La. Admin. Code tit. 33 § XV-328

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

Section XV-328 - Special Requirements for Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices that Contain Byproduct Material

A. Licensing the Introduction of Byproduct Material into Products in Exempt Concentrations. No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under LAC 33:XV.304.A. 1 or equivalent regulations of an agreement state, except in accordance with a license issued pursuant to 10 CFR 32.11.

B. Licensing the Distribution of Radioactive Material in Exempt Quantities

1. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

a. An application for a specific license to distribute naturally occurring or accelerator-produced radioactive material (NARM) to persons exempted from these regulations pursuant to LAC 33:XV.304.B will be approved if:

i. the radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

ii. the radioactive material is in the form of processed chemical elements, compounds or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances identified as radioactive and to be used for their radioactive properties but not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

iii. the applicant submits copies of prototype labels and brochures, and the Office of Environmental Compliance approves such labels and brochures.

b. The license issued under LAC 33:XV.328.B.1 is subject to the following conditions.

i. No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

ii. Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to LAC 33:XV.304.B. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

iii. The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label that:

(a), identifies the radionuclide and the quantity of radioactivity; and

(b). bears the words "Radioactive Material."

iv. In addition to the labeling information required by LAC 33:XV.328.B.l.b.m the label affixed to the immediate container or an accompanying brochure shall:

(a). state that the contents are exempt from licensing state requirements;

(b). bear the words "Radioactive Material-Not for Human Use-Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited-Exempt Quantities Shall Not Be Combined"; and

(c). set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

c. Each person licensed under this Subsection shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under LAC 33:XV.304.B or the equivalent regulations of the licensing state and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the Office of Environmental Compliance. Each report shall cover the year ending June 30 and shall be filed within 30 calendar days thereafter. If no transfers of radioactive material have been made pursuant to this Subsection during the reporting period, the report shall so indicate.

C. Licensing the Incorporation of Radioactive Material other than Source or Byproduct Material into Gas and Aerosol Detectors. An application for a specific license authorizing the incorporation of naturally occurring or accelerator-produced radioactive material (NARM) into gas and aerosol detectors to be distributed to persons exempt under LAC 33:XV.304.C3 will be approved if the application satisfies requirements equivalent to those contained in 10 CFR 32.26. The maximum quantity of radium-226 in each device shall not exceed 0.1 microcurie (3.7 kBq).

D. Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed under LAC 33:XV.322.D

1. An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under LAC 33:XV.322.D or equivalent regulations of the U.S. Nuclear Regulatory Commission, any other agreement state or licensing state will be approved under the following conditions.

a. The applicant satisfies the general requirements of LAC 33:XV.325.

b. The applicant submits to the Office of Environmental Compliance sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance of the following.

i. The device can be safely operated by persons not having training in radiological protection.

ii. Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one calendar quarter a dose in excess of 10 percent of the limits specified in the table in LAC 33:XV.410.A.

iii. Under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses.

(a). whole body, head and trunk active blood-forming organs, gonads, or lens of eye	15 rems
(b). hands and forearms, feet and ankles, localized areas of skin averaged over areas no larger than 1 square centimeter	200 rems
(c). other organs	50 rems

c. Each device bears a durable, legible, clearly visible label or labels approved by the department that contain in a clearly identified and separate statement:

i. instructions and precautions necessary to assure safe installation, operation and servicing of the device (document such as operating and service manuals may be identified in the label and used to provide this information);

ii. the requirement, or lack of requirement, for testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

iii. the information called for in the following statement in the same or substantially similar form:

(a). the receipt, possession, use, and transfer of this device Model_____, Serial No.______, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a state with which the U.S. Nuclear Regulatory Commission has entered into an agreement or the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION-RADIOACTIVE MATERIAL

___________________________

(Name of Manufacturer or Distributor)

The model, serial number, and name of manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

(b). the receipt, possession, use, and transfer of this device, Model_____, Serial No._____, are subject to a general license or the equivalent, and the regulations of a licensing state. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION - RADIOACTIVE-MATERIAL

_________________________

(Name of Manufacturer or Distributor)

d. Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words "Caution-Radioactive Material," the radiation symbol described in LAC 33:XV.450, and the name of the manufacturer or initial distributor.

e. Each device meeting the criteria of LAC 33:XV.322.D.3.1 bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing, if separable, or to the device if the source housing is not separable, that includes the words "Caution-Radioactive Material" and, if practicable, the radiation symbol described in LAC 33:XV.450.

f The device has been registered in the sealed source and device registry.

2. In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material, or for both, the applicant shall include in his or her application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the department will consider information that includes, but is not limited to:

a. primary containment (source capsule);

b. protection of primary containment;

c. method of sealing containment;

d. containment construction materials;

e. form of contained radioactive material;

f. maximum temperature withstood during prototype tests;

g. maximum pressure withstood during prototype tests;

h. maximum quantity of contained radioactive material;

i. radiotoxicity of contained radioactive material; and

j. operating experience with identical devices or similarly designed and constructed devices.

3. In the event the applicant desires that the general licensee under LAC 33:XV.322.D, or under equivalent regulations of the U.S. Nuclear Regulatory Commission or of any other agreement state or licensing state, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, he or she shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in Hdiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10 percent of the limits specified in LAC 33:XV.410.A.

a. If a device containing byproduct material is to be transferred for use under the general license referred to in this Subsection, each person who is licensed under this Subsection shall provide the information specified in this Subparagraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

i. a copy of the general license;

ii. copies of the appropriate records and of LAC33:XV. 485 and 486;

iii. a list of the services that can only be performed by a specific licensee;

iv. information on acceptable disposal options including estimated costs of disposal; and

v. an indication that the U.S. Nuclear Regulatory Commission's policy is to issue high civil penalties for improper disposal.

b. If byproduct material is to be transferred in a device for use under an equivalent general license of an agreement state, each person who is licensed under this Subsection shall provide the information specified in this Subparagraph to each person to whom a device is to be transferred. This information mist be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

i. copies of this Subsection and of LAC 33:XV. 485 and 486, and the appropriate records. If a copy of the U.S. Nuclear Regulatory Commission's regulations is provided to a prospective general licensee in lieu of the department's regulations, it shall be accompanied by a note explaining that use of the device is regulated by the department; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted;

ii. a list of the services that can only be performed by a specific licensee;

iii. information on acceptable disposal options including estimated costs of disposal; and

iv. the name or title, address, and telephone number of the contact at the agreement state regulatory agency from whom additional information may be obtained.

c. An alternative approach to informing customers may be proposed by the licensee for approval by the department.

d. Each device that is transferred after February 19, 2002, must meet the labeling requirements in Subparagraphs D. 1 .c-e of this Section.

e. If a notification of bankruptcy has been made under LAC 33:XV.331 .E-F or the license is to be terminated, each person licensed under this Subsection shall provide, upon request, to the department and to any appropriate agreement state, records of final disposition, which must be maintained for a period of three years following the date of the recorded event.

4. Each person licensed under this Subsection to distribute devices to persons generally licensed shall do the following.

a. Furnish a copy of the general license contained in LAC 33:XV.322.D to each person to whom he or she directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in LAC 33:XV.322.D. In the case where the transferee receives radioactive material in a device pursuant to a general license contained in the U.S. Nuclear Regulatory Commission's or agreement state's regulations equivalent to LAC 33:XV.322, furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's, agreement state's, or licensing state's regulations equivalent to LAC 33:XV.322.D, or alternatively, furnish a copy of the general license contained in LAC 33:XV.322.D to each person to whom he or she directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission, the agreement state, or the licensing state. If a copy of the general license in LAC 33:XV.322.D is furnished to such person, it shall be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, an agreement state, or a licensing state under requirements substantially the same as those in LAC 33:XV.322.D.

b. Report all transfers of devices to persons for use under the general license in LAC 33:XV.322.D.l and all receipts of devices from persons licensed under LAC 33:XV.322.D.1 to the Office of Environmental Compliance. The report must be submitted on a quarterly basis on a RAD-41 Form or in a clear and legible report containing all of the data required by the form.

i. The required information for transfers to general licensees includes:

(a). the identity of each general licensee by name and mailing address for the location of use. If there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use;

(b). the name, title, and telephone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

(c). the date of transfer;

(d). the type, model number, and serial number of the device transferred; and

(e). the quantity and type of byproduct material contained in the device.

ii. If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate persons.

iii. For devices received from a LAC 33:XV.322.D.1 general licensee, the report must include:

(a). the identity of the genera 1 licensee by name and address;

(b). the type, model number, and serial number of the device received;

(c). the date of receipt; and

(d). in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

iv. If the licensee makes changes to a device possessed by a LAC 33:XV.322.D.1 general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

v. The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

vi. The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

vii. If no transfers have been made to or from persons generally licensed under LAC 33:XV.322.D.1 during the reporting period, the report must so indicate.

c. Report all transfers of devices to persons for use under a general license in an agreement state's regulations that are equivalent to LAC 33:XV.322.D.1 and all receipts of devices from general licensees in the agreement state's jurisdiction to the responsible agreement state agency. The report must be submitted on a RAD-41 Form or in a clear and legible report containing all of the data required by the form.

i. The required information for transfers to general licensees includes:

(b). the name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

(c). the date of transfer;

(d). the type, model number, and serial number of the device transferred; and

(e). the quantity and type of byproduct material contained in the device.

iii. For devices received from a general licensee, the report must include:

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

(b). the type, model number, and serial number of the device received;

(c). the date of receipt; and

(d). in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

iv. If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

v. The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

vi. The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.

vii. If no transfers have been made to or from a particular agreement state during the reporting period, this information shall be reported to the responsible agreement state agency upon request of the agency.

d. Maintain all information concerning transfers and receipts of devices that supports the reports required by this Paragraph. This information and the reports must be maintained for a period of three years following the date of the recorded event.

e. Report to the Office of Environmental Compliance all transfers of such devices to persons for use under the general license in LAC 33:XV.322.D. Such reports must be maintained for a period of three years following the date of the recorded event and shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally licensed under LAC 33:XV.322.D during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter.

f For all transfers out of Louisiana, the distributor shall make reports prescribed in this Paragraph as follows.

i. Report to the U.S. Nuclear Regulatory Commission all transfers of such devices to persons for use under the U.S. Nuclear Regulatory Commission general license in 10CFR31.5.

ii. Report to the responsible state agency all transfers of devices manufactured and distributed in accordance with this Subsection for use under a general license in that state's regulations equivalent to LAC 33:XV.322.D.

iii. Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such device is transferred to the person generally licensed.

iv. If no transfers have been made to the U.S. Nuclear Regulatory Commission's licensees during the reporting period, this information shall be reported to the U. S. Nuclear Regulatory Commission.

v. If no transfers have been made to persons generally licensed within a particular state during the reporting period, this information shall be reported to the responsible state agency upon request of the agency.

g. Keep records showing the name, address, and the point of contact for each general licensee to whom he or she directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in LAC 33:XV.322.D, or equivalent regulations of the U.S. Nuclear Regulatory Commission or any other agreement state or licensing state. The records must show the date of each transfer, the isotope and the quantity of radioactive material in each device transferred, the identity of any intermediate person, and compliance with the reporting requirements of this Paragraph.

E. Special Requirements for the Manufacture, Assembly, Repair, or Initial Transfer of Luminous Safely Devices for Use in Aircraft

1. An application for a specific license to manufacture, assemble, repair, or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under LAC 33:XV.322.E, will be approved subject to the following conditions:

a. the applicant satisfies the general requirements specified in LAC 33:XV.325; and

b. the applicant satisfies the requirements of 10 CFR 32.53, 32.54, 32.55, and 32.56 or their equivalent.

F Special Requirements for License to Manufacture or Initially Transfer Calibration or Reference Sources Containing Americium-241 or Radium-226 for Distribution to Persons Generally Licensed under LAC 33:XV.322.G

1. An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under LAC 33:XV.322.G, will be approved subject to the following conditions:

a. the applicant satisfies the general requirement of LAC 33:XV.325; and

b. the applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

i. chemical and physical form and maximum quantity of americium-241 or radium-226 in the source;

ii. details of construction and design;

iii. details of the method of incorporation and binding of the americium-241 or radium-226 in the source;

iv. procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;

v. details of quality control procedures to be followed in the manufacture of the source;

vi. description of labeling to be affixed to the source or the storage container for the source; and

vii any additional information, including experimental studies and test, required by the department to facilitate a determination of the safely of the source.

c. Each source shall contain no more than 5 microcuries of americium-241 or radium-226.

d. The department determines, with respect to any type of source containing more than 0.005 microcurie of americium-241 or radium-226, that:

i. the method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 will not be released or be removed from the source under normal conditions of use and handling of the source; and

ii. the source has been subjected to and has satisfactorily passed appropriate tests required by Subparagraph F. 1 .e of this Section.

e. The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 to tests as follows:

i. the initial quantity of radioactive material deposited on each source is measured by direct counting of the source;

ii. the sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion;

iii. the sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in ClauseF.l.e.iv of this Section; and

iv. source designs are rejected for which the following has been detected for any unit: removal of more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from the source or any other evidence of physical damage.

2. Each person licensed to manufacture or initially transfer calibration or reference sources shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement:

a. the receipt, possession, use, and transfer of this source, Model ____, Serial No.____, are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION- RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241 (or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

_________________________________

(Name of Manufacturer or Initial Transferor)

3. Each person licensed to manufacturer or initially transfer calibration or reference sources shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels (0.1 microcurie) of americium-241 or radium-226 before transferring the source to a general licensee under LAC 33:XV.322.G or equivalent regulations of the U. S. Nuclear Regulatory Commission, licensing state or any other agreement state. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper shall be measured using methods capable of detecting 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described in this Paragraph, the source shall be rejected and shall not be transferred to a general licensee under LAC 33:XV.322.G or equivalent regulations of the U. S. Nuclear Regulatory Commission, licensing state, or any other agreement state.

G Reserved.

H. Licensing the Manufacture and Distribution of Byproduct Material for Certain In Vitro Clinical or Laboratory Testing under a General License

1. An application for a specific license to manufacture or distribute byproduct material for use under an appropriate general license or equivalent will be approved subject to the following conditions:

a. the applicant satisfies the general requirements specified in LAC 33:XV.325;

b. the byproduct material is to be prepared for distribution in prepackaged units of:

i. iodine-125 in units not exceeding 0.37 megabecquerel (10 microcuries) each;

ii. iodine-131 in units not exceeding 0.37 megabecquerel (10 microcuries) each;

iii. carbon-14 in units not exceeding 0.37 megabequerel (10 microcuries) each;

iv. hydrogen-3 (tritium) in units not exceeding 1.85 megabecuerels (50 microcuries) each;

v. iron-59 in units not exceeding 0.74 megabecquerel (20 microcuries) each;

vi. cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) each;

vii. selenium-75 in units not exceeding 0.37 megabecquerel (10 microcuries) each; or

viii. mock iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of americium-241 each; and

c. Each prepackaged unit bears a durable, clearly visible label:

i. identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 0.37 megabecquerel (10 microcuries) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 megabecquerels (50 microcuries) of hydrogen-3 (tritium); or 0.74 megabecquerel (20 microcuries) of iron-59; or mock iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of americium-241 each; and

ii. displaying the radiation caution symbol described in LAC 33:XV.450.A and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals."

d. One of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package.

i. This radioactive material may be received, acquired, possessed, and used only by physicians, 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, or equivalent license, 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.

_________________

Name of Manufacturer

ii. This radioactive material may be received, acquired, possessed, and used only by physicians, 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, or equivalent license, of a licensing state.

_____________________

Name of Manufacturer

2. The label affixed to the unit, or the leaflet or brochure that accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in LAC 33:XV.431.

I. Licensing the Manufacture and Distribution of Ice-Detection Devices

1. An application for a specific license to manufacture and distribute ice-detection devices to persons generally licensed under LAC 33:XV.322.1 will be approved subject to the following conditions:

a. the applicant satisfies the general requirements of LAC 33:XV.325; and

b. the criteria of 10 CFR 32.61 and 32.62 are met.

J. Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs Containing Byproduct Material for Medical Use under LAC 33:XV.Chapter 7.

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct material for use by persons authorized in accordance with LAC 33:XV.Chapter 7 shall be approved if the following conditions are met:

a. the applicant satisfies the general requirements for the issuance of specific licenses specified in LAC 33:XV.325;

b. the applicant submits to the Office of Environmental Compliance evidence that the applicant is at least one of the following:

i. registered or licensed with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);

ii. registered or licensed with a state agency as a drug manufacturer;

iii. licensed as a pharmacy by the Louisiana Board of Pharmacy;

iv. operating as a nuclear pharmacy within a federal medical institution; or

v. a positron emission tomography (PET) drug production facility licensed or registered with a state agency.

c. the applicant submits to the Office of Environmental Compliance information on the radionuclide, the chemical and physical form, the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

d. the applicant commits to the following labeling requirements:

i. the label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol and the words "caution, radioactive material" or "danger, radioactive material," the name of the radioactive drug or its abbreviation, and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted; and

ii. a label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol and the words "caution, radioactive material" or "danger, radioactive material" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

iii. the labels, leaflets, or brochures required by this Section are in addition to the labeling required by the U.S. Food and Drug Administration (FDA), and they may be separate from or, with the approval of the FDA, may be combined with the labeling required by the FDA.

2. A licensee described by Clause J. 1 .b.iii or iv of this Section:

a. may prepare radioactive drugs for medical use, as defined in LAC 33:XV. 102, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in Subparagraphs J.2.b and d of this Section, or an individual under the supervision of an authorized nuclear pharmacist as specified in LAC 33:XV.709;

b. may allow a pharmacist to work as an authorized nuclear pharmacist if:

i. this individual qualifies as an authorized nuclear pharmacist as defined in LAC 33:XV. 102;

ii. this individual meets the requirements specified in LAC 33:XV.763.K.2 and M and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

iii. this individual is designated as an authorized nuclear pharmacist in accordance with Subparagraph J.2.d of this Section;

c. may conduct the actions authorized in Subparagraphs J. 2. a and b of this Section in spite of more restrictive language in license conditions;

d. may designate a pharmacist as defined in LAC 3 3:XV. 102 as an authorized nuclear pharmacist if:

i. the individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

ii. the individual practiced at a pharmacy at a government agency or a federally recognized Indian tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or at an earlier date as recognized by the Nuclear Regulatory Commission;

e. shall provide to the Office of Environmental Compliance:

i. a copy of each individual's certification by a specialty board whose certification process has been recognized by the department, the NRC, or agreement state as specified in LAC 33:XV.763.K;

ii. the department, Nuclear Regulatory Commission, or agreement state license;

iii. Nuclear Regulatory Commission master materials licensee permit;

iv. the permit issued by a licensee or Nuclear Regulatory Commission master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

v. documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or at an earlier date as noticed by the NRC; and

vi. a copy of the state pharmacy licensure or registration, no later than 30 days after the date that the licensee allows the individual to work as an authorized nuclear pharmacist, in accordance with Clauses J.2.b.i and iii of this Section.

3. A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-emitting, beta-emitting, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

a. perform tests before initial use, periodically, and following repair on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument, and make adjustments when necessary; and

b. check each instrument for constancy and proper operation at the beginning of each day of use.

4. A licensee shall satisfy the labeling requirements in Subparagraph J.1.d. of this Section.

5. Nothing in this Section relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.

K. License Requirements for the Manufacture, Preparation, or Transfer for Commercial Distribution of Capsules Containing Carbon-14 Urea for "In Vivo" Diagnostic Use in Humans

1. An application for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing 37 kBq (1µCi) carbon-14 urea each (allowing for nominal variation that may occur during the manufacturing process) for "in vivo" diagnostic use, to persons exempt from licensing under LAC 33:XV.304.C4 will be approved if:

a. the applicant satisfies the general requirements specified in LAC 33:XV.325;

b. the applicant meets the requirements under Subparagraph J. 1 .b of this Section;

c. the applicant provides evidence that each capsule contains 37 kBq (1µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process);

d. the carbon-14 urea is not contained in any food, beverage, cosmetic, drug (except as described in this Section), or other commodity designed for ingestion or inhalation by, or topical application to, a human being;

e. the carbon-14 urea is in the form of a capsule, is identified as radioactive, and is to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution. The capsule shall meet the following conditions:

i. the immediate container of the capsule(s) bears a durable, legible label that:

(a). identifies the radioisotope, the physical and chemical form, and the quantity of radioactivity of each capsule at a specific date; and

(b). bears the words "Radioactive Material";

ii. in addition to the labeling information required by Clause K.I.e.i of this Section, an accompanying brochure or the label affixed to the immediate container also:

(a). states that the contents are exempt from department licensing requirements; and

(b). bears the words "Radioactive Material, for 'In Vivo' Diagnostic Use Only. This Material Is Not To Be Used for Research Involving Human Subjects and Shall Not Be Introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals or into Products Manufactured for Commercial Distribution. This Material May Be Disposed of in Ordinary Trash"; and

f the applicant submits copies of prototype labels and brochures and the department approves these labels and brochures.

2. Nothing in this Section relieves the licensee from complying with applicable FDA, other federal and state requirements governing drugs.

L. Licensing the Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use

1. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Chapter 7 for use as a calibration, transmission, or reference source or for the uses listed in LAC 33:XV.739, 741, and 747 of these regulations will be approved if the following conditions are met.

a. The applicant satisfies the general requirements mLAC33XV325.

b. The applicant submits to the Office of Environmental Compliance sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

i. the radioactive material contained, its chemical and physical form, and the amount;

ii. details of design and construction of the source or device;

iii. procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use;

iv. for devices containing radioactive material, the radiation profile of a prototype device;

v. details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

vi. procedures and standards for calibrating sources and devices;

vii. legend and methods for labeling sources and devices as to their radioactive content; and

viii. instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device, provided that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure referenced on the label.

c. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, date of assay, and a statement that the source or device is licensed by the administrative authority for distribution to persons licensed pursuant to Chapter 7 and LAC 33XV.739 and 741, or under equivalent licenses of the U.S. Nuclear Regulatory Commission, any other agreement state, or a licensing state, provided that such labeling for sources that do not require long-term storage (e.g., gold-198 seeds) may be on a leaflet or brochure that accompanies the source.

d. The source or device has been registered in the sealed source and device registry.

2. Intervals for Leakage Tests

a. In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he or she shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

b. In determining the acceptance interval for tests of leakage of radioactive material, the department will consider information that includes, but is not limited to:

i. primary containment (source capsule);

ii. protection of primary containment;

iii. method of sealing containment;

iv. containment construction materials;

v. form of contained radioactive material;

vi. maximum temperature withstood during prototype tests;

vii. maximum pressure withstood during prototype tests;

viii. maximum quantity of contained radioactive material;

ix. radiotoxicity of contained radioactive material; and

x. operating experience with identical sources or devices or similarly designed and constructed sources or devices.

M. Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-\61ume Applications

1. An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to LAC 33:XV.321.E or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state will be approved if the following conditions are met:

a. the applicant satisfies the general requirements in LAC 33:XV.325;

b. the applicant submits to the Office of Environmental Compliance sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one calendar quarter a radiation dose in excess of 10 percent of the limits specified in LAC 33:XV.410.A; and

c. the applicant submits to the Office of Environmental Compliance sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

2. In the case of an industrial product or device whose unique benefits are questionable, the administrative authority will approve an application for a specific license under LAC 33:XV.328.M only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

3. The administrative authority may deny any application for a specific license under LAC 33:XV.328.M if the end use(s) of the industrial product or device cannot be reasonably foreseen.

4. Each person licensed pursuant to LAC 33:XV.328.M.l shall do the following:

a. maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

b. label or mark each unit to:

i. identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

ii. state that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or of an agreement state;

c. assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium;"

d. furnish the following:

i. furnish a copy of the general license contained in LAC 33:XV.321.E and a copy of the Form DRC-21 to each person to whom the licensee transfers depleted uranium in a product or device for use pursuant to the general license contained in LAC 33:XV.321.E; or

ii. furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's or agreement state's regulation equivalent to LAC 33:XV.321.E and a copy of the U.S. Nuclear Regulatory Commission's or agreement state's certificate, or alternatively, furnish a copy of the general license contained in LAC 33:XV.321.E and a copy of Form DRC-21 to each person to whom the licensee transfers depleted uranium in a product or device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission or an agreement state, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an agreement state under requirements substantially the same as those in LAC33:XV.321.E;

e. report to the Office of Environmental Compliance all transfers of industrial products or devices to persons for use under the general license in LAC 33:XV.321.E. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under LAC 33:XV.321.E during the reporting period, the report shall so indicate;

f report the following information:

i. report to the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in 10 CFR 40.25;

ii. report to the responsible state agency all transfers of devices manufactured and distributed pursuant to LAC 33:XV.328.M for use under a general license in that state's regulations equivalent to LAC 33:XV.321 .E;

iii. such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 calendar days after the end of each calendar quarter in which such product or device is transferred to the generally license person;

iv. if no transfers have been made to the U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission;

v. if no transfers have been made to general licensees within a particular agreement state during the reporting period, this information shall be reported to the responsible agreement state agency;

g. keep records showing the name, address, and point of contact for each general licensee to whom he or she transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in LAC 33:XV.321.E or equivalent regulations of the U.S. Nuclear Regulatory Commission or of any other agreement state. The records shall be maintained for a period of two consecutive years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this Section.

¹ Calibration and reference sources licensed under LAC 33:XV.322.G before January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

La. Admin. Code tit. 33, § XV-328

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), LR 24:2092 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2569 (November 2000), LR 26:2768 (December 2000), LR 27:1228 (August 2001), LR 30:1664 (August 2004), amended by the Office of the Secretary, Legal Affairs Division, LR 31:2526 (October 2005), LR 33:2179 (October 2007), LR 36:1771 (August 2010), amended by the Office of the Secretary, Legal Division, LR 38:2746 (November 2012), LR 40:286 (February 2014), LR 40:1341 (July 2014), LR 41:1278 (July 2015), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 442137 (12/1/2018), Amended LR 471853 (12/1/2021).

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