Illinois Administrative Code › Title 32 - ENERGY › Part 330 - LICENSING OF RADIOACTIVE MATERIAL › Subpart B - TYPES OF LICENSES › Section 330.220 - General Licenses - Radioactive Material Other Than Source Material

Current through Register Vol. 48, No. 28, July 12, 2024
a) Certain
				Measuring, Gauging or Controlling Devices and Certain Devices for Producing
				Light or an Ionized Atmosphere
1) A general
				license is hereby issued to commercial and industrial firms and to research,
				educational and medical institutions, individuals in the conduct of their
				business and State or local government agencies to receive, acquire, possess,
				use or transfer, in accordance with the provisions of subsections (a)(2)
				through (9), radioactive material, excluding special nuclear material,
				contained in devices designed and manufactured for the purpose of detecting,
				measuring, gauging or controlling thickness, density, level, interface
				location, radiation, leakage, or qualitative or quantitative chemical
				composition, or for producing light or an ionized atmosphere.
2) The general license provided by subsection
				(a)(1) applies only to radioactive material contained in devices that have been
				manufactured or initially transferred and labeled in accordance with the
				specifications contained in a specific license issued by the Agency pursuant to
				Section
				330.280(d)
				or in accordance with the specifications contained in an equivalent specific
				license issued by the U.S. Nuclear Regulatory Commission, an Agreement State or
				a Licensing State that authorizes distribution of devices to persons generally
				licensed by NRC, an Agreement State or a former Licensing State. The devices
				shall have been received from a specific licensee described in this subsection
				(a)(2) or through a transfer made under subsection (a)(3)(L).
AGENCY NOTE: Regulations under the Federal Food, Drug and
				  Cosmetic Act authorizing the use of radioactive control devices in food
				  production require certain additional labeling that is found in
				  21
				  CFR 179.21.
3) Any person who receives, acquires,
				possesses, uses or transfers radioactive material in a device pursuant to the
				general license described in subsection (a)(1):
A) Shall assure that all labels affixed to
				the device at the time of receipt, and bearing a statement that removal of the
				label is prohibited, are maintained on the device and shall comply with all
				instructions and precautions provided by such labels;
B) Shall assure that the device is tested for
				leakage of, or contamination by, radioactive material and proper operation of
				the on-off mechanism and indicator, if any, at no longer than 6-month intervals
				or at such other intervals as are specified on the device labels; however:
i) A device containing only krypton need not
				be tested for leakage of, or contamination by, radioactive material;
				and
ii) A device containing only
				tritium or not more than 3.7 MBq (100 µCi) of other beta and/or gamma
				emitting material or 370 kBq (10 µCi) of alpha emitting material or a
				device held in storage in the original shipping container prior to initial
				installation need not be tested for any purpose;
C) Shall assure that the tests required by
				subsection (a)(3)(B) and other testing, installation, servicing and removal
				from installation involving the radioactive material, its shielding or
				containment is performed:
i) In accordance
				with the instructions provided by the labels; or
ii) By a person holding an applicable
				specific license from the Agency, NRC or an Agreement State to perform such
				activities;
D) Shall
				maintain records showing compliance with the requirements of subsections
				(a)(3)(B), (C), (H) and, as applicable, (a)(6)(B). The records shall show the
				results of tests. The records shall also show the dates of performance of, and
				the names of persons performing, physical inventories, testing, installation,
				servicing and removal from installation of radioactive material or its
				shielding or containment. Any person who receives, acquires, possesses, uses or
				transfers radioactive material in a device pursuant to the general license
				provided by subsection (a)(1) shall retain these records as follows:
i) A record of a test of an on-off mechanism
				and indicator or a test for leakage or contamination performed in accordance
				with subsection (a)(3)(B) shall be retained for 5 years after the next required
				test is performed or until the device is transferred or disposed of;
				and
ii) A record of testing,
				installation, servicing or removal from installation performed in accordance
				with subsection (a)(3)(C) shall be retained for 5 years from the date of the
				recorded event or until the device is transferred or disposed of; and
iii) A record of transfer or disposal of a
				device in accordance with subsection (a)(3)(H) shall be retained for 5 years
				from the date of the recorded event; and
AGENCY NOTE: Note that this record must be retained after
				  transfer of the device.
iv)
				A record of a quarterly physical inventory, performed for those devices in
				storage and not in use in accordance with subsection (a)(6)(B), shall be
				retained for 5 years after the next required test is performed or until the
				device is transferred or disposed of;
E) Shall immediately suspend operation of the
				device if there is a failure of or damage to, or any indication of a possible
				failure of or damage to, the shielding of the radioactive material or the
				on-off mechanism or indicator, or upon the detection of 185 Bq (5 nCi) or more
				removable radioactive material. The device shall not be operated until it has
				been repaired by the manufacturer or other person holding an applicable
				specific license from the Agency, NRC or an Agreement State to repair such
				devices. The device and any radioactive material from the device shall be
				disposed of only by transfer to a person authorized by an applicable specific
				license to receive the radioactive material in the device or as otherwise
				approved by the Agency. A report containing a brief description of the event
				and the remedial action taken shall be furnished to the Agency within 30 days.
				As applicable, the following shall also be furnished to the Agency:
i) A report within 5 days (as required by 32
				Ill. Adm. Code
				340.1260)
				if detection of 185 Bq (5 nCi) or more removable radioactive material indicates
				that a sealed source is leaking or contaminated; and
ii) A plan within 30 days for ensuring that
				the person's premises and environs are acceptable for unrestricted use if 185
				Bq (5 nCi) or more removable radioactive material is detected on the device or
				failure of or damage to a source is likely to result in contamination of the
				premises or the environs;
F) Shall not abandon the device containing
				radioactive material;
G) Shall not
				export the device containing radioactive material except in accordance with 10
				CFR 110, published at 73 Fed. Reg. 78615, December 23, 2008, exclusive of
				subsequent amendments or editions;
H) Shall transfer or dispose of the device
				containing radioactive material only:
i) By
				export as provided by subsection (a)(3)(G);
ii) By transfer to another general licensee
				as provided by subsection (a)(3)(L);
iii) By transfer to a person authorized to
				receive the device by a specific license issued by the Agency pursuant to
				Section
				330.280(d)
				or an equivalent specific license issued by NRC or an Agreement
				State;
iv) By transfer to a person
				authorized to perform waste collection by a specific license issued by the
				Agency, NRC or an Agreement State; or
v) As approved under subsection
				(a)(3)(K);
I) Shall
				furnish a written report to the Agency within 30 days after transferring or
				disposing of the device containing radioactive material. The notification shall
				include:
i) The identification of the device
				by manufacturer's (or initial transferor's) name, model and serial
				number;
ii) The name, address and
				license number of the transferee (license number not applicable if
				exported);
iii) The date of the
				transfer;
iv) A receipt from the
				transferee showing the serial number of the device and the date that it was
				received (not applicable if exported);
J) Shall respond to written requests from the
				Agency to provide information relating to the general license within 30
				calendar days of the date of the request, or other time specified in the
				request. If the general licensee cannot provide the requested information
				within the allotted time, it shall, within that same time period, request a
				longer period to supply the information to the Agency, by an appropriate method
				listed in 32 Ill. Adm. Code
				310.110.;
K) Shall obtain written approval from the
				Agency before transferring the device to any other specific licensee not
				authorized in subsections (a)(3)(H)(i) through (iv); however, a holder of a
				specific license may transfer a device for possession and use under its own
				specific license without prior approval, if, the holder:
i) Verifies that the specific license
				authorizes the possession and use, or applies for and obtains an amendment to
				the license authorizing the possession and use;
ii) Removes, alters, covers, or clearly and
				unambiguously augments the existing label (otherwise required by subsection
				(a)(3)(A)) so that the device is labeled in compliance with 32 Ill. Adm. Code
				340.940;
				however the manufacturer, model number, and serial number must be
				retained;
iii) Obtains the
				manufacturer's or initial transferor's information concerning maintenance that
				would be applicable under the specific license (such as leak testing
				procedures); and
iv) Reports the
				transfer under subsection (a)(3)(I).
L) Shall transfer the device to another
				general licensee only if:
i) The device
				remains in use at a particular location. In such case the transferor shall give
				the transferee a copy of subsection (a), a copy of 32 Ill. Adm. Code
				310.40,
				330.310,
				330.500,
				340.1210,
				340.1220,
				340.1260
				and any safety documents identified in the device labels; or
ii) The device is held in storage by an
				intermediate person in the original shipping container at its intended location
				of use prior to initial use by a general licensee;
M) Shall furnish a report to the Agency
				within 30 days after transferring a device containing radioactive material as
				provided by subsection (a)(3)(L)(i). The notification shall include:
i) The identification of the device by
				manufacturer's (or initial transferor's) name, model and serial
				number;
ii) The transferee's name
				and mailing address;
iii) The
				address of the transferee's location of use or storage of the device;
				and
iv) The name, title and phone
				number of the responsible individual identified by the transferee in accordance
				with subsection (a)(3)(N) to have knowledge of, and authority to take actions
				to ensure compliance with, the appropriate regulations and
				requirements;
N) Shall
				appoint an individual responsible for having knowledge of the appropriate
				regulations and requirements and the authority for taking required actions to
				comply with appropriate regulations and requirements. The general licensee,
				through this individual, shall ensure day-to-day compliance with appropriate
				regulations and requirements. This appointment does not relieve the general
				licensee of any of its responsibility in this regard.
4) Any person who receives, acquires,
				possesses or uses a device identified in subsection (a)(4)(A) shall register
				with the Agency in accordance with subsection (a)(4)(B):
A) A person shall register devices (i.e., an
				electron capture detector, gauge, x-ray fluorescence analyzer, or other
				measuring, gauging or controlling device) containing at least 370 MBq (10 mCi)
				of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60,
				3.7 MBq (0.1 mCi) of radium-226, or 37 MBq (1 mCi) of americium-241, or any
				other transuranic (i.e., element with atomic number greater than uranium (92)),
				based on the activity indicated on the label;
B) A person shall register with the Agency no
				later than 30 days after receiving a device identified in subsection (a)(4)(A).
				Registration information shall be in a format prescribed by the Agency and
				furnished in accordance with subsection (a)(4)(C);
C) When registering with the Agency, a person
				shall furnish the following and any other information requested by the Agency
				to track the location and use of a device:
i)
				The name and mailing address of the general licensee;
ii) The name, title and phone number of the
				responsible individual designated as a representative of the general licensee
				in accordance with subsection (a)(3)(N);
iii) Information about each device meeting
				the criteria of subsection (a)(4)(A). This information shall include the
				manufacturer (or initial transferor), model, serial number, radionuclide and
				activity as indicated on the labels, and the calendar quarter and year the
				person received the device;
iv) The
				address or locations at which the devices are used or stored;
AGENCY NOTE: For portable devices, these are the addresses of
				  the primary places of storage.
v) Certification by the responsible
				individual that the information about devices was verified through a physical
				inventory and examination of label information; and
vi) Certification by the responsible
				individual that the general licensee is aware of the requirements of the
				general license;
AGENCY NOTE: Fee requirements for general licenses are in 32
				  Ill. Adm. Code 331. Reporting requirements are in Section
				  330.310(b),
				  and bankruptcy notification requirements are in Section
				  330.310(j).
D) Any person who is required by
				subsection (a)(4) to register with the Agency shall report a change in mailing
				address or address of location of use or storage. This report shall be
				furnished to the Agency within 30 days after the change.
AGENCY NOTE: For portable devices, this is the address of the
				  primary place of storage.
5) A person from out of state who is
				generally licensed by NRC or an Agreement State with respect to a device
				identified in subsection (a)(4)(A) is exempt from the registration requirement
				in subsection (a)(4) if the device is used in areas subject to Agency
				jurisdiction for a period less than 180 days in any calendar year.
6) Any person who receives, acquires,
				possesses or uses radioactive material in a device under the general license
				described in subsection (a)(1) shall limit storage of a device that is not in
				use to a maximum of 2 years.
A) If a device
				with a shutter is not being used, the shutter shall be locked in the closed
				position. Testing for leakage of, or contamination by, radioactive material and
				for proper operation of the on-off mechanism and indicator is not required
				during the storage period. However, the testing required in subsection
				(a)(3)(B) shall be conducted before the device is returned to service if the
				device has not been tested within the required test interval.
B) A device kept in standby for future use is
				exempt from the 2-year storage limit if the person performs a quarterly
				physical inventory of the device while it is in standby. The requirements and
				exemption of subsection (a)(6)(A) shall apply.
AGENCY NOTE: Record keeping requirements are contained in
				  subsection (a)(3)(D).
7) Failure of any person to comply with the
				requirements of this subsection (a) may cause the Agency to impose civil
				penalties in accordance with
				420
				ILCS 40/36 and 32 Ill. Adm. Code 200.
8) The general license described in
				subsection (a)(1) does not authorize the manufacture or import of devices
				containing radioactive material.
9)
				The general license described in subsection (a)(1) is subject to the provisions
				of 32 Ill. Adm. Code 310, 326, 331, 340.1210, 340.1220, 340.1260, and 341 and
				Sections
				330.310
				and 330.500. Any person who receives, acquires, possesses, uses or transfers
				radioactive material in a device pursuant to the general license described in
				subsection (a)(1) is exempt from the requirements of 32 Ill. Adm. Code 400 and
				340 except for the Sections of 32 Ill. Adm. Code 340 specifically identified in
				subsections (a)(3)(E) and (a)(9).