Transporters of Potentially Infectious Medical Waste

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 personal 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.

Potentially Infectious Medical Waste (PIMW) is waste generated in connection with:

1. The diagnosis, treatment (i.e., provision of medical services), or immunization of human beings or animals;
2. Research pertaining to the provision of medical services; or
3. The production or testing of biological agents.

Types of PIMW wastes are:

1. Cultures and stocks;
2. Human pathological wastes;
3. Human blood and blood products;
4. Used sharps;
5. Animal waste;
6. Isolation waste;
7. Unused sharps.

The following medical wastes are not regulated for transportation as PIMW:

1. Medical waste generated as general household waste;
2. PIMW (except for sharps) which has been treated properly to eliminate its infectious nature; and
3. Sharps which have been treated to eliminate their infectious nature and which have been rendered unrecognizable by treatment.

These medical wastes can be handled and transported as municipal wastes. Treated sharps, not generated in the home, that are recognizable are still PIMW. These sharps must be packaged and transported in accordance with the regulations as PIMW; treated and properly-packaged sharps may be taken to a landfill permitted by Illinois Environmental Protection Agency (Illinois EPA) to accept municipal waste.

Haulers of PIMW are required to have:

1. A permit issued by the Illinois EPA to transport PIMW (which is different from a special waste hauling permit);
2. A completed PIMW manifest for the waste;
3. Paid the 1.5 cents/pound PIMW transportation fee; and
4. The PIMW packaged and labeled properly.

Haulers are required to have a valid PIMW hauling permit to conduct any PIMW transportation operation, EXCEPT for:

1. A person transporting PIMW generated solely by that person's activities; or
2. Noncommercial transportation of less than 50 pounds of PIMW at any one time; or
3. The U.S. Postal Service.

Haulers may only transport PIMW to Illinois EPA-permitted facilities that are in compliance with the conditions of their permits to treat, store, and/or transfer PIMW.

The Act defines a transfer station as a site or facility that accepts waste for temporary storage or consolidation and further transfer to a waste disposal, treatment, or storage facility. A hauler who consolidates PIMW into larger trucks needs a transfer station permit, in addition to a hauling permit. Any off-site storage/transfer operation requires a permit EXCEPT:

1. Any person conducting a PIMW treatment, storage, or transfer operation for PIMW generated by the person's own activities that are treated, stored, or transferred within the site where the PIMW is generated; or
2. Any hospital that treats, stores, or transfers only PIMW generated by its own activities or by members of its medical staff.

Please refer to Sections 1422.105, 1422.106, and 1422.107 of Subtitle M for details concerning permit applications, including documentation required, filing fees, and certifications necessary. Permit applications may be obtained from the Illinois EPA.

The Illinois EPA collects a $2,000 fee annually for each PIMW hauling permit application and, in addition, collects a fee of $250 for each PIMW hauling vehicle (i.e., truck or trailer) identified in the annual permit application and for each vehicle that is added to the permit during the annual period. Each applicant should submit the fee and permit application to the Illinois EPA at the same time. Those applications without the appropriate fees attached will be rejected.

A. 3 cents per pound fee must be collected from:

1. A person required to have a PIMW hauling permit; or
2. A person transporting PIMW generated solely by that person's activities to a site or facility not owned, controlled, or operated by the transporter; or
3. An owner/operator of a PIMW storage site or treatment facility where the fee has not been previously paid by a transporter.

These fees are to be submitted quarterly, along with a quarterly report.

All fees collected by the Illinois EPA under the Act shall be deposited into the Environmental Protection Permit and Inspection Fund. The Illinois EPA shall not refund any of these fees paid into the fund.

Manifests are required to track PIMW haulers and the destination of the PIMW. Manifests are initiated by the hauler and consist of an original (the first page of the form) and 3 copies. Upon delivery of PIMW by a generator to a hauler, the hauler gives one copy of the completed manifest to the generator. Upon delivery of PIMW by a hauler to a receiving facility, the hauler keeps one copy of the completed manifest, and delivers the original and one copy of the completed manifest to the receiving facility. The receiving facility keeps one copy of the completed manifest and returns the original to the generator within 35 days. Copies of each manifest must be retained for 3 years by generators, haulers, and facilities, and must be made available for inspection and copying by the Illinois EPA.

The PIMW manifest forms are available from the Illinois EPA at a cost of $4.00 each.

There is no multi-stop collection of PIMW. A manifest is required for each pick-up of PIMW.

The following transportation standards apply to persons required to have a PIMW Hauling Permit. PIMW must be transported:

1. so that the effects of putrescence are minimized;
2. only in enclosed compartments of vehicles secured against public access (except for oversized PIMW);
3. with vehicles in good repair and cleaned of visible PIMW contamination after each use;
4. in a manner that prevents a breeding place or food source for vectors;
5. so that the integrity of the container is maintained; and
6. for less than or equal to 10 days.

The Transporter must:

1. display information in accordance with the PIMW hauling permit;
2. develop and keep an emergency response plan in the vehicle. This plan must identify the names and phone numbers of State and local authorities who must be contacted in the event of an emergency or discharge. In addition, each vehicle must carry all equipment necessary to provide a response.
3. not use a vehicle which transports PIMW for the hauling of non-waste materials, except for equipment and supplies intended for the use of waste management (i.e., plastic containers, corrugated boxes, plastic bags, etc.).

Before medical waste is transported, generators must package the PIMW in accordance with Subtitle M. First, generators must separate the PIMW into the following groups: (1) sharps, (2) oversized, and (3) all other PIMW. Next, the segregated PIMW must 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.

PIMW mixed with other waste is regulated under this Subtitle as PIMW and under any other applicable regulations.

For persons who package PIMW for off-site transportation or who accept PIMW packages from off-site:

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.

Any person who stores PIMW prior to treatment or disposal on-site or transport off-site, either permitted or un-permitted, must comply with the following:

1. Maintain the integrity of the packaging and provide protection from water, rain, and wind;
2. Maintain PIMW in a non-putrescent state, using refrigeration when necessary;
3. Lock the outdoor storage areas containing PIMW to prevent unauthorized access;
4. Limit access to on-site storage areas to authorized employees;
5. Store the PIMW in a manner that affords protection from animals and does not provide a breeding place or food source for vectors (i.e., insects and rodents);
6. Must not compact the PIMW packages or subject them to stress which compromises the integrity of the container;
7. Reusable PIMW containers or equipment which are visibly contaminated with PIMW must be cleaned in a designated area.

In addition to the above requirements, facilities which are required to have a storage/transfer permit must comply with the following:

1. PIMW must be weighed in pounds on a certified scale, unless previously weighed by the transporter;
2. PIMW must be stored in designated areas, so as not to contaminate other materials;
3. Cardboard packages must be elevated above the floor in an enclosed area;
4. PIMW must be stored on a surface that allows drainage and that minimizes exposure to workers and the public;
5. Adequate aisle space must be maintained between packages to allow inspection of at least one side of each package; labels must be readable. A vehicle containing PIMW is exempt from this requirement:
   • when loading or unloading, or
   • when the vehicle is fully loaded.
   Either or both of these exemptions must not exceed five days.
6. Signs must be posted at the points of access to the secured storage area. These signs must display the International Biohazard Symbol and the word 'BIOHAZARD' in lettering readable at five feet.
7. Annual personnel training must be provided to all staff prior to handling PIMW. Training must include a thorough explanation of operating procedures for daily and emergency situations. Records verifying personnel training must be kept.
8. Storage operations must have a written contingency plan which is to be implemented in the event of a discharge or personal injury. It must include a list of emergency equipment, names and phone numbers of persons qualified to act as emergency coordinator, and procedures for cleanup. A copy must be kept at the storage operation. Emergency phone numbers and a brief description of the emergency procedures must be posted at the operation.
9. A written operating record must be kept at the facility, including operating parameters, generator information, and quantities and disposition of PIMW.
10. These records (personnel training and written operating record) must be kept at the storage operation until closure. They must be made available to the Illinois EPA upon request.
11. Unless otherwise authorized by the Illinois EPA in the permit, PIMW must not be stored for more than:
    • 72 hours unless the surface temperature of the package is maintained at or below 45 degrees Fahrenheit, and
    • 30 days, regardless of the temperature.
12. At least 60 days before closure, the owner must notify the Illinois EPA. Within 90 days after the final load is received, the owner must certify to the Illinois EPA that closure has been completed in accordance with the permit and all applicable regulations.

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 Ill. 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:

1. ash from incineration, which must be managed as a "special waste";
2. liquids ONLY may be discharged to the sewer system in accordance with a water pollution permit and local sanitary district regulations;
3. sharps must be treated to eliminate the infectious potential and be unrecognizable or packaged in accordance with these regulations before they can be placed in landfills.

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 to the landfill operator or receiving facility operator that the PIMW has been treated in accordance with 35 Ill. 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.

Effectiveness of a treatment unit is proven by performing periodic biological testing, as described in 35 Ill. Adm. Code 1422.124 and 1422.125. 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 upon request. Details of the testing requirements may be found in the regulations or in the Illinois EPA Fact Sheet on Testing Requirements.

Ash resulting from the incineration of PIMW is classified as an "industrial process waste," and therefore shall be managed as a special waste. Special waste requires a manifest, 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 haulers must keep records of their shipments. Forms for keeping these records are available from the Illinois EPA and are provided at the time a permit is granted. Daily records should be kept at the haulers' offices. Quarterly reports must be turned in, along with transportation fees, to the Illinois EPA. An annual report must be filed by March 31 each year by haulers required to have a PIMW permit. The report must specify the quantities and disposition of PIMW transported during the previous calendar year. All reports must be on forms prescribed and provided by the Illinois EPA.