Section 320.5  Purpose and Scope

 

a)         This Part establishes the registration requirements for radiation installations pursuant to Section 24.7 of the Radiation Protection Act of 1990 [420 ILCS 40].

 

b)         This Part applies to all radiation installations that possess any radiation machines that electronically produce ionizing radiation.

 

(Source:  Added at 49 Ill. Reg. 406, effective December 27, 2024)

 

Section 320.10  Registration

 

a)         For purposes of registration pursuant to this Part, the following definitions shall apply:

 

1)         "Agency" means the Illinois Emergency Management Agency and Office of Homeland Security. [420 ILCS 40/4(a-2)]

 

2)         "Inoperable radiation machine" means any radiation machine, including particle accelerators, that is not capable of producing radiation due to the absence or failure of components necessary for operation.  Radiation machines that are not in operation due only to disconnection from an electrical supply shall be considered operable.

 

3)         "Minimal threat devices" means radiation machines capable of generating or emitting fields of radiation that, during the operation of which, an individual cannot accidently place a body part in the primary beam path and no deliberate exposure or physical injury to an individual has occurred in excess of the applicable limits specified in 32 Ill. Adm. Code 340.310(a).  Examples include, but are not limited to, analytical, cabinet, and baggage/package/project type fluoroscopic units; spectroscopy; facilities with x-ray machines that are incorporated in lead boxes or enclosed in a shielded room, that comply with the requirements of 32 Ill. Adm. Code 350.3050.

 

4)         "Particle accelerator" shall have the same meaning as provided in 32 Ill. Adm. Code 310.20.

 

5)         "Radiation installation" means any location or facility where radiation machines are used. [420 ILCS 40/4(g)]

 

6)         "Radiation machine" means any device that produces radiation when in use, except those that produce radiation only from radioactive materials. [420 ILCS 40/4(h)]

 

b)         Radiation Installation Registration

 

1)         Any operator of a radiation installation shall register that radiation installation with the Agency.  The operator shall register the radiation installation, before it is placed into operation, in a format prescribed by the Agency that shall include the:

 

A)        Operator and facility name;

 

B)        Location and confines of the radiation installation;

 

C)        Type, manufacturer, model, serial number, and room or area location of all radiation machines possessed; and

 

D)        Telephone number, email address, and Federal Employer Identification Number (FEIN).

 

2)         Radiation machines that are located in a single building or in a group of buildings that are contiguous to one another, and used by the same operator, shall be treated as a single radiation installation unless requested otherwise in writing by the operator and approved by the Agency.

 

3)         Until proper disposal occurs, all inoperable radiation machines shall be included in the registration information required by subsection (b)(1)(C).

 

4)         Out-of-State Radiation Machines.

 

A)        Any owner/operator of a radiation machine brought into the State of Illinois for temporary use, not to exceed 180 days in a calendar year, shall provide notice to the Agency at least three business days before the equipment is brought into the State. 

 

B)        The notice shall include the information in subsection (b)(1)(A) through (D) and: 

 

i)          Registering state and registration number of the facility, if applicable;

 

ii)         The exact location where the radiation machine is to be used;

 

iii)        Nature, duration, and scope of work; and

 

iv)        Onsite contact in the State including name, telephone number, and email address.

 

c)         Radiation Installation Classifications

Radiation installations shall be divided into the following 4 classes:

 

1)         Class A – Class A shall include dental offices and veterinary offices with radiation machines used solely for diagnosis; nonmedical business entities that possess open radiography radiation machines used by industrial radiographers or law enforcement personnel, other non-medical registered installations including research/development, academic, industrial, law enforcement, and all other minimal threat devices used in the process of conducting their business.  

 

2)         Class B − Class B shall include offices or clinics of persons licensed under the Medical Practice Act of 1987 [225 ILCS 60] or the Podiatric Medical Practice Act of 1987 [225 ILCS 100] with radiation machines used solely for diagnosis and all radiation installations using portable radiographic/fluoroscopic units and particle accelerators.

 

3)         Class C − Class C shall include installations using radiation machines which are unique and have potential radiation threat concerns whose operation or use may require the registrant to monitor in accordance with 32 Ill. Adm. Code 340.520.  This does not include radiation installations with radiation machines that are specified as another class. 

 

4)         Class D − Class D shall include all hospitals and other facilities using mammography, computed tomography (CT), or therapeutic radiation machines.

 

5)         Radiation installations for which more than one class is applicable shall be assigned a classification based on the radiation machines' use and associated radiation hazard.

 

d)         Registration Fees

 

1)         The operator of a radiation installation shall pay an annual registration fee for each radiation machine registered with the Agency on January 1 of each year. Operators of radiation installations shall annually update their registration no later than December 31 of each year with the status of each radiation machine in their possession.

 

2)         The Agency shall bill the operator for the registration fee as soon as practical after January 1.  The registration fee shall be due and payable within 60 days after the date of billing.  If after 60 days the registration fee is not paid, the Agency may issue an order directing the operator of the installation to cease use of all radiation machines or take other appropriate enforcement action as provided in Section 36 of the Act. Fees collected under this Section are not refundable. [420 ILCS 40/24.7] The fees, based on the classification of radiation installation and radiation machines possessed, are as follows:

 

Radiation Installation Classification	Fee Per Radiation Machine
Class A – Dental and veterinary offices.	$50
Class A – Radiation installations using minimal threat devices and open radiography machines used by industrial radiographers or law enforcement personnel.	$75
Class B – Offices or clinics of persons licensed under the Medical Practice Act, and all radiation installations using portable radiographic/ fluoroscopic units or particle accelerators.	$175
Class B – Podiatric offices.	$100
Class C –	$250
Class D –	$100

 

e)         All radiation installations are subject to inspection at all times. The frequency of inspections is based on the associated radiation hazards located at the radiation installation. Class A radiation installations should expect to be inspected approximately once every 5 years. Class B should expect to be inspected approximately once every 2 years. Class C and D radiation installations should expect to be inspected approximately once annually.

 

f)         Operators of radiation installations shall comply with all applicable rules in 32 Ill. Adm. Code Chapter II, Subchapters b and d, including the accreditation requirements for radiologic technologists provided in 32 Ill. Adm. Code 401, certification requirements for industrial radiographers provided in 32 Ill. Adm. Code 405, and reporting requirements for any stolen, lost, or missing sources of radiation sources in accordance with 32 Ill. Adm. Code 340.1210.

 

(Source:  Amended at 49 Ill. Reg. 406, effective December 27, 2024)

 

Section 320.15  Incorporations by Reference (Repealed)

 

(Source:  Repealed at 23 Ill. Reg. 14488, effective January 1, 2000)

 

Section 320.20  Amendments and Changes in Status

 

a)         Operators of radiation installations that have been registered pursuant to Section 320.10 shall notify the Agency within 30 days after the installation of any new, used or relocated radiation machines, or the reactivation of any radiation machines.

 

b)         If any operator discontinues using radiation machines, the operator shall notify the Agency within 30 days after the discontinuance.  The notification shall include the date of discontinuance and the disposition of the radiation machines.

 

c)         Within 30 days after changing the operator of a radiation installation, the new operator shall notify the Agency.

 

d)         For radiation machines taken possession of as a result of foreclosure, bankruptcy, or other legal proceeding, the operator of the radiation installation shall notify the Agency within 30 days after the change in possession.

 

e)         To comply with this Section, facilities may use the online registration system located on the Agency's website at https://iemaohs.illinois.gov/ under the heading of Nuclear & Radiation Safety.

 

f)         Failure to comply with the requirements in this Section will result in the collection of registration fees for the years that the radiation installation was not properly registered.

 

(Source:  Amended at 49 Ill. Reg. 406, effective December 27, 2024)

 

Section 320.30  Discontinued Use (Repealed)

 

(Source:  Repealed at 23 Ill. Reg. 14488, effective January 1, 2000)

 

Section 320.40  Exemptions

 

An operator shall be exempt from the radiation installation registration requirements of this Part for the following:

 

a)         Electrical equipment that is manufactured for purposes other than generation of radiation, where the generation of radiation is incidental to operation (such as a television or electron microscope).

 

b)         Radiation machines while in transit or storage incident to transit.

 

c)         Radiation machines provided for temporary use (e.g. demonstration or to replace out-of-service equipment) and notification is provided in accordance with Section 320.10(b)(1)(C).

 

d)         Radiation machines taken possession by a financial institution as a result of foreclosure, bankruptcy, or other legal proceeding. 

 

(Source:  Amended at 49 Ill. Reg. 406, effective December 27, 2024)

 

Section 320.50  Noncompliance (Repealed)

 

(Source:  Repealed at 23 Ill. Reg. 14488, effective January 1, 2000)

 

Section 320.60  Requirements for All Operators of Radiation Installations

 

Operators of radiation installations shall:

 

a)         Assure that all radiation machines are maintained and operated in accordance with standards established by the Agency to protect the public health and safety as set forth in this Part and in 32 Ill. Adm. Code 310, 340, 350, 360, 370, 380, 390, 400, 401, 405 and 410.

 

b)         Assure that all persons who use a radiation machine to administer ionizing radiation to human beings are licensed in accordance with the requirements of 32 Ill. Adm. Code 360.10, accredited by the Agency or exempt from those requirements in accordance with 32 Ill. Adm. Code 401.30.

 

(Source:  Amended at 36 Ill. Reg. 17376, effective November 30, 2012)

 

Section 320.70  Additional Requirements for Operators of Class D Radiation Installations

 

a)         Each operator of a Class D radiation installation shall utilize the services of an individual, registered with the Agency pursuant to 32 Ill. Adm. Code 410, to implement and maintain a comprehensive radiation protection program.  Activities related to diagnostic radiation producing machines shall be performed by a registered diagnostic imaging specialist (DIS).  Activities related to therapeutic radiation machines shall be performed by a registered therapeutic radiological physicist (TRP).  Each operator shall ensure that registered individuals:

 

1)         Conduct an annual performance evaluation of all radiation machines and verify their inclusion in the radiation installation registration.

 

2)         Determine and document in a report to the radiation installation that the radiation machines evaluated are being maintained and operated in accordance with standards established by the Agency to protect the public health as set forth in 32 Ill. Adm. Code: Chapter II, Subchapters b and d. Noncompliance items shall be readily identified in the report.

 

3)         Establish and oversee the equipment-related quality assurance practices.  Specifically, these quality assurance practices shall include as a minimum:

 

A)        For therapeutic radiation machines, compliance with the quality assurance requirements specified in 32 Ill. Adm. Code 360.110(d) or 360.120(e).

 

B)        For computed tomography machines, compliance with the quality assurance requirements specified in 32 Ill. Adm. Code 360.75.

 

C)        For mammography machines, compliance with the quality assurance requirements specified in 32 Ill. Adm. Code 370.100.

 

4)         Users of digital imaging acquisition systems shall follow a quality assurance/quality control protocol for image processing established by the manufacturer for each radiation machine.  The program shall include the entire imaging chain from detector to the monitor used for interpretation and:

 

A)        The operator of the radiation installation shall include the protocol in its operating and safety procedures.  The procedures shall be in writing or electronically available for Agency review.

 

B)        The operator of the radiation installation shall document the frequency at which the quality assurance/quality control protocol is performed.  Documentation shall include the date and initials of the individual completing the document and shall be maintained at the site where performed for inspection by the Agency.

 

C)        The protocol shall include, but not be limited to, the following:

 

i)          Cleaning and erasure of all imaging plates used in computed radiography (CR);

 

ii)         Quality control phantom analysis including, but not limited to, low contrast detectability, spatial resolution, and artifacts;

 

AGENCY NOTE:  The phantom analysis can be done either by the facility or DIS.  Frequency and pass/fail criteria should be based on recommendations of the manufacturer or as established by the DIS.

 

iii)        Evaluation of repeat/reject x-ray examinations;

 

iv)        Review of exposure index, deviation index, s-number, or dose index values from clinically acquired radiographic images.

 

b)         Each operator of a Class D radiation installation shall maintain and have available for review by the Agency:

 

1)         Accurate and thorough radiation machine evaluation reports.

 

2)         Records of quality assurance testing performed.

 

3)         Records of calibrations, maintenance or repair.

 

4)         Records of corrective action taken for items of non-compliance.

 

5)         Records of digital imaging quality control.

 

c)         The records and reports required by this Section shall be maintained for a period of at least one inspection cycle.

 

(Source:  Amended at 49 Ill. Reg. 406, effective December 27, 2024)