ML18009A322

North Dakota Regulations Chapter 17 (Revised)

ML18009A322
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Issue date:	01/03/2018
From:	Office of Nuclear Material Safety and Safeguards
To:	State of ND
Beardsley M
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CHAPTER 33-10-17 DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL Section 33-10-17-01 Adoption by Reference of Several Sections in 10 Code of Federal Regulations Part 70 33-10-17-01. Adoption by reference of several sections in 10 Code of Federal Regulations part 70. 10 Code of Federal Regulations 70.1, 70.2, 70.3, 70.4, 70.7, 70.9, 70.10, 70.11, 70.12, 70.17, 70.18, 70.19, 70.20, 70.21, 70.22, 70.23, 70.25, 70.31, 70.32, 70.33, 70.34, 70.35, 70.36, 70.38, 70.39, 70.41, 70.42, 70.50, 70.51, 70.56, and 70.81 are adopted by reference as they exist on December 1, 2015, with the following exceptions:

1. The following are not adopted by reference: 10 Code of Federal Regulations 70.1(c),(d) and (e); 70.20a, 70.20b, 70.21(a)(1), (c), (f), (g), and (h); 70.22(b), (c),

(f), (g), (h), (i), (j), (k), (l), (m), and (n); 70.23(a)(6), (a)(7), (a)(8), (a)(9), (a)(10),

(a)(11), (a)(12), and (b); 70.23a; 70.25(a)(1); 70.31(c), (d), and (e); 70.32(a)(1),

(a)(4), (a)(5), (a)(6), (a)(7), (b)(1), (b)(3), (b)(4), (c), (d), (e), (f), (g), (h), (i), (j) and (k); 70.42(b)(6); 70.51(c); paragraph (2) of the definition of commencement of construction; and paragraph (9)(ii) of the definition of construction.

2. Requirements in 10 Code of Federal Regulations part 70 that apply to byproduct material also apply to naturally occurring or accelerator-produced radioactive material.

3. Where the words NRC, commission, nuclear regulatory commission, United States nuclear regulatory commission, NRC regional administrator, NRC regional office, administrator of the appropriate nuclear regulatory commissions regional office, administrator of the appropriate regional office or nuclear regulatory commissions office of nuclear material safety and safeguards, division of industrial and medical nuclear safety appear in 10 Code of Federal Regulations part 70, substitute the words North Dakota state department of health.

4. 10 Code of Federal Regulations 70.7 employee protection also applies to violations of North Dakota Century Code chapters 23-20 and 23-20.1.

5. Act includes North Dakota Century Code chapters 23-20 and 23-20.1.

6. North Dakota state form number 8418, application for radioactive material license, must be used instead of nuclear regulatory commission form 313 as specified in 10 Code of Federal Regulations part 70.

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7. North Dakota state form number 8414, notice to employees, must be posted instead of United States nuclear regulatory commission form 3 that is specified in 10 Code of Federal Regulations part 70.

8. For references to 10 Code of Federal Regulations part 170, section 33-10-11 for applicable fee schedules.

History: Effective January 1, 2011; amended effective October 1, 2016.

General Authority: NDCC 23-20.1-04 Law Implemented: NDCC 23-20.1-03, 23-20.1-04 17-2

PART 70--DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL Subpart A--General Provisions 70.1 Purpose.

70.2 Scope.

70.3 License requirements.

70.4 Definitions.

70.5 Communications.

70.6 Interpretations.

70.7 Employee protection.

70.8 Information collection requirements: OMB approval.

70.9 Completeness and accuracy of information.

70.10 Deliberate misconduct.

Subpart B--Exemptions 70.11 Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts.

70.12 Carriers.

70.13 Department of Defense.

70.14 Foreign military aircraft.

70.17 Specific exemptions.

Subpart C--General Licenses 70.18 Types of licenses.

70.19 General license for calibration or reference sources.

70.20 General license to own special nuclear material.

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70.20a General license to possess special nuclear material for transport.

70.20b General license for carriers of transient shipments of formula quantities of strategic special nuclear material, special nuclear material of moderate strategic significance, special nuclear material of low strategic significance, and irradiated reactor fuel.

Subpart D--License Applications 70.21 Filing.

70.22 Contents of applications.

70.23 Requirements for the approval of applications.

70.23a Hearing required for uranium enrichment facility.

70.24 Criticality accident requirements.

70.25 Financial assurance and recordkeeping for decommissioning.

Subpart E--Licenses 70.31 Issuance of licenses.

70.32 Conditions of licenses.

70.33 Renewal of licenses.

70.34 Amendment of licenses.

70.35 Commission action on applications to renew or amend.

70.36 Inalienability of licenses.

70.37 Disclaimer of warranties.

70.38 Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.

70.39 Specific licenses for the manufacture or initial transfer of calibration or reference sources.

Subpart F--Acquisition, Use, and Transfer of Special Nuclear Material, Creditors' Rights 70.40 Ineligibility of certain applicants.

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70.41 Authorized use of special nuclear material.

70.42 Transfer of special nuclear material.

70.44 Creditor regulations.

Subpart G--Special Nuclear Material Control Records, Reports, and Inspections 70.50 Reporting requirements.

70.51 Records requirements.

70.52 Reports of accidental criticality.

70.55 Inspections.

70.56 Tests.

70.59 Effluent monitoring reporting requirements.

Subpart H--Additional Requirements for Certain Licensees Authorized To Possess a Critical Mass of Special Nuclear Material 70.60 Applicability.

70.61 Performance requirements.

70.62 Safety program and integrated safety analysis.

70.64 Requirements for new facilities or new processes at existing facilities.

70.65 Additional content of applications.

70.66 Additional requirements for approval of license application.

70.72 Facility changes and change process.

70.73 Renewal of licenses.

70.74 Additional reporting requirements.

70.76 Backfitting Subpart I--Modification and Revocation of Licenses 17-5

70.81 Modification and revocation of licenses.

70.82 Suspension and operation in war or national emergency.

Subpart J--Enforcement 70.91 Violations.

70.92 Criminal penalties.

Appendix A to Part 70--Reportable Safety Events Authority: Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 953, 954, as amended, sec. 234, 83 Stat. 444, as amended, (42 U.S.C. 2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended, 202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 Stat. 2835 as amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. No. 109-58, 119 Stat. 594 (2005).

Sections 70.1(c) and 70.20a(b) also issued under secs. 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).

Section 70.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851). Section 70.21(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub. L.93-377, 88 Stat. 475 (42 U.S.C. 2077). Sections 70.36 and 70.44 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 70.81 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237). Section 70.82 also issued under sec. 108, 68 Stat.

939, as amended (42 U.S.C. 2138).

Source: 21 FR 764, Feb. 3, 1956, unless otherwise noted.

[72 FR 63974, Nov. 14, 2007; 73 FR 63572, Oct. 24, 2008]

Subpart A--General Provisions

§ 70.1 Purpose.

(a) Except as provided in paragraphs (c) and (d) of this section, the regulations of this part establish procedures and criteria for the issuance of licenses to receive title to, own, acquire, deliver, receive, possess, use, and transfer special nuclear material; and establish and provide for the terms and conditions upon which the Commission will issue such licenses.

(b) The regulations contained in this part are issued pursuant to the Atomic Energy Act of 1954, as amended (68 Stat. 919) and Title II of the Energy Reorganization Act of 1974 (88 Stat. 1242).

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(c) The regulations in part 72 of this chapter establish requirements, procedures, and criteria for the issuance of licenses to possess:

(1) Spent fuel, power reactor-related Greater than Class C (GTCC) waste, and other radioactive materials associated with spent fuel storage in an independent spent fuel storage installation (ISFSI), or (2) Spent fuel, high-level radioactive waste, power reactor-related GTCC waste, and other radioactive materials associated with the storage in a monitored retrievable storage installation (MRS), and the terms and conditions under which the Commission will issue such licenses.

(d) As provided in part 76 of this chapter, the regulations of this part establish procedures and criteria for physical security and material control and accounting for the issuance of a certificate of compliance or the approval of a compliance plan.

(e) As provided in the Atomic Energy Act of 1954, as amended, the regulations in this part establish requirements, procedures, and criteria for the issuance of licenses to uranium enrichment facilities.

[21 FR 764, Feb. 3, 1956, as amended at 32 FR 4056, Mar. 15, 1967; 40 FR 8791, Mar. 3, 1975; 43 FR 6924, Feb. 17, 1978; 45 FR 74712, Nov. 12, 1980; 53 FR 31682, Aug. 19, 1988; 59 FR 48960, Sept. 23, 1994; 62 FR 6669, Feb. 12, 1997; 66 FR 51838, Oct. 11, 2001]

§ 70.2 Scope.

Except as provided in §§ 70.11 to 70.13, inclusive, the regulations in this part apply to all persons in the United States. This part also gives notice to all persons who knowingly provide to any licensee, applicant, contractor, or subcontractor, components, equipment, materials, or other goods or services, that relate to a licensee's or applicant's activities subject to this part, that they may be individually subject to NRC enforcement action for violation of § 70.10.

[56 FR 40691, Aug. 15, 1991]

§ 70.3 License requirements.

No person subject to the regulations in this part shall receive title to, own, acquire, deliver, receive, possess, use, or transfer special nuclear material except as authorized in a license issued by the Commission pursuant to these regulations.

[32 FR 2562, Feb. 7, 1967, as amended at 43 FR 6924, Feb. 17, 1978]

§ 70.4 Definitions.

Act means the Atomic Energy Act of 1954 (68 Stat 919), including any amendments thereto; 17-7

Acute, as used in this part, means a single radiation dose or chemical exposure event or multiple radiation dose or chemical exposure events occurring within a short time (24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less).

Agreement State as designated in part 150 of this chapter means any State with which the Commission has entered into an effective agreement under subsection 274b. of the Act.

Non-agreement State means any other State.

Alert means events may occur, are in progress, or have occurred that could lead to a release of radioactive material[s] but that the release is not expected to require a response by an offsite response organization to protect persons offsite.

Atomic energy means all forms of energy released in the course of nuclear fission or nuclear transformation; Atomic weapon means any device utilizing atomic energy, exclusive of the means for transporting or propelling the device (where such means is a separable and divisible part of the device), the principal purpose of which is for use as, or for development of, a weapon, a weapon prototype, or a weapon test device; Available and reliable to perform their function when needed, as used in subpart H of this part, means that, based on the analyzed, credible conditions in the integrated safety analysis, items relied on for safety will perform their intended safety function when needed, and management measures will be implemented that ensure compliance with the performance requirements of § 70.61 of this part, considering factors such as necessary maintenance, operating limits, common-cause failures, and the likelihood and consequences of failure or degradation of the items and measures.

Commencement of construction means any clearing of land, excavation, or other substantial action that would adversely affect the natural environment of a site but does not include changes desirable for the temporary use of the land for public recreational uses, necessary borings to determine site characteristics or other preconstruction monitoring to establish background information related to the suitability of a site or to the protection of environmental values.

Commission means the Nuclear Regulatory Commission or its duly authorized representatives; Configuration management (CM) means a management measure that provides oversight and control of design information, safety information, and records of modifications (both temporary and permanent) that might impact the ability of items relied on for safety to perform their functions when needed.

Contiguous sites means licensee controlled locations, deemed by the Commission to be in close enough proximity to each other, that the special nuclear material must be considered in the aggregate for the purpose of physical protection.

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Corporation means the United States Enrichment Corporation (USEC), or its successor, a Corporation that is authorized by statute to lease the gaseous diffusion enrichment plants in Paducah, Kentucky, and Piketon, Ohio, from the Department of Energy, or any person authorized to operate one or both of the gaseous diffusion plants, or other facilities, pursuant to a plan for the privatization of USEC that is approved by the President.

Critical mass of special nuclear material (SNM), as used in Subpart H, means special nuclear material in a quantity exceeding 700 grams of contained uranium-235; 520 grams of uranium-233; 450 grams of plutonium; 1500 grams of contained uranium-235, if no uranium enriched to more than 4 percent by weight of uranium-235 is present; 450 grams of any combination thereof; or one-half such quantities if massive moderators or reflectors made of graphite, heavy water, or beryllium may be present.

Decommission means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits--

(1) Release of the property for unrestricted use and termination of the license; or (2) Release of the property under restricted conditions and termination of the license.

Department and Department of Energy means the Department of Energy Organization Act (Pub.

L. 95-91, 91 Stat. 565, 42 U.S.C. 7101 et seq.), to the extent that the Department, or its duly authorized representatives, exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Pub. L.93-438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Pub. L. 95-91, 91 Stat. 565 at 577-578, 42 U.S.C.

7151).

Double contingency principle means that process designs should incorporate sufficient factors of safety to require at least two unlikely, independent, and concurrent changes in process conditions before a criticality accident is possible.

Effective dose equivalent means the sum of the products of the dose equivalent to the body organ or tissue and the weighting factors applicable to each of the body organs or tissues that are irradiated. Weighting factors are: 0.25 for gonads, 0.15 for breast, 0.12 for red bone marrow, 0.12 for lungs, 0.03 for thyroid, 0.03 for bone surface, and 0.06 for each of the other five organs receiving the highest dose equivalent.

Effective kilograms of special nuclear material means: (1) For plutonium and uranium-233 their weight in kilograms; (2) For uranium with an enrichment in the isotope U-235 of 0.01 (1%) and above, its element weight in kilograms multiplied by the square of its enrichment expressed as a decimal weight fraction; and (3) For uranium with an enrichment in the isotope U-235 below 0.01 17-9

(1%), by its element weight in kilograms multiplied by 0.0001.

Formula quantity means strategic special nuclear material in any combination in a quantity of 5000 grams or more computed by the formula, grams=(grams contained U-235)+2.5 (grams U-233+grams plutonium). This class of material is sometimes referred to as a Category I quantity of material.

Government agency means any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government; Hazardous chemicals produced from licensed materials means substances having licensed material as precursor compound(s) or substances that physically or chemically interact with licensed materials; and that are toxic, explosive, flammable, corrosive, or reactive to the extent that they can endanger life or health if not adequately controlled. These include substances commingled with licensed material, and include substances such as hydrogen fluoride that is produced by the reaction of uranium hexafluoride and water, but do not include substances prior to process addition to licensed material or after process separation from licensed material.

Integrated safety analysis (ISA) means a systematic analysis to identify facility and external hazards and their potential for initiating accident sequences, the potential accident sequences, their likelihood and consequences, and the items relied on for safety. As used here, integrated means joint consideration of, and protection from, all relevant hazards, including radiological, nuclear criticality, fire, and chemical. However, with respect to compliance with the regulations of this part, the NRC requirement is limited to consideration of the effects of all relevant hazards on radiological safety, prevention of nuclear criticality accidents, or chemical hazards directly associated with NRC licensed radioactive material. An ISA can be performed process by process, but all processes must be integrated, and process interactions considered.

Integrated safety analysis summary means a document or documents submitted with the license application, license amendment application, license renewal application, or pursuant to § 70.62(c)(3)(ii) that provides a synopsis of the results of the integrated safety analysis and contains the information specified in § 70.65(b). The ISA Summary can be submitted as one document for the entire facility, or as multiple documents that cover all portions and processes of the facility.

Items relied on for safety mean structures, systems, equipment, components, and activities of personnel that are relied on to prevent potential accidents at a facility that could exceed the performance requirements in § 70.61 or to mitigate their potential consequences. This does not limit the licensee from identifying additional structures, systems, equipment, components, or activities of personnel (i.e., beyond those in the minimum set necessary for compliance with the performance requirements) as items relied on for safety.

License, except where otherwise specified, means a license issued pursuant to the regulations in 17-10

this part; Management measures mean the functions performed by the licensee, generally on a continuing basis, that are applied to items relied on for safety, to ensure the items are available and reliable to perform their functions when needed. Management measures include configuration management, maintenance, training and qualifications, procedures, audits and assessments, incident investigations, records management, and other quality assurance elements.

Person means (1) any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the Commission or the Department, except that the Department shall be considered a person within the meaning of the regulations in this part to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission pursuant to section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), any State or any political subdivision of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and (2) any legal successor, representative, agent, or agency of the foregoing; Plutonium processing and fuel fabrication plant means a plant in which the following operations or activities are conducted: (1) Operations for manufacture of reactor fuel containing plutonium including any of the following: (i) Preparation of fuel material; (ii) formation of fuel material into desired shapes; (iii) application of protective cladding; (iv) recovery of scrap material; and (v) storage associated with such operations; or (2) Research and development activities involving any of the operations described in paragraph (1) of this definition except for research and development activities utilizing unsubstantial amounts of plutonium.

Principal activities, as used in this part, means activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

Produce, when used in relation to special nuclear material, means (1) to manufacture, make, produce, or refine special nuclear material; (2) to separate special nuclear material from other substances in which such material may be contained; or (3) to make or to produce new special nuclear material; Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes; Restricted Data means all data concerning (1) design, manufacture or utilization of atomic weapons; (2) the production of special nuclear material; or (3) the use of special nuclear material in the production of energy, but shall not include data declassified or removed from the Restricted 17-11

Data category pursuant to section 142 of the Act; Sealed source means any special nuclear material that is encased in a capsule designed to prevent leakage or escape of the special nuclear material.

Site Area emergency means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect persons offsite.

Source material means source material as defined in section 11z. of the Act and in the regulations contained in part 40 of this chapter; Special nuclear material means (1) plutonium, uranium 233, uranium enriched in the isotope 233 or in the isotope 235, and any other material which the Commission, pursuant to the provisions of section 51 of the act, determines to be special nuclear material, but does not include source material; or (2) any material artificially enriched by any of the foregoing but does not include source material; Special nuclear material of low strategic significance means:

(1) Less than an amount of special nuclear material of moderate strategic significance as defined in paragraph (1) of the definition of strategic nuclear material of moderate strategic significance in this section, but more than 15 grams of uranium-235 (contained in uranium enriched to 20 percent or more in U-235 isotope) or 15 grams of uranium-233 or 15 grams of plutonium or the combination of 15 grams when computed by the equation, grams = (grams contained U-235) +

(grams plutonium) + (grams U-233); or (2) Less than 10,000 grams but more than 1,000 grams of uranium-235 (contained in uranium enriched to 10 percent or more but less than 20 percent in the U-235 isotope); or (3) 10,000 grams or more of uranium-235 (contained in uranium enriched above natural but less than 10 percent in the U-235 isotope).

This class of material is sometimes referred to as a Category III quantity of material.

Special nuclear material of moderate strategic significance means:

(1) Less than a formula quantity of strategic special nuclear material but more than 1,000 grams of uranium-235 (contained in uranium enriched to 20 percent or more in the U-235 isotope) or more than 500 grams of uranium-233 or plutonium, or in a combined quantity of more than 1,000 grams when computed by the equation, grams = (grams contained U-235) + 2 (grams U-233 + grams plutonium); or (2) 10,000 grams or more of uranium-235 (contained in uranium enriched to 10 percent or more 17-12

but less than 20 percent in the U-235 isotope).

This class of material is sometimes referred to as a Category II quantity of material.

Special nuclear material scrap means the various forms of special nuclear material generated during chemical and mechanical processing, other than recycle material and normal process intermediates, which are unsuitable for use in their present form, but all or part of which will be used after further processing.

Strategic special nuclear material means uranium-235 (contained in uranium enriched to 20 percent or more in the U235 isotope), uranium-233, or plutonium.

Transient shipment means a shipment of nuclear material, originating and terminating in foreign countries, on a vessel or aircraft which stops at a United States port.

Unacceptable performance deficiencies mean deficiencies in the items relied on for safety or the management measures that need to be corrected to ensure an adequate level of protection as defined in 10 CFR 70.61(b), (c), or (d).

United States, when used in a geographical sense, includes Puerto Rico and all territories and possessions of the United States.

Uranium enrichment facility means:

(1) Any facility used for separating the isotopes of uranium or enriching uranium in the isotope 235, except laboratory scale facilities designed or used for experimental or analytical purposes only; or (2) Any equipment or device, or important component part especially designed for such equipment or device, capable of separating the isotopes of uranium or enriching uranium in the isotope 235.

Worker, when used in Subpart H of this Part, means an individual who receives an occupational dose as defined in 10 CFR 20.1003.

[21 FR 764, Feb. 3, 1956]

Editorial Note: For Federal Register citations affecting § 70.4, see the List of CFR Sections Affected.

§ 70.5 Communications.

(a) Unless otherwise specified or covered under the regional licensing program as provided in paragraph (b) of this section, any communication or report concerning the regulations in this part and any application filed under these regulations may be submitted to the Commission as follows:

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(1) By mail addressed to: ATTN: Document Control Desk, Director, Office of Nuclear Material Safety and Safeguards or Director, Division of Nuclear Security, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

(2) By hand delivery to the Director, Office of Nuclear Material Safety and Safeguards or Director, Division of Nuclear Security, Office of Nuclear Security and Incident Response at the NRC's offices at 11555 Rockville Pike, Rockville, Maryland.

(3) Where practicable, by electronic submission, for example, via Electronic Information Exchange, and CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html, by calling (301) 415-0439, by e-mail to EIE@nrc.gov, or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information.

(4) Classified communications shall be transmitted to the NRC Headquarters' classified mailing address as specified in appendix A to part 73 of this chapter or delivered by hand in accordance with paragraph (a)(2) of this section.

(b) The Commission has delegated to the four Regional Administrators licensing authority for selected parts of its decentralized licensing program for nuclear materials as described in paragraph (b)(1) of this section. Any communication, report, or application covered under this licensing program must be submitted to the appropriate Regional Administrator. The Administrators' jurisdictions and mailing addresses are listed in paragraph (b)(2) of this section.

(1) The delegated licensing program includes authority to issue, renew, amend, cancel, modify, suspend, or revoke licenses for nuclear materials issued pursuant to 10 CFR parts 30 through 36, 39, 40, and 70 to all persons for academic, medical, and industrial uses, with the following exceptions:

(i) Activities in the fuel cycle and special nuclear material in quantities sufficient to constitute a critical mass in any room or area. This exception does not apply to license modifications relating to termination of special nuclear material licenses that authorize possession of larger quantities when the case is referred for action from NRC's Headquarters to the Regional Administrators.

(ii) Health and safety design review of sealed sources and devices and approval, for licensing purposes, of sealed sources and devices.

(iii) Processing of source material for extracting of metallic compounds (including Zirconium, Hafnium, Tantalum, Titanium, Niobium, etc.).

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(iv) Distribution of products containing radioactive material to persons exempt pursuant to 10 CFR 32.11 through 32.26.

(v) New uses or techniques for use of byproduct, source, or special nuclear material.

(vi) Reviews pursuant to § 70.32(c).

(vii) Uranium enrichment facilities.

(2) Submissions--(i) Region I. The regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region I non-Agreement States and the District of Columbia: Connecticut, Delaware, Maine, Massachusetts, New Jersey, Pennsylvania, and Vermont. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment or renewal of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region I, Nuclear Material Section B, 475 Allendale Road, King of Prussia, Pennsylvania 19406-1415; where e-mail is appropriate it should be addressed to RidsRgn1MailCenter@nrc.gov.

(ii) Region II. The regional licensing program involves all Federal facilties in the region and non-Federal licensees in the following Region II non-Agreement States and territories: Virginia, West Virginia, Puerto Rico, and the Virgin Islands. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment or renewal of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region II, Material Licensing/Inspection Branch, Sam Nunn Atlanta Federal Center, Suite 23T85, 61 Forsyth Street, SW, Atlanta, GA 30303-8931; where e-mail is appropriate it should be addressed to RidsRgn2MailCenter@nrc.gov.

(iii) Region III. The regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region III non-Agreement States: Indiana, Michigan, Minnesota, Missouri, Ohio, and Wisconsin. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, or renewal of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region III, Material Licensing Section, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it should be addressed to RidsRgn3MailCenter@nrc.gov.

(iv) Region IV. The regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region IV non-Agreement States and a territory: Alaska, Hawaii, Montana, Oklahoma, South Dakota, Wyoming, and Guam. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment or renewal of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S.

Nuclear Regulatory Commission, Region IV, Material Radiation Protection Section, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011-4005; where e-mail is appropriate it should be addressed to RidsRgn4MailCenter@nrc.gov.

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[48 FR 16032, Apr. 14, 1983, as amended at 49 FR 19631, May 9, 1984; 49 FR 47824, Dec. 7, 1984; 50 FR 14694, Apr. 15, 1985; 51 FR 36001, Oct. 8, 1986; 52 FR 38392, Oct. 16, 1987; 52 FR 48093, Dec. 18, 1987; 53 FR 3862, Feb. 10, 1988; 53 FR 4111, Feb. 12, 1988; 53 FR 43421, Oct.

27, 1988; 54 FR 6877, Feb. 15, 1989; 57 FR 18392, Apr. 30, 1992; 58 FR 7737, Feb. 9, 1993; 58 FR 64112, Dec. 6, 1993; 59 FR 17466, Apr. 13, 1994; 60 FR 24552, May 9, 1995; 62 FR 22880, Apr. 28, 1997; 68 FR 58816, Oct. 10, 2003; 70 FR 69421, Nov. 16, 2005; 71 FR 15012, Mar. 27, 2006; 72 FR 33386, Jun. 18, 2007]

§ 70.6 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.

§ 70.7 Employee protection.

(a) Discrimination by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reorganization Act of 1974, as amended, and in general are related to the administration or enforcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act.

(1) The protected activities include but are not limited to:

(i) Providing the Commission or his or her employer information about alleged violations of either of the statutes named in paragraph (a) introductory text of this section or possible violations of requirements imposed under either of those statutes; (ii) Refusing to engage in any practice made unlawful under either of the statutes named in paragraph (a) introductory text or under these requirements if the employee has identified the alleged illegality to the employer; (iii) Requesting the Commission to institute action against his or her employer for the administration or enforcement of these requirements; (iv) Testifying in any Commission proceeding, or before Congress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) introductory text.

(v) Assisting or participating in, or is about to assist or participate in, these activities.

(2) These activities are protected even if no formal proceeding is actually initiated as a result of the 17-16

employee assistance or participation.

(3) This section has no application to any employee alleging discrimination prohibited by this section who, acting without direction from his or her employer (or the employer's agent),

deliberately causes a violation of any requirement of the Energy Reorganization Act of 1974, as amended, or the Atomic Energy Act of 1954, as amended.

(b) Any employee who believes that he or she has been discharged or otherwise discriminated against by any person for engaging in protected activities specified in paragraph (a)(1) of this section may seek a remedy for the discharge or discrimination through an administrative proceeding in the Department of Labor. The administrative proceeding must be initiated within 180 days after an alleged violation occurs. The employee may do this by filing a complaint alleging the violation with the Department of Labor, Employment Standards Administration, Wage and Hour Division. The Department of Labor may order reinstatement, back pay, and compensatory damages.

(c) A violation of paragraphs (a), (e), or (f) of this section by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant may be grounds for--

(1) Denial, revocation, or suspension of the license.

(2) Imposition of a civil penalty on the licensee, applicant, or a contractor or subcontractor of the licensee or applicant.

(3) Other enforcement action.

(d) Actions taken by an employer, or others, which adversely affect an employee may be predicated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An employee's engagement in protected activities does not automatically render him or her immune from discharge or discipline for legitimate reasons or from adverse action dictated by nonprohibited considerations.

(e)(1) Each specific licensee, each applicant for a specific license, and each general licensee subject to part 19 shall prominently post the revision of NRC Form 3, "Notice to Employees,"

referenced in 10 CFR 19.11(c).

(2) The posting of NRC Form 3 must be at locations sufficient to permit employees protected by this section to observe a copy on the way to or from their place of work. Premises must be posted not later than 30 days after an application is docketed and remain posted while the application is pending before the Commission, during the term of the license, and for 30 days following license termination.

(3) Copies of NRC Form 3 may be obtained by writing to the Regional Administrator of the 17-17

appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D to part 20 of this chapter, by calling (301) 415-5877, via e-mail to forms@nrc.gov, or by accessing the NRC Web site at http://www.nrc.gov and selecting forms from the index found on the home page.

(f) No agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Department of Labor pursuant to section 211 of the Energy Reorganization Act of 1974, as amended, may contain any provision which would prohibit, restrict, or otherwise discourage an employee from participating in protected activity as defined in paragraph (a)(1) of this section including, but not limited to, providing information to the NRC or to his or her employer on potential violations or other matters within NRC's regulatory responsibilities.

[58 FR 52413, Oct. 8, 1993, as amended at 60 FR 24552, May 9, 1995; 61 FR 6765, Feb. 22, 1996; 68 FR 58817, Oct. 10, 2003; 72 FR 63974, Nov. 14, 2007]

§ 70.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0009.

(b) The approved information collection requirements contained in this part appear in §§ 70.9, 70.17, 70.19, 70.20a, 70.20b, 70.21, 70.22, 70.24, 70.25, 70.32, 70.33, 70.34, 70.38, 70.39, 70.42, 70.50, 70.51, 70.52, 70.59, 70.61, 70.62, 70.64, 70.65, 70.72, 70.73, 70.74, and Appendix A.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In § 70.21(g), Form N-71 and associated forms are approved under control number 3150-0056.

(2) In § 70.38, NRC form 314 is approved under control number 3150-0028.

(3) In § 70.21(g), DOC/NRC Forms AP-1, AP-A, and associated forms are approved under control number 0694-0135.

[49 FR 19628, May 9, 1984, as amended at 52 FR 19305, May 22, 1987; 56 FR 40769, Aug. 16, 1991; 57 FR 18392, Apr. 30, 1992; 58 FR 39634, July 26, 1993; 62 FR 52189, Oct. 6, 1997; 65 FR 56225, Sept. 18, 2000; 67 FR 78412, Dec. 23, 2002; 73 FR 78606, Dec. 23, 2008]

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§ 70.9 Completeness and accuracy of information.

(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.

(b) Each applicant or licensee shall notify the Commission of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the Commission of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall be provided to the Administrator of the appropriate Regional Office within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the Commission by other reporting or updating requirements.

[52 FR 49373, Dec. 31, 1987]

§ 70.10 Deliberate misconduct.

(a) Any licensee, applicant for a license, employee of a licensee or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or applicant for a license, who knowingly provides to any licensee, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's or applicant's activities in this part, may not:

(1) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or (2) Deliberately submit to the NRC, a licensee, an applicant, or a licensee's or applicant's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the NRC.

(b) A person who violates paragraph (a)(1) or (a)(2) of this section may be subject to enforcement action in accordance with the procedures in 10 CFR part 2, subpart B.

(c) For the purposes of paragraph (a)(1) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:

(1) Would cause a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commission; or 17-19

(2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, applicant, contractor, or subcontractor.

[63 FR 1899, Jan. 13, 1998]

Subpart B--Exemptions

§ 70.11 Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts.

Except to the extent that Department facilities or activities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974 are involved, any prime contractor of the Department is exempt from the requirements for a license set forth in section 53 of the Act and from the regulations in this part to the extent that such contractor, under his prime contract with the Department receives title to, owns, acquires, delivers, receives, possesses, uses, or transfers special nuclear material for:

(a) The performance of work for the Department at a United States Government-owned or controlled site, including the transportation of special nuclear material to or from such site and the performance of contract services during temporary interruptions of such transportation; (b) research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or (c) the use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel. In addition to the foregoing exemptions, and subject to the requirement for licensing of Department facilities and activities pursuant to section 202 of the Energy Reorganization Act of 1974, any prime contractor or subcontractor of the Department or the Commission is exempt from the requirements for a license set forth in section 53 of the Act and from the regulations in this part to the extent that such prime contractor or subcontractor receives title to, owns, acquires, delivers, receives, possesses, uses, or transfers special nuclear material under his prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

[40 FR 14085, Mar. 28, 1975; 40 FR 16047, Apr. 9, 1975; as amended at 43 FR 6924, Feb. 17, 1978; 65 FR 54950, Sept. 12, 2000]

§ 70.12 Carriers.

Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the regulations in this part to the extent that they transport special nuclear material in the regular course of carriage for another or storage incident thereto. This exemption does not apply to the storage in transit or transport of material by persons covered by the general license issued under § 70.20a and § 70.20b.

17-20

[46 FR 12696, Feb. 18, 1981]

§ 70.13 Department of Defense.

The regulations in this part do not apply to the Department of Defense to the extent that the Department receives, possesses and uses special nuclear material in accordance with the direction of the President pursuant to section 91 of the Act.

§ 70.14 Foreign military aircraft.

The regulations in this part do not apply to persons who carry special nuclear material (other than plutonium) in aircraft of the armed forces of foreign nations subject to 49 U.S.C. 40103(d).

[46 FR 12194, Feb. 13, 1981. Redesignated at 65 FR 56225, Sept. 18, 2000; 71 FR 15012, Mar. 27, 2006]

§ 70.17 Specific exemptions.

(a) The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

(b) [Reserved]

(c) The DOE is exempt from the requirements of the regulations in this part to the extent that its activities are subject to the requirements of part 60 or part 63 of this chapter.

(d) Except as specifically provided in part 61 of this chapter, any licensee is exempt from the requirements of the regulations in this part to the extent that its activities are subject to the requirements of part 61 of this chapter.

[37 FR 5749, Mar. 21, 1972, as amended at 45 FR 65536, Oct. 3, 1980; 46 FR 13987, Feb. 25, 1981; 47 FR 57481, Dec. 27, 1982; Redesignated at 65 FR 56225, Sept. 18, 2000, as amended at 66 FR 55815, Nov. 2, 2001]

Subpart C--General Licenses

§ 70.18 Types of licenses.

Licenses for special nuclear material are of two types: general and specific. Any general license provided in this part is effective without the filing of applications with the Commission or the issuance of licensing documents to particular persons. Specific licenses are issued to named persons upon applications filed pursuant to the regulations in this part.

17-21

[29 FR 5884, May 5, 1964]

§ 70.19 General license for calibration or reference sources.

(a) A general license is hereby issued to those persons listed below to receive title to, own, acquire, deliver, receive, possess, use and transfer in accordance with the provisions of paragraphs (b) and (c) of this section, plutonium in the form of calibration or reference sources:

(1) Any person in a non-agreement State who holds a specific license issued by the Commission or the Atomic Energy Commission which authorizes him to receive, possess, use and transfer byproduct material, source material, or special nuclear material; (2) Any Government agency as defined in § 70.4 that holds a specific license issued by the Commission that authorizes it to receive, possess, use, or transfer byproduct material, source material, or special nuclear material; and (3) Any person in an agreement State who holds a specific license issued by the Commission or the Atomic Energy Commission which authorizes him to receive, possess, use and transfer special nuclear material.

(b) The general license in paragraph (a) of this section applies only to calibration or reference sources which have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued pursuant to § 70.39 or in accordance with the specifications contained in a specific license issued by an agreement State which authorizes manufacture of the sources for distribution to persons generally licensed by the agreement State.

(c) The general license in paragraph (a) of this section is subject to the provisions of §§ 70.32, 70.50, 70.55, 70.56, 70.91, 70.81, and 70.82; the provisions of §§ 74.11 and 74.19 of this chapter; and to the provisions of parts 19, 20, and 21 of this chapter. In addition, persons who receive title to own, acquire, deliver, receive, possess, use or transfer one or more calibration or reference sources under this general license:

(1) Shall not possess at any one time, at any one location of storage or use, more than 5 microcuries of plutonium in such sources; (2) Shall not receive, possess, use or transfer such source unless the source, or the storage container, bears a label which includes the following statement or a substantially similar statement which contains the information called for in the following statement:1 The receipt, possession, use and transfer of this source, Model-- --- , Serial No.-----, are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

17-22

CAUTIONRADIOACTIVE MATERIALTHIS SOURCE CONTAINS PLUTONIUM. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

(Name of Manufacturer or Initial Transferor)

(3) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the Commission or the Atomic Energy Commission or an Agreement State to receive the source.

(4) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain plutonium which might otherwise escape during storage.

(5) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

(d) The general license in paragraph (a) of this section does not authorize the manufacture, import, or export of calibration or reference sources containing plutonium.

[29 FR 5884, May 5, 1964, as amended at 32 FR 8124, June 7, 1967; 38 FR 22221, Aug. 17, 1973; 40 FR 8792, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6924, Feb. 17, 1978; 48 FR 32329, July 15, 1983; 56 FR 40769, Aug. 16, 1991; 57 FR 33428, July 29, 1992; 67 FR 78142, Dec. 23, 2002; 72 FR 35144, June 27, 2007]

1 Sources generally licensed under this section prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.

§ 70.20 General license to own special nuclear material.

A general license is hereby issued to receive title to and own special nuclear material without regard to quantity. Notwithstanding any other provision of this chapter, a general licensee under this section is not authorized to acquire, deliver, receive, possess, use, transfer, import, or export special nuclear material, except as authorized in a specific license.

[33 FR 9810, July 9, 1968]

§ 70.20a General license to possess special nuclear material for transport.

(a) A general license is issued to any person to possess formula quantities of strategic special nuclear material of the types and quantities subject to the requirements of §§ 73.20, 73.25, 73.26 and 73.27 of this chapter, and irradiated reactor fuel containing material of the types and quantities subject to the requirements of § 73.37 of this chapter, in the regular course of carriage for another or storage incident. Carriers generally licensed under § 70.20b are exempt from the requirements of this section. Carriers of irradiated reactor fuel for the United States Department of Energy are also exempt from the requirements of this section. The general license is subject to the applicable 17-23

provisions of §§ 70.7 (a) through (e), 70.32 (a) and (b), and §§ 70.42, 70.52, 70.55, 70.91, 70.81, 70.82 and 10 CFR 74.11.

(b) Notwithstanding any other provision of this chapter, the general license issued under this section does not authorize any person to conduct any activity that would be authorized by a license issued pursuant to parts 30 through 36, 39, 40, 50, 72, 110, or other sections of this part.

(c) Notwithstanding any other provision of this chapter, the duties of a general licensee under this section while in possession of formula quantities of strategic special nuclear material or irradiated reactor fuel in the regular course of carriage for another or storage incident thereto shall be limited to providing for the physical protection of such material against theft or sabotage. Unless otherwise provided by this section, a general license under this section is not subject to the requirements of Parts 19, 20, 70 and 73.

(d) Any person who possesses formula quantities of strategic special nuclear material under this general license:

(1) Shall have submitted and received approval of a transportation security plan. The security plan shall outline the procedures that will be used to meet the requirements of §§ 73.20, 73.25, 73.26, 73.27 and 73.70(g) of this chapter including a plan for the selection, qualification, and training of armed escorts, or the specification and design of a specially designed truck or trailer as appropriate.

(2) Shall assure that the transportation is in accordance with the applicable physical protection requirements of §§ 73.20, 73.25, 73.26, 73.27 and 73.70(g) of this chapter and the applicable approved transportation security plan.

(3) Shall be subject to part 26 and § 73.80 of this chapter.

(e) Any person who possesses irradiated reactor fuel under this general license shall:

(1) Assure or receive certification from the shipper that the transportation is in accordance with the applicable physical protection requirements of § 73.37 of this chapter; and (2) Comply with the reporting requirements of § 73.71 of this chapter.

[44 FR 26851, May 8, 1979, as amended at 44 FR 68186, Nov. 28, 1979; 46 FR 12696, Feb. 18, 1981; 47 FR 30458, July 14, 1982; 53 FR 31682, Aug. 19, 1988; 58 FR 7737, Feb. 9, 1993; 58 FR 31471, June 3, 1993; 67 FR 78142, Dec. 23, 2002; 72 FR 35144, June 27, 2007]

§ 70.20b General license for carriers of transient shipments of formula quantities of strategic special nuclear material, special nuclear material of moderate strategic significance, special nuclear material of low strategic significance, and irradiated reactor fuel.

17-24

(a) A general license is hereby issued to any person to possess transient shipments of the following kinds and quantities of special nuclear material:

(1) A formula quantity of special nuclear material of the types and quantities subject to the requirements of §§ 73.20, 73.25, 73.26, and 73.27 of this chapter.

(2) Special nuclear material of moderate and low strategic significance of the types and quantities subject to the requirements of § 73.67 of this chapter.

(3) Irradiated reactor fuel of the type and quantity subject to the requirements of § 73.37 of this chapter.

(b) Persons generally licensed under this section are exempt from the requirements of parts 19 and 20 of this chapter and the requirements of this part, except §§ 70.32 (a) and (b), 70.52, 70.55, 70.91, 70.81, and 70.82.

(c) Persons generally licensed under this section to possess a transient shipment of special nuclear material of the kind and quantity specified in paragraph (a)(1) of this section shall provide physical protection for that shipment in accordance with or equivalent to §§ 73.20(a), 73.20(b), 73.25, and 73.71(b) of this chapter from the time a shipment enters a United States port until it exits that or another United States port.

(d) Persons generally licensed under this section to possess a transient shipment of special nuclear material of moderate or low strategic significance of the kind and quantity specified in paragraph (a)(2) of this section shall provide physical protection for that shipment in accordance with or equivalent to § 73.67 of this chapter and shall comply with the requirements of § 73.71(b) of this chapter.

(e) Persons generally licensed under this section to possess a transient shipment of irradiated reactor fuel of the kind and quantity specified in paragraph (a)(3) of this section shall provide physical protection for that shipment in accordance with or equivalent to § 73.37 of this chapter and shall comply with the requirements of § 73.71(b) of this chapter.

(f)(1) Persons generally licensed under this section, who plan to carry transient shipments with scheduled stops at United States ports, shall notify in writing the Director, Division of Nuclear Security, Office of Nuclear Security and Incident Response, using an appropriate method listed in

§ 70.5(a). Classified notifications shall be sent to the NRC headquarters classified mailing address listed in appendix A to part 73 of this chapter.

(2) A person generally licensed under this section shall assure that:

(i) The notification will be received at least 10 days before transport of the shipment commences at the shipping facility; 17-25

(ii) The NRC Headquarters Operations Center shall be notified by telephone at least 2 days before commencement of the shipment at the numbers listed in appendix A to part 73 of this chapter.

Classified notifications shall be made by secure telephone.

(iii) The NRC Headquarters Operations Center shall be notified by telephone of schedule changes greater than +/-6 hours at the numbers listed in appendix A to part 73 of this chapter. Classified notifications shall be made by secure telephone.

(3) Persons who are generally licensed under paragraph (a)(1) of this section must include the information listed in paragraphs (f)(3)(i) through (ix) of this section. Persons who are generally licensed under § 70.20b(a)(2) and § 70.20b(a)(3) must include the information listed in paragraphs (f)(3) (i) through (viii) of this section.

(i) Location of all scheduled stops in United States territory; (ii) Arrival and departure times for all scheduled stops in United States territory; (iii) The type of transport vehicle; (iv) A physical description of the shipment (elements, isotopes, and enrichments);

(v) The number and types of containers; (vi) The name and telephone number of the carrier's representative at each stopover location in United States territory; (vii) The estimated time and date that shipment will commence and that each country (other than the United States) along the route is scheduled to be entered; (viii) For shipments between countries that are not party to the Convention on the Physical Protection of Nuclear Material, provide assurances, as far as is practicable, that this nuclear material will be protected during international transport at levels described in Annex I to that Convention (see appendices E and F of part 73 of this chapter); and (ix) A physical protection plan for implementing the requirement of § 70.20b(c), which will include the use of armed personnel to protect the shipment during the time the shipment is in a United States port.

(g) Persons generally licensed under this section making unscheduled stops at United States ports, immediately after the decision to make an unscheduled stop, shall:

(1) Provide to the Director, Division of Nuclear Security, Office of Nuclear Security and Incident Response, the information required under paragraph (f) of this section.

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(2) In the case of persons generally licensed under paragraph (a)(1) of this section, arrange for local law enforcement authorities or trained and qualified private guards to protect the shipment during the stop.

(3) In the case of persons generally licensed under paragraph (a)(2) of this section, arrange for the shipment to be protected as required in § 73.67(e) of this chapter.

(4) In the case of persons generally licensed under paragraph (a)(3) of this section, arrange for the shipment to be protected as required in § 73.37(e) of this chapter.

(5) Implement these arrangements within a reasonable time after the arrival of the shipment at a United States port to remain in effect until the shipment exits that or another United States port.

[52 FR 9652, Mar. 26, 1987, as amended at 60 FR 24552, May 9, 1995; 67 FR 3585, Jan. 25, 2002; 68 FR 58817, Oct. 10, 2003; 72 FR 35144, June 27, 2007]

Subpart D--License Applications

§ 70.21 Filing.

(a)(1) A person may apply for a license to possess and use special nuclear material in a plutonium processing or fuel fabrication plant, or for a uranium enrichment facility license, by filing the application with the Director of the NRC's Office of Nuclear Material Safety and Safeguards in accordance with the instructions in § 70.5(a). If the application is on paper or CD-ROM, only one copy need be provided. If the application is to be submitted electronically, see guidance for electronic submissions to the Commission.

(2) A person may apply for any other license issued under this part, by filing the application in accordance with the instructions in § 70.5(a). If the application is on paper, only one copy need be provided. If the application is to be submitted electronically, see guidance for electronic submissions to the Commission.

(3) Information contained in previous applications, statements, or reports filed with the Commission may be incorporated by reference if the references are clear and specific.

(b) An application for license filed pursuant to the regulations in this part will be considered also as an application for licenses authorizing other activities for which licenses are required by the Act, provided the application specifies the additional activities for which licenses are requested and complies with regulations of the Commission as to applications for such licenses.

(c) Any application which contains Restricted Data shall be prepared in such manner that all Restricted Data are separated from the unclassified information.

(d) Applications and documents submitted to the Commission in connection with applications may 17-27

be made available for public inspection in accordance with the provisions of the regulations contained in part 2 of this chapter.

(e) Each application for a special nuclear material license, other than a license exempted from part 170 of this chapter, shall be accompanied by the fee prescribed in § 170.31 of this chapter. No fee will be required to accompany an application for renewal or amendment of a license, except as provided in § 170.31 of this chapter.

(f) An application for a license to possess and use special nuclear material for processing and fuel fabrication, scrap recovery or conversion of uranium hexafluoride, or for the conduct of any other activity which the Commission has determined pursuant to subpart A of part 51 of this chapter will significantly affect the quality of the environment shall be filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted, and shall be accompanied by an Environmental Report required under subpart A of part 51 of this chapter.

(g)(1) In response to a written request by the Commission, each applicant for a construction authorization or license and each recipient of a construction authorization or a license to possess and use special nuclear material shall submit facility information, as described in § 75.10 of this chapter, on Form N-71 and associated forms and site information on DOC/NRC Form AP-A and associated forms; (2) As required by the Additional Protocol, applicants and licensees specified in paragraph (a) of this section shall submit location information described in § 75.11 of this chapter on DOC/NRC Form AP-1 and associated forms; and (3) Shall permit verification thereof by the International Atomic Energy Agency (IAEA) and take other action as necessary to implement the US/IAEA Safeguards Agreement, as described in Part 75 of this chapter.

(h) A license application for a uranium enrichment facility must be accompanied by an Environmental Report required under subpart A of part 51 of this chapter.

[21 FR 764, Feb. 3, 1956, as amended at 23 FR 1122, Feb. 21, 1958; 31 FR 4670, Mar. 19, 1966; 34 FR 19546, Dec. 11, 1969; 36 FR 146, Jan. 6, 1971; 37 FR 5749, Mar. 21, 1972; 49 FR 9406, Mar. 12, 1984; 49 FR 19628 and 19632, May 9, 1984; 49 FR 21699, May 23, 1984; 57 FR 18392, Apr. 30, 1992; 68 FR 58817, Oct. 10, 2003; 73 FR 78606, Dec. 23, 2008]

§ 70.22 Contents of applications.

(a) Each application for a license shall contain the following information:

(1) The full name, address, age (if an individual), and citizenship of the applicant and the names and addresses of three personal references. If the applicant is a corporation or other entity, it shall 17-28

indicate the State where it was incorporated or organized, the location of the principal office, the names, addresses, and citizenship of its principal officers, and shall include information known to the applicant concerning the control or ownership, if any, exercised over the applicant by any alien, foreign corporation, or foreign government; (2) The activity for which the special nuclear material is requested, or in which special nuclear material will be produced, the place at which the activity is to be performed and the general plan for carrying out the activity; (3) The period of time for which the license is requested; (4) The name, amount, and specifications (including the chemical and physical form and, where applicable, isotopic content) of the special nuclear material the applicant proposes to use or produce; (5) [Reserved]

(6) The technical qualifications, including training and experience of the applicant and members of his staff to engage in the proposed activities in accordance with the regulations in this chapter; (7) A description of equipment and facilities which will be used by the applicant to protect health and minimize danger to life or property (such as handling devices, working areas, shields, measuring and monitoring instruments, devices for the disposal of radioactive effluents and wastes, storage facilities, criticality accident alarm systems, etc.);

(8) Proposed procedures to protect health and minimize danger to life or property (such as procedures to avoid accidental criticality, procedures for personnel monitoring and waste disposal, post-criticality accident emergency procedures, etc.).

Note: Where the nature of the proposed activities is such as to require consideration of the applicant's financial qualifications to engage in the proposed activities in accordance with the regulations in this chapter, the Commission may request the applicant to submit information with respect to his financial qualifications.

(9) As provided by § 70.25, certain applications for specific licenses filed under this part must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning. In the case of renewal applications submitted on or before July 27, 1990, this submittal may follow the renewal application but must be submitted on or before July 27, 1990.

(b) Each application for a license to possess special nuclear material, to possess equipment capable of enriching uranium, to operate an uranium enrichment facility, to possess and use at any one time and location special nuclear material in a quantity exceeding one effective kilogram, except for applications for use as sealed sources and for those uses involved in the operation of a nuclear reactor licensed pursuant to part 50 of this chapter and those involved in a waste disposal 17-29

operation, must contain a full description of the applicant's program for control and accounting of such special nuclear material or enrichment equipment that will be in the applicant's possession under license to show how compliance with the requirements of §§ 74.31, 74.33, 74.41, or 74.51 of this chapter, as applicable, will be accomplished.

(c) [Reserved]

(d) The Commission may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Commission to determine whether the application should be granted or denied or whether a license should be modified or revoked. All applications and statements shall be signed by the applicant or licensee or a corporate officer thereof.

(e) Each application and statement shall contain complete and accurate disclosure as to all matters and things required to be disclosed.

(f) Each application for a license to possess and use special nuclear material in a plutonium processing and fuel fabrication plant shall contain, in addition to the other information required by this section, a description of the plant site, a description and safety assessment of the design bases of the principal structure, systems, and components of the plant, including provisions for protection against natural phenomena, and a description of the quality assurance program to be applied to the design, fabrication, construction, testing and operation of the structures, systems, and components of the plant.2 (g)(1) Each application for a license that would authorize the transport or delivery to a carrier for transport of special nuclear material in an amount specified in § 73.1(b)(2) of this chapter must include (i) a description of the plan for physical protection of special nuclear material in transit in accordance with §§ 73.20, 73.25, 73.26, 73.27, and 73.67(a), (e), and (g) for 10 kg or more of special nuclear material of low strategic significance, and § 73.70(g) of this chapter including, as appropriate, a plan for the selection, qualification, and training of armed escorts, or the specification and design of a specially designed truck or trailer, and (ii) a licensee safeguards contingency plan or response procedures, as appropriate, for dealing with threats, thefts, and radiological sabotage relating to the special nuclear material in transit.

(2) Each application for such a license involving formula quantities of strategic special nuclear material must include the first four categories of information contained in the applicant's safeguards contingency plan. (The first four categories of information, as set forth in appendix C to part 73 of this chapter, are Background, Generic Planning Base, Licensee Planning Base, and Responsibility Matrix. The fifth category of information, Procedures, does not have to be submitted for approval.)

(3) The licensee shall retain this description of the plan for physical protection of special nuclear material in transit and the safeguards contingency plan or safeguards response procedures and each change to the plan or procedures as a record for a period of three years following the date on which 17-30

the licensee last possessed the appropriate type and quantity of special nuclear material requiring this record under each license.

(h)(1) Each application for a license to possess or use, at any site or contiguous sites subject to licensee control, a formula quantity of strategic special nuclear material, as defined in § 70.4, other than a license for possession or use of this material in the operation of a nuclear reactor licensed pursuant to part 50 of this chapter, must include a physical security plan. The plan must describe how the applicant will meet the applicable requirements of part 73 of this chapter in the conduct of the activity to be licensed, including the identification and description of jobs as required by 10 CFR 11.11(a). The plan must list tests, inspections, audits, and other means to be used to demonstrate compliance with the requirements of 10 CFR parts 11 and 73, if applicable.

(2) The licensee shall retain a copy of this physical security plan and each change to the plan as a record for a period of three years following the date on which the licensee last possessed the appropriate type and quantity of special nuclear material requiring this record under each license.

(i)(1) Each application to possess enriched uranium or plutonium for which a criticality accident alarm system is required, uranium hexafluoride in excess of 50 kilograms in a single container or 1000 kilograms total, or in excess of 2 curies of plutonium 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 radioactive materials would not exceed 1 rem effective dose equivalent or an intake of 2 milligrams of soluble uranium, 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 paragraph (i)(1)(i) of this section:

(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 or to criticality 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; 17-31

(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.

(3) Emergency plans submitted under paragraph (i)(1)(ii) of this section must include the following information:

(i) Facility description. A brief description of the licensee's facility and area near the site.

(ii) Types of accidents. An identification of each type of radioactive materials accident for which protective actions may be needed.

(iii) Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies.

(iv) Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.

(v) 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.

(vi) Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials.

(vii) 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 NRC; also responsibilities for developing, maintaining, and updating the plan.

(viii) 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 NRC operations center immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.1 (ix) 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 NRC.

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(x) Training. A brief description of the frequency, performance objectives and plans 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.

(xi) Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.

(xii) 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.

(xiii) 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, Pub. L.99-499, if applicable to the applicant's activities at the proposed place of use of the special nuclear material.

(4) 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 NRC. The licensee shall provide any comments received within the 60 days to the NRC with the emergency plan.

(j)(1) Each application for a license to possess or use at any site or contiguous sites subject to control by the licensee uranium-235 (contained in uranium enriched to 20 percent or more in the uranium-235 isotope), uranium-233, or plutonium alone or in any combination in a quantity of 5,000 grams or more computed by the formula, grams = (grams contained U - 235) + 2.5 (grams U-233 + grams plutonium) other than a license for possession or use of this material in the operation of a nuclear reactor licensed pursuant to part 50 of this chapter, must include a licensee safeguards contingency plan for dealing with threats, thefts, and radiological sabotage, as defined in part 73 of this chapter, relating to nuclear facilities licensed under part 50 of this chapter or to the possession of special nuclear material licensed under this part.

(2) Each application for such a license must include the first four categories of information contained in the applicant's safeguards contingency plan. (The first four categories of information, as set forth in appendix C to part 73 of this chapter, are Background, Generic Planning Base, 17-33

Licensee Planning Base, and Responsibility Matrix.) The fifth category of information, Procedures, does not have to be submitted for approval.

(3) The licensee shall retain a copy of this safeguards contingency plan as a record until the Commission terminates each license obtained by this application or any application for renewal of a license and retain each change to the plan as a record for three years after the date of the change.

(k) Each application for a license to possess or use at any site or contiguous sites subject to licensee control, special nuclear material of moderate strategic significance or 10 kg or more of special nuclear material of low strategic significance as defined under § 70.4, other than a license for possession or use of this material in the operation of a nuclear power reactor licensed pursuant to part 50 of this chapter, must include a physical security plan that demonstrates how the applicant plans to meet the requirements of paragraphs (d), (e), (f), and (g) of § 73.67 of this chapter, as appropriate. The licensee shall retain a copy of this physical security plan as a record for the period during which the licensee possesses the appropriate type and quantity of special nuclear material under each license, and if any portion of the plan is superseded, retain that superseded portion of the plan for 3 years after the effective date of the change.

(l) Each applicant for a license shall protect Safeguards Information against unauthorized disclosure in accordance with the requirements in § 73.21 and the requirements of § 73.22, or 73.23 of this chapter, as applicable, and shall protect classified information in accordance with the requirements of parts 25 and 95 of this chapter, as applicable.

(m) Each application for a license to possess equipment capable of enriching uranium or operate an enrichment facility, and produce, possess, or use more than one effective kilogram of special nuclear material at any site or contiguous sites subject to control by the applicant, must contain a full description of the applicant's security program to protect against theft, and to protect against unauthorized viewing of classified enrichment equipment, and unauthorized disclosure of classified matter in accordance with the requirements of 10 CFR parts 25 and 95.

(n) A license application that involves the use of special nuclear material in a uranium enrichment facility must include the applicant's provisions for liability insurance.

[21 FR 764, Feb. 3, 1956; 73 FR 63572, Oct. 24, 2008]

Editorial Note: For Federal Register citations affecting § 70.22, see the List of CFR Sections Affected.

1 These reporting requirements do not superceed or release licensees of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L.99-499 or other state or federal reporting requirements.

2 The description of the quality assurance program should include a discussion of how the criteria in appendix B of part 50 of this chapter will be met.

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§ 70.23 Requirements for the approval of applications.

(a) An application for a license will be approved if the Commission determines that:

(1) The special nuclear material is to be used for the conduct of research or development activities of a type specified in section 31 of the Act,1 in activities licensed by the Commission under section 103 or 104 of the Act, or for such other uses as the Commission determines to be appropriate to carry out the purposes of the Act; (2) The applicant is qualified by reason of training and experience to use the material for the purpose requested in accordance with the regulations in this chapter; (3) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property; (4) The applicant's proposed procedures to protect health and to minimize danger to life or property are adequate; (5) Where the nature of the proposed activities is such as to require consideration by the Commission, that the applicant appears to be financially qualified to engage in the proposed activities in accordance with the regulations in this part; (6) Where the applicant is required to submit a summary description of the fundamental material controls provided in his procedures for the control of and accounting for special nuclear material pursuant to § 70.22 (b), the applicant's proposed controls are adequate; (7) Where the proposed activity is processing and fuel fabrication, scrap recovery, conversion of uranium hexafluoride, uranium enrichment facility construction and operation, or any other activity which the Commission determines will significantly affect the quality of the environment, the Director of Nuclear Material Safety and Safeguards or his designee, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to subpart A of part 51 of this chapter, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values.

Commencement of construction prior to this conclusion is grounds for denial to possess and use special nuclear material in the plant or facility. As used in this paragraph, the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, roads necessary for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

(8) Where the proposed activity is the operation of a plutonium processing and fuel fabrication 17-35

plant, construction of the principal structures, systems, and components approved pursuant to paragraph (b) of this section has been completed in accordance with the application; (9) Where the applicant is required to submit a plan for physical protection of special nuclear material in transit pursuant to § 70.22(g), of this chapter, the applicant's plan is adequate; (10) Where the applicant is required to submit a physical security plan pursuant to § 70.22(h), the applicant's proposed plan is adequate; (11) Where the proposed activity is processing and fuel fabrication, scrap recovery, conversion of uranium hexafluoride, or involves the use of special nuclear material in a uranium enrichment facility, the applicant's proposed emergency plan is adequate.

(12) Where the proposed activity is use of special nuclear material in a uranium enrichment facility, the applicable provisions of part 140 of this chapter have been satisfied.

(b) The Commission will approve construction of the principal structures, systems, and components of a plutonium processing and fuel fabrication plant on the basis of information filed pursuant to § 70.22(f) when the Commission has determined that the design bases of the principal structures, systems, and components, and the quality assurance program provide reasonable assurance of protection against natural phenomena and the consequences of potential accidents.3 Failure to obtain Commission approval prior to beginning of such construction may be grounds for denial of a license to possess and use special nuclear material in a plutonium processing and fuel fabrication plant.

[36 FR 17574, Sept. 2, 1971, as amended at 37 FR 5749, Mar. 21, 1972; 38 FR 30534, 30538, Nov.

6, 1973; 39 FR 26286, July 18, 1974; 42 FR 17126, Mar. 31, 1977; 43 FR 6924, Feb. 17, 1978; 49 FR 9406, Mar. 12, 1984; 54 FR 14064, Apr. 7, 1989; 57 FR 18392, Apr. 30, 1992; 67 FR 78142, Dec. 23, 2002]

1 The types of research and development activities specified in section 31 are those relating to:

(1) Nuclear processes; (2) The theory and production of atomic energy, including processes, materials, and devices related to such production; (3) Utilization of special nuclear material and radioactive material for medical, biological, agricultural, health or military purposes; (4) Utilization of special nuclear material, atomic energy, and radioactive material and processes entailed in the utilization or production of atomic energy or such material for all other purposes, including industrial use, the generation of usable energy, and the demonstration of the practical value of utilization or production facilities for industrial or commercial purposes; and 17-36

(5) The protection of health and the promotion of safety during research and production activities.

3 The criteria in appendix B of part 50 of this chapter will be used by the Commission in determining the adequacy of the quality assurance program.

§ 70.23a Hearing required for uranium enrichment facility.

The Commission will hold a hearing under 10 CFR part 2, subparts A, C, G, and I, on each application for issuance of a license for construction and operation of a uranium enrichment facility. The Commission will publish public notice of the hearing in the Federal Register at least thirty (30) days before the hearing.

[57 FR 18392, Apr. 30, 1992; 69 FR 2280, Jan. 14, 2004]

§ 70.24 Criticality accident requirements.

(a) Each licensee authorized to possess special nuclear material in a quantity exceeding 700 grams of contained uranium-235, 520 grams of uranium-233, 450 grams of plutonium, 1,500 grams of contained uranium-235 if no uranium enriched to more than 4 percent by weight of uranium-235 is present, 450 grams of any combination thereof, or one-half such quantities if massive moderators or reflectors made of graphite, heavy water or beryllium may be present, shall maintain in each area in which such licensed special nuclear material is handled, used, or stored, a monitoring system meeting the requirements of either paragraph (a)(1) or (a)(2), as appropriate, and using gamma- or neutron-sensitive radiation detectors which will energize clearly audible alarm signals if accidental criticality occurs. This section is not intended to require underwater monitoring when special nuclear material is handled or stored beneath water shielding or to require monitoring systems when special nuclear material is being transported when packaged in accordance with the requirements of part 71 of this chapter.

(1) The monitoring system shall be capable of detecting a criticality that produces an absorbed dose in soft tissue of 20 rads of combined neutron and gamma radiation at an unshielded distance of 2 meters from the reacting material within one minute. Coverage of all areas shall be provided by two detectors.

(2) Persons licensed prior to December 6, 1974, to possess special nuclear material subject to this section may maintain a monitoring system capable of detecting a criticality which generates radiation levels of 300 rems per hour one foot from the source of the radiation. The monitoring devices in the system shall have a preset alarm point of not less than 5 millirems per hour (in order to avoid false alarms) nor more than 20 millirems per hour. In no event may any such device be farther than 120 feet from the special nuclear material being handled, used, or stored; lesser distances may be necessary to meet the requirements of this paragraph (a)(2) on account of intervening shielding or other pertinent factors.

(3) The licensee shall maintain emergency procedures for each area in which this licensed special 17-37

nuclear material is handled, used, or stored to ensure that all personnel withdraw to an area of safety upon the sounding of the alarm. These procedures must include the conduct of drills to familiarize personnel with the evacuation plan, and designation of responsible individuals for determining the cause of the alarm, and placement of radiation survey instruments in accessible locations for use in such an emergency. The licensee shall retain a copy of current procedures for each area as a record for as long as licensed special nuclear material is handled, used, or stored in the area. The licensee shall retain any superseded portion of the procedures for three years after the portion is superseded.

(b) Each licensee authorized to possess special nuclear material in quantities in excess of those specified in paragraph (a) shall:

(1) Provide the means for identifying quickly which individuals have received doses of 10 rads or more.

(2) Maintain facilities and supplies at the site for decontamination of personnel, arrangements for the services of a physician and other medical personnel qualified to handle radiation emergencies, arrangements for transportation of injured or contaminated individuals to treatment facilities, and arrangements for treatment of individuals at treatment facilities outside the site boundary.

(c) Holders of licenses for construction or operation of a nuclear reactor issued pursuant to part 50 of this chapter, except critical assembly reactors, are exempt for the requirements of paragraph (b) of this section with respect to special nuclear material used or to be used in the reactor.

(d)(1) The requirements in paragraphs (a) through (c) of this section do not apply to a holder of a construction permit or operating license for a nuclear power reactor issued under part 50 of this chapter or a combined license issued under part 52 of this chapter, if the holder complies with the requirements of paragraph (b) of 10 CFR 50.68.

(2) An exemption from § 70.24 held by a licensee who thereafter elects to comply with requirements of paragraph (b) of 10 CFR 50.68 does not exempt that licensee from complying with any of the requirements in § 50.68, but shall be ineffective so long as the licensee elects to comply with § 50.68.

[39 FR 39021, Nov. 5, 1974, as amended at 41 FR 31522, July 29, 1976; 53 FR 19252, May 27, 1988; 62 FR 63828, Dec. 3, 1997; 63 FR 63130, Nov. 12, 1998]

§ 70.25 Financial assurance and recordkeeping for decommissioning.

(a) Each applicant for a specific license of the types described in paragraphs (a)(1) and (2) of this section shall submit a decommissioning funding plan as described in paragraph (e) of this section.

(1) A specific license for a uranium enrichment facility; 17-38

(2) A specific license authorizing the possession and use of unsealed special nuclear material in quantities exceeding 105 times the applicable quantities set forth in appendix B to part 30. A decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1 (unity rule), where R is the sum of the ratios of the quantity of each isotope to the applicable value in appendix B to part 30.

(b) Each applicant for a specific license authorizing possession and use of unsealed special nuclear material in quantities specified in paragraph (d) of this section shall either--

(1) Submit a decommissioning funding plan as described in paragraph (e) of this section; or (2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (d) of this section using one of the methods described in paragraph (f) of this section. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (f) of this section must be submitted to NRC before receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to NRC, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (f) of this section.

(c)(1) Each holder of a specific license issued on or after July 27, 1990, which is of a type described in paragraph (a) or (b) of this section, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this section.

(2) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (a) of this section shall submit a decommissioning funding plan as described in paragraph (e) of this section or a certification of financial assurance for decommissioning in an amount at least equal to $1,125,000 in accordance with the criteria set forth in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in any application for license renewal.

(3) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (b) of this section shall submit, on or before July 27, 1990, a decommissioning funding plan, described in paragraph (e) of this section, or a certification of financial assurance for decommissioning in accordance with the criteria set forth in this section.

(4) Any licensee who has submitted an application before July 27, 1990, for renewal of license in accordance with § 70.33 shall provide financial assurance for decommissioning in accordance with paragraphs (a) and (b) of this section. This assurance must be submitted when this rule becomes effective November 24, 1995.

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(d) Table of required amounts of financial assurance for decommissioning by quantity of material.

Licensees required to submit the $1,125,000 amount must do so by December 2, 2004. Licensees required to submit the $225,000 amount must do so by June 2, 2005. Licensees having possession limits exceeding the upper bounds of this table must base financial assurance on a decommissioning funding plan.

greater than 104 but less than or equal to 105 times the applicable quantities of appendix B to part 30. (For a combination of isotopes, if R, as defined in § 70.25(a),

divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1.) $1,125,000 greater than 103 but less than or equal to 104 times the applicable quantities of appendix B to part 30. (For a combination of isotopes, if R, as defined in § 70.25(a),

divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1.) $225,000 (e)(1) Each decommissioning funding plan must be submitted for review and approval and must contain -

(i) A detailed cost estimate for decommissioning, in the amount reflecting:

(A) The cost of an independent contractor to perform all decommissioning activities; (B) The cost of meeting the 10 CFR 20.1402 criteria for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of 10 CFR 20.1403, the cost estimate may be based on meeting the 10 CFR 20.1403 criteria; (C) The volume of onsite subsurface material containing residual radioactivity that will require remediation; and (D) An adequate contingency factor.

(ii) Identification of and justification for using the key assumptions contained in the DCE; (iii) A description of the method of assuring funds for decommissioning from paragraph (f) of this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility; (iv) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and (v) A signed original, or, if permitted, a copy, of the financial instrument obtained to satisfy the requirements of paragraph (f) of this section (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed 3 years, the decommissioning 17-40

funding plan must be resubmitted with adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(i) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material; (ii) Waste inventory increasing above the amount previously estimated; (iii) Waste disposal costs increasing above the amount previously estimated; (iv) Facility modifications; (v) Changes in authorized possession limits; (vi) Actual remediation costs that exceed the previous cost estimate; (vii) Onsite disposal; and (viii) Use of a settling pond.

(f) Financial assurance for decommissioning must be provided by one or more of the following methods:

(1) Prepayment. Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix A to part 30. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this section. For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix C to part 30. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in appendix D to part 30. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the 17-41

applicant or licensee may be used if the guarantee and test are as contained in appendix E to part

30. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this section or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions:

(i) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless 90 days or more prior to the renewal date, the issurer notifies the Commission, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Commission within 30 days after receipt of notification of cancellation.

(ii) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the Commission. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.

(iii) The surety method or insurance must remain in effect until the Commission has terminated the license.

(3) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licenssee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (f)(2) of this section.

(4) In the case of Federal, State, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the Table in paragraph (d) of this section, and indicating that funds for decommissioning will be obtained when necessary.

(5) When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity.

(g) Each person licensed under this part shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use.

If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the Commission considers important to 17-42

decommissioning consists of--

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after cleanup of any leak), a list contained in a single document and updated every 2 years, of the following:

(i) All areas designated and formerly designated as restricted areas as defined under 10 CFR 20.1003 (For requirements prior to January 1, 1994, see 10 CFR 20.3 as contained in the CFR edition revised as of January 1, 1993.);

(ii) All areas outside of restricted areas that require documentation under § 70.25(g)(1);

(iii) All areas outside of restricted areas where current and previous wastes have been buried as documented under 10 CFR 20.2108; and (iv) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 10 CFR part 20, subpart E, or apply for approval for disposal under 10 CFR 20.2002.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

[53 FR 24053, June 27, 1988, as amended at 56 FR 23474, May 21, 1991; 57 FR 18393, Apr. 30, 1992; 58 FR 39634, July 26, 1993; 58 FR 67662, Dec. 22, 1993; 58 FR 68731, Dec. 29, 1993; 59 FR 1618, Jan. 12, 1994; 60 FR 38239, July 26, 1995; 61 FR 24675, May 16, 1996; 62 FR 39091, July 21, 1997; 63 FR 29544, June 1, 1998; 68 FR 57337, Oct. 3, 2003]

Subpart E--Licenses 17-43

§ 70.31 Issuance of licenses.

(a) Upon a determination that an application meets the requirements of the act and of the regulations of the Commission, the Commission will issue a license in such form and containing such conditions and limitations as it deems appropriate or necessary to effectuate the purposes of the act.

(b) [Reserved]

(c) Each license issued to a person for use of special nuclear material in activities in which special nuclear material will be produced shall (subject to the provisions of § 70.41(b)) be deemed to authorize such person to receive title to, own, acquire, receive, possess, use, and transfer the special nuclear material produced in the course of such authorized activities.

(d) No license will be issued by the Commission to any person within the United States if the Commission finds that the issuance of such license would be inimical to the common defense and security or would constitute an unreasonable risk to the health and safety of the public.

(e) No license to construct and operate a uranium enrichment facility may be issued until a hearing pursuant to 10 CFR part 2, subparts G and I, is completed and decision issued on the application.

[21 FR 764, Feb. 3, 1956, as amended at 32 FR 2563, Feb. 7, 1967; 32 FR 4056, Mar. 15, 1967; 43 FR 6925, Feb. 17, 1978; 57 FR 18393, Apr. 30, 1992]

§ 70.32 Conditions of licenses.

(a) Each license shall contain and be subject to the following conditions:

(1) [Reserved]

(2) No right to the special nuclear material shall be conferred by the license except as defined by the license; (3) Neither the license nor any right under the license shall be assigned or otherwise transferred in violation of the provisions of the Act; (4) All special nuclear material shall be subject to the right of recapture or control reserved by section 108 and to all other provisions of the Act; (5) No special nuclear material may be used in any utilization or production facility except in accordance with the provisions of the Act; (6) The licensee shall not use the special nuclear material to construct an atomic weapon or any component of an atomic weapon; 17-44

(7) Except to the extent that the indemnification and limitation of liability provisions of part 140 of this chapter apply, the licensee will hold the United States and the Department harmless from any damages resulting from the use or possession of special nuclear material leased from the Department by the licensee; (8) The license shall be subject to and the licensee shall observe, all applicable rules, regulations and orders of the Commission.

(9)(i) Each licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

(A) The licensee; (B) An entity (as that term is defined in 11 U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or (C) An affiliate (as that term is defined in 11 U.S.C. 101(a)) of the licensee.

(ii) This notification must indicate:

(A) The bankruptcy court in which the petition for bankruptcy was filed; and (B) The date of the filing of the petition.

(b) The Commission may incorporate in any license such additional conditions and requirements with respect to the licensee's ownership, receipt, possession, use, and transfer of special nuclear material as it deems appropriate or necessary in order to:

(1) Promote the common defense and security; (2) Protect health or to minimize danger to life or property; (3) Protect restricted data; (4) Guard against the loss or diversion of special nuclear material; (5) Require such reports and the keeping of such records, and to provide for such inspections, of activities under the license as may be necessary or appropriate to effectuate the purposes of the act and regulations thereunder.

(c)(1) Each license authorizing the possession and use at any one time and location of uranium source material at an uranium enrichment facility or special nuclear material in a quantity exceeding one effective kilogram, except for use as sealed sources and those uses involved in the 17-45

operation of a nuclear reactor licensed pursuant to part 50 of this chapter and those involved in a waste disposal operation, shall contain and be subject to a condition requiring the licensee to maintain and follow:

(i) The program for control and accounting of uranium source material at an uranium enrichment facility and special nuclear material at all applicable facilities as implemented pursuant to § 70.22(b), or §§ 74.31(b), 74.33(b), 74.41(b), or 74.51(c) of this chapter, as appropriate; (ii) The measurement control program for uranium source material at an uranium enrichment facility and for special nuclear material at all applicable facilities as implemented pursuant to §§ 74.31(b), 74.33(b), 74.45(c), or 74.59(e) of this chapter, as appropriate; and (iii) Other material control procedures as the Commission determines to be essential for the safeguarding of uranium source material at an uranium enrichment facility or of special nuclear material and providing that the licensee shall make no change that would decrease the effectiveness of the material control and accounting program implemented pursuant to § 70.22(b),

or §§ 74.31(b), 74.33(b), 74.41(b), or 74.51(c) of this chapter, and the measurement control program implemented pursuant to §§ 74.31(b), 74.33(b), 74.41(b), or 74.59(e) of this chapter without the prior approval of the Commission. A licensee desiring to make changes that would decrease the effectiveness of its material control and accounting program or its measurement control program shall submit an application for amendment to its license pursuant to § 70.34.

(2) The licensee shall maintain records of changes to the material control and accounting program made without prior Commission approval for a period of 5 years from the date of the change.

Licensees located in all four Regions as indicated in appendix A of part 73 of this chapter shall furnish to the Director, Division of Nuclear Security, Office of Nuclear Security and Incident Response, using an appropriate method listed in § 70.5(a), a report containing a description of each change within:

(i) Two months of the change if it pertains to uranium-233, uranium-235 contained in uranium enriched 20 percent or more in the uranium-235 isotope, or plutonium, except plutonium containing 80 percent or more by weight of the isotope Pu-238, and (ii) Six months of the change if it pertains to uranium enriched less than 20 percent in the uranium-235 isotope, or plutonium containing 80 percent or more by weight of the isotope Pu-238.

(d) The licensee shall make no change which would decrease the effectiveness of the plan for physical protection of special nuclear material in transit prepared pursuant to § 70.22(g) or § 73.20(c) of this chapter without the prior approval of the Commission. A licensee desiring to make such changes shall submit an application for a change in the technical specifications incorporated in his or her license, if any, or for an amendment to the license pursuant to § 50.90 or § 70.34 of this chapter, as appropriate. The licensee may make changes to the plan for physical protection of special nuclear material without prior Commission approval if these changes do not decrease the effectiveness of the plan. The licensee shall retain a copy of the plan as a record for the period 17-46

during which the licensee possesses a formula quantity of special nuclear material requiring this record under each license and each change to the plan for three years from the effective date of the change. Within two months after each change, a report containing a description of the change must be furnished to the Director of the NRC's Office of Nuclear Material Safety and Safeguards, using an appropriate method listed in § 70.5(a); and a copy must be sent to the appropriate NRC Regional Office shown in appendix A to part 73 of this chapter.

(e) The licensee shall make no change which would decrease the effectiveness of a security plan prepared pursuant to §§ 70.22(h), 70.22(k), or 73.20(c) without the prior approval of the Commission. A licensee desiring to make such a change shall submit an application for an amendment to its license pursuant to § 70.34. The licensee shall maintain records of changes to the plan made without prior Commission approval, for three years from the effective date of the change, and shall, within two months after the change is made, furnish a report containing a description of each change to the Director, Division of Nuclear Security, Office of Nuclear Security and Incident Response; the report may be sent using an appropriate method listed in § 70.5(a), and a copy of the report must be sent to the appropriate NRC Regional Office shown in appendix A to part 73 of this chapter.

(f) [Reserved]

(g) The licensee shall prepare and maintain safeguards contingency plan procedures in accordance with appendix C to part 73 of this chapter for bringing about the actions and decisions contained in the Responsibility Matrix of its safeguards contingency plan. The licensee shall retain the current safeguards contingency plan procedures as a record for the entire period during which the licensee possesses the appropriate type and quantity of special nuclear material under each license for which the procedures were developed and, if any portion of the plan is superseded, retain that superseded portion for 3 years after the effective date of the change. The licensee shall not make a change that would decrease the safeguards effectiveness of the first four categories of information (i.e., Background, Generic Planning Base, Licensee Planning Base, and Responsibility Matrix) contained in any licensee safeguards contingency plan prepared pursuant to §§ 70.22(g), 70.22(j),

72.184, 73.20(c), 73.26(e)(1), 73.46(h)(1), or 73.50(g)(1) of this chapter without the prior approval of the NRC. A licensee desiring to make such a change shall submit an application for an amendment to its license pursuant to § 70.34. The licensee may make changes to the licensee safeguards contingency plan without prior NRC approval if the changes do not decrease the safeguards effectiveness of the plan. The licensee shall maintain each change to the plan made without prior approval as a record during the period for which possession of a formula quantity of special nuclear material is authorized under a license and retain the superseded portion for 3 years after the effective date of the change, and shall, within 60 days after the change is made, furnish a report containing a description of each change to the Director of Nuclear Material Safety and Safeguards; the report may be sent using an appropriate method listed in § 70.5(a), and a copy of the report must be sent to the Regional Administrator of the appropriate NRC Regional Office as specified in appendix A to part 73 of this chapter.

(h) [Reserved]

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(i) Licensees required to submit emergency plans in accordance with § 70.22(i) shall follow the emergency plan approved by the Commission. The licensee may change the approved plan without Commission approval if the changes do not decrease the effectiveness of the plan. Within six months after each change is made, the licensee shall, using an appropriate method listed in § 70.5(a), furnish the Director, Division of Nuclear Security, Office of Nuclear Security and Incident Response, a copy of each change, with copies to the appropriate NRC Regional Office specified in appendix D to part 20 of this chapter and to affected offsite response organizations. Proposed changes that decrease the effectiveness of the approved emergency plan may not be implemented without prior application to and prior approval by the Commission.

(j) Each licensee who possesses special nuclear material, or who transports, or delivers to a carrier for transport, a formula quantity of strategic special nuclear material, special nuclear material of moderate strategic significance, or special nuclear material of low strategic significance, or more than 100 grams of irradiated reactor fuel shall ensure that Safeguards Information is protected against unauthorized disclosure in accordance with the requirements in § 73.21 and the requirements of § 73.22 or § 73.23 of this chapter, as applicable, and shall protect classified information in accordance with the requirements of parts 25 and 95 of this chapter, as applicable.

(k) No person may commence operation of a uranium enrichment facility until the Commission verifies through inspection that the facility has been constructed in accordance with the requirements of the license. The Commission shall publish notice of the inspection results in the Federal Register.

[21 FR 764, Feb. 3, 1956; 73 FR 63572, Oct. 24, 2008]

Editorial Note: For Federal Register citations affecting § 70.32, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 70.33 Renewal of licenses.

(a) Applications for renewal of a license should be filed in accordance with §§ 70.21 and 70.22.

Information contained in previous applications, statements or reports filed with the Commission under the license may be incorporated by reference: Provided, That such references are clear and specific.

(b) If any licensee granted the extension described in 10 CFR 70.38(a)(2) has a currently pending renewal application for that extended license, that application will be considered withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded.

[21 FR 764, Feb. 3, 1956, as amended at 59 FR 36037, July 15, 1994; 61 FR 1115, Jan. 16, 1996]

§ 70.34 Amendment of licenses.

Applications for amendment of a license shall be filed in accordance with § 70.21(a) and shall 17-48

specify the respects in which the licensee desires his license to be amended and the grounds for such amendment.

§ 70.35 Commission action on applications to renew or amend.

In considering an application by a licensee to renew or amend his license, the Commission will apply the criteria set forth in § 70.23.

§ 70.36 Inalienability of licenses.

(a) No license granted under the regulations in this part and no right to possess or utilize special nuclear material granted by any license issued pursuant to the regulations in this part shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the Commission shall after securing full information, find that the transfer is in accordance with the provisions of the Act, and shall give its consent in writing.

(b) An application for transfer of license must include:

(1) The identity, technical and financial qualifications of the proposed transferee; and (2) Financial assurance for decommissioning information required by § 70.25.

[21 FR 764, Feb. 3, 1956, as amended at 35 FR 11461, July 17, 1970]

§ 70.37 Disclaimer of warranties.

Neither the Government nor the Commission makes any warranty or other representation that special nuclear material (a) will not result in injury or damage when used for purposes approved by the Commission, (b) will accomplish the results for which it is requested and approved by the Commission, or (c) is safe for any other use.

§ 70.38 Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.

(a) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under § 70.33 not less than 30 days before the expiration date stated in the existing license. If an application for renewal has been filed at least 30 days before the expiration date stated in the existing license, the existing license expires at the end of the day on which the Commission makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(b) Each specific license revoked by the Commission expires at the end of the day on the date of 17-49

the Commission's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Commission Order.

(c) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of special nuclear material until the Commission notifies the licensee in writing that the license is terminated. During this time, the licensee shall--

(1) Limit actions involving special nuclear material to those related to decommissioning; and (2) Continue to control entry to restricted areas until they are suitable for release in accordance with NRC requirements.

(d) Within 60 days of the occurrence of any of the following, consistent with the administrative directions in § 70.5, each licensee shall provide notification to the NRC in writing and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity, so that the building or outdoor area is suitable for release in accordance with NRC requirements, or submit within 12 months of notification a decommissioning plan, if required by paragraph (g)(1) of this section, and begin decommissioning upon approval of that plan if--

(1) The license has expired pursuant to paragraph (a) or (b) of this section; or (2) The licensee has decided to permanently cease principal activities, as defined in this part, at the entire site or in any separate building or outdoor area; or (3) No principal activities under the license have been conducted for a period of 24 months; or (4) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with NRC requirements.

(e) Coincident with the notification required by paragraph (d) of this section, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to

§ 70.25 in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to paragraph (g)(4)(v) of this section.

(1) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so when this rule becomes effective November 24, 1995.

(2) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Commission.

17-50

(f) The Commission may grant a request to delay or postpone initiation of the decommissioning process if the Commission determines that this relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to paragraph (d) of this section. The schedule for decommissioning set forth in paragraph (d) of this section may not commence until the Commission has made a determination on the request.

(g)(1) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Commission and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:

(i) Procedures would involve techniques not applied routinely during cleanup or maintenance operations; (ii) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation; (iii) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or (iv) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(2) The Commission may approve an alternate schedule for submittal of a decommissioning plan required pursuant to paragraph (d) of this section if the Commission determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

(3) The procedures listed in paragraph (g)(1) of this section may not be carried out prior to approval of the decommissioning plan.

(4) The proposed decommissioning plan for the site or separate building or outdoor area must include:

(i) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan; (ii) A description of planned decommissioning activities; (iii) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning; 17-51

(iv) A description of the planned final radiation survey; and (v) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

(vi) A description of the physical security plan and material control and accounting plan provisions in place during decommissioning.

(vii) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, a justification for the delay based on the criteria in paragraph (i) of this section.

(5) The proposed decommissioning plan will be approved by the Commission if the information therein demonstrates that the decommissioning will be completed as soon as practical and that the health and safety of workers and the public will be adequately protected.

(h)(1) Except as provided in paragraph (i) of this section, licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than 24 months following the initiation of decommissioning.

(2) Except as provided in paragraph (i) of this section, when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning.

(i) The Commission may approve a request for an alternate schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the Commission determines that the alternative is warranted by consideration of the following:

(1) Whether it is technically feasible to complete decommissioning within the allotted 24-month period; (2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period; (3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay; (4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and (5) Other site-specific factors which the Commission may consider appropriate on a case-by-case basis, such as regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more 17-52

environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(j) As the final step in decommissioning, the licensee shall--

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed NRC Form 314 or equivalent information; and (2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E. The licensee shall, as appropriate--

(i) Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per 100 square centimeters removable and fixed for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and (ii) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.

(k) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Commission determines that:

(1) Special nuclear material has been properly disposed; (2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and (3)(i) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E; or (ii) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E.

(4) Records required by § 70.51(b)(6) have been received.

[59 FR 36037, July 15, 1994, as amended at 60 FR 38240, July 26, 1995; 61 FR 1115, Jan. 16, 1996; 61 FR 24675, May 16, 1996; 61 FR 29637, 29638, June 12, 1996; 62 FR 39091, July 21, 1997; 66 FR 24049, May 11, 2001; 73 FR 42675; Jul. 23, 2008]

§ 70.39 Specific licenses for the manufacture or initial transfer of calibration or reference sources.

17-53

(a) An application for a specific license to manufacture or initially transfer calibration or reference sources containing plutonium, for distribution to persons generally licensed under § 70.19, will be approved if:

(1) The applicant satisfies the general requirements of § 70.23.

(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 plutonium in the source; (ii) Details of construction and design; (iii) Details of the method of incorporation and binding of the plutonium in the source; (iv) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of plutonium, to demonstrate that the plutonium 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; (vii) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source.

(3) Each source will contain no more than 5 microcuries of plutonium.

(4) The Commission determines, with respect to any type of source containing more than 0.005 microcurie of plutonium, that:

(i) The method of incorporation and binding of the plutonium in the source is such that the plutonium 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 the prototype tests prescribed by paragraph (a)(5) of this section.

(5) For any type of source which is designed to contain more than 0.005 microcurie of plutonium, the applicant has conducted prototype tests, in the order listed, on each of five prototypes of such source, which contains more than 0.005 microcurie of plutonium, as follows:

(i) Initial measurement. The quantity of radioactive material deposited on the source shall be measured by direct counting of the source.

17-54

(ii) Dry wipe test. The entire radioactive surface of the source shall be wiped with filter paper with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper or by direct measurement of the radioactivity on the source following the dry wipe.

(iii) Wet wipe test. The entire radioactive surface of the source shall be wiped with filter paper, moistened with water, with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper after it has dried or by direct measurement of the radioactivity on the source following the wet wipe.

(iv) Water soak test. The source shall be immersed in water at room temperature for a period of 24 consecutive hours. The source shall then be removed from the water. Removal of radioactive material from the source shall be determined by direct measurement of the radioactivity on the source after it has dried or by measuring the radioactivity in the residue obtained by evaporation of the water in which the source was immersed.

(v) Dry wipe test. On completion of the preceding tests in paragraphs (a)(5)(i) through (iv) of this section, the dry wipe test described in paragraph (a)(5)(ii) of this section shall be repeated.

(vi) Observations. Removal of more than 0.005 microcurie of radioactivity in any test prescribed by this paragraph shall be cause for rejection of the source design. Results of prototype tests submitted to the Commission shall be given in terms of radioactivity in microcuries and percent of removal from the total amount of radioactive material deposited on the source.

(b) Each person licensed under this section 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.1 The receipt, possession, use and transfer of this source, Model-- --- , Serial No.-----, are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTIONRADIOACTIVE MATERIALTHIS SOURCE CONTAINS PLUTONIUM. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

(Name of Manufacturer or Initial Transferor)

(c) Each person licensed under this section shall perform a dry wipe test upon each source containing more than 0.1 microcurie of plutonium prior to transferring the source to a general licensee under § 70.19. This test shall 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 17-55

paper shall be measured by using radiation detection instrumentation capable of detecting 0.005 microcurie of plutonium. If any such test discloses more than 0.005 microcurie of radioactive material, the source shall be deemed to be leaking or losing plutonium and shall not be transferred to a general licensee under § 70.19.

[29 FR 5884, May 5, 1964, as amended at 32 FR 2563, Feb. 7, 1967; 38 FR 1272, Jan. 11, 1973; 40 FR 8792, Mar. 3, 1975; 42 FR 43966, Sept. 1, 1977; 43 FR 6925, Feb. 17, 1978]

1. Sources generally licensed under this section prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.

§ 70.40 Ineligibility of certain applicants.

A license may not be issued to the Corporation if the Commission determines that:

(a) The Corporation is owned, controlled, or dominated by an alien, a foreign corporation, or a foreign government; or (b) The issuance of such a license would be inimical to--

(1) The common defense and security of the United States; or (2) The maintenance of a reliable and economical domestic source of enrichment services.

[62 FR 6669, Feb. 12, 1997]

Subpart F--Acquisition, Use, and Transfer of Special Nuclear Material, Creditors' Rights

§ 70.41 Authorized use of special nuclear material.

(a) Each licensee shall confine his possession and use of special nuclear material to the locations and purposes authorized in his license. Except as otherwise provided in the license, each license issued pursuant to the regulations in this part shall carry with it the right to receive title to, own, acquire, receive, possess and use special nuclear material. Preparation for shipment and transport of special nuclear material shall be in accordance with the provisions of part 71 of this chapter.

(b) The possession, use and transfer of any special nuclear material produced by a licensee, in connection with or as a result of use of special nuclear material received under his license, shall be subject to the provisions of the license and the regulations in this part.

[21 FR 764, Feb. 3, 1956, as amended at 38 FR 33970, Dec. 10, 1973; 43 FR 6925, Feb. 17, 1978]

§ 70.42 Transfer of special nuclear material.

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(a) No licensee shall transfer special nuclear material except as authorized pursuant to this section.

(b) Except as otherwise provided in his license and subject to the provisions of paragraphs (c) and (d) of this section, any licensee may transfer special nuclear material:

(1) To the Department; (2) To the agency in any Agreement State which regulates radioactive materials pursuant to an agreement with the Commission or the Atomic Energy Commission under section 274 of the Act, if the quantity transferred is not sufficient to form a critical mass; (3) To any person exempt from the licensing requirements of the Act and regulations in this part, to the extent permitted under such exemption; (4) To any person in an Agreement State, subject to the jurisdiction of that State, who has been exempted from the licensing requirements and regulations of that State, to the extent permitted under such exemption; (5) To any person authorized to receive such special nuclear material under terms of a specific license or a general license or their equivalents issued by the Commission or an Agreement State; (6) To any person abroad pursuant to an export license issued under part 110 of this chapter; or (7) As otherwise authorized by the Commission in writing.

(c) Before transferring special nuclear material to a specific licensee of the Commission or an Agreement State or to a general licensee who is required to register with the Commission or with an Agreement State prior to receipt of the special nuclear material, the licensee transferring the material shall verify that the transferee's license authorizes receipt of the type, form, and quantity of special nuclear material to be transferred.

(d) The following methods for the verification required by paragraph (c) of this section are acceptable:

(1) The transferor may have in his or her possession, and read, a current copy of the transferee's specific license or registration certificate. The transferor shall retain a copy of each license or certificate for three years from the date that it was obtained.

(2) The transferor may have in its possession a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of special nuclear material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date. The transferor shall retain the written certification as a record for three years from the date of receipt of the certification; 17-57

(3) For emergency shipments the transferor may accept oral certification by the transferee that he or she is authorized by license or registration certification to receive the type, form, and quantity of special nuclear material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date, provided that the oral certification is confirmed in writing within ten days. The transferor shall retain the written confirmation of the oral certification for three years from the date of receipt of the confirmation; (4) The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or the licensing agency of an Agreement State as to the identity of licensees and the scope and expiration dates of licenses and registrations. The transferor shall retain the compilation of information as a record for three years from the date that it was obtained; or (5) When none of the methods of verification described in paragraphs (d) (1) to (4) of this section are readily available or when a transferor desires to verify that information received by one of these methods is correct or up-to-date, the transferor may obtain and record confirmation from the Commission or the licensing agency of an Agreement State that the transferee is licensed to receive the special nuclear material. The transferor shall retain the record of confirmation for three years from the date the record is made.

[38 FR 33970, Dec. 10, 1973, as amended at 40 FR 8792, Mar. 3, 1975; 43 FR 6925, Feb. 21, 1978; 53 FR 19253, May 27, 1988]

§ 70.44 Creditor regulations.

(a) Pursuant to section 184 of the Act, the Commission consents, without individual application, to the creation of any mortgage, pledge, or other lien upon any special nuclear material, not owned by the United States, which is subject to licensing: Provided:

(1) That the rights of any creditor so secured may be exercised only in compliance with and subject to the same requirements and restrictions as would apply to the licensee pursuant to the provisions of the license, the Atomic Energy Act of 1954, as amended, and regulations issued by the Commission pursuant to said Act; and (2) That no creditor so secured may take possession of the special nuclear material pursuant to the provisions of this section prior to either the issuance of a license by the Commission authorizing such possession or the transfer of a license pursuant to § 70.36.

(b) Nothing contained in this section shall be deemed to affect the means of acquiring, or the priority of, any tax lien or other lien provided by law.

(c) As used in this section, creditor includes, without implied limitation, the trustee under any mortgage, pledge, or lien on special nuclear material made to secure any creditor, any trustee or receiver of the special nuclear material appointed by a court of competent jurisdiction in any action 17-58

brought for the benefit of any creditor secured by such mortgage, pledge, or lien, any purchaser of such special nuclear material at the sale thereof upon foreclosure of such mortgage, pledge, or lien or upon exercise of any power of sale contained therein, or any assignee of any such purchaser.

[32 FR 2563, Feb. 7, 1967, as amended at 35 FR 11461, July 17, 1970]

Subpart G--Special Nuclear Material Control Records, Reports, and Inspections

§ 70.50 Reporting requirements.

(a) Immediate report. Each licensee shall notify the NRC as soon as possible but not later than 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.).

(b) Twenty-four hour report. Each licensee shall notify the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that:

(i) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> by imposing additional radiological controls or by prohibiting entry into the area; (ii) Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B of §§ 20.1001-20.2401 of 10 CFR part 20 for the material; and (iii) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(i) The equipment is required by regulation or licensee condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; (ii) The equipment is required to be available and operable when it is disabled or fails to function; and (iii) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.

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(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(i) The quantity of material involved is greater than five times the lowest annual limit on intake specified in appendix B of §§ 20.1001-20.2401 of 10 CFR part 20 for the material; and (ii) The damage affects the integrity of the licensed material or its container.

(c) Preparation and submission of reports. Reports made by licensees in response to the requirements of this section must be made as follows:

(1) Licensees shall make reports required by paragraphs (a) and (b) of this section, and by § 70.74 and Appendix A of this part, if applicable, by telephone to the NRC Operations Center.1 To the extent that the information is available at the time of notification, the information provided in these reports must include:

(i) Caller's name, position title, and call-back telephone number; (ii) Date, time, and exact location of the event; (iii) Description of the event, including:

(A) Radiological or chemical hazards involved, including isotopes, quantities, and chemical and physical form of any material released; (B) Actual or potential health and safety consequences to the workers, the public, and the environment, including relevant chemical and radiation data for actual personnel exposures to radiation or radioactive materials or hazardous chemicals produced from licensed materials (e.g.,

level of radiation exposure, concentration of chemicals, and duration of exposure);

(C) The sequence of occurrences leading to the event, including degradation or failure of structures, systems, equipment, components, and activities of personnel relied on to prevent potential accidents or mitigate their consequences; and (D) Whether the remaining structures, systems, equipment, components, and activities of personnel relied on to prevent potential accidents or mitigate their consequences are available and reliable to perform their function; (iv) External conditions affecting the event; (v) Additional actions taken by the licensee in response to the event; (vi) Status of the event (e.g., whether the event is on-going or was terminated);

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(vii) Current and planned site status, including any declared emergency class; (viii) Notifications, related to the event, that were made or are planned to any local, State, or other Federal agencies; (ix) Status of any press releases, related to the event, that were made or are planned.

(2) Written report. Each licensee that makes a report required by paragraph (a) or (b) of this sectionshall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all the necessary information, and the appropriate distribution is made. These written reports must be sent to the NRC's Document Control Desk, using an appropriate method listed in § 70.5(a), with a copy to the appropriate NRC regional office listed in appendix D to part 20 of this chapter. The reports must include the following:

(i) Complete applicable information required by § 70.50(c)(1);

(ii) The probable cause of the event, including all factors that contributed to the event and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; (iii) Corrective actions taken or planned to prevent occurrence of similar or identical events in the future and the results of any evaluations or assessments; and (iv) For licensees subject to Subpart H of this part, whether the event was identified and evaluated in the Integrated Safety Analysis.

(d) The provisions of § 70.50 do not apply to licensees subject to § 50.72. They do apply to those Part 50 licensees possessing material licensed under Part 70 that are not subject to the notification requirements in § 50.72.

[56 FR 40769, Aug. 16, 1991; 56 FR 64980, Dec. 13, 1991, as amended at 59 FR 14087, Mar. 25, 1994; 65 FR 56226, Sept. 18, 2000; 68 FR 58817, Oct. 10, 2003]

1 The commercial telephone number for the NRC Operations Center is (301) 816-5100.

§ 70.51 Records requirements.

(a) Before license termination, licensees shall forward the following records to the appropriate NRC Regional Office:

(1) Records of disposal of licensed material made under 10 CFR 20.2002 (including burials authorized before January 28, 19811), 20.2003, 20.2004, 20.2005; (2) Records required by 10 CFR 20.2103(b)(4); and 17-61

(3) Records required by § 70.25(g).

(b) If licensed activities are transferred or assigned in accordance with § 70.32(a)(3), the licensee shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(1) Records of disposal of licensed material made under 10 CFR 20.2002 (including burials authorized before January 28, 19811), 20.2003, 20.2004, 20.2005; (2) Records required by 10 CFR 20.2103(b)(4); and (3) Records required by § 70.25(g).

(c)(1) Records which must be maintained pursuant to this part may be the original or a reproduced copy, or microform if the reproduced copy or microform is duly authenticated by authorized personnel, and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(2) If there is a conflict between the Commissions regulations in this part, license condition, or other written Commission approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this part for these records shall apply unless the Commission, under § 70.17 has granted a specific exemption from the record retention requirements specified in the regulations in this part.

[38 FR 30544, Nov. 6, 1973, as amended at 38 FR 32784, Nov. 28, 1973; 41 FR 18303, May 3, 1976; 43 FR 6925, Feb. 17, 1978; 50 FR 7579, Feb. 25, 1985; 52 FR 10038, Mar. 30, 1987; 53 FR 19253, May 27, 1988; 56 FR 55998, Oct. 31, 1991; 61 FR 24675, May 16, 1996; 67 FR 78142, Dec. 23, 2002; 72 FR 35144, June 27, 2007]

1 A previous § 20.304 permitted burial of small quantities of licensed materials in soil before January 28, 1981, without specific Commission authorization. See § 20.304 contained in the 10 CFR, parts 0 to 199, edition revised as of January 1, 1981.

§ 70.52 Reports of accidental criticality.

(a) Each licensee shall notify the NRC Operations Center1 within one hour after discovery of any case of accidental criticality.

(b) This notification must be made to the NRC Operations Center via the Emergency Notification System if the licensee is party to that system. If the Emergency Notification System is inoperative 17-62

or unavailable, the licensee shall make the required notification via commercial telephonic service or other dedicated telephonic system or any other method that will ensure that a report is received by the NRC Operations Center within one hour.

[52 FR 21657, June 9, 1987, as amended at 59 FR 14087, Mar. 25, 1994; 67 FR 78143, Dec. 23, 2002]

1 Commercial telephone number of the NRC Operations Center is (301) 816-5100.

§ 70.55 Inspections.

(a) Each licensee shall afford to the Commission at all reasonable times opportunity to inspect special nuclear material and the premises and facilities wherein special nuclear material is used, produced, or stored.

(b) Each licensee shall make available to the Commission for inspection, upon reasonable notice, records kept by the licensee pertaining to his receipt, possession, use, acquisition, import, export, or transfer of special nuclear material.

(c)(1) In the case of fuel cycle facilities where nuclear reactor fuel is fabricated or processed each licensee shall upon request by the Director, Office of Nuclear Material Safety and Safeguards or the appropriate NRC Regional Administrator, provide rent-free office space for the exclusive use of Commission inspection personnel. Heat, air conditioning, light, electrical outlets and janitorial services shall be furnished by each licensee. The office shall be convenient to and have full access to the facility and, shall provide the inspector both visual and acoustic privacy.

(2) For a site with a single fuel facility licensed pursuant to part 70, the space provided shall be adequate to accommodate a full-time inspector, a part-time secretary and transient NRC personnel and will be generally commensurate with other office facilities at the site. A space of 250 square feet either within the site's office complex or in an office trailer or other on site space is suggested as a guide. For sites containing multiple fuel facilities, additional space may be requested to accommodate additional full-time inspector(s). The office space that is provided shall be subject to the approval of the Director, Office of Nuclear Material Safety and Safeguards or the appropriate NRC Regional Administrator. All furniture, supplies and communication equipment will be furnished by the Commission.

(3) The licensee shall afford any NRC resident inspector assigned to that site or other NRC inspectors identified by the Director, Office of Nuclear Material Safety and Safeguards, as likely to inspect the facility, immediate unfettered access, equivalent to access provided regular plant employees, following proper identification and compliance with applicable access control measures for security, radiological protection, and personal safety.

[21 FR 764, Feb. 3, 1956. Redesignated at 25 FR 1607, Feb. 25, 1960, and 25 FR 12730, Dec. 13, 1960, and amended at 32 FR 2563, Feb. 7, 1967; 44 FR 47919, Aug. 16, 1979; 52 FR 31612, Aug.

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21, 1987; 54 FR 6877, Feb. 15, 1989; 55 FR 5979, Feb. 21, 1990]

§ 70.56 Tests.

Each licensee shall perform, or permit the Commission to perform, such tests as the Commission deems appropriate or necessary for the administration of the regulations in this part, including tests of (a) special nuclear material, (b) facilities wherein special nuclear material is utilized, produced or stored, (c) radiation detection and monitoring instruments, and (d) other equipment and devices used in connection with the production, utilization or storage of special nuclear material.

[21 FR 764, Feb. 3, 1956. Redesignated at 25 FR 1607, Feb. 25, 1960, and 25 FR 12730, Dec. 13, 1960]

§ 70.59 Effluent monitoring reporting requirements.

Within 60 days after January 1 and July 1 of each year, and using an appropriate method listed in § 70.5(a), each licensee authorized to possess and use special nuclear material for processing and fuel fabrication, scrap recovery, conversion of uranium hexafluoride, or in a uranium enrichment facility shall submit a report addressed: ATTN: Document Control Desk, Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, with a copy to the appropriate NRC Regional Office shown in appendix D to part 20 of this chapter. The report must specify the quantity of each of the principal radionuclides released to unrestricted areas in liquid and gaseous effluents during the previous six months of operation, and such other information as the Commission may require to estimate maximum potential annual radiation doses to the public resulting from effluent releases. If quantities of radioactive materials released during the reporting periods are significantly above the licensee's design objectives previously reviewed as part of the licensing action, the report must cover this specifically. On the basis of these reports and any additional information the Commission may obtain from the licensee or others, the Commission may from time to time require the licensee to take such action as the Commission deems appropriate.

[40 FR 53230, Nov. 17, 1975, as amended at 41 FR 21627, May 27, 1976; 42 FR 25721, May 19, 1977; 52 FR 31612, Aug. 21, 1987; 57 FR 18393, Apr. 30, 1992; 68 FR 58817, Oct. 10, 2003]

Subpart H--Additional Requirements for Certain Licensees Authorized To Possess a Critical Mass of Special Nuclear Material Source: 65 FR 56226, Sept. 18, 2000, unless otherwise noted.

§ 70.60 Applicability.

The regulations in § 70.61 through § 70.76 apply, in addition to other applicable Commission regulations, to each applicant or licensee that is or plans to be authorized to possess greater than a critical mass of special nuclear material, and engaged in enriched uranium processing, fabrication 17-64

of uranium fuel or fuel assemblies, uranium enrichment, enriched uranium hexafluoride conversion, plutonium processing, fabrication of mixed-oxide fuel or fuel assemblies, scrap recovery of special nuclear material, or any other activity that the Commission determines could significantly affect public health and safety. The regulations in § 70.61 through § 70.76 do not apply to decommissioning activities performed pursuant to other applicable Commission regulations including § 70.25 and § 70.38 of this part. Also, the regulations in § 70.61 through § 70.76 do not apply to activities that are certified by the Commission pursuant to part 76 of this chapter or licensed by the Commission pursuant to other parts of this chapter. Unless specifically addressed in § 70.61 through § 70.76, implementation by current licensees of the Subpart H requirements shall be completed no later than the time of the ISA Summary submittal required in § 70.62(c)(3)(ii).

§ 70.61 Performance requirements.

(a) Each applicant or licensee shall evaluate, in the integrated safety analysis performed in accordance with § 70.62, its compliance with the performance requirements in paragraphs (b), (c),

and (d) of this section.

(b) The risk of each credible high-consequence event must be limited. Engineered controls, administrative controls, or both, shall be applied to the extent needed to reduce the likelihood of occurrence of the event so that, upon implementation of such controls, the event is highly unlikely or its consequences are less severe than those in paragrahs (b)(1)-(4) of this section. High consequence events are those internally or externally initiated events that result in:

(1) An acute worker dose of 1 Sv (100 rem) or greater total effective dose equivalent; (2) An acute dose of 0.25 Sv (25 rem) or greater total effective dose equivalent to any individual located outside the controlled area identified pursuant to paragraph (f) of this section; (3) An intake of 30 mg or greater of uranium in soluble form by any individual located outside the controlled area identified pursuant to paragraph (f) of this section; or (4) An acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed material that:

(i) Could endanger the life of a worker, or (ii) Could lead to irreversible or other serious, long-lasting health effects to any individual located outside the controlled area identified pursuant to paragraph (f) of this section. If an applicant possesses or plans to possess quantities of material capable of such chemical exposures, then the applicant shall propose appropriate quantitative standards for these health effects, as part of the information submitted pursuant to § 70.65 of this subpart.

(c) The risk of each credible intermediate-consequence event must be limited. Engineered 17-65

controls, administrative controls, or both shall be applied to the extent needed so that, upon implementation of such controls, the event is unlikely or its consequences are less than those in paragraphs (c)(1)-(4) of this section. Intermediate consequence events are those internally or externally initiated events that are not high consequence events, that result in:

(1) An acute worker dose of 0.25 Sv (25 rem) or greater total effective dose equivalent; (2) An acute dose of 0.05 Sv (5 rem) or greater total effective dose equivalent to any individual located outside the controlled area identified pursuant to paragraph (f) of this section; (3) A 24-hour averaged release of radioactive material outside the restricted area in concentrations exceeding 5000 times the values in Table 2 of Appendix B to Part 20; or (4) An acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed material that:

(i) Could lead to irreversible or other serious, long-lasting health effects to a worker, or (ii) Could cause mild transient health effects to any individual located outside the controlled area as specified in paragraph (f) of this section. If an applicant possesses or plans to possess quantities of material capable of such chemical exposures, then the applicant shall propose appropriate quantitative standards for these health effects, as part of the information submitted pursuant to § 70.65 of this subpart.

(d) In addition to complying with paragraphs (b) and (c) of this section, the risk of nuclear criticality accidents must be limited by assuring that under normal and credible abnormal conditions, all nuclear processes are subcritical, including use of an approved margin of subcriticality for safety. Preventive controls and measures must be the primary means of protection against nuclear criticality accidents.

(e) Each engineered or administrative control or control system necessary to comply with paragraphs (b), (c), or (d) of this section shall be designated as an item relied on for safety. The safety program, established and maintained pursuant to § 70.62 of this subpart, shall ensure that each item relied on for safety will be available and reliable to perform its intended function when needed and in the context of the performance requirements of this section.

(f) Each licensee must establish a controlled area, as defined in § 20.1003. In addition, the licensee must retain the authority to exclude or remove personnel and property from the area. For the purpose of complying with the performance requirements of this section, individuals who are not workers, as defined in § 70.4, may be permitted to perform ongoing activities (e.g., at a facility not related to the licensed activities) in the controlled area, if the licensee:

(1) Demonstrates and documents, in the integrated safety analysis, that the risk for those individuals at the location of their activities does not exceed the performance requirements of 17-66

paragraphs (b)(2), (b)(3), (b)(4)(ii), (c)(2), and (c)(4)(ii) of this section; or (2) Provides training that satisfies 10 CFR 19.12(a)(1)-(5) to these individuals and ensures that they are aware of the risks associated with accidents involving the licensed activities as determined by the integrated safety analysis, and conspicuously posts and maintains notices stating where the information in 10 CFR 19.11(a) may be examined by these individuals. Under these conditions, the performance requirements for workers specified in paragraphs (b) and (c) of this section may be applied to these individuals.

§ 70.62 Safety program and integrated safety analysis.

(a) Safety program. (1) Each licensee or applicant shall establish and maintain a safety program that demonstrates compliance with the performance requirements of § 70.61. The safety program may be graded such that management measures applied are graded commensurate with the reduction of the risk attributable to that item. Three elements of this safety program; namely, process safety information, integrated safety analysis, and management measures, are described in paragraphs (b) through (d) of this section.

(2) Each licensee or applicant shall establish and maintain records that demonstrate compliance with the requirements of paragraphs (b) through (d) of this section.

(3) Each licensee or applicant shall maintain records of failures readily retrievable and available for NRC inspection, documenting each discovery that an item relied on for safety or management measure has failed to perform its function upon demand or has degraded such that the performance requirements of § 70.61 are not satisfied. These records must identify the item relied on for safety or management measure that has failed and the safety function affected, the date of discovery, date (or estimated date) of the failure, duration (or estimated duration) of thetime that the item was unable to perform its function, any other affected items relied on for safety or management measures and their safety function, affected processes, cause of the failure, whether the failure was in the context of the performance requirements or upon demand or both, and any corrective or compensatory action that was taken. A failure must be recorded at the time of discovery and the record of that failure updated promptly upon the conclusion of each failure investigation of an item relied on for safety or management measure.

(b) Process safety information. Each licensee or applicant shall maintain process safety information to enable the performance and maintenance of an integrated safety analysis. This process safety information must include information pertaining to the hazards of the materials used or produced in the process, information pertaining to the technology of the process, and information pertaining to the equipment in the process.

(c) Integrated safety analysis. (1) Each licensee or applicant shall conduct and maintain an integrated safety analysis, that is of appropriate detail for the complexity of the process, that identifies:

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(i) Radiological hazards related to possessing or processing licensed material at its facility; (ii) Chemical hazards of licensed material and hazardous chemicals produced from licensed material; (iii) Facility hazards that could affect the safety of licensed materials and thus present an increased radiological risk; (iv) Potential accident sequences caused by process deviations or other events internal to the facility and credible external events, including natural phenomena; (v) The consequence and the likelihood of occurrence of each potential accident sequence identified pursuant to paragraph (c)(1)(iv) of this section, and the methods used to determine the consequences and likelihoods; and (vi) Each item relied on for safety identified pursuant to § 70.61(e) of this subpart, the characteristics of its preventive, mitigative, or other safety function, and the assumptions and conditions under which the item is relied upon to support compliance with the performance requirements of § 70.61.

(2) Integrated safety analysis team qualifications. To assure the adequacy of the integrated safety analysis, the analysis must be performed by a team with expertise in engineering and process operations. The team shall include at least one person who has experience and knowledge specific to each process being evaluated, and persons who have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process safety. One member of the team must be knowledgeable in the specific integrated safety analysis methodology being used.

(3) Requirements for existing licensees. Individuals holding an NRC license on September 18, 2000 shall, with regard to existing licensed activities:

(i) By April 18, 2001, submit for NRC approval, a plan that describes the integrated safety analysis approach that will be used, the processes that will be analyzed, and the schedule for completing the analysis of each process.

(ii) By October 18, 2004, or in accordance with the approved plan submitted under § 70.62(c)(3)(i), complete an integrated safety analysis, correct all unacceptable performance deficiencies, and submit, for NRC approval, an integrated safety analysis summary, including a description of the management measures, in accordance with § 70.65. The Commission may approve a request for an alternative schedule for completing the correction of unacceptable performance deficiencies if the Commission determines that the alternative is warranted by consideration of the following:

(A) Adequate compensatory measures have been established; 17-68

(B) Whether it is technically feasible to complete the correction of the unacceptable performance deficiency within the allotted 4-year period; (C) Other site-specific factors which the Commission may consider appropriate on a case-by-case basis and that are beyond the control of the licensee.

(iii) Pending the correction of unacceptable performance deficiencies identified during the conduct of the integrated safety analysis, the licensee shall implement appropriate compensatory measures to ensure adequate protection.

(d) Management measures. Each applicant or licensee shall establish management measures to ensure compliance with the performance requirements of § 70.61. The measures applied to a particular engineered or administrative control or control system may be graded commensurate with the reduction of the risk attributable to that control or control system. The management measures shall ensure that engineered and administrative controls and control systems that are identified as items relied on for safety pursuant to § 70.61(e) of this subpart are designed, implemented, and maintained, as necessary, to ensure they are available and reliable to perform their function when needed, to comply with the performance requirements of § 70.61 of this subpart.

§ 70.64 Requirements for new facilities or new processes at existing facilities.

(a) Baseline design criteria. Each prospective applicant or licensee shall address the following baseline design criteria in the design of new facilities. Each existing licensee shall address the following baseline design criteria in the design of new processes at existing facilities that require a license amendment under § 70.72. The baseline design criteria must be applied to the design of new facilities and new processes, but do not require retrofits to existing facilities or existing processes (e.g., those housing or adjacent to the new process); however, all facilities and processes must comply with the performance requirements in § 70.61. Licensees shall maintain the application of these criteria unless the analysis performed pursuant to § 70.62(c) demonstrates that a given item is not relied on for safety or does not require adherence to the specified criteria.

(1) Quality standards and records. The design must be developed and implemented in accordance with management measures, to provide adequate assurance that items relied on for safety will be available and reliable to perform their function when needed. Appropriate records of these items must be maintained by or under the control of the licensee throughout the life of the facility.

(2) Natural phenomena hazards. The design must provide for adequate protection against natural phenomena with consideration of the most severe documented historical events for the site.

(3) Fire protection. The design must provide for adequate protection against fires and explosions.

(4) Environmental and dynamic effects. The design must provide for adequate protection from environmental conditions and dynamic effects associated with normal operations, maintenance, 17-69

testing, and postulated accidents that could lead to loss of safety functions.

(5) Chemical protection. The design must provide for adequate protection against chemical risks produced from licensed material, facility conditions which affect the safety of licensed material, and hazardous chemicals produced from licensed material.

(6) Emergency capability. The design must provide for emergency capability to maintain control of:

(i) Licensed material and hazardous chemicals produced from licensed material; (ii) Evacuation of on-site personnel; and (iii) Onsite emergency facilities and services that facilitate the use of available offsite services.

(7) Utility services. The design must provide for continued operation of essential utility services.

(8) Inspection, testing, and maintenance. The design of items relied on for safety must provide for adequate inspection, testing, and maintenance, to ensure their availability and reliability to perform their function when needed.

(9) Criticality control. The design must provide for criticality control including adherence to the double contingency principle.

(10) Instrumentation and controls. The design must provide for inclusion of instrumentation and control systems to monitor and control the behavior of items relied on for safety.

(b) Facility and system design and facility layout must be based on defense-in-depth practices.1 The design must incorporate, to the extent practicable:

(1) Preference for the selection of engineered controls over administrative controls to increase overall system reliability; and (2) Features that enhance safety by reducing challenges to items relied on for safety.

1 As used in § 70.64, Requirements for new facilities or new processes at existing facilities, defense-in-depth practices means a design philosophy, applied from the outset and through completion of the design, that is based on providing successive levels of protection such that health and safety will not be wholly dependent upon any single element of the design, construction, maintenance, or operation of the facility. The net effect of incorporating defense-in-depth practices is a conservatively designed facility and system that will exhibit greater tolerance to failures and external challenges. The risk insights obtained through performance of the integrated safety analysis can be then used to supplement the final design by focusing attention on the prevention and mitigation of the higher-risk potential accidents.

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§ 70.65 Additional content of applications.

(a) In addition to the contents required by § 70.22, each application must include a description of the applicant's safety program established under § 70.62.

(b) The integrated safety analysis summary must be submitted with the license or renewal application (and amendment application as necessary), but shall not be incorporated in the license.

However, changes to the integrated safety analysis summary shall meet the conditions of § 70.72.

The integrated safety analysis summary must contain:

(1) A general description of the site with emphasis on those factors that could affect safety (i.e.,

meteorology, seismology);

(2) A general description of the facility with emphasis on those areas that could affect safety, including an identification of the controlled area boundaries; (3) A description of each process (defined as a single reasonably simple integrated unit operation within an overall production line) analyzed in the integrated safety analysis in sufficient detail to understand the theory of operation; and, for each process, the hazards that were identified in the integrated safety analysis pursuant to § 70.62(c)(1)(i)-(iii) and a general description of the types of accident sequences; (4) Information that demonstrates the licensee's compliance with the performance requirements of

§ 70.61, including a description of the management measures; the requirements for criticality monitoring and alarms in § 70.24; and, if applicable, the requirements of § 70.64; (5) A description of the team, qualifications, and the methods used to perform the integrated safety analysis; (6) A list briefly describing each item relied on for safety which is identified pursuant to § 70.61(e) in sufficient detail to understand their functions in relation to the performance requirements of § 70.61; (7) A description of the proposed quantitative standards used to assess the consequences to an individual from acute chemical exposure to licensed material or chemicals produced from licensed materials which are on-site, or expected to be on-site as described in § 70.61(b)(4) and (c)(4);

(8) A descriptive list that identifies all items relied on for safety that are the sole item preventing or mitigating an accident sequence that exceeds the performance requirements of § 70.61; and (9) A description of the definitions of unlikely, highly unlikely, and credible as used in the evaluations in the integrated safety analysis.

§ 70.66 Additional requirements for approval of license application.

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(a) An application for a license from an applicant subject to subpart H will be approved if the Commission determines that the applicant has complied with the requirements of § 70.21, 70.22, 70.23, and 70.60 through 70.65.

(b) Submittals by existing licensees in accordance with § 70.62(c)(3)(i) will be approved if the Commission determines that:

(1) The integrated safety analysis approach is in accordance with the requirements of § 70.61, 70.62(c)(1), and 70.62(c)(2); and (2) The schedule is in compliance with § 70.62(c)(3)(ii).

(c) Submittals by existing licensees in accordance with § 70.62(c)(3)(ii) will be approved if the Commission determines that:

(1) The requirements of § 70.65(b) are satisfied; and (2) The performance requirements in § 70.61 (b), (c) and (d) are satisfied, based on the information in the ISA Summary, together with other information submitted to NRC or available to NRC at the licensee's site.

§ 70.72 Facility changes and change process.

(a) The licensee shall establish a configuration management system to evaluate, implement, and track each change to the site, structures, processes, systems, equipment, components, computer programs, and activities of personnel. This system must be documented in written procedures and must assure that the following are addressed prior to implementing any change:

(1) The technical basis for the change; (2) Impact of the change on safety and health or control of licensed material; (3) Modifications to existing operating procedures including any necessary training or retraining before operation; (4) Authorization requirements for the change; (5) For temporary changes, the approved duration (e.g., expiration date) of the change; and (6) The impacts or modifications to the integrated safety analysis, integrated safety analysis summary, or other safety program information, developed in accordance with § 70.62.

(b) Any change to site, structures, processes, systems, equipment, components, computer programs, and activities of personnel must be evaluated by the licensee as specified in paragraph 17-72

(a) of this section, before the change is implemented. The evaluation of the change must determine, before the change is implemented, if an amendment to the license is required to be submitted in accordance with § 70.34.

(c) The licensee may make changes to the site, structures, processes, systems, equipment, components, computer programs, and activities of personnel, without prior Commission approval, if the change:

(1) Does not:

(i) Create new types of accident sequences that, unless mitigated or prevented, would exceed the performance requirements of § 70.61 and that have not previously been described in the integrated safety analysis summary; or (ii) Use new processes, technologies, or control systems for which the licensee has no prior experience; (2) Does not remove, without at least an equivalent replacement of the safety function, an item relied on for safety that is listed in the integrated safety analysis summary and is necessary for compliance with the performance requirements of § 70.61; (3) Does not alter any item relied on for safety, listed in the integrated safety analysis summary, that is the sole item preventing or mitigating an accident sequence that exceeds the performance requirements of § 70.61; and (4) Is not otherwise prohibited by this section, license condition, or order.

(d)(1) For changes that require pre-approval under § 70.72, the licensee shall submit an amendment request to the NRC in accordance with § 70.34 and § 70.65 of this chapter.

(2) For changes that do not require pre-approval under § 70.72, the licensee shall submit to NRC annually, within 30 days after the end of the calendar year during which the changes occurred, a brief summary of all changes to the records required by § 70.62(a)(2) of this subpart.

(3) For all changes that affect the integrated safety analysis summary, the licensee shall submit to NRC annually, within 30 days after the end of the calendar year during which the changes occurred, revised integrated safety analysis summary pages.

(e) If a change covered by § 70.72 is made, the affected on-site documentation must be updated promptly.

(f) The licensee shall maintain records of changes to its facility carried out under this section.

These records must include a written evaluation that provides the bases for the determination that 17-73

the changes do not require prior Commission approval under paragraph (c) or (d) of this section.

These records must be maintained until termination of the license.

[71 FR 56344, Sep. 27, 2006]

§ 70.73 Renewal of licenses.

Applications for renewal of a license must be filed in accordance with §§ 2.109, 70.21, 70.22, 70.33, 70.38, and 70.65 of this chapter. Information contained in previous applications, statements, or reports filed with the Commission under the license may be incorporated by reference, provided that these references are clear and specific.

§ 70.74 Additional reporting requirements.

(a) Reports to NRC Operations Center. (1) Each licensee shall report to the NRC Operations Center the events described in Appendix A to Part 70.

(2) Reports must be made by a knowledgeable licensee representative and by any method that will ensure compliance with the required time period for reporting.

(3) The information provided must include a description of the event and other related information as described in § 70.50(c)(1).

(4) Follow-up information to the reports must be provided until all information required to be reported in § 70.50(c)(1) of this subpart is complete.

(5) Each licensee shall provide reasonable assurance that reliable communication with the NRC Operations Center is available during each event.

(b) Written reports. Each licensee that makes a report required by paragraph (a)(1) of this section shall submit a written follow-up report within 30 days of the initial report. The written report must contain the information as described in § 70.50(c)(2).

§ 70.76 Backfitting.

(a) For each licensee, this provision shall apply to Subpart H requirements as soon as the NRC approves that licensee's ISA Summary pursuant to § 70.66. For requirements other than Subpart H, this provision applies regardless of the status of the approval of a licensee's ISA Summary.

(1) Backfitting is defined as the modification of, or addition to, systems, structures, or components of a facility; or to the procedures or organization required to operate a facility; any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previous NRC staff position.

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(2) Except as provided in paragraph (a)(4) of this section, the Commission shall require a systematic and documented analysis pursuant to paragraph (b) of this section for backfits which it seeks to impose.

(3) Except as provided in paragraph (a)(4) of this section, the Commission shall require the backfitting of a facility only when it determines, based on the analysis described in paragraph (b) of this section, that there is a substantial increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit and that the direct and indirect costs of implementation for that facility are justified in view of this increased protection.

(4) The provisions of paragraphs (a)(2) and (a)(3) of this section are inapplicable and, therefore, backfit analysis is not required and the standards in paragraph (a)(3) of this section do not apply where the Commission finds and declares, with appropriately documented evaluation for its finding, any of the following:

(i) That a modification is necessary to bring a facility into compliance with Subpart H of this part; (ii) That a modification is necessary to bring a facility into compliance with a license or the rules or orders of the Commission, or into conformance with written commitments by the licensee; (iii) That regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security; or (iv) That the regulatory action involves defining or redefining what level of protection to the public health and safety or common defense and security should be regarded as adequate.

(5) The Commission shall always require the backfitting of a facility if it determines that the regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security.

(6) The documented evaluation required by paragraph (a)(4) of this section must include a statement of the objectives of and reasons for the modification and the basis for invoking the exception. If immediate effective regulatory action is required, then the documented evaluation may follow, rather than precede, the regulatory action.

(7) If there are two or more ways to achieve compliance with a license or the rules or orders of the Commission, or with written license commitments, or there are two or more ways to reach an adequate level of protection, then ordinarily the licensee is free to choose the way that best suits its purposes. However, should it be necessary or appropriate for the Commission to prescribe a specific way to comply with its requirements or to achieve adequate protection, then cost may be a factor in selecting the way, provided that the objective of compliance or adequate protection is met.

(b) In reaching the determination required by paragraph (a)(3) of this section, the Commission will 17-75

consider how the backfit should be scheduled in light of other ongoing regulatory activities at the facility and, in addition, will consider information available concerning any of the following factors as may be appropriate and any other information relevant and material to the proposed backfit:

(1) Statement of the specific objectives that the proposed backfit is designed to achieve; (2) General description of the activity that would be required by the licensee in order to complete the backfit; (3) Potential change in the risk to the public from the accidental release of radioactive material and hazardous chemicals produced from licensed material; (4) Potential impact on radiological exposure or exposure to hazardous chemicals produced from licensed material of facility employees; (5) Installation and continuing costs associated with the backfit, including the cost of facility downtime; (6) The potential safety impact of changes in facility or operational complexity, including the relationship to proposed and existing regulatory requirements; (7) The estimated resource burden on the NRC associated with the proposed backfit and the availability of such resources; (8) The potential impact of differences in facility type, design, or age on the relevancy and practicality of the proposed backfit; and (9) Whether the proposed backfit is interim or final and, if interim, the justification for imposing the proposed backfit on an interim basis.

(c) No license will be withheld during the pendency of backfit analyses required by the Commission's rules.

(d) The Executive Director for Operations shall be responsible for implementation of this section, and all analyses required by this section shall be approved by the Executive Director for Operations or his or her designee.

Subpart I--Modification and Revocation of Licenses

§ 70.81 Modification and revocation of licenses.

(a) The terms and conditions of all licenses shall be subject to amendment, revision, or modification by reason of amendments to the Atomic Energy Act of 1954, or by reason of rules, 17-76

regulations or orders issued in accordance with the Act or any amendments thereto; (b) Any license may be revoked, suspended or modified for any material false statements in the application or any statement of fact required under section 182 of the Act or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Commission to refuse to grant a license on an original application, or for failure to construct or operate a facility in accordance with the terms of the construction permit or license, the technical specifications in the application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of any regulation of the Commission.

(c) Upon revocation, suspension or modification of a license, the Commission may immediately retake possession of all special nuclear material held by the licensee. In cases found by the Commission to be of extreme importance to the national defense or security, or to the health and safety of the public, the Commission may recapture any special nuclear material held by the licensee prior to any of the procedures provided under section 551-558 of title 5 of the United States Code.

(d) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded opportunity to demonstrate or achieve compliance with all lawful requirements.

[21 FR 764, Feb. 3, 1956, as amended at 35 FR 11461, July 17, 1970. Redesignated at 65 FR 56226, Sept. 18, 2000]

§ 70.82 Suspension and operation in war or national emergency.

Whenever Congress declares that a state of war or national emergency exists, the Commission, if it finds it necessary to the common defense and security may, (a) Suspend any license it has issued.

(b) Order the recapture of special nuclear material.

(c) Order the operation of any licensed facility.

(d) Order entry into any plant or facility in order to recapture special nuclear material or to operate the facility. Just compensation shall be paid for any damages caused by recapture of special nuclear material or by operation of any facility, pursuant to this section.

[21 FR 764, Feb. 3, 1956, as amended at 32 FR 4056, Mar. 15, 1967; 35 FR 11461, July 17, 1970.

Redesignated at 65 FR 56226, Sept. 18, 2000]

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Subpart J--Enforcement

§ 70.91 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of--

(1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of--

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55077, Nov. 24, 1992. Redesignated at 65 FR 56226, Sept. 18, 2000]

§ 70.92 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 70 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 70 that are not issued under sections 161b, 161i, or 161o, for the purposes of section 223 are as follows: § 70.1, 70.2, 70.4, 70.5, 70.6, 70.8, 70.11, 70.12, 70.13, 17-78

70.14, 70.17, 70.18, 70.23, 70.31, 70.33, 70.34, 70.35, 70.37, 70.66, 70.73, 70.76, 70.81, 70.82, 70.63, 70.91, and 70.92.

[57 FR 55077, Nov. 24, 1992. Redesignated and amended at 65 FR 56226, Sept. 18, 2000]

Appendix A to Part 70--Reportable Safety Events Licensees must comply with reporting requirements in this appendix, except for (a)(1), (a)(2), and (b)(4), after they have submitted an ISA Summary in accordance with § 70.62(c)(3)(ii). Licensees must comply with (a)(1), (a)(2), and (b)(4) after October 18, 2000. As required by 10 CFR 70.74, licensees subject to the requirements in subpart H of part 70, shall report:

(a) One hour reports. Events to be reported to the NRC Operations Center within 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of discovery, supplemented with the information in 10 CFR 70.50(c)(1) as it becomes available, followed by a written report within 30 days:

(1) An inadvertent nuclear criticality.

(2) An acute intake by an individual of 30 mg or greater of uranium in a soluble form.

(3) An acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed material that exceeds the quantitative standards established to satisfy the requirements in § 70.61(b)(4).

(4) An event or condition such that no items relied on for safety, as documented in the Integrated Safety Analysis summary, remain available and reliable, in an accident sequence evaluated in the Integrated Safety Analysis, to perform their function:

(i) In the context of the performance requirements in § 70.61(b) and § 70.61(c), or (ii) Prevent a nuclear criticality accident (i.e., loss of all controls in a particular sequence).

(5) Loss of controls such that only one item relied on for safety, as documented in the Integrated Safety Analysis summary, remains available and reliable to prevent a nuclear criticality accident, and has been in this state for greater than eight hours.

(b) Twenty-four hour reports. Events to be reported to the NRC Operations Center within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of discovery, supplemented with the information in 10 CFR 70.50(c)(1) as it becomes available, followed by a written report within 30 days:

(1) Any event or condition that results in the facility being in a state that was not analyzed, was improperly analyzed, or is different from that analyzed in the Integrated Safety Analysis, and which results in failure to meet the performance requirements of § 70.61.

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(2) Loss or degradation of items relied on for safety that results in failure to meet the performance requirement of § 70.61.

(3) An acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed materials that exceeds the quantitative standards that satisfy the requirements of § 70.61(c)(4).

(4) Any natural phenomenon or other external event, including fires internal and external to the facility, that has affected or may have affected the intended safety function or availability or reliability of one or more items relied on for safety.

(5) An occurrence of an event or process deviation that was considered in the Integrated Safety Analysis and:

(i) Was dismissed due to its likelihood; or (ii) Was categorized as unlikely and whose associated unmitigated consequences would have exceeded those in § 70.61(b) had the item(s) relied on for safety not performed their safety function(s).

(c) Concurrent Reports. Any event or situation, related to the health and safety of the public or onsite personnel, or protection of the environment, for which a news release is planned or notification to other government agencies has been or will be made, shall be reported to the NRC Operations Center concurrent to the news release or other notification.

[65 FR 56231, Sept. 18, 2000]

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