South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-63 - Radioactive Materials (Title A)
Part II - LICENSING OF RADIOACTIVE MATERIAL
Section 61-63.II.RHA 2.4 - General Licenses-Radioactive Material Other Than Source Material
Universal Citation: SC Code Regs 61-63.II.RHA 2.4
Current through Register Vol. 48, No. 9, September 27, 2024
2.4.1 Purpose and Scope.
This part establishes general licenses for the possession and use of radioactive material and a general license for ownership of radioactive material. Specific provisions of Part II are applicable to general licenses established by this section. These provisions are specified herein or in the particular general license. The general licenses provided in this part are subject to the general provisions of Part II and RHA 1.5, 1.6, 1.7, 1.8, 1.11, 1.12, 2.9, 2.17, 2.18, 2.20.2.1.2, Part III and Part VI of these regulations unless indicated otherwise in the specific provision of the general license. [FN1]
2.4.2 Certain Detecting, Measuring, Gauging or Controlling Devices and Certain Devices for Producing Light or an Ionized Atmosphere.
2.4.2.1 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 own, receive, acquire, possess, use or transfer in accordance
with the provisions of RHA 2.4.2.2, 2.4.2.3, and 2.4.2.4, 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.
2.4.2.2 The general license in RHA 2.4.2.1 applies
only to radioactive material contained in devices which have been manufactured or
initially transferred and labeled in accordance with the specifications contained in
the subparagraphs below. The devices must have been received from one of the
specific licensees described in the following subparagraphs or through a transfer
made under RHA 2.4.2.3.8 of this part:
2.4.2.2.1 A specific license issued under Part 2
of this Regulation; or
2.4.2.2.2 An
equivalent specific license issued by an Agreement State; or
2.4.2.2.3 An equivalent specific license issued by
a State with provisions comparable to Part 2 of this Regulation.
2.4.2.3 Any person who receives, acquires,
possesses, uses, or transfers radioactive material in a device pursuant to the
general license in RHA 2.4.2.1:
2.4.2.3.1 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 thereon and shall
comply with all instructions and precautions provided by such labels;
2.4.2.3.2 shall 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 six-month intervals or at such other intervals
as are specified in the label; however;
2.4.2.3.2.1 devices containing only krypton need
not be tested for leakage of radioactive material, and
2.4.2.3.2.2 devices containing only tritium or not
more than 100 microcuries of other beta and/or gamma emitting material or 10
microcuries of alpha emitting material and devices held in storage in the original
shipping container prior to initial installation need not be tested for any
purpose;
2.4.2.3.3 Shall
assure that the tests required by RHA 2.4.2.3.2 and other testing, installation,
servicing, and removal from installation involving the radioactive materials, its
shielding or containment, are performed:
2.4.2.3.3.1 in accordance with the instructions
provided by the labels; or
2.4.2.3.3.2
by a person holding a specific license from the Department, the U.S. Nuclear
Regulatory Commission, an Agreement State, or a Licensing State to perform such
activities;
2.4.2.3.4 Shall
maintain records showing compliance with the requirements of RHA 2.4.2.3.2 and
2.4.2.3.3. The records shall show the results of tests. The records also shall show
the dates of performance of, and the names of the persons performing, testing
installation services, and removal from installation concerning the radioactive
material, its shielding or containment;
The licensee shall retain these records as follows:
2.4.2.3.4.1 Each record of a test for leakage of
radioactive material required by paragraph RHA 2.4.2.3.2 of this section must be
retained for three years after the next required leak test is performed or until the
sealed source is transferred or disposed of.
2.4.2.3.4.2 Each record of a test of the on-off
mechanism and indicator required by paragraph RHA 2.4.2.3.2 of this section must be
retained for three 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.
2.4.2.3.4.3 Each record that is
required by paragraph RHA 2.4.2.3.3 of this section must be retained for three years
from the date of the recorded event or until the device is transferred or disposed
of.
2.4.2.3.5 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
0.005 microcurie (185 bequerel) or more of removable radioactive material. The
device may not be operated until it has been repaired by the manufacturer or other
person holding a specific license to repair such devices that was issued by the
Department or by the U.S. Nuclear Regulatory Commission or an Agreement State. The
device and any radioactive material from the device may only be disposed of by
transfer to a person authorized by a specific license to receive the radioactive
material in the device or as otherwise approved by the Department. A report
containing a brief description of the event and the remedial action taken; and, in
the case of detection of 0.005 microcurie or more removable radioactive material 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 Department within 30 days. Under
these circumstances, the criteria set out in RHA 3.57.2 "Radiological criteria for
unrestricted use," may be applicable, as determined by the Department on a
case-by-case basis;
2.4.2.3.6 shall not
abandon the device containing radioactive material;
2.4.2.3.7 Shall transfer or dispose of the device
containing radioactive material only by export as provided by RHA 2.4.2.3.14 of this
section, by transfer to another general licensee as authorized in RHA 2.4.2.3.8 or
to a person authorized to receive the device by a specific license issued by this
Department or by the U.S. Nuclear Regulatory Commission or an Agreement State or as
otherwise approved under RHA 2.4.2.3.7.2. In complying with this section, the
licensee:
2.4.2.3.7.1 Shall furnish a report to
the Department within 30 days after the transfer of a device to a specific licensee
or export. The report must contain the identification of the device by
manufacturer's (or initial transferor's) name, model number, and serial number; the
name, address, and license number of the person receiving the device (license number
not applicable if exported); and the date of the transfer.
2.4.2.3.7.2 Shall obtain written Departmental
approval before transferring the device to any other specific licensee not
specifically identified in RHA 2.4.2.3.7; 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:
2.4.2.3.7.2.1
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;
2.4.2.3.7.2.2 Removes, alters,
covers, or clearly and unambiguously augments the existing label (otherwise required
by RHA 2.4.2.3.1) so that the device is labeled in compliance with RHA 3.24; however
the manufacturer, model number, and serial number must be retained;
2.4.2.3.7.2.3 Obtains manufacturer's or initial
transferor's information concerning maintenance that would be applicable under the
specific license (such as leak testing procedures); and
2.4.2.3.7.2.4 Reports the transfer under RHA
2.4.2.3.7.1.
2.4.2.3.8 Shall transfer the device to another
general licensee only:
2.4.2.3.8.1 Where the
device remains in use at a particular location. In this case, the transferor shall
give the transferee a copy of this regulation, a copy of RHA 2.4.1, 2.18, 3.44, and
3.45 of this chapter, and any safety documents identified in the label of the
device. Within 30 days of the transfer, the transferor shall report to the
Department the manufacturer's (or initial transferor's) name; the model number and
the serial number of the device transferred; the transferee's name and mailing
address for the location of use; and the name, title, and phone number of the
responsible individual identified by the transferee in accordance with RHA
2.4.2.3.10 to have knowledge of and authority to take actions to ensure compliance
with the appropriate regulations and requirements or:
2.4.2.3.8.2 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.
2.4.2.3.9 shall comply with the provisions of RHA
3.17 and 3.18 for reporting radiation incidents, theft, or loss of licensed
material, but shall be exempt from the other requirements of Parts III and VI.
2.4.2.3.10 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 the
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.
2.4.2.3.11 Shall register
generally licensed devices:
2.4.2.3.11.1 When the
device contains at least 10 mCi (370 MBq) of cesium-137, 0.1 mCi (3.7 MBq) of
strontium-90, 1 mCi (37 MBq) of cobalt-60, 0.1 mCi (3.7 MBq) of radium-226, or 1 mCi
(37 MBq) 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. Each
address for a location of use, as described under paragraph RHA 2.4.2.3.11.3 (iv),
represents a separate general licensee and requires a separate registration and
fee.
2.4.2.3.11.2 Annually, if in
possession of a device meeting the criteria of RHA 2.4.2.3.11.1. Registration shall
be made with the Department and the fee required by Department Regulation Regulation
Regulation 61-30 shall be paid. Registration must be done by verifying, correcting,
and/or adding to the information provided in a request for registration received
from the Department. The registration information must be submitted to the
Department 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 RHA 2.4.2.3.11.1 is subject to the bankruptcy notification
requirement in RHA 2.10.6.
2.4.2.3.11.3
In registering devices, the general licensee shall furnish the following information
and any other information specifically requested by the Department:
(i) Name and mailing address of the general
licensee.
(ii) Information about each
device: the manufacturer (or initial transferor), model number, serial number, the
radioisotope and activity (as indicated on the label).
(iii) Name, title, and telephone number of the
responsible person designated as a representative of the general licensee under RHA
2.4.2.3.10.
(iv) Address or location at
which the device(s) are used and/or stored. For portable devices, the address of the
primary place of storage.
(v)
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.
(vi)
Certification by the responsible representative of the general licensee that they
are aware of the requirements of the general license.
2.4.2.3.11.4 Persons generally licensed by the
U.S. Nuclear Regulatory Commission with respect to devices meeting the criteria in
RHA 2.4.2.3.11.1 are not subject to registration requirements if the devices are
used in areas subject to Departmental jurisdiction for a period less than 180 days
in any calendar year. The Department will not request registration information from
such licensees.
2.4.2.3.12
Shall report changes to the mailing address for the location of use (including
change in name of general licensee) to the Department 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.
2.4.2.3.13 May not hold devices that are not in
use for longer than 2 years. If devices with shutters are not being used, the
shutter must be locked in the closed position. The testing required by RHA 2.4.2.3.2
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 must be tested for leakage before use or
transfer and the shutter tested before use. Devices kept in standby for future use
are excluded from the two-year time limit if the general licensee performs quarterly
physical inventories of these devices while they are in standby.
2.4.2.3.14 Shall not export the device containing
radioactive material except in accordance with 10 CFR part 110, Code of Federal
Regulations;
2.4.2.3.15 Shall respond to
written requests from the Department 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 by providing the Chief of the Bureau of
Radiological Health, SC Department of Health and Environmental Control, by an
appropriate method listed in RHA 1.13 of this regulation, a written justification
for the request.
2.4.2.4 The
general license in RHA 2.4.2.1 does not authorize the manufacture or import of
devices containing radioactive material.
2.4.2.5 The general license provided in RHA
2.4.2.1 is subject to the provisions of RHA 1.5 through 1.8, RHA 1.11, RHA 1.12, RHA
2.10, RHA 2.18, RHA 2.19, and RHA 2.22.
2.4.2.6 Any person who holds a specific license
issued by the NRC or an Agreement State authorizing the holder to manufacture,
install, or service a device described in RHA 2.4.2 through 2.4.2.5 is hereby
granted a general license to install and service such device and a general license
to install and service such device in South Carolina, provided that:
2.4.2.6.1 [Reserved]
2.4.2.6.2 The device has been manufactured,
labeled, installed, and serviced in accordance with applicable provisions of the
specific license issued to such person by the NRC or Agreement State.
2.4.2.6.3 Such person assures that any labels
required to be affixed to the device under regulations of the NRC or Agreement State
which licensed manufacture of the device bear a statement that removal of the label
is prohibited.
2.4.3 General License for in Vitro Clinical or Laboratory Testing
2.4.3.1 A general license is hereby issued to any
physician, veterinarian in the practice of veterinary medicine, clinical laboratory
or hospital to receive, acquire, possess, transfer, or use, for any of the following
stated tests, in accordance with the provisions of subparagraphs 2.4.3.2, 2.4.3.3,
2.4.3.4, 2.4.3.5, and 2.4.3.6 of this paragraph:
2.4.3.1.1 Iodine-125 in units not exceeding 10
microcuries each for use in in vitro clinical or laboratory tests not involving
internal or external administration of radioactive material, or the radiation
therefrom, to human beings or animals.
2.4.3.1.2 Iodine-131, in units not exceeding 10
microcuries each from use in in vitro clinical or laboratory tests not involving
internal or external administration of radioactive material, or the radiation
therefrom, to human beings or animals.
2.4.3.1.3 Carbon-14, in units not exceeding 10
microcuries each for use in in vitro clinical or laboratory tests not involving
internal or external administration of radioactive material, or the radiation
therefrom, to human beings or animals.
2.4.3.1.4 Hydrogen-3 (tritium), in units not
exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not
involving internal or external administration of radioactive material, or the
radiation therefrom, to human beings or animals.
2.4.3.1.5 Iron-59, in units not exceeding 20
microcuries each for use in in vitro clinical or laboratory tests not involving
internal or external administration of radioactive material, or the radiation
therefrom, to human beings or animals.
2.4.3.1.6 Cobalt-57, in units not exceeding 10
microcuries each for use in in vitro clinical or laboratory tests not involving
internal or external administration of radioactive material, or the radiation
therefrom, to human beings or animals.
2.4.3.1.7 Selenium-75, in units not to exceed 10
microcuries each for use in in vitro clinical or laboratory tests not involving
internal or external administration of radioactive material, or the radiation
therefrom; to human beings or animals.
2.4.3.1.8 Mock Iodine-125 reference or calibration
sources, in units not exceeding 0.05 microcurie of Iodine-129 and 0.005 microcurie
of Americium-241 each for use in in vitro clinical or laboratory administration of
radioactive material, or the radiation therefrom, to human beings or
animals.
2.4.3.2 No person
shall receive, acquire, possess, use or transfer radioactive material pursuant to
the general license established by subparagraph 2.4.3.1 of this paragraph until he
has filed Form RHA-100-1, "Certificate--In Vitro Testing with Radioactive Material
Under General License," with the Department and received from the Department a
validated copy of Form RHA-100-1 with a certification number assigned. The
physician, veterinarian, clinical laboratory or hospital shall furnish on Form
RHA-100-1 the following information and such other information as may be required by
that form:
2.4.3.2.1 Name and address of the
physician, veterinarian, clinical laboratory, or hospital;
2.4.3.2.2 The location of use; and,
2.4.3.2.3 A Statement that the physician,
veterinarian, laboratory or hospital has appropriate radiation measuring instruments
to carry out in vitro clinical or laboratory tests with radioactive materials as
authorized under the general license in subparagraph 2.4.3.1 of this paragraph and
that such tests will be performed only by personnel competent in the use of such
instruments and in the handling of the radioactive materials.
2.4.3.3 A person who receives, acquires, possesses
or uses radioactive material pursuant to the general license established by
subparagraph 2.4.3.1 of this paragraph shall comply with the following:
2.4.3.3.1 The general licensee shall not possess
at any one time, pursuant to the general license in subparagraph 2.4.3.1 of this
paragraph, at any one location of storage or use a total amount of Iodine 125 and/or
Iodine 131 in excess of 200 microcuries.
2.4.3.3.2 The general licensee shall store the
radioactive material, until used, in the original shipping container or in a
container providing equivalent radiation protection.
2.4.3.3.3 The general licensee shall use the
radioactive material only for the uses authorized by subparagraph 2.4.3.1 of this
paragraph.
2.4.3.3.4 The general licensee
shall only transfer radioactive material to a person who is authorized to receive it
pursuant to a license issued by the Department, the U.S. Nuclear Regulatory
Commission, any Agreement State, or a Licensing State nor transfer the radioactive
material in any manner other than in the unopened, labeled shipping container as
received from the supplier.
2.4.3.3.5
The general licensee shall dispose of the Mock Iodine-125 reference or calibration
sources described in subparagraph 2.4.3.1.8 as required by RHA
3.12.
2.4.3.4 The general
licensee shall not receive, acquire, possess, or use radioactive material pursuant
to subparagraph 2.4.3.1 of this paragraph:
2.4.3.4.1 Except as prepackaged units which are
labeled in accordance with the provisions of a specific license issued under
Paragraph 2.7.5 of this Part or in accordance with the provisions of a specific
license issued by the U.S. Nuclear Regulatory Commission, any Agreement State, or a
Licensing State which authorizes the manufacture of Iodine-125, Iodine-131 or Cobalt
57 for distribution to persons generally licensed under Paragraph 2.4.3 or its
equivalent.
2.4.3.4.2 Unless the
following statement, or a substantially similar statement which contains the
information called for in the following statement, appears on a label affixed to
each prepackaged unit or appears in a leaflet or brochure which accompanies the
package:
This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.
__________
Name of Manufacturer
2.4.3.5 The physician, veterinarian, clinical
laboratory or hospital possessing or using radioactive materials under the general
license of subparagraph 2.4.3.1 of this paragraph shall report in writing to the
Department, any changes in the information furnished by him in the "Certificate--In
Vitro Testing With Radioactive Material Under General License," Form RHA-100-1. The
report shall be furnished within 30 days after the effective date of such
change.
2.4.3.6 Any person using
radioactive material pursuant to the general license of subparagraph 2.4.3.1 of this
paragraph is exempt from the requirements of Part III and Part VI of these
regulations with respect to radioactive materials covered by that general license,
except that such persons using the Mock Iodine-125 described in subparagraphs
2.4.3.1.8 shall comply with the provisions RHA 3.14, RHA 3.17, and RHA 3.18.
2.4.4 Luminous Safety Devices for Aircraft.
2.4.4.1 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:
2.4.4.1.1 Each device contains not more than ten
curies of tritium or 300 millicuries of promethium 147; and
2.4.4.1.2 Each device has been manufactured,
assembled, or imported in accordance with a specific license issued by the United
States Nuclear Regulatory Commission, or each device has been manufactured or
assembled in accordance with the specifications contained in a specific license or
equivalent licensing document issued by the Department or any Agreement State to the
manufacturer or assembler of such device pursuant to licensing requirements
equivalent to those in Section 32.53 of 10 CFR Part 32 of the regulations of the
United States Nuclear Regulatory Commission.
2.4.4.2 Persons who own, receive, acquire,
possess, or use luminous safety devices pursuant to the general license in 2.4.4.1
are exempt from the requirements of Part III and Part VI, except that they shall
comply with the provisions of RHA 3.17 and RHA 3.18.
2.4.4.3 This general license does not authorize
the manufacture, assembly, or repair of luminous safety devices containing tritium
or promethium 147.
2.4.4.4 This general
license does not authorize the ownership, receipt, acquisition, possession, or use
of promethium 147 contained in instrument dials.
2.4.4.5 The general license provided in RHA 2.4.4
is subject to the provisions of RHA 1.5 through RHA 1.8, RHA 1.12, RHA 1.13, RHA
2.10, RHA 2.18, RHA 2.19, and RHA 2.22.
2.4.5 Calibration and Reference Sources.
2.4.5.1 A general license is hereby issued to
those persons listed below to own, receive, acquire, possess, use and transfer, in
accordance with the provisions of 2.4.5.3, and 2.4.5.4, americium 241 in the form of
calibration or reference sources:
2.4.5.1.1 Any
person who holds a specific license issued by the Department which authorizes him to
receive, possess, use, and transfer radioactive material; and
2.4.5.1.2 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.
2.4.5.2 A general license is hereby issued to
receive, possess, use and transfer, plutonium and radium 226 in the form of
calibration or reference sources in accordance with the provisions of 2.4.5.3 and
2.4.5.4, to any person who holds a specific license issued by the Department which
authorizes him to receive, possess, use, and transfer radioactive
material.
2.4.5.3 The general licenses
in paragraphs 2.4.5.1 and 2.4.5.2 of this subsection 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, 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 Department, any Agreement
State, or a Licensing 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.
2.4.5.4 The general licenses in paragraphs 2.4.5.1
and 2.4.5.2 of this subsection are subject to the provisions of Section RHA 1.5
through RHA 1.8, RHA 1.12, RHA 1.13, RHA 2.10, RHA 2.18, RHA 2.19, RHA 2.22, Part
III and Part VI of these regulations. In addition, persons who own, receive,
acquire, possess, use and transfer one or more calibration or reference sources
pursuant to these general licenses;
2.4.5.4.1
Shall not possess at any one time, at any one location of storage or use, more than
5 microcuries of americium 241, 5 microcuries of plutonium or 5 microcuries of
radium 226 in such sources;
2.4.5.4.2
Shall not receive, possess, use or transfer such source unless the source or the
storage container bears a label which includes the following statement 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 U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. Do not remove this label.
CAUTION--RADIOACTIVE MATERIAL--THIS SOURCE CONTAINS (AMERICIUM 241). (PLUTONIUM). [FN*] DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
__________
(Name of Manufacturer of Importer)
2.4.5.4.3 Shall not transfer, abandon, or dispose
of such source except by transfer to a person authorized by a license from the
Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a
Licensing State to receive the source;
2.4.5.4.4 Shall store such source, except when the
source is being used, in a closed container, adequately designed and constructed to
contain americium 241, plutonium or radium 226 which might otherwise escape during
storage; and,
2.4.5.4.5 Shall not use
such source for any purpose other than the calibration of radiation detectors or the
standardization of other sources.
2.4.5.5 These general licenses do not authorize
the manufacture of calibration or reference sources containing americium 241,
plutonium or radium 226.
2.4.6 Medical Diagnostic Uses.
2.4.6.1 A general license
is hereby issued to any physician to receive, possess, transfer, or use for any of
the following stated diagnostic uses, in accordance with the provisions of 2.4.6.2,
2.4.6.3, and 2.4.6.4, the following radioactive materials in capsules, disposable
syringes, or other forms of prepackaged individual doses, [FN**] and the radioactive
material has been manufactured in accordance with a specific license issued pursuant
to RHA 2.7.4 by the Department, the U.S. Nuclear Regulatory Commission, an Agreement
State, or a Licensing State authorizing distribution under the general license
granted in this paragraph or its equivalent:
2.4.6.1.1 Iodine 131 as sodium iodide (NaI-131)
for measurement of thyroid uptake;
2.4.6.1.2 Iodine 131 as iodinated human serum
albumin (IHSA) for determinations of blood and blood plasma volume;
2.4.6.1.3 Iodine 125 as iodinated human serum
albumin (IHSA) for determinations of blood and blood plasma volume;
2.4.6.1.4 Cobalt 57 for the measurement of
intestinal absorption of cyanocobalamin;
2.4.6.1.5 Cobalt 58 for the measurement of
intestinal absorption of cyanocobalamin;
2.4.6.1.6 Cobalt 60 for the measurement of
intestinal absorption of cyanocobalamin;
2.4.6.1.7 Chromium 51 as sodium radiochromate for
determination of red blood cell volumes and studies of red blood cell survival
time.
2.4.6.2 No physician
shall receive, possess, use, or transfer radioactive material pursuant to the
general license established by 2.4.6.1 until he has filed Form RHA-100,
"Certificate-Medical Use of Radioactive Material Under General License" with the
Department and received from the Department a validated copy of the Form RHA-100.
The generally licensed physician shall furnish on Form RHA-100 the following
information and such other information as may be required by that form;
2.4.6.2.1 Name and address of the generally
licensed physician;
2.4.6.2.2 A
statement that the generally licensed physician is a duly licensed physician
authorized to dispense drugs in the practice of medicine in the State of South
Carolina and specifying the license number; and,
2.4.6.2.3 A statement that the generally licensed
physician has appropriate radiation measuring instruments to carry out the
diagnostic procedures for which he proposed to use radioactive material under the
general license of 2.4.6 and that he is competent in the use of such
instruments.
2.4.6.3 A
physician who receives, possesses or uses a pharmaceutical containing radioactive
material pursuant to the general license established by 2.4.6.1 shall comply with
the following:
2.4.6.3.1 He shall not possess at
any one time pursuant to the general license in 2.4.6.1 more than:
2.4.6.3.1.1 200 microcuries of Iodine
131,
2.4.6.3.1.2 200 microcuries of
Iodine 125,
2.4.6.3.1.3 5 microcuries of
Cobalt 57
2.4.6.3.1.4 5 microcuries of
Cobalt 60, and
2.4.6.3.1.5 5 microcuries
of Cobalt 58, and
2.4.6.3.1.6 200
microcuries of Chromium 51;
2.4.6.3.2 He shall store the pharmaceutical, until
administered, in the original shipping container or a container providing the
equivalent radiation protection;
2.4.6.3.3 He shall use the pharmaceutical only for
the uses authorized by 2.4.6.1;
2.4.6.3.4 He shall not administer the
pharmaceutical to a woman with confirmed pregnancy or to a person under 18 years of
age;
2.4.6.3.5 He shall not transfer the
radioactive material to a person who is not authorized to receive it pursuant to a
license issued by the Department, the U.S. Nuclear Regulatory Commission, any
Agreement State, or a Licensing State, or in any manner other than in the unopened,
labeled shipping container as received from the supplier, except by administering it
to a patient.
2.4.6.4 The
generally licensed physician possessing or using radioactive material under the
general license of 2.4.6.1 shall report in duplicate to the Department, any changes
in the information furnished by him in the "Certificate-Medical Use of Radioactive
Material Under General License," Form RHA-100. The report shall be submitted within
30 days after the effective date of change.
2.4.6.5 Any person using radioactive material
pursuant to the general license of 2.4.6.1 is exempt from the requirements of Part
III and Part VI of these regulations with respect to the radioactive materials
covered by the general license.
2.4.7 Ice Detection Devices.
2.4.7.1 A general license is hereby issued to own,
receive, acquire, possess, use, and transfer strontium 90 contained in ice detection
devices, provided each device contains not more than fifty microcuries of strontium
90 and each device has been manufactured or imported in accordance with a specific
license issued by the U. S. Nuclear Regulatory Commission or each device has been
manufactured in accordance with specifications contained in a specific license or
equivalent licensing document issued by the Department or any agreement state to the
manufacturer of such device pursuant to licensing requirements equivalent to those
in Section 32.61 of CFR 32 of the regulations of the U. S. Nuclear Regulatory
Commission.
2.4.7.2 Persons who own,
receive, acquire, possess, use or transfer strontium 90 contained in ice detection
devices pursuant to the general license in paragraph 2.4.7.1:
2.4.7.2.1 Shall, 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 U. S. Nuclear Regulatory Commission or agreement state to
manufacture or service such devices; or shall dispose of the device pursuant to the
provisions of this regulation;
2.4.7.2.2
Shall 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
2.4.7.2.3 Are exempt from the
requirements of Part III and Part VI except that such persons shall comply with the
provisions of Sections RHA 3.12, RHA 3.17, and RHA 3.18 of these
regulations.
2.4.7.3 This
general license does not authorize the manufacture, assembly, disassembly, or repair
of strontium 90 in ice detection devices.
2.4.7.4 The general license provided in this
paragraph is subject to the provisions of Sections RHA 1.5, through RHA 1.8, RHA
1.11, RHA 1.12, RHA 2.10, RHA 2.18, RHA 2.19, and RHA 2.22.
2.4.8 Self-Luminous Products Containing Ra-226
2.4.8.1 A general license is hereby issued to any
person to acquire, receive, possess, use, or transfer, in accordance with the
provisions of paragraphs 2.4.8.2, 2.4.8.3, and 2.4.8.4 of this section, Radium-226
contained in the following products manufactured prior to November 30, 2007.
2.4.8.1.1 Antiquities originally intended for use
by the general public. For the purposes of this paragraph, antiquities mean products
originally intended for use by the general public and distributed in the late 19th
and early 20th centuries, such as radium emanator jars, revigators, radium water
jars, radon generators, refrigerator cards, radium bath salts, and healing
pads.
2.4.8.1.2 Intact timepieces
containing greater than 0.037 megabecquerel (1 microcurie), nonintact timepieces,
and timepiece hands and dials no longer installed in timepieces.
2.4.8.1.3 Luminous items installed in air, marine,
or land vehicles.
2.4.8.1.4 All other
luminous products, provided that no more than 100 items are used or stored at the
same location at any one time.
2.4.8.1.5
Small radium sources containing no more than 0.037 megabecquerel (1 microcurie) of
Radium-226. For the purposes of this paragraph, "small radium sources" means
discrete survey instrument check sources, sources contained in radiation measuring
instruments, sources used in educational demonstrations (such as cloud chambers and
spinthariscopes), electron tubes, lightning rods, ionization sources, static
eliminators, or as designated by the NRC.
2.4.8.2 Persons who acquire, receive, possess,
use, or transfer byproduct material under the general license issued in 2.4.8.1 of
this section are exempt from the provisions of Parts 3 and 6 of this Regulation, to
the extent that the receipt, possession, use, or transfer of byproduct material is
within the terms of the general license; provided, however, that this exemption
shall not be deemed to apply to any such person specifically licensed under this
chapter.
2.4.8.3 Any person who
acquires, receives, possesses, uses, or transfers byproduct material in accordance
with the general license in 2.4.8.1 of this section:
2.4.8.3.1 Shall notify the Department should there
be any indication of possible damage to the product so that it appears it could
result in a loss of the radioactive material. A report containing a brief
description of the event, and the remedial action taken, must be furnished to the
Director of the Division of Waste Management, South Carolina Department of Health
& Environmental Control, 2600 Bull Street, Columbia SC, 29201 within 30
days.
2.4.8.3.2 Shall not abandon
products containing Radium-226. The product, and any radioactive material from the
product, may only be disposed of according to Part 3 of this Regulation or by
transfer to a person authorized by a specific license to receive the Radium- 226 in
the product or as otherwise approved by the Department.
2.4.8.3.3 Shall not export products containing
Radium-226 except in accordance with this Regulation.
2.4.8.3.4 Shall dispose of products containing
Radium-226 at a disposal facility authorized to dispose of radioactive material in
accordance with any Federal or State solid or hazardous waste law, including the
Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005, by
transfer to a person authorized to receive Radium-226 by a specific license issued
under this Regulation, or equivalent regulations of an Agreement State, or as
otherwise approved by the Department.
2.4.8.3.5 Shall respond to written requests from
the Department 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 by providing the Director of the Division of Waste Management, South
Carolina Department of Health & Environmental Control, 2600 Bull Street,
Columbia SC, 29201, a written justification for the request.
2.4.8.4 The general license in paragraph 2.4.8.1
of this section does not authorize the manufacture, assembly, disassembly, repair,
or import of products containing Radium-226, except that timepieces may be
disassembled and repaired.
[FN1] Attention is directed particularly to the provisions of Part III of this regulation concerning labeling of containers.
[FN*] Showing only the name of the appropriate material.
[FN**] Note: RHA 2.7.8 requires manufacturers of radiopharmaceuticals which are under the general license in this paragraph to affix a certain identifying label to the container or in the leaflet or brochure which accompanies the radiopharmaceutical.
Disclaimer: These regulations may not be the most recent version. South Carolina may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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