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)        Demonstrate successful completion of an Initial Efficacy Test 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 comply with Section 1422.124.

 

B)        Successful completion of a Periodic Verification Test must comply with Section 1422.125, and may be demonstrated 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 approved in writing by the Agency.

 

2)         Prevents 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 the Act and Board regulations;

 

4)         Provides for quality assurance programs that must include a written plan that:

 

A)        Designates responsibility to personnel;

 

B)        Describes operating parameters that must be monitored to ensure effectiveness of the treatment process;

 

C)        Identifies monitoring devices;

 

D)        Ensures monitoring devices are operating properly;

 

E)        Establishes appropriate ranges for all operating parameters;

 

F)         Identifies the person or persons who must collect and organize data for inclusion in the operating record;

 

G)        Identifies the person or persons who must evaluate any discrepancies or problems;

 

H)        Identifies the person or persons who must propose actions to correct any problems identified; and

 

I)         Identifies the person or persons who must 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 PIMW 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) through (7) of the Act)

 

b)         In addition to the requirements in subsection (a):

 

1)         Manage residues from cleaning a PIMW contaminated container, equipment, or work surface under this Subtitle, except when directly discharged into a sanitary or combined sewer in compliance with 35 Ill. Adm. Code Subtitle C.

 

BOARD NOTE:  Interested persons should note that local government units can regulate discharges to sewer systems.

 

2)         Manage ash resulting from the incineration of PIMW as a special waste in compliance with 35 Ill. Adm. Code 807 and 809 because it is an industrial process waste, as defined in Section 3.235 of the Act.

 

3)         Retain copies of PIMW manifests required by 35 Ill. Adm. Code 1420.105 at the treatment facility for three years and make them 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 any unresolved enforcement action regarding the treatment facility or as requested in writing by the Agency.

 

4)         Each treatment facility for which a permit is required by 35 Ill. Adm. Code 1420.105 shall annually file the report required by this subsection (b)(4).  Additionally, each facility not required to have a permit under 35 Ill. Adm. Code 1420.105 that treats more than 50 pounds per month of PIMW  shall file the report.  The report shall be filed with the Agency  specifying the quantities and disposition of PIMW treated during the previous calendar year.  These reports shall be on forms prescribed and provided by the Agency.  (Section 56.3 of the Act)

 

5)         Upon closure of a treatment facility, clean the area, equipment, and structures in compliance with 35 Ill. Adm. Code 1420.107.

 

c)         In addition to the requirements listed in subsections (a) and (b), the owners or operators of PIMW treatment facilities required to have a permit by 35 Ill. Adm. Code 1420.105 must also comply with the following requirements that the Agency will review during the permitting process:

 

1)         Weigh amounts of PIMW received in pounds with a device for which certification has been obtained under the Weights and Measures Act.

 

2)         Prominently display signs identifying that the facility treats PIMW at the points of access to the treatment area.  The signs must:

 

A)        Display the International Biohazard Symbol as shown in 35 Ill. Adm. Code 1421.Illustration A and the word "Biohazard"; and

 

B)        Be marked in lettering that is readable at a minimum distance of five feet.

 

3)         Provide personnel training to all staff annually, and prior to the handling of PIMW, that includes a thorough explanation of the operating procedures to be taken during normal and emergency situations.  The owner or operator must keep records verifying training of personnel.

 

4)         Have a written contingency plan and implement the applicable sections of that plan if there is equipment failure, injury, or a discharge of PIMW. 

 

A)        The contingency plan must:

 

i)          Describe the actions to be taken by personnel in response to emergency situations such as injury, discharges of PIMW, and equipment failure; and

 

ii)         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; and

 

B)        The treatment facility must keep a copy of the contingency plan and must post emergency phone numbers and a brief description of the emergency procedures.

 

5)         Keep a written operating record that includes the following information:

 

A)        Quantities and disposition of PIMW treated;

 

B)        Date and time PIMW arrived at the permitted PIMW site;

 

C)        Date and time 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 names, location or locations, and, if applicable, the generator identification numbers issued by the Agency for each PIMW load received at the treatment facility;

 

G)        The destination of the treated waste, 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)        A separate log, with the date, time, nature, and extent of all discharges and injuries, and with the date, time, nature, and result of any responses taken.

 

6)         Retain the following records:

 

A)        The records required by subsections (c)(3) and (c)(5) must be:

 

i)          Kept at the treatment facility until closure of the treatment facility; and

 

ii)         Made available at the treatment facility during normal business hours for inspection and photocopying by the Agency. 

 

B)        The retention period in subsection (c)(6)(A) is extended automatically during any unresolved enforcement action involving the treatment facility or at the written request of  the Agency.

 

7)         For a planned closure:

 

A)        Notify the Agency of the planned closure at least 60 days prior to closing a treatment facility; and

 

B)        Certify to the Agency that final closure has been completed in compliance with the permit, the Act, and all applicable regulations promulgated under the Act within 90 days after the date the final load of PIMW is received at the storage operation.

 

(Source:  Amended at 43 Ill. Reg. 10072, effective August 30, 2019)