CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY
SUBCHAPTER b: RADIATION PROTECTION
PART 330 LICENSING OF RADIOACTIVE MATERIAL
SECTION 330.280 SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR, OR DISTRIBUTE COMMODITIES, PRODUCTS, OR DEVICES THAT CONTAIN RADIOACTIVE MATERIAL
Section 330.280 Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices that Contain Radioactive Material
a) Licensing the Introduction of Radioactive Material into Products in Exempt Concentrations
1) In addition to the requirements set forth in Section 330.250, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the radioactive material to persons exempted from this Part pursuant to Section 330.30 or 330.40(a) will be issued if:
A) 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 product or material and estimated concentration of the radioactive material in the product or material at the time of transfer; and
B) The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Appendix A, that reconcentration of the radioactive material in concentrations exceeding those in Appendix A 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.
2) Each person licensed under subsection (a) is required to maintain records of transfer of material and shall file a report with the Agency that shall identify the following:
A) Type and quantity of each product or material into which radioactive material has been introduced during the reporting period;
B) 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;
C) The radionuclide, activity and activity assay date of radioactive material introduced into each product or material; and
D) The initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee.
3) The licensee shall file the report within 30 days following:
A) 5 years after filing the preceding report; or
B) Filing an application for renewal of the license under Section 330.330; or
C) Notifying the Agency under Section 330.320(b) of the licensee's decision to permanently discontinue activities authorized under the license issued under this subsection (a).
4) The report shall cover the period between the filing of the preceding report and an occurrence specified in subsection (a)(3). If no transfers of radioactive material have been made under subsection (a) during the reporting period, the report shall so indicate.
5) The licensee shall maintain the record of a transfer for a period of 1 year after the event has been included in a report to the Agency.
b) Licensing the Distribution of Radioactive Material in Exempt Quantities
AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
1) An application for a specific license to distribute NARM to persons exempted, pursuant to Section 330.40(b) of this Part, will be approved if:
A) The radioactive material is not contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion or inhalation by, or application to, a human being;
B) The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product or device intended for commercial distribution; and
C) The applicant submits copies of prototype labels and brochures and the Agency approves such labels and brochures.
2) The license issued under subsection (b)(1) of this Section is subject to the following conditions:
A) No more than ten exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantities provided the sum of the fractions shall not exceed unity.
B) Each exempt quantity shall be separately and individually packaged. No more than ten such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to Section 330.40(b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 5 microSv (500 microrem) per hour.
C) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label that:
i) Identifies the radionuclide and activity; and
ii) Bears the words "Radioactive Material".
D) In addition to the labeling information required by subsection (b)(2)(C) of this Section, the label affixed to the immediate container, or an accompanying brochure, shall:
i) State that the contents are exempt from Licensing State requirements;
ii) Bear the words "Radioactive Material − Not for Human Use – Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals or into Products Manufactured for Commercial Distribution is Prohibited − Exempt Quantities Should Not Be Combined"; and
iii) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.
3) Each person licensed under this subsection (b) is required to maintain records and file reports as follows:
A) Records of transfer of material identifying, by name and address, each person to whom radioactive material is transferred for use under Section 330.40(b) of this Part or the equivalent regulations of an Agreement State, or a Licensing State and stating the kinds and quantities of radioactive material transferred. The licensee shall maintain the record of a transfer for a period of 1 year after the event is included in a summary report to the Agency.
B) The licensee shall file a summary report stating the total activity of each radioisotope transferred under the specific license with the Agency.
C) The licensee shall file the summary report within 30 days following:
i) 5 years after filing the preceding report; or
ii) Filing an application for renewal of the license under Section 330.330 of this Part; or
iii) Notifying the Agency under Section 330.320(b) of this Part of the licensee's decision to permanently discontinue activities authorized under the license issued under subsection (b) of this Section.
D) The report shall cover the period between the filing of the preceding report and an occurrence specified in subsection (b)(3)(C) of this Section. If no transfers of radioactive material have been made under subsection (b) of this Section during the reporting period, the report shall so indicate.
c) Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under Section 330.40(c)(3) of this Part will be approved if the application satisfies requirements equivalent to those contained in 10 CFR 32.26, published January 1, 1993, exclusive of subsequent amendments or editions. The maximum activity of radium-226 in each device shall not exceed 3.7 kBq (100 nCi).
d) Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed Under Section 330.220(b) of this Part
AGENCY NOTE: Section 330.280(n) of this Part contains requirements for radioactive material transfer reports and records.
1) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under Section 330.220(b) of this Part or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State will be approved if:
A) The applicant satisfies the general requirements of Section 330.250 of this Part.
B) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions and potential hazards of the device to provide reasonable assurance that:
i) The device can be safely operated by persons not having training in radiological protection;
ii) Under ordinary conditions of handling, storage and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device and it is unlikely that any person will receive in 1 year a dose in excess of 10 percent of the annual limits specified in 32 Ill. Adm. Code 340.210(a); 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:
Whole body; head and trunk; active blood-forming organs; gonads or lens of eye ............................. 150 mSv (15 rem)
Hands and forearms; feet and ankles or localized areas of skin averaged over areas no larger than 1 square centimeter.................................................................. 2 Sv (200 rem)
Other organs ........................................ 500 mSv (50 rem).
C) Each device bears a durable, legible, clearly visible label or labels approved by the Agency, that contain in a clearly identified and separate statement:
i) Instructions and precautions necessary to assure safe installation, operation and servicing of the device. Documents such as operating and service manuals may be identified in the label and used to provide this information;
ii) The requirement, or lack of requirement, for testing for leakage or contamination, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by radionuclide, activity and activity assay date; and
iii) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:
Devices Containing Radioactive Material Other Than Naturally Occurring Radioactive Material
The receipt, possession, use and transfer of this device, Model___, Serial No.9199_, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.
CAUTION – RADIOACTIVE MATERIAL
Name of Manufacturer or Distributor
AGENCY NOTE: The model, serial number and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.
Devices Containing Naturally-Occurring Radioactive Material
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
AGENCY NOTE: The model, serial number and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.
D) Each device having a separable source housing that provides the primary shielding for the source also bears on the source housing a durable label displaying the device model and serial number, the radionuclide and activity, the words "Caution – Radioactive Material", the radiation symbol described in 32 Ill. Adm. Code 340.Illustration A and the name of the manufacturer or distributor.
E) Each device meeting the criteria of 10 CFR 31.5(c)(13)(i) (2005) 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 32 Ill. Adm. Code 340.Illustration A.
2) Except as provided in this subsection, the interval between tests for proper operation of the on-off mechanism and indicator, if any, shall not exceed 6 months. The interval between tests for contamination of the device or for leakage of radioactive material from the device or for both shall not exceed 3 months for devices containing sources designed to emit alpha particles and 6 months for all other devices. In the event the applicant desires that the device be required to be tested at intervals longer than the above, the applicant shall include in the application sufficient information to demonstrate that such longer intervals are justified. The information shall include a description of the performance characteristics of the device or similar devices and of design features that have a significant bearing on the probability or consequences of contamination of the device or 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 or contamination of the device, the Agency will consider information that includes, but is not limited to:
A) Primary containment or 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 activity 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 Section 330.220(b) of this Part, or under 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, or contamination by, radioactive material, service the device, test the on-off mechanism and indicator or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated annual 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 an annual dose in excess of 10 percent of the limits specified in 32 Ill. Adm. Code 340.210(a).
4) A person licensed under subsection (d) of this Section to distribute devices to generally licensed persons shall provide the information in subsection (d)(4) of this Section to each person to whom a device is to be transferred for possession and use under the general license in Section 330.220(b) of this Part. This information shall be provided before a device is transferred. In the case of a transfer through an intermediate person, the information shall be provided to the intended user prior to transfer to the intermediate person. The required information is:
A) A copy of Section 330.220(b) of this Part;
AGENCY NOTE: If certain provisions of Section 330.220(b) of this Part do not apply to a particular device, they may be omitted; e.g., tests for leakage or contamination or proper operation of an on-off mechanism and indicator.
B) A copy of 32 Ill. Adm. Code 310.40, 330.310 and 340.1210, 1220 and 1260;
C) A list of the services that may only be performed by a specific licensee;
D) Information on acceptable disposal options, including estimated costs of disposal; and
E) A statement of the Agency's policy to take escalated enforcement action for improper disposal.
5) A person licensed under this subsection (d) to distribute devices to generally licensed persons shall provide the information in this subsection (d)(5) to each person to whom a device is to be transferred for possession and use under a general license equivalent to Section 330.220(b) of this Part in the regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State. This information shall be provided before a device is transferred. In the case of a transfer through an intermediate person, the information shall be provided to the intended user prior to transfer to the intermediate person. The required information is:
A) A copy of 10 CFR 31.5, 31.2, 30.51, 20.2201 and 20.2202 (2005) or the equivalent regulations of an Agreement State or Licensing State. If a copy of the NRC regulations is provided to a prospective general licensee in lieu of the applicable Agreement State or Licensing State regulations, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State or Licensing State;
AGENCY NOTE: If certain provisions of the regulations do not apply to a particular device, they may be omitted; e.g., tests for leakage or contamination or proper operation of an on-off mechanism and indicator.
B) A list of the services that may only be performed by a specific licensee;
C) Information on acceptable disposal options, including estimated costs of disposal;
D) A statement of the policies of the U.S. Nuclear Regulatory Commission and most Agreement States and Licensing States to take escalated enforcement action for improper disposal; and
E) The name or title, address and phone number of the contact at the U.S. Nuclear Regulatory Commission, Agreement State or Licensing State regulatory agency from whom additional information may be obtained.
6) A person licensed under this subsection (d) may propose, for approval by the Agency, an alternative method of informing customers.
7) Each device transferred after February 19, 2002, shall meet the labeling requirements of subsections (d)(1)(C), (D) and (E) of this Section.
8) If a license is to be terminated or if notification of bankruptcy is required by subsection (j) of this Section, a person licensed under this subsection (d) shall, upon request, provide to the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State the records of final disposition required by subsection (o)(8) of this Section.
e) Special Requirements for the Manufacture, Assembly or Repair of Luminous Safety Devices for Use in Aircraft
1) An application for a specific license to manufacture, assemble or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under Section 330.220(c) of this Part will be approved if:
A) The applicant satisfies the general requirements specified in Section 330.250 of this Part; and
B) The applicant satisfies the requirements of 10 CFR 32.53-32.55 and 32.101, published January 1, 1993, exclusive of subsequent amendments or editions, or their equivalent.
2) Each person licensed under this subsection (e) shall file an annual report with the Agency that shall state the total activity of tritium or promethium-147 transferred to persons generally licensed under Section 330.220(c) of this Part or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The report shall identify each general licensee by name and address, state the kinds and numbers of luminous devices transferred and specify the activity of tritium or promethium-147 in each kind of device. Each report shall cover the year ending June 30 and shall be filed within 30 days thereafter.
f) Special Requirements for License to Manufacture Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Generally Licensed Under Section 330.220(e) of this Part. An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under Section 330.220(e) of this Part will be approved if:
1) The applicant satisfies the general requirements of Section 330.250 of this Part; and
2) The applicant satisfies the requirements of 10 CFR 32.57 and 70.39 published January 1, 1993 and certifies that the applicant will satisfy, and subsequently satisfies, the requirements of 10 CFR 32.58, 32.59 and 32.102, published January 1, 1993, exclusive of subsequent amendments or editions.
g) Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute radioactive material for use under the general license of Section 330.220(f) of this Part, or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, will be approved if:
1) The applicant satisfies the general requirements specified in Section 330.250 of this Part.
2) The radioactive material is to be prepared for distribution in prepackaged units of:
A) Carbon-14 in units not exceeding 370 kBq (10 µCi) each.
B) Cobalt-57 in units not exceeding 370 kBq (10 µCi) each.
C) Hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 µCi) each.
D) Iodine-125 in units not exceeding 370 kBq (10 µCi) each.
E) Mock iodine-125 in units not exceeding 1.85 kBq (50 nCi) of iodine-129 and 185 Bq (5 nCi) of americium-241 each.
F) Iodine-131 in units not exceeding 370 kBq (10 µCi) each.
G) Iron-59 in units not exceeding 740 kBq (20 µCi) each.
H) Selenium-75 in units not exceeding 370 kBq (10 µCi) 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 kBq (10 µCi) of iodine-125, iodine-131, carbon-14, cobalt-57 or selenium-75; 1.85 MBq (50 µCi) of hydrogen-3 (tritium); 740 kBq (20 µCi) of iron-59; or mock iodine-125 in units not exceeding 1.85 kBq (50 nCi) of iodine-129 and 185 Bq (5 nCi) of americium-241 each; and
B) Displaying the radiation caution symbol described in 32 Ill. Adm. Code 340.910(a) and the words, "CAUTION – RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals".
4) One of the following statements, as appropriate, or a statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:
A) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, 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.
B) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, 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.
5) The label affixed to the unit, or the leaflet or brochure that accompanies the package, contains information about the precautions to be followed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the manufacturer shall state in the directions that this item shall be disposed of in compliance with 32 Ill. Adm. Code 340.1010(a).
h) Licensing the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under Section 330.220(g) of this Part, will be approved if:
1) The applicant satisfies the general requirements of Section 330.250; and
2) The criteria of 10 CFR 32.61, 32.62 and 32.103 published January 1, 1993, exclusive of subsequent amendments or editions, are met.
i) Manufacture and Distribution of Radiopharmaceuticals Containing Radioactive Material for Medical Use Under Specific Licenses. An application for a specific license to manufacture and distribute radiopharmeceuticals containing radioactive material for use by persons licensed pursuant to Section 330.260(a) for the uses described in 32 Ill. Adm. Code 335.3010, 335.4010 or 335.5010 will be approved if:
1) The applicant satisfies the general requirements specified in Section 330.250 of this Part;
2) The applicant submits information showing that:
A) The radiopharmaceutical containing radioactive material will be manufactured, labeled and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act; or
B) 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;
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 specific licensees; and
4) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, activity and activity assay date 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 Agency for distribution to persons licensed pursuant to Section 330.260(a) for radioactive material specified in 32 Ill. Adm. Code 335.3010, 335.4010 or 335.5010, as appropriate, or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State. The labels, leaflets or brochures required by this subsection (i) are in addition to the labeling required by the FDA and may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.
j) Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material
AGENCY NOTE: Although the Agency does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have such reagent kits approved by the Agency for use by persons licensed pursuant to Section 330.260(a) of this Part for generators or reagent kits specified in 32 Ill. Adm. Code 335.4010 may submit the pertinent information specified in this subsection (j).
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 Section 330.260(a) of this Part for the uses specified in 32 Ill. Adm. Code 335.4010 will be approved if:
1) The applicant satisfies the general requirements specified in Section 330.250 of this Part;
2) The applicant submits evidence that:
A) The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act; 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, activity and activity assay date; 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 the generator or reagent kit, as appropriate, is approved for use by persons licensed by the Agency pursuant to Section 330.260(a) of this Part and 32 Ill. Adm. Code 335.4010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State. The labels, leaflets or brochures required by this subsection (j) are in addition to the labeling required by the FDA and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.
k) Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Section 330.260(a) of this Part for use as a calibration or reference source or for the uses listed in 32 Ill. Adm. Code 335.6010, 335.7010 and 335.8010 will be approved if:
1) The applicant satisfies the general requirements in Section 330.250 of this Part;
2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:
A) The radioactive material contained, its chemical and physical form and activity;
B) Details of design and construction of the source or device;
C) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;
D) For devices containing radioactive material, the radiation profile of a prototype device;
E) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;
F) Procedures and standards for calibrating sources and devices;
G) Legend and methods for labeling sources and devices as to their radioactive content; and
H) Instructions for handling and storing sources or devices from the radiation safety standpoint. These instructions shall be included on a durable label attached to each source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure that is referenced on the label;
3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, activity and activity assay date, radiation symbol and/or "Caution Radioactive Material", serial number, model, manufacturer name or logo, and a statement that the source or device is licensed by the Agency for distribution to persons licensed pursuant to Section 330.260(a) of this Part and 32 Ill. Adm. Code 335.7010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, provided that the labeling for sources that do not require long-term storage may be on a leaflet or brochure that accompanies the source;
4) In the event the applicant desires that the source or device be required to be tested for leakage of, or contamination by, radioactive material at intervals longer than 6 months, the applicant shall include in the application sufficient information to demonstrate that the 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 radioactive contamination or leakage of radioactive material from the source; and
5) In determining the acceptable interval for tests of leakage of, or contamination by, radioactive material, the Agency will consider information that includes, but is not limited to:
A) Primary containment or 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 activity of contained radioactive material;
I) Radiotoxicity of contained radioactive material;
J) Operating experience with identical sources or devices or similarly designed and constructed sources or devices; and
K) Proposed use of source.
l) Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications.
An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to Section 330.210(d) of this Part or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if:
1) The applicant satisfies the general requirements specified in Section 330.250 of this Part.
2) The applicant submits sufficient information relating to the design (including blueprints), manufacture (construction materials and methods), prototype testing (description of testing that will be done and the acceptance criteria), quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to assure that possession, use or transfer of the depleted uranium in the product or device will not cause any individual to receive in any period of 1 year a radiation dose in excess of 10 percent of the limits specified in 32 Ill. Adm. Code 340.210(a).
3) The applicant submits information assuring that the presence of depleted uranium for a mass-volume application in the product or device will provide a unique benefits to the public, i.e., a benefit that could not be achieved but for the use of depleted uranium. The applicant's methods for use and handling of the product or device will not result in uncontrolled disposal or dispersal of depleted uranium into the environment.
4) The Agency will deny any application for a specific license under this subsection if the end uses of the industrial product or device cannot be reasonably foreseen.
5) Each person licensed pursuant to this subsection (l) shall:
A) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;
B) Label or mark each unit to:
i) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium and the activity of depleted uranium in each product or device; and
ii) State that the receipt, possession, use and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or 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:
i) A copy of the general license contained in Section 330.210(d) of this Part and a copy of the form "Registration Certificate – Use of Depleted Uranium Under General License", to each person to whom the licensee transfers depleted uranium in a product or device for use pursuant to the general license contained in Section 330.210(d) of this Part; or
ii) A copy of the general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to Section 330.210(d) of this Part and a copy of the U.S. Nuclear Regulatory Commission's or Agreement State's certificate, or alternatively, furnish a copy of the general license contained in Section 330.210(d) of this Part and a copy of the form "Registration Certificate – Use of Depleted Uranium Under General License", to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission or an Agreement State, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an Agreement State under requirements substantially the same as those in Section 330.210(d) of this Part;
E) Report to the Agency all transfers of industrial products or devices to persons for use under the general license in Section 330.210(d) of this Part. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Agency and the general licensee, the type and model number of device transferred and the activity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under Section 330.210(d) of this Part during the reporting period, the report shall so indicate;
F) File a report that identifies each general licensee by name and address, an individual by name and/or position who constitutes a point of contact between the Agency and the general licensee, the type and model number of the device transferred and the activity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. The licensee shall report:
i) To the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in 10 CFR 40.25;
ii) To the responsible state agency all transfers of devices manufactured and distributed pursuant to this subsection (l) for use under a general license in that state's regulations equivalent to Section 330.210(d) of this Part;
iii) To the U.S. Nuclear Regulatory Commission if no transfers have been made by the licensees during the reporting period;
iv) To the responsible Agreement State agency upon the request of that agency if no transfers have been made to general licensees within a particular Agreement State during the reporting period; and
G) Keep records showing the name, address and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in Section 330.210(d) of this Part or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be maintained for a period of 2 years and shall show the date of each transfer, the activity of depleted uranium in each product or device transferred and compliance with the report requirements of this Section.
m) Special Requirements for License to Manufacture, Import or Initially Distribute Sealed Sources or Devices Containing Sealed Sources to Persons Having a Specific License.
1) An application for license to manufacture, import or initially distribute sealed sources or devices containing sealed sources for initial transfer to persons having a specific license to receive such sealed sources or devices will be approved subject to the following conditions:
A) The applicant satisfies the general requirements specified in Section 330.250 of this Part;
B) The licensee subject to this subsection (m) shall not transfer a sealed source or device containing a sealed source to any person except in accordance with the requirements of Section 330.400 of this Part.
2) Any manufacturer, importer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to the Agency for evaluation of radiation safety information about its product and for filing an evaluation sheet in the U.S. Nuclear Regulatory Commission "Registry of Radioactive Sealed Sources and Devices".
A) A request for evaluation of a sealed source or device containing a sealed source shall be submitted in duplicate and shall include information required by subsection (m)(2)(B) or (C) of this Section, as applicable, demonstrating that the radiation safety properties of the source or device will not endanger public health and safety or property.
B) A request for evaluation of a sealed source shall include the following radiation safety information:
i) Proposed uses for the sealed source;
ii) Chemical and physical form and maximum quantity of radioactive material in the sealed source;
iii) Details of design of the sealed source, including blueprints, engineering drawings or annotated drawings;
iv) Details of construction of the sealed source, including a description of materials used in construction;
v) Radiation profile of a prototype sealed source;
vi) Procedures for and results of prototype testing;
vii) Details of quality control procedures to be followed in manufacture;
viii) A description or facsimile of labeling to be affixed to the sealed source;
ix) Leak testing procedures; and
x) Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the safety of the sealed source, as required by Section 330.250 of this Part.
C) A request for evaluation of a device containing a sealed source shall include the following radiation safety information:
i) Proposed uses for the device;
ii) Manufacturer, model number, chemical and physical form and maximum quantity of radioactivity in the sealed source or sources to be used in the device;
iii) Details of design of the sealed source, including blueprints, engineering drawings or annotated drawings;
iv) Details of construction of the sealed source, including a description of materials used in construction;
v) Radiation profile of a prototype device;
vi) Procedures for and results of prototype testing;
vii) Details of quality control procedures to be followed in manufacture;
viii) A description or facsimile of labeling to be affixed to the device;
ix) Leak testing procedures;
x) A description of potential hazards in installation, service, maintenance, handling, use and operation of the device;
xi) Information about installation, service and maintenance procedures;
xii) Handling, operating and safety instructions; and
xiii) Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the safety of the device as required by Section 330.250 of this Part.
D) When evaluating a sealed source or device, the Agency will apply the radiation safety criteria described in 10 CFR 32.210(d), published January 1, 1993, exclusive of subsequent amendments or editions.
E) The person submitting a request for evaluation of a product shall manufacture and distribute the product in accordance with:
i) The statements and representations, including the quality control program, described in the request; and
ii) The provisions of the evaluation sheet prepared by the Agency and submitted to the U.S. Department of Health and Human Services for filing in the "Radioactive Material Reference Manual", or to the U.S. Nuclear Regulatory Commission for filing in the "Registry of Radioactive Sealed Sources and Devices".
n) Manufacture and Distribution of Radioactive Material for Medical Use Under General License. A specific license authorizing the distribution of radioactive materials for diagnostic medical use by a physician under a general license shall be issued only if the applicant for the specific license satisfies the requirements of Section 330.250 of this Part and:
1) The applicant submits evidence that the radioactive material is to be manufactured, labeled and packaged in accordance with an approval by the commissioner of Food and Drugs, U.S. Food and Drug Administration, or in accordance with an approval for a biologic product issued by the Secretary, U.S. Department of Health and Human Services; and
2) One of the following statements, as appropriate, or a statement which contains the information called for in one of the following statements, appears on the label affixed to the container or appears in the leaflet or brochure that accompanies the package:
A) This radiopharmaceutical 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 its equivalent 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.
B) This radiopharmaceutical 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 its equivalent of a Licensing State.
o) Material Transfer Reports and Records
Each person licensed under subsection (d) of this Section to distribute devices to generally licensed persons shall comply with the requirements of subsection (n) of this Section.
1) The person shall report:
A) To the Agency and to the responsible regulatory agency all transfers of devices to persons for use under the general license in Section 330.220(b) of this Part or the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State;
B) To the Agency and to the responsible regulatory agency all receipts of devices from persons generally licensed under Section 330.220(b) of this Part or the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State;
C) To the Agency if no transfers were made to or from general licensees during the reporting period; and
D) To the responsible regulatory agency upon the request of the agency if no transfers during the reporting period were made to or from general licensees in the agency's area of jurisdiction.
2) The report shall be on NRC Form 653, "Transfers of Industrial Devices Report" or in a clear and legible format containing all of the information required by the form. The report shall cover each calendar quarter, shall be filed within 30 days after the end of the calendar quarter and shall clearly indicate the period covered.
3) For a transfer to a general licensee, the report shall provide:
A) The identity of the general licensee by name and mailing address for the location of use. If there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted, along with information on the actual location of use;
B) The name, title, and phone number of the individual identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;
C) The date of transfer;
D) The type, model and serial number of the device transferred; and
E) The radionuclide and activity contained in the device.
4) If one or more intermediate persons will temporarily possess a device at the intended place of use before its possession by the user, the report shall include the same information for both the intended user and each intermediate person and shall clearly designate all intermediate persons.
5) For a device received from a general licensee, the report shall provide the name and address of the general licensee and the type, model and serial number of the device and the date of receipt. For a device not initially transferred by the reporting person, the report shall provide the name of the manufacturer or distributor.
6) If the person makes a change to a device possessed by a general licensee that necessitates a change in the label, the report shall identify the general licensee, the device and the changes to information on the device label.
7) The report shall clearly identify the person licensed under subsection (d) of this Section that is furnishing the report and shall include the person's specific license number.
8) The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by this subsection (o). These records shall be maintained for 5 years following the recorded event.
(Source: Amended at 32 Ill. Reg. 9199, effective June 13, 2008)