N. C. Regulations for Protection Against Radiation

15A NCAC 11 .0309          GENERAL LICENSES: MEASURING GAUGING: CONTROLLING DEVICES

(a)  A general license shall be issued to commercial and industrial firms; research, educational and medical institutions; individuals in the conduct of their business; and federal, state, or local government agencies to acquire, receive, possess, use, or transfer in accordance with Paragraphs (b), (c), and (d) of this Rule, 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 in Paragraph (a) of this Rule applies only to radioactive material contained in devices which have been:

(1)           manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to Rule .0328 of this Section 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 the devices to persons generally licensed pursuant to equivalent regulations; and

(2)           received from one of the specific licensees referenced in Subparagraph (b)(1) of this Rule or through a transfer completed in accordance with Subparagraph (c)(8) of this Rule.

(c)  Any person who acquires, receives, possesses, uses or transfers radioactive material in a device pursuant to the general license issued under Paragraph (a) of this Rule:

(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 the labels;

(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, except as follows:

(A)          Devices containing only krypton need not be tested for leakage of radioactive material;

(B)           Devices containing only tritium or not more than 100 microcuries of other beta, gamma, or beta and gamma emitting material or ten 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;

(3)           shall assure that the tests required by Subparagraph (c)(2) of this Rule 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 on labels affixed to the device, except that tests for leakage or contamination may be performed by the general licensee using leak test kits provided and analyzed by a specific licensee who is authorized to provide leak test kit services; or

(B)           by a person holding a specific license or registration which authorizes the providing of services required by this Rule and which is issued pursuant to Rules .0205 and .0306 of this Chapter or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.

(4)           shall maintain records, showing compliance with the requirements in Subparagraphs (c)(2) and (3) of this Rule, to include:

(A)          the name of the person(s) performing the test(s) and the date(s) of the test(s);

(B)           the name of the person(s) performing installation, servicing and removal of any radioactive material, shielding or containment;

(C)           retention of leakage or contamination, on‑off mechanism and on‑off indicator test records for one year after the next required test is performed or until the sealed source is disposed of or transferred, whichever is shorter;

(D)          retention of other records of tests required in Subparagraph (c)(3) of this Rule for two years from the date of the recorded test or until the device is disposed of or transferred.

(5)           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 0.005 microcurie or more removable radioactive material, shall immediately suspend operation of the device until it has been:

(A)          repaired by the manufacturer or other person authorized to repair the device(s) by a specific license issued by the agency, the U.S. Nuclear Regulatory Commission, or an agreement state; or

(B)           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 agency at the address in Rule .0111 of this Chapter a report containing a brief description of the event and the remedial action taken.  In the event that 0.005 microcurie or more of removable radioactive contamination is detected, or if the failure of or damage to a source of radiation is likely to result in the contamination of the facility or the environment, a plan for ensuring that the facility and the environment are acceptable for unrestricted use shall be submitted to the agency at the address in Rule .0111 of this Chapter.

(6)           shall not abandon the device containing radioactive material;

(7)           except as provided in Subparagraph (c)(8) of this Rule, shall transfer or dispose of the device containing radioactive material only by transfer to a person holding a specific license authorizing receipt of the device; and, prior to the transfer of a device to a specific licensee, shall furnish to the agency at the address in Rule .0111 of this Chapter, a report that contains:

(A)          the identification of the device by manufacturer's or initial transferor's name, model number, and serial number;

(B)           the name, address and specific license number of the person receiving the device; and

(C)           the date of the transfer.

(8)           shall transfer the device to another general licensee only where the device:

(A)          remains in use at a particular location.

(i)            In this case the transferor shall give the transferee a copy of this Section and any safety documents identified in the label of the device;

(ii)           The transferor shall, within 30 days of the transfer, report to the agency at the address in Rule .0111 of this Chapter the manufacturer's or initial transferor's name, serial number, and model number of device transferred; the name and mailing address of the transferee; and the name, title, and telephone number of the individual identified by the transferee pursuant to Subparagraph (c)(10) of this Rule as having knowledge of and authority to take actions to ensure compliance with the requirements contained in these Rules; or

(B)           is held in storage by the licensee or an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

(9)           shall comply with the provisions of Sections .0100 and .1600 of this Chapter for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of Section .1600 of this Chapter;

(10)         shall appoint an individual responsible for having knowledge of the requirements contained in these Rules and the authority for taking the actions required to comply with these Rules.  The general licensee, through this individual, shall ensure the day-to-day compliance with these Rules.  The appointment of such an individual does not relieve the general licensee of any of its responsibility in this regard;

(11)         shall register, when required by the agency, any source of radiation subject to a general license in accordance with the rules in this Section.  Each address for a location of use represents a separate general license and requires a separate registration action;

(12)         shall register, on an annual basis, all devices containing, based on the activity indicated on the label, at least 10 mCi (370 MBq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, 1 mCi (37MBq) of cobalt-60, 1 mCi (37 MBq) of americium-241 or any other transuranic isotope. Each address for a location of use represents a separate general license and requires a separate registration action.  Annual registration consists of verifying, correcting, or adding to the information provided in a request for annual registration within 30 days of a request from the agency.  The general licensee shall furnish the following information for annual registration:

(A)          the name and mailing address of the general licensee;

(B)           specific information about each device to include the manufacturer or initial transferor, model number, serial number, the radioisotope, and the activity indicated on the label;

(C)           the name, title, and telephone number of the responsible person designated as a representative of the general licensee in accordance with Subparagraph (c)(10) of this Rule;

(D)          the address or location at which the device(s) are to be used or stored.  For portable devices that are granted a general license by the agency, the address of the primary place of storage;

(E)           certification by the responsible person designated by the general licensee that the information concerning the device(s) has been verified through a physical inventory and a check of label information; and

(F)           certification by the responsible person designated by the general licensee that they are aware of the requirements of the general license.

(13)         shall report changes to the mailing address to the agency within 30 days of the effective date of the change;

(14)         shall report changes to the name of the general licensee to the agency within 30 days of the effective date of the change;

(15)         shall not hold devices that are not in use for longer than two years.  If devices that have shutters are not in use, the shutter shall be locked in the closed position.  Leak testing is not required during the period of storage; however, when devices are returned to service or transferred to another person, the devices must be tested for leakage and shutter operation.  Devices kept in standby for future use shall be excluded from the two year time limit if quarterly physical inventories of these devices are performed while in standby.

(d)  The general license in Paragraph (a) of this Rule does not authorize the manufacture or distribution of devices containing radioactive material.

(e)  The general license in Paragraph (a) of this Rule is subject to the provisions of Rules .0107 to .0111, .0303(a), .0338, .0342, .0343 and .0345 of this Chapter and to labeling requirements in Section .1600 of this Chapter.

History Note:        Authority G.S. 104E‑7; 104E‑10(b);

Eff. February 1, 1980;

Amended Eff. January 1, 2005; January 1, 1994; June 1, 1989.

NC Radiation Protection, 1645 Mail Service Center,
Raleigh, NC  27699-1645  919-571-4141  Fax  919-571-4148