S.C. Code Regs. § § 61-63.II.RHA 2.7

Current through Register Vol. 48, 12, December 27, 2024

Section 61-63.II.RHA 2.7 - Special Requirements for Issuance of Certain Specific Licenses for Radioactive Materials

2.7.1 Licensing the Manufacture and the Distribution of Devices to Persons Generally Licensed under RHA 2.4.2.

2.7.1.1 An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under RHA 2.4.2 or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State will be approved if:

2.7.1.1.1 the applicant satisfies the general requirements of RHA 2.6;

2.7.1.1.2 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:

2.7.1.1.2.1 the device can be safely operated by persons not having training in radiological protection;

2.7.1.1.2.2 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 RHA 3.5.1; and

2.7.1.1.2.3 under accident conditions (such as fire and explosion) associated with handling, storage, and the 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: 15 rems head and trunk; active bloodforming organs; gonads; or lens of eye: Hands and forearms; 200 rems feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter. Other organs 50 rems.

2.7.1.1.3 Each device bears a durable, legible, clearly visible label or labels approved by the Department, which contain in a clearly identified and separate statement:

2.7.1.1.3.1 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);

2.7.1.1.3.2 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

2.7.1.1.3.3 The information called for in the following statement in the same or substantially similar form:

Receipt, possession, use, and transfer of this device Model³*, Serial No ³*, containing (Identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION-RADIOACTIVE MATERIAL

_______________________________________________

(Name of manufacturer or initial transferor)^3*

2.7.1.1.4 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 RHA 3.21, and the name of the manufacturer or initial distributor.

2.7.1.1.5 Each device meeting the criteria of RHA 2.4.2.3.11.1 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 RHA 3.21.

2.7.1.1.6 The device has been registered in the Sealed Source and Device Registry.

2.7.1.2 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 shall include in his 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 Department will consider information which includes, but is not limited to:

2.7.1.2.1 primary containment (source capsule);

2.7.1.2.2 protection of primary containment;

2.7.1.2.3 method of sealing containment;

2.7.1.2.4 containment construction materials;

2.7.1.2.5 form of contained radioactive material;

2.7.1.2.6 maximum temperature withstood during prototype test;

2.7.1.2.7 maximum pressure withstood during prototype tests;

2.7.1.2.8 maximum quantity of contained radioactive material;

2.7.1.2.9 radiotoxicity of contained radioactive material; and

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

2.7.1.3 In the event the applicant desires that the general licensee under RHA 2.4.2, or under the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, he shall include in his 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 a calendar quarter dose in excess of 10% of the limits specified in the table in RHA 3.2.1.

2.7.1.4 If a device containing radioactive material is to be transferred for use under the general license contained in RHA 2.4.2 of this part, each person that is licensed under RHA 2.7.1 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--

2.7.1.4.1 A copy of the general license contained in RHA 2.4.2; if RHA 2.4.2.3.2 through 2.4.2.3.4 or RHA 2.4.2.3.11 do not apply to the particular device, those paragraphs may be omitted.

2.7.1.4.2 A copy of RHA 2.4.1, 2.18, 3.44, and 3.45 of this part;

2.7.1.4.3 A list of the services that can only be performed by a specific licensee;

2.7.1.4.4 Information on acceptable disposal options including estimated costs of disposal; and

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

2.7.1.5 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 RHA 2.7.1 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--

2.7.1.5.1 A copy of the NRC or Agreement State or regulations equivalent to RHA 2.4.1, 2.4.2, 2.18, 3.44 and 3.45 of this part or a copy of these Agreement State regulations. If a copy of the Department's regulations is provided to a prospective general licensee in lieu of the NRC regulations, it shall be accompanied by a note explaining that use of the device is regulated by the NRC or other Agreement State; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted.

2.7.1.5.2 A list of the services that can only be performed by a specific licensee;

2.7.1.5.3 Information on acceptable disposal options including estimated costs of disposal; and

2.7.1.5.4 The name or title, address, and phone number of the contact at the appropriate regulatory agency, NRC or Agreement State, having jurisdiction at the devices new location, from which additional information may be obtained.

2.7.1.6 An alternative approach to informing customers may be proposed by the licensee for approval by the Department.

2.7.1.7 Each device that is transferred after February 2004 must meet the labeling requirements in RHA 2.7.1.4.3 through 2.7.1.4.5.

2.7.1.8 If a notification of bankruptcy has been made under RHA 2.10.6 or the license is to be terminated, each person licensed under RHA 2.7.1 shall provide, upon request, to the Department and to the appropriate regulatory agency, NRC or Agreement State, having jurisdiction at the devices new location, records of final disposition required under RHA 2.7.1.9.2.

2.7.1.9 Each person licensed under RHA 2.7.1 to initially transfer devices to generally licensed persons shall comply with the requirements of this section.

2.7.1.9.1 The person shall report all transfers of devices to persons for use under the general license in RHA 2.4.2 of these regulations and for use under equivalent NRC regulations ( 10 CFR 31.5) or other Agreement State's regulations and all receipts of devices from persons licensed under RHA 2.4.2 to the Department or to the appropriate NRC office or other Agreement State office. The report must be submitted on a quarterly basis on NRC Form 653--"Transfers of Industrial Devices Report" or in a clear and legible report containing all of the data required by the form. (NRC Form 653 may be obtained from the Department or found in NUREG-1556, Vol. 16.)

2.7.1.9.1.1 The required information for transfers to general licensees includes--

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

(ii) 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;

(iii) The date of transfer;

(iv) The type, model number, and serial number of the device transferred; and

(v) The quantity and type of radioactive material contained in the device.

2.7.1.9.1.2 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(s).

2.7.1.9.1.3 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.

2.7.1.9.1.4 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.

2.7.1.9.1.5 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.

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

2.7.1.9.1.7 If no transfers have been made to or from persons generally licensed under RHA 2.4.2 during the reporting period, the report must so indicate. If no transfers have been made to or from an NRC or other Agreement State during the reporting period, this information should be made available to the responsible agency upon their request.

2.7.1.9.2 The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this paragraph must be maintained for a period of 3 years following the date of the recorded event.

2.7.2 Licensing the Introduction of Radioactive Material Into Products in Exempt Concentration

In addition to the requirements set forth in RHA 2.6, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of a licensee or another to be transferred to persons exempt under 2.20.2.1.1 will be issued only if:

2.7.2.1 The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the radioactive material in the product or material at the time of transfer; and

2.7.2.2 The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in RHA 2.25 Schedule C, that reconcentration of the radioactive material in concentrations exceeding those in RHA 2.25 Schedule C is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being. Each person licensed under this section 2.7.2 shall file an annual report with the Department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to this section 2.7.2 during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within 30 days thereafter.

2.7.3 Manufacture and Distribution of Radioactive Materials for Medical Use Under General License.

In addition to the requirements set forth in RHA 2.6 above, a specific license authorizing the distribution of radioactive material for use by physicians under the general license of 2.4.6 will be issued only if:

2.7.3.1 The applicant submits evidence that the radioactive material is to be manufactured, labeled and packaged in accordance with a new drug application Administration has approved, or in accordance with a license for a biologic product issued by the Secretary, Department of Health, Education, and Welfare; and,

2.7.3.2 The following statement, or a substantially similar statement which contains information called for in the following statement, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package: "This radioactive drug may be received, possessed, and used only by physicians licensed to dispense drugs in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license (or the equivalent) of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State."

__________

(Name of Manufacturer)

2.7.4 Manufacture and Distribution of Radioactive Materials 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 2.4.3 of this part will be applied if:

2.7.4.1 The applicant satisfies the general requirements specified in RHA 2.6.

2.7.4.1.1 Has specialized training in the diagnostic or therapeutic use of the sealed source considered or has experience equivalent to such training, and

2.7.4.1.2 Is a physician.

2.7.4.2 The radioactive material is to be prepared for distribution in prepackaged units of:

2.7.4.2.1 Iodine-125 in units not exceeding 10 microcuries each.

2.7.4.2.2 Iodine-131 in units not exceeding 10 microcuries each.

2.7.4.2.3 Carbon-14 in units not exceeding 10 microcuries each.

2.7.4.2.4 Hydrogen-3 (tritium) in units not exceeding 50 microcuries each.

2.7.4.2.5 Iron-59 in units not exceeding 20 microcuries each.

2.7.4.2.6 Cobalt-57 in units not exceeding 10 microcuries (0.37 MBq) each.

2.7.4.2.7 Selenium-75 in units not exceeding 10 microcuries each.

2.7.4.2.8 Mock Iodine-125 in units not exceeding 0.05 microcuries of Iodine 129 and 0.005 microcuries of Americium 241 each.

2.7.4.3 Each prepackage unit bears a durable, clearly visible label:

2.7.4.3.1 Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries (0.37 MBq) of Iodine-125, Iodine-131, Selenium-75, or Carbon-14; 50 microcuries (1.85 MBq) of Hydrogen-3 (tritium); or 20 microcuries (0.74 MBq) of Iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of Iodine-129 and 0.005 microcurie (0.185 kBq) of Americium-241 each; or Cobalt-57 in units not exceeding 10 microcuries (0.37 MBq); and

2.7.4.3.2 Displaying the radiation caution symbol described in RHA 3.8 (3.8.1) of Part III and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals."

2.7.4.4 The following statement, or 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 radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the United States Nuclear Regulatory Commission, an Agreement State, or a licensing State."

__________

Name of Manufacturer

2.7.4.5 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 RHA 3.12.

2.7.5 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing radioactive material for medical use under Part IV.

2.7.5.1 An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons licensed pursuant to Part IV of these regulations will be approved if:

2.7.5.1.1 The applicant satisfies the general requirements specified in RHA 2.6;

2.7.5.1.2 The applicant submits evidence that the applicant is at least one of the following:

2.7.5.1.2.1 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);

2.7.5.1.2.3 Licensed as a pharmacy by a State Board of Pharmacy;

2.7.5.1.2.4 Operating as a nuclear pharmacy within a Federal medical institution; or

2.7.5.1.2.5 A Positron Emission Tomography (PET) drug production facility registered with a State agency.

2.7.5.1.3 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

2.7.5.1.4 The applicant commits to the following labeling requirements:

2.7.5.1.4.1 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.

2.7.5.1.4.2 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.

2.7.5.2 A licensee described by paragraph 2.7.5.1.2.3 or 2.7.5.1.2.4 of this section:

2.7.5.2.1 May prepare radioactive drugs for medical use, as defined in RHA 4.2 provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in 2.7.5.2.2 and 2.7.5.2.4 of this section, or an individual under the supervision of an authorized nuclear pharmacist as specified in RHA 4.15.

2.7.5.2.2 May allow a pharmacist to work as an authorized nuclear pharmacist if:

2.7.5.2.2.1 This individual qualifies as an authorized nuclear pharmacist as defined in RHA 4.2.

2.7.5.2.2.2 This individual meets the requirements specified in Part 4 of this Regulation, and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

2.7.5.2.2.3 This individual is designated as an authorized nuclear pharmacist in accordance with 2.7.5.2.4 of this section.

2.7.5.2.3 The actions authorized in 2.7.5.2.1 and 2.7.5.2.2 of this section are permitted in spite of more restrictive language in license conditions.

2.7.5.2.4 May designate a pharmacist (as defined in RHA 4.2) as an authorized nuclear pharmacist if:

2.7.5.2.4.1 The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

2.7.5.2.4.2 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 NRC.

2.7.5.2.5 Shall provide to the Department:

2.7.5.2.5.1 A copy of each individual's certification by a specialty board whose certification process has been recognized by the Nuclear Regulatory Commission or an Agreement State as specified in RHA 4.22.1; or

2.7.5.2.5.2 The Commission or Agreement State license; or

2.7.5.2.5.3 Commission master materials licensee permit; or

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

2.7.5.2.5.5 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 NRC; and

2.7.5.2.5.6 A copy of the State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, under paragraphs RHA 2.7.5.2.2.1 and 2.7.5.2.2.3, the individual to work as an authorized nuclear pharmacist.

2.7.5.3 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:

2.7.5.3.1 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

2.7.5.3.2 Check each instrument for constancy and proper operation at the beginning of each day of use.

2.7.5.4 A licensee shall satisfy the labeling requirements in paragraph 2.7.5.1.4 of this section.

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

2.7.6 [Deleted]

2.7.7 Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use

2.7.7.1 An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Part IV of these regulations for use as a calibration, transmission, or reference source or for the uses listed in RHA 4.46, 4.56, 4.58 and 4.88 of Part IV of these regulations will be approved if:

2.7.7.1.1 The applicant satisfies the general requirements in RHA 2.6 of this Part; and

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

2.7.7.1.2.1 The radioactive material contained, its chemical and physical form, and amount;

2.7.7.1.2.2 Details of design and construction of the source or device;

2.7.7.1.2.3 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;

2.7.7.1.2.4 For devices containing radioactive material, the radiation profile of a prototype device;

2.7.7.1.2.5 Details of quality control procedures to assure that production sources and devices meet the standards of design and prototype tests;

2.7.7.1.2.6 Procedures and standards for calibrating sources and devices;

2.7.7.1.2.7 Legend and methods for labeling sources and devices as to their radioactive content;

2.7.7.1.2.8 Instruction 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 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;

2.7.7.1.3 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 (insert name of source or device) is licensed by the Department for distribution to persons licensed pursuant to RHA 4.28, RHA 4.46, 4.56 and 4.58 of Part IV of these regulations or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

2.7.7.1.4 The source or device has been registered in the Sealed Source and Device Registry.

2.7.7.2 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 shall include in his 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. In determining the acceptable interval for test of leakage of radioactive material, the Department will consider information that includes, but is not limited to:

2.7.7.2.1 Primary containment (source capsule);

2.7.7.2.2 Protection of primary containment;

2.7.7.2.3 Method of sealing containment;

2.7.7.2.4 Containment construction materials;

2.7.7.2.5 Form of contained radioactive material;

2.7.7.2.6 Maximum temperature withstood during prototype tests;

2.7.7.2.7 Maximum pressure withstood during prototype tests;

2.7.7.2.8 Maximum quantity of contained radioactive material;

2.7.7.2.9 Radiotoxicity of contained radioactive material; and

2.7.7.2.10 Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

2.7.7.3 If an application is filed pursuant to RHA 2.7.7.1 on or before August 9, 1977, for a license to manufacture and distribute a source or device that was distributed commercially on or before July 9, 1977, the applicant may continue the distribution of such source or device to authorized licenses until the Department issues the license or notifies the applicant otherwise.

2.7.8 Manufacture and distribution of radioactive materials for medical use under general license. In addition to the requirements set forth in RHA 2.6 above, a specific license authorizing the distribution of radioactive material for use by physicians under the general license of 2.4.6 will be issued only if:

2.7.8.1 The applicant submits evidence that the radioactive material is to be manufactured, labeled and packaged in accordance with a new drug application which the Commissioner of Food and Drug Administration, has approved, or in accordance with a license for a biologic product issued by the Secretary, Department of Health, Education, and Welfare; and,

2.7.8.2 The following statement, or a substantially similar statement which contains information called for in the following statement, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package:

"This radioactive drug may be received, possessed, and used only by physicians licensed to dispense drugs in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license or the equivalent of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

__________

(Name of Manufacturer)

2.7.9 Manufacture and Distribution of Radioactive Materials 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 2.4.3 of this Part will be approved if:

2.7.9.1 The applicant satisfies the general requirements specified in RHA 2.6.

2.7.9.2 The radioactive material is to be prepared for distribution in prepackaged units of:

2.7.9.2.1 Iodine 125 in units not exceeding 10 microcuries each.

2.7.9.2.2 Iodine 131 in units not exceeding 10 microcuries each.

2.7.9.2.3 Carbon 14 in units not exceeding 10 microcuries each.

2.7.9.2.4 Hydrogen 3 (tritium) in units not exceeding 50 microcuries each.

2.7.9.2.5 Iron 59 in units not exceeding 20 microcuries each.

2.7.9.2.6 Cobalt-57 in units not exceeding 10 microcuries each.

2.7.9.2.7 Selenium-75 in units not exceeding 10 microcuries each.

2.7.9.2.8 Mock Iodine-125 in units not exceeding 0.05 microcuries of Iodine-129 and 0.005 microcuries of Americium-241 each.

2.7.9.3 Each prepackaged unit bears a durable, clearly visible label:

2.7.9.3.1 Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries of iodine-125, Iodine-131, Carbon-14, Cobalt-57, Selenium-75; 50 microcuries of Hydrogen-3; 20 microcuries of Iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie of Iodine-129 and 0.005 microcurie of Americium-241 each; and

2.7.9.3.2 Displaying the radiation caution symbol described in RHA 3.8 (3.8.1) of Part III and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals."

2.7.9.4 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 radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the United States Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

__________

Name of Manufacturer

2.7.9.5 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.

2.7.10 Manufacture and Distribution of Radiopharmaceuticals Containing Radioactive Material for Medical Use Under Group Licenses.

2.7.10.1 An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to RHA 2.7.3 for the uses listed in Group I, Group II, IV, or V of RHA 2.26 Schedule D of this part will be approved if:

2.7.10.1.1 The applicant satisfies the general requirements specified in RHA 2.6 of this part;

2.7.10.1.2 The applicant submits evidence that:

2.7.10.1.2.1 The radiopharmaceutical containing radioactive material will be manufactured, labeled and packed 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), a biologic product license issued by FDA or a "Notice of Claimed Investigational Exemption for a New Drug" (IND) that has been accepted by the FDA; or

2.7.10.1.2.2 The manufacture and distribution of the radiopharmaceutical containing radioactive material is not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

2.7.10.1.3 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 which is appropriate for safe handling and storage of radiopharmaceuticals by group licensees; and

2.7.10.1.4 The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is licensed by the Department for distribution to persons licensed pursuant to RHA 2.7.3 and RHA 2.26 Schedule D, Group I, Group II, Group IV, and V of Part II, as appropriate, or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State or that an application for such license has been filed with the Department on or before August 9, 1977 and is still pending.

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

2.7.10.2 If an application is filed pursuant to RHA 2.7.10.1 on or before [FN**] [Aug. 9, 1977], for a license to manufacture and distribute a radiopharmaceutical that was distributed commercially on or before [FN*] the applicant may continue the distribution of such radiopharmaceutical to group licensees until the Department issues the license or notifies the applicant otherwise.

2.7.11 Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material.

2.7.11.1 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 RHA 2.7.3 for the uses listed in Group III of RHA 2.26 Schedule D of this part will be approved if:

2.7.11.1.1 The applicant satisfies the general requirements specified in RHA 2.6 of this part;

2.7.11.1.2 The applicant submits evidence that:

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), a biologic product license issued by FDA, or a "Notice of Claimed Investigational Exemption for a New Drug" (IND) that has been accepted by the FDA; or

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.

2.7.11.1.3 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;

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

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

2.7.11.1.5.1 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

2.7.11.1.5.2 A statement that this generator reagent kit (as appropriate) is approved for use by persons licensed by the Department pursuant to RHA 2.7.3 and RHA 2.26 Schedule D, Group III of Part II or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State or that an application for such license has been filed with the Department on or before August 9, 1977 and is still pending. The labels, leaflets or brochures required by this paragraph 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.

2.7.11.2 If an application is filed pursuant to RHA 2.7.11.1 on or before ^** [Aug. 9, 1977], for a license to manufacture and distribute a generator or reagent kit that was distributed commercially on or before ^* the applicant may continue the distribution of such generator or reagent kit until the Department issues the license or notifies the applicant otherwise.

2.7.12 Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use.

2.7.12.1 An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to RHA 2.7.3 for use as a calibration or reference source or for the uses listed in Group VI of RHA 2.26 Schedule D of this part will be approved if:

2.7.12.1.1 The applicant satisfies the general requirements in RHA 2.6 of this Part; and

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

NOTE: Although the Department 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 reagent kits approved by the Department for use by persons licensed pursuant to RHA 2.7.3 and Group III of RHA 2.26 Schedule D of this part may submit the pertinent information specified in RHA 2.7.11.

2.7.12.1.2.1 The radioactive material contained, its chemical and physical form, and amount;

2.7.12.1.2.2 Details of design and construction of the source or device;

2.7.12.1.2.3 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;

2.7.12.1.2.4 For devices containing radioactive material, the radiation profile of a prototype device;

2.7.12.1.2.5 Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

2.7.12.1.2.6 Procedures and standards for calibrating sources and devices;

2.7.12.1.2.7 Legend and methods for labeling sources and devices as to their radioactive content;

2.7.12.1.2.8 Instruction 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 and printed in detail on a brochure which is referenced on the label;

2.7.12.1.3 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 Department for distribution to persons licensed pursuant to RHA 2.7.3 and RHA 2.26 Schedule D, Group VI of this part or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, or that a pending application for such license has been filed with the Department on or before August 9, 1977; provided, that such labeling for sources which do not require long term storage (e.g., gold-198 seeds) may be on a leaflet or brochure which accompanies the source.

2.7.12.2 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 shall include in his 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.

In determining the acceptable interval for test of leakage of radioactive material, the Department will consider information that includes, but is not limited to:

2.7.12.2.1 Primary containment (source capsule);

2.7.12.2.2 Protection of primary containment;

2.7.12.2.3 Method of sealing containment;

2.7.12.2.4 Containment construction materials;

2.7.12.2.5 Form of contained radioactive material;

2.7.12.2.6 Maximum temperature withstood during prototype tests;

2.7.12.2.7 Maximum pressure withstood during prototype tests;

2.7.12.2.8 Maximum quantity of contained radioactive material;

2.7.12.2.9 Radiotoxicity of contained radioactive material; and

2.7.12.2.10 Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

2.7.12.3 If an application is filed pursuant to RHA 2.7.12.1 on or before ^** [Aug. 9, 1977], for a license to manufacture and distribute a source or device that was distributed commercially on or before^*, the applicant may continue the distribution of such source or device to group licensees until the Department issues the license or notifies the applicant otherwise.

2.7.13 Calibration or reference sources containing Americium-241 or Radium-226: Requirements for license to manufacture or initially transfer.

2.7.13.1 An application for a specific license to manufacture or initially transfer calibration or reference sources containing Americium-241 or Radium-226, for distribution to persons generally licensed under RHA 2.4, will be approved if:

2.7.13.1.1 The applicant satisfies the general requirements of RHA 2.6;

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

2.7.13.1.2.1 Chemical and physical form and maximum quantity of Americium 241 or Radium-226 in the source;

2.7.13.1.2.2 Details of construction and design;

2.7.13.1.2.3 Details of the method of incorporation and binding of the Americium-241 or Radium-226 in the source;

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

2.7.13.1.2.5 Details of quality control procedures to be followed in manufacture of the source;

2.7.13.1.2.6 Description of labeling to be affixed to the source or the storage container for the source;

2.7.13.1.2.7 Any additional information, including experimental studies and tests, required by the Department to facilitate a determination of the safety of the source.

2.7.13.1.3 Each source will contain no more than 5 microcuries of Americium-241 or Radium-226.

2.7.13.1.4 The Department determines, with respect to any type of source containing more than 0.005 microcuries of Americium-241 or Radium-226, that:

2.7.13.1.4.1 The method of incorporation and binding of the Americium-241 or Radium-226 in the source is such that the Americium-241 will not be released or be removed from the source under normal conditions of use and handling of the source; and

2.7.13.1.4.2 The source has been subjected to and has satisfactorily passed the appropriate tests prescribed by 2.7.8.4.

2.7.13.1.5 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:

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

2.7.13.1.5.2 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.

2.7.13.1.5.3 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 RHA 2.7.8.1.5.4.

2.7.13.1.5.4 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.

2.7.13.2 Each person licensed under this Section shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement:

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

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

Name of manufacturer or initial transferor

2.7.13.3 Each person licensed under RHA 2.7.8 shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels (0.1 microcurie) of Americium-241 or Radium-226 before transferring the source to a general licensee under RHA 2.4.5, or comparable regulation. 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 methods capable of detecting 0.185 kilobecquerel (0.005 microcurie) of Americium-241 or Radium-226. If a source has been shown to be leaking or losing more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described in this section, the source must be rejected and must not be transferred to a general licensee RHA 2.4.5 or comparable regulation.

2.7.13.4 An applicant for a license under this Section shall, for any type of source which is designed to contain more than 0.185 kilobecquerel (0.005 microcurie) of Americium-241 or Radium-226, conduct prototype tests, in the order listed, on each of five prototypes of the source, which contains more than 0.185 kilobecquerel (0.005 microcurie) of Americium-241 or Radium-226, as follows:

2.7.13.4.1 Initial measurement. The quantity of radioactive material deposited on the source shall be measured by direct counting of the source.

2.7.13.4.2 Dry wipe test. The entire radioactive surface of the source shall be wiped with filter paper with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper or by direct measurement of the radioactivity on the source following the dry wipe.

2.7.13.4.3 Wet wipe test. The entire radioactive surface of the source shall be wiped with filter paper, moistened with water, with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper after it has dried or by direct measurement of the radioactivity on the source following the wet wipe.

2.7.13.4.4 Water soak test. The source shall be immersed in water at room temperature for a period of 24 consecutive hours. The source shall then be removed from the water. Removal of radioactive material from the source shall be determined by direct measurement of the radioactivity on the source after it has dried or by measuring the radioactivity in the residue obtained by evaporation of the water in which the source was immersed.

2.7.13.4.5 Dry wipe test. On completion of the preceding test in this section, the dry wipe test described in 2.7.13.4.2 shall be repeated.

2.7.13.4.6 Observations. Removal of more than 0.005 microcurie of radioactivity in any test prescribed by this section shall be cause for rejection of the source design. Results of prototype tests submitted to the Commission shall be given in terms of radioactivity in microcuries and percent of removal from the total amount of radioactive material deposited on the source.

[FN3*] The 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.

[FN**] Adoption date of these Regulatory changes

[FN*] 30 days prior to adoption date

2.7.14 Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer. An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under RHA 2.4.4, will be approved if:

2.7.14.1 The applicant satisfies the general requirements specified in RHA 2.6;

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

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

2.7.14.2.2 Details of construction and design;

2.7.14.2.3 Details of the method of binding or containing the tritium or promethium-147;

2.7.14.2.4 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;

2.7.14.2.5 Quality assurance procedures to be followed that are sufficient to ensure compliance with § 32.55;

2.7.14.2.6 Any additional information, including experimental studies and tests, required by the Department to facilitate a determination of the safety of the device.

2.7.14.3 Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium 147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber.

2.7.14.4 The Department determines that:

2.7.14.4.1 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;

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

2.7.14.4.3 The device is so designed that it cannot easily be disassembled; and

2.7.14.4.4 Prototypes of the device have been subjected to and have satisfactorily passed the tests required by 2.7.14.5.

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

2.7.14.5.1 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.

2.7.14.5.2 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 RHA 2.7.14.5.3.

2.7.14.5.3 Device designs are rejected for which the following has been detected for any unit:

2.7.14.5.3.1 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

2.7.14.5.3.2 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

2.7.14.5.3.3 Any other evidence of physical damage.

2.7.14.6 The device has been registered in the Sealed Source and Device Registry.

2.7.14.7 Quality assurance and prohibition of transfer for luminous safety devices for use in aircraft.

2.7.14.7.1 Each person licensed under RHA 2.7.14 shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147.

2.7.14.7.2 Each person licensed under RHA 2.7.14 shall:

2.7.14.7.2.1 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

2.7.14.7.2.2 Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (c) of this section and in the license issued under RHA 2.7.14, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

2.7.14.7.3 The licensee shall subject each inspection lot to:

2.7.14.7.3.1 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.

2.7.14.7.3.2 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:

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

2.7.14.7.3.2.2 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

2.7.14.7.3.2.3 Any other criteria specified in the license issued under RHA 2.7.14.

2.7.14.7.4 No person licensed under RHA 2.7.14 shall transfer to persons generally licensed under RHA 2.4.4, or under an equivalent general license of an Agreement State:

2.7.14.7.4.1 Any luminous safety device tested and found defective under any condition of a license issued under RHA 2.7.14, or RHA 2.7.14.8, 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

2.7.14.7.4.2 Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in RHA 2.7.14.8.2, unless:

2.7.14.7.4.2.1 A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under RHA 2.7.14; and

2.7.14.7.4.2.2 Each individual sub-lot is sampled, tested, and accepted in accordance with RHA 2.7.14.8.2 and RHA 2.7.14.10.2.1 and any other criteria that may be required as a condition of the license issued under RHA 2.7.14.

2.7.14.8 Material transfer reports for luminous safety devices for use in aircraft.

2.7.14.8.1 Each person licensed under RHA 2.7.14 shall file an annual report with the Director, Division of Radioactive Material, Bureau of Radiological Health, which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under RHA 2.4.4. 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 RHA 2.4.4 during the reporting period, the report must so indicate.

2.7.14.8.2 Each person licensed under RHA 2.7.14 shall report annually all transfers of devices to persons for use under a general license in an NRC or Agreement State's regulations that are equivalent to RHA 2.4.4 to the NRC or 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 NRC licensee or Agreement State during the reporting period, this information must be reported to the NRC or responsible Agreement State agency upon request of the Department.

2.7.15 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer. An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under RHA 2.4.7 will be approved if:

2.7.15.1 The applicant satisfies the general requirements specified in RHA 2.6

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

2.7.15.2.1 Chemical and physical form and maximum quantity of strontium-90 in the device;

2.7.15.2.2 Details of construction and design of the source of radiation and its shielding;

2.7.15.2.3 Radiation profile of a prototype device;

2.7.15.2.4 Procedures for and results of prototype testing of devices to demonstrate that the strontium90 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;

2.7.15.2.5 Details of quality control procedures to be followed in manufacture of the device;

2.7.15.2.6 Description of labeling to be affixed to the device;

2.7.15.2.7 Instructions for handling and installation of the device;

2.7.15.2.8 Any additional information, including experimental studies and tests, required by the Department to facilitate a determination of the safety of the device;

2.7.15.3 Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form;

2.7.15.4 Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by Part 3, 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;

2.7.15.5 The Department determines that:

2.7.15.5.1 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;

2.7.15.5.2 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 body in excess of 0.5 rem in a year under ordinary circumstances of use;

2.7.15.5.3 The device is so designed that it cannot be easily disassembled;

2.7.15.5.4 Prototypes of the device have been subjected to and have satisfactorily passed the tests required by RHA 2.7.15.6 of this section.

2.7.15.5.5 Quality control procedures have been established to satisfy the requirements of 10 CFR 32.62.

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

2.7.15.6.1 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 strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

2.7.15.6.2 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 RHA 2.7.15.6.3.

2.7.15.6.3 Device designs are rejected for which the following has been detected for any unit:

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

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

2.7.15.6.3.3 Any other evidence of physical damage.

2.7.15.7 The device has been registered in the Sealed Source and Device Registry.

2.7.16 Requirements for license to initially transfer source material for use under the 'small quantities of source material' general license

2.7.16.1 An application for a specific license to initially transfer source material for use under RHA 2.3, or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State, will be approved if:

2.7.16.1.1 The applicant satisfies the general requirements specified in RHA 2.6; and

2.7.16.1.2 The applicant submits adequate information on, and the Department approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.

2.7.16.2 Conditions of licenses to initially transfer source material for use under the 'small quantities of source material' general license: Quality control, labeling, safety instructions, and records and reports

2.7.16.2.1 Each person licensed under RHA 2.7.16 shall label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material."

2.7.16.2.2 Each person licensed under RHA 2.7.16 shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.

2.7.16.2.3 Each person licensed under RHA 2.7.16 shall provide the information specified in this paragraph to each person to whom source material is transferred for use under RHA 2.3, or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State provisions. This information must be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:

2.7.16.2.3.1 A copy of RHA 2.3 and RHA 2.18, or relevant equivalent regulations of the Agreement State.

2.7.16.2.3.2 Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.

2.7.16.2.4 Each person licensed under RHA 2.7.16 shall report transfers as follows:

2.7.16.2.4.1 File a report with the Department. The report shall include the following information:

2.7.16.2.4.1.1 The name, address, and license number of the person who transferred the source material;

2.7.16.2.4.1.2 For each general licensee under RHA 2.3,or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State provisions, to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and

2.7.16.2.4.1.3 The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.

2.7.16.2.4.2 File a report with each responsible Agreement State agency that identifies all persons, operating under provisions equivalent to RHA 2.3, to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the Agreement State being reported to:

2.7.16.2.4.2.1 The name, address, and license number of the person who transferred the source material; and

2.7.16.2.4.2.2 The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred.

2.7.16.2.4.2.3 The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the Agreement State.

2.7.16.2.4.3 Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under RHA 2.3, or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State provisions, during the current period, a report shall be submitted to the Department indicating so. If no transfers have been made to general licensees during the reporting period, this information shall be reported to the Department upon request.

2.7.16.2.5 Each person licensed under RHA 2.7.16 shall maintain all information that supports the reports required concerning each transfer to a general licensee for a period of 1 year after the event is included in a report to the Department.

S.C. Code Regs. § 61-63.II.RHA 2.7

Amended by State Register Volume 38, Issue No. 10, eff. 10/24/2014; State Register Volume 42, Issue No. 02, eff. 2/23/2018; State Register Volume 45, Issue No. 05, eff. 5/28/2021.