Current through Register No. 40, October 3, 2024
(b) A general license shall be 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 own, receive, acquire, possess, use or transfer in
accordance with the provisions of He-P 4031.04(c), (d), and (e), byproduct
material, excluding special nuclear material, contained in any fixed device
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.
(c) The
general license in He-P 4031.04(b) shall apply only to byproduct material
contained in devices which have been manufactured or initially transferred and
labeled in accordance with the specifications contained in a specific license
issued by the DHHS/RHS pursuant to He-P 4032 or in accordance with the
specifications contained in a specific license issued by the U.S. Nuclear
Regulatory Commission or an Agreement State which authorizes distribution of
devices to persons generally licensed by the NRC or an Agreement
State.
(d) Devices containing
byproduct material as described in He-P 4031.04(c) above shall have been
received only from one of the specific licensees specified in He-P 4031.04(c)
or through a transfer made in accordance with He-P 4031.04(e) (9) .
(e) Any person who owns, receives, acquires,
possesses, uses, or transfers byproduct material in a device pursuant to the
general license in He-P 4031.04(b) shall:
(1)
Assure that all labels affixed to the device at the time of receipt, and
bearing a statement that removal of the label is prohibited, shall be
maintained thereon and shall comply with all instructions and precautions
provided by such labels;
(2) Assure
that the device is tested for leakage of 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 label;
however:
a. Devices containing only krypton
shall not be required to be tested for leakage of radioactive material;
and
b. Devices containing only
tritium or not more than 3.7 MBq (100 microcuries) of other beta and/or gamma
emitting material or 370 kBq (10 microcuries) of alpha emitting material and
devices held in storage in the original shipping container prior to initial
installation shall not be required to be tested for any purpose;
(3) Assure that the tests required
by He-P 4031.04(e) (2) and other testing, installation, servicing, and removal
from installation involving the radioactive materials, its shielding or
containment, are performed:
a. In accordance
with the instructions provided by the labels; or
b. By a person holding a specific license
from the DHHS/RHS, the NRC, or an Agreement State, to perform such
activities;
(4) Maintain
records showing compliance with the requirements He-P 4031.04(e) (2) and (3)
which:
a. Show the results of tests;
and
b. Show the dates of
performance of, and the names of persons performing, testing, installing,
servicing, and removal from installation concerning the radioactive material,
its shielding or containment;
(5) Retain records as follows:
a. Each record of a test for leakage or
radioactive material required by He-P 4031.04(e) (2) shall be retained for 3
years after the next required leak test is performed or until the sealed source
is transferred or disposed of;
b.
Each record of a test on the "on-off" mechanism and indicator required by He-P
4031.04(e) (2) shall be retained for 3 years after the next required test of
the on-off mechanism and indicator is performed or until the sealed source is
transferred or disposed of; and
c.
Each record that is required by He-P 4031.04(e) (3) shall be retained for 3
years from the date of the recorded event or until the device is transferred or
disposed of;
(6) Upon
the occurrence of 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 becquerel (0.005
microcurie) or more removable radioactive material, shall immediately suspend
operation of the device until it has been repaired by the manufacturer or other
person holding a specific license from the DHHS/RHS, the NRC, or an Agreement
State to repair such devices, or disposed of by transfer to a person authorized
by a specific license to receive the radioactive material contained in the
device and, within 30 days, furnish to the DHHS/RHS a report containing a brief
description of the event and the remedial action taken, and in the case of
detection of 185 becquerel (0.005 microcurie) or more removable radioactive
contamination or failure of or damage to a source likely to result in
contamination of the premises or the environs, a plan for ensuring that the
premises and environs are acceptable for unrestricted use, must be furnished to
the DHHS/RHS, in accordance with the criteria set out in
He-P
4021.20, and He-P 4024;
(7) Not abandon the device containing
byproduct material;
(8) Not export
the device containing byproduct material except in accordance with 10 CFR
110;
(9) Except as provided in He-P
4031.04(e) (10), transfer or dispose of the device containing byproduct
material only by:
a. Export as provided by
He-P 4031.04(e) (8);
b. By transfer
to a general licensee as authorized by He-P 4031.04(e) (10); or
c. By transfer to a specific licensee of the
DHHS/RHS, the NRC, or an Agreement State whose specific license authorizes him
to receive the device and within 30 days after transfer or export of a device
to a specific licensee shall furnish to the DHHS/RHS a report containing
identification of the device by manufacturer's or initial transferor's name,
model number, and serial number, and the name, address, and license number of
the person receiving the device, and the date of the transfer;
(10) Transfer byproduct material
in a device pursuant to the general license in He-P 4031.04(b) if the general
license holder obtains pre-approval from DHHS/RHS and:
a. 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;
b. Removes, alters, covers, or clearly and
unambiguously augments the existing label required by He-P 4031.04(e) (1) so
that the device is labeled in compliance with
He-P
4022.14, except that the manufacturer, model number,
and serial number shall be retained;
c. 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
d. Reports the transfer under He-P 4031.04(e)
(9);
(11) Transfer the
device to another general licensee only:
a.
Where the device remains in use at a particular location, in which case the
transferor shall give the transferee a copy of this rule and any safety
documents identified in the label on the device and, within 30 days of the
transfer, report to the DHHS/RHS the manufacturer's or initial transferor's
name, model number, and serial number of the device transferred, the name and
address of the transferee, and the name, position, and telephone number of a
responsible individual identified by the transferee in accordance with He-P
4031.04(e) (14) to have knowledge of and authority to take actions to ensure
compliance with these rules, and who may constitute a point of contact between
the DHHS/RHS and the transferee; or
b. Where 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;
(12) Comply with the provisions of
He-P
4021.12 and 4021.13 for reporting radiation incidents,
theft, or loss of licensed material, but shall be exempt from the other
requirements of He-P 4019 through He-P 4023;
(13) Respond to written requests from the
DHHS/RHS 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, except that if the general licensee is unable to provide the requested
information within the allotted time, it shall, within that same time period,
request a longer period to supply the information by providing the DHHS/RHS a
written justification for the request;
(14) Appoint an individual responsible for
having knowledge of the appropriate rules and requirements, and for ensuring
day-to-day compliance with the appropriate rules and requirements, and vested
with the authority for taking required actions to comply with appropriate rules
and requirements, although not relieving the general licensee of its
responsibility in this regard;
(15)
Register each 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, 37 MBq (1 mCi) of
americium-241, or 3.7 MBq (0.1 mCi) of radium-226, or any other transuranic,
based on the activity indicated on the device label. Each address for a
location of use, as described under He-P 4031.04(e) (16) of this section,
represents a separate general licensee and requires a separate registration and
fee;
(16) Register any and all
devices meeting the criteria set out in He-P 4031.04(e) (15) annually with the
DHHS/RHS and submit the fee required by He-P 4070. Registration shall be done
by verifying, correcting, and/or adding to the information provided in a
request for registration received from the DHHS/RHS. The registration
information shall be submitted to the DHHS/RHS within 30 days of the date of
the request for registration or as otherwise indicated in the request. In
addition, a general licensee holding devices meeting the criteria of He-P
4031.04(e) (15) of this section is subject to the bankruptcy notification
requirement in
He-P 4030.10(h) -(i)
;
(17) In registering devices, furnish the
following information and any other information specifically requested by the
DHHS/RHS:
a. Name and mailing address of the
general licensee;
b. Information
about each device: the manufacturer (or initial transferor), model number,
serial number, the radioisotope and activity (as indicated on the
label);
c. Name, title, and
telephone number of the responsible person designated as a representative of
the general licensee under He-P 4031.04(e);
d. Address or location at which the device(s)
are used and/or stored. For portable devices, the address of the primary place
of storage;
e. Certification by the
responsible representative of the general licensee that the information
concerning the device(s) has been verified through a physical inventory and
checking of label information; and
f. Certification by the responsible
representative of the general licensee that they are aware of the requirements
of the general license;
(18) Report changes to the mailing address
for the location of use or a change in name of general licensee to the DHHS/RHS
within 30 days of the effective date of the change. For a portable device, a
report of address change is only required for a change in the device's primary
place of storage; and
(19) Not hold
devices that are not in use for longer than 2 years. If devices with shutters
are not being used, the shutter shall be locked in the closed position. The
testing required by He-P 4031.04(e) need not be performed during the period of
storage only; however, when devices are put back into service or transferred to
another person, and have not been tested within the required test interval,
they shall be tested for leakage before use or transfer and the shutter tested
before use. Devices kept in standby for future use shall be excluded from the
2-year time limit if the general licensee performs quarterly physical
inventories of these devices while they are in standby.
(f) The general license in He-P 4031.04(b)
shall not authorize the manufacture or import of devices containing byproduct
material.
(g) The general license
provided in He-P 4031.04(b) shall be subject to the provisions of He-P 4001
through He-P 4003,
He-P
4030.10,
He-P
4030.16,
He-P
4030.17, and He-P 4037.
(h) A general license is hereby issued to
own, receive, acquire, possess, and use tritium or promethium 147 contained in
luminous safety devices for use in aircraft, provided:
(1) Each device contains not more than 370
GBq (10 curies) of tritium or 11.1 GBq (300 millicuries) of promethium 147;
and
(2) Each device has been
manufactured, assembled or initially transferred in accordance with a license
issued by the U.S. Nuclear Regulatory Commission or each device has been
manufactured or assembled in accordance with the specifications contained in a
specific license issued by the DHHS/RHS or an Agreement State to the
manufacturer or assembler of such device for distribution to persons generally
licensed by an Agreement State pursuant to licensing requirements equivalent to
the previsions of 10 CFR Part 32.53 of the regulations of the U.S. Nuclear
Regulatory Commission.
(i) Persons who own, receive, acquire,
possess, or use luminous safety devices pursuant to the general license in He-P
4031.04(h) shall be exempt from the requirements of He-P 4019 through 4023,
except that they shall comply with the provisions of sections
He-P
4021.12 and
He-P
4021.13.
(j) The general license in He-P 4031.04(h)
shall not authorize the manufacture, assembly, repair, import or export of
luminous safety devices containing tritium or promethium 147.
(k) The general license in He-P 4031.04(h)
shall not authorize the ownership, receipt, acquisition, possession or use of
promethium 147 contained in instrument dials.
(l) The general license in He-P 4031.04(h)
shall be subject to the provisions of He-P 4001 through He-P 4003,
He-P
4030.10,
He-P
4030.16,
He-P
4030.17 and He-P 4037.
(m) A general license shall be issued to
those persons listed below to own, receive, acquire, possess, use, and transfer
in accordance with the provisions of He-P 4031.04(p), (q) and (s) americium 241
or radium 226 in the form of calibration or reference sources:
(1) Any person who holds a specific license
issued by the Agency which authorizes him to receive, possess, use, and
transfer byproduct materials, source material; and
(2) Any person who holds a specific license
issued by the U.S. Nuclear Regulatory Commission which authorizes him to
receive, possess, use, and transfer special nuclear material.
(o) A general license shall be issued to any
person to own, receive, possess, use, and transfer radium in the form of
calibration or reference sources in accordance with equivalent provisions of
He-P 4031.04(p), (q), and (s) who holds a specific license issued by the Agency
which authorizes him to receive, possess, use, and transfer radioactive
material.
(p) The general licenses
in He-P 4031.04(m) and (o) shall apply only to calibration or reference sources
which have been manufactured in accordance with the specifications contained in
a specific license issued to the manufacturer or importer of the sources by the
U.S. Nuclear Regulatory Commission, pursuant to section 32.57 of 10 CFR Part 32
or Section 70.39 of 10 CFR Part 70 or which have been manufactured in
accordance with the specifications contained in a specific license or
equivalent licensing document issued to the manufacturer by the DHHS/RHS, or an
Agreement State pursuant to licensing requirements equivalent to those
contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70
of the regulations of the U.S. Nuclear Regulatory Commission.
(q) The general licenses provided in He-P
4031.04(m) and (o) shall be subject to the provisions of He-P 4001 through He-P
4003, He-P 4019 through He-P 4023,
He-P
4030.10,
He-P
4030.16,
He-P
4030.17 and He-P 4037.
(r) Persons who own, receive, acquire,
possess, use, and transfer one or more calibration or reference sources
pursuant to He-P 4031.04(m) or (o):
(1) Shall
not possess at any one time, at any one location of storage or use, more than
0.185 MBq (5 microcuries) of americium 241 and 0.185 MBq (5 microcuries) of
radium 226 in such sources;
(2)
Shall not receive, possess, use, or transfer such source unless the source, or
the storage container, bears a label which includes one of the following
statements or a substantially similar statement which contains the information
called for in the following statement:
"The receipt, possession, use and transfer of this source,
Model___________, Serial No.______________, are subject to a general license
and the regulations of the Nuclear Regulatory Commission or of a state with
which the Commission has entered into an agreement for the exercise of
regulatory authority. Do not remove this label.
CAUTION-RADIOACTIVE MATERIAL
THIS SOURCE CONTAINS (AMERICIUM 241) or (RADIUM-226, as
appropriate)
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE
(Name of Manufacturer or Initial Transferor)
"
(3) Shall not transfer,
abandon, or dispose of such source except by transfer to a person authorized by
a license from the DHHS/RHS, the U.S. Nuclear Regulatory Commission, or an
Agreement State to receive the source;
(4) Shall store such source, except when the
source is being used, in a closed container designed and constructed to contain
americium 241or radium-226 which might otherwise escape during storage;
and
(5) Shall not use such source
for any purpose other than the calibration of radiation detectors or the
standardization of other sources.
(s) The general licenses in He-P 4031.04He-P
4031.04(m) and (o) shall not authorize the manufacture, import or export of
calibration or reference sources containing americium-241or
radium-226.
(t) A general license
shall be issued to own radioactive material without regard to quantity.
Notwithstanding any other provisions of this part, this general license does
not authorize the manufacture, production, transfer, receipt, possession, use,
import or export of byproduct material, except as authorized in a specific
license.
(u) A general license
shall be issued to own, receive, acquire, possess, use, and transfer strontium
90 contained in ice detection devices, provided each device contains not more
than 1.85 MBq (50 microcuries) of strontium 90 and each device has been
manufactured or initially transferred in accordance with a specific license
issued by the U.S. Nuclear Regulatory Commission or each device has been
manufactured in accordance with the specifications contained in a specific
license or equivalent licensing document issued by the DHHS/RHS, or an
Agreement State to the manufacturer of such device pursuant to licensing
requirements equivalent to those of 10 CFR Part 32.61 of the regulations of the
U.S. Nuclear Regulatory Commission.
(v) Persons who own, receive, acquire,
possess, use, or transfer strontium 90 contained in ice detection devices
pursuant to the general license in He-P 4031.04(u) shall:
(1) Upon occurrence of visually observable
damage, such as a bend or crack or discoloration from overheating, to the
device, discontinue use of the device until it has been inspected, tested for
leakage and repaired by a person holding a specific license or equivalent
licensing document from the Nuclear Regulatory Commission or an Agreement State
to manufacture or service such devices; or shall dispose of the device pursuant
to the provisions of those rules;
(2) Assure that all labels affixed to the
device at the time of receipt, and which bear a statement which prohibits
removal of the labels, are maintained thereon; and
(3) Be exempt from the requirements of He-P
4019 through He-P 4023, except that such person shall comply with the
provisions of He-P 4023,
He-P
4021.12 and
He-P
4021.13.
(w) The general license in He-P 4031.04(u)
shall not authorize the manufacture, assembly, disassembly, repair, or import
of strontium 90 in ice detection devices.
(x) The general license in He-P 4031.04(u)
shall be subject to the provisions of He-P 4001 through He-P 4003,
He-P
4030.10,
He-P
4030.16,
He-P
4030.17, and He-P 4037.
#8481, eff 11-5-05 (from
He-P
4031.02)
