180 Neb. Admin. Code, ch. 3, § 014

Current through September 17, 2024

Section 180-3-014 - SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR, OR DISTRIBUTE COMMODITIES, PRODUCTS, OR DEVICES WHICH CONTAIN RADIOACTIVE MATERIAL

This section addresses special requirements for a specific license to manufacture, assemble, repair, or distribute commodities, products, or devices which contain radioactive material.

014.01RESERVED.

014.02TRANSFER TO EXEMPT PERSONS. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under 180 NAC 3.004.01 or equivalent regulation of an Agreement State or U.S. Nuclear Regulatory Commission (NRC), other than according to a license issued under 10 CFR 32.11.

014.03LICENSING THE INCORPORATION OF NATURALLY OCCURRING ACCELERATOR-PRODUCED RADIOACTIVE MATERIAL INTO GAS AND AEROSOL DETECTORS. An applicant for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under 180 NAC 3-004.03(C) must satisfy the requirements of 10 CFR 32.26. The maximum quantity of radium-226 in each device must not exceed 3.7 kBq ( 0.1µCi).

014.04LICENSING THE MANUFACTURE AND DISTRIBUTION OF DEVICES TO PERSONS GENERALLY LICENSED UNDER 180 NAC 3-008.04. The following is applicable to licensing the manufacture and distribution of devices to person generally licensed under 180 NAC 3-008.04.

014.04(A)APPLICATION. An applicant for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 180 NAC 3-008.04 or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State must:

(i) Satisfy the general requirements of 180 NAC 3-011;

(ii) Submit 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 that:

(1) The device can be safely operated by persons not having training in radiological protection;

(2) 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 one year a dose in excess of 10% of the annual limits specified in 180 NAC 4-005.01; and

(3) 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:

Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye	150 millisievert (mSv) (15 rems)
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter	2 sievert (Sv) (200 rems)
Other organs	500 millisievert (mSv) (50 rems)

(iii) Label each device so that each device bears a durable, legible, clearly visible label or labels approved by the Department, which contain in a clearly identified and separate statement:

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

(2) The requirement, or lack of requirement, for leak testing, or for testing any on or off mechanism, or both, 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

(3) The information called for in the following statement, as appropriate in the same or substantially similar form:

The receipt, possession, use, and transfer of this device Model _______, Serial No. ______9, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission (NRC) or a state with which the U.S. Nuclear Regulatory Commission (NRC) has entered into an agreement for the exercise of regulatory authority. This label must 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 and labeling affixed to the device;

(iv) Label 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 radionuclide and quantity, the words, "Caution-Radioactive Material,'' the radiation symbol described in 180 NAC 4-033.01, and the name of the manufacturer or initial distributor;

(v) Label each device meeting the criteria of 180 NAC 3-008.04, (C)(xiii)(1) so that it bears a permanent, embossed, etched, stamped, or engraved label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, "Caution-Radioactive Material,'' and, if practicable, the radiation symbol described in 180 NAC 4-033.01; and

(vi) Register the device in the Sealed Source and Device Registry.

014.04(B)ALTERNATE LEAK TESTING INTERVALS. 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 or off mechanism, or both, and indicator, if any, or for leakage of radioactive material or for both, the applicant must include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on or off mechanism, or both, and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the information at will be considered which includes, but is not limited to:

(i) Primary containment or 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 devices or similarly designed and constructed devices.

014.04(C)GENERAL LICENSEE INSTALLATION AND LEAK TESTING. In the event the applicant desires that the general licensee under 180 NAC 3-008.04, or under equivalent regulations of U.S. Nuclear Regulatory Commission (NRC), or an Agreement 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 or off mechanism, or both, and indicator, or remove the device from installation, the applicant must 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 must demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of 10% of the annual limits specified in 180 NAC 4005.01.

014.04(D)CONDITIONS OF TRANSFER. Licensees meet the following conditions for transferring a device for use under a general license in 180 NAC 3-008.04.

014.04(D)(i)DEVICE CONTAINING RADIOACTIVE MATERIAL. If a device containing radioactive material is to be transferred for use under the general license in 180 NAC 3-008.04, each person that is licensed under 180 NAC 3-014.04 must provide the information specified in this paragraph 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:

(1) A copy of the general license contained in 180 NAC 3-008.04(C)(ii) through (iv) or (C)(xiii) do not apply to the particular device, those paragraphs may be omitted;

(2) A copy of 180 NAC 3-008.01, 180 NAC 3-030, 180 NAC 4-057 and 4-058;

(3) A list of the services that can only be performed by a specific licensee;

(4) Information on acceptable disposal options including estimated costs of disposal; and

(5) An indication that the Department's policy is to issue high civil penalties for improper disposal.

014.04(D)(ii)RADIOACTIVE MATERIAL. If radioactive material is to be transferred in a device for use under an equivalent general license of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State, each person that is licensed under 180 NAC 3-014.04 must provide the information specified in this paragraph 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:

(1) A copy of the 180 NAC 3-008.01, 180 NAC 3-008.04, 180 NAC 4-057 and 058 or a copy of equivalent U.S. Nuclear Regulatory Commission (NRC) or Agreement State's regulations. If a copy of the U.S. Nuclear Regulatory Commission (NRC) regulations is provided to a prospective general licensee in lieu of the Department's or Agreement State's regulations, it must be accompanied by a note explaining that use of the device is regulated by the U. S. Nuclear Regulatory Commission (NRC) or an Agreement State; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted;

(2) A list of the services that can only be performed by a specific licensee;

(3) Information on acceptable disposal options including estimated costs of disposal; and

(4) The name or title, address, and phone number of the contact at the Department, U.S. Nuclear Regulatory Commission (NRC) or Agreement State from which additional information may be obtained.

014.04(D)(iii)ALTERNATIVE APPROACH. An alternative approach to informing customers may be proposed by the licensee for approval by the Department.

014.04(D)(iv)LABELING. Each device that is transferred after April 12, 2003 must meet the labeling requirements in 180 NAC 3-014.04(A)(iii) through (iv).

014.04(D)(v)BANKRUPTCY. If a notification of bankruptcy has been made under 180 NAC 3-017.05 or the license is to be terminated, each person licensed under 180 NAC 3-014.04 must provide, upon request, to the Department, the U.S. Nuclear Regulatory Commission (NRC) and to any appropriate Agreement State, records of final disposition required under 180 NAC 3-014.04(E)(iii).

014.04(E)MATERIAL TRANSFER REPORTS AND RECORDS. Licensees initially transfering devices to generally licensed persons must:

(i) Report all transfers of devices to persons for use under the general license in 180 NAC 3-008.04 and all receipts of devices from persons licensed under 180 NAC 3-008.04 to the Radioactive Material Program Manager, Nebraska Department of Health and Human Services, Radiological Health, 301 Centennial Mall South, P.O. Box 95026, Lincoln, NE 68509-5026. The report must be submitted on a quarterly basis on the Form NRH 653, "Transfers of Industrial Devices Report'' or in a clear and legible report containing all of the data required by the form. Form NRH 653 is set our in Attachment 5 of this chapter.

(1) The required information for transfers to general licensees includes:

(a) The identity of each general licensee by name and mailing location of use, an alternate address for the general licensee must be submitted along with information on the actual location of use.

(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 radioactive material contained in the device;

(2) 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 person or persons;

(3) For devices received from a 180 NAC 3-008.04 general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor;

(4) If the licensee makes changes to a device possessed by a 180 NAC 3-008.04 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;

(5) 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;

(6) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee; and

(7) If no transfers have been made to or from persons generally licensed under 180 NAC 3-008.04 during the reporting period, the report must so indicate;

(ii) Report all transfers of devices to persons for use under a general license in an U.S. Nuclear Regulatory Commission (NRC) or Agreement State's regulations that are equivalent to 180 NAC 3-008.04 and all receipts of devices from general licensees in the U.S. Nuclear Regulatory Commission (NRC) or Agreement State's jurisdiction to the U.S. Nuclear Regulatory Commission (NRC) or responsible Agreement State agency. The report must be submitted on the Department's Form 653, "Transfers of Industrial Devices Report'' or in a clear and legible report containing all of the data required by the form.

(1) 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 must be submitted along with information on the actual location of use;

(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 radioactive material contained in the device.

(2) 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 person or persons;

(3) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor;

(4) 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;

(5) 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;

(6) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee;

(7) If no transfers have been made to or from the U.S. Nuclear Regulatory Commission (NRC) or a particular Agreement State during the reporting period, this information must be reported to the U.S. Nuclear Regulatory Commission (NRC) or responsible Agreement State agency upon request of the Department; and

(iii) Maintain all information concerning transfers and receipts of devices that supports the reports required by this 180 NAC 3-014.04(E). Records required by 180 NAC 3-014.04(E) must be maintained for a period of 3 years following the date of the recorded event.

014.05SPECIAL REQUIREMENTS FOR THE MANUFACTURE, ASSEMBLY, OR REPAIR OF LUMINOUS SAFETY DEVICES FOR USE IN AIRCRAFT. An applicant for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 180 NAC 3-008.05 must:

(A) Satisfy the general requirements specified in 180 NAC 3-011;

(B) Satisfy the requirements of 10 CFR 32.53 through 32.56; and

(C) Have a radiation safety officer or authorized user that meets the training and experience requirements specified in 180 NAC 15-008.01.

014.06SPECIAL REQUIREMENTS FOR LICENSE TO MANUFACTURE CALIBRATION SOURCES CONTAINING AMERICIUM-241, PLUTONIUM OR RADIUM-226 FOR DISTRIBUTION TO PERSONS GENERALLY LICENSED UNDER 180 NAC 3-008.07. An applicant for a specific license to manufacture or initially transfer calibration and reference sources containing americium-241, plutonium or radium-226 for distributions to persons generally licensed under 180 NAC 3-008.07 must:

(A) Satisfy the general requirement of 180 NAC 3-011;

(B) Satisfy the requirements of 10 CFR 32.57 through 32.59; and

(C) Have a radiation safety officer or authorized user that meets the training and experience requirements specified in 180 NAC 15-008.01.

014.07RESERVED.

014.08MANUFACTURE AND DISTRIBUTION OF RADIOACTIVE MATERIAL FOR CERTAIN IN VITRO CLINICAL OR LABORATORY TESTING UNDER GENERAL LICENSE. For a specific license to manufacture or distribute radioactive material for use under the general license of 180 NAC 3-008.09, the applicant must:

(A) Satisfy the general requirements specified in 180 NAC 3-011;

(B) Prepare the radioactive material for distribution in prepackaged units of:

(i) Iodine-125 in units not exceeding 370 kBq (10 µCi) each;

(ii) Iodine-131 in units not exceeding 370 kBq (10 µCi) each;

(iii) Carbon-14 in units not exceeding 370 kilobecquerel (kBq) (10 microcuries) each;

(iv) Hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 µCi) each;

(v) Iron-59 in units not exceeding 740 kBq (20 µCi) each;

(vi) Cobalt-57 in units not exceeding 370 kBq (10 µCi) each;

(vii) Selenium-75 in units not exceeding 370 kBq (10 µCi) each; and

(viii) Mock Iodine-125 in units not exceeding 1.85 kBq ( 0.05µCi) of iodine-129 and 185 Bq ( 0.005µCi) of americium-241 each;

(C) Label each prepackaged unit with 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 370 kBq (10 µCi) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 MBq (50 µCi) of hydrogen-3 (tritium); 740 kBq (20 µCi) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kBq ( 0.05µCi) of iodine-129 and 185 Bq ( 0.005µCi) of americium-241 each or colbalt-57 in units not exceeding 0.37 MBq (10 µCi); and

(ii) Displaying the radiation caution symbol described in 180 NAC 4-033.01 and the words, "CAUTION, RADIOACTIVE MATERIAL" and "Not for Internal or External Use in Humans or Animals";

(D) Include the following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for In Vitro clinical or laboratory tests not involving internal or external administration of the material, or the resulting radiation, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission (NRC) or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

_____________________

Name of Manufacturer

(E) Affix a label to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of 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 180 NAC 4-039; and

(F) Demonstrate that the radiation safety officer or authorized user has training and experience requirements consistent with training specified in 180 NAC 15-009.01.

014.09LICENSING THE MANUFACTURE AND DISTRIBUTION OF ICE DETECTION DEVICES CONTAINING STRONTIUM 90. An applicant for a specific license to manufacture and distribute ice detection devices to persons generally licensed under 180 NAC 3-008.10 must satisfy the general requirements of 180 NAC 3-011, the criteria of 10 CFR 32.61, and 32.62. The radiation safety officer or authorized user must have training and experience requirements specified in 180 NAC 15-008.01.

014.10MANUFACTURE, PREPARATION, OR TRANSFER FOR COMMERCIAL DISTRIBUTION OF RADIOACTIVE DRUGS CONTAINING RADIOACTIVE MATERIAL FOR MEDICAL USE UNDER 180 NAC 7. The following requirements apply to the manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing radioactive material for medical use under 180 NAC 7.

014.10(A)APPLICATION. An applicant for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized according to 180 NAC 7, must:

(i) Satisfy the general requirements specified in 180 NAC 3-011;

(ii) Submit evidence that the applicant is at least one of the following:

(1) Registered 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);

(2) Registered or licensed with a state agency as a drug manufacturer;

(3) Licensed according to 175 NAC 8, Pharmacies;

(4) Operating as a nuclear pharmacy within a Federal medical institution; or

(5) A Positron Emission Tomography (PET) drug production facility registered with the Department;

(iii) Submit 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

(iv) Commit to the following labeling requirements:

(1) A 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 must 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

(2) 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 must 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.

014.10(B)DRUG MANUFACTURERS AND PHARMACIES. A licensee described by 180 NAC 3-014.10, (A)(ii)(3) or (A)(ii)(4):

(i) May prepare radioactive drugs for medical use, as defined in 180 NAC 7-002, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, according to 180 NAC 3-014.10(A)(ii) and (iv), or an individual under the supervision of an authorized nuclear pharmacist according to 180 NAC 7-018;

(ii) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(1) This individual qualifies as an authorized nuclear pharmacist as defined in 180 NAC 7-002;

(2) This individual meets the requirements specified in 180 NAC 7-024.02 and 7027 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or

(3) This individual is designated as an authorized nuclear pharmacist according to 180 NAC 3-014.10(B)(iii);

(iii) May be permitted to perform the actions authorized in 180 NAC 3-014.10(B)(i) and (ii) despite more restrictive language in license conditions;

(iv) Reserved;

(v) May designate a pharmacist, as defined in 180 NAC 1-002, as an authorized nuclear pharmacist if the individual is identified as of the effective date of these regulations, as an "authorized user" on a nuclear pharmacy license issued by the Department under 180 NAC 3 if:

(1) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

(2) The individual practiced at a pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the U.S. Nuclear Regulatory Commission (NRC); and

(vi) Must provide to the Department a copy of each individual's:

(1) Certification by a specialty board whose certification process has been recognized by the Department, U.S. Nuclear Regulatory Commission (NRC), or any Agreement State according to 7-024.01 with the written attestation signed by a preceptor as required by 7-024.03; or

(2) The Department, the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State license, or

(3) U.S. Nuclear Regulatory Commission (NRC) master materials licensee permit, or

(4) The permit issued by a licensee or U.S. Nuclear Regulatory Commission (NRC) master material permittee of broad scope, or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist, or

(5) 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 an earlier date as noticed by the U.S. Nuclear Regulatory Commission (NRC); and

(6) State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, according to 180 NAC 3-014.10, (B)(ii)(1) and (3), the individual to work as an authorized nuclear pharmacist.

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

(i) 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

(ii) Check each instrument for constancy and proper operation at the beginning of each day of use.

014.10(D)ADDITIONAL REQUIREMENTS. Nothing in 180 NAC 3-014.10 relieves the licensee from complying with applicable U.S. Food and Drug Administration (FDA), other Federal, and State requirements governing radioactive drugs.

014.10(E)ELUATE CONTAMINATION TESTING. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators must test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, according to 180 NAC 7-045. The licensee must record the results of each test and retain each record for 3 years after the record is made. The licensee must report the results of any test that exceeds the permissible concentration listed in 180 NAC 7-045 at the time of generator elution, according to 180 NAC 7-120.

014.10(F)POSITRON EMISSION TOMOGRAPHY (PET). Licensees authorized under 180 NAC 3-010.11 to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium must:

(i) Comply with applicable U.S. Food and Drug Administration (FDA), other Federal, and State requirements governing radioactive drugs;

(ii) Satisfy the labeling requirements in 180 NAC 3-014.10(A)(iv) for each Positron Emission Tomography (PET) radioactive drug transport radiation shield and each syringe, vial, or other container;

(iii) Possess and use instrumentation to measure the radioactivity of the Positron Emission Tomography (PET) radioactive drugs and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in 180 NAC 3-014.10(C).

(iv) Require that any individual that prepares Positron Emission Tomography (PET) radioactive drugs in a pharmacy to be:

(1) An authorized nuclear pharmacist that meets the requirements in 180 NAC 3014.10, (B)(ii); or

(2) An individual under the supervision of an authorized nuclear pharmacist according to 180 NAC 7-018; and

(v) Meet the requirements of 180 NAC 3-014(B)(vi).

014.10(G)LABELING. A licensee must satisfy the labeling requirements in 180 NAC 3-014.10(A)(iv).

014.11RESERVED.

014.12MANUFACTURE AND DISTRIBUTION OF SOURCES OR DEVICES CONTAINING RADIOACTIVE MATERIAL FOR MEDICAL USE. An applicant for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed according to 180 NAC 7 for use as a calibration, transmission or reference source or for the uses listed in 180 NAC 7-055, 7-065, 7-067 and 7-085 must:

(A) Satisfy the general requirements in 180 NAC 3-011.

(B) Submit 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 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 and accidents;

(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 which is referenced on the label.

(C) Affix a label to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the Department has approved distribution of the (name of the source or device) to persons licensed to use radioactive material identified in 180 NAC 7-032, 7-055, 7-065 and 7-067 as appropriate, and to persons who hold an equivalent license issued by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State.

(D) Register the source or device in the Sealed Source and Device Registry.

(E) Include in their application sufficient information to demonstrate that a 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 if the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months;

(F) Provide information to the Department to support a determination that the acceptable interval for test of leakage of radioactive material is longer than six months. The information includes, but is not limited to:

(i) Primary containment or 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; and

(G) Demonstrate that radiation safety officer or authorized user has training and experience requirements consistent with training specified in 180 NAC 15-008.01.

014.13REQUIREMENTS FOR LICENSE TO MANUFACTURE AND DISTRIBUTE INDUSTRIAL PRODUCTS CONTAINING DEPLETED URANIUM FOR MASS-VOLUME APPLICATIONS. The following requirements are applicable for license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications.

014.13(A)APPLICATION. An applicant for a specific license to manufacture industrial products and devices containing depleted uranium for use according to 180 NAC 3-007.04 or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State must:

(i) Satisfy the general requirements specified in 180 NAC 3-011;

(ii) Submit 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 year a radiation dose in excess of 10% of the annual limits specified in 180 NAC 4-005.01; and

(iii) Submit 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.

014.13(B)DEMONSTRATION. In the case of an industrial product or device whose unique benefits are questionable the licensee must demonstrate that the product or device combines a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

014.13(C)END USE. Any application for a specific license under 180 NAC 3-014.13 must demonstrate that the end use or uses of the industrial product or device can be reasonably foreseen.

014.13(D) ADDITIONAL REQUIREMENTS. Each person licensed according to 180 NAC 3-014.13(A) must:

(i) 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;

(ii) Label or mark each unit to:

(a) 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

(b) 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 (NRC) or of an Agreement State;

(iii) 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";

(iv) Furnish:

(1) A copy of the general license contained in 180 NAC 3-007.04 and a copy of Department Form NRH-11 to each person to whom the licensee transfers depleted uranium in a product or device for use according to the general license contained in 180 NAC 3-007.04; or

(2) A copy of the general license contained in the U.S. Nuclear Regulatory Commission (NRC) or Agreement State's regulation equivalent to 180 NAC 3007.04 and a copy of the U.S. Nuclear Regulatory Commission (NRC) or Agreement State's certificate; or alternatively, furnish a copy of the general license contained in 180 NAC 3-007.04 and a copy of Department Form NRH-11 to each person to whom the licensee transfers depleted uranium in a product or device for use according to the general license of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State under requirements substantially the same as those in 180 NAC 3-007.04;

(v) Report to the Department all transfers of industrial products or devices to persons for use under the general license in 180 NAC 3-007.04. Such report must identify each general licensee by name and address, an individual by name and 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 must 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 180 NAC 3-007.04 during the reporting period, the report must so indicate; and

(vi) File a report which identifies each general licensee by name and address, an individual by name and 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 must be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. The licensee must report:

(1) To the U.S. Nuclear Regulatory Commission (NRC) all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission (NRC) general license in 10 CFR 40.25;

(2) To the responsible State agency all transfers of devices manufactured and distributed according to 180 NAC 3-014.13 for use under a general license in that State's regulations equivalent to 180 NAC 3-007.04;

(3) To the U.S. Nuclear Regulatory Commission (NRC) if no transfers have been made by the licensees during the reporting period; and

(4) To the responsible Agreement State Agency, upon the request of the Department, if no transfers have been made to general licensees within a particular Agreement State during the reporting period;

(vii) Keep records showing the name, address, and point of contact for each general licensee to whom the licensee transfers depleted uranium in industrial products or devices for use according to the general license provided in 180 NAC 3-008.04 or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) or of an Agreement State. The records must be maintained for a period of two years and must show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements; and

(viii) Demonstrate that the radiation safety officer or authorized user have training and experience consistent with the requirements of training specified in 180 NAC 15008.01.

014.14SERIALIZATION OF NATIONALLY TRACKED SOURCES. Each licensee who manufactures a nationally tracked source after February 6, 2007, must assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alphanumeric characters.

014.15RESERVED.

180 Neb. Admin. Code, ch. 3, § 014

Amended effective 6/15/2021