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III. CONTROL AND TRACKING

A. Any licensee who transfers radioactive waste to a land disposal facility or a licensed waste collector shall comply with the requirements in paragraphs A.1 through 9 of this section. Any licensee who transfers waste to a licensed waste processor for waste treatment or repackaging shall comply with the requirements of paragraphs A.4 through 9 of this section. A licensee shall:

1. Prepare all wastes so that the waste is classified according to §61.55 and meets the waste characteristics requirements in §61.56 of this chapter;

2. Label each disposal container (or transport package if potential radiation hazards preclude labeling of the individual disposal container) of waste to identify whether it is Class A waste, Class B waste, Class C waste, or greater then Class C waste, in accordance with §61.55 of this chapter;

3. Conduct a quality assurance program to assure compliance with §§ 61.55 and 61.56 of this chapter (the program must include management evaluation of audits);

4. Prepare the NRC Uniform Low-Level Radioactive Waste Manifest as required by this appendix;

5. Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either (i) receipt of the manifest precedes the LLW shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;

6. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the option chosen in paragraph A.5 of this section;

7. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;

8. Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by 10 CFR parts 30, 40, and 70 of this chapter; and

9. For any shipments or any part of a shipment for which acknowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix.

B. Any waste collector licensee who handles only prepackaged waste shall:

1. Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540;

2. Prepare a new manifest to reflect consolidated shipments that meet the requirements of this appendix. The waste collector shall ensure that, for each container of waste

in the shipment, the manifest identifies the generator of that container of waste;

3. Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either: (i) Receipt of the manifest precedes the LLW shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;

4. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the option chosen in paragraph B.3 of this section;

5. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;

6. Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by 10 CFR parts 30, 40, and 70 of this chapter;

7. For any shipments or any part of a shipment for which acknowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix; and

8. Notify the shipper and the Administrator of the nearest Commission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.

C. Any licensed waste processor who treats or repackages waste shall:

1. Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540;

2. Prepare a new manifest that meets the requirements of this appendix. Preparation of the new manifest reflects that the processor is responsible for meeting these requirements. For each container of waste in the shipment, the manifest shall identify the waste generators, the preprocessed waste volume, and the other information as required in paragraph I.E. of this appendix;

3. Prepare all wastes so that the waste is classified according to $61.55 of this chapter and meets the waste characteristics requirements in §61.56 of this chapter:

4. Label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with §§ 61.55 and 61.57 of this chapter;

5. Conduct a quality assurance program to assure compliance with §§ 61.55 and 61.56 of this chapter (the program shall include management evaluation of audits);

6. Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so

that either: (i) Receipt of the manifest precedes the LLW shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;

7. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the option chosen in paragraph C.6 of this section;

8. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;

9. Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by 10 CFR parts 30, 40, and 70 of this chapter;

10. For any shipment or any part of a shipment for which acknowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix; and

11. Notify the shipper and the Administrator of the nearest Commission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.

D. The land disposal facility operator shall:

1. Acknowledge receipt of the waste within one week of receipt by returning, as a minimum, a signed copy of NRC Form 540 to the shipper. The shipper to be notified is the licensee who last possessed the waste and transferred the waste to the operator. If any discrepancy exists between materials listed on the Uniform Low-Level Radioactive Waste Manifest and materials received, copies or electronic transfer of the affected forms must be returned indicating the discrepancy;

2. Maintain copies of all completed manifests and electronically store the information required by 10 CFR 61.80(1) until the Commission terminates the license; and

3. Notify the shipper and the Administrator of the nearest Commission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.

E. Any shipment or part of a shipment for which acknowledgement is not received within the times set forth in this section must:

1. Be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and

2. Be traced and reported. The investigation shall include tracing the shipment and filing a report with the nearest Commission

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ENFORCEMENT

21.61 Failure to notify. 21.62 Criminal penalties.

AUTHORITY: Sec. 161, 68 Stat. 948, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat. 2951, 2953 (42 U.S.C. 2201, 2282, 2297f); secs. 201, as amended, 206, 88 Stat. 1242, as amended, 1246 (42 U.S.C. 5841, 5846).

Section 21.2 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).

SOURCE: 42 FR 28893, June 6, 1977, unless otherwise noted.

GENERAL PROVISIONS

$21.1 Purpose.

The regulations in this part establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. That section requires any individual director or responsible officer of a firm constructing, owning, operating or supplying the components of any facility

or activity which is licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended, or the Energy Reorganization Act of 1974, who obtains information reasonably indicating: (a) That the facility, activity or basic component supplied to such facility or activity fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to substantial safety hazards or (b) that the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard, to immediately notify the Commission of such failure to comply or such defect, unless he has actual knowledge that the Commission has been adequately informed of such defect or failure to comply.

$21.2 Scope.

(a) The regulations in this part apply, except as specifically provided otherwise in parts 31, 34, 35, 39, 40, 60, 61, 63, 70, or part 72 of this chapter, to each individual, partnership, corporation, or other entity licensed pursuant to the regulations in this chapter to possess, use, or transfer within the United States source material, byproduct material, special nuclear material, and/or spent fuel and high-level radioactive waste, or to construct, manufacture, possess, own, operate, or transfer within the United States, any production or utilization facility or independent spent fuel storage installation (ISFSI) or monitored retrievable storage installation (MRS); and to each director and responsible officer of such a licensee. The regulations in this part apply also to each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such organization, that constructs a production or utilization facility licensed for the manufacture, construction, or operation pursuant to part 50 of this chapter, an ISFSI for the storage of spent fuel licensed pursuant to part 72 of this chapter, an MRS for the storage of spent fuel or high-level radioactive waste pursuant to part 72 of this chapter, or a geologic repository for the disposal of high-level radio

active waste under part 60 or 63 of this chapter; or supplies basic components for a facility or activity licensed, other than for export, under parts 30, 40, 50, 60, 61, 63, 70, 71, or part 72 of this chapter.

(b) For persons licensed to construct a facility under a construction permit issued under $50.23 of this chapter, evaluation of potential defects and failures to comply and reporting of defects and failures to comply under § 50.55(e) of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects and failures to comply under this part and the responsibility of individual directors and responsible officers of such licensees to report defects under section 206 of the Energy Reorganization Act of 1974.

(c) For persons licensed to operate a nuclear power plant under part 50 of this chapter, evaluation of potential defects and appropriate reporting of defects under §§ 50.72, 50.73 or $73.71 of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects under this part and the responsibility of individual directors and responsible officers of such licensees to report defects under section 206 of the Energy Reorganization Act of 1974.

(d) Nothing in these regulations should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item (as defined in §21.3) not subject to the regulations in this part from reporting to the Commission, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. NRC regional offices and headquarters will accept collect telephone calls from individuals who wish to speak to NRC representatives concerning nuclear safety-related problems. The location and telephone numbers of the four regions (answered during regular working hours), are listed in appendix D to part 20 of this chapter. The telephone number of the NRC Operations Center (answered 24 hours a day-including holidays) is (301) 816

5100.

(e) The regulations in this part apply in accordance with 10 CFR 76.60 to each

individual, partnership, corporation, or other entity required to obtain a certificate of compliance or an approved compliance plan under part 76 of this chapter.

[56 FR 36089, July 31, 1991, as amended at 59 FR 14086, Mar. 25, 1994; 59 FR 48959, Sept. 23, 1994; 60 FR 48373, Sept. 19, 1995; 66 FR 55790, Nov. 2, 2001]

§ 21.3 Definitions.

As used in this part:

Basic component. (1)(i) When applied to nuclear power plants licensed pursuant to 10 CFR part 50 of this chapter, basic component means a structure, system, or component, or part thereof that affects its safety function necessary to assure:

(A) The integrity of the reactor coolant pressure boundary;

(B) The capability to shut down the reactor and maintain it in a safe shutdown condition; or

(C) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to those referred to in §50.34(a)(1), § 50.67(b)(2), or §100.11 of this chapter, as applicable.

(ii) Basic components are items designed and manufactured under a quality assurance program complying with 10 CFR part 50, appendix B, or commercial grade items which have successfully completed the dedication process.

(2) When applied to other facilities and when applied to other activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, basic component means a structure, system, or component, or part thereof that affects their safety function, that is directly procured by the licensee of a facility or activity subject to the regulations in this part and in which a defect or failure to comply with any applicable regulation in this chapter, order, or license issued by the Commission could create a substantial safety hazard.

(3) In all cases, basic component includes safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these serv

ices are performed by the component supplier or others.

Commercial grade item. (1) When applied to nuclear power plants licensed pursuant to 10 CFR part 50, commercial grade item means a structure, system, or component, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical characteristics of the item cannot be verified).

(2) When applied to facilities and activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, commercial grade item means an item that is:

(i) Not subject to design or specification requirements that are unique to those facilities or activities;

(ii) Used in applications other than those facilities or activities; and

(iii) To be ordered from the manufacturer/supplier on the basis of specifications set forth in the manufacturer's published product description (for example, a catalog).

Commission means the Nuclear Regulatory Commission or its duly authorized representatives.

Constructing or construction means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to the regulations in this part and consulting services related to the facility or activity that are safety related.

Critical characteristics. When applied to nuclear power plants licensed pursuant to 10 CFR part 50, critical characteristics are those important design, material, and performance characteristics of a commercial grade item that, once verified, will provide reasonable assurance that the item will perform its intended safety function.

Dedicating entity. When applied to nuclear power plants licensed pursuant to 10 CFR part 50, dedicating entity means the organization that performs the dedication process. Dedication may

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Dedication. (1) When applied to nuclear power plants licensed pursuant to 10 CFR part 50, dedication is an acceptance process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended safety function and, in this respect, is deemed equivalent to an item designed and manufactured under a 10 CFR part 50, appendix B, quality assurance program. This assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspections, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial grade surveys; product inspections or witness at holdpoints at the manufacturer's facility, and analysis of historical records for acceptable performance. In all cases, the dedication process must be conducted in accordance with the applicable provisions of 10 CFR part 50, appendix B. The process is considered complete when the item is designated for use as a basic component.

(2) When applied to facilities and activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, dedication occurs after receipt when that item is designated for use as a basic component.

Defect means:

(1) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to the regulations in this part if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or

(2) The installation, use, or operation of a basic component containing a defect as defined in this section; or

(3) A deviation in a portion of a facility subject to the construction permit

or

manufacturing licensing requirements of part 50 of this chapter provided the deviation could, on the basis of an evaluation, create a substantial safety hazard and the portion of the facility containing the deviation has been offered to the purchaser for acceptance; or

(4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued pursuant to part 50 of this chapter.

Deviation means a departure from the technical requirements included in a procurement document.

Director means an individual, appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship. director means the individual.

Discovery means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed § 21.21(a).

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Evaluation means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.

Notification means the telephonic communication to the NRC Operations Center or written transmittal of information to the NRC Document Control Desk.

Operating or operation means the operation of a facility or the conduct of a licensed activity which is subject to the regulations in this part and consulting services related to operations that are safety related.

Procurement document means a contract that defines the requirements which facilities or basic components must meet in order to be considered acceptable by the purchaser.

Responsible officer means the president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is

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