Hospitals and 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) 524-3299.

Hospitals should separate their waste as follows:

1. General refuse (e.g., paper generated by administrative support) should be handled as non-hazardous municipal waste.
2. Non-hazardous special waste (e.g., chemotherapy waste, pharmaceutical waste, incineration ash) must be handled in accordance with 35 Illinois Adm. Code, Section 807.210 and Part 809.
3. Hazardous waste (e.g., laboratory wastes, print shop wastes, maintenance shop wastes) is regulated by the Resource Conservation and Recovery Act (RCRA) and must be handled in accordance with 35 Illinois Adm. Code, Parts 700-750.
4. Radioactive material must be managed in accordance with a hospital's radioactive material license issued pursuant to 32 Illinois Adm. Code.
5. Potentially Infectious Medical Waste (PIMW) must be managed in accordance with the Act and 35 Illinois Adm. Code Subtitle M. Hospitals must segregate their PIMW into 3 categories: (1) sharps, (2) oversized, and (3) all other PIMW.

In cases where these wastes are mixed, the whole lot must be managed in accordance with the regulations for each waste type.

All PIMW which is to be shipped OFF-SITE, except for oversized PIMW, must be placed 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 during transport. In addition to the requirements listed above, 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.

Hospitals which package PIMW for off-site transportation 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 hospital must securely attach a water-resistant label or tag to each package and write in indelible ink: (1) hospital's name, (2) hospital's address, and (3) hospital's phone number (24-hour number, if available).

Inner packages must be marked with the word 'BIOHAZARD', the word 'SHARPS' if they contain sharps, and the International Biohazard Symbol.

Hospitals which store PIMW prior to treatment on-site or transport off-site 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.

Multiple generators in the same building may store their PIMW in a common storage area, and must comply with the above standards.

Haulers of PIMW are required to have:

1. A permit issued by the Illinois Environmental Protection Agency (Illinois EPA) to transport PIMW, if required;
2. A completed PIMW manifest for the waste if a manifest is required;
3. Paid the PIMW transportation fee (1.5 cents per pound), if required; and
4. The PIMW packaged and labeled properly prior to transporting it.

Exemptions:

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

1. The person is transporting PIMW generated solely by that person's activities, if the PIMW is transported within or between sites or facilities owned, controlled, or operated by that person;
2. The person is transporting less than 50 pounds of PIMW at any one time non-commercially; or
3. The transporter is the U.S. Postal Service.

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.

PIMW facilities must receive a permit from the Illinois EPA Bureau of Land to treat, store, or transfer PIMW from off-site. Only PIMW that has been stored and packaged in accordance with the Act and regulations promulgated thereunder may be shipped to these facilities. A hospital can accept PIMW from members of its medical staff without a permit provided it has been properly packaged.

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.

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.

Treatment of PIMW must be conducted in a manner that:

1. 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 of these tests.
2. prevents compaction and rupture of containers during handling operations, except when this is an integral part of the treatment process;
3. disposes of treatment residuals in accordance with all applicable regulations;
4. provides for quality assurance programs that must include a written plan;
5. provides for periodic testing using biological testing;
6. provides for assurances that clearly demonstrate that PIMW has been properly treated; and
7. is in compliance with all Federal and State laws and regulations pertaining to environmental protection.

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 governments or sanitary districts may have requirements that are more stringent 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 landfill.

Hospitals which treat their own waste must comply with the treatment unit standards. A treatment unit must be:

1. Designed and operated to eliminate the infectious potential of PIMW as demonstrated by the IET and PVTs;
2. Operated according to the manufacturer's instructions, if commercially available;
3. Operated day-to-day under the same conditions, including feed rate, used to demonstrate the elimination of the infectious potential;
4. Designed and operated to limit the emission of microorganisms into the air.

A treatment unit may be used by a hospital which is not required to have a treatment permit if one of the following is met:

1. The manufacturer and hospital meet all the testing requirements, as defined in the regulations. Proof that these requirements have been met must be kept on file and made available to the Agency upon request.
2. The hospital applies for a voluntary permit.
3. The hospital or manufacturer obtains an adjusted standard from the Illinois Pollution Control Board (IPCB).

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 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.

A hospital incinerator requires a permit from the Illinois EPA Bureau of Air to burn its own waste and that of its medical staff. If the hospital accepts any off-site waste from a person who is not a member of its medical staff, then a permit from the Illinois EPA Bureau of Land will be required. Incinerators must meet all testing requirements as described in 35 Illinois Adm. Code: Subtitle M, even if no Bureau of Land permit is required.

Ash resulting from the incineration of PIMW is categorized 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.

Hospital autoclaves do not require a permit from Illinois EPA for the treatment of PIMW generated on-site or by members of its medical staff. If the hospital accepts any off-site waste from a person who is not a member of its medical staff, then a permit from the Illinois EPA Bureau of Land will be required. Autoclaves must meet all testing requirements as described in 35 Illinois Adm. Code: Subtitle M, even if no Bureau of Land permit is required.

Manifests:

Manifests are required for the transport of PIMW (except for the exemptions described above). Transporters of PIMW initiate the manifests and a copy is given to the generator. Hospitals 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:

Hospitals 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.