Code of Maine Rules, , Section 144-220-C-11 - Special requirements for a specific license to manufacture, assemble, repair or distribute commodities, products or devices which contain radioactive material | Code of Maine Rules

A. Licensing the introduction of radioactive material into products in exempt concentrations.

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 C.3.A. or equivalent regulations of the NRC, or an Agreement State, except in accordance with a license issued under 10 CFR 32.11

B. Licensing the distribution of radioactive material in exempt quantities. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing radioactive 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

C. Licensing the incorporation of radioactive material into gas and aerosol detectors. An application for a specific license authorizing the incorporation of radioactive material into gas and aerosol detectors to be distributed to persons exempt under C.3 will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32 . The maximum quantity of Radium-226 in each device shall not exceed 0.1 microcurie (3.7 kBq). NARM radionuclides are found in Appendix B to Part C.

D. Licensing the manufacture and distribution of devices to persons generally licensed under C.6.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 C.6.D or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if:

(a) The applicant satisfies the general requirements of C.8;

(b) The applicant submits 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:

(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 one year a dose in excess of 10 percent of the limits specified in D.6, and

(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:

Table D.1

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

(c) Each device bears a durable, legible, clearly visible label or labels approved by the Agency, which contain in a clearly identified and separate statement:

(i) 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),

(ii) The requirement, or lack of requirement, for leak 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, as appropriate, in the same or substantially similar form:

The receipt, possession, use, and transfer of this device, Model_______, Serial No._______7 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 for 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)

(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 Part D.1901 of this rule, and the name of the manufacturer or initial distributor.

(e) Each device meeting the criteria of Part C bears a permanent (e.g., 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 Part D.1901 of this rule.

(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, he or she shall include in his/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 which 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 Agency will consider information, which 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 C.6.D, or under equivalent regulations of the U.S. Nuclear Regulatory Commission 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-off mechanism and indicator, or remove the device from installation, he or she shall include in his/her 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 radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive in one year a dose in excess of 10 percent of the limits specified in D.1201.A.

(4) Conditions of transferring a device for use under a general license in C.11.D. Each person licensed under C.11.D to initially transfer devices to generally licensed persons shall:

(a) If a device containing radioactive material is to be transferred for use under a general license in C.11.D, each person that is licensed under C, shall provide the information specified in this paragraph to each person to whom a device may be transferred. The information shall be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information shall 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 contained in C.6.C; if paragraphs C.6.C(3)(b) through (d) or (m) do not apply to the particular device, these paragraphs may be omitted to each person to whom the owner directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in C.6.C.

(ii) A copy of C.25, 2201 and D.2202 of this rule;

(iii) A list of 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 Agency's policy is to issue high civil penalties for improper disposal.

(b) If radioactive material is to be transferred in a device for use under an equivalent general license of the NRC or an Agreement State, each person that is licensed under C.11.D. shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information shall be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information shall also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

(i) A copy of the C.6.A., C.6.D., D.2201, and D.2202 of this rule, or a copy of equivalent NRC or Agreement State's regulations. If a copy of the NRC regulations is provided to a prospective general licensee in lieu of the Agency's or Agreement State's regulations, it shall be accompanied by a note explaining that use of the device is regulated by the NRC or an Agreement State;

(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 Agency, NRC or Agreement State from which additional information may be obtained.

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

(d) Each device that is transferred after the effective date of this rule shall meet the labeling requirements in C.11.D(1)(c) through C.11.D(1)(e)

(e) If a notification of bankruptcy has been made under C.14.E or the license is to be terminated, each person licensed under C.11.D shall provide, upon request, to the Agency, the NRC, and to any appropriate Agreement State, records of final disposition required under C.11.D(5) (c).

(5) Material transfer reports and records. Each person licensed under C.11.D to initially transfer devices to generally licensed persons shall comply with the requirements of C.11.D.

(a) The person shall report all transfers of devices to persons for use under the general license in C.11.D and all receipts of devices from persons licensed under C.11.D in a clear and legible report containing all of the data required.

(b) Furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's, or Agreement State's regulation equivalent to C.6.D, or alternatively, furnish a copy of the general license contained in C.6.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. If a copy of the general license in C.6.D is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, Agreement State or under requirements substantially the same as those in C.6.D.

(c) Report to the Agency all transfers of such devices to persons for use under the general license in C.6.D.

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

(a) The identity of each general licensee by name and 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 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.

(ii) 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.

(iii) For devices received from a C.11.D. 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.

(iv) If the licensee makes changes to a device possessed by a C.11.D. 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 persons generally licensed under C.6.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.

(d) Reports to Other Agencies.

(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 10 CFR Part 32.52 .

(ii) Report to the responsible State Agency all transfers of devices manufactured and distributed pursuant to C.11.D for use under general license in that State's regulations equivalent to C.6.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 a device is transferred to the generally licensed person.

(iv) If no transfers have been made to Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the Nuclear Regulatory Commission.

(v) If no transfers have been made to general licensees within a particular State during the reporting period, this information shall be reported to the responsible State Agency upon request of the Agency.

(e) 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 C.6.D., or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of C.11.D(4).

(f) If radioactive material is to be transferred in a device for use under an equivalent general license of an Agreement State, or the NRC, each person that is licensed under this Part shall 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:

(i) A copy of the Agreement State's, or NRC's, regulations equivalent to Parts C and D or a copy of Parts C and D. If a copy of the Agency regulations is provided to a prospective general licensee in lieu of the appropriate regulations, it shall be accompanied by a note explaining that use of the device is regulated by another Agreement State, or the NRC; 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 phone number of the contact at the appropriate regulatory Agency from which additional information may be obtained.

(g) An alternative approach to informing customers may be proposed by the licensee for approval by the Agency.

(h) Each device that is transferred after February 19, 2002 must meet the labeling requirements in this Part.

(i) If a notification of bankruptcy has been made this Part or the license is to be terminated, each person licensed under Part C shall provide, upon request, to the Agency and to any appropriate Agreement State, or NRC records of final disposition required under this Part.

E. Special Requirements for the manufacture, assembly, or repair, or initial transfer of luminous safety devices for use in aircraft.

(1) An application 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 C.6.C will be approved if:

(a) The applicant satisfies the general requirements specified in C.8;

(b) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:

(i) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;

(ii) Details of construction and design;

(iii) Details of the method of binding or containing the tritium or promethium-147;

(iv) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;

(v) Quality assurance procedures to be followed that are sufficient to ensure compliance with C.11.E(3)..

(vi) Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the safety of the device;

(c) Each device will contain no more than 370 GBq (10 Ci) of tritium or 11.1 GBq (300 mCi) of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 5 µSv (0.5 mrad) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber; and

(d) The Agency determines that:

(i) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(ii) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;

(iii) The device is so designed that it cannot easily be disassembled; and

(iv) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (v) of this section.

(v) The applicant shall subject at least five prototypes of the device to tests as follows:

(1) The devices 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 of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

(2) The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (v)(3) of this section.

(3) Device designs are rejected for which the following has been detected for any unit:

(i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium- 147 from the device; or

(ii) Surface contamination of tritium or promethium- 147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or

(iii) Any other evidence of physical damage.

(vi) The device has been registered in the Sealed Source and Device Registry.

(e) The device has been registered in the Sealed Source and Device Registry.

(2) Labeling of devices.

(a) A person licensed under C.11.E to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under C.6.C of this rule shall, except as provided in C.11.E(2)(b) affix to each device a label containing the radiation symbol prescribed by D.1901 of this rule, such other information as may be required by the Agency including disposal instructions when appropriate, and the following or a substantially similar statement which contains the information called for in the following statement8:

The receipt, possession, use, and transfer of this device, Model ________, Serial No. _______9, containing (identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL

(Name of manufacturer, assembler, or initial transferor).

(b) If the Agency determines that it is not feasible to affix a label to the device containing all the information called for in C.11.E(2)(a) it may waive the requirements of that paragraph and require in lieu thereof that:

(i) A label be affixed to the device identifying:

(a) The manufacturer, assembler, or initial transferor; and

(b) The type of radioactive material; and

(ii) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:

(a) The name of the manufacturer, assembler, or initial transferor,

(b) The type and quantity of radioactive material,

(c) The model number,

(d) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the NRC or of an Agreement State, and

(e) Such other information as may be required by the Agency, including disposal instructions when appropriate.

(3) Quality assurance; prohibition of transfer.

(a) Each person licensed under C.11.E shall visually inspect each device and shall reject any that has an observable physical defect that could affect containment of the tritium or promethium -147.

(b) Each person licensed under C.11.E. shall:

(1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and

(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (c) of this section and in the license issued under C.11.E., to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

(c) The licensee shall subject each inspection lot to:

(1) 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 of tritium or promethium-147, such as absolute pressure and water immersion.

(2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective:

(i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device;

(ii) Levels of radiation in excess of 5 microgray (0.5 millirad) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the device contains promethium-147; and

(iii) Any other criteria specified in the license issued under C.11.E.

(d) No person licensed under C.11.E shall transfer to persons generally licensed under C.6.D of these rules or under an equivalent general license of an Agreement State:

(1) Any luminous safety device tested and found defective under any condition of a license issued under C.11.E, or paragraph (b) of this section, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (b)(2) of this section, unless:

(i) A procedure for defining sub lot size, independence, and additional testing procedures is contained in the license issued under C.11.E; and

(ii) Each individual sub lot is sampled, tested, and accepted in accordance with paragraphs (b)(2) and (d)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under C.11.E.

(4) Omitted

(5) Material transfer reports.

(a) Each person licensed under C.11.E shall file an annual report with the Agency, which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under C.6.J. The report must identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report must cover the year ending June 30 and must be filed within thirty (30) days thereafter. If no transfers have been made to persons generally licensed under C.6.J during the reporting period, the report must so indicate.

(b) Each person licensed under C.11.E shall report annually all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to C.6.J of these rules to the responsible Agreement State agency. The report must state the total quantity of tritium or promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. If no transfers have been made to a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State agency upon request of the agency.

F. Special Requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226 for distribution to persons Generally licensed under C.6.E.

(1) An application for a specific license to manufacture or initially transfer, calibration or reference sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under C.6.E will be approved if:

(a) The applicant satisfies the general requirement of C.8;

(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 185 Bq (0.005 µCi) of americium-241, 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 manufacture of the source;

(vi) Description of labeling to be affixed to the source or the storage container for the source;

(vii) Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the safety of the source;

(c) The applicant satisfies the requirements of Sections 32.57, 32.58, 32.59, 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent;

(d) Each source will contain no more than 185 kBq (5 µCi) of americium-241 or radium-226; and

(e) The Agency determines, with respect to any type of source containing more than 185 Bq (0.005 µCi) 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 or radium-226 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 paragraph (f) of this section.

(f) 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 paragraph (f)(iv) of this section.

(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) Omitted.

(3) Labeling of devices. Each person licensed under C.11.F 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 statement10:

The receipt, possession, use and transfer of this source, Model No.__, Serial No. __, are subject to a general license and the regulations of the NRC or an Agreement State. 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

(4) Leak testing of each source. Each person licensed under C.11.F shall perform a dry wipe test upon each source containing more than 3.7 kBq (0.1 µCi) of americium241 or radium-226 prior to transferring the source to a general licensee under C.6.E or equivalent regulations of an 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 paper shall be measured by using radiation detection instrumentation capable of detecting 185 Bq (0.005 µCi) of americium241or radium-226. If any has been shown to be leaking or losing more than 0.185 kilobecquerel (0.005 microcurie) of americium241, or radium226 by the methods described in this section, the source must be rejected and must not be transferred to a general licensee under C.6.E. of these rules or equivalent regulations of an Agreement State.

G. Serialization of nationally tracked sources. Each licensee who manufactures a nationally tracked source after February 6, 2007 shall assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters.

H. Manufacture and distribution of radioactive material for certain in-vitro clinical or laboratory testing under general license. An application for a specific license to manufacture or distribute radioactive material for use under the general license of C.6.F will be approved if:

(1) The applicant satisfies the general requirements specified in C.8.

(2) The radioactive material is to be prepared for distribution in prepackaged units of:

(a) Iodine-125 in units not exceeding 10 microcuries (370 kBq) each.

(b) Iodine-131 in units not exceeding 10 microcuries (370 kBq) each.

(c) Carbon-14 in units not exceeding 10 microcuries (370 kBq) each.

(d) Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each.

(e) Iron-59 in units not exceeding 20 microcuries (740 kBq) each.

(f) Cobalt-57 in units not exceeding 10 (370 kBq) microcuries each.

(g) Selenium-75 in units not exceeding 10 microcuries (370 kBq) each.

(h) Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each.

(3) Each prepackaged unit bears a durable, clearly visible label:

(a) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries (370 kBq) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries (1.85 MBq) of hydrogen-3 (tritium); 20 microcuries (740 kBq) of iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 (185 Bq) microcurie of americium-241 each; and

(b) Displaying the radiation caution symbol described in D.2001 and the words, "CAUTION, RADIOACTIVE MATERIAL," and "NOT FOR INTERNAL OR EXTERNAL USE IN HUMANS OR ANIMALS."

(4) The following statement, as appropriate, 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, 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 there from, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and general 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)

(5) The label affixed 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 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 D.2001 of this rule.

I. Licensing the manufacture and distribution of ice detection devices containing strontium-90.

(1) An application for a specific license to manufacture or initially transfer ice detection devices to persons generally licensed under C.6.G will be approved if:

(a) The applicant satisfies the general requirements of C.8; and

(b) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

(i) Chemical and physical form and maximum quantity of strontium -90 in the device;

(ii) Details of construction and design of the source of radiation and its shielding;

(iii) Radiation profile of a prototype device;

(iv) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;

(v) Details of quality control procedures to be followed in manufacture of the device;

(vi) Description of labeling to be affixed to the device;

(vii) Instructions for handling and installation of the device;

(viii) Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the safety of the device;

(c) Each device will contain no more than 1.85 MBq (50 µCi) of strontium -90 in an insoluble form;

(d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by D.1901(a) of this rule, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices; and

(e) The Agency determines that:

(i) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(ii) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his/her body in excess of 5 mSv (0.5 rem) in a year under ordinary circumstances of use;

(iii) The device is so designed that it cannot be easily disassembled;

(iv) Prototypes of the device have been subjected to and have satisfactorily passed the requirements of this section; and

(v) Quality control procedures have been established to satisfy the requirements of C.11(I)(2).

(f) The applicant shall subject at least five prototypes of the device to tests as follows:

(i) The devices 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 of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

(ii) The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (f)(iii) of this section.

(iii) Device designs are rejected for which the following has been detected for any unit:

a. A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device; or

b. Surface contamination of strontium-90 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or

c. Any other evidence of physical damage.

(g) The device has been registered in the Sealed Source and Device Registry.

(2) Quality assurance; prohibition of transfer.

(a) Each person licensed under C.11.I shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

(b) Each person licensed under C.11.I shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 37 Bq (2,200 disintegrations per minute) of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

(c) Each person licensed under C.11.I shall:

(i) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety related components of the distributed devices are capable of performing their intended functions; and

(ii) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (d) of this section and in the license issued under C.11.I, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

(d) Each person licensed under C.11.I shall subject each inspection lot to:

(i) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion.

(ii) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing, using methods of inspection adequate to determine compliance with the following criteria for defective: A leak resulting in a loss of 0.1 percent or more of the original amount of strontium 90 from the device and any other criteria specified in the license issued under C.11.I.

(e) No person licensed under C.11.I shall transfer to persons generally licensed under C.6.G of these rules, or under an equivalent general license of an Agreement State:

(i) Any ice detection device containing strontium 90 tested and found defective under the criteria specified in a license issued under C.11.I, unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(ii) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (c)(ii) of this section, unless:

(a) A procedure for defining sub lot size, independence, and additional testing procedures is contained in the license issued under C.11.I; and

(b) Each individual sub lot is sampled, tested, and accepted in accordance with paragraphs (c)(ii) and (e)(ii)(a) of this section and any other criteria as may be required as a condition of the license issued under C.11.I.

J. Manufacture and distribution of radiopharmaceuticals containing radioactive material for medical use under Part G licenses.

(1) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to Part G will be approved if:

(a) The applicant satisfies the general requirements specified in C.8 of this Part;

(b) The applicant submits 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); or

(ii) Registered or licensed with a State Agency as a drug manufacturer; or

(iii) Licensed as a pharmacy by a State Board of Pharmacy; or

(iv) Operating as a nuclear pharmacy within a federal medical institution.

(v) A positron emission tomography (PET) drug production facility registered with a State Agency.

(c) The applicant submits 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 The applicant satisfies the following labeling requirements:

(i) 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.

(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 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.

(2) A licensee described by paragraph (1)(b)(iii) or (iv) of this section:

(a) May prepare radioactive drugs for medical use, as defined in Part G.2, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraph (2)(b) and (2)(c) of this section, or an individual under the supervision of an authorized nuclear pharmacist as specified in Part G.

(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 Part G.2,

(ii) This individual meets the requirements specified in Part G 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 paragraph (2)(c) of this section.

(c) The actions authorized in paragraphs (2)(a) and (2)(b) of this section are permitted in spite of more restrictive language in license conditions.

(d) May designate a pharmacist (as defined in Part A.2 as an authorized nuclear pharmacist if the individual is identified as of December 2, 1994, as an authorized user on a nuclear pharmacy license issued by the Agency under this Part.

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

(ii) The individual practiced 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 dater as noticed by the NRC.

(e) Shall provide to the Agency a copy of each individual's:

(i) Certification by a specialty board whose certification process has been recognized by the Agency, the NRC or an Agreement State as specified in G.55.A with the written attestation signed by a preceptor as required by G.55B(2); or

(ii) The Agency, the NRC the Board of Pharmaceutical Specialties, the Commission or an Agreement State license, or

(iii) NRC master materials license permit, or

(iv) The permit issued by a licensee or NRC masters materials permittee of broad scope, or the authorization form from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist, and

(v) 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 under paragraphs C.11.J.(2)(b)(i) and C.11.J.(2)(b)(iii).

(vi) 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 NRC; and

(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-, beta-, 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 labelling requirements in C.J.1(c).

(5) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.

K. Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceuticals containing radioactive material. An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to Part G.200 will be approved if:

(1) The applicant satisfies the general requirements specified in C.8;

(2) The applicant submits evidence that:

(a) The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a Notice of Claimed Investigational Exemption for a New Drug (IND) that has been accepted by the FDA, or

(b) The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;

(3) The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit;

(4) The label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and

(5) The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains:

(a) Adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and

(b) A statement that this generator or reagent kit (as appropriate) is approved for use by persons licensed by the Agency pursuant to Part G.200 or under equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State. The labels, leaflets or brochures required by C.11.J are in addition to the labeling required by FDA and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

NOTE: Although the Agency does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have his/her reagent kits approved by the Agency for use by persons licensed pursuant to Part G.200 may submit the pertinent information specified in C.11.J.

L. Manufacture and distribution of sources or devices containing radioactive material for medical use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Part G for use as a calibration, transmission, or reference source or for the uses listed in Part G.400, G.500, G.600 and G.1000 will be approved if:

(1) The applicant satisfies the general requirements in C.8 of this Part.

(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(a) The radioactive material contained, its chemical and physical form, and amount,

(b) Details of design and construction of the source or device,

(c) 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,

(d) For devices containing radioactive material, the radiation profile of a prototype device,

(e) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,

(f) Procedures and standards for calibrating sources and devices,

(g) Legend and methods for labeling sources and devices as to their radioactive content, and

(h) 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, the 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.

(3) 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, and date of assay, and a statement that the name of source or device is licensed by the Agency for distribution to persons licensed pursuant to Part G.65, G.400, G.500 and G.600 or under equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State.

(4) The source or device has been registered in the Sealed Source and Device Registry.

(5) 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 his/her 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.

(6) In determining the acceptable interval for test of leakage of radioactive material, the Agency 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 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-volume applications.

(1) An application for specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to C.5.D or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if:

(a) The applicant satisfies the general requirements specified in C.8;

(b) The applicant submits 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 one year a radiation dose in excess of 10 percent of the limits specified in D.1201.; and

(c) The applicant submits 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 Agency will approve an application for a specific license under C.11.L 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 Agency may deny any application for a specific license under C.11.L if the end use(s) of the industrial product or device cannot be reasonably foreseen.

(4) Each person licensed pursuant to C.11.L a shall:

(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)

(i) Furnish a copy of the general license contained in C.5.D and a copy of HHE Form 860 to each person to whom he or she transfers depleted uranium in a product or device for use pursuant to the general license contained in C.5.D, 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 C.5.D 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 C.5.D and a copy of HHE Form 860 to each person to whom he or she 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 C.5.D;

(e) Report to the Agency all transfers of industrial products or devices to persons for use under general license in C.5.D. 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 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 C.5.D during the reporting period, the report shall so indicate;

(f)

(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 Section 40.25 of 10 CFR Part 40 ,

(ii) Report to the responsible State Agency all transfers of devices manufactured and distributed pursuant to C.11.L for use under a general license in that State's regulations equivalent to C.5.D,

(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 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person,

(iv) If no transfers have been made to 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; and

(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 C.5.D or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be maintained for a period of two 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.

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

8Devices licensed under C.28.E prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.

9The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

10 Sources licensed under C.28f prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.