Home Table of Contents

§ 30192.1. General Licenses--Gauging and Controlling.

17 CA ADC § 30192.1Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 5. Sanitation (Environmental) (Refs & Annos)
Subchapter 4. Radiation
Group 2. Licensing of Radioactive Materials
Article 4. Licenses
17 CCR § 30192.1
§ 30192.1. General Licenses--Gauging and Controlling.
Currentness
(a) A general license is hereby issued to commercial and industrial firms, research, educational and medical institutions, individuals in the conduct of their business, and government agencies, to acquire, receive, possess, use or transfer, in accordance with this section, radioactive 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.
(b) The general license issued pursuant to subsection (a) applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the provisions of:
(1) A specific license, which authorizes distribution of the device, issued by the Department pursuant to section 30196;
(2) An equivalent specific license issued by an Agreement State other than this State; or
(3) A specific license issued by the United States Nuclear Regulatory Commission (NRC) under section 32.51 of title 10, Code of Federal Regulations (10 CFR), Part 32.
(c) Devices described in subsection (a) shall have been received from one of the specific licensees described in subsection (b), or through a transfer made pursuant to subsection (d)(12).
(d) Persons who acquire, receive, possess, use or transfer a device under the general license issued pursuant to subsection (a) shall:
(1) Register and renew registration pursuant to section 30108.1 any devices containing at least 10 millicuries (mCi) of cesium-137, 0.1 mCi of strontium-90, 1 mCi of cobalt-60, 0.1 mCi of radium-226, or 1 mCi of americium-241 or any other transuranic (i.e., an element with atomic number greater than uranium (92)), based on the activity indicated on the label. The licensee shall be subject to the reporting requirement in section 30108.1(c) for such devices;
(2) Ensure 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 comply with all instructions and precautions provided by such labels;
(3) Ensure that the device is tested for leakage of radioactive material and that the on-off mechanism and indicator, if any, operate as designed. These tests shall be performed at intervals no longer than six months or at such other intervals as are specified in the device's label. However:
(A) Devices containing only krypton need not be tested for leakage; and
(B) Devices containing only tritium, or not more than 100 microcuries (uCi) of other beta and/or gamma emitting material or 10 uCi 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;
(4) Ensure that the tests required by subsection (d)(3) and any testing, installation, servicing, and removal from installation involving the radioactive material, its shielding, or containment, are performed:
(A) In accordance with the instructions provided by the device's labels; or
(B) By a person holding a specific license issued by the Department or an Agreement State other than this State, authorizing the licensee to perform those activities;
(5) Maintain records showing compliance with the requirements of subsections (d)(3) and (d)(4), to include the results of tests, the dates of performance of tests, and the names of the persons performing testing, installing, servicing, and removing from the installation radioactive material, its shielding, or containment. The licensee shall retain records of tests required by:
(A) Subsection (d)(3) for three years after the next required test for leakage and test of the on-off mechanism and indicator is performed, or until the sealed source is transferred or disposed of; and
(B) Subsection (d)(4) for three years from the date of the recorded event or other test, or until the device is transferred or disposed of;
(6) 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 uCi or more of removable radioactive material. The device shall not be operated until it has been repaired by the manufacturer or a person holding a specific license issued by the Department, the NRC, or an Agreement State other than this State, authorizing the licensee to repair the device. The device, and any radioactive material from the device, may only be disposed of in accordance with subsection (d)(10);
(7) Within 30 calendar days of an event specified in subsection (d)(6), submit a report to the Department containing:
(A) A brief description of the event and the remedial action taken; and
(B) If removable radioactive material greater than or equal to 0.005 uCi has been detected, or failure of or damage to a sealed source is likely to result in contamination of the premises or the environs, a plan to ensure that the premises and environs are acceptable for unrestricted use;
(8) Not abandon the device;
(9) Not export the device except in accordance with an export license issued by the NRC pursuant to 10 CFR, Part 110. This provision shall not be construed to incorporate by reference 10 CFR, Part 110;
(10) Transfer or dispose of the device only:
(A) By export as provided by subsection (d)(9);
(B) By transfer to a specific licensee authorized to receive such device or another general licensee as authorized in subsection (d)(12); or
(C) After obtaining written Department approval authorizing transfer or disposal to any other specific licensee not specifically identified in subsection (d)(10)(A) or (B), except that 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:
1. Verifies that the specific license authorizes the possession and use, or pursuant to section 30194.2 applies for and obtains an amendment to the license authorizing the possession and use;
2. Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by subsection (d)(2)), so that the device is labeled in compliance with section 20.1904 of 10 CFR, Part 20, incorporated by reference in section 30253; however, the manufacturer, model number, and serial number shall be retained;
3. 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
4. Reports the transfer under subsection (d)(11);
(11) Within 30 calendar days after transfer of a device pursuant to subsection (d)(10), submit a report to the Department containing the:
(A) Identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number;
(B) Name, address, and license number of the person receiving the device (license number not applicable if exported); and
(C) Date of the transfer;
(12) Transfer the device to another general licensee only if:
(A) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this section, sections 30108.1, 30254, 30257 and 30293(a) of this subchapter, sections 20.2201 and 20.2202 of 10 CFR, Part 20, incorporated by reference in section 30253, and any safety documents identified in the label of the device. Within 30 calendar days of the transfer, the transferor shall submit a report to the Department containing:
1. The manufacturer's (or initial transferor's) name;
2. The model number and the serial number of the device transferred;
3. The transferee's name and mailing address for the location of use; and
4. The name, title, and phone number of the responsible individual identified by the transferee pursuant to subsection (d)(15); or
(B) 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;
(13) Comply with sections 20.2201 and 20.2202 of 10 CFR, Part 20, incorporated by reference in section 30253, for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from other requirements in Group 3 of this subchapter, except for sections 30257 and 30293(a);
(14) Upon Department request, 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 is unable to provide the requested information within the allotted time, a request for extending that time shall be submitted prior to the end of the allotted time, and the request for an extension of time shall include a written justification as to why the allotted time should be extended;
(15) Appoint an individual responsible for having knowledge of required actions and authority for taking required actions, so as to comply with this section and all sections cited or referenced within this section. Appointment of the responsible individual does not relieve the general licensee of any of its own responsibility for complying with the Act and this subchapter; and
(16) Not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required by subsection (d)(3) need not be performed during the period of storage. 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 are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.
(e) The general license issued pursuant to this section does not authorize the manufacture or import of devices containing radioactive material.

Credits

Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
History
1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).
2. Change without regulatory effect of subsection (b)(5) (Register 88, No. 6).
3. Amendment of subsection (c) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).
4. Repealer and new section and amendment of Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).
5. Amendment subsection (b)(1) filed 12-30-2014; operative 4-1-2015 (Register 2015, No. 1).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 30192.1, 17 CA ADC § 30192.1
End of Document