Tenn. Comp. R. & Regs. 0400-20-10-.30

Current through June 26, 2024

Section 0400-20-10-.30 - PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL

(1) This rule establishes requirements for packaging, preparation for shipment, and transportation of radioactive material and applies to any licensee or registrant authorized by specific or general license to receive, possess, use, or transfer licensed material, if the person delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the license, or transports that material on public highways. This rule does not authorize possession of licensed material.

(2) Except as authorized in a general license or a specific license issued by the Division, or as exempted in this rule, no licensee may:

(a) Deliver licensed material to a carrier for transport; or

(b) Transport licensed material.

(3) Any physician as defined in Rule 0400-20-04-.04 is exempt from paragraph (4) of this rule with respect to transport by the physician of licensed material for use in the practice of medicine. However, any physician operating under this exemption must be licensed under Chapter 0400-20-07 or 10 CFR Part 35.

(4) A licensee who, under a general or specific license, transports licensed material outside its site of authorized use or on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of this rule and with the applicable requirements of the U.S. DOT regulations in 49 CFR Parts 107, 171 through 180, and 390 through 397, appropriate to the mode of transport.

(a) The licensee shall particularly note U.S. DOT regulations in the following areas:

1. Packaging: 49 CFR part 173, subparts A and B and I;

2. Marking and labeling: 49 CFR 172, subpart D, 172.400 through 172.407, and 172.436 through 172.441 of subpart E;

3. Placarding: 49 CFR part 172, subpart F, especially 172.500 through 172.519, 172.556 and appendices B and C;

4. Accident reporting: 49 CFR part 171, 171.15 and 171.16;

5. Shipping papers and emergency information: 49 CFR Part 172, subparts C and G;

6. Hazardous material employee training: 49 CFR part 172, subpart H;

7. Hazardous material shipper/carrier registration: 49 CFR part 107, subpart G; and

8. Security plans: 49 CFR Part 172, Subpart I.

(b) The licensee shall also note U.S. DOT regulations pertaining to the following modes of transportation:

1. Rail: 49 CFR part 174, subparts A through D and K;

2. Air: 49 CFR part 175 ;

3. Vessel: 49 CFR part 176, subparts A through F and M; and

4. Public highway: 49 CFR part 177 and parts 390 through 397.

(5) If U.S. DOT regulations are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of the U.S. DOT specified in subparagraph (4)(a) of this rule to the same extent as if the shipment or transportation were subject to U.S. DOT regulations. A request for modification, waiver or exemption from those requirements, and any notification referred to in those requirements, shall be filed with, or made to, the Director of the Division of Radiological Health at the address given in Rule 0400-20-04-.07.

(6) Exemptions.

(a) Carriers.

Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the rules in this Chapter and the requirements for a license set in this Chapter to the extent that they transport or store byproduct material in the regular course of carriage for another or storage incident thereto.

(b) Exemption for low-level materials.

1. A licensee is exempt from all requirements of this rule with respect to shipment or carriage of the following low-level materials:

(i) Natural material and ores containing naturally occurring radionuclides that are either in their natural state, or have only been processed for purposes other than for the extraction of the radionuclides, and which are not intended to be processed for use of these radionuclides, provided the activity concentration of the material does not exceed ten times the values specified in Table A-2 or Table A-3 of Schedule 10-6 in Rule 0400-20-10-.38; and

(ii) Materials for which the activity concentration is not greater than the activity concentration values specified in Table A-2 or Table A-3 of Schedule 10-6 in Rule 0400-20-10-.38, or for which the consignment activity is not greater than the limit for an exempt consignment found in Table A-2 or Table A-3 of Schedule 10-6 in Rule 0400-20-10-.38.

(iii) Non-radioactive solid objects with radioactive substances present on any surfaces in quantities not in excess of the levels cited in the definition of contamination in Rule 0400-20-04-.04.

2. Reserved.

3. Reserved.

(c) Exemption from classification as fissile material.

1. Fissile material meeting the requirements of at least one of the subparts (i) through (vi) of this part are exempt from classification as fissile material, but are subject to all other requirements of this rule, except as noted;

(i) Individual package containing 2 grams or less fissile material;

(ii) Individual or bulk packaging containing 15 grams or less of fissile material provided the package has at least 200 grams of solid nonfissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid nonfissile material;

(iii)

(I) Low concentrations of solid fissile material commingled with solid nonfissile material, provided that:

I. There is at least 2000 grams of solid nonfissile material for every gram of fissile material, and

II. There is no more than 180 grams of fissile material distributed within 360 kg of contiguous nonfissile material;

(II) Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material;

(iv) Uranium enriched in uranium-235 to a maximum of 1 percent by weight, and with total plutonium and uranium-233 content of up to 1 percent of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than 5 percent of the uranium mass, and that the fissile material is distributed homogeneously and does not form a lattice arrangement within the package;

(v) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of 2 percent by mass, with a total plutonium and uranium-233 content not exceeding 0.002 percent of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of 2. The material must be contained in at least a DOT Type A package; and

(vi) Packages containing, individually, a total plutonium mass of not more than 1000 grams, of which not more than 20 percent by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.

(7) General license: U.S. NRC-approved package.

(a) A general license is hereby issued to any licensee of the Division to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, certificate of compliance or other approval has been issued by the U.S. Nuclear Regulatory Commission.

(b)

1. This general license applies only to a licensee who has a quality assurance program approved by the Division as satisfying the provisions of this rule.

2. Each licensee issued a general license under subparagraph (a) of this paragraph shall:

(i) Maintain a copy of the NRC-issued certificate of compliance, or other approval of the package, and the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the actions to be taken before shipment;

(ii) Comply with the terms and conditions of the license, certificate, or other approval, as applicable, and the applicable requirements of this rule; and

(iii) Submit in writing before the first use of the package to: ATTN: Document Control Desk, Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards, using an appropriate method listed in 10 C.F.R. § 71.1(a), the licensee's name and license number and the package identification number specified in the package approval.

(c) This general license applies only when the package approval authorizes use of the package under this general license.

(d) For a Type B or fissile material package, the design of which was approved by U.S. NRC before April 1, 1996, the general license is subject to the additional restrictions in 10 CFR 71.19.

(8) Reserved.

(9) General license: Use of foreign approved package.

(a) A general license is issued to any licensee of the Division to transport, or to deliver to a carrier for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate that has been revalidated by U.S. DOT as meeting the applicable requirements of 49 CFR 171.23.

(b) Except as otherwise provided in this paragraph, the general license applies only to a licensee who has a quality assurance program approved by the Division as satisfying the applicable provisions of this rule.

(c) This general license applies only to shipments made to or from locations outside the United States.

(d) Each licensee issued a general license under subparagraph (a) of this paragraph shall:

1. Maintain a copy of the applicable certificate, the revalidation and the drawings and other documents referenced in the certificate, relating to the use and maintenance of the packaging and to the actions to be taken before shipment;

2. Comply with the terms and conditions of the certificate and revalidation and with the applicable requirements of this rule.

(10) General license: Fissile material

(a) A general license is issued to any licensee of the Division or U.S. NRC to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this paragraph. The fissile material need not be contained in a package which meets the standards of 10 CFR Part 71 subparts E and F of U.S. NRC regulations; however, the material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 CFR 173.417(a).

(b) The general license applies only to a licensee who has submitted to the Division and received Division approval for a quality assurance program that satisfies the provisions found in this rule.

(c) The general license applies only when a package's contents:

1. Contain less than a Type A quantity of fissile material; and

2. Contain less than 500 total grams of beryllium, graphite, or hydrogenous material enriched in deuterium.

(d) The general license applies only to packages containing fissile material that are labeled with a CSI which:

1. Has been determined in accordance with subparagraph (e) of this paragraph;

2. Has a value less than or equal to 10; and

3. For a shipment of multiple packages containing fissile material, the sum of the CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or equal to 100 (for shipment on an exclusive use conveyance).

(e)

1. The value for the CSI must be greater than or equal to the number calculated by the following equation:

Click to view Image

2. The calculated CSI must be rounded up to the first decimal place;

3. The values of X, Y, and Z used in the CSI equation must be taken from Tables RHS 7-3 or 7-4, as appropriate;

4. If Table RHS 7-4 is used to obtain the value of X, then the values for the terms in the equation for uranium-233 and plutonium must be assumed to be zero; and

5. Table RHS 7-3 values for X, Y, and Z must be used to determine the CSI if:

(i) Uranium-233 is present in the package;

(ii) The mass of plutonium exceeds 1 percent of the mass of uranium-235;

(iii) The uranium is of unknown uranium-235 enrichment or greater than 24 weight percent enrichment; or

(iv) Substances having a moderating effectiveness (i.e., an average hydrogen density greater than H₂O) (e.g., certain hydrocarbon oils or plastics) are present in any form, except as polyethylene used for packing or wrapping.

Table RHS 7-3. Mass Limits for General License Packages Containing Mixed Quantities of Fissile Material or Uranium-235 of Unknown Enrichment per subparagraph (10)(e) of Rule 0400-20-10-.30

Fissile material	Fissile material mass mixed with moderating substances having an average hydrogen density less than or equal to H₂O (grams)	Fissile material mass mixed with moderating substances having an average hydrogen density greater than H₂O^a (grams)
²³⁵U (X)	60	38
²³³U (Y)	43	27
²³⁹Pu or ²⁴¹Pu (Z)	37	24

^a When mixtures of moderating substances are present, the lower mass limits shall be used if more than 15 percent of the moderating substance has an average hydrogen density greater than H₂O.

Table RHS 7-4 Mass Limits for General License Packages Containing Uranium-235 of Known Enrichment per subparagraph (10)(e) of Rule 0400-20-10-.30

Uranium enrichment in weight percent of ²³⁵U not exceeding	Fissile material mass of ²³⁵U (X) (grams)
24	60
20	63
15	67
11	72
10	76
9.5	78
9	81
8.5	82
8	85
7.5	88
7	90
6.5	93
6	97
5.5	102
5	108
4.5	114
4	120
3.5	132
3	150
2.5	180
2	246
1.5	408
1.35	480
1	1,020
0.92	1,800

(11) General license: Plutonium-beryllium special form material.

(a) A general license is issued to any licensee of the Division or the U.S. NRC to transport fissile material in the form of plutonium-beryllium (Pu-Be) special form sealed sources, or to deliver Pu-Be sealed sources to a carrier for transport, if the material is shipped in accordance with this rule. This material need not be contained in a package which meets the standards of 10 CFR Part 71 subparts E and F; however, the material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 CFR 173.417(a).

(c) The general license applies only when a package's contents:

1. Contain no more than a Type A quantity of radioactive material; and

2. Contain less than 1000 g of plutonium, provided that: plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than 240 g of the total quantity of plutonium in the package.

(d) The general license applies only to packages labeled with a CSI which:

1. Has been determined in accordance with subparagraph (e) of this paragraph;

2. Has a value less than or equal to 100; and

3. For a shipment of multiple packages containing Pu-Be sealed sources, the sum of the CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or equal to 100 (for shipment on an exclusive use conveyance).

(e)

1. The value for the CSI must be greater than or equal to the number calculated by the following equation:

Click to view Image

2. The calculated CSI must be rounded up to the first decimal place.

(12) Fissile Material: Assumptions as to unknown properties of fissile material.

(a) When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.

(13) Before the first use of any packaging for the shipment of licensed material, a licensee shall ascertain that the determinations in 10 CFR 71.85(a)-(c) have been made.

(14) Routine determinations.

(a) Before each shipment of licensed material, the licensee shall ensure that the package with its contents satisfies the applicable requirements of this rule and of the license. The licensee shall determine that:

1. The package is proper for the contents to be shipped;

2. The package is in unimpaired physical condition except for superficial defects such as marks or dents;

3. Each closure device of the packaging, including any required gasket, is properly installed, secured and free of defects;

4. Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid in accordance with 10 CFR 71, Subpart F;

5. Any pressure relief device is operable and set in accordance with written procedures;

6. The package has been loaded and closed in accordance with written procedures;

7. For fissile material, any moderator or neutron absorber, if required, is present and in proper condition;

8. Any structural part of the package that could be used to lift or tie down the package during transport is rendered inoperable for that purpose, unless it satisfies the design requirements of 10 CFR 71.45;

9. The level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable and within the limits specified in U.S. DOT regulations in 49 CFR 173.443;

10. External radiation levels around the package and around the vehicle, if applicable, will not exceed the limits specified in 10 CFR 71.47 at any time during transportation; and

11. Accessible package surface temperatures will not exceed the limits specified in 10 CFR 71.43(g) at any time during transportation.

(b) Reserved.

(15) Air transport of plutonium.

(a) Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this rule or included indirectly by citation of 49 CFR Chapter I, as may be applicable, the licensee shall assure that plutonium in any form, whether for import, export or domestic shipment, is not transported by air or delivered to a carrier for air transport unless:

1. The plutonium is contained in a medical device designed for individual human application; or

2. The plutonium is contained in a material in which the specific activity is less than or equal to the activity concentration values for plutonium specified in Table A-2 of Schedule 10-6 in Rule 0400-20-10-.38 and in which the radioactivity is essentially uniformly distributed; or

3. The plutonium is shipped in a single package containing no more than an A2 quantity of plutonium in any isotope or form and is shipped in accordance with paragraphs (4) and (5) of this rule; or

4. The plutonium is shipped in a package specifically authorized for the shipment of plutonium by air in the Certificate of Compliance for that package issued by the U.S. Nuclear Regulatory Commission.

(b) Nothing in subparagraph (a) of this paragraph is to be interpreted as removing or diminishing the requirements of 10 CFR 73.24.

(c) For a shipment of plutonium by air that is subject to part (a)4 of this paragraph, the licensee shall, through special arrangement with the carrier, require compliance with 49 CFR 175.704, U.S. Department of Transportation regulations applicable to the air transport of plutonium.

(16) Opening instructions.

Before delivery of a package to a carrier for transport, the licensee shall ensure that any special instructions needed to safely open the package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with subparagraphs (5)(a) and (b) of Rule 0400-20-05-.115.

(17) Records.

(a) Each licensee shall maintain, for a period of 3 years after shipment, a record of each shipment of licensed material not exempt under paragraph (6) of this rule, showing where applicable:

1. Identification of the packaging by model number and serial number;

2. Verification that there are no significant defects in the packaging, as shipped;

3. Volume and identification of coolant;

4. Type and quantity of licensed material in each package and the total quantity of each shipment;

5. For each item of irradiated fissile material:

(i) Identification by model number and serial number;

(ii) Irradiation and decay history to the extent appropriate to demonstrate that its nuclear and thermal characteristics comply with license conditions; and

(iii) Any abnormal or unusual condition relevant to radiation safety;

6. Date of the shipment;

7. For fissile packages and for Type B packages, any special controls exercised;

8. Name and address of the transferee;

9. Address to which the shipment was made; and

10. Results of the determinations required by paragraph (14) of this rule and by the conditions of the package approval.

(b) The licensee shall make available to the Division for inspection, upon reasonable notice, all records required by this rule. Records are only valid if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated.

(c) The licensee shall maintain sufficient written records to furnish evidence of the quality of packaging. The records to be maintained include results of the determinations required by paragraph (13) of this rule; design, fabrication, and assembly records; results of reviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; and results of maintenance, modification, and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability and the action taken in connection with any deficiencies noted. The records must be retained for three years after the life of the packaging to which they apply.

(18) Reserved.

(19) Inspection and tests.

In addition to the requirements in paragraph (1) of Rule 0400-20-10-.27 and Rule 0400-20-10-.28, the licensee shall notify the Director, Division of Radiological Health, at the address given in Rule 0400-20-10-.07, at least 45 days before fabrication of a package to be used for the shipment of licensed material having a decay heat load in excess of 5 kW or with a maximum normal operating pressure in excess of 103 kPa (15 lbf/in²) gauge.

(20) Reports.

The licensee shall report to the Director, Division of Radiological Health, within 30 days:

(a) Any instance in which there is significant reduction in the effectiveness of any approved Type B, or fissile, packaging during use;

(b) Details of any defects with safety significance in Type B, or fissile, packaging after first use, with the means employed to repair the defects and prevent their recurrence; or

(c) Instances in which the conditions of approval in the certificate of compliance were not observed in making a shipment.

(21) Advance notification of shipment of nuclear waste.

(a)

1. As specified in subparagraphs (b), (c) and (d) of this paragraph, each licensee shall provide advance notification to the governor of a state, or the governor's designee, and to the Director, Division of Radiological Health, of the shipment of licensed material, within or across the boundary of the State, before the transport, or delivery to a carrier for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage.

2. As specified in subparagraphs (b), (c), and (d) of this paragraph, each licensee shall provide advance notification to the Tribal official of participating Tribes referenced in subpart (c)3(iii) of this paragraph, or the official's designee, of the shipment of licensed material, within or across the boundary of the Tribe's reservation, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage.

(b) Advance notification is also required under this paragraph for shipment of licensed material, other than irradiated fuel, meeting the following three conditions:

1. The licensed material is required by 10 CFR 71 to be in Type B packaging for transportation;

2. The licensed material is being transported to or across the State boundary en route to a disposal facility or to a collection point for transport to a disposal facility; and

3. The quantity of licensed material in a single package exceeds the least of the following:

(i) 3000 times the A1 value of the radionuclides as specified in Schedule 10-6 in Rule 0400-20-10-.38, Table A-1 for special form radioactive material;

(ii) 3000 times the A2 value of the radionuclides as specified in Schedule 10-6 in Rule 0400-20-10-.38, Table A-1 for normal form radioactive material; or

(iii) 1000 TBq (27,000 Ci).

(c) Procedures for submitting advance notification.

1. The notification shall be made in writing to the office of each appropriate governor or governor's designee, the office of each appropriate Tribal official or Tribal official's designee, the Director, Division of Radiological Health, and to the Director, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission.

2. A notification delivered by mail shall be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

3. A notification delivered by any other means than mail shall reach the office of the governor, or of the governor's designee, the Tribal official or Tribal official's designee, and the Director, Division of Radiological Health, at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(i) Reserved.

(ii) Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and participating Tribes, including telephone and mailing addresses of Tribal officials and Tribal officials' designees, is available on the U.S. Nuclear Regulatory Commission Web site at: https://scp.nrc.gov/special/designee.pdf.

(iii) A list of the names and mailing addresses of the governors' designees and Tribal officials' designees of participating Tribes is available on request from the Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

(iv) The licensee shall retain a copy of the notification as a record for three years.

(d) Information to be furnished in advance notification of shipment. Each advance notification of shipment nuclear waste shall contain the following information:

1. The name, address and telephone number of the shipper, carrier and receiver of the nuclear waste shipment;

2. A description of the nuclear waste contained in the shipment, as specified in the regulations of U.S. DOT in 49 CFR 172.202 and 172.203(d);

3. The point of origin of the shipment and the 7-day period during which departure of the shipment is estimated to occur;

4. The 7-day period during which arrival of the shipment at the State boundaries or Tribal reservation boundaries is estimated to occur;

5. The destination of the shipment and the 7-day period during which arrival of the shipment is estimated to occur; and

6. A point of contact, with a telephone number, for current shipment information.

(e) Revision notice.

A licensee who finds that schedule information previously furnished to the governor, or governor's designee, or a Tribal official or Tribal official's designee, and to the Director, Division of Radiological Health, in accordance with this paragraph, will not be met, shall telephone a responsible individual in the office of the governor of the State, or of the governor's designee, or a Tribal official or Tribal official's designee, and of the Division of Radiological Health and inform those individuals of the extent of the delay beyond the schedule originally reported. The licensee shall maintain a record of the name of the individual contacted for 3 years.

(f) Cancellation notice.

1. Each licensee who cancels a nuclear waste shipment for which advance notification has been sent shall send a cancellation notice to the governor of each State, or to the governor's designee, previously notified, each Tribal official or to the Tribal official's designee previously notified, and to the Director, Division of Radiological Health.

2. The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled. The licensee shall retain a copy of the notice as a record for 3 years.

(22) Quality assurance.

(a) Quality assurance requirements.

1. This subparagraph describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. As used in this paragraph, "quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. Each licensee is responsible for the quality assurance requirements that apply to its use of a packaging for the shipment of licensed material subject to this paragraph.

2. Establishment of program.

Each licensee shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of this rule and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.

3. Approval of program.

Before the use of any package for the shipment of licensed material subject to this paragraph, each licensee shall obtain Division approval of its quality assurance program. Using an appropriate method listed in Rule 0400-20-04-.07 each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this paragraph are applicable and how they will be satisfied.

4. Radiography containers.

A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of subparagraph (8)(b) of Rule 0400-20-08-.04 or equivalent Nuclear Regulatory Commission, or Agreement State requirement, is deemed to satisfy the requirements of part (7)(b)4 of this rule and part 2 of this subparagraph.

(b) Quality assurance organization.

1. A licensee shall be responsible for the establishment and execution of the quality assurance program. The licensee may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions.

2. The quality assurance functions are:

(i) Assuring that an appropriate quality assurance program is established and effectively executed; and

(ii) Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed.

3. The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:

(i) Identify quality problems;

(ii) Initiate, recommend, or provide solutions; and

(iii) Verify implementation of solutions.

(c) Quality assurance program.

1. A licensee shall establish, at the earliest practicable time consistent with the schedule for accomplishing the activities, a quality assurance program that complies with the requirements of this rule. The licensee shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which the packaging is used. The licensee shall identify the material and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.

2. A licensee, through its quality assurance program, shall provide control over activities affecting the quality of the identified materials and components to an extent consistent with their importance to safety, and as necessary to assure conformance to the approved design of each individual package used for the shipment of radioactive material. The licensee shall assure that activities affecting quality are accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The licensee shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.

3. A licensee shall base the requirements and procedures of its quality assurance program on the following considerations concerning the complexity and proposed use of the package and its components:

(i) The impact of malfunction or failure of the item to safety;

(ii) The design and fabrication complexity or uniqueness of the item;

(iii) The need for special controls and surveillance over processes and equipment;

(iv) The degree to which functional compliance can be demonstrated by inspection or test; and

(v) The quality history and degree of standardization of the item.

4. A licensee shall provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure that suitable proficiency is achieved and maintained. The licensee shall review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program shall review regularly the status and adequacy of that part of the quality assurance program they are executing.

(d) Handling, storage, and shipping control.

The licensee shall establish measures to control, in accordance with instructions, the handling, storage, shipping, cleaning, and preservation of materials and equipment to be used in packaging to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, and specific moisture content and temperature levels must be specified and provided.

(e) Inspection, test, and operating status.

1. A licensee shall establish measures to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the packaging. These measures must provide for the identification of items that have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent bypassing of the inspections and tests.

2. A licensee shall establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation.

(f) Nonconforming materials, parts, or components.

A licensee shall establish measures to control materials, parts, or components that do not conform to the licensee's requirements to prevent their inadvertent use or installation. These measures must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items must be reviewed and accepted, rejected, repaired, or reworked in accordance with documented procedures.

(g) Corrective action.

A licensee shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. In the case of a significant condition adverse to quality, the measures must assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken must be documented and reported to appropriate levels of management.

(h) Quality assurance records.

A licensee shall maintain sufficient written records to describe the activities affecting quality. The records must include changes to the quality assurance program as required by this rule, the instructions, procedures, and drawings required by 10 CFR 71.111 to prescribe quality assurance activities and must include closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures which establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee shall retain these records for three years beyond the date when the licensee last engages in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee shall retain the superseded material for three years after it is superseded.

(i) Audits.

A licensee shall carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits must be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audited results must be documented and reviewed by management having responsibility in the area audited. Follow up action, including re-audit of deficient areas, must be taken where indicated.

(j) Changes to quality assurance program

1. Each quality assurance program approval holder shall submit, in accordance with Rule 0400-20-04-.07, a description of a proposed change to its Division-approved quality assurance program that will reduce commitments in the program description as approved by the Division. The quality assurance program approval holder shall not implement the change before receiving Division approval.

(i) The description of a proposed change to the Division-approved quality assurance program must identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of this paragraph.

(ii) Reserved.

2. Each quality assurance program approval holder may change a previously approved quality assurance program without prior approval, if the change does not reduce the commitments in the quality assurance program previously approved by the Division. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the Division every 24 months, in accordance with this rule. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:

(i) The use of a quality assurance standard approved by the Division that is more recent than the quality assurance standard in the program approval holder's current quality assurance program at the time of the change;

(ii) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting responsibilities;

(iii) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities;

(iv) The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record; and

(v) Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

3. Each quality assurance program approval holder shall maintain records of quality assurance program changes.

Tenn. Comp. R. & Regs. 0400-20-10-.30

Original rule filed February 22, 2012; effective May 22, 2012. Amendment filed March 3, 2015; effective June 1, 2015. Amendments filed September 1, 2021; effective November 30, 2021. Amendments filed December 4, 2023; effective 3/3/2024.

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