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).