Tenn. Comp. R. & Regs. 0400-20-10-.13 - SPECIAL REQUIREMENTS FOR ISSUANCE OF SPECIFIC LICENSES

(1) Reserved.

(2) Reserved.

(3) An application for a specific license to initially transfer source material for use under Rule 0400-20-10-.09, or provisions equivalent to Rule 0400-20-10-.09, will be approved if:

(a) The applicant satisfies the general requirements specified in Rule 0400-20-10-.12; and

(b) The applicant submits adequate information on, and the Division approves, the methods to be used for quality control, labeling, and providing safety instructions to recipients.

(4) Multiple quantities of types of radioactive material for use in research and development. In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license for multiple quantities or types of radioactive material for use in research and development will be issued only if:

(a) The applicant has established an isotope committee (composed of such persons as a radiological safety officer, a representative of the business office, and one or more persons trained or experienced in the safe use of radioactive materials) which will review and approve, in advance of purchase of radioisotopes, proposals for use; and

(b) The applicant has appointed a radiological safety officer who will advise and assist on radiological safety problems.

(5) Manufacture, distribution or initial distribution of devices to persons generally licensed under paragraph (2) of Rule 0400-20-10-.10.

(a) In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license to distribute certain devices of the types enumerated in paragraph (2) of Rule 0400-20-10-.10 to persons generally licensed under paragraph (2) of Rule 0400-20-10-.10 or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State will be issued only if:

1. 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 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 no person will receive in 1 year a dose in excess of 10 percent of the limits specified in Rule 0400-20-05-.50; 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 dose to the appropriate organ as specified in Table RHS 7-1:

TABLE RHS 7-1 TABLE OF ORGAN DOSES

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

2. Each device bears a durable, legible clearly visible label or labels approved by the Division that contain(s) in a clearly identified and separate statement:

(i) Instructions and precautions for 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 requirements, 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 the 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 similar form:

(I) The receipt, possession, use, and transfer of this device, Model __________, ¹⁰ Serial No. __________,¹⁰ are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or of a State with which the NRC 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)

(II) The receipt, possession, use and transfer of this device Model __________,10 Serial No. __________,¹⁰ 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)

3. 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," and, if practicable, the radiation symbol described in Rule 0400-20-05-.110 and the name of the manufacturer or initial distributor.

4. Each device meeting the criteria of Rule 0400-20-10-.10 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 Rule 0400-20-05-.110.

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

(b) In the event the applicant desires that the device be tested at intervals longer than 6 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 information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material or failure of the on-off mechanism indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Division will consider information that includes, but is not limited to:

1. Primary containment (source capsule);

2. Protection of primary containment;

3. Method of sealing containment;

4. Containment construction materials;

5. Form of contained radioactive material;

6. Maximum temperature withstood during prototype tests;

7. Maximum pressure withstood during prototype tests;

8. Maximum quantity of contained radioactive material;

9. Radiotoxicity of contained radioactive material; and

10. Operating experience with identical devices or similarly designed and constructed devices;

(c) In the event the applicant desires that the general licensee under paragraph (2) of Rule 0400-20-10-.10 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 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 the basis 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, will not cause that individual to receive in one year a dose in excess of 10 percent of the limits specified in Rule 0400-20-05-.50;

(d) Before radioactive material may be transferred in a device for use under a general license, each person licensed under this paragraph shall furnish the following information to each person to whom he directly or through an intermediate person transfers radioactive material in a device. In the case of a transfer through an intermediate person, the information shall be provided to the intended user and to the intermediate person prior to initial transfer to the intermediate person.

For use under the general license contained in paragraph (2) of Rule 0400-20-10-.10	For use under equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State or a Licensing State
1. A copy of the general license contained in paragraph (2) of Rule 0400-20-10-.10.	A copy of the general license contained in the U.S. Nuclear Regulatory Commission's, Agreement State's, or Licensing State's regulations equivalent to paragraph (2) Rule 0400-20-10-.10. Alternatively, he may furnish a copy of the general license contained in paragraph (2) of Rule 0400-20-10-.10. If a copy of the general license in paragraph (2) of Rule 0400-20-10-.10 is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, Agreement State or Licensing State under requirements substantially the same as those in paragraph (2) of Rule 0400-20-10-.10;
If parts (2)(c)2 through 4 or 13 of Rule 0400-20-10-.10 do not apply to the particular device, those parts may be omitted;	If parts (2)(c)2 through 4 or 13 of Rule 0400-20-10-.10, or sections of the Agreement State or Licensing State regulations equivalent to those parts, do not apply to the particular device, those parts may be omitted.
2. A copy of Rules 0400-20-10-.26, 0400-20-05-.140 and 0400-20-05-.141.	A copy of 10 CFR §§ 31.2, 30.51, 20.2201, and 20.2202 or the Agreement State or Licensing State regulations equivalent to these NRC regulations.

3. A list of services that may only be performed by a specific licensee;

4. Information on acceptable disposal options including estimated costs of disposal;

5. A statement that regulatory agencies may issue citations and civil penalties for improper disposal; and

6. The name or title, address, and phone number of the person at the appropriate regulatory agency from whom additional information may be obtained.

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

(f) Each device that is transferred on May 26, 2008 or later shall meet the labeling requirements in parts (a)2, 3, and 4 of this paragraph.

(g)

1. Each person licensed under this paragraph to distribute devices to generally licensed persons shall:

(i) Report to the Division, at its offices located at the address in Rule 0400-20-04-.07, all transfers of such devices to persons for use under the general license in paragraph (2) of Rule 0400-20-10-.10.

(ii) Report to the U.S. Nuclear Regulatory Commission all transfers of such devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR Part 31.

(iii) Report to the responsible Agreement or Licensing State agency all transfers of devices manufactured and distributed pursuant to this paragraph for use under a general license in that state's regulations equivalent to paragraph (2) of Rule 0400-20-10-.10.

2. Reports required by subparts 1(i), (ii) and (iii) of this subparagraph shall identify:

(i) 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.

3. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

4. For devices received from a general licensee, the report shall 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.

5. 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 shall identify the general licensee, the device, and the changes to information on the device label.

6.

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

(ii) The report shall clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(iii) If no transfers have been made to or from persons generally licensed under paragraph (2) of Rule 0400-20-10-.10 during the reporting period, the report shall so indicate.

(h) Each person licensed under this paragraph to distribute devices to generally licensed persons shall keep records showing the name, address of use, and responsible individual for each general licensee to whom he directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in paragraph (2) of Rule 0400-20-10-.10 or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State. The records shall show the date of each transfer, the model number, serial number and the isotope and quantity of radioactivity in each device transferred, the identity of any intermediate person(s), and compliance with the report requirements of subparagraph (g) of this paragraph. The records required by this subparagraph shall be maintained for a period of 3 years from the date of the recorded event.

(6) The use of sealed sources in industrial radiography.

In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license for use of sealed sources in industrial radiography will be issued only if:

(a) The applicant will have a program for training radiographers and radiographer's assistants and submits to the Division for approval a schedule or description of such program which specifies the:

1. Initial training:

(i) This initial training will consist of a complete training program as outlined in Rule 0400-20-08-.07; or

(ii) Résumés of prior training and experience of individuals that show fulfillment of the requirements of subparagraphs (7)(a) and (b) of Rule 0400-20-08-.07 and the program for the initial training of such individuals in the licensee's or registrant's specific industrial radiography program as outlined in subparagraphs (7)(c), (d) and (e) of Rule 0400-20-08-.07;

2. Periodic training;

3. On-the-job training;

4. Means to be used by the applicant to determine the radiographer's knowledge and understanding of and ability to comply with Division regulations and licensing requirements and the operating and emergency procedures of the applicant; and

5. Means to be used by the applicant to determine the radiographer's assistant's knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant;

(b) The applicant has established and submits to the Division for approval written operating and emergency procedures as described in paragraph (2) of Rule 0400-20-08-.05;

(c) The applicant will have an internal inspection system to assure that Division regulations, license provisions, and the applicant's operating and emergency procedures are followed by radiographers and radiographer's assistants; the inspection system shall include the performance of internal inspections at intervals not to exceed 3 months and the retention of records of such inspections for inspection by the Division.

(d) The applicant submits to the Division a description of his overall organizational structure pertaining to the radiography program, including specified delegations of authority and responsibility for operation of the program; and

(e) The applicant who desires to conduct his own leak tests must establish procedures to be followed in testing sealed sources for possible leakage and contamination and submit to the Division for approval a description of such procedures including:

1. Instrumentation to be used;

2. Method of performing tests, e.g., points on equipment to be smeared and method of taking smear; and

3. Pertinent experience of the person who will perform the test.

(7) Multiple quantities or types of radioactive material for use in processing.

In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license for multiple quantities or types of radioactive material for use in processing for distribution to other authorized persons will be issued only if 11:

(a) The applicant's staff has experience in the use of radioisotopes for processing and distribution; and

(b) The applicant has appointed a radiological safety officer who will advise and assist on radiological safety problems.

(8) Introduction of radioactive material into products in exempt concentrations.

In addition to the requirements set forth in Rule 0400-20-10-.12, 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 to be transferred to persons exempt under subparagraph (1)(a) of Rule 0400-20-10-.04 will be issued only 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 assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Schedule RHS 8-4, that reconcentration of the radioactive material in concentrations exceeding those in Schedule RHS 8-4 is not likely, that lower concentrations cannot be used, 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 paragraph, shall file an annual report with the Division 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 owns or possesses the product or material into which radioactive material has been introduced at the time of introduction, the type and quantity of radioactive material introduced into each product or material, and the initial concentrations of radioactive material in the product or material at the tie of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to this paragraph during the reporting period, the report shall so indicate. The report shall be submitted within 30 days after the end of each calendar year.

(9) Radioactive material in luminous safety devices for use in aircraft.

In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license to manufacture, assemble, repair, or distribute to persons generally licensed under paragraph (3) of Rule 0400-20-10-.10 luminous safety devices containing radioactive materials for use in aircraft will be issued only if the requirements of Sections 32.53, 32.54, 32.55, 32.56 and 32.101 of 10 CFR Part 32 or their equivalent are met.

(10) Manufacture, preparation, or transfer for commercial distribution of radiopharmaceuticals containing radioactive material for medical use.

(a) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radiopharmaceuticals containing radioactive material for use by persons authorized pursuant to Chapter 0400-20-07 will be approved if:

1. The applicant satisfies the general requirements of Rule 0400-20-10-.12;

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

(i) Registered or licensed with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 C.F.R. § 207.17(a);

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

(iii) Licensed as a pharmacy by the Tennessee Board of Pharmacy;

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

(v) A Positron Emission Tomography (PET) drug production facility registered with a state agency.

3. The applicant submits information on the radionuclide; chemical and physical form; packaging including maximum activity per vial, syringe, generator, or other container of the radioactive drug; and shielding provided by the packaging of the radioactive material for safe handling and storage of radiopharmaceuticals by medical use licensees; and

4. The applicant commits to the following labeling requirements:

(i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted.

(ii) A label is affixed to each syringe, vial or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(b) A licensee described by subpart (a)2(iii) of this paragraph:

1. May prepare radiopharmaceuticals for medical use, as defined in Rule 0400-20-07-.05, provided that the radiopharmaceuticals are prepared by either an authorized nuclear pharmacist, as specified in parts 2 and 4 of this subparagraph, or an individual under the supervision of an authorized nuclear pharmacist as specified in Rule 0400-20-07-.19.

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

(i) This individual qualifies as an authorized nuclear pharmacist as defined in Rule 0400-20-07-.05;

(ii) This individual meets the requirements specified in paragraph (2) of Rule 0400-20-07-.25 and Rule 0400-20-07-.27, and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

(iii) This individual is designated as an authorized nuclear pharmacist in accordance with part 4 of this subparagraph.

3. May take the actions authorized in parts 1 and 2 of this subparagraph notwithstanding more restrictive language in license conditions.

4. May designate a pharmacist (as defined in Rule 0400-20-07-.05) as an authorized nuclear pharmacist if the individual was a nuclear pharmacist at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the U.S. Nuclear Regulatory Commission.

5. Shall provide to the Division a copy of each individual's:

(i) Certification by a specialty board whose certification process has been recognized by the Division, U.S. Nuclear Regulatory Commission, or an Agreement State as specified in paragraph (1) of Rule 0400-20-07-.25; or

(ii) The Division, U.S. Nuclear Regulatory Commission, or other Agreement State license; or

(iii) U.S. Nuclear Regulatory Commission master materials licensee permit; or

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

(v) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the U.S. Nuclear Regulatory Commission; and

(vi) A copy of the state pharmacy licensure or registration no later than 30 days after the date that the licensee allows the individual to work as an authorized nuclear pharmacist under subparts 2(i) and (ii) of this subparagraph.

(c) 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 before transfer for commercial distribution. In addition, the licensee shall:

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

(d) A licensee shall satisfy the labeling requirements of part (a)4 of this paragraph.

(e) Nothing in this rule relieves the licensee from complying with applicable FDA, other federal, and other state requirements governing radioactive drugs.

(11) Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceuticals containing radioactive material. In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to Chapter 0400-20-07 will be issued only if 12:

(a) The requested site for manufacture and/or distribution of generators or reagent kits is located within this State;

(b) The applicant submits evidence that:

1. 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 United States Food and Drug Administration (FDA), a biologic product license issued by FDA or a "Notice of Claimed Investigational Exemption for a New Drug" (IND) accepted by FDA; or

2. 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;

(c) 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;

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

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

1. 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. A statement that this generator or reagent kit, as appropriate, is approved for use by persons licensed by the Division pursuant to Chapter 0400-20-07 of these rules, or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State; and

(f) The labels, leaflets or brochures required by subparagraphs (d) and (e) of this paragraph 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.

(12) Manufacture and distribution of sources or devices containing radioactive material for medical uses.

(a) In addition to the requirements set forth in Rule 0400-20-10-.12, an application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed under Chapter 0400-20-07 of these rules for use as a calibration, transmission, or reference source or for the uses listed in Rules 0400-20-07-.51, 0400-20-07-.61, 0400-20-07-.63, and 0400-20-07-.81 will be approved if:

1. The applicant satisfies the general requirements in Rule 0400-20-10-.12.

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

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

(ii) Details of design and construction of the source or device;

(iii) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered;

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

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

(vi) Procedures and standards for calibrating sources and devices;

(vii) Legend and methods for labeling sources and devices as to their radioactive content; and

(viii) Instructions for handling and storing the source or device for radiation safety; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

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 Division has approved distribution of the (name of the source or device) to persons licensed to use radioactive material identified in Rules 0400-20-07-.31, 0400-20-07-.51, 0400-20-07-.61, and 0400-20-07-.63 as appropriate, and to persons who hold an equivalent license issued by the U.S. NRC or an Agreement State.

4. The course or device has been registered in the Sealed Source and Device Registry.

(b) 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 6 months, the applicant shall include in his application 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 Division will consider information that includes, but is not limited to:

1. Primary containment (source capsule);

2. Protection of primary containment;

3. Method of sealing containment;

4. Containment construction materials;

5. Form of contained radioactive material;

6. Maximum temperature withstood during prototype tests;

7. Maximum pressure withstood during prototype tests;

8. Maximum quantity of contained radioactive material;

9. Radiotoxicity of contained radioactive material; and

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

(13) Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license.

In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license to manufacture or distribute radioactive material for use under the general license of paragraph (7) of Rule 0400-20-10-.10 will be issued only if:

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

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

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

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

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

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

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

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

8. Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each.

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

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-131, iodine-125, cobalt-57, selenium-75, or carbon-14; 50 microcuries of hydrogen-3 (tritium); 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. Displaying the radiation caution symbol described in Rule 0400-20-05-.110 and the words, "Caution, Radioactive Material" and "Not for Internal or External Use in Humans or Animals."

(c) 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:

1. 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 there from, 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)

(d) 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 Rule 0400-20-05-.120.

(14) Distribution of radioactive material in exempt quantities Each exempt quantity 13.

(a) An application for a specific license to distribute NARM to persons exempt from these rules pursuant to paragraph (3) of Rule 0400-20-10-.04 will be approved if:

1. 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;

2. 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

3. The applicant submits copies of prototype labels and brochures and the Division approves such labels and brochures.

(b) The license issued under subparagraph (a) of this paragraph is subject to the following conditions:

1. No more than 10 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 quantity provided the sum of the fractions shall not exceed unity.

2. Each exempt quantity shall be separately and individually packaged. No more that 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to paragraph (3) of Rule 0400-20-10-.04. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

3. The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which

(i) Identifies the radionuclide and the quantity of radioactivity; and

(ii) Bears the words "Radioactive Material."

4. In addition to the labeling information required by part 3 of this subparagraph, 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 - Incorporation 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.

(c) Each person licensed under this paragraph shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under paragraph (3) of Rule 0400-20-10-.04 or the equivalent regulations of a Licensing State, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the Division. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to this paragraph during the reporting period, the report shall so indicate.

(15) Special requirements for license to manufacture or initially transfer calibration sources containing americium-241, or radium-226 for distribution to persons generally licensed under paragraph (4) of Rule 0400-20-10-.10.

(a) 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 paragraph (4) of Rule 0400-20-10-.10 will be approved if:

1. The applicant satisfies the general requirement of Rule 0400-20-10-.12; and

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

(i) Chemical and physical form and maximum quantity of americium 241, or radium-226 in the source;

(ii) Details of construction and design;

(iii) Details of the method of incorporation and binding of the americium-241, or radium-226 in the source;

(iv) Procedures for and results of prototype testing of sources, which are designed to contain more than 185 Bq (0.005 µCi) of americium-241, 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;

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

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

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

3. Each source will contain no more than 185 kBq (5 µCi) of americium-241, or radium-226.

4. The Division determines, with respect to any type of source containing more than 185 Bq (0.005 µCi) of americium-241, or radium-226, that:

(i) The method of incorporation and binding of the americium-241, or radium-226 in the source is such that the americium-241, or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and

(ii) The source has been subjected to and has satisfactorily passed appropriate tests prescribed by part 5 of this subparagraph.

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:

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

(ii) The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion.

(iii) The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in subpart (iv) of this part.

(iv) Source designs are rejected for which the following has been detected for any unit: Removal of more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from the source or any other evidence of physical damage.

(b) Reserved.

(c) Labeling of devices.

Each person licensed under subparagraph (a) of this paragraph 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 NRC or an Agreement State. Do not remove this label.

CAUTION-RADIOACTIVE MATERIAL-

THIS SOURCE CONTAINS AMERICIUM-241 [OR RADIUM-226]. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

_______________________________

Name of manufacturer or initial transferor

(d) Leak testing of each source. Each person licensed under subparagraph (a) of this paragraph shall perform a dry wipe test upon each source containing more than 3.7 kBq (0.1 µCi) of americium-241, or radium 226 prior to transferring the source to a general licensee under paragraph (4) of Rule 0400-20-10-.10. This test must 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 filter paper must be measured by using methods capable of detecting 185 Bq (0.005 µCi) of americium-241, or radium-226. If a source has been shown to be leaking or losing more than 185 Bq (0.005 µCi) of americium-241 or radium-226 by the methods described in this subparagraph, the source must be rejected and must not be transferred to a general licensee under paragraph (4) of Rule 0400-20-10-. 10 or equivalent regulations of the NRC or an Agreement State.

(16) Reserved.

(17) Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer; quality assurance; prohibition of transfer.

(a) An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under Rule 0400-20-10-.10 will be approved if:

1. The applicant satisfies the general requirements specified in Rule 0400-20-10-.12;

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

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

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

(iii) Radiation profile of a prototype device;

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

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

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

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

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

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

4. Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by Rule 0400-20-05-.110, 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;

5. The Division determines that:

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

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

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

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

(v) Quality control procedures have been established to satisfy the requirements of subparagraph (c) of this paragraph.

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

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

1. The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

2. The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in part 3 of this subparagraph.

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

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

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

(iii) Any other evidence of physical damage.

(c)

1. Each person licensed under this paragraph shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

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

3. Each person licensed under this paragraph shall:

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

(ii) Subject inspection lots to acceptance sampling procedures, by procedures specified in part 4 of this subparagraph and in the license issued under this paragraph, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

4. Each person licensed under this paragraph shall subject each inspection lot to:

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

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

5. No person licensed under this paragraph shall transfer to persons generally licensed under paragraph (6) of Rule 0400-20-10-.10, or under an equivalent general license of an Agreement State:

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

(ii) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in subpart 3(ii) of this subparagraph, unless:

(I) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under this paragraph, and

(II) Each individual sub-lot is sampled, tested, and accepted in accordance with subpart 3(ii) of this subparagraph and item (I) of this subpart and any other criteria as may be required as a condition of the license issued under this paragraph.

(18) Registration of sealed source and device product information.

(a) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the Division for evaluation of radiation safety information about its product and for its registration.

(b) The request for review must be sent to the Tennessee Division of Radiological Health at the address given in subparagraph (1)(c) of Rule 0400-20-04-.07.

(c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(d) The Division normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the Division formulates reasonable standards and criteria with the help of the manufacturer or distributor. The Division shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Rule 0400-20-10-.04 includes specific criteria that apply to certain exempt products and Rule 0400-20-10-.10 includes specific criteria applicable to certain generally licensed devices. This rule includes specific provisions that apply to certain specifically licensed items.

(e) After completion of the evaluation, the Division issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

(f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

1. The statements and representations, including quality control program, contained in the request; and

2. The provisions of the registration certificate.

(g) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

1. Calibration and reference sources containing no more than:

(i) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or

(ii) 0.37 MBq (10 µCi), for alpha emitting radionuclides; or

2. The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(i) The intended recipients are licensed under paragraph (4) of this rule;

(ii) The recipients are authorized for research and development; or

(iii) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.

(h) After the certificate is issued, the Division may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Division will complete its evaluation in accordance with criteria specified in this paragraph. The Division may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested.

(19) Inactivation of certificates of registration of sealed sources and devices.

(a) A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the Division shall request inactivation of the registration certificate. Such a request must be made to the Tennessee Division of Radiological Health at the address given in subparagraph (1)(c) of Rule 0400-20-04-.07 and must normally be made no later than two years after initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within 90 days of this determination and briefly describe the circumstances of the delay.

(b) If a distribution license is to be terminated in accordance with Rule 0400-20-10-.17, the licensee shall request inactivation of its registration certificates associated with that distribution license before the Division will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.

(c) A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.

(20) Emergency preparedness.

(a) Emergency preparedness for possession of radioactive material other than uranium and plutonium.

1. In addition to the requirements set forth in Rule 0400-20-10-.12, all specific licenses issued, or for which an initial application or an application to amend is submitted, to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in Table RHS 7-2 must contain either:

(i) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or

(ii) An emergency plan for responding to a release of radioactive material.

2. One or more of the following factors may be used to support an evaluation submitted under subpart 1(i) of this subparagraph:

(i) The radioactive material is physically separated so that only a portion could be involved in an accident;

(ii) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(iii) The release fraction in the respirable size range would be lower than the release fraction shown in Table RHS 7-2 due to the chemical or physical form of the material;

(iv) The solubility of the radioactive material would reduce the dose received;

(v) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in Table RHS 7-2;

(vi) Operating restrictions or procedures would prevent a release fraction as large as that shown in Table RHS 7-2; or

(vii) Other factors appropriate for the specific facility.

Table RHS 7-2

Quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release.

Radioactive material 1	Release fraction	Quantity (curies)
Actinium-228	0.001	4,000
Americium-241	0.001	2
Americium-242	0.001	2
Americium-243	0.001	2
Antimony-124	0.01	4,000
Antimony-126	0.01	6,000
Barium-133	0.01	10,000
Barium-140	0.01	30,000
Bismuth-207	0.01	5,000
Bismuth-210	0.01	600
Cadmium-109	0.01	1,000
Cadmium-113	0.01	80
Calcium-45	0.01	20,000
Californium-252	0.001	9 (20 mg)
Carbon-14	0.01	50,000
Cerium-141	0.01	10,000
Cerium-144	0.01	300
Cesium-134	0.01	2,000
Cesium-137	0.01	3,000
Chlorine-36	0.5	100
Chromium-51	0.01	300,000
Cobalt-60	0.001	5,000
Copper-64	0.01	200,000
Curium-242	0.001	60
Curium-243	0.001	3
Curium-244	0.001	4
Curium-245	0.001	2
Europium-152	0.01	500
Europium-154	0.01	400
Europium-155	0.01	3,000
Germanium-68	0.01	2,000
Gadolinium-153	0.01	5,000
Gold-198	0.01	30,000
Hafnium-172	0.01	400
Hafnium-181	0.01	7,000
Holmium-166m	0.01	100
Hydrogen-3	0.5	20,000
Iodine-125	0.5	10
Iodine-131	0.5	10
Indium-114m	0.01	1,000
Iridium-192	0.001	40,000
Iron-55	0.01	40,000
Iron-59	0.01	7,000
Krypton-85	1.0	6,000,000
Lead-210	0.01	8
Manganese-56	0.01	60,000
Mercury-203	0.01	10,000
Molybdenum-99	0.01	30,000
Neptunium-237	0.001	2
Nickel-63	0.01	20,000
Niobium-94	0.01	300
Phosphorus-32	0.5	100
Phosphorus-33	0.5	1,000
Polonium-210	0.01	10
Potassium-42	0.01	9,000
Promethium-145	0.01	4,000
Promethium-147	0.01	4,000
Radium-226	0.001	100
Ruthenium-106	0.01	200
Samarium-151	0.01	4,000
Scandium-46	0.01	3,000
Selenium-75	0.01	10,000
Silver-110m	0.01	1,000
Sodium-22	0.01	9,000
Sodium-24	0.01	10,000
Strontium-89	0.01	3,000
Strontium-90	0.01	90
Sulfur-35	0.5	900
Technetium-99	0.01	10,000
Technetium-99m	0.01	400,000
Tellurium-127m	0.01	5,000
Tellurium-129m	0.01	5,000
Terbium-160	0.01	4,000
Thulium-170	0.01	4,000
Tin-113	0.01	10,000
Tin-123	0.01	3,000
Tin-126	0.01	1,000
Titanium-44	0.01	100
Vanadium-48	0.01	7,000
Xenon-133	1.0	900,000
Yttrium-91	0.01	2,000
Zinc-65	0.01	5,000
Zirconium-93	0.01	400
Zirconium-95	0.01	5,000
Any other beta-gamma emitter	0.01	10,000
Mixed fission products	0.01	1,000
Mixed corrosion products	0.01	10,000
Contaminated equipment beta-gamma	0.001	10,000
Irradiated material, any form other than solid noncombustible	0.01	1,000
Irradiated material, solid noncombustible	0.001	10,000
Mixed radioactive waste, beta-gamma	0.01	1,000
Packaged mixed waste, beta-gamma2	0.001	10,000
Any other alpha emitter	0.001	2
Contaminated equipment, alpha	0.0001	20
Packaged waste, alpha2	0.0001	20
Combinations of radioactive materials listed above 1

¹ For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Table RHS 7-2 exceeds one.

² Waste packaged in Type B containers does not require an emergency plan.

(b) Emergency preparedness for possession of uranium hexafluoride.

1. In addition to the requirements set forth in Rule 0400-20-10-.12, all specific licenses to possess uranium hexafluoride in excess of 50 kilograms in a single container or 1000 kilograms total must contain either:

(i) An evaluation showing that the maximum intake of uranium by a member of the public due to a release would not exceed 2 milligrams; or

(ii) An emergency plan for responding to the radiological hazards of an accidental release of source material and to any associated chemical hazards directly incident thereto.

2. One or more of the following factors may be used to support an evaluation submitted under subpart 1(i) of this subparagraph:

(i) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(ii) Facility design or engineered safety features in the facility would reduce the amount of the release; or

(iii) Other factors appropriate for the specific facility.

(c) Emergency preparedness for possession of plutonium.

1. In addition to the requirements set forth in Rule 0400-20-10-.12, all specific licenses to possess plutonium in excess of 2 curies in unsealed form or on foils or plated sources must contain either:

(i) An evaluation showing that the maximum dose to a member of the public offsite due to a release of plutonium would not exceed 1 rem effective dose equivalent, or

(ii) An emergency plan for responding to the radiological hazards of an accidental release of special nuclear material and to any associated chemical hazards directly incident thereto.

2. One or more of the following factors may be used to support an evaluation submitted under subpart 1(i) of this subparagraph:

(i) The plutonium is physically separated so that only a portion could be involved in an accident;

(ii) All or part of the plutonium is not subject to release during an accident because of the way it is stored or packaged;

(iii) In the case of fires or explosions, the release fraction would be lower than 0.001 due to the chemical or physical form of the material;

(iv) The solubility of the material released would reduce the dose received;

(v) The facility design or engineered safety features in the facility would cause the release fraction to be lower than 0.001;

(vi) Operating restrictions or procedures would prevent a release large enough to cause a member of the public offsite to receive a dose exceeding 1 rem effective dose equivalent; or

(vii) Other factors appropriate for the specific facility.

(d) An emergency plan for responding to a release of radioactive material submitted under subpart (a)1(ii), (b)1(ii) or (c)1(ii) of this paragraph must include the following information:

1. Facility description.

A brief description of the licensee's facility and area near the site.

2. Types of accidents.

An identification of each type of accident for which protective actions may be needed.

3. Classification of accidents.

A classification system for classifying accidents as alerts or site area emergencies.

4. Detection of accidents.

Identification of the means of detecting each type of radioactive materials accident in a timely manner.

5. Mitigation of consequences.

A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

6. Assessment of releases.

A brief description of the methods and equipment to assess releases of radioactive material.

7. Responsibilities.

A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Division of Radiological Health; also responsibilities for developing, maintaining and updating the plan.

8. Notification and coordination.

A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated, injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the Division of Radiological Health immediately after notification of the offsite response organizations and not later than 1 hour after the licensee declares an emergency. 14

9. Information to be communicated.

A brief description of the types of information on facility status, radioactive releases and recommended protective actions, if necessary, to be given to offsite response organizations and to the Division of Radiological Health.

10. Training.

A brief description of the frequency, performance objectives and plan for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.

11. Safe shutdown.

A brief description of the means of restoring the facility to a safe condition after an accident.

12. Exercises.

Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises although recommended is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

13. Hazardous chemicals.

A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Public Law 99-499 (42 U.S.C. Chapter 116), if applicable to the applicant's activities at the proposed place of the use of the source material.

(e) The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the Division of Radiological Health. The licensee shall provide any comments received within the 60 days to the Division of Radiological Health with the emergency plan.

(f) Licensees required to submit emergency plans by this paragraph shall follow the emergency plan approved by the Division of Radiological Health. The licensee may change the plan without Division of Radiological Health approval if the changes do not decrease the effectiveness of the plan. The licensee shall furnish the change to the Division of Radiological Health and to affected offsite response organizations within 6 months after the change is made. Proposed changes that decrease the effectiveness of the approved emergency plan may not be implemented without application to and prior approval by the Division of Radiological Health.

Notes

Tenn. Comp. R. & Regs. 0400-20-10-.13

Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed June 14, 2017; effective September 12, 2017. Amendments filed September 1, 2021; effective November 30, 2021. Amendments filed December 4, 2023; effective March 3, 2024. Amendments filed February 28, 2024; effective 5/28/2024.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.

If specified elsewhere in labeling affixed to the device, the model, serial number and manufacturer or distributor may be omitted from this label.

Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing by product 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, DC 20555.

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 reagent kits approved by the Department for use by persons licensed pursuant to Chapter 0400-20-07 may submit the pertinent information specified in this paragraph.

See footnote 2 of this Chapter.

These reporting requirements do not supersede or release licensees of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Public Law 99-499 (42 U.S.C. Chapter 112) or other state or federal reporting requirements.