Ariz. Admin. Code § 9-7-311

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-7-311 - Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices that Contain Radioactive Material

A. Licensing the manufacture and distribution of devices to persons generally licensed under R9-7-306(A).

1. The Department shall grant a specific license to manufacture or distribute each device that contains radioactive material, excluding special nuclear material, to persons generally licensed under R9-7-306(A) or equivalent regulations of the NRC, an Agreement State, or the Licensing State if:

a. The applicant satisfies the requirements of R9-7-309;

b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, pro-posed 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 a dose in excess of 10 percent of the limits specified in R9-7-408; 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:

(1) Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye: 150 mSv (15 rem);

(2) Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter; 2 Sv (200 rem);

(3) Other organs: 500 mSv (50 rem);

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

i. Instructions and precautions necessary to assure safe installation, operating, 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 the 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 one of the following statements in the same or substantially similar form:

The receipt, possession, use, and transfer of this device, Model _____, Serial No. _____, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a state with which the 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)

The receipt, possession, use and transfer of this device, Model _____, Serial No. _____, are subject to a general license or the equivalent, and the regulations of a Licensing State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION - RADIOACTIVE MATERIAL

__________________________________

(name of manufacturer or distributor)

d. The model, serial number, and name of manufacturer or distributor may be omitted from the label if the information location is specified in labeling affixed to the device;

e. Each device with a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label that provides the device model number and serial number, the isotope and quantity, the words, "Caution-Radioactive Material," the radiation symbol described in R9-7-428, and the name of the manufacturer or initial distributor;

f. Each device meets the criteria in 10 CFR 31.5(c)(13)(i) (revised December 19, 2014, incorporated by reference, available under R9-7-101, and containing no future editions or amendments.) and 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, "CautionRadioactive Material," and, if practicable, the radiation symbol described in R9-7-428; and

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

2. In the event the applicant desires that the device undergo mandatory testing at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, the application shall contain sufficient information to demonstrate that the longer interval is justified by performance characteristics of the device or similar de-vices 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 shall 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 R9-7-306(A), or under equivalent regulations of the NRC or an Agreement State or Licensing State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the application shall include written instructions to be followed by the general licensee, estimated calendar quarter doses associated with the activity or activities, and bases for the estimates. The submitted information shall demonstrate that performance of the activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of 10 percent of the limits specified in R9-7-408.

4. A licensee authorized under subsection (A) to distribute a device to a generally licensed person shall provide, if a device that contains radioactive material is to be transferred for use under the general license granted in R9-7-306(A), the name of each person that is licensed under subsection (A) and the information specified in this subsection for each person to whom a device will be transferred. The licensee shall provide this information before the device may be transferred. In the case of transfer through another person, the licensee shall provide the listed information to the intended user before initial transfer to the other person.

a. The licensee shall provide:

i. A copy of the general license, issued under R9-7-306(A);

ii. A copy of R9-7-443 and R9-7-445;

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

iv. Information on authorized disposal options, including estimated costs of disposal; and

v. A list of civil penalties for improper disposal.

b. The licensee shall:

i. Report on a quarterly basis to the responsible Agreement State or NRC all transfers of devices to persons for use under a general license in accordance with 10 CFR 32.52, revised December 19, 2014, incorporated by reference, available under R9-7-101, and containing no future editions or amendments;

ii. Maintain all information concerning transfers and receipts of devices that supports the reports required by subsection (A)(4)(b)(i); and

iii. Maintain records required by subsection (A)(4)(b)(i) for a period of at least three years following the date of the recorded event.

5. If radioactive material is to be transferred in a device for use under an equivalent general license of the NRC or another Agreement State, each person that is licensed under R9-7-304(B) shall provide the information specified in this subsection to each person to whom a device will be transferred. The licensee shall provide this information before the device is transferred. In the case of transfer through another person, the licensee shall provide the listed information to the intended user before initial transfer to the other person. The licensee shall provide:

a. A copy of the Agreement State's requirements that are equivalent to R9-7-306(A), R9-7-443, and R9-7-445, and to A.R.S. § 30-657. If a copy of NRC regulations is provided to a prospective general licensee in lieu of the Agreement State's requirements, the licensee shall explain in writing that use of the device is regulated by the Agreement State. If certain requirements do not apply to a particular device, the licensee may omit the requirement from the material provided;

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

c. Information on authorized disposal options, including estimated costs of disposal; and

d. The name, title, address, and telephone number of the individual at the Agreement State regulatory agency who can provide additional information.

6. A licensee may propose to the Department an alternate method of informing the customer.

7. If a licensee has notified the Department of bankruptcy under R9-7-313(E) or is terminating under R9-7-319, the licensee shall provide, upon request, to the Department, the NRC, or another Agreement State, records of the disposition as required under A.R.S. § 30-657.

8. A licensee authorized to transfer a device to a generally licensed person, shall comply with the following requirements:

a. The person licensed under subsection (A) shall report all transfers of devices to persons for use under a general license obtained under R9-7-306(A), and all receipts of devices from persons licensed under R9-7-306(A) to the Department, the NRC, or other affected Agreement State. The report shall be submitted on a quarterly basis, in a clear and legible form, and contain the following information:

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, the person licensed under subsection (A) shall submit an alternate address for the general licensee, along with information on the actual location of use;

ii. The name, title, and telephone number of a person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the applicable laws;

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.

b. If one or more intermediaries will temporarily possess the device at the intended place of use before its possession by the in-tended user, the report shall include the information required of the general licensee in subsection (A)(4) for both the intended user and each intermediary, clearly identifying the intended user and each intermediary.

c. For devices received from a general licensee, licensed under R9-7-306(A), the report shall include:

i. The identity of the general licensee by name and address;

ii. The type, model number, and serial number of the device received;

iii. The date of receipt; and

iv. In the case of a device not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

d. If the person licensed under subsection (A) makes a change to a device possessed by a general licensee so that the label must be changed to update required information, the report shall identify the general licensee, the device, and the changes to information on the device label.

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

f. The report shall clearly identify the person licensed under subsection (A) submitting the report and include the license number of the license.

g. If no transfers are made to or from persons generally licensed under R9-7-306(A) during a reporting period, the person licensed under subsection (A) shall submit a report indicating the lack of activity.

9. The licensee shall maintain records of all transfers for Department inspection. Records shall be maintained for at least three years after termination of the license to manufacture the generally licensed devices regulated under R9-7-306(A).

B. The Department shall grant a specific license to manufacture, assemble, repair, or initially transfer luminous safety devices that contain tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under R9-7-306(B), if the applicant satisfies:

1. The general requirements specified in R9-7-309; and

2. The requirements of 10 CFR 32.53 through 32.56, revised July 25, 2012, incorporated by reference, available under R9-7-101, and containing no future editions or amendments.

C. The Department shall grant a specific license to manufacture or initially transfer calibration or reference sources that contain americium-241, radium-226, or plutonium for distribution to persons generally licensed under R9-7-306(C) if the applicant satisfies:

1. The general requirements of R9-7-309; and

2. The requirements of 10 CFR 32.57, 32.58, 32.59, and 70.39, revised July 25, 2012, incorporated by reference, available under R9-7-101, and containing no future editions or amendments.

D. The Department shall grant a specific license to distribute radioactive material for use by a physician under the general license in R9-7-306(D) if:

1. The general requirements of R9-7-309; and

2. The requirements of 10 CFR 32.57, 32.58, 32.59, and 70.39, revised July 25, 2012, incorporated by reference, available under R9-7-101, and containing no future editions or amendments.

E. The Department shall grant for a specific license to manufacture or distribute radioactive material for use under the general license of R9-7-306(E) if:

1. The applicant satisfies the general requirements specified in R9-7-309.

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

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

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

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

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

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

f. Cobalt-57 or selenium-75 in units not exceeding 370 kilobecquerels (10 microcuries) each;

g. Mock iodine-125 in units not exceeding 1.85 kBq (50 nanocuries) of iodine-129 and 185 Bq (5 nanocuries) 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 370 kilobecquerels (10 microcuries) of iodine-125, iodine-131, cobalt-57, selenium-75, or carbon-14; 1.85 mega-becquerels (50 microcuries) of hydrogen-3 (tritium); 740 kilobecquerels (20 microcuries) of iron-59; or mock iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 185 becquerels (0.005 microcurie) of americium-241 each; and

b. Displaying the radiation caution symbol described in R9-7-428, the words, "CAUTION, RADIOACTIVE MATERIAL," and the phrase "Not for Internal or External Use in Humans or Animals."

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

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

_____________________

Name of Manufacturer

b. This radioactive drug may be received, acquired, possessed, and used only by physicians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation from the radioactive material, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State.

_____________________

Name of Manufacturer

5. The label affixed to the unit, or the leaflet or brochure that accompanies the package, contains adequate information about the precautions to be observed in handling and storing the specified 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 R9-7-434.

F. The Department shall grant for a specific license to manufacture and distribute ice detection devices to persons generally licensed under R9-7-306(F) if the applicant satisfies:

1. The general requirements of R9-7-309; and

2. The criteria of 10 CFR 32.61 and 32.62, revised July 25, 2012, incorporated by reference, available under R9-7-101, and containing no future editions or amendments.

G. The Department shall grant a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs that contain radioactive material for use by a person authorized in accordance with Article 7 of this Chapter, if the applicant meets all of the requirements in 10 CFR 30.32(j), revised November 21, 2023, or 10 CFR 32.72, revised August 24, 2023, both incorporated by reference, available under R9-7-101, and containing no future editions or amendments.

1. Authorization under this Section to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.

2. Each licensee authorized under this Section to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

a. Satisfy the labeling requirements in R9-7-431 for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium; and

b. Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in R9-7-449.

3. A licensee that is a pharmacy authorized under this Section to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual who prepares PET radioactive drugs be an:

a. Authorized nuclear pharmacist that meets the requirements in R9-7-712, or

b. Individual under the supervision of an authorized nuclear pharmacist as specified in R9-7-706.

4. A pharmacy, authorized under this Section to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of R9-7-712.

H. The Department shall grant a specific license to manufacture and distribute generators or reagent kits that contain radioactive material for preparation of radiopharmaceuticals by persons licensed according to 9 A.A.C. 7, Article 7 if:

1. The applicant satisfies the general requirements of R9-7-309;

2. The applicant submits evidence that:

a. The generator or reagent kit is to be manufactured, labeled and packaged according to the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, 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

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, including quantity, and date of assay; and

5. The label affixed to the generator or reagent kit, or the leaflet or brochure that 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 Department under 9 A.A.C. 7, Article 7, or equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State or Licensing State. The labels, leaflets, or brochures required by this subsection supplement the labeling required by FDA, and they may be separate from or, with the approval of FDA, combined with the labeling required by FDA.

I. The Department shall grant a specific license to manufacture and distribute sources and devices that contain radioactive material to a person licensed in accordance with Article 7 of this Chapter for use as a calibration, transmission, or reference source or for medical purposes, if the applicant meets all of the requirements in 10 CFR 32.74, revised July 25, 2012, incorporated by reference, available under R9-7-101, and containing no future editions or amendments.

J. Requirements for license to manufacture and distribute industrial products containing depleted uranium for mass volume applications.

1. The Department shall grant a specific license to manufacture industrial products and devices that contain depleted uranium for use under R9-7-305(F) or equivalent regulations of the NRC or another Agreement State if:

a. The applicant satisfies the general requirements in R9-7-309;

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 a radiation dose in excess of 10 percent of the limits specified in R9-7-408; 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 Department shall approve an application for a specific license under this subsection 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 Department may deny any application for a specific license under this subsection if the end use or uses of the industrial product or device cannot be reasonably foreseen.

4. Each person licensed under subsection (J)(1) shall:

a. Maintain the level of quality control required by the license in the manufacture of the industrial product or device and 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, the number of the license under which the product or device was manufactured or initially transferred, 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 regulations of the U.S. Nuclear Regulatory Commission or an Agreement State;

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

d. Furnish a copy of the general license contained in R9-7-305(F) and a copy of ARRA-23 to each person to whom depleted uranium in a product or device is transferred for use under a general license contained in R9-7-305(F); or

e. Furnish a copy of the general license contained in the NRC's or Agreement State's regulation equivalent to R9-7-305(F) and a copy of the NRC's or Agreement State's certificate, or alternatively, furnish a copy of the general license contained in R9-7-305(F) and a copy of ARRA-23 to each person to whom depleted uranium in a product or device is transferred for use under a general license of the NRC or an Agreement State, with a document explaining that use of the product or device is regulated by the NRC or an Agreement State under requirements substantially the same as those in R9-7-305(F);

f. Report to the Department all transfers of industrial products or devices to persons for use under the general license in R9-7-305(F). The report shall identify each general licensee by name and address, an individual by name or position who serves as the point of contact person for 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 a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under R9-7-305(F) during the reporting period, the report shall so indicate;

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

ii. Report to the responsible state agency all transfers of devices manufactured and distributed under subsection (J)(4)(f) for use under a general license in that state's regulations equivalent to R9-7-305(F);

iii. The report required in subsection (J)(4)(f)(i) or (ii) shall identify each general licensee by name and address, an individual by name or position who serves as the contact person for 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 a product or device is transferred to the generally licensed person;

iv. If no transfers have been made to NRC licensees during the reporting period, this information shall be reported to the NRC;

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

vi. Records showing the name, address, and contact person for each general licensee to whom depleted uranium in industrial products or devices is transferred for use under a general license provided in R9-7-305(F) or equivalent regulations of the NRC or of another Agreement State shall be maintained for a period of at least three years and show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the reporting requirements of this Section.

K. A licensee who manufactures nationally tracked sources, as defined in Article 4, shall:

1. Serialize the sources in accordance with 10 CFR 32.201, revised November 8, 2006, incorporated by reference, available under R9-7-101, and containing no future editions or amendments; and

2. Report manufacturing activities in accordance with R9-7-454.

Ariz. Admin. Code § R9-7-311

New Section R9-7-311 recodified from R12-1-311, at A.A.R. 813, effective March 22, 2018 (Supp. 18-1). Amended by final expedited rulemaking at 24 A.A.R. 2151, effective July 12, 2018 (Supp. 18-3). Amended by final expedited rulemaking at 30 A.A.R. 2681, effective 8/7/2024.