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

Current through Register Vol. 48, No. 6, June 28, 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.