TITLE 35: ENVIRONMENTAL PROTECTION
SUBTITLE M: BIOLOGICAL MATERIALS
CHAPTER I: POLLUTION CONTROL BOARD
SUBCHAPTER b: POTENTIALLY INFECTIOUS MEDICAL WASTES
PART 1422 DESIGN AND OPERATION OF FACILITIES
SECTION 1422.122 DESIGN AND OPERATING STANDARDS
Section 1422.122 Design and Operating Standards
a) 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 owner or operator of a treatment unit demonstrates that an Initial Efficacy Test and Periodic Verification Test have been completed successfully.
A) Successful completion of an Initial Efficacy Test must be demonstrated by a 6-log kill of test microorganisms. For a thermal unit that maintains the integrity of the container, a 6-log kill of indicator microorganism spores may be used as an alternative test. These demonstrations must be conducted in accordance with Section 1422.124.
B) Successful completion of a Periodic Verification Test must be demonstrated, in accordance with Section 1422.125, by:
i) a 6-log kill of test microorganisms or indicator microorganism spores as provided in subsection (a)(1)(A) above; or
ii) a minimum 3-log kill of indicator microorganism spores that has been correlated with a 6-log kill of test microorganisms; or
iii) an alternate method submitted to and approved in writing by the Agency.
2) Prevents the compaction and rupture of containers during handling operations, except when compaction or rupture is an integral part of the treatment process and the treatment process is conducted without discharge of PIMW to the environment;
3) Disposes of treatment residuals in accordance with this Act and regulations adopted thereunder;
4) Provides for quality assurance programs that must include, at a minimum, a written plan that:
A) Designates responsibility to personnel;
B) Describes operating parameters that must be monitored to insure effectiveness of the treatment process;
C) Identifies monitoring devices;
D) Insures monitoring devices are operating properly;
E) Establishes appropriate ranges for all operating parameters;
F) Identifies the person(s) who shall collect and organize data for inclusion in the operating record;
G) Identifies the person(s) who shall evaluate any discrepancies or problems;
H) Identifies the person(s) who shall propose actions to correct any problems identified; and
I) Identifies the person(s) who shall assess actions taken and document improvement;
5) Provides for periodic testing using biological testing, where appropriate, that demonstrate proper treatment of the waste;
6) Provides for assurances that clearly demonstrate that potentially infectious medical waste has been properly treated; and
7) Is in compliance with all Federal and State laws and regulations pertaining to environmental protection. (Section 56.2(a)(1)-(7) of the Act)
b) In addition to the requirements in subsection (a) of this Section:
1) Residues from cleaning a PIMW contaminated container, equipment or work surface are regulated under this Subtitle, except when directly discharged into a sanitary or combined sewer in accordance with 35 Ill. Adm. Code: Subtitle C.
BOARD NOTE: Interested persons should note that discharges to sewer systems can also be regulated by units of local government.
2) Ash resulting from the incineration of PIMW is an industrial process waste, as defined in Section 3.17 of the Act, and must be managed as a special waste in accordance with 35 Ill. Adm. Code 807 and 809.
3) Copies of PIMW manifests required by 35 Ill. Adm. Code 1420.105 of this Subtitle must be retained by and kept at the treatment facility for three (3) years and must be made available at the treatment facility during normal business hours for inspection and photocopying by the Agency. The retention period for PIMW manifests is extended automatically during the course of any unresolved enforcement action regarding the treatment facility or as requested in writing by the Agency.
4) Commencing March 31, 1993, and annually thereafter, each treatment facility for which a permit is required pursuant to 35 Ill. Adm. Code 1420.105 of this Subtitle and each facility not required to have a permit pursuant to Section 1420.105 of this Subtitle that treats more than 50 pounds per month of potentially infectious medical waste shall file a report with the agency specifying the quantities and disposition of potentially infectious medical waste treated during the previous calendar year. Such reports shall be on forms prescribed and provided by the Agency. (Section 56.3 of the Act)
5) Upon closure of a treatment facility, the owner or operator shall clean the area, equipment and structures in accordance with 35 Ill. Adm. Code 1420.107 of this Subtitle.
c) In addition to the requirements listed in subsections (a) and (b) of this Section, owners or operators of treatment facilities required to have a permit pursuant to 35 Ill. Adm. Code 1420.105 of this Subtitle shall also comply with the following requirements that the Agency shall review during the permitting process:
1) Amounts of PIMW received must be weighed in pounds with a device for which certification has been obtained under the Weights and Measures Act (Ill. Rev. Stat. 1991, ch. 147, pars. 101 et seq.). [225 ILCS 470]
2) Signs identifying that the facility treats PIMW must be prominently displayed at the points of access to the treatment area. Signs must be marked in lettering that is readable at a minimum distance of five (5) feet. At a minimum, the signs must display the International Biohazard Symbol as shown in 35 Ill. Adm. Code 1421.Illustration A and the word "biohazard".
3) Personnel training must be provided to all staff prior to the handling of PIMW. Annual personnel training must include, at a minimum, a thorough explanation of the operating procedures to be taken during normal and emergency situations. The owner or operator shall keep records verifying training of personnel.
4) Treatment facilities must have a written contingency plan and the applicable sections must be implemented in the event of a discharge, equipment failure or personal injury. The contingency plan must describe the actions that personnel shall take in response to emergency situations such as, but not limited to, personal injury, discharges of PIMW and equipment failure. This contingency plan must, at a minimum, include a list of all emergency equipment at the treatment facility, an up-to-date list of names, addresses and phone numbers (office and home) of all persons qualified to act as emergency coordinator, procedures for cleanup, protection of personnel, disposal of spill residue and alternative arrangements for PIMW treatment. A copy of the contingency plan must be maintained at the treatment facility. Emergency phone numbers and a brief description of the emergency procedures must be posted at the treatment facility.
5) The owner or operator shall keep a written operating record at the treatment facility. At a minimum, the following information must be recorded and maintained in the operating record:
A) Quantities and disposition of PIMW treated;
B) Date and time the PIMW arrived at the permitted PIMW site;
C) Date and time the PIMW was treated;
D) The operating parameters of the treatment unit (e.g., temperature, pressure, residence time, chemical concentration, irradiation dose);
E) Date and time the PIMW left the treatment facility;
F) Generator name(s), location(s) and, if applicable, the generator identification number(s) issued by the Agency for each PIMW load received at the treatment facility;
G) The destination of the treated waste which must include, at a minimum, the name of the receiving facility, the location of the receiving facility, the identification number of the receiving facility issued by the Agency (if applicable) and the disposition; and
H) In a separate log, the date, time, nature and extent of all discharges and personal injuries and the date, time, nature and result of any response(s) taken.
6) The records required by subsections (c)(3) and (c)(5) of this Section must be retained by and kept at the treatment facility and must be made available at the treatment facility during normal business hours for inspection and photocopying by the Agency. These records must be kept until closure of the treatment facility. The retention period is extended automatically during the course of any unresolved enforcement action regarding the treatment facility or as requested in writing by the Agency.
7) At least sixty (60) days prior to closing a treatment facility, the owner or operator shall notify the Agency of the planned closure. Within ninety (90) days after the date the final load of PIMW is received at the treatment facility, the owner or operator shall certify to the Agency that final closure has been completed in accordance with the permit, the Act and all applicable regulations promulgated thereunder.