La. Admin. Code tit. 33 § XV-322

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-322 - General Licenses: Radioactive Material Other Than Source Material

A. Reserved.

B. Antiquities, Timepieces, and Luminous Devices

1. A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with the provisions of Paragraphs B.l -4 of this Section, radium-226 contained in the following products manufactured prior to November 30, 2007:

a. Antiquities Originally Intended for Use by the General Public. For the purposes of this Paragraph, antiquities are products originally intended for use by the general public and distributed in the late nineteenth and twentieth centuries, (e.g., radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads);

b. intact timepieces containing greater than 0.037 megabecquerel (1 microcurie), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces;

c. luminous items installed in air, marine, or land vehicles;

d. all other luminous products, provided that no more than 100 items are used or stored at the same location at any one time; and

e. small radium sources containing no more than 0.037 megabecquerel (1 microcurie) of radium-226. [For the purposes of this Paragraph, small radium sources are: discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (e.g., cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC]

2. Persons who acquire, receive, possess, use, or transfer byproduct material under the general license issued under Paragraph B.l of this Section are exempt from the provisions of LAC 33:XV. Chapters 3, 4, and 10, and specifically LAC 33:XV.341 and 342 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.

3. Any person who acquires, receives, possesses, uses, or transfers byproduct material in accordance with the general license in Paragraph B. 1 of this Section shall:

a. notify the Office of Environmental Compliance within 30 days of possible damage to the product which may result in a loss of the radioactive material, including a brief description of the event and the remedial action taken;

b. not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to LAC 33:XV.465.F or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by another agreement state or the NRC;

c. not export products containing radium-226, except in accordance with 10 CFR 110 ;

d. 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. This includes 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 LAC 33:XV. Chapter 3 of these regulations, equivalent regulations of an agreement state, or as approved by the NRC; and

e. 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 the 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 additional time to supply the information by providing the department with a written justification for the request.

4. The general license in Paragraph B.l 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.

C. Reserved.

D. Certain Detecting, Measuring, Gauging, and Controlling Devices

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 federal, state, or local government agencies to own, receive, acquire, possess, use, or transfer in accordance with the provisions of Paragraph D.2 of this Section, byproduct 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. The general license in Paragraph D. 1 of this Section applies only to byproduct material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued by the administrative authority in accordance with LAC 33:XV.328.D or in accordance with the specifications contained in a specific license issued by the U.S. Nuclear Regulatory Commission, any other agreement state, or a licensing state that authorizes distribution of devices to persons generally licensed by the U.S. Nuclear Regulatory Commission, an agreement state, or a licensing state. Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon that is found in 21 CFR 179.21. The devices shall be received from one of the specific licensees described in this Paragraph or through a transfer made under Subparagraph D.3. h of this Section.

3. Any person who owns, receives, acquires, possesses, uses, or transfers byproduct material in a device pursuant to the general license in Paragraph D. 1 of this Section shall do the following:

a. 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;

b. 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:

i. devices containing only krypton need not be tested for leakage of radioactive material, and

ii. 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;

c. assure that the tests required by Subparagraph D.3.b of this Section and other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding, or containment are performed:

i. in accordance with the instructions provided by the labels; or

ii. by a person holding an applicable specific license from the administrative authority, the U.S. Nuclear Regulatory Commission, any other agreement state, or a licensing state to perform such activities;

d. maintain records showing compliance with the requirements of Subparagraphs D.3.b and c of this Section. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installation, servicing, and removal from installation of the radioactive material, its shielding, or containment. Records of tests for leakage of radioactive material required by Subparagraph D.3.b of this Section shall be retained for three years after the next required leak test is performed, or until the sealed source is transferred or disposed. Records of tests of the on-off mechanism and indicator required by Subparagraph D.3.b of this Section shall be maintained 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. Records required by Subparagraph D.3.C of this Section shall be maintained for a period of three years from the date of the recorded event or until the device is transferred or disposed;

e. 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 (185 bequerel) or more of removable radioactive material, immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific license from the administrative authority, the U.S. Nuclear Regulatory Commission, or any other agreement state or licensing state to repair such devices, or disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device and, within 30 days, furnish to the Office of Environmental Compliance a report containing a brief description of the event and the remedial action taken. In the case of detection of 0.005 microcurie or more of removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use in accordance with LAC 33:XV.332.D shall be submitted to the Office of Environmental Compliance within 30 days of occurrence;

f. shall not abandon the device containing byproduct material;

g. except as provided in Subparagraph D.3.h of this Section, transfer or dispose of the device containing byproduct material only by export as provided in 10 CFR Part 110 or by transfer to a specific licensee of the department, the U.S. Nuclear Regulatory Commission, or any other agreement state or licensing state whose specific license authorizes him or her to receive the device and, within 30 days after transfer of a device to a specific licensee, except when the device is transferred to the specific licensee in order to obtain a replacement device, shall furnish to the Office of Environmental Compliance a report containing:

i. identification of the device by the manufacturer's name, model number, and serial number, or by the initial transferor's name;

ii. the name, address, and license number of the person receiving the device; and

iii. the date of the transfer;

h. transfer the device to another general licensee only:

i. where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this regulation and any safety documents identified in the label on the device and, within 30 days of the transfer, report to the Office of Environmental Compliance the manufacturer's (or the initial transferor's) name; the model number and serial number of the device tansferred; the name, mailing address for the location of use, and license number of the transferee; the date of the transfer; and the name and/or position of an individual who may constitute a point of contact between the department and the transferee; or

ii. 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;

i. comply with the provisions of LAC 33:XV.485 and 486 for reporting radiation incidents, theft, or loss of licensed material. Such person shall be exempt from the other requirements of Chapters 4 and 10 of these regulations.

j. Reserved.

k. 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 the appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard;

l. register, in accordance with the provisions in this Subparagraph, devices containing at least 370 MBq (10 mCi) of cesmml37, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 3.7 megabecquerels (0.1 millicurie) of radium-226, or 37 MBq (1 mCi) 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 in this Subparagraph, represents a separate general licensee and requires a separate registration and fee:

i. annual registration with the Office of Environmental Compliance shall include payment of the fee required by LAC 33:XV.2505. 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;

ii. in registering devices, the general licensee shall furnish the following information, as indicated on the label, and any other information specifically requested by the department:

(a). the name and mailing address of the general licensee;

(b). information about each device:

(i). the manufacturer (or initial transferor);

(ii). the model number;

(iii). the serial number; and

(iv). the radioisotope and activity;

(c). the name, title, and telephone number of the responsible person designated as a representative of the general licensee and identified by the transferee to have knowledge of and authority to take actions to ensure day-today compliance with the appropriate regulations and requirements without relieving the general licensee of any of his or her responsibility in this regard;

(d). the address or location at which the devices are used and/or stored. For portable devices, list the address of the primary place of storage;

(e). certification by the responsible representative of the general licensee that the information concerning the devices has been verified through a physical inventory and checking of label information; and

(f). certification by the responsible representative of the general licensee that he or she is aware of the requirements of the general license;

iii. persons generally licensed by an agreement state with respect to devices meeting the criteria in this Subparagraph are not subject to registration requirements if the devices are used in areas subject to department jurisdiction for a period less than 180 days in any calendar year. The department will not request registration information from such licensees;

m. report changes to the mailing address for the location of use (including change in the name of the general licensee) to the Office of Environmental Compliance 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;

n. not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by this Subsection 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.

4. The general license in LAC 33:XV. 322.D.1 does not authorize the manufacture or import of devices containing radioactive material.

5. The general license provided in LAC 33:XV.322.D.l is subject to the provisions of LAC 33:XV.104-109, 331, 340, 350, and Chapter 15.

E. Luminous Safety Devices for Aircraft

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 that:

a. each device contains not more than 10 curies of tritium or 300 millicuries of promethium-147; and

b. each device has been manufactured, assembled, or imported in accordance with a specific 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 administrative authority or any other agreement state to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in 10 CFR 32.53.

2. Persons who own, receive, acquire, possess, or use luminous safety devices in accordance with the general license in LAC 33:XV.322.E.l are exempt from the requirements of Chapters 4 and 10 of these regulations, except that they shall comply with the provisions of LAC33:XV.485 and 486.

3. This general license does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium 147.

4. This general license does not authorize the ownership, receipt, acquisition, possessbn, or use of promethium-147 contained in instrument dials.

5. This general license is subject to the provisions of LAC 33:XV.104-109, 331, 340, 350, and Chapter 15.

F Ownership of Radioactive Material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this Chapter, this general license does not authorize the manufacture, production, transfer, receipt, possession, or use of radioactive material.

G Calibration and Reference Sources: Americium-241, Plutonium, or Radium-226

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 LAC 33:XV.322.G.4 and 5, amencium-241 in the form of calibration or reference sources:

a. any person who holds a specific license issued by the administrative authority that authorizes him or her to receive, possess, use, and transfer radioactive material; and

b. any person in this state who holds a specific license issued by the U.S. Nuclear Regulatory Commission that authorizes him or her to receive, possess, use, and transfer special nuclear material.

2. A general license is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of LAC 33:XV.322.G.4 and 5 to any person who holds a specific license issued by the administrative authority that authorizes him or her to receive, possess, use, and transfer radioactive material.

3. A general license is hereby issued to own, receive, possess, use, and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of LAC 33:XV.322.G.4 and 5 to any person who holds a specific license issued by the administrative authority that authorizes him or her to receive, possess, use, and transfer radioactive material.

4. The general licenses in LAC 33:XV.322.G. 1, 2, and 3 apply only to calibration or reference sources that 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 10 CFR 32.57 or 10 CFR 70.39 or that have been manufactured in accordance with the specification contained in a specific license issued to the manufacturer by the administrative authority or any other agreement state or licensing state pursuant to licensing requirements equivalent to those contained in 10 CFR 32.57 or 10 CFR 70.39 of the regulations of the U.S. Nuclear Regulatory Commission.

5. The general licenses provided in LAC 33:XV.322.G.l, 2, and 3 are subject to the provisions of LAC 33:XV.104-109, 331, 340, 350, and Chapter 15. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses:

a. 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, and 5 microcuries of radium-226 in such sources;

b. shall not receive, possess, use, or transfer such source unless the source or the storage container bears a label that includes the following statement or a substantially similar statement that 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 or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority or a licensing state. Do not remove this label.

CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS (Show the name of the appropriate material) DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

___________________________

Name of Manufacturer or Importer

c. shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the administrative authority, the U.S. Nuclear Regulatory Commission, any other agreement state, or a licensing state to receive the source;

d. 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 that might otherwise escape during storage; and

e. shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

6. These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium, or radium-226.

H. Reserved.

I. Calibration and Reference Sources: Mock Iodine-125

1. A general license is hereby issued to any physician, clinical laboratory, or hospital to own, receive, acquire, possess, transfer, or use, in accordance with the provisions of LAC 33:XV.322.L2, 3, 4, 5, and 6, 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 vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the mdiation therefrom, to human beings or animals.

2. No person shall receive, acquire, possess, use, or transfer radioactive material pursuant to the general license established by LAC 33:XV.322.I.1 until he or she has been authorized by LAC 33:XV.325, 327, or 718, to use radioactive material. The physician, clinical laboratory, or hospital shall furnish the following information and such other information as may be required:

a. name and address of the physician, clinical laboratory, or hospital; and

b. the location of use.

3. A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by LAC 33:XV.322.I.1 shall comply with the following:

a. the general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection;

b. the general licensee shall use the radioactive material only for the uses authorized by LAC 33:XV.322.1.1;

c. the general licensee shall transfer the radioactive material only in accordance with LAC 33:XV.340; and

d. the general licensee shall dispose of the mock iodine-125 reference or calibration sources described in LAC 33:XV.322.I.1 as required by LAC 33:XV.431.

4. The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to LAC 33:XV.322.I.1 except as prepackaged units labeled in accordance with the provisions of an applicable specific license issued pursuant to LAC 33:XV.328.H or in accordance with the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission, any agreement state, or licensing state that authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or mock iodine-125 to persons generally licensed under LAC 33 :XV.322.1 or its equivalent.

5. Any person using radioactive material in accordance with the general license of Paragraph 1.1 of this Section is exempt from the requirements of Chapters 4 and 10 of these regulations with respect to radioactive material covered by that general license, except that such persons using the mock iodine-125 described in Paragraph 1.1 of this Section shall comply with the provisions of LAC 33:XV.431, 485, and 486.

J. Ice Detection Devices

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 50 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 the specifications contained in a specific license issued by the administrative authority or any other agreement state to the manufacturer of such device pursuant to licensing requirements equivalent to those in 10 CFR 32.61 of the regulations of the U.S. Nuclear Regulatory Commission.

2. Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in LAC 33:XV.322.J:

a. 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 from the administrative authority, the U.S. Nuclear Regulatory Commission, or any other agreement state to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of LAC 33:XV.431;

b. shall assure that all labels affixed to the device at the time of receipt, and which bear a statement that prohibits removal of the labels, are maintained in legible form thereon; and

c. are exempt from the requirements of LAC 33 :XV.Chapters 4 and 10, except that such persons shall comply with the provisions of LAC 33:XV.431, 485, and 486.

3. This general license does not authorize the manufacture, assembly, disassembly, or repair of strontium-90 in ice-detection devices.

4. This general license is subject to the provisions of LAC 33:XV.104-109, 331, 340, 350, and Chapter 15.

La. Admin. Code tit. 33, § XV-322

Promulgated by the Department of Environmental Quality, Nuclear Energy Division, LR 13:569 (October 1987), amended by the Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2567 (November 2000), LR 27:1226 (August 2001), LR 30:1663 (August 2004), amended by the Office of the Secretary, Legal Affairs Division, LR 31:2524 (October 2005), LR 32:811 (May 2006), LR 33:448 (March 2007), LR 33:2177 (October 2007), amended by the Office of the Secretary, Legal Division, LR 40:284 (February 2014), LR 40:1340 (July 2014), LR 41:1277 (July 2015).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq., and 2104(B)l.