Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors

10 CFR Part 1

Flags, Organization and functions (Government Agencies), Seals and insignia.

10 CFR Part 2

Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Confidential business information, Freedom of information, Environmental protection, Hazardous waste, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal.

10 CFR Part 10

Administrative practice and procedure, Classified information, Government employees, Security measures.

10 CFR Part 11

Hazardous materials transportation, Investigations, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Security measures, Special nuclear material.

10 CFR Part 19

Criminal penalties, Environmental protection, Nuclear Energy, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Sex discrimination.

10 CFR Part 20

Byproduct material, Criminal penalties, Hazardous waste, Licensed material, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalties, Radiation protection, Reporting and recordkeeping requirements, Source material, Special nuclear material, Waste treatment and disposal.

10 CFR Part 21

Nuclear power plants and reactors, Penalties, Radiation protection, Reporting and recordkeeping requirements.

10 CFR Part 25

Classified information, Criminal penalties, Investigations, Penalties, Reporting and recordkeeping requirements, Security measures.

10 CFR Part 26

Administrative practice and procedure, Alcohol abuse, Alcohol testing, Appeals, Drug abuse, Drug testing, Employee assistance programs, Fitness for duty, Management actions, Nuclear power plants and reactors, Privacy, Protection of information, Radiation protection, Reporting and recordkeeping requirements.

10 CFR Part 30

Byproduct material, Criminal penalties, Fusion, Government contracts, Intergovernmental relations, Isotopes, Nuclear energy, Nuclear materials, Penalties, Radiation protection, Reporting and recordkeeping requirements, Whistleblowing.

10 CFR Part 40

Criminal penalties, Exports, Government contracts, Hazardous materials transportation, Hazardous waste, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Source material, Uranium, Whistleblowing.

10 CFR Part 50

Administrative practice and procedure, Antitrust, Backfitting, Classified information, Criminal penalties, Education, Emergency planning, Fire prevention, Fire protection, Intergovernmental relations, Nuclear power plants and reactors, Penalties, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements, Whistleblowing.

10 CFR Part 51

Administrative practice and procedure, Environmental impact statements, Hazardous waste, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Reporting and recordkeeping requirements.

10 CFR Part 53

Administrative practice and procedure, Antitrust, Backfitting, Construction permit, Combined license, Classified information, Criminal penalties, Early site permit, Emergency planning, Fees, Fire prevention, Fire protection, Inspection, Intergovernmental relations, Limited work authorization, Manufacturing license, Nuclear power plants and reactors, Operating license, Penalties, Prototype, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements, Standard design, Standard design certification, Training programs.

10 CFR Part 70

Classified information, Criminal penalties, Emergency medical services, Hazardous materials transportation, Material control and accounting, Nuclear energy, Nuclear materials, Packaging and containers, Penalties, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment, Security measures, Special nuclear material, Whistleblowing.

10 CFR Part 72

Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

10 CFR Part 73

Criminal penalties, Exports, Hazardous materials transportation, Imports, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Security measures.

10 CFR Part 74

Accounting, Criminal penalties, Hazardous materials transportation, Material control and accounting, Nuclear energy, Nuclear materials, Packaging and containers, Penalties, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment, Special nuclear material.

10 CFR Part 75

Criminal penalties, Intergovernmental relations, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Security measures, Treaties.

10 CFR Part 95

Classified information, Criminal penalties, Penalties, Reporting and recordkeeping requirements, Security measures.

10 CFR Part 140

Insurance, Intergovernmental relations, Nuclear materials, Nuclear power plants and reactors, Penalties,

Reporting and recordkeeping requirements.

10 CFR Part 150

Criminal penalties, Hazardous materials transportation, Intergovernmental relations, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Security measures, Source material, Special nuclear material.

10 CFR Part 170

Byproduct material, Import and export licenses, Intergovernmental relations, Non-payment penalties, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.

10 CFR Part 171

Annual charges, Approvals, Byproduct material, Holders of certificates, Intergovernmental relations, Nonpayment penalties, Nuclear materials, Nuclear power plants and reactors, Registrations, Source material, Special nuclear material.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR chapter I:

PART 1--STATEMENT OF ORGANIZATION AND GENERAL INFORMATION

0 1. The authority citation for part 1 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 23, 25, 29, 161, 191 (42 U.S.C. 2033, 2035, 2039, 2201, 2241); Energy Reorganization Act of 1974, secs. 201, 203, 204, 205, 209 (42 U.S.C. 5841, 5843, 5844, 5845, 5849); Administrative Procedure Act (5 U.S.C. 552, 553); Reorganization Plan No. 1 of 1980, 5 U.S.C. Appendix (Reorganization Plans).

Sec. 1.43 [Amended]

0 2. In Sec. 1.43, in paragraph (a)(2), remove “50, 52, and 54” add in its place “50, 52, 53, and 54”.

PART 2--AGENCY RULES OF PRACTICE AND PROCEDURE

0 3. The authority citation for part 2 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 29, 53, 62, 63, 81, 102, 103, 104, 105, 161, 181, 182, 183, 184, 186, 189, 191, 234 (42 U.S.C. 2039, 2073, 2092, 2093, 2111, 2132, 2133, 2134, 2135, 2201, 2231, 2232, 2233, 2234, 2236, 2239, 2241, 2282); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); Nuclear Waste Policy Act of 1982, secs. 114(f), 134, 135, 141 (42 U.S.C. 10134(f), 10154, 10155, 10161); Administrative Procedure Act (5 U.S.C. 552, 553, 554, 557, 558); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note. Section 2.205(j) also issued under Sec. 31001(s), Pub. L. 104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 note).

Sec. 2.1 [Amended]

0 4. In Sec. 2.1, in paragraph (e), remove the phrase “part 52” and add in its place the phrase “part 52 or 53”.

0 5. In Sec. 2.4, revise the definitions for “Contested proceeding” and “Facility” to read as follows:

Sec. 2.4 Definitions.

* * * * *

Contested proceeding means--

(1) A proceeding in which there is a controversy between the NRC staff and the applicant for a license or permit concerning the issuance of the license or permit or any of the terms or conditions thereof;

(2) A proceeding in which the NRC is imposing a civil penalty or other enforcement action, and the subject of the civil penalty or enforcement action is an applicant for or holder of a license or permit, or is or was an applicant for or holder of a license or permit, or is or was an applicant for a standard design certification under part 52 or 53 of this chapter; and

(3) A proceeding in which a petition for leave to intervene in opposition to an application for a license or permit has been granted or is pending before the Commission. * * * * *

Facility means a production facility or a utilization facility as defined in Sec. Sec. 50.2 and 53.020 of this chapter. * * * * *

Sec. 2.100 [Amended]

0 6. In Sec. 2.100, remove the phrase “subpart E of part 52” and add in its place the phrase “subpart E of part 52 or subpart H of part 53”.

0 7. In Sec. 2.101, revise paragraphs (a)(3)(i), (a)(5), (a)(9) introductory text, and (a)(9)(i) to read as follows:

Sec. 2.101 Filing of application.

(a) * * *

(3) * * *

(i) Submit to the Director, Office of Nuclear Reactor Regulation, or Director, Office of Nuclear Material Safety and Safeguards, as appropriate, such additional copies as the regulations in part 50, subpart A of part 51, and part 53 of this chapter require; * * * * *

(5) An applicant for a construction permit under part 50 or 53 of this chapter or a combined license under part 52 or 53 of this chapter for a production or utilization facility which is subject to Sec. 51.20(b) of this chapter, and is of the type specified in Sec. 50.21(b)(2) or (3); or Sec. 50.22; or part 53, as applicable, of this chapter, or is a testing facility, may submit the information required of applicants by part 50, 52, or 53 of this chapter in two parts. One part shall be accompanied by the information required by Sec. 50.30(f), Sec. 52.80(b), or Sec. 53.1100(f) of this chapter, as applicable. The other part shall include any information required by Sec. 50.34(a) and, if applicable, Sec. 50.34a of this chapter; or Sec. Sec. 52.79 and 52.80(a) of this chapter; or Sec. Sec. 53.1109, 53.1306, 53.1309, and 53.1312 of this chapter; or Sec. Sec. 53.1109, 53.1413, 53.1416, and 53.1419 of this chapter, as applicable. One part may precede or follow other parts by no longer than 6 months. If it is determined that either of the parts as described above is incomplete and not acceptable for processing, the Director, Office of Nuclear Reactor Regulation, or Director, Office of Nuclear Material Safety and Safeguards, as appropriate, will inform the applicant of this determination and the respects in which the document is deficient. Such a determination of completeness will generally be made within a period of 30 days. Whichever part is filed first shall also include the fee required by Sec. 50.30(e) or Sec. 53.1100(e) and Sec. 170.21 of this chapter and the information required by Sec. Sec. 50.33, 50.34(a)(1), and 52.79(a)(1) of this chapter; or Sec. Sec. 53.1109, 53.1309, and 53.1416 of this chapter, as applicable, and Sec. 50.37 or Sec. 53.1115, as applicable, of this chapter. The Director, Office of Nuclear Reactor Regulation, or Director, Office of Nuclear Material Safety and Safeguards, as appropriate, will accept for docketing an application for a construction permit under part 50 or 53 of this chapter or a combined license under part 52 or 53 of this chapter for a production or utilization facility which is subject to Sec. 51.20(b) of this chapter, and is of the type specified in Sec. 50.21(b)(2) or (3), or Sec. 50.22, or part 53, as applicable, of this chapter or is a testing facility where one part of the application as described above is complete and conforms to the requirements of part 50 of this chapter. The additional parts will be docketed upon a determination by the Director, Office of Nuclear Reactor Regulation, or Director, Office of Nuclear Material Safety and Safeguards, as appropriate, that it is complete. * * * * *

(9) An applicant for a construction permit for a utilization facility which is subject to Sec. 51.20(b) of this chapter and is of the type specified in Sec. 50.21(b)(2) or (3), or Sec. 50.22, or part 53 of this chapter, an applicant for or holder of an early site permit under part 52 or 53 of this chapter, or an applicant for a combined license under part 52 or 53 of this chapter, who seeks to conduct the activities authorized under Sec. 50.10(d) or Sec. 53.1130 of this chapter may submit a complete application under paragraphs (a)(1) through (4) of this section, which includes the information required by Sec. 50.10(d) or Sec. 53.1130 of this chapter. Alternatively, the applicant (other than an applicant for or holder of an early site permit) may submit its application in two parts:

(i) Part one must include the information required by Sec. 50.33(a) through (f) or Sec. Sec. 53.1109(a) through (e) and 53.1306 of this chapter, and the information required by Sec. 50.10(d)(2) and (3) or Sec. 53.1130(a)(2) and (3) of this chapter, as applicable. * * * * *

0 8. In Sec. 2.104, revise paragraph (a) to read as follows:

Sec. 2.104 Notice of hearing.

(a) In the case of an application on which a hearing is required by the Act or this chapter, or in which the Commission finds that a hearing is required in the public interest, the Secretary will issue a notice of hearing to be published in the Federal Register. The notice must be published at least 15 days, and in the case of an application concerning a limited work authorization, construction permit, early site permit, or combined license for a facility of the type described in Sec. 50.21(b) or Sec. 50.22 or subpart H of part 53 of this chapter, as applicable, or a testing facility, at least 30 days, before the date set for hearing in the notice.\1\ In addition, in the case of an application for a limited work authorization, construction permit, early site permit, or combined license for a facility of the type described in Sec. 50.22 or subpart H of part 53 of this chapter, as applicable, or a testing facility, the notice must be issued as soon as practicable after the NRC has docketed the application. If the Commission decides, under Sec. 2.101(a)(2), to determine the acceptability of the application based on its technical adequacy as well as completeness, the notice must be issued as soon as practicable after the application has been tendered. * * * * *

\1\ If the notice of hearing concerning an application for a limited work authorization, construction permit, early site permit, or combined license for a facility of the type described in Sec. 50.21(b) or Sec. 50.22 or subpart H of part 53 of this chapter, as applicable, or a testing facility, does not specify the time and place of initial hearing, a subsequent notice will be published in the Federal Register which will provide at least 30-day notice of the time and place of that hearing. After this notice is given, the presiding officer may reschedule the commencement of the initial hearing for a later date or reconvene a recessed hearing without again providing at least 30-day notice.

0 9. In Sec. 2.105, revise paragraph (a) introductory text and paragraphs (a)(4), (10), (12), and (13), (b)(3) introductory text, and (b)(3)(i), (ii), and (iv) to read as follows:

Sec. 2.105 Notice of proposed action.

(a) If a hearing is not required by the Act or this chapter, and if the Commission has not found that a hearing is in the public interest, it will, before acting thereon, publish in the Federal Register, as applicable, or on the NRC's website, https://www.nrc.gov, or both, at the Commission's discretion, either a notice of intended operation under Sec. 52.103(a) or Sec. 53.1452(a) of this chapter, as applicable, and a proposed finding that inspections, tests, analyses, and acceptance criteria for a combined license under subpart C of part 52 or under subpart H of part 53 of this chapter, have been or will be met, or a notice of proposed action with respect to an application for: * * * * *

(4) An amendment to an operating license, combined license, or manufacturing license for a facility licensed under Sec. 50.21(b) or Sec. 50.22 or under subpart H of part 53 of this chapter, as applicable, or for a testing facility, as follows:

(i) If the Commission determines under Sec. 50.58 or Sec. 53.1515 of this chapter that the amendment involves no significant hazards consideration, though it will provide notice of opportunity for a hearing pursuant to this section, it may make the amendment immediately effective and grant a hearing thereafter; or

(ii) If the Commission determines under Sec. Sec. 50.58 and 50.91 or Sec. 53.1515 of this chapter, as applicable, that an emergency situation exists or that exigent circumstances exist and that the amendment involves no significant hazards consideration, it will provide notice of opportunity for a hearing pursuant to Sec. 2.106 (if a hearing is requested, it will be held after issuance of the amendment); * * * * *

(10) In the case of an application for an operating license for a facility of a type described in Sec. 50.21(b) or Sec. 50.22 or part 53 of this chapter, or a testing facility, a notice of opportunity for hearing shall be issued as soon as practicable after the application has been docketed; or * * * * *

(12) An amendment to an early site permit issued under subpart A of part 52, or under subpart H of part 53 of this chapter, as follows:

(i) If the early site permit does not provide authority to conduct the activities allowed under Sec. 50.10(e)(1) or Sec. 53.1130(b)(1) of this chapter, the amendment will involve no significant hazards consideration, and though the NRC will provide notice of opportunity for a hearing under this section, it may make the amendment immediately effective and grant a hearing thereafter; and

(ii) If the early site permit provides authority to conduct the activities allowed under Sec. 50.10(e)(1) or Sec. 53.1130(b)(1) of this chapter and the Commission determines under Sec. Sec. 50.58 and 50.91 or Sec. 53.1515 of this chapter that an emergency situation exists or that exigent circumstances exist and that the amendment involves no significant hazards consideration, it will provide notice of opportunity for a hearing under Sec. 2.106 (if a hearing is requested, which will be held after issuance of the amendment).

(13) A manufacturing license under subpart F of part 52 or subpart H of part 53 of this chapter.

(b) * * *

(3) For a notice of intended operation under Sec. 52.103(a) or Sec. 53.1452(a) of this chapter, the following information:

(i) The identification of the NRC action as making the finding required under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter;

(ii) The manner in which the licensee notifications under Sec. 52.99(c) or Sec. 53.1449(c) of this chapter which are required to be made available by Sec. 52.99(e)(2) or Sec. 53.1449(e)(2) of this chapter may be obtained and examined; * * * * *

(iv) Any conditions, limitations, or restrictions to be placed on the license in connection with the finding under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter, and the expiration date or circumstances (if any) under which the conditions, limitations or restrictions will no longer apply. * * * * *

0 10. In Sec. 2.106, revise paragraphs (a)(2) and (3) and (b)(2) introductory text to read as follows:

Sec. 2.106 Notice of issuance.

(a) * * *

(2) An amendment of a license for a facility of the type described in Sec. 50.21(b) or Sec. 50.22 or part 53 of this chapter, as applicable, or a testing facility, whether or not a notice of proposed action has been previously published; and

(3) The finding under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter.

(b) * * *

(2) In the case of a finding under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter: * * * * *

0 11. In Sec. 2.109, revise paragraphs (b), (c), and (d) to read as follows:

Sec. 2.109 Effect of timely renewal application.

* * * * *

(b) If the licensee of a nuclear power plant licensed under Sec. 50.21(b) or Sec. 50.22 or under subpart H of part 53 of this chapter files a sufficient application for renewal of either an operating license or a combined license at least 5 years before the expiration of the existing license, the existing license will not be deemed to have expired until the application has been finally determined.

(c) If the holder of an early site permit licensed under subpart A of part 52 or under subpart H of part 53 of this chapter, as applicable, files a sufficient application for renewal under Sec. 52.29 or Sec. 53.1173 of this chapter, as applicable, at least 12 months before the expiration of the existing early site permit, the existing permit will not be deemed to have expired until the application has been finally determined.

(d) If the licensee of a manufacturing license under subpart F of part 52 or under subpart H of part 53 of this chapter files a sufficient application for renewal under Sec. 52.177 or Sec. 53.1295 of this chapter at least 12 months before the expiration of the existing license, the existing license will not be deemed to have expired until the application has been finally determined. * * * * *

0 12. In Sec. 2.110, revise paragraphs (a)(1) and (b) to read as follows:

Sec. 2.110 Filing and administrative action on submittals for standard design approval or early review of site suitability issues.

(a)(1) A submittal for a standard design approval under subpart E of part 52 or under subpart H of part 53 of this chapter shall be subject to Sec. Sec. 2.101(a) and 2.390 to the same extent as if it were an application for a permit or license. * * * * *

(b) Upon initiation of review by the NRC staff of a submittal for an early review of site suitability issues under appendix Q to part 50 of this chapter, or for a standard design approval under subpart E of part 52 or under subpart H of part 53 of this chapter, the Director, Office of Nuclear Reactor Regulation, shall publish in the Federal Register a notice of receipt of the submittal, inviting comments from interested persons within 60 days of publication or other time as may be specified, for consideration by the NRC staff and ACRS in their review. * * * * *

0 13. In Sec. 2.202, revise paragraph (e) to read as follows:

Sec. 2.202 Orders.

* * * * *

(e)(1) If the order involves the modification of a part 50 or a part 53 license and is a backfit, the requirements of Sec. 50.109 or Sec. 53.1590 of this chapter, as applicable, shall be followed, unless the licensee has consented to the action required.

(2) If the order involves the modification of combined license under subpart C of part 52 or subpart H of part 53 of this chapter, the requirements of Sec. 52.98 or Sec. 53.1443 of this chapter, as applicable, shall be followed unless the licensee has consented to the action required.

(3) If the order involves a change to an early site permit under subpart A of part 52 or under subpart H of part 53 of this chapter, the requirements of Sec. 52.39 or Sec. 53.1188 of this chapter, as applicable, must be followed, unless the applicant or licensee has consented to the action required.

(4) If the order involves a change to a standard design certification rule referenced by that plant's application, the requirements, if any, in the referenced design certification rule with respect to changes must be followed, or, in the absence of these requirements, the requirements of Sec. 52.63 or Sec. 53.1263 of this chapter, as applicable, must be followed, unless the applicant or licensee has consented to follow the action required.

(5) If the order involves a change to a standard design approval referenced by that plant's application, the requirements of Sec. 52.145 or Sec. 53.1221 of this chapter, as applicable, must be followed unless the applicant or licensee has consented to follow the action required.

(6) If the order involves a modification of a manufacturing license under subpart F of part 52 or under subpart H of part 53 of this chapter, the requirements of Sec. 52.171 or Sec. 53.1288 of this chapter, as applicable, must be followed, unless the applicant or licensee has consented to the action required.

0 14. In Sec. 2.309, revise paragraphs (a), (f)(1)(i), (vi), and (vii), (g), (h)(2), (i)(2), and (j) to read as follows:

Sec. 2.309 Hearing requests, petitions to intervene, requirements for standing, and contentions.

(a) General requirements. Any person whose interest may be affected by a proceeding and who desires to participate as a party must file a written request for hearing and a specification of the contentions which the person seeks to have litigated in the hearing. In a proceeding under Sec. 52.103 or Sec. 53.1452 of this chapter, as applicable, the Commission, acting as the presiding officer, will grant the request if it determines that the requestor has standing under the provisions of paragraph (d) of this section and has proposed at least one admissible contention that meets the requirements of paragraph (f) of this section. For all other proceedings, except as provided in paragraph (e) of this section, the Commission, presiding officer, or the Atomic Safety and Licensing Board designated to rule on the request for hearing and/or petition for leave to intervene, will grant the request/petition if it determines that the requestor/petitioner has standing under the provisions of paragraph (d) of this section and has proposed at least one admissible contention that meets the requirements of paragraph (f) of this section. In ruling on the request for hearing/ petition to intervene submitted by petitioners seeking to intervene in the proceeding on the HLW repository, the Commission, the presiding officer, or the Atomic Safety and Licensing Board shall also consider any failure of the petitioner to participate as a potential party in the pre-license application phase under subpart J of this part in addition to the factors in paragraph (d) of this section. If a request for hearing or petition to intervene is filed in response to any notice of hearing or opportunity for hearing, the applicant/licensee shall be deemed to be a party. * * * * *

(f) * * *

(1) * * *

(i) Provide a specific statement of the issue of law or fact to be raised or controverted, provided further, that the issue of law or fact to be raised in a request for hearing under Sec. 52.103(b) or Sec. 53.1452(b) of this chapter, as applicable, must be directed at demonstrating that one or more of the acceptance criteria in the combined license have not been, or will not be

met, and that the specific operational consequences of nonconformance would be contrary to providing reasonable assurance of adequate protection of the public health and safety; * * * * *

(vi) In a proceeding other than one under Sec. 52.103 or Sec. 53.1452 of this chapter provide sufficient information to show that a genuine dispute exists with the applicant/licensee on a material issue of law or fact. This information must include references to specific portions of the application (including the applicant's environmental report and safety report) that the petitioner disputes and the supporting reasons for each dispute, or, if the petitioner believes that the application fails to contain information on a relevant matter as required by law, the identification of each failure and the supporting reasons for the petitioner's belief; and

(vii) In a proceeding under Sec. 52.103(b) or Sec. 53.1452(b) of this chapter, as applicable, the information must be sufficient, and include supporting information showing, prima facie, that one or more of the acceptance criteria in the combined license have not been, or will not be met, and that the specific operational consequences of nonconformance would be contrary to providing reasonable assurance of adequate protection of the public health and safety. This information must include the specific portion of the report required by Sec. 52.99(c) or Sec. 53.1449(c) of this chapter, as applicable, which the requestor believes is inaccurate, incorrect, and/or incomplete (i.e., fails to contain the necessary information required by Sec. 52.99(c) or Sec. 53.1449(c) of this chapter, as applicable). If the requestor identifies a specific portion of the report under Sec. 52.99(c) or Sec. 53.1449(c) of this chapter, as applicable, as incomplete and the requestor contends that the incomplete portion prevents the requestor from making the necessary prima facie showing, then the requestor must explain why this deficiency prevents the requestor from making the prima facie showing. * * * * *

(g) Selection of hearing procedures. A request for hearing and/or petition for leave to intervene may, except in a proceeding under Sec. 52.103 or Sec. 53.1452 of this chapter, as applicable, also address the selection of hearing procedures, taking into account the provisions of Sec. 2.310. If a request/petition relies upon Sec. 2.310(d), the request/petition must demonstrate, by reference to the contention and the bases provided and the specific procedures in subpart G of this part, that resolution of the contention necessitates resolution of material issues of fact which may be best determined through the use of the identified procedures.

(h) * * *

(2) If the proceeding pertains to a production or utilization facility (as defined in Sec. 50.2 or Sec. 53.020 of this chapter) located within the boundaries of the State, local governmental body, or Federally-recognized Indian Tribe seeking to participate as a party, no further demonstration of standing is required. If the production or utilization facility is not located within the boundaries of the State, local governmental body, or Federally-recognized Indian Tribe seeking to participate as a party, the State, local governmental body, or Federally-recognized Indian Tribe also must demonstrate standing. * * * * *

(i) * * *

(2) Except in a proceeding under Sec. 52.103 or Sec. 53.1452 of this chapter, as applicable, the participant who filed the hearing request, intervention petition, or motion for leave to file new or amended contentions after the deadline may file a reply to any answer. The reply must be filed within 7 days after service of that answer. * * * * *

(j) Decision on request/petition. (1) In all proceedings other than a proceeding under Sec. 52.103 or Sec. 53.1452 of this chapter, as applicable, the presiding officer shall issue a decision on each request for hearing or petition to intervene within 45 days of the conclusion of the initial pre-hearing conference or, if no pre-hearing conference is conducted, within 45 days after the filing of answers and replies under paragraph (i) of this section. With respect to a request to admit amended or new contentions, the presiding officer shall issue a decision on each such request within 45 days of the conclusion of any pre-hearing conference that may be conducted regarding the proposed amended or new contentions or, if no pre-hearing conference is conducted, within 45 days after the filing of answers and replies, if any. In the event the presiding officer cannot issue a decision within 45 days, the presiding officer shall issue a notice advising the Commission and the parties, and the notice shall include the expected date of when the decision will issue.

(2) The Commission, acting as the presiding officer, shall expeditiously grant or deny the request for hearing in a proceeding under Sec. 52.103 or Sec. 53.1452 of this chapter, as applicable. The Commission's decision may not be the subject of any appeal under Sec. 2.311.

0 15. Amend Sec. 2.310 by: 0 a. In paragraphs (a) and (h) introductory text, removing the cross- reference “parts 30, 32 through 36, 39, 40, 50, 52, 54, 55, 61, 70 and 72 of this chapter” and adding, in its place, the cross reference “parts 30, 32 through 36, 39, 40, 50, 52, 53, 54, 55, 61, 70, and 72 of this chapter”; and 0 b. Revising paragraphs (i) and (j).

The revisions read as follows:

Sec. 2.310 Selection of hearing procedures.

* * * * *

(i) In design certification rulemaking proceedings under part 52 or part 53 of this chapter, any informal hearing held under Sec. 52.51 or Sec. 53.1242 of this chapter, as applicable, must be conducted under the procedures of subpart O of this part.

(j) Proceedings on a Commission finding under Sec. 52.103(c) and (g) or Sec. 53.1452(c) and (g) of this chapter, as applicable, shall be conducted in accordance with the procedures designated by the Commission in each proceeding. * * * * *

0 16. In Sec. 2.329, revise paragraph (a) to read as follows:

Sec. 2.329 Prehearing conference.

(a) Necessity for prehearing conference; timing. The Commission or the presiding officer may, and in the case of a proceeding on an application for a construction permit or an operating license for a facility of a type described in Sec. 50.21(b) or Sec. 50.22 or part 53 of this chapter, or a testing facility, must direct the parties or their counsel to appear at a specified time and place for a conference or conferences before trial. A prehearing conference in a proceeding involving a construction permit or operating license for a facility of a type described in Sec. 50.21(b) or Sec. 50.22 or part 53 of this chapter must be held within sixty (60) days after discovery has been completed or any other time specified by the Commission or the presiding officer. * * * * *

0 17. In Sec. 2.339, revise paragraph (d) to read as follows:

Sec. 2.339 Expedited decision-making procedure.

* * * * *

(d) The provisions of this section do not apply to an initial decision directing the issuance of a limited work authorization under Sec. 50.10 or Sec. 53.1130

of this chapter; an early site permit under subpart A of part 52 or under subpart H of part 53 of this chapter; a construction permit or construction authorization under part 50 or 53 of this chapter; a combined license under subpart C of part 52 or under subpart H of part 53 of this chapter; or a manufacturing license under subpart F of part 52 or under subpart H of part 53.

0 18. In Sec. 2.340, revise paragraphs (b), (c), (d), (f), (i), and (j) to read as follows:

Sec. 2.340 Initial decision in certain contested proceedings; immediate effectiveness of initial decisions; issuance of authorizations, permits and licenses.

* * * * *

(b) Initial decision--combined license under part 52 or 53 of this chapter--(1) Matters in controversy; presiding officer consideration of matters not put in controversy by parties. In any initial decision in a contested proceeding on an application for a combined license under part 52 or 53 of this chapter (including an amendment to or renewal of combined license), the presiding officer shall make findings of fact and conclusions of law on the matters put into controversy by the parties and any matter designated by the Commission to be decided by the presiding officer. The presiding officer shall also make findings of fact and conclusions of law on any matter not put into controversy by the parties, but only to the extent that the presiding officer determines that a serious safety, environmental, or common defense and security matter exists, and the Commission approves of an examination of and decision on the matter upon its referral by the presiding officer under, inter alia, the provisions of Sec. Sec. 2.323 and 2.341.

(2) Presiding officer initial decision and issuance of permit or license. (i) In a contested proceeding for the initial issuance or renewal of a combined license under part 52 or 53 of this chapter, or the amendment of a combined license where the NRC has not made a determination of no significant hazards consideration, the Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate after making the requisite findings, shall issue, deny, or appropriately condition the permit or license in accordance with the presiding officer's initial decision once that decision becomes effective.

(ii) In a contested proceeding for the amendment of a combined license under part 52 or 53 of this chapter where the NRC has made a determination of no significant hazards consideration, the Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate (appropriate official), after making the requisite findings and complying with any applicable provisions of Sec. 2.1202(a) or Sec. 2.1403(a), may issue the amendment before the presiding officer's initial decision becomes effective. Once the presiding officer's initial decision becomes effective, the appropriate official shall take action with respect to that amendment in accordance with the initial decision. If the presiding officer's initial decision becomes effective before the appropriate official issues the amendment, then the appropriate official, after making the requisite findings, shall issue, deny, or appropriately condition the amendment in accordance with the presiding officer's initial decision.

(c) Initial decision on findings under Sec. 52.103 or Sec. 53.1452 of this chapter with respect to acceptance criteria in nuclear power reactor combined licenses. In any initial decision under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter with respect to whether acceptance criteria have been or will be met, the presiding officer shall make findings of fact and conclusions of law on the matters put into controversy by the parties, and any matter designated by the Commission to be decided by the presiding officer. Matters not put into controversy by the parties but identified by the presiding officer as matters requiring further examination, shall be referred to the Commission for its determination; the Commission may, in its discretion, treat any of these referred matters as a request for action under Sec. 2.206 and process the matter in accordance with Sec. 52.103(f) or Sec. 53.1452(f) of this chapter.

(d) Initial decision--manufacturing license under part 52 or 53 of this chapter--(1) Matters in controversy; presiding officer consideration of matters not put in controversy by parties. In any initial decision in a contested proceeding on an application for a manufacturing license under subpart C of part 52 or subpart H of part 53 of this chapter (including an amendment to or renewal of a manufacturing license), the presiding officer shall make findings of fact and conclusions of law on the matters put into controversy by the parties and any matter designated by the Commission to be decided by the presiding officer. The presiding officer also shall make findings of fact and conclusions of law on any matter not put into controversy by the parties, but only to the extent that the presiding officer determines that a serious safety, environmental, or common defense and security matter exists, and the Commission approves of an examination of and decision on the matter upon its referral by the presiding officer under, inter alia, the provisions of Sec. Sec. 2.323 and 2.341.

(2) Presiding officer initial decision and issuance of permit or license. (i) In a contested proceeding for the initial issuance or renewal of a manufacturing license under subpart C of part 52 or subpart H of part 53 of this chapter, or the amendment of a manufacturing license, the Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate, after making the requisite findings, shall issue, deny, or appropriately condition the permit or license in accordance with the presiding officer's initial decision once that decision becomes effective.

(ii) In a contested proceeding for the initial issuance or renewal of a manufacturing license under subpart C of part 52 or subpart H of part 53 of this chapter, or the amendment of a manufacturing license, the Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate (appropriate official), may issue the license, permit, or license amendment in accordance with Sec. 2.1202(a) or Sec. 2.1403(a) before the presiding officer's initial decision becomes effective. If, however, the presiding officer's initial decision becomes effective before the license, permit, or license amendment is issued under Sec. 2.1202 or Sec. 2.1403, then the Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate, shall issue, deny, or appropriately condition the license, permit, or license amendment in accordance with the presiding officer's initial decision. * * * * *

(f) Immediate effectiveness of certain presiding officer decisions. A presiding officer's initial decision directing the issuance or amendment of a limited work authorization under Sec. 50.10 or Sec. 53.1130 of this chapter; an early site permit under subpart A of part 52 or under subpart H of part 53 of this chapter; a construction permit or construction authorization under part 50 or 53 of this chapter; an operating license under part 50 or 53 of this chapter; a combined license under subpart C of part 52 or subpart H or part 53 of this chapter; a manufacturing license under subpart F of part 52 or subpart H of part 53 of this chapter; a renewed license under part 53 or 54 of this chapter; or a license under part 72 of this chapter to store spent fuel in an independent spent fuel storage facility (ISFSI) or a monitored retrievable storage installation (MRS); an initial decision directing issuance of a license

under part 61 of this chapter; or an initial decision under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter that acceptance criteria in a combined license have been met, is immediately effective upon issuance unless the presiding officer finds that good cause has been shown by a party why the initial decision should not become immediately effective. * * * * *

(i) Issuance of authorizations, permits, and licenses--production and utilization facilities. The Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate, shall issue a limited work authorization under Sec. 50.10 or Sec. 53.1130 of this chapter; an early site permit under subpart A of part 52 or subpart H of part 53 of this chapter; a construction permit or construction authorization under part 50 or 53 of this chapter; an operating license under part 50 or 53 of this chapter; a combined license under subpart C of part 52 or part 53 of this chapter; or a manufacturing license under subpart F of part 52 or part 53 of this chapter within 10 days from the date of issuance of the initial decision:

(1) If the Commission or the Director has made all findings necessary for issuance of the authorization, permit or license, not within the scope of the initial decision of the presiding officer; and

(2) Notwithstanding the pendency of a petition for reconsideration under Sec. 2.345, a petition for review under Sec. 2.341, or a motion for stay under Sec. 2.342, or the filing of a petition under Sec. 2.206.

(j) Issuance of finding on acceptance criteria under Sec. 52.103 or Sec. 53.1452 of this chapter. The Commission or the Director, Office of Nuclear Reactor Regulation, as appropriate, shall make the finding under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter, that acceptance criteria in a combined license are met within 10 days from the date of the presiding officer's initial decision:

(1) If the Commission or the Director is otherwise able to make the finding under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter, that the prescribed acceptance criteria are met for those acceptance criteria not within the scope of the initial decision of the presiding officer;

(2) If the presiding officer's initial decision--with respect to contentions that the prescribed acceptance criteria have not been met-- finds that those acceptance criteria have been met, and the Commission or the Director thereafter is able to make the finding that those acceptance criteria are met;

(3) If the presiding officer's initial decision--with respect to contentions that the prescribed acceptance criteria will not be met-- finds that those acceptance criteria will be met, and the Commission or the Director thereafter is able to make the finding that those acceptance criteria are met; and

(4) Notwithstanding the pendency of a petition for reconsideration under Sec. 2.345, a petition for review under Sec. 2.341, or a motion for stay under Sec. 2.342, or the filing of a petition under Sec. 2.206. * * * * *

Sec. 2.341 [Amended]

0 19. In Sec. 2.341, in paragraph (a)(1), remove the phrase “Sec. 52.103(c)” and add in its place the phrase “Sec. 52.103(c) or Sec. 53.1452(c)”.

Sec. 2.400 [Amended]

0 20. In Sec. 2.400, remove the phrase “parts 50 or 52” and add in its place the phrase “part 50 or part 52 or Sec. 53.1470”.

0 21. In Sec. 2.401, revise the section heading and paragraph (a) to read as follows:

Sec. 2.401 Notice of hearing on construction permit or combined license applications pursuant to appendix N of 10 CFR part 50, 52, or 53.

(a) In the case of applications under appendix N of part 50 or Sec. 53.1470 of this chapter for construction permits for nuclear power reactors of the type described in Sec. 50.22 or part 53 of this chapter, or applications under appendix N of part 52 or Sec. 53.1470 of this chapter for combined licenses, the Secretary will issue notices of hearing pursuant to Sec. 2.104. * * * * *

0 22. In Sec. 2.402, revise paragraph (a) to read as follows:

Sec. 2.402 Separate hearings on separate issues; consolidation of proceedings.

(a) In the case of applications under appendix N of part 50 or Sec. 53.1470 of this chapter for construction permits for nuclear power reactors of a type described in Sec. 50.22 or part 53 of this chapter, or applications pursuant to appendix N of part 52 or Sec. 53.1470 of this chapter for combined licenses, the Commission or the presiding officer may order separate hearings on particular phases of the proceeding, such as matters related to the acceptability of the design of the reactor in the context of the site parameters postulated for the design or environmental matters. * * * * *

Sec. 2.403 [Amended]

0 23. In Sec. 2.403, remove the phrase “appendix N of part 50” and add in its place the phrase “appendix N to part 50 or Sec. 53.1470”.

Sec. 2.404 [Amended]

0 24. In Sec. 2.404, remove the phrase “appendix N of part 50” and add in its place the phrase “appendix N to part 50 or Sec. 53.1470”.

Sec. 2.405 [Amended]

0 25. In Sec. 2.405, remove the phrase “part 52” and add in its place the phrase “part 52 or 53”.

Sec. 2.406 [Amended]

0 26. In Sec. 2.406, remove the phrase “appendices N of parts 50 or 52” and add in its place the phrase “appendix N to part 50 or part 52 or Sec. 53.1470”.

Sec. 2.500 [Amended]

0 27. In Sec. 2.500, remove the phrase “subpart F of part 52” and add in its place the phrase “subpart F of part 52 or subpart H of part 53”.

0 28. In Sec. 2.501, revise the section heading and paragraph (a) introductory text to read as follows:

Sec. 2.501 Notice of hearing on application under 10 CFR part 52 or 53 for a license to manufacture nuclear power reactors.

(a) In the case of an application under subpart F of part 52 or subpart H of part 53 of this chapter for a license to manufacture nuclear power reactors of the type described in Sec. 50.22 or part 53 of this chapter to be operated at sites not identified in the license application, the Secretary will issue a notice of hearing to be published in the Federal Register at least 30 days before the date set for hearing in the notice.\1\ The notice shall be issued as soon as practicable after the application has been docketed. The notice will state: * * * * *

\1\ The thirty-day (30) requirement of this paragraph (a) is not applicable to a notice of the time and place of hearing published by the presiding officer after notice of hearing described in this section has been published.

0 29. In Sec. 2.643, revise paragraph (b) to read as follows:

Sec. 2.643 Acceptance and docketing of application for limited work authorization.

* * * * *

(b) The Director will accept for docketing part one of an application for a construction permit for a utilization facility which is subject to Sec. 51.20(b) of this chapter and is of the type specified in Sec. 50.21(b)(2) or (3) or Sec. 50.22 or part 53 of this chapter or an application for a combined license where part one of

the application as described in Sec. 2.101(a)(9) is complete. Part one will not be considered complete unless it contains the information required by Sec. 50.10(d)(3) or Sec. 53.1130(a)(3) of this chapter. Upon assignment of a docket number, the procedures in Sec. 2.101(a)(3) and (4) relating to formal docketing and the submission and distribution of additional copies of the application must be followed. * * * * *

Sec. 2.645 [Amended]

0 30. In Sec. 2.645, in paragraph (a), remove the phrase “Sec. 50.33(a) through (f) of this chapter” and add in its place the phrase “Sec. Sec. 50.33(a) through (f), 53.1109, and 53.1306(a) or Sec. 53.1413 of this chapter, as applicable”.

Sec. 2.649 [Amended]

0 31. In Sec. 2.649, remove the phrase “10 CFR 50.10(d)” and add in its place the phrase “Sec. 50.10(d) or Sec. 53.1130(a) of this chapter”.

Sec. 2.800 [Amended]

0 32. In Sec. 2.800: 0 a. In paragraph (c), remove the phrase “subpart B of part 52” and add in its place the phrase “subpart B of part 52 or subpart H of part 53”; and 0 b. In paragraph (d), remove the phrase “subpart B of part 52” and add in its place the phrase “subpart B of part 52 or subpart H of part 53 of this chapter”.

Sec. 2.801 [Amended]

0 33. In Sec. 2.801, remove the phrase “subpart B of part 52” and add in its place the phrase “subpart B of part 52 or subpart H of part 53”.

Sec. 2.813 [Amended]

0 34. In Sec. 2.813, in paragraph (a), remove the phrase “parts 50, 52, and 100” and add in its place the phrase “parts 50, 52, 53, and 100”.

Sec. 2.1103 [Amended]

0 35. In Sec. 2.1103, remove the phrase “part 50 of this chapter” and add in its place the phrase “part 50 or 53 of this chapter”.

Sec. 2.1200 [Amended]

0 36. In Sec. 2.1200, remove the phrase “parts 30, 32 through 36, 39, 40, 50, 52, 54, 55, 61, 70, and 72 of this chapter,” and add in its place “parts 30, 32 through 36, 39, 40, 50, 52, 53, 54, 55, 61, 70, and 72 of this chapter,”.

0 37. In Sec. 2.1202, revise paragraphs (a)(1) through (3) and (6) to read as follows:

Sec. 2.1202 Authority and role of NRC staff.

(a) * * *

(1) An application to construct and/or operate a production or utilization facility (including an application for a limited work authorization under 10 CFR 50.10 or 53.1130, or an application for a combined license under subpart C of 10 CFR part 52, or under subpart H of 10 CFR part 53;

(2) An application for an early site permit under subpart A of 10 CFR part 52 or under subpart H of 10 CFR part 53;

(3) An application for a manufacturing license under subpart F of 10 CFR part 52 or under subpart H of 10 CFR part 53; * * * * *

(6) Production or utilization facility licensing actions that involve significant hazards considerations as defined in 10 CFR 50.92 or 53.1520. * * * * *

Sec. 2.1301 [Amended]

0 38. In Sec. 2.1301, in paragraph (b), remove “part 50 and part 52” and add in its place “parts 50, 52, and 53”.

Sec. 2.1403 [Amended]

0 39. In Sec. 2.1403, in paragraph (a)(3), remove the phrase “10 CFR 50.92” and add in its place the phrase “10 CFR 50.92 or 53.1520”.

Sec. 2.1500 [Amended]

0 40. In Sec. 2.1500, remove the phrase “subpart B of part 52” and add in its place the phrase “subpart B of part 52 or under subpart H of part 53”.

Sec. 2.1502 [Amended]

0 41. In Sec. 2.1502: 0 a. In paragraph (a), remove the phrase “Sec. 52.51(b)” and add in its place the phrase “Sec. 52.51(b) or Sec. 53.1242(b)(2)”; and 0 b. In paragraph (b)(1), wherever it may appear, remove the phrase “Sec. 52.51(a)” and add in its place the phrase “Sec. 52.51(a) or Sec. 53.1242(b)”.

PART 10--CRITERIA AND PROCEDURES FOR DETERMINING ELIGIBILITY FOR ACCESS TO RESTRICTED DATA OR NATIONAL SECURITY INFORMATION OR AN EMPLOYMENT CLEARANCE

0 42. The authority citation for part 10 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 145, 161 (42 U.S.C. 2165, 2201); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); E.O. 10450, 18 FR 2489, 3 CFR, 1949-1953 Comp., p. 936, as amended; E.O. 10865, 25 FR 1583, 3 CFR, 1959-1963 Comp., p. 398, as amended; E.O. 12968, 60 FR 40245, 3 CFR, 1995 Comp., p. 391.

Sec. 10.1 [Amended]

0 43. In Sec. 10.1, in paragraph (a)(3), remove the phrase “under part 52” and add in its place the phrase “under part 52 or 53”.

Sec. 10.2 [Amended]

0 44. In Sec. 10.2, in paragraph (b), wherever it may appear, remove the phrase “under part 52” and add in its place the phrase “under part 52 or 53”.

PART 11--CRITERIA AND PROCEDURES FOR DETERMINING ELIGIBILITY FOR ACCESS TO OR CONTROL OVER SPECIAL NUCLEAR MATERIAL

0 45. The authority citation for part 11 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 161, 223 (42 U.S.C. 2201, 2273); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note.

Section 11.15(e) also issued under 31 U.S.C. 9701; 42 U.S.C. 2214.

Sec. 11.7 [Amended]

0 46. In Sec. 11.7: 0 a. Revise the introductory text; and 0 b. Remove the first undesignated paragraph.

The revision reads as follows:

Sec. 11.7 Definitions.

Terms defined in parts 10, 25, 50, 53, 70, 72, 73, and 95 of this chapter have the same meaning when used in this part. Also, as used in this part: * * * * *

PART 19--NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION AND INVESTIGATIONS

0 47. The authority citation for part 19 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 53, 63, 81, 103, 104, 161, 223, 234, 1701 (42 U.S.C. 2073, 2093, 2111, 2133, 2134, 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 211, 401 (42 U.S.C. 5841, 5851, 5891); 44 U.S.C. 3504 note.

0 48. In Sec. 19.2, revise paragraph (a) to read as follows:

Sec. 19.2 Scope.

(a) The regulations in this part apply to:

(1) All persons who receive, possess, use, or transfer material licensed by the NRC under the regulations in parts 30 through 36 or part 39, 40, 60, 61, 63, 70, or 72 of this chapter, including persons licensed to operate a production or utilization facility under part 50, 52, or 53 of this chapter, persons licensed to possess power reactor spent fuel in an

independent spent fuel storage installation (ISFSI) under part 72 of this chapter, and in accordance with 10 CFR 76.60 to persons required to obtain a certificate of compliance or an approved compliance plan under part 76 of this chapter;

(2) All applicants for and holders of licenses (including construction permits and early site permits) under parts 50, 52, 53, and 54 of this chapter;

(3) All applicants for and holders of a standard design approval under subpart E of part 52 or under subpart H of part 53 of this chapter; and

(4) All applicants for a standard design certification under subpart B of part 52 or under subpart H of part 53 of this chapter, and those (former) applicants whose designs have been certified under that subpart. * * * * *

0 49. In Sec. 19.3, revise the definitions for “License” and “Regulated entities” to read as follows:

Sec. 19.3 Definitions.

* * * * *

License means a license issued under the regulations in parts 30 through 36 or part 39, 40, 60, 61, 63, 70, or 72 of this chapter, including licenses to manufacture, construct and/or operate a production or utilization facility under part 50, 52, 53, or 54 of this chapter. * * * * *

Regulated entities means any individual, person, organization, or corporation that is subject to the regulatory jurisdiction of the NRC, including (but not limited to) an applicant for or holder of a standard design approval under subpart E of part 52 or under subpart H of part 53 of this chapter or a standard design certification under subpart B of part 52 or under subpart H of part 53 of this chapter. * * * * *

Sec. 19.11 [Amended]

0 50. In Sec. 19.11, in paragraph (a) introductory text, paragraph (b) introductory text, and paragraph (e)(1), wherever it may appear, remove the phrase “of part 52” and add in its place the phrase “of part 52 or under subpart H of part 53”.

Sec. 19.14 [Amended]

0 51. In Sec. 19.14, in paragraph (a), wherever it may appear, remove the phrase “of part 52” and add in its place the phrase “of part 52 or under subpart H of part 53”.

Sec. 19.20 [Amended]

0 52. In Sec. 19.20, remove “parts 30, 40, 50, 52, 54, 60, 61, 63, 70, 72, 76, or 150” and add in its place “part 30, 40, 50, 52, 53, 54, 60, 61, 63, 70, 72, 76, or 150”.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

0 53. The authority citation for part 20 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 11, 53, 63, 65, 81, 103, 104, 161, 170H, 182, 186, 223, 234, 274, 1701 (42 U.S.C. 2014, 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2210h, 2232, 2236, 2273, 2282, 2021, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); Low-Level Radioactive Waste Policy Amendments Act of 1985, sec. 2 (42 U.S.C. 2021b); 44 U.S.C. 3504 note.

Sec. 20.1002 [Amended]

0 54. In Sec. 20.1002, remove “parts 30 through 36, 39, 40, 50, 52, 60, 61, 63, 70, or 72” and add in its place “under parts 30 through 36 or part 39, 40, 50, 52, 53, 60, 61, 63, 70, or 72”.

0 55. In Sec. 20.1003, revise the definition for “License” to read as follows:

Sec. 20.1003 Definitions.

* * * * *

License means a license issued under the regulations in parts 30 through 36 or part 39, 40, 50, 53, 60, 61, 63, 70, or 72 of this chapter. * * * * *

Sec. 20.1101 [Amended]

0 56. In Sec. 20.1101, in paragraph (d): 0 a. Remove “Sec. 20.1101 (b)” and add in its place “paragraph (b) of this section”; 0 b. Remove “of this part”; and 0 c. Remove the phrase “subject to Sec. 50.34a” and add in its place the phrase “subject to Sec. 50.34a or Sec. 53.260 of this chapter”.

Sec. 20.1401 [Amended]

0 57. In Sec. 20.1401: 0 a. In paragraph (a), remove “parts 30, 40, 50, 52, 60, 61, 63, 70, and 72” and add in its place “under parts 30, 40, 50, 52, 53, 60, 61, 63, 70, and 72”; and 0 b. In paragraphs (a) and (c), remove the phrase “in accordance with Sec. 50.83” and add in its place the phrase “in accordance with Sec. 50.83 or Sec. 53.1080”.

0 58. In Sec. 20.1403, revise paragraph (d) introductory text to read as follows:

Sec. 20.1403 Criteria for license termination under restricted conditions.

* * * * *

(d) The licensee has submitted a decommissioning plan or License Termination Plan (LTP) to the Commission indicating the licensee's intent to decommission in accordance with Sec. 30.36(d), Sec. 40.42(d), Sec. 50.82 (a) and (b), subpart G of part 53, Sec. 70.38(d), or Sec. 72.54 of this chapter, and specifying that the licensee intends to decommission by restricting use of the site. The licensee shall document in the LTP or decommissioning plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice. * * * * *

0 59. In Sec. 20.1404, revise paragraph (a)(4) introductory text to read as follows:

Sec. 20.1404 Alternate criteria for license termination.

(a) * * *

(4) Has submitted a decommissioning plan or License Termination Plan (LTP) to the Commission indicating the licensee's intent to decommission in accordance with Sec. 30.36(d), Sec. 40.42(d), Sec. 50.82 (a) and (b), subpart G of part 53, Sec. 70.38(d), or Sec. 72.54 of this chapter, and specifying that the licensee proposes to decommission by use of alternate criteria. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for: * * * * *

Sec. 20.1406 [Amended]

0 60. In Sec. 20.1406, in paragraphs (a) and (b), remove the phrase “under part 52” and add in its place the phrase “under part 52 or 53”.

0 61. In Sec. 20.1501, revise paragraph (b) to read as follows:

Sec. 20.1501 General.

* * * * *

(b) Notwithstanding Sec. 20.2103(a), records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with Sec. 30.35(g), Sec. 40.36(f), Sec. 50.75(g), subpart G of part 53, Sec. 70.25(g), or Sec. 72.30(d) of this chapter, as applicable. * * * * *

Sec. 20.1905 [Amended]

0 62. In Sec. 20.1905, in paragraph (g) introductory text, remove the phrase “Parts 50 or 52” and add in its place the phrase “part 50, 52, or 53”.

0 63. In Sec. 20.2004, revise paragraph (b)(1) to read as follows:

Sec. 20.2004 Treatment or disposal by incineration.

* * * * *

(b)(1) Waste oils (petroleum derived or synthetic oils used principally as lubricants, coolants, hydraulic or insulating fluids, or metalworking oils) that have been radioactively contaminated in the course of the operation or maintenance of a nuclear power reactor licensed under part 50 or 53 of this chapter may be incinerated on the site where generated provided that the total radioactive effluents from the facility, including the effluents from such incineration, conform to the requirements of appendix I to part 50 or Sec. 53.425(c) of this chapter and the effluent release limits contained in applicable license conditions other than effluent limits specifically related to incineration of waste oil. The licensee shall report any changes or additions to the information supplied under Sec. 50.34 or Sec. 50.34a or under subpart H of part 53 of this chapter associated with this incineration pursuant to Sec. 50.71 or Sec. 53.1620 of this chapter, as appropriate. The licensee shall also follow the procedures of Sec. 50.59 or Sec. 53.1565 of this chapter with respect to such changes to the facility or procedures. * * * * *

0 64. In Sec. 20.2201, revise paragraphs (a)(2)(i), (b)(2)(i), and (c) to read as follows:

Sec. 20.2201 Reports of theft or loss of licensed material.

(a) * * *

(2) * * *

(i) Licensees having an installed Emergency Notification System shall make the reports to the NRC Operations Center under Sec. 50.72 or Sec. 53.1630 of this chapter, and * * * * *

(b) * * *

(2) * * *

(i) For holders of an operating license for a nuclear power plant, the events included in paragraph (b) of this section must be reported under the procedures described in Sec. 50.73(b) through (e) and (g) or Sec. 53.1640(b) through (e) of this chapter and must include the information required in paragraph (b)(1) of this section; and * * * * *

(c) A duplicate report is not required under paragraph (b) of this section if the licensee is also required to submit a report pursuant to Sec. 30.55(c), Sec. 37.57, Sec. 37.81, Sec. 40.64(c), Sec. 50.72, Sec. 50.73, Sec. 53.1630, Sec. 53.1640, Sec. 70.52, Sec. 73.27(b), Sec. 73.67(e)(3)(vii) or (g)(3)(iii), Sec. 73.1205, or Sec. 150.19(c) of this chapter. * * * * *

Sec. 20.2202 [Amended]

0 65. In Sec. 20.2202, in paragraph (d)(1), remove the phrase “10 CFR 50.72” and add in its place the phrase “Sec. 50.72 or Sec. 53.1630 of this chapter;”.

0 66. In Sec. 20.2203, revise paragraph (c) to read as follows:

Sec. 20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or limits.

* * * * *

(c) For holders of an operating license or a combined license for a nuclear power plant, the occurrences included in paragraph (a) of this section must be reported under the procedures described in Sec. 50.73(b) through (e) and (g) or Sec. 53.1640(b) through (e) of this chapter, and must include the information required by paragraph (b) of this section. Occurrences reported under Sec. 50.73 or Sec. 53.1640 of this chapter need not be reported by a duplicate report under paragraph (a) of this section. * * * * *

Sec. 20.2206 [Amended]

0 67. In Sec. 20.2206, in paragraph (a)(1), remove the phrase “or Sec. 50.22” and add in its place the phrase “or Sec. 50.22 or part 53”.

PART 21--REPORTING OF DEFECTS AND NONCOMPLIANCE

0 68. The authority citation for part 21 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 53, 63, 81, 103, 104, 161, 223, 234, 1701 (42 U.S.C. 2073, 2093, 2111, 2133, 2134, 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.

0 69. In Sec. 21.2, revise paragraphs (a)(2) through (4), (b), and (c) to read as follows:

Sec. 21.2 Scope.

(a) * * *

(2) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, that constructs a production or utilization facility licensed for manufacture, construction, or operation under part 50, 52, or 53 of this chapter, an ISFSI for the storage of spent fuel licensed under part 72 of this chapter, an MRS for the storage of spent fuel or high-level radioactive waste under part 72 of this chapter, or a geologic repository for the disposal of high-level radioactive waste under part 60 or 63 of this chapter; or supplies basic components for a facility or activity licensed, other than for export, under part 30, 40, 50, 52, 53, 60, 61, 63, 70, 71, or 72 of this chapter;

(3) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, applying for a design certification rule under part 52 or 53 of this chapter; or supplying basic components with respect to that design certification, and each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, whose application for design certification has been granted under part 52 or 53 of this chapter, or who has supplied or is supplying basic components with respect to that design certification;

(4) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, applying for or holding a standard design approval under part 52 or 53 of this chapter; or supplying basic components with respect to a standard design approval under part 52 or 53 of this chapter;

(b) For persons licensed to construct a facility under either a construction permit issued under Sec. 50.23 or Sec. 53.1333 of this chapter or a combined license under part 52 or 53 of this chapter (for the period of construction until the date that the Commission makes the finding under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter), or to manufacture a facility under part 52 or 53 of this chapter, evaluation of potential defects and failures to comply and reporting of defects and failures to comply under Sec. 50.55(e) or Sec. 53.605 of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects and failures to comply under this part and the responsibility of individual directors and responsible officers of these licensees to report defects under section 206 of the Energy Reorganization Act of 1974.

(c) For persons licensed to operate a nuclear power plant under part 50, 52, or 53 of this chapter, evaluation of potential defects and appropriate reporting of defects under Sec. 50.72, Sec. 50.73, Sec. 53.1630, Sec. 53.1640, or Sec. Sec. 73.1200 and 73.1205 of this chapter, satisfies each person's evaluation, notification, and reporting obligation to report defects under this part, and the responsibility of individual directors

and responsible officers of these licensees to report defects under Section 206 of the Energy Reorganization Act of 1974. * * * * *

0 70. In Sec. 21.3, revise the definitions for “Basic component”, “Commercial grade item”, “Critical characteristics”, “Dedicating entity”, “Dedication”, “Defect”, and “Substantial safety hazard” to read as follows:

Sec. 21.3 Definitions.

* * * * *

Basic component. (1)(i) When applied to nuclear power plants licensed under part 53 of this chapter, basic component means a safety- related structure, system, or component (SSC), or part thereof, and when applied to nuclear power plants licensed under part 50 or 52 of this chapter, basic component means an SSC, or part thereof, that affects its safety function necessary to assure:

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

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

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

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

(2) When applied to standard design certifications and approvals under part 53 of this chapter, basic component means the design or procurement information approved or to be approved within the scope of the design certification or approval for a safety-related SSC, or part thereof. When applied to standard design certifications under subpart B of part 52 of this chapter and standard design approvals under part 52 of this chapter, basic component means the design or procurement information approved or to be approved within the scope of the design certification or approval for an SSC, or part thereof, that affects its safety function necessary to assure:

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

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

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

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

(4) In all cases, basic component includes safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware, design certification, design approval, or information in support of an early site permit application under part 52 or 53 of this chapter, whether these services are performed by the component supplier or others.

Commercial grade item. (1) When applied to nuclear power plants licensed under part 50 or 53 of this chapter, commercial grade item means an SSC, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical characteristics of the item cannot be verified).

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

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

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

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

Critical characteristics. When applied to nuclear power plants licensed under part 50, 52, or 53 of this chapter, critical characteristics are those important design, material, and performance characteristics of a commercial grade item that, once verified, will provide reasonable assurance that the item will perform its intended safety function.

Dedicating entity. When applied to nuclear power plants licensed under part 50, 52, or 53 of this chapter, dedicating entity means the organization that performs the dedication process. Dedication may be performed by the manufacturer of the item, a third-party dedicating entity, or the licensee itself. The dedicating entity, under Sec. 21.21(c), is responsible for identifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintaining auditable records of the dedication process.

Dedication. (1) When applied to nuclear power plants licensed pursuant to part 30, 40, 50, 53, or 60 of this chapter, dedication is an acceptance process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended safety function and, in this respect, is deemed equivalent to an item designed and manufactured under a quality assurance program under appendix B to part 50 of this chapter. This assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspections, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial grade surveys; product inspections or witness at holdpoints at the manufacturer's facility, and analysis of historical records for acceptable performance. In all cases, the dedication process must be conducted under the applicable provisions of appendix B to part 50. The process is considered complete when the item is designated for use as a basic component.

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

Defect means:

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

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

(3) A deviation in a portion of a facility subject to the early site permit, standard design certification, standard design approval, construction permit,

combined license or manufacturing licensing requirements of part 50, 52, or 53 of this chapter, provided the deviation could, on the basis of an evaluation, create a substantial safety hazard and the portion of the facility containing the deviation has been offered to the purchaser for acceptance;

(4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued under part 50, 52, or 53 of this chapter; or

(5) An error, omission or other circumstance in a design certification, or standard design approval that, on the basis of an evaluation, could create a substantial safety hazard. * * * * *

Substantial safety hazard means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to public health and safety for any facility or activity licensed or otherwise approved or regulated by the NRC, other than for export, under part 30, 40, 50, 52, 53, 60, 61, 63, 70, 71, or 72 of this chapter. * * * * *

Sec. 21.21 [Amended]

0 71. In Sec. 21.21: 0 a. In paragraphs (a)(3) introductory text and (a)(3)(i), remove the phrase “under part 52” and add in its place the phrase “under part 52 or 53”; and 0 b. In paragraphs (d)(1)(i) and (ii), remove “parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72” and add “part 30, 40, 50, 52, 53, 60, 61, 63, 70, 71, or 72” in its place.

Sec. 21.51 [Amended]

0 72. In Sec. 21.51, in paragraphs (a)(4) and (5), remove the phrase “of part 52” and add in its place the phrase “of part 52 or under subpart H of part 53”.

Sec. 21.61 [Amended]

0 73. In Sec. 21.61, in paragraph (b), remove the phrase “under part 52” wherever it may appear and add in its place the phrase “under part 52 or 53”.

PART 25--ACCESS AUTHORIZATION

0 74. The authority citation for part 25 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 145, 161, 223, 234 (42 U.S.C. 2165, 2201, 2273, 2282); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note; E.O. 10865, 25 FR 1583, as amended, 3 CFR, 1959-1963 Comp., p. 398; E.O. 12829, 58 FR 3479, 3 CFR, 1993 Comp., p. 570; E.O. 13526, 75 FR 707, 3 CFR, 2009 Comp., p. 298; E.O. 12968, 60 FR 40245, 3 CFR, 1995 Comp., p. 391. Section 25.17(f) and Appendix A also issued under 31 U.S.C. 9701; 42 U.S.C. 2214.

0 75. In Sec. 25.5, revise the definition for “License” to read as follows:

Sec. 25.5 Definitions.

* * * * *

License means a license issued pursuant to part 50, 52, 53, 60, 63, 70, or 72 of this chapter. * * * * *

Sec. 25.17 [Amended]

0 76. In Sec. 25.17, in paragraph (a), remove “10 CFR parts 50, 52, 54, 60, 63, 70, 72, or 76” and add in its place “part 50, 52, 53, 54, 60, 63, 70, 72, or 76 of this chapter”.

Sec. 25.35 [Amended]

0 77. In Sec. 25.35, in paragraph (a), wherever it may appear, remove the phrase “under part 52” and add in its place the phrase “under part 52 or 53”.

PART 26--FITNESS FOR DUTY PROGRAMS

0 78. The authority citation for part 26 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 53, 103, 104, 107, 161, 223, 234, 1701 (42 U.S.C. 2073, 2133, 2134, 2137, 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); 44 U.S.C. 3504 note.

0 79. In Sec. 26.3, revise paragraph (d) and add paragraph (f) to read as follows:

Sec. 26.3 Scope.

* * * * *

(d) Contractor/vendors (C/Vs) who implement FFD programs or program elements, to the extent that the licensees and other entities specified in paragraphs (a) through (c) and (f) of this section rely on those C/V FFD programs or program elements to meet the requirements of this part, shall comply with the requirements of this part. * * * * *

(f) No later than the start of construction activities, licensees and other entities that have applied for or have been issued a license under part 53 of this chapter, other than a manufacturing license (ML), must implement the requirements in subpart M of this part or all the requirements of this part except subparts K and M. Holders of an ML under part 53 of this chapter must implement the requirements in subpart M or all the requirements of this part except subparts K and M, before commencing activities that assemble a manufactured reactor.

0 80. In Sec. 26.4, revise paragraphs (a) introductory text, (a)(1) and (4), (b), (c), (e) introductory, (e)(4), (f), (g) introductory text, and (h) to read as follows:

Sec. 26.4 FFD program applicability to categories of individuals.

(a) All persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in Sec. 26.3(a) and, as applicable, (c) and perform the following duties shall be subject to an FFD program that meets all of the requirements of this part, except subparts K and M of this part, and those persons who are granted unescorted access to either nuclear power reactor protected areas or remote facilities where safety-significant systems or components may be operated within the design basis of a licensed commercial nuclear plant, by the licensees and other entities in Sec. 26.3(f) and perform the following duties must be subject to an FFD program that satisfies the requirements in subpart M of this part, unless the licensee or other entity subjects these individuals to an FFD program that satisfies all of the requirements of this part except for those requirements in subparts K and M:

(1) For persons who are granted unescorted access by the licensees in Sec. 26.3(a) and, as applicable, (c), operating or onsite directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety; for those persons who are granted unescorted access by the licensees and other entities in Sec. 26.3(f), operating or directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety; * * * * *

(4) For persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in Sec. 26.3(a) and, as applicable, (c), performing maintenance or onsite directing of the maintenance of SSCs that a risk-informed evaluation process has shown to be significant to public health and safety; for those persons who are granted unescorted access to nuclear power reactor protected areas by the licensees and other entities in Sec. 26.3(f), performing maintenance or directing of the maintenance of SSCs that a risk- informed evaluation process has shown to be significant to public health and safety; and * * * * *

(b) All persons who are granted unescorted access to nuclear power reactor protected areas by the licensees

in Sec. 26.3(a) and, as applicable, (c) and who do not perform the duties described in paragraph (a) of this section shall be subject to an FFD program that meets all of the requirements of this part, except Sec. Sec. 26.205 through 26.209 and subparts K and M of this part. All persons who are granted unescorted access to a facility licensed under part 53 of this chapter, and who do not perform or direct the performance of the duties described in paragraph (a) of this section, must be subject to the requirements in subpart M of this part, unless the licensee or other entity implements an FFD program that satisfies all of the requirements of this part, except Sec. Sec. 26.205 through 26.209 and subparts K and M.

(c) All persons who are required by a licensee in Sec. 26.3(a) and, as applicable, (c) to physically report to the licensee's Technical Support Center or Emergency Operations Facility by licensee emergency plans and procedures shall be subject to an FFD program that meets all of the requirements of this part, except Sec. Sec. 26.205 through 26.209 and subparts K and M of this part. Also, for licensees or other entities in Sec. 26.3(f), all persons without unescorted access to the facility who make decisions and/or direct actions regarding plant safety and security, and all persons who participate remotely in emergency response activities or physically report to the Technical Support Center or Emergency Operations Facility (or an equivalent facility), must be subject to an FFD program that satisfies all of the requirements described in subpart M of this part, unless the licensee or other entity implements an FFD program that satisfies all of the requirements of this part, except Sec. Sec. 26.205 through 26.209 and subparts K and M. * * * * *

(e) When construction activities, as defined in Sec. 26.5, begin, any individual whose duties for the licensees and other entities in Sec. 26.3(c) require him or her to have the following types of access or perform the following activities at the location where the nuclear power plant will be constructed and operated shall be subject to an FFD program that meets all of the requirements of this part, except subparts I, K, and M of this part, and for any individual whose duties for the licensees and other entities in Sec. 26.3(f) require him or her to have the following types of access, perform construction activities as defined in Sec. 26.5, or perform the following activities must be subject to an FFD program as described in subpart M or an FFD program that satisfies all of the requirements of this part, except subparts I, K, and M: * * * * *

(4) Witnesses or determines inspections, tests, and analyses certification required under part 52 or 53 of this chapter; * * * * *

(f) Any individual who is constructing or directing the construction of safety- or security-related SSCs shall be subject to an FFD program that meets the requirements of subpart K, or, if applicable, subpart M of this part, unless the licensee or other entity subjects these individuals to an FFD program that meets all of the requirements of this part, except for subparts I, K, and M of this part.

(g) All FFD program personnel who are involved in the day-to-day operations of the program, as defined by the procedures of the licensees and other entities in Sec. 26.3(a) through (c), and, as applicable, (d) and whose duties require them to have the following types of access or perform the following activities shall be subject to an FFD program that meets all of the requirements of this part, except subparts I, K, and M of this part, and, at the licensee's or other entity's discretion, subpart C of this part. All personnel whose duties require them to have the following types of access or perform the following activities at facilities licensed under part 53 of this chapter must be subject to the requirements in subpart M or an FFD program that satisfies all of the requirements of this part, except subparts I, K, and M, and, at the licensee's or other entity's discretion, subpart C of this part: * * * * *

(h) Individuals who have applied for authorization to have the types of access or perform the activities described in paragraphs (a) through (d) of this section shall be subject to Sec. Sec. 26.31(c)(1), 26.35(b), 26.37, and 26.39, and the applicable requirements of subparts C, E through H, and M of this part. * * * * *

0 81. Amend Sec. 26.5 by: 0 a. Adding the definitions for “Biological marker”, “Change”, and “Consortium/Third party administrator (C/TPA)” in alphabetical order; 0 b. Revising the definition for “Constructing or construction activities” and “Contractor/vendor (C/V)”; 0 c. Adding the definition of “Illicit substance” in alphabetical order; 0 d. Revising the definition of “Other entity”; 0 e. Adding the definition of “Reduction in FFD program effectiveness” in alphabetical order; 0 f. Revising the definitions of “Reviewing official”, “Safety-related structures, systems, and components (SSCs)”, and “Security-related SSCs”; 0 g. Adding the definition of “Special nuclear material (SNM)” in alphabetical order; and 0 h. Revising the definition of “Unit outage”.

The additions and revisions read as follows:

Sec. 26.5 Definitions.

* * * * *

Biological marker means, for a part 53 licensee implementing subpart M of this part, an endogenous substance that is used to validate that the biological specimen collected for testing was produced by the donor. * * * * *

Change as used in Sec. 26.603(e) means an action that results in a modification of, addition to, or removal from the licensee's or other entity's FFD program. * * * * *

Consortium/Third-party administrator (C/TPA) means a contractor/ vendor that provides or coordinates one or more FFD program elements for a group of licensees or other entities, such as administering a collective random testing pool and random testing selections under Sec. 26.607(b)(2)(vi), that otherwise could not be independently implemented by those licensees or other entities. A C/TPA also could provide access to, for example, the services of medical review officers, substance abuse experts, employee assistance programs, and HHS-certified laboratories under contract to perform drug testing.

Constructing or construction activities means, for the purposes of this part, the tasks involved in building a nuclear power plant that are performed at the location where the nuclear power plant will be constructed and operated. These tasks include fabricating, erecting, integrating, and testing safety- and security-related SSCs, and the installation of their foundations, including the placement of concrete. For a licensee or other entity described in Sec. 26.3(f), construction is defined in Sec. 53.020 of this chapter.

Contractor/vendor (C/V) means any company, or any individual not employed by a licensee or other entity specified in Sec. 26.3(a) through (c) and (f), who is providing work or services to a licensee or other entity covered in Sec. 26.3(a) through (c) and (f), either by contract, purchase order, oral agreement, or other arrangement. * * * * *

Illicit substance means a substance that causes impairment and possible addiction but is not an illegal drug as defined in this section. * * * * *

Other entity means any corporation, firm, partnership, limited liability company, association, C/V, or other organization who is subject to this part under Sec. 26.3(a) through (c) and (f) but is not licensed by the NRC. * * * * *

Reduction in FFD program effectiveness means, for a part 53 licensee or other entity implementing subpart M of this part, a change or series of changes to an element of the FFD program that reduces or eliminates the licensee's ability to satisfy or maintain site-specific FFD program performance when compared to historical site-specific performance, the licensee's fleet-level program performance, or industry performance. * * * * *

Reviewing official means an employee of a licensee or other entity specified in Sec. 26.3(a) through (c) and (f), who is designated by the licensee or other entity to be responsible for reviewing and evaluating any potentially disqualifying FFD information about an individual, including, but not limited to, the results of a determination of fitness, as defined in Sec. 26.189, in order to determine whether the individual may be granted or maintain authorization.

Safety-related structures, systems, and components (SSCs) means, for part 50 or 52 licensees and other entities described in Sec. 26.3(a) through (d), those SSCs that are relied on to remain functional during and following design-basis events to ensure the integrity of the reactor coolant pressure boundary, the capability to shut down the reactor and maintain it in a safe shutdown condition, or the capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposure comparable to the guidelines in Sec. 50.34(a)(1) of this chapter. For part 53 licensees and other entities described in Sec. 26.3(d) and (f), safety-related has the same meaning as that in Sec. 53.020 of this chapter.

Security-related SSCs means, for the purposes of this part, those structures, systems, and components that the licensee will rely on to implement the licensee's physical security and safeguards contingency plans that either are required under part 73 of this chapter if the licensee is a construction permit applicant or holder or an early site permit holder, as described in Sec. 26.3(c)(3) through (5), respectively, or are included in the licensee's application if the licensee is a combined license applicant or holder, as described in Sec. 26.3(c)(1) and (2), respectively, or a licensee or other entity described in Sec. 26.3(d) or (f). * * * * *

Special nuclear material (SNM) has the same meaning as that in Sec. 70.4 of this chapter. * * * * *

Unit outage means, for the purposes of this part, for electricity- generation units, that the reactor unit is disconnected from the electrical grid. Unit outage means, for the purposes of this part, for non-electricity-generation units, that the reactor unit is disconnected from the loads to which its output is supplied under normal operating conditions. * * * * *

0 82. In Sec. 26.8, revise paragraph (b) to read as follows:

Sec. 26.8 Information collection requirements: OMB approval.

* * * * *

(b) The approved information collection requirements contained in this part appear in Sec. Sec. 26.9, 26.27, 26.29, 26.31, 26.33, 26.35, 26.37, 26.39, 26.41, 26.53, 26.55, 26.57, 26.59, 26.61, 26.63, 26.65, 26.67, 26.69, 26.75, 26.77, 26.85, 26.87, 26.89, 26.91, 26.93, 26.95, 26.97, 26.99, 26.101, 26.103, 26.107, 26.109, 26.111, 26.113, 26.115, 26.117, 26.119, 26.125, 26.127, 26.129, 26.135, 26.137, 26.139, 26.153, 26.157, 26.159, 26.163, 26.165, 26.167, 26.168, 26.169, 26.183, 26.185, 26.187, 26.189, 26.202, 26.203, 26.205, 26.207, 26.211, 26.401, 26.403, 26.405, 26.406, 26.407, 26.411, 26.413, 26.415, 26.417, 26.603, 26.605, 26.606, 26.607, 26.608, 26.609, 26.611, 26.613, 26.617, 26.619, 26.711, 26.713, 26.715, 26.717, 26.719, and 26.821.

0 83. Revise Sec. 26.21 to read as follows:

Sec. 26.21 Fitness-for-duty program.

The licensees and other entities specified in Sec. 26.3(a) through (c) and (f) (for those licensees and other entities that do not implement the requirements in subparts M and K of this part) shall establish, implement, and maintain FFD programs that, at a minimum, comprise the program elements contained in this subpart. The individuals specified in Sec. 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, Sec. 26.4(f), and, if necessary, Sec. 26.4(j) shall be subject to these FFD programs. Licensees and other entities may rely on the FFD program or program elements of a C/V, as defined in Sec. 26.5, if the C/V's FFD program or program elements satisfy the applicable requirements of this part.

0 84. In Sec. 26.35, revise paragraph (c)(3) to read as follows:

Sec. 26.35 Employee assistance programs.

* * * * *

(c) * * *

(3) If a licensee or other entity receives a report from EAP personnel under paragraph (c)(2) of this section, the licensee or other entity must ensure that the requirements of Sec. Sec. 26.69(d) and 26.77(b), or the procedures and actions required by Sec. 26.606(b)(2)(vii) are implemented, as applicable.

0 85. Revise Sec. 26.51 to read as follows:

Sec. 26.51 Applicability.

The requirements in this subpart apply to the licensees and other entities identified in Sec. 26.3(a), (b), and, as applicable, (c) for the categories of individuals in Sec. 26.4(a) through (d), and, at the licensee's or other entity's discretion, in Sec. 26.4(g) and, if necessary, Sec. 26.4(j). The requirements in this subpart also apply to the licensees and other entities specified in Sec. 26.3(c), as applicable, for the categories of individuals in Sec. 26.4(e). At the discretion of a licensee or other entity in Sec. 26.3(c), the requirements of this subpart also may be applied to the categories of individuals identified in Sec. 26.4(f). In addition, the requirements in this subpart apply to the entities in Sec. 26.3(d) to the extent that a licensee or other entity relies on the C/V to satisfy the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in Sec. 26.4(h). The requirements in this subpart apply to the FFD programs of licensees and other entities identified in Sec. 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in Sec. 26.4 and those licensees and other entities that elect to implement the requirements in Sec. 26.605.

Sec. 26.53 [Amended]

0 86. In Sec. 26.53: 0 a. In paragraph (e), wherever it may appear, remove the phrase “Sec. 26.3(a) through (c)” and add in its place the phrase “Sec. 26.3(a) through (c) and (f)”; 0 b. In paragraph (g) and paragraph (h) introductory text, remove the phrase “(c) and (d)” and add in its place the phrase “(c), (d), and (f)”; and 0 c. In paragraph (i) introductory text, remove the phrase “(c) and(d)” and add in its place the phrase “(c), (d), and (f)”.

Sec. 26.63 [Amended]

0 87. In Sec. 26.63, in paragraph (d), remove the phrase “Sec. 26.3(a) through

(d)” and add in its place the phrase “Sec. 26.3(a) through (d) and (f)”.

0 88. Revise Sec. 26.73 to read as follows:

Sec. 26.73 Applicability.

The requirements in this subpart apply to the licensees and other entities identified in Sec. 26.3(a), (b), and, as applicable, (c) for the categories of individuals specified in Sec. 26.4(a) through (d) and (g). The requirements in this subpart also apply to the licensees and other entities specified in Sec. 26.3(c), as applicable, for the categories of individuals in Sec. 26.4(e). At the discretion of a licensee or other entity in Sec. 26.3(c), the requirements of this subpart also may be applied to the categories of individuals identified in Sec. 26.4(f). In addition, the requirements in this subpart apply to the entities in Sec. 26.3(d) to the extent that a licensee or other entity relies on the C/V to satisfy the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in Sec. 26.4(h) and (j), as appropriate. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in Sec. 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in Sec. 26.4 and those licensees and other entities that elect to implement the requirements in Sec. 26.605(b).

0 89. Revise Sec. 26.81 to read as follows:

Sec. 26.81 Purpose and applicability.

This subpart contains requirements for collecting specimens for drug testing and conducting alcohol tests by or on behalf of the licensees and other entities in Sec. 26.3(a) through (d) for the categories of individuals specified in Sec. 26.4(a) through (d) and (g). At the discretion of a licensee or other entity in Sec. 26.3(c), specimen collections and alcohol tests must be conducted either under this subpart for the individuals specified in Sec. 26.4(e) and (f) or the licensee or other entity may rely on specimen collections and alcohol tests conducted under the requirements of 49 CFR part 40 for the individuals specified in Sec. 26.4(e) and (f). The requirements of this subpart do not apply to specimen collections and alcohol tests that are conducted under the requirements of 49 CFR part 40, as permitted in this section and under Sec. Sec. 26.4(j) and 26.31(b)(2) and subpart K of this part. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in Sec. 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in Sec. 26.4 and those licensees and other entities that elect to implement the requirements in Sec. 26.605.

0 90. In Sec. 26.97, revise paragraph (a) introductory text and paragraph (b) introductory text to read as follows:

Sec. 26.97 Collecting oral fluid specimens for alcohol and drug testing.

(a) The collector, with the assistance of a virtual collection monitor as permitted under Sec. 26.607(g)(2) if applicable, shall perform the oral fluid specimen collection consistent with the device manufacturer's instructions. The collector shall: * * * * *

(b) If all steps in paragraph (a) of this section could not be completed successfully (e.g., the device breaks, the device is dropped on the floor, the device fails to activate), the collector, with the assistance of a virtual collection monitor as permitted under Sec. 26.607(g)(2) if applicable, shall: * * * * *

0 91. Revise Sec. 26.201 to read as follows:

Sec. 26.201 Applicability.

(a) The requirements in this subpart, with the exception of Sec. 26.202, apply to the licensees and other entities identified in Sec. 26.3(a); if applicable, (c), (d), and (f), for licensees and other entities not implementing the requirements in subparts K and M. For the licensees and other entities to whom the requirements in this subpart, with the exception of Sec. 26.202, apply, the requirements in Sec. Sec. 26.203 and 26.211 apply to the individuals identified in Sec. 26.4(a) through (c). In addition, the requirements in Sec. 26.205 through Sec. 26.209 apply to the individuals identified in Sec. 26.4(a).

(b) The requirements in this subpart, with the exception of Sec. 26.203, apply to the licensees or other entities identified in Sec. 26.3(f) implementing this subpart under Sec. 26.605. For these licensees and other entities, the requirements in Sec. Sec. 26.202 and 26.211 apply to the individuals identified in Sec. 26.4(a) through (c) and any person licensed to operate under 10 CFR part 53; and the requirements in Sec. Sec. 26.205 through 26.209 apply to the individuals identified in Sec. 26.4(a).

0 92. Add Sec. 26.202 to read as follows:

Sec. 26.202 General provisions for facilities licensed under 10 CFR part 53.

(a) Policy. Licensees must establish a policy for the management of fatigue for all individuals who are subject to the licensee's FFD program and incorporate it into the written policy required in Sec. 26.606(a).

(b) Procedures. In addition to the procedures required in Sec. 26.606(b), licensees must develop, implement, and maintain procedures that--

(1) Describe the process to be followed when any individual identified in Sec. 26.4(a) through (c) makes a self-declaration that he or she is not fit to safely and competently perform his or her duties for any part of a working tour as a result of fatigue. The procedure must--

(i) Describe the individual's and licensee's rights and responsibilities related to self-declaration;

(ii) Describe requirements for establishing controls and conditions under which an individual may be permitted or required to perform work after that individual declares that he or she is not fit due to fatigue; and

(iii) Describe the process to be followed if the individual disagrees with the results of a fatigue assessment that is required under Sec. 26.211(a)(2);

(2) Describe the process for implementing the controls required under Sec. 26.205 for the individuals who are performing the duties listed in Sec. 26.4(a);

(3) Describe the process to be followed in conducting fatigue assessments under Sec. 26.211; and

(4) Describe the disciplinary actions that the licensee may impose on an individual following a fatigue assessment, and the conditions and considerations for taking those disciplinary actions.

(c) Training and assessments. Licensees must include the following KAs in the content of the training and trainee assessments required in Sec. 26.608:

(1) Knowledge of the contributors to worker fatigue, circadian variations in alertness and performance, indications and risk factors for common sleep disorders, shiftwork strategies for obtaining adequate rest, and the effective use of fatigue countermeasures; and

(2) Ability to identify symptoms of worker fatigue and contributors to decreased alertness in the workplace.

(d) Recordkeeping. Licensees must retain the following records for at least 3 years or until the completion of all related legal proceedings, whichever is later:

(1) Records of work hours for individuals who are subject to the work hour controls in Sec. 26.205;

(2) For licensees implementing the requirements of Sec. 26.205(d)(3), records of shift schedules and shift cycles, or, for licensees implementing the requirements of Sec. 26.205(d)(7), records of shift schedules and records showing the beginning and end times and dates of all averaging periods, of individuals

who are subject to the work hour controls in Sec. 26.205;

(3) The documentation of waivers that is required in Sec. 26.207(a)(4), including the bases for granting the waivers;

(4) The documentation of work hour reviews that is required in Sec. 26.205(e)(3) and (e)(4); and

(5) The documentation of fatigue assessments that is required in Sec. 26.211(g).

(e) Reporting. Licensees must include the following information in a standard format in the annual FFD program performance report required under Sec. 26.617(b)(2):

(1) A summary for each nuclear power plant site of all instances during the previous calendar year when the licensee waived one or more of the work hour controls specified in Sec. 26.205(d)(1) through (d)(5)(i) and (d)(7) for individuals described in Sec. 26.4(a). The summary must include only those waivers under which work was performed. If it was necessary to waive more than one work hour control during any single extended work period, the summary of instances must include each of the work hour controls that were waived during the period. For each category of individuals specified in Sec. 26.4(a), the licensee must report--

(i) The number of instances when each applicable work hour control specified in Sec. 26.205(d)(1)(i) through (iii), (d)(2)(i) and (ii), (d)(3)(i) through (v), and (d)(7) was waived for individuals not working on outage activities;

(ii) The number of instances when each applicable work hour control specified in Sec. 26.205(d)(1)(i) through (iii), (d)(2)(i) and (ii), (d)(3)(i) through (v), (d)(4), (d)(5)(i), and (d)(7) was waived for individuals working on outage activities; and

(iii) A summary that shows the distribution of waiver use among the individuals applicable within each category of individuals identified in Sec. 26.4(a) (e.g., a table that shows the number of individuals who received only one waiver during the reporting period, the number of individuals who received a total of two waivers during the reporting period).

(2) A summary of corrective actions, if any, resulting from the analyses of these data, including fatigue assessments.

(f) Audits. Licensees must audit the management of worker fatigue under Sec. 26.615.

0 93. In Sec. 26.205, revise paragraphs (d)(7)(iii) and (d)(8) to read as follows:

Sec. 26.205 Work hours.

* * * * *

(d) * * *

(7) * * *

(iii) Each licensee shall state, in its FFD policy and procedures required by either Sec. Sec. 26.27 and 26.203(a) and (b) or Sec. Sec. 26.202(a) and (b) and 26.606, the work hour counting system in paragraph (d)(7)(ii) of this section the licensee is using.

(8) Each licensee shall state, in its FFD policy and procedures required by either Sec. Sec. 26.27 and 26.203(a) and (b) or Sec. Sec. 26.202(a) and (b) and 26.606, the requirements with which the licensee is complying: the minimum days off requirements in paragraph (d)(3) of this section or maximum average work hours requirements in paragraph (d)(7) of this section. * * * * *

0 94. In Sec. 26.207, revise paragraph (a)(1)(ii) to read as follows:

Sec. 26.207 Waivers and exceptions.

(a) * * *

(1) * * *

(ii) A supervisor assesses the individual face-to-face and determines that there is reasonable assurance that the individual will be able to safely and competently perform his or her duties during the additional work period for which the waiver will be granted. The supervisor performing the assessment shall be trained as required by either Sec. Sec. 26.29 and 26.203(c) or Sec. Sec. 26.202(c) and 26.608 and shall be qualified to direct the work to be performed by the individual. If there is no supervisor on site who is qualified to direct the work, the assessment may be performed by a supervisor who is qualified to provide oversight of the work to be performed by the individual. At a minimum, the assessment must address the potential for acute and cumulative fatigue considering the individual's work history for at least the past 14 days, the potential for circadian degradations in alertness and performance considering the time of day for which the waiver will be granted, the potential for fatigue-related degradations in alertness and performance to affect risk-significant functions, and whether any controls and conditions must be established under which the individual will be permitted to perform work. For licensees and other entities in Sec. 26.3(f), the assessment may be performed remotely using electronic communications. In such instances, the assessment must be supported by someone who is present in-person with the individual whose alertness may be impaired, and that supporting person must be trained under the requirements of either Sec. Sec. 26.29 and 26.203(c) or Sec. Sec. 26.202(c) and 26.608. * * * * *

0 95. In Sec. 26.211, revise paragraphs (a)(1) and (3) and paragraph (b) introductory text to read as follows:

Sec. 26.211 Fatigue assessments.

(a) * * *

(1) For-cause. In addition to any other test or determination of fitness that may be required under Sec. Sec. 26.31(c), 26.77, 26.607(b), and 26.619, a fatigue assessment must be conducted in response to an observed condition of impaired individual alertness creating a reasonable suspicion that an individual is not fit to safely and competently perform his or her duties, except if the condition is observed during an individual's break period. If the observed condition is impaired alertness with no other behaviors or physical conditions creating a reasonable suspicion of possible substance abuse, then the licensee need only conduct a fatigue assessment. If the licensee has reason to believe that the observed condition is not due to fatigue, the licensee need not conduct a fatigue assessment; * * * * *

(3) Post-event. A fatigue assessment must be conducted in response to events requiring post-event drug and alcohol testing as specified in Sec. 26.31(c) or post-event tests in Sec. 26.607(b)(4). Licensees may not delay necessary medical treatment in order to conduct a fatigue assessment; and * * * * *

(b) Only supervisors and FFD program personnel who are trained under either Sec. Sec. 26.29 and 26.203(c) or Sec. Sec. 26.202(c) and 26.608 may conduct a fatigue assessment. The fatigue assessment must be conducted face-to-face with the individual whose alertness may be impaired. For licensees and other entities in Sec. 26.3(f), a fatigue assessment may be performed remotely using electronic communications. In such instances, the fatigue assessment must be supported by someone who is present in-person with the individual whose alertness may be impaired, and that supporting person must be trained in accordance with the requirements of either Sec. Sec. 26.29 and 26.203(c) or Sec. Sec. 26.202(c) and 26.608. * * * * *

0 96. Add subpart M, consisting of Sec. Sec. 26.601 through 26.619, to read as follows:

Subpart M--Fitness-for-Duty Programs for Facilities Licensed Under 10 CFR Part 53

Sec. 26.601 Applicability. 26.603 General provisions. 26.605 FFD program requirements. 26.606 Written policy and procedures. 26.607 Drug and alcohol testing. 26.608 FFD program training. 26.609 Behavioral observation. 26.610 Sanctions. 26.611 Protection of information. 26.613 Appeals process. 26.615 Audits. 26.617 Recordkeeping, reporting, and FFD program performance. 26.619 Suitability and fitness determinations.

Sec. 26.601 Applicability.

(a) A licensee or other entity in Sec. 26.3(f), at its discretion, may establish, implement, and maintain a fitness-for-duty (FFD) program that satisfies the requirements of this subpart for those categories of individuals in Sec. 26.4, as applicable, and any person licensed to operate under part 53 of this chapter. If a licensee or other entity in Sec. 26.3(f) does not elect to implement an FFD program that satisfies the requirements of this subpart, then those categories of individuals in Sec. 26.4, as applicable, and any person licensed to operate under part 53 of this chapter must be subject to an FFD program that satisfies all requirements under this part, except for those requirements in subpart K and this subpart.

(b) A licensee or other entity in Sec. 26.3(f) that elects to implement an FFD program that satisfies the requirements of this subpart, and that demonstrates compliance with Sec. 73.100(a)(1)(i) of this chapter, must establish, implement, and maintain an FFD program under Sec. 26.605(a) or (b).

(c) A licensee or other entity in Sec. 26.3(f) that elects to implement an FFD program that satisfies the requirements of this subpart and does not demonstrate compliance with Sec. 73.100(a)(1)(i) of this chapter must establish, implement, and maintain an FFD program under Sec. 26.605(a) and (b).

Sec. 26.603 General provisions.

(a) FFD program description. An applicant's description of the FFD program in its Final Safety Analysis Report, required by subpart H of part 53 of this chapter, must include--

(1) Whether the applicant demonstrates compliance with Sec. 73.100(a)(1)(i) of this chapter;

(2) A statement whether the FFD program will be implemented pursuant to Sec. 26.605(a) or (b) or Sec. 26.605(a) and (b), or will satisfy all requirements under this part, except for the requirements in subpart K and this subpart;

(3) A discussion of the applicability of the FFD program to those individuals described in Sec. 26.4 and how the program will be implemented offsite at a U.S. Nuclear Regulatory Commission (NRC)- licensed facility authorized to assemble or test a manufactured reactor, if applicable; and

(4) A description of the drug and alcohol testing and fitness determination process to be implemented through the licensee's or other entity's procedures, including the collection and testing facilities to be used, biological specimens to be collected and tested, and sanctions to be imposed for FFD policy violations.

(b) FFD program implementation and availability. For the licensees and other entities in Sec. 26.3(f), other than the holder of a manufacturing license (ML), the FFD program must be maintained until the NRC's docketing of the license holder's certifications described in Sec. 53.1070 of this chapter. For holders of an ML, the FFD program must be maintained until expiration of the ML.

(c)-(d) [Reserved]

(e) FFD program change control. (1) The licensee or other entity may make changes to its FFD program under this subpart if--

(i) The licensee or other entity performs and retains an analysis demonstrating that the changes do not reduce the effectiveness of the FFD program; or

(ii) The change was necessitated or justified by a change to this part, laboratory processes or procedures, or guidance issued by the U.S. Department of Health and Human Services (HHS) or NRC, as implemented by the licensee or other entity though its procedures.

(2) A licensee or other entity desiring to make a change that decreases FFD program effectiveness must implement a mitigating strategy so the FFD program, as revised, will continue to satisfy the performance objectives in Sec. 26.23 and not result in a reduction in FFD program effectiveness.

(3) Except for phencyclidine, and notwithstanding paragraph (e)(1)(ii) of this section, the change control process may not be used to reduce the minimum panel of drugs to be tested in Sec. 26.607(c)(1).

(4) The licensee must retain a record of each change made under this section for a period of at least 5 years from the date the change was implemented and summarize this change in its annual FFD performance report required by Sec. 26.617(b)(2) or Sec. 26.717, as applicable.

Sec. 26.605 FFD program requirements.

(a)(1) The licensee or other entity must establish, implement, and maintain an FFD program under this paragraph (a) before the start of--

(i) Construction activities as defined in Sec. 26.5;

(ii) Activities performed under an ML that authorizes the assembly, non-operational testing, or both of a manufactured reactor; or

(iii) Activities described in paragraphs (a)(1)(i) and (ii) of this section.

(2) An FFD program under this paragraph (a) must--

(i) Apply to those individuals described in Sec. 26.4, as applicable; and,

(ii) Implement the following requirements and subparts:

(A) Section 26.23, for performance objectives;

(B) Section 26.35, for employee assistance programs:

(1) For licensees and other entities who demonstrate compliance with Sec. 73.100(a)(1)(i) of this chapter, Sec. 26.35 must be implemented before the earliest occurrence of the following, as applicable: the loading of fuel onsite into a reactor vessel; receiving a fueled manufactured reactor; or individuals subject to this part operate, test, perform maintenance of, or direct the maintenance or surveillance of security-related equipment or equipment that a risk- informed evaluation process has shown to be significant to public health and safety; and

(2) For licensees and other entities that do not demonstrate compliance with Sec. 73.100(a)(1)(i) of this chapter, Sec. 26.35 must be implemented before the start of activities performed under an ML that allows the assembly, non-operational testing, or both, of a manufactured reactor;

(C) Section 26.603, for general provisions;

(D) Section 26.606, for written policy and procedures;

(E) Section 26.607, for drug and alcohol testing;

(F) Section 26.608, for FFD program training;

(G) Section 26.609, for behavioral observation;

(H) Section 26.610, for sanctions;

(I) Section 26.611, for protection of information;

(J) Section 26.613, for the appeals process;

(K) Section 26.615, for audits;

(L) Section 26.617, for recordkeeping, reporting, and FFD program performance;

(M) Section 26.619, for suitability and fitness determinations;

(N) Subpart A, for administrative provisions;

(O) Subpart I, for managing fatigue, in the case of holders of an ML that allows the assembly, non-operational testing, or both of a manufactured reactor; and

(P) Subpart O, for inspections, violations, and penalties.

(b)(1) Except for a licensee or other entity that demonstrates compliance with Sec. 73.100(a)(1)(i) of this chapter and elects to implement an FFD program that satisfies the requirements of this paragraph (b), for which its FFD program must be established, implemented, and maintained no later than the start of construction activities, as defined in Sec. 26.5, and except for holders of manufacturing licenses if they possess a separate license to load fuel into a manufactured reactor, for which its FFD program under this paragraph (b) must be established, implemented, and maintained no later than the start of the loading of fuel into the reactor, the licensee or other entity must establish, implement, and maintain an FFD program under this paragraph (b) before the earliest occurrence of the following, as applicable:

(i) The loading of fuel onsite into a reactor vessel;

(ii) Receiving a fueled manufactured reactor; and

(iii) Individuals subject to this part operate, test, perform maintenance of, or direct the maintenance or surveillance of security- related equipment or equipment that a risk-informed evaluation process has shown to be significant to public health and safety.

(2) An FFD program under this paragraph (b) must--

(i) Apply to those individuals described in Sec. 26.4, as applicable; and

(ii) Implements the following requirements and subparts:

(A) Section 26.23, for performance objectives;

(B) Section 26.35, for employee assistance programs;

(C) Section 26.603, for general provisions;

(D) Section 26.606, for written policy and procedures;

(E) Section 26.607, for drug and alcohol testing;

(F) Section 26.608, for FFD program training;

(G) Section 26.609, for behavioral observation;

(H) Section 26.611, for protection of information;

(I) Section 26.613, for the appeals process;

(J) Section 26.615, for audits;

(K) Subpart A, for administrative provisions;

(L) Subpart C, for granting and maintaining authorization;

(M) Subpart D, for management actions and sanctions to be imposed;

(N) Subpart H, for determining fitness-for-duty Policy violations and determining fitness, unless using the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) for Medical Review Officer (MRO) evaluation of drug test results, and determining fitness;

(O) Subpart I, for managing fatigue;

(P) Subpart N, for recordkeeping and reporting requirements; and

(Q) Subpart O, for inspections, violations, and penalties.

Sec. 26.606 Written policy and procedures.

(a) Licensees and other entities that implement an FFD program under this subpart must ensure that--

(1) A written FFD policy statement is provided to each individual who is subject to the program before the individual is subject to drug and alcohol testing.

(2) The FFD policy statement describes the performance objectives in Sec. 26.23.

(3) The FFD policy statement describes the minimum days off requirements in Sec. 26.205(d)(3) or maximum average work hours requirements in Sec. 26.205(d)(7).

(4) The FFD policy statement must be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy, including those elements described in paragraph (b) of this section, sanctions required under this part, and required medical/ clinical treatment and follow-up testing for FFD policy violations.

(5) The FFD policy statement describes the individual's responsibilities to report for work in a physiological and psychological condition that enables the safe and competent performance of assigned duties and responsibilities and inform a licensee- or other entity-designated representative when the individual determines that this cannot be accomplished.

(6) The FFD policy statement must prohibit the consumption of alcohol, at a minimum, within an abstinence period of 5 hours preceding the individual's arrival at the licensee's or other entity's facility.

(7) The FFD policy statement must convey that abstinence from alcohol for the 5 hours preceding any scheduled tour of duty is considered to be a minimum that is necessary, but may not be sufficient, to ensure that the individual is fit for duty.

(b) Licensees and other entities must establish, implement, and maintain written procedures that address the following topics:

(1) For the drug and alcohol testing program under this subpart:

(i) The methods and techniques to collect and test for drugs and alcohol and for the shipping and temporary storage of biological specimens used for drug testing at HHS-certified laboratories;

(ii) The urine specimen volumes, techniques for split specimen collections, and the acceptability of a urine specimen as described in Sec. 26.111 or as described in the HHS Guidelines;

(iii) Protecting the privacy of an individual who provides a specimen, protecting the integrity of the specimen, and ensuring that the test results are valid and attributable to the correct individual; and

(iv) If the licensee or other entity elects to use the HHS Guidelines, the name of the specific HHS Guideline and revision being implemented by the licensee or other entity and a description of the specific sections in the guideline that are being implemented in the procedure, including specimen collections, drug testing, and evaluation of test results.

(2) The immediate and follow-up actions that will be taken, and the procedures to be used, in those cases in which individuals who are subject to the FFD program:

(i) Have been involved in the use, sale, or possession of illegal substances, illegal drugs, or illicit substances;

(ii) Are impaired by any illegal substances, illegal drugs, or illicit substances or the consumption of alcohol as determined by behavioral observation or a test that measures blood alcohol concentration;

(iii) Attempted to subvert the testing process by adulterating or diluting specimens (in vivo or in vitro), substituting specimens, or by any other means;

(iv) Refused to provide a specimen for analysis or follow instructions provided by FFD program personnel;

(v) Had legal action taken relating to drug or alcohol use;

(vi) Demonstrated character or actions indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, special nuclear material (SNM), or sensitive information; or

(vii) Have a condition or have taken actions that pose or have posed an immediate hazard to themselves or others, as notified by EAP personnel under Sec. 26.35(c)(2).

(3) The process, including the duties and responsibilities of FFD program

personnel, to be followed if an individual's behavior or condition raises a concern regarding the possible use, sale, or possession of illegal drugs on- or offsite; the possible use or possession of alcohol on the NRC-licensed facility; impairment from any cause that in any way could adversely affect the individual's ability to safely and competently perform the individual's duties; or the receipt of credible information indicating that the individual cannot be trusted or relied on to perform those duties and responsibilities making the individual subject to this part.

(4) Operation and oversight of any onsite or offsite collection facility.

(5) The fatigue management requirements in Sec. 26.202(b) and either Sec. 26.205(d)(3) or (7).

(6) Measures to prevent subversion of drug and alcohol tests conducted onsite and offsite.

Sec. 26.607 Drug and alcohol testing.

Licensees and other entities must perform drug and alcohol testing that complies with the following requirements--

(a) Split specimens. Split specimen collections of oral fluid or urine must be used for the test conditions described in paragraph (b) of this section. Testing of the split specimen (specimen B) requires the donor's permission unless ordered by the MRO to resolve an invalid test result obtained for specimen A.

(b) Test conditions. Individuals identified in Sec. 26.4 must be subject to drug and alcohol testing under the following conditions:

(1) Pre-access. A pre-access test must be conducted for drugs and alcohol before performing or directing the conduct of roles and responsibilities making the individual subject to this subpart or being granted unescorted access to the protected areas of the NRC-licensed facility. A pre-access test must have been conducted no more than 14 days before the individual is granted unescorted access.

(2) Random. Random testing for drugs and alcohol must--

(i) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected;

(ii) Require individuals who are selected for random testing to report to the onsite collection site as soon as reasonably practicable after notification, within the time period specified in the FFD program procedure;

(iii) Ensure that all individuals in the population that is subject to random testing on a given day have an equal probability of being selected and tested;

(iv) Ensure that an individual completing a test is immediately eligible for another random test; and

(v) Ensure that the sampling process used to select individuals for random testing provides that the number of random tests performed annually is equal to at least 50 percent of the population that is subject to the FFD program at the NRC-licensed site.

(vi) If the number of individuals subject to random testing at an NRC-licensed site is such that paragraph (b)(2)(v) of this section cannot be implemented without predictable outcomes, the licensee must use a consortium/third-party administrator to manage the random testing pool and make selections for testing throughout the year.

(3) For-cause. For-cause drug and alcohol tests must be conducted onsite in response to an individual's observed behavior or physical condition indicating possible substance abuse, as defined in Sec. 26.5. A for-cause drug test, alcohol test, or both, must be conducted onsite after receiving credible information either that an individual is engaging in substance abuse or in response to a portal area screening test result under paragraph (j) of this section.

(4) Post-event. A post-event test for drugs and alcohol must be conducted--

(i) As soon as practical after an event involving a human error that was committed by an individual specified in Sec. 26.4, where the human error may have caused or contributed to the event. This test must be conducted onsite unless the individual requires offsite medical care. The licensee or other entity must test the individual(s) who committed or directed the error and need not test individuals who were affected by the event and whose actions likely did not cause or contribute to the event. The licensee or other entity must describe in its procedures what constitutes a human error.

(ii) Within 4 hours of an event unless immediate medical intervention precludes the conduct of the test on the individual(s) who caused or contributed to the accident(s), if the event results in--

(A) An illness or personal injury to any individual which results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury, as diagnosed by a licensee- or other entity-designated physician or other licensed health care professional, even if the illness or injury does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness; or

(B) Damage to any safety- or security-related structures, systems, and components; and

(5) Follow-up. An individual subject to this part who has violated the FFD policy for substance use or abuse, or the sale, use, or possession of illegal drugs must be subject to a follow-up series of tests for drugs, alcohol, or both to verify an individual's continued abstinence from substance abuse.

(c) Urine and oral fluid specimens. (1) All urine or oral fluid specimens must be tested for the substances listed in Sec. 26.31(d)(1), except as allowed by Sec. 26.603(e)(3). All urine specimens must be subject to validity testing as specified in either this part or the HHS Guidelines. All oral fluid specimens may be subject to validity testing, including a biological marker, as specified in either this part or the HHS Guidelines.

(2) For the use of urine as the biological specimen to be tested, the following requirements must be implemented--

(i) Section 26.115, for collecting a urine specimen under direct observation;

(ii) Section 26.119, for determining “shy” bladder; and

(iii) Section 26.163, for cutoff levels for drugs and drug metabolites.

(3) For alcohol testing onsite, the following requirements must be implemented--

(i) Section 26.91, for acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use;

(ii) Section 26.93, for preparing for alcohol testing;

(iii) Section 26.95, for conducting an initial test for alcohol using a breath specimen;

(iv) Section 26.97, for collecting oral fluid specimens for alcohol and drug testing;

(v) Section 26.99, for determining the need for a confirmatory test for alcohol;

(vi) Section 26.101, for conducting a confirmatory test for alcohol; and,

(vii) Section 26.103, for determining a confirmed positive test result for alcohol.

(4) For all test conditions in paragraph (b) of this section and for MRO-directed tests under Sec. 26.185, drug testing must be performed at an HHS-certified laboratory for the specific biological specimen to be tested. Only HHS-certified laboratory test results from urine and oral fluid specimens may be used for the issuance of a sanction

required under this part. The licensee or other entity must establish and maintain a contract with a primary and a back-up HHS-certified laboratory (with a different Certifying Scientist) for the specimen(s) to be tested. These contracts must stipulate that the laboratories are subject to inspection or audit by the licensee or other entity and that records and documents must be provided and/or able to be photocopied and removed from the premises to support the inspection or audit.

(d) Privacy and integrity. The specimen collection and drug and alcohol testing procedures of FFD programs must protect the donor's privacy and the integrity of the specimen and implement quality controls to ensure that test results are valid and attributable to the correct individual.

(e) Offsite collection facilities. At the licensee's or other entity's discretion, except for those specimens that must be collected onsite under paragraphs (b)(3) and (4) of this section, specimen collections and alcohol testing may be conducted at a local hospital or other facility licensed to conduct specimen collections and perform alcohol testing and audited by the State or a State-designated entity. The licensee or other entity must audit these facilities, if used, before their initial use and then on a biennial basis to confirm that the facility procedures are comparable to those described in subpart E of this part or the HHS Guidelines for urine and oral fluid.

(f) Initial testing. A licensee or other entity subject to this subpart performing an initial test must use an immunoassay, or an alternative technology as specified in the HHS Guidelines for the specific biological specimen that is to be tested. Specimens that yield positive, positive and dilute, adulterated, substituted, or invalid initial validity or drug test results or discrepant biological markers must be subject to confirmatory testing by an HHS-certified laboratory, certified for that biological specimen, except for invalid specimens that cannot be tested.

(g) Oral fluid testing. (1) If the licensee or other entity elects to use oral fluid for drug or alcohol testing, the collection, packaging, temporary storage, and shipment of an oral fluid specimen to an HHS-certified laboratory for drug testing, or the collection of an oral fluid specimen for alcohol testing must be performed in accordance with licensee- or other entity-established procedures based either on the requirements in this part or the procedures in HHS Guidelines identified by the licensee or other entity in Sec. 26.606(b)(1)(iv). The oral fluid device must not expire before the date of the collection of the specimen for testing. The drugs, drug metabolites, initial and confirmatory testing cutoffs, and biological markers, if applicable, must be those established by the HHS Guidelines for oral fluid testing and the alcohol cutoffs in this part or, if not established by the HHS Guidelines or this part for the panel of drugs and drug metabolites to be tested, as determined and documented by a forensic toxicologist review conducted pursuant to Sec. 26.31(d)(1)(i)(D).

(2) The virtual collection of oral fluid specimens for drug and alcohol testing is only permitted for sites that must use a C/TPA to implement random testing under paragraph (b)(2)(vi) of this section. For a licensee or other entity to utilize a virtual oral fluid specimen collection process, the following must apply or should be considered, as applicable:

(i) The specimen collector completing the virtual collection must meet the requirements in Sec. 26.85.

(ii) The oral fluid specimen collection process must be completed as described under Sec. Sec. 26.97 and 26.99.

(iii) An individual other than the donor (i.e., a virtual collection monitor) may be needed in the location where the specimen collection is to be performed to assist the virtual collector in completing activities, performing observations, or both.

(iv) If a virtual collection monitor is used to assist the specimen collector in completing an oral fluid specimen collection, then the virtual specimen collector must explain the collection process to the monitor and provide instruction to the monitor on required activities to be performed during the collection process. The monitor's name must be recorded on the Federal custody and control form (Federal CCF) for drug testing specimens, or an analogous document for alcohol testing.

(v) Video teleconference communication method(s) must provide sufficient visual and aural clarity to complete the process and ensure that a donor is not able to subvert the testing process.

(vi) Collection kit materials must be maintained in a secure fashion until the virtual collector initiates the virtual collection process with the donor.

(vii) The licensee or other entity's written FFD procedures must describe in detail the virtual collection process and when and how it is to be implemented.

(viii) The virtual collection procedure must address problem collections, such as the video teleconference becomes inoperable during the collection process or the donor is unable to provide an oral fluid specimen of sufficient quantity to complete the specimen collection process for drug or alcohol testing.

(ix) The virtual collection procedure must include steps to collect a breath specimen using an evidential breath testing device (EBT) if the oral fluid specimen test result under Sec. 26.99(b) requires a confirmatory testing for alcohol under Sec. 26.101. At a minimum, a donor with an oral fluid specimen test result requiring confirmatory testing for alcohol must be removed from duty pending additional testing.

(h) [Reserved]

(i) Hair testing. The testing of hair specimens may only be used to inform a licensee's or other entity's determination of whether the individual is trustworthy and reliable under the test condition in paragraph (b)(1) of this section to supplement the information gained from a pre-access test using oral fluid or urine as the test specimen and must be conducted at an HHS-certified laboratory certified to test hair specimens.

(1) If used, this process must be described in the licensee's or other entity's FFD policy and described in detail in its procedure. The panel of drugs and drug metabolites to be evaluated must only include those listed as Schedule I or II of section 202 of the Controlled Substances Act [21 U.S.C. 812]. The collection, packaging, and temporary storage of a hair specimen and shipment of the specimen to an HHS-certified laboratory must be conducted in accordance with the HHS Guidelines. The licensee- or other entity-designated FFD program personnel must conduct the collection, packaging, temporary storage, shipping, and custody and control of the specimen.

(2) Before the licensee or other entity begins to conduct hair testing, the initial and confirmatory testing cutoffs must be the cutoffs established by the HHS Guidelines for hair testing or, if not established by the HHS Guidelines or this part, as determined by a forensic toxicologist review conducted pursuant to Sec. 26.31(d)(1)(i)(D).

(3) Confirmed positive test results must be considered potentially disqualifying FFD information until proven otherwise by a review under Sec. 26.613. Sanctions under this subpart must not be issued for any FFD policy violation involving a drug test using a hair specimen unless the licensee or other entity determines that the individual has attempted to subvert the testing process, as defined in Sec. 26.5, for the hair test.

(j) Portal area screening. A non-invasive testing instrument may be used to screen individuals for drugs, drug metabolites, and alcohol before the individuals' entry into or exit from a protected or vital area.

(1) The instrument must be operated in accordance with the manufacturer's specifications. If screening detects the presence of any drug, drug metabolite, or alcohol at or above the instrument set point, the individual screened by the instrument must be subject to for-cause testing under paragraph (b)(3) of this section.

(2) Annually, the licensee or other entity must verify the accuracy of the portal area screening test for each substance with any positive results. If at least 85 percent of the positive portal area screening test results for a substance in the past 12 months do not subsequently confirm positive on for-cause testing performed under paragraph (j)(1) of this section, the licensee or other entity cannot continue to use the screening test for the particular substance until such time as corrective actions have been implemented to improve the testing accuracy.

(3) A sanction under this part may not be issued to an individual based solely on a portal area screening instrument detection that drugs or alcohol exceed the instrument's established setpoint.

(k) Blood testing. The testing of blood specimens may only be conducted under the order of the licensee- or other entity-designated MRO for a valid medical reason as confirmed by the MRO pursuant to Sec. 26.31(d)(5). This specimen must be subject to testing by a laboratory that satisfies quality control requirements that are comparable to those required for certification by the HHS.

(l) Federal custody and control form. For the collection and packaging of urine, oral fluid, and hair specimens for drug testing, the licensee or other entity must use a Federal CCF.

(m) Medical Review Officer. Licensees or other entities must--

(1) Require their designated MRO to review positive, positive and dilute, adulterated, substituted, and invalid confirmatory drug and validity test results to determine whether the donor has violated the FFD policy. The review must be completed before reporting the results to the individual designated by the licensee or other entity to assess authorization or perform the suitability and fitness determinations required under Sec. 26.619, or, if required, that are described in subpart H of this part.

(2) Require their MRO to satisfy the requirements in Sec. 26.183 and, prior to conducting any activities under this part, attend and pass a medical- or clinical-based training session to improve his/her knowledge of MRO duties and responsibilities, drug and alcohol testing processes and procedures, and evaluation of drug testing results. This training session must be conducted by a nationally recognized MRO training and certification organization that has been assessed by the licensee's or other entity's FFD program personnel to include the technical elements an MRO must implement under Sec. 26.185. An MRO who performed the duties and responsibilities in Sec. Sec. 26.185 and 26.187 for at least 3 continuous years in the last 10 years prior to being hired or contracted by the licensee or other entity satisfies the requirements in this paragraph (m)(2).

(3) Require their MRO to attend a medical- or clinical-based training session at least every 5 years to improve his/her knowledge of changes in drug and alcohol testing processes and procedures and evaluation of drug testing results.

(4) Require their MRO to determine whether a biological specimen is positive, positive and dilute, adulterated, substituted, or invalid by implementing the requirements in Sec. 26.185 or the HHS Guidelines through the licensee's or other entity's procedures.

(i) If Sec. 26.185 or the HHS Guidelines, as used by the licensee or other entity in its procedures, are insufficient to make this determination, then guidance issued by a State agency in the State in which the NRC-licensed facility is located, Federal agencies, or nationally recognized MRO training and certification organizations may be used to inform an MRO determination.

(ii) An MRO need not review alcohol test results, including positive confirmatory alcohol test results determined by an EBT under paragraphs (c)(3)(vi) and (vii) of this section.

(5) Require their MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a specimen for testing. This determination and the retest must be documented and completed as soon as reasonably practicable.

(6) Require the MRO to review all specimen test results associated with drug-related FFD policy violations. This review includes split specimens and all specimens taken to resolve a discrepant condition, such as a possible subversion attempt, impairment without a known cause, or a donor-requested or MRO-directed re-test. To resolve a discrepant condition, the MRO is authorized to test a specimen for a biological marker, adulterants, or additional drugs.

(n) Limitations of screening and testing. Specimens collected under NRC regulations may only be designated or approved for screening and testing as described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses, screens, and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes. No biological specimens may be passively sampled and analyzed in a manner different than described in this subpart.

(o) Specimen collectors. All onsite specimen collections, except a collection by a portal area screening instrument in paragraph (j) of this section, must be conducted by licensee- or other entity-designated and -trained personnel.

Sec. 26.608 FFD program training.

(a) FFD program training. (1) Individuals must be trained in the FFD policy and procedure, including fatigue management, and their FFD program responsibilities. Individuals who collect specimens for testing must also be trained in specimen collector duties and responsibilities, including, at a minimum, specimen collection, custody and control, identification and response to subversion attempts, and privacy. For licensees and other entities of commercial nuclear plants, the FFD program training program must use a systems approach to training as defined in Sec. 53.725 of this chapter and described in Sec. 53.830 of this chapter for those individuals in Sec. 26.4.

(2) FFD program training must include training on the behavioral observation program. The behavioral observation program training must include the detection of physiological behaviors or conditions that may indicate--

(i) Possible use, sale, or possession of illegal drugs or illicit drugs, or substance abuse on- or offsite;

(ii) Use or possession of alcohol onsite or use while on duty offsite;

(iii) Impairment from fatigue or any cause that, if left unattended, could result in inattentiveness or human errors; and

(iv) Any individual's inability to safely and competently perform assigned duties and responsibilities or act in a trustworthy and reliable manner while having access to protected areas, SNM, or sensitive information.

(3) Training must explain that an individual's FFD policy violation will--

(i) Subject the individual to an FFD program-required sanction designed to preclude recurrence of an FFD policy violation;

(ii) Contribute to the licensee's or other entity's assessment of whether the individual can be trusted and relied upon to safely and competently perform the assigned duties and responsibilities making the individual subject to this subpart;

(iii) Be used to inform the licensee's or other entity's insider mitigation and access authorization programs under Sec. 73.55, Sec. 73.56, Sec. 73.100, or Sec. 73.120 of this chapter; and

(iv) Be used to inform other NRC licensees and other entities subject to this part when FFD program information is requested to support authorization determinations under subpart C of this part or Sec. 73.56 or Sec. 73.120 of this chapter.

(b) Training and assessments. Training and a trainee assessment must be conducted before pre-access testing, and FFD program refresher training and trainee assessments must be conducted on a nominal 24- month frequency, or more frequently where the need is indicated. Indications of the need for more frequent training include, but are not limited to, an individual's failure to properly implement FFD program procedures and the frequency, nature, or severity of problems discovered through audits or the administration of the program.

(c) Training program review. The licensee or other entity must periodically evaluate its FFD training program and revise it as appropriate to reflect industry experience as well as applicable changes to the regulations in this part, the HHS Guidelines, if used, and specimen collection and testing processes implemented by the licensee or other entity.

Sec. 26.609 Behavioral observation.

(a) Licensees and other entities must ensure that the individuals who are subject to this subpart are subject to behavioral observation and that behavioral observation is performed by all individuals subject to this subpart.

(b) Licensees and other entities must require all individuals subject to the FFD program to report to the licensee- or other entity- designated representative any onsite or offsite behaviors or activities by individuals subject to this part that may constitute an unreasonable risk to the safety or security of the NRC-licensed facility or SNM or may cause harm to others. This reporting must include any information relating to character or reputation of the individual indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, SNM, or sensitive information that makes them subject to this part.

(c) Behavioral observation must be performed visually, in-person, and, when necessary, remotely by live video and audible streaming and capture, to observe the behavior of individuals in the workforce subject to the requirements in this subpart.

(d) Not withstanding paragraph (c) of this section, for a reactor facility where individual task loading does not allow for the effective conduct of behavior observation in addition to assigned operational tasks, the licensee or other entity must implement a live video and audible streaming and capture system to conduct behavioral observation of persons licensed to operate under part 53 of this chapter who manipulate the controls of any commercial nuclear plant licensed under part 53.

Sec. 26.610 Sanctions.

(a) Licensees and other entities that implement an FFD program under this subpart must establish sanctions for FFD policy violations that, at a minimum, prohibit the individuals specified in Sec. 26.4 from being assigned to perform or direct those duties and responsibilities or maintaining authorization making them subject to this subpart.

(b) The severity of the sanction must escalate with the number of occurrences and severity of the FFD policy violation. The sanction must be long enough to act as a deterrent and, if the individual is retained as a licensee employee or contractor/vendor, facilitate the individual to complete counseling or treatment. The sanctions must include an immediate unfavorable termination of the individual's authorization as follows:

(1) A minimum 14-day denial of access for a first violation of the FFD policy involving a confirmed positive drug or alcohol test result;

(2) A minimum 3-year denial of access for a second violation of the FFD policy involving a confirmed positive drug or alcohol test result;

(3) A minimum 5-year denial of access for any individual who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any facility licensed under part 53 of this chapter or within a transporter's facility or vehicle used in the conveyance of formula quantities of strategic SNM while the individual is subject to this subpart; and

(4) A permanent denial of access for a third violation of the FFD policy involving a confirmed positive drug or alcohol test result or a subversion attempt of any drug or alcohol test or screening process.

Sec. 26.611 Protection of information.

(a) Licensees and other entities that collect personal information about an individual for the purpose of complying with this subpart must establish and maintain a system of files and procedures to prevent unauthorized disclosure.

(b) Licensees and other entities must obtain a signed consent that documents the individual's acceptance of being subject to the FFD program and authorizes the disclosure of the personal information collected and maintained under this subpart, except for disclosures to the individuals and entities specified in Sec. 26.37(b)(1) through (6) and (8), and persons deciding matters under review in Sec. 26.613. This signed and dated consent must be obtained before making the individual subject to the FFD program.

Sec. 26.613 Appeals process.

Licensees and other entities that implement an FFD program under this subpart must establish and implement procedures for the review of a determination that an individual in Sec. 26.4 has violated the FFD policy. The procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy and a schedule for the completion of the review.

Sec. 26.615 Audits.

(a) Licensees and other entities that implement an FFD program under this subpart must audit their programs at a frequency that ensures the continuing effectiveness of their FFD program, FFD program elements that are provided by C/Vs, and the FFD programs of C/Vs that are accepted by the licensee or other entity. Corrective actions must be taken as soon as reasonably practicable to resolve any problems identified in an audit and preclude recurrence.

(b) The subject matter, scope, and frequency of audits must be revised as necessary to improve or maintain program performance based on annual FFD program performance data reviews performed under Sec. 26.617(d) and unsatisfactory performance or programmatic weaknesses identified under Sec. 26.617(b)(3) and (e).

(c) Licensees and other entities may conduct joint audits or accept audits of C/Vs so long as the audit addresses the relevant services of the C/Vs.

(d) Licensees and other entities must audit HHS-certified laboratories unless the licensee's or other entity's panel of drugs and drug metabolites to be tested is equivalent to the panel by which the laboratory is certified by HHS or is subject to the standards and procedures for drug testing and evaluation used by the laboratory under the HHS Guidelines. Licensees and other entities must audit any hospital or other facility licensed by the State (or State-designated entity) if used to conduct specimen collections and perform alcohol testing under this part on a biennial basis to confirm that the facility procedures are comparable to those described in subpart E of this part, for urine and oral fluid.

Sec. 26.617 Recordkeeping, reporting, and FFD program performance.

(a) Licensees and other entities that implement FFD programs under this subpart must ensure that records pertaining to the administration of their program, which may be stored and archived electronically, are maintained so that they are available for NRC inspection purposes and for any legal proceedings resulting from the administration of the program. Records pertaining to the administration of the FFD program and FFD performance data required by Sec. 26.717 must be retained until license termination.

(b) Licensees and other entities must make the following reports:

(1) Reports to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers any intentional act that casts doubt on the integrity of the FFD program and any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse by individuals who are subject to this subpart. These events must be reported under this subpart, rather than under the provisions of Sec. 73.1200 of this chapter;

(2) Annual FFD program performance data under Sec. 26.717(b) for each FFD program subject to this subpart. Licensees and other entities must submit FFD program performance data (for January through December) to the NRC annually, before March 1 of the following year and must use unexpired NRC-provided forms for the electronic submission of FFD information to the NRC; and

(3) Reports on drug and alcohol testing errors within 30 days of completing an investigation of any testing errors or unsatisfactory performance, discovered at an HHS-certified laboratory or through the processing of appeals under Sec. 26.613, or errors or matters that could adversely reflect on the integrity of the random selection or random testing process. The reports must describe the incident and any corrective actions taken or planned.

(c) Licensees and other entities subject to this subpart must describe in sufficient detail to support an authorization determination, an individual's FFD policy violation (while protecting privacy information under Sec. 26.611) and FFD program weakness to NRC, licensees, and other entities subject to this part when requested to support authorization determinations under subpart C of this part or Sec. 73.120 of this chapter, as applicable, or to support licensee or other entity performance monitoring.

(d) Licensees and other entities must analyze FFD program performance data at least annually and take appropriate actions to correct any identified program weakness.

(e) Licensees and other entities must document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee's or other entity's corrective action program, but may not track or trend drug and alcohol test results in a manner that would permit the identification of any individuals.

Sec. 26.619 Suitability and fitness determinations.

Licensees and other entities that implement FFD programs under this subpart must develop, implement, and maintain procedures for evaluating whether to assign individuals to perform or direct those duties and responsibilities making them subject to this subpart. A suitability or fitness determination conducted for cause must be performed face-to- face. A suitability or fitness determination conducted for cause may be performed remotely using electronic communications that provide sufficient visual and aural clarity to complete the assessment. A fitness determination may be supported by someone who is present in- person with the individual being assessed only during for-cause drug and alcohol testing determinations under Sec. 26.607(b)(3) and fatigue assessments performed under Sec. 26.211(a)(1). The supporting person must be trained in accordance with the requirements of either Sec. 26.29 or Sec. 26.608.

0 97. Revise Sec. 26.709 to read as follows:

Sec. 26.709 Applicability.

(a) The requirements of this subpart apply to the FFD programs of licensees and other entities specified in Sec. 26.3(a) through (d), except for FFD programs that are implemented under subpart K of this part.

(b) The requirements in this subpart apply to the FFD programs of licensees and other entities specified in Sec. 26.3(f) that elect not to implement the requirements in subpart M or elect to implement the requirements in Sec. 26.605(b).

Sec. 26.711 [Amended]

0 98. In Sec. 26.711, in paragraphs (c) and (d), remove the phrase “(c) and (d),” and add in its place the phrase “(c), (d), and (f),”.

0 99. In Sec. 26.825, revise paragraph (b) to read as follows:

Sec. 26.825 Criminal penalties.

* * * * *

(b) The regulations in this part that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: Sec. Sec. 26.1, 26.3, 26.5, 26.7, 26.8, 26.9, 26.11, 26.51, 26.81, 26.121, 26.151, 26.181, 26.201, 26.601, 26.823, and 26.825.

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL

0 100. The authority citation for part 30 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 11, 81, 161, 181, 182, 183, 184, 186, 187, 223, 234, 274 (42 U.S.C. 2014, 2111, 2201, 2231, 2232, 2233, 2234, 2236, 2237, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); 44 U.S.C. 3504 note.

0 101. In Sec. 30.4, revise the definition for “Utilization facility” to read as follows:

Sec. 30.4 Definitions.

* * * * *

Utilization facility means a utilization facility as defined in the regulations contained in part 50 or 53 of this chapter.

0 102. In Sec. 30.50, revise paragraph (c)(3) to read as follows:

Sec. 30.50 Reporting requirements.

* * * * *

(c) * * *

(3) The provisions of this section do not apply to licensees subject to the notification requirements in Sec. 50.72 or Sec. 53.1630 of this chapter. They do apply to those licensees under part 50 of this chapter possessing material licensed under this part, who are not subject to

the notification requirements in Sec. 50.72 of this chapter.

PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL

0 103. The authority citation for part 40 continues to read as follows:

Authority: Atomic Energy Act of 1954, secs. 62, 63, 64, 65, 69, 81, 83, 84, 122, 161, 181, 182, 183, 184, 186, 187, 193, 223, 234, 274, 275 (42 U.S.C. 2092, 2093, 2094, 2095, 2099, 2111, 2113, 2114, 2152, 2201, 2231, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2022); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Uranium Mill Tailings Radiation Control Act of 1978, sec. 104 (42 U.S.C. 7914); 44 U.S.C. 3504 note.

0 104. In Sec. 40.60, revise paragraph (c)(3) to read as follows:

Sec. 40.60 Reporting requirements.

* * * * *

(c) * * *

(3) The provisions of this section do not apply to licensees subject to the notification requirements in Sec. 50.72 or Sec. 53.1630 of this chapter. They do apply to those licensees under part 50 of this chapter possessing material licensed under this part who are not subject to the notification requirements in Sec. 50.72 of this chapter.

PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES

0 105. The authority citation for part 50 is revised to read as follows:

Authority: Atomic Energy Act of 1954, secs. 11, 101, 102, 103, 104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186, 187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135, 2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, sec. 306(42 U.S.C. 10226); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note.

0 106. In Sec. 50.47, revise paragraphs (a)(1) and (e) to read as follows:

Sec. 50.47 Emergency plans.

(a)(1)(i) Except as provided in paragraph (d) of this section, no initial operating license for a nuclear power reactor will be issued under this part or under part 53 of this chapter unless a finding is made by the NRC that there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. No finding under this section is necessary for issuance of a renewed nuclear power reactor operating license.

(ii) No initial combined license under part 52 or 53 of this chapter will be issued unless a finding is made by the NRC that there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. No finding under this section is necessary for issuance of a renewed combined license.

(iii) If an application for an early site permit under subpart A of part 52 of this chapter includes complete and integrated emergency plans under Sec. 52.17(b)(2)(ii) of this chapter or an application for an early site permit under subpart H of part 53 of this chapter includes complete and integrated emergency plans under Sec. 53.1146(b)(2)(ii) of this chapter, no early site permit will be issued unless a finding is made by the NRC that the emergency plans provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency.

(iv) If an application for an early site permit proposes major features of the emergency plans under Sec. 52.17(b)(2)(i) or Sec. 53.1146(b)(2)(i) of this chapter, no early site permit will be issued unless a finding is made by the NRC that the major features are acceptable in accordance with the applicable standards of either this section and appendix E to this part or the applicable requirements of Sec. 50.160, within the scope of emergency preparedness matters addressed in the major features. * * * * *

(e) Notwithstanding the requirements of paragraph (b) of this section and the provisions of Sec. 52.103 or Sec. 53.1452 of this chapter, a holder of a combined license under part 52 or 53 of this chapter, as applicable, that is complying with the requirements of paragraph (b) of this section and appendix E to this part may not load fuel or operate except as provided in accordance with appendix E to this part and Sec. 50.54(gg), and a holder of a combined license under part 52 or 53 of this chapter that is complying with the requirements of Sec. 50.160 may not load fuel or operate except as provided in accordance with Sec. Sec. 50.160(c)(2) and 50.54(gg). * * * * *

0 107. In Sec. 50.54, revise paragraph (gg)(1) introductory text to read as follows:

Sec. 50.54 Conditions of licenses.

* * * * *

(gg)(1) Notwithstanding Sec. 52.103 or Sec. 53.1452 of this chapter, if following the conduct of the exercise required by paragraph IV.f.2.a of appendix E to this part or Sec. 50.160(c)(2), as applicable, FEMA identifies one or more deficiencies in the state of offsite emergency preparedness, the holder of a combined license under part 52 or 53 of this chapter, as applicable, may operate at up to 5 percent of rated thermal power only if the Commission finds that the state of onsite emergency preparedness provides reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. The NRC will base this finding on its assessment of the applicant's onsite emergency plans against the pertinent standards in either Sec. 50.47 and appendix E to this part, or Sec. 50.160, as applicable. Review of the applicant's emergency plans will include the following standards with offsite aspects: * * * * *

0 108. In Sec. 50.160, revise paragraphs (b)(3) and (c)(2) to read as follows:

Sec. 50.160 Emergency preparedness for small modular reactors, non- light-water reactors, and non-power production or utilization facilities.

* * * * *

(b) * * *

(3) Emergency planning zone. For an applicant whose analysis required by Sec. 50.33(g)(2) or Sec. 53.1109(g)(2) of this chapter meets the criteria in Sec. 50.33(g)(2)(i) or Sec. 53.1109(g)(2)(i) of this chapter, as applicable, determine and describe the boundary and physical characteristics of the EPZ in the emergency plan. * * * * *

(c) * * *

(2) A holder of a combined license issued under part 52 or 53 of this chapter before the Commission has made the finding under Sec. 52.103(g) or Sec. 53.1452(g) of this chapter, as applicable, must establish, implement, and maintain an emergency preparedness program that meets the requirements of paragraph (b) of this section, as described in the approved emergency plan and license, and conduct an initial exercise to demonstrate this compliance within 2 years before the scheduled date for initial loading of fuel (or, for a fueled manufactured reactor, within 2 years before the scheduled date for initiating the removal of the features to prevent criticality required under Sec. 53.620(d)(1) of this chapter).

0 109. In appendix B to part 50, revise the first paragraph in the Introduction section, the first paragraph of section III, and section IV to read as follows:

Appendix B to Part 50--Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants

Introduction. Every applicant for a construction permit is required by the provisions of Sec. 50.34 or Sec. 53.1309 of this chapter to include in its Preliminary Safety Analysis Report a description of the quality assurance program to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility. Every applicant for an operating license is required by the provisions of Sec. 50.34 or Sec. 53.1369 of this chapter to include, in its Final Safety Analysis Report, information pertaining to the managerial and administrative controls to be used to assure safe operation. Every applicant for a combined license is required by the provisions of Sec. 52.79 or Sec. 53.1416 of this chapter to include in its Final Safety Analysis Report a description of the quality assurance applied to the design, and to be applied to the fabrication, construction, and testing of the structures, systems, and components of the facility and to the managerial and administrative controls to be used to assure safe operation. For applications submitted after September 27, 2007, every applicant for an early site permit is required by the provisions of Sec. 52.17 or Sec. 53.1146 of this chapter to include in its Site Safety Analysis Report a description of the quality assurance program applied to site activities related to the design, fabrication, construction, and testing of the structures, systems, and components of a facility or facilities that may be constructed on the site. Every applicant for a design approval is required by the provisions of Sec. 52.137 or Sec. 53.1209 of this chapter to include in its Final Safety Analysis Report a description of the quality assurance program applied to the design of the structures, systems, and components of the facility. Every applicant for a design certification is required by the provisions of Sec. 52.47 or Sec. 53.1239 of this chapter to include in its Final Safety Analysis Report a description of the quality assurance program applied to the design of the structures, systems, and components of the facility. Every applicant for a manufacturing license is required by the provisions of Sec. 52.157 or Sec. 53.1279 of this chapter to include in its Final Safety Analysis Report a description of the quality assurance program applied to the design, and to be applied to the manufacture of, the structures, systems, and components of the reactor. Nuclear power plants and fuel reprocessing plants include structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. This appendix establishes quality assurance requirements for the design, manufacture, construction, and operation of those structures, systems, and components. The pertinent requirements of this appendix apply to all activities affecting the safety-related functions of those structures, systems, and components; these activities include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying. * * * * *

III. * * *

Measures shall be established to assure that applicable regulatory requirements and the design bases, as defined in Sec. 50.2 and as specified in the license application, or the functional design criteria, as defined in Sec. 53.020 of this chapter and as specified in the license application, for those structures, systems, and components to which this appendix applies are correctly translated into specifications, drawings, procedures, and instructions. These measures shall include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled. Measures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components. * * * * *