
Effectiveness of a treatment unit is proven by performing periodic biological testing, as described in Sections 1422.124 and 1422.125 of 35 Illinois Adm. Code: Subtitle M. All treatment units must perform these periodic tests, even treatment units for small generators. Results of these tests must be kept on file at the facility and made available to the Illinois EPA upon request. Details of the testing requirements may be found in the regulations or in the Illinois EPA Fact Sheet on Testing Requirements.
Autoclaves, incinerators, and ethylene oxide units installed or operated prior to June 21, 1993 are not required to perform an IET. The first PVT must be performed by September 21, 1993 to demonstrate that the infectious potential has been eliminated.
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. A treatment facility must certify to the transporter, if other than the generator, and certify to the landfill operator or receiving facility operator that the PIMW has been treated in accordance with 35 Illinois Adm. Code 1422 and, if applicable, with all terms and conditions specified in its operating permit. Data verifying the efficacy of the treatment unit must be made available to the receiving facility upon request of the receiving facility.
PIMW treated by Incineration
Waste incinerators require a permit from the Illinois EPA Bureau of Air. If the incinerator owner/operator accepts any waste from an off-site person or facility, then a permit from the Illinois EPA Bureau of Land will be required. Incinerators must meet all testing requirements as described in the regulations, even if no Bureau of Land permit is required.
Ash resulting from the incineration of PIMW is classified as an industrial process waste, and therefore must be managed as a special waste. Special waste requires a special waste manifest, must be transported by a permitted special waste hauler, and can only be disposed of into landfills permitted to accept special waste. Details of the management of special waste may be found in Section 3.45 of the Act or in the Illinois EPA Fact Sheet on Non-Special Waste Certification.
PIMW treated by Autoclaving
Autoclaves will not require a permit from Illinois EPA for the treatment of PIMW generated at the site. If the owner/operator accepts any waste from an off-site person or facility, then a permit from the Illinois EPA Bureau of Land will be required. Autoclaves must meet all testing requirements as described in the regulations, even if no Bureau of Land permit is required.
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