Fact Sheets

Potentially Infectious Medical Waste

A Summary of Regulatory Requirements

Storage/Transfer 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.

Do I need a Permit to accept PIMW for storage or transfer?

A storage operation is defined in the Act as the containment of waste, either on a temporary basis or for a period of years, in such a manner as not to constitute disposal. The Act also 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.

In order to accept PIMW, a storage and/or transfer facility must be permitted by the Illinois EPA Bureau of Land. Only PIMW that has been stored and packaged in accordance with the Act may be shipped to these facilities. Any hospital that treats, stores, or transfers only PIMW from its own activities or members of its medical staff does not need a permit. Any person conducting a PIMW treatment, storage, or transfer operation for PIMW generated by the person's own activities that are stored or transferred within the site where the PIMW is generated does not need a permit.

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.

How should PIMW be segregated & packaged before I can accept it?

Before medical waste can be accepted for storage/transfer, the potentially infectious medical waste (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, 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?

PIMW packages which can be accepted for storage/transfer must be 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 must transporters have to bring PIMW to my facility?

Transporters of PIMW are required to have:

1. A permit issued by the Illinois Environmental Protection Agency (Illinois EPA) to transport PIMW;
2. A completed PIMW manifest for the waste if a manifest is required;
3. Paid the PIMW transportation fee (3 cents per pound); and
4. The PIMW packaged and labeled properly prior to transporting it.

Exemptions:
A person can transport PIMW without a hauling permit or manifest if:

1. The PIMW was generated solely by that person's activities;
2. There is less than 50 pounds of PIMW being transported non-commercially in a vehicle at any one time; or
3. The transporter is the U.S. Postal Service.

How must PIMW be transported to my facility?

Transporters are required to obtain a hauling permit to haul PIMW EXCEPT:

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.

Persons required to have a PIMW Hauling Permit must transport PIMW:

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.

How must PIMW be stored at my facility?

Any person who stores PIMW 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.

What fees are required for PIMW?

It is the transporter's responsibility to carry a completed PIMW manifest. The manifest must be in a form prescribed and provided by the Illinois EPA. The Illinois EPA assesses a fee of $2.00 for each PIMW manifest, payable by the transporter.

A 1.5 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/transfer site or treatment facility where the fee has not been previously paid by a transporter.

Transporters who are exempt from obtaining a hauling permit are also exempt from carrying a manifest.

There is no fee for a storage/transfer facility permit application.

Operation Requirements for Storage/ Transfer Facilities

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/transfer 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 facility 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.

What records and reports does a storage/transfer facility need to complete for PIMW?

Manifests:
Manifests are required for the transport of PIMW (except for the exemptions described above). Storage/transfer facilities will be required to retain a copy of these manifests for 3 years and must make them available for inspection and copying by Illinois EPA.

Annual Reports:
All facilities permitted to store or transfer PIMW or those un-permitted facilities which treat more than 50 pounds per month of PIMW must file an annual report with Illinois EPA by March 31 specifying the quantities and disposition of PIMW transported, stored, treated, disposed, or transferred during the previous calendar year. Such reports must be on forms prescribed and provided by Illinois EPA.