[Title 10 CFR ]
[Code of Federal Regulations (annual edition) - January 1, 2019 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

                                 Title 10

                                  Energy


                        ________________________

                            Parts 1 to 50

                         Revised as of January 1, 2019

          Containing a codification of documents of general 
          applicability and future effect

          As of January 1, 2019
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

[[Page ii]]

          U.S. GOVERNMENT OFFICIAL EDITION NOTICE

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[[Page iii]]




                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 10:
          Chapter I--Nuclear Regulatory Commission                   3
  Finding Aids:
      Table of CFR Titles and Chapters........................    1075
      Alphabetical List of Agencies Appearing in the CFR......    1095
      List of CFR Sections Affected...........................    1105

[[Page iv]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 10 CFR 1.1 refers to 
                       title 10, part 1, section 
                       1.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, January 1, 2019), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
in the past by using the appropriate List of CFR Sections Affected 
(LSA). For the convenience of the reader, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume. For changes to 
the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not accidentally dropped due to a printing or computer error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed as 
an approved incorporation by reference, please contact the agency that 
issued the regulation containing that incorporation. If, after 
contacting the agency, you find the material is not available, please 
notify the Director of the Federal Register, National Archives and 
Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, 
or call 202-741-6010.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Authorities 
and Rules. A list of CFR titles, chapters, subchapters, and parts and an 
alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, 8601 Adelphi Road, College Park, MD 
20740-6001 or e-mail [email protected].

SALES

    The Government Publishing Office (GPO) processes all sales and 
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ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, the LSA (List of 
CFR Sections Affected), The United States Government Manual, the Federal 
Register, Public Laws, Public Papers of the Presidents of the United 
States, Compilation of Presidential Documents and the Privacy Act 
Compilation are available in electronic format via www.govinfo.gov. For 
more information, contact the GPO Customer Contact Center, U.S. 
Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-
free). E-mail, [email protected].
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.archives.gov/federal-
register.
    The e-CFR is a regularly updated, unofficial editorial compilation 
of CFR material and Federal Register amendments, produced by the Office 
of the Federal Register and the Government Publishing Office. It is 
available at www.ecfr.gov.

    Oliver A. Potts,
    Director,
    Office of the Federal Register
    January 1, 2019.







[[Page ix]]



                               THIS TITLE

    Title 10--Energy is composed of four volumes. The parts in these 
volumes are arranged in the following order: Parts 1-50, 51-199, 200-499 
and part 500-end. The first and second volumes containing parts 1-199 
are comprised of chapter I--Nuclear Regulatory Commission. The third and 
fourth volumes containing part 200-end are comprised of chapters II, III 
and X--Department of Energy, chapter XIII--Nuclear Waste Technical 
Review Board, chapter XVII--Defense Nuclear Facilities Safety Board, and 
chapter XVIII--Northeast Interstate Low-Level Radioactive Waste 
Commission. The contents of these volumes represent all current 
regulations codified under this title of the CFR as of January 1, 2019.

    For this volume, Susannah C. Hurley was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

[[Page 1]]



                            TITLE 10--ENERGY




                   (This book contains parts 1 to 50)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Nuclear Regulatory Commission....................           1

[[Page 3]]



                CHAPTER I--NUCLEAR REGULATORY COMMISSION




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter I appear at 70 FR 
69421, Nov. 16, 2005, and at 72 FR 33386, June 18, 2007.
Part                                                                Page
1               Statement of organization and general 
                    information.............................           5
2               Agency rules of practice and procedure......          18
4               Nondiscrimination in federally assisted 
                    programs or activities receiving Federal 
                    financial assistance from the Commission         165
5               Nondiscrimination on the basis of sex in 
                    education programs or activities 
                    receiving Federal financial assistance..         197
7               Advisory committees.........................         214
8               [Reserved]

9               Public records..............................         225
10              Criteria and procedures for determining 
                    eligibility for access to restricted 
                    data or national security information or 
                    an employment clearance.................         259
11              Criteria and procedures for determining 
                    eligibility for access to or control 
                    over special nuclear material...........         274
12              Implementation of the Equal Access to 
                    Justice Act in agency proceedings.......         282
13              Program fraud civil remedies................         288
14              Administrative claims under Federal Tort 
                    Claims Act..............................         306
15              Debt collection procedures..................         312
16              Salary offset procedures for collecting 
                    debts owed by Federal employees to the 
                    Federal Government......................         327
19              Notices, instructions and reports to 
                    workers: Inspection and investigations..         333
20              Standards for protection against radiation..         341
21              Reporting of defects and noncompliance......         449
25              Access authorization........................         457
26              Fitness for duty programs...................         467
30              Rules of general applicability to domestic 
                    licensing of byproduct material.........         566

[[Page 4]]

31              General domestic licenses for byproduct 
                    material................................         611
32              Specific domestic licenses to manufacture or 
                    transfer certain items containing 
                    byproduct material......................         622
33              Specific domestic licenses of broad scope 
                    for byproduct material..................         654
34              Licenses for industrial radiography and 
                    radiation safety requirements for 
                    industrial radiographic operations......         659
35              Medical use of byproduct material...........         676
36              Licenses and radiation safety requirements 
                    for irradiators.........................         740
37              Physical protection of category 1 and 
                    category 2 quantities of radioactive 
                    material................................         755
39              Licenses and radiation safety requirements 
                    for well logging........................         779
40              Domestic licensing of source material.......         791
50              Domestic licensing of production and 
                    utilization facilities..................         851

[[Page 5]]



PART 1_STATEMENT OF ORGANIZATION AND GENERAL INFORMATION--
Table of Contents



                         Subpart A_Introduction

Sec.
1.1 Creation and authority.
1.3 Sources of additional information.
1.5 Location of principal offices and regional offices.

                         Subpart B_Headquarters

1.11 The Commission.

                            Inspector General

1.12 Office of the Inspector General.

                     Panels, Boards, and Committees

1.13 Advisory Committee on Reactor Safeguards.
1.15 Atomic Safety and Licensing Board Panel.
1.18 [Reserved]
1.19 Other committees, boards, and panels.

                            Commission Staff

1.23 Office of the General Counsel.
1.24 Office of Commission Appellate Adjudication.
1.25 Office of the Secretary of the Commission.
1.26 [Reserved]
1.27 Office of Congressional Affairs.
1.28 Office of Public Affairs.
1.29 Office of International Programs.

                         Chief Financial Officer

1.31 Office of the Chief Financial Officer.

                    Executive Director for Operations

1.32 Office of the Executive Director for Operations.

                              Staff Offices

1.33 Office of Enforcement.
1.34 Office of Administration.
1.35 Office of the Chief Information Officer.
1.36 Office of Investigations.
1.37 Office of Small Business and Civil Rights.
1.38 [Reserved]
1.39 Office of the Chief Human Capital Officer.
1.40-1.41 [Reserved]

                             Program Offices

1.42 Office of Nuclear Material Safety and Safeguards.
1.43 [Reserved]
1.44 Office of New Reactors.
1.45 Office of Nuclear Regulatory Research.
1.46 Office of Nuclear Security and Incident Response.
1.47 NRC Regional Offices.

                       Subpart C_NRC Seal and Flag

1.51 Description and custody of NRC seal.
1.53 Use of NRC seal or replicas.
1.55 Establishment of official NRC flag.
1.57 Use of NRC flag.
1.59 Report of violations.

    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).

    Source: 52 FR 31602, Aug. 21, 1987, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 1 appear at 78 FR 
34247, June 7, 2013.



                         Subpart A_Introduction



Sec.1.1  Creation and authority.

    (a) The Nuclear Regulatory Commission was established by the Energy 
Reorganization Act of 1974, as amended, Pub. L. 93-438, 88 Stat. 1233 
(42 U.S.C. 5801 et seq.). This Act abolished the Atomic Energy 
Commission and, by section 201, transferred to the Nuclear Regulatory 
Commission all the licensing and related regulatory functions assigned 
to the Atomic Energy Commission by the Atomic Energy Act of 1954, as 
amended, Pub. L. 83-703, 68 Stat. 919 (42 U.S.C. 2011 et seq.). These 
functions included those of the Atomic Safety and Licensing Board Panel. 
The Energy Reorganization Act became effective January 19, 1975 (E.O. 
11834).
    (b) As used in this part:
    Commission means the five members of the Nuclear Regulatory 
Commission or a quorum thereof sitting as a body, as provided by section 
201 of the Energy Reorganization Act of 1974, as amended.
    NRC means the Nuclear Regulatory Commission, the agency established 
by title II of the Energy Reorganization Act of 1974, as amended, 
comprising the members of the Commission and all offices, employees, and 
representatives authorized to act in any case or matter.

[52 FR 31602, Aug. 21, 1987, as amended at 56 FR 29407, June 27, 1991]

[[Page 6]]



Sec.1.3  Sources of additional information.

    (a) A statement of the NRC's organization, policies, procedures, 
assignments of responsibility, and delegations of authority is in the 
Nuclear Regulatory Commission Management Directives System and other NRC 
issuances, including local directives issued by Regional Offices. 
Letters and memoranda containing directives, delegations of authority 
and the like are also issued from time to time and may not yet be 
incorporated into the Management Directives System, parts of which are 
revised as necessary. Copies of the Management Directives System and 
other delegations of authority are available for public inspection and 
copying for a fee at the NRC Public Document Room, One White Flint 
North, 11555 Rockville Pike (first floor), Rockville, Maryland 20852-
2738, and at each of NRC's Regional Offices. Information may also be 
obtained from the Office of Public Affairs or from Public Affairs 
Officers at the Regional Offices.
    (b) Commission meetings are open to the public, as provided by the 
Government in the Sunshine Act, unless they fall within an exemption to 
the Act's openness requirement and the Commission also has determined 
that the public interest requires that those particular meetings be 
closed. Information concerning Commission meetings may be obtained from 
the Office of the Secretary.
    (c) Information regarding the availability of NRC records under the 
Freedom of Information Act and Privacy Act of 1974 may be obtained from 
the Office of the Chief Information Officer. NRC's regulations are 
published in the Federal Register and codified in Title 10, Chapter 1, 
of the Code of Federal Regulations. They may be viewed electronically at 
the NRC Web site, http://www.nrc.gov/reading-rm/doc-collections/cfr/. 
Final opinions made in the adjudication of cases are published in 
``Nuclear Regulatory Commission Issuances,'' and are available on a 
subscription basis from the National Technical Information Service, 5301 
Shawnee Road, Alexandria, VA 22312.

[52 FR 31602, Aug. 21, 1987, as amended at 53 FR 43419, Oct. 27, 1988; 
53 FR 52993, Dec. 30, 1988; 54 FR 53313, Dec. 28, 1989; 57 FR 1639, Jan. 
15, 1992; 63 FR 15740, Apr. 1, 1998; 64 FR 48947, Sept. 9, 1999; 67 FR 
67097, Nov. 4, 2002; 70 FR 69421, Nov. 16, 2005; 79 FR 75737, Dec. 19, 
2014; 80 FR 45842, Aug. 3, 2015; 80 FR 74977, Dec. 1, 2015]



Sec.1.5  Location of principal offices and regional offices.

    (a) The principal NRC offices are located in the Washington, DC, 
area. Facilities for the service of process and documents are maintained 
in the State of Maryland at 11555 Rockville Pike, Rockville, Maryland 
20852-2738. The agency's official mailing address is U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001. The locations of NRC 
offices in the Washington, DC, area are as follows:
    (1) One White Flint North Building, 11555 Rockville Pike, Rockville, 
Maryland 20852-2738.
    (2) Two White Flint North Building, 11545 Rockville Pike, Rockville, 
Maryland 20852-2738.
    (3) Three White Flint North Building, 11601 Landsdown Street, North 
Bethesda, Maryland 20852.
    (b) The addresses of the NRC Regional Offices are as follows:
    (1) Region I, U.S. NRC, 2100 Renaissance Boulevard, Suite 100, King 
of Prussia, PA 19406-2713.
    (2) Region II, USNRC, 245 Peachtree Center Avenue, NE., Suite 1200, 
Atlanta, GA 30303-1257.
    (3) Region III, USNRC, 2443 Warrenville Road, Suite 210, Lisle, IL 
60532-4352.
    (4) Region IV, US NRC, 1600 E. Lamar Blvd., Arlington, TX 76011-
4511.

[67 FR 67097, Nov. 4, 2002; 67 FR 70835, Nov. 27, 2002, as amended at 67 
FR 77652, Dec. 19, 2002; 68 FR 75389, Dec. 31, 2003; 70 FR 69421, Nov. 
16, 2005; 71 FR 15007, Mar. 27, 2006; 72 FR 49148, Aug. 28, 2007; 73 FR 
5711, Jan. 31, 2008; 73 FR 30457, May 28, 2008; 75 FR 21980, Apr. 27, 
2010; 76 FR 72084, Nov. 22, 2011; 77 FR 39903, July 6, 2012; 79 FR 
75757, Dec. 19, 2014]



                         Subpart B_Headquarters



Sec.1.11  The Commission.

    (a) The Nuclear Regulatory Commission, composed of five members, one 
of

[[Page 7]]

whom is designated by the President as Chairman, is established pursuant 
to section 201 of the Energy Reorganization Act of 1974, as amended. The 
Chairman is the principal executive officer of the Commission, and is 
responsible for the executive and administrative functions with respect 
to appointment and supervision of personnel, except as otherwise 
provided by the Energy Reorganization Act of 1974, as amended, and 
Reorganization Plan No. 1 of 1980 (45 FR 40561); distribution of 
business; use and expenditures of funds (except that the function of 
revising budget estimates and purposes is reserved to the Commission); 
and appointment, subject to approval of the Commission, of heads of 
major administrative units under the Commission. The Chairman is the 
official spokesman, as mandated by the Reorganization Plan No. 1 of 
1980. The Chairman has ultimate authority for all NRC functions 
pertaining to an emergency involving an NRC Licensee. The Chairman's 
actions are governed by the general policies of the Commission.
    (b) The Commission is responsible for licensing and regulating 
nuclear facilities and materials and for conducting research in support 
of the licensing and regulatory process, as mandated by the Atomic 
Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, 
as amended; and the Nuclear Nonproliferation Act of 1978; and in 
accordance with the National Environmental Policy Act of 1969, as 
amended, and other applicable statutes. These responsibilities include 
protecting public health and safety, protecting the environment, 
protecting and safeguarding nuclear materials and nuclear power plants 
in the interest of national security, and assuring conformity with 
antitrust laws. Agency functions are performed through standards setting 
and rulemaking; technical reviews and studies; conduct of public 
hearings; issuance of authorizations, permits, and licenses; inspection, 
investigation, and enforcement; evaluation of operating experience; and 
confirmatory research. The Commission is composed of five members, 
appointed by the President and confirmed by the Senate.
    (c) The following staff units and officials report directly to the 
Commission: Atomic Safety and Licensing Board Panel, Office of the 
General Counsel, Office of the Secretary, Office of Commission Appellate 
Adjudication, Office of International Programs, and other committees and 
boards that are authorized or established specifically by the Act. The 
Advisory Committee on Reactor Safeguards and the Advisory Committee on 
Nuclear Waste also report directly to the Commission.
    (d) The Offices of Congressional Affairs and Public Affairs report 
directly to the Chairman.

[52 FR 31602, Aug. 21, 1987, as amended at 57 FR 1639, Jan. 15, 1992; 59 
FR 63882, Dec. 12, 1994]

                            Inspector General



Sec.1.12  Office of the Inspector General.

The Office of the Inspector General--
    (a) Develops policies and standards that govern NRC's financial and 
management audit program;
    (b) Plans, directs, and executes the long-range, comprehensive audit 
program;
    (c) Conducts and reports on investigations and inquiries, as 
necessary, to ascertain and verify the facts with regard to the 
integrity of all NRC programs and operations;
    (d) Investigates possible irregularities or alleged misconduct of 
NRC employees and contractors;
    (e) Refers suspected or alleged criminal violations concerning NRC 
employees or contractors to the Department of Justice;
    (f) Reviews existing and proposed legislation and regulations for 
their impact on economy and efficiency in the administration of NRC's 
programs and operations;
    (g) Keeps the Commission and the Congress fully and currently 
informed, by means of semiannual and other reports, about fraud, abuse, 
and other serious deficiencies in NRC's programs and operations; and
    (h) Maintains liaison with audit and inspector general organizations 
and other law enforcement agencies in regard to all matters relating to 
the promotion of economy and efficiency and the detection of fraud and 
abuse in programs and operations.

[54 FR 53313, Dec. 28, 1989]

[[Page 8]]

                     Panels, Boards, and Committees



Sec.1.13  Advisory Committee on Reactor Safeguards.

    The Advisory Committee on Reactor Safeguards (ACRS) was established 
by section 29 of the Atomic Energy Act of 1954, as amended. Consisting 
of a maximum of 15 members, it reviews and reports on safety studies and 
applications for construction permits and facility operating licenses; 
advises the Commission with regard to hazards of proposed or existing 
reactor facilities and the adequacy of proposed reactor safety 
standards; upon request of the Department of Energy (DOE), reviews and 
advises with regard to the hazards of DOE nuclear activities and 
facilities; reviews any generic issues or other matters referred to it 
by the Commission for advice. The Committee, on its own initiative, may 
conduct reviews of specific generic matters or nuclear facility safety-
related items. The ACRS conducts studies of reactor safety research and 
submits reports thereon to the U.S. Congress and the NRC as appropriate.



Sec.1.15  Atomic Safety and Licensing Board Panel.

    The Atomic Safety and Licensing Board Panel, established pursuant to 
section 191 of the Atomic Energy Act of 1954, as amended, conducts 
hearings for the Commission and such other regulatory functions as the 
Commission authorizes. The Panel is comprised of any number of 
Administrative Judges (full-time and part-time), who may be lawyers, 
physicists, engineers, and environmental scientists; and Administrative 
Law Judges, who hear antitrust, civil penalty, and other cases and serve 
as Atomic Safety and Licensing Board Chairmen. The Chief Administrative 
Judge develops and applies procedures governing the activities of 
Boards, Administrative Judges, and Administrative Law Judges and makes 
appropriate recommendations to the Commission concerning the rules 
governing the conduct of hearings. The Panel conducts all licensing and 
other hearings as directed by the Commission primarily through 
individual Atomic Safety and Licensing Boards composed of one or three 
Administrative Judges. Those boards are appointed by either the 
Commission or the Chief Administrative Judge.



Sec.1.18  [Reserved]



Sec.1.19  Other committees, boards, and panels.

    Under section 161a. of the Atomic Energy Act of 1954, as amended, 
the Commission may establish advisory bodies to make recommendations to 
it. Currently, four committees are in existence.
    (a) The Advisory Committee on Medical Uses of Isotopes (ACMUI) was 
established by the Atomic Energy Commission in July 1958. The ACMUI, 
composed of physicians and scientists, considers medical questions 
referred to it by the NRC staff and renders expert opinions regarding 
medical uses of radioisotopes. The ACMUI also advises the NRC staff, as 
requested, on matters of policy regarding licensing of medical uses of 
radioisotopes.
    (b) The Licensing Support Network Advisory Review Panel (LSNARP) was 
established by the Commission on October 3, 1989, pursuant to 10 CFR 
2.1011(e) of the Commission's regulations. The LSNARP provides advice to 
the Commission on the design, development, and operation of the 
Licensing Support Network (LSN) an electronic information management 
system for use in the Commission's high-level radioactive waste (HLW) 
licensing proceeding. Membership consists of those interests that will 
be affected by the use of the LSN, and selected Federal agencies with 
expertise in large-scale electronic information systems. The individual 
representatives of these interests and agencies possess expertise in 
management information science and in managing records of the 
Commission's licensing process for the HLW repository.

[52 FR 31602, Aug. 21, 1987, as amended at 54 FR 53314, Dec. 28, 1989; 
68 FR 75389, Dec. 31, 2003; 79 FR 75737, Dec. 19, 2014]

                            Commission Staff



Sec.1.23  Office of the General Counsel.

    The Office of the General Counsel, established pursuant to section 
25 of the

[[Page 9]]

Atomic Energy Act of 1954, as amended--
    (a) Directs matters of law and legal policy, providing opinions, 
advice, and assistance to the agency with respect to all of its 
activities;
    (b) Reviews and prepares appropriate draft Commission decisions on 
public petitions seeking direct Commission action and rulemaking 
proceedings involving hearings, monitors cases pending before presiding 
officers and reviews draft Commission decisions on Atomic Safety and 
Licensing Board decisions and rulings;
    (c) Provides interpretation of laws, regulations, and other sources 
of authority;
    (d) Reviews the legal form and content of proposed official actions;
    (e) As requested, provides the agency with legal advice and opinions 
on acquisition matters, including agency procurement contracts; 
placement of work at Department of Energy national laboratories; 
interagency agreements to acquire supplies and services; and grants and 
cooperative agreements. Prepares or concurs in all other interagency 
agreements, delegations of authority, regulations; orders; licenses; and 
other legal documents and prepares legal interpretations thereof;
    (f) Reviews and directs intellectual property (patent) work;
    (g) Represents and protects the interests of the NRC in legal 
matters and in court proceedings, and in relation to other government 
agencies, administrative bodies, committees of Congress, foreign 
governments, and members of the public; and
    (h) Represents the NRC staff as a party in NRC administrative 
hearings.

[52 FR 31602, Aug. 21, 1987, as amended at 56 FR 29407, June 27, 1991; 
65 FR 59272, Oct. 4, 2000]



Sec.1.24  Office of Commission Appellate Adjudication.

    The Office of Commission Appellate Adjudication--
    (a) Monitors cases pending before presiding officers;
    (b) Provides the Commission with an analysis of any adjudicatory 
matter requiring a Commission decision (e.g., petitions for review, 
certified questions, stay requests) including available options;
    (c) Drafts any necessary decisions pursuant to the Commission's 
guidance after presentation of options; and
    (d) Consults with the Office of the General Counsel in identifying 
the options to be presented to the Commission and in drafting the final 
decision to be presented to the Commission.

[56 FR 29407, June 27, 1991]



Sec.1.25  Office of the Secretary of the Commission.

    The Office of the Secretary of the Commission--
    (a) Provides general management services to support the Commission 
and to implement Commission decisions; and advises and assists the 
Commission and staff on the planning, scheduling, and conduct of 
Commission business including preparation of internal procedures;
    (b) Prepares the Commission's meeting agenda;
    (c) Manages the Commission Staff Paper and COMSECY systems;
    (d) Receives, processes, and controls Commission mail, 
communications, and correspondence;
    (e) Maintains the Commission's official records and acts as Freedom 
of Information administrative coordinator for Commission records;
    (f) Codifies Commission decisions in memoranda directing staff 
action and monitors compliance;
    (g) Receives, processes, and controls motions and pleadings filed 
with the Commission; issues and serves adjudicatory orders on behalf of 
the Commission; receives and distributes public comments in rulemaking 
proceedings; issues proposed and final rules on behalf of the 
Commission; maintains the official adjudicatory and rulemaking dockets 
of the Commission; and exercises responsibilities delegated to the 
Secretary in 10 CFR 2.303 and 2.346;
    (h) Administers the NRC Historical Program;
    (i) Integrates office automation initiatives into the Commission's 
administrative system;
    (j) Functions as the NRC Federal Advisory Committee Management 
Officer; and

[[Page 10]]

    (k) Provides guidance and direction on the use of the NRC seal and 
flag.

[52 FR 31602, Aug. 21, 1987, as amended at 63 FR 15741, Apr. 1, 1998; 69 
FR 2233, Jan. 14, 2004]



Sec.1.26  [Reserved]



Sec.1.27  Office of Congressional Affairs.

    The Office of Congressional Affairs--
    (a) Advises the Chairman, the Commission, and NRC staff on all NRC 
relations with Congress and the views of Congress toward NRC policies, 
plans and activities;
    (b) Maintains liaison with Congressional committees and members of 
Congress on matters of interest to NRC;
    (c) Serves as primary contact point for all NRC communications with 
Congress;
    (d) Coordinates NRC internal activities with Congress;
    (e) Plans, develops, and manages NRC's legislative programs; and
    (f) Monitors legislative proposals, bills, and hearings.

[57 FR 1639, Jan. 15, 1992]



Sec.1.28  Office of Public Affairs.

    The Office of Public Affairs--
    (a) Develops policies, programs, and procedures for the Chairman's 
approval for informing the public of NRC activities;
    (b) Prepares, clears, and disseminates information to the public and 
the news media concerning NRC policies, programs, and activities;
    (c) Keeps NRC management informed on media coverage of activities of 
interest to the agency;
    (d) Plans, directs, and coordinates the activities of public 
information staffs located at Regional Offices;
    (e) Conducts a cooperative program with schools; and
    (f) Carries out assigned activities in the area of consumer affairs.

[57 FR 1639, Jan. 15, 1992]



Sec.1.29  Office of International Programs.

    The Office of International Programs--
    (a) Advises the Chairman, the Commission, and NRC staff on 
international issues;
    (b) Recommends policies concerning nuclear exports and imports, 
international safeguards, international physical security, 
nonproliferation matters, and international cooperation and assistance 
in nuclear safety and radiation protection;
    (c) Plans, develops, and manages international nuclear safety 
information exchange programs and coordinates international research 
agreements;
    (d) Obtains, evaluates, and uses pertinent information from other 
NRC and U.S. Government offices in processing nuclear export and import 
license applications;
    (e) Establishes and maintains working relationships with individual 
countries and international nuclear organizations, as well as other 
involved U.S. Government agencies; and
    (f) Assures that all international activities carried out by the 
Commission and staff are well coordinated internally and Government-wide 
and are consistent with NRC and U.S. policies.

[57 FR 1639, Jan. 15, 1992]

                         Chief Financial Officer



Sec.1.31  Office of the Chief Financial Officer.

    The Office of the Chief Financial Officer--
    (a) Oversees all financial management activities relating to NRC's 
programs and operations and provides advice to the Chairman on financial 
management matters;
    (b) Develops and transmits the NRC's budget estimates to the Office 
of Management and Budget (OMB) and Congress;
    (c) Establishes financial management policy including accounting 
principles and standards for the agency and provides policy guidance to 
senior managers on the budget and all other financial management 
activities;
    (d) Provides an agencywide management control program for financial 
and program managers that establishes internal control processes and 
provides for timely corrective actions regarding material weaknesses 
that are disclosed

[[Page 11]]

to comply with the Federal Manager's Financial Integrity Act of 1982;
    (e) Develops and manages an agencywide planning, budgeting, and 
performance management process;
    (f) Develops and maintains an integrated agency accounting and 
financial management system, including an accounting system, and 
financial reporting and internal controls;
    (g) Directs, manages, and provides policy guidance and oversight of 
agency financial management personnel activities and operations;
    (h) Prepares and transmits an annual financial management report to 
the Chairman and the Director, Office of Management and Budget, 
including an audited financial statement;
    (i) Monitors the financial execution of NRC's budget in relation to 
actual expenditures, controls the use of NRC funds to ensure that they 
are expended in accordance with applicable laws and financial management 
principles, and prepares and submits to the Chairman timely cost and 
performance reports;
    (j) Establishes, maintains, and oversees the implementation of 
license fee polices and regulations; and
    (k) Reviews, on a periodic basis, fees and other charges imposed by 
NRC for services provided and makes recommendations for revising those 
charges, as appropriate.

[63 FR 15741, Apr. 1, 1998]

                    Executive Director for Operations



Sec.1.32  Office of the Executive Director for Operations.

    (a) The Executive Director for Operations (EDO) reports for all 
matters to the Chairman, and is subject to the supervision and direction 
of the Chairman as provided in Reorganization Plan No. 1 of 1980.
    (b) The EDO supervises and coordinates policy development and 
operational activities in the following offices: The Office of Nuclear 
Reactor Regulation, the Office of New Reactors, the Office of Nuclear 
Material Safety and Safeguards, the Office of Nuclear Regulatory 
Research, the Office of Nuclear Security and Incident Response, and the 
NRC Regional Offices; and the following staff offices: The Office of 
Enforcement, the Office of Administration, the Office of the Chief 
Information Officer, the Office of Investigations, the Office of Small 
Business and Civil Rights, the Office of the Chief Human Capital 
Officer, and other organizational units as shall be assigned by the 
Commission. The EDO is also responsible for implementing the 
Commission's policy directives pertaining to these offices.
    (c) The EDO exercises powers and functions delegated to the EDO 
under the Reorganization Plan No. 1 of 1980, this chapter, or otherwise 
by the Commission or Chairman, as appropriate. The EDO has the authority 
to perform any function that may be performed by an office director 
reporting to the EDO.

[54 FR 53314, Dec. 28, 1989, as amended at 59 FR 63882, Dec. 12, 1994. 
Redesignated and amended at 63 FR 15741, Apr. 1, 1998; 67 FR 3585, Jan. 
25, 2002; 70 FR 69421, Nov. 16, 2005; 73 FR 5711, Jan. 31, 2008; 78 FR 
34247, June 7, 2013; 79 FR 75737, Dec. 19, 2014; 80 FR 74978, Dec. 1, 
2015]

                              Staff Offices



Sec.1.33  Office of Enforcement.

    The Office of Enforcement--
    (a) Develops policies and programs for enforcement of NRC 
requirements;
    (b) Manages major enforcement action;
    (c) Assesses the effectiveness and uniformity of Regional 
enforcement actions; and
    (d) Manages the NRC allegation program.

[70 FR 69422, Nov. 16, 2005]



Sec.1.34  Office of Administration.

    The Office of Administration--
    (a) Develops and implements agencywide contracting policies and 
procedures;
    (b) Develops policies and procedures and manages the operation and 
maintenance of NRC offices, facilities, and equipment;
    (c) Plans, develops, establishes, and administers policies, 
standards, and procedures for the overall NRC security program; and

[[Page 12]]

    (d) Manages the NRC Management Directives Program and provides 
translation services.

[63 FR 15741, Apr. 1, 1998, as amended at 70 FR 69422, Nov. 16, 2005; 83 
FR 30287, June 28, 2018]



Sec.1.35  Office of the Chief Information Officer.

    The Office of the Chief Information Officer--
    (a) Plans, directs, and oversees the NRC's information resources, 
including technology infrastructure and delivery of information 
management services, to meet the mission and goals of the agency;
    (b) Provides principal advice to the Chairman to ensure that 
information technology (IT) is acquired and information resources across 
the agency are managed in a manner consistent with Federal information 
resources management (IRM) laws and regulations;
    (c) Assists senior management in recognizing where information 
technology can add value while improving NRC operations and service 
delivery;
    (d) Directs the implementation of a sound and integrated IT 
architecture to achieve NRC's strategic and IRM goals;
    (e) Monitors and evaluates the performance of information technology 
and information management programs based on applicable performance 
measures and assesses the adequacy of IRM skills of the agency;
    (f) Provides guidance and oversight for the selection, control and 
evaluation of information technology investments;
    (g) Provides oversight and quality assurance for the design and 
operation of the Licensing Support Network (LSN) services and for the 
completeness and integrity of the LSN database, ensures that the LSN 
meets the requirements of 10 CFR part 2, subpart J, concerning the use 
of the LSN in the Commission's high-level waste licensing proceedings, 
and provides technical oversight of DOE in the design, development, and 
operation of the LSN; and
    (h) Plans, recommends, and oversees the NRC's Information Technology 
(IT) Security Program consistent with applicable laws, regulations, 
management initiatives, and policies;
    (i) Provides principal advice to the NRC on the infrastructure, as 
well as the programmatic and administrative aspects of cybersecurity;
    (j) Establishes NRC-wide cybersecurity guidelines;
    (k) Guides security process maturity, as well as formulating and 
overseeing the cybersecurity program budget; and
    (l) Ensures NRC-wide integration, direction, and coordination of IT 
security planning and performance within the framework of the NRC IT 
Security Program.

[70 FR 69422, Nov. 16, 2005, as amended at 80 FR 74978, Dec. 1, 2015]



Sec.1.36  Office of Investigations.

    The Office of Investigations (OI)--
    (a) Conducts investigations of licensees, applicants, their 
contractors or vendors, including the investigation of all allegations 
of wrongdoing by other than NRC employees and contractors;
    (b) Maintains current awareness of inquiries and inspections by 
other NRC offices to identify the need for formal investigations;
    (c) Makes appropriate referrals to the Department of Justice;
    (d) Maintains liaison with other agencies and organizations to 
ensure the timely exchange of information of mutual interest; and
    (e) Issues subpoenas where necessary or appropriate for the conduct 
of investigations.

[54 FR 53315, Dec. 28, 1989]



Sec.1.37  Office of Small Business and Civil Rights.

    The Office of Small Business and Civil Rights--
    (a) Develops and implements an effective small and disadvantaged 
business program in accordance with the Small Business Act, as amended, 
and plans and implements NRC policies and programs relating to equal 
employment oppportunity and civil rights matters as required by the 
Equal Employment Opportunity Commission (EEOC) and the Office of 
Personnel Management (OPM);
    (b) Ensures that appropriate consideration is given to Labor Surplus 
Area firms and Women Business Enterprises, and conducts an outreach 
program

[[Page 13]]

aimed at contractors desiring to do business with NRC;
    (c) Maintains liaison with other Government agencies and trade 
associations;
    (d) Coordinates efforts with the Director, Division of Contracts, 
and Directors of other affected offices;
    (e) Develops and recommends for approval by the Executive Director 
for Operations, NRC policy providing for equal employment opportunity in 
all aspects of Federal personnel practice;
    (f) Develops, monitors, and evaluates the agency's equal employment 
opportunity efforts and affirmative action programs to ensure compliance 
with NRC policy;
    (g) Serves as the principal contact with local and national public 
and private organizations to facilitate the NRC equal opportunity 
program; and
    (h) Coordinates all efforts pertaining to small and disadvantaged 
business utilization and equal employment opportunity with Office 
Directors and Regional Administrators.

[52 FR 31602, Aug. 21, 1987, as amended at 59 FR 63882, Dec. 12, 1994]



Sec.1.38  [Reserved]



Sec.1.39  Office of the Chief Human Capital Officer.

    The Office of the Chief Human Capital Officer--
    (a) Plans and implements NRC policies, programs, and services to 
provide for the effective organization, utilization, and development of 
the agency's human resources;
    (b) Provides labor relations and personnel policy guidance and 
supporting services to NRC managers and employees;
    (c) Provides training, benefits administration, and counseling 
services for NRC employees;
    (d) Collects, analyzes, and provides data on the characteristics, 
allocation, utilization, and retention of NRC's workforce;
    (e) Provides staffing advice and services to NRC managers and 
employees; and
    (f) Provides executive resources management and organizational and 
managerial development services to the NRC.

[52 FR 31602, Aug. 21, 1987, as amended at 63 FR 15742, Apr. 1, 1998; 78 
FR 34247, June 7, 2013]



Sec. Sec.1.40-1.41  [Reserved]

                             Program Offices



Sec.1.42  Office of Nuclear Material Safety and Safeguards.

    (a) The Office of Nuclear Material Safety and Safeguards (NMSS) is 
responsible for regulating activities that provide for the safe and 
secure production of nuclear fuel used in commercial nuclear reactors; 
the safe storage, transportation, and disposal of low-level and high-
level radioactive waste and spent nuclear fuel; the transportation of 
radioactive materials regulated under the Atomic Energy Act of 1954, as 
amended (the Act); and all other medical, industrial, academic, and 
commercial uses of radioactive isotopes. The NMSS ensures safety and 
security by implementing a regulatory program involving activities 
including licensing, inspection, assessment of environmental impacts for 
all nuclear material facilities and activities, assessment of licensee 
performance, events analysis, enforcement, and identification and 
resolution of generic issues. The NMSS leads, manages, and facilitates 
rulemaking activities for new, advanced, and operating power reactors, 
as well as non-power utilization facilities; nuclear materials, 
including production of nuclear fuel used in commercial nuclear 
reactors, as well as storage, transportation, and disposal of high-level 
radioactive waste and spent nuclear fuel, and the transportation of 
radioactive materials regulated by the NRC.
    (b) The Office of Nuclear Material Safety and Safeguards--
    (1) Develops and implements NRC policy for the regulation of: 
Uranium recovery, conversion, and enrichment; fuel fabrication and 
development; transportation of nuclear materials, including 
certification of transport containers and reactor spent fuel storage; 
safe management and disposal of spent fuel and low-level and high-level 
radioactive waste; and medical, industrial,

[[Page 14]]

academic, and commercial uses of radioactive isotopes;
    (2) Has lead responsibility within NRC for domestic and 
international safeguards policy and regulation for fuel cycle 
facilities, including material control and accountability;
    (3) Plans and directs NRC's program of cooperation and liaison with 
States, local governments, interstate and Indian Tribe organizations; 
and coordinates liaison with other Federal agencies;
    (4) Participates in formulation of policies involving NRC/State 
cooperation and liaison;
    (5) Develops and directs administrative and contractual programs for 
coordinating and integrating Federal and State regulatory activities;
    (6) Maintains liaison between NRC and State, interstate, regional, 
Tribal, and quasi-governmental organizations on regulatory matters;
    (7) Promotes NRC visibility and performs general liaison with other 
Federal agencies, and keeps NRC management informed of significant 
developments at other Federal agencies that affect the NRC;
    (8) Monitors nuclear-related State legislative activities;
    (9) Directs regulatory activities of State Liaison and State 
Agreement Officers located in Regional Offices;
    (10) Participates in policy matters on State Public Utility 
Commissions (PUCs);
    (11) Administers the State Agreements program in a partnership 
arrangement with the States;
    (12) Develops staff policy and procedures and implements State 
Agreements program under the provisions of Section 274b of the Act;
    (13) Provides oversight of the program for reviews of Agreement 
State programs to determine their adequacy and compatibility as required 
by Section 274j of the Act and other periodic reviews that may be 
performed to maintain a current level of knowledge of the status of the 
Agreement State programs;
    (14) Provides training to the States as provided by Section 274i of 
the Act and also to NRC staff and staff of the U.S. Navy and U.S. Air 
Force;
    (15) Provides technical assistance to Agreement States;
    (16) Maintains an exchange of information with the States;
    (17) Conducts negotiations with States expressing an interest in 
seeking a Section 274b Agreement;
    (18) Supports, consistent with Commission directives, State efforts 
to improve regulatory control for radiation safety over radioactive 
materials not covered by the Act;
    (19) Serves as the NRC liaison to the Conference of Radiation 
Control Program Directors, Inc. (CRCPD) and coordinates NRC technical 
support of CRCPD committees;
    (20) Conducts high-level waste pre-licensing activities, consistent 
with direction in the Nuclear Waste Policy Act and the Energy Policy 
Act, to ensure appropriate standards and regulatory guidance are in 
place, and interacts with the applicant;
    (21) Is responsible for regulation and licensing of recycling 
technologies intended to reduce the amount of waste to be disposed 
through geologic disposal and to reduce proliferation concerns since the 
technologies do not produce separated plutonium;
    (22) Interacts with the Department of Energy and international 
experts, in order to develop an appropriate regulatory framework, in 
recycling during development, demonstration, and deployment of new 
advanced recycling technologies that recycle nuclear fuel in a manner 
that does not produce separated plutonium;
    (23) Creates and maintains the regulatory infrastructure to support 
the agency's role in licensing a reprocessing facility and a related 
fuel fabrication facility and vitrification and/or waste storage 
facility;
    (24) Prepares the NRC to perform its regulatory role for new, 
expanded, and modified commercial fuel cycle facilities that may include 
recycling, transmutation, and actinide burning. This includes regulatory 
processes such as licensing, inspection, assessment of license 
performance assessment, events analysis, and enforcement that will 
ensure that this technology can be safely and securely implemented 
commercially in the United States;

[[Page 15]]

    (25) Develops, promulgates, and amends regulations generally 
associated with the materials regulated by NMSS and for all security-
related regulations that will be applied to licensees and holders of 
certificates of compliance issued by NMSS;
    (26) Leads, manages, and facilitates the following rulemaking 
activities:
    (i) Develops and implements policies and procedures for the review 
and publication of NRC rulemakings, and ensures compliance with the 
Regulatory Flexibility Act and the Congressional Review Act;
    (ii) Supports all technical, financial, legal, and administrative 
rules, including the development of regulatory analyses and the orderly 
codification of the NRC's regulations in chapter I of this title; and
    (iii) Manages all aspects of the 10 CFR 2.802 Petition for 
Rulemaking process.
    (27) Supports safeguards activities including--
    (i) Developing overall agency policy;
    (ii) Monitoring and assessing the threat environment, including 
liaison with intelligence agencies, as appropriate; and
    (iii) Conducting licensing and review activities appropriate to 
deter and protect against threats of radiological sabotage and threats 
of theft or diversion of nuclear material at regulated facilities and 
during transport;
    (28) Regulates medical, industrial, academic, and commercial uses of 
radioactive isotopes;
    (29) Oversees safe management and disposal of low-level radioactive 
wastes;
    (30) Plans and directs program for financial assurance of NMSS 
licensees;
    (31) Manages the decommissioning of facilities and sites when their 
licensed functions are over; and
    (32) Identifies and takes action for activities under its 
responsibility, including consulting and coordinating with 
international, Federal, State, Tribal and local agencies, as 
appropriate.

[79 FR 75737, Dec. 19, 2014, as amended at 80 FR 74978, Dec. 1, 2015; 83 
FR 30287, June 28, 2018]



Sec.1.43  Office of Nuclear Reactor Regulation.

    The Office of Nuclear Reactor Regulation--
    (a) Develops, promulgates and implements regulations and develops 
and implements policies, programs, and procedures for all aspects of 
licensing, inspection, and safeguarding of--
    (1) Manufacturing, production, and utilization facilities, except 
for those concerning fuel reprocessing plants and isotopic enrichment 
plants;
    (2) Receipt, possession, and ownership of source, byproduct, and 
special nuclear material used or produced at facilities licensed under 
10 CFR parts 50, 52, and 54;
    (3) Operators of such facilities;
    (4) Emergency preparedness at such facilities; and
    (5) Contractors and suppliers of such facilities.
    (b) Identifies and takes action regarding conditions and licensee 
performance that may adversely affect public health and safety, the 
environment, or the safeguarding of nuclear reactor facilities;
    (c) Assesses and recommends or takes action regarding incidents or 
accidents;
    (d) Provides special assistance as required in matters involving 
reactor facilities exempt from licensing;
    (e) Provides guidance and implementation direction to Regional 
Offices on reactor licensing, inspection, and safeguards programs 
assigned to the Region, and appraises Regional program performance in 
terms of effectiveness and uniformity;
    (f) Performs other functions required for implementation of the 
reactor licensing, inspection, and safeguard programs; and
    (g) Performs review and evaluation related to regulated facilities 
insurance, indemnity, and antitrust matters.

[70 FR 69422, Nov. 16, 2005, as amended at 72 FR 49470, Aug. 28, 2007]



Sec.1.44  Office of New Reactors.

    The Office of New Reactors--

[[Page 16]]

    (a) Develops, promulgates and implements regulations and develops 
and implements policies, programs, and procedures for all aspects of 
licensing, inspection, and safeguarding of--
    (1) Manufacturing, production, and utilization facilities licensed 
under part 52 of this chapter prior to initial commencement of 
operation;
    (2) Receipt, possession, and ownership of source, byproduct, and 
special nuclear material used or produced at facilities licensed under 
part 52 of this chapter prior to initial commencement of operation;
    (3) Operators of such facilities licensed under part 52 of this 
chapter prior to initial commencement of operation;
    (4) Emergency preparedness at such facilities licensed under part 52 
of this chapter prior to initial commencement of operation; and
    (5) Contractors and suppliers of such facilities licensed under part 
52 of this chapter prior to initial commencement of operation;
    (b) Identifies and takes action regarding conditions and licensee 
performance that may adversely affect public health and safety, the 
environment, or the safeguarding of nuclear reactor facilities licensed 
under part 52 of this chapter prior to initial commencement of 
operation;
    (c) Assesses and recommends or takes action regarding incidents or 
accidents related to facilities licensed under part 52 of this chapter 
prior to initial commencement of operation;
    (d) Provides guidance and implementation direction to Regional 
Offices on reactor licensing, inspection, and safeguards programs 
assigned to the Region, and appraises Regional program performance in 
terms of effectiveness and uniformity, for facilities licensed under 10 
CFR part 52 prior to initial commencement of operation;
    (e) Performs other functions required for implementation of the 
reactor licensing, inspection, and safeguard programs for facilities 
licensed under part 52 of this chapter prior to initial commencement of 
operation; and
    (f) Performs review and evaluation related to regulated facilities 
insurance and indemnity for facilities licensed under part 52 of this 
chapter prior to initial commencement of operation.

[73 FR 5712, Jan. 31, 2008]



Sec.1.45  Office of Nuclear Regulatory Research.

    The Office of Nuclear Regulatory Research--
    (a) Plans, recommends, and implements programs of nuclear regulatory 
research, standards development, and resolution of generic safety issues 
for nuclear power plants and other facilities regulated by the NRC;
    (b) Coordinates research activities within and outside the agency 
including appointment of staff to committees and conferences; and
    (c) Coordinates NRC participation in international standards-related 
activities and national volunteer standards efforts, including 
appointment of staff to committees.

[52 FR 31602, Aug. 21, 1987, as amended at 63 FR 69544, Dec. 17, 1998]



Sec.1.46  Office of Nuclear Security and Incident Response.

    The Office of Nuclear Security and Incident Response--
    (a) Develops overall agency policy and provides management direction 
for evaluation and assessment of technical issues involving security at 
nuclear facilities, and is the agency safeguards and security interface 
with the Department of Homeland Security (DHS), the Department of Energy 
(DOE), other agencies; and the international activities related to the 
security of radioactive material and nuclear facilities;
    (b) Develops, in participation with domestic and international 
agencies, foreign policy guidance and provides international assistance 
in nuclear security and safeguards;
    (c) Develops emergency preparedness policies, regulations, programs, 
and guidelines for nuclear facilities;
    (d) Provides technical expertise regarding emergency preparedness 
issues and interpretations; and
    (e) Develops and directs the NRC program for response to incidents, 
and is the agency emergency preparedness and incident response interface 
with

[[Page 17]]

the DHS, the Federal Emergency Management Agency (FEMA) and other 
Federal agencies.

[70 FR 69422, Nov. 16, 2005, as amended at 72 FR 28450, May 21, 2007]



Sec.1.47  NRC Regional Offices.

    Each Regional Administrator executes established NRC policies and 
assigned programs relating to inspection, enforcement, licensing, State 
agreements, State liaison, and emergency response within Regional 
boundaries set out in Sec.1.5(b) of this part.



                       Subpart C_NRC Seal and Flag



Sec.1.51  Description and custody of NRC seal.

    (a) Pursuant to section 201(a) of the Energy Reorganization Act of 
1974, the Nuclear Regulatory Commission, has adopted an official seal. 
Its description is as follows: An American bald eagle (similar to that 
on the Great Seal of the United States of America) of brown and tan with 
claws and beak of yellow, behind a shield of red, white, and blue, 
clutching a cluster of thirteen arrows in its left claw and a green 
olive branch in its right claw, positioned on a field of white, with the 
words ``United States Nuclear Regulatory Commission'' in dark blue 
encircling the eagle. The eagle represents the United States of America 
and its interests.
    (b) The Official Seal of the Nuclear Regulatory Commission is 
illustrated as follows:
[GRAPHIC] [TIFF OMITTED] TC02OC91.055

    (c) The Secretary of the Commission is responsible for custody of 
the impression seals and of replica (plaque) seals.



Sec.1.53  Use of NRC seal or replicas.

    (a) The use of the seal or replicas is restricted to the following:
    (1) NRC letterhead stationery;
    (2) NRC award certificates and medals;
    (3) Security credentials and employee identification cards;
    (4) NRC documents, including agreements with States, interagency or 
governmental agreements, foreign patent applications, certifications, 
special reports to the President and Congress and, at the discretion of 
the Secretary of the Commission, such other documents as the Secretary 
finds appropriate;
    (5) Plaques--the design of the seal may be incorporated in plaques 
for display at NRC facilities in locations such as auditoriums, 
presentation rooms, lobbies, offices of senior officials, on the fronts 
of buildings, and other places designated by the Secretary;
    (6) The NRC flag (which incorporates the design of the seal);
    (7) Official films prepared by or for the NRC, if deemed appropriate 
by the Director of Governmental and Public Affairs;
    (8) Official NRC publications that represent an achievement or 
mission of NRC as a whole, or that are cosponsored by NRC and other 
Government departments or agencies; and
    (9) Any other uses as the Secretary of the Commission finds 
appropriate.
    (b) Any person who uses the official seal in a manner other than as 
permitted by this section shall be subject to the provisions of 18 
U.S.C. 1017, which provides penalties for the fraudulent or wrongful use 
of an official seal, and to other provisions of law as applicable.



Sec.1.55  Establishment of official NRC flag.

    The official flag is based on the design of the NRC seal. It is 50 
inches by 66 inches in size with a 38-inch diameter seal incorporated in 
the center of a dark blue field with a gold fringe.



Sec.1.57  Use of NRC flag.

    (a) The use of the flag is restricted to the following:
    (1) On or in front of NRC installations;

[[Page 18]]

    (2) At NRC ceremonies;
    (3) At conferences involving official NRC participation (including 
permanent display in NRC conference rooms);
    (4) At Governmental or public appearances of NRC executives;
    (5) In private offices of senior officials; or
    (6) As the Secretary of the Commission otherwise authorizes.
    (b) The NRC flag must only be displayed together with the U.S. flag.

When they are both displayed on a speaker's platform, the U.S. flag must 
occupy the position of honor and be placed at the speaker's right as he 
or she faces the audience, and the NRC flag must be placed at the 
speaker's left.



Sec.1.59  Report of violations.

    In order to ensure adherence to the authorized uses of the NRC seal 
and flag as provided in this subpart, a report of each suspected 
violation of this subpart, or any questionable use of the NRC seal or 
flag, should be submitted to the Secretary of the Commission.



PART 2_AGENCY RULES OF PRACTICE AND PROCEDURE--Table of Contents



Sec.
2.1 Scope.
2.2 Subparts.
2.3 Resolution of conflict.
2.4 Definitions.
2.8 Information collection requirements: OMB approval.

 Subpart A_Procedure for Issuance, Amendment, Transfer, or Renewal of a 
                  License, and Standard Design Approval

2.100 Scope of subpart.
2.101 Filing of application.
2.102 Administrative review of application.
2.103 Action on applications for byproduct, source, special nuclear 
          material, facility and operator licenses.

                  Hearing on Application--How Initiated

2.104 Notice of hearing.
2.105 Notice of proposed action.
2.106 Notice of issuance.
2.107 Withdrawal of application.
2.108 Denial of application for failure to supply information.
2.109 Effect of timely renewal application.
2.110 Filing and administrative action on submittals for standard design 
          approval or early review of site suitability issues.
2.111 Prohibition of sex discrimination.

     Subpart B_Procedure for Imposing Requirements by Order, or for 
 Modification, Suspension, or Revocation of a License, or for Imposing 
                             Civil Penalties

2.200 Scope of subpart.
2.201 Notice of violation.
2.202 Orders.
2.203 Settlement and compromise.
2.204 Demand for information.
2.205 Civil penalties.
2.206 Requests for action under this subpart.

Subpart C_Rules of General Applicability: Hearing Requests, Petitions To 
  Intervene, Availability of Documents, Selection of Specific Hearing 
Procedures, Presiding Officer Powers, and General Hearing Management for 
                        NRC Adjudicatory Hearings

2.300 Scope of subpart C.
2.301 Exceptions.
2.302 Filing of documents.
2.303 Docket.
2.304 Formal requirements for documents; signatures; acceptance for 
          filing.
2.305 Service of documents, methods, proof.
2.306 Computation of time.
2.307 Extension and reduction of time limits; delegated authority to 
          order use of procedures for access by potential parties to 
          certain sensitive unclassified information.
2.308 Treatment of requests for hearing or petitions for leave to 
          intervene by the Secretary.
2.309 Hearing requests, petitions to intervene, requirements for 
          standing, and contentions.
2.310 Selection of hearing procedures.
2.311 Interlocutory review of rulings on requests for hearings/petitions 
          to intervene, selection of hearing procedures, and requests by 
          potential parties for access to sensitive unclassified non-
          safeguards information and safeguards information.
2.312 Notice of hearing.
2.313 Designation of presiding officer, disqualification, 
          unavailability, and substitution.
2.314 Appearance and practice before the Commission in adjudicatory 
          proceedings.
2.315 Participation by a person not a party.
2.316 Consolidation of parties.
2.317 Separate hearings; consolidation of proceedings.
2.318 Commencement and termination of jurisdiction of presiding officer.
2.319 Power of the presiding officer.
2.320 Default.
2.321 Atomic Safety and Licensing Boards.

[[Page 19]]

2.322 Special assistants to the presiding officer.
2.323 Motions.
2.324 Order of procedure.
2.325 Burden of proof.
2.326 Motions to reopen.
2.327 Official recording; transcript.
2.328 Hearings to be public.
2.329 Prehearing conference.
2.330 Stipulations.
2.331 Oral argument before the presiding officer.
2.332 General case scheduling and management.
2.333 Authority of the presiding officer to regulate procedure in a 
          hearing.
2.334 Implementing hearing schedule for proceeding.
2.335 Consideration of Commission rules and regulations in adjudicatory 
          proceedings.
2.336 General discovery.
2.337 Evidence at a hearing.
2.338 Settlement of issues; alternative dispute resolution.
2.339 Expedited decisionmaking procedure.
2.340 Initial decision in certain contested proceedings; immediate 
          effectiveness of initial decisions; issuance of 
          authorizations, permits, and licenses.
2.341 Review of decisions and actions of a presiding officer.
2.342 Stays of decisions.
2.343 Oral argument.
2.344 Final decision.
2.345 Petition for reconsideration.
2.346 Authority of the Secretary.
2.347 Ex parte communications.
2.348 Separation of functions.
2.390 Public inspections, exemptions, requests for withholding.

   Subpart D_Additional Procedures Applicable to Proceedings for the 
Issuance of Licenses To Construct and/or Operate Nuclear Power Plants of 
                   Identical Design at Multiple Sites

2.400 Scope of subpart.
2.401 Notice of hearing on construction permit or combined license 
          applications pursuant to appendix N of 10 CFR parts 50 or 52.
2.402 Separate hearings on separate issues; consolidation of 
          proceedings.
2.403 Notice of proposed action on applications for operating licenses 
          pursuant to appendix N of 10 CFR part 50.
2.404 Hearings on applications for operating licenses pursuant to 
          appendix N of 10 CFR part 50.
2.405 Initial decisions in consolidated hearings.
2.406 Finality of decisions on separate issues.
2.407 Applicability of other sections.

   Subpart E_Additional Procedures Applicable to Proceedings for the 
    Issuance of Licenses To Manufacture Nuclear Power Reactors To Be 
Operated at Sites Not Identified in the License Application and Related 
                          Licensing Proceedings

2.500 Scope of subpart.
2.501 Notice of hearing on application under subpart F of 10 CFR part 52 
          for a license to manufacture nuclear power reactors.
2.502-2.504 [Reserved]

Subpart F_Additional Procedures Applicable to Early Partial Decisions on 
    Site Suitability Issues in Connection With an Application for a 
Construction Permit or Combined License To Construct Certain Utilization 
     Facilities; and Advance Issuance of Limited Work Authorizations

2.600 Scope of subpart.
2.601 Applicability of other sections.

    Early Partial Decisions on Site Suitability--Construction Permit

2.602 Filing Fees.
2.603 Acceptance and docketing of application for early review of site 
          suitability issues in a construction permit proceeding.
2.604 Notice of hearing on application for early review of site 
          suitability issues in construction permit proceeding.
2.605 Additional considerations.
2.606 Partial decision on site suitability issues in construction permit 
          proceeding.

 Early Partial Decisions on Site Suitability--Combined License Under 10 
                               CFR Part 52

2.621 Acceptance and docketing of application for early review of site 
          suitability issues in a combined license proceeding.
2.623 Notice of hearing on application for early review of site 
          suitability issues in combined license proceeding.
2.625 Additional considerations.
2.627 Partial decision on site suitability issues in combined license 
          proceeding.
2.629 Finality of partial decision on site suitability issues in 
          combined license proceeding.

        Phased Applications Involving Limited Work Authorizations

2.641 Filing fees.
2.643 Acceptance and docketing of application for limited work 
          authorization.
2.645 Notice of hearing.
2.647 [Reserved]
2.649 Partial decisions on limited work authorization.

[[Page 20]]

                Subpart G_Rules for Formal Adjudications

2.700 Scope of subpart G.
2.701 Exceptions.
2.702 Subpoenas.
2.703 Examination by experts.
2.704 Discovery--required disclosures.
2.705 Discovery--additional methods.
2.706 Depositions upon oral examination and written interrogatories; 
          interrogatories to parties.
2.707 Production of documents and things; entry upon land for inspection 
          and other purposes.
2.708 Admissions.
2.709 Discovery against NRC staff.
2.710 Motions for summary disposition.
2.711 Evidence.
2.712 Proposed findings and conclusions.
2.713 Initial decision and its effect.

                          Subpart H_Rulemaking

2.800 Scope and applicability.
2.801 Initiation of rulemaking.
2.802 Petition for rulemaking--requirements for filing.
2.803 Petition for rulemaking--NRC action.
2.804 Notice of proposed rulemaking.
2.805 Participation by interested persons.
2.806 Commission action.
2.807 Effective date.
2.808 Authority of the Secretary to rule on procedural matters.
2.809 Participation by the Advisory Committee on Reactor Safeguards.
2.810 NRC size standards.
2.811 Filing of standard design certification application; required 
          copies.
2.813 Written communications.
2.815 Docketing and acceptance review.
2.817 Withdrawal of application.
2.819 Denial of application for failure to supply information.

  Subpart I_Special Procedures Applicable to Adjudicatory Proceedings 
     Involving Restricted Data and/or National Security Information

2.900 Purpose.
2.901 Scope of subpart I.
2.902 Definitions.
2.903 Protection of restricted data and national security information.
2.904 Classification assistance.
2.905 Access to restricted data and national security information for 
          parties; security clearances.
2.906 Obligation of parties to avoid introduction of restricted data or 
          national security information.
2.907 Notice of intent to introduce restricted data or national security 
          information.
2.908 Contents of notice of intent to introduce restricted data or other 
          national security information.
2.909 Rearrangement or suspension of proceedings.
2.910 Unclassified statements required.
2.911 Admissibility of restricted data or other national security 
          information.
2.912 Weight to be attached to classified evidence.
2.913 Review of Restricted Data or other National Security Information 
          received in evidence.

   Subpart J_Procedures Applicable to Proceedings for the Issuance of 
 Licenses for the Receipt of High-Level Radioactive Waste at a Geologic 
                               Repository

2.1000 Scope of subpart J.
2.1001 Definitions.
2.1002 [Reserved]
2.1003 Availability of material.
2.1004 Amendments and additions.
2.1005 Exclusions.
2.1006 Privilege.
2.1007 Access.
2.1008 [Reserved]
2.1009 Procedures.
2.1010 Pre-License Application Presiding Officer.
2.1011 Management of electronic information.
2.1012 Compliance.
2.1013 Use of the electronic docket during the proceeding.
2.1015 Appeals.
2.1017 Computation of time.
2.1018 Discovery.
2.1019 Depositions.
2.1020 Entry upon land for inspection.
2.1021 First prehearing conference.
2.1022 Second prehearing conference.
2.1023 Immediate effectiveness.
2.1025 Authority of the Presiding Officer to dispose of certain issues 
          on the pleadings.
2.1026 Schedule.
2.1027 Sua sponte.

Subpart K_Hybrid Hearing Procedures for Expansion of Spent Nuclear Fuel 
           Storage Capacity at Civilian Nuclear Power Reactors

2.1101 Purpose.
2.1103 Scope of subpart K.
2.1105 Definitions.
2.1107 Notice of proposed action.
2.1109 Requests for oral argument.
2.1113 Oral argument.
2.1115 Designation of issues for adjudicatory hearing.
2.1117 Burden of proof.
2.1119 Applicability of other sections.

[[Page 21]]

      Subpart L_Simplified Hearing Procedures for NRC Adjudications

2.1201 Definitions.
2.1202 Authority and role of NRC staff.
2.1203 Hearing file; prohibition on discovery.
2.1204 Motions and requests.
2.1205 Summary disposition.
2.1206 Informal hearings.
2.1207 Process and schedule for submissions and presentations in an oral 
          hearing.
2.1208 Process and schedule for a hearing consisting of written 
          presentations.
2.1209 Findings of fact and conclusions of law.
2.1210 Initial decision and its effect.
2.1212 Petitions for Commission review of initial decisions.
2.1213 Application for a stay.

   Subpart M_Procedures for Hearings on License Transfer Applications

2.1300 Scope of subpart M.
2.1301 Public notice of receipt of a license transfer application.
2.1302 Notice of withdrawal of an application.
2.1303 Availability of documents.
2.1305 Written comments.
2.1308 Oral hearings.
2.1309 Notice of oral hearing.
2.1310 Notice of hearing consisting of written comments.
2.1311 Conditions in a notice or order.
2.1315 Generic determination regarding license amendments to reflect 
          transfers.
2.1316 Authority and role of NRC staff.
2.1319 Presiding Officer.
2.1320 Responsibility and power of the Presiding Officer in an oral 
          hearing.
2.1321 Participation and schedule for submissions in a hearing 
          consisting of written comments.
2.1322 Participation and schedule for submissions in an oral hearing.
2.1323 Presentation of testimony in an oral hearing.
2.1324 Appearance in an oral hearing.
2.1325 Motions and requests.
2.1327 Application for a stay of the effectiveness of NRC staff action 
          on license transfer.
2.1331 Commission action.

           Subpart N_Expedited Proceedings with Oral Hearings

2.1400 Purpose and scope of subpart N.
2.1401 Definitions.
2.1402 General procedures and limitations; requests for other 
          procedures.
2.1403 Authority and role of the NRC staff.
2.1404 Prehearing conference.
2.1405 Hearing.
2.1406 Initial decision--issuance and effectiveness.
2.1407 Appeal and Commission review of initial decision.

                     Subpart O_Legislative Hearings

2.1500 Purpose and scope.
2.1501 Definitions.
2.1502 Commission decision to hold legislative hearing.
2.1503 Authority of presiding officer.
2.1504 Request to participate in legislative hearing.
2.1505 Role of the NRC staff.
2.1506 Written statements and submission of information.
2.1507 Oral hearing.
2.1508 Recommendation of presiding officer.
2.1509 Ex parte communications and separation of functions.

Appendix A to Part 2 [Reserved]
Appendix B to Part 2--Model Milestones To Be Used By a Presiding Officer 
          as a Guideline in Developing a Hearing Schedule for the 
          Conduct of an Adjudicatory Proceeding in Accordance With 10 
          CFR 2.332.
Appendix C to Part 2 [Reserved]
Appendix D to Part 2--Schedule for the Proceeding on Consideration of 
          Construction Authorization for a High-Level Waste Geologic 
          Repository.

    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 28 U.S.C. 2461 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).

    Source: 27 FR 377, Jan. 13, 1962, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 2 appear at 79 FR 
75739, Dec. 19, 2014.



Sec.2.1  Scope.

    This part governs the conduct of all proceedings, other than export 
and import licensing proceedings described in part 110, under the Atomic 
Energy Act of 1954, as amended, and the Energy Reorganization Act of 
1974, for--
    (a) Granting, suspending, revoking, amending, or taking other action 
with

[[Page 22]]

respect to any license, construction permit, or application to transfer 
a license;
    (b) Issuing orders and demands for information to persons subject to 
the Commission's jurisdiction, including licensees and persons not 
licensed by the Commission;
    (c) Imposing civil penalties under Section 234 of the Act;
    (d) Rulemaking under the Act and the Administrative Procedure Act; 
and
    (e) Standard design approvals under part 52 of this chapter.

[56 FR 40684, Aug. 15, 1991, as amended at 72 FR 49470, Aug. 28, 2007]



Sec.2.2  Subparts.

    Each subpart other than subpart C of this part sets forth special 
rules applicable to the type of proceeding described in the first 
section of that subpart. Subpart C sets forth general rules applicable 
to all types of proceedings except rulemaking, and should be read in 
conjunction with the subpart governing a particular proceeding. Subpart 
I of this part sets forth special procedures to be followed in 
proceedings in order to safeguard and prevent disclosure of Restricted 
Data.

[69 FR 2233, Jan. 14, 2004]



Sec.2.3  Resolution of conflict.

    (a) In any conflict between a general rule in subpart C of this part 
and a special rule in another subpart or other part of this chapter 
applicable to a particular type of proceeding, the special rule governs.
    (b) Unless otherwise specifically referenced, the procedures in this 
part do not apply to hearings in 10 CFR parts 4, 9, 10, 11, 12, 13, 15, 
16, and subparts H and I of 10 CFR part 110.

[69 FR 2233, Jan. 14, 2004]



Sec.2.4  Definitions.

    As used in this part,
    ACRS means the Advisory Committee on Reactor Safeguards established 
by the Act.
    Act means the Atomic Energy Act of 1954, as amended (68 Stat. 919).
    Adjudication means the process for the formulation of an order for 
the final disposition of the whole or any part of any proceeding subject 
to this part, other than rule making.
    Administrative Law Judge means an individual appointed pursuant to 
section 11 of the Administrative Procedure Act to conduct proceedings 
subject to this part.
    Commission means the Commission of five members or a quorum thereof 
sitting as a body, as provided by section 201 of the Energy 
Reorganization Act of 1974 (88 Stat. 1242), or any officer to whom has 
been delegated authority pursuant to section 161n of the Act.
    Commission adjudicatory employee means--
    (1) The Commissioners and members of their personal staffs;
    (2) The employees of the Office of Commission Appellate 
Adjudication;
    (3) The members of the Atomic Safety and Licensing Board Panel and 
staff assistants to the Panel;
    (4) A presiding officer appointed under Sec.2.313, and staff 
assistants to a presiding officer;
    (5) Special assistants (as defined in Sec.2.322);
    (6) The General Counsel, the Solicitor, the Associate General 
Counsel for Licensing and Regulation, and employees of the Office of the 
General Counsel under the supervision of the Solicitor;
    (7) The Secretary and employees of the Office of the Secretary; and
    (8) Any other Commission officer or employee who is appointed by the 
Commission, the Secretary, or the General Counsel to participate or 
advise in the Commission's consideration of an initial or final decision 
in a proceeding. Any other Commission officer or employee who, as 
permitted by Sec.2.348, participates or advises in the Commission's 
consideration of an initial or final decision in a proceeding must be 
appointed as a Commission adjudicatory employee under this paragraph and 
the parties to the proceeding must be given written notice of the 
appointment.
    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;

[[Page 23]]

    (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 a standard design certification under part 
52 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.
    Department means the Department of Energy established by the 
Department of Energy Organization Act (Pub. L. 95-91, 91 Stat. 565 42 
U.S.C. 7101 et seq.) to the extent that the Department, or its duly 
authorized representatives, exercises functions formerly vested in the 
U.S. Atomic Energy Commission, its Chairman, members, officers and 
components and transferred to the U.S. Energy Research and Development 
Administration and to the Administrator thereof pursuant to sections 104 
(b), (c) and (d) of the Energy Reorganization Act of 1974 (Pub. L. 93-
438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the 
Secretary of Energy pursuant to section 301(a) of the Department of 
Energy Organization Act (Pub. L. 95-91, 91 Stat. 565 at 577-578, 42 
U.S.C. 7151).
    Digital ID certificate means a file stored on a participant's 
computer that contains the participant's name, e-mail address, and 
participant's digital signature, proves the participant's identity when 
filing documents and serving participants electronically through the E-
Filing system, and contains public keys, which allow for the encryption 
and decryption of documents so that the documents can be securely 
transferred over the Internet.
    Electric utility means any entity that generates or distributes 
electricity and which recovers the costs of this electricity, either 
directly or indirectly through rates established by the entity itself or 
by a separate regulatory authority. Investor-owned utilities including 
generation or distribution subsidiaries, public utility districts, 
municipalities, rural electric cooperatives, and State and Federal 
agencies, including associations of any of the foregoing, are included 
within the meaning of ``electric utility.''
    Electronic acknowledgment means a communication transmitted 
electronically from the E-Filing system to the submitter confirming 
receipt of electronic filing and service.
    Electronic Hearing Docket means the publicly available Web site 
which houses a visual presentation of the docket and a link to its 
files.
    E-Filing System means an electronic system that receives, stores, 
and distributes documents filed in proceedings for which an electronic 
hearing docket has been established.
    Ex parte communication means an oral or written communication not on 
the public record with respect to which reasonable prior notice to all 
parties is not given.
    Facility means a production facility or a utilization facility as 
defined in Sec.50.2 of this chapter.
    Guidance for Electronic Submissions to the NRC means the document 
issued by the Commission that sets forth the transmission methods and 
formatting standards for filing and service under E-Filing. The document 
can be obtained by visiting the NRC's Web site at http://www.nrc.gov.
    Investigative or litigating function means--
    (1) Personal participation in planning, conducting, or supervising 
an investigation; or
    (2) Personal participation in planning, developing, or presenting, 
or in supervising the planning, development or presentation of 
testimony, argument, or strategy in a proceeding.
    License means a license, including an early site permit, 
construction permit, operating license, combined license, manufacturing 
license, or renewed license issued by the Commission.
    Licensee means a person who is authorized to conduct activities 
under a license.
    NRC personnel means:
    (1) NRC employees;
    (2) For the purpose of Sec. Sec.2.702 and 2.709 only, persons 
acting in the capacity of consultants to the Commission, regardless of 
the form of the contractual arrangements under which such persons act as 
consultants to the Commission; and

[[Page 24]]

    (3) Members of advisory boards, committees, and panels of the NRC; 
members of boards designated by the Commission to preside at 
adjudicatory proceedings; and officers or employees of Government 
agencies, including military personnel, assigned to duty at the NRC.
    NRC Public Document Room means the facility at One White Flint 
North, 11555 Rockville Pike (first floor), Rockville, Maryland, where 
certain public records of the NRC that were made available for public 
inspection in paper or microfiche prior to the implementation of the NRC 
Agencywide Documents Access and Management System, commonly referred to 
as ADAMS, will remain available for public inspection. It is also the 
place where NRC makes computer terminals available to access the 
Publicly Available Records System (PARS) component of ADAMS on the NRC 
Web site, http://www.nrc.gov, and where copies of publicly available 
documents can be viewed or ordered for a fee as set forth in Sec.9.35 
of this chapter. The facility is staffed with reference librarians to 
assist the public in identifying and locating documents and in using the 
NRC Web site and ADAMS. The NRC Public Document Room is open from 7:45 
am to 4:15 pm, Monday through Friday, except on Federal holidays. 
Reference service and access to documents may also be requested by 
telephone (301-415-4737 or 800-397-4209) between 8:30 am and 4:15 pm, or 
by e-mail ([email protected]), facsimile (301-415-3548), or letter (NRC Public 
Document Room, One White Flint North, 11555 Rockville Pike (first 
floor), Rockville, Maryland 20852-2738).
    NRC records and documents means any book, paper, map, photograph, 
brochure, punch card, magnetic tape, paper tape, sound recording, 
pamphlet, slide, motion picture, or other documentary material 
regardless of form or characteristics, made by, in the possession of, or 
under the control of the NRC pursuant to Federal law or in connection 
with the transaction of public business as evidence of NRC organization, 
functions, policies, decisions, procedures, operations, programs or 
other activities. ``NRC records and documents'' do not include objects 
or articles such as structures, furniture, tangible exhibits or models, 
or vehicles and equipment.
    NRC Web site, http://www.nrc.gov, is the Internet uniform resource 
locator name for the Internet address of the Web site where NRC will 
ordinarily make available its public records for inspection.
    Optical Storage Media means any physical computer component that 
meets E-Filing Guidance standards for storing, saving, and accessing 
electronic documents.
    Participant means an individual or organization (including a 
governmental entity) that has petitioned to intervene in a proceeding or 
requested a hearing but that has not yet been granted party status by an 
Atomic Safety and Licensing Board or other presiding officer. 
Participant also means a party to a proceeding and any interested State, 
local governmental body, or Federally-recognized Indian Tribe that seeks 
to participate in a proceeding under Sec.2.315(c). For the purpose of 
service of documents, the NRC staff is considered a participant even if 
not participating as a party.
    Person means (1) any individual, corporation, partnership, firm, 
association, trust, estate, public or private institution, group, 
government agency other than the Commission or the Department, except 
that the Department shall be considered a person with respect to those 
facilities of the Department specified in section 202 of the Energy 
Reorganization Act of 1974 (88 Stat. 1244), any State or any political 
subdivision of, or any political entity within a State, any foreign 
government or nation or any political subdivision of any such government 
or nation, or other entity; and (2) any legal successor, representative, 
agent, or agency of the foregoing.
    Potential party means any person who has requested, or who may 
intend to request, a hearing or petition to intervene in a hearing under 
10 CFR part 2, other than hearings conducted under Subparts J and M of 
10 CFR part 2.
    Presiding officer means the Commission, an administrative law judge, 
an administrative judge, an Atomic Safety and Licensing Board, or other 
person designated in accordance with the provisions of this part, 
presiding over

[[Page 25]]

the conduct of a hearing conducted under the provisions of this part.
    Public Document Room means the place at One White Flint North, 11555 
Rockville Pike (first floor), Rockville, Maryland 20852-2738, at which 
public records of the Commission will ordinarily be made available for 
inspection.
    Safeguards Information means information not classified as National 
Security Information or Restricted Data which specifically identifies a 
licensee's or applicant's detailed control and accounting procedures for 
the physical protection of special nuclear material in quantities 
determined by the Commission through order or regulation to be 
significant to the public health and safety or the common defense and 
security; detailed security measures (including security plans, 
procedures, and equipment) for the physical protection of source, 
byproduct, or special nuclear material in quantities determined by the 
Commission through order or regulation to be significant to the public 
health and safety or the common defense and security; security measures 
for the physical protection and location of certain plant equipment 
vital to the safety of production or utilization facilities; and any 
other information within the scope of Section 147 of the Atomic Energy 
Act of 1954, as amended, the unauthorized disclosure of which, as 
determined by the Commission through order or regulation, could 
reasonably be expected to have a significant adverse effect on the 
health and safety of the public or the common defense and security by 
significantly increasing the likelihood of sabotage or theft or 
diversion of source, byproduct, or special nuclear material.
    Secretary means the Secretary to the Commission.
    Except as redefined in this section, words and phrases which are 
defined in the Act and in this chapter have the same meaning when used 
in this part.

[27 FR 377, Jan. 13, 1962]

    Editorial Note: For Federal Register citations affecting Sec.2.4, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfoo.gov.



Sec.2.8  Information collection requirements: OMB approval.

    This part contains no information collection requirements and 
therefore is not subject to requirements of the Paperwork Reduction Act 
(44 U.S.C. 3501 et seq.).

[61 FR 43408, Aug. 22, 1996]



 Subpart A_Procedure for Issuance, Amendment, Transfer, or Renewal of a 
                  License, and Standard Design Approval



Sec.2.100  Scope of subpart.

    This subpart prescribes the procedure for issuance of a license; 
amendment of a license at the request of the licensee; transfer and 
renewal of a license; and issuance of a standard design approval under 
subpart E of part 52 of this chapter.

[72 FR 49470, Aug. 28, 2007]



Sec.2.101  Filing of application.

    (a)(1) An application for a permit, a license, a license transfer, a 
license amendment, a license renewal, or a standard design approval, 
shall be filed with the Director, Office of New Reactors, the Director, 
Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear 
Material Safety and Safeguards, as prescribed by the applicable 
provisions of this chapter. A prospective applicant may confer 
informally with the NRC staff before filing an application.
    (2) Each application for a license for a facility or for receipt of 
waste radioactive material from other persons for the purpose of 
commercial disposal by the waste disposal licensee will be assigned a 
docket number. However, to allow a determination as to whether an 
application for a limited work authorization, construction permit, 
operating license, early site permit, standard design approval, combined 
license, or manufacturing license for a production or utilization 
facility is complete and acceptable for docketing, it will be initially 
treated as a tendered application. A copy of the tendered application 
will be available for public inspection at the NRC Web site, http://

[[Page 26]]

www.nrc.gov, and/or at the NRC PDR. Generally, the determination on 
acceptability for docketing will be made within a period of 30 days. 
However, in selected applications, the Commission may decide to 
determine acceptability based on the technical adequacy of the 
application as well as its completeness. In these cases, the Commission, 
under Sec.2.104(a), will direct that the notice of hearing be issued 
as soon as practicable after the application has been tendered, and the 
determination of acceptability will be made generally within a period of 
60 days. For docketing and other requirements for applications under 
part 61 of this chapter, see paragraph (f) of this section.
    (3) If the Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, determines that a tendered application 
for a construction permit or operating license for a production or 
utilization facility, and/or any environmental report required pursuant 
to subpart A of part 51 of this chapter, or part thereof as provided in 
paragraphs (a)(5) or (a-1) of this section are complete and acceptable 
for docketing, a docket number will be assigned to the application or 
part thereof, and the applicant will be notified of the determination. 
With respect to the tendered application and/or environmental report or 
part thereof that is acceptable for docketing, the applicant will be 
requested to:
    (i) Submit to the Director, Office of Nuclear Reactor Regulation, 
Director, Office of New Reactors, or Director, Office of Nuclear 
Material Safety and Safeguards, as appropriate, such additional copies 
as the regulations in part 50 and subpart A of part 51 of this chapter 
require;
    (ii) Serve a copy on the chief executive of the municipality in 
which the facility or site which is the subject of an early site permit 
is to be located or, if the facility or site which is the subject of an 
early site permit is not to be located within a municipality, on the 
chief executive of the county, and serve a notice of availability of the 
application or environmental report on the chief executives of the 
municipalities or counties which have been identified in the application 
or environmental report as the location of all or part of the 
alternative sites, containing as applicable, the docket number of the 
application; a brief description of the proposed site and facility; the 
location of the site and facility as primarily proposed and 
alternatively listed; the name, address, telephone number, and e-mail 
address (if available) of the applicant's representative who may be 
contacted for further information; notification that a draft 
environmental impact statement will be issued by the Commission and will 
be made available upon request to the Commission; and notification that 
if a request is received from the appropriate chief executive, the 
applicant will transmit a copy of the application and environmental 
report, and any changes to these documents which affect the alternative 
site location, to the executive who makes the request. In complying with 
the requirements of this paragraph, the applicant should not make public 
distribution of those parts of the application subject to Sec.
2.390(d). The applicant shall submit to the Director, Office of New 
Reactors or Director, Office of Nuclear Reactor Regulation, as 
appropriate, an affidavit that service of the notice of availability of 
the application or environmental report has been completed along with a 
list of names and addresses of those executives upon whom the notice was 
served; and
    (iii) Make direct distribution of additional copies to Federal, 
State, and local officials in accordance with the requirements of this 
chapter and written instructions furnished to the applicant by the 
Director, Office of Nuclear Reactor Regulation, Director, Office of New 
Reactors, or Director, Office of Nuclear Material Safety and Safeguards, 
as appropriate. Such written instructions will be furnished as soon as 
practicable after all or any part of the application, or environmental 
report, is tendered. The copies submitted to the Director, Office of 
Nuclear Reactor Regulation, Director, Office of New Reactors, or 
Director, Office of Nuclear Material Safety and Safeguards, or, as 
appropriate, and distributed by the applicant shall be completely 
assembled

[[Page 27]]

documents, identified by docket number. Subsequently distributed 
amendments to applications, however, may include revised pages to 
previous submittals and, in such cases, the recipients will be 
responsible for inserting the revised pages.
    (4) The tendered application for a construction permit, operating 
license, early site permit, standard design approval, combined license, 
or manufacturing license will be formally docketed upon receipt by the 
Director, Office of New Reactors, Director, Office of Nuclear Reactor 
Regulation, or Director, Office of Nuclear Material Safety and 
Safeguards, as appropriate, of the required additional copies. 
Distribution of the additional copies shall be deemed to be complete as 
of the time the copies are deposited in the mail or with a carrier 
prepaid for delivery to the designated addresses. The date of docketing 
shall be the date when the required copies are received by the Director, 
Office of New Reactors, Director, Office of Nuclear Reactor Regulation, 
or Director, Office of Nuclear Material Safety and Safeguards, as 
appropriate. Within 10 days after docketing, the applicant shall submit 
to the Director, Office of New Reactors, Director, Office of Nuclear 
Reactor Regulation, or Director, Office of Nuclear Material Safety and 
Safeguards, as appropriate, an affidavit that distribution of the 
additional copies to Federal, State, and local officials has been 
completed in accordance with requirements of this chapter and written 
instructions furnished to the applicant by the Director, Office of New 
Reactors, Director, Office of Nuclear Reactor Regulation, or Director, 
Office of Nuclear Material Safety and Safeguards, as appropriate. 
Amendments to the application and environmental report shall be filed 
and distributed and an affidavit shall be furnished to the Director, 
Office of New Reactors, Director, Office of Nuclear Reactor Regulation, 
or Director, Office of Nuclear Material Safety and Safeguards, as 
appropriate, in the same manner as for the initial application and 
environmental report. If it is determined that all or any part of the 
tendered application and/or environmental report is incomplete and 
therefore not acceptable for processing, the applicant will be informed 
of this determination, and the respects in which the document is 
deficient.
    (5) An applicant for a construction permit under part 50 of this 
chapter or a combined license under part 52 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 
(b)(3) or Sec.50.22 of this chapter or is a testing facility may 
submit the information required of applicants by part 50 or part 52 of 
this chapter in two parts. One part shall be accompanied by the 
information required by Sec.50.30(f) of this chapter, or Sec.
52.80(b) 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), 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, Director, Office of New Reactors, 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. Sec.50.30(e) and 170.21 of this chapter and the information 
required by Sec. Sec.50.33, 50.34(a)(1), or 52.79(a)(1), as 
applicable, and Sec.50.37 of this chapter. The Director, Office of 
Nuclear Reactor Regulation, Director, Office of New Reactors, or 
Director, Office of Nuclear Material Safety and Safeguards, as 
appropriate, will accept for docketing an application for a construction 
permit under part 52 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 (b)(3) or Sec.50.22 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

[[Page 28]]

Regulation, Director, Office of New Reactors, or Director, Office of 
Nuclear Material Safety and Safeguards, as appropriate, that it is 
complete.
    (6)-(8) [Reserved]
    (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 (b)(3) or Sec.50.22 of this 
chapter, an applicant for or holder of an early site permit under part 
52 of this chapter, or an applicant for a combined license under part 52 
of this chapter, who seeks to conduct the activities authorized under 
Sec.50.10(d) of this chapter may submit a complete application under 
paragraphs (a)(1) through (a)(4) of this section which includes the 
information required by Sec.50.10(d) 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) of this chapter, and the information required by Sec.
50.10(d)(2) and (d)(3) of this chapter.
    (ii) Part two must include the remaining information required by the 
Commission's regulations in this chapter which was not submitted in part 
one, provided, however, that this information may be submitted in 
accordance with the applicable provisions of paragraph (a)(5) of this 
section, or, for a construction permit applicant, paragraph (a)(1) of 
this section. Part two of the application must be submitted no later 
than 18 months after submission of part one.
    (a-1) Early consideration of site suitability issues. An applicant 
for a construction permit under part 50 of this chapter or a combined 
license under part 52 of this chapter 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 of this chapter or 
is a testing facility, may request that the Commission conduct an early 
review and hearing and render an early partial decision in accordance 
with subpart F of this part on issues of site suitability within the 
purview of the applicable provisions of parts 50, 51, 52, and 100 of 
this chapter.
    (1) Construction permit. The applicant for the construction permit 
may submit the information required of applicants by the provisions of 
this chapter in three parts:
    (i) Part one shall include or be accompanied by any information 
required by Sec. Sec.50.34(a)(1) and 50.30(f) of this chapter which 
relates to the issue(s) of site suitability for which an early review, 
hearing, and partial decision are sought, except that information with 
respect to operation of the facility at the projected initial power 
level need not be supplied, and shall include the information required 
by Sec. Sec.50.33(a) through (e) and 50.37 of this chapter. The 
information submitted shall also include:
    (A) Proposed findings on the issues of site suitability on which the 
applicant has requested review and a statement of the bases or the 
reasons for those findings,
    (B) A range of postulated facility design and operation parameters 
that is sufficient to enable the Commission to perform the requested 
review of site suitability issues under the applicable provisions of 
parts 50, 51, and 100, and
    (C) Information concerning the applicant's site selection process 
and long-range plans for ultimate development of the site required by 
Sec.2.603(b)(1).
    (ii) Part two shall include or be accompanied by the remaining 
information required by Sec. Sec.50.30(f), 50.33, and 50.34(a)(1) of 
this chapter.
    (iii) Part three shall include the remaining information required by 
Sec. Sec.50.34a and (in the case of a nuclear power reactor) 50.34(a) 
of this chapter.
    (iv) The information required for part two or part three shall be 
submitted during the period the partial decision on part one is 
effective. Submittal of the information required for part three may 
precede by no more than 6 months or follow by no more than 6 months the 
submittal of the information required for part two.
    (2) Combined license under part 52. An applicant for a combined 
license under part 52 of this chapter may submit the information 
required of applicants by the provisions of this chapter in three parts:
    (i) Part one shall include or be accompanied by any information 
required

[[Page 29]]

by Sec. Sec.52.79(a)(1) and 50.30(f) of this chapter which relates to 
the issue(s) of site suitability for which an early review, hearing, and 
partial decision are sought, except that information with respect to 
operation of the facility at the projected initial power level need not 
be supplied, and shall include the information required by Sec. Sec.
50.33(a) through (e) and 50.37 of this chapter. The information 
submitted shall also include:
    (A) Proposed findings on the issues of site suitability on which the 
applicant has requested review and a statement of the bases or the 
reasons for those findings;
    (B) A range of postulated facility design and operation parameters 
that is sufficient to enable the Commission to perform the requested 
review of site suitability issues under the applicable provisions of 
parts 50, 51, 52, and 100; and
    (C) Information concerning the applicant's site selection process 
and long-range plans for ultimate development of the site required by 
Sec.2.621(b)(1).
    (ii) Part two shall include or be accompanied by the remaining 
information required by Sec. Sec.50.30(f), 50.33, and 52.79(a)(1) of 
this chapter.
    (iii) Part three shall include the remaining information required by 
Sec. Sec.52.79 and 52.80 of this chapter.
    (iv) The information required for part two or part three shall be 
submitted during the period the partial decision on part one is 
effective. Submittal of the information required for part three may 
precede by no more than 6 months or follow by no more than 6 months the 
submittal of the information required for part two.
    (b) After the application has been docketed, each applicant for a 
license for receipt of waste radioactive material from other persons for 
the purpose of commercial disposal by the waste disposal licensee, 
except applicants under part 61 of this chapter, which must comply with 
paragraph (f) of this section, shall serve a copy of the application and 
environmental report, as appropriate, on the chief executive of the 
municipality in which the activity is to be conducted or, if the 
activity is not to be conducted within a municipality on the chief 
executive of the county, and serve a notice of availability of the 
application or environmental report on the chief executives of the 
municipalities or counties which have been identified in the application 
or environmental report as the location of all or part of the 
alternative sites, containing the docket number of the application; a 
brief description of the proposed site and facility; the location of the 
site and facility as primarily proposed and alternatively listed; the 
name, address, telephone number, and email address (if available) of the 
applicant's representative who may be contacted for further information; 
notification that a draft environmental impact statement will be issued 
by the Commission and will be made available upon request to the 
Commission; and notification that if a request is received from the 
appropriate chief executive, the applicant will transmit a copy of the 
application and environmental report, and any changes to such documents 
which affect the alternative site location, to the executive who makes 
the request. In complying with the requirements of this paragraph the 
applicant should not make public distribution of those parts of the 
application subject to Sec.2.390(d). The applicant shall submit to the 
Director, Office of Nuclear Material Safety and Safeguards or as 
appropriate, an affidavit that service of the notice of availability of 
the application or environmental report has been completed along with a 
list of names and addresses of those executives upon whom the notice was 
served.
    (c) Upon receipt and acceptance for docketing of the required 
portions of the application dealing with radiological health and safety 
and environmental matters, notice of receipt will be published in the 
Federal Register including an appropriate notice of hearing.
    (d) The Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, will give notice of the docketing of the 
public health and safety, common defense and security, and environmental 
parts of an application for a license for a facility or

[[Page 30]]

for receipt of waste radioactive material from other persons for the 
purpose of commercial disposal by the waste disposal licensee, except 
that for applications pursuant to part 61 of this chapter, paragraph (f) 
of this section applies to the Governor or other appropriate official of 
the State in which the facility is to be located or the activity is to 
be conducted and will publish in the Federal Register a notice of 
docketing of the application, which states the purpose of the 
application and specifies the location at which the proposed activity 
would be conducted.
    (e)(1) Each application for construction authorization for a HLW 
repository at a geologic repository operations area pursuant to parts 60 
or 63 of this chapter, and each application for a license to receive and 
possess high-level radioactive waste at a geologic repository operations 
area pursuant to parts 60 or 63 of this chapter, and any environmental 
impact statement required in connection therewith pursuant to subpart A 
of part 51 of this chapter shall be processed in accordance with the 
provisions of this paragraph.
    (2) To allow a determination as to whether the application is 
complete and acceptable for docketing, it will be initially treated as a 
tendered document, and a copy will be available for public inspection in 
the Commission's Public Document Room. Twenty copies shall be filed to 
enable this determination to be made.
    (3) If the Director, Office of Nuclear Material Safety and 
Safeguards or as appropriate, determines that the tendered document is 
complete and acceptable for docketing, a docket number will be assigned 
and the applicant will be notified of the determination. If it is 
determined that all or any part of the tendered document is incomplete 
and therefore not acceptable for processing, the applicant will be 
informed of this determination and the respects in which the document is 
deficient.
    (4) [Reserved]
    (5) If a tendered document is acceptable for docketing, the 
applicant will be requested to submit to the Director of Nuclear 
Material Safety and Safeguards such additional copies of the application 
and environmental impact statement as the regulations in part 60 or 63 
and subpart A of part 51 of this chapter require; serve a copy of such 
application and environmental impact statement on the chief executive of 
the municipality in which the geologic repository operations area is to 
be located, or if the geologic repository operations area is not to be 
located within a municipality, on the chief executive of the county (or 
to the Tribal organization, if it is to be located within an Indian 
reservation); and make direct distribution of additional copies to 
Federal, State, Indian Tribe, and local officials in accordance with the 
requirements of this chapter, and written instructions from the Director 
of Nuclear Material Safety and Safeguards. All such copies shall be 
completely assembled documents, identified by docket number. 
Subsequently distributed amendments to the application, however, may 
include revised pages to previous submittals and, in such cases, the 
recipients are responsible for inserting the revised pages.
    (6) The tendered document will be formally docketed upon receipt by 
the Director, Office of Nuclear Material Safety and Safeguards as 
appropriate, of the required additional copies. The date of docketing 
shall be the date when the required copies are received by the Director, 
Office of Nuclear Material Safety and Safeguards, as appropriate. Within 
ten (10) days after docketing, the applicant shall submit to the 
Director, Office of Nuclear Material Safety and Safeguards as 
appropriate, a written statement that distribution of the additional 
copies to Federal, State, Indian Tribe, and local officials has been 
completed in accordance with requirements of this chapter and written 
instructions furnished to the applicant by the Director, Office of 
Nuclear Material Safety and Safeguards, as appropriate. Distribution of 
the additional copies shall be deemed to be complete as of the time the 
copies are deposited in the mail or with a carrier prepaid for delivery 
to the designated addressees.
    (7) Amendments to the application and supplements to the 
environmental impact statement shall be filed and distributed and a 
written statement shall be furnished to the Director, Office of Nuclear 
Material Safety and

[[Page 31]]

Safeguards , as appropriate, in the same manner as for the initial 
application and environmental impact statement.
    (8) The Director, Office of Nuclear Material Safety and Safeguards 
as appropriate, will cause to be published in the Federal Register a 
notice of docketing which identifies the State and location at which the 
proposed geologic repository operations area would be located and will 
give notice of docketing to the governor of that State. The notice of 
docketing will state that the Commission finds that a hearing is 
required in the public interest, prior to issuance of a construction 
authorization, and will recite the matters specified in Sec.2.104(a) 
of this part.
    (f) Each application for a license to receive radioactive waste from 
other persons for disposal under part 61 of this chapter and the 
accompanying environmental report shall be processed in accordance with 
the provisions of this paragraph.
    (1) To allow a determination as to whether the application or 
environmental report is complete and acceptable for docketing, it will 
be initially treated as a tendered document, and a copy will be 
available for public inspection in the Commission's Public Document 
Room, One White Flint North, 11555 Rockville Pike (first floor), 
Rockville, Maryland 20852-2738. One original and two copies shall be 
filed to enable this determination to be made.
    (i) Upon receipt of a tendered application, the Commission will 
publish in the Federal Register notice of the filed application and will 
notify the governors, legislatures and other appropriate State, county, 
and municipal officials and Tribal governing bodies of the States and 
areas containing or potentially affected by the activities at the 
proposed site and the alternative sites. The Commission will inform 
these officials that the Commission staff will be available for 
consultation pursuant to Sec.61.71 of this chapter. The Federal 
Register notice will note the opportunity for interested persons to 
submit views and comments on the tendered application for consideration 
by the Commission and applicant. The Commission will also notify the 
U.S. Bureau of Indian Affairs when Tribal governing bodies are notified.
    (ii) The Commission will also post a public notice in a newspaper or 
newspapers of general circulation in the affected States and areas 
summarizing information contained in the applicant's tendered 
application and noting the opportunity to submit views and comments.
    (iii) When the Director, Office of Nuclear Material Safety and 
Safeguards as appropriate, determines that the tendered document is 
complete and acceptable for docketing, a docket number will be assigned 
and the applicant will be notified of the determination. If it is 
determined that all or any part of the tendered document is incomplete 
and therefore not acceptable for processing, the applicant will be 
informed of this determination and the aspects in which the document is 
deficient.
    (2)(i) With respect to any tendered document that is acceptable for 
docketing, the applicant will be requested to:
    (A) Submit to the Director, Office of Nuclear Material Safety and 
Safeguards as appropriate, such additional copies as required by the 
regulations in part 61 and subpart A of part 51 of this chapter;
    (B) Serve a copy on the chief executive of the municipality in which 
the waste is to be disposed of or, if the waste is not to be disposed of 
within a municipality, serve a copy on the chief executive of the county 
in which the waste is to be disposed of;
    (C) Make direct distribution of additional copies to Federal, State, 
Indian Tribal, and local officials in accordance with the requirements 
of this chapter and written instructions from the Director, Office of 
Nuclear Material Safety and Safeguards as appropriate; and
    (D) Serve a notice of availability of the application and 
environmental report on the chief executives or governing bodies of the 
municipalities or counties which have been identified in the application 
and environmental report as the location of all or part of the 
alternative sites if copies are not distributed under paragraph 
(f)(2)(i)(C) of this section to the executives or bodies.

[[Page 32]]

    (ii) All distributed copies shall be completely assembled documents 
identified by docket number. However, subsequently distributed 
amendments may include revised pages to previous submittals and, in 
these cases, the recipients will be responsible for inserting the 
revised pages. In complying with the requirements of paragraph (f) of 
this section the applicant may not make public distribution of those 
parts of the application subject to Sec.2.390(d).
    (3) The tendered document will be formally docketed upon receipt by 
the Director, Office of Nuclear Material Safety and Safeguards as 
appropriate, of the required additional copies. Distribution of the 
additional copies shall be deemed to be complete as of the time the 
copies are deposited in the mail or with a carrier prepaid for delivery 
to the designated addressees. The date of docketing shall be the date 
when the required copies are received by the Director, Office of Nuclear 
Material Safety and Safeguards as appropriate. Within ten (10) days 
after docketing, the applicant shall submit to the Director, Office of 
Nuclear Material Safety and Safeguards or, as appropriate, a written 
statement that distribution of the additional copies to Federal, State, 
Indian Tribal, and local officials has been completed in accordance with 
requirements of this section and written instructions furnished to the 
applicant by the Director, Office of Nuclear Material Safety and 
Safeguards as appropriate.
    (4) Amendments to the application and environmental report shall be 
filed and distributed and a written statement shall be furnished to the 
Director, Office of Nuclear Material Safety and Safeguards as 
appropriate, in the same manner as for the initial application and 
environmental report.
    (5) The Director, Office of Nuclear Material Safety and Safeguards 
as appropriate, will cause to be published in the Federal Register a 
notice of docketing which identifies the State and location of the 
proposed waste disposal facility and will give notice of docketing to 
the governor of that State and other officials listed in paragraph 
(f)(3) of this section and will, in a reasonable period thereafter, 
publish in the Federal Register a notice under Sec.2.105 offering an 
opportunity to request a hearing to the applicant and other potentially 
affected persons.

[41 FR 15833, Apr. 15, 1976]

    Editorial Note: For Federal Register citations affecting Sec.
2.101, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfoo.gov.



Sec.2.102  Administrative review of application.

    (a) During review of an application by the NRC staff, an applicant 
may be required to supply additional information. The staff may request 
any one party to the proceeding to confer with the NRC staff informally. 
In the case of docketed application for a limited work authorization, 
construction permit, operating license, early site permit, standard 
design approval, combined license, or manufacturing license under this 
chapter, the NRC staff shall establish a schedule for its review of the 
application, specifying the key intermediate steps from the time of 
docketing until the completion of its review.
    (b) The Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, will refer the docketed application to 
the ACRS as required by law and in such additional cases as he or the 
Commission may determine to be appropriate. The ACRS will render to the 
Commission one or more reports as required by law or as requested by the 
Commission.
    (c) The Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, will make each report of the ACRS a part 
of the record of the docketed application, and transmit copies to the 
appropriate State and local officials.

[27 FR 377, Jan. 13, 1962, as amended at 36 FR 13270, July 17, 1971; 37 
FR 15130, July 28, 1972; 47 FR 9986, Mar. 9, 1982; 69 FR 2235, Jan. 14, 
2004; 70 FR 61887, Oct. 27, 2005; 72 FR 49472, Aug. 28, 2007; 72 FR 
57439, Oct. 9, 2007; 73 FR 5715, Jan. 31, 2008]

[[Page 33]]



Sec.2.103  Action on applications for byproduct, source, special
nuclear material, facility and operator licenses.

    (a) If the Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, finds that an application for a 
byproduct, source, special nuclear material, facility, or operator 
license complies with the requirements of the Act, the Energy 
Reorganization Act, and this chapter, he will issue a license. If the 
license is for a facility, or for receipt of waste radioactive material 
from other persons for the purpose of commercial disposal by the waste 
disposal licensee, or for a construction authorization for a HLW 
repository at a geologic repository operations area under parts 60 or 63 
of this chapter, or if it is to receive and possess high-level 
radioactive waste at a geologic repository operations area under parts 
60 or 63 of this chapter, the Director, Office of Nuclear Reactor 
Regulation, Director, Office of New Reactors, or Director, Office of 
Nuclear Material Safety and Safeguards, as appropriate, will inform the 
State, Tribal and local officials specified in Sec.2.104(c) of the 
issuance of the license. For notice of issuance requirements for 
licenses issued under part 61 of this chapter, see Sec.2.106(d).
    (b) If the Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, finds that an application does not 
comply with the requirements of the Act and this chapter he may issue a 
notice of proposed denial or a notice of denial of the application and 
inform the applicant in writing of:
    (1) The nature of any deficiencies or the reason for the proposed 
denial or the denial, and
    (2) The right of the applicant to demand a hearing within twenty 
(20) days from the date of the notice or such longer period as may be 
specified in the notice.

[28 FR 10152, Sept. 17, 1963, as amended at 47 FR 57478, Dec. 27, 1982; 
66 FR 55787, Nov. 2, 2001; 69 FR 2235, Jan. 14, 2004; 73 FR 5715, Jan. 
31, 2008; 77 FR 46589, Aug. 3, 2012; 79 FR 75739, Dec. 19, 2014]

                  Hearing on Application--How Initiated



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. Sec.
50.21(b) or 50.22 of this chapter 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 of this chapter, 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. Sec.50.21(b) or 
50.22 of this chapter 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 days 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 days notice.
---------------------------------------------------------------------------

    (b) The notice of hearing must state:
    (1) The nature of the hearing;

[[Page 34]]

    (2) The authority under which the hearing is to be held;
    (3) The matters of fact and law to be considered;
    (4) The date by which requests for hearing or petitions to intervene 
must be filed;
    (5) The presiding officer designated for the hearing, or the 
procedure that the Commission will use to designate a presiding officer 
for the hearing.
    (c)(1) The Secretary will transmit a notice of hearing on an 
application for a license for a production or utilization facility, 
including a limited work authorization, early site permit, combined 
license, but not for a manufacturing license, for a license for receipt 
of waste radioactive material from other persons for the purpose of 
commercial disposal by the waste disposal licensee, for a license under 
part 61 of this chapter, for a construction authorization for a high-
level waste repository at a geologic repository operations area under 
parts 60 or 63 of this chapter, for a license to receive and possess 
high-level radioactive waste at a geologic repository operations area 
under parts 60 or 63 of this chapter, and for a license under part 72 of 
this chapter to acquire, receive or possess spent fuel for the purpose 
of storage in an independent spent fuel storage installation (ISFSI) to 
the governor or other appropriate official of the State and to the chief 
executive of the municipality in which the facility is to be located or 
the activity is to be conducted or, if the facility is not to be located 
or the activity conducted within a municipality, to the chief executive 
of the county (or to the Tribal organization, if it is to be located or 
conducted within an Indian reservation).
    (2) The Secretary will transmit a notice of hearing on an 
application for a license under part 72 of this chapter to acquire, 
receive or possess spent fuel, high-level radioactive waste or 
radioactive material associated with high-level radioactive waste for 
the purpose of storage in a monitored retrievable storage installation 
(MRS) to the same persons who received the notice of docketing under 
Sec.72.16(e) of this chapter.

[72 FR 49472, Aug. 28, 2007, as amended at 72 FR 57439, Oct. 9, 2007]



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 Web site, http://www.nrc.gov, or both, at 
the Commission's discretion, either a notice of intended operation under 
Sec.52.103(a) of this chapter and a proposed finding that inspections, 
tests, analyses, and acceptance criteria for a combined license under 
subpart C of part 52 have been or will be met, or a notice of proposed 
action with respect to an application for:
    (1) A license for a facility;
    (2) A license for receipt of waste radioactive material from other 
persons for the purpose of commercial disposal by the waste disposal 
licensee. All licenses issued under part 61 of this chapter shall be so 
noticed;
    (3) An amendment of a license specified in paragraph (a) (1) or (2) 
of this section and which involves a significant hazards consideration;
    (4) An amendment to an operating license, combined license, or 
manufacturing license for a facility licensed under Sec. Sec.50.21(b) 
or 50.22 of this chapter, or for a testing facility, as follows:
    (i) If the Commission determines under Sec.50.58 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 
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 pursuant to Sec.2.106 (if a hearing is requested, it will be 
held after issuance of the amendment);
    (5) A license to receive and possess high-level radioactive waste at 
a geologic repository operations area pursuant to parts 60 or 63 of this 
chapter, or an amendment thereto, when the license or amendment would 
authorize

[[Page 35]]

actions which may significantly affect the health and safety of the 
public;
    (6) An amendment to a construction authorization for a high-level 
radioactive waste at a geologic repository operations area pursuant to 
parts 60 or 63 of this chapter, when such an amendment would authorize 
actions which may significantly affect the health and safety of the 
public;
    (7) A license under part 72 of this chapter to acquire, receive or 
possess spent fuel for the purpose of storage in an independent spent 
fuel storage installation (ISFSI) or to acquire, receive or possess 
spent fuel, high-level radioactive waste or radioactive material 
associated with high-level radioactive waste for the purpose of storage 
in a monitored retrievable storage installation (MRS);
    (8) An amendment to a license specified in paragraph (a)(7) of this 
section when such an amendment presents a genuine issue as to whether 
the health and safety of the public will be significantly affected; or
    (9) Any other license or amendment as to which the Commission 
determines that an opportunity for a public hearing should be afforded;
    (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 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
    (11) In the case of an application for a license to receive and 
possess high-level radioactive waste at a geologic repository operations 
area, a notice of opportunity for hearing, as required by this 
paragraph, shall be published prior to Commission action authorizing 
receipt of such wastes; this requirement is in addition to the 
procedures set out in Sec. Sec.2.101(f)(8) and 2.104 of this part, 
which provide for a hearing on the application prior to issuance of a 
construction authorization.
    (12) An amendment to an early site permit issued under subpart A of 
part 52 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) 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) and the Commission determines 
under Sec. Sec.50.58 and 50.91 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 of this chapter 
(if a hearing is requested, which will be held after issuance of the 
amendment).
    (13) A manufacturing license under subpart F of part 52 of this 
chapter.
    (b) A notice of proposed action published in the Federal Register 
will set forth:
    (1) The nature of the action proposed;
    (2) The manner in which a copy of the safety analysis and of the 
ACRS report, if any, may be obtained or examined.
    (3) For a notice of intended operation under Sec.52.103(a) of this 
chapter, the following information:
    (i) The identification of the NRC action as making the finding 
required under Sec.52.103(g) of this chapter;
    (ii) The manner in which the licensee notifications under 10 CFR 
52.99(c) which are required to be made available by 10 CFR 52.99(e)(2) 
may be obtained and examined;
    (iii) The manner in which copies of the safety analysis may be 
obtained and examined; and
    (iv) Any conditions, limitations, or restrictions to be placed on 
the license in connection with the finding under Sec.52.103(g) of this 
chapter, and the expiration date or circumstances (if any) under which 
the conditions, limitations or restrictions will no longer apply.
    (c) If an application for a license is complete enough to permit all 
evaluations, other than completion inspection, necessary for the 
issuance of a construction permit and operating license, the notice of 
proposed issuance of a construction permit may provide that on 
completion of construction and inspection the operating license will be 
issued without further prior notice.

[[Page 36]]

    (d) The notice of proposed action will provide that, within the time 
period provided under Sec.2.309(b):
    (1) The applicant may file a request for a hearing; and
    (2) Any person whose interest may be affected by the proceeding may 
file a request for a hearing or a petition for leave to intervene if a 
hearing has already been requested.
    (e)(1) If no request for a hearing or petition for leave to 
intervene is filed within the time prescribed in the notice, the 
Director, Office of Nuclear Reactor Regulation, Director, Office of New 
Reactors, or Director, Office of Nuclear Material Safety and Safeguards, 
as appropriate, may take the proposed action, inform the appropriate 
State and local officials, and publish in the Federal Register a notice 
of issuance of the license or other action.
    (2) If a request for a hearing or a petition for leave to intervene 
is filed within the time prescribed in the notice, the presiding officer 
who shall be an Atomic Safety and Licensing Board established by the 
Commission or by the Chief Administrative Judge of the Atomic Safety and 
Licensing Board Panel, will rule on the request and/or petition, and the 
Secretary or the presiding officer will issue a notice of hearing or an 
appropriate order.

[27 FR 377, Jan. 13, 1962]

    Editorial Note: For Federal Register citations affecting Sec.
2.105, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfoo.gov.



Sec.2.106  Notice of issuance.

    (a) The Director, Office of New Reactors, Director, Office of 
Nuclear Reactor Regulation, or Director, Office of Nuclear Material 
Safety and Safeguards, as appropriate, will inform the State and local 
officials specified in Sec.2.104(c) and publish a document in the 
Federal Register announcing the issuance of:
    (1) A license or an amendment of a license for which a notice of 
proposed action has been previously published;
    (2) An amendment of a license for a facility of the type described 
in Sec.50.21(b) or Sec.50.22 of this chapter, 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) of this chapter.
    (b) The notice of issuance will set forth:
    (1) In the case of a license or amendment:
    (i) The nature of the license or amendment;
    (ii) The manner in which copies of the safety analysis, if any, may 
be obtained and examined; and
    (iii) A finding that the application for the license or amendment 
complies with the requirements of the Act and this chapter.
    (2) In the case of a finding under Sec.52.103(g) of this chapter:
    (i) The manner in which copies of the safety analysis, if any, may 
be obtained and examined; and
    (ii) A finding that the prescribed inspections, tests, and analyses 
have been performed, the prescribed acceptance criteria have been met, 
and that the license complies with the requirements of the Act and this 
chapter.
    (c) The Director of Nuclear Material Safety and Safeguards will also 
cause to be published in the Federal Register notice of, and will inform 
the State, local, and Tribal officials specified in Sec.2.104(c) of 
any action with respect to an application for construction authorization 
for a high-level radioactive waste repository at a geologic repository 
operations area, a license to receive and possess high-level radioactive 
waste at a geologic repository operations area pursuant to parts 60 or 
63 of this chapter, or an amendment to such license for which a notice 
of proposed action has been previously published.
    (d) The Office of Nuclear Material Safety and Safeguards will also 
cause to be published in the Federal Register notice of, and will inform 
the State and local officials or Tribal governing body specified in 
Sec.2.104(c) of any licensing action with respect to a license to 
receive radioactive waste from other persons for disposal under part 61 
of this chapter or the amendment of

[[Page 37]]

such a license for which a notice of proposed action has been previously 
published.

[37 FR 15131, July 28, 1972, as amended at 38 FR 9586, Apr. 18, 1973; 46 
FR 13978, Feb. 25, 1981; 47 FR 57478, Dec. 27, 1982; 66 FR 55787, Nov. 
2, 2001; 69 FR 2235, Jan. 14, 2004; 72 FR 49473, Aug. 28, 2007; 73 FR 
5716, Jan. 31, 2008; 77 FR 46590, Aug. 3, 2012]



Sec.2.107  Withdrawal of application.

    (a) The Commission may permit an applicant to withdraw an 
application prior to the issuance of a notice of hearing on such terms 
and conditions as it may prescribe, or may, on receiving a request for 
withdrawal of an application, deny the application or dismiss it with 
prejudice. If the application is withdrawn prior to issuance of a notice 
of hearing, the Commission shall dismiss the proceeding. Withdrawal of 
an application after the issuance of a notice of hearing shall be on 
such terms as the presiding officer may prescribe.
    (b) The withdrawal of an application does not authorize the removal 
of any document from the files of the Commission.
    (c) The Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, will cause to be published in the 
Federal Register a notice of the withdrawal of an application if notice 
of receipt of the application has been previously published.

[27 FR 377, Jan. 13, 1962, as amended at 28 FR 10152, Sept. 17, 1963; 69 
FR 2236, Jan. 14, 2004; 73 FR 5716, Jan. 31, 2008; 77 FR 46590, Aug. 3, 
2012]



Sec.2.108  Denial of application for failure to supply information.

    (a) The Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, may deny an application if an applicant 
fails to respond to a request for additional information within thirty 
(30) days from the date of the request, or within such other time as may 
be specified.
    (b) The Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, will cause to be published in the 
Federal Register a notice of denial when notice of receipt of the 
application has previously been published, but notice of hearing has not 
yet been published. The notice of denial will provide that, within 
thirty (30) days after the date of publication in the Federal Register.
    (1) The applicant may demand a hearing, and
    (2) Any person whose interest may be affected by the proceeding may 
file a petition for leave to intervene.
    (c) When both a notice of receipt of the application and a notice of 
hearing have been published, the presiding officer, upon a motion made 
by the staff under Sec.2.323, will rule whether an application should 
be denied by the Director, Office of Nuclear Reactor Regulation, 
Director, Office of New Reactors, or Director, Office of Nuclear 
Material Safety and Safeguards, as appropriate, under paragraph (a) of 
this section.

[77 FR 46590, Aug. 3, 2012]



Sec.2.109  Effect of timely renewal application.

    (a) Except for the renewal of an operating license for a nuclear 
power plant under 10 CFR 50.21(b) or 50.22, an early site permit under 
subpart A of part 52 of this chapter, a manufacturing license under 
subpart F of part 52 of this chapter, or a combined license under 
subpart C of part 52 of this chapter, if at least 30 days before the 
expiration of an existing license authorizing any activity of a 
continuing nature, the licensee files an application for a renewal or 
for a new license for the activity so authorized, the existing license 
will not be deemed to have expired until the application has been 
finally determined.
    (b) If the licensee of a nuclear power plant licensed under 10 CFR 
50.21(b) or 50.22 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

[[Page 38]]

of this chapter files a sufficient application for renewal under Sec.
52.29 of this chapter 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 of this chapter files a sufficient application for renewal under 
Sec.52.177 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.

[72 FR 49473, Aug. 28, 2007]



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 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.
    (2) Except as specifically provided otherwise by the provisions of 
appendix Q to parts 50 of this chapter, a submittal for early review of 
site suitability issues under appendix Q to parts 50 of this chapter 
shall be subject to Sec. Sec.2.101(a)(2) through (4) 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 of part 50 of 
this chapter, or for a standard design approval under subpart E of part 
52 of this chapter, the Director, Office of New Reactors, or Director, 
Office of Nuclear Reactor Regulation, as appropriate 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.
    (c)(1) Upon completion of review by the NRC staff and the ACRS of a 
submittal for a standard design approval, the Director, Office of New 
Reactors or Director, Office of Nuclear Reactor Regulation, as 
appropriate shall publish in the Federal Register a determination as to 
whether or not the design is acceptable, subject to terms and conditions 
as may be appropriate, and shall make available at the NRC Web site, 
http://www.nrc.gov, a report that analyzes the design.
    (2) Upon completion of review by the NRC staff and, if appropriate 
by the ACRS, of a submittal for early review of site suitability issues, 
the NRC staff shall prepare a staff site report which shall identify the 
location of the site, state the site suitability issues reviewed, 
explain the nature and scope of the review, state the conclusions of the 
staff regarding the issues reviewed and state the reasons for those 
conclusions. Upon issuance of an NRC staff site report, the NRC staff 
shall publish a notice of the availability of the report in the Federal 
Register and shall make the report available at the NRC Web site, http:/
/www.nrc.gov. The NRC staff shall also send a copy of the report to the 
Governor or other appropriate official of the State in which the site is 
located, and to the chief executive of the municipality in which the 
site is located or, if the site is not located in a municipality, to the 
chief executive of the county.

[72 FR 49474, Aug. 28, 2007; 73 FR 5716, Jan. 31, 2008]



Sec.2.111  Prohibition of sex discrimination.

    No person shall on the grounds of sex be excluded from participation 
in, be denied a license, standard design approval, or petition for 
rulemaking (including a design certification), be denied the benefits 
of, or be subjected to discrimination under any program or activity 
carried on or receiving Federal assistance under the Act or the Energy 
Reorganization Act of 1974.

[72 FR 49474, Aug. 28, 2007]



     Subpart B_Procedure for Imposing Requirements by Order, or for 
 Modification, Suspension, or Revocation of a License, or for Imposing 
                             Civil Penalties



Sec.2.200  Scope of subpart.

    (a) This subpart prescribes the procedures in cases initiated by the 
staff, or

[[Page 39]]

upon a request by any person, to impose requirements by order, or to 
modify, suspend, or revoke a license, or to take other action as may be 
proper, against any person subject to the jurisdiction of the 
Commission. However, with regard to the holder of a part 76 certificate 
of compliance or compliance plan, except for civil penalty procedures in 
this subpart, the applicable procedures are set forth in Sec.76.70 of 
this chapter.
    (b) This subpart also prescribes the procedures in cases initiated 
by the staff to impose civil penalties pursuant to section 234 of the 
Act and section 206 of the Energy Reorganization Act of 1974.

[36 FR 16896, Aug. 26, 1971, as amended at 42 FR 28893, June 6, 1977; 48 
FR 44172, Sept. 28, 1983; 62 FR 6668, Feb. 12, 1997]



Sec.2.201  Notice of violation.

    (a) In response to an alleged violation of any provision of the Act 
or this chapter or the conditions of a license or an order issued by the 
Commission, the Commission may serve on the licensee or other person 
subject to the jurisdiction of the Commission a written notice of 
violation; a separate notice may be omitted if an order pursuant to 
Sec.2.202 or demand for information pursuant to Sec.2.204 is issued 
that otherwise identifies the apparent violation. The notice of 
violation will concisely state the alleged violation and may require 
that the licensee or other person submit, within 20 days of the date of 
the notice or other specified time, a written explanation or statement 
in reply if the Commission believes that the licensee has not already 
addressed all the issues contained in the notice of violation, 
including:
    (1) Corrective steps which have been taken by the licensee or other 
person and the results achieved;
    (2) Corrective steps which will be taken; and
    (3) The date when full compliance will be achieved.
    (b) The notice may require the licensee or other person subject to 
the jurisdiction of the Commission to admit or deny the violation and to 
state the reasons for the violation, if admitted. It may provide that, 
if an adequate reply is not received within the time specified in the 
notice, the Commission may issue an order or a demand for information as 
to why the license should not be modified, suspended or revoked or why 
such other action as may be proper should not be taken.

[56 FR 40684, Aug. 15, 1991, as amended at 61 FR 43408, Aug. 22, 1996]



Sec.2.202  Orders.

    (a) The Commission may institute a proceeding to modify, suspend, or 
revoke a license or to take such other action as may be proper by 
serving on the licensee or other person subject to the jurisdiction of 
the Commission an order that will:
    (1) Allege the violations with which the licensee or other person 
subject to the Commission's jurisdiction is charged, or the potentially 
hazardous conditions or other facts deemed to be sufficient ground for 
the proposed action, and specify the action proposed;
    (2) Provide that the licensee or other person must file a written 
answer to the order under oath or affirmation within twenty (20) days of 
its date, or such other time as may be specified in the order;
    (3) Inform the licensee or any other person adversely affected by 
the order of his or her right, within twenty (20) days of the date of 
the order, or such other time as may be specified in the order, to 
demand a hearing on all or part of the order, except in a case where the 
licensee or other person has consented in writing to the order;
    (4) Specify the issues for hearing; and
    (5) State the effective date of the order; if the Commission finds 
that the public health, safety, or interest so requires or that the 
violation or conduct causing the violation is willful, the order may 
provide, for stated reasons, that the proposed action be immediately 
effective pending further order.
    (b) A licensee or other person to whom the Commission has issued an 
order under this section must respond to the order by filing a written 
answer under oath or affirmation. The answer shall specifically admit or 
deny each allegation or charge made in the order, and shall set forth 
the matters of fact and law on which the licensee or other person 
relies, and, if the order is not

[[Page 40]]

consented to, the reasons as to why the order should not have been 
issued. Except as provided in paragraph (d) of this section, the answer 
may demand a hearing.
    (c) If the answer demands a hearing, the Commission will issue an 
order designating the time and place of hearing.
    (1) If the answer demands a hearing with respect to an immediately 
effective order, the hearing will be conducted expeditiously, giving due 
consideration to the rights of the parties.
    (2)(i) The licensee or other person to whom the Commission has 
issued an immediately effective order in accordance with paragraph 
(a)(5) of this section, may, in addition to demanding a hearing, at the 
time the answer is filed or sooner, file a motion with the presiding 
officer to set aside the immediate effectiveness of the order on the 
ground that the order, including the need for immediate effectiveness, 
is not based on adequate evidence but on mere suspicion, unfounded 
allegations, or error. The motion must state with particularity the 
reasons why the order is not based on adequate evidence and must be 
accompanied by affidavits or other evidence relied on.
    (ii) Any party may file a motion with the presiding officer 
requesting that the presiding officer order live testimony. Any motion 
for live testimony must be made in conjunction with the motion to set 
aside the immediate effectiveness of the order or any party's response 
thereto. The presiding officer may, on its own motion, order live 
testimony. The presiding officer's basis for approving any motion for, 
or ordering on its own motion, live testimony shall be that taking live 
testimony would assist in its decision on the motion to set aside the 
immediate effectiveness of the order.
    (iii) The NRC staff shall respond in writing within 5 days of the 
receipt of either a motion to set aside the immediate effectiveness of 
the order or the presiding officer's order denying a motion for live 
testimony. In cases in which the presiding officer orders live 
testimony, the staff may present its response through live testimony 
rather than a written response.
    (iv) The presiding officer shall conduct any live testimony pursuant 
to its powers in Sec.2.319 of this part, except that no subpoenas, 
discovery, or referred rulings or certified questions to the Commission 
shall be permitted for this purpose.
    (v) The presiding officer may, on motion by the staff or any other 
party to the proceeding, where good cause exists, delay the hearing on 
the immediately effective order at any time for such periods as are 
consistent with the due process rights of the licensee or other person 
and other affected parties.
    (vi) The licensee or other person challenging the immediate 
effectiveness of an order bears the burden of going forward with 
evidence that the immediately effective order is not based on adequate 
evidence, but on mere suspicion, unfounded allegations, or error. The 
NRC staff bears the burden of persuading the presiding officer that 
adequate evidence supports the grounds for the immediately effective 
order and immediate effectiveness is warranted.
    (vii) The presiding officer shall issue a decision on the motion to 
set aside the immediate effectiveness of the order expeditiously. During 
the pendency of the motion to set aside the immediate effectiveness of 
the order or at any other time, the presiding officer may not stay the 
immediate effectiveness of the order, either on its own motion, or upon 
motion of the licensee or other person.
    (viii) The presiding officer shall uphold the immediate 
effectiveness of the order if it finds that there is adequate evidence 
to support immediate effectiveness. An order upholding immediate 
effectiveness will constitute the final agency action on immediate 
effectiveness. The presiding officer will promptly refer an order 
setting aside immediate effectiveness to the Commission and such order 
setting aside immediate effectiveness will not be effective pending 
further order of the Commission.
    (d) An answer may consent to the entry of an order in substantially 
the form proposed in the order with respect to all or some of the 
actions proposed in the order. The consent, in the answer or other 
written document, of the licensee or other person to whom the order has 
been issued to the entry of an

[[Page 41]]

order shall constitute a waiver by the licensee or other person of a 
hearing, findings of fact and conclusions of law, and of all right to 
seek Commission and judicial review or to contest the validity of the 
order in any forum as to those matters which have been consented to or 
agreed to or on which a hearing has not been requested. An order that 
has been consented to shall have the same force and effect as an order 
made after hearing by a presiding officer or the Commission, and shall 
be effective as provided in the order.
    (e)(1) If the order involves the modification of a part 50 license 
and is a backfit, the requirements of Sec.50.109 of this chapter 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 of this chapter, the requirements of Sec.52.98 of 
this chapter 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 of this chapter, the requirements of Sec.52.39 of 
this chapter 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 of this chapter 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 
of this chapter 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, the requirements of Sec.52.171 of this 
chapter must be followed, unless the applicant or licensee has consented 
to the action required.

[56 FR 40684, Aug. 15, 1991, as amended at 57 FR 20198, May 12, 1992; 72 
FR 49474, Aug. 28, 2007; 80 FR 63419, Oct. 20, 2015]



Sec.2.203  Settlement and compromise.

    At any time after the issuance of an order designating the time and 
place of hearing in a proceeding to modify, suspend, or revoke a license 
or for other action, the staff and a licensee or other person may enter 
into a stipulation for the settlement of the proceeding or the 
compromise of a civil penalty. The stipulation or compromise shall be 
subject to approval by the designated presiding officer or, if none has 
been designated, by the Chief Administrative Law Judge, according due 
weight to the position of the staff. The presiding officer, or if none 
has been designated, the Chief Administrative Law Judge, may order such 
adjudication of the issues as he may deem to be required in the public 
interest to dispose of the proceeding. If approved, the terms of the 
settlement or compromise shall be embodied in a decision or order 
settling and discontinuing the proceeding.

[36 FR 16896, Aug. 26, 1971]



Sec.2.204  Demand for information.

    (a) The Commission may issue to a licensee or other person subject 
to the jurisdiction of the Commission a demand for information for the 
purpose of determining whether an order under Sec.2.202 should be 
issued, or whether other action should be taken, which demand will:
    (1) Allege the violations with which the licensee or other person is 
charged, or the potentially hazardous conditions or other facts deemed 
to be sufficient ground for issuing the demand; and
    (2) Provide that the licensee must, or the other person may, file a 
written answer to the demand for information under oath or affirmation 
within twenty (20) days of its date, or such other time as may be 
specified in the demand for information.
    (b) A licensee to whom the Commission has issued a demand for 
information under this section must respond to the demand by filing a 
written answer under oath or affirmation; any other

[[Page 42]]

person to whom the Commission has issued a demand for information may, 
in its discretion, respond to the demand by filing a written answer 
under oath or affirmation. The licensee's answer shall specifically 
admit or deny each allegation or charge made in the demand for 
information, and shall set forth the matters of fact and law on which 
the licensee relies. A person other than a licensee may answer as 
described above, or by setting forth its reasons why the demand should 
not have been issued and, if the requested information is not provided, 
the reasons why it is not provided.
    (c) Upon review of the answer filed pursuant to paragraph (a)(2) of 
this section, or if no answer is filed, the Commission may institute a 
proceeding pursuant to 10 CFR 2.202 to take such action as may be 
proper.
    (d) An answer may consent to the entry of an order pursuant to Sec.
2.202 in substantially the form proposed in the demand for information. 
Such consent shall constitute a waiver as provided in Sec.2.202(d).

[56 FR 40685, Aug. 15, 1991]



Sec.2.205  Civil penalties.

    (a) Before instituting any proceeding to impose a civil penalty 
under section 234 of the Act, the Executive Director for Operations or 
the Executive Director's designee, as appropriate, shall serve a written 
notice of violation upon the person charged. This notice may be included 
in a notice issued pursuant to Sec.2.201 or Sec.76.70(d) of this 
chapter. The notice of violation shall specify the date or dates, facts, 
and the nature of the alleged act or omission with which the person is 
charged, and shall identify specifically the particular provision or 
provisions of the law, rule, regulation, license, permit, part 76 
certificate of compliance or compliance plan, or cease and desist order 
involved in the alleged violation and must state the amount of each 
proposed penalty. The notice of violation shall also advise the person 
charged that the civil penalty may be paid in the amount specified 
therein, or the proposed imposition of the civil penalty may be 
protested in its entirety or in part, by a written answer, either 
denying the violation or showing extenuating circumstances. The notice 
of violation shall advise the person charged that upon failure to pay a 
civil penalty subsequently determined by the Commission, if any, unless 
compromised, remitted, or mitigated, be collected by civil action, 
pursuant to Section 234c of the Act.
    (b) Within twenty (20) days of the date of a notice of violation or 
other time specified in the notice, the person charged may either pay 
the penalty in the amount proposed or answer the notice of violation. 
The answer to the notice of violation shall state any facts, 
explanations, and arguments, denying the charges of violation, or 
demonstrating any extenuating circumstances, error in the notice of 
violation, or other reason why the penalty should not be imposed and may 
request remission or mitigation of the penalty.
    (c) If the person charged with violation fails to answer within the 
time specified in paragraph (b) of this section, an order may be issued 
imposing the civil penalty in the amount set forth in the notice of 
violation described in paragraph (a) of this section.
    (d) If the person charged with violation files an answer to the 
notice of violation, the Executive Director for Operations or the 
Executive Director's designee, upon consideration of the answer, will 
issue an order dismissing the proceeding or imposing, mitigating, or 
remitting the civil penalty. The person charged may, within twenty (20) 
days of the date of the order or other time specified in the order, 
request a hearing.
    (e) If the person charged with violation requests a hearing, the 
Commission will issue an order designating the time and place of 
hearing.
    (f) If a hearing is held, an order will be issued after the hearing 
by the presiding officer or the Commission dismissing the proceeding or 
imposing, mitigating, or remitting the civil penalty.
    (g) The Executive Director for Operations or the Executive 
Director's designee, as appropriate may compromise any civil penalty, 
subject to the provisions of Sec.2.203.
    (h) If the civil penalty is not compromised, or is not remitted by 
the Executive Director for Operations or the

[[Page 43]]

Executive Director's designee, as appropriate, the presiding officer, or 
the Commission, and if payment is not made within ten (10) days 
following either the service of the order described in paragraph (c) or 
(f) of this section, or the expiration of the time for requesting a 
hearing described in paragraph (d) of this section, the Executive 
Director for Operations or the Executive Director's designee, as 
appropriate, may refer the matter to the Attorney General for 
collection.
    (i) Except when payment is made after compromise or mitigation by 
the Department of Justice or as ordered by a court of the United States, 
following reference of the matter to the Attorney General for 
collection, payment of civil penalties imposed under Section 234 of the 
Act are to be made payable to the U.S. Nuclear Regulatory Commission, in 
U.S. funds, by check, draft, money order, credit cars, or electronic 
funds transfer such as Automated Clearing House (ACH) using Electronic 
Data Interchange (EDI). Federal agencies may also make payment by the 
On-Line Payment and Collections System (OPAC's). All payments are to be 
made in accordance with the specific payment instructions provided with 
Notices of Violation that propose civil penalties and Orders Imposing 
Civil Monetary Penalties.
    (j) Amount. A civil monetary penalty imposed under Section 234 of 
the Atomic Energy Act of 1954, as amended, or any other statute within 
the jurisdiction of the Commission that provides for the imposition of a 
civil penalty in an amount equal to the amount set forth in Section 234, 
may not exceed $290,875 for each violation. If any violation is a 
continuing one, each day of such violation shall constitute a separate 
violation for the purposes of computing the applicable civil penalty.

[36 FR 16896, Aug. 26, 1971, as amended at 52 FR 31608, Aug. 21, 1987; 
54 FR 53315, Dec. 28, 1989; 61 FR 53555, Oct. 11, 1996; 62 FR 6668, Feb. 
12, 1997; 63 FR 31850, June 10, 1998; 65 FR 59272, Oct. 4, 2000; 69 FR 
62394, Oct. 26, 2004; 73 FR 54673, Sept. 23, 2008; 81 FR 43021, July 1, 
2016; 82 FR 8135, Jan. 24, 2017; 83 FR 1517, Jan. 12, 2018]



Sec.2.206  Requests for action under this subpart.

    (a) Any person may file a request to institute a proceeding pursuant 
to Sec.2.202 to modify, suspend, or revoke a license, or for any other 
action as may be proper. Requests must be addressed to the Executive 
Director for Operations and must be filed either by hand delivery to the 
NRC's Offices at 11555 Rockville Pike, Rockville, Maryland; by mail or 
telegram addressed to the Executive Director for Operations, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001; or by 
electronic submissions, for example, via facsimile, Electronic 
Information Exchange, e-mail, or CD-ROM. Electronic submissions must be 
made in a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The request must specify the action requested and set forth the facts 
that constitute the basis for the request. The Executive Director for 
Operations will refer the request to the Director of the NRC office with 
responsibility for the subject matter of the request for appropriate 
action in accordance with paragraph (b) of this section.
    (b) Within a reasonable time after a request pursuant to paragraph 
(a) of this section has been received, the Director of the NRC office 
with responsibility for the subject matter of the request shall either 
institute the requested proceeding in accordance with this subpart or 
shall advise the person who made the request in writing that no 
proceeding will be instituted in whole or in part, with respect to the 
request, and the reasons for the decision.
    (c)(1) Director's decisions under this section will be filed with 
the Office of the Secretary. Within twenty-five (25)

[[Page 44]]

days after the date of the Director's decision under this section that 
no proceeding will be instituted or other action taken in whole or in 
part, the Commission may on its own motion review that decision, in 
whole or in part, to determine if the Director has abused his 
discretion. This review power does not limit in any way either the 
Commission's supervisory power over delegated staff actions or the 
Commission's power to consult with the staff on a formal or informal 
basis regarding institution of proceedings under this section.
    (2) No petition or other request for Commission review of a 
Director's decision under this section will be entertained by the 
Commission.
    (3) The Secretary is authorized to extend the time for Commission 
review on its own motion of a Director's denial under paragraph (c) of 
this section.

[39 FR 12353, Apr. 5, 1974, as amended at 42 FR 36240, July 14, 1977; 45 
FR 73466, Nov. 5, 1980; 52 FR 31608, Aug. 21, 1987; 53 FR 43419, Oct. 
27, 1988; 64 FR 48948, Sept. 9, 1999; 68 FR 58799, Oct. 10, 2003; 69 FR 
2236, Jan. 14, 2004; 69 FR 41749, July 12, 2004; 74 FR 62679, Dec. 1, 
2009; 80 FR 74978, Dec. 1, 2015]



Subpart C_Rules of General Applicability: Hearing Requests, Petitions To 
  Intervene, Availability of Documents, Selection of Specific Hearing 
Procedures, Presiding Officer Powers, and General Hearing Management for 
                        NRC Adjudicatory Hearings

    Source: 69 FR 2236, Jan. 14, 2004, unless otherwise noted.



Sec.2.300  Scope of subpart C.

    The provisions of this subpart apply to all adjudications conducted 
under the authority of the Atomic Energy Act of 1954, as amended, the 
Energy Reorganization Act of 1974, and 10 CFR Part 2, unless 
specifically stated otherwise in this subpart.



Sec.2.301  Exceptions.

    Consistent with 5 U.S.C. 554(a)(4) of the Administrative Procedure 
Act, the Commission may provide alternative procedures in adjudications 
to the extent that the conduct of military or foreign affairs functions 
is involved.



Sec.2.302  Filing of documents.

    (a) Documents filed in Commission adjudicatory proceedings subject 
to this part shall be electronically transmitted through the E-Filing 
system, unless the Commission or presiding officer grants an exemption 
permitting an alternative filing method or unless the filing falls 
within the scope of paragraph (g)(1) of this section.
    (b) Upon an order from the Commission or presiding officer 
permitting alternative filing methods, or as otherwise set forth in 
Guidance for Electronic Submissions to the NRC, documents may be filed 
by:
    (1) First-class mail: Office of the Secretary, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings 
and Adjudications Staff; or
    (2) Courier, express mail, and expedited delivery services: Office 
of the Secretary, Sixteenth Floor, One White Flint North, 11555 
Rockville Pike, Rockville, MD 20852, Attention: Rulemakings and 
Adjudications Staff.
    (c) All documents offered for filing must be accompanied by a 
certificate of service stating the names and addresses of the persons 
served as well as the manner and date of service.
    (d) Filing is considered complete:
    (1) By electronic transmission when the filer performs the last act 
that it must perform to transmit a document, in its entirety, 
electronically;
    (2) By first-class mail as of the time of deposit in the mail;
    (3) By courier, express mail, or expedited delivery service upon 
depositing the document with the provider of the service; or
    (4) If a filing must be submitted by two or more methods, such as a 
filing that the Guidance for Electronic Submission to the NRC indicates 
should be transmitted electronically as well as physically delivered or 
mailed on optical storage media, the filing is complete when all methods 
of filing have been completed.
    (e) For filings by electronic transmission, the filer must make a 
good faith effort to successfully transmit the entire filing. 
Notwithstanding

[[Page 45]]

paragraph (d) of this section, a filing will not be considered complete 
if the filer knows or has reason to know that the entire filing has not 
been successfully transmitted.
    (f) Digital ID Certificates. (1) Through digital ID certificates, 
the NRC permits participants in the proceeding to access the E-Filing 
system to file documents, serve other participants, and retrieve 
documents in the proceeding.
    (2) Any participant or participant representative that does not have 
a digital ID certificate shall request one from the NRC before that 
participant or representative intends to make its first electronic 
filing to the E-Filing system. A participant or representative may apply 
for a digital ID certificate on the NRC Web site at http://www.nrc.gov/
site-help/e-submittals.html.
    (3) Group ID Certificate. A participant wishing to obtain a digital 
ID certificate valid for several persons may obtain a group digital ID 
certificate. A Group ID cannot be used to file documents. The Group ID 
provides access to the E-Filing system for the individuals specifically 
identified in the group's application to retrieve documents recently 
received by the system. The Group ID also enables a group of people, all 
of whom may not have individual digital ID certificates, to be notified 
when a filing has been made in a particular proceeding.
    (g) Filing Method Requirements--(1) Electronic filing. Unless 
otherwise provided by order, all filings must be made as electronic 
submissions in a manner that enables the NRC to receive, read, 
authenticate, distribute, and archive the submission, and process and 
retrieve it a single page at a time. Detailed guidance on making 
electronic submissions may be found in the Guidance for Electronic 
Submissions to the NRC and on the NRC Web site at http://www.nrc.gov/
site-help/e-submittals.html. If a filing contains sections of 
information or electronic formats that may not be transmitted 
electronically for security or other reasons, the portions not 
containing those sections will be transmitted electronically to the E-
Filing system. In addition, optical storage media (OSM) containing the 
entire filing must be physically delivered or mailed. In such cases, the 
submitter does not need to apply to the Commission or presiding officer 
for an exemption to deviate from the requirements in paragraph (g)(1) of 
this section.
    (2) Electronic transmission exemption. Upon a finding of good cause, 
the Commission or presiding officer can grant an exemption from 
electronic transmission requirements found in paragraph (g)(1) of this 
section to a participant who is filing electronic documents. The exempt 
participant is permitted to file electronic documents by physically 
delivering or mailing an OSM containing the documents. A participant 
granted this exemption would still be required to meet the electronic 
formatting requirement in paragraph (g)(1) of this section.
    (3) Electronic document exemption. Upon a finding of good cause, the 
Commission or presiding officer can exempt a participant from both the 
electronic (computer file) formatting and electronic transmission 
requirements in paragraph (g)(1) of this section. A participant granted 
such an exemption can file paper documents either in person or by 
courier, express mail, some other expedited delivery service, or first-
class mail, as ordered by the Commission or presiding officer.
    (4) Requesting an exemption. A filer seeking an exemption under 
paragraphs (g)(2) or (g)(3) of this section must submit the exemption 
request with its first filing in the proceeding. In the request, a filer 
must show good cause as to why it cannot file electronically. The filer 
may not change its formats or delivery methods for filing until a ruling 
on the exemption request is issued. Exemption requests under paragraphs 
(g)(2) or (g)(3) of this section sought after the first filing in the 
proceeding will be granted only if the requestor shows that the 
interests of fairness so require.

[72 FR 49149, Aug. 28, 2007]



Sec.2.303  Docket.

    The Secretary shall maintain a docket for each proceeding conducted 
under this part, commencing with either the initial notice of hearing, 
notice of proposed action, order, request for hearing or petition for 
leave to intervene, as

[[Page 46]]

appropriate. The Secretary shall maintain all files and records of 
proceedings, including transcripts and video recordings of testimony, 
exhibits, and all papers, correspondence, decisions and orders filed or 
issued. All documents, records, and exhibits filed in any proceeding 
must be filed with the Secretary as described in Sec. Sec.2.302 and 
2.304.



Sec.2.304  Formal requirements for documents; signatures;
acceptance for filing.

    (a) Docket numbers and titles. Each document filed in an 
adjudication to which a docket number has been assigned must contain a 
caption setting forth the docket number and the title of the proceeding 
and a description of the document (e.g., motion to quash subpoena).
    (b) Paper documents. In addition to the requirements in this part, 
paper documents must be stapled or bound on the left side; typewritten, 
printed, or otherwise reproduced in permanent form on good unglazed 
paper of standard letterhead size; signed in ink by the participant, its 
authorized representative, or an attorney having authority with respect 
to it; and filed with an original and two conforming copies.
    (c) Format. Each page in a document must begin not less than one 
inch from the top, with side and bottom margins of not less than one 
inch. Text must be double-spaced, except that quotations may be single-
spaced and indented. The requirements of this paragraph do not apply to 
original documents, or admissible copies, offered as exhibits, or to 
specifically prepared exhibits.
    (d) Signatures. The original of each document must be signed by the 
participant or its authorized representative, or by an attorney having 
authority with respect to it. The document must state the capacity of 
the person signing; his or her address, phone number, and e-mail 
address; and the date of signature. The signature of a person signing a 
pleading or other similar document submitted by a participant is a 
representation that the document has been subscribed in the capacity 
specified with full authority, that he or she has read it and knows the 
contents, that to the best of his or her knowledge, information, and 
belief the statements made in it are true, and that it is not interposed 
for delay. The signature of a person signing an affidavit or similar 
document, which should be submitted in accord with the form outlined in 
28 U.S.C. 1746, is a representation that, under penalty of perjury, the 
document is true and correct to the best of that individual's knowledge 
and belief. If a document is not signed, or is signed with intent to 
defeat the purpose of this section, it may be struck.
    (1) An electronic document must be signed using a participant's or a 
participant representative's digital ID certificate. Additional 
signatures can be added to the electronic document, including to any 
affidavits that accompany the document, by a typed-in designation that 
indicates the signer understands and acknowledges that he or she is 
assenting to the representations in paragraph (d) of this section.
    (i) When signing an electronic document using a digital ID 
certificate, the signature page for the electronic document should 
contain a typed signature block that includes the phrase ``Signed 
(electronically) by'' typed onto the signature line; the name and the 
capacity of the person signing; the person's address, phone number, and 
e-mail address; and the date of signature.
    (ii) If additional individuals need to sign an electronic document, 
including any affidavits that accompany the document, such individuals 
must sign by inserting a typed signature block in the electronic 
document that includes the phrase ``Executed in Accord with 10 CFR 
2.304(d)'' or its equivalent typed on the signature line as well as the 
name and the capacity of the person signing; the person's address, phone 
number, and e-mail address; and the date of signature to the extent any 
of these items are different from the information provided for the 
digital ID certificate signer.
    (2) Paper documents must be signed in ink.
    (e) Designation for service. The first document filed by any 
participant in a proceeding must designate the name and address of a 
person on whom service may be made. This document must also designate 
the e-mail address, if

[[Page 47]]

any, of the person on whom service may be made.
    (f) Acceptance for filing. Any document that fails to conform to the 
requirements of this section may be refused acceptance for filing by the 
Secretary or the presiding officer and may be returned with an 
indication of the reason for nonacceptance. Any document that is not 
accepted for filing will not be entered on the Commission's docket.
    (g) Pre-filed written testimony and exhibits. In any instance in 
which a participant submits electronically through the E-Filing system 
written testimony or hearing exhibits in advance of a hearing, the 
written testimony of each individual witness or witness panel and each 
individual exhibit shall be submitted as an individual electronic file.

[72 FR 49150, Aug. 28, 2007]



Sec.2.305  Service of documents, methods, proof.

    (a) Service of documents by the Commission. Except for subpoenas, 
the Commission shall serve all orders, decisions, notices, and other 
documents to all participants, by the same delivery method those 
participants use to file and accept service.
    (b) Who may be served. Any document required to be served upon a 
participant shall be served upon that person or upon the representative 
designated by the participant or by law to receive service of documents. 
When a participant has appeared by attorney, service shall be made upon 
the attorney of record.
    (c) Method of service accompanying a filing. Service must be made 
electronically to the E-Filing system. Upon an order from the Commission 
or presiding officer permitting alternative filing methods under Sec.
2.302(g)(4), service may be made by personal delivery, courier, 
expedited delivery service, or by first-class, express, certified or 
registered mail. As to each participant that cannot serve 
electronically, the Commission or presiding officer shall require 
service by the most expeditious means permitted under this paragraph 
that are available to the participant, unless the Commission or 
presiding officer finds that this requirement would impose undue burden 
or expense on the participant.
    (1) Unless otherwise provided in this section, a participant will 
serve documents on the other participants by the same method by which 
those participants filed.
    (2) A participant granted an exemption under Sec.2.302(g)(2) will 
serve the presiding officer and the participants in the proceeding that 
filed electronically by physically delivering or mailing optical storage 
media containing the electronic document.
    (3) A participant granted an exemption under Sec.2.302(g)(3) will 
serve the presiding officer and the other participants in the proceeding 
by physically delivering or mailing a paper copy.
    (4) Each document served (as may be required by law, rule, or order 
of the presiding officer) upon a participant to the proceeding must be 
accompanied by a signed certificate of service.
    (i) If a document is served on participants through only the E-
filing system, then the certificate of service must state that the 
document has been filed through the E-Filing system.
    (ii) If a document is served on participants by only a method other 
than the E-Filing system, then the certificate of service must state the 
name, address, and method and date of service for all participants 
served.
    (iii) If a document is served on some participants through the E-
Filing system and other participants by another method of service, then 
the certificate of service must include a list of participants served 
through the E-filing system, and it must state the name, address, and 
method and date of service for all participants served by the other 
method of service.
    (d) Method of service not accompanying a filing. Service of 
demonstrative evidence, e.g., maps and other physical evidence, may be 
made by first-class mail in all cases, unless the presiding officer 
directs otherwise or the participant desires to serve by a faster 
method. In instances when service of a document, such as a discovery 
document under Sec.2.336, will not accompany a filing with the agency, 
the participant may use any reasonable method of service to which the 
recipient agrees.

[[Page 48]]

    (e) Service on the Secretary. (1) All motions, briefs, pleadings, 
and other documents must be served on the Secretary of the Commission by 
the same or equivalent method, such as by electronic transmission or 
first-class mail, that they are served upon the presiding officer, so 
that the Secretary will receive the filing at approximately the same 
time that it is received by the presiding officer to which the filing is 
directed.
    (2) When pleadings are personally delivered to a presiding officer 
conducting proceedings outside the Washington, DC area, service on the 
Secretary may be accomplished electronically to the E-Filing system, as 
well as by courier, express mail, or expedited delivery service.
    (3) Service of demonstrative evidence (e.g., maps and other physical 
exhibits) on the Secretary of the Commission may be made by first-class 
mail in all cases, unless the presiding officer directs otherwise or the 
participant desires to serve by a faster method. All pre-filed testimony 
and exhibits shall be served on the Secretary of the Commission by the 
same or equivalent method that it is served upon the presiding officer 
to the proceedings, i.e., electronically to the E-Filing system, 
personal delivery or courier, express mail, or expedited delivery 
service.
    (4) The addresses for the Secretary are:
    (i) Internet: The E-Filing system at http://www.nrc.gov.
    (ii) First-class mail: Office of the Secretary, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings 
and Adjudications Staff; and
    (iii) Courier, express mail, and expedited delivery services: Office 
of the Secretary, Sixteenth Floor, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852, Attention: Rulemakings and 
Adjudications Staff.
    (f) When service is complete. Service upon a participant is 
complete:
    (1) By the E-Filing system, when filing electronically to the E-
Filing system is considered complete under Sec.2.302(d).
    (2) By personal delivery, upon handing the document to the person, 
or leaving it at his or her office with that person's clerk or other 
person in charge or, if there is no one in charge, leaving it in a 
conspicuous place in the office, or if the office is closed or the 
person to be served has no office, leaving it at his or her usual place 
of residence with some person of suitable age and discretion then 
residing there;
    (3) By mail, upon deposit in the United States mail, properly 
stamped and addressed;
    (4) By expedited service, upon depositing the document with the 
provider of the expedited service; or
    (5) When service cannot be effected by a method provided by 
paragraphs (f)(1)-(4) of this section, by any other method authorized by 
law.
    (6) When two or more methods of service are required, service is 
considered complete when service by each method is complete under 
paragraphs (f)(1)-(4) of this section.
    (g) Service on the NRC staff. (1) Service shall be made upon the NRC 
staff of all documents required to be filed with participants and the 
presiding officer in all proceedings, including those proceedings where 
the NRC staff informs the presiding officer of its determination not to 
participate as a party. Service upon the NRC staff shall be by the same 
or equivalent method as service upon the Office of the Secretary and the 
presiding officer, e.g., electronically, personal delivery or courier, 
express mail, or expedited delivery service. If no attorney representing 
the NRC Staff has filed a notice of appearance in the proceeding and 
service is not being made through the E-Filing System, service will be 
made using the following addresses, as applicable: by delivery to the 
Associate General Counsel for Hearings, Enforcement & Administration, 
One White Flint North, 11555 Rockville Pike, Rockville MD 20852-0001; by 
mail addressed to the Associate General Counsel for Hearings, 
Enforcement & Administration, U.S. Nuclear Regulatory Commission, 
Washington DC 20555-0001; by email to [email protected]; or 
by facsimile to 301-415-3200.
    (2) If the NRC staff decides not to participate as a party in a 
proceeding,

[[Page 49]]

it shall, in its notification to the presiding officer and participants 
of its determination not to participate, designate a person and address 
for service of documents.

[72 FR 49150, Aug. 28, 2007, as amended at 77 FR 46590, Aug. 3, 2012; 81 
FR 86909, Dec. 2, 2016]



Sec.2.306  Computation of time.

    (a) In computing any period of time, the day of the act, event, or 
default after which the designated period of time begins to run is not 
included. The last day of the period so computed is included unless it 
is a Saturday or Sunday, a Federal legal holiday at the place where the 
action or event is to occur, or a day upon which, because of an 
emergency closure of the Federal government in Washington, DC, NRC 
Headquarters does not open for business, in which event the period runs 
until the end of the next day that is not a Saturday, Sunday, Federal 
legal holiday, or emergency closure.
    (b) Whenever a participant has the right or is required to do some 
act within a prescribed period after the service of a notice or other 
document upon him or her, no additional time is added to the prescribed 
period except in the following circumstances:
    (1) If a notice or document is served upon a participant, by first-
class mail only, three (3) calendar days will be added to the prescribed 
period for all the participants in the proceeding.
    (2) If a notice or document is served upon a participant, by express 
mail or other expedited service only, two (2) calendar days will be 
added to the prescribed period for all the participants in the 
proceeding.
    (3) If a document is to be served by multiple service methods, such 
as partially electronic and entirely on optical storage media, the 
additional number of days is computed according to the service method 
used to deliver the entire document, excluding courtesy copies, to all 
of the other participants in the proceeding. The presiding officer may 
determine the calculation of additional days when a participant is not 
entitled to receive an entire filing served by multiple methods.
    (4) In mixed service proceedings when all participants are not using 
the same filing and service method, the number of days for service will 
be determined by the presiding officer based on considerations of 
fairness and efficiency.
    (c) To be considered timely, a document must be served:
    (1) By 5 p.m. Eastern Time for a document served in person or by 
expedited service; and
    (2) By 11:59 p.m. Eastern Time for a document served by the E-Filing 
system.

[72 FR 49151, Aug. 28, 2007]



Sec.2.307  Extension and reduction of time limits; delegated authority
to order use of procedures for access by potential parties to certain
sensitive unclassified information.
          

    (a) Except as otherwise provided by law, the time fixed or the 
period of time prescribed for an act that is required or allowed to be 
done at or within a specified time, may be extended or shortened either 
by the Commission or the presiding officer for good cause, or by 
stipulation approved by the Commission or the presiding officer.
    (b) If this part does not prescribe a time limit for an action to be 
taken in the proceeding, the Commission or the presiding officer may set 
a time limit for the action.
    (c) In circumstances where, in order to meet Commission requirements 
for intervention, potential parties may deem it necessary to obtain 
access to safeguards information (as defined in Sec.73.2 of this 
chapter) or to sensitive unclassified non-safeguards information, the 
Secretary is delegated authority to issue orders establishing procedures 
and timelines for submitting and resolving requests for this 
information.

[69 FR 2236, Jan. 14, 2004, as amended at 73 FR 10980, Feb. 29, 2008]



Sec.2.308  Treatment of requests for hearing or petitions for leave
to intervene by the Secretary.

    Upon receipt of a request for hearing or a petition to intervene, 
the Secretary will forward the request or petition and/or proffered 
contentions and any answers and replies either to the Commission for a 
ruling on the request/petition and/or proffered contentions or to the 
Chief Administrative Judge of the Atomic Safety and Licensing Board

[[Page 50]]

Panel for the designation of a presiding officer under Sec.2.313(a) to 
rule on the matter.



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 
10 CFR 52.103, 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.
    (b) Timing. Unless specified elsewhere in this chapter or otherwise 
provided by the Commission, the request or petition and the list of 
contentions must be filed as follows:
    (1) In proceedings for the direct or indirect transfer of control of 
an NRC license when the transfer requires prior approval of the NRC 
under the Commission's regulations, governing statute, or pursuant to a 
license condition, twenty (20) days from the date of publication of the 
notice in the Federal Register.
    (2) In proceedings for the initial authorization to construct a 
high-level radioactive waste geologic repository, and the initial 
licensee to receive and process high level radioactive waste at a 
geological repository operations area, thirty (30) days from the date of 
publication of the notice in the Federal Register.
    (3) In proceedings for which a Federal Register notice of agency 
action is published (other than a proceeding covered by paragraphs 
(b)(1) or (b)(2) of this section), not later than:
    (i) The time specified in any notice of hearing or notice of 
proposed action or as provided by the presiding officer or the Atomic 
Safety and Licensing Board designated to rule on the request and/or 
petition, which may not be less than sixty (60) days from the date of 
publication of the notice in the Federal Register; or
    (ii) If no period is specified, sixty (60) days from the date of 
publication of the notice.
    (4) In proceedings for which a Federal Register notice of agency 
action is not published, not later than the latest of:
    (i) Sixty (60) days after publication of notice on the NRC Web site 
at http://www.nrc.gov/public-involve/major-actions.html, or
    (ii) Sixty (60) days after the requestor receives actual notice of a 
pending application, but not more than sixty (60) days after agency 
action on the application.
    (c) Filings after the deadline; submission of hearing request, 
intervention petition, or motion for leave to file new or amended 
contentions--(1) Determination by presiding officer. Hearing requests, 
intervention petitions, and motions for leave to file new or amended 
contentions filed after the deadline in paragraph (b) of this section 
will not be entertained absent a determination by the presiding officer 
that a participant has demonstrated good cause by showing that:

[[Page 51]]

    (i) The information upon which the filing is based was not 
previously available;
    (ii) The information upon which the filing is based is materially 
different from information previously available; and
    (iii) The filing has been submitted in a timely fashion based on the 
availability of the subsequent information.
    (2) Applicability of Sec. Sec.2.307 and 2.323. (i) Section 2.307 
applies to requests to change a filing deadline (requested before or 
after that deadline has passed) based on reasons not related to the 
substance of the filing.
    (ii) Section 2.323 does not apply to hearing requests, intervention 
petitions, or motions for leave to file new or amended contentions filed 
after the deadline in paragraph (b) of this section.
    (3) New petitioner. A hearing request or intervention petition filed 
after the deadline in paragraph (b) of this section must include a 
specification of contentions if the petitioner seeks admission as a 
party, and must also demonstrate that the petitioner meets the 
applicable standing and contention admissibility requirements in 
paragraphs (d) and (f) of this section.
    (4) Party or participant. A new or amended contention filed by a 
party or participant to the proceeding must also meet the applicable 
contention admissibility requirements in paragraph (f) of this section. 
If the party or participant has already satisfied the requirements for 
standing under paragraph (d) of this section in the same proceeding in 
which the new or amended contentions are filed, it does not need to do 
so again.
    (d) Standing. (1) General requirements. A request for hearing or 
petition for leave to intervene must state:
    (i) The name, address and telephone number of the requestor or 
petitioner;
    (ii) The nature of the requestor's/petitioner's right under the Act 
to be made a party to the proceeding;
    (iii) The nature and extent of the requestor's/petitioner's 
property, financial or other interest in the proceeding; and
    (iv) The possible effect of any decision or order that may be issued 
in the proceeding on the requestor's/petitioner's interest.
    (2) Rulings. In ruling on a request for hearing or petition for 
leave to intervene, the Commission, the presiding officer, or the Atomic 
Safety and Licensing Board designated to rule on such requests must 
determine, among other things, whether the petitioner has an interest 
affected by the proceeding considering the factors enumerated in 
paragraph (d)(1) of this section.
    (3) Standing in enforcement proceedings. In enforcement proceedings, 
the licensee or other person against whom the action is taken shall have 
standing.
    (e) Discretionary Intervention. The presiding officer may consider a 
request for discretionary intervention when at least one requestor/
petitioner has established standing and at least one admissible 
contention has been admitted so that a hearing will be held. A 
requestor/petitioner may request that his or her petition be granted as 
a matter of discretion in the event that the petitioner is determined to 
lack standing to intervene as a matter of right under paragraph (d)(1) 
of this section. Accordingly, in addition to addressing the factors in 
paragraph (d)(1) of this section, a petitioner who wishes to seek 
intervention as a matter of discretion in the event it is determined 
that standing as a matter of right is not demonstrated shall address the 
following factors in his/her initial petition, which the Commission, the 
presiding officer or the Atomic Safety and Licensing Board will consider 
and balance:
    (1) Factors weighing in favor of allowing intervention--
    (i) The extent to which the requestor's/petitioner's participation 
may reasonably be expected to assist in developing a sound record;
    (ii) The nature and extent of the requestor's/petitioner's property, 
financial or other interests in the proceeding; and
    (iii) The possible effect of any decision or order that may be 
issued in the proceeding on the requestor's/petitioner's interest;
    (2) Factors weighing against allowing intervention--

[[Page 52]]

    (i) The availability of other means whereby the requestor's/
petitioner's interest will be protected;
    (ii) The extent to which the requestor's/petitioner's interest will 
be represented by existing parties; and
    (iii) The extent to which the requestor's/petitioner's participation 
will inappropriately broaden the issues or delay the proceeding.
    (f) Contentions. (1) A request for hearing or petition for leave to 
intervene must set forth with particularity the contentions sought to be 
raised. For each contention, the request or petition must:
    (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 10 CFR 52.103(b) 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;
    (ii) Provide a brief explanation of the basis for the contention;
    (iii) Demonstrate that the issue raised in the contention is within 
the scope of the proceeding;
    (iv) Demonstrate that the issue raised in the contention is material 
to the findings the NRC must make to support the action that is involved 
in the proceeding;
    (v) Provide a concise statement of the alleged facts or expert 
opinions which support the requestor's/petitioner's position on the 
issue and on which the petitioner intends to rely at hearing, together 
with references to the specific sources and documents on which the 
requestor/petitioner intends to rely to support its position on the 
issue;
    (vi) In a proceeding other than one under 10 CFR 52.103, 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 10 CFR 52.103(b), 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 
10 CFR 52.99(c) which the requestor believes is inaccurate, incorrect, 
and/or incomplete (i.e., fails to contain the necessary information 
required by Sec.52.99(c)). If the requestor identifies a specific 
portion of the Sec.52.99(c) report 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.
    (2) Contentions must be based on documents or other information 
available at the time the petition is to be filed, such as the 
application, supporting safety analysis report, environmental report or 
other supporting document filed by an applicant or licensee, or 
otherwise available to a petitioner. On issues arising under the 
National Environmental Policy Act, participants shall file contentions 
based on the applicant's environmental report. Participants may file new 
or amended environmental contentions after the deadline in paragraph (b) 
of this section (e.g., based on a draft or final NRC environmental 
impact statement, environmental assessment, or any supplements to these 
documents) if the contention complies with the requirements in paragraph 
(c) of this section.
    (3) If two or more requestors/petitioners seek to co-sponsor a 
contention, the requestors/petitioners shall jointly designate a 
representative who

[[Page 53]]

shall have the authority to act for the requestors/petitioners with 
respect to that contention. If a requestor/petitioner seeks to adopt the 
contention of another sponsoring requestor/petitioner, the requestor/
petitioner who seeks to adopt the contention must either agree that the 
sponsoring requestor/petitioner shall act as the representative with 
respect to that contention, or jointly designate with the sponsoring 
requestor/petitioner a representative who shall have the authority to 
act for the requestors/petitioners with respect to that contention.
    (g) Selection of hearing procedures. A request for hearing and/or 
petition for leave to intervene may, except in a proceeding under 10 CFR 
52.103, 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) Requirements applicable to States, local governmental bodies, 
and Federally-recognized Indian Tribes seeking party status. (1) If a 
State, local governmental body (county, municipality or other 
subdivision), or Federally-recognized Indian Tribe seeks to participate 
as a party in a proceeding, it must submit a request for hearing or a 
petition to intervene containing at least one admissible contention, and 
must designate a single representative for the hearing. If a request for 
hearing or petition to intervene is granted, the Commission, the 
presiding officer or the Atomic Safety and Licensing Board ruling on the 
request will admit as a party to the proceeding a single designated 
representative of the State, a single designated representative for each 
local governmental body (county, municipality or other subdivision), and 
a single designated representative for each Federally-recognized Indian 
Tribe. Where a State's constitution provides that both the Governor and 
another State official or State governmental body may represent the 
interests of the State in a proceeding, the Governor and the other State 
official/government body will be considered separate participants.
    (2) If the proceeding pertains to a production or utilization 
facility (as defined in Sec.50.2 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.
    (3) In any proceeding on an application for a construction 
authorization for a high-level radioactive waste repository at a 
geologic repository operations area under parts 60 or 63 of this 
chapter, or an application for a license to receive and possess high-
level radioactive waste at a geologic repository operations area under 
parts 60 or 63 of this chapter, the Commission shall permit intervention 
by the State and local governmental body (county, municipality or other 
subdivision) in which such an area is located and by any affected 
Federally-recognized Indian Tribe as defined in parts 60 or 63 of this 
chapter if the requirements of paragraph (f) of this section are 
satisfied with respect to at least one contention. All other petitions 
for intervention in any such proceeding must be reviewed under the 
provisions of paragraphs (a) through (f) of this section.
    (i) Answers to hearing requests, intervention petitions, and motions 
for leave to file new or amended contentions filed after the deadline. 
Unless otherwise specified by the Commission, the presiding officer, or 
the Atomic Safety and Licensing Board designated to rule on the request, 
petition, or motion--
    (1) The applicant/licensee, the NRC staff, and other parties to a 
proceeding may file an answer to a hearing request, intervention 
petition, or motion for leave to file amended or new contentions filed 
after the deadline in Sec.2.309(b) within 25 days after service of

[[Page 54]]

the request, petition, or motion. Answers should address, at a minimum, 
the factors set forth in paragraphs (a) through (h) of this section 
insofar as these sections apply to the filing that is the subject of the 
answer.
    (2) Except in a proceeding under Sec.52.103 of this chapter, 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.
    (3) No other written answers or replies will be entertained.
    (j) Decision on request/petition. (1) In all proceedings other than 
a proceeding under Sec.52.103 of this chapter, 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 of this chapter. The Commission's decision may not be 
the subject of any appeal under Sec.2.311.

[69 FR 2236, Jan. 14, 2004, as amended at 72 FR 49474, Aug. 28, 2007; 73 
FR 44620, July 31, 2008; 77 FR 46591, Aug. 3, 2012]



Sec.2.310  Selection of hearing procedures.

    Upon a determination that a request for hearing/petition to 
intervene should be granted and a hearing held, the Commission, the 
presiding officer, or the Atomic Safety and Licensing Board designated 
to rule on the request/petition will determine and identify the specific 
hearing procedures to be used for the proceeding as follows--
    (a) Except as determined through the application of paragraphs (b) 
through (h) of this section, proceedings for the grant, renewal, 
licensee-initiated amendment, or termination of licenses or permits 
subject to parts 30, 32 through 36, 39, 40, 50, 52, 54, 55, 61, 70 and 
72 of this chapter may be conducted under the procedures of subpart L of 
this part.
    (b) Proceedings on enforcement matters must be conducted under the 
procedures of subpart G of this part, unless all parties agree and 
jointly request that the proceedings be conducted under the procedures 
of subpart L or subpart N of this part, as appropriate.
    (c) Proceedings on the licensing of the construction and operation 
of a uranium enrichment facility must be conducted under the procedures 
of subpart G of this part.
    (d) In proceedings for the grant, renewal, licensee-initiated 
amendment, or termination of licenses or permits for nuclear power 
reactors, where the presiding officer by order finds that resolution of 
the contention or contested matter necessitates resolution of issues of 
material fact relating to the occurrence of a past activity, where the 
credibility of an eyewitness may reasonably be expected to be at issue, 
and/or issues of motive or intent of the party or eyewitness material to 
the resolution of the contested matter, the hearing for resolution of 
that contention or contested matter will be conducted under subpart G of 
this part.
    (e) Proceedings on applications for a license or license amendment 
to expand the spent nuclear fuel storage capacity at the site of a 
civilian nuclear power plant must be conducted under the procedures of 
subpart L of this part, unless a party requests that the proceeding be 
conducted under the procedures of subpart K of this part, or if all 
parties agree and jointly request that the proceeding be conducted under 
the procedures of subpart N of this part.

[[Page 55]]

    (f) Proceedings on an application for initial construction 
authorization for a high-level radioactive waste repository at a 
geologic repository operations area noticed pursuant to Sec. Sec.
2.101(f)(8) or 2.105(a)(5), and proceedings on an initial application 
for a license to receive and possess high-level radioactive waste at a 
geologic repository operations area must be conducted under the 
procedures of subparts G and J of this part. Subsequent amendments to a 
construction authorization for a high-level radioactive geologic 
repository, and amendments to a license to receive and possess high 
level radioactive waste at a high level waste geologic repository may be 
conducted under the procedures of subpart L of this part, unless all 
parties agree and jointly request that the proceeding be conducted under 
the procedures of subpart N of this part.
    (g) Proceedings on an application for the direct or indirect 
transfer of control of an NRC license which transfer requires prior 
approval of the NRC under the Commission's regulations, governing 
statutes or pursuant to a license condition shall be conducted under the 
procedures of subpart M of this part, unless the Commission determines 
otherwise in a case-specific order.
    (h) Except as determined through the application of paragraphs (b) 
through (g) of this section, proceedings for the grant, renewal, 
licensee-initiated amendment, or termination of licenses or permits 
subject to parts 30, 32 through 36, 39, 40, 50, 52, 54, 55, 61, 70 and 
72 of this chapter, and proceedings on an application for the direct or 
indirect transfer of control of an NRC license may be conducted under 
the procedures of subpart N of this part if--
    (1) The hearing itself is expected to take no more than two (2) days 
to complete; or
    (2) All parties to the proceeding agree that it should be conducted 
under the procedures of subpart N of this part.
    (i) In design certification rulemaking proceedings under part 52 of 
this chapter, any informal hearing held under Sec.52.51 of this 
chapter must be conducted under the procedures of subpart O of this 
part.
    (j) Proceedings on a Commission finding under 10 CFR 52.103(c) and 
(g) shall be conducted in accordance with the procedures designated by 
the Commission in each proceeding.
    (k) In proceedings where the Commission grants a petition filed 
under Sec.2.335(b), the Commission may, in its discretion, conduct a 
hearing under the procedures of subpart O of this part to assist the 
Commission in developing a record on the matters raised in the petition.

[69 FR 2236, Jan. 14, 2004, as amended at 72 FR 49475, Aug. 28, 2007]



Sec.2.311  Interlocutory review of rulings on requests for hearings/
petitions to intervene, selection of hearing procedures, and requests
by potential parties for access to sensitive unclassified non-
safeguards information and safeguards information.

    (a) An order of the presiding officer, or if a presiding officer has 
not been designated, of the Chief Administrative Judge, or if he or she 
is unavailable, of another administrative judge, or of an administrative 
law judge with jurisdiction under Sec.2.318(a), may be appealed to the 
Commission with respect to:
    (1) A request for hearing;
    (2) A petition to intervene; or
    (3) A request for access to sensitive unclassified non-safeguards 
information (SUNSI), including, but not limited to, proprietary, 
confidential commercial, and security-related information, and 
Safeguards Information (SGI). An appeal to the Commission may also be 
taken from an order of an officer designated to rule on information 
access issues.
    (b) These appeals must be made as specified by the provisions of 
this section, within 25 days after the service of the order. The appeal 
must be initiated by the filing of a notice of appeal and accompanying 
supporting brief. Any party who opposes the appeal may file a brief in 
opposition to the appeal within 25 days after service of the appeal. The 
supporting brief and any answer must conform to the requirements of 
Sec.2.341(c)(3). No other appeals from rulings on requests for hearing 
are allowed.
    (c) An order denying a petition to intervene, and/or request for 
hearing, or

[[Page 56]]

a request for access to the information described in paragraph (a) of 
this section, is appealable by the requestor/petitioner on the question 
as to whether the request and/or petition should have been granted.
    (d) An order granting a petition to intervene, and/or request for 
hearing, or granting a request for access to the information described 
in paragraph (a) of this section, is appealable by a party other than 
the requestor/petitioner on the question as to:
    (1) Whether the request for hearing or petition to intervene should 
have been wholly denied; or
    (2) Whether the request for access to the information described in 
paragraph (a)(3) of this section should have been denied in whole or in 
part. However, such a question with respect to SGI may only be appealed 
by the NRC staff, and such a question with respect to SUNSI may be 
appealed only by the NRC staff or by a party whose interest independent 
of the proceeding would be harmed by the release of the information.
    (e) An order selecting a hearing procedure may be appealed by any 
party on the question as to whether the selection of the particular 
hearing procedures was in clear contravention of the criteria set forth 
in Sec.2.310. The appeal must be filed with the Commission no later 
than ten (10) days after issuance of the order selecting a hearing 
procedure.

[73 FR 12631, Mar. 10, 2008, as amended at 77 FR 46592, Aug. 3, 2012; 78 
FR 34247, June 7, 2013]



Sec.2.312  Notice of hearing.

    (a) In a proceeding in which the terms of a notice of hearing are 
not otherwise prescribed by this part, the order or notice of hearing 
will state:
    (1) The nature of the hearing and its time and place, or a statement 
that the time and place will be fixed by subsequent order;
    (2) The legal authority and jurisdiction under which the hearing is 
to be held;
    (3) The matters of fact and law asserted or to be considered; and
    (4) A statement describing the specific hearing procedures or 
subpart that will be used for the hearing.
    (b) The time and place of hearing will be fixed with due regard for 
the convenience of the parties or their representatives, the nature of 
the proceeding and the public interest.



Sec.2.313  Designation of presiding officer, disqualification, 
unavailability, and substitution.

    (a) Designation of presiding officer. The Commission may provide in 
the notice of hearing that one or more members of the Commission, an 
administrative law judge, an administrative judge, an Atomic Safety and 
Licensing Board, or a named officer who has been delegated final 
authority in the matter, shall be the presiding officer. The Commission 
alone shall designate the presiding officer in a hearing conducted under 
subpart O. If the Commission does not designate the presiding officer 
for a hearing under subparts G, J, K, L, M, or N of this part, then the 
Chief Administrative Judge shall issue an order designating:
    (1) An Atomic Safety and Licensing Board appointed under Section 191 
of the Atomic Energy Act of 1954, as amended, or an administrative law 
judge appointed pursuant to 5 U.S.C. 3105, for a hearing conducted under 
subparts G, J, K, L, or N of this part; or
    (2) An Atomic Safety and Licensing Board, an administrative law 
judge, or an administrative judge for a hearing conducted under subpart 
M of this part.
    (b) Disqualification. (1) If a designated presiding officer or a 
designated member of an Atomic Safety and Licensing Board believes that 
he or she is disqualified to preside or to participate as a board member 
in the hearing, he or she shall withdraw by notice on the record and 
shall notify the Commission or the Chief Administrative Judge, as 
appropriate, of the withdrawal.
    (2) If a party believes that a presiding officer or a designated 
member of an Atomic Safety and Licensing Board should be disqualified, 
the party may move that the presiding officer or the Licensing Board 
member disqualify himself or herself. The motion must be supported by 
affidavits setting forth the alleged grounds for disqualification. If 
the presiding officer does not grant the motion or the Licensing

[[Page 57]]

Board member does not disqualify himself, the motion must be referred to 
the Commission. The Commission will determine the sufficiency of the 
grounds alleged.
    (c) Unavailability. If a presiding officer or a designated member of 
an Atomic Safety and Licensing Board becomes unavailable during the 
course of a hearing, the Commission or the Chief Administrative Judge, 
as appropriate, will designate another presiding officer or Atomic 
Safety and Licensing Board member. If he or she becomes unavailable 
after the hearing has been concluded, then:
    (1) The Commission may designate another presiding officer;
    (2) The Chief Administrative Judge or the Commission, as 
appropriate, may designate another Atomic Safety and Licensing Board 
member to participate in the decision;
    (3) The Commission may direct that the record be certified to it for 
decision.
    (d) Substitution. If a presiding officer or a designated member of 
an Atomic Safety and Licensing Board is substituted for the one 
originally designated, any motion predicated upon the substitution must 
be made within five (5) days after the substitution.



Sec.2.314  Appearance and practice before the Commission in 
adjudicatory proceedings.

    (a) Standards of practice. In the exercise of their functions under 
this subpart, the Commission, the Atomic Safety and Licensing Boards, 
Administrative Law Judges, and Administrative Judges function in a 
quasi-judicial capacity. Accordingly, parties and their representatives 
in proceedings subject to this subpart are expected to conduct 
themselves with honor, dignity, and decorum as they should before a 
court of law.
    (b) Representation. A person may appear in an adjudication on his or 
her own behalf or by an attorney-at-law. A partnership, corporation, or 
unincorporated association may be represented by a duly authorized 
member or officer, or by an attorney-at-law. A party may be represented 
by an attorney-at-law if the attorney is in good standing and has been 
admitted to practice before any Court of the United States, the District 
of Columbia, or the highest court of any State, territory, or possession 
of the United States. Any person appearing in a representative capacity 
shall file with the Commission a written notice of appearance. The 
notice must state his or her name, address, telephone number, and 
facsimile number and email address, if any; the name and address of the 
person or entity on whose behalf he or she appears; and, in the case of 
an attorney-at-law, the basis of his or her eligibility as a 
representative or, in the case of another representative, the basis of 
his or her authority to act on behalf of the party.
    (c) Reprimand, censure or suspension from the proceeding. (1) A 
presiding officer, or the Commission may, if necessary for the orderly 
conduct of a proceeding, reprimand, censure or suspend from 
participation in the particular proceeding pending before it any party 
or representative of a party who refuses to comply with its directions, 
or who is disorderly, disruptive, or engages in contemptuous conduct.
    (2) A reprimand, censure, or a suspension that is ordered to run for 
one day or less must state the grounds for the action in the record of 
the proceeding, and must advise the person disciplined of the right to 
appeal under paragraph (c)(3) of this section. A suspension that is 
ordered for a longer period must be in writing, state the grounds on 
which it is based, and advise the person suspended of the right to 
appeal and to request a stay under paragraphs (c)(3) and (c)(4) of this 
section. The suspension may be stayed for a reasonable time in order for 
an affected party to obtain other representation if this would be 
necessary to prevent injustice.
    (3) Anyone disciplined under this section may file an appeal with 
the Commission within 25 days after issuance of the order. The appeal 
must be in writing and state concisely, with supporting argument, why 
the appellant believes the order was erroneous, either as a matter of 
fact or law. The Commission shall consider each appeal on the merits, 
including appeals in cases in which the suspension period has already 
run. If necessary for a full and fair consideration of the facts, the

[[Page 58]]

Commission may conduct further evidentiary hearings, or may refer the 
matter to another presiding officer for development of a record. In the 
latter event, unless the Commission provides specific directions to the 
presiding officer, that officer shall determine the procedure to be 
followed and who shall present evidence, subject to applicable 
provisions of law. The hearing must begin as soon as possible. In the 
case of an attorney, if no appeal is taken of a suspension, or, if the 
suspension is upheld at the conclusion of the appeal, the presiding 
officer, or the Commission, as appropriate, shall notify the State 
bar(s) to which the attorney is admitted. The notification must include 
copies of the order of suspension, and, if an appeal was taken, briefs 
of the parties, and the decision of the Commission.
    (4) A suspension exceeding one (1) day is not effective for seventy-
two (72) hours from the date the suspension order is issued. Within this 
time, a suspended individual may request a stay of the sanction from the 
appropriate reviewing tribunal pending appeal. No responses to the stay 
request from other parties will be entertained. If a timely stay request 
is filed, the suspension must be stayed until the reviewing tribunal 
rules on the motion. The stay request must be in writing and contain the 
information specified in Sec.2.342(b). The Commission shall rule on 
the stay request within ten (10) days after the filing of the motion. 
The Commission shall consider the factors specified in Sec.2.342(e)(1) 
and (e)(2) in determining whether to grant or deny a stay application.

[69 FR 2236, Jan. 14, 2004, as amended at 77 FR 46592, Aug. 3, 2012]



Sec.2.315  Participation by a person not a party.

    (a) A person who is not a party (including persons who are 
affiliated with or represented by a party) may, in the discretion of the 
presiding officer, be permitted to make a limited appearance by making 
an oral or written statement of his or her position on the issues at any 
session of the hearing or any prehearing conference within the limits 
and on the conditions fixed by the presiding officer. However, that 
person may not otherwise participate in the proceeding. Such statements 
of position shall not be considered evidence in the proceeding.
    (b) The Secretary will give notice of a hearing to any person who 
requests it before the issuance of the notice of hearing, and will 
furnish a copy of the notice of hearing to any person who requests it 
thereafter. If a communication bears more than one signature, the 
Commission will give the notice to the person first signing unless the 
communication clearly indicates otherwise.
    (c) The presiding officer will afford an interested State, local 
governmental body (county, municipality or other subdivision), and 
Federally-recognized Indian Tribe that has not been admitted as a party 
under Sec.2.309, a reasonable opportunity to participate in a hearing. 
The participation of any State, local governmental body, or Federally-
recognized Indian Tribe shall be limited to unresolved issues and 
contentions, and issues and contentions that are raised after the State, 
local governmental body, or Federally-recognized Indian Tribe becomes a 
participant. Each State, local governmental body, and Federally-
recognized Indian Tribe shall, in its request to participate in a 
hearing, designate a single representative for the hearing. The 
representative shall be permitted to introduce evidence, interrogate 
witnesses where cross examination by the parties is permitted, advise 
the Commission without requiring the representative to take a position 
with respect to the issue, file proposed findings in those proceedings 
where findings are permitted, and petition for review by the Commission 
under Sec.2.341 with respect to the admitted contentions. The 
representative shall identify those contentions on which they will 
participate in advance of any hearing held.
    (d) If a matter is taken up by the Commission under Sec.2.341 or 
sua sponte, a person who is not a party may, in the discretion of the 
Commission, be permitted to file a brief ``amicus curiae.'' Such a 
person shall submit the amicus brief together with a motion for leave to 
do so which identifies the interest of the person and states the reasons 
why

[[Page 59]]

a brief is desirable. Unless the Commission provides otherwise, the 
brief must be filed within the time allowed to the party whose position 
the brief will support. A motion of a person who is not a party to 
participate in oral argument before the Commission will be granted at 
the discretion of the Commission.

[69 FR 2236, Jan. 14, 2004, as amended at 77 FR 46592, Aug. 3, 2012]



Sec.2.316  Consolidation of parties.

    On motion or on its or his own initiative, the Commission or the 
presiding officer may order any parties in a proceeding who have 
substantially the same interest that may be affected by the proceeding 
and who raise substantially the same questions, to consolidate their 
presentation of evidence, cross-examination, briefs, proposed findings 
of fact, and conclusions of law and argument. However, it may not order 
any consolidation that would prejudice the rights of any party. A 
consolidation under this section may be for all purposes of the 
proceeding, all of the issues of the proceeding, or with respect to any 
one or more issues thereof.



Sec.2.317  Separate hearings; consolidation of proceedings.

    (a) Separate hearings. On motion by the parties or upon request of 
the presiding officer for good cause shown, or on its own initiative, 
the Commission may establish separate hearings in a proceeding if it is 
found that the action will be conducive to the proper dispatch of its 
business and to the ends of justice and will be conducted in accordance 
with the other provisions of this subpart.
    (b) Consolidation of proceedings. On motion and for good cause shown 
or on its own initiative, the Commission or the presiding officers of 
each affected proceeding may consolidate for hearing or for other 
purposes two or more proceedings, or may hold joint hearings with 
interested States and/or other Federal agencies on matters of concurrent 
jurisdiction, if it is found that the action will be conducive to the 
proper dispatch of its business and to the ends of justice and will be 
conducted in accordance with the other provisions of this subpart.



Sec.2.318  Commencement and termination of jurisdiction of presiding
officer.

    (a) Unless the Commission orders otherwise, the jurisdiction of the 
presiding officer designated to conduct a hearing over the proceeding, 
including motions and procedural matters, commences when the proceeding 
commences. If a presiding officer has not been designated, the Chief 
Administrative Judge has jurisdiction or, if he or she is unavailable, 
another administrative judge or administrative law judge has 
jurisdiction. A proceeding commences when a notice of hearing or a 
notice of proposed action under Sec.2.105 is issued. When a notice of 
hearing provides that the presiding officer is to be an administrative 
judge or an administrative law judge, the Chief Administrative Judge 
will designate by order the administrative judge or administrative law 
judge, as appropriate, who is to preside. The presiding officer's 
jurisdiction in each proceeding terminates when the period within which 
the Commission may direct that the record be certified to it for final 
decision expires, when the Commission renders a final decision, or when 
the presiding officer withdraws from the case upon considering himself 
or herself disqualified, whichever is earliest.
    (b) The Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or the Director, Office of Nuclear Material 
Safety and Safeguards, as appropriate, may issue an order and take any 
otherwise proper administrative action with respect to a licensee who is 
a party to a pending proceeding. Any order related to the subject matter 
of the pending proceeding may be modified by the presiding officer as 
appropriate for the purpose of the proceeding.

[69 FR 2236, Jan. 14, 2004, as amended at 73 FR 5716, Jan. 31, 2008; 77 
FR 46592, Aug. 3, 2012]



Sec.2.319  Power of the presiding officer.

    A presiding officer has the duty to conduct a fair and impartial 
hearing according to law, to take appropriate action to control the 
prehearing and hearing process, to avoid delay and to maintain order. 
The presiding officer

[[Page 60]]

has all the powers necessary to those ends, including the powers to:
    (a) Administer oaths and affirmations;
    (b) Issue subpoenas authorized by law, including subpoenas requested 
by a participant for the attendance and testimony of witnesses or the 
production of evidence upon the requestor's showing of general relevance 
and reasonable scope of the evidence sought;
    (c) Consolidate parties and proceedings in accordance with 
Sec. Sec.2.316 and 2.317 and/or direct that common interests be 
represented by a single spokesperson;
    (d) Rule on offers of proof and receive evidence. In proceedings 
under this part, strict rules of evidence do not apply to written 
submissions. However, the presiding officer may, on motion or on the 
presiding officer's own initiative, strike any portion of a written 
presentation or a response to a written question that is irrelevant, 
immaterial, unreliable, duplicative or cumulative.
    (e) Restrict irrelevant, immaterial, unreliable, duplicative or 
cumulative evidence and/or arguments;
    (f) Order depositions to be taken as appropriate;
    (g) Regulate the course of the hearing and the conduct of 
participants;
    (h) Dispose of procedural requests or similar matters;
    (i) Examine witnesses;
    (j) Hold conferences before or during the hearing for settlement, 
simplification of contentions, or any other proper purpose;
    (k) Set reasonable schedules for the conduct of the proceeding and 
take actions reasonably calculated to maintain overall schedules;
    (l) Refer rulings to the Commission under Sec.2.323(f)(1), or 
certify questions to the Commission for its determination, either in the 
presiding officer's discretion, or on petition of a party under Sec.
2.323(f)(2), or on direction of the Commission.
    (m) Reopen a proceeding for the receipt of further evidence at any 
time before the initial decision;
    (n) Appoint special assistants from the Atomic Safety and Licensing 
Board Panel under Sec.2.322;
    (o) Issue initial decisions as provided in this part;
    (p) Dispose of motions by written order or by oral ruling during the 
course of a hearing or prehearing conference. The presiding officer 
should ensure that parties not present for the oral ruling are notified 
promptly of the ruling;
    (q) Issue orders necessary to carry out the presiding officer's 
duties and responsibilities under this part; and
    (r) Establish a schedule for briefs and oral arguments to decide any 
admitted contentions that, as determined by the presiding officer, 
constitute pure issues of law.
    (s) Take any other action consistent with the Act, this chapter, and 
5 U.S.C. 551-558.

[69 FR 2236, Jan. 14, 2004, as amended at 77 FR 46592, Aug. 3, 2012]



Sec.2.320  Default.

    If a party fails to file an answer or pleading within the time 
prescribed in this part or as specified in the notice of hearing or 
pleading, to appear at a hearing or prehearing conference, to comply 
with any prehearing order entered by the presiding officer, or to comply 
with any discovery order entered by the presiding officer, the 
Commission or the presiding officer may make any orders in regard to the 
failure that are just, including, among others, the following:
    (a) Without further notice, find the facts as to the matters 
regarding which the order was made in accordance with the claim of the 
party obtaining the order, and enter the order as appropriate; or
    (b) Proceed without further notice to take proof on the issues 
specified.



Sec.2.321  Atomic Safety and Licensing Boards.

    (a) The Commission or the Chief Administrative Judge may establish 
one or more Atomic Safety and Licensing Boards, each comprised of three 
members, one of whom will be qualified in the conduct of administrative 
proceedings and two of whom have such technical or other qualifications 
as the Commission or the Chief Administrative Judge determines to be 
appropriate to the issues to be decided. The members of an Atomic Safety 
and Licensing Board shall be designated from

[[Page 61]]

the Atomic Safety and Licensing Board Panel established by the 
Commission. In proceedings for granting, suspending, revoking, or 
amending licenses or authorizations as the Commission may designate, the 
Atomic Safety and Licensing Board shall perform the adjudicatory 
functions that the Commission determines are appropriate.
    (b) The Commission or the Chief Administrative Judge may designate 
an alternate qualified in the conduct of administrative proceedings, or 
an alternate having technical or other qualifications, or both, for an 
Atomic Safety and Licensing Board established under paragraph (a) of 
this section. If a member of a board becomes unavailable, the Commission 
or the Chief Administrative Judge may constitute the alternate qualified 
in the conduct of administrative proceedings, or the alternate having 
technical or other qualifications, as appropriate, as a member of the 
board by notifying the alternate who will, as of the date of the 
notification, serve as a member of the board. If an alternate is 
unavailable or no alternates have been designated, and a member of a 
board becomes unavailable, the Commission or Chief Administrative Judge 
may appoint a member of the Atomic Safety and Licensing Board Panel who 
is qualified in the conduct of administrative proceedings or a member 
having technical or other qualifications, as appropriate, as a member of 
the Atomic Safety and Licensing Board by notifying the appointee who 
will, as of the date of the notification, serve as a member of the 
board.
    (c) An Atomic Safety and Licensing Board has the duties and may 
exercise the powers of a presiding officer as granted by Sec.2.319 and 
otherwise in this part. Any time when a board is in existence but is not 
actually in session, any powers which could be exercised by a presiding 
officer or by the Chief Administrative Judge may be exercised with 
respect to the proceeding by the chairman of the board having 
jurisdiction over it. Two members of an Atomic Safety and Licensing 
Board constitute a quorum if one of those members is the member 
qualified in the conduct of administrative proceedings.



Sec.2.322  Special assistants to the presiding officer.

    (a) In consultation with the Chief Administrative Judge, the 
presiding officer may, at his or her discretion, appoint personnel from 
the Atomic Safety and Licensing Board Panel established by the 
Commission to assist the presiding officer in taking evidence and 
preparing a suitable record for review. The appointment may occur at any 
appropriate time during the proceeding but must, at the time of the 
appointment, be subject to the notice and disqualification provisions as 
described in Sec.2.313. The special assistants may function as:
    (1) Technical interrogators in their individual fields of expertise. 
The interrogators shall study the written testimony and sit with the 
presiding officer to hear the presentation and, where permitted in the 
proceeding, the cross-examination by the parties of all witnesses on the 
issues of the interrogators' expertise. The interrogators shall take a 
leading role in examining the witnesses to ensure that the record is as 
complete as possible;
    (2) Upon consent of all the parties, special masters to hear 
evidentiary presentations by the parties on specific technical matters, 
and, upon completion of the presentation of evidence, to prepare a 
report that would become part of the record. Special masters may rule on 
evidentiary issues brought before them, in accordance with Sec.2.333. 
Appeals from special masters' rulings may be taken to the presiding 
officer in accordance with procedures established in the presiding 
officer's order appointing the special master. Special masters' reports 
are advisory only; the presiding officer retains final authority with 
respect to the issues heard by the special master;
    (3) Alternate Atomic Safety and Licensing Board members to sit with 
the presiding officer, to participate in the evidentiary sessions on the 
issue for which the alternate members were designated by examining 
witnesses, and to advise the presiding officer of their conclusions 
through an on-the-record report. This report is advisory only; the 
presiding officer retains final authority on the issue for which the 
alternate member was designated; or

[[Page 62]]

    (4) Discovery master to rule on the matters specified in Sec.
2.1018(a)(2).
    (b) The presiding officer may, as a matter of discretion, informally 
seek the assistance of members of the Atomic Safety and Licensing Board 
Panel to brief the presiding officer on the general technical background 
of subjects involving complex issues that the presiding officer might 
otherwise have difficulty in quickly grasping. These briefings take 
place before the hearing on the subject involved and supplement the 
reading and study undertaken by the presiding officer. They are not 
subject to the procedures described in Sec.2.313.



Sec.2.323  Motions.

    (a) Scope and general requirements--(1) Applicability to Sec.
2.309(c). Section 2.309 motions for new or amended contentions filed 
after the deadline in Sec.2.309(b) are not subject to the requirements 
of this section. For the purposes of this section the term ``all 
motions'' includes any motion except Sec.2.309 motions for new or 
amended contentions filed after the deadline.
    (2) Presentation and disposition. All motions must be addressed to 
the Commission or other designated presiding officer. All motions must 
be made no later than ten (10) days after the occurrence or circumstance 
from which the motion arises. All written motions must be filed with the 
Secretary and served on all parties to the proceeding.
    (b) Form and content. Unless made orally on-the-record during a 
hearing, or the presiding officer directs otherwise, or under the 
provisions of subpart N of this part, a motion must be in writing, state 
with particularity the grounds and the relief sought, be accompanied by 
any affidavits or other evidence relied on, and, as appropriate, a 
proposed form of order. A motion must be rejected if it does not include 
a certification by the attorney or representative of the moving party 
that the movant has made a sincere effort to contact other parties in 
the proceeding and resolve the issue(s) raised in the motion, and that 
the movant's efforts to resolve the issue(s) have been unsuccessful.
    (c) Answers to motions. Within ten (10) days after service of a 
written motion, or other period as determined by the Secretary, the 
Assistant Secretary, or the presiding officer, a party may file an 
answer in support of or in opposition to the motion, accompanied by 
affidavits or other evidence. The moving party has no right to reply, 
except as permitted by the Secretary, the Assistant Secretary, or the 
presiding officer. Permission may be granted only in compelling 
circumstances, such as where the moving party demonstrates that it could 
not reasonably have anticipated the arguments to which it seeks leave to 
reply.
    (d) Accuracy in filing. All parties are obligated, in their filings 
before the presiding officer and the Commission, to ensure that their 
arguments and assertions are supported by appropriate and accurate 
references to legal authority and factual basis, including, as 
appropriate, citations to the record. Failure to do so may result in 
appropriate sanctions, including striking a matter from the record or, 
in extreme circumstances, dismissal of the party.
    (e) Motions for reconsideration. Motions for reconsideration may not 
be filed except upon leave of the presiding officer or the Commission, 
upon a showing of compelling circumstances, such as the existence of a 
clear and material error in a decision, which could not have reasonably 
been anticipated, that renders the decision invalid. A motion must be 
filed within ten (10) days of the action for which reconsideration is 
requested. The motion and any responses to the motion are limited to ten 
(10) pages.
    (f) Referral and certifications to the Commission. (1) If, in the 
judgment of the presiding officer, the presiding officer's decision 
raises significant and novel legal or policy issues, or prompt decision 
by the Commission is necessary to materially advance the orderly 
disposition of the proceeding, then the presiding officer may promptly 
refer the ruling to the Commission. This standard also applies to 
matters certified to the Commission. The presiding officer shall notify 
the parties of the referral or certification either by announcement on-
the-record or by written notice if the hearing is not in session.

[[Page 63]]

    (2) A party may petition the presiding officer to certify a question 
to the Commission for early review. The presiding officer shall apply 
the criteria in Sec.2.341(f)(1) in determining whether to grant the 
petition for certification. No motion for reconsideration of the 
presiding officer's ruling on a petition for certification will be 
entertained.
    (g) Effect of filing a motion, petition, or certification of 
question to the Commission. Unless otherwise ordered, neither the filing 
of a motion, the filing of a petition for certification, nor the 
certification of a question to the Commission stays the proceeding or 
extends the time for the performance of any act.
    (h) Motions to compel discovery. Parties may file answers to motions 
to compel discovery in accordance with paragraph (c) of this section. 
The presiding officer, in his or her discretion, may order that the 
answer be given orally during a telephone conference or other prehearing 
conference, rather than in writing. If responses are given over the 
telephone, the presiding officer shall issue a written order on the 
motion summarizing the views presented by the parties. This does not 
preclude the presiding officer from issuing a prior oral ruling on the 
matter effective at the time of the ruling, if the terms of the ruling 
are incorporated in the subsequent written order.

[69 FR 2236, Jan. 14, 2004, as amended at 77 FR 46593, Aug. 3, 2012]



Sec.2.324  Order of procedure.

    The presiding officer or the Commission will designate the order of 
procedure at a hearing. The proponent of an order will ordinarily open 
and close.



Sec.2.325  Burden of proof.

    Unless the presiding officer otherwise orders, the applicant or the 
proponent of an order has the burden of proof.



Sec.2.326  Motions to reopen.

    (a) A motion to reopen a closed record to consider additional 
evidence will not be granted unless the following criteria are 
satisfied:
    (1) The motion must be timely. However, an exceptionally grave issue 
may be considered in the discretion of the presiding officer even if 
untimely presented;
    (2) The motion must address a significant safety or environmental 
issue; and
    (3) The motion must demonstrate that a materially different result 
would be or would have been likely had the newly proffered evidence been 
considered initially.
    (b) The motion must be accompanied by affidavits that set forth the 
factual and/or technical bases for the movant's claim that the criteria 
of paragraph (a) of this section have been satisfied. Affidavits must be 
given by competent individuals with knowledge of the facts alleged, or 
by experts in the disciplines appropriate to the issues raised. Evidence 
contained in affidavits must meet the admissibility standards of this 
subpart. Each of the criteria must be separately addressed, with a 
specific explanation of why it has been met. When multiple allegations 
are involved, the movant must identify with particularity each issue it 
seeks to litigate and specify the factual and/or technical bases which 
it believes support the claim that this issue meets the criteria in 
paragraph (a) of this section.
    (c) A motion predicated in whole or in part on the allegations of a 
confidential informant must identify to the presiding officer the source 
of the allegations and must request the issuance of an appropriate 
protective order.
    (d) A motion to reopen that relates to a contention not previously 
in controversy among the parties must also satisfy the Sec.2.309(c) 
requirements for new or amended contentions filed after the deadline in 
Sec.2.309(b).

[69 FR 2236, Jan. 14, 2004, as amended at 77 FR 46593, Aug. 3, 2012]



Sec.2.327  Official recording; transcript.

    (a) Recording hearings. A hearing will be recorded stenographically 
or by other means under the supervision of the presiding officer. If the 
hearing is recorded on videotape or some other video medium, before an 
official transcript is prepared under paragraph (b) of this section, 
that video recording will be considered to constitute the record of 
events at the hearing.

[[Page 64]]

    (b) Official transcript. For each hearing, a transcript will be 
prepared from the recording made in accordance with paragraph (a) of 
this section that will be the sole official transcript of the hearing. 
The transcript will be prepared by an official reporter who may be 
designated by the Commission or may be a regular employee of the 
Commission. Except as limited by section 181 of the Act or order of the 
Commission, the transcript will be available for inspection in the 
agency's public records system.
    (c) Availability of copies. Copies of transcripts prepared in 
accordance with paragraph (b) of this section are available to the 
parties and to the public from the official reporter on payment of the 
charges fixed therefor. If a hearing is recorded on videotape or other 
video medium, copies of the recording of each daily session of the 
hearing may be made available to the parties and to the public from the 
presiding officer upon payment of a charge specified by the Chief 
Administrative Judge.
    (d) Transcript corrections. Corrections ordered or approved by the 
presiding officer must be included in the record through the issuance of 
an order by the presiding officer or the Secretary, as appropriate under 
the regulations in this part. The order shall reflect the corrections to 
the transcript through the use of a table, the issuance of a corrected 
or new transcript, or some other method selected by the presiding 
officer that will ensure a clear and concise description of the 
corrections.

[69 FR 2236, Jan. 14, 2004, as amended at 81 FR 47006, July 20, 2016]



Sec.2.328  Hearings to be public.

    Except as may be requested under section 181 of the Act, all 
hearings will be public unless otherwise ordered by the Commission.



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. Sec.50.21(b) or 50.22 of this 
chapter or a testing facility, shall 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. Sec.50.21(b) or 50.22 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.
    (b) Objectives. The following subjects may be discussed, as directed 
by the Commission or the presiding officer, at the prehearing 
conference:
    (1) Expediting the disposition of the proceeding;
    (2) Establishing early and continuing control so that the proceeding 
will not be protracted because of lack of management;
    (3) Discouraging wasteful prehearing activities;
    (4) Improving the quality of the hearing through more thorough 
preparation, and;
    (5) Facilitating the settlement of the proceeding or any portions of 
it.
    (c) Other matters for consideration. As appropriate for the 
particular proceeding, a prehearing conference may be held to consider 
such matters as:
    (1) Simplification, clarification, and specification of the issues;
    (2) The necessity or desirability of amending the pleadings;
    (3) Obtaining stipulations and admissions of fact and the contents 
and authenticity of documents to avoid unnecessary proof, and advance 
rulings from the presiding officer on the admissibility of evidence;
    (4) The appropriateness and timing of summary disposition motions 
under subparts G and L of this part, including appropriate limitations 
on the page length of motions and responses thereto;
    (5) The control and scheduling of discovery, including orders 
affecting disclosures and discovery under the discovery provisions in 
subpart G of this part.
    (6) Identification of witnesses and documents, and the limitation of 
the number of expert witnesses, and other steps to expedite the 
presentation of evidence, including the establishment

[[Page 65]]

of reasonable limits on the time allowed for presenting direct and, 
where permitted, cross-examination evidence;
    (7) The disposition of pending motions;
    (8) Settlement and the use of special procedures to assist in 
resolving any issues in the proceeding;
    (9) The need to adopt special procedures for managing potentially 
difficult or protracted proceedings that may involve particularly 
complex issues, including the establishment of separate hearings with 
respect to any particular issue in the proceeding;
    (10) The setting of a hearing schedule, including any appropriate 
limitations on the scope and time permitted for cross-examination where 
cross-examination is permitted; and
    (11) Other matters that the Commission or presiding officer 
determines may aid in the just and orderly disposition of the 
proceeding.
    (d) Reports. Prehearing conferences may be reported stenographically 
or by other means.
    (e) Prehearing conference order. The presiding officer shall enter 
an order that recites the action taken at the conference, the amendments 
allowed to the pleadings and agreements by the parties, and the issues 
or matters in controversy to be determined in the proceeding. Any 
objections to the order must be filed by a party within five (5) days 
after service of the order. Parties may not file replies to the 
objections unless the presiding officer so directs. The filing of 
objections does not stay the decision unless the presiding officer so 
orders. The presiding officer may revise the order in the light of the 
objections presented and, as permitted by Sec.2.319(l), may certify 
for determination to the Commission any matter raised in the objections 
the presiding officer finds appropriate. The order controls the 
subsequent course of the proceeding unless modified for good cause.



Sec.2.330  Stipulations.

    Apart from any stipulations made during or as a result of a 
prehearing conference, the parties may stipulate in writing at any stage 
of the proceeding or orally during the hearing, any relevant fact or the 
contents or authenticity of any document. These stipulations may be 
received in evidence. The parties may also stipulate as to the procedure 
to be followed in the proceeding. These stipulations may, on motion of 
all parties, be recognized by the presiding officer to govern the 
conduct of the proceeding.



Sec.2.331  Oral argument before the presiding officer.

    When, in the opinion of the presiding officer, time permits and the 
nature of the proceeding and the public interest warrant, the presiding 
officer may allow, and fix a time for, the presentation of oral 
argument. The presiding officer will impose appropriate limits of time 
on the argument. The transcript of the argument is part of the record.



Sec.2.332  General case scheduling and management.

    (a) Scheduling order. The presiding officer shall, as soon as 
practicable after consulting with the parties by a scheduling 
conference, telephone, mail, or other suitable means, enter a scheduling 
order that establishes limits for the time to file motions, conclude 
discovery, commence the oral phase of the hearing (if applicable), and 
take other actions in the proceeding. The scheduling order may also 
include:
    (1) Modifications of the times for disclosures under Sec. Sec.
2.336 and 2.704 and of the extent of discovery to be permitted;
    (2) The date or dates for prehearing conferences; and
    (3) Any other matters appropriate in the circumstances of the 
proceeding.
    (b) Model milestones. In developing the scheduling order under 
paragraph (a) of this section, the presiding officer shall utilize the 
applicable model milestones in Appendix B to this part as a starting 
point. The presiding officer shall make appropriate modifications based 
upon all relevant information, including but not limited to, the number 
of contentions admitted, the complexity of the issues presented, 
relevant considerations which a party may bring to the attention of the 
presiding officer, the NRC staff's schedule for completion of its safety 
and environmental evaluations (paragraph (e) of this section), and the 
NRC's interest in providing a

[[Page 66]]

fair and expeditious resolution of the issues sought to be adjudicated 
by the parties in the proceeding.
    (c) Objectives of scheduling order. The scheduling order must have 
as its objectives proper case management purposes such as:
    (1) Expediting the disposition of the proceeding;
    (2) Establishing early and continuing control so that the proceeding 
will not be protracted because of lack of management;
    (3) Discouraging wasteful prehearing activities;
    (4) Improving the quality of the hearing through more thorough 
preparation; and
    (5) Facilitating the settlement of the proceeding or any portions 
thereof, including the use of Alternative Dispute Resolution, when and 
if the presiding officer, upon consultation with the parties, determines 
that these types of efforts should be pursued.
    (d) Effect of NRC staff's schedule on scheduling order. In 
establishing a schedule, the presiding officer shall take into 
consideration the NRC staff's projected schedule for completion of its 
safety and environmental evaluations to ensure that the hearing schedule 
does not adversely impact the staff's ability to complete its reviews in 
a timely manner. Hearings on safety issues may be commenced before 
publication of the NRC staff's safety evaluation upon a finding by the 
presiding officer that commencing the hearings at that time would 
expedite the proceeding. Where an environmental impact statement (EIS) 
is involved, hearings on environmental issues addressed in the EIS may 
not commence before the issuance of the final EIS. In addition, 
discovery against the NRC staff on safety or environmental issues, 
respectively, should be suspended until the staff has issued the SER or 
EIS, unless the presiding officer finds that the commencement of 
discovery against the NRC staff (as otherwise permitted by the 
provisions of this part) before the publication of the pertinent 
document will not adversely affect completion of the document and will 
expedite the hearing.

[69 FR 2236, Jan. 14, 2004, as amended at 70 FR 20461, Apr. 20, 2005]



Sec.2.333  Authority of the presiding officer to regulate procedure
in a hearing.

    To prevent unnecessary delays or an unnecessarily large record, the 
presiding officer:
    (a) May limit the number of witnesses whose testimony may be 
cumulative;
    (b) May strike argumentative, repetitious, cumulative, unreliable, 
immaterial, or irrelevant evidence;
    (c) Shall require each party or participant who requests permission 
to conduct cross-examination to file a cross-examination plan for each 
witness or panel of witnesses the party or participant proposes to 
cross-examine;
    (d) Must ensure that each party or participant permitted to conduct 
cross-examination conducts its cross-examination in conformance with the 
party's or participant's cross-examination plan filed with the presiding 
officer;
    (e) May take necessary and proper measures to prevent argumentative, 
repetitious, or cumulative cross-examination; and
    (f) May impose such time limitations on arguments as the presiding 
officer determines appropriate, having regard for the volume of the 
evidence and the importance and complexity of the issues involved.



Sec.2.334  Implementing hearing schedule for proceeding.

    (a) Unless the Commission directs otherwise in a particular 
proceeding, the presiding officer assigned to the proceeding shall, 
based on information and projections provided by the parties and the NRC 
staff, take appropriate action to maintain the hearing schedule 
established by the presiding officer in accordance with 10 CFR 2.332(a) 
of this part for the completion of the evidentiary record and, as 
appropriate, the issuance of its initial decision.
    (b) Modification of hearing schedule. A hearing schedule may not be 
modified except upon a finding of good cause by the presiding officer or 
the Commission. In making such a good cause determination, the presiding 
officer or the Commission should take into account the following 
factors, among other things:

[[Page 67]]

    (1) Whether the requesting party has exercised due diligence to 
adhere to the schedule;
    (2) Whether the requested change is the result of unavoidable 
circumstances; and
    (3) Whether the other parties have agreed to the change and the 
overall effect of the change on the schedule of the case.
    (c) The presiding officer shall provide written notification to the 
Commission any time during the course of the proceeding when it appears 
that there will be a delay of more than forty-five (45) days in meeting 
any of the dates for major activities in the hearing schedule 
established by the presiding officer under 10 CFR 2.332(a), or that the 
completion of the record or the issuance of the initial decision will be 
delayed more than sixty (60) days beyond the time specified in the 
hearing schedule established under 10 CFR 2.332(a). The notification 
must include an explanation of the reasons for the projected delay and a 
description of the actions, if any, that the presiding officer or the 
Board proposes to take to avoid or mitigate the delay.

[70 FR 20461, Apr. 20, 2005]



Sec.2.335  Consideration of Commission rules and regulations 
in adjudicatory proceedings.

    (a) Except as provided in paragraphs (b), (c), and (d) of this 
section, no rule or regulation of the Commission, or any provision 
thereof, concerning the licensing of production and utilization 
facilities, source material, special nuclear material, or byproduct 
material, is subject to attack by way of discovery, proof, argument, or 
other means in any adjudicatory proceeding subject to this part.
    (b) A participant to an adjudicatory proceeding subject to this part 
may petition that the application of a specified Commission rule or 
regulation or any provision thereof, of the type described in paragraph 
(a) of this section, be waived or an exception be made for the 
particular proceeding. The sole ground for petition of waiver or 
exception is that special circumstances with respect to the subject 
matter of the particular proceeding are such that the application of the 
rule or regulation (or a provision of it) would not serve the purposes 
for which the rule or regulation was adopted. The petition must be 
accompanied by an affidavit that identifies the specific aspect or 
aspects of the subject matter of the proceeding as to which the 
application of the rule or regulation (or provision of it) would not 
serve the purposes for which the rule or regulation was adopted. The 
affidavit must state with particularity the special circumstances 
alleged to justify the waiver or exception requested. Any other 
participant may file a response by counter-affidavit or otherwise.
    (c) If, on the basis of the petition, affidavit, and any response 
permitted under paragraph (b) of this section, the presiding officer 
determines that the petitioning participant has not made a prima facie 
showing that the application of the specific Commission rule or 
regulation (or provision thereof) to a particular aspect or aspects of 
the subject matter of the proceeding would not serve the purposes for 
which the rule or regulation was adopted and that application of the 
rule or regulation should be waived or an exception granted, no evidence 
may be received on that matter and no discovery, cross examination, or 
argument directed to the matter will be permitted, and the presiding 
officer may not further consider the matter.
    (d) If, on the basis of the petition, affidavit and any response 
provided for in paragraph (b) of this section, the presiding officer 
determines that the prima facie showing required by paragraph (b) of 
this section has been made, the presiding officer shall, before ruling 
on the petition, certify the matter directly to the Commission (the 
matter will be certified to the Commission notwithstanding other 
provisions on certification in this part) for a determination in the 
matter of whether the application of the Commission rule or regulation 
or provision thereof to a particular aspect or aspects of the subject 
matter of the proceeding, in the context of this section, should be 
waived or an exception made. The Commission may, among other things, on 
the basis of the petition, affidavits, and any response, determine 
whether the application of the specified rule or regulation

[[Page 68]]

(or provision thereof) should be waived or an exception be made. The 
Commission may direct further proceedings as it considers appropriate to 
aid its determination.
    (e) Whether or not the procedure in paragraph (b) of this section is 
available, a participant to an initial or renewal licensing proceeding 
may file a petition for rulemaking under Sec.2.802.

[69 FR 2236, Jan. 14, 2004, as amended at 77 FR 46593, Aug. 3, 2012]



Sec.2.336  General discovery.

    (a) Except for proceedings conducted under subparts G and J of this 
part or as otherwise ordered by the Commission, the presiding officer or 
the Atomic Safety and Licensing Board assigned to the proceeding, all 
parties, other than the NRC staff, to any proceeding subject to this 
part shall, within thirty (30) days of the issuance of the order 
granting a request for hearing or petition to intervene and without 
further order or request from any party, disclose and provide:
    (1) The name and, if known, the address and telephone number of any 
person, including any expert, upon whose opinion the party bases its 
claims and contentions and may rely upon as a witness, and a copy of the 
analysis or other authority upon which that person bases his or her 
opinion;
    (2)(i) A copy, or a description by category and location, of all 
documents and data compilations in the possession, custody, or control 
of the party that are relevant to the contentions, provided that if only 
a description is provided of a document or data compilation, a party 
shall have the right to request copies of that document and/or data 
compilation, and
    (ii) A copy (for which there is no claim of privilege or protected 
status), or a description by category and location, of all tangible 
things (e.g., books, publications and treatises) in the possession, 
custody or control of the party that are relevant to the contention.
    (iii) When any document, data compilation, or other tangible thing 
that must be disclosed is publicly available from another source, such 
as at the NRC Web site, http://www.nrc.gov, and/or the NRC Public 
Document Room, a sufficient disclosure would be the location, the title 
and a page reference to the relevant document, data compilation, or 
tangible thing.
    (3) A list of documents otherwise required to be disclosed for which 
a claim of privilege or protected status is being made, together with 
sufficient information for assessing the claim of privilege or protected 
status of the documents.
    (b) Except for proceedings conducted under subparts G and J of this 
part or as otherwise ordered by the Commission, the presiding officer, 
or the Atomic Safety and Licensing Board assigned to the proceeding, the 
NRC staff must, within 30 days of the issuance of the order granting a 
request for hearing or petition to intervene and without further order 
or request from any party, disclose or provide to the extent available 
(but excluding those documents for which there is a claim of privilege 
or protected status):
    (1) The application (if applicable) and applicant or licensee 
requests that are relevant to the admitted contentions and are 
associated with the application or proposed action that is the subject 
of the proceeding;
    (2) NRC correspondence with the applicant or licensee that is 
relevant to the admitted contentions and associated with the application 
or proposed action that is the subject of the proceeding;
    (3) All documents (including documents that provide support for, or 
opposition to, the application or proposed action) that both support the 
NRC staff's review of the application or proposed action that is the 
subject of the proceeding and are relevant to the admitted contentions;
    (4) Any NRC staff documents that both represent the NRC staff's 
determination on the application or proposal that is the subject of the 
proceeding and are relevant to the admitted contentions; and
    (5) A list of all otherwise-discoverable documents for which a claim 
of privilege or protected status is being made, together with sufficient 
information for assessing the claim of privilege or protected status of 
the documents.
    (c) Each party and the NRC staff shall make its initial disclosures 
under

[[Page 69]]

paragraphs (a) and (b) of this section, based on the information and 
documentation then reasonably available to it. A party, including the 
NRC staff, is not excused from making the required disclosures because 
it has not fully completed its investigation of the case, it challenges 
the sufficiency of another entity's disclosures, or that another entity 
has not yet made its disclosures. All disclosures under this section 
must be accompanied by a certification (by sworn affidavit) that all 
relevant materials required by this section have been disclosed, and 
that the disclosures are accurate and complete as of the date of the 
certification.
    (d) The duty of disclosure under this section is continuing. Parties 
must update their disclosures every month after initial disclosures on a 
due date selected by the presiding officer in the order admitting 
contentions, unless the parties agree upon a different due date or 
frequency. The disclosure update shall be limited to documents subject 
to disclosure under this section and does not need to include documents 
that are developed, obtained, or discovered during the two weeks before 
the due date. Disclosure updates shall include any documents subject to 
disclosure that were not included in any previous disclosure update. The 
duty to update disclosures relevant to an admitted contention ends when 
the presiding officer issues a decision resolving the contention, or at 
such other time as may be specified by the presiding officer or the 
Commission.
    (e)(1) The presiding officer may impose sanctions, including 
dismissal of specific contentions, dismissal of the adjudication, denial 
or dismissal of the application or proposed action, or the use of the 
discovery provisions in subpart G of this part against the offending 
party, for the offending party's continuing unexcused failure to make 
the disclosures required by this section.
    (2) The presiding officer may impose sanctions on a party that fails 
to provide any document or witness name required to be disclosed under 
this section, unless the party demonstrates good cause for its failure 
to make the disclosure required by this section. A sanction that may be 
imposed by the presiding officer is prohibiting the admission into 
evidence of documents or testimony of the witness proffered by the 
offending party in support of its case.
    (f)(1) In the event of a dispute over disclosure of documents and 
records including Safeguards Information referred to in Sections 147 and 
181 of the Atomic Energy Act of 1954, as amended, the presiding officer 
may issue an order requiring disclosure if--
    (i) The presiding officer finds that the individual seeking access 
to Safeguards Information to participate in an NRC adjudication has the 
requisite ''need to know'', as defined in 10 CFR 73.2;
    (ii) The individual has undergone an FBI criminal history records 
check, unless exempt under 10 CFR 73.22(b)(3) or 73.23(b)(3), as 
applicable, by submitting fingerprints to the NRC Office of 
Administration, Security Processing Unit, Mail Stop T-6E46, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, and otherwise 
following the procedures in 10 CFR 73.57(d) for submitting and 
processing fingerprints. However, before a final adverse determination 
by the NRC Office of Administration on an individual's criminal history 
records check is made, the individual shall be afforded the protections 
provided by 10 CFR 73.57; and
    (iii) The NRC Office of Administration has found, based upon a 
background check, that the individual is trustworthy and reliable, 
unless exempt under 10 CFR 73.22(b)(3) or 73.23(b)(3), as applicable. In 
addition to the protections provided by 10 CFR 73.57 for adverse 
determinations based on criminal history records checks, the Office of 
Administration must take the following actions before making a final 
adverse determination on an individual's background check for 
trustworthiness and reliability. The Office of Administration will:
    (A) For the purpose of assuring correct and complete information, 
provide to the individual any records, in addition to those required to 
be provided under 10 CFR 73.57(e)(1), that were considered in the 
trustworthiness and reliability determination;

[[Page 70]]

    (B) Resolve any challenge by the individual to the completeness or 
accuracy of the records described in Sec.2.336(f)(1)(iii)(A). The 
individual may make this challenge by submitting information and/or an 
explanation to the Office of Administration. The challenge must be 
submitted within 10 days of the distribution of the records described in 
Sec.2.336(f)(1)(iii)(A), and the Office of Administration must 
promptly resolve any challenge.
    (iv) Individuals seeking access to Safeguards Information to 
participate in an NRC adjudication for whom the NRC Office of 
Administration has made a final adverse determination on trustworthiness 
and reliability may submit a request to the Chief Administrative Judge 
for review of the adverse determination. Upon receiving such a request, 
the Chief Administrative Judge shall designate an officer other than the 
presiding officer of the proceeding to review the adverse determination. 
For purposes of review, the adverse determination must be in writing and 
set forth the grounds for the determination. The request for review 
shall be served on the NRC staff and may include additional information 
for review by the designated officer. The request must be filed within 
15 days after receipt of the adverse determination by the person against 
whom the adverse determination has been made. Within 10 days of receipt 
of the request for review and any additional information, the NRC staff 
will file a response indicating whether the request and additional 
information has caused the NRC Office of Administration to reverse its 
adverse determination. The designated officer may reverse the Office of 
Administration's final adverse determination only if the officer finds, 
based on all the information submitted, that the adverse determination 
constitutes an abuse of discretion. The designated officer's decision 
must be rendered within 15 days after receipt of the staff filing 
indicating that the request for review and additional information has 
not changed the NRC Office of Administration's adverse determination.
    (2) The presiding officer may include in an order any protective 
terms and conditions (including affidavits of nondisclosure) as may be 
necessary and appropriate to prevent the unauthorized disclosure of 
Safeguards Information.
    (3) When Safeguards Information protected from unauthorized 
disclosure under Section 147 of the Atomic Energy Act of 1954, as 
amended, is received and possessed by anyone other than the NRC staff, 
it must also be protected according to the requirements of Sec.73.21 
and the requirements of Sec.73.22 or Sec.73.23 of this chapter, as 
applicable.
    (4) The presiding officer may also prescribe additional procedures 
to effectively safeguard and prevent disclosure of Safeguards 
Information to unauthorized persons with minimum impairment of the 
procedural rights which would be available if Safeguards Information 
were not involved.
    (5) In addition to any other sanction that may be imposed by the 
presiding officer for violation of an order issued pursuant to this 
paragraph, violation of a provision for the protection of Safeguards 
Information from unauthorized disclosure that is contained in an order 
may be subject to a civil penalty imposed under Sec.2.205.
    (6) For the purpose of imposing the criminal penalties contained in 
Section 223 of the Atomic Energy Act of 1954, as amended, a provision 
for the protection of Safeguards Information from unauthorized 
disclosure that is contained in an order issued pursuant to this 
paragraph is considered to be issued under Section 161b of the Atomic 
Energy Act of 1954, as amended.
    (7) If a presiding officer has yet to be appointed, the authority to 
take the actions described in paragraphs (f)(1) to (f)(6) of this 
section resides in the officer with jurisdiction under Sec.2.318(a).
    (g) The disclosures required by this section constitute the sole 
discovery permitted for NRC proceedings under this part unless there is 
further provision for discovery under the specific subpart under which 
the hearing will be conducted or unless the Commission provides 
otherwise in a specific proceeding.

[69 FR 2236, Jan. 14, 2004, as amended at 73 FR 63567, Oct. 24, 2008, 77 
FR 46593, Aug. 3, 2012]



Sec.2.337  Evidence at a hearing.

    (a) Admissibility. Only relevant, material, and reliable evidence 
which is not

[[Page 71]]

unduly repetitious will be admitted. Immaterial or irrelevant parts of 
an admissible document will be segregated and excluded so far as is 
practicable.
    (b) Objections. An objection to evidence must briefly state the 
grounds of objection. The transcript must include the objection, the 
grounds, and the ruling. Exception to an adverse ruling is preserved 
without notation on-the-record.
    (c) Offer of proof. An offer of proof, made in connection with an 
objection to a ruling of the presiding officer excluding or rejecting 
proffered oral testimony, must consist of a statement of the substance 
of the proffered evidence. If the excluded evidence is in written form, 
a copy must be marked for identification. Rejected exhibits, adequately 
marked for identification, must be retained in the record.
    (d) Exhibits. A written exhibit will not be received in evidence 
unless the original and two copies are offered and a copy is furnished 
to each party, or the parties have been previously furnished with copies 
or the presiding officer directs otherwise. The presiding officer may 
permit a party to replace with a true copy an original document admitted 
in evidence.
    (e) Official record. An official record of a government agency or 
entry in an official record may be evidenced by an official publication 
or by a copy attested by the officer having legal custody of the record 
and accompanied by a certificate of his custody.
    (f) Official notice. (1) The Commission or the presiding officer may 
take official notice of any fact of which a court of the United States 
may take judicial notice or of any technical or scientific fact within 
the knowledge of the Commission as an expert body. Each fact officially 
noticed under this paragraph must be specified in the record with 
sufficient particularity to advise the parties of the matters which have 
been noticed or brought to the attention of the parties before final 
decision and each party adversely affected by the decision shall be 
given opportunity to controvert the fact.
    (2) If a decision is stated to rest in whole or in part on official 
notice of a fact which the parties have not had a prior opportunity to 
controvert, a party may controvert the fact by filing an appeal from an 
initial decision or a petition for reconsideration of a final decision. 
The appeal must clearly and concisely set forth the information relied 
upon to controvert the fact.
    (g) Proceedings involving applications--(1) Facility construction 
permits. In a proceeding involving an application for construction 
permit for a production or utilization facility, the NRC staff shall 
offer into evidence any report submitted by the ACRS in the proceeding 
in compliance with section 182(b) of the Act, any safety evaluation 
prepared by the NRC staff, and any environmental impact statement 
prepared in the proceeding under subpart A of part 51 of this chapter by 
the Director, Office of Nuclear Reactor Regulation, Director, Office of 
New Reactors, or Director, Office of Nuclear Material Safety and 
Safeguards, as appropriate, or his or her designee.
    (2) Other applications where the NRC staff is a party. In a 
proceeding involving an application for other than a construction permit 
for a production or utilization facility, the NRC staff shall offer into 
evidence:
    (i) Any report submitted by the ACRS in the proceeding in compliance 
with section 182(b) of the Act;
    (ii) At the discretion of the NRC staff, a safety evaluation 
prepared by the NRC staff and/or NRC staff testimony and evidence on the 
contention or contested matter prepared in advance of the completion of 
the safety evaluation;
    (iii) Any NRC staff statement of position on the contention or 
contested matter provided to the presiding officer under Sec.
2.1202(a); and
    (iv) Any environmental impact statement or environmental assessment 
prepared in the proceeding under subpart A of part 51 of this chapter by 
the Director, Office of Nuclear Reactor Regulation, Director, Office of 
New Reactors, or Director, Office of Nuclear Material Safety and 
Safeguards, as appropriate, or his or her designee if there is any, but 
only if there are admitted contentions or contested matters with respect 
to the adequacy of the environmental impact statement or environmental 
assessment.

[[Page 72]]

    (3) Other applications where the NRC staff is not a party. In a 
proceeding involving an application for other than a construction permit 
for a production or utilization facility, the NRC staff shall offer into 
evidence, and (with the exception of an ACRS report) provide one or more 
sponsoring witnesses, for:
    (i) Any report submitted by the ACRS in the proceeding in compliance 
with section 182(b) of the Act;
    (ii) At the discretion of the NRC staff, a safety evaluation 
prepared by the NRC staff and/or NRC staff testimony and evidence on the 
contention or contested matter prepared in advance of the completion of 
the safety evaluation;
    (iii) Any NRC staff statement of position on the contention or 
contested matter under Sec.2.1202(a); and
    (iv) Any environmental impact statement or environmental assessment 
prepared in the proceeding under subpart A of part 51 of this chapter by 
the Director, Office of Nuclear Reactor Regulation, Director, Office of 
New Reactors, or Director, Office of Nuclear Material Safety and 
Safeguards, as appropriate, or his or her designee if there is any, but 
only if there are admitted contentions or contested matters with respect 
to the adequacy of the environmental impact statement or environmental 
assessment.

[69 FR 2236, Jan. 14, 2004, as amended at 73 FR 5716, Jan. 31, 2008; 77 
FR 46594, Aug. 3, 2012]



Sec.2.338  Settlement of issues; alternative dispute resolution.

    The fair and reasonable settlement and resolution of issues proposed 
for litigation in proceedings subject to this part is encouraged. 
Parties are encouraged to employ various methods of alternate dispute 
resolution to address the issues without the need for litigation in 
proceedings subject to this part.
    (a) Availability. The parties shall have the opportunity to submit a 
proposed settlement of some or all issues to the Commission or presiding 
officer, as appropriate, or submit a request for alternative dispute 
resolution under paragraph (b) of this section.
    (b) Settlement judge; alternative dispute resolution. (1) The 
presiding officer, upon joint motion of the parties, may request the 
Chief Administrative Judge to appoint a Settlement Judge to conduct 
settlement negotiations or remit the proceeding to alternative dispute 
resolution as the Commission may provide or to which the parties may 
agree. The order appointing the Settlement Judge may confine the scope 
of settlement negotiations to specified issues. The order must direct 
the Settlement Judge to report to the Chief Administrative Judge at 
specified time periods.
    (2) If a Settlement Judge is appointed, the Settlement Judge shall:
    (i) Convene and preside over conferences and settlement negotiations 
between the parties and assess the practicalities of a potential 
settlement;
    (ii) Report to the Chief Administrative Judge describing the status 
of the settlement negotiations and recommending the termination or 
continuation of the settlement negotiations; and
    (iii) Not discuss the merits of the case with the Chief 
Administrative Judge or any other person, or appear as a witness in the 
case.
    (3) Settlement negotiations conducted by the Settlement Judge 
terminate upon the order of the Chief Administrative Judge issued after 
consultation with the Settlement Judge.
    (4) No decision concerning the appointment of a Settlement Judge or 
the termination of the settlement negotiation is subject to review by, 
appeal to, or rehearing by the presiding officer or the Commission.
    (c) Availability of parties' attorneys or representatives. The 
presiding officer (or Settlement Judge) may require that the attorney or 
other representative who is expected to try the case for each party be 
present and that the parties, or agents having full settlement 
authority, also be present or available by telephone.
    (d) Admissibility in subsequent hearing. No evidence, statements, or 
conduct in settlement negotiations under this section will be admissible 
in any subsequent hearing, except by stipulation of the parties. 
Documents disclosed may not be used in litigation unless obtained 
through appropriate discovery or subpoena.

[[Page 73]]

    (e) Imposition of additional requirements. The presiding officer (or 
Settlement Judge) may impose on the parties and persons having an 
interest in the outcome of the adjudication additional requirements as 
the presiding officer (or Settlement Judge) finds necessary for the fair 
and efficient resolution of the case.
    (f) Effects of ongoing settlement negotiations. The conduct of 
settlement negotiations does not divest the presiding officer of 
jurisdiction and does not automatically stay the proceeding. A hearing 
must not be unduly delayed because of the conduct of settlement 
negotiations.
    (g) Form. A settlement must be in the form of a proposed settlement 
agreement, a consent order, and a motion for its entry that includes the 
reasons why it should be accepted. It must be signed by the consenting 
parties or their authorized representatives.
    (h) Content of settlement agreement. The proposed settlement 
agreement must contain the following:
    (1) An admission of all jurisdictional facts;
    (2) An express waiver of further procedural steps before the 
presiding officer, of any right to challenge or contest the validity of 
the order entered into in accordance with the agreement, and of all 
rights to seek judicial review or otherwise to contest the validity of 
the consent order;
    (3) A statement that the order has the same force and effect as an 
order made after full hearing; and
    (4) A statement that matters identified in the agreement, required 
to be adjudicated have been resolved by the proposed settlement 
agreement and consent order.
    (i) Approval of settlement agreement. Following issuance of a notice 
of hearing, a settlement must be approved by the presiding officer or 
the Commission as appropriate in order to be binding in the proceeding. 
The presiding officer or Commission may order the adjudication of the 
issues that the presiding officer or Commission finds is required in the 
public interest to dispose of the proceeding. In an enforcement 
proceeding under subpart B of this part, the presiding officer shall 
accord due weight to the position of the NRC staff when reviewing the 
settlement. If approved, the terms of the settlement or compromise must 
be embodied in a decision or order. Settlements approved by a presiding 
officer are subject to the Commission's review in accordance with Sec.
2.341.



Sec.2.339  Expedited decisionmaking procedure.

    (a) The presiding officer may determine a proceeding by an order 
after the conclusion of a hearing without issuing an initial decision, 
when:
    (1) All parties stipulate that the initial decision may be omitted 
and waive their rights to file a petition for review, to request oral 
argument, and to seek judicial review;
    (2) No unresolved substantial issue of fact, law, or discretion 
remains, and the record clearly warrants granting the relief requested; 
and
    (3) The presiding officer finds that dispensing with the issuance of 
the initial decision is in the public interest.
    (b) An order entered under paragraph (a) of this section is subject 
to review by the Commission on its own motion within forty (40) days 
after its date.
    (c) An initial decision may be made effective immediately, subject 
to review by the Commission on its own motion within thirty (30) days 
after its date, except as otherwise provided in this chapter, when:
    (1) All parties stipulate that the initial decision may be made 
effective immediately and waive their rights to file a petition for 
review, to request oral argument, and to seek judicial review;
    (2) No unresolved substantial issue of fact, law, or discretion 
remains and the record clearly warrants granting the relief requested; 
and
    (3) The presiding officer finds that it is in the public interest to 
make the initial decision effective immediately.
    (d) The provisions of this section do not apply to an initial 
decision directing the issuance of a limited work authorization under 10 
CFR 50.10, an early site permit under subpart A of part 52 of this 
chapter, a construction permit or construction authorization, a combined 
license under subpart C of part 52

[[Page 74]]

of this chapter, or a manufacturing license under subpart F of part 52.

[69 FR 2236, Jan. 14, 2004, as amended at 72 FR 49475, Aug. 28, 2007]



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

    (a) Initial decision--production or utilization facility operating 
license. (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 an operating license or 
renewed license (including an amendment to or renewal of an operating 
license or renewed license) for a production or utilization facility, 
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 construction permit, operating license, or renewed license, 
or the amendment of an operating or renewed license where the NRC has 
not made a determination of no significant hazards consideration, the 
Commission, the Director, Office of Nuclear Reactor Regulation, or the 
Director, Office of New Reactors, 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 construction 
permit, operating license, or renewed license where the NRC has made a 
determination of no significant hazards consideration, the Commission, 
the Director, Office of Nuclear Reactor Regulation, or the Director, 
Office of New Reactors, 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.
    (b) Initial decision--combined license under 10 CFR part 52. (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 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 of this chapter, or the 
amendment of a combined license

[[Page 75]]

where the NRC has not made a determination of no significant hazards 
consideration, the Commission, the Director, Office of Nuclear Reactor 
Regulation, or the Director, Office of New Reactors, 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 of this chapter where the NRC has made a 
determination of no significant hazards consideration, the Commission, 
the Director, Office of Nuclear Reactor Regulation, or the Director, 
Office of New Reactors, 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 10 CFR 52.103 with respect to 
acceptance criteria in nuclear power reactor combined licenses. In any 
initial decision under Sec.52.103(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) of this chapter.
    (d) Initial decision--manufacturing license under 10 CFR part 52. 
(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 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 of this 
chapter, or the amendment of a manufacturing license, the Commission, 
the Director, Office of Nuclear Reactor Regulation, or the Director, 
Office of New Reactors, 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 of this chapter, 
or the amendment of a manufacturing license, the Commission, the 
Director, Office of Nuclear Reactor Regulation, or the Director, Office 
of New Reactors, as appropriate, may issue the license, permit, or 
license amendment in accordance with Sec.2.1202(a) or Sec.2.1403(a) 
before the

[[Page 76]]

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, the Director, Office of Nuclear 
Reactor Regulation, or the Director, Office of New Reactors, as 
appropriate, shall issue, deny, or appropriately condition the license, 
permit, or license amendment in accordance with the presiding officer's 
initial decision.
    (e) Initial decision--other proceedings not involving production or 
utilization facilities--(1) Matters in controversy; presiding officer 
consideration of matters not put in controversy by parties. In a 
proceeding not involving production or utilization facilities, the 
presiding officer shall make findings of fact and conclusions of law on 
the matters put into controversy by the parties to the proceeding, and 
on any matters 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 requiring further examination, 
must be referred to the Director, Office of Nuclear Material Safety and 
Safeguards, or as appropriate. Depending on the resolution of those 
matters, the Director, Office of Nuclear Material Safety and Safeguards 
or as appropriate, after making the requisite findings, shall issue, 
deny, revoke or appropriately condition the license, or take other 
action as necessary or appropriate.
    (2) Presiding officer initial decision and issuance of permit or 
license. (i) In a contested proceeding under this paragraph (e), the 
Commissionor the Director, Office of Nuclear Material Safety and 
Safeguards, or as appropriate, shall issue, deny, or appropriately 
condition the permit, license, or license amendment in accordance with 
the presiding officer's initial decision once that decision becomes 
effective.
    (ii) In a contested proceeding under this paragraph (e), the 
Commission, the Director, Office of Nuclear Material Safety and 
Safeguards, or as appropriate, may issue the permit, license, or 
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 
permit, license, or amendment is issued under Sec.2.1202 or Sec.
2.1403, then the Commission, the Director, Office of Nuclear Material 
Safety and Safeguards, or as appropriate, shall issue, deny, or 
appropriately condition the permit, license, or 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 of this 
chapter, an early site permit under subpart A of part 52 of this 
chapter, a construction permit or construction authorization under part 
50 of this chapter, an operating license under part 50 of this chapter, 
a combined license under subpart C of part 52 of this chapter, a 
manufacturing license under subpart F of part 52 of this chapter, a 
renewed license under part 54, 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) 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.
    (g)-(h) [Reserved]
    (i) Issuance of authorizations, permits, and licenses--production 
and utilization facilities. The Commission, the Director, Office of New 
Reactors, or the Director, Office of Nuclear Reactor Regulation, as 
appropriate, shall issue a limited work authorization under Sec.50.10 
of this chapter, an early site permit under subpart A of part 52 of this 
chapter, a construction permit or construction authorization under part 
50 of this chapter, an operating license under part 50 of this chapter, 
a combined license under subpart C of part 52 of this chapter, or a 
manufacturing license under subpart F of part 52 of this chapter within 
10 days from the date of issuance of the initial decision:

[[Page 77]]

    (1) If the Commission or the appropriate 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 10 CFR 52.103. 
The Commission, the Director of the Office of New Reactors, or the 
Director of the Office of Nuclear Reactor Regulation, as appropriate, 
shall make the finding under 10 CFR 52.103(g) 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 appropriate director is otherwise able 
to make the finding under 10 CFR 52.103(g) 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 appropriate 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 appropriate 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 10 CFR 2.345, a petition for review under 10 CFR 2.341, or a 
motion for stay under 10 CFR 2.342, or the filing of a petition under 10 
CFR 2.206.
    (k) Issuance of other licenses. The Commissionor the Director, 
Office of Nuclear Material Safety and Safeguards, or as appropriate, 
shall issue a license, including a license under part 72 of this chapter 
to store spent fuel in either an independent spent fuel storage facility 
(ISFSI) located away from a reactor site or at a monitored retrievable 
storage installation (MRS), within 10 days from the date of issuance of 
the initial decision:
    (1) If the Commission or the appropriate Director has made all 
findings necessary for issuance of the 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.

[77 FR 46594, Aug. 3, 2012, as amended at 77 FR 51891, Aug. 28, 2012;79 
FR 75739, Dec. 19, 2014]



Sec.2.341  Review of decisions and actions of a presiding officer.

    (a)(1) Review of decisions and actions of a presiding officer are 
treated under this section; provided, however, that no party may request 
further Commission review of a Commission determination to allow a 
period of interim operation under Sec.52.103(c) of this chapter. This 
section does not apply to appeals under Sec.2.311 or to appeals in the 
high-level waste proceeding, which are governed by Sec.2.1015.
    (2) Within 120 days after the date of a decision or action by a 
presiding officer, or within 120 days after a petition for review of the 
decision or action has been served under paragraph (b) of this section, 
whichever is greater, the Commission may review the decision or action 
on its own motion, unless the Commission, in its discretion, extends the 
time for its review.
    (b)(1) Within 25 days after service of a full or partial initial 
decision by a presiding officer, and within 25 days after service of any 
other decision or action by a presiding officer with respect to which a 
petition for review is authorized by this part, a party may file a 
petition for review with the Commission on the grounds specified in 
paragraph (b)(4) of this section. Unless otherwise authorized by law, a 
party to an NRC proceeding must file a petition for Commission review 
before seeking judicial review of an agency action.

[[Page 78]]

    (2) A petition for review under this paragraph may not be longer 
than twenty-five (25) pages, and must contain the following:
    (i) A concise summary of the decision or action of which review is 
sought;
    (ii) A statement (including record citation) where the matters of 
fact or law raised in the petition for review were previously raised 
before the presiding officer and, if they were not, why they could not 
have been raised;
    (iii) A concise statement why in the petitioner's view the decision 
or action is erroneous; and
    (iv) A concise statement why Commission review should be exercised.
    (3) Any other party to the proceeding may, within 25 days after 
service of a petition for review, file an answer supporting or opposing 
Commission review. This answer may not be longer than 25 pages and 
should concisely address the matters in paragraph (b)(2) of this section 
to the extent appropriate. The petitioning party may file a reply brief 
within 10 days of service of any answer. This reply brief may not be 
longer than 5 pages.
    (4) The petition for review may be granted in the discretion of the 
Commission, giving due weight to the existence of a substantial question 
with respect to the following considerations:
    (i) A finding of material fact is clearly erroneous or in conflict 
with a finding as to the same fact in a different proceeding;
    (ii) A necessary legal conclusion is without governing precedent or 
is a departure from or contrary to established law;
    (iii) A substantial and important question of law, policy, or 
discretion has been raised;
    (iv) The conduct of the proceeding involved a prejudicial procedural 
error; or
    (v) Any other consideration which the Commission may deem to be in 
the public interest.
    (5) A petition for review will not be granted to the extent that it 
relies on matters that could have been but were not raised before the 
presiding officer. A matter raised sua sponte by a presiding officer has 
been raised before the presiding officer for the purpose of this 
section.
    (6) A petition for review will not be granted as to issues raised 
before the presiding officer on a pending motion for reconsideration.
    (c)(1) If within 120 days after the filing of a petition for review 
the Commission does not grant the petition, in whole or in part, the 
petition is deemed to be denied, unless the Commission, in its 
discretion, extends the time for its consideration of the petition and 
any answers to the petition.
    (2) If a petition for review is granted, the Commission may issue an 
order specifying the issues to be reviewed and designating the parties 
to the review proceeding. The Commission may, in its discretion, decide 
the matter on the basis of the petition for review or it may specify 
whether any briefs may be filed.
    (3) Unless the Commission orders otherwise, any briefs on review may 
not exceed 30 pages in length, exclusive of pages containing the table 
of contents, table of citations, and any addendum containing appropriate 
exhibits, statutes, or regulations. A brief in excess of 10 pages must 
contain a table of contents with page references and a table of cases 
(alphabetically arranged), cited statutes, regulations, and other 
authorities, with references to the pages of the brief where they are 
cited.
    (d) Petitions for reconsideration of Commission decisions granting 
or denying review in whole or in part will not be entertained. A 
petition for reconsideration of a Commission decision after review may 
be filed within ten (10) days, but is not necessary for exhaustion of 
administrative remedies. However, if a petition for reconsideration is 
filed, the Commission decision is not final until the petition is 
decided. Any petition for reconsideration will be evaluated against the 
standard in Sec.2.323(e).
    (e) Neither the filing nor the granting of a petition under this 
section stays the effect of the decision or action of the presiding 
officer, unless the Commission orders otherwise.
    (f) Interlocutory review. (1) A ruling referred or question 
certified to the Commission under Sec. Sec.2.319(l) or 2.323(f) may be 
reviewed if the certification or referral raises significant and novel

[[Page 79]]

legal or policy issues, or resolution of the issues would materially 
advance the orderly disposition of the proceeding.
    (2) The Commission may, in its discretion, grant interlocutory 
review at the request of a party despite the absence of a referral or 
certification by the presiding officer. A petition and answer to it must 
be filed within the times and in the form prescribed in paragraph (b) of 
this section and must be treated in accordance with the general 
provisions of this section. The petition for interlocutory review will 
be granted only if the party demonstrates that the issue for which the 
party seeks interlocutory review:
    (i) Threatens the party adversely affected by it with immediate and 
serious irreparable impact which, as a practical matter, could not be 
alleviated through a petition for review of the presiding officer's 
final decision; or
    (ii) Affects the basic structure of the proceeding in a pervasive or 
unusual manner.

[69 FR 2236, Jan. 14, 2004, as amended at 72 FR 49476, Aug. 28, 2007; 77 
FR 46596, Aug. 3, 2012]



Sec.2.342  Stays of decisions.

    (a) Within ten (10) days after service of a decision or action of a 
presiding officer, any party to the proceeding may file an application 
for a stay of the effectiveness of the decision or action pending filing 
of and a decision on a petition for review. This application may be 
filed with the Commission or the presiding officer, but not both at the 
same time.
    (b) An application for a stay may be no longer than ten (10) pages, 
exclusive of affidavits, and must contain the following:
    (1) A concise summary of the decision or action which is requested 
to be stayed;
    (2) A concise statement of the grounds for stay, with reference to 
the factors specified in paragraph (e) of this section; and
    (3) To the extent that an application for a stay relies on facts 
subject to dispute, appropriate references to the record or affidavits 
by knowledgeable persons.
    (c) Service of an application for a stay on the other parties must 
be by the same method, e.g., electronic or facsimile transmission, mail, 
as the method for filing the application with the Commission or the 
presiding officer.
    (d) Within ten (10) days after service of an application for a stay 
under this section, any party may file an answer supporting or opposing 
the granting of a stay. This answer may not be longer than ten (10) 
pages, exclusive of affidavits, and should concisely address the matters 
in paragraph (b) of this section to the extent appropriate. Further 
replies to answers will not be entertained. Filing of and service of an 
answer on the other parties must be by the same method, e.g., electronic 
or facsimile transmission, mail, as the method for filing the 
application for the stay.
    (e) In determining whether to grant or deny an application for a 
stay, the Commission or presiding officer will consider:
    (1) Whether the moving party has made a strong showing that it is 
likely to prevail on the merits;
    (2) Whether the party will be irreparably injured unless a stay is 
granted;
    (3) Whether the granting of a stay would harm other parties; and
    (4) Where the public interest lies.
    (f) In extraordinary cases, where prompt application is made under 
this section, the Commission or presiding officer may grant a temporary 
stay to preserve the status quo without waiting for filing of any 
answer. The application may be made orally provided the application is 
promptly confirmed by electronic or facsimile transmission message. Any 
party applying under this paragraph shall make all reasonable efforts to 
inform the other parties of the application, orally if made orally.



Sec.2.343  Oral argument.

    In its discretion, the Commission may allow oral argument upon the 
request of a party made in a petition for review, brief on review, or 
upon its own initiative.

[[Page 80]]



Sec.2.344  Final decision.

    (a) The Commission will ordinarily consider the whole record on 
review, but may limit the issues to be reviewed to those identified in 
an order taking review.
    (b) The Commission may adopt, modify, or set aside the findings, 
conclusions and order in the initial decision, and will state the basis 
of its action. The final decision will be in writing and will include:
    (1) A statement of findings and conclusions, with the basis for them 
on all material issues of fact, law or discretion presented;
    (2) All facts officially noticed;
    (3) The ruling on each material issue; and
    (4) The appropriate ruling, order, or denial of relief, with the 
effective date.



Sec.2.345  Petition for reconsideration.

    (a)(1) Any petition for reconsideration of a final decision must be 
filed by a party within ten (10) days after the date of the decision.
    (2) Petitions for reconsideration of Commission decisions are 
subject to the requirements in Sec.2.341(d).
    (b) A petition for reconsideration must demonstrate a compelling 
circumstance, such as the existence of a clear and material error in a 
decision, which could not have been reasonably anticipated, which 
renders the decision invalid. The petition must state the relief sought. 
Within ten (10) days after a petition for reconsideration has been 
served, any other party may file an answer in opposition to or in 
support of the petition.
    (c) Neither the filing nor the granting of the petition stays the 
decision unless the Commission orders otherwise.



Sec.2.346  Authority of the Secretary.

    When briefs, motions or other documents are submitted to the 
Commission itself, as opposed to officers who have been delegated 
authority to act for the Commission, the Secretary or the Assistant 
Secretary is authorized to:
    (a) Prescribe procedures for the filing of briefs, motions, or other 
pleadings, when the schedules differ from those prescribed by the rules 
of this part or when the rules of this part do not prescribe a schedule;
    (b) Rule on motions for extensions of time;
    (c) Reject motions, briefs, pleadings, and other documents filed 
with the Commission later then the time prescribed by the Secretary or 
the Assistant Secretary or established by an order, rule or regulation 
of the Commission unless good cause is shown for the late filing;
    (d) Prescribe all procedural arrangements relating to any oral 
argument to be held before the Commission;
    (e) Extend the time for the Commission to rule on a petition for 
review under Sec.2.341;
    (f) Extend the time for the Commission to grant review on its own 
motion under Sec.2.341;
    (g) Direct pleadings improperly filed before the Commission to the 
appropriate presiding officer for action;
    (h) Deny a request for hearings, where the request fails to comply 
with the Commission's pleading requirements set forth in this part, and 
fails to set forth an arguable basis for further proceedings;
    (i) Refer to the Atomic Safety and Licensing Board Panel or an 
Administrative Judge, as appropriate requests for hearing not falling 
under Sec.2.104, where the requestor is entitled to further 
proceedings; and
    (j) Take action on other minor matters.

[69 FR 2236, Jan. 14, 2004, as amended at 72 FR 49152, Aug. 28, 2007; 77 
FR 46597, Aug. 3, 2012; 78 FR 34247, June 7, 2013]



Sec.2.347  Ex parte communications.

    In any proceeding under this subpart--
    (a)(1) Interested persons outside the agency may not make or 
knowingly cause to be made to any Commission adjudicatory employee, any 
ex parte communication relevant to the merits of the proceeding.
    (2) For purposes of this section, merits of the proceeding includes:
    (i) A disputed issue;
    (ii) A matter which a presiding officer seeks to be referred to the 
Commission under 10 CFR 2.340(a); and

[[Page 81]]

    (iii) A matter for which the Commission has approved examination by 
the presiding officer under Sec.2.340(a).
    (b) Commission adjudicatory employees may not request or entertain 
from any interested person outside the agency or make or knowingly cause 
to be made to any interested person outside the agency, any ex parte 
communication relevant to the merits of the proceeding.
    (c) Any Commission adjudicatory employee who receives, makes, or 
knowingly causes to be made a communication prohibited by this section 
shall ensure that it, and any responses to the communication, are 
promptly served on the parties and placed in the public record of the 
proceeding. In the case of oral communications, a written summary must 
be served and placed in the public record of the proceeding.
    (d) Upon receipt of a communication knowingly made or knowingly 
caused to be made by a party in violation of this section, the 
Commission or other adjudicatory employee presiding in a proceeding may, 
to the extent consistent with the interests of justice and the policy of 
the underlying statutes, require the party to show cause why its claim 
or interest in the proceeding should not be dismissed, denied, 
disregarded, or otherwise adversely affected on account of the 
violation.
    (e)(1) The prohibitions of this section apply--
    (i) When a notice of hearing or other comparable order is issued in 
accordance with Sec. Sec.2.104(a), 2.105(e)(2), 2.202(c), 2.205(e), or 
2.312; or
    (ii) Whenever the interested person or Commission adjudicatory 
employee responsible for the communication has knowledge that a notice 
of hearing or other comparable order will be issued in accordance with 
Sec.2.104(a), Sec.2.105(e)(2), Sec.2.202(c), 2.205(e), or Sec.
2.312.
    (2) The prohibitions of this section cease to apply to ex parte 
communications relevant to the merits of a full or partial initial 
decision when, in accordance with Sec.2.341, the time has expired for 
Commission review of the decision.
    (f) The prohibitions in this section do not apply to--
    (1) Requests for and the provision of status reports;
    (2) Communications specifically permitted by statute or regulation;
    (3) Communications made to or by Commission adjudicatory employees 
in the Office of the General Counsel regarding matters pending before a 
court or another agency; and
    (4) Communications regarding generic issues involving public health 
and safety or other statutory responsibilities of the agency (e.g., 
rulemakings, congressional hearings on legislation, budgetary planning) 
not associated with the resolution of any proceeding under this subpart 
pending before the NRC.
    (5) Communications, in contested proceedings and uncontested 
mandatory proceeding, regarding an undisputed issue.

[69 FR 2236, Jan. 14, 2004, as amended at 72 FR 49476, Aug. 28, 2007; 77 
FR 46597, Aug. 3, 2012]



Sec.2.348  Separation of functions.

    (a) In any proceeding under this part, any NRC officer or employee 
engaged in the performance of any investigative or litigating function 
in the proceeding or in a factually related proceeding with respect to a 
disputed issue in that proceeding, may not participate in or advise a 
Commission adjudicatory employee about the initial or final decision 
with respect to that disputed issue, except--
    (1) As witness or counsel in the proceeding;
    (2) Through a written communication served on all parties and made 
on-the-record of the proceeding; or
    (3) Through an oral communication made both with reasonable prior 
notice to all parties and with reasonable opportunity for all parties to 
respond.
    (b) The prohibition in paragraph (a) of this section does not apply 
to--
    (1) Communications to or from any Commission adjudicatory employee 
regarding--
    (i) The status of a proceeding;
    (ii) Matters for which the communications are specifically permitted 
by statute or regulation;
    (iii) NRC participation in matters pending before a court or another 
agency; or
    (iv) Generic issues involving public health and safety or other 
statutory

[[Page 82]]

responsibilities of the NRC (e.g., rulemakings, congressional hearings 
on legislation, budgetary planning) not associated with the resolution 
of any proceeding under this subpart pending before the NRC.
    (2) Communications to or from Commissioners, members of their 
personal staffs, Commission adjudicatory employees in the Office of the 
General Counsel, and the Secretary and employees of the Office of the 
Secretary, regarding--
    (i) Initiation or direction of an investigation or initiation of an 
enforcement proceeding;
    (ii) Supervision of NRC staff to ensure compliance with the general 
policies and procedures of the agency;
    (iii) NRC staff priorities and schedules or the allocation of agency 
resources; or
    (iv) General regulatory, scientific, or engineering principles that 
are useful for an understanding of the issues in a proceeding and are 
not contested in the proceeding.
    (3) None of the communications permitted by paragraph (b)(2) (i) 
through (iii) of this section is to be associated by the Commission 
adjudicatory employee or the NRC officer or employee performing 
investigative or litigating functions with the resolution of any 
proceeding under this subpart pending before the NRC.
    (c) Any Commission adjudicatory employee who receives a 
communication prohibited under paragraph (a) of this section shall 
ensure that it, and any responses to the communication, are placed in 
the public record of the proceeding and served on the parties. In the 
case of oral communications, a written summary must be served and placed 
in the public record of the proceeding.
    (d)(1) The prohibitions in this section apply--
    (i) When a notice of hearing or other comparable order is issued in 
accordance with Sec. Sec.2.104(a), 2.105(e)(2), 2.202(c), 2.205(e), or 
2.312; or
    (ii) Whenever an NRC officer or employee who is or has reasonable 
cause to believe he or she will be engaged in the performance of an 
investigative or litigating function or a Commission adjudicatory 
employee has knowledge that a notice of hearing or other comparable 
order will be issued in accordance with Sec. Sec.2.104(a), 
2.105(e)(2), 2.202(c), 2.205(e), or 2.312.
    (iii) A matter which a presiding officer seeks to be referred to the 
Commission under 10 CFR 2.340(a); and
    (iv) A matter for which the Commission has approved examination by 
the presiding officer under Sec.2.340(a).
    (2) The prohibitions of this section cease to apply to the disputed 
issues pertinent to a full or partial initial decision when the time has 
expired for Commission review of the decision in accordance with Sec.
2.341.
    (3) Separation of functions does not apply to uncontested 
proceedings, or to an undisputed issue in contested initial licensing 
proceedings.
    (e) Communications to, from, and between Commission adjudicatory 
employees not prohibited by this section may not serve as a conduit for 
a communication that otherwise would be prohibited by this section or 
for an ex parte communication that otherwise would be prohibited by 
Sec.2.347.
    (f) If an initial or final decision is stated to rest in whole or in 
part on fact or opinion obtained as a result of a communication 
authorized by this section, the substance of the communication must be 
specified in the record of the proceeding and every party must be 
afforded an opportunity to controvert the fact or opinion. If the 
parties have not had an opportunity to controvert the fact or opinion 
before the decision is filed, a party may controvert the fact or opinion 
by filing a petition for review of an initial decision, or a petition 
for reconsideration of a final decision that clearly and concisely sets 
forth the information or argument relied on to show the contrary. If 
appropriate, a party may be afforded the opportunity for cross-
examination or to present rebuttal evidence.

[69 FR 2236, Jan. 14, 2004, as amended at 72 FR 49477, Aug. 28, 2007; 77 
FR 46597, Aug. 3, 2012]



Sec.2.390  Public inspections, exemptions, requests for withholding.

    (a) Subject to the provisions of paragraphs (b), (d), (e), and (f) 
of this section, final NRC records and documents,

[[Page 83]]

including but not limited to correspondence to and from the NRC 
regarding the issuance, denial, amendment, transfer, renewal, 
modification, suspension, revocation, or violation of a license, permit, 
order, or standard design approval, or regarding a rulemaking proceeding 
subject to this part shall not, in the absence of an NRC determination 
of a compelling reason for nondisclosure after a balancing of the 
interests of the person or agency urging nondisclosure and the public 
interest in disclosure, be exempt from disclosure and will be made 
available for inspection and copying at the NRC Web site, http://
www.nrc.gov, and/or at the NRC Public Document Room, except for matters 
that are:
    (1)(i) Specifically authorized under criteria established by an 
Executive order to be kept secret in the interest of national defense or 
foreign policy; and
    (ii) Are in fact properly classified under that Executive order;
    (2) Related solely to the internal personnel rules and practices of 
the Commission;
    (3) Specifically exempted from disclosure by statute (other than 5 
U.S.C. 552(b)), but only if that statute requires that the matters be 
withheld from the public in such a manner as to leave no discretion on 
the issue, or establishes particular criteria for withholding or refers 
to particular types or matters to be withheld.
    (4) Trade secrets and commercial or financial information obtained 
from a person and privileged or confidential;
    (5) Interagency or intra-agency memorandums or letters that would 
not be available by law to a party other than an agency in litigation 
with the agency, provided that the deliberative process privilege shall 
not apply to records created 25 years or more before the date on which 
the records were requested;
    (6) Personnel and medical files and similar files, the disclosure of 
which would constitute a clearly unwarranted invasion of personal 
privacy;
    (7) Records or information compiled for law enforcement purposes, 
but only to the extent that the production of such law enforcement 
records or information:
    (i) Could reasonably be expected to interfere with enforcement 
proceedings;
    (ii) Would deprive a person of a right to a fair trial or an 
impartial adjudication;
    (iii) Could reasonably be expected to constitute an unwarranted 
invasion of personal privacy;
    (iv) Could reasonably be expected to disclose the identity of a 
confidential source, including a State, local, or foreign agency or 
authority, or any private institution which furnished information on a 
confidential basis, and, in the case of a record or information compiled 
by a criminal law enforcement authority in the course of a criminal 
investigation, or by an agency conducting a lawful national security 
intelligence investigation, information furnished by a confidential 
source;
    (v) Would disclose techniques and procedures for law enforcement 
investigations or prosecutions, or would disclose guidelines for law 
enforcement investigations or prosecutions if such disclosure could 
reasonably be expected to risk circumvention of the law; or
    (vi) Could reasonably be expected to endanger the life or physical 
safety of any individual;
    (8) Contained in or related to examination, operating, or condition 
reports prepared by, on behalf of, or for the use of an agency 
responsible for the regulation or supervision of financial institutions; 
or
    (9) Geological and geophysical information and data, including maps, 
concerning wells.
    (b) The procedures in this section must be followed by anyone 
submitting a document to the NRC who seeks to have the document, or a 
portion of it, withheld from public disclosure because it contains trade 
secrets, privileged, or confidential commercial or financial 
information.
    (1) The submitter shall request withholding at the time the document 
is submitted and shall comply with the document marking and affidavit 
requirements set forth in this paragraph. The NRC has no obligation to 
review documents not so marked to determine whether they contain 
information eligible for withholding under paragraph

[[Page 84]]

(a) of this section. Any documents not so marked may be made available 
to the public at the NRC Web site, http://www.nrc.gov or at the NRC 
Public Document Room.
    (i) The submitter shall ensure that the document containing 
information sought to be withheld is marked as follows:
    (A) The first page of the document, and each successive page 
containing such information, must be marked so as to be readily visible, 
at the top, or by electronic watermark or other suitable marking on the 
body of the page, with language substantially similar to: ``confidential 
information submitted under 10 CFR 2.390,'' ``withhold from public 
disclosure under 10 CFR 2.390,'' or ``proprietary,'' to indicate that it 
contains information the submitter seeks to have withheld.
    (B) Each document or page, as appropriate, containing information 
sought to be withheld from public disclosure must indicate, adjacent to 
the information, or as specified in paragraph (b)(1)(i)(A) of this 
section if the entire page is affected, the basis (i.e., trade secret, 
personal privacy, etc.) for proposing that the information be withheld 
from public disclosure under paragraph (a) of this section.
    (ii) The Commission may waive the affidavit requirements on request, 
or on its own initiative, in circumstances the Commission, in its 
discretion, deems appropriate. Otherwise, except for personal privacy 
information, which is not subject to the affidavit requirement, the 
request for withholding must be accompanied by an affidavit that--
    (A) Identifies the document or part sought to be withheld;
    (B) Identifies the official position of the person making the 
affidavit;
    (C) Declares the basis for proposing the information be withheld, 
encompassing considerations set forth in Sec.2.390(a);
    (D) Includes a specific statement of the harm that would result if 
the information sought to be withheld is disclosed to the public; and
    (E) Indicates the location(s) in the document of all information 
sought to be withheld.
    (iii) In addition, an affidavit accompanying a withholding request 
based on paragraph (a)(4) of this section must contain a full statement 
of the reason for claiming the information should be withheld from 
public disclosure. This statement must address with specificity the 
considerations listed in paragraph (b)(4) of this section. In the case 
of an affidavit submitted by a company, the affidavit shall be executed 
by an officer or upper-level management official who has been 
specifically delegated the function of reviewing the information sought 
to be withheld and authorized to apply for its withholding on behalf of 
the company. The affidavit shall be executed by the owner of the 
information, even though the information sought to be withheld is 
submitted to the Commission by another person. The application and 
affidavit shall be submitted at the time of filing the information 
sought to be withheld. The information sought to be withheld shall be 
incorporated, as far as possible, into a separate document. The affiant 
must designate with appropriate markings information submitted in the 
affidavit as a trade secret, or confidential or privileged commercial or 
financial information within the meaning of Sec.9.17(a)(4) of this 
chapter, and such information shall be subject to disclosure only in 
accordance with the provisions of Sec.9.19 of this chapter.
    (2) A person who submits commercial or financial information 
believed to be privileged or confidential or a trade secret shall be on 
notice that it is the policy of the Commission to achieve an effective 
balance between legitimate concerns for protection of competitive 
positions and the right of the public to be fully apprised as to the 
basis for and effects of licensing or rulemaking actions, and that it is 
within the discretion of the Commission to withhold such information 
from public disclosure.
    (3) The Commission shall determine whether information sought to be 
withheld from public disclosure under this paragraph:
    (i) Is a trade secret or confidential or privileged commercial or 
financial information; and (ii) If so, should be withheld from public 
disclosure.

[[Page 85]]

    (4) In making the determination required by paragraph (b)(3)(i) of 
this section, the Commission will consider:
    (i) Whether the information has been held in confidence by its 
owner;
    (ii) Whether the information is of a type customarily held in 
confidence by its owner and, except for voluntarily submitted 
information, whether there is a rational basis therefor;
    (iii) Whether the information was transmitted to and received by the 
Commission in confidence;
    (iv) Whether the information is available in public sources;
    (v) Whether public disclosure of the information sought to be 
withheld is likely to cause substantial harm to the competitive position 
of the owner of the information, taking into account the value of the 
information to the owner; the amount of effort or money, if any, 
expended by the owner in developing the information; and the ease or 
difficulty with which the information could be properly acquired or 
duplicated by others.
    (5) If the Commission determines, under paragraph (b)(4) of this 
section, that the record or document contains trade secrets or 
privileged or confidential commercial or financial information, the 
Commission will then determine whether the right of the public to be 
fully apprised as to the bases for and effects of the proposed action 
outweighs the demonstrated concern for protection of a competitive 
position, and whether the information should be withheld from public 
disclosure under this paragraph. If the record or document for which 
withholding is sought is deemed by the Commission to be irrelevant or 
unnecessary to the performance of its functions, it will be returned to 
the applicant.
    (6) Withholding from public inspection does not affect the right, if 
any, of persons properly and directly concerned to inspect the document. 
Either before a decision of the Commission on the matter of whether the 
information should be made publicly available or after a decision has 
been made that the information should be withheld from public 
disclosure, the Commission may require information claimed to be a trade 
secret or privileged or confidential commercial or financial information 
to be subject to inspection under a protective agreement by contractor 
personnel or government officials other than NRC officials, by the 
presiding officer in a proceeding, and under protective order by the 
parties to a proceeding. In camera sessions of hearings may be held when 
the information sought to be withheld is produced or offered in 
evidence. If the Commission subsequently determines that the information 
should be disclosed, the information and the transcript of such in 
camera session will be made publicly available.
    (c) The Commission either may grant or deny a request for 
withholding under this section.
    (1) If the request is granted, the Commission will notify the 
submitter of its determination to withhold the information from public 
disclosure.
    (2) If the Commission denies a request for withholding under this 
section, it will provide the submitter with a statement of reasons for 
that determination. This decision will specify the date, which will be a 
reasonable time thereafter, when the document will be available at the 
NRC Web site, http://www.nrc.gov. The document will not be returned to 
the submitter.
    (3) Whenever a submitter desires to withdraw a document from 
Commission consideration, it may request return of the document, and the 
document will be returned unless the information--
    (i) Forms part of the basis of an official agency decision, 
including but not limited to, a rulemaking proceeding or licensing 
activity;
    (ii) Is contained in a document that was made available to or 
prepared for an NRC advisory committee;
    (iii) Was revealed, or relied upon, in an open Commission meeting 
held in accordance with 10 CFR part 9, subpart C;
    (iv) Has been requested in a Freedom of Information Act request; or
    (v) Has been obtained during the course of an investigation 
conducted by the NRC Office of Investigations.
    (d) The following information is considered commercial or financial 
information within the meaning of Sec.9.17(a)(4) of this chapter and 
is subject

[[Page 86]]

to disclosure only in accordance with the provisions of Sec.9.19 of 
this chapter.
    (1) Correspondence and reports to or from the NRC which contain 
information or records concerning a licensee's or applicant's physical 
protection, classified matter protection, or material control and 
accounting program for special nuclear material not otherwise designated 
as Safeguards Information or classified as National Security Information 
or Restricted Data.
    (2) Information submitted in confidence to the Commission by a 
foreign source.
    (e) Submitting information to NRC for consideration in connection 
with NRC licensing or regulatory activities shall be deemed to 
constitute authority for the NRC to reproduce and distribute sufficient 
copies to carry out the Commission's official responsibilities.
    (f) The presiding officer, if any, or the Commission may, with 
reference to the NRC records and documents made available pursuant to 
this section, issue orders consistent with the provisions of this 
section and Sec.2.705(c).

[69 FR 2236, Jan. 14, 2004, as amended at 72 FR 49152, Aug. 28, 2007; 72 
FR 49477, Aug. 28, 2007; 75 FR 73937, Nov. 30, 2010; 81 FR 96346, Dec. 
30, 2016]



   Subpart D_Additional Procedures Applicable to Proceedings for the 
Issuance of Licenses To Construct and/or Operate Nuclear Power Plants of 
                   Identical Design at Multiple Sites

    Source: 72 FR 49477, Aug. 28, 2007, unless otherwise noted.



Sec.2.400  Scope of subpart.

    This subpart describes procedures applicable to licensing 
proceedings which involve the consideration in hearings of a number of 
applications, filed by one or more applicants pursuant to appendix N of 
parts 50 or 52 of this chapter, for licenses to construct and/or operate 
nuclear power reactors of identical design to be located at multiple 
sites.



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

    (a) In the case of applications pursuant to appendix N of part 50 of 
this chapter for construction permits for nuclear power reactors of the 
type described in Sec.50.22 of this chapter, or applications pursuant 
to appendix N of part 52 of this chapter for combined licenses, the 
Secretary will issue notices of hearing pursuant to Sec.2.104.
    (b) The notice of hearing will also state the time and place of the 
hearings on any separate phase of the proceeding.



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

    (a) In the case of applications under appendix N of part 50 of this 
chapter for construction permits for nuclear power reactors of a type 
described in 10 CFR 50.22, or applications pursuant to appendix N of 
part 52 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.
    (b) If a separate hearing is held on a particular phase of the 
proceeding, the Commission or presiding officers of each affected 
proceeding may, under 10 CFR 2.317, consolidate for hearing on that 
phase two or more proceedings to consider common issues relating to the 
applications involved in the proceedings, if it finds that this action 
will be conducive to the proper dispatch of its business and to the ends 
of justice. In specifying the place of this consolidated hearing, due 
regard will be given to the convenience and necessity of the parties, 
petitioners for leave to intervene, or the attorneys or representatives 
of such persons, and the public interest.

[[Page 87]]



Sec.2.403  Notice of proposed action on applications for operating
licenses pursuant to appendix N of 10 CFR part 50.

    In the case of applications pursuant to appendix N of part 50 of 
this chapter for operating licenses for nuclear power reactors, if the 
Commission has not found that a hearing is in the public interest, the 
Commission, the Director, Office of New Reactors or Director, Office of 
Nuclear Reactor Regulation, as appropriate will, prior to acting 
thereon, cause to be published in the Federal Register, pursuant to 
Sec.2.105, a notice of proposed action with respect to each 
application as soon as practicable after the applications have been 
docketed.

[73 FR 5717, Jan. 31, 2008]



Sec.2.404  Hearings on applications for operating licenses pursuant
to appendix N of 10 CFR part 50.

    If a request for a hearing and/or petition for leave to intervene is 
filed within the time prescribed in the notice of proposed action on an 
application for an operating license pursuant to appendix N of part 50 
of this chapter with respect to a specific reactor(s) at a specific 
site, and the Commission, the Chief Administrative Judge, or a presiding 
officer has issued a notice of hearing or other appropriate order, then 
the Commission, the Chief Administrative Judge, or the presiding officer 
may order separate hearings on particular phases of the proceeding and/
or consolidate for hearing two or more proceedings in the manner 
described in Sec.2.402.



Sec.2.405  Initial decisions in consolidated hearings.

    At the conclusion of a hearing held under this subpart, the 
presiding officer will render a partial initial decision on the common 
design. The partial initial decision on the common design may be 
appealed under Sec.2.341. If the proceedings have also been 
consolidated with respect to matters other than the common design under 
Sec.2.317(b), the presiding officer may issue a consolidated partial 
initial decision for those proceedings. No construction permit, full-
power operating license, or combined license under part 52 of this 
chapter will be issued until an initial decision has been issued on all 
phases of the hearing and all issues under the Act and the National 
Environmental Policy Act of 1969 appropriate to the proceeding have been 
resolved.



Sec.2.406  Finality of decisions on separate issues.

    Notwithstanding any other provision of this chapter, in a proceeding 
conducted pursuant to this subpart and appendices N of parts 50 or 52 of 
this chapter, no matter which has been reserved for consideration in one 
phase of the hearing shall be considered at another phase of the hearing 
except on the basis of significant new information that substantially 
affects the conclusion(s) reached at the other phase or other good 
cause.



Sec.2.407  Applicability of other sections.

    The provisions of subparts A, C, G, L, and N of this part relating 
to construction permits, operating licenses, and combined licenses 
apply, respectively, to construction permits, operating licenses, and 
combined licenses subject to this subpart, except as may be qualified by 
the provisions of this subpart.



   Subpart E_Additional Procedures Applicable to Proceedings for the 
    Issuance of Licenses To Manufacture Nuclear Power Reactors To Be 
Operated at Sites Not Identified in the License Application and Related 
                          Licensing Proceedings

    Source: 38 FR 30252, Nov. 2, 1973, unless otherwise noted.



Sec.2.500  Scope of subpart.

    This subpart prescribes procedures applicable to licensing 
proceedings which involve the consideration in separate hearings of an 
application for a license to manufacture nuclear power reactors under 
subpart F of part 52 of this chapter.

[72 FR 49478, Aug. 28, 2007]

[[Page 88]]



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

    (a) In the case of an application under subpart F of part 52 of this 
chapter for a license to manufacture nuclear power reactors of the type 
described in Sec.50.22 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 is not 
applicable to a notice of the time and place of hearing published by the 
presiding officer after the notice of hearing described in this section 
has been published.
---------------------------------------------------------------------------

    (1) The time, place, and nature of the hearing and/or the prehearing 
conference;
    (2) The authority within which the hearing is to be held;
    (3) The matters of fact and law to be considered; and
    (4) The time within which answers to the notice shall be filed.
    (b) The notice of hearing shall comply with the requirements of 
Sec.2.104(f) of this chapter.
    (c) The place of hearing on an application for a manufacturing 
license will be Washington, DC, or such other location as the Commission 
deems appropriate.

[38 FR 30252, Nov. 2, 1973, as amended at 39 FR 26279, July 18, 1974; 39 
FR 33202, Sept. 16, 1974; 49 FR 9401, Mar. 12, 1984; 54 FR 15398, Apr. 
18, 1989; 54 FR 52342, Dec. 21, 1989; 72 FR 49478, Aug. 28, 2007]



Sec. Sec.2.502-2.504  [Reserved]



Subpart F_Additional Procedures Applicable to Early Partial Decisions on 
    Site Suitability Issues in Connection With an Application for a 
Construction Permit or Combined License To Construct Certain Utilization 
     Facilities; and Advance Issuance of Limited Work Authorizations

    Source: 72 FR 49478, Aug. 28, 2007, unless otherwise noted.



Sec.2.600  Scope of subpart.

    This subpart prescribes procedures applicable to licensing 
proceedings which involve an early submittal of site suitability 
information in accordance with Sec.2.101(a-1), and a hearing and early 
partial decision on issues of site suitability, in connection with an 
application for a permit to construct 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 of this chapter or is a 
testing facility. This subpart also prescribes procedures applicable to 
proceedings 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 of this chapter, or 
proceedings for a combined license under part 52 of this chapter, either 
of which includes a request to conduct the activities authorized under 
Sec.50.10(d) of part 50 of this chapter in advance of issuance of the 
construction permit or combined license, and submits an application in 
accordance with Sec.2.101(a)(9).
    (a) The procedures in Sec. Sec.2.601 through 2.609 apply to all 
applications under this subpart.
    (b) The procedures in Sec. Sec.2.611 through 2.619 apply to 
applications for a permit to construct 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 of this chapter or is a 
testing facility.
    (c) The procedures in Sec. Sec.2.621 through 2.629 apply to 
applications for combined license under part 52 of this chapter for a 
nuclear power facility.

[[Page 89]]

    (d) The procedures in Sec. Sec.2.641 through 2.649 apply to phased 
applications for construction permits or combined licenses which request 
limited work authorizations to be issued in advance of issuance of the 
construction permit or combined license (i.e., a phased application).

[72 FR 49478, Aug. 28, 2007, as amended at 72 FR 57440, Oct. 9, 2007]



Sec.2.601  Applicability of other sections.

    The provisions of subparts A, C, G, L, and N relating to 
applications for construction permits and combined licenses, and 
proceedings thereon apply, respectively, to such applications and 
proceedings in accordance with this subpart, except as specifically 
provided otherwise by the provisions of this subpart.

    Early Partial Decisions on Site Suitability--Construction Permit



Sec.2.602  Filing fees.

    Each application which contains a request for early review of site 
suitability issues under the procedures of this subpart shall be 
accompanied by any fee required by Sec.50.30(e) and part 170 of this 
chapter.



Sec.2.603  Acceptance and docketing of application for early review
of site suitability issues in a construction permit proceeding.

    (a) Each part of an application for a construction permit submitted 
in accordance with Sec.2.101(a-1) of this part will be initially 
treated as a tendered application. If it is determined that any one of 
the parts as described in Sec.2.101(a-1) is incomplete and not 
acceptable for processing, the Director of the Office of New Reactors or 
the Director of the Office of Nuclear Reactor Regulation, 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.
    (b)(1) The Director of the Office of New Reactors or the Director of 
the Office of Nuclear Reactor Regulation, as appropriate, 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 
of this chapter, or is a testing facility where part one of the 
application as described in Sec.2.101(a-1) is complete. Part one of 
any application will not be considered complete unless it contains 
proposed findings as required by Sec.2.101(a-1)(1)(i) and unless it 
describes the applicant's site selection process, specifies the extent 
to which that process involves the consideration of alternative sites, 
explains the relationship between that process and the application for 
early review of site suitability issues, and briefly describes the 
applicant's long-range plans for ultimate development of the site. 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 shall be followed.
    (2) Additional parts of the application will be docketed upon a 
determination by the Director of the Office of New Reactors or the 
Director of the Office of Nuclear Reactor Regulation, as appropriate, 
that they are complete.
    (c) If part one of the application is docketed, the Director of the 
Office of New Reactors or the Director of the Office of Nuclear Reactor 
Regulation, as appropriate, will cause to be published in the Federal 
Register and send to the Governor or other appropriate official of the 
State in which the site is located, a notice of docketing of the 
application which states the purpose of the application, states the 
location of the proposed site, states that a notice of hearing will be 
published, requests comments within 120 days or such other time as may 
be specified on the initiation or outcome of an early site review from 
Federal, State, and local agencies and interested persons.



Sec.2.604  Notice of hearing on application for early review of site
suitability issues in construction permit proceeding.

    (a) Where an applicant for a construction permit requests an early 
review and hearing and an early partial decision on issues of site 
suitability pursuant to Sec.2.101(a-1), the provisions in the notice 
of hearing setting forth

[[Page 90]]

the matters of fact and law to be considered, as required by Sec.
2.104, shall be modified so as to relate only to the site suitability 
issue or issues under review.
    (b) After docketing of part two of the application, as provided in 
Sec. Sec.2.101(a-1) and 2.603, a supplementary notice of hearing will 
be published under Sec.2.104 with respect to the remaining unresolved 
issues in the proceeding within the scope of Sec.2.104. This 
supplementary notice of hearing will provide that any person whose 
interest may be affected by the proceeding and who desires to 
participate as a party in the resolution of the remaining issues shall 
file a petition for leave to intervene pursuant to Sec.2.309 within 
the time prescribed in the notice. This supplementary notice will also 
provide appropriate opportunities for participation by a representative 
of an interested State under Sec.2.315(c) and for limited appearances 
under Sec.2.315(a).
    (c) Any person who was permitted to intervene as a party under the 
initial notice of hearing on site suitability issues and who was not 
dismissed or did not withdraw as a party may continue to participate as 
a party to the proceeding with respect to the remaining unresolved 
issues, provided that within the time prescribed for filing of petitions 
for leave to intervene in the supplementary notice of hearing, he or she 
files a notice of his intent to continue as a party, along with a 
supporting affidavit identifying the specific aspect or aspects of the 
subject matter of the proceeding as to which he or she wishes to 
continue to participate as a party and setting forth with particularity 
the basis for his contentions with regard to each aspect or aspects. A 
party who files a non-timely notice of intent to continue as a party may 
be dismissed from the proceeding, absent a determination that the party 
has made a substantial showing of good cause for failure to file on 
time, and with particular reference to the factors specified in 
Sec. Sec.2.309(c)(1)(i) through (iv) and 2.309(d). The notice will be 
ruled upon by the Commission or presiding officer designated to rule on 
petitions for leave to intervene.
    (d) To the maximum extent practicable, the membership of any atomic 
safety and licensing board designated to preside in the proceeding on 
the remaining unresolved issues pursuant to the supplemental notice of 
hearing will be the same as the membership designated to preside in the 
initial notice of hearing on site suitability issues.



Sec.2.605  Additional considerations.

    (a) The Commission will not conduct more than one review of site 
suitability issues with regard to a particular site prior to filing and 
review of part two of the application described in Sec.2.101(a-1) of 
this part.
    (b) The Commission, upon its own initiative, or upon the motion of 
any party to the proceeding filed at least 60 days prior to the date of 
the commencement of the evidentiary hearing on site suitability issues, 
may decline to initiate an early hearing or render an early partial 
decision on any issue or issues of site suitability:
    (1) In cases where no partial decision on the relative merits of the 
proposed site and alternative sites under subpart A of part 51 of this 
chapter is requested, upon determination that there is a reasonable 
likelihood that further review would identify one or more preferable 
alternative sites and the partial decision on one or more site 
suitability issues would lead to an irreversible and irretrievable 
commitment of resources prior to the submittal of the remainder of the 
information required by Sec.50.30(f) of this chapter that would 
prejudice the later review and decision on such alternative sites; or
    (2) In cases where it appears that an early partial decision on any 
issue or issues of site suitability would not be in the public interest 
considering:
    (i) The degree of likelihood that any early findings on those issues 
would retain their validity in later reviews;
    (ii) The objections, if any, of cognizant State or local government 
agencies to the conduct of an early review on those issues; and
    (iii) The possible effect on the public interest and the parties of 
having an early, if not necessarily conclusive, resolution of those 
issues.

[[Page 91]]



Sec.2.606  Partial decision on site suitability issues in construction
permit proceeding.

    (a) The provisions of Sec. Sec.2.331, 2.339, 2.340(b), 2.343, 
2.712, and 2.713 apply to any partial initial decision rendered in 
accordance with this subpart. Section 2.340(c) does not apply to any 
partial initial decision rendered in accordance with this subpart. No 
construction permit or combined license may be issued without completion 
of the full review required by Section 102(2) of the NEPA, as amended, 
and subpart A of part 51 of this chapter. The authority of the 
Commission to review such a partial initial decision sua sponte, or to 
raise sua sponte an issue that has not been raised by the parties, will 
be exercised within the same time as in the case of a full decision 
relating to the issuance of a construction permit or combined license.
    (b)(1) A partial decision on one or more site suitability issues 
pursuant to the applicable provisions of part 50, subpart A of part 51, 
and part 100 of this chapter issued in accordance with this subpart 
shall:
    (i) Clearly identify the site to which the partial decision applies; 
and
    (ii) Indicate to what extent additional information may be needed 
and additional review may be required to enable the Commission to 
determine in accordance with the provisions of the Act and the 
applicable provisions of the regulations in this chapter whether a 
construction permit for a facility to be located on the site identified 
in the partial decision should be issued or denied.
    (2) Following either the Commission (acting in the function of a 
presiding officer) issuance of a partial initial decision, or completion 
of Commission review of the partial initial decision of the Atomic 
Safety and Licensing Board, after hearing, on the site suitability 
issues, the partial decision shall remain in effect either for a period 
of 5 years or, where the applicant for the construction permit has made 
timely submittal of the information required to support the application 
as provided in Sec.2.101(a-1), until the proceeding for a permit to 
construct a facility on the site identified in the partial decision has 
been concluded, \3\ unless the Commission or Atomic Safety and Licensing 
Board, upon its own initiative or upon motion by a party to the 
proceeding, finds that there exists significant new information that 
substantially affects the earlier conclusions and reopens the hearing 
record on site suitability issues. Upon good cause shown, the Commission 
may extend the 5-year period during which a partial decision shall 
remain in effect for a reasonable period of time not to exceed 1 year.
---------------------------------------------------------------------------

    \3\ The partial decision on site suitability issues shall be 
incorporated in the decision regarding issuance of the combined license 
to the extent that it serves as a basis for the decision on a specific 
site issue.

[72 FR 49479, Aug. 28, 2007, as amended at 72 FR 57440, Oct. 9, 2007]

 Early Partial Decisions on Site Suitability--Combined License Under 10 
                               CFR Part 52



Sec.2.621  Acceptance and docketing of application for early review 
of site suitability issues in a combined license proceeding.

    (a) Each part of an application submitted in accordance with Sec.
2.101(a-1) of this part will be initially treated as a tendered 
application. If it is determined that any one of the parts as described 
in Sec.2.101(a-1) is incomplete and not acceptable for processing, the 
Director of the Office of New Reactors or the Director of the Office of 
Nuclear Reactor Regulation, 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.
    (b)(1) The Director of the Office of New Reactors or the Director of 
the Office of Nuclear Reactor Regulation, as appropriate, will accept 
for docketing an application for a combined license for a nuclear power 
facility where part one of the application as described in Sec.
2.101(a-1) is complete. Part one of any application will not be 
considered complete unless it contains proposed findings as required by 
Sec.2.101(a-1)(1)(i) and unless it describes the applicant's site 
selection process, specifies the extent

[[Page 92]]

to which that process involves the consideration of alternative sites, 
explains the relationship between that process and the application for 
early review of site suitability issues, and briefly describes the 
applicant's long-range plans for ultimate development of the site. 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 shall be followed.
    (2) Additional parts of the application will be docketed upon a 
determination by the Director of the Office of New Reactors or the 
Director of the Office of Nuclear Reactor Regulation, as appropriate, 
that they are complete.
    (c) If part one of the application is docketed, the Director of the 
Office of New Reactors or the Director of the Office of Nuclear Reactor 
Regulation, as appropriate, will cause to be published in the Federal 
Register and send to the Governor or other appropriate official of the 
State in which the site is located, a notice of docketing of the 
application which states the purpose of the application, states the 
location of the proposed site, states that a notice of hearing will be 
published, requests comments within 120 days or such other time as may 
be specified on the initiation or outcome of an early site review from 
Federal, State, and local agencies and interested persons.



Sec.2.623  Notice of hearing on application for early review of site
suitability issues in combined license proceeding.

    (a) Where an applicant for a combined license under part 52 of this 
chapter requests an early review and hearing and an early partial 
decision on issues of site suitability pursuant to Sec.2.101(a-2), the 
provisions in the notice of hearing setting forth the matters of fact 
and law to be considered, as required by Sec.2.104, shall be modified 
so as to relate only to the site suitability issue or issues under 
review. The notice will provide appropriate opportunities for 
participation by a representative of an interested State under Sec.
2.315(c) and for limited appearances under Sec.2.315(a), limited 
however, to the issues of site suitability for which early review has 
been requested by the applicant.
    (b) After docketing of part two of the application, as provided in 
Sec. Sec.2.101(a-1) and 2.603, a supplementary notice of hearing will 
be published under Sec.2.104 with respect to the remaining unresolved 
issues in the proceeding within the scope of Sec.2.104. This 
supplementary notice of hearing will provide that any person whose 
interest may be affected by the proceeding and who desires to 
participate as a party in the resolution of the remaining issues shall 
file a petition for leave to intervene pursuant to Sec.2.309 within 
the time prescribed in the notice. This supplementary notice will also 
provide appropriate opportunities for participation by a representative 
of an interested State under Sec.2.315(c) and for limited appearances 
under Sec.2.315(a).
    (c) Any person who was permitted to intervene as a party under the 
initial notice of hearing on site suitability issues and who was not 
dismissed or did not withdraw as a party may continue to participate as 
a party to the proceeding without having to demonstrate standing under 
Sec.2.309(d), provided, however, that within the time prescribed for 
filing of petitions for leave to intervene in the supplementary notice 
of hearing, the party files a notice of intent to continue as a party. 
The notice must include the information required by Sec.2.309(f). A 
party who files a non-timely notice of intent to continue as a party may 
be dismissed from the proceeding, absent a determination that the party 
has made a substantial showing of good cause for failure to file on 
time, and with particular reference to the factors specified in 
Sec. Sec.2.309(c)(1)(i) through (iv) and 2.309(d). The notice will be 
ruled upon by the Commission or presiding officer designated to rule on 
petitions for leave to intervene.
    (d) To the maximum extent practicable, the presiding officer (as 
applicable, the membership of the licensing board) designated to preside 
in the proceeding on the remaining unresolved issues pursuant to the 
supplemental notice of hearing will be the same as the presiding officer 
(as applicable, the membership of the licensing board)

[[Page 93]]

designated to preside in the initial notice of hearing on site 
suitability issues.



Sec.2.625  Additional considerations.

    (a) The Commission will not conduct more than one review of site 
suitability issues with regard to a particular site prior to filing and 
review of part two of the application described in Sec.2.101(a-1) of 
this part.
    (b) The Commission, upon its own initiative, or upon the motion of 
any party to the proceeding filed at least 60 days prior to the date of 
the commencement of the evidentiary hearing on site suitability issues, 
may decline to initiate an early hearing or render an early partial 
decision on any issue or issues of site suitability:
    (1) In cases where no partial decision on the relative merits of the 
proposed site and alternative sites under subpart A of part 51 is 
requested, upon determination that there is a reasonable likelihood that 
further review would identify one or more preferable alternative sites 
and the partial decision on one or more site suitability issues would 
lead to an irreversible and irretrievable commitment of resources prior 
to the submittal of the remainder of the information required by Sec.
50.30(f) of this chapter that would prejudice the later review and 
decision on such alternative sites; or
    (2) In cases where it appears that an early partial decision on any 
issue or issues of site suitability would not be in the public interest 
considering:
    (i) The degree of likelihood that any early findings on those issues 
would retain their validity in later reviews;
    (ii) The objections, if any, of cognizant State or local government 
agencies to the conduct of an early review on those issues; and
    (iii) The possible effect on the public interest and the parties of 
having an early, if not necessarily conclusive, resolution of those 
issues.



Sec.2.627  Partial decision on site suitability issues in combined
license proceeding.

    (a) The provisions of Sec. Sec.2.331, 2.339, 2.340(b), 2.343, 
2.712, and 2.713 shall apply to any partial initial decision rendered in 
accordance with this subpart. Section 2.340(c) shall not apply to any 
partial initial decision rendered in accordance with this subpart. A 
limited work authorization may not be issued under 10 CFR 50.10(e) and 
no construction permit may be issued without completion of the full 
review required by Section 102(2) of the National Environmental Policy 
Act of 1969, as amended, and subpart A of part 51 of this chapter. The 
authority of the Commission to review such a partial initial decision 
sua sponte, or to raise sua sponte an issue that has not been raised by 
the parties, will be exercised within the same time period as in the 
case of a full decision relating to the issuance of a construction 
permit.
    (b)(1) A partial decision on one or more site suitability issues 
pursuant to the applicable provisions of part 50, subpart A of part 51, 
and part 100 of this chapter issued in accordance with this subpart 
shall:
    (i) Clearly identify the site to which the partial decision applies; 
and
    (ii) Indicate to what extent additional information may be needed 
and additional review may be required to enable the Commission to 
determine in accordance with the provisions of the Act and the 
applicable provisions of the regulations in this chapter whether a 
construction permit for a facility to be located on the site identified 
in the partial decision should be issued or denied.
    (2) Following either the Commission (acting in the function of a 
presiding officer) issuance of a partial initial decision, or completion 
of Commission review of the partial initial decision of the presiding 
officer, after hearing, on the site suitability issues, the partial 
decision shall remain in effect either for a period of 5 years or, where 
the applicant for the combined license has made timely submittal of the 
information required to support the application as provided in Sec.
2.101(a-2), until the proceeding for a combined license on the site 
identified in the partial decision has been concluded, unless the 
Commission or presiding officer, upon its own initiative or upon motion 
by a party to the proceeding, finds that

[[Page 94]]

there exists significant new information that substantially affects the 
earlier conclusions and reopens the hearing record on site suitability 
issues. Upon good cause shown, the Commission may extend the 5-year 
period during which a partial decision shall remain in effect for a 
reasonable period of time not to exceed 1 year.



Sec.2.629  Finality of partial decision on site suitability issues 
in a combined license proceeding.

    (a) The partial decision on site suitability issues in a combined 
license proceeding shall be incorporated in the decision regarding 
issuance of a combined license. Except as provided in 10 CFR 2.758, in 
making the findings required for issuance of a combined license, the 
Commission shall treat as resolved those matters resolved in connection 
with the issuance of the partial decision on site suitability issues. If 
the Commission reaches an adverse decision, the application shall be 
denied without prejudice for resubmission, provided, however, that in 
determining whether the resubmitted application is complete and 
acceptable for docketing under Sec.2.101(a)(3), the Director of the 
Office of New Reactors or the Director of the Office of Nuclear Reactor 
Regulation, as appropriate, shall determine whether the resubmitted 
application addresses those matters identified as bases for denial of 
the original application.
    (b) Notwithstanding any provision in 10 CFR 50.109, while a partial 
decision on site suitability is in effect under Sec.2.617(b)(2), the 
Commission may not modify, rescind, or impose new requirements with 
respect to matters within the scope of the site suitability decision, 
whether on its own motion, or in response to a request or petition from 
any person, unless the Commission determines that a modification to the 
original decision is necessary either for compliance with the 
Commission's regulations applicable and in effect at the time the 
partial decision was issued, or to assure adequate protection of the 
public health and safety or the common defense and security.

        Phased Applications Involving Limited Work Authorizations

    Source: 72 FR 57440, Oct. 9, 2007, unless otherwise noted.



Sec.2.641  Filing fees.

    Each application which contains a request for limited work 
authorization under the procedures of Sec.2.101(a)(9) and this subpart 
shall be accompanied by any fee required by Sec.50.30(e) and part 170 
of this chapter.



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

    (a) Each part of an application submitted in accordance with Sec.
2.101(a)(9) will be initially treated as a tendered application. If it 
is determined that any one of the parts as described in Sec.
2.101(a)(9) is incomplete and not acceptable for processing, the 
Director of New Reactors or the Director of Nuclear Reactor Regulation 
will inform the applicant of this determination and the respects in 
which the document is deficient. A determination of completeness will 
generally be made within a period of 30 days.
    (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 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) 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.
    (c) If part one of the application is docketed, the Director will 
cause to be published in the Federal Register and send to the Governor 
or other appropriate official of the State in which the site is located, 
a notice of docketing of the application which states the purpose of the 
application, states the location of the proposed site, states

[[Page 95]]

that a notice of hearing will be published, and requests comments on the 
limited work authorization from Federal, State, and local agencies and 
interested persons. The notice will state that comments must be 
submitted to the NRC within 60 days or such other time as may be 
specified in the notice.
    (d) Part two of the application will be docketed upon a 
determination by the Director that it is complete.
    (e) If part two of the application is docketed, the Director will 
cause to be published in the Federal Register and sent to the Governor 
or other appropriate official of the State in which the site is located, 
a notice of docketing of part two of the application which states the 
purpose of the application, states that a notice of hearing will be 
published, and requests comments on the construction permit or combined 
license application, as applicable, from Federal, State, and local 
agencies and interested persons. The notice will state that comments 
must be submitted to the NRC within 60 days or such other time as may be 
specified in the notice.



Sec.2.645  Notice of hearing.

    (a) The notice of hearing on part one of the application must set 
forth the matters of fact and law to be considered, as required by Sec.
2.104, which will be modified to state that the hearing will relate only 
to the matters related to Sec.50.33(a) through (f) of this chapter, 
and the limited work authorization.
    (b) After docketing of part two of the application, as provided in 
Sec. Sec.2.101(a)(9) and 2.643(d), a supplementary notice of hearing 
will be published under Sec.2.104 with respect to the remaining 
unresolved issues in the proceeding within the scope of Sec.2.104. The 
supplementary notice of hearing will provide that any person whose 
interest may be affected by the proceeding and who desires to 
participate as a party in the resolution of the remaining issues shall, 
file a petition for leave to intervene within the time prescribed in the 
notice. The petition to intervene must meet the applicable requirements 
in subpart C of this part, including Sec.2.309. This supplementary 
notice will also provide appropriate opportunities for participation by 
a representative of an interested State under Sec.2.315(c) and for 
limited appearances under Sec.2.315(a).
    (c) Any person who was permitted to intervene under the initial 
notice of hearing on the limited work authorization and who was not 
dismissed or did not withdraw as a party, may continue to participate as 
a party with respect to the remaining unresolved issues only if, within 
the time prescribed for filing of petitions for leave to intervene in 
the supplementary notice of hearing, that person files a petition for 
intervention which meets the applicable requirements in subpart C of 
this part, including Sec.2.309, provided, however, that the petition 
need not address Sec.2.309(d). However, a person who was granted 
discretionary intervention under Sec.2.309(e) must address in its 
petition the factors in Sec.2.309(e) as they apply to the 
supplementary hearing.
    (d) A party who files a non-timely petition for intervention under 
paragraph (b) of this section to continue as a party may be dismissed 
from the proceeding, absent a determination that the party has made a 
substantial showing of good cause for failure to file on time, and with 
particular reference to the factors specified in Sec. Sec.
2.309(c)(1)(i) through (iv) and 2.309(d). The notice will be ruled upon 
by the Commission or presiding officer designated to rule on petitions 
for leave to intervene.
    (e) To the maximum extent practicable, the membership of the Atomic 
Safety and Licensing Board, or the individual presiding officer, as 
applicable, designated to preside in the proceeding on the remaining 
unresolved issues under the supplemental notice of hearing will be the 
same as the membership or individual designated to preside in the 
initial notice of hearing.



Sec.2.647  [Reserved]



Sec.2.649  Partial decisions on limited work authorization.

    The provisions of Sec. Sec.2.331, 2.339, 2.340(b), 2.343, 2.712, 
and 2.713 apply to any partial initial decision rendered in accordance 
with this subpart. Section 2.340(c) does not apply to any partial 
initial decision rendered in accordance with this subpart. A limited 
work authorization may not be issued under 10 CFR 50.10(d) without 
completion of the

[[Page 96]]

review for limited work authorizations required by subpart A of part 51 
of this chapter. The authority of the Commission to review such a 
partial initial decision sua sponte, or to raise sua sponte an issue 
that has not been raised by the parties, will be exercised within the 
same time as in the case of a full decision relating to the issuance of 
a construction permit or combined license.



                Subpart G_Rules for Formal Adjudications

    Source: 69 FR 2256, Jan. 14, 2004, unless otherwise noted.



Sec.2.700  Scope of subpart G.

    The provisions of this subpart apply to and supplement the 
provisions set forth in subpart C of this part with respect to 
enforcement proceedings initiated under subpart B of this part unless 
otherwise agreed to by the parties, proceedings conducted with respect 
to the initial licensing of a uranium enrichment facility, proceedings 
for the grant, renewal, licensee-initiated amendment, or termination of 
licenses or permits for nuclear power reactors, where the presiding 
officer by order finds that resolution of the contention necessitates 
resolution of: issues of material fact relating to the occurrence of a 
past event, where the credibility of an eyewitness may reasonably be 
expected to be at issue, and/or issues of motive or intent of the party 
or eyewitness material to the resolution of the contested matter, 
proceedings for initial applications for construction authorization for 
high-level radioactive waste repository noticed under Sec. Sec.
2.101(f)(8) or 2.105(a)(5), proceedings for initial applications for a 
license to receive and possess high-level radioactive waste at a 
geologic repository operations area, and any other proceeding as ordered 
by the Commission. If there is any conflict between the provisions of 
this subpart and those set forth in subpart C of this part, the 
provisions of this subpart control.



Sec.2.701  Exceptions.

    Consistent with 5 U.S.C. 554(a)(4) of the Administrative Procedure 
Act, the Commission may provide alternative procedures in adjudications 
to the extent that there is involved the conduct of military or foreign 
affairs functions.



Sec.2.702  Subpoenas.

    (a) On application by any party, the designated presiding officer 
or, if he or she is not available, the Chief Administrative Judge, or 
other designated officer will issue subpoenas requiring the attendance 
and testimony of witnesses or the production of evidence. The officer to 
whom application is made may require a showing of general relevance of 
the testimony or evidence sought, and may withhold the subpoena if such 
a showing is not made. However, the officer may not determine the 
admissibility of evidence.
    (b) Every subpoena will bear the name of the Commission, the name 
and office of the issuing officer and the title of the hearing, and will 
command the person to whom it is directed to attend and give testimony 
or produce specified documents or other things at a designated time and 
place. The subpoena will also advise of the quashing procedure provided 
in paragraph (f) of this section.
    (c) Unless the service of a subpoena is acknowledged on its face by 
the witness or is served by an officer or employee of the Commission, it 
must be served by a person who is not a party to the hearing and is not 
less than eighteen (18) years of age. Service of a subpoena must be made 
by delivery of a copy of the subpoena to the person named in it and 
tendering that person the fees for one day's attendance and the mileage 
allowed by law. When the subpoena is issued on behalf of the Commission, 
fees and mileage need not be tendered and the subpoena may be served by 
registered mail.
    (d) Witnesses summoned by subpoena must be paid the fees and mileage 
paid to witnesses in the district courts of the United States by the 
party at whose instance they appear.
    (e) The person serving the subpoena shall make proof of service by 
filing the subpoena and affidavit or acknowledgment of service with the 
officer before whom the witness is required to testify or produce 
evidence or with the Secretary. Failure to make proof of service does 
not affect the validity of the service.

[[Page 97]]

    (f) On motion made promptly, and in any event at or before the time 
specified in the subpoena for compliance by the person to whom the 
subpoena is directed, and on notice to the party at whose instance the 
subpoena was issued, the presiding officer or, if he is unavailable, the 
Commission may:
    (1) Quash or modify the subpoena if it is unreasonable or requires 
evidence not relevant to any matter in issue, or
    (2) Condition denial of the motion on just and reasonable terms.
    (g) On application and for good cause shown, the Commission will 
seek judicial enforcement of a subpoena issued to a party and which has 
not been quashed.
    (h) The provisions of paragraphs (a) through (g) of this section are 
not applicable to the attendance and testimony of the Commissioners or 
NRC personnel, or to the production of records or documents in their 
custody.



Sec.2.703  Examination by experts.

    (a) A party may request the presiding officer to permit a qualified 
individual who has scientific or technical training or experience to 
participate on behalf of that party in the examination and cross-
examination of expert witnesses. The presiding officer may permit the 
individual to participate on behalf of the party in the examination and 
cross-examination of expert witnesses, upon finding:
    (1) That cross-examination by that individual would serve the 
purpose of furthering the conduct of the proceeding;
    (2) That the individual is qualified by scientific or technical 
training or experience to contribute to the development of an adequate 
decisional record in the proceeding by the conduct of such examination 
or cross-examination;
    (3) That the individual has read any written testimony on which he 
intends to examine or cross-examine and any documents to be used or 
referred to in the course of the examination or cross-examination; and
    (4) That the individual has prepared himself to conduct a meaningful 
and expeditious examination or cross-examination, and has submitted a 
cross-examination plan in accordance with Sec.2.711(c).
    (b) Examination or cross-examination conducted under this section 
must be limited to areas within the expertise of the individual 
conducting the examination or cross-examination. The party on behalf of 
whom this examination or cross-examination is conducted and his or her 
attorney is responsible for the conduct of examination or cross-
examination by such individuals.



Sec.2.704  Discovery-required disclosures.

    (a) Initial disclosures. Except to the extent otherwise stipulated 
or directed by order of the presiding officer or the Commission, a party 
other than the NRC staff shall, without awaiting a discovery request, 
provide to other parties:
    (1) The name and, if known, the address and telephone number of each 
individual likely to have discoverable information relevant to disputed 
issues alleged with particularity in the pleadings, identifying the 
subjects of the information; and
    (2) A copy of, or a description by category and location of, all 
documents, data compilations, and tangible things in the possession, 
custody, or control of the party that are relevant to disputed issues 
alleged with particularity in the pleadings. When any document, data 
compilation, or other tangible thing that must be disclosed is publicly 
available from another source, such as at the NRC Web site, http://
www.nrc.gov, and/or the NRC Public Document Room, a sufficient 
disclosure would be the location, the title and a page reference to the 
relevant document, data compilation, or tangible thing;
    (3) Unless otherwise stipulated by the parties or directed by order 
of the presiding officer, these disclosures must be made within 45 days 
after the issuance of a prehearing conference order following the 
initial prehearing conference specified in Sec.2.329. A party must 
make its initial disclosures based on the information then reasonably 
available to it. A party is not excused from making its disclosures 
because it has not fully completed its investigation of the case, 
because it challenges

[[Page 98]]

the sufficiency of another party's disclosures, or because another party 
has not made its disclosures. The duty of disclosure under this section 
is continuing. A disclosure update must be made every month after 
initial disclosures on a due date selected by the presiding officer, 
unless the parties agree upon a different due date or frequency. The 
disclosure update shall be limited to documents subject to disclosure 
under this section and does not need to include documents that are 
developed, obtained, or discovered during the two weeks before the due 
date. Disclosure updates shall include any documents subject to 
disclosure that were not included in any previous disclosure update. The 
duty to update disclosures relevant to a disputed issue ends when the 
presiding officer issues a decision resolving that disputed issue, or at 
such other time as may be specified by the presiding officer or the 
Commission.
    (b) Disclosure of expert testimony. (1) In addition to the 
disclosures required by paragraph (a) of this section, a party other 
than the NRC staff shall disclose to other parties the identity of any 
person who may be used at trial to present evidence under Sec.2.711.
    (2) Except in proceedings with pre-filed written testimony, or as 
otherwise stipulated or directed by the presiding officer, this 
disclosure must be accompanied by a written report prepared and signed 
by the witness, containing: A complete statement of all opinions to be 
expressed and the basis and reasons therefor; the data or other 
information considered by the witness in forming the opinions; any 
exhibits to be used as a summary of or support for the opinions; the 
qualifications of the witness, including a list of all publications 
authored by the witness within the preceding ten years; and a listing of 
any other cases in which the witness has testified as an expert at trial 
or by deposition within the preceding four (4) years.
    (3) These disclosures must be made at the times and in the sequence 
directed by the presiding officer. In the absence of other directions 
from the presiding officer, or stipulation by the parties, the 
disclosures must be made at least ninety (90) days before the hearing 
commencement date or the date the matter is to be presented for hearing. 
If the evidence is intended solely to contradict or rebut evidence on 
the same subject matter identified by another party under paragraph 
(b)(2) of this section, the disclosures must be made within thirty (30) 
days after the disclosure made by the other party. The parties shall 
supplement these disclosures when required under paragraph (e) of this 
section.
    (c) Pretrial disclosures. (1) In addition to the disclosures 
required in the preceding paragraphs, a party other than the NRC staff 
shall provide to other parties the following information regarding the 
evidence that it may present at trial other than solely for impeachment 
purposes:
    (i) The name and, if not previously provided, the address and 
telephone number of each witness, separately identifying those whom the 
party expects to present and those whom the party may call if the need 
arises;
    (ii) The designation of those witnesses whose testimony is expected 
to be presented by means of a deposition and, when available, a 
transcript of the pertinent portions of the deposition testimony; and
    (iii) An appropriate identification of each document or other 
exhibit, including summaries of other evidence, separately identifying 
those which the party expects to offer and those which the party may 
offer if the need arises.
    (2) Unless otherwise directed by the presiding officer or the 
Commission, these disclosures must be made at least thirty (30) days 
before commencement of the hearing at which the issue is to be 
presented.
    (3) A party may object to the admissibility of documents identified 
under paragraph (c) of this section. A list of those objections must be 
served and filed within fourteen (14) days after service of the 
disclosures required by paragraphs (c)(1) and (2) of this section, 
unless a different time is specified by the presiding officer or the 
Commission. Objections not so disclosed, other than objections as to a 
document's admissibility under Sec.2.711(e), are waived unless excused 
by the presiding officer or Commission for good cause shown.

[[Page 99]]

    (d) Form of disclosures; filing. Unless otherwise directed by order 
of the presiding officer or the Commission, all disclosures under 
paragraphs (a) through (c) of this section must be made in writing, 
signed, served, and promptly filed with the presiding officer or the 
Commission.
    (e) Supplementation of responses. A party who has made a disclosure 
under this section is under a duty to supplement or correct the 
disclosure to include information thereafter acquired if ordered by the 
presiding officer or in the following circumstances:
    (1) When a party learns that in some material respect the 
information disclosed under paragraph (a) of this section is incomplete 
or incorrect, and if additional or corrective information has not 
otherwise been made known to the other parties during the discovery 
process or in writing, a party shall supplement its disclosures in 
accordance with the disclosure update schedule in paragraph (a)(3) of 
this section.
    (2) With respect to testimony of an expert from whom a report is 
required under paragraph (b) of this section, the duty extends both to 
information contained in the report and to information provided through 
a deposition of the expert, and any additions or other changes to this 
information must be disclosed by the time the party's disclosures under 
Sec.2.704(c) are due.
    (f) Disclosure under this section of documents and records including 
Safeguards Information referred to in Sections 147 and 181 of the Atomic 
Energy Act of 1954, as amended, will be according to the provisions in 
Sec.2.705(c)(3) through (c)(8).

[69 FR 2256, Jan. 14, 2004, as amended at 73 FR 63567, Oct. 24, 2008; 77 
FR 46597, Aug. 3, 2012]



Sec.2.705  Discovery-additional methods.

    (a) Discovery methods. Parties may obtain discovery by one or more 
of the following methods: depositions upon oral examination or written 
interrogatories (Sec.2.706); interrogatories to parties (Sec.2.706); 
production of documents or things or permission to enter upon land or 
other property, for inspection and other purposes (Sec.2.707); and 
requests for admission (Sec.2.708).
    (b) Scope of discovery. Unless otherwise limited by order of the 
presiding officer in accordance with this section, the scope of 
discovery is as follows:
    (1) In general. Parties may obtain discovery regarding any matter, 
not privileged, that is relevant to the subject matter involved in the 
proceeding, whether it relates to the claim or defense of any other 
party, including the existence, description, nature, custody, condition, 
and location of any books, documents, or other tangible things and the 
identity and location of persons having knowledge of any discoverable 
matter. When any book, document, or other tangible thing sought is 
reasonably available from another source, such as at the NRC Web site, 
http://www.nrc.gov, and/or the NRC Public Document Room, sufficient 
response to an interrogatory on materials would be the location, the 
title and a page reference to the relevant book, document, or tangible 
thing. In a proceeding on an application for a construction permit or an 
operating license for a production or utilization facility, discovery 
begins only after the prehearing conference and relates only to those 
matters in controversy which have been identified by the Commission or 
the presiding officer in the prehearing order entered at the conclusion 
of that prehearing conference. In such a proceeding, discovery may not 
take place after the beginning of the prehearing conference held under 
Sec.2.329 except upon leave of the presiding officer upon good cause 
shown. It is not a ground for objection that the information sought will 
be inadmissible at the hearing if the information sought appears 
reasonably calculated to lead to the discovery of admissible evidence.
    (2) Limitations. Upon his or her own initiative after reasonable 
notice or in response to a motion filed under paragraph (c) of this 
section, the presiding officer may set limits on the number of 
depositions and interrogatories, and may also limit the length of 
depositions under Sec.2.706 and the number of requests under 
Sec. Sec.2.707 and 2.708. The presiding officer shall limit the 
frequency or extent of use of the discovery methods otherwise permitted 
under these rules if he or she determines that:

[[Page 100]]

    (i) The discovery sought is unreasonably cumulative or duplicative, 
or is obtainable from some other source that is more convenient, less 
burdensome, or less expensive;
    (ii) The party seeking discovery has had ample opportunity by 
discovery in the proceeding to obtain the information sought; or
    (iii) The burden or expense of the proposed discovery outweighs its 
likely benefit, taking into account the needs of the proceeding, the 
parties' resources, the importance of the issue in the proceeding, and 
the importance of the proposed discovery in resolving the issues.
    (3) Trial preparation materials. A party may obtain discovery of 
documents and tangible things otherwise discoverable under paragraph 
(b)(1) of this section and prepared in anticipation of or for the 
hearing by or for another party's representative (including his 
attorney, consultant, surety, indemnitor, insurer, or agent) only upon a 
showing that the party seeking discovery has substantial need of the 
materials in the preparation of this case and that he is unable without 
undue hardship to obtain the substantial equivalent of the materials by 
other means. In ordering discovery of such materials when the required 
showing has been made, the presiding officer shall protect against 
disclosure of the mental impressions, conclusions, opinions, or legal 
theories of an attorney for a party concerning the proceeding.
    (4) Claims of privilege or protection of trial preparation 
materials. When a party withholds information otherwise discoverable 
under these rules by claiming that it is privileged or subject to 
protection as trial preparation material, the party shall make the claim 
expressly and shall describe the nature of the documents, 
communications, or things not produced or disclosed in a manner that, 
without revealing information itself privileged or protected, will 
enable other parties to assess the applicability of the privilege or 
protection. Identification of these privileged materials must be made 
within the time provided for disclosure of the materials, unless 
otherwise extended by order of the presiding officer or the Commission.
    (5) Nature of interrogatories. Interrogatories may seek to elicit 
factual information reasonably related to a party's position in the 
proceeding, including data used, assumptions made, and analyses 
performed by the party. Interrogatories may not be addressed to, or be 
construed to require:
    (i) Reasons for not using alternative data, assumptions, and 
analyses where the alternative data, assumptions, and analyses were not 
relied on in developing the party's position; or
    (ii) Performance of additional research or analytical work beyond 
that which is needed to support the party's position on any particular 
matter.
    (c) Protective order. (1) Upon motion by a party or the person from 
whom discovery is sought, accompanied by a certification that the movant 
has in good faith conferred or attempted to confer with other affected 
parties in an effort to resolve the dispute without action by the 
presiding officer, and for good cause shown, the presiding officer may 
make any order which justice requires to protect a party or person from 
annoyance, embarrassment, oppression, or undue burden or expense, 
including one or more of the following:
    (i) That the discovery not be had;
    (ii) That the discovery may be had only on specified terms and 
conditions, including a designation of the time or place;
    (iii) That the discovery may be had only by a method of discovery 
other than that selected by the party seeking discovery;
    (iv) That certain matters not be inquired into, or that the scope of 
discovery be limited to certain matters;
    (v) That discovery be conducted with no one present except persons 
designated by the presiding officer;
    (vi) That, subject to the provisions of Sec. Sec.2.709 and 2.390, 
a trade secret or other confidential research, development, or 
commercial information not be disclosed or be disclosed only in a 
designated way; or
    (vii) That studies and evaluations not be prepared.
    (2) If the motion for a protective order is denied in whole or in 
part, the presiding officer may, on such terms and conditions as are 
just, order that

[[Page 101]]

any party or person provide or permit discovery.
    (3) In the case of documents and records including Safeguards 
Information referred to in Sections 147 and 181 of the Atomic Energy Act 
of 1954, as amended, the presiding officer may issue an order requiring 
disclosure if--
    (i) The presiding officer finds that the individual seeking access 
to Safeguards Information in order to participate in an NRC proceeding 
has the requisite ``need to know,'' as defined in 10 CFR 73.2;
    (ii) The individual has undergone an FBI criminal history records 
check, unless exempt under 10 CFR 73.22(b)(3) or 73.23(b)(3), as 
applicable, by submitting fingerprints to the NRC Office of 
Administration, Security Processing Unit, Mail Stop T-6E46, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, and otherwise 
following the procedures in 10 CFR 73.57(d) for submitting and 
processing fingerprints. However, before a final adverse determination 
by the NRC Office of Administration on an individual's criminal history 
records check is made, the individual shall be afforded the protections 
provided by 10 CFR 73.57; and
    (iii) The NRC Office of Administration has found, based upon a 
background check, that the individual is trustworthy and reliable, 
unless exempt under 10 CFR 73.22(b)(3) or 73.23(b)(3), as applicable. In 
addition to the protections provided by 10 CFR 73.57 for adverse 
determinations based on criminal history records checks, the Office of 
Administration must take the following actions before making a final 
adverse determination on an individual's background check for 
trustworthiness and reliability. The Office of Administration will:
    (A) For the purpose of assuring correct and complete information, 
provide to the individual any records, in addition to those required to 
be provided under 10 CFR 73.57(e)(1), that were considered in the 
trustworthiness and reliability determination;
    (B) Resolve any challenge by the individual to the completeness or 
accuracy of the records described in Sec.2.705(c)(3)(iii)(A). The 
individual may make this challenge by submitting information and/or an 
explanation to the Office of Administration. The challenge must be 
submitted within 10 days of the distribution of the records described in 
Sec.2.705(c)(3)(iii)(A), and the Office of Administration must 
promptly resolve any challenge.
    (iv) Individuals seeking access to Safeguards Information to 
participate in an NRC adjudication for whom the NRC Office of 
Administration has made a final adverse determination on trustworthiness 
and reliability may submit a request to the Chief Administrative Judge 
for review of the adverse determination. Upon receiving such a request, 
the Chief Administrative Judge shall designate an officer other than the 
presiding officer of the proceeding to review the adverse determination. 
For purposes of review, the adverse determination must be in writing and 
set forth the grounds for the determination. The request for review 
shall be served on the NRC staff and may include additional information 
for review by the designated officer. The request must be filed within 
15 days after receipt of the adverse determination by the person against 
whom the adverse determination has been made. Within 10 days of receipt 
of the request for review and any additional information, the NRC staff 
will file a response indicating whether the request and additional 
information has caused the NRC Office of Administration to reverse its 
adverse determination. The designated officer may reverse the Office of 
Administration's final adverse determination only if the officer finds, 
based on all the information submitted, that the adverse determination 
constitutes an abuse of discretion. The designated officer's decision 
must be rendered within 15 days after receipt of the staff filing 
indicating that the request for review and additional information has 
not changed the NRC Office of Administration's adverse determination.
    (4) The presiding officer may include in an order any protective 
terms and conditions (including affidavits of nondisclosure) as may be 
necessary and appropriate to prevent the unauthorized disclosure of 
Safeguards Information.
    (5) When Safeguards Information protected from unauthorized 
disclosure under Section 147 of the Atomic Energy Act of 1954, as 
amended, is received and

[[Page 102]]

possessed by anyone other than the NRC staff, it must also be protected 
according to the requirements of Sec.73.21 and the requirements of 
Sec.73.22 or Sec.73.23 of this chapter, as applicable.
    (6) The presiding officer may also prescribe additional procedures 
to effectively safeguard and prevent disclosure of Safeguards 
Information to unauthorized persons with minimum impairment of the 
procedural rights which would be available if Safeguards Information 
were not involved.
    (7) In addition to any other sanction that may be imposed by the 
presiding officer for violation of an order issued pursuant to this 
paragraph, violation of a provision for the protection of Safeguards 
Information from unauthorized disclosure that is contained in an order 
may be subject to a civil penalty imposed under Sec.2.205.
    (8) For the purpose of imposing the criminal penalties contained in 
Section 223 of the Atomic Energy Act of 1954, as amended, a provision 
for the protection of Safeguards Information from unauthorized 
disclosure that is contained in an order issued pursuant to this 
paragraph is considered to be issued under Section 161b of the Atomic 
Energy Act of 1954, as amended.
    (d) Sequence and timing of discovery. Except when authorized under 
these rules or by order of the presiding officer, or agreement of the 
parties, a party may not seek discovery from any source before the 
parties have met and conferred as required by paragraph (f) of this 
section, nor may a party seek discovery after the time limit established 
in the proceeding for the conclusion of discovery. Unless the presiding 
officer upon motion, for the convenience of parties and witnesses and in 
the interests of justice, orders otherwise, methods of discovery may be 
used in any sequence and the fact that a party is conducting discovery, 
whether by deposition or otherwise, does not operate to delay any other 
party's discovery.
    (e) Supplementation of responses. A party who responded to a request 
for discovery with a response is under a duty to supplement or correct 
the response to include information thereafter acquired if ordered by 
the presiding officer or, with respect to a response to an 
interrogatory, request for production, or request for admission, within 
a reasonable time after a party learns that the response is in some 
material respect incomplete or incorrect, and if the additional or 
corrective information has not otherwise been made known to the other 
parties during the discovery process or in writing.
    (f) Meeting of parties; planning for discovery. Except when 
otherwise ordered, the parties shall, as soon as practicable and in any 
event no more than thirty (30) days after the issuance of a prehearing 
conference order following the initial prehearing conference specified 
in Sec.2.329, meet to discuss the nature and basis of their claims and 
defenses and the possibilities for a prompt settlement or resolution of 
the proceeding or any portion thereof, to make or arrange for the 
disclosures required by Sec.2.704, and to develop a proposed discovery 
plan.
    (1) The plan must indicate the parties' views and proposals 
concerning:
    (i) What changes should be made in the timing, form, or requirement 
for disclosures under Sec.2.704, including a statement as to when 
disclosures under Sec.2.704(a)(1) were made or will be made;
    (ii) The subjects on which discovery may be needed, when discovery 
should be completed, and whether discovery should be conducted in phases 
or be limited to or focused upon particular issues;
    (iii) What changes should be made in the limitations on discovery 
imposed under these rules, and what other limitations should be imposed; 
and
    (iv) Any other orders that should be entered by the presiding 
officer under paragraph (c) of this section.
    (2) The attorneys of record and all unrepresented parties that have 
appeared in the proceeding are jointly responsible for arranging and 
being present or represented at the meeting, for attempting in good 
faith to agree on the proposed discovery plan, and for submitting to the 
presiding officer within ten (10) days after the meeting a written 
report outlining the plan.
    (g) Signing of disclosures, discovery requests, responses, and 
objections. (1) Every disclosure made in accordance with Sec.2.704 
must be signed by at least

[[Page 103]]

one attorney of record in the attorney's individual name, whose address 
must be stated. An unrepresented party shall sign the disclosure and 
state the party's address. The signature of the attorney or party 
constitutes a certification that to the best of the signer's knowledge, 
information, and belief, formed after a reasonable inquiry, the 
disclosure is complete and correct as of the time it is made.
    (2) Every discovery request, response, or objection made by a party 
represented by an attorney must be signed by at least one attorney of 
record in the attorney's individual name, whose address must be stated. 
An unrepresented party shall sign the request, response, or objection 
and state the party's address. The signature of the attorney or party 
constitutes a certification that to the best of the signer's knowledge, 
information, and belief, formed after a reasonable inquiry, the request, 
response, or objection is:
    (i) Consistent with these rules and warranted by existing law or a 
good faith argument for the extension, modification, or reversal of 
existing law;
    (ii) Not interposed for any improper purpose, such as to harass or 
to cause unnecessary delay or needless increase in the cost of 
litigation; and
    (iii) Not unreasonable or unduly burdensome or expensive, given the 
needs of the case, the discovery already had in the case, the amount in 
controversy, and the importance of the issues at stake in the 
litigation.
    (3) If a request, response, or objection is not signed, it must be 
stricken unless it is signed promptly after the omission is called to 
the attention of the party making the request, response, or objection, 
and a party shall not be obligated to take any action with respect to it 
until it is signed.
    (4) If a certification is made in violation of the rule without 
substantial justification, the presiding officer, upon motion or upon 
its own initiative, shall impose upon the person who made the 
certification, the party on whose behalf the disclosure, request, 
response, or objection is made, or both, an appropriate sanction, which 
may, in appropriate circumstances, include termination of that person's 
right to participate in the proceeding.
    (h) Motion to compel discovery. (1) If a deponent or party upon whom 
a request for production of documents or answers to interrogatories is 
served fails to respond or objects to the request, or any part thereof, 
or fails to permit inspection as requested, the deposing party or the 
party submitting the request may move the presiding officer, within ten 
(10) days after the date of the response or after failure of a party to 
respond to the request, for an order compelling a response or inspection 
in accordance with the request. The motion must set forth the nature of 
the questions or the request, the response or objection of the party 
upon whom the request was served, and arguments in support of the 
motion. The motion must be accompanied by a certification that the 
movant has in good faith conferred or attempted to confer with other 
affected parties in an effort to resolve the dispute without action by 
the presiding officer. Failure to answer or respond may not be excused 
on the ground that the discovery sought is objectionable unless the 
person or party failing to answer or respond has applied for a 
protective order pursuant to paragraph (c) of this section. For purposes 
of this paragraph, an evasive or incomplete answer or response will be 
treated as a failure to answer or respond.
    (2) In ruling on a motion made under this section, the presiding 
officer may issue a protective order under paragraph (c) of this 
section.
    (3) This section does not preclude an independent request for 
issuance of a subpoena directed to a person not a party for production 
of documents and things. This section does not apply to requests for the 
testimony or interrogatories of the NRC staff under Sec.2.709(a), or 
the production of NRC documents under Sec. Sec.2.709(b) or Sec.
2.390, except for paragraphs (c) and (e) of this section.

[69 FR 2256, Jan. 14, 2004, as amended at 73 FR 63568, Oct. 24, 2008; 77 
FR 46597, Aug. 3, 2012]

[[Page 104]]



Sec.2.706  Depositions upon oral examination and written 
interrogatories; interrogatories to parties.

    (a) Depositions upon oral examination and written interrogatories. 
(1) Any party desiring to take the testimony of any party or other 
person by deposition on oral examination or written interrogatories 
shall, without leave of the Commission or the presiding officer, give 
reasonable notice in writing to every other party, to the person to be 
examined and to the presiding officer of the proposed time and place of 
taking the deposition; the name and address of each person to be 
examined, if known, or if the name is not known, a general description 
sufficient to identify him or the class or group to which he belongs; 
the matters upon which each person will be examined and the name or 
descriptive title and address of the officer before whom the deposition 
is to be taken.
    (2) [Reserved]
    (3) Within the United States, a deposition may be taken before any 
officer authorized to administer oaths by the laws of the United States 
or of the place where the examination is held. Outside of the United 
States, a deposition may be taken before a secretary of an embassy or 
legation, a consul general, vice consul or consular agent of the United 
States, or a person authorized to administer oaths designated by the 
Commission.
    (4) Before any questioning, the deponent shall either be sworn or 
affirm the truthfulness of his or her answers. Examination and cross-
examination must proceed as at a hearing. Each question propounded must 
be recorded and the answer taken down in the words of the witness. 
Objections on questions of evidence must be noted in short form without 
the arguments. The officer may not decide on the competency, 
materiality, or relevancy of evidence but must record the evidence 
subject to objection. Objections on questions of evidence not made 
before the officer will not be considered waived unless the ground of 
the objection is one which might have been obviated or removed if 
presented at that time.
    (5) When the testimony is fully transcribed, the deposition must be 
submitted to the deponent for examination and signature unless he or she 
is ill, cannot be found, or refuses to sign. The officer shall certify 
the deposition or, if the deposition is not signed by the deponent, 
shall certify the reasons for the failure to sign, and shall promptly 
forward the deposition by registered mail to the Commission.
    (6) Where the deposition is to be taken on written interrogatories, 
the party taking the deposition shall serve a copy of the 
interrogatories, showing each interrogatory separately and consecutively 
numbered, on every other party with a notice stating the name and 
address of the person who is to answer them, and the name, description, 
title, and address of the officer before whom they are to be taken. 
Within ten (10) days after service, any other party may serve cross-
interrogatories. The interrogatories, cross-interrogatories, and answers 
must be recorded and signed, and the deposition certified, returned, and 
filed as in the case of a deposition on oral examination.
    (7) A deposition will not become a part of the record in the hearing 
unless received in evidence. If only part of a deposition is offered in 
evidence by a party, any other party may introduce any other parts. A 
party does not make a person his or her own witness for any purpose by 
taking his deposition.
    (8) A deponent whose deposition is taken and the officer taking a 
deposition are entitled to the same fees as are paid for like services 
in the district courts of the United States. The fees must be paid by 
the party at whose instance the deposition is taken.
    (9) The witness may be accompanied, represented, and advised by 
legal counsel.
    (10) The provisions of paragraphs (a)(1) through (a)(9) of this 
section are not applicable to NRC personnel. Testimony of NRC personnel 
by oral examination and written interrogatories addressed to NRC 
personnel are subject to the provisions of Sec.2.709.
    (b) Interrogatories to parties. (1) Any party may serve upon any 
other party (other than the NRC staff) written interrogatories to be 
answered in writing by the party served, or if the party served is a 
public or private corporation or a partnership or association, by any 
officer or agent, who shall furnish

[[Page 105]]

such information as is available to the party. A copy of the 
interrogatories, answers, and all related pleadings must be filed with 
the Secretary of the Commission, and must be served on the presiding 
officer and all parties to the proceeding.
    (2) Each interrogatory must be answered separately and fully in 
writing under oath or affirmation, unless it is objected to, in which 
event the reasons for objection must be stated in lieu of an answer. The 
answers must be signed by the person making them, and the objections by 
the attorney making them. The party upon whom the interrogatories were 
served shall serve a copy of the answers and objections upon all parties 
to the proceeding within fourteen (14) days after service of the 
interrogatories, or within such shorter or longer period as the 
presiding officer may allow. Answers may be used in the same manner as 
depositions (see Sec.2.706(a)(7)).



Sec.2.707  Production of documents and things; entry upon land for
inspections and other purposes.

    (a) Request for discovery. Any party may serve on any other party a 
request to:
    (1) Produce and permit the party making the request, or a person 
acting on his or her behalf, to inspect and copy any designated 
documents, or to inspect and copy, test, or sample any tangible things 
which are within the scope of Sec.2.704 and which are in the 
possession, custody, or control of the party upon whom the request is 
served; or
    (2) Permit entry upon designated land or other property in the 
possession or control of the party upon whom the request is served for 
the purpose of inspection and measuring, surveying, photographing, 
testing, or sampling the property or any designated object or operation 
on the property, within the scope of Sec.2.704.
    (b) Service. The request may be served on any party without leave of 
the Commission or the presiding officer. Except as otherwise provided in 
Sec.2.704, the request may be served after the proceeding is set for 
hearing.
    (c) Contents. The request must identify the items to be inspected 
either by individual item or by category, and describe each item and 
category with reasonable particularity. The request must specify a 
reasonable time, place, and manner of making the inspection and 
performing the related acts.
    (d) Response. The party upon whom the request is served shall serve 
on the party submitting the request a written response within thirty 
(30) days after the service of the request. The response must state, 
with respect to each item or category, that inspection and related 
activities will be permitted as requested, unless the request is 
objected to, in which case the reasons for objection must be stated. If 
objection is made to part of an item or category, the part must be 
specified.
    (e) NRC records and documents. The provisions of paragraphs (a) 
through (d) of this section do not apply to the production for 
inspection and copying or photographing of NRC records or documents. 
Production of NRC records or documents is subject to the provisions of 
Sec. Sec.2.709 and 2.390.



Sec.2.708  Admissions.

    (a) Apart from any admissions made during or as a result of a 
prehearing conference, at any time after his or her answer has been 
filed, a party may file a written request for the admission of the 
genuineness and authenticity of any relevant document described in or 
attached to the request, or for the admission of the truth of any 
specified relevant matter of fact. A copy of the document for which an 
admission of genuineness and authenticity is requested must be delivered 
with the request unless a copy has already been furnished.
    (b)(1) Each requested admission is considered made unless, within a 
time designated by the presiding officer or the Commission, and not less 
than ten (10) days after service of the request or such further time as 
may be allowed on motion, the party to whom the request is directed 
serves on the requesting party either:
    (i) A sworn statement denying specifically the relevant matters of 
which an admission is requested or setting forth in detail the reasons 
why he can neither truthfully admit nor deny them; or

[[Page 106]]

    (ii) Written objections on the ground that some or all of the 
matters involved are privileged or irrelevant or that the request is 
otherwise improper in whole or in part.
    (2) Answers on matters to which such objections are made may be 
deferred until the objections are determined. If written objections are 
made to only a part of a request, the remainder of the request must be 
answered within the time designated.
    (c) Admissions obtained under the procedure in this section may be 
used in evidence to the same extent and subject to the same objections 
as other admissions.



Sec.2.709  Discovery against NRC staff.

    (a)(1) In a proceeding in which the NRC staff is a party, the NRC 
staff will make available one or more witnesses, designated by the 
Executive Director for Operations or a delegee of the Executive Director 
for Operations, for oral examination at the hearing or on deposition 
regarding any matter, not privileged, that is relevant to the issues in 
the proceeding. The attendance and testimony of the Commissioners and 
named NRC personnel at a hearing or on deposition may not be required by 
the presiding officer, by subpoena or otherwise. However, the presiding 
officer may, upon a showing of exceptional circumstances, such as a case 
in which a particular named NRC employee has direct personal knowledge 
of a material fact not known to the witnesses made available by the 
Executive Director for Operations or a delegee of the Executive Director 
for Operations, require the attendance and testimony of named NRC 
personnel.
    (2) A party may file with the presiding officer written 
interrogatories to be answered by NRC personnel with knowledge of the 
facts, as designated by the Executive Director for Operations, or a 
delegee of the Executive Director for Operations. Upon a finding by the 
presiding officer that answers to the interrogatories are necessary to a 
proper decision in the proceeding and that answers to the 
interrogatories are not reasonably obtainable from any other source, the 
presiding officer may require that the NRC staff answer the 
interrogatories.
    (3) A deposition of a particular named NRC employee or answer to 
interrogatories by NRC personnel under paragraphs (a)(1) and (2) of this 
section may not be required before the matters in controversy in the 
proceeding have been identified by order of the Commission or the 
presiding officer, or after the beginning of the prehearing conference 
held in accordance with Sec.2.329, except upon leave of the presiding 
officer for good cause shown.
    (4) The provisions of Sec.2.704(c) and (e) apply to 
interrogatories served under this paragraph.
    (5) Records or documents in the custody of the Commissioners and NRC 
personnel are available for inspection and copying or photographing 
under paragraph (b) of this section and Sec.2.390.
    (6)(i) The NRC staff shall, except to the extent otherwise 
stipulated or directed by order of the presiding officer or the 
Commission, provide to the other parties within 45 days after the 
issuance of a prehearing conference order following the initial 
prehearing conference specified in Sec.2.329 and without awaiting a 
discovery request:
    (A) Except for those documents, data compilations, or other tangible 
things for which there is a claim of privilege or protected status, all 
NRC staff documents, data compilations, or other tangible things in 
possession, custody, or control of the NRC staff that are relevant to 
disputed issues alleged with particularity in the pleadings, including 
any Office of Investigations report and supporting exhibits, and any 
Office of Enforcement documents, data compilations, or other tangible 
things regarding the order. When any document, data compilation, or 
other tangible thing that must be disclosed is publicly available from 
another source, such as the NRC Web site, http://www.nrc.gov, or the NRC 
Public Document Room, a sufficient disclosure would be the location, the 
title, and a page reference to the relevant document, data compilation, 
or tangible thing; and
    (B) A list of all documents, data compilations, or other tangible 
things otherwise responsive to paragraph (a)(6)(i)(A) of this section 
for which a claim of privilege or protected status is being made, 
together with sufficient information for assessing the claim of

[[Page 107]]

privilege or protected status of the documents.
    (ii) The duty of disclosure under this section is continuing. A 
disclosure update must be made every month after initial disclosures on 
a due date selected by the presiding officer, unless the parties agree 
upon a different due date or frequency. The disclosure update shall be 
limited to documents subject to disclosure under this section and does 
not need to include documents that are developed, obtained, or 
discovered during the two weeks before the due date. Disclosure updates 
shall include any documents subject to disclosure that were not included 
in any previous disclosure update. The duty to update disclosures 
relevant to a disputed issue ends when the presiding officer issues a 
decision resolving that dispute issue, or at such other time as may be 
specified by the presiding officer or the Commission.
    (7) When any document, data compilation, or other tangible thing 
that must be disclosed is publicly available from another source, such 
as at the NRC Web site, http://www.nrc.gov, and/or the NRC Public 
Document Room, a sufficient disclosure would identify the location 
(including the ADAMS accession number, when available), the title and a 
page reference to the relevant document, data compilation, or tangible 
thing.
    (b) A request for the production of an NRC record or document not 
available under Sec.2.390 by a party to an initial licensing 
proceeding may be served on the Executive Director for Operations or a 
delegee of the Executive Director for Operations, without leave of the 
Commission or the presiding officer. The request must identify the 
records or documents requested, either by individual item or by 
category, describe each item or category with reasonable particularity, 
and state why that record or document is relevant to the proceeding.
    (c) If the Executive Director for Operations, or a delegee of the 
Executive Director for Operations, objects to producing a requested 
record or document on the ground that it is not relevant or it is 
exempted from disclosure under Sec.2.390 and the disclosure is not 
necessary to a proper decision in the proceeding or the document or the 
information therein is reasonably obtainable from another source, the 
Executive Director for Operations, or a delegee of the Executive 
Director for Operations, shall advise the requesting party.
    (d) If the Executive Director for Operations, or a delegee of the 
Executive Director for Operations, objects to producing a record or 
document, the requesting party may apply to the presiding officer, in 
writing, to compel production of that record or document. The 
application must set forth the relevancy of the record or document to 
the issues in the proceeding. The application will be processed as a 
motion in accordance with Sec.2.323 (a) through (d). The record or 
document covered by the application must be produced for the in camera 
inspection of the presiding officer, exclusively, if requested by the 
presiding officer and only to the extent necessary to determine:
    (1) The relevancy of that record or document;
    (2) Whether the document is exempt from disclosure under Sec.
2.390;
    (3) Whether the disclosure is necessary to a proper decision in the 
proceeding; and
    (4) Whether the document or the information therein is reasonably 
obtainable from another source.
    (e) Upon a determination by the presiding officer that the 
requesting party has demonstrated the relevancy of the record or 
document and that its production is not exempt from disclosure under 
Sec.2.390 or that, if exempt, its disclosure is necessary to a proper 
decision in the proceeding, and the document or the information therein 
is not reasonably obtainable from another source, the presiding officer 
shall order the Executive Director for Operations, or a delegee of the 
Executive Director for Operations, to produce the document.
    (f)(1) In the case of requested documents and records including 
Safeguards Information referred to in Sections 147 and 181 of the Atomic 
Energy Act of 1954, as amended exempt from disclosure under Sec.2.390, 
the presiding officer may issue an order requiring disclosure to the 
Executive Director

[[Page 108]]

for Operations or a delegee of the Executive Director for Operations, to 
produce the documents or records (or any other order issued ordering 
production of the document or records) if--
    (i) The presiding officer finds that the individual seeking access 
to Safeguards Information to participate in an NRC adjudication has the 
requisite ``need to know,'' as defined in 10 CFR 73.2;
    (ii) The individual has undergone an FBI criminal history records 
check, unless exempt under 10 CFR 73.22(b)(3) or 73.23(b)(3), as 
applicable, by submitting fingerprints to the NRC Office of 
Administration, Security Processing Unit, Mail Stop T-6E46, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, and otherwise 
following the procedures in 10 CFR 73.57(d) for submitting and 
processing fingerprints. However, before a final adverse determination 
by the NRC Office of Administration on an individual's criminal history 
records check is made, the individual shall be afforded the protections 
provided by 10 CFR 73.57; and
    (iii) The NRC Office of Administration has found, based upon a 
background check, that the individual is trustworthy and reliable, 
unless exempt under 10 CFR 73.22(b)(3) or 73.23(b)(3), as applicable. In 
addition to the protections provided by 10 CFR 73.57 for adverse 
determinations based on criminal history records checks, the Office of 
Administration must take the following actions before making a final 
adverse determination on an individual's background check for 
trustworthiness and reliability. The Office of Administration will:
    (A) For the purpose of assuring correct and complete information, 
provide to the individual any records, in addition to those required to 
be provided under 10 CFR 73.57(e)(1), that were considered in the 
trustworthiness and reliability determination;
    (B) Resolve any challenge by the individual to the completeness or 
accuracy of the records described in Sec.2.709(f)(1)(iii)(A). The 
individual may make this challenge by submitting information and/or an 
explanation to the Office of Administration. The challenge must be 
submitted within 10 days of the distribution of the records described in 
Sec.2.709(f)(1)(iii)(A), and the Office of Administration must 
promptly resolve any challenge.
    (iv) Individuals seeking access to Safeguards Information to 
participate in an NRC adjudication for whom the NRC Office of 
Administration has made a final adverse determination on trustworthiness 
and reliability may submit a request to the Chief Administrative Judge 
for review of the adverse determination. Upon receiving such a request, 
the Chief Administrative Judge shall designate an officer other than the 
presiding officer of the proceeding to review the adverse determination. 
For purposes of review, the adverse determination must be in writing and 
set forth the grounds for the determination. The request for review 
shall be served on the NRC staff and may include additional information 
for review by the designated officer. The request must be filed within 
15 days after receipt of the adverse determination by the person against 
whom the adverse determination has been made. Within 10 days of receipt 
of the request for review and any additional information, the NRC staff 
will file a response indicating whether the request and additional 
information has caused the NRC Office of Administration to reverse its 
adverse determination. The designated officer may reverse the Office of 
Administration's final adverse determination only if the officer finds, 
based on all the information submitted, that the adverse determination 
constitutes an abuse of discretion. The designated officer's decision 
must be rendered within 15 days after receipt of the staff filing 
indicating that the request for review and additional information has 
not changed the NRC Office of Administration's adverse determination.
    (2) The presiding officer may include in an order any protective 
terms and conditions (including affidavits of nondisclosure) as may be 
necessary and appropriate to prevent the unauthorized disclosure of 
Safeguards Information.
    (3) When Safeguards Information protected from disclosure under 
Section 147 of the Atomic Energy Act of 1954, as amended, is received 
and possessed by anyone other than the NRC staff, it must also be 
protected according to the

[[Page 109]]

requirements of Sec.73.21 and the requirements of Sec.73.22 or Sec.
73.23 of this chapter, as applicable.
    (4) The presiding officer may also prescribe additional procedures 
to effectively safeguard and prevent disclosure of Safeguards 
Information to unauthorized persons with minimum impairment of the 
procedural rights which would be available if Safeguards Information 
were not involved.
    (5) In addition to any other sanction that may be imposed by the 
presiding officer for violation of an order issued pursuant to this 
paragraph, violation of a provision for the protection of Safeguards 
Information from unauthorized disclosure that is contained in an order 
may be subject to a civil penalty imposed under Sec.2.205.
    (6) For the purpose of imposing the criminal penalties contained in 
Section 223 of the Atomic Energy Act of 1954, as amended, a provision 
for the protection of Safeguards Information from unauthorized 
disclosure that is contained in an order issued pursuant to this 
paragraph is considered to be issued under Section 161b of the Atomic 
Energy Act of 1954, as amended.
    (g) A ruling by the presiding officer or the Commission for the 
production of a record or document will specify the time, place, and 
manner of production.
    (h) A request under this section may not be made or entertained 
before the matters in controversy have been identified by the Commission 
or the presiding officer, or after the beginning of the prehearing 
conference held under Sec.2.329 except upon leave of the presiding 
officer for good cause shown.
    (i) The provisions of Sec.2.705 (c) and (e) apply to production of 
NRC records and documents under this section.

[69 FR 2256, Jan. 14, 2004, as amended at 73 FR 63568, Oct. 24, 2008; 77 
FR 46597, Aug. 3, 2012]



Sec.2.710  Motions for summary disposition.

    (a) Any party to a proceeding may move, with or without supporting 
affidavits, for a decision by the presiding officer in that party's 
favor as to all or any part of the matters involved in the proceeding. 
Summary disposition motions must be filed no later than 20 days after 
the close of discovery. The moving party shall attach to the motion a 
short and concise statement of the material facts as to which the moving 
party contends that there is no genuine issue to be heard. Any other 
party may serve an answer supporting or opposing the motion, with or 
without affidavits, within 20 days after service of the motion. The 
party shall attach to any answer opposing the motion a short and concise 
statement of the material facts as to which it is contended there exists 
a genuine issue to be heard. All material facts set forth in the 
statement required to be served by the moving party will be considered 
to be admitted unless controverted by the statement required to be 
served by the opposing party. The opposing party may, within 10 days 
after service, respond in writing to new facts and arguments presented 
in any statement filed in support of the motion. No further supporting 
statements or responses to the motion will be entertained.
    (b) Affidavits must set forth the facts that would be admissible in 
evidence, and must demonstrate affirmatively that the affiant is 
competent to testify to the matters stated in the affidavit. The 
presiding officer may permit affidavits to be supplemented or opposed by 
depositions, answers to interrogatories or further affidavits. When a 
motion for summary decision is made and supported as provided in this 
section, a party opposing the motion may not rest upon the mere 
allegations or denials of his answer. The answer by affidavits or as 
otherwise provided in this section must set forth specific facts showing 
that there is a genuine issue of fact. If no answer is filed, the 
decision sought, if appropriate, must be rendered.
    (c) Should it appear from the affidavits of a party opposing the 
motion that he or she cannot, for reasons stated, present by affidavit 
facts essential to justify the party's opposition, the presiding officer 
may refuse the application for summary decision, order a continuance to 
permit affidavits to be obtained, or make an order as is appropriate. A 
determination to that effect must be made a matter of record.

[[Page 110]]

    (d)(1) The presiding officer need not consider a motion for summary 
disposition unless its resolution will serve to expedite the proceeding 
if the motion is granted. The presiding officer may dismiss summarily or 
hold in abeyance untimely motions filed shortly before the hearing 
commences or during the hearing if the other parties or the presiding 
officer would be required to divert substantial resources from the 
hearing in order to respond adequately to the motion and thereby extend 
the proceeding.
    (2) The presiding officer shall render the decision sought if the 
filings in the proceeding, depositions, answers to interrogatories, and 
admissions on file, together with the statements of the parties and the 
affidavits, if any, show that there is no genuine issue as to any 
material fact and that the moving party is entitled to a decision as a 
matter of law. However, in any proceeding involving a construction 
permit for a production or utilization facility, the procedure described 
in this section may be used only for the determination of specific 
subordinate issues and may not be used to determine the ultimate issue 
as to whether the permit shall be issued.
    (e) The presiding officer shall issue an order no later than forty 
(40) days after any responses to the summary disposition motion are 
filed, indicating whether the motion is granted, or denied, and the 
bases therefore.

[69 FR 2256, Jan. 14, 2004, as amended at 77 FR 46598, Aug. 3, 2012]



Sec.2.711  Evidence.

    (a) General. Every party to a proceeding has the right to present 
oral or documentary evidence and rebuttal evidence and to conduct, in 
accordance with an approved cross-examination plan that contains the 
information specified in paragraph (c) of this section, any cross-
examination required for full and true disclosure of the facts.
    (b) Testimony. The parties shall submit direct testimony of 
witnesses in written form, unless otherwise ordered by the presiding 
officer on the basis of objections presented. In any proceeding in which 
advance written testimony is to be used, each party shall serve copies 
of its proposed written testimony on every other party at least fifteen 
(15) days in advance of the session of the hearing at which its 
testimony is to be presented. The presiding officer may permit the 
introduction of written testimony not so served, either with the consent 
of all parties present or after they have had a reasonable opportunity 
to examine it. Written testimony must be incorporated into the 
transcript of the record as if read or, in the discretion of the 
presiding officer, may be offered and admitted in evidence as an 
exhibit.
    (c) Cross-examination. (1) The presiding officer shall require a 
party seeking an opportunity to cross-examine to request permission to 
do so in accordance with a schedule established by the presiding 
officer. A request to conduct cross-examination must be accompanied by a 
cross-examination plan containing the following information:
    (i) A brief description of the issue or issues on which cross-
examination will be conducted;
    (ii) The objective to be achieved by cross-examination; and
    (iii) The proposed line of questions that may logically lead to 
achieving the objective of the cross-examination.
    (2) The cross-examination plan may be submitted only to the 
presiding officer and must be kept by the presiding officer in 
confidence until issuance of the initial decision on the issue being 
litigated. The presiding officer shall then provide each cross-
examination plan to the Commission's Secretary for inclusion in the 
official record of the proceeding.
    (d) Non-applicability to subpart B proceedings. Paragraphs (b) and 
(c) of this section do not apply to proceedings initiated under subpart 
B of this part for modification, suspension, or revocation of a license 
or to proceedings for imposition of a civil penalty, unless otherwise 
directed by the presiding officer.
    (e) Admissibility. Only relevant, material, and reliable evidence 
which is not unduly repetitious will be admitted. Immaterial or 
irrelevant parts of an admissible document will be segregated and 
excluded so far as is practicable.
    (f) Objections. An objection to evidence must briefly state the 
grounds of objection. The transcript must include

[[Page 111]]

the objection, the grounds, and the ruling. Exception to an adverse 
ruling is preserved without notation on-the-record.
    (g) Offer of proof. An offer of proof, made in connection with an 
objection to a ruling of the presiding officer excluding or rejecting 
proffered oral testimony, must consist of a statement of the substance 
of the proffered evidence. If the excluded evidence is in written form, 
a copy must be marked for identification. Rejected exhibits, adequately 
marked for identification, must be retained in the record.
    (h) Exhibits. A written exhibit will not be received in evidence 
unless the original and two copies are offered and a copy is furnished 
to each party, or the parties have been previously furnished with copies 
or the presiding officer directs otherwise. The presiding officer may 
permit a party to replace with a true copy an original document admitted 
in evidence.
    (i) Official record. An official record of a government agency or 
entry in an official record may be evidenced by an official publication 
or by a copy attested by the officer having legal custody of the record 
and accompanied by a certificate of his custody.
    (j) Official notice. (1) The Commission or the presiding officer may 
take official notice of any fact of which a court of the United States 
may take judicial notice or of any technical or scientific fact within 
the knowledge of the Commission as an expert body. Each fact officially 
noticed under this paragraph must be specified in the record with 
sufficient particularity to advise the parties of the matters which have 
been noticed or brought to the attention of the parties before final 
decision and each party adversely affected by the decision shall be 
given opportunity to controvert the fact.
    (2) If a decision is stated to rest in whole or in part on official 
notice of a fact which the parties have not had a prior opportunity to 
controvert, a party may controvert the fact by filing an appeal from an 
initial decision or a petition for reconsideration of a final decision. 
The appeal must clearly and concisely set forth the information relied 
upon to controvert the fact.



Sec.2.712  Proposed findings and conclusions.

    (a) Any party to a proceeding may, or if directed by the presiding 
officer shall, file proposed findings of fact and conclusions of law, 
briefs and a proposed form of order or decision within the time provided 
by this section, except as otherwise ordered by the presiding officer:
    (1) The party who has the burden of proof shall, within thirty (30) 
days after the record is closed, file proposed findings of fact and 
conclusions of law and briefs, and a proposed form of order or decision.
    (2) Other parties may file proposed findings, conclusions of law and 
briefs within forty (40) days after the record is closed.
    (3) A party who has the burden of proof may reply within five (5) 
days after filing of proposed findings and conclusions of law and briefs 
by other parties.
    (b) Failure to file proposed findings of fact, conclusions of law, 
or briefs when directed to do so may be considered a default, and an 
order or initial decision may be entered accordingly.
    (c) Proposed findings of fact must be clearly and concisely set 
forth in numbered paragraphs and must be confined to the material issues 
of fact presented on-the-record, with exact citations to the transcript 
of record and exhibits in support of each proposed finding. Proposed 
conclusions of law must be set forth in numbered paragraphs as to all 
material issues of law or discretion presented on-the-record. An 
intervenor's proposed findings of fact and conclusions of law must be 
confined to issues which that party placed in controversy or sought to 
place in controversy in the proceeding.



Sec.2.713  Initial decision and its effect.

    (a) After hearing, the presiding officer will render an initial 
decision which will constitute the final action of the Commission forty 
(40) days after its date unless any party petitions for Commission 
review in accordance with Sec.2.341 or the Commission takes review sua 
sponte.
    (b) Where the public interest so requires, the Commission may direct 
that the presiding officer certify the

[[Page 112]]

record to it without an initial decision, and may:
    (1) Prepare its own decision which will become final unless the 
Commission grants a petition for reconsideration under Sec.2.345; or
    (2) Omit an initial decision on a finding that due and timely 
execution of its functions imperatively and unavoidably so requires.
    (c) An initial decision will be in writing and will be based on the 
whole record and supported by reliable, probative, and substantial 
evidence. The initial decision will include:
    (1) Findings, conclusions, and rulings, with the reasons or basis 
for them, on all material issues of fact, law, or discretion presented 
on-the-record;
    (2) All facts officially noticed and relied on in making the 
decision;
    (3) The appropriate ruling, order, or denial of relief with the 
effective date;
    (4) The time within which a petition for review of the decision may 
be filed, the time within which answers in support of or in opposition 
to a petition for review filed by another party may be filed and, in the 
case of an initial decision which may become final in accordance with 
paragraph (a) of this section, the date when it may become final.



                          Subpart H_Rulemaking



Sec.2.800  Scope and applicability.

    (a) This subpart governs the issuance, amendment, and repeal of 
regulations in which participation by interested persons is prescribed 
under Section 553 of title 5 of the U.S. Code.
    (b) The procedures in Sec. Sec.2.804 through 2.810 apply to all 
rulemakings.
    (c) The procedures in Sec. Sec.2.802 through 2.803 apply to all 
petitions for rulemaking except for initial applications for standard 
design certification rulemaking under subpart B of part 52 of this 
chapter, and subsequent petitions for amendment of an existing design 
certification rule filed by the original applicant for the design 
certification rule.
    (d) The procedures in Sec. Sec.2.811 through 2.819, as 
supplemented by the provisions of subpart B of part 52, apply to 
standard design certification rulemaking.

[72 FR 49481, Aug. 28, 2007]



Sec.2.801  Initiation of rulemaking.

    Rulemaking may be initiated by the Commission at its own instance, 
on the recommendation of another agency of the United States, or on the 
petition of any other interested person, including an application for 
design certification under subpart B of part 52 of this chapter.

[72 FR 49482, Aug. 28, 2007]



Sec.2.802  Petition for rulemaking--requirements for filing.

    (a) Filing a petition for rulemaking. Any person may petition the 
Commission to issue, amend, or rescind any regulation in 10 CFR chapter 
I. The petition for rulemaking should be addressed to the Secretary, 
Attention: Rulemakings and Adjudications Staff, and sent by mail 
addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001; by email to [email protected]; or by hand delivery 
to 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. 
and 4:15 p.m. (Eastern time) on Federal workdays.
    (b) Consultation with the NRC. A petitioner may consult with the NRC 
staff before and after filing a petition for rulemaking by contacting 
the Chief, Regulatory Analysis and Rulemaking Support Branch, Division 
of Rulemaking, Office of Nuclear Material Safety and Safeguards, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 1-
800-368-5642.
    (1) In any consultation regarding the drafting or amendment of a 
petition for rulemaking, the assistance that the NRC staff may provide 
is limited to the following:
    (i) Describing the process for filing, docketing, tracking, closing, 
amending, withdrawing, and resolving a petition for rulemaking;
    (ii) Clarifying an existing NRC regulation and the basis for the 
regulation; and
    (iii) Assisting the petitioner to clarify a petition for rulemaking 
so that the Commission is able to understand the issues of concern to 
the petitioner.

[[Page 113]]

    (2) In any consultation regarding the drafting or amendment of a 
petition for rulemaking, in providing the assistance permitted in 
paragraph (b)(1) of this section, the NRC staff will not draft or 
develop text or alternative approaches to address matters in the 
petition for rulemaking.
    (3) In any consultation regarding a petition for rulemaking, the NRC 
staff will not advise a petitioner on whether a petition should be 
amended or withdrawn.
    (c) Content of petition. (1) Each petition for rulemaking filed 
under this section must clearly and concisely:
    (i) Specify the name of the petitioner, a telephone number, a 
mailing address, and an email address (if available) that the NRC may 
use to communicate with the petitioner;
    (ii) If the petitioner is an organization, provide additional 
identifying information (as applicable) including the petitioner's 
organizational or corporate status, the petitioner's State of 
incorporation, the petitioner's registered agent, and the name and 
authority of the individual who signed the petition on behalf of the 
organizational or corporate petitioner.
    (iii) Present the specific problems or issues that the petitioner 
believes should be addressed through rulemaking, including any specific 
circumstances in which the NRC's codified requirements are incorrect, 
incomplete, inadequate, or unnecessarily burdensome;
    (iv) Cite, enclose, or reference publicly-available technical, 
scientific, or other data or information supporting the petitioner's 
assertion of the problems or issues;
    (v) Present the petitioner's proposed solution to the problems or 
issues raised in the petition for rulemaking (e.g., a proposed solution 
may include specific regulations or regulatory language to add to, amend 
in, or delete from 10 CFR chapter I);
    (vi) Provide an analysis, discussion, or argument that explains how 
the petitioner's proposed solution solves the problems or issues 
identified by the petitioner; and
    (vii) Cite, enclose, or reference any other publicly-available data 
or information supporting the petitioner's proposed solution; and
    (viii) If required by 10 CFR 51.68 of this chapter, submit a 
separate document entitled ``Petitioner's Environmental Report,'' which 
contains the information specified in 10 CFR 51.45.
    (2) To assist the NRC in its evaluation of the petition for 
rulemaking, the petitioner should clearly and concisely:
    (i) Explain why the proposed rulemaking solution is within the 
authority of the NRC to adopt; and
    (ii) Explain why rulemaking is the most favorable approach to 
address the problem or issue, as opposed to other NRC actions such as 
licensing, issuance of an order, or referral to another Federal or State 
agency.
    (3) If the petition is signed by multiple petitioners, the petition 
must designate a lead petitioner who is responsible for disseminating 
communications received from the NRC to co-petitioners.
    (d) [Reserved]
    (e) Request for suspension of an adjudication involving licensing. 
The petitioner may request the Commission to suspend all or any part of 
any licensing proceeding to which the petitioner is a participant 
pending disposition of the petition for rulemaking.
    (f) Amendment; withdrawal. If the petitioner wants to amend or 
withdraw a docketed petition for rulemaking, then the petitioner should 
include the docket number and the date that the original petition for 
rulemaking was submitted in a filing addressed to the Secretary, 
Attention: Rulemakings and Adjudications Staff, and sent by mail 
addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001; or by email to [email protected].

[80 FR 60526, Oct. 7, 2015, as amended at 83 FR 30287, June 28, 2018]



Sec.2.803  Petition for rulemaking--NRC action.

    (a) Notification of receipt. Following receipt of a petition for 
rulemaking, the NRC will acknowledge its receipt to the petitioner.
    (b) Docketing review. (1) The NRC will evaluate the petition for 
rulemaking,

[[Page 114]]

including supporting data or information submitted under Sec.2.802(c), 
for sufficiency according to the review criteria in Sec.2.803(b).
    (2) If the NRC determines that the petition for rulemaking does not 
include the information set out in Sec.2.802(c), that the regulatory 
change sought by the petitioner is not within the legal authority of the 
NRC, or that the petition for rulemaking does not raise a potentially 
valid issue that warrants further consideration, then the NRC will 
notify the petitioner in writing and explain the deficiencies in the 
petition for rulemaking.
    (3) The petitioner may resubmit the petition for rulemaking without 
prejudice.
    (c) Docketing. (1) The NRC will docket a petition for rulemaking and 
assign a docket number to the petition if the NRC determines the 
following:
    (i) The petition for rulemaking includes the information required by 
paragraph Sec.2.802(c),
    (ii) The regulatory change sought by the petitioner is within the 
NRC's legal authority, and
    (iii) The petition for rulemaking raises a potentially valid issue 
that warrants further consideration.
    (2) A copy of the docketed petition for rulemaking will be posted in 
the NRC's Agencywide Documents Access and Management System (ADAMS) and 
on the Federal rulemaking Web site at: http://www.regulations.gov. The 
NRC will publish a notice of docketing in the Federal Register informing 
the public that the NRC is reviewing the merits of the petition for 
rulemaking. The notice of docketing will include the docket number and 
explain how the public may track the status of the petition for 
rulemaking.
    (d) NRC communication with petitioners. If the petition is signed by 
multiple petitioners, any NRC obligation to inform a petitioner (as may 
be required under 10 CFR part 2, subpart H) is satisfied, with respect 
to all petitioners, when the NRC transmits the required notification to 
the lead petitioner.
    (e)-(f) [Reserved]
    (g) Public comment on a petition for rulemaking; hearings. (1) At 
its discretion, the NRC may request public comment on a docketed 
petition for rulemaking.
    (2) The NRC will post all comment submissions at http://
www.regulations.gov and enter the comment submissions into ADAMS, 
without removing identifying or contact information from comment 
submissions. Anyone requesting or aggregating comments from other 
persons for submission to the NRC is responsible for informing those 
persons not to include identifying or contact information that they do 
not want to be publicly disclosed in their comment submissions.
    (3) No adjudicatory or legislative hearing under the procedures of 
10 CFR part 2 will be held on a petition for rulemaking unless the 
Commission determines to do so, at its discretion.
    (h) Determination on a petition for rulemaking; Closure of docket on 
a petition for rulemaking. (1) Determination. Following docketing of a 
petition for rulemaking, the NRC's determination on the petition for 
rulemaking may be based upon, but is not limited to, the following 
considerations:
    (i) The merits of the petition;
    (ii) The immediacy of the safety, environmental, or security concern 
raised;
    (iii) The availability of NRC resources and the priority of the 
issues raised in relation to other NRC rulemaking issues;
    (iv) Whether the problems or issues are already under consideration 
by the NRC in other NRC processes;
    (v) The substance of any public comment received, if comment is 
requested; and
    (vi) The NRC's relevant past decisions and current policies.
    (2) Petition for rulemaking docket closure. After the NRC determines 
the appropriate regulatory action in response to the petition for 
rulemaking, the NRC will administratively close the docket for the 
petition. The NRC will publish a notice describing that action with any 
related Docket Identification number (Docket ID), as applicable, in the 
Federal Register. The NRC may make a determination on a petition for 
rulemaking and administratively close the docket for the petition for 
rulemaking by:

[[Page 115]]

    (i) Deciding not to undertake a rulemaking to address the issue 
raised by the petition for rulemaking, and informing the petitioner in 
writing of the grounds for denial.
    (ii) Initiating a rulemaking action (e.g., initiating a new 
rulemaking, addressing the petition for rulemaking in an ongoing 
rulemaking, addressing the petition for rulemaking in a planned 
rulemaking) that considers the issues raised by a petition for 
rulemaking, and informing the petitioner in writing of this decision and 
the associated Docket ID of the rulemaking action, if applicable.
    (i) Petition for rulemaking resolution.--(1) Petition for rulemaking 
resolution published in the Federal Register. The NRC will publish a 
Federal Register notice informing the public that it has concluded all 
planned regulatory action with respect to some or all of the issues 
presented in a petition for rulemaking. This may occur by adoption of a 
final rule related to the petition for rulemaking, denial by the NRC of 
the petition for rulemaking at any stage of the regulatory process, or 
the petitioner's withdrawal of the petition for rulemaking before the 
NRC has entered the rulemaking process. As applicable, the Federal 
Register notice will include a discussion of how the regulatory action 
addresses the issue raised by the petitioner, the NRC's grounds for 
denial of the petition for rulemaking, or information on the withdrawal. 
The notice will normally include the NRC's response to any public 
comment received (if comment is requested), unless the NRC has indicated 
that it will not be providing a formal written response to each comment 
received.
    (2) NRC decision not to proceed with rulemaking after closure of a 
petition for rulemaking docket. If the NRC closes a petition for 
rulemaking docket under paragraph (h)(2)(ii) of this section but 
subsequently decides not to carry out the planned rulemaking to 
publication of a final rule, the NRC will notify the petitioner in 
writing of this decision and publish a notice in the Federal Register 
explaining the basis for its decision. The decision not to complete the 
rulemaking action will be documented as denial of the petition for 
rulemaking in the docket of the closed petition for rulemaking, in the 
Web sites, in the Government-wide Unified Agenda of Federal Regulatory 
and Deregulatory Actions, online in ADAMS, and at http://
www.regulations.gov as described in paragraph (j) of this section.
    (j) Status of petitions for rulemaking and rulemakings. (1) The NRC 
provides current information on rulemakings and petitions for rulemaking 
in the NRC Library at http://www.nrc.gov/about-nrc/regulatory/
rulemaking.html.
    (2) The NRC includes a summary of the NRC's planned and ongoing 
rulemakings in the Government-wide Unified Agenda of Federal Regulatory 
and Deregulatory Actions (the Unified Agenda), published semiannually. 
This Unified Agenda is available at http://www.reginfo.gov/public/do/
eAgendaMain/.
    (3) All docketed petitions, rulemakings, and public comments are 
posted online in ADAMS and at http://www.regulations.gov.

[80 FR 60526, Oct. 7, 2015]



Sec.2.804  Notice of proposed rulemaking.

    (a) Except as provided by paragraph (d) of this section, when the 
Commission proposes to adopt, amend, or repeal a regulation, it will 
cause to be published in the Federal Register a notice of proposed 
rulemaking, unless all persons subject to the notice are named and 
either are personally served or otherwise have actual notice in 
accordance with law.
    (b) The notice will include:
    (1) Either the terms or substance of the proposed rule, or a 
specification of the subjects and issues involved;
    (2) The manner and time within which interested members of the 
public may comment, and a statement that copies of comments may be 
examined will be made available at the NRC Web site, http://www.nrc.gov;
    (3) The authority under which the regulation is proposed;
    (4) The time, place, and nature of the public hearing, if any;
    (5) If a hearing is to be held, designation of the presiding officer 
and any special directions for the conduct of the hearing; and
    (6) Such explanatory statement as the Commission may consider 
appropriate.

[[Page 116]]

    (c) The publication or service of notice will be made not less than 
fifteen (15) days prior to the time fixed for hearing, if any, unless 
the Commission for good cause stated in the notice provides otherwise.
    (d) The notice and comment provisions contained in paragraphs (a), 
(b), and (c) of this section will not be required to be applied--
    (1) To interpretative rules, general statements of policy, or rules 
of agency organization, procedure, or practice; or
    (2) When the Commission for good cause finds that notice and public 
comment are impracticable, unnecessary, or contrary to the public 
interest, and are not required by statute. This finding, and the reasons 
therefor, will be incorporated into any rule issued without notice and 
comment for good cause.
    (e) The Commission shall provide for a 30-day post-promulgation 
comment period for--
    (1) Any rule adopted without notice and comment under the good cause 
exception on paragraph (d)(2) of this section where the basis is that 
notice and comment is ``impracticable'' or ``contrary to the public 
interest.''
    (2) Any interpretative rule, or general statement of policy adopted 
without notice and comment under paragraph (d)(1) of this section, 
except for those cases for which the Commission finds that such 
procedures would serve no public interest, or would be so burdensome as 
to outweigh any foreseeable gain.
    (f) For any post-promulgation comments received under paragraph (e) 
of this section, the Commission shall publish a statement in the Federal 
Register containing an evaluation of the significant comments and any 
revisions of the rule or policy statement made as a result of the 
comments and their evaluation.

[27 FR 377, Jan. 13, 1962, as amended at 50 FR 13010, Apr. 2, 1985; 64 
FR 48949, Sept. 9, 1999]



Sec.2.805  Participation by interested persons.

    (a) In all rulemaking proceedings conducted under the provisions of 
Sec.2.804(a), the Commission will afford interested persons an 
opportunity to participate through the submission of statements, 
information, opinions, and arguments in the manner stated in the notice. 
The Commission may grant additional reasonable opportunity for the 
submission of comments.
    (b) The Commission may hold informal hearings at which interested 
persons may be heard, adopting procedures which in its judgment will 
best serve the purpose of the hearing.

[27 FR 377, Jan. 13, 1962, as amended at 50 FR 13010, Apr. 2, 1985; 50 
FR 15865, Apr. 22, 1985]



Sec.2.806  Commission action.

    The Commission will incorporate in the notice of adoption of a 
regulation a concise general statement of its basis and purpose, and 
will cause the notice and regulation to be published in the Federal 
Register or served upon affected persons.



Sec.2.807  Effective date.

    The notice of adoption of a regulation will specify the effective 
date. Publication or service of the notice and regulation, other than 
one granting or recognizing exemptions or relieving from restrictions, 
will be made not less than thirty (30) days prior to the effective date 
unless the Commission directs otherwise on good cause found and 
published in the notice of rule making.



Sec.2.808  Authority of the Secretary to rule on procedural matters.

    When briefs, motions or other documents listed herein are submitted 
to the Commission itself, as opposed to officers who have been delegated 
authority to act for the Commission, the Secretary or the Assistant 
Secretary is authorized to:
    (a) Prescribe schedules for the filing of statements, information, 
briefs, motions, responses or other pleadings, where such schedules may 
differ from those elsewhere prescribed in these rules or where these 
rules do not prescribe a schedule;
    (b) Rule on motions for extensions of time;
    (c) Reject motions, briefs, pleadings, and other documents filed 
with the Commission later than the time prescribed by the Secretary or 
the Assistant Secretary or established by an

[[Page 117]]

order, rule, or regulation of the Commission unless good cause is shown 
for the late filing; and
    (d) Prescribe all procedural arrangements relating to any oral 
argument to be held before the Commission.

[39 FR 24219, July 1, 1974, as amended at 72 FR 49152, Aug. 28, 2007]



Sec.2.809  Participation by the Advisory Committee on Reactor 
Safeguards.

    (a) In its advisory capacity to the Commission, the ACRS may 
recommend that the Commission initiate rulemaking in a particular area. 
The Commission will respond to such rulemaking recommendation in writing 
within 90 days, noting its intent to implement, study, or defer action 
on the recommendation. In the event the Commission decides not to accept 
or decides to defer action on the recommendation, it will give its 
reasons for doing so. Both the ACRS recommendation and the Commission's 
response will be made available at the NRC Web site, http://www.nrc.gov, 
following transmittal of the Commission's response to the ACRS.
    (b) When a rule involving nuclear safety matters within the purview 
of the ACRS is under development by the NRC Staff, the Staff will ensure 
that the ACRS is given an opportunity to provide advice at appropriate 
stages and to identify issues to be considered during rulemaking 
hearings.

[46 FR 22358, Apr. 17, 1981, as amended at 64 FR 48949, Sept. 9, 1999]



Sec.2.810  NRC size standards.

    The NRC shall use the size standards contained in this section to 
determine whether a licensee qualifies as a small entity in its 
regulatory programs.
    (a) A small business is a for-profit concern and is a--
    (1) Concern that provides a service or a concern not engaged in 
manufacturing with average gross receipts of $7.0 million or less over 
its last 3 completed fiscal years; or
    (2) Manufacturing concern with an average number of 500 or fewer 
employees based upon employment during each pay period for the preceding 
12 calendar months.
    (b) A small organization is a not-for-profit organization which is 
independently owned and operated and has annual gross receipts of $7.0 
million or less.
    (c) A small governmental jurisdiction is a government of a city, 
county, town, township, village, school district, or special district 
with a population of less than 50,000.
    (d) A small educational institution is one that is--
    (1) Supported by a qualifying small governmental jurisdiction; or
    (2) Not state or publicly supported and has 500 or fewer employees.
    (e) For the purposes of this section, the NRC shall use the Small 
Business Administration definition of receipts (13 CFR 121.104). A 
licensee who is a subsidiary of a large entity does not qualify as a 
small entity for purposes of this section.
    (f) Whenever appropriate in the interest of administering statutes 
and regulations within its jurisdiction, it is the practice of the NRC 
to answer inquiries from small entities concerning information on and 
advice about compliance with the statutes and regulations that affect 
them. To help small entities obtain information quickly, the NRC has 
established a toll-free telephone number at 1-800-368-5642.

[60 FR 18346, Apr. 11, 1995, as amended at 62 FR 26220, May 13, 1997; 72 
FR 44953, Aug. 10, 2007; 73 FR 42673, July 23, 2008; 77 FR 39387, July 
3, 2012; 79 FR 66601, Nov. 10, 2014]



Sec.2.811  Filing of standard design certification application;
required copies.

    (a) Serving of applications. The signed original of an application 
for a standard design certification, including all amendments to the 
applications, must be sent either by mail addressed: ATTN: Document 
Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001; by facsimile; by hand delivery to the NRC's offices at 11555 
Rockville Pike, Rockville, Maryland, between the hours of 7:30 a.m. and 
4:15 p.m. eastern time; or, where practicable, by electronic submission, 
for example, via Electronic Information Exchange, e-mail, or CD-ROM. 
Electronic submissions must be made in a manner that enables the

[[Page 118]]

NRC to receive, read, authenticate, distribute, and archive the 
submission, and process and retrieve it a single page at a time. 
Detailed guidance on making electronic submissions can be obtained by 
visiting the NRC's Web site at http://www.nrc.gov/site-help/e-
submittals.html; by e-mail to [email protected]; or by writing the 
Office of the Chief Information Officer, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001. The guidance discusses, among 
other topics, the formats the NRC can accept, the use of electronic 
signatures, and the treatment of nonpublic information. If the 
communication is on paper, the signed original must be sent.
    (b) Form of application. Each original of an application and an 
amendment of an application must meet the requirements in Sec.2.813.
    (c) Capability to provide additional copies. The applicant shall 
maintain the capability to generate additional copies of the general 
information and the safety analysis report, or part thereof or amendment 
thereto, for subsequent distribution in accordance with the written 
instructions of the Director, Office of New Reactors, the Director, 
Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear 
Material Safety and Safeguards, as appropriate.
    (d) Public hearing copy. In any hearing conducted under subpart O of 
this part for a design certification rulemaking, the applicant must make 
a copy of the updated application available at the public hearing for 
the use of any other parties to the proceeding, and shall certify that 
the updated copies of the application contain the current contents of 
the application submitted in accordance with the requirements of this 
part.
    (e) Pre-application consultation. A prospective applicant for a 
standard design certification may consult with NRC staff before filing 
an application by writing to the Director, Division of New Reactor 
Licensing, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, with respect to the subject matters listed in Sec.2.802(b)(1). A 
prospective applicant also may telephone the Rules, Announcements, and 
Directives Branch, toll free on 1-800-368-5642, or send an email to 
[email protected] on these subject matters. In addition, a 
prospective applicant may confer informally with NRC staff before filing 
an application for a standard design certification, and the limitations 
on consultation in Sec.2.802(b)(2) do not apply.

[72 FR 49482, Aug. 28, 2007, as amended at 74 FR 62679, Dec. 1, 2009; 77 
FR 46598, Aug. 3, 2012; 80 FR 60527, Oct. 7, 2015; 80 FR 74978, Dec. 1, 
2015]



Sec.2.813  Written communications.

    (a) General requirements. All correspondence, reports, and other 
written communications from the applicant to the Nuclear Regulatory 
Commission concerning the regulations in this subpart, and parts 50, 52, 
and 100 of this chapter must be sent either by mail addressed: ATTN: 
Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville 
Pike, Rockville, Maryland, between the hours of 7:30 a.m. and 4:15 p.m. 
eastern time; or, where practicable, by electronic submission, for 
example, via Electronic Information Exchange, e-mail, or CD-ROM. 
Electronic submissions must be made in a manner that enables the NRC to 
receive, read, authenticate, distribute, and archive the submission, and 
process and retrieve it a single page at a time. Detailed guidance on 
making electronic submissions can be obtained by visiting the NRC's Web 
site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information. If the communication is on paper, the signed original must 
be sent. If a submission due date falls on a Saturday, Sunday, or 
Federal holiday, the next Federal working day becomes the official due 
date.
    (b) Form of communications. All paper copies submitted to meet the 
requirements set forth in paragraph (a) of this section must be 
typewritten, printed or otherwise reproduced in permanent

[[Page 119]]

form on unglazed paper. Exceptions to these requirements imposed on 
paper submissions may be granted for the submission of micrographic, 
photographic, or similar forms.
    (c) Regulation governing submission. An applicant submitting 
correspondence, reports, and other written communications under the 
regulations of this chapter is requested but not required to cite 
whenever practical, in the upper right corner of the first page of the 
submission, the specific regulation or other basis requiring submission.

[72 FR 49482, Aug. 28, 2007, as amended at 74 FR 62679, Dec. 1, 2009; 80 
FR 74978, Dec. 1, 2015]



Sec.2.815  Docketing and acceptance review.

    (a) Each application for a standard design certification will be 
assigned a docket number. However, to allow a determination as to 
whether an application is complete and acceptable for docketing, it will 
be initially treated as a tendered application. A copy of the tendered 
application will be available for public inspection at the NRC Web site, 
http://www.nrc.gov, and/or at the NRC Public Document Room. Generally, 
the determination on acceptability for docketing will be made within a 
period of 30 days. The Commission may decide to determine acceptability 
on the basis of the technical adequacy of the application as well as its 
completeness.
    (b) If the Commission determines that a tendered application is 
complete and acceptable for docketing, a docket number will be assigned 
to the application or part thereof, and the applicant will be notified 
of the determination.

[72 FR 49482, Aug. 28, 2007]



Sec.2.817  Withdrawal of application.

    (a) The Commission may permit an applicant to withdraw an 
application for a standard design certification before the issuance of a 
notice of proposed rulemaking on such terms and conditions as the 
Commission may prescribe, or may, on receiving a request for withdrawal 
of an application, deny the application or dismiss it without prejudice. 
The NRC will publish in the Federal Register a document withdrawing the 
application, if the notice of receipt of the application, an advance 
notice of proposed rulemaking, or a notice of proposed rulemaking for 
the standard design certification has been previously published in the 
Federal Register. If the notice of receipt, advance notice of proposed 
rulemaking or notice of proposed rulemaking was published on the NRC Web 
site, then the notice of action on the withdrawal will also be published 
on the NRC Web site.
    (b) The withdrawal of an application does not authorize the removal 
of any document from the files of the Commission.

[72 FR 49482, Aug. 28, 2007]



Sec.2.819  Denial of application for failure to supply information.

    (a) The Commission may deny an application for a standard design 
certification if an applicant fails to respond to a request for 
additional information within 30 days from the date of the request, or 
within such other time as may be specified.
    (b) If the Commission denies an application because the applicant 
has failed to respond in a timely fashion to a request for additional 
information, the NRC will publish in the Federal Register a notice of 
denial and will notify the applicant with a simple statement of the 
grounds of denial. If a notice of receipt of application, advance notice 
of proposed rulemaking, or notice of proposed rulemaking for a standard 
design certification was published on the NRC Web site, then the notice 
of action on the denial will also be published on the NRC Web site.

[72 FR 49482, Aug. 28, 2007]



  Subpart I_Special Procedures Applicable to Adjudicatory Proceedings 
     Involving Restricted Data and/or National Security Information

    Source: 41 FR 53329, Dec. 6, 1976, unless otherwise noted.

[[Page 120]]



Sec.2.900  Purpose.

    This subpart is issued pursuant to section 181 of the Atomic Energy 
Act of 1954, as amended, and section 201 of the Energy Reorganization 
Act of 1974, as amended, to provide such procedures in proceedings 
subject to this part as will effectively safeguard and prevent 
disclosure of Restricted Data and National Security Information to 
unauthorized persons, with minimum impairment of procedural rights.



Sec.2.901  Scope of subpart I.

    This subpart applies, as applicable, to all proceedings under 
subparts G, J, K, L, M, and N of this part.

[69 FR 2264, Jan. 14, 2004]



Sec.2.902  Definitions.

    As used in this subpart:
    (a) Government agency means any executive department, commission, 
independent establishment, corporation, wholly or partly owned by the 
United States of America, which is an instrumentality of the United 
States, or any board, bureau, division, service, office, officer, 
authority, administration, or other establishment in the executive 
branch of the Government.
    (b) Interested party means a party having an interest in the issue 
or issues to which particular Restricted Data or National Security 
Information is relevant. Normally the interest of a party in an issue 
may be determined by examination of the notice of hearing, the answers 
and replies.
    (c) The phrase introduced into a proceeding refers to the 
introduction or incorporation of testimony or documentary matter into 
any part of the official record of a proceeding subject to this part.
    (d) National Security Information means information that has been 
classified pursuant to Executive Order 12356.
    (e) Party, in the case of proceedings subject to this subpart 
includes a person admitted as a party under Sec.2.309 or an interested 
State admitted under Sec.2.315(c).

[41 FR 53329, Dec. 6, 1976, as amended at 47 FR 56314, Dec. 16, 1982; 69 
FR 2264, Jan. 14, 2004]



Sec.2.903  Protection of restricted data and national security 
information.

    Nothing in this subpart shall relieve any person from safeguarding 
Restricted Data or National Security Information in accordance with the 
applicable provisions of laws of the United States and rules, 
regulations or orders of any Government Agency.



Sec.2.904  Classification assistance.

    On request of any party to a proceeding or of the presiding officer, 
the Commission will designate a representative to advise and assist the 
presiding officer and the parties with respect to security 
classification of information and the safeguards to be observed.



Sec.2.905  Access to restricted data and national security information
for parties; security clearances.

    (a) Access to restricted data and national security information 
introduced into proceedings. Except as provided in paragraph (h) of this 
section, restricted data or national security information introduced 
into a proceeding subject to this part will be made available to any 
interested party having the required security clearance; to counsel for 
an interested party provided the counsel has the required security 
clearance; and to such additional persons having the required security 
clearance as the Commission or the presiding officer determined are 
needed by such party for adequate preparation or presentation of his 
case. Where the interest of such party will not be prejudiced, the 
Commission or presiding officer may postpone action upon an application 
for access under this paragraph until after a notice of hearing, 
answers, and replies have been filed.
    (b) Access to Restricted Data or National Security Information not 
introduced into proceedings. (1) On application showing that access to 
Restricted Data or National Security Information may be required for the 
preparation of a party's case, and except as provided in paragraph (h) 
of this section, the Commission or the presiding officer will issue an 
order granting access to such Restricted Data or National Security 
Information to the party upon his obtaining the required security 
clearance, to counsel for the party upon

[[Page 121]]

their obtaining the required security clearance, and to such other 
individuals as may be needed by the party for the preparation and 
presentation of his case upon their obtaining the required clearance.
    (2) Where the interest of the party applying for access will not be 
prejudiced, the Commission or the presiding officer may postpone action 
on an application pursuant to this paragraph until after a notice of 
hearing, answers and replies have been filed.
    (c) The Commission will consider requests for appropriate security 
clearances in reasonable numbers pursuant to this section. A reasonable 
charge will be made by the Commission for costs of security clearance 
pursuant to this section.
    (d) The presiding officer may certify to the Commission for its 
consideration and determination any questions relating to access to 
Restricted Data or National Security Information arising under this 
section. Any party affected by a determination or order of the presiding 
officer under this section may appeal forthwith to the Commission from 
the determination or order. The filing by the staff of an appeal from an 
order of a presiding officer granting access to Restricted Data or 
National Security Information shall stay the order pending determination 
of the appeal by the Commission.
    (e) Application granting access to restricted data or national 
security information. (1) An application under this section for orders 
granting access to restricted data or national security information not 
received from another Government agency will normally be acted upon by 
the presiding officer, or if a proceeding is not before a presiding 
officer, by the Commission.
    (2) An application under this section for orders granting access to 
restricted data or national security information where the information 
has been received by the Commission from another Government agency will 
be acted upon by the Commission.
    (f) To the extent practicable, an application for an order granting 
access under this section shall describe the subjects of Restricted Data 
or National Security Information to which access is desired and the 
level of classification (confidential, secret or other) of the 
information; the reasons why access to the information is requested; the 
names of individuals for whom clearances are requested; and the reasons 
why security clearances are being requested for those individuals.
    (g) On the conclusion of a proceeding, the Commission will terminate 
all orders issued in the proceeding for access to Restricted Data or 
National Security Information and all security clearances granted 
pursuant to them; and may issue such orders requiring the disposal of 
classified matter received pursuant to them or requiring the observance 
of other procedures to safeguard such classified matter as it deems 
necessary to protect Restricted Data or National Security Information.
    (h) Refusal to grant access to restricted data or national security 
information. (1) The Commission will not grant access to restricted data 
or national security information unless it determines that the granting 
of access will not be inimical to the common defense and security.
    (2) Access to Restricted Data or National Security Information which 
has been received by the Commission from another Government agency will 
not be granted by the Commission if the originating agency determines in 
writing that access should not be granted. The Commission will consult 
the originating agency prior to granting access to such data or 
information received from another Government agency.



Sec.2.906  Obligation of parties to avoid introduction of restricted
data or national security information.

    It is the obligation of all parties in a proceeding subject to this 
part to avoid, where practicable, the introduction of Restricted Data or 
National Security Information into the proceeding. This obligation rests 
on each party whether or not all other parties have the required 
security clearance.



Sec.2.907  Notice of intent to introduce restricted data or national
security information.

    (a) If, at the time of publication of a notice of hearing, it 
appears to the staff that it will be impracticable for it to avoid the 
introduction of Restricted

[[Page 122]]

Data or National Security Information into the proceeding, it will file 
a notice of intent to introduce Restricted Data or National Security 
Information.
    (b) If, at the time of filing of an answer to the notice of hearing 
it appears to the party filing that it will be impracticable for the 
party to avoid the introduction of Restricted Data or National Security 
Information into the proceeding, the party shall state in the answer a 
notice of intent to introduce Restricted Data or National Security 
Information into the proceeding.
    (c) If, at any later stage of a proceeding, it appears to any party 
that it will be impracticable to avoid the introduction of Restricted 
Data or National Security Information into the proceeding, the party 
shall give to the other parties prompt written notice of intent to 
introduce Restricted Data or National Security Information into the 
proceeding.
    (d) Restricted Data or National Security Information shall not be 
introduced into a proceeding after publication of a notice of hearing 
unless a notice of intent has been filed in accordance with Sec.2.908, 
except as permitted in the discretion of the presiding officer when it 
is clear that no party or the public interest will be prejudiced.



Sec.2.908  Contents of notice of intent to introduce restricted data
or other national security information.

    (a) A party who intends to introduce Restricted Data or other 
National Security Information shall file a notice of intent with the 
Secretary. The notice shall be unclassified and, to the extent 
consistent with classification requirements, shall include the 
following:
    (1) The subject matter of the Restricted Data or other National 
Security Information which it is anticipated will be involved;
    (2) The highest level of classification of the information 
(confidential, secret, or other);
    (3) The stage of the proceeding at which he anticipates a need to 
introduce the information; and
    (4) The relevance and materiality of the information to the issues 
on the proceeding.
    (b) In the discretion of the presiding officer, such notice, when 
required by Sec.2.907(c), may be given orally on the record.



Sec.2.909  Rearrangement or suspension of proceedings.

    In any proceeding subject to this part where a party gives a notice 
of intent to introduce Restricted Data or other National Security 
Information, and the presiding officer determines that any other 
interested party does not have required security clearances, the 
presiding officer may in his discretion:
    (a) Rearrange the normal order of the proceeding in a manner which 
gives such interested parties an opportunity to obtain required security 
clearances with minimum delay in the conduct of the proceeding.
    (b) Suspend the proceeding or any portion of it until all interested 
parties have had opportunity to obtain required security clearances. No 
proceeding shall be suspended for such reasons for more than 100 days 
except with the consent of all parties or on a determination by the 
presiding officer that further suspension of the proceeding would not be 
contrary to the public interest.
    (c) Take such other action as he determines to be in the best 
interest of all parties and the public.



Sec.2.910  Unclassified statements required.

    (a) Whenever Restricted Data or other National Security Information 
is introduced into a proceeding, the party offering it shall submit to 
the presiding officer and to all parties to the proceeding an 
unclassified statement setting forth the information in the classified 
matter as accurately and completely as possible.
    (b) In accordance with such procedures as may be agreed upon by the 
parties or prescribed by the presiding officer, and after notice to all 
parties and opportunity to be heard thereon, the presiding officer shall 
determine whether the unclassified statement or any portion of it, 
together with any appropriate modifications suggested by any party, may 
be substituted for the classified matter or any portion of it without 
prejudice to the interest of any party or to the public interest.

[[Page 123]]

    (c) If the presiding officer determines that the unclassified 
statement, together with such unclassified modifications as he finds are 
necessary or appropriate to protect the interest of other parties and 
the public interest, adequately sets forth information in the classified 
matter which is relevant and material to the issues in the proceeding, 
he shall direct that the classified matter be excluded from the record 
of the proceeding. His determination will be considered by the 
Commission as a part of the decision in the event of review.
    (d) If the presiding officer determines that an unclassified 
statement does not adequately present the information contained in the 
classified matter which is relevant and material to the issues in the 
proceeding, he shall include his reasons in his determination. This 
determination shall be included as part of the record and will be 
considered by the Commission in the event of review of the 
determination.
    (e) The presiding officer may postpone all or part of the procedures 
established in this section until the reception of all other evidence 
has been completed. Service of the unclassified statement required in 
paragraph (a) of this section shall not be postponed if any party does 
not have access to Restricted Data or other National Security 
Information.



Sec.2.911  Admissibility of restricted data or other national 
security information.

    A presiding officer shall not receive any Restricted Data or other 
National Security Information in evidence unless:
    (a) The relevance and materiality of the Restricted Data or other 
National Security Information to the issues in the preceeding, and its 
competence, are clearly established; and
    (b) The exclusion of the Restricted Data or other National Security 
Information would prejudice the interests of a party or the public 
interest.



Sec.2.912  Weight to be attached to classified evidence.

    In considering the weight and effect of any Restricted Data or other 
National Security Information received in evidence to which an 
interested party has not had opportunity to receive access, the 
presiding officer and the Commission shall give to such evidence such 
weight as is appropriate under the circumstances, taking into 
consideration any lack of opportunity to rebut or impeach the evidence.



Sec.2.913  Review of Restricted Data or other National Security 
Information received in evidence.

    At the close of the reception of evidence, the presiding officer 
shall review the record and shall direct that any Restricted Data or 
other National Security Information be expunged from the record where 
such expunction would not prejudice the interests of a party or the 
public interest. Such directions by the presiding officer will be 
considered by the Commission in the event of review of the 
determinations of the presiding officer.



   Subpart J_Procedures Applicable to Proceedings for the Issuance of 
 Licenses for the Receipt of High-Level Radioactive Waste at a Geologic 
                               Repository

    Source: 54 FR 14944, Apr. 14, 1989, unless otherwise noted.



Sec.2.1000  Scope of subpart J.

    The rules in this subpart, together with the rules in subparts C and 
G of this part, govern the procedure for an application for 
authorization to construct a high-level radioactive waste repository at 
a geologic repository operations area noticed under Sec. Sec.
2.101(f)(8) or 2.105(a)(5), and for an application for a license to 
receive and possess high level radioactive waste at a geologic 
repository operations area. The procedures in this subpart take 
precedence over those in 10 CFR part 2, subpart C, except for the 
following provisions: Sec. Sec.2.301; 2.303; 2.307; 2.309; 2.312; 
2.313; 2.314; 2.315; 2.316; 2.317(a); 2.318; 2.319; 2.320; 2.321; 2.322; 
2.323; 2.324; 2.325; 2.326; 2.327; 2.328; 2.330; 2.331; 2.333; 2.335; 
2.338; 2.339; 2.342; 2.343; 2.344; 2.345; 2.346; 2.348; and 2.390. The 
procedures in this subpart take precedence over those in 10 CFR part 2, 
subpart G, except for the

[[Page 124]]

following provisions: Sec. Sec.2.701, 2.702; 2.703; 2.708; 2.709; 
2.710; 2.711; 2.712.

[69 FR 2264, Jan. 14, 2004]



Sec.2.1001  Definitions.

    Bibliographic header means the minimum series of descriptive fields 
that a potential party, interested governmental participant, or party 
must submit with a document or other material.
    Circulated draft means a nonfinal document circulated for 
supervisory concurrence or signature in which the original author or 
others in the concurrence process have non-concurred. A ``circulated 
draft'' meeting the above criterion includes a draft of a document that 
eventually becomes a final document, and a draft of a document that does 
not become a final document due to either a decision not to finalize the 
document or the passage of a substantial period of time in which no 
action has been taken on the document.
    Complex document means a document that consists (entirely or in 
part) of electronic files having substantial portions that are neither 
textual nor image in nature, and graphic or other Binary Large Objects 
that exceed 50 megabytes and cannot logically be divided. For example, 
specialized submissions may include runtime executable software, viewer 
or printer executables, dynamic link library (.dll) files, large data 
sets associated with an executable, and actual software code for 
analytical programs that a party may intend to introduce into the 
proceeding.
    Document means any written, printed, recorded, magnetic, graphic 
matter, or other documentary material, regardless of form or 
characteristic.
    Documentary material means:
    (1) Any information upon which a party, potential party, or 
interested governmental participant intends to rely and/or to cite in 
support of its position in the proceeding for a construction 
authorization for a high-level radioactive waste repository at a 
geologic repository operations area pursuant to parts 60 or 63 of this 
chapter, a license to receive and possess high-level radioactive waste 
at a geologic repository operations area pursuant to parts 60 or 63 of 
this chapter;
    (2) Any information that is known to, and in the possession of, or 
developed by the party that is relevant to, but does not support, that 
information or that party's position; and
    (3) All reports and studies, prepared by or on behalf of the 
potential party, interested governmental participant, or party, 
including all related ``circulated drafts,'' relevant to both the 
license application and the issues set forth in the Topical Guidelines 
in Regulatory Guide 3.69, regardless of whether they will be relied upon 
and/or cited by a party. The scope of documentary material shall be 
guided by the topical guidelines in the applicable NRC Regulatory Guide.
    DOE means the U.S. Department of Energy or its duly authorized 
representatives.
    Electronic docket means the NRC information system that receives, 
distributes, stores, and retrieves the Commission's adjudicatory docket 
materials.
    Image means a visual likeness of a document, presented on a paper 
copy, microform, or a bit-map on optical or magnetic media.
    Interested governmental participant means any person admitted under 
Sec.2.315(c) of this part to the proceeding on an application for a 
construction authorization for a high-level radioactive waste repository 
at a geologic repository operations area under parts 60 or 63 of this 
chapter, and an application for a license to receive and possess high 
level radioactive waste at a geologic repository operations area under 
parts 60 and 63 of this chapter.
    Large document means a document that consists of electronic files 
that are larger than 50 megabytes.
    Licensing Support Network means the combined system that makes 
documentary material available electronically to parties, potential 
parties, and interested governmental participants to a proceeding for a 
construction authorization for a high-level radioactive waste repository 
at a geologic repository operations area, and an application for a 
license to receive and possess high level radioactive waste at a 
geologic repository operations area under parts 60 and 63 of this 
chapter.
    LSN Administrator means the person within the U.S. Nuclear 
Regulatory

[[Page 125]]

Commission responsible for coordinating access to and the integrity of 
data available on the Licensing Support Network. The LSN Administrator 
shall not be in any organizational unit that either represents the U.S. 
Nuclear Regulatory Commission staff as a party to the high-level waste 
repository licensing proceeding or is a part of the management chain 
reporting to the Director, Office of Nuclear Material Safety and 
Safeguards. For the purposes of this subpart, the organizational unit 
within the NRC selected to be the LSN Administrator shall not be 
considered to be a party to the proceeding.
    Marginalia means handwritten, printed, or other types of notations 
added to a document excluding underlining and highlighting.
    NRC means the U.S. Nuclear Regulatory Commission or its duly 
authorized representatives.
    Party for the purpose of this subpart means the DOE, the NRC staff, 
the host State, any affected unit of local government as defined in 
Section 2 of the Nuclear Waste Policy Act of 1982, as amended (42 U.S.C. 
10101), any affected Indian Tribe as defined in section 2 of the Nuclear 
Waste Policy Act of 1982, as amended (42 U.S.C. 10101), and a person 
admitted under Sec.2.309 to the proceeding on an application for 
construction authorization for a high-level radioactive waste repository 
at a geologic repository operations area under parts 60 or 63 of this 
chapter, and an application for a license to receive and possess high 
level radioactive waste at a geologic repository operations area under 
parts 60 and 63 of this chapter; provided that a host State, affected 
unit of local government, or affected Indian Tribe files a list of 
contentions in accordance with the provisions of Sec.2.309.
    Personal record means a document in the possession of an individual 
associated with a party, interested governmental participant, or 
potential party that was not required to be created or retained by the 
party, interested governmental participant, or potential party, and can 
be retained or discarded at the possessor's sole discretion, or 
documents of a personal nature that are not associated with any business 
of the party, interested governmental participant, or potential party.
    Potential party means any person who, during the period before the 
issuance of the first pre-hearing conference order under Sec.
2.1021(d), is given access to the Licensing Support Network and who 
consents to comply with the regulations set forth in subpart J of this 
part, including the authority of the Pre-License Application Presiding 
Officer designated pursuant to Sec.2.1010.
    Pre-license application electronic docket means the NRC's electronic 
information system that receives, distributes, stores, and maintains NRC 
pre-license application docket materials during the pre-license 
application phase.
    Pre-license application phase means the time period before a 
construction authorization for a high-level radioactive waste repository 
at a geologic repository operations area under parts 60 or 63 of this 
chapter is docketed under Sec.2.101(f)(3), and the time period before 
a license application to receive and possess high-level radioactive 
waste at a geologic repository operations area under parts 60 or 63 is 
docketed under Sec.2.101(f)(3).
    Pre-License Application Presiding Officer means one or more members 
of the Commission, or an atomic safety and licensing board, or a named 
officer who has been delegated final authority in the pre-license 
application phase with jurisdiction specified at the time of 
designation.
    Preliminary draft means any nonfinal document that is not a 
circulated draft.
    Presiding Officer means one or more members of the Commission, or an 
atomic safety and licensing board, or a named officer who has been 
delegated final authority in the matter, designated in the notice of 
hearing to preside.
    Searchable full text means the electronic indexed entry of a 
document that allows the identification of specific words or groups of 
words within a text file.
    Simple document means a document that consists of electronic files 
that are 50 megabytes or less.
    Topical Guidelines means the set of topics set forth in Regulatory 
Guide

[[Page 126]]

3.69, Topical Guidelines for the Licensing Support System, which are 
intended to serve as guidance on the scope of ``documentary material''.

[54 FR 14944, Apr. 14, 1989, as amended at 56 FR 7795, Feb. 26, 1991; 63 
FR 71736, Dec. 30, 1998; 66 FR 29465, May 31, 2001; 66 FR 55788, Nov. 2, 
2001; 69 FR 2264, Jan. 14, 2004; 69 FR 32848, June 14, 2004]



Sec.2.1002  [Reserved]



Sec.2.1003  Availability of material.

    (a) Subject to the exclusions in Sec.2.1005 and paragraphs (b), 
(c), and (e) of this section, DOE shall make available, no later than 
six months in advance of submitting its license application for a 
geologic repository, the NRC shall make available no later than thirty 
days after the DOE certification of compliance under Sec.2.1009(b), 
and each other potential party, interested governmental participant or 
party shall make available no later than ninety days after the DOE 
certification of compliance under Sec.2.1009(b)--
    (1) An electronic file including bibliographic header for all 
documentary material (including circulated drafts but excluding 
preliminary drafts) generated by, or at the direction of, or acquired 
by, a potential party, interested governmental participant or party; 
provided, however, that an electronic file need not be provided for 
acquired documentary material that has already been made available by 
the potential party, interested governmental participant or party that 
originally created the documentary material. Concurrent with the 
production of the electronic files will be an authentication statement 
for posting on the LSN Web site that indicates where an authenticated 
image copy of the documents can be obtained.
    (2) In electronic image format, subject to the claims of privilege 
in Sec.2.1006, graphic-oriented documentary material that includes raw 
data, computer runs, computer programs and codes, field notes, 
laboratory notes, maps, diagrams and photographs, which have been 
printed, scripted, or hand written. Text embedded within these documents 
need not be separately entered in searchable full text. A bibliographic 
header must be provided for all graphic-oriented documentary material. 
Graphic-oriented documents may include--
    (i) Calibration procedures, logs, guidelines, data and 
discrepancies;
    (ii) Gauge, meter and computer settings;
    (iii) Probe locations;
    (iv) Logging intervals and rates;
    (v) Data logs in whatever form captured;
    (vi) Text data sheets;
    (vii) Equations and sampling rates;
    (viii) Sensor data and procedures;
    (ix) Data Descriptions;
    (x) Field and laboratory notebooks;
    (xi) Analog computer, meter or other device print-outs;
    (xii) Digital computer print-outs;
    (xiii) Photographs;
    (xiv) Graphs, plots, strip charts, sketches;
    (xv) Descriptive material related to the information identified in 
this paragraph.
    (3) In an electronic file, subject to the claims of privilege in 
Sec.2.1006, only a bibliographic header for each item of documentary 
material that is not suitable for image or searchable full text.
    (4) An electronic bibliographic header for each documentary 
material--
    (i) For which a claim of privilege is asserted;
    (ii) Which constitutes confidential financial or commercial 
information; or
    (iii) Which constitutes Safeguards Information under Sec.73.21 and 
the requirements of Sec.73.22 or Sec.73.23 of this chapter, as 
applicable.
    (b) Basic licensing documents generated by DOE, such as the Site 
Characterization Plan, the Environmental Impact Statement, and the 
license application, or by NRC, such as the Site Characterization 
Analysis, and the Safety Evaluation Report, shall be made available in 
electronic form by the respective agency that generated the document.
    (c) The participation of the host State in the pre-license 
application phase shall not affect the State's ability to exercise its 
disapproval rights under section 116(b)(2) of the Nuclear Waste Policy 
Act, as amended, 42 U.S.C. 10136(b)(2).
    (d) This subpart shall not affect any independent right of a 
potential party,

[[Page 127]]

interested governmental participant or party to receive information.
    (e) Each potential party, interested governmental participant or 
party shall continue to supplement its documentary material made 
available to other participants via the LSN with any additional material 
created after the time of its initial certification in accordance with 
paragraph (a)(1) through (a)(4) of this section until the discovery 
period in the proceeding has concluded.

[63 FR 71737, Dec. 30, 1998, as amended at 66 FR 29465, May 31, 2001; 69 
FR 2264, Jan. 14, 2004; 69 FR 32848, June 14, 2004; 73 FR 63569, Oct. 
24, 2008]



Sec.2.1004  Amendments and additions.

    Any document that has not been provided to other parties in 
electronic form must be identified in an electronic notice and made 
available for inspection and copying by the potential party, interested 
governmental participant, or party responsible for the submission of the 
document within five days after it has been requested unless some other 
time is approved by the Pre-License Application Presiding Officer or the 
Presiding Officer designated for the high-level waste proceeding. The 
time allowed under this paragraph will be stayed pending Officer action 
on a motion to extend the time.

[63 FR 71737, Dec. 30, 1998]



Sec.2.1005  Exclusions.

    The following material is excluded from the requirement to provide 
electronic access, either pursuant to Sec.2.1003, or through 
derivative discovery pursuant to Sec.2.1019(i)--
    (a) Official notice materials;
    (b) Reference books and text books;
    (c) Material pertaining exclusively to administration, such as 
material related to budgets, financial management, personnel, office 
space, general distribution memoranda, or procurement, except for the 
scope of work on a procurement related to repository siting, 
construction, or operation, or to the transportation of spent nuclear 
fuel or high-level waste;
    (d) Press clippings and press releases;
    (e) Junk mail;
    (f) References cited in contractor reports that are readily 
available;
    (g) Classified material subject to subpart I of this part;
    (h) Readily available references, such as journal articles and 
proceedings, which may be subject to copyright.
    (i) Correspondence between a potential party, interested 
governmental participant, or party and the Congress of the United 
States.

[63 FR 71738, Dec. 30, 1998, as amended at 69 FR 32848, June 14, 2004]



Sec.2.1006  Privilege.

    (a) Subject to the requirements in Sec.2.1003(a)(4), the 
traditional discovery privileges recognized in NRC adjudicatory 
proceedings and the exceptions from disclosure in Sec.2.390 may be 
asserted by potential parties, interested States, local governmental 
bodies, Federally-recognized Indian Tribes, and parties. In addition to 
Federal agencies, the deliberative process privilege may also be 
asserted by States, local governmental bodies, and Federally-recognized 
Indian Tribes.
    (b) Any document for which a claim of privilege is asserted, but is 
denied in whole or in part by the Pre-License Application Presiding 
Officer or the Presiding Officer, must be provided in electronic form by 
the party, interested governmental participant, or potential party that 
asserted the claim to--
    (1) The other participants; or
    (2) To the Pre-License Application Presiding Officer or to the 
Presiding Officer, for entry into a Protective Order file, if the Pre-
License Application Presiding Officer or the Presiding Officer so 
directs under Sec. Sec.2.1010(b) or 2.1018(c).
    (c) Notwithstanding any availability of the deliberative process 
privilege under paragraph (a) of this section, circulated drafts not 
otherwise privileged shall be provided for electronic access pursuant to 
Sec.2.1003(a).

[63 FR 71738, Dec. 30, 1998; 64 FR 15920, Apr. 2, 1999, as amended at 69 
FR 2265, Jan. 14, 2004]

[[Page 128]]



Sec.2.1007  Access.

    (a)(1) A system to provide electronic access to the Licensing 
Support Network shall be provided at the headquarters of DOE, and at all 
DOE Local Public Document Rooms established in the vicinity of the 
likely candidate site for a geologic repository, beginning in the pre-
license application phase.
    (2) A system to provide electronic access to the Licensing Support 
Network shall be provided at the NRC Web site, http://www.nrc.gov, and/
or at the NRC Public Document Room beginning in the pre-license 
application phase.
    (3) [Reserved]
    (b) Public availability of paper and electronic copies of the 
records of NRC and DOE, as well as duplication fees, and fee waiver for 
those records, is governed by the regulations of the respective 
agencies.

[63 FR 71738, Dec. 30, 1998, as amended at 64 FR 48949, Sept. 9, 1999]



Sec.2.1008  [Reserved]



Sec.2.1009  Procedures.

    (a) Each potential party, interested governmental participant, or 
party shall--
    (1) Designate an official who will be responsible for administration 
of its responsibility to provide electronic files of documentary 
material ;
    (2) Establish procedures to implement the requirements in Sec.
2.1003;
    (3) Provide training to its staff on the procedures for 
implementation of the responsibility to provide electronic files of 
documentary material;
    (4) Ensure that all documents carry the submitter's unique 
identification number;
    (5) Cooperate with the advisory review process established by the 
NRC under Sec.2.1011(d).
    (b) The responsible official designated under paragraph (a)(1) of 
this section shall certify to the Pre-License Application Presiding 
Officer that the procedures specified in paragraph (a)(2) of this 
section have been implemented, and that to the best of his or her 
knowledge, the documentary material specified in Sec.2.1003 has been 
identified and made electronically available. The initial certification 
must be made at the time the participant is required to comply with 
Sec.2.1003. The responsible official for the DOE shall also update 
this certification at the time DOE submits the license application.

[63 FR 71738, Dec. 30, 1998, as amended at 66 FR 29466, May 31, 2001]



Sec.2.1010  Pre-License Application Presiding Officer.

    (a)(1) The Commission may designate one or more members of the 
Commission, or an atomic safety and licensing board, or a named officer 
who has been delegated final authority on the matter to serve as the 
Pre-License Application Presiding Officer to rule on disputes over the 
electronic availability of documents during the pre-license application 
phase, including disputes relating to privilege, and disputes relating 
to the implementation of the recommendations of the Advisory Review 
Panel established under Sec.2.1011(d).
    (2) The Pre-License Application Presiding Officer shall be 
designated at such time during the pre-license application phase as the 
Commission finds it appropriate, but in any event no later than fifteen 
days after the DOE certification of initial compliance under Sec.
2.1009(b).
    (b) The Pre-License Application Presiding Officer shall rule on any 
claim of document withholding to determine--
    (1) Whether it is documentary material within the scope of this 
subpart;
    (2) Whether the material is excluded under Sec.2.1005;
    (3) Whether the material is privileged or otherwise excepted from 
disclosure under Sec.2.1006;
    (4) If privileged, whether it is an absolute or qualified privilege;
    (5) If qualified, whether the document should be disclosed because 
it is necessary to a proper decision in the proceeding;
    (6) Whether the material should be disclosed under a protective 
order containing such protective terms and conditions (including 
affidavits of nondisclosure) as may be necessary and appropriate to 
limit the disclosure to potential parties, interested governmental 
participants, and parties in the proceeding, or to their qualified 
witnesses and counsel.

[[Page 129]]

    (i) The Pre-License Application Presiding Officer may issue an order 
requiring disclosure of Safeguards Information if--
    (A) The Pre-License Application Presiding Officer finds that the 
individual seeking access to Safeguards Information in order to 
participate in an NRC adjudication has the requisite ``need to know,'' 
as defined in 10 CFR 73.2;
    (B) The individual has undergone an FBI criminal history records 
check, unless exempt under 10 CFR 73.22(b)(3) or 73.23(b)(3), as 
applicable, by submitting fingerprints to the NRC Office of 
Administration, Security Processing Unit, Mail Stop T-6E46, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, and otherwise 
following the procedures in 10 CFR 73.57(d) for submitting and 
processing fingerprints. However, before a final adverse determination 
by the NRC Office of Administration on an individual's criminal history 
records check is made, the individual shall be afforded the protections 
provided by 10 CFR 73.57; and
    (C) The NRC Office of Administration has found, based upon a 
background check, that the individual is trustworthy and reliable, 
unless exempt under 10 CFR 73.22(b)(3) or 73.23(b)(3), as applicable. In 
addition to the protections provided by 10 CFR 73.57 for adverse 
determinations based on criminal history records checks, the Office of 
Administration must take the following actions before making a final 
adverse determination on an individual's background check for 
trustworthiness and reliability. The Office of Administration will:
    (1) For the purpose of assuring correct and complete information, 
provide to the individual any records, in addition to those required to 
be provided under 10 CFR 73.57(e)(1), that were considered in the 
trustworthiness and reliability determination;
    (2) Resolve any challenge by the individual to the completeness or 
accuracy of the records described in Sec.2.1010(b)(6)(i)(C)(1). The 
individual may make this challenge by submitting information and/or an 
explanation to the Office of Administration. The challenge must be 
submitted within 10 days of the distribution of the records described in 
Sec.2.1010(b)(6)(i)(C)(1), and the Office of Administration must 
promptly resolve any challenge.
    (D) Individuals seeking access to Safeguards Information to 
participate in an NRC adjudication for whom the NRC Office of 
Administration has made a final adverse determination on trustworthiness 
and reliability may submit a request to the Chief Administrative Judge 
for review of the adverse determination. Upon receiving such a request, 
the Chief Administrative Judge shall designate an officer other than the 
Pre-License Application Presiding Officer to review the adverse 
determination. For purposes of review, the adverse determination must be 
in writing and set forth the grounds for the determination. The request 
for review shall be served on the NRC staff and may include additional 
information for review by the designated officer. The request must be 
filed within 15 days after receipt of the adverse determination by the 
person against whom the adverse determination has been made. Within 10 
days of receipt of the request for review and any additional 
information, the NRC staff will file a response indicating whether the 
request and additional information has caused the NRC Office of 
Administration to reverse its adverse determination. The designated 
officer may reverse the Office of Administration's final adverse 
determination only if the officer finds, based on all the information 
submitted, that the adverse determination constitutes an abuse of 
discretion. The designated officer's decision must be rendered within 15 
days after receipt of the staff filing indicating that the request for 
review and additional information has not changed the NRC Office of 
Administration's adverse determination.
    (ii) The Pre-License Application Presiding Officer may include in an 
order any protective terms and conditions (including affidavits of 
nondisclosure) as may be necessary and appropriate to prevent the 
unauthorized disclosure of Safeguards Information.
    (iii) When Safeguards Information, protected from disclosure under 
Section 147 of the Atomic Energy Act of 1954, as amended, is received 
and possessed by a potential party, interested government participant, 
or party,

[[Page 130]]

other than the NRC staff, it shall also be protected according to the 
requirements of Sec.73.21 and the requirements of Sec. Sec.73.22 or 
73.23 of this chapter, as applicable.
    (iv) The Pre-License Application Presiding Officer may also 
prescribe such additional procedures as will effectively safeguard and 
prevent disclosure of Safeguards Information to unauthorized persons 
with minimum impairment of the procedural rights which would be 
available if Safeguards Information were not involved.
    (v) In addition to any other sanction that may be imposed by the 
Pre-License Application Presiding Officer for violation of a provision 
for the protection of Safeguards Information from unauthorized 
disclosure that is contained in an order, the entity in violation may be 
subject to a civil penalty imposed pursuant to Sec.2.205.
    (vi) For the purpose of imposing the criminal penalties contained in 
Section 223 of the Atomic Energy Act of 1954, as amended, a provision 
for the protection of Safeguards Information from unauthorized 
disclosure that is contained in an order issued pursuant to this 
paragraph is considered to be issued under Section 161b of the Atomic 
Energy Act of 1954, as amended.
    (c) Upon a final determination that the material is relevant, and 
not privileged, exempt from disclosure, or otherwise exempt from 
production under Sec.2.1005, the potential party, interested 
governmental participant, or party who asserted the claim of withholding 
must make the document available in accordance with the provisions of 
this subpart within five days.
    (d) The service of all pleadings and answers, orders, and decisions 
during the pre-license application phase shall be made according to the 
procedures specified in Sec.2.1013(c) and entered into the pre-license 
application electronic docket.
    (e) The Pre-License Application presiding officer possesses all the 
general powers specified in Sec. Sec.2.319 and 2.321(c).
    (f) The Commission, in designating the Pre-License Application 
Presiding Officer in accordance with paragraphs (a) (1) and (2) of this 
section, shall specify the jurisdiction of the Officer.

[63 FR 71738, Dec. 30, 1998, as amended at 66 FR 29466, May 31, 2001; 69 
FR 2265, Jan. 14, 2004; 73 FR 63569, Oct. 24, 2008]



Sec.2.1011  Management of electronic information.

    (a) Electronic document production and the electronic docket are 
subject to the provisions of this subpart.
    (b)(1) The NRC, DOE, parties, and potential parties participating in 
accordance with the provision of this subpart shall be responsible for 
obtaining the computer system necessary to comply with the requirements 
for electronic document production and service.
    (2) The NRC, DOE, parties, and potential parties participating in 
accordance with the provision of this subpart shall comply with the 
following standards in the design of the computer systems necessary to 
comply with the requirements for electronic document production and 
service:
    (i) The participants shall make textual (or, where non-text, image) 
versions of their documents available on a web accessible server which 
is able to be canvassed by web indexing software (i.e., a ``robot'', 
``spider'', ``crawler'') and the participant system must make both data 
files and log files accessible to this software.
    (ii) The participants shall make bibliographic header data available 
in an HTTP (Hypertext Transfer Protocol) accessible, ODBC (Open Database 
Connectivity) and SQL (Structured Query Language)-compliant (ANSI 
IX3.135-1992/ISO 9075-1992) database management system (DBMS). 
Alternatively, the structured data containing the bibliographic header 
may be made available in a standard database readable (e.g., XML 
(Extensible Markup Language http://www.w3.org/xml/), comma delimited, or 
comma separated value (.csv)) file.
    (iii) Textual material must be formatted to comply with the ISO/IEC 
8859-1 character set and be in one of the following acceptable formats: 
ASCII, native word processing (Word, WordPerfect), PDF Normal, or HTML.
    (iv) Image files must be formatted as TIFF CCITT G4 for bi-tonal 
images or PNG (Portable Network Graphics) per

[[Page 131]]

[http://www.w3.org/TR/REC-png-multi.html]) format for grey-scale or 
color images, or PDF (Portable Document Format--Image). TIFF, PDF, or 
PNG images will be stored at 300 dpi (dots per inch) or greater, grey 
scale images at 150 dpi or greater with eight bits of tonal depth, and 
color images at 150 dpi or greater with 24 bits of color depth. Images 
found on participant machines will be stored as single image-per-page to 
facilitate retrieval of no more than a single page, or alternatively, 
images may be stored in an image-per-document format if software is 
incorporated in the web server that allows image-per-page representation 
and delivery.
    (v) The participants shall programmatically link, preferably via 
hyperlink or some other automated process, the bibliographic header 
record with the text or image file it represents. Each participant's 
system must afford the LSN software enough information to allow a text 
or image file to be identified to the bibliographic data that describes 
it.
    (vi) To facilitate data exchange, participants shall adhere to 
hardware and software standards, including, but not limited to:
    (A) Network access must be HTTP/1.1 [http://www.faqs.org/rfcs/
rfc2068.html] over TCP (Transmission Control Protocol, [http://
www.faqs.org/rfcs/rfc793.html]) over IP (Internet Protocol, [http://
www.faqs.org/rfcs/rfc791.html]).
    (B) Associating server names with IP addresses must follow the DNS 
(Domain Name System), [http://www.faqs.org/rfcs/rfc1034.html] and 
[http://www.faqs.org/rfcs/rfc1035.html].
    (C) Web page construction must be HTML [http://www.w3.org/TR/REC-
html40/].
    (D) Electronic mail (e-mail) exchange between e-mail servers must be 
SMTP (Simple Mail Transport Protocol, [http://www.faqs.org/rfcs/
rfc821.html]).
    (E) Format of an electronic mail message must be per [http://
www.faqs.org/rfcs/rfc822.html] optionally extended by MIME (Multipurpose 
Internet Mail Extensions) per [http://www.faqs.org/rfcs/rfc2045.html]) 
to accommodate multipurpose e-mail.
    (c) The Licensing Support Network shall be coordinated by the LSN 
Administrator, who shall be designated before the start of the pre-
license application phase. The LSN Administrator shall have the 
responsibility to--
    (1) Identify technical and policy issues related to implementation 
of the LSN for LSN Advisory Review Panel and Commission consideration;
    (2) Address the consensus advice of the LSN Advisory Review Panel 
under paragraph (e)(1) of this section that is consistent with the 
requirements of this subpart;
    (3) Identify any problems experienced by participants regarding LSN 
availability, including the availability of individual participant's 
data, and provide a recommendation to resolve any such problems to the 
participant(s) and the Pre-License Application Presiding Officer 
relative to the resolution of any disputes regarding LSN availability, 
including disputes on the availability of an individual participant's 
data;
    (4) Identify any problems regarding the integrity of documentary 
material certified in accordance with Sec.2.1009(b) by the 
participants to be in the LSN, and provide a recommendation to resolve 
any such problems to the participant(s) and the Pre-License Application 
Presiding Officer relative to the resolution of any disputes regarding 
the integrity of documentary material;
    (5) Provide periodic reports to the Commission on the status of LSN 
functionality and operability.
    (6) Evaluate LSN participant compliance with the basic design 
standards in paragraph (b)(2) of this section, and provide for 
individual variances from the design standards to accommodate changes in 
technology or problems identified during initial operability testing of 
the individual documentary collection websites or the ``central LSN 
site''.
    (7) Issue guidance for LSN participants on how best to comply with 
the design standards in paragraph (b)(2) of this section.
    (d) The Secretary of the Commission shall reconstitute the LSS 
Advisory Review Panel as the LSN Advisory Review Panel, composed of the 
interests currently represented on the LSS Advisory Review Panel. The 
Secretary of

[[Page 132]]

the Commission shall have the authority to appoint additional 
representatives to the LSN Advisory Review Panel consistent with the 
requirements of the Federal Advisory Committee Act, 5 U.S.C. app. I, 
giving particular consideration to potential parties, parties, and 
interested governmental participants who were not members of the NRC HLW 
Licensing Support System Advisory Review Panel.
    (e)(1) The LSN Advisory Review Panel shall provide advice to--
    (i) NRC on the fundamental issues of the type of computer system 
necessary to access the Licensing Support Network effectively under 
paragraph (b) of this section; and
    (ii) The Secretary of the Commission on the operation and 
maintenance of the electronic docket established for the HLW geologic 
repository licensing proceeding under the Commission's Rules of Practice 
(10 CFR part 2).
    (iii) The LSN Administrator on solutions to improve the functioning 
of the LSN;
    (2) The responsibilities of the LSN Advisory Review Panel shall 
include advice on--
    (i) Format standards for providing electronic access to the 
documentary material certified by each participant to be made available 
in the LSN to the other parties, interested governmental participants, 
or potential parties;
    (ii) The procedures and standards for the electronic transmission of 
filings, orders, and decisions during both the pre-license application 
phase and the high-level waste licensing proceeding;
    (iii) Other duties as specified in this subpart or as directed by 
the Secretary of the Commission.

[63 FR 71739, Dec. 30, 1998, as amended at 66 FR 29466, May 31, 2001]



Sec.2.1012  Compliance.

    (a) If the Department of Energy fails to make its initial 
certification at least six months prior to tendering the application, 
upon receipt of the tendered application, notwithstanding the provisions 
of Sec.2.101(f)(3), the Director of the NRC's Office of Nuclear 
Material Safety and Safeguards will not docket the application until at 
least six months have elapsed from the time of the certification. The 
Director may determine that the tendered application is not acceptable 
for docketing under this subpart if the application is not accompanied 
by an updated certification pursuant to Sec.2.1009(b), or if the 
Secretary of the Commission determines that the application is not 
submitted on optical storage media in a format consistent with NRC 
regulations and guidance, or for non-compliance with any other 
requirements identified in this subpart.
    (b)(1) A person, including a potential party given access to the 
Licensing Support Network under this subpart, may not be granted party 
status under Sec.2.309, or status as an interested governmental 
participant under Sec.2.315, if it cannot demonstrate substantial and 
timely compliance with the requirements of Sec.2.1003 at the time it 
requests participation in the HLW licensing proceeding under Sec.2.309 
or Sec.2.315.
    (2) A person denied party status or interested governmental 
participant status under paragraph (b)(1) of this section may request 
party status or interested governmental participant status upon a 
showing of subsequent compliance with the requirements of Sec.2.1003. 
Admission of such a party or interested governmental participant under 
Sec. Sec.2.309 or 2.315, respectively, is conditioned on accepting the 
status of the proceeding at the time of admission.
    (c) The Presiding Officer shall not make a finding of substantial 
and timely compliance pursuant to paragraph (b) of this section for any 
person who is not in compliance with all applicable orders of the Pre-
License Application Presiding Officer designated pursuant to Sec.
2.1010.

[54 FR 14944, Apr. 14, 1989, as amended at 56 FR 7796, Feb. 26, 1991; 63 
FR 71739, Dec. 30, 1998; 66 FR 29466, May 31, 2001; 69 FR 2265, Jan. 14, 
2004; 69 FR 32848, June 14, 2004]



Sec.2.1013  Use of the electronic docket during the proceeding.

    (a)(1) As specified in Sec.2.303, the Secretary of the Commission 
will maintain the official docket of the proceeding on the application 
for construction authorization for a high-level radioactive waste 
repository at a geologic repository operations area under parts 60 or 63 
of this chapter, and for

[[Page 133]]

applications for a license to receive and possess high level radioactive 
waste at a geologic repository operations area under parts 60 or 63 of 
this Chapter.
    (2) The Secretary of the Commission will establish an electronic 
docket to contain the official record materials of the high-level 
radioactive waste repository licensing proceeding in searchable full 
text, or, for material that is not suitable for entry in searchable full 
text, by header and image, as appropriate.
    (b) Absent good cause, all exhibits tendered during the hearing must 
have been made available to the parties in electronic form before the 
commencement of that portion of the hearing in which the exhibit will be 
offered. The electronic docket will contain a list of all exhibits, 
showing where in the transcript each was marked for identification and 
where it was received into evidence or rejected. For any hearing 
sessions recorded stenographically or by other means, transcripts will 
be entered into the electronic docket on a daily basis in order to 
afford next-day availability at the hearing. However, for any hearing 
sessions recorded on videotape or other video medium, if a copy of the 
video recording is made available to all parties on a daily basis that 
affords next-day availability at the hearing, a transcript of the 
session prepared from the video recording will be entered into the 
electronic docket within twenty-four (24) hours of the time the 
transcript is tendered to the electronic docket by the transcription 
service.
    (c)(1) All filings in the adjudicatory proceeding on the application 
for a high-level radioactive waste geologic repository under part 60 or 
63 of this chapter shall be transmitted by the submitter to the 
Presiding Officer, parties, and Secretary of the Commission, according 
to the following requirements--
    (i) ``Simple documents'' must be transmitted electronically via EIE;
    (ii) ``Large documents'' must be transmitted electronically in 
multiple transmissions of 50 megabytes or less each via EIE;
    (iii) ``Complex documents'':
    (A) Those portions that can be electronically submitted through the 
EIE, in 50 MB or less segments, must be transmitted electronically, 
along with a transmittal letter; and
    (B) Those portions that are not capable of being transmitted 
electronically must be submitted on optical storage media which must 
also include those portions of the document that had been or will be 
transmitted electronically.
    (iv) Electronic submissions must have the following resolution--
    (A) Electronic submissions of files created after January 1, 2004 
must have 300 dots per inch (dpi) as the minimum resolution for bi-
tonal, color, and grayscale, except in limited circumstances where 
submitters may need to use an image scanned before January 1, 2004, in a 
document created after January 1, 2004, or the scanning process for a 
large, one-page image may not successfully complete at the 300 dpi 
standard resolution.
    (B) Electronic submissions of files created before January 1, 2004, 
or electronic submissions created after January 1, 2004, which cannot 
meet the 300 dpi standard for color and grayscale, must meet the 
standard for documents placed on LSN participant Web sites in Sec.
2.1011(b)(2)(iv) of this subpart, which is 150 dpi for color and 
grayscale documents and 300 dpi for bi-tonal documents.
    (v) Electronic submissions must be generated in the appropriate PDF 
output format by using:
    (A) PDF--Formatted Text and Graphics for textual documents converted 
from native applications;
    (B) PDF--Searchable Image (Exact) for textual documents converted 
from scanned documents; and
    (C) PDF--Image Only for graphic-, image-, and forms-oriented 
documents. In addition, Tagged Image File Format (TIFF) images and the 
results of spreadsheet applications must to be converted to PDF, except 
in those rare instances where PDF conversion is not practicable.
    (vi) Electronic submissions must not rely on hyperlinks to other 
documents or Web sites for completeness or access except for hyperlinks 
that link to material within the same PDF file. If the submittal 
contains hyperlinks to other

[[Page 134]]

documents or Web sites, then it must include a disclaimer to the effect 
that the hyperlinks may be inoperable or are not essential to the use of 
the filing. Information contained in hyperlinks to a Web site on the 
Internet or to another PDF file, that is necessary for the completeness 
of a filing, must be submitted in its entirety in the filing or as an 
attachment to the filing.
    (vii) All electronic submissions must be free of author-imposed 
security restrictions.
    (2) Filings required to be served shall be served upon either the 
parties and interested governmental participants, or their designated 
representatives. When a party or interested governmental participant has 
appeared by attorney, service must be made upon the attorney of record.
    (3) Service upon a party or interested governmental participant is 
completed when the sender receives electronic acknowledgment (``delivery 
receipt'') that the electronic submission has been placed in the 
recipient's electronic mailbox.
    (4) Proof of service, stating the name and address of the person on 
whom served and the manner and date of service, shall be shown for each 
document filed, by--
    (i) Electronic acknowledgment (``delivery receipt'');
    (ii) The affidavit of the person making the service; or
    (iii) The certificate of counsel.
    (5) All Presiding Officer and Commission issuances and orders will 
be transmitted electronically to the parties and interested governmental 
participants.
    (d) Online access to the electronic docket, including a Protective 
Order File if authorized by a Presiding Officer, shall be provided to 
the Presiding Officer, the representatives of the parties and interested 
governmental participants, and the witnesses while testifying, for use 
during the hearing. Use of paper copy and other images will also be 
permitted at the hearing.

[63 FR 71739, Dec. 30, 1998, as amended at 66 FR 55788, Nov. 2, 2001; 69 
FR 2265, Jan. 14, 2004; 69 FR 32849, June 14, 2004]



Sec.2.1015  Appeals.

    (a) No appeals from any Pre-License Application Presiding Officer or 
Presiding Officer order or decision issued under this subpart are 
permitted, except as prescribed in paragraphs (b), (c), and (d) of this 
section.
    (b) A notice of appeal from a Pre-License Application presiding 
officer order issued under Sec.2.1010, a presiding officer prehearing 
conference order issued under Sec.2.1021, a presiding officer order 
granting or denying a motion for summary disposition issued in 
accordance with Sec.2.1025, or a presiding officer order granting or 
denying a petition to amend one or more contentions under Sec.2.309, 
must be filed with the Commission no later than ten (10) days after 
service of the order. A supporting brief must accompany the notice of 
appeal. Any other party, interested governmental participant, or 
potential party may file a brief in opposition to the appeal no later 
than ten (10) days after service of the appeal.
    (c) Appeals from a Presiding Officer initial decision or partial 
initial decision must be filed and briefed before the Commission in 
accordance with the following requirements.
    (1) Notice of appeal. Within ten (10) days after service of an 
initial decision, any party may take an appeal to the Commission by 
filing a notice of appeal. The notice shall specify:
    (i) The party taking the appeal; and
    (ii) The decision being appealed.
    (2) Filing appellant's brief. Each appellant shall file a brief 
supporting its position on appeal within thirty (30) days (40 days if 
Commission staff is the appellant) after the filing of notice required 
by paragraph (a) of this section.
    (3) Filing responsive brief. Any party who is not an appellant may 
file a brief in support of or in opposition to the appeal within thirty 
(30) days after the period has expired for the filing and service of the 
brief of all appellants. Commission staff may file a responsive brief 
within forty (40) days after the period has expired for the filing and 
service of the briefs of all appellants. A responding party shall file a 
single responsive brief regardless of the number of appellants' briefs 
filed.
    (4) Brief content. A brief in excess of ten (10) pages must contain 
a table of

[[Page 135]]

contents, with page references, and a table of cases (alphabetically 
arranged), statutes, regulations, and other authorities cited, with 
references to the pages of the brief where they are cited.
    (i) An appellant's brief must clearly identify the errors of fact or 
law that are the subject of the appeal. An intervenor-appellant's brief 
must be confined to issues which the intervenor-appellant placed in 
controversy or sought to place in controversy in the proceeding. For 
each issue appealed, the precise portion of the record relied upon in 
support of the assertion of error must also be provided.
    (ii) Each responsive brief must contain a reference to the precise 
portion of the record which supports each factual assertion made.
    (5) Brief length. A party shall not file a brief in excess of 
seventy (70) pages in length, exclusive of pages containing the table of 
contents, table of citations and any addendum containing statutes, 
rules, regulations, etc. A party may request an increase of this page 
limit for good cause. Such a request shall be made by motion submitted 
at least seven (7) days before the date upon which the brief is due for 
filing and shall specify the enlargement requested.
    (6) Certificate of service. All documents filed under this section 
must be accompanied by a certificate reflecting service upon all other 
parties to the proceeding.
    (7) Failure to comply. A brief which in form or content is not in 
substantial compliance with the provisions of this section may be 
stricken, either on motion of a party or by the Commission on its own 
initiative.
    (d) When, in the judgment of a Pre-License Application presiding 
officer or presiding officer, prompt appellate review of an order not 
immediately appealable under paragraph (b) of this section is necessary 
to prevent detriment to the public interest or unusual delay or expense, 
the Pre-License Application presiding officer or presiding officer may 
refer the ruling promptly to the Commission, and shall provide notice of 
this referral to the parties, interested governmental participants, or 
potential parties. The parties, interested governmental participants, or 
potential parties may also request that the Pre-License Application 
presiding officer or presiding officer certify under Sec.2.319 rulings 
not immediately appealable under paragraph (b) of this section.
    (e) Unless otherwise ordered, the filing of an appeal, petition for 
review, referral, or request for certification of a ruling shall not 
stay the proceeding or extend the time for the performance of any act.

[56 FR 7797, Feb. 26, 1991, as amended at 56 FR 29410, June 27, 1991; 69 
FR 2265, Jan. 14, 2004]



Sec.2.1017  Computation of time.

    In computing any period of time, the day of the act, event, or 
default after which the designated period of time begins to run is not 
included. The last day of the period so computed is included unless it 
is a Saturday, Sunday, or legal holiday at the place where the action or 
event is to occur, in which event the period runs until the end of the 
next day which is neither a Saturday, Sunday, nor holiday. Whenever a 
party, potential party, or interested governmental participant, has the 
right or is required to do some act within a prescribed period after the 
service of a notice or other document upon it, one day shall be added to 
the prescribed period. If the electronic docket is unavailable for more 
than four access hours of any day that would be counted in the 
computation of time, that day will not be counted in the computation of 
time.

[63 FR 71740, Dec. 30, 1998]



Sec.2.1018  Discovery.

    (a)(1) Parties, potential parties, and interested governmental 
participants in the high-level waste licensing proceeding may obtain 
discovery by one or more of the following methods:
    (i) Access to the documentary material made available pursuant to 
Sec.2.1003;
    (ii) Entry upon land for inspection, access to raw data, or other 
purposes pursuant to Sec.2.1020;
    (iii) Access to, or the production of, copies of documentary 
material for which bibliographic headers only have been submitted 
pursuant to Sec.2.1003(a);

[[Page 136]]

    (iv) Depositions upon oral examination pursuant to Sec.2.1019;
    (v) Requests for admissions pursuant to Sec.2.708;
    (vi) Informal requests for information not made electronically 
available, such as the names of witnesses and the subjects they plan to 
address; and
    (vii) Interrogatories and depositions upon written questions, as 
provided in paragraph (a)(2) of this section.
    (2) Interrogatories and depositions upon written questions may be 
authorized by order of the discovery master appointed under paragraph 
(g) of this section, or if no discovery master has been appointed, by 
order of the Presiding Officer, in the event that the parties are 
unable, after informal good faith efforts, to resolve a dispute in a 
timely fashion concerning the production of information.
    (b)(1) Parties, potential parties, and interested governmental 
participants, pursuant to the methods set forth in paragraph (a) of this 
section, may obtain discovery regarding any matter, not privileged, 
which is relevant to the licensing of the likely candidate site for a 
geologic repository, whether it relates to the claim or defense of the 
person seeking discovery or to the claim or defense of any other person. 
Except for discovery pursuant to Sec. Sec.2.1018(a)(2) and 2.1019 of 
this subpart, all other discovery shall begin during the pre-license 
application phase. Discovery pursuant to Sec. Sec.2.1018(a)(2) and 
2.1019 of this subpart shall begin after the issuance of the first pre-
hearing conference order under Sec.2.1021 of this subpart, and shall 
be limited to the issues defined in that order or subsequent amendments 
to the order. It is not ground for objection that the information sought 
will be inadmissible at the hearing if the information sought appears 
reasonably calculated to lead to the discovery of admissible evidence.
    (2) A party, potential party, or interested governmental participant 
may obtain discovery of documentary material otherwise discoverable 
under paragraph (b)(1) of this section and prepared in anticipation of, 
or for the hearing by, or for another party's, potential party's, or 
interested governmental participant's representative (including its 
attorney, surety, indemnitor, insurer, or similar agent) only upon a 
showing that the party, potential party, or interested governmental 
participant seeking discovery has substantial need of the materials in 
the preparation of its case and that it is unable without undue hardship 
to obtain the substantial equivalent of the materials by other means. In 
ordering discovery of these materials when the required showing has been 
made, the Presiding Officer shall protect against disclosure of the 
mental impressions, conclusions, opinions, or legal theories of an 
attorney or other representative of a party, potential party, or 
interested governmental participant concerning the proceeding.
    (c)(1) Upon motion by a party, potential party, interested 
governmental participant, or the person from whom discovery is sought, 
and for good cause shown, the presiding officer may make any order that 
justice requires to protect a party, potential party, interested 
governmental participant, or other person from annoyance, embarrassment, 
oppression, or undue burden, delay, or expense, including one or more of 
the following:
    (i) That the discovery not be had;
    (ii) That the discovery may be had only on specified terms and 
conditions, including a designation of the time or place;
    (iii) That the discovery may be had only by a method of discovery 
other than that selected by the party, potential party, or interested 
governmental participant seeking discovery;
    (iv) That certain matters not be inquired into, or that the scope of 
discovery be limited to certain matters;
    (v) That discovery be conducted with no one present except persons 
designated by the presiding officer;
    (vi) That, subject to the provisions of Sec.2.390 of this part, a 
trade secret or other confidential research, development, or commercial 
information not be disclosed or be disclosed only in a designated way; 
or
    (vii) That studies and evaluations not be prepared.
    (2) If the motion for a protective order is denied in whole or in 
part, the presiding officer may, on such terms and conditions as are 
just, order that any party, potential party, interested

[[Page 137]]

governmental participant or other person provide or permit discovery.
    (d) Except as provided in paragraph (b) of this section, and unless 
the Presiding Officer upon motion, for the convenience of parties, 
potential parties, interested governmental participants, and witnesses 
and in the interest of justice, orders otherwise, methods of discovery 
may be used in any sequence, and the fact that a party, potential party, 
or interested governmental participant is conducting discovery, whether 
by deposition or otherwise, shall not operate to delay any other 
party's, potential party's, or interested governmental participant's 
discovery.
    (e) A party, potential party, or interested governmental participant 
who has made available in electronic form all material relevant to any 
discovery request or who has responded to a request for discovery with a 
response that was complete when made is under no duty to supplement its 
response to include information thereafter acquired, except as follows:
    (1) To the extent that written interrogatories are authorized 
pursuant to paragraph (a)(2) of this section, a party or interested 
governmental participant is under a duty to seasonably supplement its 
response to any question directly addressed to (i) the identity and 
location of persons having knowledge of discoverable matters, and (ii) 
the identity of each person expected to be called as an expert witness 
at the hearing, the subject matter on which the witness is expected to 
testify, and the substance of the witness' testimony.
    (2) A party, potential party, or interested governmental participant 
is under a duty seasonably to amend a prior response if it obtains 
information upon the basis of which (i) it knows that the response was 
incorrect when made, or (ii) it knows that the response though correct 
when made is no longer true and the circumstances are such that a 
failure to amend the response is in substance a knowing concealment.
    (3) A duty to supplement responses may be imposed by order of the 
Presiding Officer or agreement of the parties, potential parties, and 
interested governmental participants.
    (f)(1) If a deponent of a party, potential party, or interested 
governmental participant upon whom a request for discovery is served 
fails to respond or objects to the request, or any part thereof, the 
party, potential party, or interested governmental participant 
submitting the request or taking the deposition may move the Presiding 
Officer, within five days after the date of the response or after 
failure to respond to the request, for an order compelling a response in 
accordance with the request. The motion shall set forth the nature of 
the questions or the request, the response or objection of the party, 
potential party, interested governmental participant, or other person 
upon whom the request was served, and arguments in support of the 
motion. For purposes of this paragraph, an evasive or incomplete answer 
or response shall be treated as a failure to answer or respond. Failure 
to answer or respond shall not be excused on the ground that the 
discovery sought is objectionable unless the person, party, potential 
party, or interested governmental participant failing to answer or 
respond has applied for a protective order pursuant to paragraph (c) of 
this section.
    (2) In ruling on a motion made pursuant to this section, the 
Presiding Officer may make such a protective order as it is authorized 
to make on a motion made pursuant to paragraph (c) of this section.
    (3) An independent request for issuance of a subpoena may be 
directed to a nonparty for production of documents. This section does 
not apply to requests for the testimony of the NRC regulatory staff 
under Sec.2.709.
    (g) The presiding officer, under Sec.2.322, may appoint a 
discovery master to resolve disputes between parties concerning informal 
requests for information as provided in paragraphs (a)(1) and (a)(2) of 
this section.
    (h) Discovery under this section of documentary material including 
Safeguards Information referred to in Sections 147 and 181 of the Atomic 
Energy Act of 1954, as amended, will be according to the provisions in 
Sec.2.1010(b)(6)(i) through (b)(6)(vi).

[54 FR 14944, Apr. 14, 1989, as amended at 56 FR 7797, Feb. 26, 1991; 63 
FR 71740, Dec. 30, 1998; 69 FR 2266, Jan. 14, 2004; 73 FR 63570, Oct. 
24, 2008]

[[Page 138]]



Sec.2.1019  Depositions.

    (a) Any party or interested governmental participant desiring to 
take the testimony of any person by deposition on oral examination 
shall, without leave of the Commission or the Presiding Officer, give 
reasonable notice in writing to every other party and interested 
governmental participant, to the person to be examined, and to the 
Presiding Officer of the proposed time and place of taking the 
deposition; the name and address of each person to be examined, if 
known, or if the name is not known, a general description sufficient to 
identify him or her or the class or group to which he or she belongs, 
the matters upon which each person will be examined and the name or 
descriptive title and address of the officer before whom the deposition 
is to be taken.
    (b) Within the United States, a deposition may be taken before any 
officer authorized to administer oaths by the laws of the United States 
or of the place where the examination is held. Outside of the United 
States, a deposition may be taken before a secretary of an embassy or 
legation, a consul general, vice consul or consular agent of the United 
States, or a person authorized to administer oaths designated by the 
Commission. Depositions may be conducted by telephone or by video 
teleconference at the option of the party or interested governmental 
participant taking the deposition.
    (c) The deponent shall be sworn or shall affirm before any questions 
are put to him or her. Examination and cross-examination shall proceed 
as at a hearing. Each question propounded shall be recorded and the 
answer taken down in the words of the witness. Objections on questions 
of evidence shall be noted in short form without the arguments. The 
officer shall not decide on the competency, materiality, or relevancy of 
evidence but shall record the evidence subject to objection. Objections 
on questions of evidence not made before the officer shall not be deemed 
waived unless the ground of the objection is one which might have been 
obviated or removed if presented at that time.
    (d) When the testimony is fully transcribed, the deposition shall be 
submitted to the deponent for examination and signature unless the 
deponent is ill or cannot be found or refuses to sign. The officer shall 
certify the deposition or, if the deposition is not signed by the 
deponent, shall certify the reasons for the failure to sign, and shall 
promptly transmit an electronic copy of the deposition to the Secretary 
of the Commission for entry into the electronic docket.
    (e) Where the deposition is to be taken on written questions as 
authorized under Sec.2.1018(a)(2), the party or interested 
governmental participant taking the deposition shall electronically 
serve a copy of the questions, showing each question separately and 
consecutively numbered, on every other party and interested governmental 
participant with a notice stating the name and address of the person who 
is to answer them, and the name, description, title, and address of the 
officer before whom they are to be asked. Within ten days after service, 
any other party or interested governmental participant may serve cross-
questions. The questions, cross-questions, and answers shall be recorded 
and signed, and the deposition certified, returned, and transmitted in 
electronic form to the Secretary of the Commission for entry into the 
electronic docket as in the case of a deposition on oral examination.
    (f) A deposition will not become a part of the evidentiary record in 
the hearing unless received in evidence. If only part of a deposition is 
offered in evidence by a party or interested governmental participant, 
any other party or interested governmental participant may introduce any 
other parts. A party or interested governmental participant shall not be 
deemed to make a person its own witness for any purpose by taking his or 
her deposition.
    (g) A deponent whose deposition is taken and the officer taking a 
deposition shall be entitled to the same fees as are paid for like 
services in the district courts of the United States, to be paid by the 
party or interested governmental participant at whose instance the 
deposition is taken.
    (h) The deponent may be accompanied, represented, and advised by 
legal counsel.

[[Page 139]]

    (i)(1) After receiving written notice of the deposition under 
paragraph (a) or paragraph (e) of this section, and ten days before the 
scheduled date of the deposition, the deponent shall submit an 
electronic index of all documents in his or her possession, relevant to 
the subject matter of the deposition, including the categories of 
documents set forth in paragraph (i)(2) of this section, to all parties 
and interested governmental participants. The index shall identify those 
records which have already been made available electronically. All 
documents that are not identical to documents already made available 
electronically, whether by reason of subsequent modification or by the 
addition of notations, shall be treated as separate documents.
    (2) The following material is excluded from the initial requirements 
of Sec.2.1003 to be made available electronically, but is subject to 
derivative discovery under paragraph (i)(1) of this section--
    (i) Personal records;
    (ii) Travel vouchers;
    (iii) Speeches;
    (iv) Preliminary drafts;
    (v) Marginalia.
    (3) Subject to paragraph (i)(6) of this section, any party or 
interested governmental participant may request from the deponent a 
paper copy of any or all of the documents on the index that have not 
already been provided electronically.
    (4) Subject to paragraph (i)(6) of this section, the deponent shall 
bring a paper copy of all documents on the index that the deposing party 
or interested governmental participant requests that have not already 
been provided electronically to an oral deposition conducted pursuant to 
paragraph (a) of this section, or in the case of a deposition taken on 
written questions pursuant to paragraph (e) of this section, shall 
submit such documents with the certified deposition.
    (5) Subject to paragraph (i)(6) of this section, a party or 
interested governmental participant may request that any or all 
documents on the index that have not already been provided 
electronically, and on which it intends to rely at hearing, be made 
electronically available by the deponent.
    (6) The deposing party or interested governmental participant shall 
assume the responsibility for the obligations set forth in paragraphs 
(i)(1), (i)(3), (i)(4), and (i)(5) of this section when deposing someone 
other than a party or interested governmental participant.

[54 FR 14944, Apr. 14, 1989, as amended at 56 FR 7797, Feb. 26, 1991; 63 
FR 71740, Dec. 30, 1998; 69 FR 2266, Jan. 14, 2004]



Sec.2.1020  Entry upon land for inspection.

    (a) Any party, potential party, or interested governmental 
participant may serve on any other party, potential party, or interested 
governmental participant a request to permit entry upon designated land 
or other property in the possession or control of the party, potential 
party, or interested governmental participant upon whom the request is 
served for the purpose of access to raw data, inspection and measuring, 
surveying, photographing, testing, or sampling the property or any 
designated object or operation thereon, within the scope of Sec.2.1018 
of this subpart.
    (b) The request may be served on any party, potential party, or 
interested governmental participant without leave of the Commission or 
the Presiding Officer.
    (c) The request shall describe with reasonable particularity the 
land or other property to be inspected either by individual item or by 
category. The request shall specify a reasonable time, place, and manner 
of making the inspection and performing the related acts.
    (d) The party, potential party, or interested governmental 
participant upon whom the request is served shall serve on the party, 
potential party, or interested governmental participant submitting the 
request a written response within ten days after the service of the 
request. The response shall state, with respect to each item or 
category, that inspection and related activities will be permitted as 
requested, unless the request is objected to, in which case the reasons 
for objection shall be stated. If objection is made to

[[Page 140]]

part of an item or category, the part shall be specified.

[54 FR 14944, Apr. 14, 1989, as amended at 56 FR 7797, Feb. 26, 1991]



Sec.2.1021  First prehearing conference.

    (a) In any proceeding involving an application for a construction 
authorization for a HLW repository at a geologic repository operations 
area under parts 60 or 63 of this chapter, or an application for a 
license to receive and possess high-level radioactive waste at a 
geologic repository operations area pursuant to parts 60 or 63 of this 
chapter, the Commission or the presiding officer will direct the 
parties, interested governmental participants and any petitioners for 
intervention, or their counsel, to appear at a specified time and place, 
within seventy days after the notice of hearing is published, or such 
other time as the Commission or the presiding officer may deem 
appropriate, for a conference to:
    (1) Permit identification of the key issues in the proceeding;
    (2) Take any steps necessary for further identification of the 
issues;
    (3) Consider all intervention petitions to allow the Presiding 
Officer to make such preliminary or final determination as to the 
parties and interested governmental participants, as may be appropriate;
    (4) Establish a schedule for further actions in the proceeding; and
    (5) Establish a discovery schedule for the proceeding taking into 
account the objective of meeting the three year time schedule specified 
in section 114(d) of the Nuclear Waste Policy Act of 1982, as amended, 
42 U.S.C. 10134(d).
    (b) The Presiding Officer may order any further formal and informal 
conferences among the parties and interested governmental participants 
including teleconferences, to the extent that it considers that such a 
conference would expedite the proceeding.
    (c) A prehearing conference held pursuant to this section shall be 
stenographically reported.
    (d) The Presiding Officer shall enter an order which recites the 
action taken at the conference, the schedule for further actions in the 
proceeding, and any agreements by the parties, and which identifies the 
key issues in the proceeding, makes a preliminary or final determination 
as to the parties and interested governmental participants in the 
proceeding, and provides for the submission of status reports on 
discovery.

[54 FR 14944, Apr. 14, 1989, as amended at 56 FR 7797, Feb. 26, 1991; 66 
FR 55788, Nov. 2, 2001; 69 FR 2266, Jan. 14, 2004]



Sec.2.1022  Second prehearing conference.

    (a) The Commission or the presiding officer in a proceeding on 
either an application for construction authorization for a high-level 
radioactive waste repository at a geologic repository operations area 
under parts 60 or 63 of this chapter, or an application for a license to 
receive and possess high-level radioactive waste at a geologic 
repository operations area under parts 60 or 63 of this chapter, shall 
direct the parties, interested governmental participants, or their 
counsel to appear at a specified time and place not later than thirty 
days after the Safety Evaluation Report is issued by the NRC staff for a 
conference to consider:
    (1) Any amended contentions submitted, which must be reviewed under 
the criteria in Sec.2.309(c) of this part;
    (2) Simplification, clarification, and specification of the issues;
    (3) The obtaining of stipulations and admissions of fact and of the 
contents and authenticity of documents to avoid unnecessary proof;
    (4) Identification of witnesses and the limitation of the number of 
expert witnesses, and other steps to expedite the presentation of 
evidence;
    (5) The setting of a hearing schedule;
    (6) Establishing a discovery schedule for the proceeding taking into 
account the objective of meeting the three year time schedule specified 
in section 114(d) of the Nuclear Waste Policy Act of 1982, as amended, 
42 U.S.C. 10134(d); and
    (7) Such other matters as may aid in the orderly disposition of the 
proceeding.
    (b) A prehearing conference held pursuant to this section shall be 
stenographically reported.
    (c) The Presiding Officer shall enter an order which recites the 
action taken at the conference and the agreements

[[Page 141]]

by the parties, limits the issues or defines the matters in controversy 
to be determined in the proceeding, sets a discovery schedule, and sets 
the hearing schedule.

[54 FR 14944, Apr. 14, 1989, as amended at 56 FR 7797, Feb. 26, 1991; 69 
FR 2266, Jan. 14, 2004]



Sec.2.1023  Immediate effectiveness.

    (a) Pending review and final decision by the Commission, an initial 
decision resolving all issues before the presiding officer in favor of 
issuance or amendment of either an authorization to construct a high-
level radioactive waste repository at a geological repository operations 
area under parts 60 or 63 of this chapter, or a license to receive and 
possess high-level radioactive waste at a geologic repository operations 
area under parts 60 or 63 of this chapter will be immediately effective 
upon issuance except:
    (1) As provided in any order issued in accordance with Sec.2.342 
that stays the effectiveness of an initial decision; or
    (2) As otherwise provided by the Commission in special 
circumstances.
    (b) The Director of Nuclear Material Safety and Safeguards, 
notwithstanding the filing or pendency of an appeal or a petition for 
review pursuant to Sec.2.1015 of this subpart, promptly shall issue a 
construction authorization or a license to receive and possess high-
level radioactive waste at a geologic respository operations area, or 
amendments thereto, following an initial decision resolving all issues 
before the Presiding Officer in favor of the licensing action, upon 
making the appropriate licensing findings, except--
    (1) As provided in paragraph (c) of this section; or
    (2) As provided in any order issued in accordance with Sec.2.342 
of this part that stays the effectiveness of an initial decision; or
    (3) As otherwise provided by the Commission in special 
circumstances.
    (c)(1) Before the Director of Nuclear Material Safety and Safeguards 
may issue a construction authorization or a license to receive and 
possess waste at a geologic repository operations area in accordance 
with paragraph (b) of this section, the Commission, in the exercise of 
its supervisory authority over agency proceedings, shall undertake and 
complete a supervisory examination of those issues contested in the 
proceeding before the Presiding Officer to consider whether there is any 
significant basis for doubting that the facility will be constructed or 
operated with adequate protection of the public health and safety, and 
whether the Commission should take action to suspend or to otherwise 
condition the effectiveness of a Presiding Officer decision that 
resolves contested issues in a proceeding in favor of issuing a 
construction authorization or a license to receive and possess high-
level radioactive waste at a geologic repository operations area. This 
supervisory examination is not part of the adjudicatory proceeding. The 
Commission shall notify the Director in writing when its supervisory 
examination conducted in accordance with this paragraph has been 
completed.
    (2) Before the Director of Nuclear Material Safety and Safeguards 
issues a construction authorization or a license to receive and possess 
high-level radioactive waste at a geologic repository operations area, 
the Commission shall review those issues that have not been contested in 
the proceeding before the Presiding Officer but about which the Director 
must make appropriate findings prior to the issuance of such a license. 
The Director shall issue a construction authorization or a license to 
receive and possess high-level radioactive waste at a geologic 
repository operations area only after written notification from the 
Commission of its completion of its review under this paragraph and of 
its determination that it is appropriate for the Director to issue such 
a construction authorization or license. This Commission review of 
uncontested issues is not part of the adjudicatory proceeding.
    (3) No suspension of the effectiveness of a Presiding Officer's 
initial decision or postponement of the Director's issuance of a 
construction authorization or license that results from a Commission 
supervisory examination of contested issues under paragraph (c)(1) of 
this section or a review of uncontested issues under paragraph (c)(2) of 
this section will be entered except in writing with a statement of the

[[Page 142]]

reasons. Such suspension or postponement will be limited to such period 
as is necessary for the Commission to resolve the matters at issue. If 
the supervisory examination results in a suspension of the effectiveness 
of the Presiding Officer's initial decision under paragraph (c)(1) of 
this section, the Commission will take review of the decision sua sponte 
and further proceedings relative to the contested matters at issue will 
be in accordance with procedures for participation by the DOE, the NRC 
staff, or other parties and interested governmental participants to the 
Presiding Officer proceeding established by the Commission in its 
written statement of reasons. If a postponement results from a review 
under paragraph (c)(2) of this section, comments on the uncontested 
matters at issue may be filed by the DOE within ten days of service of 
the Commission's written statement.

[54 FR 14944, Apr. 14, 1989, as amended at 56 FR 7797, Feb. 26, 1991; 66 
FR 55789, Nov. 2, 2001; 69 FR 2266, Jan. 14, 2004; 79 FR 66601, Nov. 10, 
2014]



Sec.2.1025  Authority of the Presiding Officer to dispose of certain
issues on the pleadings.

    (a) Any party may move, with or without supporting affidavits, for a 
decision by the Presiding Officer in that party's favor as to all or any 
part of the matters involved in the proceeding. The moving party shall 
annex to the motion a separate, short, and concise statement of the 
material facts as to which the moving party contends that there is no 
genuine issue to be heard. Motions may be filed at any time. Any other 
party may file an answer supporting or opposing the motion, with or 
without affidavits, within twenty (20) days after service of the motion. 
The party shall annex to any answer opposing the motion a separate, 
short, and concise, statement of the material facts as to which it is 
contended there exists a genuine issue to be heard. All material facts 
set forth in the statement to be filed by the moving party will be 
deemed to be admitted unless controverted by the statement required to 
be filed by the opposing party. The opposing party may, within ten (10) 
days after service, respond in writing to new facts and arguments 
presented in any statement filed in support of the motion. No further 
supporting statements or responses thereto may be entertained. The 
Presiding Officer may dismiss summarily or hold in abeyance motions 
filed shortly before the hearing commences or during the hearing if the 
other parties or the Presiding Officer would be required to divert 
substantial resources from the hearing in order to respond adequately to 
the motion.
    (b) Affidavits must set forth those facts that would be admissible 
in evidence and show affirmatively that the affiant is competent to 
testify to the matters stated therein. The Presiding Officer may permit 
affidavits to be supplemented or opposed by further affidavits. When a 
motion for summary disposition is made and supported as provided in this 
section, a party opposing the motion may not rest upon the mere 
allegations or denials of its answer; its answer by affidavits or as 
otherwise provided in this section must set forth specific facts showing 
that there is a genuine issue of fact. If no such answer is filed, the 
decision sought, if appropriate, must be rendered.
    (c) The Presiding Officer shall render the decision sought if the 
filings in the proceeding show that there is no genuine issue as to any 
material fact and that the moving party is entitled to a decision as a 
matter of law. However, in any proceeding involving a construction 
authorization for a geologic repository operations area, the procedure 
described in this section may be used only for the determination of 
specific subordinate issues and may not be used to determine the 
ultimate issue as to whether the authorization must be issued.

[56 FR 7798, Feb. 26, 1991]



Sec.2.1026  Schedule.

    (a) Subject to paragraphs (b) and (c) of this section, the Presiding 
Officer shall adhere to the schedule set forth in appendix D of this 
part.
    (b)(1) Pursuant to Sec.2.307, the presiding officer may approve 
extensions of no more than fifteen (15) days beyond any required time 
set forth in this subpart for a filing by a party to the proceeding. 
Except in the case of

[[Page 143]]

exceptional and unforseen circumstances, requests for extensions of more 
than fifteen (15) days must be filed no later than five (5) days in 
advance of the required time set forth in this subpart for a filing by a 
party to the proceeding.
    (2) Extensions beyond 15 days must be referred to the Commission. If 
the Commission does not disapprove the extension within 10 days of 
receiving the request, the extension will be effective. If the 
Commission disapproves the extension, the date which was the subject of 
the extension request will be set for 5 days after the Commission's 
disapproval action.
    (c)(1) The Presiding Officer may delay the issuance of an order up 
to thirty days beyond the time set forth for the issuance in appendix D.
    (2) If the Presiding Officer anticipates that the issuance of an 
order will not occur until after the thirty day extension specified in 
paragraph (c)(1) of this section, the Presiding Officer shall notify the 
Commission at least ten days in advance of the scheduled date for the 
milestone and provide a justification for the delay.

[56 FR 7798, Feb. 26, 1991, as amended at 69 FR 2266, Jan. 14, 2004]



Sec.2.1027  Sua sponte.

    In any initial decision in a proceeding on an application for a 
construction authorization for a high-level radioactive waste repository 
at a geologic repository operations area under parts 60 or 63 of this 
chapter, or an application for a license to receive and possess high-
level radioactive waste at a geologic repository operations area under 
parts 60 or 63 of this chapter, the Presiding Officer, other than the 
Commission, shall make findings of fact and conclusions of law on, and 
otherwise give consideration to, only those matters put into controversy 
by the parties and determined to be litigable issues in the proceeding.

[69 FR 2266, Jan. 14, 2004]



Subpart K_Hybrid Hearing Procedures for Expansion of Spent Nuclear Fuel 
           Storage Capacity at Civilian Nuclear Power Reactors

    Source: 50 FR 41670, Oct. 15, 1985, unless otherwise noted.



Sec.2.1101  Purpose.

    The regulations in this subpart establish hybrid hearing procedures, 
as authorized by section 134 of the Nuclear Waste Policy Act of 1982 (96 
Stat. 2230), to be used at the request of any party in certain contested 
proceedings on applications for a license or license amendment to expand 
the spent nuclear fuel storage capacity at the site of a civilian 
nuclear power plant. These procedures are intended to encourage and 
expedite onsite expansion of spent nuclear fuel storage capacity.



Sec.2.1103  Scope of subpart K.

    The provisions of this subpart, together with subpart C and 
applicable provisions of subparts G and L of this part, govern all 
adjudicatory proceedings on applications filed after January 7, 1983, 
for a license or license amendment under part 50 of this chapter, to 
expand the spent fuel storage capacity at the site of a civilian nuclear 
power plant, through the use of high density fuel storage racks, fuel 
rod compaction, the transshipment of spent nuclear fuel to another 
civilian nuclear power reactor within the same utility system, the 
construction of additional spent nuclear fuel pool capacity or dry 
storage capacity, or by other means. This subpart also applies to 
proceedings on applications for a license under part 72 of this chapter 
to store spent nuclear fuel in an independent spent fuel storage 
installation located at the site of a civilian nuclear power reactor. 
This subpart shall not apply to the first application for a license or 
license amendment to expand the spent fuel storage capacity at a 
particular site through the use of a new technology not previously 
approved by the Commission for use at any other nuclear power plant. 
This subpart shall not apply to proceedings on applications for transfer 
of a license

[[Page 144]]

issued under part 72 of this chapter. Subpart M of this part applies to 
license transfer proceedings.

[69 FR 2266, Jan. 14, 2004]



Sec.2.1105  Definitions.

    As used in this part:
    (a) Civilian nuclear power reactor means a civilian nuclear power 
plant required to be licensed as a utilization facility under section 
103 or 104(b) of the Atomic Energy Act of 1954.
    (b) Spent nuclear fuel means fuel that has been withdrawn from a 
nuclear reactor following irradiation, the constituent elements of which 
have not been separated by reprocessing.



Sec.2.1107  Notice of proposed action.

    In connection with each application filed after January 7, 1983, for 
a license or an amendment to a license to expand the spent nuclear fuel 
storage capacity at the site of a civilian nuclear power plant, for 
which the Commission has not found that a hearing is required in the 
public interest, for which an adjudicatory hearing has not yet been 
convened, and for which a notice of proposed action has not yet been 
published as of the effective date of this subpart, the Commission will, 
prior to acting thereon, cause to be published in the Federal Register a 
notice of proposed action in accordance with Sec.2.105. The notice of 
proposed action will identify the availability of the hybrid hearing 
procedures in this subpart, specify that any party may invoke these 
procedures by filing a timely request for oral argument under Sec.
2.1109, and provide that if a request for oral argument is granted, any 
hearing held on the application shall be conducted in accordance with 
the procedures in this subpart.



Sec.2.1109  Requests for oral argument.

    (a)(1) In its request for hearing/petition to intervene filed in 
accordance with Sec.2.309 or in the applicant's or the NRC staff's 
response to a request for a hearing/petition to intervene, any party may 
invoke the hybrid hearing procedures in this Subpart by requesting an 
oral argument. If it is determined that a hearing will be held, the 
presiding officer shall grant a timely request for oral argument.
    (2) The presiding officer may grant an untimely request for oral 
argument only upon a showing of good cause by the requesting party for 
failure to file on time and after providing the other parties an 
opportunity to respond to the untimely request.
    (b) The presiding officer shall issue a written order ruling on any 
requests for oral argument. If the presiding officer grants a request 
for oral argument, the order shall include a schedule for discovery and 
subsequent oral argument with respect to the admitted contentions.
    (c) If no party to the proceeding requests oral argument, or if all 
untimely requests for oral argument are denied, the presiding officer 
shall conduct the proceeding in accordance with the subpart under which 
the proceeding was initially conducted as determined in accordance with 
Sec.2.310.

[50 FR 41670, Oct. 15, 1985, as amended at 69 FR 2267, Jan. 14, 2004]



Sec.2.1113  Oral argument.

    (a) Twenty-five (25) days prior to the date set for oral argument, 
each party, including the NRC staff, shall submit to the presiding 
officer a detailed written summary of all the facts, data, and arguments 
which are known to the party at such time and on which the party 
proposes to rely at the oral argument either to support or to refute the 
existence of a genuine and substantial dispute of fact. Each party shall 
also submit all supporting facts and data in the form of sworn written 
testimony or other sworn written submission. Each party's written 
summary and supporting information shall be simultaneously served on all 
other parties to the proceeding.
    (b) Ten (10) days prior to the date set for oral argument, each 
party, including the NRC staff, may submit to the presiding officer a 
reply limited to addressing whether the written summaries, facts, data, 
and arguments filed under paragraph (a) of this section support or 
refute the existence of a genuine and substantial dispute of fact. Each 
party's reply shall be simultaneously served on all other parties to the 
proceeding.

[[Page 145]]

    (c) Only facts and data in the form of sworn written testimony or 
other sworn written submission may be relied on by the parties during 
oral argument, and the presiding officer shall consider those facts and 
data only if they are submitted in that form.

[50 FR 41670, Oct. 15, 1985, as amended at 69 FR 2267, Jan. 14, 2004]



Sec.2.1115  Designation of issues for adjudicatory hearing.

    (a) After due consideration of the oral presentation and the written 
facts and data submitted by the parties and relied on at the oral 
argument, the presiding officer shall promptly by written order:
    (1) Designate any disputed issues of fact, together with any 
remaining issues of law, for resolution in an adjudicatory hearing; and
    (2) Dispose of any issues of law or fact not designated for 
resolution in an adjudicatory hearing.

With regard to each issue designated for resolution in an adjudicatory 
hearing, the presiding officer shall identify the specific facts that 
are in genuine and substantial dispute, the reason why the decision of 
the Commission is likely to depend on the resolution of that dispute, 
and the reason why an adjudicatory hearing is likely to resolve the 
dispute. With regard to issues not designated for resolution in an 
adjudicatory hearing, the presiding officer shall include a brief 
statement of the reasons for the disposition. If the presiding officer 
finds that there are no disputed issues of fact or law requiring 
resolution in an adjudicatory hearing, the presiding officer shall also 
dismiss the proceeding.
    (b) No issue of law or fact shall be designated for resolution in an 
adjudicatory hearing unless the presiding officer determines that:
    (1) There is a genuine and substantial dispute of fact which can 
only be resolved with sufficient accuracy by the introduction of 
evidence in an adjudicatory hearing; and
    (2) The decision of the Commission is likely to depend in whole or 
in part on the resolution of that dispute.
    (c) In making a determination under paragraph (b) of this section, 
the presiding officer shall not consider:
    (1) Any issue relating to the design, construction, or operation of 
any civilian nuclear power reactor already licensed to operate at the 
site, or any civilian nuclear power reactor for which a construction 
permit has been granted at the site, unless the presiding officer 
determines that any such issue substantially affects the design, 
construction, or operation of the facility or activity for which a 
license application, authorization, or amendment to expand the spent 
nuclear fuel storage capacity is being considered; or
    (2) Any siting or design issue fully considered and decided by the 
Commission in connection with the issuance of a construction permit or 
operating license for a civilian nuclear power reactor at that site, 
unless (i) such issue results from any revision of siting or design 
criteria by the Commission following such decision; and (ii) the 
presiding officer determines that such issue substantially affects the 
design, construction, or operation of the facility or activity for which 
a license application, authorization, or amendment to expand the spent 
nuclear fuel storage capacity is being considered.
    (d) The provisions of paragraph (c) of this section shall apply only 
with respect to licenses, authorizations, or amendments to licenses or 
authorizations applied for under the Atomic Energy Act of 1954, as 
amended, before December 31, 2005.
    (e) Unless the presiding officer disposes of all issues and 
dismisses the proceeding, appeals from the presiding officer's order 
disposing of issues and designating one or more issues for resolution in 
an adjudicatory hearing are interlocutory and must await the end of the 
proceeding.

[50 FR 41671, Oct. 15, 1985; 50 FR 45398, Oct. 31, 1985]



Sec.2.1117  Burden of proof.

    The applicant bears the ultimate burden of proof (risk of non-
persuasion) with respect to the contention in the proceeding. The 
proponent of the request for an adjudicatory hearing bears the burden of 
demonstrating under Sec.2.1115(b) that an adjudicatory hearing should 
be held.

[69 FR 2267, Jan. 14, 2004]

[[Page 146]]



Sec.2.1119  Applicability of other sections.

    In proceedings subject to this part, the provisions of subparts A, 
C, and L of this part are also applicable, except where inconsistent 
with the provisions of this subpart.

[69 FR 2267, Jan. 14, 2004]



      Subpart L_Simplified Hearing Procedures for NRC Adjudications

    Source: 69 FR 2267, Jan. 14, 2004, unless otherwise noted.



Sec.2.1200  Scope of subpart L.

    The provisions of this subpart, together with subpart C of this 
part, govern all adjudicatory proceedings conducted under the authority 
of the Atomic Energy Act of 1954, as amended, the Energy Reorganization 
Act, and 10 CFR part 2, except for proceedings on the licensing of the 
construction and operation of a uranium enrichment facility, proceedings 
on an initial application for construction authorization for a high-
level radioactive waste geologic repository at a geologic repository 
operations area noticed under Sec. Sec.2.101(e)(8) or 2.105(a)(5), 
proceedings on an initial application for a license to receive and 
possess high-level radioactive waste at a geologic repository operations 
area, proceedings on enforcement matters unless all parties otherwise 
agree and request the application of Subpart L procedures, and 
proceedings for the direct or indirect transfer of control of an NRC 
license when the transfer requires prior approval of the NRC under the 
Commission's regulations, governing statutes, or pursuant to a license 
condition.

[69 FR 2267, Jan. 14, 2004, as amended at 82 FR 52825, Nov. 15, 2017]



Sec.2.1201  Definitions.

    The definitions of terms contained in Sec.2.4 apply to this 
subpart unless a different definition is provided in this subpart.



Sec.2.1202  Authority and role of NRC staff.

    (a) During the pendency of any hearing under this subpart, 
consistent with the NRC staff's findings in its review of the 
application or matter which is the subject of the hearing and as 
authorized by law, the NRC staff is expected to promptly issue its 
approval or denial of the application, or take other appropriate action 
on the underlying regulatory matter for which a hearing was provided. 
When the NRC staff takes its action, it must notify the presiding 
officer and the parties to the proceeding of its action. That notice 
must include the NRC staff's explanation why the public health and 
safety is protected and why the action is in accord with the common 
defense and security despite the pendency of the contested matter before 
the presiding officer. The NRC staff's action on the matter is effective 
upon issuance by the staff, except in matters involving:
    (1) An application to construct and/or operate a production or 
utilization facility (including an application for a limited work 
authorization under 10 CFR 50.12, or an application for a combined 
license under subpart C of 10 CFR part 52);
    (2) An application for an early site permit under subpart A of 10 
CFR part 52;
    (3) An application for a manufacturing license under subpart F of 10 
CFR part 52;
    (4) An application for an amendment to a construction authorization 
for a high-level radioactive waste repository at a geologic repository 
operations area falling under either 10 CFR 60.32(c)(1) or 10 CFR part 
63;
    (5) An application for the construction and operation of an 
independent spent fuel storage installation (ISFSI) located at a site 
other than a reactor site or a monitored retrievable storage 
installation (MRS) under 10 CFR part 72; and
    (6) Production or utilization facility licensing actions that 
involve significant hazards considerations as defined in 10 CFR 50.92.
    (b)(1) The NRC staff is not required to be a party to a proceeding 
under this subpart, except where:
    (i) The proceeding involves an application denied by the NRC staff 
or an enforcement action proposed by the NRC staff; or
    (ii) The presiding officer determines that the resolution of any 
issue in the

[[Page 147]]

proceeding would be aided materially by the NRC staff's participation in 
the proceeding as a party and orders the staff to participate as a party 
for the identified issue. In the event that the presiding officer 
determines that the NRC staff's participation is necessary, the 
presiding officer shall issue an order identifying the issue(s) on which 
the staff is to participate as well as setting forth the basis for the 
determination that staff participation will materially aid in resolution 
of the issue(s).
    (2) Within fifteen (15) days of the issuance of the order granting 
requests for hearing/petitions to intervene and admitting contentions, 
the NRC staff shall notify the presiding officer and the parties whether 
it desires to participate as a party, and identify the contentions on 
which it wishes to participate as a party. If the NRC staff desires to 
be a party thereafter, the NRC staff shall notify the presiding officer 
and the parties, identify the contentions on which it wishes to 
participate as a party, and make the disclosures required by Sec.
2.336(b)(3) through (5) unless accompanied by an affidavit explaining 
why the disclosures cannot be provided to the parties with the notice.
    (3) Once the NRC staff chooses to participate as a party, it shall 
have all the rights and responsibilities of a party with respect to the 
admitted contention/matter in controversy on which the staff chooses to 
participate.

[69 FR 2267, Jan. 14, 2004, as amended at 72 FR 49483, Aug. 28, 2007; 77 
FR 46598, Aug. 3, 2012]



Sec.2.1203  Hearing file; prohibition on discovery.

    (a)(1) Within thirty (30) days of the issuance of the order granting 
requests for hearing/petitions to intervene and admitting contentions, 
the NRC staff shall file in the docket, present to the presiding 
officer, and make available to the parties to the proceeding a hearing 
file.
    (2) The hearing file must be made available to the parties either by 
service of hard copies or by making the file available at the NRC Web 
site, http://www.nrc.gov.
    (3) The hearing file also must be made available for public 
inspection and copying at the NRC Web site, http://www.nrc.gov, and/or 
at the NRC Public Document Room.
    (b) The hearing file consists of the application, if any, and any 
amendment to the application, and, when available, any NRC environmental 
impact statement or assessment and any NRC report related to the 
proposed action, as well as any correspondence between the applicant/
licensee and the NRC that is relevant to the proposed action. Hearing 
file documents already available at the NRC Web site and/or the NRC 
Public Document Room when the hearing request/petition to intervene is 
granted may be incorporated into the hearing file at those locations by 
a reference indicating where at those locations the documents can be 
found. The presiding officer shall rule upon any issue regarding the 
appropriate materials for the hearing file.
    (c) The NRC staff has a continuing duty to keep the hearing file up 
to date with respect to the materials set forth in paragraph (b) of this 
section and to provide those materials as required in paragraphs (a) and 
(b) of this section.
    (d) Except as otherwise permitted by subpart C of this part, a party 
may not seek discovery from any other party or the NRC or its personnel, 
whether by document production, deposition, interrogatories or 
otherwise.



Sec.2.1204  Motions and requests.

    (a) General requirements. In proceedings under this subpart, 
requirements for motions and requests and responses to them are as 
specified in Sec.2.323.
    (b) Requests for cross-examination by the parties. (1) In any oral 
hearing under this subpart, a party may file a motion with the presiding 
officer to permit cross-examination by the parties on particular 
admitted contentions or issues. The motion must be accompanied by a 
cross-examination plan containing the following information:
    (i) A brief description of the issue or issues on which cross-
examination will be conducted;
    (ii) The objective to be achieved by cross-examination; and
    (iii) The proposed line of questions that may logically lead to 
achieving the objective of the cross-examination.

[[Page 148]]

    (2) The cross-examination plan may be submitted only to the 
presiding officer and must be kept by the presiding officer in 
confidence until issuance of the initial decision on the issue being 
litigated. The presiding officer shall then provide each cross-
examination plan to the Commission's Secretary for inclusion in the 
official record of the proceeding.
    (3) The presiding officer shall allow cross-examination by the 
parties only if the presiding officer determines that cross-examination 
by the parties is necessary to ensure the development of an adequate 
record for decision.



Sec.2.1205  Summary disposition.

    (a) Unless the presiding officer or the Commission directs 
otherwise, motions for summary disposition may be submitted to the 
presiding officer by any party no later than 45 days before the 
commencement of hearing. The motions must be in writing and must include 
a written explanation of the basis of the motion. The moving party must 
attach a short and concise statement of material facts for which the 
moving party contends that there is no genuine issue to be heard. 
Motions for summary disposition must be served on the parties and the 
Secretary at the same time that they are submitted to the presiding 
officer.
    (b) Any other party may serve an answer supporting or opposing the 
motion within twenty (20) days after service of the motion.
    (c) The presiding officer shall issue a determination on each motion 
for summary disposition no later than fifteen (15) days before the date 
scheduled for commencement of hearing. In ruling on motions for summary 
disposition, the presiding officer shall apply the standards for summary 
disposition set forth in subpart G of this part.

[69 FR 2267, Jan. 14, 2004, as amended at 77 FR 46598, Aug. 3, 2012]



Sec.2.1206  Informal hearings.

    Hearings under this subpart will be oral hearings as described in 
Sec.2.1207, unless, within fifteen (15) days of the service of the 
order granting the request for hearing, the parties unanimously agree 
and file a joint motion requesting a hearing consisting of written 
submissions. A motion to hold a hearing consisting of written 
submissions will not be entertained unless there is unanimous consent of 
the parties.



Sec.2.1207  Process and schedule for submissions and presentations
in an oral hearing.

    (a) Unless otherwise limited by this subpart or by the presiding 
officer, participants in an oral hearing may submit and sponsor in the 
hearings:
    (1) Initial written statements of position and written testimony 
with supporting affidavits on the admitted contentions. These materials 
must be filed on the dates set by the presiding officer.
    (2) Written responses and rebuttal testimony with supporting 
affidavits directed to the initial statements and testimony of other 
participants. These materials must be filed within twenty (20) days of 
the service of the materials submitted under paragraph (a)(1) of this 
section unless the presiding officer directs otherwise.
    (3)(i) Proposed questions for the presiding officer to consider for 
propounding to the persons sponsoring the testimony. Unless the 
presiding officer directs otherwise, these questions must be received by 
the presiding officer no later than twenty (20) days after the service 
of the materials submitted under paragraph (a)(1) of this section, 
unless that date is less than five (5) days before the scheduled 
commencement of the oral hearing, in which case the questions must be 
received by the presiding officer no later than five (5) days before the 
scheduled commencement of the hearing. Proposed questions need not be 
filed with any other party.
    (ii) Proposed questions directed to rebuttal testimony for the 
presiding officer to consider for propounding to persons sponsoring the 
testimony. Unless the presiding officer directs otherwise, these 
questions must be received by the presiding officer no later than seven 
(7) days after the service of the rebuttal testimony submitted under 
paragraph (a)(2) of this section, unless that date is less than five (5) 
days before the scheduled commencement of the oral hearing, in which 
case the

[[Page 149]]

questions must be received by the presiding officer no later than five 
(5) days before the scheduled commencement of the hearing. Proposed 
questions directed to rebuttal need not be filed with any other party.
    (iii) Questions submitted under paragraphs (a)(3)(i) and (ii) of 
this section may be propounded at the discretion of the presiding 
officer. All questions must be kept by the presiding officer in 
confidence until they are either propounded by the presiding officer, or 
until issuance of the initial decision on the issue being litigated. The 
presiding officer shall then provide all proposed questions to the 
Commission's Secretary for inclusion in the official record of the 
proceeding.
    (b) Oral hearing procedures. (1) The oral hearing must be 
transcribed.
    (2) Written testimony will be received into evidence in exhibit 
form.
    (3) Participants may designate and present their own witnesses to 
the presiding officer.
    (4) Testimony for the NRC staff will be presented only by persons 
designated by the Executive Director for Operations or his delegee for 
that purpose.
    (5) The presiding officer may accept written testimony from a person 
unable to appear at the hearing, and may request that person to respond 
in writing to questions.
    (6) Participants and witnesses will be questioned orally or in 
writing and only by the presiding officer or the presiding officer's 
designee (e.g., a Special Assistant appointed under Sec.2.322). The 
presiding officer will examine the participants and witnesses using 
questions prepared by the presiding officer or the presiding officer's 
designee, questions submitted by the participants at the discretion of 
the presiding officer, or a combination of both. Questions may be 
addressed to individuals or to panels of participants or witnesses. No 
party may submit proposed questions to the presiding officer at the 
hearing, except upon request by, and in the sole discretion of, the 
presiding officer.



Sec.2.1208  Process and schedule for a hearing consisting of written
presentations.

    (a) Unless otherwise limited by this subpart or by the presiding 
officer, participants in a hearing consisting of written presentations 
may submit:
    (1) Initial written statements of position and written testimony 
with supporting affidavits on the admitted contentions. These materials 
must be filed on the dates set by the presiding officer;
    (2) Written responses, rebuttal testimony with supporting affidavits 
directed to the initial statements and testimony of witnesses and other 
participants, and proposed written questions for the presiding officer 
to consider for submission to the persons sponsoring testimony under 
paragraph (a)(1) of this section. These materials must be filed within 
twenty (20) days of the service of the materials submitted under 
paragraph (a)(1) of this section unless the presiding officer directs 
otherwise;
    (3) Written questions on the written responses and rebuttal 
testimony submitted under paragraph (a)(2) of this section, which the 
presiding officer may, in his or her discretion, require the persons 
offering the written responses and rebuttal testimony to provide 
responses. These questions must be filed within seven (7) days of 
service of the materials submitted under paragraph (a)(2) of this 
section unless the presiding officer directs otherwise; and
    (4) Written concluding statements of position on the contentions. 
These statements shall be filed within twenty (20) days of the service 
of written responses to the presiding officer's questions to the 
participants or, in the absence of questions from the presiding officer, 
within twenty (20) days of the service of the materials submitted under 
paragraph (a)(2) of this section unless the presiding officer directs 
otherwise.
    (b) The presiding officer may formulate and submit written questions 
to the participants that he or she considers appropriate to develop an 
adequate record.

[[Page 150]]



Sec.2.1209  Findings of fact and conclusions of law.

    Each party shall file written post-hearing proposed findings of fact 
and conclusions of law on the contentions addressed in an oral hearing 
under Sec.2.1207 or a written hearing under Sec.2.1208 within 30 
days of the close of the hearing or at such other time as the presiding 
officer directs. Proposed findings of fact and conclusions of law must 
conform to the format requirements in Sec.2.712(c).

[77 FR 46598, Aug. 3, 2012]



Sec.2.1210  Initial decision and its effect.

    (a) Unless the Commission directs that the record be certified to it 
in accordance with paragraph (b) of this section, the presiding officer 
shall render an initial decision after completion of an informal hearing 
under this subpart. That initial decision constitutes the final action 
of the Commission on the contested matter 120 days after the date of 
issuance, unless:
    (1) Any party files a petition for Commission review in accordance 
with Sec.2.1212;
    (2) The Commission, in its discretion, determines that the presiding 
officer's initial decision is inconsistent with the staff's action as 
described in the notice required by Sec.2.1202(a) and that the 
inconsistency warrants Commission review, in which case the Commission 
will review the initial decision; or
    (3) The Commission takes review of the decision sua sponte.
    (b) The Commission may direct that the presiding officer certify the 
record to it without an initial decision and prepare a final decision if 
the Commission finds that due and timely execution of its functions 
warrants certification.
    (c) An initial decision must be in writing and must be based only 
upon information in the record or facts officially noticed. The record 
must include all information submitted in the proceeding with respect to 
which all parties have been given reasonable prior notice and an 
opportunity to comment as provided in Sec. Sec.2.1207 or 2.1208. The 
initial decision must include:
    (1) Findings, conclusions, and rulings, with the reasons or basis 
for them, on all material issues of fact or law admitted as part of the 
contentions in the proceeding;
    (2) The appropriate ruling, order, or grant or denial of relief with 
its effective date;
    (3) The action the NRC staff shall take upon transmittal of the 
decision to the NRC staff under paragraph (e) of this section, if the 
initial decision is inconsistent with the NRC staff action as described 
in the notice required by Sec.2.1202(a); and
    (4) The time within which a petition for Commission review may be 
filed, the time within which any answers to a petition for review may be 
filed, and the date when the decision becomes final in the absence of a 
petition for Commission review or Commission sua sponte review.
    (d) Pending review and final decision by the Commission, an initial 
decision resolving all issues before the presiding officer is 
immediately effective upon issuance except as otherwise provided by this 
part (e.g., Sec.2.340) or by the Commission in special circumstances.
    (e) Once an initial decision becomes final, the Secretary shall 
transmit the decision to the NRC staff for action in accordance with the 
decision.

[69 FR 2267, Jan. 14, 2004, as amended at 77 FR 46598, Aug. 3, 2012; 79 
FR 66601, Nov. 10, 2014]



Sec.2.1212  Petitions for Commission review of initial decisions.

    Parties may file petitions for review of an initial decision under 
this subpart in accordance with the procedures set out in Sec.2.341. 
Unless otherwise authorized by law, a party to an NRC proceeding must 
file a petition for Commission review before seeking judicial review of 
an agency action.



Sec.2.1213  Application for a stay.

    (a) Any application for a stay of the effectiveness of the NRC 
staff's action on a matter involved in a hearing under this subpart must 
be filed with the presiding officer within five (5) days of the issuance 
of the notice of the NRC staff's action under Sec.2.1202(a) and must 
be filed and considered in accordance with paragraphs (b), (c) and (d) 
of this section.

[[Page 151]]

    (b) An application for a stay of the NRC staff's action may not be 
longer than ten (10) pages, exclusive of affidavits, and must contain:
    (1) A concise summary of the action which is requested to be stayed; 
and
    (2) A concise statement of the grounds for a stay, with reference to 
the factors specified in paragraph (d) of this section.
    (c) Within ten (10) days after service of an application for a stay 
of the NRC staff's action under this section, any party and/or the NRC 
staff may file an answer supporting or opposing the granting of a stay. 
Answers may not be longer than ten (10) pages, exclusive of affidavits, 
and must concisely address the matters in paragraph (b) of this section 
as appropriate. Further replies to answers will not be entertained.
    (d) In determining whether to grant or deny an application for a 
stay of the NRC staff's action, the following will be considered:
    (1) Whether the requestor will be irreparably injured unless a stay 
is granted;
    (2) Whether the requestor has made a strong showing that it is 
likely to prevail on the merits;
    (3) Whether the granting of a stay would harm other participants; 
and
    (4) Where the public interest lies.
    (e) Any application for a stay of the effectiveness of the presiding 
officer's initial decision or action under this subpart shall be filed 
with the Commission in accordance with Sec.2.342.
    (f) Stays are not available on matters limited to whether a no 
significant hazards consideration determination was proper in 
proceedings on power reactor license amendments.

[69 FR 2267, Jan. 14, 2004, as amended at 77 FR 46598, Aug. 3, 2012]



   Subpart M_Procedures for Hearings on License Transfer Applications

    Source: 63 FR 66730, Dec. 3, 1998, unless otherwise noted.



Sec.2.1300  Scope of subpart M.

    The provisions of this subpart, together with the generally 
applicable intervention provisions in subpart C of this part, govern all 
adjudicatory proceedings on an application for the direct or indirect 
transfer of control of an NRC license when the transfer requires prior 
approval of the NRC under the Commission's regulations, governing 
statutes, or pursuant to a license condition. This subpart provides the 
only mechanism for requesting hearings on license transfer requests, 
unless contrary case specific orders are issued by the Commission.

[77 FR 46598, Aug. 3, 2012]



Sec.2.1301  Public notice of receipt of a license transfer application.

    (a) The Commission will notice the receipt of each application for 
direct or indirect transfer of a specific NRC license by placing a copy 
of the application at the NRC Web site, http://www.nrc.gov.
    (b) The Commission will also publish in the Federal Register a 
notice of receipt of an application for approval of a license transfer 
involving 10 CFR part 50 and part 52 licenses, major fuel cycle facility 
licenses issued under part 70, or part 72 licenses. This notice 
constitutes the notice required by Sec.2.105 with respect to all 
matters related to the application requiring NRC approval.
    (c) Periodic lists of applications received may be obtained upon 
request addressed to the NRC Public Document Room, US Nuclear Regulatory 
Commission, Washington, DC 20555-0001.

[63 FR 66730, Dec. 3, 1998, as amended at 64 FR 48949, Sept. 9, 1999]



Sec.2.1302  Notice of withdrawal of an application.

    The Commission will notice the withdrawal of an application by 
publishing the notice of withdrawal in the same manner as the notice of 
receipt of the application was published under Sec.2.1301.



Sec.2.1303  Availability of documents.

    Unless exempt from disclosure under part 9 of this chapter, the 
following documents pertaining to each application for a license 
transfer requiring Commission approval will be placed at the NRC Web 
site, http://www.nrc.gov, when available:

[[Page 152]]

    (a) The license transfer application and any associated requests;
    (b) Commission correspondence with the applicant or licensee related 
to the application;
    (c) Federal Register notices;
    (d) The NRC staff Safety Evaluation Report (SER).
    (e) Any NRC staff order which acts on the license transfer 
application; and
    (f) If a hearing is held, the hearing record and decision.

[63 FR 66730, Dec. 3, 1998, as amended at 64 FR 48949, Sept. 9, 1999]



Sec.2.1305  Written comments.

    (a) As an alternative to requests for hearings and petitions to 
intervene, persons may submit written comments regarding license 
transfer applications. The Commission will consider and, if appropriate, 
respond to these comments, but these comments do not otherwise 
constitute part of the decisional record.
    (b) These comments should be submitted within 30 days after public 
notice of receipt of the application and addressed to the Secretary, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, 
Attention: Rulemakings and Adjudications Staff.
    (c) The Commission will provide the applicant with a copy of the 
comments. Any response the applicant chooses to make to the comments 
must be submitted within 10 days of service of the comments on the 
applicant. Such responses do not constitute part of the decisional 
record.



Sec.2.1308  Oral hearings.

    Hearings under this subpart will be oral hearings, unless, within 15 
days of the service of the notice or order granting the hearing, the 
parties unanimously agree and file a joint motion requesting a hearing 
consisting of written comments. No motion to hold a hearing consisting 
of written comments will be entertained absent consent of all the 
parties.

[69 FR 2270, Jan. 14, 2004]



Sec.2.1309  Notice of oral hearing.

    (a) A notice of oral hearing will--
    (1) State the time, place, and issues to be considered;
    (2) Provide names and addresses of participants,
    (3) Specify the time limit for participants and others to indicate 
whether they wish to present views;
    (4) Specify the schedule for the filing of written testimony, 
statements of position, proposed questions for the Presiding Officer to 
consider, and rebuttal testimony consistent with the schedule provisions 
of Sec.2.1321.
    (5) Specify that the oral hearing shall commence within 15 days of 
the date for submittal of rebuttal testimony unless otherwise ordered;
    (6) State any other instructions the Commission deems appropriate;
    (7) If so determined by the NRC staff or otherwise directed by the 
Commission, direct that the staff participate as a party with respect to 
some or all issues.
    (b) If the Commission is not the Presiding Officer, the notice of 
oral hearing will also state:
    (1) When the jurisdiction of the Presiding Officer commences and 
terminates;
    (2) The powers of the Presiding Officer;
    (3) Instructions to the Presiding Officer to certify promptly the 
completed hearing record to the Commission without a recommended or 
preliminary decision.



Sec.2.1310  Notice of hearing consisting of written comments.

    A notice of hearing consisting of written comments will:
    (a) State the issues to be considered;
    (b) Provide the names and addresses of participants;
    (c) Specify the schedule for the filing of written testimony, 
statements of position, proposed questions for the Presiding Officer to 
consider for submission to the other parties, and rebuttal testimony, 
consistent with the schedule provisions of Sec.2.1321.
    (d) State any other instructions the Commission deems appropriate.



Sec.2.1311  Conditions in a notice or order.

    (a) A notice or order granting a hearing or permitting intervention 
shall--
    (1) Restrict irrelevant or duplicative testimony; and

[[Page 153]]

    (2) Require common interests to be represented by a single 
participant.
    (b) If a participant's interests do not extend to all the issues in 
the hearing, the notice or order may limit her/his participation 
accordingly.



Sec.2.1315  Generic determination regarding license amendments 
to reflect transfers.

    (a) Unless otherwise determined by the Commission with regard to a 
specific application, the Commission has determined that any amendment 
to the license of a utilization facility or the license of an 
Independent Spent Fuel Storage Installation which does no more than 
conform the license to reflect the transfer action, involves 
respectively, ``no significant hazards consideration,'' or ``no genuine 
issue as to whether the health and safety of the public will be 
significantly affected.''
    (b) Where administrative license amendments are necessary to reflect 
an approved transfer, such amendments will be included in the order that 
approves the transfer. Any challenge to the administrative license 
amendment is limited to the question of whether the license amendment 
accurately reflects the approved transfer.

[63 FR 66730, Dec. 3, 1998, as amended at 69 FR 2270, Jan. 14, 2004]



Sec.2.1316  Authority and role of NRC staff.

    (a) During the pendency of any hearing under this subpart, 
consistent with the NRC staff's findings in its Safety Evaluation Report 
(SER), the staff is expected to promptly issue approval or denial of 
license transfer requests. Notice of such action shall be promptly 
transmitted to the Presiding Officer and parties to the proceeding.
    (b) Except as otherwise directed in accordance with Sec.
2.1309(a)(7), the NRC staff is not required to be a party to proceedings 
under this subpart but will offer into evidence its SER associated with 
the transfer application and provide one or more sponsoring witnesses.
    (c)(1) Within 15 days of the issuance of the order granting requests 
for hearing/petitions to intervene and admitting contentions, the NRC 
staff must notify the presiding officer and the parties whether it 
desires to participate as a party, and identify the contentions on which 
it wishes to participate as a party. If the NRC staff desires to be a 
party thereafter, the NRC staff must notify the presiding officer and 
the parties, and identify the contentions on which it wishes to 
participate as a party, and make the disclosures required by Sec.
2.336(b)(3) through (b)(5) unless accompanied by an affidavit explaining 
why the disclosures cannot be provided to the parties with the notice.
    (2) Once the NRC staff chooses to participate as a party, it will 
have all the rights and responsibilities of a party with respect to the 
admitted contention/matter in controversy on which the staff chooses to 
participate.

[63 FR 66730, Dec. 3, 1998, as amended at 77 FR 46599, Aug. 3, 2012]



Sec.2.1319  Presiding Officer.

    (a) The Commission will ordinarily be the Presiding Officer at a 
hearing under this part. However, the Commission may provide in a 
hearing notice that one or more Commissioners, or any other person 
permitted by law, will preside.
    (b) A participant may submit a written motion for the 
disqualification of any person presiding. The motion shall be supported 
by an affidavit setting forth the alleged grounds for disqualification. 
If the Presiding Officer does not grant the motion or the person does 
not disqualify himself and the Presiding Officer or such other person is 
not the Commission or a Commissioner, the Commission will decide the 
matter.
    (c) If any person presiding deems himself or herself disqualified, 
he or she shall withdraw by notice on the record after notifying the 
Commission.
    (d) If a Presiding Officer becomes unavailable, the Commission will 
designate a replacement.
    (e) Any motion concerning the designation of a replacement Presiding 
Officer shall be made within 5 days after the designation.
    (f) Unless otherwise ordered by the Commission, the jurisdiction of 
a Presiding Officer other than the Commission commences as designated in 
the hearing notice and terminates upon certification of the hearing 
record to

[[Page 154]]

the Commission, or when the Presiding Officer is disqualified.



Sec.2.1320  Responsibility and power of the Presiding Officer 
in an oral hearing.

    (a) The Presiding Officer in any oral hearing shall conduct a fair 
hearing, develop a record that will contribute to informed 
decisionmaking, and, within the framework of the Commission's orders, 
have the power necessary to achieve these ends, including the power to:
    (1) Take action to avoid unnecessary delay and maintain order;
    (2) Dispose of procedural requests;
    (3) Question participants and witnesses, and entertain suggestions 
as to questions which may be asked of participants and witnesses.
    (4) Order consolidation of participants;
    (5) Establish the order of presentation;
    (6) Hold conferences before or during the hearing;
    (7) Establish time limits;
    (8) Limit the number of witnesses; and
    (9) Strike or reject duplicative, unreliable, immaterial, or 
irrelevant presentations.
    (b) Where the Commission itself does not preside:
    (1) The Presiding Officer may certify questions or refer rulings to 
the Commission for decision;
    (2) Any hearing order may be modified by the Commission; and
    (3) The Presiding Officer will certify the completed hearing record 
to the Commission, which may then issue its decision on the hearing or 
provide that additional testimony be presented.



Sec.2.1321  Participation and schedule for submission in a hearing 
consisting of written comments.

    Unless otherwise limited by this subpart or by the Commission, 
participants in a hearing consisting of written comments may submit:
    (a) Initial written statements of position and written testimony 
with supporting affidavits on the issues. These materials must be filed 
on the date set by the Commission or the presiding officer.
    (b) Written responses, rebuttal testimony with supporting affidavits 
directed to the initial statements and testimony of other participants, 
and proposed written questions for the Presiding Officer to consider for 
submittal to persons sponsoring testimony submitted under paragraph (a) 
of this section. These materials shall be filed within 20 days of the 
filing of the materials submitted under paragraph (a) of this section, 
unless the Commission or Presiding Officer directs otherwise. Proposed 
written questions directed to rebuttal testimony for the Presiding 
Officer to consider for submittal to persons offering such testimony 
shall be filed within 7 days of the filing of the rebuttal testimony.
    (c) Written concluding statements of position on the issues. These 
materials shall be filed within 20 days of the filing of the materials 
submitted under paragraph (b) of this section, unless the Commission or 
the Presiding Officer directs otherwise.

[63 FR 66730, Dec. 3, 1998, as amended at 69 FR 2271, Jan. 14, 2004; 77 
FR 46599, Aug. 3, 2012]



Sec.2.1322  Participation and schedule for submissions in an oral
hearing.

    (a) Unless otherwise limited by this subpart or by the Commission, 
participants in an oral hearing may submit and sponsor in the hearings:
    (1) Initial written statements of position and written testimony 
with supporting affidavits on the issues. These materials must be filed 
on the date set by the Commission or the presiding officer.
    (2)(i) Written responses and rebuttal testimony with supporting 
affidavits directed to the initial statements and testimony of other 
participants;
    (ii) Proposed questions for the Presiding Officer to consider for 
propounding to persons sponsoring testimony.
    (3) These materials must be filed within 20 days of the filing of 
the materials submitted under paragraph (a)(1) of this section, unless 
the Commission or Presiding Officer directs otherwise.
    (4) Proposed questions directed to rebuttal testimony for the 
Presiding Officer to consider for propounding to persons offering such 
testimony shall be

[[Page 155]]

filed within 7 days of the filing of the rebuttal testimony.
    (b) The oral hearing should commence within 65 days of the date of 
the Commission's notice granting a hearing unless the Commission or 
Presiding Officer directs otherwise. Ordinarily, questioning in the oral 
hearing will be conducted by the Presiding Officer, using either the 
Presiding Officer's questions or questions submitted by the participants 
or a combination of both.
    (c) Written post-hearing statements of position on the issues 
addressed in the oral hearing may be submitted within 20 days of the 
close of the oral hearing.
    (d) The Commission, on its own motion, or in response to a request 
from a Presiding Officer other than the Commission, may use additional 
procedures, such as direct and cross-examination, or may convene a 
formal hearing under subpart G of this part on specific and substantial 
disputes of fact, necessary for the Commission's decision, that cannot 
be resolved with sufficient accuracy except in a formal hearing. The 
staff will be a party in any such formal hearing. Neither the Commission 
nor the Presiding Officer will entertain motions from the parties that 
request such special procedures or formal hearings.

[63 FR 66730, Dec. 3, 1998, as amended at 69 FR 2271, Jan. 14, 2004]



Sec.2.1323  Presentation of testimony in an oral hearing.

    (a) All direct testimony in an oral hearing shall be filed no later 
than 15 days before the hearing or as otherwise ordered or allowed 
pursuant to the provisions of Sec.2.1322.
    (b) Written testimony will be received into evidence in exhibit 
form.
    (c) Participants may designate and present their own witnesses to 
the Presiding Officer.
    (d) Testimony for the NRC staff will be presented only by persons 
designated for that purpose by either the Executive Director for 
Operations or a delegee of the Executive Director for Operations.
    (e) Participants and witnesses will be questioned orally or in 
writing and only by the Presiding Officer. Questions may be addressed to 
individuals or to panels of participants or witnesses.
    (f) The Presiding Officer may accept written testimony from a person 
unable to appear at the hearing, and may request him or her to respond 
to questions.
    (g) No subpoenas will be granted at the request of participants for 
attendance and testimony of participants or witnesses or the production 
of evidence.

[63 FR 66730, Dec. 3, 1998, as amended at 69 FR 2271, Jan. 14, 2004]



Sec.2.1324  Appearance in an oral hearing.

    (a) A participant may appear in a hearing on her or his own behalf 
or be represented by an authorized representative.
    (b) A person appearing shall file a written notice stating her or 
his name, address and telephone number, and if an authorized 
representative, the basis of her or his eligibility and the name and 
address of the participant on whose behalf she or he appears.
    (c) A person may be excluded from a hearing for disorderly, dilatory 
or contemptuous conduct, provided he or she is informed of the grounds 
and given an opportunity to respond.



Sec.2.1325  Motions and requests.

    (a) Motions and requests shall be addressed to the Presiding 
Officer, and, if written, also filed with the Secretary and served on 
other participants.
    (b) Other participants may respond to the motion or request. 
Responses to written motions or requests shall be filed within 5 days 
after service unless the Commission or Presiding Officer directs 
otherwise.
    (c) The Presiding Officer may entertain motions for extension of 
time and changes in schedule in accordance with paragraphs (a) and (b) 
of this section.
    (d) When the Commission does not preside, in response to a motion or 
request, the Presiding Officer may refer a ruling or certify a question 
to the Commission for decision and notify the participants.
    (e) Unless otherwise ordered by the Commission, a motion or request, 
or

[[Page 156]]

the certification of a question or referral of a ruling, shall not stay 
or extend any aspect of the hearing.



Sec.2.1327  Application for a stay of the effectiveness of NRC staff
action on license transfer.

    (a) Any application for a stay of the effectiveness of the NRC 
staff's order on the license transfer application shall be filed with 
the Commission within 5 days of the issuance of the notice of staff 
action pursuant to Sec.2.1316(a).
    (b) An application for a stay must be no longer than 10 pages, 
exclusive of affidavits, and must contain:
    (1) A concise summary of the action which is requested to be stayed; 
and
    (2) A concise statement of the grounds for a stay, with reference to 
the factors specified in paragraph (d) of this section.
    (c) Within 10 days after service of an application for a stay under 
this section, any participant may file an answer supporting or opposing 
the granting of a stay. Answers must be no longer than 10 pages, 
exclusive of affidavits, and should concisely address the matters in 
paragraph (b) of this section, as appropriate. No further replies to 
answers will be entertained.
    (d) In determining whether to grant or deny an application for a 
stay, the Commission will consider:
    (1) Whether the requestor will be irreparably injured unless a stay 
is granted;
    (2) Whether the requestor has made a strong showing that it is 
likely to prevail on the merits;
    (3) Whether the granting of a stay would harm other participants; 
and
    (4) Where the public interest lies.



Sec.2.1331  Commission action.

    (a) Upon completion of a hearing, the Commission will issue a 
written opinion including its decision on the license transfer 
application and the reasons for the decision.
    (b) The decision on issues designated for hearing under Sec.2.309 
will be based on the record developed at hearing.

[63 FR 66730, Dec. 3, 1998, as amended at 69 FR 2271, Jan. 14, 2004]



           Subpart N_Expedited Proceedings with Oral Hearings

    Source: 69 FR 2271, Jan. 14, 2004, unless otherwise noted.



Sec.2.1400  Purpose and scope of subpart N.

    The purpose of this subpart is to provide simplified procedures for 
the expeditious resolution of disputes among parties in an informal 
hearing process. The provisions of this subpart, together with subpart C 
of this part, govern all adjudicatory proceedings conducted under the 
authority of the Atomic Energy Act of 1954, as amended, the Energy 
Reorganization Act of 1974, and 10 CFR part 2 except for proceedings on 
the licensing of the construction and operation of a uranium enrichment 
facility, proceedings on an initial application for authorization to 
construct a high-level radioactive waste repository at a geologic 
repository operations area noticed under Sec. Sec.2.101(f)(8) or 
2.105(a)(5), proceedings on an initial application for authorization to 
receive and possess high-level radioactive waste at a geologic 
repository operations area, proceedings on an initial application for a 
license to receive and possess high-level radioactive waste at a 
geologic repository operations area, proceedings on enforcement matters 
unless all parties otherwise agree and request the application of 
subpart N procedures, and proceedings for the direct or indirect control 
of an NRC license when the transfer requires prior approval of the NRC 
under the Commission's regulations, governing statutes, or pursuant to a 
license condition.



Sec.2.1401  Definitions.

    The definitions of terms in Sec.2.4 apply to this subpart unless a 
different definition is provided in this subpart.



Sec.2.1402  General procedures and limitations; requests for other
procedures.

    (a) Generally-applicable procedures. For proceedings conducted under 
this subpart:
    (1) Except where provided otherwise in this subpart or specifically 
requested by the presiding officer or the

[[Page 157]]

Commission, written pleadings and briefs (regardless of whether they are 
in the form of a letter, a formal legal submission, or otherwise) are 
not permitted;
    (2) Requests to schedule a conference to consider oral motions may 
be in writing and served on the Presiding officer and the parties;
    (3) Motions for summary disposition before the hearing has concluded 
and motions for reconsideration to the presiding officer or the 
Commission are not permitted;
    (4) All motions must be presented and argued orally;
    (5) The presiding officer will reflect all rulings on motions and 
other requests from the parties in a written decision. A verbatim 
transcript of oral rulings satisfies this requirement;
    (6) Except for the information disclosure requirements set forth in 
subpart C of this part, requests for discovery will not be entertained; 
and
    (7) The presiding officer may issue written orders and rulings 
necessary for the orderly and effective conduct of the proceeding;
    (b) Other procedures. If it becomes apparent at any time before a 
hearing is held that a proceeding selected for adjudication under this 
subpart is not appropriate for application of this subpart, the 
presiding officer or the Commission may, on its own motion or at the 
request of a party, order the proceeding to continue under another 
appropriate subpart. If a proceeding under this subpart is discontinued 
because the proceeding is not appropriate for application of this 
subpart, the presiding officer may issue written orders necessary for 
the orderly continuation of the hearing process under another subpart.
    (c) Request for cross-examination. A party may present an oral 
motion to the presiding officer to permit cross-examination by the 
parties on particular admitted contentions or issues. The presiding 
officer may allow cross-examination by the parties if he or she 
determines that cross-examination by the parties is necessary for the 
development of an adequate record for decision.



Sec.2.1403  Authority and role of the NRC staff.

    (a) During the pendency of any hearing under this subpart, 
consistent with the NRC staff's findings in its review of the 
application or matter that is the subject of the hearing and as 
authorized by law, the NRC staff is expected to promptly issue its 
approval or denial of the application, or take other appropriate action 
on the matter that is the subject of the hearing. When the NRC staff 
takes its action, it must notify the presiding officer and the parties 
to the proceeding of its action. That notice must include the NRC 
staff's explanation why the public health and safety is protected and 
why the action is in accord with the common defense and security despite 
the pendency of the contested matter before the presiding officer. The 
NRC staff's action on the matter is effective upon issuance, except in 
matters involving:
    (1) An application to construct and/or operate a production or 
utilization facility;
    (2) An application for the construction and operation of an 
independent spent fuel storage installation located at a site other than 
a reactor site or a monitored retrievable storage facility under 10 CFR 
part 72; or
    (3) Production or utilization facility licensing actions that 
involve significant hazards considerations as defined in 10 CFR 50.92.
    (b)(1) The NRC staff is not required to be a party to proceedings 
under this subpart, except where:
    (i) The proceeding involves an application denied by the NRC staff 
or an enforcement action proposed by the staff; or
    (ii) The presiding officer determines that the resolution of any 
issue in the proceeding would be aided materially by the NRC staff's 
participation in the proceeding as a party and orders the staff to 
participate as a party for the identified issue. In the event that the 
presiding officer determines that the NRC staff's participation is 
necessary, the presiding officer shall issue an order identifying the 
issue(s) on which the staff is to participate as well as setting forth 
the basis for the determination that staff participation will

[[Page 158]]

materially aid in resolution of the issue(s).
    (2) Within fifteen (15) days of the issuance of the order granting 
requests for hearing/petitions to intervene and admitting contentions, 
the NRC staff shall notify the presiding officer and the parties whether 
it desires to participate as a party, and identify the contentions on 
which it wishes to participate as a party. If the NRC staff desires to 
be a party thereafter, the NRC staff shall notify the presiding officer 
and the parties, identify the contentions on which it wishes to 
participate as a party, and make the disclosures required by Sec.
2.336(b)(3) through (5) unless accompanied by an affidavit explaining 
why the disclosures cannot be provided to the parties with the notice.
    (3) Once the NRC staff chooses to participate as a party, it shall 
have all the rights and responsibilities of a party with respect to the 
admitted contention/matter in controversy on which the staff chooses to 
participate.

[69 FR 2271, Jan. 14, 2004, as amended at 77 FR 46599, Aug. 3, 2012]



Sec.2.1404  Prehearing conference.

    (a) No later than forty (40) days after the order granting requests 
for hearing/petitions to intervene, the presiding officer shall conduct 
a prehearing conference. At the discretion of the presiding officer, the 
prehearing conference may be held in person or by telephone or through 
the use of video conference technology.
    (b) At the prehearing conference, each party shall provide the 
presiding officer and the parties participating in the conference with a 
statement identifying each witness the party plans to present at the 
hearing and a written summary of the oral and written testimony of each 
proposed witness. If the prehearing conference is not held in person, 
each party shall forward the summaries of the party's witnesses' 
testimony to the presiding officer and the other parties by such means 
that will ensure the receipt of the summaries by the commencement of the 
prehearing conference.
    (c) At the prehearing conference, the parties shall describe the 
results of their efforts to settle their disputes or narrow the 
contentions that remain for hearing, provide an agreed statement of 
facts, if any, identify witnesses that they propose to present at 
hearing, provide questions or question areas that they would propose to 
have the presiding officer cover with the witnesses at the hearing, and 
discuss other pertinent matters. At the conclusion of the conference, 
the presiding officer will issue an order specifying the issues to be 
addressed at the hearing and setting forth any agreements reached by the 
parties. The order must include the scheduled date for any hearing that 
remains to be held, and address any other matters as appropriate.



Sec.2.1405  Hearing.

    (a) No later than twenty (20) days after the conclusion of the 
prehearing conference, the presiding officer shall hold a hearing on any 
contention that remains in dispute. At the beginning of the hearing, the 
presiding officer shall enter into the record all agreements reached by 
the parties before the hearing.
    (b) A hearing will be recorded stenographically or by other means, 
under the supervision of the presiding officer. A transcript will be 
prepared from the recording that will be the sole official transcript of 
the hearing. The transcript will be prepared by an official reporter who 
may be designated by the Commission or may be a regular employee of the 
Commission. Except as limited by section 181 of the Act or order of the 
Commission, the transcript will be available for inspection in the 
agency's public records system. Copies of transcripts are available to 
the parties and to the public from the official reporter on payment of 
the charges fixed therefor. If a hearing is recorded on videotape or 
other video medium, copies of the recording of each daily session of the 
hearing may be made available to the parties and to the public from the 
presiding officer upon payment of a charge fixed by the Chief 
Administrative Judge. Parties may purchase copies of the transcript from 
the reporter.
    (c) Hearings will be open to the public, unless portions of the 
hearings involving proprietary or other protectable information are 
closed in

[[Page 159]]

accordance with the Commission's regulations.
    (d) At the hearing, the presiding officer will not receive oral 
evidence that is irrelevant, immaterial, unreliable or unduly 
repetitious. Testimony will be under oath or affirmation.
    (e) The presiding officer may question witnesses who testify at the 
hearing, but the parties may not do so.
    (f) Each party may present oral argument and a final statement of 
position at the close of the hearing. Written post-hearing briefs and 
proposed findings are not permitted unless ordered by the presiding 
officer.



Sec.2.1406  Initial decision--issuance and effectiveness.

    (a) Where practicable, the presiding officer will render a decision 
from the bench. In rendering a decision from the bench, the presiding 
officer shall state the issues in the proceeding and make clear its 
findings of fact and conclusions of law on each issue. The presiding 
officer's decision and order must be reduced to writing and transmitted 
to the parties as soon as practicable, but not later than twenty (20) 
days, after the hearing ends. If a decision is not rendered from the 
bench, a written decision and order will be issued not later than thirty 
(30) days after the hearing ends. Approval of the Chief Administrative 
Judge must be obtained for an extension of these time periods, and in no 
event may a written decision and order be issued later than sixty (60) 
days after the hearing ends without the express approval of the 
Commission.
    (b) The presiding officer's written decision must be served on the 
parties and filed with the Commission when issued.
    (c) The presiding officer's initial decision is effective and 
constitutes the final action of the Commission twenty-five (25) days 
after the date of issuance of the written decision unless any party 
appeals to the Commission in accordance with Sec.2.1407 or the 
Commission takes review of the decision sua sponte or the regulations in 
this part specify other requirements with regard to the effectiveness of 
decisions on certain applications.

[69 FR 2271, Jan. 14, 2004, as amended at 79 FR 66602, Nov. 10, 2014]



Sec.2.1407  Appeal and Commission review of initial decision.

    (a)(1) Within 25 days after service of a written initial decision, a 
party may file a written appeal seeking the Commission's review on the 
grounds specified in paragraph (b) of this section. Unless otherwise 
authorized by law, a party must file an appeal with the Commission 
before seeking judicial review.
    (2) An appeal under this section may not be longer than twenty (20) 
pages and must contain the following:
    (i) A concise statement of the specific rulings and decisions that 
are being appealed;
    (ii) A concise statement (including record citations) where the 
matters of fact or law raised in the appeal were previously raised 
before the presiding officer and, if they were not, why they could not 
have been raised;
    (iii) A concise statement why, in the appellant's view, the decision 
or action is erroneous; and
    (iv) A concise statement why the Commission should review the 
decision or action, with particular reference to the grounds specified 
in paragraph (b) of this section.
    (3) Any other party to the proceeding may, within 25 days after 
service of the appeal, file an answer supporting or opposing the appeal. 
The answer may not be longer than 20 pages and should concisely address 
the matters specified in paragraph (a)(2) of this section. The appellant 
does not have a right to reply. Unless it directs additional filings or 
oral arguments, the Commission will decide the appeal on the basis of 
the filings permitted by this paragraph.
    (b) In considering the appeal, the Commission will give due weight 
to the existence of a substantial question with respect to the following 
considerations:
    (1) A finding of material fact is clearly erroneous or in conflict 
with a finding as to the same fact in a different proceeding;
    (2) A necessary legal conclusion is without governing precedent or 
is a departure from, or contrary to, established law;
    (3) A substantial and important question of law, policy or 
discretion has been raised by the appeal;

[[Page 160]]

    (4) The conduct of the proceeding involved a prejudicial procedural 
error; or
    (5) Any other consideration which the Commission may deem to be in 
the public interest.
    (c) Once a decision becomes final agency action, the Secretary shall 
transmit the decision to the NRC staff for action in accordance with the 
decision.

[69 FR 2271, Jan. 14, 2004, as amended at 77 FR 46599, Aug. 3, 2012]



                     Subpart O_Legislative Hearings

    Source: 69 FR 2273, Jan. 14, 2004, unless otherwise noted.



Sec.2.1500  Purpose and scope.

    The purpose of this subpart is to provide for simplified, 
legislative hearing procedures to be used, at the Commission's sole 
discretion, in:
    (a) Any design certification rulemaking hearings under subpart B of 
part 52 of this chapter that the Commission may choose to conduct; and
    (b) Developing a record to assist the Commission in resolving, under 
Sec.2.335(d), a petition filed under Sec.2.335(b).



Sec.2.1501  Definitions.

    Demonstrative information means physical things, not constituting 
documentary information.
    Documentary information means information, ordinarily contained in 
documents or electronic files, but may also include photographs and 
digital audio files.



Sec.2.1502  Commission decision to hold legislative hearing.

    (a) The Commission may, in its discretion, hold a legislative 
hearing in either a design certification rulemaking under Sec.52.51(b) 
of this chapter, or a proceeding where a question has been certified to 
it under Sec.2.335(d).
    (b) Notice of Commission decision--(1) Hearing in design 
certification rulemakings. If, at the time a proposed design 
certification rule is published in the Federal Register under Sec.
52.51(a) of this chapter, the Commission decides that a legislative 
hearing should be held, the information required by paragraph (c) of 
this section must be included in the Federal Register notice for the 
proposed design certification rule. If, following the submission of 
written public comments submitted on the proposed design certification 
rule which are submitted in accordance with Sec.52.51(a) of this 
chapter, the Commission decides to conduct a legislative hearing, the 
Commission shall publish a notice in the Federal Register and on the NRC 
Web site indicating its determination to conduct a legislative hearing. 
The notice shall contain the information specified in paragraph (c) of 
this section, and specify whether the Commission or a presiding officer 
will conduct the legislative hearing.
    (2) Hearings under Sec.2.335(d). If, following a certification of 
a question to the Commission by a Licensing Board under Sec.2.335(d), 
the Commission decides to hold a legislative hearing to assist it in 
resolving the certified question, the Commission shall issue an order 
containing the information required by paragraph (c) of this section. 
The Commission shall serve the order on all parties in the proceeding. 
In addition, if the Commission decides that persons and entities other 
than those identified in paragraph (c)(2) may request to participate in 
the legislative hearing, the Commission shall publish a notice of its 
determination to hold a legislative hearing in the Federal Register and 
on the NRC Web site. The notice shall contain the information specified 
in paragraph (c) of this section, and refer to the criteria in Sec.
2.1504 which will be used in determining requests to participate in the 
legislative hearing.
    (c) If the Commission decides to hold a legislative hearing, it 
shall, in accordance with paragraph (b) of this section:
    (1) Identify with specificity the issues on which it wishes to 
compile a record;
    (2) Identify, in a hearing associated with a question certified to 
the Commission under Sec.2.335(d), the parties and interested 
State(s), governmental bodies, and Federally-recognized Indian Tribe 
under Sec.2.315(c), who may participate in the legislative hearing;

[[Page 161]]

    (3) Identify persons and entities that may, in the discretion of the 
Commission, be invited to participate in the legislative hearing;
    (4) Indicate whether other persons and entities may request, in 
accordance with Sec.2.1504, to participate in the legislative hearing, 
and the criteria that the Commission or presiding officer will use in 
determining whether to permit such participation;
    (5) Indicate whether the Commission or a presiding officer will 
conduct the legislative hearing;
    (6) Specify any special procedures to be used in the legislative 
hearing;
    (7) Set the dates for submission of requests to participate in the 
legislative hearing, submission of written statements and demonstrative 
and documentary information, and commencement of the oral hearing; and
    (8) Specify the location where the oral hearing is to be held. 
Ordinarily, oral hearings will be held in the Washington, DC 
metropolitan area.



Sec.2.1503  Authority of presiding officer.

    If the Commission appoints a presiding officer to conduct the 
legislative hearing, the presiding officer shall be responsible for 
expeditious development of a sufficient record on the Commission-
identified issues, consistent with the direction provided by the 
Commission under Sec.2.1502(c). The presiding officer has the 
authority otherwise accorded to it under Sec. Sec.2.319(a), (c), (e), 
(g), (h), and (i), 2.324, and 2.333 to control the course of the 
proceeding, and may exercise any other authority granted to it by the 
Commission in accordance with Sec.2.1502(c)(6).



Sec.2.1504  Request to participate in legislative hearing.

    (a) Any person or entity who wishes to participate in a legislative 
hearing noticed under either Sec.2.1502(b)(1) or (b)(2) shall submit a 
request to participate by the date specified in the notice. The request 
must address:
    (1) A summary of the person's position on the subject matter of the 
legislative hearing; and
    (2) The specific information, expertise or experience that the 
person possesses with respect to the subject matter of the legislative 
hearing.
    (b) The Commission or presiding officer shall, within ten (10) days 
of the date specified for submission of requests to participate, 
determine whether the person or entity has met the criteria specified by 
the Commission under Sec.2.1502(c)(4) for determining requests to 
participate in the legislative hearing, and issue an order to that 
person or entity informing them of the presiding officer's decision. A 
presiding officer's determinations in this regard are final and not 
subject to any motion for reconsideration or appeal to the Commission; 
and the Commission's determination in this regard are final and are not 
subject to a motion for reconsideration.



Sec.2.1505  Role of the NRC staff.

    The NRC staff shall be available to answer any Commission or 
presiding officer's questions on staff-prepared documents, provide 
additional information or documentation that may be available to the 
staff, and provide other assistance that the Commission or presiding 
officer may request without requiring the NRC staff to assume the role 
of an advocate. The NRC staff may request to participate in the 
legislative hearing by providing notice to the Commission or presiding 
officer, as applicable, within the time period established for 
submitting a request to participate; or if no notice is provided under 
Sec.2.1502(b)(2), within ten (10) days of the Commission's order 
announcing its determination to conduct a legislative hearing.



Sec.2.1506  Written statements and submission of information.

    All participants shall file written statements on the Commission-
identified issues, and may submit documentary and demonstrative 
information. Written statements, copies of documentary information, and 
a list and short description of any demonstrative information to be 
submitted must be received by the NRC (and in a hearing on issues 
stemming from a Sec.2.335(b) petition, by the parties in the 
proceeding in which the petition was filed) no later than ten (10) days 
before the commencement of the oral hearing.

[[Page 162]]



Sec.2.1507  Oral hearing.

    (a) Not less than five (5) days before the commencement of the oral 
hearing, the presiding officer shall issue an order setting forth the 
grouping and order of appearance of the witnesses at the oral hearing. 
The order shall be filed upon all participants by email or facsimile 
transmission if possible, otherwise by overnight mail.
    (b) The Commission or presiding officer may question witnesses. 
Neither the Commission nor the presiding officer will ordinarily permit 
participants to submit recommended questions for the Commission or 
presiding officer to propound to witnesses. However, if the Commission 
or presiding officer believe that the conduct of the oral hearing will 
be expedited and that consideration of such proposed questions will 
assist in developing a more focused hearing record, the Commission or 
presiding officer may, in its discretion, permit the participants to 
submit recommended questions for the Commission or presiding officer's 
consideration.
    (c) The Commission or presiding officer may request, or upon request 
of a participant may, in the presiding officer's discretion, permit the 
submission of additional information following the close of the oral 
hearing. Such information must be submitted no later than five (5) days 
after the close of the oral hearing and must be served at the same time 
upon all participants at the oral hearing.



Sec.2.1508  Recommendation of presiding officer.

    (a) If the Commission is not acting as a presiding officer, the 
presiding officer shall, within thirty (30) days following the close of 
the legislative hearing record, certify the record to the Commission on 
each of the issues identified by the Commission.
    (b) The presiding officer's certification for each Commission-
identified issue shall contain:
    (1) A transcript of the oral phase of the legislative hearing;
    (2) A list of all participants;
    (3) A list of all witnesses at the oral hearing, and their 
affiliation with a participant;
    (4) A list, and copies of, all documentary information submitted by 
the participants with ADAMS accession numbers;
    (5) All demonstrative information submitted by the participants;
    (6) Any written answers submitted by the NRC staff in response to 
questions posed by the presiding officer with ADAMS accession numbers;
    (7) A certification that all documentary information has been 
entered into ADAMS, and have been placed on the NRC Web site unless 
otherwise protected from public disclosure;
    (8) A certification by the presiding officer that the record 
contains sufficient information for the Commission to make a reasoned 
determination on the Commission-identified issue; and
    (9) At the option of the presiding officer, a summary of the 
information in the record and a proposed resolution of the Commission-
identified issue with a supporting basis.



Sec.2.1509  Ex parte communications and separation of functions.

    Section 2.347 applies in a legislative hearing. Section 2.348 
applies in a legislative hearing only where the hearing addresses an 
issue certified to the Commission under Sec.2.335(d), and then only 
with respect to the underlying contested matter.



                  Sec. Appendix A to Part 2 [Reserved]



   Sec. Appendix B to 10 CFR Part 2--Model Milestones To Be Used By a 
 Presiding Officer as a Guideline in Developing a Hearing Schedule for 
  the Conduct of an Adjudicatory Proceeding in Accordance With 10 CFR 
                                 2.332.

  I. Model Milestones for a Hearing on an Enforcement Action Conducted 
                     Under 10 CFR Part 2, Subpart G

    These model milestones would apply to enforcement proceedings 
conducted under 10 CFR Part 2, Subpart G. As required by 10 CFR 2.332 
and 2.334, the presiding officer establishes, by order, a schedule for 
the conduct of the proceeding. In establishing a schedule, the presiding 
officer should use these milestones as a starting point, make 
appropriate modifications to the milestones, and set detailed schedules 
(e.g., for filings) based upon all relevant information. Such

[[Page 163]]

information would include, but not be limited to, the complexity of the 
issues, any other relevant consideration that a party brings to the 
attention of the presiding officer, and the NRC's interest in providing 
a fair and expeditious resolution of the issues to be adjudicated in the 
proceeding. The model milestones are based on the Commission's Rules of 
Practice in 10 CFR Part 2, Subparts B, C, and G.
    The model milestones are based upon the following assumptions: (i) 
the issues to be litigated will involve both disputes over fact and 
issues of compliance with the Commission's regulations and requirements; 
and (ii) no petitions to intervene are filed pursuant to 10 CFR 
2.309(a)-(b). The model milestones reflect electronic filing and service 
in accordance with 10 CFR 2.305. In some cases, preparation of direct 
testimony and motions for summary disposition can proceed once initial 
mandatory disclosures have been made. The time periods set forth in the 
model milestones reflect these assumptions.

                            Model Milestones
                       [10 CFR Part 2, Subpart G]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
 Within 20 days of date   Person subject to order
 of enforcement order:                       files answer; if order
                                             immediately effective,
                                             motion to set aside
                                             immediate effectiveness
                                             due; requests for hearing
                                             due.
 Within 100 days of       Presiding officer issues
 enforcement order:                          order on hearing request by
                                             person who is subject of
                                             enforcement order.
 Within 25 days of        Presiding officer sets
 presiding officer decision granting         initial schedule for the
 hearing:                                    proceeding.
 Within 145 days of       Discovery complete.
 presiding officer decision granting
 hearing:
 Within 155 days of       Motions for summary
 presiding officer decision granting         disposition due.
 hearing:
 Within 235 days of       Presiding officer decisions
 presiding officer decision granting         on motions for summary
 hearing:                                    disposition.
 Within 245 days of       Prehearing conference
 presiding officer decision granting         (optional); presiding
 hearing:                                    officer sets schedule for
                                             remainder of proceeding.
 Within 275 days of       Written testimony filed.
 presiding officer decision granting
 hearing:
 Within 90 days of end    Presiding officer issues
 of evidentiary hearing and closing of       initial decision.
 record:
------------------------------------------------------------------------

II. Model Milestones for Hearings Conducted Under 10 CFR Part 2, Subpart 
                                    L

    These model milestones would apply to proceedings conducted under 10 
CFR Part 2, Subpart L, including those on applications for combined 
licenses (COLs), renewed licenses, and license amendments. While such 
proceedings differ insofar as the scope and complexity of the NRC staff 
reviews for the requested actions may vary, such differences will be 
reflected in the staff's schedule for issuing its review documents in a 
particular type of action. Because the milestones are keyed to the 
staff's review schedule, separate milestones are not identified for 
proceedings on the different types of actions.
    As required by 10 CFR 2.332 and 2.334, the presiding officer 
establishes, by order, a schedule for the conduct of each proceeding. In 
establishing a schedule, the presiding officer should use these 
milestones as a starting point, make appropriate modifications to the 
milestones, and set detailed schedules (e.g., for filings) based upon 
all relevant information. Such information would include, but not be 
limited to, the number of contentions admitted, the complexity of the 
issues, the NRC staff's schedule for completion of its safety and 
environmental evaluations, any other relevant consideration that a party 
brings to the attention of the presiding officer, and the NRC's interest 
in providing a fair and expeditious resolution of the issues sought to 
be admitted for adjudication in the proceeding. The model milestones are 
based on the Commission's Rules of Practice in 10 CFR Part 2, Subparts 
B, C, and L.
    The model milestones include only the most significant events in the 
proceeding and are based upon the following assumptions: (I) the issues 
to be litigated will involve both disputes over fact and issues of 
compliance with the Commission's regulations and requirements; (ii) an 
oral hearing under 10 CFR 2.1207 will be held rather than a written 
hearing under 10 CFR 2.1208; and (iii) the final Safety Evaluation 
Report (SER) and final environmental document will be issued 
simultaneously. The model milestones reflect electronic filing and 
service in accordance with 10 CFR 2.305.

                            Model Milestones
                       [10 CFR Part 2, Subpart L]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
 Within 140 of            Presiding officer decision
 publication days of notice in Federal       on intervention petitions
 Register:                                   and admission of
                                             contentions.
 Within 55 days of        Presiding officer to set
 presiding officer decision granting         initial schedule for
 intervention and admitting contentions:     proceeding, based on staff
                                             schedule for issuing draft
                                             and final SERs and any
                                             necessary NEPA document.
 Within 30 days of        Proposed late-filed
 issuance of SER and any necessary NEPA      contentions on SER and
 document:                                   necessary NEPA documents
                                             filed; motions for summary
                                             disposition on previously
                                             admitted contentions due.
 Within 85 days of        Presiding officer decision
 issuance of SER and NEPA document:          on admission of proposed
                                             late-filed contentions and
                                             motions for summary
                                             disposition; presiding
                                             officer sets schedule for
                                             remainder of proceeding.

[[Page 164]]

 
 Within 14 days after     All parties complete updates
 presiding officer decision on amended/      of mandatory disclosures.
 late-filed contentions:
 Within 115 days of       Motions for summary
 issuance of SER and NEPA document:          disposition due.
 Within 155 days of       Written direct testimony
 issuance of SER and NEPA document:          filed.
 Within 175 days of       Evidentiary hearing begins.
 issuance of SER and NEPA document:
 Within 90 days of end    Presiding officer issues
 of evidentiary hearing and closing of       initial decision.
 record:
------------------------------------------------------------------------

III. Model Milestones for a Hearing on a Transfer of a License Conducted 
                     Under 10 CFR Part 2, Subpart M

    These model milestones would apply to proceedings conducted under 10 
CFR Part 2, Subpart M on applications for license transfer. As required 
by 10 CFR 2.332 and 2.334, the presiding officer establishes, by order, 
a schedule for the conduct of each proceeding. In establishing a 
schedule, the presiding officer should use these milestones as a 
starting point, make appropriate modifications to the milestones, and 
set detailed schedules (e.g., for filings) based upon all relevant 
information. Such information would include, but not be limited to, the 
number of contentions admitted, the complexity of the issues, the NRC 
staff's schedule for completion of its safety and environmental 
evaluations, any other relevant consideration that a party brings to the 
attention of the presiding officer, and the NRC's interest in providing 
a fair and expeditious resolution of the issues sought to be admitted 
for adjudication in the proceeding. The model milestones are based on 
the Commission's Rules of Practice in 10 CFR Part 2, Subparts B, C and 
M.
    The model milestones include only the most significant events in the 
proceeding, and are based upon the following assumptions: (i) The issues 
to be litigated will involve both disputes over fact and issues of 
compliance with the Commission's regulations and requirements; (ii) the 
parties do not file a joint request under 10 CFR 2.1308 for a hearing 
consisting of written comments; (iii) the final Safety Evaluation Report 
(SER) is not necessary to resolve the issues to be litigated; (iv) the 
Commission itself does not serve as the presiding officer; and (v) the 
Commission does not order further taking of testimony after the 
presiding officer certifies the record to the Commission under 10 CFR 
2.1319(f). The model milestones reflect electronic filing and service in 
accordance with 10 CFR 2.305.

                            Model Milestones
                       [10 CFR Part 2, Subpart M]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
 Within 100 days of       Presiding officer decision
 publication of Federal Register notice of   on intervention petitions
 opportunity for hearing:                    and admission of
                                             contentions.
 Within 30 days of order  NRC staff and other parties
 granting hearing petitions:                 complete mandatory
                                             disclosures.
 Within 12 days of        Presiding Officer issues
 completion of mandatory disclosures:        scheduling order to
                                             address, inter alia,
                                             scheduling of oral hearing,
                                             filing of written
                                             statements of position,
                                             direct testimony, and
                                             rebuttal testimony.
 Within 45 days of        Oral hearing commences.
 scheduling order:
 Within 25 days after     Presiding officer certifies
 hearing ends:                               hearing record to the
                                             Commission.
------------------------------------------------------------------------

 IV. Model Milestones for a Hearing on an Enforcement Action Conducted 
                     Under 10 CFR Part 2, Subpart N

    These model milestones would apply to enforcement proceedings 
conducted under 10 CFR Part 2, Subpart N. As required by 10 CFR 2.332 
and 2.334, the presiding officer establishes, by order, a schedule for 
the conduct of each proceeding. In establishing a schedule, the 
presiding officer should use these milestones as a starting point, make 
appropriate modifications to the milestones, and set detailed schedules 
based upon all relevant information. The model milestones are based on 
the Commission's Rules of Practice in 10 CFR Part 2, Subparts B, C, and 
N.
    The model milestones are based upon the following assumptions: (i) 
The issues to be litigated will involve both disputes over fact and 
issues of compliance with the Commission's regulations and requirements; 
and (ii) no petitions to intervene are filed pursuant to 10 CFR 
2.309(a)-(b). The model milestones reflect electronic filing and service 
in accordance with 10 CFR 2.305. The only discovery provided is the 
mandatory disclosure made by each party pursuant to 10 CFR 2.336.

                            Model Milestones
                       [10 CFR Part 2, Subpart N]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
 Within 20 of date of     Person subject to order
 enforcement order:                          files answer; if order
                                             immediately effective,
                                             motion to set aside
                                             immediate effectiveness
                                             due; requests for hearing
                                             due, including joint motion
                                             to use Subpart N
                                             procedures.

[[Page 165]]

 
 Within 50 days of date   Presiding officer decision
 of enforcement order:                       on requests for hearing and
                                             confirms use of Subpart N
                                             procedures (note: if
                                             presiding officer concludes
                                             that Subpart N procedures
                                             should not be used, the
                                             Model Milestone for
                                             Enforcement Actions under
                                             Subpart G are applicable).
 Within 30 days of        Mandatory disclosures
 presiding officer decision granting         complete.
 hearing:
 Within 40 days of        Prehearing conference to
 presiding officer decision granting         specify issues for hearing
 hearing:                                    and set schedules for
                                             remaining course of
                                             proceeding.
 Within 60 days of        Evidentiary hearing begins.
 presiding officer decision granting
 hearing:
 Within 30 days of end    Presiding officer issues
 of evidentiary hearing and closing of       initial decision.
 record:
------------------------------------------------------------------------


[70 FR 20462, Apr. 20, 2005]



                  Sec. Appendix C to Part 2 [Reserved]



Sec. Appendix D to Part 2--Schedule for the Proceeding on Consideration 
     of Construction Authorization for a High-Level Waste Geologic 
                               Repository.

------------------------------------------------------------------------
 Day          Regulation (10 CFR)                     Action
------------------------------------------------------------------------
    0  2.101(f)(8), 2.105(a)(5)........  Federal Register Notice of
                                          Hearing.
   30  2.309(b)(2).....................  Petition to intervene/request
                                          for hearing, w/contentions.
   30  2.309(b)(2).....................  Petition for status as
                                          interested government
                                          participant.
   55  2.315(c)........................  Answers to intervention &
                                          interested government
                                          participant Petitions.
   62  2.309(h)(1).....................  Petitioner's response to
                                          answers.
   70  2.1021..........................  First Prehearing conference.
  100  2.309(h)(2).....................  First Prehearing Conference
                                          Order identifying participants
                                          in proceeding, admitted
                                          contentions, and setting
                                          discovery and other schedules.
  110  2.1021..........................  Appeals from First Prehearing
                                          Conference Order.
  120  ................................  Briefs in opposition to
                                          appeals.
  150  2.1021, 2.329...................  Commission ruling on appeals
                                          for First Prehearing
                                          Conference Order.
  548  ................................  NRC Staff issues SER.
  578  2.1022..........................  Second Prehearing Conference.
  608  2.1021, 2.1022..................  Discovery complete; Second
                                          Prehearing Conference Order
                                          finalizes issues for hearing
                                          and sets schedule for prefiled
                                          testimony and hearing.
  618  2.1015(b).......................  Appeals from Second Prehearing
                                          Conference Order.
  628  2.1015(b), c.f. 2.710(a)........  Briefs in opposition to
                                          appeals; last date for filing
                                          motions for summary
                                          disposition.
  648  c.f. 2.710(a)...................  Last date for responses to
                                          summary disposition motions.
  658  2.710(a)........................  Commission ruling on appeals
                                          from Second Prehearing
                                          Conference Order; last date
                                          for party opposing summary
                                          disposition motion to file
                                          response to new facts and
                                          arguments in any response
                                          supporting summary disposition
                                          motion.
  698  2.1015(b).......................  Decision on summary disposition
                                          motions (may be determination
                                          to dismiss or to hold in
                                          abeyance).
  720  c.f. 2.710(a)...................  Evidentiary hearing begins.
  810  ................................  Evidentiary hearing ends.
  840  2.712(a)(1).....................  Applicant's proposed findings.
  850  2.712(a)(2).....................  Other parties' proposed
                                          findings.
  855  2.712(a)(3).....................  Applicant's reply to other
                                          parties' proposed findings.
  955  2.713...........................  Initial decision.
  965  2.342(a), 2.345(a), 2.1015(c)(1)  Stay motion. Petition for
                                          reconsideration, notice of
                                          appeal.
  975  2.342(d), 2.345(b)..............  Other parties' responses to
                                          stay motion and Petitions for
                                          reconsideration.
  985  ................................  Commission ruling on stay
                                          motion.
  995  2.1015(c)(2)....................  Appellant's briefs.
 1015  2.1015(c)(3)....................  Appellee's briefs.
 1055  2.1023 Supp. Info...............  Completion of NMSS and
                                          Commission supervisory review;
                                          issuance of construction
                                          authorization; NWPA 3-year
                                          period tolled.
 1125  ................................  Commission decision.
------------------------------------------------------------------------


[69 FR 2275, Jan. 14, 2004; 69 FR 25997, May 11, 2004]



PART 4_NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES
RECEIVING FEDERAL FINANCIAL ASSISTANCE FROM THE COMMISSION--
Table of Contents



                           General Provisions

Sec.
4.1 Purpose and scope.
4.2 Subparts.
4.3 Application of this part.
4.4 Definitions.
4.5 Communications and reports.
4.6 Maintenance of records.
4.8 Information collection requirements: OMB approval.

 Subpart A_Regulations Implementing Title VI of the Civil Rights Act of 
       1964 and Title IV of the Energy Reorganization Act of 1974

                        Discrimination Prohibited

4.11 General prohibition.

[[Page 166]]

4.12 Specific discriminatory actions prohibited.
4.13 Employment practices.
4.14 Medical emergencies.

                           Assurances Required

4.21 General requirements.
4.22 Continuing Federal financial assistance.
4.24 Assurances from institutions.

                         Compliance Information

4.31 Cooperation and assistance.
4.32 Compliance reports.
4.33 Access to sources of information.
4.34 Information to beneficiaries and participants.

                        Conduct of Investigations

4.41 Periodic compliance reviews.
4.42 Complaints.
4.43 Investigations.
4.44 Resolution of matters.
4.45 Intimidatory or retaliatory acts prohibited.

                      Means of Effecting Compliance

4.46 Means available.
4.47 Noncompliance with Sec.4.21.
4.48 Termination of or refusal to grant or to continue Federal financial 
          assistance.
4.49 Other means authorized by law.

                         Opportunity for Hearing

4.51 Notice of opportunity for hearing.

                          Hearings and Findings

4.61 Presiding officer.
4.62 Right to counsel.
4.63 Procedures, evidence, and record.
4.64 Consolidated or joint hearings.

                          Decisions and Notices

4.71 Initial decision or certification.
4.72 Exceptions and final decision.
4.73 Rulings required.
4.74 Content of orders.
4.75 Post termination proceedings.

                             Judicial Review

4.81 Judicial review.

           Effect on Other Regulations; Forms and Instructions

4.91 Effect on other regulations.
4.92 Forms and instructions.
4.93 Supervision and coordination.

Subpart B_Regulations Implementing Section 504 of the Rehabilitation Act 
                           of 1973, as Amended

4.101 Definitions.

                        Discriminatory Practices

4.121 General prohibitions against discrimination.
4.122 General prohibitions against employment discrimination.
4.123 Reasonable accommodation.
4.124 Employment criteria.
4.125 Preemployment inquiries.
4.126 General requirement concerning accessibility.
4.127 Existing facilities.
4.128 New construction.

                               Enforcement

4.231 Responsibility of applicants and recipients.
4.232 Notice.
4.233 Enforcement procedures.

 Subpart C_Regulations Implementing the Age Discrimination Act of 1975, 
                               as Amended

                                 General

4.301 Purpose and scope.
4.302 Application of this subpart.
4.303 Definitions.

              Standards for Determining Age Discrimination

4.311 Rules against age discrimination.
4.312 Definitions of ``normal operation'' and ``statutory objective''.
4.313 Exceptions to the rules against age discrimination. Normal 
          operation or statutory objective of any program or activity.
4.314 Exceptions to the rules against age discrimination. Reasonable 
          factors other than age.
4.315 Burden of proof.

                        Duties of NRC Recipients

4.321 Assurance of compliance.
4.322 Written notice, technical assistance, and educational materials.
4.324 Information requirements.

         Investigation, Conciliation, and Enforcement Procedures

4.331 Compliance reviews.
4.332 Complaints.
4.333 Mediation.
4.334 Investigation.
4.335 Prohibition against intimidation or retaliation.
4.336 Compliance procedure.
4.337 Hearings, descisions, post-termination proceedings.
4.338 Remedial and affirmative action by recipients.
4.339 Alternate funds disbursal procedure.
4.340 Exhaustion of administrative remedies.
4.341 Reports.

[[Page 167]]

Subpart D [Reserved]

Subpart E_Enforcement of Nondiscrimination on the Basis of Disability in 
    Programs or Activities Conducted by the U.S. Nuclear Regulatory 
                               Commission

4.501 Purpose.
4.502 Application.
4.503 Definitions.
4.504-4.509 [Reserved]
4.510 Self-evaluation.
4.511 Notice.
4.512-4.529 [Reserved]
4.530 General prohibitions against discrimination.
4.531-4.539 [Reserved]
4.540 Employment.
4.541-4.548 [Reserved]
4.549 Program accessibility: Discrimination prohibited.
4.550 Program accessibility: Existing facilities.
4.551 Program accessibility: New construction and alterations.
4.552-4.559 [Reserved]
4.560 Communications.
4.561-4.569 [Reserved]
4.570 Compliance procedures.
4.571-4.999 [Reserved]

Appendix A to Part 4--Federal Financial Assistance to Which This Part 
          Applies

    Authority: Atomic Energy Act of 1954, secs. 161, 223, 234, 274 (42 
U.S.C. 2201, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 
201, 401 (42 U.S.C. 5841, 5891); 29 U.S.C. 794; 42 U.S.C. 12101 et seq.; 
44 U.S.C. 3504 note.
    Subpart A also issued under 42 U.S.C. 2000d through d-7.
    Subpart B also issued under 29 U.S.C. 706.
    Subpart C also issued under 42 U.S.C. 6101 through 6107.

    Source: 29 FR 19277, Dec. 31, 1964, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 4 appear at 77 FR 
39904, July 6, 2012.

                           General Provisions



Sec.4.1  Purpose and scope.

    The regulations in this part implement:
    (a) The provisions of title VI of the Civil Rights Act of 1964, Pub. 
L. 88-352; (78 Stat. 241; 42 U.S.C. 2000a note), and title IV of the 
Energy Reorganization Act of 1974, Pub. L. 93-438, (88 Stat. 1233; 42 
U.S.C. 5801 note), which relate to nondiscrimination with respect to 
race, color, national origin or sex in any program or activity receiving 
Federal financial assistance from NRC;
    (b) The provisions of section 504 of the Rehabilitation Act of 1973, 
as amended, Pub. L. 93-112 (87 Stat. 355; 29 U.S.C. 701 note), Pub. L. 
95-602 (92 Stat. 2955; 29 U.S.C. 701 note), which relates to 
nondiscrimination with respect to the disabled in any program or 
activity receiving Federal financial assistance; and
    (c) The provisions of the Age Discrimination Act of 1975, as amended 
Pub. L. 94-135 (89 Stat. 713; 42 U.S.C. 3001 note), Pub. L. 95-478 (92 
Stat. 1513; 42 U.S.C. 3001 note), which relates to nondiscrimination on 
the basis of age in any program or activity receiving Federal financial 
assistance.

[52 FR 25357, July 7, 1987]



Sec.4.2  Subparts.

    Subpart A sets forth rules applicable to title VI of the Civil 
Rights Act of 1964 and title IV of the Energy Reorganization Act of 
1974. (The Acts are collectively referred to in subpart A as ``the 
Act''.) Subpart B sets forth rules applicable specifically to matters 
pertaining to section 504 of the Rehabilitation Act of 1973, as amended. 
Subpart C sets forth rules pertaining to the provisions of the Age 
Discrimination Act of 1975, as amended, Pub. L. 94-135 (89 Stat. 713; 42 
U.S.C. 3001 note), Pub. L. 95-478 (92 Stat. 1513; 42 U.S.C. 3001 note), 
which relates to nondiscrimination on the basis of age in any program or 
activity receiving Federal financial assistance.

[52 FR 25358, July 7, 1987]



Sec.4.3  Application of this part.

    This part applies to any program for which Federal financial 
assistance is authorized under a law administered by NRC. The types of 
Federal financial assistance to which this part applies are listed in 
appendix A of this part; appendix A may be revised from time to time by 
notice published in the Federal Register. This part applies to money 
paid, property transferred, or other Federal assistance extended, by way 
of grant, entitlement, cooperative agreement, loan, contract, or other 
agreement by NRC, or an authorized contractor or subcontractor of NRC, 
the terms of which require compliance

[[Page 168]]

with this part. If any statutes implemented by this part are otherwise 
applicable, the failure to list a type of Federal financial assistance 
in appendix A does not mean a program or activity is not covered by this 
part. This part does not apply to--
    (a) Contracts of insurance or guaranty; or
    (b) Procurement contracts; or
    (c) Employment practices under any program or activity except as 
provided in Sec. Sec.4.13, 4.122 and 4.302.

[52 FR 25358, July 7, 1987, as amended at 68 FR 51344, Aug. 26, 2003]



Sec.4.4  Definitions.

    (a) Applicant means one who submits an application, request, or plan 
required to be approved by NRC, or by a primary recipient, as a 
condition to eligibility for Federal financial assistance; 
``application'' means such an application, request, or plan.
    (b) Commission means the Commission of five members or a quorum 
thereof sitting as a body; ``NRC'' means the Nuclear Regulatory 
Commission and its duly authorized representatives.
    (c) Facility includes all or any portion of structures, equipment, 
or other real or personal property or interests therein, and the 
provisions of facilities includes the construction, expansion, 
renovation, remodeling, alteration or acquisition of facilities.
    (d) Federal financial assistance means any grant, entitlement, loan, 
cooperative agreement, contract (other than a procurement contract or a 
contract of insurance or guaranty), or any other arrangement by which 
NRC provides or otherwise makes available assistance in the form of--
    (1) Funds;
    (2) Services of Federal personnel or other personnel at Federal 
expense; or
    (3) Real and personal property or any interest in or use of 
property, including--
    (i) Transfers or leases of property for less than fair market value 
or for reduced consideration;
    (ii) Proceeds from a subsequent transfer or lease of property if the 
Federal share of its fair market value is not returned to the Federal 
Government; and the
    (iii) Sale and lease of, and the permission to use (other than on 
casual or transient basis) Federal property or any interest in such 
property without consideration or at a nominal consideration, or at a 
consideration which is reduced for the purpose of assisting the 
recipient, or in recognition of the public interest to be served by such 
sale or lease to the recipient.
    (e) Administrative Law Judge means an individual appointed pursuant 
to section 11 of the Administrative Procedure Act to conduct proceedings 
subject to this part.
    (f) Primary recipient means any recipient which is authorized or 
required to extend Federal financial assistance to another recipient.
    (g) Program or activity and program mean all of the operations of 
any entity described in paragraphs (g)(1) through (4) of this section, 
any part of which is extended Federal financial assistance:
    (1)(i) A department, agency, special purpose district, or other 
instrumentality of a State or of a local government; or
    (ii) The entity of such State or local government that distributes 
such assistance and each such department or agency (and each other State 
or local government entity) to which the assistance is extended, in the 
case of assistance to a State or local government;
    (2)(i) A college, university or other postsecondary institution, or 
a public system of higher education; or
    (ii) A local educational agency (as defined in 20 U.S.C. 8801), 
system of vocational education, or other school system;
    (3)(i) An entire corporation, partnership, or other private 
organization, or an entire sole proprietorship--
    (A) If assistance is extended to such corporation, partnership, 
private organization, or sole proprietorship as a whole; or
    (B) Which is principally engaged in the business of providing 
education, health care, housing, social services, or parks and 
recreation; or
    (ii) The entire plant or other comparable, geographically separate 
facility to which Federal financial assistance is extended, in the case 
of any

[[Page 169]]

other corporation, partnership, private organization, or sole 
proprietorship; or
    (4) Any other entity which is established by two or more of the 
entities described in paragraph (g)(1), (2), or (3) of this section.
    (h) Recipient means any State, political subdivision of any State, 
or instrumentality of any State or political subdivision, any public or 
private agency, institution, or organization, or other entity, or any 
individual, in any State, to whom Federal financial assistance is 
extended, directly or through another recipient, including any 
successor, assignee, or transferee thereof, but such term does not 
include any ultimate beneficiary.
    (i) Responsible NRC official means the Director of the Office of 
Small Business and Civil Rights or any other officer to whom the 
Executive Director for Operations has delegated the authority to act.
    (j) United States means the States of the United States, the 
District of Columbia, Puerto Rico, the Virgin Islands, American Samoa, 
Guam, Wake Island, and the territories and possessions of the United 
States, and the term ``State'' means any one of the foregoing.

[29 FR 19277, Dec. 31, 1964, as amended at 45 FR 14535, Mar. 6, 1980; 45 
FR 18905, Mar. 24, 1980. Redesignated and amended at 52 FR 25358, July 
7, 1987; 63 FR 15742, Apr. 1, 1998; 68 FR 51344, Aug. 26, 2003; 68 FR 
75389, Dec. 31, 2003]



Sec.4.5  Communications and reports.

    Except as otherwise indicated, communications and reports relating 
to this part may be sent to the NRC by mail addressed to the U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand 
delivery to the NRC's offices at 11555 Rockville Pike, Rockville, 
Maryland; or, where practicable, by electronic submission, for example, 
via Electronic Information Exchange, or CD-ROM. Electronic submissions 
must be made in a manner that enables the NRC to receive, read, 
authenticate, distribute, and archive the submission, and process and 
retrieve it a single page at a time. Detailed guidance on making 
electronic submissions can be obtained by visiting the NRC's Web site at 
http://www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information.

[68 FR 58799, Oct. 10, 2003, as amended at 74 FR 62679, Dec. 1, 2009; 80 
FR 74978, Dec. 1, 2015]



Sec.4.6  Maintenance of records.

    Each record required by this part must be legible throughout the 
retention period specified by each Commission regulation. The record may 
be the original or a reproduced copy or a microform provided that the 
copy or microform is authenticated by authorized personnel and that the 
microform is capable of producing a clear copy throughout the required 
retention period. The record may also be stored in electronic media with 
the capability for producing legible, accurate, and complete records 
during the required retention period. Records such as letters, drawings, 
specifications, must include all pertinent information such as stamps, 
initials, and signatures. The licensee shall maintain adequate 
safeguards against tampering with and loss of records.

[53 FR 19244, May 27, 1988]



Sec.4.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0053.
    (b) The approved information collection requirements contained in 
this

[[Page 170]]

part appear in Sec. Sec.4.32, 4.34, 4.125, 4.127, 4.231, 4.232, 4.322, 
and 4.324.

[62 FR 52184, Oct. 6, 1997]



 Subpart A_Regulations Implementing Title VI of the Civil Rights Act of 
       1964 and Title IV of the Energy Reorganization Act of 1974

                        Discrimination Prohibited



Sec.4.11  General prohibition.

    No person in the United States shall, on the ground of sex, race, 
color, or national origin, be excluded from participation in, be denied 
the benefits of, or be otherwise subjected to discrimination under any 
program to which this subpart applies.

[29 FR 19277, Dec. 31, 1964, as amended at 40 FR 8778, Mar. 3, 1975]



Sec.4.12  Specific discriminatory actions prohibited.

    (a) A recipient to which this subpart applies may not, directly or 
through contractual or other arrangements, on the ground of sex, race, 
color, or national origin:
    (1) Deny an individual any service, financial aid, or other benefit 
provided under the program;
    (2) Provide any service, financial aid, or other benefit to an 
individual which is different, or is provided in a different manner, 
from that provided to others under the program;
    (3) Subject an individual to segregation or separate treatment in 
any matter related to his receipt of any service, financial aid, or 
other benefit under the program;
    (4) Restrict an individual in any way in the enjoyment of any 
advantage or privilege enjoyed by others receiving any service, 
financial aid, or other benefit under the program;
    (5) Treat an individual differently from others in determining 
whether he satisfies any admission, enrollment, quota, eligibilty, 
membership or other requirement or condition which individuals must meet 
in order to be provided any service, financial aid, or other benefit 
provided under the program;
    (6) Deny an individual an opportunity to participate in the program 
through the provision of services or otherwise or afford him an 
opportunity to do so which is different from that afforded others under 
the program (including the opportunity to participate in the program as 
an employee but only to the extent set forth in Sec.4.13).
    (b) A recipient in determining the types of services, financial aid, 
or other benefits, or facilities which will be provided under any such 
program, or the class of individuals to whom, or the situations in 
which, such services, financial aid, other benefits, or facilities will 
be provided under any such program, or the class of individuals to be 
afforded an opportunity to participate in any such program, may not, 
directly or through contractual or other arrangements, utilize criteria 
or methods of administration which have the effect of subjecting 
individuals to discrimination because of their sex, race, color, or 
national origin, or have the effect of defeating or substantially 
impairing accomplishment of the objectives of the program as respects 
individuals of a particular sex, race, color, or national origin.
    (c) In determining the site or location of facilities, a recipient 
or applicant may not make selections with the purpose or effect of 
excluding individuals from, denying them the benefits of, or subjecting 
them to discrimination under any program to which this subpart applies, 
on the grounds of sex, race, color, or national origin; or with the 
purpose or effect of defeating or substantially impairing the 
accomplishment of the objectives of the Act or this subpart.
    (d) As used in this section the services, financial aid, or other 
benefits provided under a program receiving Federal financial assistance 
shall be deemed to include any services, financial aid, or other benefit 
provided in or through a facility provided with the aid of Federal 
financial assistance.
    (e) The enumeration of specific forms of prohibited discrimination 
in this section and Sec.4.13 does not limit the generality of the 
prohibition in Sec.4.11.
    (f) This subpart does not prohibit the consideration of sex, race, 
color, or national origin if the purpose and effect

[[Page 171]]

are to remove or overcome the consequences of practices or impediments 
which have restricted the availability of, or participation in, the 
program or activity receiving Federal financial assistance, on the 
grounds of sex, race, color or national origin. Where previous 
discriminatory practice or usage tends, on the grounds of sex, race, 
color, or national origin, to exclude individuals from participation in, 
to deny them the benefits of, or to subject them to discrimination under 
any program or activity to which this subpart applies, the applicant or 
recipient has an obligation to take reasonable action to remove or 
overcome the consequences of the prior discriminatory practice or usage, 
and to accomplish the purposes of the Act.

[29 FR 19277, Dec. 31, 1964, as amended at 38 FR 17927, July 5, 1973; 40 
FR 8778, Mar. 3, 1975; 68 FR 51344, Aug. 26, 2003]



Sec.4.13  Employment practices.

    (a) Where a primary objective of the Federal financial assistance to 
a program to which this subpart applies is to provide employment, a 
recipient may not, directly or through contractual or other 
arrangements, subject an individual to discrimination on the ground of 
sex, race, color, or national origin in its employment practices under 
such program (including recruitment or recruitment advertising, 
employment, layoff or termination, upgrading, demotion, or transfer, 
rates of pay or other forms of compensation, and use of facilities), 
including programs where a primary objective of the Federal financial 
assistance to a program is (1) to assist such individuals through 
employment to meet expenses incident to the commencement or continuation 
of their education or training, or (2) to provide work experience which 
contributes to the education or training of such individuals. (Examples 
of such Federal financial assistance are nuclear training equipment 
grants, grants and loans of materials for training, and fellowships.) 
The requirements applicable to construction employment under any such 
program shall be those specified in or pursuant to part III of Executive 
Order 11246 or any Executive order which supersedes it.
    (b) Where a primary objective of the Federal financial assistance is 
not to provide employment, but discrimination on the grounds of sex, 
race, color, or national origin in the employment practices of the 
recipient or other persons subject to this subpart tends, on the grounds 
of sex, race, color, or national origin, to exclude individuals from 
participation in, to deny them the benefits of, or to subject them to 
discrimination under any program to which this subpart applies, the 
provisions of paragraph (a) of this section shall apply to the 
employment practices of the recipient or other persons subject to this 
subpart to the extent necessary to assure equality of opportunity to, 
and nondiscriminatory treatment of, beneficiaries.

[38 FR 17927, July 5, 1973, as amended at 40 FR 8778, Mar. 3, 1975; 68 
FR 51344, Aug. 26, 2003]



Sec.4.14  Medical emergencies.

    A recipient shall not be deemed to have failed to comply with Sec.
4.11 if immediate provision of a service or other benefit to an 
individual is necessary to prevent his death or serious impairment of 
his health, and such service or other benefit cannot be provided except 
by or through a medical institution which refuses or fails to comply 
with Sec.4.11.

                           Assurances Required



Sec.4.21  General requirements.

    (a) Every grant, loan or contract to which this subpart applies, 
except an application to which Sec.4.22 applies, shall, as a condition 
to its approval by NRC, or by the appropriate NRC contractor or 
subcontractor, and the extension of any Federal financial assistance 
pursuant thereto, contain or be accompanied by an assurance that the 
program will be conducted in compliance with all requirements imposed by 
or pursuant to this subpart. In the case of a grant, loan, or contract 
involving Federal financial assistance to provide real property or 
structures thereon, the assurance shall obligate the recipient, or, in 
the case of a subsequent transfer, the transferee, for the period during 
which the real property or structures are used for a purpose for

[[Page 172]]

which the Federal financial assistance is extended, or for another 
purpose involving the provision of similar services or benefits. In the 
case of personal property the assurance shall obligate the recipient for 
the period during which he retains ownership or possession of the 
property. In all other cases the assurance shall obligate the recipient 
for the period during which Federal financial assistance is extended 
pursuant to the grant, loan or contract. The Commission will specify the 
form of the foregoing assurances and the extent to which like assurances 
will be required of subgrantees, contractors and subcontractors, 
successors in interest, and other participants. Any such assurance shall 
include provisions which give the United States a right to seek its 
judicial enforcement.
    (b) In the case of real property, structures or improvements 
thereon, or interests therein, which was acquired with Federal financial 
assistance, or in the case where Federal financial assistance is 
provided in the form of a transfer of real property or interest therein 
from the Federal Government, the instrument effecting or recording the 
transfer shall contain a covenant running with the land assuring 
nondiscrimination for the period during which the real property is used 
for a purpose for which the Federal financial assistance is extended or 
for another purpose involving the provision of similar services or 
benefits. Where no transfer of property is involved, but property is 
improved with Federal financial assistance, the recipient shall agree to 
include such a covenant in any subsequent transfer of such property. 
Where the property is obtained from the Federal Government, such 
covenant may also include a condition coupled with a right to be 
reserved by the NRC to revert title to the property in the event of a 
breach of the covenant where, in the discretion of the NRC, such a 
condition and right of reverter is appropriate to the program and to the 
nature of the grant and the grantee. In such event if a transferee of 
real property proposes to mortgage or otherwise encumber the real 
property as security for financing construction of new, or improvement 
of existing, facilities on such property for the purposes for which the 
property was transferred, the NRC may agree, upon request of the 
transferee and if necessary to accomplish such financing, and upon such 
conditions as the NRC deems appropriate, to forbear the exercise of such 
right to revert title for so long as the lien of such mortgage or other 
encumbrance remains effective.
    (c) Transfers of surplus property are subject to regulations issued 
by the Administrator of General Services (41 CFR 101-6.2).

[29 FR 19277, Dec. 31, 1964, as amended at 38 FR 17927, July 5, 1973; 68 
FR 51344, Aug. 26, 2003; 68 FR 75389, Dec. 31, 2003]



Sec.4.22  Continuing Federal financial assistance.

    Every application by a State or a State agency for continuing 
Federal financial assistance shall require the submission of and every 
grant, loan, or contract to or with a State or a State agency for 
continuing Federal financial assistance to which this subpart applies, 
shall, as a condition to its approval and the extension of any Federal 
financial assistance pursuant to the grant, loan or contract, contain or 
be accompanied by, a statement that the program is (or, in the case of a 
new program, will be) conducted in compliance with all requirements 
imposed by or pursuant to this subpart, and shall provide or be 
accompanied by provisions for such methods of administration for the 
program as are found by the responsible NRC official to give reasonable 
assurance that the recipient and all other recipients of Federal 
financial assistance under such program will comply with all 
requirements imposed by or pursuant to this subpart.

[38 FR 17928, July 5, 1973, as amended at 68 FR 51344, Aug. 26, 2003]



Sec.4.24  Assurances from institutions.

    (a) In the case of a grant, loan or contract involving Federal 
financial assistance to an institution of higher education, the 
assurance required by Sec.4.21 shall extend to admission practices and 
to all other practices relating to the treatment of students.
    (b) The assurance required with respect to an institution of higher 
education, hospital, or any other institution, insofar as the assurance 
relates to

[[Page 173]]

the institution's practices with respect to admission or other treatment 
of individuals as students, patients, or clients of the institution or 
to the opportunity to participate in the provision of services or other 
benefits to such individuals, shall be applicable to the entire 
institution.

[29 FR 19277, Dec. 31, 1964, as amended at 68 FR 51344, Aug. 26, 2003]

                         Compliance Information



Sec.4.31  Cooperation and assistance.

    The responsible NRC official shall to the fullest extent practicable 
seek the cooperation of recipients in obtaining compliance with this 
subpart and shall provide assistance and guidance to recipients to help 
them comply voluntarily with this subpart.



Sec.4.32  Compliance reports.

    (a) Each recipient shall keep records and submit to the responsible 
NRC official, timely, complete, and accurate compliance reports at the 
times and in the form and containing the information that the 
responsible NRC official may determine to be necessary to enable the 
official to ascertain whether the recipient has complied or is complying 
with this subpart.
    (b) In the case in which a primary recipient extends Federal 
financial assistance to any other recipient, the other recipient shall 
also submit necessary compliance reports to the primary recipient to 
enable the primary recipient to carry out its obligations under this 
subpart.
    (c) The primary recipient shall retain each record of information 
needed to complete a compliance report pursuant to paragraph (a) of this 
section for three years or as long as the primary recipient retains the 
status of primary recipient as defined in Sec.4.4, whichever is 
shorter.

[53 FR 19244, May 27, 1988, as amended at 68 FR 51344, Aug. 26, 2003]



Sec.4.33  Access to sources of information.

    Each recipient shall permit access by the responsible NRC official 
during normal business hours to such of its books, records, accounts, 
and other sources of information, and its facilities as may be pertinent 
to ascertain compliance with this subpart. Where any information 
required of a recipient is in the exclusive possession of any other 
agency, institution or person and that agency, institution or person 
shall fail or refuse to furnish this information, the recipient shall so 
certify in its report and shall set forth what efforts it has made to 
obtain the information.



Sec.4.34  Information to beneficiaries and participants.

    Each recipient shall make available to participants, beneficiaries, 
and other interested persons such information regarding the provisions 
of this subpart and its applicability to the program for which the 
recipient receives Federal financial assistance, and make such 
information available to them in such manner, as the responsible NRC 
official finds necessary to apprise such persons of the protections 
against discrimination assured them by the Act and this subpart.

[29 FR 19277, Dec. 31, 1964, as amended at 68 FR 51344, Aug. 26, 2003]

                        Conduct of Investigations



Sec.4.41  Periodic compliance reviews.

    The responsible NRC official shall from time to time review the 
practices of recipients to determine whether they are complying with 
this subpart.



Sec.4.42  Complaints.

    Any person who believes himself or any specific class of individuals 
to be subjected to discrimination prohibited by this subpart may by 
himself or by a representative file with the responsible NRC official a 
written complaint. A complaint must be filed not later than ninety (90) 
days from the date of the alleged discrimination, unless the time for 
filing is extended by the responsible NRC official. A complaint shall be 
signed by the complainant or his representative.



Sec.4.43  Investigations.

    The responsible NRC official will make a prompt investigation 
whenever a compliance review, report, complaint, or any other 
information indicates a possible failure to comply with

[[Page 174]]

this subpart. The investigation should include, where appropriate, a 
review of the pertinent practices and policies of the recipient, the 
circumstances under which the possible noncompliance with this subpart 
occurred, and other factors relevant to a determination as to whether 
the recipient has failed to comply with this subpart.



Sec.4.44  Resolution of matters.

    (a) If an investigation pursuant to Sec.4.43 indicates a failure 
to comply with this subpart, the responsible NRC official will so inform 
the recipient and the matter will be resolved by voluntary means 
whenever possible. If it has been determined that the matter cannot be 
resolved by voluntary means, action will be taken as provided for in 
Sec. Sec.4.46 through 4.49.
    (b) If an investigation does not warrant action pursuant to 
paragraph (a) of this section, the responsible NRC official will so 
inform the recipient and the complainant, if any, in writing.



Sec.4.45  Intimidatory or retaliatory acts prohibited.

    No recipient or other person shall intimidate, threaten, coerce, or 
discriminate against any individual for the purpose of interfering with 
any right or privilege secured by the Act or this subpart, or because he 
has made a complaint, testified, assisted, or participated in any manner 
in an investigation, proceeding, or hearing under this subpart. The 
identity of complainants shall be kept confidential, except to the 
extent necessary to carry out the purposes of this subpart including the 
conduct of any investigation, hearing, or judicial proceeding arising 
thereunder.

[29 FR 19277, Dec. 31, 1964, as amended at 40 FR 8778, Mar. 3, 1975]

                      Means of Effecting Compliance



Sec.4.46  Means available.

    If there appears to be a failure or threatened failure to comply 
with any of the provisions of this subpart, and if the noncompliance or 
threatened concompliance cannot be corrected by informal means, 
compliance with this subpart may be effected by the suspension or 
termination of or refusal to grant or to continue Federal financial 
assistance or by any other means authorized by law. Such other means may 
include, but are not limited to: (a) A reference to the Department of 
Justice with a recommendation that appropriate proceedings be brought to 
enforce any rights of the United States under any law of the United 
States (including other titles of the Act), or any assurance or other 
contractual undertaking, and (b) any applicable proceeding under State 
or local law.



Sec.4.47  Noncompliance with Sec.4.21.

    If an applicant fails or refuses to furnish an assurance required 
under Sec.4.21 or otherwise fails or refuses to comply with a 
requirement imposed by or pursuant to that section, Federal financial 
assistance may be refused in accordance with the procedures of Sec.
4.48.

[45 FR 14535, Mar. 6, 1980]



Sec.4.48  Termination of or refusal to grant or to continue Federal
financial assistance.

    No order suspending, terminating, or refusing to grant or continue 
Federal financial assistance shall become effective until: (a) The 
responsible NRC official has advised the applicant or recipient of his 
failure to comply and has determined that compliance cannot be secured 
by voluntary means, (b) there has been an express finding on the record, 
after opportunity for hearing, of a failure by the applicant or 
recipient to comply with the requirement imposed by or pursuant to this 
subpart, (c) the action has been approved by the Commission pursuant to 
Sec.4.72, and (d) the expiration of thirty (30) days after the 
Commission has filed with the committee of the House and the committee 
of the Senate having legislative jurisdiction over the program involved, 
a full written report of the circumstances and the grounds for such 
action. Any action to suspend or terminate or to refuse to grant or to 
continue Federal financial assistance shall be limited to the particular 
political entity, or part thereof, or other applicant or recipient as to 
whom such finding has been made and shall be limited in its effect to 
the particular program, or part thereof, in which such noncompliance has 
been so found.

[[Page 175]]



Sec.4.49  Other means authorized by law.

    No action to effect compliance by any other means authorized by law 
shall be taken until: (a) The responsible NRC official has determined 
that compliance cannot be secured by voluntary means, (b) the recipient 
or other person has been notified of its failure to comply and of the 
action to be taken to effect compliance, and (c) the expiration of at 
least ten (10) days from the mailing of such notice to the recipient or 
other person. During this period of at least ten (10) days, additional 
efforts shall be made to persuade the recipient or other person to 
comply with this subpart and to take such corrective action as may be 
appropriate.

[38 FR 17928, July 5, 1973]

                         Opportunity for Hearing



Sec.4.51  Notice of opportunity for hearing.

    (a) Whenever an opportunity for hearing is required by Sec.4.48, 
the responsible NRC official shall serve on the applicant or recipient, 
by registered or certified mail, return receipt requested, a notice of 
opportunity for hearing which will:
    (1) Inform the applicant or recipient of his right within twenty 
(20) days of the date of the notice of opportunity for hearing, or such 
other period as may be specified in the notice, to request a hearing;
    (2) Set forth the alleged item or items of noncompliance with this 
subpart;
    (3) Specify the issues;
    (4) State that compliance with this subpart may be effected by an 
order providing for the termination of or refusal to grant or to 
continue assistance, as appropriate; and
    (5) Provide that the applicant or recipient may file a written 
answer to the notice of opportunity for hearing under oath or 
affirmation within twenty (20) days of its date, or such other period as 
may be specified in the notice.
    (b) The applicant or recipient may respond to a notice of 
opportunity for hearing by filing a written answer under oath or 
affirmation. The answer shall specifically admit or deny each 
allegation, or, where the applicant or recipient does not have knowledge 
or information sufficient to form a belief, the answer may so state and 
the statements shall have the effect of a denial. Allegations of fact 
not denied shall be deemed to be admitted. The answer shall separately 
state and identify matters alleged as affirmative defenses and may also 
set forth the matters of fact and law on which the applicant or 
recipient relies. The answer may request a hearing.
    (c) If the answer requests a hearing, the Commission will issue a 
notice of hearing specifying:
    (1) The time, place, and nature thereof;
    (2) The legal authority and jurisdiction under which the hearing is 
to be held; and
    (3) The matters of fact and law asserted or to be considered. The 
time and place of hearing will be fixed with due regard for the 
convenience and necessity of the parties or their representatives and 
for the public interest. An answer to a notice of hearing is not 
required.
    (d) An applicant or recipient may file an answer, and waive or fail 
to request a hearing, without waiving the requirement for findings of 
fact and conclusions of law or the right to seek Commission review in 
accordance with the provisions of Sec. Sec.4.71 through 4.74. At the 
time an answer is filed the applicant or recipient may also submit 
written information or argument for the record if he does not request a 
hearing.
    (e) An answer or stipulation may consent to the entry of an order in 
substantially the form set forth in the notice of opportunity for 
hearing; such order may be entered by the responsible Commission 
official. The consent of the applicant or recipient to the entry of an 
order shall constitute a waiver by him of a right to: (1) A hearing 
under the Act and Sec.4.48, (2) findings of fact and conclusions of 
law, and (3) seek Commission review.
    (f) The failure of an applicant or recipient to file an answer 
within the period prescribed, or, if he requests a hearing, his failure 
to appear therefor, shall constitute a waiver by him of a right to: (1) 
A hearing under the Act and Sec.4.48, (2) conclusions of law, and (3) 
seek Commission review. In the event

[[Page 176]]

of such waiver, the responsible NRC official may find the facts on the 
basis of the record available and enter an order in substantially the 
form set forth in the notice of opportunity for hearing.
    (g) An order entered in accordance with paragraph (e) or (f) of this 
section shall constitute the final decision of the Commission, unless 
the Commission, on its own motion, within forty-five (45) days after 
entry of the order, issues its own decision, which shall then constitute 
the final decision of the Commission.
    (h) A copy of an order entered by the responsible NRC official shall 
be mailed to the applicant or recipient and to the complainant, if any.
    (i) Nothing in this section shall be deemed to place the burden of 
proof on the applicant or recipient.

[29 FR 19277, Dec. 31, 1964, as amended at 38 FR 17928, July 5, 1973; 40 
FR 8778, Mar. 3, 1975; 68 FR 51344, Aug. 26, 2003]

                          Hearings and Findings



Sec.4.61  Presiding officer.

    One or more members of the Commission or one or more administrative 
law judges appointed pursuant to section 3105 of title 5 of the United 
States Code shall: (a) Preside at a hearing and (b) make findings of 
fact and conclusions of law if an applicant or recipient waives a 
hearing and submits written information or argument for the record in 
accordance with Sec.4.51(d).

[35 FR 11459, July 17, 1970]



Sec.4.62  Right to counsel.

    In all proceedings under Sec. Sec.4.51-4.81, the applicant or 
recipient and the responsible NRC official shall have the right to be 
represented by counsel. A notice of appearance shall be filed by counsel 
prior to participation in any such proceedings.



Sec.4.63  Procedures, evidence, and record.

    (a) The hearing, decision, and any administrative review thereof 
shall be conducted in conformity with 5 U.S.C. 554-557 (sections 5-8 of 
the Administrative Procedure Act), and in accordance with such 
procedures as are proper (and not inconsistent with Sec. Sec.4.61 
through 4.64) relating to the conduct of the hearing, giving of notices 
subsequent to those provided for in Sec.4.51, taking of testimony, 
exhibits, arguments and briefs, requests for finding, and other related 
matters. Both the responsible NRC official and the applicant or 
recipient shall be entitled to introduce all relevant evidence on the 
issues as stated in the notice of hearing or as determined by the 
presiding officer at the outset of or during the hearing.
    (b) Technical rules of evidence shall not apply to hearings 
conducted pursuant to this subpart, but rules or principles designed to 
assure production of the most credible evidence available and to subject 
testimony to test by cross-examination shall be applied where reasonably 
necessary by the presiding officer. The presiding officer may exclude 
irrelevant, immaterial, or unduly repetitious evidence. All documents 
and other evidence offered or taken for the record shall be open to 
examination by the parties and opportunity shall be given to refute 
facts and arguments advanced on either side of the issues. A transcript 
shall be made of the oral evidence except to the extent the substance 
thereof is stipulated for the record.
    (c) Each decision made after a hearing has been held shall be based 
on the hearing record, and written findings of fact and conclusions of 
law shall be made.
    (d) If an applicant or recipient waives a hearing and submits 
written information or argument for the record in accordance with Sec.
4.51(d), written findings of fact and conclusions of law shall be made.

[29 FR 19277, Dec. 31, 1964, as amended at 35 FR 11459, July 17, 1970; 
38 FR 17928, July 5, 1973]



Sec.4.64  Consolidated or joint hearings.

    In cases in which the same or related facts are asserted to 
constitute noncompliance with this subpart with respect to two or more 
Federal statutes, authorities, or other means by which Federal financial 
assistance is extended and to which this subpart applies or 
noncompliance with this subpart and the regulations of one or more other 
Federal departments or agencies issued under title VI of the Civil 
Rights Act of 1964, the Commission may, by

[[Page 177]]

agreement with such other departments or agencies, where applicable, 
provide for the conduct of consolidated or joint hearings, and for the 
application to such hearings of rules of procedure not inconsistent with 
this subpart. Final decisions in such cases, insofar as this regulation 
is concerned shall be made in accordance with Sec.4.72.

[29 FR 19277, Dec. 31, 1964, as amended at 40 FR 8778, Mar. 3, 1975; 68 
FR 51344, Aug. 26, 2003]

                           Decision and Notice



Sec.4.71  Initial decision or certification.

    The officer designated:
    (a) To preside at a hearing, or,
    (b) To make findings of fact and conclusions of law if an applicant 
or recipient waives a hearing and submits written information or 
argument for the record in accordance with Sec.4.51(d), shall render 
an initial decision on the record, or, if the Commission so directs, 
shall certify the entire record to the Commission for decision, together 
with a recommended decision on the record. A copy of such initial 
decision, or of such certification and recommended decision, shall be 
mailed to the applicant or recipient.



Sec.4.72  Exceptions and final decision.

    (a) The applicant or recipient, within thirty (30) days of the 
mailing of an initial decision or a recommended decision, may file with 
the Commission his exceptions to such decision, with his reasons 
therefor.
    (b) In the absence of exceptions to an initial decision, the 
Commission may, on its own motion within forty-five (45) days after the 
mailing of such initial decision, serve on the applicant or recipient a 
notice that the Commission will review the decision.
    (c) Upon the filing of exceptions to an initial decision or of a 
notice of review, the Commission shall review such initial decision and 
issue its own decision on the record with its reasons therefor.
    (d) In the absence of either exceptions to an initial decision or of 
a notice of review, such initial decision shall constitute the final 
decision of the Commission.
    (e) Upon the filing of exceptions to a recommended decision, the 
Commission shall review such recommended decision and issue its own 
decision on the record with its reasons therefor.
    (f) In the absence of exceptions to a recommended decision, the 
Commission shall review such recommended decision and issue its own 
decision on the record with its reasons therefor.



Sec.4.73  Rulings required.

    Each decision of a presiding officer or the Commission shall set 
forth the rulings on each finding, conclusion, or exception presented, 
and shall identify the requirement or requirements imposed by or 
pursuant to this subpart with which it is found that the applicant or 
recipient has failed to comply.



Sec.4.74  Content of orders.

    The final decision may provide for suspension or termination of, or 
refusal to grant or continue Federal financial assistance, in whole or 
in part, to which this regulation applies, and may contain such terms, 
conditions, and other provisions as are consistent with and will 
effectuate the purposes of the Act and this subpart, including 
provisions designed to assure that no Federal financial assistance to 
which this regulation applies will thereafter be extended to the 
applicant or recipient determined by such decision to be in default in 
its performance of an assurance given by it pursuant to this subpart, or 
to have otherwise failed to comply with this subpart, unless and until 
it corrects its noncompliance and satisfies the NRC that it will fully 
comply with this subpart. A copy of the final decision shall be mailed 
to the applicant or recipient and the complainant, if any.

[29 FR 19277, Dec. 31, 1964, as amended at 68 FR 51344, Aug. 26, 2003]



Sec.4.75  Post termination proceedings.

    (a) An applicant or recipient adversely affected by an order issued 
under Sec.4.74 shall be restored to full eligibility to receive 
Federal financial assistance if it satisfies the terms and conditions of 
that order for such eligibility or if it brings itself into compliance 
with this subpart and provides reasonable assurance that it will fully 
comply with this subpart.

[[Page 178]]

    (b) Any applicant or recipient adversely affected by an order 
entered pursuant to Sec.4.74 may at any time request the responsible 
NRC official to restore fully its eligibility to receive Federal 
financial assistance. Any such request shall be supported by information 
showing that the applicant or recipient has met the requirements of 
paragraph (a) of this section. If the responsible NRC official 
determines that those requirements have been satisfied, he shall restore 
such eligibility.
    (c) If the responsible NRC official denies any such request, the 
applicant or recipient may submit a request for a hearing in writing, 
specifying why it believes such official to have been in error. It shall 
thereupon be given an expeditious hearing, with the decision on the 
record, in accordance with rules of procedure issued by the responsible 
NRC official. The applicant or recipient will be restored to such 
eligibility if it proves at such a hearing that it satisfied the 
requirements of paragraph (a) of this section. While proceedings under 
this section are pending, the sanctions imposed by the order issued 
under Sec.4.74 shall remain in effect.

[38 FR 17928, July 5, 1973, as amended at 40 FR 8778, Mar. 3, 1975]

                             Judicial Review



Sec.4.81  Judicial review.

    Action taken pursuant to section 602 of the Civil Rights Act of 1964 
is subject to judicial review as provided in section 603 of that Act.

[40 FR 8778, Mar. 3, 1975]

           Effect on Other Regulations; Forms and Instructions



Sec.4.91  Effect on other regulations.

    All regulations, orders, or like directions heretofore issued by any 
officer of the NRC which impose requirements designed to prohibit any 
discrimination against individuals on the grounds of sex, race, color, 
or national origin under any program to which this subpart applies, and 
which authorize the suspension or termination of or refusal to grant or 
to continue Federal financial assistance to any applicant for or 
recipient of such assistance for failure to comply with such 
requirements, are hereby superseded to the extent that such 
discrimination is prohibited by this subpart, except that nothing in 
this subpart shall be deemed to relieve any person of any obligation 
assumed or imposed under any such superseded regulation, order, 
instruction, or like direction prior to the effective date of this 
subpart. Nothing in this subpart, however, shall be deemed to supersede 
any of the following (including future amendments thereof):
    (a) Executive Orders 10925, 11114, and 11246 and regulations issued 
thereunder, or
    (b) Executive Order 11063 and regulations issued thereunder and any 
other regulations or instructions insofar as such order, regulations or 
instructions prohibit discrimination on the grounds of sex, race, color, 
or national origin in any program or situation to which this subpart is 
inapplicable, or prohibit discrimination on any other ground.

[29 FR 19277, Dec. 31, 1964, as amended at 38 FR 17928, July 5, 1973; 40 
FR 8778, Mar. 3, 1975; 68 FR 51344, Aug. 26, 2003]



Sec.4.92  Forms and instructions.

    The responsible NRC official shall issue and promptly make available 
to interested persons forms and detailed instructions and procedures for 
effectuating this subpart as applied to programs to which this subpart 
applies and for which he is responsible.



Sec.4.93  Supervision and coordination.

    The Commission may from time to time assign to officials of other 
departments or agencies of the Government, with the consent of the 
department or agency involved, responsibilities in connection with the 
effectuation of the purposes of title VI of the Civil Rights Act of 1964 
and this subpart, other than responsibility for final decision as 
provided in Sec.4.72, including the achievement of effective 
coordination and maximum uniformity within the NRC and within the 
Executive Branch of the Government in the application of title VI of the 
Civil Rights Act and this subpart to similar programs and in similar 
situations. Any action taken, determination made, or requirement imposed 
by an official of another department or agency acting pursuant to an 
assignment of responsibility under this

[[Page 179]]

section shall have the same effect as though such action had been taken 
by the responsible NRC official.

[40 FR 8778, Mar. 3, 1975]



Subpart B_Regulations Implementing Section 504 of the Rehabilitation Act 
                           of 1973, as Amended

    Source: 45 FR 14535, Mar. 6, 1980, unless otherwise noted.



Sec.4.101  Definitions.

    As used in this subpart:
    (a) Disabled person means any person who has a physical or mental 
impairment that substantially limits one or more major life activities, 
has a record of such an impairment, or is regarded as having such an 
impairment. Such term does not include any individual who is an 
alcoholic or drug abuser whose current use of alcohol or drugs prevents 
such individual from performing the duties of the job in question or 
whose employment, by reason of such current alcohol or drug abuse, would 
constitute a direct threat to property or the safety of others.
    (b) As used in paragraph (a) of this section, the phrase:
    (1) Physical or mental impairment means: (i) Any physiological 
disorder or condition, cosmetic disfigurement, or anatomical loss 
affecting one or more of the following body systems: Neurological; 
musculoskeletal; special sense organs; respiratory, including speech 
organs; cardiovascular; reproductive; digestive, genitourinary; hemic 
and lymphatic; skin; and endocrine; or (ii) any mental or psychological 
disorder, such as mental retardation, organic brain syndrome, emotional 
or mental illness, and specific learning disabilities. The term physical 
or mental impairment includes, but is not limited to, such diseases and 
conditions as orthopedic, visual, speech, and hearing impairments, 
cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, 
cancer, heart disease, diabetes, mental retardation, and emotional 
illness.
    (2) Major life activities means functions such as caring for one's 
self, performing manual tasks, walking, seeing, hearing, speaking, 
breathing, learning, and working.
    (3) Has a record of such an impairment means has a history of, or 
has been misclassified as having, a mental or physical impairment that 
substantially limits one or more major life activities.
    (4) Is regarded as having an impairment means:
    (i) Has a physical or mental impairment that does not substantially 
limit major life activities but is treated by a recipient as 
constituting such a limitation;
    (ii) Has a physical or mental impairment that substantially limits 
major life activities only as a result of the attitudes of others toward 
such impairment; or
    (iii) Does not have a physical or mental impairment but is treated 
by a recipient as having such an impairment.
    (c) Qualified disabled person means: (1) With respect to employment, 
a disabled person who, with reasonable accommodation, can perform 
essential functions of the job in question and (2) with respect to 
services, a disabled person who meets the essential eligibility 
requirements for the receipt of such services.
    (d) Section 504 means section 504 of the Rehabilitation Act of 1973, 
Pub. L. 93-112, as amended by the Rehabilitation, Comprehensive 
Services, and Developmental Disabilities Amendments of 1978, Pub. L. 95-
602 (29 U.S.C. 794).

                        Discriminatory Practices



Sec.4.121  General prohibitions against discrimination.

    (a) No qualified disabled person, shall, on the basis of disability, 
be excluded from participation in, be denied the benefits of, or 
otherwise be subject to discrimination under any program or activity 
that receives Federal financial assistance.
    (b)(1) A recipient, in providing any aid, benefit, or service, may 
not, directly or through contractual, licensing, or other arrangements, 
on the basis of disability:
    (i) Deny a qualified disabled person the opportunity to participate 
in or benefit from the aid, benefit, or service;

[[Page 180]]

    (ii) Afford a qualified disabled person an opportunity to 
participate in or benefit from the aid, benefit, or service that is not 
equal to that afforded others;
    (iii) Provide a qualified disabled person with an aid, benefit, or 
service that is not as effective in affording equal opportunity to 
obtain the same result, to gain the same benefit, or to reach the same 
level of achievement as that provided to others;
    (iv) Provide different or separate aid, benefits, or services to 
disabled persons or to any class of disabled persons than is provided to 
others unless such action is necessary to provide qualified disabled 
persons with aid, benefits, or services that are as effective as those 
provided to others;
    (v) Aid or perpetuate discrimination against a qualified disabled 
person by providing significant assistance to any agency, organization, 
or person that discriminates on the basis of disability in providing any 
aid, benefit, or service to beneficiaries of the recipient's program or 
activity;
    (vi) Deny a qualified disabled person the opportunity to participate 
as a member of planning or advisory boards; or
    (vii) Otherwise limit a qualified disabled person in the enjoyment 
of any right, privilege, advantage, or opportunity enjoyed by others 
receiving the aid, benefit, or service.
    (2) A recipient may not deny a qualified disabled person the 
opportunity to participate in aid, benefits, or services that are not 
separate or different, despite the existence of permissibly separate or 
different aid, benefits, or services.
    (3) A recipient may not directly or through contractual or other 
arrangements, utilize criteria or methods of administration:
    (i) That have the effect of subjecting qualified disabled persons to 
discrimination on the basis of disability,
    (ii) That have the purpose or effect of defeating or substantially 
impairing accomplishment of the objectives of the recipient's program or 
activity with respect to disabled persons, or
     (iii) That perpetuate the discrimination of another recipient if 
both recipients are subject to common administrative control or are 
agencies of the same State.
    (4) A recipient may not, in determining the site or location of a 
facility, make selections:
     (i) That have the effect of excluding disabled persons from, 
denying them the benefits of, or otherwise subjecting them to 
discrimination under any program or activity that receives Federal 
financial assistance or
    (ii) That have the purpose or effect of defeating or substantially 
impairing the accomplishment of the objectives of the program or 
activity with respect to disabled persons.
    (c) The exclusion of nondisabled persons from aid, benefits, or 
services limited by Federal statute or Executive Order to disabled 
persons or the exclusion of a specific class of disabled persons from 
aid, benefits, or services limited by Federal statute or Executive Order 
to a different class of disabled persons is not prohibited by this 
subpart.
    (d) Recipients shall administer programs or activities in the most 
integrated setting appropriate to the needs of qualified disabled 
persons.
    (e) Recipients shall take appropriate steps to ensure that 
communications with their applicants, employees, and beneficiaries are 
available to persons with impaired vision and hearing.

[45 FR 14535, Mar. 6, 1980, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.122  General prohibitions against employment discrimination.

    (a) No qualified disabled person shall, on the basis of disability, 
be subjected to discrimination in employment under any program or 
activity that receives Federal financial assistance.
    (b) A recipient shall make all decisions concerning employment under 
any program or activity to which this subpart applies in a manner which 
ensures that discrimination on the basis of disability does not occur 
and may not limit, segregate, or classify applicants or employees in any 
way that adversely affects their opportunities or status because of 
disability.
    (c) The prohibition against discrimination in employment applies to 
the following activities:

[[Page 181]]

    (1) Recruitment, advertising, and the processing of applications for 
employment;
    (2) Hiring, upgrading, promotion, award of tenure, demotion, 
transfer, layoff, termination, right of return from layoff, and 
rehiring;
    (3) Rates of pay or any other form of compensation and changes in 
compensation;
    (4) Job assignments, job classifications, organizational structures, 
position descriptions, lines of progression, and seniority lists;
    (5) Leaves of absence, sick leave, or any other leave;
    (6) Fringe benefits available by virtue of employment, whether or 
not administered by the recipient;
    (7) Selection and financial support for training, including 
apprenticeship, professional meetings, conferences, and other related 
activities and selection for leaves of absence to pursue training;
    (8) Employer sponsored activities, including those that are social 
or recreational; and
    (9) Any other term, condition, or privilege of employment.
    (d) A recipient may not participate in a contractual or other 
relationship that has the effect of subjecting qualified disabled 
applicants or employees to discrimination prohibited by this subpart. 
The relationships referred to in this paragraph include relationships 
with employment and referral agencies, with labor unions, with 
organizations providing or administering fringe benefits to employees of 
the recipient, and with organizations providing training and 
apprenticeships.

[45 FR 14535, Mar. 6, 1980, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.123  Reasonable accommodation.

    (a) A recipient shall make reasonable accommodation to the known 
physical or mental limitations of an otherwise qualified disabled 
applicant or employee unless the recipient can demonstrate that the 
accommodation would impose an undue hardship on the operation of its 
program or activity.
    (b) Reasonable accommodation may include: (1) Making facilities used 
by employees readily accessible to and usable by disabled persons, and 
(2) job restructuring, part-time or modified work schedules, acquisition 
or modification of equipment or devices, the provision of readers or 
interpreters, and other similar actions. This list is neither all-
inclusive nor meant to suggest that an employer must follow all the 
actions listed.
    (c) In determining pursuant to paragraph (a) of this section whether 
an accommodation would impose an undue hardship on the operation of a 
recipient's program or activity, factors to be considered include:
    (1) The overall size of the recipient's program or activity with 
respect to number of employees, number and type of facilities, and size 
of budget;
    (2) The type of the recipient's operations, including the 
composition and structure of the recipient's workforce; and
    (3) The nature and cost of the accommodation needed.
    (d) A recipient may not deny any employment opportunity to a 
qualified disabled employee or applicant if the basis for denial is the 
need to make reasonable accommodation to the physical or mental 
limitations of the employee or applicant.

[45 FR 14535, Mar. 6, 1980, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.124  Employment criteria.

    (a) A recipient may not make use of any employment test or other 
selection criterion that screens out or tends to screen out disabled 
persons or any class of disabled persons unless:
    (1) The test score or other selection criterion as used by the 
recipient is shown to be job-related for the position in question; and
    (2) Alternative job-related tests or criteria that do not screen out 
or tend to screen out as many disabled persons are not available.
    (b) A recipient shall select and administer tests concerning 
employment so as best to ensure that, when administered to an applicant 
or employee who has a disability that impairs sensory, manual, or 
speaking skills, the test results accurately reflect the applicant's or 
employee's job skills, aptitude, or whatever other factor the test 
purports to measure, rather than reflecting the applicant's or 
employee's

[[Page 182]]

impaired sensory, manual, or speaking skills (except where those skills 
are the factors that the test purports to measure).



Sec.4.125  Preemployment inquiries.

    (a) Except as provided in paragraphs (b) and (c) of this section, a 
recipient may not conduct a preemployment medical examination or may not 
make preemployment inquiry of an applicant as to whether the applicant 
is a disabled person or as to the nature of severity of a disability. A 
recipient may, however, make preemployment inquiry into an applicant's 
ability to perform job-related functions.
    (b) When a recipient is taking remedial action to correct the 
effects of past discrimination, or when a recipient is taking voluntary 
action to overcome the effects of conditions that resulted in limited 
participation in its federally assisted program or activity, or when a 
recipient is taking affirmative action pursuant to section 503 of the 
Rehabilitation Act of 1973, the recipient may invite applicants for 
employment to indicate whether and to what extent they are disabled: 
Provided, That:
    (1) The recipient makes clear to the applicant that the information 
requested is intended for use solely in connection with its remedial 
action obligations or its voluntary or affirmative action efforts; and
    (2) The recipient makes clear to the applicant that the information 
is being requested on a voluntary basis, that it will be kept 
confidential as provided in paragraph (d) of this section, that refusal 
to provide it will not subject the applicant to any adverse treatment, 
and that it will be used only in accordance with this subpart.
    (c) Nothing in this section shall prohibit a recipient from 
conditioning an offer of employment on the results of a medical 
examination conducted prior to the employee's entrance on duty: 
Provided, That:
    (1) All entering employees are subjected to such an examination 
regardless of disability; and
    (2) The results of such an examination are used only in accordance 
with the requirements of this subpart.
    (d) Information obtained in accordance with this section as to the 
medical condition or history of the applicant must be collected on 
separate forms. The recipient shall retain each form as a record for 
three years from the date the applicant's employment ends, or, if not 
hired, from the date of application. Each form must be accorded 
confidentiality as a medical record, except that:
    (1) Supervisors and managers may be informed regarding restrictions 
on the work or duties that may be assigned to disabled persons and 
regarding necessary accommodations;
    (2) First aid and safety personnel may be informed, where 
appropriate, if the condition associated with the disability might 
require emergency treatment; and
    (3) Government officials investigating compliance with the 
Rehabilitation Act of 1973 shall be provided relevant information upon 
request.

[45 FR 14535, Mar. 6, 1980, as amended at 53 FR 19244, May 27, 1988]



Sec.4.126  General requirement concerning accessibility.

    No qualified disabled person shall, because a recipient's facilities 
are inaccessible to or unusable by disabled persons, be denied the 
benefits of, be excluded from participation in, or otherwise be 
subjected to discrimination under any program or activity that receives 
Federal financial assistance.

[45 FR 14535, Mar. 6, 1980, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.127  Existing facilities.

    (a) Accessibility. A recipient shall operate each program or 
activity so that when each part is viewed in its entirety it is readily 
accessible to and usable by disabled persons. This paragraph does not 
necessarily require a recipient to make each of its existing facilities 
or every part of an existing facility accessible to and usable by 
disabled persons.
    (b) Methods. A recipient may comply with the requirements of 
paragraph (a) of this section through such means as redesign of 
equipment, reassignment of classes or other services to accessible 
buildings, assignment of aids to beneficiaries, home visits, delivery of

[[Page 183]]

health, welfare or other social services at alternate accessible sites, 
alteration of existing facilities and construction of new facilities in 
conformance with the requirements of Sec.4.128 or any other methods 
that result in making its program or activity accessible to and usable 
by disabled persons. A recipient is not required to make structural 
changes in existing facilities where other methods are effective in 
achieving compliance with paragraph (a) of this section. In choosing 
among available methods for meeting the requirement of paragraph (a) of 
this section, a recipient shall give priority to those methods that 
serve disabled persons in the most integrated setting appropriate.
    (c) Time period. A recipient shall comply with the requirement of 
paragraph (a) of this section within 60 days of the effective date of 
this subpart except that where structural changes in facilities are 
necessary, the changes are to be made within three years of the 
effective date of this subpart, but in any event, as expeditiously as 
possible.
    (d) Transition plan. In the event that structural changes to 
facilities are necessary to meet the requirement of paragraph (a) of 
this section, a recipient shall develop a transition plan setting forth 
the steps necessary to complete the changes. The plan is to be developed 
with the assistance of interested persons, including disabled persons, 
or organizations representing disabled persons, and the plan is to meet 
with the approval of the NRC. The recipient shall retain a copy of the 
transition plan as a record until any structural change to a facility is 
complete. A copy of the transition plan is to be made available for 
public inspection. At a minimum, the plan is to:
    (1) Identify physical obstacles in the recipient's facilities that 
limit the accessibility and usability of its program or activity to 
disabled persons;
    (2) Describe in detail the methods that will be used to make the 
facilities accessible to and usable by disabled persons;
    (3) Specify the schedule for taking the steps necessary to achieve 
full accessibility under paragraph (a) of this section and, if the time 
period or the transition plan is longer than 1 year, identify steps that 
will be taken during each year of the transition period; and
    (4) Indicate the person responsible for implementation of the plan.
    (e) Notice. The recipient shall adopt and implement procedures to 
ensure that interested persons, including persons with impaired vision 
or hearing, can obtain information concerning the existence and location 
of services, activities, and facilities that are accessible to, and 
usable by, disabled persons.

[45 FR 14535, Mar. 6, 1980, as amended at 53 FR 19244, May 27, 1988; 68 
FR 51345, Aug. 26, 2003]



Sec.4.128  New construction.

    (a) Design, construction, and alteration. New facilities shall be 
designed and constructed to be readily accessible to and usable by 
disabled persons. Alterations to existing facilities shall, to the 
maximum extent feasible, be designed and constructed to be readily 
accessible to and usable by disabled persons.
    (b) Conformance with Uniform Federal Accessibility Standards. (1) 
Effective as of January 18, 1991, design, construction, or alteration of 
buildings in conformance with sections 3--8 of the Uniform Federal 
Accessibility Standards (USAF) (appendix A to 41 CFR subpart 101-19.6) 
shall be deemed to comply with the requirements of this section with 
respect to those buildings. Departures from particular technical and 
scoping requirements of UFAS by the use of other methods are permitted 
where substantially equivalent or greater access to and usability of the 
building is provided.
    (2) For purposes of this section, section 4.1.6(1)(g) of UFAS shall 
be interpreted to exempt from the requirements of UFAS only mechanical 
rooms and other spaces that, because of their intended use, will not 
require accessibility to the public or beneficiaries or result in the 
employment or residence therein of persons with physical disabilities.
    (3) This section does not require recipients to make building 
alterations

[[Page 184]]

that have little likelihood of being accomplished without removing or 
altering a load-bearing structural member.

[55 FR 52138, 52139, Dec. 19, 1990]

                               Enforcement



Sec.4.231  Responsibility of applicants and recipients.

    (a) Assurances. An applicant for Federal financial assistance to 
which this subpart applies shall submit an assurance, on a form 
specified by the responsible NRC official, that the program or activity 
will be operated in compliance with the subpart. An applicant may 
incorporate these assurances by reference in subsequent applications to 
the NRC.
    (b) Duration of obligation. The assurance will obligate the 
recipient for the period during which Federal financial assistance is 
extended.
    (c) Remedial action. (1) If the responsible NRC official finds that 
a recipient has discriminated against persons on the basis of disability 
in violation of section 504 or this subpart, the recipient shall take 
such remedial action as the responsible NRC official deems necessary to 
overcome the effect of the discrimination.
    (2) Where a recipient is found to have discriminated against persons 
on the basis of disability in violation of section 504 or this subpart 
and where another recipient exercises control over the recipient that 
has discriminated, the responsible NRC official, where appropriate, may 
require either or both recipients to take remedial action.
    (3) The responsible NRC official may, where necessary to overcome 
the effects of discrimination in violation of section 504 or this 
subpart, require a recipient to take remedial action: (i) With respect 
to disabled persons who are no longer participants in the recipient's 
program or activity but who were participants in the program when such 
discrimination occurred or (ii) with respect to disabled persons who 
would have been participants in the program or activity had the 
discrimination not occurred.
    (d) Voluntary action. A recipient may take steps, in addition to any 
action that is required by this subpart, to overcome the effects of 
conditions that resulted in limited participation in the recipient's 
program or activity by qualified disabled persons.
    (e) Self-evaluation. (1) A recipient shall as soon as practicable:
    (i) Evaluate, with the assistance of interested persons, including 
disabled persons or organizations representing disabled persons, its 
current policies and practices and the effects thereof that do not or 
may not meet the requirements of this subpart;
    (ii) Modify, after consultation with interested persons, including 
disabled persons or organizations representing disabled persons, any 
policies and practices that do not meet the requirements of this 
subpart; and
    (iii) Take, after consultation with interested persons, including 
disabled persons or organizations representing disabled persons, 
appropriate remedial steps to eliminate the effects of any 
discrimination that resulted from adherence to those policies and 
practices.
    (2) A recipient shall, for at least three years following completion 
of the evaluation required under paragraph (e)(1) of this section, 
maintain on file, make available for public inspection, and provide to 
the responsible NRC official upon request: (i) A list of the interested 
persons consulted, (ii) a description of areas examined and any problems 
identified, and (iii) a description of any modifications made and of any 
remedial steps taken.
    (f) Designation of responsible employee. A recipient shall designate 
at least one person to coordinate its efforts to comply with this 
subpart.

[45 FR 14535, Mar. 6, 1980, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.232  Notice.

    (a) A recipient shall take appropriate initial and continuing steps 
to notify participants, beneficiaries, applicants, and employees, 
including those with impaired vision or hearing, and unions or 
professional organizations holding collective bargaining or professional 
agreements with the recipient that it does not discriminate on the basis 
of disability in violation of section 504 and this subpart. The 
notification shall

[[Page 185]]

state, where appropriate, that the recipient does not discriminate in 
admission or access to, or treatment or employment in, its programs or 
activities. The notification shall also include an identification of the 
responsible employee designated pursuant to Sec.4.231(f). A present 
recipient shall make the initial notification required by this paragraph 
within 90 days of the effective date of this subpart. Methods of initial 
and continuing notification may include the posting of notices, 
publication in newspapers and magazines, placement of notices in 
recipients' publications, and distribution of memoranda or other written 
communications.
    (b) If a recipient publishes or uses recruitment materials or 
publications containing general information that it makes available to 
participants, beneficiaries, applicants, or employees, if shall include 
in those materials or publications a statement of the policy described 
in paragraph (a) of this section. A recipient may meet the requirement 
of this paragraph either by including appropriate inserts in existing 
materials and publications or by revising and reprinting the materials 
and publications.

[45 FR 14535, Mar. 6, 1980, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.233  Enforcement procedures.

    The enforcement and hearing procedures set forth in Sec. Sec.4.41 
through 4.75 of subpart A with respect to discrimination based on sex, 
race, color or national origin shall be used for the enforcement of the 
regulations in subpart B with respect to discrimination based on 
disability.



 Subpart C_Regulations Implementing the Age Discrimination Act of 1975, 
                               as Amended

    Source: 52 FR 25358, July 7, 1987, unless otherwise noted.

                                 General



Sec.4.301  Purpose and scope.

    The purpose of this subpart is to set forth NRC policies and 
procedures under the Age Discrimination Act of 1975 which prohibits 
discrimination on the basis of age in programs or activities receiving 
Federal financial assistance.



Sec.4.302  Application of this subpart.

    (a) The Age Discrimination Act of 1975 and these regulations apply 
to any program or activity receiving Federal financial assistance from 
NRC.
    (b) The Age Discrimination Act of 1975 and these regulations do not 
apply to--
    (1) An age distinction contained in that part of a Federal, State, 
or local statute or ordinance adopted by an elected, general purpose 
legislative body that--
    (i) Provides any benefits or assistance to persons based on age; or
    (ii) Establishes criteria for participation in age-related terms; or
    (iii) Describes intended beneficiaries or target groups in age-
related terms.
    (2) Any employment practice of any employer, employment agency, 
labor organization, or any labor-management joint apprenticeship 
training program, except for any program or activity receiving Federal 
financial assistance for public service employment under the 
Comprehensive Employment and Training Act of 1974 (CETA) (29 U.S.C. 801 
et seq.).



Sec.4.303  Definitions.

    As used in this subpart:
    (a) Act means the Age Discrimination Act of 1975, as amended, (title 
III of Pub. L. 94-135; 89 Stat. 713; 42 U.S.C. 3001 note).
    (b) Action means any act, activity, policy, rule, standard, or 
method of administration; or the use of any policy, rule, standard, or 
method of administration.
    (c) Age means how old a person is, or the number of elapsed years 
from the date of a person's birth.
    (d) Age distinction means any action using age or an age-related 
term.
    (e) Age-related term means a word or words which necessarily imply a 
particular age or range of ages (for example, ``children,'' ``adult,'' 
``older persons,'' but not ``student'').
    (f) Subrecipient means any of the entities in the definition of 
``recipient'' to

[[Page 186]]

which a recipient extends or passes on Federal financial assistance. A 
subrecipient is generally regarded as a recipient of Federal financial 
assistance and has all the duties of a recipient in these regulations.

              Standards for Determining Age Discrimination



Sec.4.311  Rules against age discrimination.

    The rules stated in this section are limited by the exceptions 
contained in Sec. Sec.4.313 and 4.314 of this subpart.
    (a) General rule. No person in the United States shall, on the basis 
of age, be excluded from participation in, be denied the benefits of, or 
be subjected to discrimination under, any program or activity receiving 
Federal financial assistance.
    (b) Specific rules. A recipient may not, in any program or activity 
receiving Federal financial assistance, directly or through contractual, 
licensing, or other arrangements use age distinctions or take any other 
actions which have the effect, on the basis of age, of--
    (1) Excluding individuals from, denying them the benefits of, or 
subjecting them to discrimination under, a program or activity receiving 
Federal financial assistance, or
    (2) Denying or limiting individuals in their opportunity to 
participate in any program or activity receiving Federal financial 
assistance.
    (c) The specific forms of age discrimination listed in paragraph (b) 
of this section do not necessarily constitute a complete list.



Sec.4.312  Definitions of ``normal operation'' and ``statutory 
objective''.

    For purposes of Sec. Sec.4.313 and 4.314, the terms ``normal 
operation'' and ``statutory objective'' have the following meaning:
    (a) Normal operation means the operation of a program or activity 
without significant changes that would impair its ability to meet its 
objectives.
    (b) Statutory objective means any purposes of a program or activity 
expressly stated in any Federal statute State statute, or local statute 
or ordinance adopted by an elected general purpose legislative body.



Sec.4.313  Exceptions to the rules against age discrimination. Normal operation or statutory objective of any program or activity.

    A recipient is permitted to take an action, otherwise prohibited by 
Sec.4.311, if the action reasonably takes into account age as a factor 
necessary to the normal operation or the achievement of any statutory 
objective of a program or activity. An action reasonably takes into 
account age as a factor necessary to the normal operation or the 
achievement of any statutory objective of a program or activity, if--
    (a) Age is used as a measure or approximation of one or more other 
characteristics; and
    (b) The other characteristic(s) must be measured or approximated in 
order for the normal operation of the program or activity to continue, 
or to achieve any statutory objective of the program or activity; and
    (c) The other characteristic(s) can be reasonably measured or 
approximated by the use of age; and
    (d) The other characteristic(s) are impractical to measure directly 
on an individual basis.

[52 FR 25358, July 7, 1987, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.314  Exceptions to the rule against age discrimination. 
Reasonable factors other than age.

    A recipient is permitted to take an action otherwise prohibited by 
Sec.4.311 which is based on a factor other than age, even though that 
action may have a disproportionate effect on persons of different ages. 
An action may be based on a factor other than age only if the factor 
bears a direct and substantial relationship to the normal operation of 
the program or activity or to the achievement of a statutory objective.



Sec.4.315  Burden of proof.

    The burden of proving that an age distinction or other action falls 
within the exceptions outlined in Sec. Sec.4.313 and 4.314 is on the 
recipient of Federal financial assistance.

[[Page 187]]

                        Duties of NRC Recipients



Sec.4.321  Assurance of compliance.

    Each NRC recipient has primary responsibility to ensure that its 
programs or activities are in compliance with the Act and these 
regulations. Each recipient will sign an assurance of compliance that 
its programs or activities will be conducted in compliance with all the 
requirements imposed by the Act and these regulations. A recipient also 
has responsibility to maintain records, provide information, and to 
afford access to its records to NRC, to the extent required to determine 
whether it is in compliance with the Act and these regulations.

[52 FR 25358, July 7, 1987, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.322  Written notice, technical assistance, and educational materials.

    (a) NRC will provide written notice to each recipient of its 
obligations under the Act and these regulations, including its 
obligation under paragraph (b) of this section.
    (b) Where a recipient makes available Federal financial assistance 
from NRC to a subrecipient, the recipient shall provide the subrecipient 
written notice of the subrecipient's obligations under the Act and these 
regulations.
    (c) NRC will provide technical assistance, where necessary, to 
recipients to aid them in complying with the Act and these regulations.
    (d) NRC will make available educational materials which set forth 
the rights and obligations of recipients and beneficiaries under the Act 
and these regulations.



Sec.4.324  Information requirements.

    Each recipient shall:
    (a) Make available upon request to NRC information necessary to 
determine whether the recipient is complying with the Act and these 
regulations.
    (b) Permit reasonable access by NRC to the recipient's books, 
records, accounts, facilities, and other sources of information to the 
extent necessary to determine whether the recipient is in compliance 
with the Act and these regulations.

         Investigation, Conciliation, and Enforcement Procedures



Sec.4.331  Compliance reviews.

    (a) NRC may conduct compliance reviews and preaward reviews of 
recipients or use other similar procedures that will permit it to 
investigate and correct violations of the Act and these regulations. NRC 
may conduct these reviews even in absence of a complaint against a 
recipient. The review may be as comprehensive as necessary to determine 
whether a violation of these regulations has occurred.
    (b) If a compliance review or preaward review indicates a violation 
of the Act or these regulations, NRC will attempt to achieve voluntary 
compliance with the Act. If voluntary compliance cannot be achieved, NRC 
will arrange for enforcement as described in Sec.4.336.



Sec.4.332  Complaints.

    (a) Any person, individually or as a member of a class or on behalf 
of others, may file a complaint with NRC, alleging discrimination 
prohibited by the Act or these regulations based on an action occurring 
on or after July 1, 1979. A complainant shall file a complaint within 
180 days from the date the complainant first had knowledge of the 
alleged act of discrimination. However, for good cause shown, NRC may 
extend this time limit.
    (b) NRC will attempt to facilitate the filing of complaints wherever 
possible, including taking the following measures:
    (1) Accepting a complaint as sufficient for further processing 
that--
    (i) Is made in writing;
    (ii) Alleges a violation of the Act;
    (iii) Identifies the parties involved and the date the complainant 
first had knowledge of the alleged violation;
    (iv) Describes generally the action or practice complained of; and
    (v) Is signed by the complainant.
    (2) Freely permitting a complainant to add information to the 
complaint to meet the requirements of a sufficient complaint.
    (3) Notifying the complainant and the recipient of their rights and 
obligations under the complaint procedure,

[[Page 188]]

including the right to have a representative at all stages of the 
complaint procedures.
    (4) Notifying the complainant and the recipient (or their 
representatives) of their right to contact NRC for information and 
assistance regarding the complaint resolution process.
    (c) Each recipient and complainant shall participate actively in 
efforts toward speedy resolution of the complaint.
    (d) NRC will return to the complainant any complaint outside the 
jurisdiction of these regulations, and will state the reason(s) why it 
is outside the jurisdiction of these regulations.



Sec.4.333  Mediation.

    (a) Referral of complaints for mediation. NRC will refer to a 
mediation agency designated by the Secretary of the Department of Health 
and Human Services all complaints that--
    (1) Fall within the jurisdiction of the Act and these regulations; 
and
    (2) Contain all information necessary for further processing.
    (b) Both the complainant and the recipient shall participate in the 
mediation process to the extent necessary to reach an agreement or make 
an informed judgment that an agreement is not possible. There must be at 
least one meeting with the mediator before NRC will accept a judgment 
that an agreement is not possible. However, the recipient and the 
complainant need not meet with the mediator at the same time.
    (c) If the complainant and the recipient reach an agreement, the 
mediator shall prepare a written statement of the agreement and have the 
complainant and recipient sign it. The mediator shall send a copy of the 
agreement to NRC. NRC will take no further action on the complaint 
unless the complainant or recipient fails to comply with the agreement.
    (d) The mediator shall protect the confidentiality of all 
information obtained in the course of the mediation process. No mediator 
shall testify in any adjudicative proceeding, produce any document, or 
otherwise disclose any information obtained in the course of the 
mediation process without prior approval of the head of the agency 
appointing the mediator.
    (e) NRC will use the mediation process for a maximum of 60 days 
after receiving a complaint. Mediation ends if--
    (1) From the time NRC receives the complaint 60 days elapse; or
    (2) Prior to the end of that 60-day period, the mediator determines 
an agreement is reached; or
    (3) Prior to the end of that 60-day period, the mediator determines 
that an agreement cannot be reached.
    (f) The mediator shall return unresolved complaints to NRC.



Sec.4.334  Investigation.

    (a) Informal investigation. (1) NRC will investigate complaints that 
are unresolved after mediation or are reopened because of a violation of 
a mediation agreement.
    (2) As part of the initial investigation, NRC will use informal 
fact-finding methods, including joint or separate discussions with the 
complaint and recipient to establish the facts and, if possible, settle 
the complaint on terms that are mutually agreeable to the parties. NRC 
may seek the assistance of any involved State agency.
    (3) NRC will put any agreement in writing and have it signed by the 
parties and an authorized official at NRC.
    (4) The settlement shall not affect the operation of any other 
enforcement effort of NRC, including compliance reviews and 
investigation of other complaints which may involve the recipient.
    (5) Settlement of a complaint under this section will not constitute 
a finding of discrimination by the NRC against a recipient or an 
admission of discrimination by the recipient.
    (b) Formal investigation. If NRC cannot resolve the complaint 
through informal investigation, it will begin to develop formal findings 
through further investigation of the complaint. If the investigation 
indicates a violation of these regulations, NRC will attempt to obtain 
voluntary compliance. If NRC cannot obtain voluntary compliance, it will 
begin enforcement as described in Sec.4.336.

[52 FR 25358, July 7, 1987, as amended at 68 FR 51345, Aug. 26, 2003]

[[Page 189]]



Sec.4.335  Prohibition against intimidation or retaliation.

    A recipient may not engage in acts of intimidation or retaliation 
against any person who--
    (a) Attempts to assert a right protected by the Act or these 
regulations; or
    (b) Cooperates in any mediation, investigation, hearing, or other 
part of NRC's investigation, conciliation, and enforcement process.



Sec.4.336  Compliance procedure.

    (a) NRC may enforce the Act and these regulations through--
    (1) Termination of a recipient's Federal financial assistance from 
NRC under the program or activity involved where the recipient has 
violated the Act or these regulations. The determination of the 
recipient's violation may be made only after a recipient has had an 
opportunity for a hearing on the record before an administrative law 
judge. Therefore, cases that are settled in mediation, or prior to a 
hearing, will not involve termination of a recipient's Federal fiancial 
assistance from NRC.
    (2) Any other means authorized by law including but not limited to--
    (i) Referral to the Department of Justice for proceedings to enforce 
any rights of the United States or obligations of the recipients created 
by the Act or these regulations.
    (ii) Use of any requirement of or referral to any Federal, State, or 
local government agency that will have the effect of correcting a 
violation of the Act or these regulations.
    (b) NRC will limit any termination under Sec.4.336(a)(1) to the 
particular recipient and particular program or activity NRC finds in 
violation of Act or these regulations. NRC will not base any part of a 
termination on a finding with respect to any program or activity of the 
recipient that does not receive Federal financial assistance from NRC.
    (c) NRC will take no action under paragraph (a) until--
    (1) The Commission, or designee, has advised the recipient of its 
failure to comply with the Act or these regulations and has determined 
that voluntary compliance cannot be obtained.
    (2) 30 days have elapsed after the Commission, or designee, has sent 
a written report of the circumstances and grounds of the action to the 
committees of the Congress having legislative jurisdiction over the 
program or activity involved. A report will be filed whenever any action 
is taken under paragraph (a) of this section.
    (d) NRC also may defer granting new Federal financial assistance to 
a recipient when termination proceedings under Sec.4.336(a)(1) are 
initiated.
    (1) New Federal financial assistance includes all assistance for 
which NRC requires an application or approval, including renewal or 
continuation of existing activities or authorization of new activities, 
during the deferral period. New Federal financial assistance does not 
include increases in funding as a result of change computation of 
formula awards or assistance approved prior to the beginning of 
termination proceedings under Sec.4.336(a)(1).
    (2) NRC will not begin a deferral until the recipient has received a 
notice of an opportunity for a hearing under Sec.4.336(a)(1). NRC will 
not continue a deferral for more than 60 days unless a hearing has begun 
within that time or the time for beginning the hearings has been 
extended by mutual consent of the recipient and NRC. NRC will not 
continue a deferral for more than 30 days after the close of the 
hearing, unless the hearing results in a finding against the recipient.

[52 FR 25358, July 7, 1987, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.337  Hearings, decisions, post-termination proceedings.

    Certain NRC procedural provisions applicable to title VI of the 
Civil Rights Act of 1964 apply to NRC enforcement of these regulations. 
They are Sec. Sec.4.61 through 4.64 and Sec. Sec.4.71 through 4.75.



Sec.4.338  Remedial and affirmative action by recipients.

    (a) Where NRC finds a recipient has discriminated on the basis of 
age, the recipient shall take any remedial action that NRC may require 
to overcome the effects of the discrimination. If another recipient 
exercises control

[[Page 190]]

over the recipient that has discriminated, NRC may require both 
recipients to take remedial action.
    (b) Even in the absence of a finding of discrimination, a recipient 
may take affirmative action to overcome the effects of conditions that 
resulted in limited participation in the recipient's program or activity 
on the basis of age.
    (c) If a recipient, operating a program that serves the elderly or 
children in addition to persons of other ages, provides special benefits 
to the elderly or to children, the provision of those benefits shall be 
presumed to be voluntary affirmative action provided that it does not 
have the effect of excluding otherwise eligible persons from 
participation in the program or activity.

[52 FR 25358, July 7, 1987, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.339  Alternate funds disbursal procedure.

    (a) When NRC withholds funds from a recipient under these 
regulations, the Commission, or designee, may disburse the withheld 
funds directly to an alternate recipient, any public or nonprofit 
private organization or agency, or State or political subdivision of the 
State.
    (b) Any alternative recipient will be required to demonstrate--
    (1) The ability to comply with these regulations; and
    (2) The ability to achieve the goals of the Federal statute 
authorizing the Federal financial assistance.

[52 FR 25358, July 7, 1987, as amended at 68 FR 51345, Aug. 26, 2003]



Sec.4.340  Exhaustion of administrative remedies.

    (a) A complainant may file a civil action following the exhaustion 
of administrative remedies under the Act. Administrative remedies are 
exhausted if--
    (1) 180 days have elapsed since the complainant filed the complaint 
and NRC has made no finding with regard to the complaint; or
    (2) NRC issues any finding in favor of the recipient.
    (b) If NRC fails to make a finding within 180 days or issues a 
finding in favor of the recipient, NRC will--
    (1) Promptly advise the complainant; and
    (2) Advise the complainant of his or her right to bring a civil 
action under section 305(e) of the Act of injunctive relief that will 
effect the purposes of the Act; and
    (3) Inform the complainant that--
    (i) The complainant may bring a civil action only in a United States 
District Court for the district in which the recipient is found or 
transacts business;
    (ii) A complainant prevailing in a civil action has the right to be 
awarded the costs of the action, including reasonable attorney's fees, 
but that the complainant must demand these costs in the complaint;
    (iii) That before commencing the action, the complainant shall give 
30 days notice by registered mail to the Commission, the Secretary of 
the Department of Health and Human Services, the Attorney General of the 
United States, and the recipient;
    (iv) The notice must state the relief requested, the court in which 
the complainant is bringing the action, and whether or not attorney's 
fees are demanded in the event the complainant prevails; and
    (v) The complainant may not bring an action if the same alleged 
violation of the Act by the same recipient is the subject of pending 
action in any court of the United States.



Sec.4.341  Reports.

    The NRC shall submit to the Secretary of Health and Human Services, 
not later than December 31 of each year, a report which--
    (a) Describes in detail the steps taken during the preceding fiscal 
year to carry out the Act; and
    (b) Contains data on the frequency, type, and resolution of 
complaints and on any compliance reviews, sufficient to permit analysis 
of the agency's progress in reducing age discrimination in programs or 
activities receiving Federal financial assistance from NRC; and
    (c) Contains data directly relevant to the extent of any pattern or 
practice of age discrimination which NRC has identified in any programs 
or activities receiving Federal financial assistance

[[Page 191]]

from NRC and to progress toward eliminating it; and
    (d) Contains evaluative or interpretative information which NRC 
determines is useful in analyzing agency progress in reducing age 
discrimination in programs or activities receiving Federal financial 
assistance from NRC; and
    (e) Contains whatever other data the Secretary of HHS may require.

[52 FR 25358, July 7, 1987, as amended at 68 FR 51345, Aug. 26, 2003]

Subpart D [Reserved]



Subpart E_Enforcement of Nondiscrimination on the Basis of Disability in 
    Programs or Activities Conducted by the U.S. Nuclear Regulatory 
                               Commission

    Source: 51 FR 22888, 22896, June 23, 1986, unless otherwise noted.



Sec.4.501  Purpose.

    This part effectuates section 119 of the Rehabilitation, 
Comprehensive Services, and Developmental Disabilities Amendments of 
1978, which amended section 504 of the Rehabilitation Act of 1973 to 
prohibit discrimination on the basis of disability in programs or 
activities conducted by Executive agencies or the United States Postal 
Service.



Sec.4.502  Application.

    This part applies to all programs or activities conducted by the 
agency.



Sec.4.503  Definitions.

    For purposes of this part, the term--
    Assistant Attorney General means the Assistant Attorney General, 
Civil Rights Division, United States Department of Justice.
    Auxiliary aids means services or devices that enable persons with 
impaired sensory, manual, or speaking skills to have an equal 
opportunity to participate in, and enjoy the benefits of, programs or 
activities conducted by the agency. For example, auxiliary aids useful 
for persons with impaired vision include readers, brailled materials, 
audio recordings, telecommunications devices and other similar services 
and devices. Auxiliary aids useful for persons with impaired hearing 
include telephone handset amplifiers, telephones compatible with hearing 
aids, telecommunication devices for deaf persons (TDD's), interpreters, 
notetakers, written materials, and other similar services and devices.
    Complete complaint means a written statement that contains the 
complainant's name and address and describes the agency's alleged 
discriminatory action in sufficient detail to inform the agency of the 
nature and date of the alleged violation of section 504. It shall be 
signed by the complainant or by someone authorized to do so on his or 
her behalf. Complaints filed on behalf of classes or third parties shall 
describe or identify (by name, if possible) the alleged victims of 
discrimination.
    Disabled person means any person who has a physical or mental 
impairment that substantially limits one or more major life activities, 
has a record of such an impairment, or is regarded as having such an 
impairment.
    As used in this definition, the phrase:
    (1) Physical or mental impairment includes--
    (i) Any physiological disorder or condition, cosmetic disfigurement, 
or anatomical loss affecting one or more of the following body systems: 
Neurological; musculoskeletal; special sense organs; respiratory, 
including speech organs; cardiovascular; reproductive; digestive; 
genitourinary; hemic and lymphatic; skin; and endocrine; or
    (ii) Any mental or psychological disorder, such as mental 
retardation, organic brain syndrome, emotional or mental illness, and 
specific learning disabilities. The term ``physical or mental 
impairment'' includes, but is not limited to, such diseases and 
conditions as orthopedic, visual, speech, and hearing impairments, 
cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, 
cancer, heart disease, diabetes, mental retardation, emotional illness, 
and drug addiction and alcoholism.
    (2) Major life activities includes functions such as caring for 
one's self, performing manual tasks, walking, seeing,

[[Page 192]]

hearing, speaking, breathing, learning, and working.
    (3) Has a record of such an impairment means has a history of, or 
has been misclassified as having, a mental or physical impairment that 
substantially limits one or more major life activities.
    (4) Is regarded as having an impairment means--
    (i) Has a physical or mental impairment that does not substantially 
limit major life activities but is treated by the agency as constituting 
such a limitation;
    (ii) Has a physical or mental impairment that substantially limits 
major life activities only as a result of the attitudes of others toward 
such impairment; or
    (iii) Has none of the impairments defined in paragraph (1) of this 
definition but is treated by the agency as having such an impairment.
    Facility means all or any portion of buildings, structures, 
equipment, roads, walks, parking lots, rolling stock or other 
conveyances, or other real or personal property.
    Historic preservation programs means programs conducted by the 
agency that have preservation of historic properties as a primary 
purpose.
    Historic properties means those properties that are listed or 
eligible for listing in the National Register of Historic Places or 
properties designated as historic under a statute of the appropriate 
State or local government body.
    Qualified disabled person means--
    (1) With respect to preschool, elementary, or secondary education 
services provided by the agency, a disabled person who is a member of a 
class of persons otherwise entitled by statute, regulation, or agency 
policy to receive education services from the agency.
    (2) With respect to any other agency program or activity under which 
a person is required to perform services or to achieve a level of 
accomplishment, a disabled person who meets the essential eligibility 
requirements and who can achieve the purpose of the program or activity 
without modifications in the program or activity that the agency can 
demonstrate would result in a fundamental alteration in its nature;
    (3) With respect to any other program or activity, a disabled person 
who meets the essential eligibility requirements for participation in, 
or receipt of benefits from, that program or activity; and
    (4) Qualified disabled person is defined for purposes of employment 
in 29 CFR 1613.702(f), which is made applicable to this part by Sec.
4.540.
    Section 504 means section 504 of the Rehabilitation Act of 1973 
(Pub. L. 93-112, 87 Stat. 394 (29 U.S.C. 794)), as amended by the 
Rehabilitation Act Amendments of 1974 (Pub. L. 93-516, 88 Stat. 1617), 
and the Rehabilitation, Comprehensive Services, and Developmental 
Disabilities Amendments of 1978 (Pub. L. 95-602, 92 Stat. 2955). As used 
in this part, section 504 applies only to programs or activities 
conducted by Executive agencies and not to federally assisted programs.
    Substantial impairment means a significant loss of the integrity of 
finished materials, design quality, or special character resulting from 
a permanent alteration.



Sec. Sec.4.504-4.509  [Reserved]



Sec.4.510  Self-evaluation.

    (a) The agency shall, by August 24, 1987, evaluate its current 
policies and practices, and the effects thereof, that do not or may not 
meet the requirements of this part, and, to the extent modification of 
any such policies and practices is required, the agency shall proceed to 
make the necessary modifications.
    (b) The agency shall provide an opportunity to interested persons, 
including disabled persons or organizations representing disabled 
persons, to participate in the self-evaluation process by submitting 
comments (both oral and written).
    (c) The agency shall, until three years following the completion of 
the self-evaluation, maintain on file and make available for public 
inspection:
    (1) A description of areas examined and any problems identified, and
    (2) A description of any modifications made.

[[Page 193]]



Sec.4.511  Notice.

    The agency shall make available to employees, applicants, 
participants, beneficiaries, and other interested persons such 
information regarding the provisions of this part and its applicability 
to the programs or activities conducted by the agency, and make such 
information available to them in such manner as the head of the agency 
finds necessary to apprise such persons of the protections against 
discrimination assured them by section 504 and this regulation.



Sec. Sec.4.512-4.529  [Reserved]



Sec.4.530  General prohibitions against discrimination.

    (a) No qualified disabled person shall, on the basis of disability, 
be excluded from participation in, be denied the benefits of, or 
otherwise be subjected to discrimination under any program or activity 
conducted by the agency.
    (b)(1) The agency, in providing any aid, benefit, or service, may 
not, directly or through contractual, licensing, or other arrangements, 
on the basis of disability--
    (i) Deny a qualified disabled person the opportunity to participate 
in or benefit from the aid, benefit, or service;
    (ii) Afford a qualified disabled person an opportunity to 
participate in or benefit from the aid, benefit, or service that is not 
equal to that afforded others;
    (iii) Provide a qualified disabled person with an aid, benefit, or 
service that is not as effective in affording equal opportunity to 
obtain the same result, to gain the same benefit, or to reach the same 
level of achievement as that provided to others;
    (iv) Provide different or separate aid, benefits, or services to 
disabled persons or to any class of disabled persons than is provided to 
others unless such action is necessary to provide qualified disabled 
persons with aid, benefits, or services that are as effective as those 
provided to others;
    (v) Deny a qualified disabled person the opportunity to participate 
as a member of planning or advisory boards; or
    (vi) Otherwise limit a qualified disabled person in the enjoyment of 
any right, privilege, advantage, or opportunity enjoyed by others 
receiving the aid, benefit, or service.
    (2) The agency may not deny a qualified disabled person the 
opportunity to participate in programs or activities that are not 
separate or different, despite the existence of permissibly separate or 
different programs or activities.
    (3) The agency may not, directly or through contractual or other 
arrangments, utilize criteria or methods of administration the purpose 
or effect of which would--
    (i) Subject qualified disabled persons to discrimination on the 
basis of disability; or
    (ii) Defeat or substantially impair accomplishment of the objectives 
of a program or activity with respect to disabled persons.
    (4) The agency may not, in determining the site or location of a 
facility, make selections the purpose or effect of which would--
    (i) Exclude disabled persons from, deny them the benefits of, or 
otherwise subject them to discrimination under any program or activity 
conducted by the agency; or
    (ii) Defeat or substantially impair the accomplishment of the 
objectives of a program or activity with respect to disabled persons.
    (5) The agency, in the selection of procurement contractors, may not 
use criteria that subject qualified disabled persons to discrimination 
on the basis of disability.
    (6) The agency may not administer a licensing or certification 
program in a manner that subjects qualified disabled persons to 
discrimination on the basis of disability, nor may the agency establish 
requirements for the programs or activities of licensees or certified 
entities that subject qualified disabled persons to discrimination on 
the basis of disability. However, the programs or activities of entities 
that are licensed or certified by the agency are not, themselves, 
covered by this part.
    (c) The exclusion of nondisabled persons from the benefits of a 
program limited by Federal statute or Executive order to disabled 
persons or the exclusion of a specific class of disabled

[[Page 194]]

persons from a program limited by Federal statute or Executive order to 
a different class of disabled persons is not prohibited by this part.
    (d) The agency shall administer programs and activities in the most 
integrated setting appropriate to the needs of qualified disabled 
persons.



Sec. Sec.4.531-4.539  [Reserved]



Sec.4.540  Employment.

    No qualified disabled person shall, on the basis of disability, be 
subjected to discrimination in employment under any program or activity 
conducted by the agency. The definitions, requirements, and procedures 
of section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 791), as 
established by the Equal Employment Opportunity Commission in 29 CFR 
part 1613, shall apply to employment in federally conducted programs or 
activities.



Sec. Sec.4.541-4.548  [Reserved]



Sec.4.549  Program accessibility: Discrimination prohibited.

    Except as otherwise provided in Sec.4.550, no qualified disabled 
person shall, because the agency's facilities are inaccessible to or 
unusable by disabled persons, be denied the benefits of, be excluded 
from participation in, or otherwise be subjected to discrimination under 
any program or activity conducted by the agency.



Sec.4.550  Program accessibility: Existing facilities.

    (a) General. The agency shall operate each program or activity so 
that the program or activity, when viewed in its entirety, is readily 
accessible to and usable by disabled persons. This paragraph does not--
    (1) Necessarily require the agency to make each of its existing 
facilities accessible to and usable by disabled persons;
    (2) In the case of historic preservation programs, require the 
agency to take any action that would result in a substantial impairment 
of significant historic features of an historic property; or
    (3) Require the agency to take any action that it can demonstrate 
would result in a fundamental alteration in the nature of a program or 
activity or in undue financial and administrative burdens. In those 
circumstances where agency personnel believe that the proposed action 
would fundamentally alter the program or activity or would result in 
undue financial and administrative burdens, the agency has the burden of 
proving that compliance with Sec.4.550(a) would result in such 
alteration or burdens. The decision that compliance would result in such 
alteration or burdens must be made by the agency head or his or her 
designee after considering all agency resources available for use in the 
funding and operation of the conducted program or activity, and must be 
accompanied by a written statement of the reasons for reaching that 
conclusion. If an action would result in such an alteration or such 
burdens, the agency shall take any other action that would not result in 
such an alteration or such burdens but would nevertheless ensure that 
disabled persons receive the benefits and services of the program or 
activity.
    (b) Methods--(1) General. The agency may comply with the 
requirements of this section through such means as redesign of 
equipment, reassignment of services to accessible buildings, assignment 
of aides to beneficiaries, home visits, delivery of services at 
alternate accessible sites, alteration of existing facilities and 
construction of new facilities, use of accessible rolling stock, or any 
other methods that result in making its programs or activities readily 
accessible to and usable by disabled persons. The agency is not required 
to make structural changes in existing facilities where other methods 
are effective in achieving compliance with this section. The agency, in 
making alterations to existing buildings, shall meet accessibility 
requirements to the extent compelled by the Architectural Barriers Act 
of 1968, as amended (42 U.S.C. 4151-4157), and any regulations 
implementing it. In choosing among available methods for meeting the 
requirements of this section, the agency shall give priority to those 
methods that offer programs and activities to qualified disabled persons 
in the most integrated setting appropriate.
    (2) Historic preservation programs. In meeting the requirements of 
Sec.4.550(a)

[[Page 195]]

in historic preservation programs, the agency shall give priority to 
methods that provide physical access to disabled persons. In cases where 
a physical alteration to an historic property is not required because of 
Sec.4.550(a)(2) or (a)(3), alternative methods of achieving program 
accessibility include--
    (i) Using audio-visual materials and devices to depict those 
portions of an historic property that cannot otherwise be made 
accessible;
    (ii) Assigning persons to guide disabled persons into or through 
portions of historic properties that cannot otherwise be made 
accessible; or
    (iii) Adopting other innovative methods.
    (c) Time period for compliance. The agency shall comply with the 
obligations established under this section by October 21, 1986, except 
that where structural changes in facilities are undertaken, such changes 
shall be made by August 22, 1989, but in any event as expeditiously as 
possible.
    (d) Transition plan. In the event that structural changes to 
facilities will be undertaken to achieve program accessibility, the 
agency shall develop, by February 23, 1987 a transition plan setting 
forth the steps necessary to complete such changes. The agency shall 
provide an opportunity to interested persons, including disabled persons 
or organizations representing disabled persons, to participate in the 
development of the transition plan by submitting comments (both oral and 
written). A copy of the transition plan shall be made available for 
public inspection. The plan shall, at a minimum--
    (1) Identify physical obstacles in the agency's facilities that 
limit the accessibility of its programs or activities to disabled 
persons;
    (2) Describe in detail the methods that will be used to make the 
facilities accessible;
    (3) Specify the schedule for taking the steps necessary to achieve 
compliance with this section and, if the time period of the transition 
plan is longer than one year, identify steps that will be taken during 
each year of the transition period; and
    (4) Indicate the official responsible for implementation of the 
plan.



Sec.4.551  Program accessibility: New construction and alterations.

    Each building or part of a building that is constructed or altered 
by, on behalf of, or for the use of the agency shall be designed, 
constructed, or altered so as to be readily accessible to and usable by 
disabled persons. The definitions, requirements, and standards of the 
Architectural Barriers Act (42 U.S.C. 4151-4157), as established in 41 
CFR 101-19.600 to 101-19.607, apply to buildings covered by this 
section.



Sec. Sec.4.552-4.559  [Reserved]



Sec.4.560  Communications.

    (a) The agency shall take appropriate steps to ensure effective 
communication with applicants, participants, personnel of other Federal 
entities, and members of the public.
    (1) The agency shall furnish appropriate auxiliary aids where 
necessary to afford a disabled person an equal opportunity to 
participate in, and enjoy the benefits of, a program or activity 
conducted by the agency.
    (i) In determining what type of auxiliary aid is necessary, the 
agency shall give primary consideration to the requests of the disabled 
person.
    (ii) The agency need not provide individually prescribed devices, 
readers for personal use or study, or other devices of a personal 
nature.
    (2) Where the agency communicates with applicants and beneficiaries 
by telephone, telecommunication devices for deaf person (TDD's) or 
equally effective telecommunication systems shall be used.
    (b) The agency shall ensure that interested persons, including 
persons with impaired vision or hearing, can obtain information as to 
the existence and location of accessible services, activities, and 
facilities.
    (c) The agency shall provide signage at a primary entrance to each 
of its inaccessible facilities, directing users to a location at which 
they can obtain information about accessible facilities. The 
international symbol for accessibility shall be used at each primary 
entrance of an accessible facility.
    (d) This section does not require the agency to take any action that 
it can

[[Page 196]]

demonstrate would result in a fundamental alteration in the nature of a 
program or activity or in undue financial and adminstrative burdens. In 
those circumstances where agency personnel believe that the proposed 
action would fundamentally alter the program or activity or would result 
in undue financial and administrative burdens, the agency has the burden 
of proving that compliance with Sec.4.560 would result in such 
alteration or burdens. The decision that compliance would result in such 
alteration or burdens must be made by the agency head or his or her 
designee after considering all agency resources available for use in the 
funding and operation of the conducted program or activity, and must be 
accompanied by a written statement of the reasons for reaching that 
conclusion. If an action required to comply with this section would 
result in such an alteration or such burdens, the agency shall take any 
other action that would not result in such an alteration or such burdens 
but would nevertheless ensure that, to the maximum extent possible, 
disabled persons receive the benefits and services of the program or 
activity.



Sec. Sec.4.561-4.569  [Reserved]



Sec.4.570  Compliance procedures.

    (a) Except as provided in paragraph (b) of this section, this 
section applies to all allegations of discrimination on the basis of 
disability in programs or activities conducted by the agency.
    (b) The agency shall process complaints alleging violations of 
section 504 with respect to employment according to the procedures 
established by the Equal Employment Opportunity Commission in 29 CFR 
part 1613 pursuant to section 501 of the Rehabilitation Act of 1973 (29 
U.S.C. 791).
    (c) The Civil Rights Program Manager, Office of Small Business and 
Civil Rights, shall be responsible for coordinating implementation of 
this section. Complaints should be sent to the NRC using an appropriate 
method listed in Sec.4.5.
    (d) The agency shall accept and investigate all complete complaints 
for which it has jurisdiction. All complete complaints must be filed 
within 180 days of the alleged act of discrimination. The agency may 
extend this time period for good cause.
    (e) If the agency receives a complaint over which it does not have 
jurisdiction, it shall promptly notify the complainant and shall make 
reasonable efforts to refer the complaint to the appropriate government 
entity.
    (f) The agency shall notify the Architectural and Transportation 
Barriers Compliance Board upon receipt of any complaint alleging that a 
building or facility that is subject to the Architectural Barriers Act 
of 1968, as amended (42 U.S.C. 4151-4157), or section 502 of the 
Rehabilitation Act of 1973, as amended (29 U.S.C. 792), is not readily 
accessible to and usable by disabled persons.
    (g) Within 180 days of the receipt of a complete complaint for which 
it has jurisdiction, the agency shall notify the complainant of the 
results of the investigation in a letter containing--
    (1) Findings of fact and conclusions of law;
    (2) A description of a remedy for each violation found; and
    (3) A notice of the right to appeal.
    (h) Appeals of the findings of fact and conclusions of law or 
remedies must be filed by the complainant within 90 days of receipt from 
the agency of the letter required by Sec.4.570(g). The agency may 
extend this time for good cause.
    (i) Timely appeals shall be accepted and processed by the head of 
the agency.
    (j) The head of the agency shall notify the complainant of the 
results of the appeal within 60 days of the receipt of the request. If 
the head of the agency determines that additional information is needed 
from the complainant, he or she shall have 60 days from the date of 
receipt of the additional information to make his or her determination 
on the appeal.
    (k) The time limits cited in paragraphs (g) and (j) of this section 
may be extended with the permission of the Assistant Attorney General.
    (l) The agency may delegate its authority for conducting complaint 
investigations to other Federal agencies, except that the authority for 
making

[[Page 197]]

the final determination may not be delegated to another agency.

[51 FR 22888, 22896, June 23, 1986, as amended at 68 FR 58799, Oct. 10, 
2003]



Sec. Sec.4.571-4.999  [Reserved]



 Sec. Appendix A to Part 4--Federal Financial Assistance to Which This 
                            Part Applies \1\
---------------------------------------------------------------------------

    \1\ Categories of assistance may be added to appendix A from time to 
time by notice published in the Federal Register. This part shall be 
deemed to apply to all grants, loans or contracts entered into under any 
such category of assistance on or after the effective date of the 
inclusion of the category of assistance in appendix A.
---------------------------------------------------------------------------

    (a) Conferences on regulatory programs. Agreements for financial 
assistance to State officials, without full-cost recovery, for visits to 
NRC facilities and offices or to other locations to confer on regulatory 
programs and related matters.
    (b) Orientation and instruction. Agreements for assistance to State 
and local officials, without full-cost recovery, to receive orientation 
and on-the-job instruction at NRC facilities and offices.
    (c) Courses in fundamentals of radiation. Agreements for the conduct 
of courses for State and local employees, without full-cost recovery, in 
fundamentals of radiation and radiation protection.
    (d) Participation in meetings and conferences. Agreements for 
participation, without full-cost recovery, in meetings, conferences, 
workshops, and symposia to assist scientific, professional or 
educational institutions or groups.
    (e) Research Support. Agreements for the financial support of basic 
and applied scientific research and for the exchange of scientific 
information.

[29 FR 19277, Dec. 31, 1964, as amended at 38 FR 17929, July 5, 1973; 40 
FR 8778, Mar. 3, 1975; 45 FR 14539, Mar. 6, 1980; 52 FR 25361, July 7, 
1987]



PART 5_NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS
OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE--
Table of Contents



                         Subpart A_Introduction

Sec.
5.100 Purpose and effective date.
5.105 Definitions.
5.110 Remedial and affirmative action and self-evaluation.
5.115 Assurance required.
5.120 Transfers of property.
5.125 Effect of other requirements.
5.130 Effect of employment opportunities.
5.135 Designation of responsible employee and adoption of grievance 
          procedures.
5.140 Dissemination of policy.

                           Subpart B_Coverage

5.200 Application.
5.205 Educational institutions and other entities controlled by 
          religious organizations.
5.210 Military and merchant marine educational institutions.
5.215 Membership practices of certain organizations.
5.220 Admissions.
5.225 Educational institutions eligible to submit transition plans.
5.230 Transition plans.
5.235 Statutory amendments.

     Subpart C_Discrimination on the Basis of Sex in Admission and 
                         Recruitment Prohibited

5.300 Admission.
5.305 Preference in admission.
5.310 Recruitment.

 Subpart D_Discrimination on the Basis of Sex in Education Programs or 
                          Activities Prohibited

5.400 Education programs or activities.
5.405 Housing.
5.410 Comparable facilities.
5.415 Access to course offerings.
5.420 Access to schools operated by LEAs.
5.425 Counseling and use of appraisal and counseling materials.
5.430 Financial assistance.
5.435 Employment assistance to students.
5.440 Health and insurance benefits and services.
5.445 Marital or parental status.
5.450 Athletics.
5.455 Textbooks and curricular material.

Subpart E_Discrimination on the Basis of Sex in Employment in Education 
                    Programs or Activities Prohibited

5.500 Employment.
5.505 Employment criteria.
5.510 Recruitment.
5.515 Compensation.
5.520 Job classification and structure.
5.525 Fringe benefits.
5.530 Marital or parental status.
5.535 Effect of state or local law or other requirements.
5.540 Advertising.
5.545 Pre-employment inquiries.

[[Page 198]]

5.550 Sex as a bona fide occupational qualification.

                          Subpart F_Procedures

5.600 Notice of covered programs.
5.605 Enforcement procedures.

Appendix A to Part 5--List of Federal Financial Assistance Administered 
          by the Nuclear Regulatory Commission to Which Title IX Applies

    Authority: 20 U.S.C. 1681, 1682, 1683, 1685, 1686, 1687, 1688.

    Source: 65 FR 52865, 52875, Aug. 30, 2000, unless otherwise noted.



                         Subpart A_Introduction



Sec.5.100  Purpose and effective date.

    The purpose of these Title IX regulations is to effectuate Title IX 
of the Education Amendments of 1972, as amended (except sections 904 and 
906 of those Amendments) (20 U.S.C. 1681, 1682, 1683, 1685, 1686, 1687, 
1688), which is designed to eliminate (with certain exceptions) 
discrimination on the basis of sex in any education program or activity 
receiving Federal financial assistance, whether or not such program or 
activity is offered or sponsored by an educational institution as 
defined in these Title IX regulations. The effective date of these Title 
IX regulations shall be September 29, 2000.



Sec.5.105  Definitions.

    As used in these Title IX regulations, the term:
    Administratively separate unit means a school, department, or 
college of an educational institution (other than a local educational 
agency) admission to which is independent of admission to any other 
component of such institution.
    Admission means selection for part-time, full-time, special, 
associate, transfer, exchange, or any other enrollment, membership, or 
matriculation in or at an education program or activity operated by a 
recipient.
    Applicant means one who submits an application, request, or plan 
required to be approved by an official of the Federal agency that awards 
Federal financial assistance, or by a recipient, as a condition to 
becoming a recipient.
    Designated agency official means Program Manager, Civil Rights 
Program.
    Educational institution means a local educational agency (LEA) as 
defined by 20 U.S.C. 8801(18), a preschool, a private elementary or 
secondary school, or an applicant or recipient that is an institution of 
graduate higher education, an institution of undergraduate higher 
education, an institution of professional education, or an institution 
of vocational education, as defined in this section.
    Federal financial assistance means any of the following, when 
authorized or extended under a law administered by the Federal agency 
that awards such assistance:
    (1) A grant or loan of Federal financial assistance, including funds 
made available for:
    (i) The acquisition, construction, renovation, restoration, or 
repair of a building or facility or any portion thereof; and
    (ii) Scholarships, loans, grants, wages, or other funds extended to 
any entity for payment to or on behalf of students admitted to that 
entity, or extended directly to such students for payment to that 
entity.
    (2) A grant of Federal real or personal property or any interest 
therein, including surplus property, and the proceeds of the sale or 
transfer of such property, if the Federal share of the fair market value 
of the property is not, upon such sale or transfer, properly accounted 
for to the Federal Government.
    (3) Provision of the services of Federal personnel.
    (4) Sale or lease of Federal property or any interest therein at 
nominal consideration, or at consideration reduced for the purpose of 
assisting the recipient or in recognition of public interest to be 
served thereby, or permission to use Federal property or any interest 
therein without consideration.
    (5) Any other contract, agreement, or arrangement that has as one of 
its purposes the provision of assistance to any education program or 
activity, except a contract of insurance or guaranty.
    Institution of graduate higher education means an institution that:
    (1) Offers academic study beyond the bachelor of arts or bachelor of 
science

[[Page 199]]

degree, whether or not leading to a certificate of any higher degree in 
the liberal arts and sciences;
    (2) Awards any degree in a professional field beyond the first 
professional degree (regardless of whether the first professional degree 
in such field is awarded by an institution of undergraduate higher 
education or professional education); or
    (3) Awards no degree and offers no further academic study, but 
operates ordinarily for the purpose of facilitating research by persons 
who have received the highest graduate degree in any field of study.
    Institution of professional education means an institution (except 
any institution of undergraduate higher education) that offers a program 
of academic study that leads to a first professional degree in a field 
for which there is a national specialized accrediting agency recognized 
by the Secretary of Education.
    Institution of undergraduate higher education means:
    (1) An institution offering at least two but less than four years of 
college-level study beyond the high school level, leading to a diploma 
or an associate degree, or wholly or principally creditable toward a 
baccalaureate degree; or
    (2) An institution offering academic study leading to a 
baccalaureate degree; or
    (3) An agency or body that certifies credentials or offers degrees, 
but that may or may not offer academic study.
    Institution of vocational education means a school or institution 
(except an institution of professional or graduate or undergraduate 
higher education) that has as its primary purpose preparation of 
students to pursue a technical, skilled, or semiskilled occupation or 
trade, or to pursue study in a technical field, whether or not the 
school or institution offers certificates, diplomas, or degrees and 
whether or not it offers full-time study.
    Recipient means any State or political subdivision thereof, or any 
instrumentality of a State or political subdivision thereof, any public 
or private agency, institution, or organization, or other entity, or any 
person, to whom Federal financial assistance is extended directly or 
through another recipient and that operates an education program or 
activity that receives such assistance, including any subunit, 
successor, assignee, or transferee thereof.
    Student means a person who has gained admission.
    Title IX means Title IX of the Education Amendments of 1972, Public 
Law 92-318, 86 Stat. 235, 373 (codified as amended at 20 U.S.C. 1681-
1688) (except sections 904 and 906 thereof), as amended by section 3 of 
Public Law 93-568, 88 Stat. 1855, by section 412 of the Education 
Amendments of 1976, Public Law 94-482, 90 Stat. 2234, and by Section 3 
of Public Law 100-259, 102 Stat. 28, 28-29 (20 U.S.C. 1681, 1682, 1683, 
1685, 1686, 1687, 1688).
    Title IX regulations means the provisions set forth at Sec. Sec.
5.100 through 5.605.
    Transition plan means a plan subject to the approval of the 
Secretary of Education pursuant to section 901(a)(2) of the Education 
Amendments of 1972, 20 U.S.C. 1681(a)(2), under which an educational 
institution operates in making the transition from being an educational 
institution that admits only students of one sex to being one that 
admits students of both sexes without discrimination.



Sec.5.110  Remedial and affirmative action and self-evaluation.

    (a) Remedial action. If the designated agency official finds that a 
recipient has discriminated against persons on the basis of sex in an 
education program or activity, such recipient shall take such remedial 
action as the designated agency official deems necessary to overcome the 
effects of such discrimination.
    (b) Affirmative action. In the absence of a finding of 
discrimination on the basis of sex in an education program or activity, 
a recipient may take affirmative action consistent with law to overcome 
the effects of conditions that resulted in limited participation therein 
by persons of a particular sex. Nothing in these Title IX regulations 
shall be interpreted to alter any affirmative action obligations that a 
recipient may have under Executive Order 11246, 3 CFR, 1964-1965 Comp., 
p. 339; as amended by Executive Order 11375, 3 CFR, 1966-1970 Comp., p. 
684; as amended by

[[Page 200]]

Executive Order 11478, 3 CFR, 1966-1970 Comp., p. 803; as amended by 
Executive Order 12086, 3 CFR, 1978 Comp., p. 230; as amended by 
Executive Order 12107, 3 CFR, 1978 Comp., p. 264.
    (c) Self-evaluation. Each recipient education institution shall, 
within one year of September 29, 2000:
    (1) Evaluate, in terms of the requirements of these Title IX 
regulations, its current policies and practices and the effects thereof 
concerning admission of students, treatment of students, and employment 
of both academic and non-academic personnel working in connection with 
the recipient's education program or activity;
    (2) Modify any of these policies and practices that do not or may 
not meet the requirements of these Title IX regulations; and
    (3) Take appropriate remedial steps to eliminate the effects of any 
discrimination that resulted or may have resulted from adherence to 
these policies and practices.
    (d) Availability of self-evaluation and related materials. 
Recipients shall maintain on file for at least three years following 
completion of the evaluation required under paragraph (c) of this 
section, and shall provide to the designated agency official upon 
request, a description of any modifications made pursuant to paragraph 
(c)(2) of this section and of any remedial steps taken pursuant to 
paragraph (c)(3) of this section.



Sec.5.115  Assurance required.

    (a) General. Either at the application stage or the award stage, 
Federal agencies must ensure that applications for Federal financial 
assistance or awards of Federal financial assistance contain, be 
accompanied by, or be covered by a specifically identified assurance 
from the applicant or recipient, satisfactory to the designated agency 
official, that each education program or activity operated by the 
applicant or recipient and to which these Title IX regulations apply 
will be operated in compliance with these Title IX regulations. An 
assurance of compliance with these Title IX regulations shall not be 
satisfactory to the designated agency official if the applicant or 
recipient to whom such assurance applies fails to commit itself to take 
whatever remedial action is necessary in accordance with Sec.5.110(a) 
to eliminate existing discrimination on the basis of sex or to eliminate 
the effects of past discrimination whether occurring prior to or 
subsequent to the submission to the designated agency official of such 
assurance.
    (b) Duration of obligation. (1) In the case of Federal financial 
assistance extended to provide real property or structures thereon, such 
assurance shall obligate the recipient or, in the case of a subsequent 
transfer, the transferee, for the period during which the real property 
or structures are used to provide an education program or activity.
    (2) In the case of Federal financial assistance extended to provide 
personal property, such assurance shall obligate the recipient for the 
period during which it retains ownership or possession of the property.
    (3) In all other cases such assurance shall obligate the recipient 
for the period during which Federal financial assistance is extended.
    (c) Form. (1) The assurances required by paragraph (a) of this 
section, which may be included as part of a document that addresses 
other assurances or obligations, shall include that the applicant or 
recipient will comply with all applicable Federal statutes relating to 
nondiscrimination. These include but are not limited to: Title IX of the 
Education Amendments of 1972, as amended (20 U.S.C. 1681-1683, 1685-
1688).
    (2) The designated agency official will specify the extent to which 
such assurances will be required of the applicant's or recipient's 
subgrantees, contractors, subcontractors, transferees, or successors in 
interest.



Sec.5.120  Transfers of property.

    If a recipient sells or otherwise transfers property financed in 
whole or in part with Federal financial assistance to a transferee that 
operates any education program or activity, and the Federal share of the 
fair market value of the property is not upon such sale or transfer 
properly accounted for to the Federal Government, both the transferor 
and the transferee shall be deemed to be recipients, subject to the 
provisions of Sec. Sec.5.205 through 5.235(a).

[[Page 201]]



Sec.5.125  Effect of other requirements.

    (a) Effect of other Federal provisions. The obligations imposed by 
these Title IX regulations are independent of, and do not alter, 
obligations not to discriminate on the basis of sex imposed by Executive 
Order 11246, 3 CFR, 1964-1965 Comp., p. 339; as amended by Executive 
Order 11375, 3 CFR, 1966-1970 Comp., p. 684; as amended by Executive 
Order 11478, 3 CFR, 1966-1970 Comp., p. 803; as amended by Executive 
Order 12087, 3 CFR, 1978 Comp., p. 230; as amended by Executive Order 
12107, 3 CFR, 1978 Comp., p. 264; sections 704 and 855 of the Public 
Health Service Act (42 U.S.C. 295m, 298b-2); Title VII of the Civil 
Rights Act of 1964 (42 U.S.C. 2000e et seq.); the Equal Pay Act of 1963 
(29 U.S.C. 206); and any other Act of Congress or Federal regulation.
    (b) Effect of State or local law or other requirements. The 
obligation to comply with these Title IX regulations is not obviated or 
alleviated by any State or local law or other requirement that would 
render any applicant or student ineligible, or limit the eligibility of 
any applicant or student, on the basis of sex, to practice any 
occupation or profession.
    (c) Effect of rules or regulations of private organizations. The 
obligation to comply with these Title IX regulations is not obviated or 
alleviated by any rule or regulation of any organization, club, athletic 
or other league, or association that would render any applicant or 
student ineligible to participate or limit the eligibility or 
participation of any applicant or student, on the basis of sex, in any 
education program or activity operated by a recipient and that receives 
Federal financial assistance.



Sec.5.130  Effect of employment opportunities.

    The obligation to comply with these Title IX regulations is not 
obviated or alleviated because employment opportunities in any 
occupation or profession are or may be more limited for members of one 
sex than for members of the other sex.



Sec.5.135  Designation of responsible employee and adoption 
of grievance procedures.

    (a) Designation of responsible employee. Each recipient shall 
designate at least one employee to coordinate its efforts to comply with 
and carry out its responsibilities under these Title IX regulations, 
including any investigation of any complaint communicated to such 
recipient alleging its noncompliance with these Title IX regulations or 
alleging any actions that would be prohibited by these Title IX 
regulations. The recipient shall notify all its students and employees 
of the name, office address, and telephone number of the employee or 
employees appointed pursuant to this paragraph.
    (b) Complaint procedure of recipient. A recipient shall adopt and 
publish grievance procedures providing for prompt and equitable 
resolution of student and employee complaints alleging any action that 
would be prohibited by these Title IX regulations.



Sec.5.140  Dissemination of policy.

    (a) Notification of policy. (1) Each recipient shall implement 
specific and continuing steps to notify applicants for admission and 
employment, students and parents of elementary and secondary school 
students, employees, sources of referral of applicants for admission and 
employment, and all unions or professional organizations holding 
collective bargaining or professional agreements with the recipient, 
that it does not discriminate on the basis of sex in the educational 
programs or activities that it operates, and that it is required by 
Title IX and these Title IX regulations not to discriminate in such a 
manner. Such notification shall contain such information, and be made in 
such manner, as the designated agency official finds necessary to 
apprise such persons of the protections against discrimination assured 
them by Title IX and these Title IX regulations, but shall state at 
least that the requirement not to discriminate in education programs or 
activities extends to employment therein, and to admission thereto 
unless Sec. Sec.5.300 through 5.310 do not apply to the recipient, and 
that inquiries concerning the application of Title IX and

[[Page 202]]

these Title IX regulations to such recipient may be referred to the 
employee designated pursuant to Sec.5.135, or to the designated agency 
official.
    (2) Each recipient shall make the initial notification required by 
paragraph (a)(1) of this section within 90 days of September 29, 2000 or 
of the date these Title IX regulations first apply to such recipient, 
whichever comes later, which notification shall include publication in:
    (i) Newspapers and magazines operated by such recipient or by 
student, alumnae, or alumni groups for or in connection with such 
recipient; and
    (ii) Memoranda or other written communications distributed to every 
student and employee of such recipient.
    (b) Publications. (1) Each recipient shall prominently include a 
statement of the policy described in paragraph (a) of this section in 
each announcement, bulletin, catalog, or application form that it makes 
available to any person of a type, described in paragraph (a) of this 
section, or which is otherwise used in connection with the recruitment 
of students or employees.
    (2) A recipient shall not use or distribute a publication of the 
type described in paragraph (b)(1) of this section that suggests, by 
text or illustration, that such recipient treats applicants, students, 
or employees differently on the basis of sex except as such treatment is 
permitted by these Title IX regulations.
    (c) Distribution. Each recipient shall distribute without 
discrimination on the basis of sex each publication described in 
paragraph (b)(1) of this section, and shall apprise each of its 
admission and employment recruitment representatives of the policy of 
nondiscrimination described in paragraph (a) of this section, and shall 
require such representatives to adhere to such policy.



                           Subpart B_Coverage



Sec.5.200  Application.

    Except as provided in Sec. Sec.5.205 through 5.235(a), these Title 
IX regulations apply to every recipient and to each education program or 
activity operated by such recipient that receives Federal financial 
assistance.



Sec.5.205  Educational institutions and other entities controlled 
by religious organizations.

    (a) Exemption. These Title IX regulations do not apply to any 
operation of an educational institution or other entity that is 
controlled by a religious organization to the extent that application of 
these Title IX regulations would not be consistent with the religious 
tenets of such organization.
    (b) Exemption claims. An educational institution or other entity 
that wishes to claim the exemption set forth in paragraph (a) of this 
section shall do so by submitting in writing to the designated agency 
official a statement by the highest-ranking official of the institution, 
identifying the provisions of these Title IX regulations that conflict 
with a specific tenet of the religious organization.



Sec.5.210  Military and merchant marine educational institutions.

    These Title IX regulations do not apply to an educational 
institution whose primary purpose is the training of individuals for a 
military service of the United States or for the merchant marine.



Sec.5.215  Membership practices of certain organizations.

    (a) Social fraternities and sororities. These Title IX regulations 
do not apply to the membership practices of social fraternities and 
sororities that are exempt from taxation under section 501(a) of the 
Internal Revenue Code of 1954, 26 U.S.C. 501(a), the active membership 
of which consists primarily of students in attendance at institutions of 
higher education.
    (b) YMCA, YWCA, Girl Scouts, Boy Scouts, and Camp Fire Girls. These 
Title IX regulations do not apply to the membership practices of the 
Young Men's Christian Association (YMCA), the Young Women's Christian 
Association (YWCA), the Girl Scouts, the Boy Scouts, and Camp Fire 
Girls.
    (c) Voluntary youth service organizations. These Title IX 
regulations do not apply to the membership practices of a voluntary 
youth service organization that is exempt from taxation under section 
501(a) of the Internal Revenue Code of 1954, 26 U.S.C. 501(a), and the

[[Page 203]]

membership of which has been traditionally limited to members of one sex 
and principally to persons of less than nineteen years of age.



Sec.5.220  Admissions.

    (a) Admissions to educational institutions prior to June 24, 1973, 
are not covered by these Title IX regulations.
    (b) Administratively separate units. For the purposes only of this 
section, Sec. Sec.5.225 and 5.230, and Sec. Sec.5.300 through 5.310, 
each administratively separate unit shall be deemed to be an educational 
institution.
    (c) Application of Sec. Sec.5.300 through 5.310. Except as 
provided in paragraphs (d) and (e) of this section, Sec. Sec.5.300 
through 5.310 apply to each recipient. A recipient to which Sec. Sec.
5.300 through 5.310 apply shall not discriminate on the basis of sex in 
admission or recruitment in violation of Sec. Sec.5.300 through 5.310.
    (d) Educational institutions. Except as provided in paragraph (e) of 
this section as to recipients that are educational institutions, 
Sec. Sec.5.300 through 5.310 apply only to institutions of vocational 
education, professional education, graduate higher education, and public 
institutions of undergraduate higher education.
    (e) Public institutions of undergraduate higher education. 
Sec. Sec.5.300 through 5.310 do not apply to any public institution of 
undergraduate higher education that traditionally and continually from 
its establishment has had a policy of admitting students of only one 
sex.



Sec.5.225  Educational institutions eligible to submit transition 
plans.

    (a) Application. This section applies to each educational 
institution to which Sec. Sec.5.300 through 5.310 apply that:
    (1) Admitted students of only one sex as regular students as of June 
23, 1972; or
    (2) Admitted students of only one sex as regular students as of June 
23, 1965, but thereafter admitted, as regular students, students of the 
sex not admitted prior to June 23, 1965.
    (b) Provision for transition plans. An educational institution to 
which this section applies shall not discriminate on the basis of sex in 
admission or recruitment in violation of Sec. Sec.5.300 through 5.310.



Sec.5.230  Transition plans.

    (a) Submission of plans. An institution to which Sec.5.225 applies 
and that is composed of more than one administratively separate unit may 
submit either a single transition plan applicable to all such units, or 
a separate transition plan applicable to each such unit.
    (b) Content of plans. In order to be approved by the Secretary of 
Education, a transition plan shall:
    (1) State the name, address, and Federal Interagency Committee on 
Education Code of the educational institution submitting such plan, the 
administratively separate units to which the plan is applicable, and the 
name, address, and telephone number of the person to whom questions 
concerning the plan may be addressed. The person who submits the plan 
shall be the chief administrator or president of the institution, or 
another individual legally authorized to bind the institution to all 
actions set forth in the plan.
    (2) State whether the educational institution or administratively 
separate unit admits students of both sexes as regular students and, if 
so, when it began to do so.
    (3) Identify and describe with respect to the educational 
institution or administratively separate unit any obstacles to admitting 
students without discrimination on the basis of sex.
    (4) Describe in detail the steps necessary to eliminate as soon as 
practicable each obstacle so identified and indicate the schedule for 
taking these steps and the individual directly responsible for their 
implementation.
    (5) Include estimates of the number of students, by sex, expected to 
apply for, be admitted to, and enter each class during the period 
covered by the plan.
    (c) Nondiscrimination. No policy or practice of a recipient to which 
Sec.5.225 applies shall result in treatment of applicants to or 
students of such recipient in violation of Sec. Sec.5.300 through 
5.310 unless such treatment is necessitated by an obstacle identified in 
paragraph (b)(3) of this section and a schedule for eliminating that 
obstacle has been provided as required by paragraph (b)(4) of this 
section.
    (d) Effects of past exclusion. To overcome the effects of past 
exclusion of

[[Page 204]]

students on the basis of sex, each educational institution to which 
Sec.5.225 applies shall include in its transition plan, and shall 
implement, specific steps designed to encourage individuals of the 
previously excluded sex to apply for admission to such institution. Such 
steps shall include instituting recruitment programs that emphasize the 
institution's commitment to enrolling students of the sex previously 
excluded.



Sec.5.235  Statutory amendments.

    (a) This section, which applies to all provisions of these Title IX 
regulations, addresses statutory amendments to Title IX.
    (b) These Title IX regulations shall not apply to or preclude:
    (1) Any program or activity of the American Legion undertaken in 
connection with the organization or operation of any Boys State 
conference, Boys Nation conference, Girls State conference, or Girls 
Nation conference;
    (2) Any program or activity of a secondary school or educational 
institution specifically for:
    (i) The promotion of any Boys State conference, Boys Nation 
conference, Girls State conference, or Girls Nation conference; or
    (ii) The selection of students to attend any such conference;
    (3) Father-son or mother-daughter activities at an educational 
institution or in an education program or activity, but if such 
activities are provided for students of one sex, opportunities for 
reasonably comparable activities shall be provided to students of the 
other sex;
    (4) Any scholarship or other financial assistance awarded by an 
institution of higher education to an individual because such individual 
has received such award in a single-sex pageant based upon a combination 
of factors related to the individual's personal appearance, poise, and 
talent. The pageant, however, must comply with other nondiscrimination 
provisions of Federal law.
    (c) Program or activity or program means:
    (1) All of the operations of any entity described in paragraphs 
(c)(1)(i) through (iv) of this section, any part of which is extended 
Federal financial assistance:
    (i)(A) A department, agency, special purpose district, or other 
instrumentality of a State or of a local government; or
    (B) The entity of such State or local government that distributes 
such assistance and each such department or agency (and each other State 
or local government entity) to which the assistance is extended, in the 
case of assistance to a State or local government;
    (ii)(A) A college, university, or other postsecondary institution, 
or a public system of higher education; or
    (B) A local educational agency (as defined in section 8801 of title 
20), system of vocational education, or other school system;
    (iii)(A) An entire corporation, partnership, or other private 
organization, or an entire sole proprietorship--
    (1) If assistance is extended to such corporation, partnership, 
private organization, or sole proprietorship as a whole; or
    (2) Which is principally engaged in the business of providing 
education, health care, housing, social services, or parks and 
recreation; or
    (B) The entire plant or other comparable, geographically separate 
facility to which Federal financial assistance is extended, in the case 
of any other corporation, partnership, private organization, or sole 
proprietorship; or
    (iv) Any other entity that is established by two or more of the 
entities described in paragraphs (c)(1)(i), (ii), or (iii) of this 
section.
    (2)(i) Program or activity does not include any operation of an 
entity that is controlled by a religious organization if the application 
of 20 U.S.C. 1681 to such operation would not be consistent with the 
religious tenets of such organization.
    (ii) For example, all of the operations of a college, university, or 
other postsecondary institution, including but not limited to 
traditional educational operations, faculty and student housing, campus 
shuttle bus service, campus restaurants, the bookstore, and other 
commercial activities are part of a ``program or activity'' subject to

[[Page 205]]

these Title IX regulations if the college, university, or other 
institution receives Federal financial assistance.
    (d)(1) Nothing in these Title IX regulations shall be construed to 
require or prohibit any person, or public or private entity, to provide 
or pay for any benefit or service, including the use of facilities, 
related to an abortion. Medical procedures, benefits, services, and the 
use of facilities, necessary to save the life of a pregnant woman or to 
address complications related to an abortion are not subject to this 
section.
    (2) Nothing in this section shall be construed to permit a penalty 
to be imposed on any person or individual because such person or 
individual is seeking or has received any benefit or service related to 
a legal abortion. Accordingly, subject to paragraph (d)(1) of this 
section, no person shall be excluded from participation in, be denied 
the benefits of, or be subjected to discrimination under any academic, 
extracurricular, research, occupational training, employment, or other 
educational program or activity operated by a recipient that receives 
Federal financial assistance because such individual has sought or 
received, or is seeking, a legal abortion, or any benefit or service 
related to a legal abortion.



     Subpart C_Discrimination on the Basis of Sex in Admission and 
                         Recruitment Prohibited



Sec.5.300  Admission.

    (a) General. No person shall, on the basis of sex, be denied 
admission, or be subjected to discrimination in admission, by any 
recipient to which Sec. Sec.5.300 through Sec. Sec.5.310 apply, 
except as provided in Sec. Sec.5.225 and Sec. Sec.5.230.
    (b) Specific prohibitions. (1) In determining whether a person 
satisfies any policy or criterion for admission, or in making any offer 
of admission, a recipient to which Sec. Sec.5.300 through 5.310 apply 
shall not:
    (i) Give preference to one person over another on the basis of sex, 
by ranking applicants separately on such basis, or otherwise;
    (ii) Apply numerical limitations upon the number or proportion of 
persons of either sex who may be admitted; or
    (iii) Otherwise treat one individual differently from another on the 
basis of sex.
    (2) A recipient shall not administer or operate any test or other 
criterion for admission that has a disproportionately adverse effect on 
persons on the basis of sex unless the use of such test or criterion is 
shown to predict validly success in the education program or activity in 
question and alternative tests or criteria that do not have such a 
disproportionately adverse effect are shown to be unavailable.
    (c) Prohibitions relating to marital or parental status. In 
determining whether a person satisfies any policy or criterion for 
admission, or in making any offer of admission, a recipient to which 
Sec. Sec.5.300 through 5.310 apply:
    (1) Shall not apply any rule concerning the actual or potential 
parental, family, or marital status of a student or applicant that 
treats persons differently on the basis of sex;
    (2) Shall not discriminate against or exclude any person on the 
basis of pregnancy, childbirth, termination of pregnancy, or recovery 
therefrom, or establish or follow any rule or practice that so 
discriminates or excludes;
    (3) Subject to Sec.5.235(d), shall treat disabilities related to 
pregnancy, childbirth, termination of pregnancy, or recovery therefrom 
in the same manner and under the same policies as any other temporary 
disability or physical condition; and
    (4) Shall not make pre-admission inquiry as to the marital status of 
an applicant for admission, including whether such applicant is ``Miss'' 
or ``Mrs.'' A recipient may make pre-admission inquiry as to the sex of 
an applicant for admission, but only if such inquiry is made equally of 
such applicants of both sexes and if the results of such inquiry are not 
used in connection with discrimination prohibited by these Title IX 
regulations.



Sec.5.305  Preference in admission.

    A recipient to which Sec. Sec.5.300 through 5.310 apply shall not 
give preference to applicants for admission, on the basis of attendance 
at any educational institution or other school or entity that

[[Page 206]]

admits as students only or predominantly members of one sex, if the 
giving of such preference has the effect of discriminating on the basis 
of sex in violation of Sec. Sec.5.300 through 5.310.



Sec.5.310  Recruitment.

    (a) Nondiscriminatory recruitment. A recipient to which Sec. Sec.
5.300 through 5.310 apply shall not discriminate on the basis of sex in 
the recruitment and admission of students. A recipient may be required 
to undertake additional recruitment efforts for one sex as remedial 
action pursuant to Sec.5.110(a), and may choose to undertake such 
efforts as affirmative action pursuant to Sec.5.110(b).
    (b) Recruitment at certain institutions. A recipient to which 
Sec. Sec.5.300 through 5.310 apply shall not recruit primarily or 
exclusively at educational institutions, schools, or entities that admit 
as students only or predominantly members of one sex, if such actions 
have the effect of discriminating on the basis of sex in violation of 
Sec. Sec.5.300 through 5.310.



 Subpart D_Discrimination on the Basis of Sex in Education Programs or 
                          Activities Prohibited



Sec.5.400  Education programs or activities.

    (a) General. Except as provided elsewhere in these Title IX 
regulations, no person shall, on the basis of sex, be excluded from 
participation in, be denied the benefits of, or be subjected to 
discrimination under any academic, extracurricular, research, 
occupational training, or other education program or activity operated 
by a recipient that receives Federal financial assistance. Sections 
5.400 through 5.455 do not apply to actions of a recipient in connection 
with admission of its students to an education program or activity of a 
recipient to which Sec. Sec.5.300 through 5.310 do not apply, or an 
entity, not a recipient, to which Sec. Sec.5.300 through 5.310 would 
not apply if the entity were a recipient.
    (b) Specific prohibitions. Except as provided in Sec. Sec.5.400 
through 5.455, in providing any aid, benefit, or service to a student, a 
recipient shall not, on the basis of sex:
    (1) Treat one person differently from another in determining whether 
such person satisfies any requirement or condition for the provision of 
such aid, benefit, or service;
    (2) Provide different aid, benefits, or services or provide aid, 
benefits, or services in a different manner;
    (3) Deny any person any such aid, benefit, or service;
    (4) Subject any person to separate or different rules of behavior, 
sanctions, or other treatment;
    (5) Apply any rule concerning the domicile or residence of a student 
or applicant, including eligibility for in-state fees and tuition;
    (6) Aid or perpetuate discrimination against any person by providing 
significant assistance to any agency, organization, or person that 
discriminates on the basis of sex in providing any aid, benefit, or 
service to students or employees;
    (7) Otherwise limit any person in the enjoyment of any right, 
privilege, advantage, or opportunity.
    (c) Assistance administered by a recipient educational institution 
to study at a foreign institution. A recipient educational institution 
may administer or assist in the administration of scholarships, 
fellowships, or other awards established by foreign or domestic wills, 
trusts, or similar legal instruments, or by acts of foreign governments 
and restricted to members of one sex, that are designed to provide 
opportunities to study abroad, and that are awarded to students who are 
already matriculating at or who are graduates of the recipient 
institution; Provided, that a recipient educational institution that 
administers or assists in the administration of such scholarships, 
fellowships, or other awards that are restricted to members of one sex 
provides, or otherwise makes available, reasonable opportunities for 
similar studies for members of the other sex. Such opportunities may be 
derived from either domestic or foreign sources.
    (d) Aids, benefits or services not provided by recipient. (1) This 
paragraph (d) applies to any recipient that requires participation by 
any applicant, student, or employee in any education

[[Page 207]]

program or activity not operated wholly by such recipient, or that 
facilitates, permits, or considers such participation as part of or 
equivalent to an education program or activity operated by such 
recipient, including participation in educational consortia and 
cooperative employment and student-teaching assignments.
    (2) Such recipient:
    (i) Shall develop and implement a procedure designed to assure 
itself that the operator or sponsor of such other education program or 
activity takes no action affecting any applicant, student, or employee 
of such recipient that these Title IX regulations would prohibit such 
recipient from taking; and
    (ii) Shall not facilitate, require, permit, or consider such 
participation if such action occurs.



Sec.5.405  Housing.

    (a) Generally. A recipient shall not, on the basis of sex, apply 
different rules or regulations, impose different fees or requirements, 
or offer different services or benefits related to housing, except as 
provided in this section (including housing provided only to married 
students).
    (b) Housing provided by recipient. (1) A recipient may provide 
separate housing on the basis of sex.
    (2) Housing provided by a recipient to students of one sex, when 
compared to that provided to students of the other sex, shall be as a 
whole:
    (i) Proportionate in quantity to the number of students of that sex 
applying for such housing; and
    (ii) Comparable in quality and cost to the student.
    (c) Other housing. (1) A recipient shall not, on the basis of sex, 
administer different policies or practices concerning occupancy by its 
students of housing other than that provided by such recipient.
    (2)(i) A recipient which, through solicitation, listing, approval of 
housing, or otherwise, assists any agency, organization, or person in 
making housing available to any of its students, shall take such 
reasonable action as may be necessary to assure itself that such housing 
as is provided to students of one sex, when compared to that provided to 
students of the other sex, is as a whole:
    (A) Proportionate in quantity; and
    (B) Comparable in quality and cost to the student.
    (ii) A recipient may render such assistance to any agency, 
organization, or person that provides all or part of such housing to 
students of only one sex.



Sec.5.410  Comparable facilities.

    A recipient may provide separate toilet, locker room, and shower 
facilities on the basis of sex, but such facilities provided for 
students of one sex shall be comparable to such facilities provided for 
students of the other sex.



Sec.5.415  Access to course offerings.

    (a) A recipient shall not provide any course or otherwise carry out 
any of its education program or activity separately on the basis of sex, 
or require or refuse participation therein by any of its students on 
such basis, including health, physical education, industrial, business, 
vocational, technical, home economics, music, and adult education 
courses.
    (b)(1) With respect to classes and activities in physical education 
at the elementary school level, the recipient shall comply fully with 
this section as expeditiously as possible but in no event later than one 
year from September 29, 2000. With respect to physical education classes 
and activities at the secondary and post-secondary levels, the recipient 
shall comply fully with this section as expeditiously as possible but in 
no event later than three years from September 29, 2000.
    (2) This section does not prohibit grouping of students in physical 
education classes and activities by ability as assessed by objective 
standards of individual performance developed and applied without regard 
to sex.
    (3) This section does not prohibit separation of students by sex 
within physical education classes or activities during participation in 
wrestling, boxing, rugby, ice hockey, football, basketball, and other 
sports the purpose or major activity of which involves bodily contact.

[[Page 208]]

    (4) Where use of a single standard of measuring skill or progress in 
a physical education class has an adverse effect on members of one sex, 
the recipient shall use appropriate standards that do not have such 
effect.
    (5) Portions of classes in elementary and secondary schools, or 
portions of education programs or activities, that deal exclusively with 
human sexuality may be conducted in separate sessions for boys and 
girls.
    (6) Recipients may make requirements based on vocal range or quality 
that may result in a chorus or choruses of one or predominantly one sex.



Sec.5.420  Access to schools operated by LEAs.

    A recipient that is a local educational agency shall not, on the 
basis of sex, exclude any person from admission to:
    (a) Any institution of vocational education operated by such 
recipient; or
    (b) Any other school or educational unit operated by such recipient, 
unless such recipient otherwise makes available to such person, pursuant 
to the same policies and criteria of admission, courses, services, and 
facilities comparable to each course, service, and facility offered in 
or through such schools.



Sec.5.425  Counseling and use of appraisal and counseling materials.

    (a) Counseling. A recipient shall not discriminate against any 
person on the basis of sex in the counseling or guidance of students or 
applicants for admission.
    (b) Use of appraisal and counseling materials. A recipient that uses 
testing or other materials for appraising or counseling students shall 
not use different materials for students on the basis of their sex or 
use materials that permit or require different treatment of students on 
such basis unless such different materials cover the same occupations 
and interest areas and the use of such different materials is shown to 
be essential to eliminate sex bias. Recipients shall develop and use 
internal procedures for ensuring that such materials do not discriminate 
on the basis of sex. Where the use of a counseling test or other 
instrument results in a substantially disproportionate number of members 
of one sex in any particular course of study or classification, the 
recipient shall take such action as is necessary to assure itself that 
such disproportion is not the result of discrimination in the instrument 
or its application.
    (c) Disproportion in classes. Where a recipient finds that a 
particular class contains a substantially disproportionate number of 
individuals of one sex, the recipient shall take such action as is 
necessary to assure itself that such disproportion is not the result of 
discrimination on the basis of sex in counseling or appraisal materials 
or by counselors.



Sec.5.430  Financial assistance.

    (a) General. Except as provided in paragraphs (b) and (c) of this 
section, in providing financial assistance to any of its students, a 
recipient shall not:
    (1) On the basis of sex, provide different amounts or types of such 
assistance, limit eligibility for such assistance that is of any 
particular type or source, apply different criteria, or otherwise 
discriminate;
    (2) Through solicitation, listing, approval, provision of 
facilities, or other services, assist any foundation, trust, agency, 
organization, or person that provides assistance to any of such 
recipient's students in a manner that discriminates on the basis of sex; 
or
    (3) Apply any rule or assist in application of any rule concerning 
eligibility for such assistance that treats persons of one sex 
differently from persons of the other sex with regard to marital or 
parental status.
    (b) Financial aid established by certain legal instruments. (1) A 
recipient may administer or assist in the administration of 
scholarships, fellowships, or other forms of financial assistance 
established pursuant to domestic or foreign wills, trusts, bequests, or 
similar legal instruments or by acts of a foreign government that 
require that awards be made to members of a particular sex specified 
therein; Provided, that the overall effect of the award of such sex-
restricted scholarships, fellowships, and other forms of financial 
assistance does not discriminate on the basis of sex.

[[Page 209]]

    (2) To ensure nondiscriminatory awards of assistance as required in 
paragraph (b)(1) of this section, recipients shall develop and use 
procedures under which:
    (i) Students are selected for award of financial assistance on the 
basis of nondiscriminatory criteria and not on the basis of availability 
of funds restricted to members of a particular sex;
    (ii) An appropriate sex-restricted scholarship, fellowship, or other 
form of financial assistance is allocated to each student selected under 
paragraph (b)(2)(i) of this section; and
    (iii) No student is denied the award for which he or she was 
selected under paragraph (b)(2)(i) of this section because of the 
absence of a scholarship, fellowship, or other form of financial 
assistance designated for a member of that student's sex.
    (c) Athletic scholarships. (1) To the extent that a recipient awards 
athletic scholarships or grants-in-aid, it must provide reasonable 
opportunities for such awards for members of each sex in proportion to 
the number of students of each sex participating in interscholastic or 
intercollegiate athletics.
    (2) A recipient may provide separate athletic scholarships or 
grants-in-aid for members of each sex as part of separate athletic teams 
for members of each sex to the extent consistent with this paragraph (c) 
and Sec.5.450.



Sec.5.435  Employment assistance to students.

    (a) Assistance by recipient in making available outside employment. 
A recipient that assists any agency, organization, or person in making 
employment available to any of its students:
    (1) Shall assure itself that such employment is made available 
without discrimination on the basis of sex; and
    (2) Shall not render such services to any agency, organization, or 
person that discriminates on the basis of sex in its employment 
practices.
    (b) Employment of students by recipients. A recipient that employs 
any of its students shall not do so in a manner that violates Sec. Sec.
5.500 through 5.550.



Sec.5.440  Health and insurance benefits and services.

    Subject to Sec.5.235(d), in providing a medical, hospital, 
accident, or life insurance benefit, service, policy, or plan to any of 
its students, a recipient shall not discriminate on the basis of sex, or 
provide such benefit, service, policy, or plan in a manner that would 
violate Sec. Sec.5.500 through 5.550 if it were provided to employees 
of the recipient. This section shall not prohibit a recipient from 
providing any benefit or service that may be used by a different 
proportion of students of one sex than of the other, including family 
planning services. However, any recipient that provides full coverage 
health service shall provide gynecological care.



Sec.5.445  Marital or parental status.

    (a) Status generally. A recipient shall not apply any rule 
concerning a student's actual or potential parental, family, or marital 
status that treats students differently on the basis of sex.
    (b) Pregnancy and related conditions. (1) A recipient shall not 
discriminate against any student, or exclude any student from its 
education program or activity, including any class or extracurricular 
activity, on the basis of such student's pregnancy, childbirth, false 
pregnancy, termination of pregnancy, or recovery therefrom, unless the 
student requests voluntarily to participate in a separate portion of the 
program or activity of the recipient.
    (2) A recipient may require such a student to obtain the 
certification of a physician that the student is physically and 
emotionally able to continue participation as long as such a 
certification is required of all students for other physical or 
emotional conditions requiring the attention of a physician.
    (3) A recipient that operates a portion of its education program or 
activity separately for pregnant students, admittance to which is 
completely voluntary on the part of the student as provided in paragraph 
(b)(1) of this section, shall ensure that the separate portion is 
comparable to that offered to non-pregnant students.
    (4) Subject to Sec.5.235(d), a recipient shall treat pregnancy, 
childbirth, false pregnancy, termination of pregnancy and recovery 
therefrom in the same

[[Page 210]]

manner and under the same policies as any other temporary disability 
with respect to any medical or hospital benefit, service, plan, or 
policy that such recipient administers, operates, offers, or 
participates in with respect to students admitted to the recipient's 
educational program or activity.
    (5) In the case of a recipient that does not maintain a leave policy 
for its students, or in the case of a student who does not otherwise 
qualify for leave under such a policy, a recipient shall treat 
pregnancy, childbirth, false pregnancy, termination of pregnancy, and 
recovery therefrom as a justification for a leave of absence for as long 
a period of time as is deemed medically necessary by the student's 
physician, at the conclusion of which the student shall be reinstated to 
the status that she held when the leave began.



Sec.5.450  Athletics.

    (a) General. No person shall, on the basis of sex, be excluded from 
participation in, be denied the benefits of, be treated differently from 
another person, or otherwise be discriminated against in any 
interscholastic, intercollegiate, club, or intramural athletics offered 
by a recipient, and no recipient shall provide any such athletics 
separately on such basis.
    (b) Separate teams. Notwithstanding the requirements of paragraph 
(a) of this section, a recipient may operate or sponsor separate teams 
for members of each sex where selection for such teams is based upon 
competitive skill or the activity involved is a contact sport. However, 
where a recipient operates or sponsors a team in a particular sport for 
members of one sex but operates or sponsors no such team for members of 
the other sex, and athletic opportunities for members of that sex have 
previously been limited, members of the excluded sex must be allowed to 
try out for the team offered unless the sport involved is a contact 
sport. For the purposes of these Title IX regulations, contact sports 
include boxing, wrestling, rugby, ice hockey, football, basketball, and 
other sports the purpose or major activity of which involves bodily 
contact.
    (c) Equal opportunity. (1) A recipient that operates or sponsors 
interscholastic, intercollegiate, club, or intramural athletics shall 
provide equal athletic opportunity for members of both sexes. In 
determining whether equal opportunities are available, the designated 
agency official will consider, among other factors:
    (i) Whether the selection of sports and levels of competition 
effectively accommodate the interests and abilities of members of both 
sexes;
    (ii) The provision of equipment and supplies;
    (iii) Scheduling of games and practice time;
    (iv) Travel and per diem allowance;
    (v) Opportunity to receive coaching and academic tutoring;
    (vi) Assignment and compensation of coaches and tutors;
    (vii) Provision of locker rooms, practice, and competitive 
facilities;
    (viii) Provision of medical and training facilities and services;
    (ix) Provision of housing and dining facilities and services;
    (x) Publicity.
    (2) For purposes of paragraph (c)(1) of this section, unequal 
aggregate expenditures for members of each sex or unequal expenditures 
for male and female teams if a recipient operates or sponsors separate 
teams will not constitute noncompliance with this section, but the 
designated agency official may consider the failure to provide necessary 
funds for teams for one sex in assessing equality of opportunity for 
members of each sex.
    (d) Adjustment period. A recipient that operates or sponsors 
interscholastic, intercollegiate, club, or intramural athletics at the 
elementary school level shall comply fully with this section as 
expeditiously as possible but in no event later than one year from 
September 29, 2000. A recipient that operates or sponsors 
interscholastic, intercollegiate, club, or intramural athletics at the 
secondary or postsecondary school level shall comply fully with this 
section as expeditiously as possible but in no event later than three 
years from September 29, 2000.

[[Page 211]]



Sec.5.455  Textbooks and curricular material.

    Nothing in these Title IX regulations shall be interpreted as 
requiring or prohibiting or abridging in any way the use of particular 
textbooks or curricular materials.



Subpart E_Discrimination on the Basis of Sex in Employment in Education 
                    Programs or Activities Prohibited



Sec.5.500  Employment.

    (a) General. (1) No person shall, on the basis of sex, be excluded 
from participation in, be denied the benefits of, or be subjected to 
discrimination in employment, or recruitment, consideration, or 
selection therefor, whether full-time or part-time, under any education 
program or activity operated by a recipient that receives Federal 
financial assistance.
    (2) A recipient shall make all employment decisions in any education 
program or activity operated by such recipient in a nondiscriminatory 
manner and shall not limit, segregate, or classify applicants or 
employees in any way that could adversely affect any applicant's or 
employee's employment opportunities or status because of sex.
    (3) A recipient shall not enter into any contractual or other 
relationship which directly or indirectly has the effect of subjecting 
employees or students to discrimination prohibited by Sec. Sec.5.500 
through 5.550, including relationships with employment and referral 
agencies, with labor unions, and with organizations providing or 
administering fringe benefits to employees of the recipient.
    (4) A recipient shall not grant preferences to applicants for 
employment on the basis of attendance at any educational institution or 
entity that admits as students only or predominantly members of one sex, 
if the giving of such preferences has the effect of discriminating on 
the basis of sex in violation of these Title IX regulations.
    (b) Application. The provisions of Sec. Sec.5.500 through 5.550 
apply to:
    (1) Recruitment, advertising, and the process of application for 
employment;
    (2) Hiring, upgrading, promotion, consideration for and award of 
tenure, demotion, transfer, layoff, termination, application of nepotism 
policies, right of return from layoff, and rehiring;
    (3) Rates of pay or any other form of compensation, and changes in 
compensation;
    (4) Job assignments, classifications, and structure, including 
position descriptions, lines of progression, and seniority lists;
    (5) The terms of any collective bargaining agreement;
    (6) Granting and return from leaves of absence, leave for pregnancy, 
childbirth, false pregnancy, termination of pregnancy, leave for persons 
of either sex to care for children or dependents, or any other leave;
    (7) Fringe benefits available by virtue of employment, whether or 
not administered by the recipient;
    (8) Selection and financial support for training, including 
apprenticeship, professional meetings, conferences, and other related 
activities, selection for tuition assistance, selection for sabbaticals 
and leaves of absence to pursue training;
    (9) Employer-sponsored activities, including social or recreational 
programs; and
    (10) Any other term, condition, or privilege of employment.



Sec.5.505  Employment criteria.

    A recipient shall not administer or operate any test or other 
criterion for any employment opportunity that has a disproportionately 
adverse effect on persons on the basis of sex unless:
    (a) Use of such test or other criterion is shown to predict validly 
successful performance in the position in question; and
    (b) Alternative tests or criteria for such purpose, which do not 
have such disproportionately adverse effect, are shown to be 
unavailable.



Sec.5.510  Recruitment.

    (a) Nondiscriminatory recruitment and hiring. A recipient shall not 
discriminate on the basis of sex in the recruitment and hiring of 
employees. Where a recipient has been found to be presently 
discriminating on the basis of sex

[[Page 212]]

in the recruitment or hiring of employees, or has been found to have so 
discriminated in the past, the recipient shall recruit members of the 
sex so discriminated against so as to overcome the effects of such past 
or present discrimination.
    (b) Recruitment patterns. A recipient shall not recruit primarily or 
exclusively at entities that furnish as applicants only or predominantly 
members of one sex if such actions have the effect of discriminating on 
the basis of sex in violation of Sec. Sec.5.500 through 5.550.



Sec.5.515  Compensation.

    A recipient shall not make or enforce any policy or practice that, 
on the basis of sex:
    (a) Makes distinctions in rates of pay or other compensation;
    (b) Results in the payment of wages to employees of one sex at a 
rate less than that paid to employees of the opposite sex for equal work 
on jobs the performance of which requires equal skill, effort, and 
responsibility, and that are performed under similar working conditions.



Sec.5.520  Job classification and structure.

    A recipient shall not:
    (a) Classify a job as being for males or for females;
    (b) Maintain or establish separate lines of progression, seniority 
lists, career ladders, or tenure systems based on sex; or
    (c) Maintain or establish separate lines of progression, seniority 
systems, career ladders, or tenure systems for similar jobs, position 
descriptions, or job requirements that classify persons on the basis of 
sex, unless sex is a bona fide occupational qualification for the 
positions in question as set forth in Sec.5.550.



Sec.5.525  Fringe benefits.

    (a) ``Fringe benefits'' defined. For purposes of these Title IX 
regulations, fringe benefits means: Any medical, hospital, accident, 
life insurance, or retirement benefit, service, policy or plan, any 
profit-sharing or bonus plan, leave, and any other benefit or service of 
employment not subject to the provision of Sec.5.515.
    (b) Prohibitions. A recipient shall not:
    (1) Discriminate on the basis of sex with regard to making fringe 
benefits available to employees or make fringe benefits available to 
spouses, families, or dependents of employees differently upon the basis 
of the employee's sex;
    (2) Administer, operate, offer, or participate in a fringe benefit 
plan that does not provide for equal periodic benefits for members of 
each sex and for equal contributions to the plan by such recipient for 
members of each sex; or
    (3) Administer, operate, offer, or participate in a pension or 
retirement plan that establishes different optional or compulsory 
retirement ages based on sex or that otherwise discriminates in benefits 
on the basis of sex.



Sec.5.530  Marital or parental status.

    (a) General. A recipient shall not apply any policy or take any 
employment action:
    (1) Concerning the potential marital, parental, or family status of 
an employee or applicant for employment that treats persons differently 
on the basis of sex; or
    (2) Which is based upon whether an employee or applicant for 
employment is the head of household or principal wage earner in such 
employee's or applicant's family unit.
    (b) Pregnancy. A recipient shall not discriminate against or exclude 
from employment any employee or applicant for employment on the basis of 
pregnancy, childbirth, false pregnancy, termination of pregnancy, or 
recovery therefrom.
    (c) Pregnancy as a temporary disability. Subject to Sec.5.235(d), 
a recipient shall treat pregnancy, childbirth, false pregnancy, 
termination of pregnancy, recovery therefrom, and any temporary 
disability resulting therefrom as any other temporary disability for all 
job-related purposes, including commencement, duration, and extensions 
of leave, payment of disability income, accrual of seniority and any 
other benefit or service, and reinstatement, and under any fringe 
benefit offered to employees by virtue of employment.
    (d) Pregnancy leave. In the case of a recipient that does not 
maintain a leave policy for its employees, or in the case of an employee 
with insufficient

[[Page 213]]

leave or accrued employment time to qualify for leave under such a 
policy, a recipient shall treat pregnancy, childbirth, false pregnancy, 
termination of pregnancy, and recovery therefrom as a justification for 
a leave of absence without pay for a reasonable period of time, at the 
conclusion of which the employee shall be reinstated to the status that 
she held when the leave began or to a comparable position, without 
decrease in rate of compensation or loss of promotional opportunities, 
or any other right or privilege of employment.



Sec.5.535  Effect of state or local law or other requirements.

    (a) Prohibitory requirements. The obligation to comply with 
Sec. Sec.5.500 through 5.550 is not obviated or alleviated by the 
existence of any State or local law or other requirement that imposes 
prohibitions or limits upon employment of members of one sex that are 
not imposed upon members of the other sex.
    (b) Benefits. A recipient that provides any compensation, service, 
or benefit to members of one sex pursuant to a State or local law or 
other requirement shall provide the same compensation, service, or 
benefit to members of the other sex.



Sec.5.540  Advertising.

    A recipient shall not in any advertising related to employment 
indicate preference, limitation, specification, or discrimination based 
on sex unless sex is a bona fide occupational qualification for the 
particular job in question.



Sec.5.545  Pre-employment inquiries.

    (a) Marital status. A recipient shall not make pre-employment 
inquiry as to the marital status of an applicant for employment, 
including whether such applicant is ``Miss'' or ``Mrs.''
    (b) Sex. A recipient may make pre-employment inquiry as to the sex 
of an applicant for employment, but only if such inquiry is made equally 
of such applicants of both sexes and if the results of such inquiry are 
not used in connection with discrimination prohibited by these Title IX 
regulations.



Sec.5.550  Sex as a bona fide occupational qualification.

    A recipient may take action otherwise prohibited by Sec. Sec.5.500 
through 5.550 provided it is shown that sex is a bona fide occupational 
qualification for that action, such that consideration of sex with 
regard to such action is essential to successful operation of the 
employment function concerned. A recipient shall not take action 
pursuant to this section that is based upon alleged comparative 
employment characteristics or stereotyped characterizations of one or 
the other sex, or upon preference based on sex of the recipient, 
employees, students, or other persons, but nothing contained in this 
section shall prevent a recipient from considering an employee's sex in 
relation to employment in a locker room or toilet facility used only by 
members of one sex.



                          Subpart F_Procedures



Sec.5.600  Notice of covered programs.

    Within 60 days of September 29, 2000, each Federal agency that 
awards Federal financial assistance shall publish in the Federal 
Register a notice of the programs covered by these Title IX regulations. 
Each such Federal agency shall periodically republish the notice of 
covered programs to reflect changes in covered programs. Copies of this 
notice also shall be made available upon request to the Federal agency's 
office that enforces Title IX.



Sec.5.605  Enforcement procedures.

    The investigative, compliance, and enforcement procedural provisions 
of Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d) (``Title 
VI'') are hereby adopted and applied to these Title IX regulations. 
These procedures may be found at 10 CFR 4.21 through 4.75.

[65 FR 52875, Aug. 30, 2000]



    Sec. Appendix A to Part 5--List of Federal Financial Assistance 
  Administered by the Nuclear Regulatory Commission to Which Title IX 
                                 Applies

    Note: All recipients of Federal financial assistance from NRC are 
subject to Title IX,

[[Page 214]]

but Title IX's anti-discrimination prohibitions are limited to the 
educational components of the recipient's program or activity, if any. 
Failure to list a type of Federal assistance below shall not mean, if 
Title IX is otherwise applicable, that a program or activity is not 
covered by Title IX.
    (a) Conferences on regulatory programs and related matters. 
Agreements for financial assistance to State and local officials, 
without full-cost recovery, to confer on regulatory programs and related 
matters at NRC facilities and offices, or other locations.
    (b) Orientations and instruction. Agreements for financial 
assistance to State and local officials, without full-cost recovery, to 
receive orientation and on-the-job instruction at NRC facilities and 
offices, or other locations.
    (c) Technical training courses. Agreements for financial assistance 
to State and local officials, without full-cost recovery to attend 
training on nuclear material licensing, inspection and emergency 
response regulatory responsibilities to ensure compatibility between NRC 
and Agreement State regulation.
    (d) Participation in meetings and conferences. Agreements for 
participation, without full-cost recovery, in meetings, conferences, 
workshops, and symposia to assist scientific, professional or 
educational institutions or groups.
    (e) Research support. Agreements for the financial support of basic 
and applied scientific research and for the exchanges of scientific 
information.

[66 FR 709, Jan. 4, 2001]



PART 7_ADVISORY COMMITTEES--Table of Contents



Sec.
7.1 Policy.
7.2 Definitions.
7.3 Interpretations.
7.4 Establishment of advisory committees.
7.5 Consultation with Committee Management Secretariat on establishment 
          of advisory committees; advisory committee charters.
7.6 Amendments to advisory committee charters.
7.7 Termination, renewal, and rechartering of advisory committees.
7.8 Charter filing requirements.
7.9 Public notice of advisory committee establishment, reestablishment, 
          or renewal.
7.10 The NRC Advisory Committee Management Officer.
7.11 The Designated Federal Officer.
7.12 Public participation in and public notice of advisory committee 
          meetings.
7.13 Minutes of advisory committee meetings.
7.14 Public information on advisory committees.
7.15 Procedures for closing an NRC advisory committee meeting.
7.16 Annual comprehensive review.
7.17 Reports required for advisory committees.
7.18 Appointment, compensation, and expense reimbursement of advisory 
          committee members, staffs, and consultants.
7.19 Advisory committee members with disabilities.
7.20 Conflict of interest reviews of advisory committee members' outside 
          interests.
7.21 Costs of duplication of documents.
7.22 Fiscal and administrative responsibilities.

    Authority: Atomic Energy Act of 1954, sec. 161 (42 U.S.C. 2201); 
Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 5 U.S.C. 
Appendix (Federal Advisory Committee Act).

    Source: 54 FR 26948, June 27, 1989, unless otherwise noted.



Sec.7.1  Policy.

    The regulations in this part define the policies and procedures to 
be followed by the Nuclear Regulatory Commission in the establishment, 
utilization, and termination of advisory committees. In general, it is 
the policy of the Commission that--
    (a) Except where there is express legal authority to the contrary, 
the function of NRC advisory committees shall be advisory only.
    (b) Each NRC advisory committee shall function in compliance with 
the Federal Advisory Committee Act and this part.
    (c) The number of NRC advisory committees shall be kept to the 
minimum necessary, and the number of members of each NRC advisory 
committee shall be limited to the fewest necessary to accomplish 
committee objectives.
    (d)(1) An NRC advisory committee shall be established only:
    (i) When establishment of the committee is required by law;
    (ii) When the Commission determines that the committee is essential 
to the conduct of NRC business; or
    (iii) When the information to be obtained is not available through 
an existing advisory committee or a source within the Federal 
Government.
    (2) Before establishing an advisory committee, the Commission shall 
consider whether:
    (i) Committee deliberations will result in a significant 
contribution to the creation, amendment, or elimination of

[[Page 215]]

regulations, guidelines, or rules affecting NRC business;
    (ii) The information to be obtained is available through another 
source within the Federal Government;
    (iii) The committee will make recommendations resulting in 
significant improvements in service or reductions in cost; or
    (iv) The committee's recommendations will provide an important 
additional perspective or viewpoint relating to NRC's mission. The 
advice or recommendations of an advisory committee should be the result 
of the advisory committee's independent judgment.
    (e) Except where otherwise required by law, an NRC advisory 
committee shall be terminated whenever the stated objectives of the 
committee have been accomplished, the subject matter or work of the 
committee has become obsolete, the committee's main functions have been 
assumed by another entity within the Federal Government, or the cost of 
operating the committee has become excessive in relation to the benefits 
accruing to the Federal Government from its activities.
    (1) An advisory committee not required to be established by statute 
terminates no later than two years after its establishment or last 
renewal, unless renewed.
    (2) An advisory committee required to be established by statute 
terminates upon the expiration of the time explicitly specified in the 
statute or implied by operation of the statute.
    (f) NRC advisory committees shall be balanced in their membership in 
terms of the points of view represented and the functions to be 
performed.
    (g) The Congress shall be kept informed of the number, purpose, 
membership, activities, and cost of NRC advisory committees.
    (h) NRC advisory committee meetings shall be open to the public, 
except where closure is determined to be justified under Sec.7.15.
    (i) The Commission may periodically invite feedback from the public 
regarding the effectiveness of NRC advisory committees.

[54 FR 26948, June 27, 1989, as amended at 67 FR 79838, Dec. 31, 2002]



Sec.7.2  Definitions.

    Act means the Federal Advisory Committee Act, as amended, 5 U.S.C. 
App.
    Administrator means the Administrator of General Services.
    Advisory committee means any committee, board, commission, council, 
conference, panel, task force, or similar group, or any subcommittee or 
other subgroup thereof, that is established by statute for the purpose 
of providing advice or recommendations on issues of policy to an 
official, branch, or agency of the Federal Government, or that is 
established or utilized by the President or any agency official to 
obtain advice or recommendations on issues or policies that fall within 
the scope of his or her responsibilities, except that the term 
``advisory committee'' does not include the following advisory meetings 
or groups:
    (1) Any group composed wholly of full-time officers or employees of 
the Federal Government;
    (2) Any group specifically exempted from the Act or these 
regulations by an Act of Congress;
    (3) Any local civic group whose primary function is that of 
rendering a public service with respect to a Federal program, or any 
State or local committee, council, board, commission, or similar group 
established to advise or make recommendations to any State or local 
government unit or an official thereof;
    (4) Any group that performs primarily operational functions 
specifically provided by law. Operational functions are those 
specifically authorized by statute or Presidential directive, such as 
making or implementing Government decisions or policy, as long as the 
group does not become primarily advisory in nature;
    (5) Any meeting initiated by the President or one or more Federal 
employees for the purpose of obtaining advice or recommendations from 
one individual;
    (6) Any meeting between an NRC employee with a non-governmental 
individual or group where advice or recommendations are provided by the 
attendees on an individual basis and are not sought from the group as a 
whole;

[[Page 216]]

    (7) Any meeting with a committee or group created by a non-Federal 
entity that is not managed or controlled by the President or a Federal 
employee;
    (8) Any meeting of two or more advisory committee members convened 
solely to:
    (i) Discuss administrative matters relating to the operation of 
their advisory committee;
    (ii) Receive administrative information from a Federal employee;
    (iii) Gather information or conduct research for a chartered 
advisory committee to analyze relevant issues and facts for their 
advisory committee; or
    (iv) Draft proposed position papers for deliberation by their 
advisory committee;
    (9) Any meeting with a group initiated by the President or by one or 
more Federal employees for the purpose of exchanging facts or 
information;
    (10) Any meeting attended only by full-time or permanent part-time 
officers or employees of the Federal Government and elected officers of 
State, local, and Tribal governments (or their designated employees with 
authority to act on their own behalf), acting in their official 
capacities. However, the purpose of the meeting must be solely to 
exchange views, information, or advice relating to the management or 
implementation of Federal programs established pursuant to statute, that 
explicitly or inherently share intergovernmental responsibilities or 
administration;
    (11) Any meeting of an NRC contractor, applicant, or licensee with 
an NRC employee to discuss specific matters involving the solicitation, 
issuance, or implementation of a contract or the Commission's effort to 
ensure compliance with its regulations; and
    (12) Any meeting of a subcommittee or other subgroup of an advisory 
committee where the subgroup's recommendations will be reviewed by its 
parent advisory committee.
    Agency means an agency of the Government of the United States as 
defined in 5 U.S.C. 551(1).
    Commission means the Nuclear Regulatory Commission of five members, 
or a quorum thereof, sitting as a body, as provided by section 201 of 
the Energy Reorganization Act of 1974, 42 U.S.C. 5841, (88 Stat. 1242).
    Committee Management Secretariat means the organization established 
within the General Services Administration, pursuant to section 7(a) of 
the Act, which is responsible for all matters relating to advisory 
committees, and carries out the responsibilities of the Administrator of 
the General Services Administration under the Act and Executive Order 
12024 (42 FR 61445; December 1, 1977).
    Committee meeting means any gathering of advisory committee members 
(whether in person, by telephone, or through electronic means) held with 
the approval of an agency for the purpose of deliberating on the 
substantive matters upon which the advisory committee provides advice or 
recommendations.
    Committee member means an individual who is appointed to serve on an 
advisory committee and has the full right and obligation to participate 
in the activities of the committee, including voting on committee 
recommendations.
    Designated Federal Officer means a government employee appointed, 
pursuant to Sec.7.11(a), to chair or attend each meeting of an NRC 
advisory committee to which he or she is assigned.
    Discretionary advisory committee means any advisory committee that 
is established, but not required to be established, under the authority 
of an agency head, and its establishment or termination is within the 
legal discretion of an agency head.
    GSA means the General Services Administration.
    Non-discretionary advisory committee means any advisory committee 
either required by statute or Presidential directive. A non-
discretionary committee required by statute generally is identified 
specifically in a statute by name, purpose, or functions and its 
establishment is mandated.
    NRC means the agency established by title II of the Energy 
Reorganization Act of 1974, 42 U.S.C. 5801 (88 Stat. 1233), and known as 
the Nuclear Regulatory Commission.
    NRC Advisory Committee Management Officer means the individual 
appointed,

[[Page 217]]

pursuant to Sec.7.10(a), to supervise and control the establishment 
and management of NRC advisory committees.
    NRC Public Document Room means the Public Document Room maintained 
by the NRC at 11555 Rockville Pike, Rockville, Maryland 20852-2738.
    Presidential advisory committee means an advisory committee 
established by statute or directed by the President to advise the 
President.
    Staff member means any individual who serves in a support capacity 
to an advisory committee.
    Subcommittee means a subgroup of an advisory committee, whether or 
not its members are drawn in whole or in part from the parent advisory 
committee.
    Utilized committee means a committee or group not established by the 
Federal Government, but whose operations are managed or controlled by a 
Federal agency.

[67 FR 79839, Dec. 31, 2002, as amended at 80 FR 74978, Dec. 1, 2015]



Sec.7.3  Interpretations.

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



Sec.7.4  Establishment of advisory committees.

    (a) An NRC advisory committee may be established under this part 
only if its establishment--
    (1) Is specifically directed or authorized by statute or by 
Executive Order of the President; or
    (2) Has been determined by the Commission to be in the public 
interest and essential to the performance of the duties imposed on the 
Commission by law.

The determination required by paragraph (a)(2) of this section shall be 
a matter of formal record, and shall include a statement of a clearly 
defined purpose for the advisory committee.



Sec.7.5  Consultation with Committee Management Secretariat on 
establishment of advisory committees; advisory committee charters.

    (a) Before establishing a discretionary advisory committee, the NRC 
shall consult with the Committee Management Secretariat. With a full 
understanding of the background and purpose behind the proposed advisory 
committee, the Committee Management Secretariat may share its knowledge 
and experience with the NRC on how best to make use of the proposed 
committee, alternate methods of attaining the agency's purpose, or 
whether a pre-existing advisory committee performs similar functions. 
Such consultation should include the transmittal of the proposed 
committee charter and the following information:
    (1) A request for a review of the proposed charter;
    (2) An explanation stating why the committee is essential to the 
conduct of NRC business and is in the public interest;
    (3) An explanation stating why the committee's functions cannot be 
performed by the NRC, an existing NRC advisory committee, or other means 
(such as a public hearing); and
    (4) A description of NRC's plan to attain balanced membership on the 
committee. The plan must ensure that, in the selection of members for 
the advisory committee, the NRC will consider a cross-section of those 
directly affected, interested, and qualified, as appropriate to the 
nature and functions of the committee. For purposes of attaining balance 
in an NRC advisory committee's membership, the Commission shall consider 
for membership interested persons and groups with professional, 
technical, or personal qualifications or experience that will contribute 
to the functions and tasks to be performed.
    (b) Each proposed committee charter submitted for review pursuant to 
paragraph (a) of this section shall contain the following information:
    (1) The committee's official designation;
    (2) The committee's objectives and the scope of its activity;

[[Page 218]]

    (3) The period of time necessary for the committee to carry out its 
purposes;
    (4) The NRC official to whom the committee will report;
    (5) The NRC office responsible for providing support for the 
committee;
    (6) A description of the duties that the committee will perform, and 
if such duties are not solely advisory, a specification of the authority 
for the functions that are not advisory;
    (7) The estimated annual operating costs, in dollars and person 
years, for the committee;
    (8) The estimated number and frequency of committee meetings; and
    (9) The committee's termination date, if less than two years from 
the date of the committee's establishment.
    (c) The requirements of this part, including the requirements of 
paragraphs (a) and (b) of this section, shall apply to any subcommittee 
that functions independently of the parent advisory committee (such as 
by making recommendations directly to the agency rather than to the 
parent advisory committee), regardless of whether the subcommittee's 
members are drawn in whole or in part from the parent advisory 
committee.
    (d) After the Committee Management Secretariat has notified the 
Commission of the results of its review of a proposal to establish or 
utilize an NRC discretionary advisory committee, submitted pursuant to 
paragraph (a) of this section, the Commission shall notify the Committee 
Management Secretariat whether the advisory committee is actually being 
established. Filing of the advisory committee charter pursuant to Sec.
7.8 shall be deemed to fulfill this notification requirement. If the 
advisory committee is not being established, the Commission shall so 
advise the Committee Management Secretariat, stating whether NRC intends 
to take any further action with respect to the proposed advisory 
committee.
    (e) The date of filing of an advisory committee charter pursuant to 
Sec.7.8 shall be added to the charter when such filing takes place, 
shall appear on the face of the charter, and shall constitute the date 
of establishment, renewal, or reestablishment of the committee.

[67 FR 79840, Dec. 31, 2002]



Sec.7.6  Amendment to advisory committee charters.

    (a) Final authority for amending the charter of an NRC advisory 
committee established or utilized by the NRC is vested in the 
Commission.
    (b) Any proposed changes made to a current charter for an NRC 
advisory committee shall be coordinated with the General Counsel to 
ensure that they are consistent with applicable legal requirements. When 
a statute or Executive Order that directed or authorized the 
establishment of an advisory committee is amended, those sections of the 
advisory committee's charter affected by the amendments shall also be 
amended.
    (c)(1) The charter of an NRC advisory committee established under 
general agency authority may be amended when the Commission determines 
that the existing charter no longer reflects the objectives or functions 
of the committee. Such changes may be minor (such as revising the name 
of the advisory committee or modifying the estimated number or frequency 
of meetings), or they may be major (such as revising the objectives or 
composition of the committee).
    (2) The procedures in paragraph (b) of this section shall be used in 
the case of charter amendments involving minor changes. A proposed major 
amendment to the charter of an advisory committee established under 
general agency authority shall be submitted to the Committee Management 
Secretariat for review with an explanation of the purpose of the changes 
and why they are necessary.
    (3) A committee charter that has been amended pursuant to this 
paragraph is subject to the filing requirements set forth in Sec.7.8.
    (4) Amendment of an existing advisory committee charter pursuant to 
this paragraph does not constitute renewal of the committee for purposes 
of Sec.7.7.

[67 FR 79840, Dec. 31, 2002]

[[Page 219]]



Sec.7.7  Termination, renewal, and rechartering of advisory 
committees.

    (a) Except as provided in paragraph (b)(1) of this section, each NRC 
advisory committee shall terminate two years after it is established, 
reestablished, or renewed, unless--
    (1) It has been terminated sooner;
    (2) It has been renewed or reestablished before the end of such 
period in accordance with the procedures set forth in paragraph (b) of 
this section; or
    (3) Its duration has been otherwise designated by law. The NRC 
Committee Management Officer shall notify the Committee Management 
Secretariat of the effective date of termination of any advisory 
committee that has been terminated by the NRC.
    (b)(1) An NRC advisory committee that is established by statute 
shall require rechartering by the filing of a new charter every 2 years 
after the date of enactment of the statute establishing the committee. 
If a new charter is not filed, the committee is not terminated, but it 
may not meet or take any actions.
    (2) Any other NRC advisory committee may be renewed, provided that 
such renewal is carried out in compliance with the procedures set forth 
in Sec.7.5, except that an advisory committee established by the 
President may be renewed by appropriate action of the President and the 
filing of a new charter. Renewal of an NRC advisory committee shall not 
be deemed to terminate the appointment of any committee member who was 
previously appointed to serve on the committee.

[54 FR 26948, June 27, 1989, as amended at 67 FR 79840, Dec. 31, 2002]



Sec.7.8  Charter filing requirements.

    No advisory committee may meet or take any action until a charter 
has been filed by the Committee Management Officer designated in 
accordance with Sec.7.10.
    (a) To establish, renew, or reestablish a discretionary advisory 
committee, a charter must be filed with:
    (1) The Commission;
    (2) The Committee on Environment and Public Works of the United 
States Senate and the Committee on Energy and Commerce of the United 
States House of Representatives;
    (3) The Library of Congress, Anglo-American Acquisitions Division, 
Government Documents Section, Federal Advisory Committee Desk, 101 
Independence Avenue, S.E., Washington, DC 20540-4172; and
    (4) The Committee Management Secretariat, indicating the date the 
charter was filed with the congressional committees.
    (b) Charter filing requirements for non-discretionary advisory 
committees are the same as those in paragraph (a) of this section, 
except the date of establishment for a Presidential advisory committee 
is the date the charter is filed with the Secretariat.
    (c) Subcommittees that report directly to a Federal employee or 
agency must comply with this subpart.

[67 FR 79841, Dec. 31, 2002]



Sec.7.9  Public notice of advisory committee establishment,
reestablishment, or renewal.

    (a) After the Commission has received notice from the Committee 
Management Secretariat that its review of a proposal to establish, 
reestablish, renew, or utilize an NRC discretionary advisory committee 
has been completed, the Commission shall publish a notice in the Federal 
Register that the committee is being established, reestablished, 
renewed, or utilized. In the case of a new committee, the notice shall 
also describe the nature and purpose of the committee and shall include 
a statement that the committee is necessary and in the public interest.
    (b) Notices required to be published pursuant to paragraph (a) of 
this section shall be published at least 15 calendar days before the 
committee charter is filed pursuant to Sec.7.8, except that the 
Committee Management Secretariat may approve publication for less than 
15 days for good cause shown. The 15-day advance notice requirement does 
not apply to advisory committee renewals, notices of which may be 
published concurrently with the filing of the charter.

[67 FR 79841, Dec. 31, 2002]

[[Page 220]]



Sec.7.10  The NRC Advisory Committee Management Officer.

    (a) The Chairman of the Commission or designee shall appoint an NRC 
Advisory Committee Management Officer to carry out the functions 
specified in paragraph (b) of this section.
    (b) The NRC Advisory Committee Management Officer shall--
    (1) Carry out all responsibilities relating to NRC advisory 
committees delegated to such officer by the Commission;
    (2) Ensure that administrative guidelines and management controls 
are issued that apply to all NRC advisory committees;
    (3) Exercise control and supervision over the establishment, 
procedures, and accomplishments of NRC advisory committees;
    (4) Assemble and maintain the reports, records, and other papers of 
any such committee during this existence;
    (5) Carry out, on behalf of the NRC, the provisions of the Freedom 
of Information Act (5 U.S.C. 552) and implementing NRC regulations (10 
CFR part 9, subpart A) with respect to such reports, records, and other 
papers;
    (6) Ensure that, subject to the Freedom of Information Act and 
implementing NRC regulations at 10 CFR part 9, subpart A, copies of the 
records, reports, transcript minutes, appendices, working papers, 
drafts, studies, agenda, or other documents that were made available to 
or prepared for or by each NRC advisory committee are available for 
public inspection and copying at the NRC Web site, http://www.nrc.gov, 
at the NRC Public Document Room, or both, until the advisory committee 
ceases to exist;
    (7) Ensure that, subject to the Freedom of Information Act and 
implementing NRC regulations, at least eight copies of each report made 
by each NRC advisory committee and, where appropriate, background papers 
prepared by consultants, shall be filed with the Library of Congress;
    (8) Ensure that NRC keeps such records as will fully disclose the 
disposition of any funds that may be at the disposal of NRC advisory 
committees and the nature and extent of their activities; and
    (9) Ensure that NRC keeps such other records and provides such 
support services as are required by Sec.7.22.
    (c) For purposes of paragraph (b) of this section, the term 
``records'' includes (but is not limited to):
    (1) A set of approved charters and membership lists for each NRC 
advisory committee;
    (2) Copies of NRC's portion of the Committee Management Secretariat 
Annual Comprehensive Review of Federal advisory committees required by 
section 7(b) of the Act;
    (3) NRC guidelines on committee management operations and procedures 
as maintained and updated; and
    (4) NRC determinations to close advisory committee meetings made 
pursuant to Sec.7.15.

[54 FR 26948, June 27, 1989; 54 FR 28554, July 6, 1989; 54 FR 31646, 
Aug. 1, 1989; 64 FR 48949, Sept. 9, 1999; 67 FR 79841, Dec. 31, 2002]



Sec.7.11  The Designated Federal Officer.

    (a) The Chairman of the Commission or designee shall appoint a 
Designated Federal Officer or alternate Designated Federal Officer for 
each NRC advisory committee. The individual holding either position must 
be employed by the Federal Government on either a full-time or a 
permanent part-time basis.
    (b) All meetings of an NRC advisory committee must be convened or 
approved by the committee's Designated Federal Officer or alternate, and 
the agenda for each committee meeting (except a meeting of a 
Presidential advisory committee) must be approved by that individual.
    (c) An NRC advisory committee may not hold a meeting in the absence 
of its Designated Federal Officer or alternate.
    (d) It shall also be the responsibility of the Designated Federal 
Officer or alternate to:
    (1) Attend all meetings of the committee for which he or she has 
been appointed;
    (2) Adjourn the meetings of the committee when such adjournment is 
in the public interest;
    (3) Chair the meetings of the committee when so directed by the 
Commission;

[[Page 221]]

    (4) Ensure compliance with the requirements of Sec.7.13 regarding 
minutes of meetings of the committee; and
    (5) Make copies of committee documents required to be maintained for 
public inspection and copying pursuant to Sec.7.14(b) and ensure their 
availability at the NRC Web site, http://www.nrc.gov, at the NRC Public 
Document Room, or both.

[67 FR 79841, Dec. 31, 2002]



Sec.7.12  Public participation in and public notice of advisory
committee meetings.

    (a) Each meeting of an NRC advisory committee shall be held at a 
reasonable time and in a place reasonably accessible to the public, 
including persons with disabilities. Any advisory committee meeting 
conducted in whole or part by teleconference, video conference, the 
Internet, or other electronic medium must comply with this section. The 
size of the meeting room must be sufficient to accommodate advisory 
committee members, committee or agency staff, and interested members of 
the public, except that the provisions of this paragraph relating to the 
room size shall not apply to any part of an NRC advisory committee 
meeting that has been closed pursuant to Sec.7.15.
    (b) Any member of the public who wishes to do so shall be permitted 
to file a written statement with an NRC advisory committee regarding any 
matter discussed at a meeting of the committee. The committee chairman 
may also permit members of the public to speak at meetings of the 
committee in accordance with procedures established by the committee.
    (c)(1) Except when the President or designee determines in writing 
that no notice should be published for reasons of national security, at 
least 15 days prior to an NRC advisory committee meeting, a notice that 
includes the following information shall be published in the Federal 
Register:
    (i) The exact name of the advisory committee as chartered;
    (ii) The time, date, place, and purpose of the meeting;
    (iii) A summary of the agenda of the meeting;
    (iv) Whether all or part of the meeting is open to the public; and
    (v) The name and telephone number of the Designated Federal Officer, 
alternate, or other responsible agency employee who may be contacted for 
additional information concerning the meeting.
    (2) If any part of the meeting is closed, the notice shall provide 
the reasons for the closure, citing the specific matter that has been 
determined to justify the closure under Sec.7.15. The Commission may 
publish a single notice announcing multiple meetings; however, a meeting 
may not be announced so far in advance as to prevent the public from 
being adequately informed of an NRC advisory committee's schedule.
    (d) In exceptional circumstances, less than 15 days notice of an 
advisory committee meeting may be given, provided that there is as much 
prior notice as possible and the reasons for the shorter time are 
included in the committee meeting notice published in the Federal 
Register.
    (e) In addition to notice required by paragraph (c) of this section, 
the NRC may also use other forms of notice, such as press releases, 
posting the information on the NRC Web site, http://www.nrc.gov, or 
notice by mail, to inform the public of advisory committee meetings. To 
that end, the Designated Federal Officer or alternate for each NRC 
advisory committee will, to the extent practicable, maintain lists of 
people and organizations interested in that advisory committee and 
notify them of meetings by mail.
    (f) Meetings of a subcommittee whose recommendations will not be 
reviewed by its parent advisory committee shall be conducted in 
accordance with all notice and openness requirements contained in this 
section and in Sec. Sec.7.13, 7.14, and 7.15.

[54 FR 26948, June 27, 1989, as amended at 67 FR 79841, Dec. 31, 2002]



Sec.7.13  Minutes of advisory committee meetings.

    (a) Detailed minutes shall be kept of each NRC advisory committee 
meeting. The minutes shall include the following information:

[[Page 222]]

    (1) The time, date, and place of the meeting;
    (2) A list of the attendees at the meeting who are advisory 
committee members or staff, agency employees, or members of the public 
who presented oral or written statements;
    (3) An estimate of the number of other members of the public who 
were present;
    (4) The extent of public participation; and
    (5) An accurate description of each matter discussed during the 
meeting and its resolution, if any, by the committee.
    (b) The minutes of an NRC advisory committee meeting shall include a 
copy of each report or other document received, issued, or approved by 
the committee in connection with the meeting. If it is impracticable to 
attach a document to the minutes, the minutes shall describe the 
document in sufficient detail to permit it to be identified readily.
    (c) The chairperson of an NRC advisory committee shall certify the 
accuracy of the minutes of each of the committee's meetings.
    (d) A verbatim transcript of an advisory committee meeting may be 
substituted for minutes required by this section, providing that the use 
of such a transcript is in accordance with the requirements of 
paragraphs (a), (b), and (c) of this section.

[54 FR 26948, June 27, 1989, as amended at 67 FR 79842, Dec. 31, 2002]



Sec.7.14  Public information on advisory committees.

    (a) The Nuclear Regulatory Commission shall maintain systematic 
information on the nature, functions, and operations of each NRC 
advisory committee. A complete set of the charters of NRC advisory 
committees and copies of the annual reports required by Sec.7.17(a) 
will be maintained for public inspection at either the NRC Web site, 
http://www.nrc.gov, at the NRC Public Document Room, or both.
    (b) Subject to the provisions of the Freedom of Information Act (5 
U.S.C. 552) and NRC's Freedom of Information Act regulations at 10 CFR 
part 9, subpart A, copies of NRC advisory committees' records, reports, 
transcripts, minutes, appendices, working papers, drafts, studies, 
agenda, and other documents shall be maintained for public inspection 
and copying at the NRC Web site, http://www.nrc.gov, at the NRC Public 
Document Room, or both. To provide the public a meaningful opportunity 
to comprehend fully the work undertaken by an NRC advisory committee, 
advisory committee records should be available to the public as soon as 
practicable. Members of the public or other interested parties may 
review non-exempt advisory committee records without filing a request 
for these records under the Freedom of Information Act.
    (c) Official records generated by or for an advisory committee must 
be retained for the duration of the advisory committee. Upon termination 
of the advisory committee, the records must be processed in accordance 
with the Federal Records Act (44 U.S.C. Chapters 21, 29-33) and 
regulations issued by the National Archives and Records Administration 
(see 36 CFR Parts 1220, 1222, 1228, and 1234), or in accordance with the 
Presidential Records Act (44 U.S.C. Chapter 22).

[67 FR 79842, Dec. 31, 2002]



Sec.7.15  Procedures for closing an NRC advisory committee meeting.

    (a) To close all or part of a meeting of an NRC advisory committee, 
the committee shall submit a written request for closure to the General 
Counsel, citing specific exemptions listed in the Government in the 
Sunshine Act (5 U.S.C. 552b), as implemented by 10 CFR 9.104, that 
justify the closure. The request shall provide the General Counsel 
sufficient time for review in order to make a determination prior to 
publication of the meeting notice pursuant to Sec.7.12.
    (b) If the General Counsel finds that the request for closure is 
consistent with the provisions of the Government in the Sunshine Act and 
this part, a determination shall be issued in writing that all or part 
of the meeting will be closed. The determination shall include a 
statement of the reasons for the closing, citing the applicable 
exemptions in the Government in the Sunshine Act (as implemented by 10 
CFR 9.104).

[[Page 223]]

    (c) Except when the President or designee determines in writing that 
no notice should be published for reasons of national security, the 
Secretary of the Commission shall make a copy of the determination to 
close all or part of an NRC advisory committee meeting available to the 
public upon request. If such a determination has been issued, the 
meeting notice published in the Federal Register should comply with the 
provisions of Sec.7.12 applicable to closed meetings.

[67 FR 79842, Dec. 31, 2002]



Sec.7.16  Annual comprehensive review.

    (a) The Chairman of the Commission shall conduct an annual 
comprehensive review of the activities and responsibilities of each NRC 
advisory committee to determine whether the committee--
    (1) Is carrying out its purposes or, consistent with the provisions 
of applicable statutes, its responsibilities should be revised.
    (2) Should be merged with another advisory committee.
    (3) Should be terminated.
    (b) The comprehensive review required by paragraph (a) of this 
section shall include consideration of such information regarding the 
committee as is required for the Commission's annual report to the GSA 
Secretariat pursuant to Sec.7.17(a) and such other information as may 
be requested from the Committee by the NRC Advisory Committee Management 
Officer. The results of such review shall be included in the annual 
report to the GSA Secretariat.
    (c) If, as a result of the review required by this section, the 
Commission determines that an advisory committee is no longer needed, 
the committee shall be terminated; except that in the case of an 
advisory committee established by an Act of Congress or the President, 
the committee's termination shall be recommended to the President or the 
Congress, as the case may be.

[54 FR 26948, June 27, 1989, as amended at 67 FR 79842, Dec. 31, 2002]



Sec.7.17  Reports required for advisory committees.

    (a) The Commission shall furnish a report on the activities of NRC 
advisory committees annually to the Committee Management Secretariat on 
a fiscal year basis. The report must contain information regarding NRC 
advisory committees consistent with instructions provided by the 
Committee Management Secretariat. A copy of the report shall be made 
available at the NRC Web site, http://www.nrc.gov, at the NRC Public 
Document Room, or both. The information provided by the Commission 
regarding its advisory committees is contained in the Committee 
Management Secretariat's report which is available on its Web site, 
http://www.gsa.gov/committeemanagement.
    (b) Any NRC advisory committee holding closed or partially closed 
meetings shall issue a report, at least annually, setting forth a 
summary of its activities consistent with the policy of the Government 
in the Sunshine Act (5 U.S.C. 552b), as implemented by 10 CFR 9.104. A 
copy of the report shall be made available at the NRC Web site, http://
www.nrc.gov, at the NRC Public Document Room, or both.
    (c) Subject to the Freedom of Information Act (5 U.S.C. 552) and 
implementing NRC regulations (10 CFR part 9, subpart A), eight copies of 
each report made by an advisory committee, including any report on 
closed meetings pursuant to paragraph (b) of this section, and, where 
appropriate, background papers prepared by consultants, shall be filed 
for public inspection and use with the Library of Congress, Anglo-
American Acquisitions Division, Government Documents Section, Federal 
Advisory Committee Desk, 101 Independence Avenue, SE., Washington, DC 
20540-4172.

[67 FR 79842, Dec. 31, 2002]



Sec.7.18  Appointment, compensation, and expense reimbursement of
advisory committee members, staffs, and consultants.

    (a) Unless otherwise provided by law, advisory committee members 
serve at the pleasure of the Commission and their terms are at the sole 
discretion of the Commission.

[[Page 224]]

    (b) Except where otherwise provided by law, the Commission may 
accept the gratuitous services of an NRC advisory committee member, 
staff member, or consultant who agrees in advance to serve without 
compensation.
    (c)(1) Subject to the provisions of paragraph (c)(2) of this 
section, if the Commission determines that compensation of a member of 
an NRC advisory committee is appropriate, the amount that will be paid 
shall be fixed by the Chairman of the Commission at a rate that is the 
daily equivalent of a rate in NRC's General Grade Salary Schedule, 
unless the member is appointed as a consultant and compensated at a rate 
applicable to NRC consultants.
    (2) In determining an appropriate rate of pay for a member of an NRC 
advisory committee, the Chairman of the Commission shall give 
consideration to the significance, scope, and technical complexity of 
the matters with which the advisory committee is concerned and the 
qualifications required of the committee member; provided that the 
Chairman may not set the rate of pay for an NRC advisory committee 
member higher than the daily equivalent rate for level IV of the 
Executive Schedule under 5 U.S.C. 5315, unless a higher rate is 
expressly allowed by another statute. The Chairman may authorize a rate 
of basic pay in excess of the maximum rate of basic pay established for 
NRC's General Grade Salary Schedule. This maximum rate includes an 
applicable locality payment. The Commission may pay advisory committee 
members on either an hourly or a daily rate basis. The Commission may 
not provide additional compensation in any form, such as bonuses or 
premium pay. The Chairman may not delegate the responsibility for making 
a determination that a higher rate of pay than that established by NRC's 
General Grade Salary Schedule is necessary and justified for an NRC 
advisory committee member, and such a determination must be reviewed 
annually.
    (d)(1) Each NRC advisory committee staff member may be paid at a 
rate that is the daily equivalent of a rate in NRC's General Grade 
Salary Schedule in which the staff member's position would appropriately 
be placed.
    (2) A staff member of an NRC advisory committee may not be paid at a 
rate higher than the daily equivalent of the maximum rate for a GG-15 
under NRC's General Grade Salary Schedule, unless the Chairman of the 
Commission determines that the staff member's position would 
appropriately be placed at a grade higher than GG-15, provided that in 
establishing rates of compensation, the Chairman shall comply with any 
applicable statutes, regulations, Executive Orders, and administrative 
guidelines. The Commission may provide advisory committee staff members 
with additional compensation, such as bonuses or premium pay, as long as 
the aggregate compensation does not exceed the rate of pay for Executive 
Schedule level IV.
    (3) A Federal employee may serve as a staff member of an NRC 
advisory committee only with the knowledge of the advisory committee's 
Designated Federal Officer or alternate and the approval of the 
employee's direct supervisor. A staff member who is not otherwise a 
Federal employee shall be appointed in accordance with applicable agency 
procedures, following consultation with the advisory committee.
    (e)(1) Subject to the limitations in paragraph (e)(2) of this 
section, the following factors shall be considered in determining an 
appropriate rate of pay for a consultant to an NRC advisory committee:
    (i) The qualifications required of the consultant, and
    (ii) The significance, scope, and technical complexity of the work 
for which his services are required;
    (2) The rate of pay for an NRC advisory committee consultant may not 
be higher than the maximum rate of basic pay established by NRC's 
General Salary Schedule (that is, the GG-15, step 10 rate, excluding 
locality pay or any other supplement), unless a higher rate is expressly 
allowed by another statute. The appointment and compensation of NRC 
experts and consultants must be in conformance with applicable 
regulations issued by the United States Office of Personnel Management 
(see 5 CFR part 304).

[[Page 225]]

    (f) A member or staff member of an NRC advisory committee engaged in 
the performance of duties away from his or her home or regular place of 
business may be allowed travel expenses, including per diem in lieu of 
subsistence, as authorized by section 5703, title 5, United States Code, 
for persons employed intermittently in the Government service.
    (g) Nothing in this section shall:
    (1) Prevent any full-time Federal employee who provides services to 
an NRC advisory committee from receiving compensation at a rate at which 
he or she would otherwise be compensated as a full-time Federal 
employee;
    (2) Prevent any individual who provides services to an NRC advisory 
committee, and who immediately before providing such services was a 
full-time Federal employee, from receiving compensation at a rate at 
which he or she was compensated as a full-time Federal employee; or
    (3) Affect a rate of pay or a limitation on a rate of pay that is 
specifically established by law or a rate of pay established under the 
NRC's General Grade Salary Schedule and evaluation system.

[67 FR 79843, Dec. 31, 2002]



Sec.7.19  Advisory committee members with disabilities.

    An NRC advisory committee member who is disabled may be provided 
services by a personal assistant while performing advisory committee 
duties, if the member;
    (a) Qualifies as disabled under section 501 of the Rehabilitation 
Act of 1973 (29 U.S.C. 794) ; and
    (b) Does not otherwise qualify for assistance under 5 U.S.C. 3102 by 
reason of being an employee of NRC.

[67 FR 79843, Dec. 31, 2002]



Sec.7.20  Conflict of interest reviews of advisory committee members'
outside interests.

    The Designated Federal Officer or alternate for each NRC advisory 
committee and the General Counsel or designee shall review the interests 
and affiliations of each member of the Designated Federal Officer's 
advisory committee annually, and upon the commencement of the member's 
appointment to the committee, for the purpose of ensuring that such 
appointment is consistent with the laws and regulations on conflict of 
interest applicable to that member.

[67 FR 79843, Dec. 31, 2002]



Sec.7.21  Cost of duplication of documents.

    Copies of the records, reports, transcripts, minutes, appendices, 
working papers, drafts, studies, agenda, or other documents that were 
made available to or prepared for or by an NRC advisory committee shall 
be made available to any person at the actual cost of duplication 
prescribed in part 9 of this chapter. (For availability of information 
on advisory committees, see Sec.7.14.)



Sec.7.22  Fiscal and administrative responsibilities.

    (a) The Office of the Chief Financial Officer shall keep such 
records as will fully disclose the disposition of any funds that may be 
at the disposal of NRC advisory committees.
    (b) The Office of the Chief Information Officer shall keep such 
records as will fully disclose the nature and extent of activities of 
NRC advisory committees.
    (c) NRC shall provide support services (including staff support and 
meeting space) for each advisory committee established by or reporting 
to it unless the establishing authority provides otherwise. Where any 
such advisory committee reports to another agency in addition to NRC, 
only one agency shall be responsible for support services at any one 
time, and the establishing authority shall designate the agency 
responsible for providing such services.

[54 FR 26948, June 27, 1989, as amended at 63 FR 15742, Apr. 1, 1998; 80 
FR 74978, Dec. 1, 2015]

                            PART 8 [RESERVED]



PART 9_PUBLIC RECORDS--Table of Contents



Sec.
9.1 Scope and purpose.
9.3 Definitions.
9.5 Interpretations.
9.6 Communications.

[[Page 226]]

9.8 Information collection requirements: OMB approval.

            Subpart A_Freedom of Information Act Regulations

9.11 Scope of subpart.
9.13 Definitions.
9.15 Availability of records.
9.17 Agency records exempt from public disclosure.
9.19 Segregation of exempt information and deletion of identifying 
          details.
9.21 Publicly available records.
9.23 Requests for records.
9.25 Initial disclosure determination.
9.27 Form and content of responses.
9.28 Predisclosure notification procedures for information containing 
          trade secrets or confidential commercial or financial 
          information.
9.29 Appeal from initial determination.
9.30 Contact for dispute resolution services.
9.31 Extension of time for response.
9.33 Search, review, and special service fees.
9.34 Assessment of interest and debt collection.
9.35 Duplication fees.
9.37 Fees for search and review of agency records by NRC personnel.
9.39 Search and duplication provided without charge.
9.40 Assessment of fees.
9.41 Requests for waiver or reduction of fees.
9.43 Processing of requests for a waiver or reduction of fees.
9.45 Annual report to the Attorney General of the United States and 
          Director of the Office of Government Information Services.

                    Subpart B_Privacy Act Regulations

9.50 Scope of subpart.
9.51 Definitions.

Procedures Applicable to Requests by Individuals for Information, Access 
              or Amendment of Records Maintained About Them

                        presentation of requests

9.52 Types of requests.
9.53 Requests; how and where presented.
9.54 Verification of identity of individuals making requests.
9.55 Specification of records.
9.56 Accompanying persons.

                 nrc procedures for processing requests

9.60 Acknowledgement of requests.
9.61 Procedures for processing requests for records exempt in whole or 
          in part.
9.62 Records under control of another Government agency.

                       determinations and appeals

9.65 Access determinations; appeals.
9.66 Determinations authorizing or denying correction of records; 
          appeals.
9.67 Statements of disagreement.
9.68 NRC statement of explanation.
9.69 Notices of correction or dispute.

            disclosure to others of records about individuals

9.80 Disclosure of record to persons other than the individual to whom 
          it pertains.
9.81 Notices of subpoenas.
9.82 Notices of emergency disclosures.

                                  fees

9.85 Fees.

                               enforcement

9.90 Violations.

                               exemptions

9.95 Specific exemptions.

          Subpart C_Government in the Sunshine Act Regulations

9.100 Scope of subpart.
9.101 Definitions.
9.102 General requirement.
9.103 General provisions.
9.104 Closed meetings.
9.105 Commission procedures.
9.106 Persons affected and motions for reconsideration.
9.107 Public announcement of Commission meetings.
9.108 Certification, transcripts, recordings and minutes.
9.109 Report to Congress.

 Subpart D_Production or Disclosure in Response to Subpoenas or Demands 
                     of Courts or Other Authorities

9.200 Scope of subpart.
9.201 Production or disclosure prohibited unless approved by appropriate 
          NRC official.
9.202 Procedure in the event of a demand for production or disclosure.
9.203 Procedure where response to demand is required prior to receiving 
          instructions.
9.204 Procedure in the event of an adverse ruling.

    Authority: Atomic Energy Act of 1954, sec. 161 (42 U.S.C. 2201); 
Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 
3504 note.
    Subpart A also issued under 31 U.S.C. 9701.
    Subpart B also issued under 5 U.S.C. 552a.
    Subpart C also issued under 5 U.S.C. 552b.

    Editorial Note: Nomenclature changes to part 9 appear at 82 FR 
52825, Nov. 15, 2017.

[[Page 227]]



Sec.9.1  Scope and purpose.

    (a) Subpart A implements the provisions of the Freedom of 
Information Act, 5 U.S.C. 552, concerning the availability to the public 
of Nuclear Regulatory Commission records for inspection and copying.
    (b) Subpart B implements the provisions of the Privacy Act of 1974, 
5 U.S.C. 552a, concerning disclosure and availability of certain Nuclear 
Regulatory Commission records maintained on individuals.
    (c) Subpart C implements the provisions of the Government in the 
Sunshine Act, 5 U.S.C. 552b, concerning the opening of Commission 
meetings to public observation.
    (d) Subpart D describes procedures governing the production of 
agency records, information, or testimony in response to subpoenas or 
demands of courts or other judicial or quasi-judicial authorities in 
State and Federal proceedings.

[52 FR 49355, Dec. 31, 1987]



Sec.9.3  Definitions.

    As used in this part:
    Commission means the Commission of five members or a quorum thereof 
sitting as a body, as provided by section 201 of the Energy 
Reorganization Act of 1974.
    Government agency means any executive department, military 
department, Government corporation, Government-controlled corporation, 
or other establishment in the executive branch of the Government 
(including the Executive Office of the President), or any independent 
regulatory agency.
    NRC means the Nuclear Regulatory Commission, established by the 
Energy Reorganization Act of 1974.
    NRC personnel means employees, consultants, and members of advisory 
boards, committees, and panels of the NRC; members of boards designated 
by the Commission to preside at adjudicatory proceedings; and officers 
or employees of Government agencies, including military personnel, 
assigned to duty at the NRC.
    Working days mean Monday through Friday, except legal holidays.

[52 FR 49355, Dec. 31, 1987]



Sec.9.5  Interpretations.

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

[52 FR 49356, Dec. 31, 1987]



Sec.9.6  Communications.

    Except as otherwise indicated, communications relating to this part 
shall be addressed to the Freedom of Information Act and Privacy Act 
Officer, may be sent to the NRC by mail addressed to the U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; by hand delivery to 
the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, 
where practicable, by electronic submission via facsimile to (301) 415-
5130 or e-mail to [email protected]. Electronic submissions must be made in a 
manner that enables the NRC to receive, read, authenticate, distribute, 
and archive the submission, and process and retrieve it a single page at 
a time. Detailed guidance on making electronic submissions can be 
obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/
e-submittals.html; by e-mail to [email protected]; or by writing the 
Office of the Chief Information Officer, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001. The guidance discusses, among 
other topics, the formats the NRC can accept, the use of electronic 
signatures, and the treatment of nonpublic information.

[68 FR 58799, Oct. 10, 2003, as amended at 74 FR 62680, Dec. 1, 2009; 80 
FR 74978, Dec. 1, 2015]



Sec.9.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC

[[Page 228]]

may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number. OMB has approved the information collection requirements 
contained in this part under control number 3150-0043.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.9.23, 9.25, 9.28, 9.29, 9.40, 9.41, 9.53, 
9.54, 9.55, 9.65, 9.66, and 9.67.

[62 FR 52184, Oct. 6, 1997, as amended at 63 FR 2876, Jan. 20, 1998; 70 
FR 34306, June 14, 2005]



            Subpart A_Freedom of Information Act Regulations

    Source: 63 FR 2876, Jan. 20, 1998, unless otherwise noted.



Sec.9.11  Scope of subpart.

    This subpart prescribes procedures for making NRC agency records 
available to the public for inspection and copying pursuant to the 
provisions of the Freedom of Information Act (5 U.S.C. 552) and provides 
notice of procedures for obtaining NRC records otherwise publicly 
available. This subpart does not affect the dissemination or 
distribution of NRC-originated, or NRC contractor-originated, 
information to the public under any other NRC public, technical, or 
other information program or policy.



Sec.9.13  Definitions.

    Agency record means a record in the possession and control of the 
NRC that is associated with Government business. Agency record does not 
include records such as--
    (1) Publicly-available books, periodicals, or other publications 
that are owned or copyrighted by non-Federal sources;
    (2) Records solely in the possession and control of NRC contractors;
    (3) Personal records in possession of NRC personnel that have not 
been circulated, were not required to be created or retained by the NRC, 
and can be retained or discarded at the author's sole discretion, or 
records of a personal nature that are not associated with any Government 
business; or
    (4) Non-substantive information in logs or schedule books of the 
Chairman or Commissioners, uncirculated except for typing or recording 
purposes.
    Commercial-use request means a request made under Sec.9.23(b) for 
a use or purpose that furthers the commercial, trade, or profit 
interests of the requester or the person on whose behalf the request is 
made.
    Direct costs mean the expenditures that an agency incurs in 
searching for and duplicating agency records. For a commercial-use 
request, direct costs include the expenditures involved in reviewing 
records to respond to the request. Direct costs include the salary of 
the employee category performing the work based on that basic rate of 
pay plus 16 percent of that rate to cover fringe benefits and the cost 
of operating duplicating machinery.
    Duplication means the process of making a copy of a record necessary 
to respond to a request made under Sec.9.23. Copies may take the form 
of paper copy, microform, audio-visual materials, disk, magnetic tape, 
or machine readable documentation, among others.
    Educational institution means an institution that operates a program 
or programs of scholarly research. Educational institution refers to a 
preschool, a public or private elementary or secondary school, an 
institution of graduate higher education, an institution of 
undergraduate higher education, an institution of professional 
education, or an institution of vocational education.
    Freedom of Information Act and Privacy Act Officer means the NRC 
official designated to fulfill the responsibilities for implementing and 
administering the Freedom of Information Act and the Privacy Act as 
specifically designated under the regulations in this part.
    Noncommercial scientific institution means an institution that is 
not operated on a commercial basis, as the term ``commercial'' is 
referred to in the definition of ``commercial-use request,'' and is 
operated solely for the purpose of conducting scientific research, the 
results of which are not intended to promote any particular product or 
industry.

[[Page 229]]

    Office, unless otherwise indicated, means all offices, boards, 
panels, and advisory committees of the NRC.
    Record means any information that would be an agency record subject 
to the requirements of the Freedom of Information Act when maintained by 
the NRC in any format, including an electronic format. Record also 
includes a book, paper, map, drawing, diagram, photograph, brochure, 
punch card, magnetic tape, paper tape, sound recording, pamphlet, slide, 
motion picture, or other documentary material regardless of form or 
characteristics. Record does not include an object or article such as a 
structure, furniture, a tangible exhibit or model, a vehicle, or piece 
of equipment.
    Representative of the news media means any person actively gathering 
news for an entity that is organized and operated to publish or 
broadcast news to the public. The term news means information that is 
about current events or that would be of current interest to the public. 
Examples of news media entities include television or radio stations 
broadcasting to the public at large, and publishers of periodicals (but 
only in those instances when they can qualify as disseminators of 
``news'') who make their products available for purchase or 
subscriptions by the general public.
    Review time means the period devoted to examining records retrieved 
in response to a request to determine whether they are exempt from 
disclosure in whole or in part. Review time also includes the period 
devoted to examining records to determine which Freedom of Information 
Act exemptions, if any, are applicable and identifying records, or 
portions thereof, to be disclosed.
    Search time means the period devoted to looking for agency records, 
either manually or by automated means, for the purpose of locating those 
records that are responsive to a request. This includes a page-by-page 
or line-by-line identification of responsive information within the 
records.
    Unusual circumstances mean--
    (1) The need to search for and collect the requested records from 
field facilities or other establishments that are separate from the 
office processing the request;
    (2) The need to search for, collect, and appropriately examine a 
voluminous amount of separate and distinct records demanded in a single 
request; or
    (3) The need for consultation, which will be conducted with all 
practicable speed, with another agency having a substantial interest in 
the determination of the request or among two or more components of the 
NRC having substantial subject-matter interest therein.

[63 FR 2876, Jan. 20, 1998, as amended at 70 FR 34306, June 14, 2005]



Sec.9.15  Availability of records.

    The NRC will make available for public inspection and copying any 
reasonably described agency record in the possession and control of the 
NRC under the provisions of this subpart, and upon request by any 
person. Records will be made available in any form or format requested 
by a person if the record is readily reproducible by NRC in that form or 
format. NRC will make reasonable efforts to maintain its records in 
forms or formats that are reproducible. NRC will make reasonable efforts 
to search for records in electronic form or format when requested, 
except when these efforts would significantly interfere with the 
operation of any of the NRC's automated information systems. Records 
that the NRC routinely makes publicly available are described in Sec.
9.21. Procedures and conditions governing requests for records are set 
forth in Sec.9.23.



Sec.9.17  Agency records exempt from public disclosure.

    (a) The following types of agency records are exempt from public 
disclosure under Sec.9.15:
    (1) Records--
    (i) That are specifically authorized under criteria established by 
an Executive Order to be kept secret in the interest of national defense 
or foreign policy, and
    (ii) That are in fact properly classified pursuant to such Executive 
Order;
    (2) Records related solely to the internal personnel rules and 
practices of the agency;

[[Page 230]]

    (3) Records specifically exempted from disclosure by statute (other 
than 5 U.S.C. 552b), provided that the statute--
    (i) Requires that the matters be withheld from the public in a 
manner that leaves no discretion on the issue; or
    (ii) Establishes particular criteria for withholding or refers to 
particular types of matters to be withheld;
    (4) Trade secrets and commercial or financial information obtained 
from a person that are privileged or confidential;
    (5) Interagency or intra-agency memorandums or letters that would 
not be available by law to a party other than an agency in litigation 
with the agency, provided that the deliberative process privilege shall 
not apply to records created 25 years or more before the date on which 
the records were requested;
    (6) Personnel and medical files and similar files, the disclosure of 
which would constitute a clearly unwarranted invasion of personal 
privacy;
    (7) Records or information compiled for law enforcement purposes, 
but only to the extent that the production of these law enforcement 
records or information--
    (i) Could reasonably be expected to interfere with enforcement 
proceedings;
    (ii) Would deprive a person of a right to a fair trial or an 
impartial adjudication;
    (iii) Could reasonably be expected to constitute an unwarranted 
invasion of personal privacy;
    (iv) Could reasonably be expected to disclose the identity of a 
confidential source, including a State, local, or foreign agency or 
authority, or any private institution which furnished information on a 
confidential basis, and, in the case of a record or information compiled 
by a criminal law enforcement authority in the course of a criminal 
investigation, or by an agency conducting a lawful national security 
intelligence investigation, or information furnished by a confidential 
source;
    (v) Would disclose techniques and procedures for law enforcement 
investigations or prosecutions, or would disclose guidelines for law 
enforcement investigations or prosecutions, if the disclosure could 
reasonably be expected to risk circumvention of the law; or
    (vi) Could reasonably be expected to endanger the life or physical 
safety of any individual;
    (8) Matters contained in or related to examination, operating, or 
condition reports prepared by, on behalf of, or for the use of any 
agency responsible for the regulation or supervision of financial 
institutions; or
    (9) Geological and geophysical information and data, including maps, 
concerning wells.
    (b) Nothing in this subpart authorizes withholding of information or 
limiting the availability of records to the public except as 
specifically provided in this part, nor is this subpart authority to 
withhold information from Congress.
    (c)(1) The NRC shall withhold information under this subpart only 
if--
    (i) The NRC reasonably foresees that disclosure would harm an 
interest protected by an exemption described in paragraph (a) of this 
section; or
    (ii) Disclosure is prohibited by law.
    (2) Nothing in this subpart requires disclosure of information that 
is otherwise prohibited from disclosure by law, or otherwise exempted 
from disclosure under 5 U.S.C. 552(b)(3).
    (d) Whenever a request is made that involves access to agency 
records described in paragraph (a)(7) of this section, the NRC may, 
during only the time as that circumstance continues, treat the records 
as not subject to the requirements of this subpart when--
    (1) The investigation or proceeding involves a possible violation of 
criminal law; and
    (2) There is reason to believe that--
    (i) The subject of the investigation or proceeding is not aware of 
its pendency; and
    (ii) Disclosure of the existence of the records could reasonably be 
expected to interfere with enforcement proceedings.

[63 FR 2876, Jan. 20, 1998, as amended at 81 FR 96346, Dec. 30, 2016]

[[Page 231]]



Sec.9.19  Segregation of exempt information and deletion of 
identifying details.

    (a) For records required to be made available under 5 U.S.C. 
552(a)(2), the NRC shall delete information that is exempt under one or 
more of the exemptions cited in Sec.9.17. The amount of information 
deleted will be indicated on the released portion of the record, unless 
providing this indication would harm an interest protected by the 
exemption(s) under which the matter has been withheld.
    (b) In responding to a request for information submitted under Sec.
9.23, in which it has been determined to withhold exempt information, 
the NRC shall segregate--
    (1) Information that is exempt from public disclosure under Sec.
9.17 from nonexempt information; and
    (2) Factual information from advice, opinions, and recommendations 
in predecisional records unless the information is inextricably 
intertwined, or is contained in drafts, legal work products, and records 
covered by the lawyer-client privilege, or is otherwise exempt from 
disclosure.
    (c) In denying a request for records, in whole or in part, NRC will 
make a reasonable effort to estimate the volume of any information 
requested that is denied and provide the estimate to the person making 
the request, unless providing the estimate would harm an interest 
protected by the exemption(s) under which the information has been 
denied.
    (d) When entire records or portions thereof are denied and deletions 
are made from parts of the record by computer, the amount of information 
deleted will be indicated on the released portion of the record, unless 
providing this indication would harm an interest protected by the 
exemption(s) under which the matter has been denied.

[63 FR 2876, Jan. 20, 1998, as amended at 81 FR 96346, Dec. 30, 2016]



Sec.9.21  Publicly available records.

    (a) Single copies of NRC publications in the NUREG series, NRC 
Regulatory Guides, and Standard Review Plans can be ordered from the 
National Technical Information Service, 5285 Port Royal Road, 
Springfield, Virginia, 22161.
    (b) For the convenience of persons who may wish to inspect without 
charge, or purchase copies of a record or a limited category of records 
for a fee, publicly available records of the NRC's activities described 
in paragraph (c) of this section are also made available at the NRC Web 
site, http://www.nrc.gov, and/or at the Public Document Room located at 
One White Flint North, 11555 Rockville Pike (first floor), Rockville, 
Maryland 20852-2738, between 7:45 am and 4:15 pm on Monday through 
Friday except Federal holidays.
    (c) The following records of NRC activities are available for public 
inspection in an electronic format:
    (1) Final opinions including concurring and dissenting opinions as 
well as orders of the NRC issued as a result of adjudication of cases;
    (2) Statements of policy and interpretations that have been adopted 
by the NRC and have not been published in the Federal Register;
    (3) Nuclear Regulatory Commission rules and regulations;
    (4) Nuclear Regulatory Commission Manuals and instructions to NRC 
personnel that affect any member of the public;
    (5) Copies of all records, regardless of form or format--
    (i) That have been released to any person under Sec.9.23; and
    (ii)(A) That because of the nature of their subject matter, the NRC 
determines have become or are likely to become the subject of subsequent 
requests for substantially the same records; or
    (B) That have been requested 3 or more times;
    (6) Individual indexes to publicly available records, including 
those records specified in paragraph (c) of this section, may be created 
by using the search features of the Agencywide Documents Access and 
Management System (ADAMS), located at the NRC Web site, http://
www.nrc.gov. This capability made it unnecessary for the NRC to continue 
publishing its monthly publication, Documents Made Publicly Available 
(NUREG-0540) after March 1999.
    (d) The published versions of the records made publicly available 
under

[[Page 232]]

paragraph (c)(1) of this section are available under the title, Nuclear 
Regulatory Issuances, NUREG-0750, for purchase through the National 
Technical Information Service.

[64 FR 48950, Sept. 9, 1999, as amended at 67 FR 67098, Nov. 4, 2002; 70 
FR 34306, June 14, 2005; 81 FR 96346, Dec. 30, 2016]



Sec.9.23  Requests for records.

    (a)(1) A person may request access to records routinely made 
available by the NRC under Sec.9.21 in person, by telephone, by e-
mail, facsimile, or U.S. mail from the NRC Public Document Room, One 
White Flint North, 11555 Rockville Pike (first floor), Rockville, 
Maryland 20852-2738.
    (i) Each record requested must be described in sufficient detail to 
enable the NRC Public Document Room staff to locate the record.
    (ii) To obtain copies of records expeditiously, a person may open an 
account with the NRC Public Document Room reproduction contractor. 
Payment for reproduction services will be made directly to the 
contractor.
    (2) [Reserved]
    (b) A person may request agency records by submitting a request 
authorized by 5 U.S.C. 552(a)(3) to the Freedom of Information Act and 
Privacy Act Officer by an appropriate method listed in Sec.9.6 of this 
chapter. The request must be in writing and clearly state on the 
envelope and in the letter that it is a ``Freedom of Information Act 
request.'' The NRC does not consider a request as received until the 
date it is actually received by the Freedom of Information Act and 
Privacy Act Officer.
    (1) A Freedom of Information Act request covers only agency records 
that are in existence on the date the Freedom of Information Act and 
Privacy Act Officer receives the request. A request does not cover 
agency records destroyed or discarded before receipt of a request or 
which are created after the date of the request.
    (2) All Freedom of Information Act requests for copies of agency 
records must reasonably describe the agency records sought in sufficient 
detail to permit the NRC to identify the requested agency records. Where 
possible, the requester should provide specific information regarding 
dates, titles, docket numbers, file designations, and other information 
which may help identify the agency records. If a requested agency record 
is not described in sufficient detail to permit its identification, the 
Freedom of Information Act and Privacy Act Officer will contact the 
requester within 10 working days after receipt of the request and inform 
the requester of the additional information or clarification needed to 
process the request.
    (3) Upon receipt of a request made under paragraph (b) of this 
section, the NRC will provide written notification to the requester that 
indicates the request has been received, the name and telephone number 
of the NRC point of contact to find out the status of the request, and 
other pertinent matters regarding the processing of the request.
    (4)(i) The NRC shall advise a requester that fees will be assessed 
if--
    (A) A request involves anticipated costs in excess of the minimum 
specified in Sec.9.39; and
    (B) Search and duplication is not provided without charge under 
Sec.9.39; or
    (C) The requester does not specifically state that the cost involved 
is acceptable or acceptable up to a specified limit.
    (ii) The NRC has discretion to discontinue processing a request made 
under this paragraph until--
    (A) A required advance payment has been received;
    (B) The requester has agreed to bear the estimated costs;
    (C) A determination has been made on a request for waiver or 
reduction of fees; or
    (D) The requester meets the requirements of Sec.9.39.
    (c) If a requested agency record that has been reasonably described 
is located at a place other than at the NRC Web site, http://
www.nrc.gov, the NRC Public Document Room, or the NRC headquarters, the 
NRC may, at its discretion, make the record available for inspection and 
copying at either of the locations.
    (d) Except as provided in Sec.9.39--
    (1) If the record requested under paragraph (b) of this section is a 
record available through the National Technical Information Service, the 
NRC

[[Page 233]]

shall refer the requester to the National Technical Information Service; 
and
    (2) If the requested record has been placed on the NRC Internet Web 
site, under Sec.9.21, the NRC may inform the requester that the record 
is available at the NRC Web site, http://www.nrc.gov, and/or at the NRC 
Public Document Room, and that the record may be obtained in accordance 
with the procedures set forth in paragraph (a) of this section.
    (e) The Freedom of Information Act and Privacy Act Officer will 
promptly forward a Freedom of Information Act request made under 
paragraph (b) of this section for an agency record to the head of the 
office(s) primarily concerned with the records requested, as 
appropriate. The responsible office will conduct a search for the agency 
records responsive to the request and compile those agency records to be 
reviewed for initial disclosure determination and/or identify those that 
have already been made publicly available at the NRC Web site, http://
www.nrc.gov, and/or at the NRC Public Document Room.

[63 FR 2876, Jan. 20, 1998, as amended at 64 FR 48950, Sept. 9, 1999; 67 
FR 67098, Nov. 4, 2002; 68 FR 58800, Oct. 10, 2003; 70 FR 34306, June 
14, 2005]



Sec.9.25  Initial disclosure determination.

    (a) Time for initial disclosure determination. The NRC will notify a 
requester within 20 working days of its determination. If the NRC cannot 
act upon the request within this period, the NRC will provide the 
requester with the reasons for the delay and provide a projected 
response date.
    (b) Extension of time limit in unusual circumstances. In unusual 
circumstances, the NRC may extend the time limit prescribed in paragraph 
(a) of this section by not more than 10 working days. The extension may 
be made by written or telephonic notice to the person making the request 
to explain the reasons for the extension and indicate the date on which 
a determination is expected to be made. ``Unusual circumstances'' is 
limited to one or more of the following reasons for delay:
    (1) The need to search for and collect the requested records from 
field facilities or other establishments that are separate from the 
office processing the request;
    (2) The need to search for, collect, and appropriately examine a 
voluminous amount of separate and distinct records which are demanded in 
a single request; or
    (3) The need for consultation, which will be conducted with all 
practicable speed, with another agency having a substantial interest in 
the determination of the request or among two or more components of the 
NRC having substantial subject-matter interest therein.
    (c) Exceptional circumstances. A requester may be notified in 
certain exceptional circumstances, when it appears that a request cannot 
be completed within the allowable time, and will be provided an 
opportunity to limit the scope of the request so that it may be 
processed in the time limit, or to agree to a reasonable alternative 
time frame for processing. When notifying a requester under this 
paragraph, the NRC, to aid the requester, shall make available its FOIA 
Public Liaison to assist in the resolution of any disputes between the 
requester and the agency and shall notify the requester of the 
requester's right to seek dispute resolution services from the Office of 
Government Information Services within the National Archives and Records 
Administration. For purposes of this paragraph, the term ``exceptional 
circumstances'' does not include delays that result from the normal 
predictable workload of FOIA requests or a failure by the NRC to 
exercise due diligence in processing the request. A requester's 
unwillingness to agree to reasonable modification of the request or an 
alternative time for processing the request may be considered as factors 
in determining whether exceptional circumstances exist and whether the 
agency exercised due diligence in responding to the request.
    (d) Multiple-Track processing. To ensure the most equitable 
treatment possible of all requesters, the NRC will process requests on a 
first-in, first-out basis, using multiple tracking systems based upon 
the estimated time it will take to process the request.
    (1) NRC uses a three-track system.

[[Page 234]]

    (i) The first track is for requests of simple to moderate complexity 
that are expected to be completed within 20 working days.
    (ii) The second track is for requests involving ``unusual 
circumstances'' that are expected to take between 21-30 working days to 
complete (e.g. requests involving possible records from two or three 
offices and/or various types of files of moderate volume, of which, some 
are expected to be exempt)
    (iii) The third track is for requests that, because of their unusual 
volume or other complexity, are expected to take more than 30 working 
days to complete (e.g. requests involving several offices, regional 
offices, another agency's records, classified records requiring 
declassification review, records from businesses that are required to be 
referred to the submitter for their proprietary review prior to 
disclosure, records in large volumes which require detailed review 
because of the sensitive nature of the records such as investigative 
records or legal opinions and recordings of internal deliberations of 
agency staff).
    (2) Upon receipt of requests, NRC will notify requesters of the 
track in which the request has been placed for processing and the 
estimated time for completion. Should subsequent information 
substantially change the estimated time to process a request, the 
requester will be notified telephonically or in writing. A requester may 
modify the request to allow it to be processed faster or to reduce the 
cost of processing. Partial responses may be sent to requesters as 
documents are obtained by the FOIA office from the supplying offices.
    (e) Expedited processing. (1) NRC may place a person's request at 
the front of the queue for the appropriate track for that request upon 
receipt of a written request that clearly demonstrates a compelling need 
for expedited processing. For purposes of determining whether to grant 
expedited processing, the term compelling need means--
    (i) That a failure to obtain requested records on an expedited basis 
could reasonably be expected to pose an imminent threat to the life or 
physical safety of an individual; or
    (ii) With respect to a request made by a person primarily engaged in 
disseminating information, urgency to inform the public concerning 
actual or alleged Federal Government activity.
    (2) A person requesting expedited processing must include a 
statement certifying the compelling need given to be true and correct to 
the best of his or her knowledge and belief. The certification 
requirement may be waived by the NRC as a matter of agency discretion.
    (3) The Freedom of Information Act and Privacy Act Officer will make 
the initial determination whether to grant or deny a request for 
expedited processing and will notify a requester within 10 calendar days 
after the request has been received whether expedited processing will be 
granted.
    (f) Disclosure review. The head of the responsible office shall 
review agency records located in a search under Sec.9.23(b) to 
determine whether the agency records are exempt from disclosure under 
Sec.9.17. If the head of the office determines that, although exempt, 
the disclosure of the agency records will not be contrary to the public 
interest and will not affect the rights of any person, the head of the 
office may authorize disclosure of the agency records. If the head of 
the office authorizes disclosure of the agency records, the head of the 
office will furnish the agency records to the Freedom of Information Act 
and Privacy Act Officer, who will notify the requester of the 
determination in the manner provided in Sec.9.27.
    (g)(1) Initial disclosure determination on requests for records 
originated by, or located in the files of the Office of the Inspector 
General. If, as a result of the review specified in paragraph (f) of 
this section, the Assistant Inspector General for Investigations finds 
that agency records that are originated by or located in the Office of 
the Inspector General are exempt from disclosure and should be denied in 
whole or in part, and disclosure of the records is contrary to the 
public interest and will adversely affect the rights of any person, the 
Assistant Inspector General for Investigations will submit that finding 
to the Freedom of Information Act and Privacy Act Officer who will

[[Page 235]]

notify the requester of the determination in the manner provided in 
Sec.9.27.
    (2) Initial disclosure determinations on requests for records 
originated by or transmitted to the Commission, or a Commissioner, or 
records originated by, or for which the Office of the Secretary or an 
Advisory Committee has primary responsibility. If, as a result of the 
review specified in paragraph (f) of this section, the Executive 
Assistant to the Secretary of the Commission finds that agency records 
originated by or transmitted to the Commission or a Commissioner, or 
records originated by, or for which the Office of the Secretary or an 
Advisory Committee has primary responsibility, are exempt from 
disclosure and should be denied in whole or in part, and disclosure of 
the records is contrary to the public interest and will adversely affect 
the rights of any person, the Executive Assistant to the Secretary of 
the Commission will submit that finding to the Freedom of Information 
Act and Privacy Act Officer who will notify the requester of the 
determination in the manner provided in Sec.9.27.
    (3) Initial disclosure determination for records originated by, or 
for which the Office of the General Counsel has principal 
responsibility. If, as a result of the review specified in paragraph (f) 
of this section, the General Counsel finds that agency records that are 
originated by, or for which the Office of the General Counsel has 
primary responsibility, are exempt from disclosure and should be denied 
in whole or in part, and disclosure of the records is contrary to the 
public interest and will adversely affect the rights of any person, the 
General Counsel will submit that finding to the Freedom of Information 
Act and Privacy Act Officer who will notify the requester of the 
determination in the manner provided in Sec.9.27.
    (h) Initial disclosure determinations on requests for records other 
than those for which the initial disclosure determination is made by the 
Assistant Inspector General for Investigations, the Executive Assistant 
to the Secretary of the Commission, or the General Counsel. If, as a 
result of the review specified in paragraph (f) of this section, the 
head of the responsible office finds that agency records other than 
those described in paragraph (g) of this section, that are originated 
by, or for which the office has primary responsibility, should be denied 
in whole or in part, the head of the office will submit that finding to 
the Freedom of Information Act and Privacy Act Officer, who will, in 
consultation with the Office of the General Counsel, make an independent 
determination whether the agency records should be denied in whole or in 
part. If the Freedom of Information Act and Privacy Act Officer 
determines that the agency records sought are exempt from disclosure and 
disclosure of the records is contrary to the public interest and will 
adversely affect the rights of any person, the Freedom of Information 
Act and Privacy Act Officer will notify the requester of the 
determination in the manner provided in Sec.9.27.
    (i) Records and information originated by another Federal agency. If 
a requested record is located that was originated or contains 
information originated by another Federal Government agency, or deals 
with subject matter over which an agency other than the NRC has 
exclusive or primary responsibility, the NRC will promptly refer the 
record to that Federal Government agency for disposition or for guidance 
regarding disposition.
    (j) If the NRC does not respond to a request within the 20 working-
day period, or within the extended periods described in paragraph (b) of 
this section, the requester may treat that delay as a denial of the 
request and immediately appeal as provided in Sec.9.29(a) or sue in a 
Federal District Court as noted in Sec.9.29(c).

[63 FR 2876, Jan. 20, 1998, as amended at 70 FR 34306, June 14, 2005; 81 
FR 96346, Dec. 30, 2016]



Sec.9.27  Form and content of responses.

    (a) When the NRC has located a requested agency record and has 
determined to disclose the agency record, the Freedom of Information Act 
and Privacy Act Officer will promptly furnish the agency record or 
notify the requester where and when the agency record will be available 
for inspection and copying. The NRC's response will notify the requester 
of the requester's right to seek assistance from the NRC's FOIA Public 
Liaison. The NRC will also advise the requester of any

[[Page 236]]

applicable fees under Sec. Sec.9.35 and 9.37. The NRC will routinely 
make copies of non-sensitive records disclosed in response to Freedom of 
Information Act requests publicly available through the Agencywide 
Document Access and Management System (ADAMS) located in the NRC Library 
that can be accessed via the NRC Web site at http://www.nrc.gov/NRC/
reading-rm/adams.html. Records that contain information personal to the 
requester, involve matters that are not likely to be of public interest 
to anyone other than the requester or contain privileged or confidential 
information that should only be disclosed to the requester will not be 
made publicly available on the NRC Web site.
    (b) When the NRC denies access to a requested agency record or 
denies a request for expedited processing or for a waiver or reduction 
of fees, the Freedom of Information Act and Privacy Act Officer will 
notify the requester in writing. The denial will include as 
appropriate--
    (1) The reason for the denial;
    (2) A reference to the specific exemption under the Freedom of 
Information Act, or other appropriate reason, and the Commission's 
regulations authorizing the denial;
    (3) The name and title or position of each person responsible for 
the denial of the request, including the head of the office recommending 
denial of the record;
    (4) A statement stating why the request does not meet the 
requirements of Sec.9.41 if the request is for a waiver or reduction 
of fees; and
    (5) A statement that the denial may be appealed within 90 calendar 
days from the date of the denial to the Executive Director for 
Operations, to the Secretary of the Commission, or to the Inspector 
General, as appropriate.
    (6) A statement that the requester has a right to seek assistance 
from the NRC's FOIA Public Liaison; and
    (7) A statement that the requester has a right to seek dispute 
resolution services from the NRC's FOIA Public Liaison or the Office of 
Government Information Services within the National Archives and Records 
Administration.
    (c) The Freedom of Information Act and Privacy Act Officer will 
maintain a copy of each letter granting or denying requested agency 
records, denying a request for expedited processing, or denying a 
request for a waiver or reduction of fees in accordance with the NRC 
Comprehensive Records Disposition Schedule.

[63 FR 2876, Jan. 20, 1998, as amended at 70 FR 34307, June 14, 2005; 76 
FR 72084, Nov. 22, 2011; 81 FR 96346, Dec. 30, 2016]



Sec.9.28  Predisclosure notification procedures for information
containing trade secrets or confidential commercial or financial
information.

    (a) Notice of opportunity to object to NRC's initial disclosure 
determination. Whenever NRC makes an initial determination that 
information should be disclosed in response to a Freedom of Information 
Act request or a Freedom of Information Act appeal which has been 
designated by the submitter as trade secrets or confidential commercial 
or financial information, or the NRC believes the information contains 
such trade secrets or confidential commercial or financial information, 
the NRC will give the submitter of the information written notice of 
NRC's initial determination, or NRC's need for information on which to 
base a determination, and an opportunity to object. The notice must 
describe the business information requested or include copies of the 
requested records or record portions containing the information.
    (b) Submitter objection to disclosure. The submitter will be allowed 
30 calendar days from date of the notice described in paragraph (a) of 
this section to object to disclosure, unless the Commission determines 
that a shorter period of time to respond is necessary in a particular 
instance. If a submitter has any objection to disclosure, the submitter 
must provide a detailed written statement. The statement must specify 
all grounds that support why the information is a trade secret or 
commercial or financial information that is privileged or confidential. 
If a submitter fails to respond to the notice within the time specified 
in the notice, the submitter will be considered to have no objection to 
disclosure of the information. Information provided by the submitter 
that is not received until

[[Page 237]]

after the date specified for response will not be considered unless that 
date is extended by the Freedom of Information Act and Privacy Act 
Officer upon request by the submitter.
    (c) Notice of final decision to disclose. The NRC shall consider a 
submitter's written statement and specific grounds for nondisclosure. If 
the NRC agrees to withhold the information from public disclosure, the 
NRC will inform the requester in the manner described in Sec.9.27 of 
the agency decision to deny access to the requested information. 
Whenever the NRC denies the submitter's request for nondisclosure and 
decides to disclose the information, the NRC shall give the submitter 
written notice, which must include:
    (1) A statement of the reason(s) for the determination;
    (2) A description of the business information to be disclosed; and
    (3) A specified disclosure date, which will be 30 calendar days 
subsequent to the date of the notice, or less, as provided under 
paragraph (b) of this section, after which the information will be made 
available to the public.
    (d) Corresponding notice to requesters. When the NRC provides a 
submitter with notice and opportunity to object to disclosure under 
paragraph (b) of this section, the NRC shall also notify the 
requester(s). Whenever the NRC notifies a submitter of its final 
decision to disclose the requested information under paragraph (c) of 
this section, the NRC shall also notify the requester(s). When a 
submitter files a lawsuit seeking to prevent the disclosure of trade 
secrets or confidential commercial or financial information, the NRC 
shall notify the requester(s).
    (e) Notice to submitter of Freedom of Information Act lawsuit. 
Whenever a requester files a lawsuit seeking to compel disclosure of 
trade secrets or confidential commercial or financial information, the 
NRC shall promptly notify the submitter.

[70 FR 34307, June 14, 2005]



Sec.9.29  Appeal from initial determination.

    (a) A requester may appeal a notice of denial of a Freedom of 
Information Act request for access to agency records, denial of a 
request for waiver or reduction of fees, or denial of a request for 
expedited processing under this subpart within 90 calendar days of the 
date of the NRC's denial.
    (b) For agency records to which access is denied by the Assistant 
Inspector General for Investigations, the appeal must be in writing 
directed to the Inspector General and sent to the Freedom of Information 
Act and Privacy Act Officer by an appropriate method listed in Sec.
9.6. The appeal should clearly state on the envelope and in the letter 
that it is an ``Appeal from Initial Freedom of Information Act 
Decision.'' The NRC does not consider an appeal received until the date 
it is actually received by the Freedom of Information Act and Privacy 
Act Officer. The Inspector General will make the NRC determination on 
the appeal within 20 working days after the receipt of the appeal. If 
the Inspector General denies an appeal of access to records, in whole or 
in part, the Inspector General will notify the requester of the denial, 
explaining the exemptions relied upon and how the exemptions apply to 
the agency records withheld. The notice will inform the requester that 
the denial is a final agency action and that judicial review is 
available in a district court of the United States in the district in 
which the requester resides or has a principal place of business, in 
which the agency records are situated, or in the District of Columbia.
    (c) For agency records to which access is denied by the Executive 
Assistant to the Secretary of the Commission, the General Counsel, or an 
office director reporting to the Commission, the appeal must be in 
writing directed to the Secretary of the Commission and sent to the 
Freedom of Information Act and Privacy Act Officer by an appropriate 
method listed in Sec.9.6. The appeal should clearly state on the 
envelope and in the letter that it is an ``Appeal from Initial Freedom 
of Information Act Decision.'' The NRC does not consider an appeal 
received until the date it is actually received by the Freedom of 
Information Act and Privacy Act Officer. The Secretary of the Commission 
will make the NRC determination on the appeal within 20 working days 
after the receipt of the appeal.

[[Page 238]]

If the Secretary of the Commission denies an appeal of access to 
records, in whole or in part, the Secretary of the Commission will 
notify the requester of the denial, explaining the exemptions relied 
upon and how the exemptions apply to the agency records withheld. The 
notice will inform the requester that the denial is a final agency 
action and that judicial review is available in a district court of the 
United States in the district in which the requester resides or has a 
principal place of business, in which the agency records are situated, 
or in the District of Columbia.
    (d) For agency records to which access is denied by agency officials 
other than the Assistant Inspector General for Investigations, the 
Executive Assistant to the Secretary of the Commission, the General 
Counsel, or other office director reporting to the Commission, the 
appeal must be in writing directed to the Executive Director for 
Operations and sent to the Freedom of Information Act and Privacy Act 
Officer by an appropriate method listed in Sec.9.6. The appeal should 
clearly state on the envelope and in the letter that it is an ``Appeal 
from Initial FOIA Decision.'' The NRC does not consider an appeal 
received until the date it is actually received by the Freedom of 
Information Act and Privacy Act Officer. The Executive Director for 
Operations or a Deputy Executive Director will make the NRC 
determination on the appeal within 20 working days after the receipt of 
the appeal. If the Executive Director for Operations or a Deputy 
Executive Director denies an appeal of access to records, in whole or in 
part, the Executive Director for Operations or a Deputy Executive 
Director, will notify the requester of the denial, explaining the 
exemptions relied upon and how the exemptions apply to the agency 
records withheld. The notice will inform the requester that the denial 
is a final agency action and that judicial review is available in a 
district court of the United States in the district in which the 
requester resides or has a principal place of business, in which the 
agency records are situated, or in the District of Columbia.
    (e) For the denial of a request for expedited processing the appeal 
must be in writing directed to the Executive Director for Operations and 
sent to the Freedom of Information Act and Privacy Act Officer by an 
appropriate method listed in Sec.9.6. The appeal should clearly state 
on the envelope and in the letter that it is an ``Appeal from Initial 
FOIA Decision.'' The NRC does not consider an appeal received until the 
date it is actually received by the Freedom of Information Act and 
Privacy Act Officer. The NRC will make a determination on the appeal 
within 10 working days after the receipt of the appeal. If the Executive 
Director for Operations or a Deputy Executive Director denies an appeal 
for expedited processing, the Executive Director for Operations or a 
Deputy Executive Director, will notify the person making the request of 
the decision to sustain the denial, including a statement explaining why 
the request does not meet the requirements of Sec.9.25(e)(1) and (2). 
The notice will inform the requester that the denial is a final agency 
action and that judicial review is available in a district court of the 
United States in the district in which the requester resides or has a 
principal place of business, in which the agency records are situated, 
or in the District of Columbia.
    (f) For denial of a waiver or reduction of fees for locating and 
reproducing agency records, the appeal must be in writing directed to 
the Executive Director for Operations and sent to the Freedom of 
Information Act and Privacy Act Officer by an appropriate method listed 
in Sec.9.6. The appeal should clearly state on the envelope and in the 
letter that it is an ``Appeal from Initial FOIA Decision.'' The NRC does 
not consider an appeal received until the date it is actually received 
by the Freedom of Information Act and Privacy Act Officer. The NRC will 
make a determination on the appeal within 20 working days after the 
receipt of the appeal. If the Executive Director for Operations or a 
Deputy Executive Director denies an appeal of a waiver or reduction of 
fees for locating and reproducing agency records, the Executive Director 
for Operations or a Deputy Executive Director, will notify the person 
making the request of the

[[Page 239]]

decision to sustain the denial, including a statement explaining why the 
request does not meet the requirements of Sec.9.41. The notice will 
inform the requester that the denial is a final agency action and that 
judicial review is available in a district court of the United States in 
the district in which the requester resides or has a principal place of 
business, in which the agency records are situated, or in the District 
of Columbia.
    (g) The Executive Director for Operations, a Deputy Executive 
Director, the Secretary of the Commission, or the Inspector General will 
furnish copies of all appeals and written determinations on appeals to 
the Freedom of Information Act and Privacy Act Officer.

[70 FR 34307, June 14, 2005, as amended at 81 FR 96346, Dec. 30, 2016]



Sec.9.30  Contact for dispute resolution services.

    (a) NRC's FOIA Public Liaison:
    (1) By mail--11555 Rockville Pike, Rockville, MD 20852;
    (2) By facsimile--301-415-5130; and
    (3) By [email protected].
    (b) Office of Government Information Services within National 
Archives and Records Administration:
    (1) By mail--8601 Adelphi Road-OGIS, College Park, MD 20740;
    (2) By facsimile--202-741-5769; and
    (3) By [email protected].

[81 FR 96346, Dec. 30, 2016]



Sec.9.31  Extension of time for response.

    (a) In unusual circumstances defined in Sec.9.13, the NRC may 
extend the time limits prescribed in Sec.9.25 or Sec.9.29 by not 
more than 10 working days. The extension may be made by written notice 
to the person making the request to explain the reasons for the 
extension and indicate the date on which a determination is expected to 
be dispatched.
    (b) An extension of the time limits prescribed in Sec. Sec.9.25 
and 9.29 may not exceed a combined total of 10 working days per request, 
unless a requester has agreed to an alternative time frame as described 
in Sec.9.25 (c).



Sec.9.33  Search, review, and special service fees.

    (a) The NRC charges fees for--
    (1) Search, duplication, and review, when agency records are 
requested for commercial use;
    (2) Duplication of agency records provided in excess of 100 pages 
when agency records are not sought for commercial use and the request is 
made by an educational or noncommercial scientific institution, or a 
representative of the news media;
    (3) Search time that exceeds two hours and duplication of agency 
records of more than 100 pages for requests from all other categories of 
requesters not described in paragraphs (a)(1) and (a)(2) of this 
section;
    (4) The direct costs of searching for agency records. The NRC will 
assess fees even when no agency records are located as a result of the 
search or when agency records that are located as a result of the search 
are not disclosed; and
    (5) Computer searches which includes the cost of operating the 
Central Processing Unit for the portion of operating time that is 
directly attributable to searching for agency records plus the operator/
programmer salary apportionable to the search.
    (b) The NRC may charge requesters who request the following services 
for the direct costs of the service:
    (1) Certifying that records are true copies;
    (2) Sending records by special methods, such as express mail, 
package delivery service, courier, and other means other than first 
class mail; or
    (3) Producing or converting records to formats specified by a 
requester other than ordinary copying processes that are readily 
available in NRC.



Sec.9.34  Assessment of interest and debt collection.

    (a) The NRC will assess interest on the fee amount billed starting 
on the 31st day following the day on which the billing was sent in 
accordance with NRC's regulations set out in Sec.15.37 of this 
chapter. The rate of interest is prescribed in 31 U.S.C. 3717.
    (b) The NRC will use its debt collection procedures under part 15 of 
this chapter for any overdue fees.

[[Page 240]]



Sec.9.35  Duplication fees.

    (a)(1) The charges by the duplicating service contractor for the 
duplication of records made available under Sec.9.21 at the NRC Public 
Document Room (PDR), One White Flint North, 11555 Rockville Pike, Room 
O-1F23, Rockville, Maryland, may be found on the NRC's Web site at 
http://www.nrc.gov/reading-rm/pdr/copy-service.html or by calling the 
PDR at 1-800-397-4209 or 301-415-4737, by e-mail [email protected] and are as 
follows:
    (i) Paper-to-paper reproduction is $0.30 per page for standard size 
(up to and including 11 x 14 reduced). Pages 
11 x 17 are $0.30 per page. Pages larger than 
11 x 17, including engineering drawings, are $1.50 
per square foot.
    (ii) Pages larger than 11 x 17 are $1.50 per 
square foot.
    (iii) Microfiche-to-paper reproduction is $0.30 per page. Aperture 
card blowback to paper is $3.00 per square foot.
    (iv) Microfiche card duplication is $5.00 per card; CD-ROM 
duplication is $10.00 each.
    (v) The charges for Electronic Full Text (EFT) (ADAMS documents) 
copying are as follows:
    (A) Electronic Full Text (EFT) copying of ADAMS documents to paper 
(applies to images, OCR TIFF, and PDF text) is $0.30 per page.
    (B) EFT copying of ADAMS documents to CD-ROM is $5.00 per CD plus 
$0.15 per page.
    (C) CD-ROM-to-paper reproduction is $0.30 per page.
    (vi) Priority rates (rush processing) are as follows:
    (A) The priority rate offered for standard size paper-to-paper 
reproduction is $0.35, microfiche-to-paper reproduction is $0.40, EFT 
copying of ADAMS documents to paper and CD-ROM-to-paper production is 
$0.35 per page.
    (B) The priority rate for aperture cards is $3.50 per square foot. 
The priority rate for copying EFT to CD-ROM is $6.00 per CD-ROM plus 
$0.20 per page.
    (vii) Facsimile charges are $1.00 per page for local calls; $2.00 
per page for U.S. long distance calls, and $6.00 per page for foreign 
long distance calls, plus the regular per page copying charge.
    (2) A requester may submit mail-order requests for contractor 
duplication of NRC records made by writing to the NRC Public Document 
Room. The charges for mail-order duplication of records are the same as 
those set out in paragraph (a)(1) of this section, plus mailing or 
shipping charges.
    (3) A requester may open an account with the duplicating service 
contractor. A requester may obtain the name and address and billing 
policy of the contractor from the NRC Public Document Room.
    (4) Any change in the costs specified in this section will become 
effective immediately pending completion of the final rulemaking that 
amends this section to reflect the new charges. The Commission will post 
the charges that will be in effect for the interim period at the NRC 
Public Document Room. The Commission will publish a final rule in the 
Federal Register that includes the new charges within 15 working days 
from the beginning of the interim period.
    (b) The NRC will assess the following charges for copies of records 
to be duplicated by the NRC at locations other than the NRC Public 
Document Room located at One White Flint North, 11555 Rockville Pike 
(first floor), Rockville, Maryland.
    (1) Sizes up to 8\1/2\ x 14 inches made on office copying machines--
$0.20 per page of copy; and
    (2) The charge for duplicating records other than those specified in 
paragraphs (a) and (b) of this section is computed on the basis of NRC's 
direct costs.
    (c) In compliance with the Federal Advisory Committee Act, a 
requester may purchase copies of transcripts of testimony in NRC 
Advisory Committee proceedings, which are transcribed by a reporting 
firm under contract with the NRC directly from the reporting firm at the 
cost of reproduction as provided for in the contract with the reporting 
firm. A requester may also purchase transcripts from the NRC at the cost 
of reproduction as set out in paragraphs (a) and (b) of this section.
    (d) Copyrighted material may not be reproduced in violation of the 
copyright laws. Requesters will be given the citation to any copyrighted 
publication

[[Page 241]]

and advised to contact the NRC Public Document Room to arrange to view 
the publication.

[63 FR 2876, Jan. 20, 1998, as amended at 64 FR 48951, Sept. 9, 1999; 67 
FR 67098, Nov. 4, 2002; 70 FR 34308, June 14, 2005; 71 FR 54571, Sept. 
18, 2006]



Sec.9.37  Fees for search and review of agency records by NRC personnel.

    The NRC will charge the following hourly rates for search and review 
of agency records by NRC personnel:
    (a) Clerical search and review at a salary rate that is equivalent 
to a GG-7/step 6, plus 16 percent fringe benefits;
    (b) Professional/managerial search and review at a salary rate that 
is equivalent to a GG-13/step 6, plus 16 percent fringe benefits; and
    (c) Senior executive or Commissioner search and review at a salary 
rate that is equivalent to an ES-Maximum, plus 16 percent fringe 
benefits.

[63 FR 2876, Jan. 20, 1998, as amended at 75 FR 41369, July 16, 2010]

    Effective Date Note: At 83 FR 65077, Dec. 19, 2018, Sec.9.37 was 
amended by revising paragraphs (a) and (b), effective Mar. 4, 2019. For 
the convenience of the user, the revised text is set forth as follows:



Sec.9.37  Fees for search and review of agency records by NRC 
          personnel.

                                * * * * *

    (a) Clerical search and review at a salary rate that is equivalent 
to a GG-9/step 7, plus 16 percent fringe benefits;
    (b) Professional/managerial search and review at a salary rate that 
is equivalent to a GG-14/step 7, plus 16 percent fringe benefits; and



Sec.9.39  Search and duplication provided without charge.

    (a) The NRC will search for agency records requested under Sec.
9.23(b) without charges when agency records are not sought for 
commercial use and the records are requested by an educational or 
noncommercial scientific institution, or a representative of the news 
media.
    (b) The NRC will search for agency records requested under Sec.
9.23(b) without charges for the first two hours of search for any 
request not sought for commercial use and not covered in paragraph (a) 
of this section.
    (c) The NRC will duplicate agency records requested under Sec.
9.23(b) without charge for the first 100 pages of standard paper copies, 
or the equivalent cost of 100 pages of standard paper copies when 
providing the requester copies in microfiche or electronic form such as 
computer disks, if the requester is not a commercial use requester.
    (d) The NRC may not bill any requester for fees if the cost of 
collecting the fee would be equal to or greater than the fee itself.
    (e) The NRC may aggregate requests in determining search and 
duplication to be provided without charge as provided in paragraphs (a) 
and (b) of this section, if the NRC finds a requester or group of 
requesters acting in concert, has filed multiple requests that actually 
constitute a single request, and that the requests involve clearly-
related matters.
    (f)(1) Except as described in paragraphs (f)(2), (3), and (4) of 
this section, if the NRC fails to comply with any time limit under 
Sec. Sec.9.25 or 9.29, it may not charge search fees or, in the case 
of requests from requesters described in Sec.9.33(a)(2), may not 
charge duplication fees.
    (2) If the NRC has determined that unusual circumstances, as defined 
in Sec.9.13, apply and the NRC provided timely written notice to the 
requester in accordance with the Freedom of Information Act, a failure 
to comply with the time limit shall be excused for an additional 10 
days.
    (3) If the NRC has determined that unusual circumstances, as defined 
in Sec.9.13, apply and more than 5,000 pages are necessary to respond 
to the request, the NRC may charge search fees or, in the case of 
requests from requesters described in Sec.9.33(a)(2), may charge 
duplication fees, if the NRC has provided timely written notice to the 
requester in accordance with the Freedom of Information Act and the NRC 
has discussed with the requester via written mail, email, or telephone 
(or made not less than three good-faith attempts to do so) how the 
requester could effectively limit the scope of the request in accordance 
with 5 U.S.C. 552(a)(6)(B)(ii).

[[Page 242]]

    (4) If a court has determined that exceptional circumstances exist, 
as defined by 5 U.S.C. 552(a)(6)(C), a failure to comply with the time 
limit shall be excused for the length of time provided by the court 
order.

[63 FR 2876, Jan. 20, 1998, as amended at 81 FR 96346, Dec. 30, 2016]



Sec.9.40  Assessment of fees.

    (a) If the request is expected to require the NRC to assess fees in 
excess of $25 for search and/or duplication, the NRC will notify the 
requester that fees will be assessed unless the requester has indicated 
in advance his or her willingness to pay fees as high as estimated.
    (b) In the notification, the NRC will include the estimated cost of 
search fees and the nature of the search required and estimated cost of 
duplicating fees.
    (c) The NRC will encourage requesters to discuss with the NRC the 
possibility of narrowing the scope of the request with the goal of 
reducing the cost while retaining the requester's original objective.
    (d) If the fee is determined to be in excess of $250, the NRC will 
require an advance payment.
    (e) Unless a requester has agreed to pay the estimated fees or, as 
provided for in paragraph (d) of this section, the requester has paid an 
estimated fee in excess of $250, the NRC may not begin to process the 
request.
    (f) If the NRC receives a new request and determines that the 
requester has previously failed to pay a properly charged fee under the 
Freedom of Information Act to the NRC or other Federal agency within 30 
calendar days of receipt of the bill on a previous request, the NRC may 
refuse to accept the new request for processing until payment is made of 
the full amount owed on the prior request, plus any applicable interest 
assessed as provided in Sec.9.34.
    (g) Within 10 working days of the receipt of NRC's notice that fees 
will be assessed, the requester will provide advance payment if 
required, notify the NRC in writing that the requester agrees to bear 
the estimated costs, or submit a request for a waiver or reduction of 
fees pursuant to Sec.9.41.

[63 FR 2876, Jan. 20, 1998, as amended at 70 FR 34308, June 14, 2005]



Sec.9.41  Requests for waiver or reduction of fees.

    (a)(1) The NRC will collect fees for searching for, reviewing, and 
duplicating agency records, except as provided in Sec.9.39, unless a 
requester submits a request in writing for a waiver or reduction of 
fees. To ensure that there will be no delay in the processing of Freedom 
of Information Act requests, the request for a waiver or reduction of 
fees should be included in the initial Freedom of Information Act 
request letter.
    (2) Each request for a waiver or reduction of fees should be 
addressed to the Office of the Chief Information Officer, and sent using 
an appropriate method listed in Sec.9.6.
    (b) A person requesting the NRC to waive or reduce search, review, 
or duplication fees will--
    (1) Describe the purpose for which the requester intends to use the 
requested information;
    (2) Explain the extent to which the requester will extract and 
analyze the substantive content of the agency record;
    (3) Describe the nature of the specific activity or research in 
which the agency records will be used and the specific qualifications 
the requester possesses to utilize information for the intended use in 
such a way that it will contribute to public understanding;
    (4) Describe the likely impact on the public's understanding of the 
subject as compared to the level of public understanding of the subject 
before disclosure;
    (5) Describe the size and nature of the public to whose 
understanding a contribution will be made;
    (6) Describe the intended means of dissemination to the general 
public;
    (7) Indicate if public access to information will be provided free 
of charge or provided for an access fee or publication fee; and
    (8) Describe any commercial or private interest the requester or any 
other party has in the agency records sought.

[[Page 243]]

    (c) The NRC will waive or reduce fees, without further specific 
information from the requester if, from information provided with the 
request for agency records made under Sec.9.23(b), it can determine 
that disclosure of the information in the agency records is in the 
public interest because it is likely to contribute significantly to 
public understanding of the operations or activities of the Federal 
Government and is not primarily in the commercial interest of the 
requester.
    (d) In making a determination regarding a request for a waiver or 
reduction of fees, the NRC will consider the following factors:
    (1) How the subject of the requested agency records concerns the 
operations or activities of the Federal Government;
    (2) How the disclosure of the information is likely to contribute 
significantly to public understanding of Federal Government operations 
or activities;
    (3) The extent to which, the requester has a commercial interest 
that would be furthered by the disclosure of the requested agency 
records; and whether that commercial interest exceeds the public 
interest in disclosure.
    (e) The Freedom of Information Act and Privacy Act Officer will make 
an initial determination whether a request for a waiver or reduction of 
fees meets the requirements of this section. The Freedom of Information 
Act and Privacy Act Officer will inform requesters whenever their 
request for a waiver or reduction of fees is denied and will inform them 
of their appeal rights under Sec.9.29.

[63 FR 2876, Jan. 20, 1998, as amended at 68 FR 58800, Oct. 10, 2003; 80 
FR 74978, Dec. 1, 2015]



Sec.9.43  Processing requests for a waiver or reduction of fees.

    (a) Within 20 working days after receipt of a request for access to 
agency records for which the NRC agrees to waive fees under Sec.9.39 
(a) through (d) or Sec.9.41(c), the NRC will respond to the request as 
provided in Sec.9.25.
    (b) In making a request for a waiver or reduction of fees, a 
requester shall provide the information required by Sec.9.41(b).
    (c) After receipt of a request for the waiver or reduction of fees 
made in accordance with Sec.9.41, the NRC will either waive or reduce 
the fees and notify the requester of the NRC's intent to provide the 
agency records promptly or deny the request and provide a statement to 
the requester explaining why the request does not meet the requirements 
of Sec.9.41(b).
    (d) As provided in Sec.9.29, a requester may appeal a denial of a 
request to waive or reduce fees to the Executive Director for 
Operations. The appeal must be submitted within 90 calendar days from 
the date of the notice.

[63 FR 2876, Jan. 20, 1998, as amended at 70 FR 34308, June 14, 2005; 81 
FR 96347, Dec. 30, 2016]



Sec.9.45  Annual report to the Attorney General of the United States
and Director of the Office of Government Information Services.

    (a) On or before February 1 of each year, the NRC will submit a 
report covering the preceding fiscal year to the Attorney General of the 
United States and to the Director of the Office of Government 
Information Services which shall include the information required by 5 
U.S.C. 552(e)(1).
    (b) The NRC will make its annual FOIA reports available to the 
public at the NRC Web site, http://www.nrc.gov.

[81 FR 96347, Dec. 30, 2016]



                    Subpart B_Privacy Act Regulations

    Source: 40 FR 44484, Sept. 26, 1975, unless otherwise noted.



Sec.9.50  Scope of subpart.

    This subpart implements the provisions of section 3 of the Privacy 
Act of 1974, Pub. L. 93-579, 5 U.S.C. 552a, with respect to (a) the 
procedures by which individuals may determine the existence of, seek 
access to and request correction of NRC records concerning themselves, 
and (b) the requirements applicable to NRC personnel with respect to the 
use and dissemination of such records. The regulations in this subpart 
apply to all records which are retrievable from a system of records

[[Page 244]]

under the control of the Nuclear Regulatory Commission by the use of an 
individual's name or of an identifying number, symbol, or other 
identifying particular assigned to such individual. Except where 
specifically provided otherwise, this subpart applies to all NRC records 
maintained on individuals whether they predate or postdate September 27, 
1975.



Sec.9.51  Definitions.

    As used in this subpart:
    (a) Individual means a citizen of the United States or an alien 
lawfully admitted for permanent residence.
    (b) The term maintain includes maintain, collect, use or 
disseminate.
    (c) Record means any item, collection or grouping of information 
about an individual that is maintained by the NRC, including, but not 
limited to, his or her education, financial transactions, medical 
history, employment history or criminal history, and that contains the 
individual's name, or the identifying number, symbol or other 
identifying particular assigned to the individual, such as a finger or 
voice print or a photograph.
    (d) System manager means the NRC official responsible for 
maintaining a system of records.
    (e) Systems of records means a group of records under the control of 
the NRC from which information is retrieved by the name of an individual 
or by an identifying number, symbol, or other identifying particular 
assigned to an individual.
    (f) Statistical record means a record in a system of records 
maintained for statistical research or reporting purposes only and not 
used in whole or in part in making any determination about an 
identifiable individual, except as provided by the Census Act, 13 U.S.C. 
8.
    (g) Routine use means, with respect to the disclosure of a record, 
the use of such record for a purpose which is compatible with the 
purpose for which it was collected, as described in a notice published 
in the Federal Register.

Procedures Applicable to Requests by Individuals for Information, Access 
              or Amendment of Records Maintained About Them

                        presentation of requests



Sec.9.52  Types of requests.

    (a) Individuals may make the following requests respecting records 
about themselves maintained by NRC in a system of records subject to the 
provisions of the Privacy Act of 1974:
    (1) Request a determination whether a record about the individual is 
contained in a system of records.
    (2) Request access to a record about the individual. Access requests 
may include requests to review the record and to have a copy made of all 
or any portion thereof in a form comprehensible to the individual.
    (3) Request correction or amendment of a record about the 
individual.
    (b) Requests for accounting of disclosures. Individuals may, at any 
time, request an accounting by NRC of disclosures to any other person or 
Government agency of any record about themselves contained in a system 
of records controlled by NRC, except the following: (1) Disclosures made 
pursuant to the Freedom of Information Act, 5 U.S.C. 552; (2) 
disclosures made within the Nuclear Regulatory Commission; (3) 
disclosures made to another Government agency or instrumentality for an 
authorized law enforcement activity pursuant to 5 U.S.C. 552a(b)(7); (4) 
disclosures expressly exempted by NRC regulations from the requirements 
of 5 U.S.C. 552a(c)(3) pursuant to 5 U.S.C. 552a (j)(2) and (k).

[40 FR 44484, Sept. 26, 1975, as amended at 60 FR 63900, Dec. 13, 1995]



Sec.9.53  Requests; how and where presented.

    (a) Requests may be made in person or in writing. Assistance 
regarding equests or other matters relating to the Privacy Act of 1974 
may be obtained by writing to the Freedom of Information Act and Privacy 
Act Officer, by an appropriate method listed in Sec.9.6. Requests 
relating to records in multiple systems of records should be made to the 
same Officer. That Officer shall assist the requestor in identifying his

[[Page 245]]

or her request more precisely and shall be responsible for forwarding 
the request to the appropriate system manager.
    (b) All written requests must be made to the Freedom of Information 
Act and Privacy Act Officer, U.S. Nuclear Regulatory Commission, and 
sent by an appropriate method listed in Sec.9.6, and should clearly 
state on the envelope and in the letter, as appropriate: ``Privacy Act 
Request,'' ``Privacy Act Disclosure Accounting Request,'' ``Privacy Act 
Correction Request.'' The NRC does not consider a request received until 
the date it is actually received by the Freedom of Information Act and 
Privacy Act Officer.
    (c) Requests may be made in person during official hours at the U.S. 
Nuclear Regulatory Commission office where the record is located, as 
listed in the ``Notice of System of Records'' for the system in which 
the record is contained.

[40 FR 44484, Sept. 26, 1975, as amended at 41 FR 20645, May 20, 1976; 
52 FR 31609, Aug. 21, 1987; 54 FR 53316, Dec. 28, 1989; 63 FR 15743, 
Apr. 1, 1998; 68 FR 58800, Oct. 10, 2003; 70 FR 34308, June 14, 2005]



Sec.9.54  Verification of identity of individuals making requests.

    (a) Identification requirements in paragraphs (a) (1) and (2) of 
this section are applicable to any individual who makes requests 
respecting records about himself or herself, except that no verification 
of identity shall be required if the records requested are available to 
the public under the provisions of the Freedom of Information Act. With 
respect to certain sensitive records, additional requirements for 
verification of identity stated in the appropriate published ``Notice of 
System of Records'' may be imposed.
    (1) Written requests. An individual making a written request 
respecting a record about himself or herself may establish his or her 
identity by a signature, address, date of birth, employee identification 
number, if any, and one other item of identification such as a copy of a 
driver's license or other document.
    (2) Requests in person. An individual making a request in person 
respecting a record about himself or herself may establish his or her 
identity by the presentation of a single document bearing a photograph 
(such as a passport or identification badge) or by the presentation of 
two items of identification which do not bear a photograph but do bear a 
name, address and signature (such, as a driver's license or credit 
card).
    (b) Inability to provide requisite documentation of identity. An 
individual making a request in person or in writing respecting a record 
about himself or herself who cannot provide the necessary documentation 
of identity may provide a notarized statement, swearing or affirming to 
his or her identity and to the fact that he or she understands that 
penalties for false statements may be imposed pursuant to 18 U.S.C. 
1001, and that penalties for obtaining a record concerning an individual 
under false pretenses may be imposed pursuant to 5 U.S.C. 552a(i)(3). 
Forms for such notarized statements may be obtained on request from the 
Freedom of Information Act and Privacy Act Officer, and sent by an 
appropriate method listed in Sec.9.6.
    (c) Verification of parentage or guardianship. In addition to 
establishing the identity of the minor, or other individual he or she 
represents as required in paragraph (a) of this section, the parent or 
legal guardian of a minor or of an individual judicially determined to 
be incompetent shall establish his or her status as parent or guardian 
by furnishing a copy of a birth certificate of the minor showing 
parentage or a copy of a court order establishing guardianship.

[40 FR 44484, Sept. 26, 1975, as amended at 52 FR 31609, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989; 63 FR 15743, Apr. 1, 1998; 68 FR 58800, Oct. 
10, 2003; 70 FR 34309, June 14, 2005]



Sec.9.55  Specification of records.

    (a)(1) Requests relating to records shall, insofar as practicable, 
specify the nature of the record sought, the approximate dates covered 
by the record, the system of records in which the record is thought to 
be included and the system manager having custody of the record system 
as shown in the annual compilation, ``Notices of Records Systems'', 
published by the General Services Administration. Requests

[[Page 246]]

shall, in addition, comply with any additional specification 
requirements contained in the published ``Notice of System of Records'' 
for that system.
    (2) Requests for correction or amendment of records shall, in 
addition, specify the particular record involved, state the nature of 
the correction or amendment sought and furnish justification for the 
correction or amendment.
    (b) Requests which do not contain information sufficient to identify 
the record requested will be returned promptly to the requestor, with a 
notice indicating what information is lacking. Individuals making 
requests in person will be informed of any deficiency in the 
specification of records at the time the request is made. Individuals 
making requests in writing will be notified of any such deficiency when 
their request is acknowledged.



Sec.9.56  Accompanying persons.

    An individual requesting access to records about himself or herself 
may be accompanied by another individual of his or her own choosing. 
Both the individual requesting access and the individual accompanying 
him or her shall sign the required form indicating that the Nuclear 
Regulatory Commission is authorized to discuss the contents of the 
subject record in the presence of both individuals.

                 nrc procedures for processing requests



Sec.9.60  Acknowledgement of requests.

    (a) Written requests by individuals to verify the existence of, 
obtain access to or correct or amend records about themselves maintained 
by NRC in a system of records subject to the provisions of the Privacy 
Act of 1974, shall be acknowledged in writing by the Freedom of 
Information Act and Privacy Act Officer within ten working days after 
date of actual receipt. The acknowledgement shall advise the requestor 
if any additional information is needed to process the request. Wherever 
practicable, the acknowledgement shall notify the individual whether his 
or her request to obtain access to the record or to correct or amend the 
record has been granted or denied.
    (b) When an individual requests access to records or permission to 
correct or amend records in person, every effort will be made to make an 
immediate determination as to whether access or correction or amendment 
should be granted. If an immediate determination cannot be made, the 
request will be processed in the same manner as a written request. 
Records will be made available for immediate inspection whenever 
possible.

[40 FR 44484, Sept. 26, 1975, as amended at 53 FR 17689, May 18, 1988; 
54 FR 53316, Dec. 28, 1989; 63 FR 15743, Apr. 1, 1998]



Sec.9.61  Procedures for processing requests for records exempt 
in whole or in part.

    (a) When an individual requests information concerning the existence 
of, or access to, records about himself or herself which have been 
compiled in reasonable anticipation of a civil action or proceeding in 
either a court or before an administrative tribunal, the NRC shall 
advise the individual only that no record available to him or her 
pursuant to the Privacy Act of 1974 has been identified.
    (b) General exemptions. Generally, 5 U.S.C. 552a(j)(2) allows the 
exemption of any system of records within the NRC from any part of 
section 552a except subsections (b), (c) (1) and (2), (e)(4) (A) through 
(F), (e) (6), (7), (9), (10), and (11), and (i) of the act if the system 
of records is maintained by an NRC component that performs as one of its 
principal functions any activity pertaining to the enforcement of 
criminal laws, including police efforts to prevent, control, or reduce 
crimes, or to apprehend criminals, and consists of--
    (1) Information compiled for the purpose of identifying individual 
criminal offenders and alleged offenders and consisting only of 
identifying data and notations of arrests, the nature and disposition of 
criminal charges, sentencing, confinement, release and parole, and 
probation status;
    (2) Information compiled for the purpose of a criminal 
investigation, including reports of informants and investigators, and 
associated with an identifiable individual; or

[[Page 247]]

    (3) Reports identifiable to an individual compiled at any stage of 
the process of enforcement of the criminal laws from arrest or 
indictment through release from supervision.
    (c) Specific exemptions under 5 U.S.C. 552a(k). Individual requests 
for access to records which have been exempted from access under the 
provisions of 5 U.S.C. 552a(k) shall be processed as follows:
    (1) Information classified under criteria established by an 
Executive Order to be kept secret in the interest of national defense or 
foreign policy, and exempted under 5 U.S.C. 552a(k)(1). (i) Requested 
information classified by NRC will be reviewed by the responsible 
official of the NRC to determine whether it continues to warrant 
classification under criteria established by an Executive Order to be 
kept secret in the interest of national defense or foreign policy.
    (ii) Information which no longer warrants classification under these 
criteria shall be declassified and made available to the individual. If 
the requested information has been classified by another agency, the 
responsible official of the NRC will request the classifying agency to 
review the information to ascertain if classification is still 
warranted. If the information continues to warrant classification, the 
individual shall be advised that the information sought is classified, 
that it has been reviewed and continues to warrant classification, and 
that it has been exempted from access pursuant to 5 U.S.C. 552a(k)(1).
    (2) Investigatory material compiled for law enforcement purposes 
exempted pursuant to 5 U.S.C. 552a(k)(2). Requests shall be responded to 
in the manner provided in paragraph (a) of this section unless a review 
of the information indicates that the information has been used or is 
being used to deny the individual any right, privilege or benefit for 
which he or she is eligible or to which he or she would otherwise be 
entitled under Federal law. In that event, the individual shall be 
advised of the existence of the information and shall be provided the 
information except to the extent it would reveal the identity of a 
confidential source. Information that would reveal the identity of a 
confidential source shall be extracted or summarized in a manner which 
protects the source and the summary or extract shall be provided to the 
requesting individual.
    (3) Material within a system of records required by statute to be 
maintained and used solely as statistical records and exempted pursuant 
to 5 U.S.C. 552a(k)(4). The exempted information requested will be 
reviewed by the responsible official of the NRC to determine whether it 
continues to warrant exemption. Information which no longer warrants 
exemption shall be made available to the individual. If the information 
continues to warrant exemption, the individual shall be advised that the 
information sought is exempt from disclosure, that it has been reviewed 
and continues to warrant exemption, and that it has been exempted from 
access pursuant to 5 U.S.C. 552a(k)(4).
    (4) Investigatory material compiled solely for the purpose of 
determining suitability, eligibility, or qualifications for Federal 
civilian employment, Federal contracts, or access to classified 
information and exempted pursuant to 5 U.S.C. 552a(k)(5). Information 
exempted pursuant to 5 U.S.C. 552a(k)(5) shall be made available to an 
individual upon request except to the extent that the information would 
reveal the identity of a confidential source. Material that would reveal 
the identity of a confidential source shall be extracted or summarized 
in a manner which protects the source and the summary or extract shall 
be provided to the requesting individual.
    (5) Testing or examination material exempted pursuant to 5 U.S.C. 
552a(k)(6). Testing or examination material used solely to determine 
individual qualifications for appointment or promotion in the Federal 
service which has been exempted pursuant to 5 U.S.C. 552a(k)(6) shall 
not be made available to an individual if disclosure would compromise 
the objectivity or fairness of the testing or examination process but 
may be made available if no possibility of such compromise exists.

[40 FR 44484, Sept. 26, 1975, as amended at 44 FR 50804, Aug. 30, 1979; 
50 FR 50284, Dec. 10, 1985; 60 FR 63900, Dec. 13, 1995; 70 FR 34309, 
June 14, 2005]

[[Page 248]]



Sec.9.62  Records under control of another Government agency.

    Requests received by NRC pertaining to records under the control of 
another Government agency will be returned to the requester with the 
name of the controlling Government agency, if known, within ten working 
days after receipt by the NRC.

[70 FR 34309, June 14, 2005]

                       determinations and appeals



Sec.9.65  Access determinations; appeals.

    (a) Initial determinations. For agency records located in the Office 
of the Inspector General, the Assistant Inspector General for 
Investigations shall determine whether access to the record is available 
under the Privacy Act. For all other agency records, the Freedom of 
Information Act and Privacy Act Officer with the advice of the system 
manager having control of the record to which access is requested, shall 
determine whether access to the record is available under the Privacy 
Act. The Freedom of Information Act and Privacy Act Officer shall notify 
the requesting individual in person or in writing of the determination. 
Unless the request presents unusual difficulties or involves extensive 
numbers of records, individuals shall be notified of determinations to 
grant or deny access within 30 working days after receipt of the 
request.
    (1) Notices granting access shall inform the individual when and 
where the requested record may be seen, how copies may be obtained, and 
of any fees or anticipated charges which may be incurred pursuant to 
Sec.9.85 of this subpart.
    (2) Notices denying access must state the reasons for the denial, 
and advise the individual that the denial may be appealed to the 
Inspector General, for agency records located in the Office of Inspector 
General, or the Executive Director for Operations, for all other agency 
records, in accordance with the procedures set forth in this section.
    (b) Appeals from denials of access. If an individual has been denied 
access to a record the individual may request a final review and 
determination of that individual's request by the Inspector General or 
the Executive Director for Operations, as appropriate. A request for 
final review of an initial determination must be filed within 60 
calendar days of the receipt of the initial determination. For agency 
records denied by the Assistant Inspector General for Investigations, 
the appeal must be in writing directed to the Inspector General and sent 
to the Freedom of Information Act and Privacy Act Officer by an 
appropriate method listed in Sec.9.6. For agency records denied by the 
Freedom of Information Act and Privacy Act Officer, the appeal must be 
in writing directed to the Executive Director for Operations and sent to 
the Freedom of Information Act and Privacy Act Officer by an appropriate 
method listed in Sec.9.6. The appeal should clearly state on the 
envelope and in the letter ``Privacy Act Appeal-Denial of Access.'' The 
NRC does not consider an appeal received until the date it is actually 
received by the Freedom of Information Act and Privacy Act Officer.
    (c) Final determinations. (1) The Inspector General, or the 
Executive Director for Operations or the EDO's designee, shall make a 
final determination within 30 working days of the receipt of the request 
for final review, unless the time is extended for good cause shown such 
as the need to obtain additional information, the volume of records 
involved, or the complexity of the issue. The extension of time may not 
exceed 30 additional working days. The requester shall be advised in 
advance of any extension of time and of the reasons therefor.
    (2) If the Inspector General, or the Executive Director for 
Operations or the EDO's designee, determines that access was properly 
denied because the information requested has been exempted from 
disclosure, the Inspector General, or the Executive Director for 
Operations or the EDO's designee shall undertake a review of the 
exemption to determine whether the information should continue to be 
exempt from disclosure. The Inspector General, or the Executive Director 
for Operations or the EDO's designee, shall notify the individual in 
writing of the final agency determination to grant or deny the request 
for access. Notices denying access must state the reasons therefor and 
must advise the individual of his/

[[Page 249]]

her right to judicial review pursuant to 5 U.S.C. 552a(g).

[40 FR 44484, Sept. 26, 1975, as amended at 41 FR 20645, May 20, 1976; 
41 FR 25997, June 24, 1976; 52 FR 31609, Aug. 21, 1987; 54 FR 53316, 
Dec. 28, 1989; 55 FR 33647, Aug. 17, 1990; 63 FR 15743, Apr. 1, 1998; 68 
FR 58800, Oct. 10, 2003; 70 FR 34309, June 14, 2005]



Sec.9.66  Determinations authorizing or denying correction of records;
appeals.

    (a) Initial determinations. (1) For agency records located in the 
Office of the Inspector General, the Assistant Inspector General for 
Investigations shall determine whether to authorize or refuse correction 
or amendment of a record. For all other agency records, the Freedom of 
Information Act and Privacy Act Officer with the advice of the system 
manager having control of the record, shall determine whether to 
authorize or refuse correction or amendment of a record. The Freedom of 
Information Act and Privacy Act Officer shall notify the requesting 
individual. Unless the request presents unusual difficulties or involves 
extensive numbers of records, individuals must be notified of 
determinations to authorize or refuse correction or amendment of a 
record within 30 working days after receipt of the request. In making 
this determination, the NRC official shall be guided by the following 
standards:
    (i) Records shall contain only such information about an individual 
as is relevant and necessary to accomplish an NRC function required to 
be accomplished by statute or by executive order of the President;
    (ii) Records used by NRC in making any determination about any 
individual shall be as accurate, relevant, current, and complete as is 
reasonably necessary to assure fairness to the individual in the 
determination;
    (iii) No record shall describe how any individual has exercised 
rights guaranteed by the First Amendment unless such record is expressly 
authorized by statute or by the individual about whom the record is 
maintained, or is pertinent to and within the scope of an authorized law 
enforcement activity.
    (2) For agency records located in the Office of Inspector General, 
if correction or amendment of a record is authorized, the Assistant 
Inspector General for Investigations shall correct or amend the record. 
For all other agency records, the Freedom of Information Act and Privacy 
Act Officer shall correct or amend the record. The Freedom of 
Information Act and Privacy Act Officer shall notify the requesting 
individual in writing that the correction or amendment has been made and 
provide the individual with a courtesy copy of the corrected record.
    (3) If correction or amendment of a record is refused, the Freedom 
of Information Act and Privacy Act Officer shall notify the requesting 
individual in writing of the refusal and the reasons therefor, and shall 
advise the individual that the refusal may be appealed to the Inspector 
General or the Executive Director for Operations, as appropriate, in 
accordance with the procedures set forth in this section.
    (b) Appeals from initial adverse determinations. If an individual's 
request to amend or correct a record has been denied, in whole or in 
part, the individual may appeal that action and request a final review 
and determination of that individual's request by the Inspector General 
or the Executive Director for Operations, as appropriate. An appeal of 
an initial determination must be filed within 60 calendar days of the 
receipt of the initial determination. For agency records denied by the 
Assistant Inspector General for Investigations, the appeal must be in 
writing directed to the Inspector General and sent to the Freedom of 
Information Act and Privacy Act Officer by an appropriate method listed 
in Sec.9.6. For agency records denied by the Freedom of Information 
Act and Privacy Act Officer the appeal must be in writing directed to 
the Executive Director for Operations and sent to the Freedom of 
Information Act and Privacy Act Officer by an appropriate method listed 
in Sec.9.6. The appeal should clearly state on the envelope and in the 
letter ``Privacy Act Correction Appeal.'' The NRC does not consider an 
appeal received until the date it is actually received by the Freedom of 
Information Act and Privacy Act Officer. Requests for final review must 
set forth the specific item of information sought to be corrected or

[[Page 250]]

amended and should include, where appropriate, records supporting the 
correction or amendment.
    (c) Final determinations. (1) The Inspector General, for agency 
records located in the Office of the Inspector General, or the Executive 
Director for Operations or the EDO's designee, for all other agency 
records, shall make a final agency determination within 30 working days 
of receipt of the request for final review, unless the time is extended 
for good cause shown such as the need to obtain additional information, 
the volume of records involved, or the complexity of the issue. The 
extension of time may not exceed 30 additional working days. The 
requester shall be advised in advance of any extension of time and of 
the reasons therefor.
    (2) For agency records located in the Office of the Inspector 
General, if the Inspector General makes a final determination that an 
amendment or correction of the record is warranted on the facts, the 
Inspector General or the IG's designee, shall correct or amend the 
record pursuant to the procedures in Sec.9.66(a)(2). For all other 
agency records, if the Executive Director for Operations, or the EDO's 
designee, makes a final determination that an amendment or correction of 
the record is warranted on the facts, the EDO or the EDO's designee, 
shall notify the Freedom of Information Act and Privacy Act Officer to 
correct or amend the record to the procedures in Sec.9.66(a)(2).
    (3) If the Inspector General, or the Executive Director for 
Operations or the EDO's designee, makes a final determination that an 
amendment or correction of the record is not warranted on the facts, the 
individual shall be notified in writing of the refusal to authorize 
correction or amendment of the record in whole or in part, and of the 
reasons therefor, and the individual shall be advised of his/her right 
to provide a ``Statement of Disagreement'' for the record and of his/her 
right to judicial review pursuant to 5 U.S.C. 552a(g).

[40 FR 44484, Sept. 26, 1975, as amended at 41 FR 20645, May 20, 1976; 
41 FR 25997, June 24, 1976; 52 FR 31609, Aug. 21, 1987; 54 FR 53316, 
Dec. 28, 1989; 55 FR 33647, Aug. 17, 1990; 63 FR 15743, Apr. 1, 1998; 68 
FR 58800, Oct. 10, 2003; 70 FR 34309, June 14, 2005]



Sec.9.67  Statements of disagreement.

    (a) Written ``Statements of Disagreement'' may be furnished by the 
individual within 30 calendar days of the date of receipt of the final 
adverse determination of the Inspector General or the Executive Director 
for Operations. ``Statements of Disagreement'' directed to the Executive 
Director for Operations must be sent to the Freedom of Information Act 
and Privacy Act Officer by an appropriate method listed in Sec.9.6, 
and should be clearly marked on the statement and on the envelope, 
``Privacy Act Statement of Disagreement.'' ``Statements of 
Disagreement'' directed to the Inspector General must be sent to the 
Freedom of Information Act and Privacy Officer by an appropriate method 
listed in Sec.9.6, and should be clearly marked on the statement and 
on the envelope ``Privacy Act Statement of Disagreement''.
    (b) The Inspector General or the Executive Director for Operations, 
or their designees, as appropriate, are responsible for ensuring that: 
(1) The ``Statement of Disagreement'' is included in the system or 
systems of records in which the disputed item of information is 
maintained; and (2) the original record is marked to indicate the 
information disputed, the existence of a ``Statement of Disagreement'' 
and the location of the ``Statement of Disagreement'' within the system 
of records.

[55 FR 33848, Aug. 17, 1990, as amended at 68 FR 58800, Oct. 10, 2003; 
70 FR 34309, June 14, 2005]



Sec.9.68  NRC statement of explanation.

    The Inspector General, or the Executive Director for Operations or 
the EDO's designee, may if deemed appropriate, prepare a concise 
statement of the reasons why the requested amendments or corrections 
were not made. Any NRC ``Statement of Explanation'' must be included in 
the system of

[[Page 251]]

records in the same manner as the ``Statement of Disagreement''. 
Courtesy copies of the NRC statement and of the notation of the dispute 
as marked on the original record must be furnished to the individual who 
requested correction or amendment of the record.

[55 FR 33648, Aug. 17, 1990]



Sec.9.69  Notices of correction or dispute.

    (a) When a record has been corrected upon request or when a 
``Statement of Disagreement'' has been filed, the Freedom of Information 
Act and Privacy Act Officer shall, within 30 working days thereof, 
advise all prior recipients of the affected record whose identity can be 
determined pursuant to an accounting of disclosures required by the 
Privacy Act or any other accounting previously made, of the correction 
or of the filing of the ``Statement of Disagreement''.
    (b) Any disclosure of disputed information occurring after a 
``Statement of Disagreement'' has been filed shall clearly identify the 
specific information disputed and be accompanied by a copy of the 
``Statement of Disagreement'' and a copy of any NRC ``Statement of 
Explanation''.

[40 FR 44484, Sept. 26, 1975, as amended at 52 FR 31609, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989; 63 FR 15743, Apr. 1, 1998]

            disclosure to others of records about individuals



Sec.9.80  Disclosure of record to persons other than the individual
to whom it pertains.

    (a) NRC Commissioners and NRC personnel shall not disclose any 
record which is contained in a system of records maintained by NRC by 
any means of communication to any person, or to another Government 
agency, except pursuant to a written request by, or with the prior 
written consent of, the individual to whom the record pertains, unless 
disclosure of the record is:
    (1) To NRC Commissioners and NRC personnel who have a need for the 
record in the performance of their duties;
    (2) Required under 5 U.S.C. 552;
    (3) For a routine use published in the Federal Register;
    (4) To the Bureau of the Census for purposes of planning or carrying 
out a census or survey or related activity pursuant to the provisions of 
Title 13 of the United States Code;
    (5) To a recipient who has provided the agency with advance adequate 
written assurance that the record will be used solely as a statistical 
research or reporting record and the record is transferred in a form 
that is not individually identifiable. The advance written statement of 
assurance shall (i) state the purpose for which the record is requested, 
and (ii) certify that the record will be used only for statistical 
purposes. Prior to release for statistical purposes in accordance with 
the provisions of this paragraph, the record shall be stripped of all 
personally identifying information and reviewed to ensure that the 
identity of any individual cannot reasonably be determined by combining 
two or more statistical records;
    (6) To the National Archives and Records Administration as a record 
that has sufficient historical or other value to warrant its continued 
preservation by the United States Government, or to the Archivist of the 
United States or designee for evaluation to determine whether the record 
has such value;
    (7) To another agency or to an instrumentality of any governmental 
jurisdiction within or under the control of the United States for a 
civil or criminal law enforcement activity if the activity is authorized 
by law, and if the head of the agency or instrumentality has made a 
written request to the NRC specifying the particular portion of the 
record desired and the law enforcement activity for which the record is 
sought. A record may be disclosed to a law enforcement agency at the 
initiative of the NRC if criminal conduct is suspected, provided that 
such disclosure has been established as a routine use by publication in 
the Federal Register, and the instance of misconduct is directly related 
to the purpose for which the record is maintained;
    (8) To any person upon a showing of compelling circumstances 
affecting the health or safety of any individual;

[[Page 252]]

    (9) To either House of Congress or, to the extent of matter within 
its jurisdiction, to any committee or subcommittee thereof or to any 
joint committee of the Congress or to any subcommittee of such joint 
committee;
    (10) To the Comptroller General, or any authorized representatives, 
in the course of the performance of the duties of the General Accounting 
Office;
    (11) Pursuant to the order of a court of competent jurisdiction; or
    (12) To a consumer reporting agency in accordance with 31 U.S.C. 
3711(f).
    (b) [Reserved]

[40 FR 44484, Sept. 26, 1975, as amended at 60 FR 63900, Dec. 13, 1995]



Sec.9.81  Notices of subpoenas.

    When records concerning an individual are subpoenaed or otherwise 
disclosed pursuant to court order, the NRC officer or employee served 
with the subpoena shall be responsible for assuring that the individual 
is notified of the disclosure within five days after such subpoena or 
other order becomes a matter of public record. The notice shall be 
mailed to the last known address of the individual and shall contain the 
following information: (a) The date the subpoena is returnable; (b) the 
court in which it is returnable; (c) the name and number of the case or 
proceeding; and (d) the nature of the information sought.



Sec.9.82  Notices of emergency disclosures.

    When information concerning an individual has been disclosed to any 
person under compelling circumstances affecting health or safety, the 
NRC officer or employee who made or authorized the disclosure shall 
notify the individual at his or her last known address within five days 
of the disclosure. The notice shall contain the following information: 
(a) The nature of the information disclosed; (b) the person or agency to 
whom the information was disclosed; (c) the date of the disclosure; and 
(d) the compelling circumstances justifying the disclosure.

                                  fees



Sec.9.85  Fees.

    Fees shall not be charged for search or review of records requested 
under this subpart or for making copies or extracts of records to make 
them available for review, although fees may be charged for additional 
copies. Fees established under 31 U.S.C. 483c and 5 U.S.C. 552a(f)(5) 
shall be charged according to the schedule contained in Sec.9.35 for 
actual copies of records disclosed under the Freedom of Information Act 
from Privacy Act Systems of Records.

[70 FR 34309, June 14, 2005]

                               enforcement



Sec.9.90  Violations.

    (a) An injunction or other court order may be obtained pursuant to 5 
U.S.C. 552a(g) (1-3) to compel NRC to permit an individual to review, 
amend or copy a record pertaining to him, or to be accompanied by 
someone of his or her own choosing when he or she reviews his or her 
record. A court order may be obtained for the payment of a civil penalty 
imposed pursuant to 5 U.S.C. 552a(g)(4) if NRC intentionally or 
willfully fails to maintain a record accurately, or fails to comply with 
any provision of 5 U.S.C. 552a, or any provision of this subpart, if 
such failure results in an adverse determination or has an adverse 
effect on an individual. Court costs and attorney's fees may be awarded 
in civil actions.
    (b) Any officer or employee of NRC who willfully maintains a system 
of records without meeting the notice requirements of 5 U.S.C. 
552a(e)(4), or who willfully discloses information knowing such 
disclosure to be prohibited by 5 U.S.C. 552a or by any rules or 
regulations issued thereunder, may be guilty of a criminal misdemeanor 
and upon conviction may be fined up to $5000. Any person who knowingly 
and willfully requests or obtains any record concerning an individual 
from NRC under false pretenses may be convicted of a criminal 
misdemeanor and upon conviction may be fined up to $5,000.

[[Page 253]]

                               exemptions



Sec.9.95  Specific exemptions.

    Exemptions applicable to Privacy Act Systems of Records are stated 
in each Privacy Act System of Records Notice which is published in the 
Federal Register and is available at the NRC Web site, http://
www.nrc.gov.

[70 FR 34309, June 14, 2005]



          Subpart C_Government in the Sunshine Act Regulations

    Source: 42 FR 12877, Mar. 7, 1977, unless otherwise noted.



Sec.9.100  Scope of subpart.

    This subpart prescribes procedures pursuant to which NRC meetings 
shall be open to public observation pursuant to the provisions of 5 
U.S.C. 552b. This subpart does not affect the procedures pursuant to 
which NRC records are made available to the public for inspection and 
copying which remain governed by subpart A, except that the exemptions 
set forth in Sec.9.104(a) shall govern in the case of any request made 
pursuant to Sec.9.23 to copy or inspect the transcripts, recordings, 
or minutes described in Sec.9.108. Access to records considered at NRC 
meetings shall continue to be governed by subpart A of this part.

[52 FR 49362, Dec. 31, 1987]



Sec.9.101  Definitions.

    As used in this subpart:
    (a) Commission means the collegial body of five Commissioners or a 
quorum thereof as provided by section 201 of the Energy Reorganization 
Act of 1974, or any subdivision of that collegial body authorized to act 
on its behalf, and shall not mean any body not composed of members of 
that collegial body.
    (b) Commissioner means an individual who is a member of the 
Commission.
    (c) Meeting means the deliberations of at least a quorum of 
Commissioners where such deliberations determine or result in the joint 
conduct or disposition of official Commission business, that is, where 
discussions are sufficiently focused on discrete proposals or issues as 
to cause or to be likely to cause the individual participating members 
to form reasonably firm positions regarding matters pending or likely to 
arise before the agency. Deliberations required or permitted by 
Sec. Sec.9.105, 9.106, or 9.108(c) do not constitute ``meetings'' 
within this definition.
    (d) Closed meeting means a meeting of the Commission closed to 
public observation as provided by Sec.9.104.
    (e) Open meeting means a meeting of the Commission open to public 
observation pursuant to this subpart.
    (f) Secretary means the Secretary to the Commission.
    (g) General Counsel means the General Counsel of the commission as 
provided by section 25(b) of the Atomic Energy Act of 1954 and section 
201(f) of the Energy Reorganization Act of 1974, and, until such time as 
the offices of that officer are in the same location as those of the 
Commission, any member of his or her office specially designated in 
writing by him or her pursuant to this subsection to carry out his or 
her responsibilities under this subpart.

[42 FR 12877, Mar. 7, 1977, as amended at 50 FR 20891, May 21, 1985]



Sec.9.102  General requirement.

    Commissioners shall not jointly conduct or dispose of Commission 
business in Commission meetings other than in accordance with this 
subpart. Except as provided in Sec.9.104, every portion of every 
meeting of the Commission shall be open to public observation.



Sec.9.103  General provisions.

    The Secretary shall ensure that all open Commission meetings are 
held in a location such that there is reasonable space and adequate 
visibility and acoustics, for public observation. No additional right to 
participate in Commission meetings is granted to any person by this 
subpart. An open meeting is not part of the formal or informal record of 
decision of the matters discussed therein except as otherwise required 
by law. Statements of views or expressions of opinion made by 
Commissioners or NRC employees at open meetings are not intended to 
represent final determinations or beliefs. Such statements may not be 
pleaded, cited, or relied upon before the Commission

[[Page 254]]

or in any proceeding under part 2 of these regulations (10 CFR part 2) 
except as the Commission may direct. Members of the public attending 
open Commission meetings may use small electronic sound recorders to 
record the meeting, but the use of other electronic recording equipment 
and cameras requires the advance written approval of the Secretary.

[42 FR 12877, Mar. 7, 1977, as amended at 43 FR 13055, Mar. 29, 1978; 43 
FR 37421, Aug. 23, 1978]



Sec.9.104  Closed meetings.

    (a) Except where the Commission finds that the public interest 
requires otherwise, Commission meetings shall be closed, and the 
requirements of Sec. Sec.9.105 and 9.107 shall not apply to any 
information pertaining to such meeting otherwise required by this 
subpart to be disclosed to the public, where the Commission determines 
in accordance with the procedures of Sec.9.105 that opening such 
meetings or portions thereof or disclosing such information, is likely 
to:
    (1) Disclose matters that are (i) specifically authorized under 
criteria established by an Executive order to be kept secret in the 
interests of national defense or foreign policy, and (ii) in fact 
properly classified pursuant to such Executive order;
    (2) Relate solely to the internal personnel rules and practices of 
the Commission;
    (3) Disclose matters specifically exempted from disclosure by 
statute (other than 5 U.S.C. 552) provided that such statute (i) 
requires that the matters be withheld from the public in such a manner 
as to leave no discretion on the issue, or (ii) establishes particular 
criteria for withholding or refers to particular types of matters to be 
withheld;
    (4) Disclose trade secrets and commercial or financial information 
obtained from a person and privileged or confidential, including such 
information as defined in Sec.2.790(d) of this title;
    (5) Involve accusing any person of a crime, imposing a civil penalty 
on any person pursuant to 42 U.S.C. 2282 or 42 U.S.C. 5846, or any 
revocation of any license pursuant to 42 U.S.C. sec. 2236, or formally 
censuring any person;
    (6) Disclose information of a personal nature where such disclosure 
would constitute a clearly unwarranted invasion of personal privacy;
    (7) Disclose investigatory reports compiled for law enforcement 
purposes, including specifically enforcement of the Atomic Energy Act of 
l1954, as amended, 42 U.S.C. 2011 et seq., and the Energy Reorganization 
Act of 1974, as amended, 42 U.S.C. 5801 et seq., or information which if 
written would be contained in such records, but only to the extent that 
the production of such records or information would: (i) Interfere with 
enforcement proceedings, (ii) deprive a person of a right to a fair 
trial or an impartial adjudication, (iii) constitute an unwarranted 
invasion of personal privacy, (iv) disclose the identity of a 
confidential source and, in the case of a record compiled by a criminal 
law enforcement authority in the course of a criminal investigation, or 
by an agency conducting a lawful national security intelligence 
investigation, confidential information furnished only by the 
confidential source, (v) disclose investigative techniques and 
procedures, or (vi) endanger the life or physical safety of law 
enforcement personnel;
    (8) [Reserved]
    (9) Disclose information the premature disclosure of which would be 
likely to significantly frustrate implementation of a proposed 
Commission action, except that this subparagraph shall not apply in any 
instance where the Commission has already disclosed to the public the 
content or nature of its proposed action, or where the Commission is 
required to make such disclosure on its own initative prior to taking 
final action on such proposal; or
    (10) Specifically concern the Commission's issuance of a subpoena, 
or the Commission's participation in a civil action or proceeding or an 
action or proceeding before a state or federal administrative agency, an 
action in a foreign court or international tribunal, or an arbitration, 
or the initiation, conduct or disposition by the Commission of a 
particular case of formal agency adjudication pursuant to 5 U.S.C. 554 
or otherwise involving a determination on the record after an 
opportunity for a

[[Page 255]]

hearing pursuant to part 2 or similar provisions.
    (b) Examples of situations in which Commission action may be deemed 
to be significantly frustrated are: (1) If opening any Commission 
meeting or negotiations would be likely to disclose information provided 
or requests made to the Commission in confidence by persons outside the 
Commission and which would not have been provided or made otherwise; (2) 
if opening a meeting or disclosing any information would reveal legal or 
other policy advice, public knowledge of which could substantially 
affect the outcome or conduct of pending or reasonably anticipated 
litigation or negotiations; or (3) if opening any meeting or disclosing 
any information would reveal information requested by or testimony or 
proposals to be given to other agencies of government, including the 
Congress and the Executive Branch before the requesting agency would 
receive the information, testimony or proposals. The examples in the 
above sentence are for illustrative purposes only and are not intended 
to be exhaustive.



Sec.9.105  Commission procedures.

    (a) Action under Sec.9.104 shall be taken only when a majority of 
the entire membership of the Commission votes to take such action. A 
separate vote of the Commissioners shall be taken with respect to each 
Commission meeting a portion or portions of which are proposed to be 
closed to the public pursuant to Sec.9.104, or which respect to any 
information which is proposed to be withheld under Sec.9.105(c). A 
single vote may be taken with respect to a series of meetings, a portion 
or portions of which are proposed to be closed to the public, or with 
respect to any information concerning such series of meetings, so long 
as each meeting in such series involves the same particular matters and 
is scheduled to be held no more than thirty days after the initial 
meeting in such series. The vote of each Commissioner participating in 
such vote shall be recorded and no proxies shall be allowed.
    (b) Within one day of any vote taken pursuant to paragraph (a) of 
this section, Sec.9.106(a), or Sec.9.108(c), the Secretary shall 
make publicly available at the NRC Web site, http://www.nrc.gov, a 
written copy of such vote reflecting the vote of each member on the 
question. If a portion of a meeting is to be closed to the public, the 
Secretary shall, within one day of the vote taken pursuant to paragraph 
(a) of this section or Sec.9.106(a), make publicly available at the 
NRC Web site, http://www.nrc.gov, a full written explanation of its 
action closing the portion together with a list of all persons expected 
to attend the meeting and their affiliation.
    (c) The notices and lists required by paragraph (b) of this section 
to be made public may be withheld from the public to the extent that the 
Commission determines that such information itself would be protected 
against disclosure by Sec.9.104(a). Any such determination shall be 
made independently of the Commission's determination pursuant to 
paragraph (a) of this section to close a meeting, but in accordance with 
the procedure of that subsection. Any such determination, including a 
written explanation for the action and the specific provision or 
provisions of Sec.9.104(a) relied upon, must be made publicly 
available to the extent permitted by the circumstances.

[42 FR 12877, Mar. 7, 1977, as amended at 64 FR 48951, Sept. 9, 1999]



Sec.9.106  Persons affected and motions for reconsideration.

    (a) Whenever any person whose interests may be directly affected by 
a portion of a meeting requests that the Commission close such portion 
to the public for any of the reasons referred to in paragraphs (a) (5), 
(6), or (7) of Sec.9.104, the Commission, upon request of any one 
Commissioner, shall vote by recorded vote whether to close such meeting.
    (b) Any person may petition the Commission to reconsider its action 
under Sec.9.105(a) or paragraph (a) of this section by filing a 
petition for reconsideration with the Commission within seven days after 
the date of such action and before the meeting in question is held.
    (c) A petition for reconsideration filed pursuant to paragraph (b) 
of this section shall state specifically the grounds on which the 
Commission action is claimed to be erroneous, and

[[Page 256]]

shall set forth, if appropriate, the public interest in the closing or 
opening of the meeting. The filing of such a petition shall not act to 
stay the effectiveness of the Commission action or to postpone or delay 
the meeting in question unless the Commission orders otherwise.



Sec.9.107  Public announcement of Commission meetings.

    (a) In the case of each meeting, the Secretary shall make public 
announcement, at least one week before the meeting, of the time, place, 
and subject matter of the meeting, whether it is to be open or closed to 
the public, and the name and phone number of the official designated by 
the Commission to respond to requests for information about the meeting. 
Such announcement shall be made unless a majority of the members of the 
Commission determines by a recorded vote that Commission business 
requires that such meeting be called at an earlier date, in which case 
the Secretary shall make public announcement of the time, place and 
subject matter of such meeting, and whether open or closed to the 
public, at the earliest practical time.
    (b) The time or place of a meeting may be changed following the 
public announcement required by paragraph (a) of this section only if 
the Secretary publicly announces such changes at the earliest 
practicable time. The subject matter of as meeting, or the determination 
of the Commission to open or close a meeting, or portion of a meeting, 
to the public, may be changed following the public announcement required 
by this subsection only if: (1) A majority of the entire membership of 
the Commission determines by a recorded vote that Commission business so 
requires and that no earlier announcement of the change was possible, 
and (2) the Secretary publicly announces such change and the vote of 
each member upon such change at the earliest practicable time.
    (c) Immediately following each public announcement required by this 
section, notice of the time, place, and subject matter of a meeting, 
whether the meeting is open or closed, any change in one of the 
preceding, and the name and phone number of the official designated by 
the Commission to respond to requests for information about the meeting, 
shall also be submitted for publication in the Federal Register.
    (d) The public announcement required by paragraph (a) of this 
section shall consist of the Secretary:
    (1) Publicly posting a copy of the document at the NRC Web site, 
http://www.nrc.gov and, to the extent appropriate under the 
circumstances;
    (2) Mailing a copy to all persons whose names are on a mailing list 
maintained for this purpose;
    (3) Submitting a copy for possible publication to at least two 
newspapers of general circulation in the Washington, DC metropolitan 
area;
    (4) Any other means which the Secretary believes will serve to 
further inform any persons who might be interested.
    (e) Action under the second sentence of paragraph (a) or (b) of this 
section shall be taken only when the Commission finds that the public 
interest in prompt Commission action or the need to protect the common 
defense or security or to protect the public health or safety overrides 
the public interest in having full prior notice of Commission meetings.

[42 FR 12877, Mar. 7, 1977, as amended at 53 FR 43420, Oct. 27, 1988; 64 
FR 48951, Sept. 9, 1999]



Sec.9.108  Certification, transcripts, recordings and minutes.

    (a) For every meeting closed pursuant to paragraphs (a) (1) through 
(10) of Sec.9.104 and for every determination pursuant to Sec.
9.105(c), the General Counsel shall publicly certify at the time of the 
public announcement of the meeting, or if there is no public 
announcement at the earliest practical time, that, in his or her 
opinion, the meeting may be closed to the public and shall state each 
relevant exemptive provision unless the Commission votes pursuant to 
Sec.9.105(c) that such certification is protected against disclosure 
by Sec.9.104(a). A copy of such certification, together with a 
statement from the presiding officer of the meeting setting forth the 
time and place of the meeting, and the persons present, shall be 
retained by the Commission. The Commission shall

[[Page 257]]

maintain a complete transcript or electronic recording adequate to 
record fully the proceedings of each meeting, or portion of a meeting 
closed to the public, except that in the case of a meeting, or portion 
of a meeting, closed to the public pursuant to paragraph (c)(10) of 
Sec.9.104, the Commission shall maintain such a transcript, or 
recording or a set of minutes. Such minutes shall fully and clearly 
describe all matters discussed and shall provide a full and accurate 
summary of any actions taken, and the reasons therefor, including a 
description of each of the views expressed on any item and the record of 
any rollcall vote (reflecting the vote of each Commissioner on the 
question). All documents considered in connection with any action shall 
be identified in such minutes.
    (b) The Commission shall make promptly available to the public at 
the NRC Web site, http://www.nrc.gov, the transcript, electronic 
recording, or minutes (as required by paragraph (a) of this section) of 
the discussion of any item on the agenda, or of any item of the 
testimony of any witness received at the meeting, except for such item 
or items of such discussion or testimony as the Commission determines 
pursuant to paragraph (c) of this section to contain information which 
may be withheld under Sec.9.104 or Sec.9.105(c). Copies of such 
transcript, or minutes, or a transcription of such recording disclosing 
the identity of each speaker, shall be furnished to any person upon 
payment of the actual cost of duplication or transcription as provided 
in Sec.9.14. The Secretary shall maintain a complete verbatim copy of 
the transcript, a complete copy of the minutes, or a complete electronic 
recording of each meeting, or portion of a meeting, closed to the 
public, for a period of at least two years after such meeting, or until 
one year after the conclusion of any Commission proceeding with respect 
to which the meeting or portion was held, whichever occurs later.
    (c) In the case of any meeting closed pursuant to Sec.9.104, the 
Secretary of the Commission, upon the advice of the General Counsel and 
after consultation with the Commission, shall determine which, if any, 
portions of the electronic recording, transcript or minutes and which, 
if any, items of information withheld pursuant to Sec.9.105(c) contain 
information which should be withheld pursuant to Sec.9.104, in the 
event that a request for the recording, transcript, or minutes is 
received within the period during which the recording, transcript, or 
minutes must be retained, under paragraph (b) of this section.
    (d) If at some later time the Commission determines that there is no 
further justification for withholding any transcript, recording or other 
item of information from the public which has previously been withheld, 
then such information shall be made available.

[42 FR 12877, Mar. 7, 1977, as amended at 50 FR 20891, May 21, 1985; 64 
FR 48951, Sept. 9, 1999]



Sec.9.109  Report to Congress.

    The Secretary shall annually report to the Congress regarding the 
Commission's compliance with the Government in the Sunshine Act, 
including a tabulation of the total number of open meetings, the total 
number of closed meetings, the reasons for closing such meetings and a 
description of any litigation brought against the Commission pursuant to 
the Government in the Sunshine Act, including any cost assessed against 
the Commission in such litigation (whether or not paid by the 
Commission).



 Subpart D_Production or Disclosure in Response to Subpoenas or Demands 
                     of Courts or Other Authorities

    Source: 50 FR 37645, Sept. 17, 1985, unless otherwise noted.



Sec.9.200  Scope of subpart.

    (a) This subpart sets forth the procedures to be followed when a 
subpoena, order, or other demand (hereinafter referred to as a 
``demand'') for the production of NRC records or disclosure of NRC 
information, including testimony regarding such records, is issued by a 
court or other judicial or quasi-judicial authority in a proceeding, 
excluding Federal grand jury proceedings, to which the NRC is not a 
party. Information and documents subject to this subpart include:

[[Page 258]]

    (1) Any material contained in the files of the NRC;
    (2) Any information relating to material contained in the files of 
the NRC.
    (b) For purposes of this subpart, the term ``employee of the NRC'' 
includes all NRC personnel as that term is defined in Sec.9.3 of this 
part, including NRC contractors.
    (c) This subpart is intended to provide instructions regarding the 
internal operations of the NRC and is not intended, and does not, and 
may not, be relied upon to create any right or benefit, substantive or 
procedural, enforceable at law by a party against the NRC.

[50 FR 37645, Sept. 17, 1985, as amended at 52 FR 49362, Dec. 31, 1987]



Sec.9.201  Production or disclosure prohibited unless approved by 
appropriate NRC official.

    (a) No employee of the NRC shall, in response to a demand of a court 
or other judicial or quasi-judicial authority, produce any material 
contained in the files of the NRC or disclose, through testimony or 
other means, any information relating to material contained in the files 
of the NRC, or disclose any information or produce any material acquired 
as part of the performance of that employee's official duties or 
official status without prior approval of the appropriate NRC official. 
When the demand is for material contained in the files of the Office of 
the Inspector General or for information acquired by an employee of that 
Office, the Inspector General is the appropriate NRC official. In all 
other cases, the General Counsel is the appropriate NRC official.
    (b) Any NRC response to a demand of a court or other judicial or 
quasi-judicial authority that requires an employee of the NRC to expend 
more than 50 hours of official time shall be subject to hourly fees in 
accordance with 10 CFR 170.12(d).

[81 FR 41185, June 24, 2016]



Sec.9.202  Procedure in the event of a demand for production 
or disclosure.

    (a) Prior to or simultaneous with a demand upon an employee of the 
NRC for the production of material or the disclosure of information 
described in Sec.9.200, the party seeking production or disclosure 
shall serve the General Counsel of the NRC with an affidavit or 
statement as described in paragraphs (b) (1) and (2) of this section. 
Except for employees in the Office of Inspector General, whenever a 
demand is made upon an employee of the NRC for the production of 
material or the disclosure of information described in Sec.9.200, that 
employee shall immediately notify the General Counsel. If the demand is 
made upon a regional NRC employee, that employee shall immediately 
notify the Regional Counsel who, in turn, shall immediately request 
instructions from the General Counsel. If the demand is made upon an 
employee in the Office of Inspector General, that employee shall 
immediately notify the Inspector General. The Inspector General shall 
immediately provide a copy of the demand to the General Counsel, and as 
deemed necessary, consult with the General Counsel.
    (b)(1) If oral testimony is sought by the demand, a summary of the 
testimony desired must be furnished to the General Counsel by a detailed 
affidavit or, if that is not feasible, a detailed statement by the party 
seeking the testimony or the party's attorney. This requirement may be 
waived by the General Counsel in appropriate circumstances.
    (2) The General Counsel may request a plan from the party seeking 
discovery of all demands then reasonably foreseeable, including but not 
limited to, names of all NRC personnel from whom discovery is or will be 
sought, areas of inquiry, length of time away from duty involved, and 
identification of documents to be used in each deposition, where 
appropriate.
    (c) The Inspector General or the General Counsel will notify the 
employee and such other persons, as circumstances may warrant, of the 
decision on the matter.

[50 FR 37645, Sept. 17, 1985, as amended at 55 FR 33648, Aug. 17, 1990]



Sec.9.203  Procedure where response to demand is required prior
to receiving instructions.

    If a response to the demand is required before the instructions from 
the

[[Page 259]]

Inspector General or the General Counsel are received, a U.S. attorney 
or NRC attorney designated for the purpose shall appear with the 
employee of the NRC upon whom the demand has been made, and shall 
furnish the court or other authority with a copy of the regulations 
contained in this subpart and inform the court or other authority that 
the demand has been, or is being, as the case may be, referred for the 
prompt consideration of the appropriate NRC official and shall 
respectfully request the court or authority to stay the demand pending 
receipt of the requested instructions. In the event that an immediate 
demand for production or disclosure is made in circumstances which would 
preclude the proper designation or appearance of a U.S. or NRC attorney 
on the employee's behalf, the employee shall respectfully request the 
demanding authority for sufficient time to obtain advice of counsel.

[55 FR 33649, Aug. 17, 1990]



Sec.9.204  Procedure in the event of an adverse ruling.

    If the court or other judicial or quasi-judicial authority declines 
to stay the effect of the demand in response to a request made in 
accordance with Sec.9.203 pending receipt of instructions, or if the 
court or other authority rules that the demand must be complied with 
irrespective of instructions not to produce the material or disclose the 
information sought, the employee upon whom the demand has been made 
shall respectfully decline to comply with the demand, citing these 
regulations and United States ex rel. Touhy v. Ragen, 340 U.S. 462 
(1951).



PART 10_CRITERIA AND PROCEDURES FOR DETERMINING ELIGIBILITY FOR ACCESS
TO RESTRICTED DATA OR NATIONAL SECURITY INFORMATION OR AN EMPLOYMENT
CLEARANCE--Table of Contents



                      Subpart A_General Provisions

Sec.
10.1 Purpose.
10.2 Scope.
10.3 [Reserved]
10.4 Policy.
10.5 Definitions.

Subpart B_Criteria for Determining Eligibility for Access to Restricted 
    Data or National Security Information or an Employment Clearance

10.10 Application of the criteria.
10.11 Criteria.
10.12 Interview and other investigation.

                          Subpart C_Procedures

10.20 Purpose of the procedures.
10.21 Suspension of access authorization and/or employment clearance.
10.22 Notice to individual.
10.23 Failure of individual to request a hearing.
10.24 Procedures for hearing and review.
10.25 NRC Hearing Counsel.
10.26 Appointment of Hearing Examiner.
10.27 Prehearing proceedings.
10.28 Conduct of hearing.
10.29 Recommendation of the Hearing Examiner.
10.30 New evidence.
10.31 Actions on the recommendations.
10.32 Recommendation of the NRC Personnel Security Review Panel.
10.33 Action by the Deputy Executive Director for Materials, Waste, 
          Research, State, Tribal, Compliance, Administration, and Human 
          Capital Programs.
10.34 Action by the Commission.
10.35 Reconsideration of cases.

                         Subpart D_Miscellaneous

10.36 Terminations.
10.37 Attorney representation.
10.38 Certifications.

    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.

    Source: 47 FR 38676, Sept. 2, 1982, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 10 appear at 70 FR 
30897, May 31, 2005; 77 FR 39904, July 6, 2012; 81 FR 86909, Dec. 2, 
2016.



                      Subpart A_General Provisions



Sec.10.1  Purpose.

    (a) This part establishes the criteria, procedures, and methods for 
resolving questions concerning:

[[Page 260]]

    (1) The eligibility of individuals who are employed by or applicants 
for employment with NRC contractors, agents, and other individuals who 
are NRC employees or applicants for NRC employment, and other persons 
designated by the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs of the NRC, for access to Restricted Data under the Atomic 
Energy Act of 1954, as amended, and the Energy Reorganization Act of 
1974, or for access to national security information;
    (2) The eligibility of NRC employees, or the eligibility of 
applicants for employment with the NRC, for employment clearance; and
    (3) The eligibility of individuals who are employed by or are 
applicants for employment with NRC licensees, certificate holders, 
holders of standard design approvals under part 52 of this chapter, 
applicants for licenses, certificates, and NRC approvals, and others who 
may require access related to a license, certificate, or NRC approval, 
or other activities as the Commission may determine, for access to 
Restricted Data under the Atomic Energy Act of 1954, as amended, and the 
Energy Reorganization Act of 1974, or for access to national security 
information.
    (b) This part is published to implement the Atomic Energy Act of 
1954, as amended, the Energy Reorganization Act of 1974, as amended, 
Executive Order 10865, 25 FR 1583 (February 24, 1960) Executive Order 
10450, 18 FR 2489 (April 27, 1954), and Executive Order 12968, 60 FR 
40245 (August 2, 1995).

[64 FR 15641, Apr. 1, 1999, as amended at 72 FR 49483, Aug. 28, 2007]



Sec.10.2  Scope.

    The criteria and procedures in this part shall be used in 
determining eligibility for NRC access authorization and/or employment 
clearance involving:
    (a) Employees (including consultants) of contractors and agents of 
the Nuclear Regulatory Commission and applicants for employment;
    (b) NRC licensees, certificate holders and holders of standard 
design approvals under part 52 of this chapter, applicants for licenses, 
certificates, and standard design approvals under part 52 of this 
chapter, and their employees (including consultants) and applicants for 
employment (including consulting);
    (c) NRC employees (including consultants) and applicants for 
employment; and
    (d) Any other person designated by the Deputy Executive Director for 
Materials, Waste, Research, State, Tribal, Compliance, Administration, 
and Human Capital Programs of the Nuclear Regulatory Commission.

[47 FR 38676, Sept. 2, 1982, as amended at 64 FR 15641, Apr. 1, 1999; 72 
FR 49483, Aug. 28, 2007]



Sec.10.3  [Reserved]



Sec.10.4  Policy.

    It is the policy of the Nuclear Regulatory Commission to carry out 
its responsibility for the security of the nuclear energy program in a 
manner consistent with traditional American concepts of justice. To this 
end, the Commission has established criteria for determining eligibility 
for access authorization and/or employment clearance and will afford 
those individuals described in Sec.10.2 the opportunity for 
administrative review of questions concerning their eligibility for 
access authorization and/or employment clearance.



Sec.10.5  Definitions.

    Access authorization means an administrative determination that an 
individual (including a consultant) who is employed by or an applicant 
for employment with the NRC, NRC contractors, agents, and licensees of 
the NRC, or other person designated by the Deputy Executive Director for 
Materials, Waste, Research, State, Tribal, Compliance, Administration, 
and Human Capital Programs, is eligible for a security clearance for 
access to Restricted Data or National Security Information.
    Commission means the Nuclear Regulatory Commission of five members 
or a quorum thereof sitting as a body, as provided by section 201 of the 
Energy Reorganization Act of 1974, or its designee.

[[Page 261]]

    Eligible or Eligibility means both initial eligibility and continued 
eligibility of an individual for access authorization and/or employment 
clearance.
    Employment Clearance means an administrative determination that an 
individual (including a consultant) who is an NRC employee or applicant 
for NRC employment and other persons designated by the Deputy Executive 
Director for Materials, Waste, Research, State, Tribal, Compliance, 
Administration, and Human Capital Programs of the NRC is eligible for 
employment or continued employment pursuant to subsection 145(b) of the 
Atomic Energy Act of 1954, as amended.
    Hearing Counsel means an NRC attorney assigned by the General 
Counsel to prepare and administer hearings in accordance with this part.
    Hearing Examiner means a qualified attorney appointed by the 
Director, Office of Administration, to conduct a hearing in accordance 
with this part.
    National Security Information means information that has been 
determined under Executive Order 13526 or any predecessor or successor 
order to require protection against unauthorized disclosure and that is 
so designated.
    NRC Personnel Security Review Panel means an appeal panel appointed 
by the Deputy Executive Director for Materials, Waste, Research, State, 
Tribal, Compliance, Administration, and Human Capital Programs and 
consisting of three members, two of whom shall be selected from outside 
the security field. One member of the Panel shall be designated as 
Chairman.
    Personnel Security Review Examiners are persons designated by the 
Executive Director for Operations to conduct a review of the record in 
accordance with this part.
    Restricted Data means all data concerning design, manufacture, or 
utilization of atomic weapons, the production of special nuclear 
material, or the use of special nuclear material in the production of 
energy, but shall not include data declassified or removed from the 
Restricted Data category pursuant to section 142 of the Atomic Energy 
Act of 1954, as amended.

[47 FR 38676, Sept. 2, 1982, as amended at 51 FR 35999, Oct. 8, 1986; 52 
FR 31609, Aug. 21, 1987; 54 FR 53316, Dec. 28, 1989; 64 FR 15641, Apr. 
1, 1999; 75 FR 73938, Nov. 30, 2010]



Subpart B_Criteria for Determining Eligibility for Access to Restricted 
    Data or National Security Information or an Employment Clearance



Sec.10.10  Application of the criteria.

    (a) The decision as to access authorization and/or employment 
clearance is a comprehensive, common-sense judgment, made after 
consideration of all the information, favorable or unfavorable, relevant 
to whether the granting of access authorization and/or employment 
clearance would not endanger the common defense and security and would 
be clearly consistent with the national interest.
    (b) The criteria in Sec.10.11 set forth a number of the types of 
derogatory information used to assist in making determinations of 
eligibility for access authorization and/or employment clearance. These 
criteria are not exhaustive but contain the principal types of 
derogatory information which create a question as to the individual's 
eligibility for access authorization and/or employment clearance. While 
there must necessarily be adherence to such criteria, the NRC is not 
limited to them, nor precluded from exercising its judgment that 
information or facts in a case under its cognizance are derogatory 
although at variance with, or outside the scope of, the stated 
categories. These criteria are subject to continuing review and may be 
revised from time to time as experience and circumstances may make 
desirable.
    (c) When the reports of investigation of an individual contain 
information reasonably tending to establish the truth of one or more of 
the items in the criteria, such information shall be regarded as 
derogatory and shall create a question as to the individual's 
eligibility for access authorization and/or employment clearance. A 
question concerning the eligibility of an individual

[[Page 262]]

for access authorization and/or employment clearance shall be resolved 
in accordance with the procedures set forth in Sec.10.20 et seq.
    (d) In resolving a question concerning the eligibility or continued 
eligibility of an individual for access authorization and/or employment 
clearance, the following principles shall be applied by the Director, 
Division of Facilities and Security, Hearing Examiners, and the NRC 
Personnel Security Review Panel:
    (1) Information reasonably tending to establish the truth of one or 
more of the items in the criteria shall be the basis for recommending 
denial or revocation of access authorization and/or employment clearance 
unless evidence to support faith in the individual's reliability and 
trust-worthiness is affirmatively shown.
    (2) When deemed material to the deliberations, the extent of the 
activity, conduct, or condition, the period in which they occurred or 
existed, the length of time which has since elapsed, and the attitude 
and convictions of the individual shall be considered in determining 
whether the recommendation will be adverse or favorable.

[47 FR 38676, Sept. 2, 1982, as amended at 64 FR 15641, Apr. 1, 1999]



Sec.10.11  Criteria.

    (a) The criteria for determining eligibility for access 
authorization and/or employment clearance shall relate, but not be 
limited, to the following where an individual:
    (1) Committed, attempted to commit, aided, or abetted another who 
committed or attempted to commit any act of sabotage, espionage, 
treason, sedition, or terrorism.
    (2) Publicly or privately advocated actions that may be inimical to 
the interest of the United States, or publicly or privately advocated 
the use of force or violence to overthrow the Government of the United 
States or the alteration of the form of government of the United States 
by unconstitutional means.
    (3) Knowingly established or continued a sympathetic association 
with a saboteur, spy, traitor, seditionist, anarchist, terrorist, or 
revolutionist, or with an espionage agent or other secret agent or 
representative of a foreign nation whose interests may be inimical to 
the interests of the United States, or with any person who advocates the 
use of force or violence to overthrow the Government of the United 
States or the alteration of the form of government of the United States 
by unconstitutional means.
    (4) Joined or engaged in any activity knowingly in sympathy with or 
in support of any foreign or domestic organization, association, 
movement, group, or combination of persons which unlawfully advocates or 
practices the commission of acts of force or violence to prevent others 
from exercising their rights under the Constitution or laws of the 
United States or any State or any subdivisions thereof by unlawful 
means, or which advocate the use of force and violence to overthrow the 
Government of the United States or the alteration of the form of 
government of the United States by unconstitutional means. (Ordinarily, 
criteria (3) and (4) will not include chance or casual meetings or 
contacts limited to normal business or official relations.)
    (5) Deliberately misrepresented, falsified or omitted relevant and 
material facts from or in a personnel security questionnaire, a personal 
qualifications statement, a personnel security interview, or any other 
information submitted pursuant this part.
    (6) Willfully violated or disregarded security regulations or was 
grossly negligent with respect thereto to a degree which could endanger 
the common defense and security; or by intention or gross carelessness 
disclosed Restricted Data or national security information to any person 
not authorized to receive it.
    (7) Has any illness or mental condition which in the opinion of 
competent medical authority may cause significant defect in the judgment 
or reliability of the individual.
    (8) Has been convicted of crimes indicating habitual criminal 
tendencies.
    (9) Has been convicted of a crime, or has a background, where the 
facts, circumstances, or conduct are of a nature indicating poor 
judgment, unreliabilty, or untrustworthiness.
    (10) Is a user of alcohol habitually and to excess, or has been such 
without adequate evidence of rehabilitation.

[[Page 263]]

    (11) Has been, or is, a user of a drug or other substance listed in 
the schedules of Controlled Substances established pursuant to the 
Controlled Substances Act of 1970 (such as amphetamines, barbiturates, 
narcotics, etc.), except as prescribed or administered by a physician 
licensed to dispense drugs in the practice of medicine, without adequate 
evidence of rehabilitation.
    (12) Refused, without satisfactory explanation, to answer questions 
before a congressional committee, Federal or state court, or Federal 
administrative body including the NRC regarding charges relevant to the 
individual's eligibility for access authorization and/or employment 
clearance.
    (13) Engaged in any other conduct or is subject to any other 
circumstances which tend to show that the individual is not reliable or 
trustworthy, or which furnishes reason to believe that the individual 
may be subject to coercion, influence, or pressures which may cause the 
individual to act contrary to the national interest.



Sec.10.12  Interview and other investigation.

    (a) The Director, Division of Facilities and Security, Office of 
Administration, may authorize the granting of access authorization and/
or employment clearance on the basis of the information in the 
possession of the NRC or may authorize an interview with the individual, 
if the individual consents to be interviewed, or other investigation as 
the Director deems appropriate. On the basis of this interview and/or an 
investigation, the Director may authorize the granting of access 
authorization and/or employment clearance.
    (b) The individual may elect on constitutional or other grounds not 
to participate in an interview or other investigation; however, such 
refusal or failure to furnish or authorize the furnishing of relevant 
and material information is deemed to be derogatory information pursuant 
to Sec.10.11(a) (5) and (12).
    (c) If the Director, Division of Facilities and Security, cannot 
make a favorable finding regarding the eligibility of an individual for 
access authorization and/or employment clearance, the question of the 
individual's eligibility must be resolved in accordance with the 
procedures set forth in Sec.10.20 et seq.

[47 FR 38676, Sept. 2, 1982, as amended at 52 FR 31609, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989; 64 FR 15642, Apr. 1, 1999]



                          Subpart C_Procedures



Sec.10.20  Purpose of the procedures.

    These procedures establish methods for the conduct of hearings and 
administrative review of questions concerning an individual's 
eligibility for an access authorization and/or an employment clearance 
pursuant to the Atomic Energy Act of 1954, as amended, and Executive 
Orders 10450, 10865, and 12968 when a resolution favorable to the 
individual cannot be made on the basis of the interview or other 
investigation.

[64 FR 15642, Apr. 1, 1999]



Sec.10.21  Suspension of access authorization and/or employment clearance.

    In those cases where information is received which raises a question 
concerning the continued eligibility of an individual for an access 
authorization and/or an employment clearance, the Director, Division of 
Facilities and Security, through the Director, Office of Administration, 
shall forward to the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs or other Deputy Executive Director, his or her recommendation 
as to whether the individual's access authorization and/or employment 
clearance should be suspended pending the final determination resulting 
from the operation of the procedures provided in this part. In making 
this recommendation the Director, Division of Facilities and Security, 
shall consider factors such as the seriousness of the derogatory 
information developed, the degree of access of the individual to 
classified information, and the individual's opportunity by reason of 
his or her position to commit acts adversely affecting the national 
security. An individual's access authorization and/or employment 
clearance may not be suspended except by the direction of the Executive 
Director for

[[Page 264]]

Operations, Deputy Executive Director for Materials, Waste, Research, 
State, Tribal, Compliance, Administration, and Human Capital Programs or 
other Deputy Executive Director.

[64 FR 15642, Apr. 1, 1999]



Sec.10.22  Notice to individual.

    A notification letter, prepared by the Division of Facilities and 
Security, approved by the Office of the General Counsel, and signed by 
the Director, Office of Administration, must be presented to each 
individual whose eligibility for an access authorization and/or an 
employment clearance is in question. Where practicable, the letter will 
be presented to the individual in person. The letter will be accompanied 
by a copy of this part and must state:
    (a) That reliable information in the possession of the NRC has 
created a substantial doubt concerning the individual's eligibility for 
an access authorization and/or an employment clearance;
    (b) The information that creates a substantial doubt regarding the 
individual's eligibility for an access authorization and/or an 
employment clearance, that must be as comprehensive and detailed as the 
national security interests and other applicable law permit;
    (c) That the individual has the right to be represented by counsel 
or other representative at their own expense;
    (d) That the individual may request within 20 days of the date of 
the notification letter, any documents, records and reports which form 
the basis for the question of their eligibility for an access 
authorization and/or an employment clearance. The individual will be 
provided within 30 days all such documents, records and reports to the 
extent they are unclassified and do not reveal a confidential source. 
The individual may also request the entire investigative file, which 
will be promptly provided, as permitted by the national security 
interests and other applicable law;
    (e) That unless the individual files with the Director, Office of 
Administration, a written request for a hearing within 20 days of the 
individual's receipt of the notification letter or 20 days after receipt 
of the information provided in response to a request made under 
paragraph (d) of this section, whichever is later, the Director, 
Division of Facilities and Security, through the Director, Office of 
Administration, will submit a recommendation as to the final action to 
the Deputy Executive Director for Materials, Waste, Research, State, 
Tribal, Compliance, Administration, and Human Capital Programs on the 
basis of the information in the possession of the NRC;
    (f) That if the individual files a written request for a hearing 
with the Director, Office of Administration, the individual shall file 
with that request a written answer under oath or affirmation that admits 
or denies specifically each allegation and each supporting fact 
contained in the notification letter. A general denial is not sufficient 
to controvert a specific allegation. If the individual is without 
knowledge, he or she shall so state and that statement will operate as a 
denial. The answer must also state any additional facts and information 
that the individual desires to have considered in explanation or 
mitigation of allegations in the notification letter. Failure to 
specifically deny or explain or deny knowledge of any allegation or 
supporting fact will be deemed an admission that the allegation or fact 
is true.
    (g) That if the individual does not want to exercise his or her 
right to a hearing, but does want to submit an answer to the allegations 
in the notification letter, the individual may do so by filing with the 
Director, Office of Administration, within 20 days of receipt of the 
notification letter or 20 days after receipt of the information provided 
in response to a request made under paragraph (d) of this section, 
whichever is later, a written answer in accordance with the requirements 
of paragraph (f) of this section;
    (h) That the procedures in Sec.10.24 et seq. will apply to any 
hearing and review.

[64 FR 15642, Apr. 1, 1999]



Sec.10.23  Failure of individual to request a hearing.

    (a) In the event the individual fails to file a timely written 
request for a hearing pursuant to Sec.10.22, a recommendation as to 
the final action to be taken

[[Page 265]]

will be made by the Director, Division of Facilities and Security, 
through the Director, Office of Administration, to the Deputy Executive 
Director for Materials, Waste, Research, State, Tribal, Compliance, 
Administration, and Human Capital Programs on the basis of the 
information in the possession of the NRC, including any answer filed by 
the individual.
    (b) The Director, Office of Administration, may for good cause 
shown, at the request of the individual, extend the time for filing a 
written request for a hearing or for filing a written answer to the 
matters contained in the notification letter.

[47 FR 38676, Sept. 2, 1982, as amended at 52 FR 31609, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989; 64 FR 15642, Apr. 1, 1999]



Sec.10.24  Procedures for hearing and review.

    (a) Upon receipt of a timely filed request for a hearing and answer 
complying with the requirements set forth in Sec.10.22, the Director, 
Office of Administration, shall forthwith appoint a Hearing Examiner, 
and the General Counsel shall forthwith assign an NRC attorney to act as 
Hearing Counsel. The Director, Office of Administration, shall promptly 
notify the individual of the identity of the Hearing Examiner and 
proposed hearing date, which shall be selected with due regard for the 
convenience of the parties and their representatives.
    (b) Within 72 hours of being notified of the identity of the Hearing 
Examiner, the individual may request that the Hearing Examiner be 
disqualified for cause by filing with the Director, Office of 
Administration, a written statement of the individual's reasons for 
seeking disqualification. The time for filing the request may be 
extended by the Director, Office of Administration, for good cause 
shown. If the Director, Office of Administration, grants the request the 
procedures of paragraph (a) of this section and this paragraph shall be 
followed just as though there had been no prior appointment.
    (c) The individual shall have the right to appear at the hearing 
before the Hearing Examiner, to be represented by counsel or other 
representative, to introduce documentary or other evidence, and to call, 
examine, and cross-examine witnesses, subject to the provisions and 
limitations set forth in this part.

[47 FR 38676, Sept. 2, 1982, as amended at 51 FR 35999, Oct. 8, 1986; 52 
FR 31609, Aug. 21, 1987; 54 FR 53316, Dec. 28, 1989]



Sec.10.25  NRC Hearing Counsel.

    (a) Hearing Counsel assigned pursuant to Sec.10.24 will, before 
the scheduling of the hearing, review the information in the case and 
will request the presence of witnesses and the production of documents 
and other physical evidence relied upon by the Director, Division of 
Facilities and Security, in making a finding that a question exists 
regarding the eligibility of the individual for an NRC access 
authorization and/or an employment clearance in accordance with the 
provisions of this part. When the presence of a witness and the 
production of documents and other physical evidence is deemed by the 
Hearing Counsel to be necessary or desirable for a determination of the 
issues, the Director, Division of Facilities and Security, will make 
arrangements for the production of evidence and for witnesses to appear 
at the hearing by subpoena or otherwise.
    (b) Hearing Counsel is authorized to consult directly with 
individual's counsel or representative or the individual, if the 
individual is not so represented, for purposes of reaching mutual 
agreement upon arrangements for expeditious hearing of the case. Such 
arrangements may include clarification of issues and stipulations with 
respect to testimony and contents of documents and other physical 
evidence. Such stipulations when entered into shall be binding upon the 
individual and the NRC for the purposes of this part. Prior to any 
consultation with the individual, the Hearing Counsel shall advise the 
individual of his or her rights under this part, of his or her right to 
counsel or other representation, and of the possibility that any 
statement made by the individual to the Hearing Counsel may be used in 
subsequent proceedings.
    (c) The individual is responsible for producing witnesses in his or 
her own behalf and/or presenting other evidence

[[Page 266]]

before the Hearing Examiner to support the individual's answer and 
defense to the allegations contained in the notification letter. When 
requested by the individual, however, the Hearing Counsel may assist the 
individual to the extent practicable and necessary. The Hearing Counsel 
may at his or her discretion request the Director, Division of 
Facilities and Security, to arrange for the issuance of subpoenas for 
witnesses to attend the hearing in the individual's behalf, or for the 
production of specific documents or other physical evidence, provided a 
showing of the necessity for assistance has been made.

[47 FR 38676, Sept. 2, 1982, as amended at 64 FR 15643, Apr. 1, 1999]



Sec.10.26  Appointment of Hearing Examiner.

    The appointment of a Hearing Examiner, pursuant to Sec.10.24 of 
this part, shall be from a list of qualified attorneys possessing the 
highest degree of integrity, ability, and good judgment. To qualify, an 
attorney shall have an NRC ``Q'' access authorization and may be an 
employee of the NRC, its contractors, agents or licensees. However, no 
employee or consultant of the NRC shall serve as Hearing Examiner 
hearing the case of an employee (including a consultant) or applicant 
for employment with the NRC; nor shall any employee or consultant of an 
NRC contractor, agent or licensee serve as Hearing Examiner hearing the 
case of an employee (including a consultant) or an applicant for 
employment of that contractor, agent, or licensee. No Hearing Examiner 
shall be selected who has knowledge of the case or of any information 
relevant to the disposition of it, or who for any reason would be unable 
to issue a fair and unbiased recommendation.



Sec.10.27  Prehearing proceedings.

    (a) After the appointment of the Hearing Examiner, he or she shall 
be furnished the record in the case, which shall consist of the letter 
of notification, the request for hearing and its supporting answer, and 
the notice of hearing, if it has been issued, and any stipulations 
agreed to by the individual and the Hearing Counsel.
    (b) The Hearing Examiner may on his or her own motion, or on that of 
either party, convene a prehearing conference with the Hearing Counsel 
and the individual and his or her counsel or representative, if any, for 
the purpose of clarifying the issues, identifying witnesses who may be 
called, identifying documents and other physical evidence that may be 
offered into evidence, and entering into stipulations of fact.
    (c) The parties will be notified by the Hearing Examiner at least 
ten days in advance of the hearing of the time and place of the hearing. 
For good cause shown, the Hearing Examiner may order postponements or 
continuances from time to time. If, after due notice, the individual 
fails to appear at the hearing, or appears but is not prepared to 
proceed, the Hearing Examiner shall, unless good cause is shown, return 
the case to the Director, Division of Facilities and Security, who shall 
make a recommendation on final action to be taken, through the Director, 
Office of Administration, to the Deputy Executive Director for 
Materials, Waste, Research, State, Tribal, Compliance, Administration, 
and Human Capital Programs on the basis of the information in the 
possession of the NRC.

[47 FR 38676, Sept. 2, 1982, as amended at 52 FR 31609, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989; 64 FR 15643, Apr. 1, 1999]



Sec.10.28  Conduct of hearing.

    (a) The Hearing Examiner shall conduct the hearing in an orderly, 
impartial and decorous manner. Technical rules of evidence may be 
relaxed so that a full evidentiary record may be made based on all 
material and relevant facts. Hearsay evidence may for good cause shown 
be received at the discretion of the Hearing Examiner and accorded such 
weight as the circumstances warrant.
    (b) The proceedings shall be open only to duly authorized 
representatives of the staff of the NRC, the individual, his or her 
counsel or representative, and such persons as may be officially 
authorized by the Hearing Examiner. Witnesses shall not testify in the 
presence of other witnesses except that the Hearing Examiner may, at his 
or her discretion, allow for expert witnesses

[[Page 267]]

to be present during testimony relevant to their own testimony.
    (c) Witnesses, including the individual, shall be examined under 
oath or affirmation by the party who called them and may be cross-
examined by the other. The Hearing Examiner shall rule on all 
evidentiary matters, may further examine any witness, and may call for 
additional witnesses or the production of documentary or other physical 
evidence if, in the exercise of his or her discretion, such additional 
evidence is deemed necessary to the resolution of an issue.
    (d) If it appears during the hearing that Restricted Data or 
national security information may be disclosed, the Hearing Examiner 
shall assure that disclosure is made only to persons authorized to 
receive it.
    (e) The Hearing Examiner may, at any time during the hearing, permit 
the Hearing Counsel to amend the notification letter to add or modify 
allegations to be considered. In the event of such an amendment to the 
notification letter, the individual shall be given an opportunity to 
answer the amended allegations. If the changes are of such a substantial 
nature that the individual cannot answer the amended allegations without 
additional time, the Hearing Examiner shall grant such additional time 
as he or she deems necessary.
    (f) The Hearing Examiner may receive and consider evidence in the 
form of depositions or responses to interrogatories upon a showing that 
the witness is not available for good reason such as death, serious 
illness or similar cause, or in the form of depositions, 
interrogatories, affidavits or statements with agreement of the parties. 
The Hearing Examiner may take official notice at any stage of the 
proceeding, where appropriate, of any fact not subject to reasonable 
dispute in that it is either (1) generally known within the United 
States or (2) capable of accurate and ready determination by resort to 
sources whose accuracy cannot reasonably be questioned. A party is 
entitled upon timely request to an opportunity to be heard as to the 
propriety of taking such official notice. In the absence of prior 
notification the request may be made after notice is taken.
    (g) Hearing Counsel shall examine and cross-examine witnesses and 
otherwise assist the Hearing Examiner in such a manner as to bring out a 
full and true disclosure of all facts, both favorable and unfavorable, 
having a bearing on the issues before the Hearing Examiner. In 
performing these duties, the Hearing Counsel shall avoid the attitude of 
a prosecutor and shall always bear in mind that the proceeding is an 
administrative hearing and not a trial.
    (h) Hearing Counsel shall not participate in the deliberations of 
the Hearing Examiner, and shall express no opinion to the Hearing 
Examiner concerning the merits of the case. Hearing Counsel shall also, 
during the course of the hearing, advise the individual of his or her 
rights under these procedures when the individual is not represented by 
counsel or other representative.
    (i) The individual shall be afforded an opportunity to cross-examine 
persons who have made oral or written statements adverse to the 
individual relating to a controverted issue except that any such 
statement may be received and considered by the Hearing Examiner without 
affording such opportunity in either of the following circumstances:
    (1) The head of the department or agency supplying the statement 
certifies that the person who furnished the information is a 
confidential informant who has been engaged in obtaining intelligence 
information for the Government and that disclosure of the informant's 
identity would substantially harm the national interest or would 
endanger the well-being of the informant.
    (2) The Commission has determined, after considering the information 
furnished by the investigative agency concerning the reliability of the 
person who furnished the information and the accuracy of the statement 
concerned, that the statement appears to be reliable and material, and 
that failure of the Hearing Examiner to receive and consider such 
statement would, in view of the fact that access authorization and/or 
employment clearance is being sought, be substantially harmful to the 
national security and that the person who furnished the information 
cannot

[[Page 268]]

appear to testify due to death, serious illness, or similar cause.
    (j)(1) Whenever the procedure under paragraph (i)(1) of this section 
is used, the individual shall be given a summary of the information 
which shall be as comprehensive and detailed as the national security 
permits.
    (2) Whenever the procedure under paragraph (i)(2) is used, the 
individual shall be provided the identity of the person and the 
information to be considered.
    (3) In both paragraph (i) (1) and (2) procedures, appropriate 
consideration shall be accorded to the fact that the individual did not 
have an opportunity to cross-examine such informant or person.
    (k) Records provided by investigative agencies that were compiled as 
a regular or routine procedure by the business or agency from which 
obtained, or other physical evidence other than investigative reports, 
may be received and considered subject to rebuttal without 
authenticating witnesses, provided that the investigative agency 
furnished such information to the NRC pursuant to its responsibilities 
in connection with assisting the NRC in determining the individual's 
eligibility for access authorization and/or employment clearance.
    (l) Records compiled in the regular course of business, or other 
physical evidence other than investigative reports, relating to a 
controverted issue which, because they are classified, may not be 
inspected by the individual, may be received and considered provided 
that:
    (1) The Commission has made a determination that such records or 
other physical evidence appears to be material;
    (2) The Commission has made a determination that failure to receive 
and consider such records or other physical evidence would, in view of 
the fact that access authorization and/or employment clearance is being 
sought, be substantially harmful to the national security; and
    (3) To the extent that national security permits, a summary or 
description of such records or other physical evidence is made available 
to the individual. In every such case, information as to the 
authenticity and accuracy of such physical evidence furnished by the 
investigative agency shall be considered.
    (m) If the Hearing Examiner determines that additional investigation 
of any material information is required, he or she shall request in 
writing that the Director, Office of Administration, arrange for the 
investigation and shall specify those issues upon which more evidence is 
requested and identify, where possible, any persons or sources that 
might provide the evidence sought.
    (n) A written transcript of the entire proceeding must be made by a 
person possessing appropriate NRC access authorization and/or employment 
clearance and, except for portions containing Restricted Data or 
National Security Information, or other lawfully withholdable 
information, a copy of the transcript will be furnished the individual 
without cost. The transcript or recording will be made part of the 
applicant's or employee's personnel security file.

[47 FR 38676, Sept. 2, 1982, as amended at 52 FR 31609, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989; 64 FR 15643, Apr. 1, 1999]



Sec.10.29  Recommendation of the Hearing Examiner.

    (a) The Hearing Examiner's findings and recommendation shall be 
based upon the entire record consisting of the transcript of the 
hearing, the documentary and other evidence adduced therein, and the 
letter of notification and answer. The Hearing Examiner shall also 
consider the circumstances of the receipt of evidence pursuant to Sec.
10.28, the individual's record of past employment, and the nature and 
sensitivity of the job the individual is or may be expected to perform.
    (b) The Hearing Examiner shall make specific findings on each 
allegation in the notification letter including the reasons for his or 
her findings, and shall make a recommendation as to the action which 
should be taken in the case.
    (c) The Hearing Examiner's recommendation shall be predicated upon 
his or her findings. If, after considering all the factors in light of 
the criteria in this part, the Hearing Examiner is of

[[Page 269]]

the opinion that granting or continuing access authorization and/or 
employment clearance to the individual will not endanger the common 
defense and security and will be clearly consistent with the national 
interest, a favorable recommendation shall be made; otherwise, an 
adverse recommendation shall be made.
    (d) The Hearing Examiner shall submit his or her findings and 
recommendation in a signed report together with the record of the case 
to the Director, Office Administration, with the least practical delay.
    (e) The Hearing Examiner shall not consider the possible impact of 
the loss of the individual's services upon the NRC program.

[47 FR 38676, Sept. 2, 1982, as amended at 52 FR 31609, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989]



Sec.10.30  New evidence.

    After the close of the hearing, in the event the individual 
discovers new evidence not previously available or known to him or her, 
the individual may petition the Hearing Examiner if the Hearing 
Examiner's recommendation has not yet been issued, or thereafter, the 
Director, Office of Administration, to reopen the record to receive that 
evidence. If the Hearing Examiner or the Director, respectively, deem it 
material and appropriate, the record may be reopened to accept the 
evidence either by stipulation, with the agreement of the Hearing 
Counsel, or in a reconvened hearing.

[47 FR 38676, Sept. 2, 1982, as amended at 52 FR 31610, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989]



Sec.10.31  Actions on the recommendations.

    (a) Upon receipt of the findings and recommendation from the Hearing 
Examiner, and the record, the Director, Office of Administration, shall 
forthwith transmit it to the Deputy Executive Director for Materials, 
Waste, Research, State, Tribal, Compliance, Administration, and Human 
Capital Programs who has the discretion to return the record to the 
Director, Office of Administration, for further proceedings by the 
Hearing Examiner with respect to specific matters designated by 
theDeputy Executive Director for Materials, Waste, Research, State, 
Tribal, Compliance, Administration, and Human Capital Programs .
    (b)(1) In the event of a recommendation by the Hearing Examiner that 
an individual's access authorization and/or employment clearance be 
denied or revoked, the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs shall immediately notify the individual in writing of the 
Hearing Examiner's findings with respect to each allegation contained in 
the notification letter, and that the individual has a right to request 
a review of his or her case by the NRC Personnel Security Review Panel 
and of the right to submit a brief in support of his or her contentions. 
The request for a review must be submitted to the Deputy Executive 
Director for Materials, Waste, Research, State, Tribal, Compliance, 
Administration, and Human Capital Programs within five days after the 
receipt of the notice. The brief will be forwarded to the , for 
transmission to the NRC Personnel Security Review Panel not later than 
10 days after receipt of the notice.
    (2) In the event the individual fails to request a review by the NRC 
Personnel Security Review Panel of an adverse recommendation within the 
prescribed time, the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs may at his or her discretion request a review of the record of 
the case by the NRC Personnel Security Review Panel. The request will 
set forth those matters at issue in the hearing on which the Deputy 
Executive Director for Materials, Waste, Research, State, Tribal, 
Compliance, Administration, and Human Capital Programs desires a review 
by the NRC Personnel Security Review Panel.
    (c) Where the Hearing Examiner has made a recommendation favorable 
to the individual, the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs may at his or her discretion request a review of the record of 
the case by the NRC Personnel Security Review

[[Page 270]]

Panel. If this request is made, the Deputy Executive Director for 
Materials, Waste, Research, State, Tribal, Compliance, Administration, 
and Human Capital Programs shall immediately cause the individual to be 
notified of that fact and of those matters at issue in the hearing on 
which the Deputy Executive Director for Materials, Waste, Research, 
State, Tribal, Compliance, Administration, and Human Capital Programs 
desires a review by the NRC Personnel Security Review Panel. The Deputy 
Executive Director for Materials, Waste, Research, State, Tribal, 
Compliance, Administration, and Human Capital Programs will further 
inform the individual that within 10 days of receipt of this notice, the 
individual may submit a brief concerning those matters at issue for the 
consideration of the NRC Personnel Security Review Panel. The brief must 
be forwarded to the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs for transmission to the NRC Personnel Security Review Panel.
    (d) In the event of a request for a review pursuant to paragraphs 
(b) and (c) of this section, the Hearing Counsel may file a brief within 
10 days of being notified by the Deputy Executive Director for 
Materials, Waste, Research, State, Tribal, Compliance, Administration, 
and Human Capital Programs that a review has been requested. The brief 
will be forwarded to the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs for transmission to the NRC Personnel Security Review Panel.
    (e) The Hearing Counsel may also request a review of the case by the 
NRC Personnel Security Review Panel. The request for review, which will 
set forth those matters at issue in the hearing on which the Hearing 
Counsel desires a review, will be submitted to the Deputy Director 
Executive for Management Services within five days after receipt of the 
Hearing Examiner's findings and recommendation. Within 10 days of the 
request for review, the Hearing Counsel may file a brief which will be 
forwarded to the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs and Chief for transmission to the NRC Personnel Security Review 
Panel. A copy of the request for review, and a copy of any brief filed, 
will be immediately sent to the individual. If the Hearing Counsel's 
request is for a review of a recommendation favorable to the individual, 
the individual may, within 10 days of receipt of a copy of the request 
for review, submit a brief concerning those matters at issue for 
consideration of the NRC Personnel Security Review Panel. The brief will 
be forwarded to the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs and Chief Information Officer for transmission to the NRC 
Personnel Security Review Panel and Hearing Counsel. A copy of the brief 
will be made a part of the applicant's personnel security file.
    (f) The time limits imposed by this section for requesting reviews 
and the filing of briefs may be extended by the Deputy Executive 
Director for Materials, Waste, Research, State, Tribal, Compliance, 
Administration, and Human Capital Programs for good cause shown.
    (g) In the event a request is made for a review of the record by the 
NRC Personnel Security Review Panel, the Deputy Executive Director for 
Materials, Waste, Research, State, Tribal, Compliance, Administration, 
and Human Capital Programs shall send the record, with all findings and 
recommendations and any briefs filed by the individual and the Hearing 
Counsel, to the NRC Personnel Security Review Panel. If neither the 
individual, the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs and, nor the Hearing Counsel requests a review, the final 
determination will be made by the Deputy Executive Director for 
Materials, Waste, Research, State, Tribal, Compliance, Administration, 
and Human Capital Programs on the basis of the record with all findings 
and recommendations.

[64 FR 15643, Apr. 1, 1999]

[[Page 271]]



Sec.10.32  Recommendation of the NRC Personnel Security Review Panel.

    (a) The Deputy Executive Director for Materials, Waste, Research, 
State, Tribal, Compliance, Administration, and Human Capital Programs 
shall designate an NRC Personnel Security Review Panel to conduct a 
review of the record of the case. The NRC Personnel Security Review 
Panel shall be comprised of three members, two of whom shall be selected 
from outside the security field. To qualify as an NRC Personnel Security 
Review Panel member, the person designated shall have an NRC ``Q'' 
access authorization and may be an employee of the NRC, its contractors, 
agents, or licensees. However, no employee or consultant of the NRC 
shall serve as an NRC Personnel Security Review Panel member reviewing 
the case of an employee (including a consultant) or applicant for 
employment with the NRC; nor shall any employee or consultant of an NRC 
contractor, agent or licensee serve as an NRC Personnel Security Review 
Panel member reviewing the case of an employee (including a consultant) 
or an applicant for employment of that contractor, agent, or licensee. 
No NRC Personnel Security Review Panel member shall be selected who has 
knowledge of the case or of any information relevant to the disposition 
of it, or who for any reason would be unable to issue a fair and 
unbiased recommendation.
    (b) The NRC Personnel Security Review Panel shall consider the 
matter under review based upon the record supplemented by any brief 
submitted by the individual or the Hearing Counsel. The NRC Personnel 
Security Review Panel may request additional briefs as the Panel deems 
appropriate. When the NRC Personnel Security Review Panel determines 
that additional evidence or further proceedings are necessary, the 
record may be returned to the Deputy Executive Director for Materials, 
Waste, Research, State, Tribal, Compliance, Administration, and Human 
Capital Programs with a recommendation that the case be returned to the 
Director, Office of Administration, for appropriate action, which may 
include returning the case to the Hearing Examiner and reconvening the 
hearing to obtain additional testimony. When additional testimony is 
taken by the Hearing Examiner, a written transcript of the testimony 
will be made a part of the record and will be taken by a person 
possessing an appropriate NRC access authorization and/or employment 
clearance and, except for portions containing Restricted Data or 
National Security Information, or other lawfully withholdable 
information, a copy of the transcript will be furnished the individual 
without cost.
    (c) In conducting the review, the NRC Personnel Security Review 
Panel shall make its findings and recommendations as to the eligibility 
or continued eligibility of an individual for an access authorization 
and/or an employment clearance on the record supplemented by additional 
testimony or briefs, as has been previously determined by the NRC 
Personnel Security Review Panel as appropriate.
    (d) The NRC Personnel Security Review Panel shall not consider the 
possible impact of the loss of the individual's services upon the NRC 
program.
    (e) If, after considering all the factors in light of the criteria 
set forth in this part, the NRC Personnel Security Review Panel is of 
the opinion that granting or continuing an access authorization and/or 
an employment clearance to the individual will not endanger the common 
defense and security and will be clearly consistent with the national 
interest, the NRC Personnel Security Review Panel shall make a favorable 
recommendation; otherwise, the NRC Personnel Security Review Panel shall 
make an adverse recommendation. The NRC Personnel Security Review Panel 
shall prepare a report of its findings and recommendations and submit 
the report in writing to the Deputy Executive Director for Materials, 
Waste, Research, State, Tribal, Compliance, Administration, and Human 
Capital Programs , who shall furnish a copy to the individual. The 
findings and recommendations must be fully supported by stated reasons.

[64 FR 15644, Apr. 1, 1999]

[[Page 272]]



Sec.10.33  Action by the Deputy Executive Director for Materials, 
Waste, Research, State, Tribal, Compliance, Administration, 
and Human Capital Programs.

    (a) The Deputy Executive Director for Materials, Waste, Research, 
State, Tribal, Compliance, Administration, and Human Capital Programs, 
on the basis of the record accompanied by all findings and 
recommendations, shall make a final determination whether access 
authorization and/or employment clearance shall be granted, denied, or 
revoked, except when the provisions of Sec.10.28 (i), (j), or (l) have 
been used and the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs determination is adverse, the Commission shall make the final 
agency determination.
    (b) In making the determination as to whether an access 
authorization and/or an employment clearance shall be granted, denied, 
or revoked, the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs or the Commission shall give due recognition to the favorable 
as well as the unfavorable information concerning the individual and 
shall take into account the value of the individual's services to the 
NRC's program and the consequences of denying or revoking access 
authorization and/or employment clearance.
    (c) In the event of an adverse determination, the Deputy Executive 
Director for Materials, Waste, Research, State, Tribal, Compliance, 
Administration, and Human Capital Programs shall promptly notify the 
individual through the Director, Office of Administration, of his or her 
decision that an access authorization and/or an employment clearance is 
being denied or revoked and of his or her findings with respect to each 
allegation contained in the notification letter for transmittal to the 
individual.
    (d) In the event of a favorable determination, the Deputy Executive 
Director for Materials, Waste, Research, State, Tribal, Compliance, 
Administration, and Human Capital Programs shall promptly notify the 
individual through the Director, Office of Administration.

[64 FR 15644, Apr. 1, 1999]



Sec.10.34  Action by the Commission.

    (a) Whenever, under the provisions of Sec.10.28(i), (j), or (l) an 
individual has not been afforded an opportunity to confront and cross-
examine witnesses who have furnished information adverse to the 
individual and an adverse recommendation has been made by the Deputy 
Executive Director for Materials, Waste, Research, State, Tribal, 
Compliance, Administration, and Human Capital Programs , the Commission 
shall review the record and determine whether an access authorization 
and/or an employment clearance should be granted, denied, or revoked, 
based upon the record.
    (b) When the Commission determines to deny or revoke access 
authorization and/or employment clearance, the individual shall promptly 
be notified through the Director, Office of Administration, of its 
decision that access authorization and/or employment clearance is being 
denied or revoked and of its findings and conclusions with respect to 
each allegation contained in the notification letter for transmittal to 
the individual.
    (c) Nothing contained in these procedures shall be deemed to limit 
or affect the responsibility and powers of the Commission to deny or 
revoke access to Restricted Data or national security information if the 
security of the nation so requires. Such authority may not be delegated 
and may be exercised when the Commission determines that invocation of 
the procedures prescribed in this part is inconsistent with the national 
security. Such determination shall be conclusive.

[47 FR 38676, Sept. 2, 1982, as amended at 52 FR 31610, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989; 64 FR 15645, Apr. 1, 1999]



Sec.10.35  Reconsideration of cases.

    (a) Where, pursuant to the procedures set forth in Sec. Sec.10.20 
through 10.34, the Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs or the Commission has made a determination

[[Page 273]]

granting an access authorization and/or an employment clearance to an 
individual, the individual's eligibility for an access authorization 
and/or an employment clearance will be reconsidered only when subsequent 
to the time of that determination, new derogatory information has been 
received or the scope or sensitivity of the Restricted Data or National 
Security Information to which the individual has or will have access has 
significantly increased. All new derogatory information, whether 
resulting from the NRC's reinvestigation program or other sources, will 
be evaluated relative to an individual's continued eligibility in 
accordance with the procedures of this part.
    (b) Where, pursuant to these procedures, the Commission or Deputy 
Executive Director for Materials, Waste, Research, State, Tribal, 
Compliance, Administration, and Human Capital Programs has made a 
determination denying or revoking an access authorization and/or an 
employment clearance to an individual, the individual's eligibility for 
an access authorization and/or an employment clearance may be 
reconsidered when there is a bona fide offer of employment and/or a bona 
fide need for access to Restricted Data or National Security Information 
and either material and relevant new evidence is presented, which the 
individual and his or her representatives are without fault in failing 
to present before, or there is convincing evidence of reformation or 
rehabilitation. Requests for reconsideration must be submitted in 
writing to the Deputy Executive Director for Materials, Waste, Research, 
State, Tribal, Compliance, Administration, and Human Capital Programs 
through the Director, Office of Administration. Requests must be 
accompanied by an affidavit setting forth in detail the information 
referred to above. The Deputy Executive Director for Materials, Waste, 
Research, State, Tribal, Compliance, Administration, and Human Capital 
Programs shall cause the individual to be notified as to whether his or 
her eligibility for an access authorization and/or an employment 
clearance will be reconsidered and if so, the method by which a 
reconsideration will be accomplished.
    (c) Where an access authorization and/or an employment clearance has 
been granted to an individual by the Director, Division of Facilities 
and Security, without recourse to the procedures set forth in Sec. Sec.
10.20 through 10.34, the individual's eligibility for an access 
authorization and/or an employment clearance will be reconsidered only 
in a case where, subsequent to the granting of the access authorization 
and/or employment clearance, new derogatory information has been 
received or the scope or sensitivity of the Restricted Data or National 
Security Information to which the individual has or will have access has 
significantly increased. All new derogatory information, whether 
resulting from the NRC's reinvestigation program or other sources, will 
be evaluated relative to an individual's continued eligibility in 
accordance with the procedures of this part.

[64 FR 15645, Apr. 1, 1999]



                         Subpart D_Miscellaneous



Sec.10.36  Terminations.

    In the event the individual is no longer an applicant for access 
authorization and/or employment clearance or no longer requires such, 
the procedures of this part shall be terminated without a final 
determination as to the individual's eligibility for access 
authorization and/or employment clearance.



Sec.10.37  Attorney representation.

    In the event the individual is represented by an attorney or other 
representative, the individual shall file with the Director, Office of 
Administration, a document designating such attorney or representative 
and authorizing such attorney or representative to receive all 
correspondence, transcripts, and other documents pertaining to the 
proceeding under this part.

[47 FR 38676, Sept. 2, 1982, as amended at 52 FR 31610, Aug. 21, 1987; 
54 FR 53316, Dec. 28, 1989]

[[Page 274]]



Sec.10.38  Certifications.

    Whenever information is made a part of the record under the 
exceptions authorized by Sec.10.28 (i), (j), or (l), the record shall 
contain certificates evidencing that the required determinations have 
been made.



PART 11_CRITERIA AND PROCEDURES FOR DETERMINING ELIGIBILITY FOR
ACCESS TO OR CONTROL OVER SPECIAL NUCLEAR MATERIAL--Table of Contents



                           General Provisions

Sec.
11.1 Purpose.
11.3 Scope.
11.5 Policy.
11.7 Definitions.
11.8 Information collection requirements: OMB approval.
11.9 Specific exemptions.
11.10 Maintenance of records.

     Requirements for Special Nuclear Material Access Authorization

11.11 General requirements.
11.13 Special requirements for transportation.
11.15 Application for special nuclear material access authorization.
11.16 Cancellation of request for special nuclear material access 
          authorization.

  Criteria for Determining Eligibility for Access to, or Control Over, 
                        Special Nuclear Material

11.21 Application of the criteria.

                               Violations

11.30 Violations.
11.32 Criminal penalties.

    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.

    Source: 45 FR 76970, Nov. 21, 1980, unless otherwise noted.

                           General Provisions



Sec.11.1  Purpose.

    This part establishes the requirements for special nuclear material 
access authorization, and the criteria and procedures for resolving 
questions concerning the eligibility of individuals to receive special 
nuclear material access authorization for conduct of certain activities, 
licensed or otherwise, which involve access to or control over special 
nuclear material.



Sec.11.3  Scope.

    (a) The requirements, criteria, and procedures of this part apply to 
the establishment of and eligibility for special nuclear material access 
authorization for employees, contractors, consultants of, and applicants 
for employment with licensees or contractors of the Nuclear Regulatory 
Commission. This employment, contract, service, or consultation may 
involve any duties or assignments within the criteria of Sec.11.11 or 
Sec.11.13 requiring access to, or control over, formula quantities of 
special nuclear material (as defined in part 73 of this chapter).
    (b) The requirements, criteria, and procedures of this part are in 
addition to and not in lieu of any requirements, criteria, or procedures 
for access to or control over classified special nuclear material.

[45 FR 76970, Nov. 21, 1980, as amended at 64 FR 15645, Apr. 1, 1999]



Sec.11.5  Policy.

    It is the policy of the Nuclear Regulatory Commission to carry out 
its authority to establish and administer, in a manner consistent with 
traditional American concepts of justice, a personnel security program 
in the interests of the common defense and security for the purpose of 
safeguarding special nuclear material and preventing sabotage which 
would endanger the public by exposure to radiation. To this end, the 
Commission has established criteria for determining eligibility for 
special nuclear material access authorization and will afford affected 
individuals the opportunity for administrative review of questions 
concerning their eligibility for special nuclear material access 
authorization.



Sec.11.7  Definitions.

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

[[Page 275]]

    NRC-``R'' special nuclear material access authorization means an 
administrative determination based upon a national agency check with law 
and credit investigation that an individual in the course of employment 
is eligible to work at a job falling within the criterion of Sec.
11.11(a)(2).
    NRC-``U'' special nuclear material access authorization means an 
administrative determination based upon a single scope background 
investigation, normally conducted by the Office of Personnel Management, 
that an individual in the course of employment is eligible to work at a 
job falling within the criterion of 11.11(a)(1) or 11.13.
    Special nuclear material access authorization means an 
administrative determination that an individual (including a contractor 
or consultant) who is employed by or is an applicant for employment with 
an affected Commission contractor, licensee of the Commission, or 
contractor of a licensee of the Commission may work at a job which 
affords access to or control over special nuclear material and that 
permitting the individual to work at that job would not be inimical to 
the common defense and security.

[45 FR 76970, Nov. 21, 1980, as amended at 46 FR 58282, Dec. 1, 1981; 50 
FR 39077, Sept. 27, 1985; 55 FR 11574, Mar. 29, 1990; 64 FR 15645, Apr. 
1, 1999]



Sec.11.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. et seq.). The NRC may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has 
approved the information collection requirements contained in this part 
under control number 3150-0062.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.11.9, 11.11, 11.13, 11.15, and 11.16.

[62 FR 52185, Oct. 6, 1997]



Sec.11.9  Specific exemptions.

    The Commission may, upon application of any interested party, grant 
an exemption from the requirements of this part. Exemptions will be 
granted only if they are authorized by law and will not constitute an 
undue risk to the common defense and security. Documentation related to 
the request, notification and processing of an exemption shall be 
maintained for three years beyond the period covered by the exemption.

[45 FR 76970, Nov. 21, 1980, as amended at 53 FR 19245, May 27, 1988]



Sec.11.10  Maintenance of records.

    Each record required by this part must be legible throughout the 
retention period specified by each Commission regulation. The record may 
be the original or a reproduced copy or a microform provided that the 
copy or microform is authenticated by authorized personnel and that the 
microform is capable of producing a clear copy throughout the required 
retention period. The record may also be stored in electronic media with 
the capability for producing legible, accurate, and complete records 
during the required retention period. Records such as letters, drawing, 
specification, must include all pertinent information such as stamps, 
initials, and signatures etc. The licensee shall maintain adequate 
safeguards against tampering with and loss of records.

[53 FR 19245, May 27, 1988]

     Requirements for Special Nuclear Material Access Authorization



Sec.11.11  General requirements.

    (a) Each licensee who uses, processes, stores, transports, or 
delivers to a carrier for transport, formula quantities of special 
nuclear material (as defined in part 73 of this chapter) subject to the 
physical protection requirements of Sec. Sec.73.20, 73.25, 73.26, 
73.45, and 73.46, and each person subject to the general licensing 
requirements of Sec.70.20a, shall identify at its facility or plant 
(excluding all non-power reactor facilities and storage of fuel incident 
thereto and facilities and plants in which the licensee possesses or 
uses only irradiated

[[Page 276]]

special nuclear material subject to the exemption of Sec.73.6(b)), 
describe, and if not already provided, provide to the Commission, by 
December 26, 1985 by amendment to its security plan:
    (1) All jobs in which an individual could steal or divert special 
nuclear material, or commit sabotage which would endanger the public by 
exposure to radiation, by working alone or in cooperation with an 
individual who does not possess an NRC-U special nuclear material access 
authorization, or by directing or coercing any individual to assist in 
the theft, diversion, or sabotage. Such jobs include but are not limited 
to:
    (i) All positions in the licensee's security force,
    (ii) Management positions with the authority to:
    (A) Direct the actions of members of the security force or alter 
security procedures, or
    (B) Direct routine movements of special nuclear material, or
    (C) Direct the routine status of vital equipment.
    (iii) All jobs which require unescorted access within onsite alarm 
stations.
    (iv) All jobs which require unescorted access \2\ to special nuclear 
material or within vital areas.
---------------------------------------------------------------------------

    \2\ This does not alter the requirement for methods to observe 
individuals within material access areas as stated in Sec.73.46(e)(9) 
of this chapter.
---------------------------------------------------------------------------

    (2) All jobs which require unescorted access within protected areas 
and which do not fall within the criterion of paragraph (a)(1) of this 
section.
    (b) After 365 days following Commission approval of the amended 
security plan submitted in accordance with paragraph (a) of this 
section, no individual may be permitted to work at any job determined by 
the Commission to fall within the criterion of paragraph (a)(1) of this 
section without an NRC-U special nuclear material access authorization, 
and no individual may be permitted unescorted access to any protected 
area at any site subject to this part without either an NRC-U or NRC-R 
special nuclear material access authorization. The exceptions to the 
requirement for an NRC-U and NRC-R special nuclear material access 
authorization are as follows:
    (1) Exceptions to the requirement for an NRC-U special nuclear 
material access authorization for an individual to work at a job within 
the criteria of paragraph (a)(1) are provided for:
    (i) Any individual employed in such a job on October 28, 1985, who 
is not yet in receipt of an NRC-U special nuclear material access 
authorization from the Commission, provided that a complete application 
has been submitted to and is pending before the NRC for processing for 
that employee in accordance with Sec.11.15 (a) and (b); or
    (ii) Any individual in possession of an NRC-L or R access 
authorization or an equivalent active Federal security clearance but not 
yet in receipt of the NRC-U special nuclear material access 
authorization, provided that a complete application has been submitted 
to and is pending before the NRC for processing for that employee in 
accordance with Sec.11.15 (a) or (b), or both.
    (2) Exceptions to the requirement for an NRC-R special nuclear 
material access authorization for an individual to have unescorted 
access to a protected area are provided for:
    (i) Any individual employed in such a job on October 28, 1985 who is 
not yet in receipt of an NRC-R special nuclear material access 
authorization from the Commission, provided that a complete application 
has been submitted to and is pending before the NRC for processing for 
that employee in accordance with Sec.11.15 (a) and (b); or
    (ii) Any individual in possession of an NRC-L access authorization 
or an equivalent active Federal security clearance, provided that a 
complete application has been submitted to the NRC for processing for 
that employee in accordance with Sec.11.15 (a) or (b), or both.

[45 FR 76970, Nov. 21, 1980, as amended at 46 FR 56599, Nov. 18, 1981; 
50 FR 39077, Sept. 27, 1985]



Sec.11.13  Special requirements for transportation.

    (a) All individuals who, after 365 days following approval of the 
amended security plan submitted in accordance with Sec.11.11(a), 
transport, arrange for transport, drive motor vehicles in road

[[Page 277]]

shipments of special nuclear material, pilot aircraft in air shipments 
of special nuclear material, act as monitors at transfer points, or 
escort road, rail, sea, or air shipments of special nuclear material 
subject to the appropriate physical protection requirements of 
Sec. Sec.73.20, 73.25, 73.26, or 73.27 of this chapter, or who are 
authorized to alter the scheduling and routing of such transport shall 
have NRC-U special nuclear material access authorization. Exceptions are 
provided for:
    (1) Any individual who is employed in such a job on October 28, 1985 
and who is not yet in receipt of an NRC-U special nuclear material 
access authorization from the Commission, provided that a complete 
application has been submitted to and is pending before the NRC for 
processing for that employee in accordance with Sec.11.15 (a) and (b) 
or
    (2) Any individual in possession of an NRC-L or R access 
authorization or equivalent active Federal security clearance but not 
yet in receipt of the NRC-U special nuclear material access 
authorization, provided that a complete application has been submitted 
to and is pending before the NRC for processing for that employee in 
accordance with Sec.11.15 (a) or (b), or both.
    (b) Each licensee who, 365 days after Commission approval of the 
amended security plan submitted in accordance with Sec.11.11(a), 
transports or delivers to a carrier for transport special nuclear 
material subject to the physical protection requirement of Sec. Sec.
73.20, 73.25, 73.26, or 73.27 of this chapter shall confirm and record 
prior to shipment the name and special nuclear material access 
authorization number of all individuals identified in paragraph (a) of 
this section assigned to the shipment. The licensee shall retain this 
record for three years after the last shipment is made. However, the 
licensee need not confirm and record the special nuclear material access 
authorization number in the case of any individual for whom an 
application has been submitted and is pending before the NRC in 
accordance with paragraph (a) of this section.

[50 FR 39078, Sept. 27, 1985, as amended at 53 FR 19245, May 27, 1988]



Sec.11.15  Application for special nuclear material access 
authorization.

    (a)(1) Application for special nuclear material access 
authorization, renewal, or change in level must be filed by the licensee 
on behalf of the applicant with the Director, Division of Facilities and 
Security, Mail Stop T7-D57, either by mail addressed to the U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; by hand delivery to 
the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, 
where practicable, by electronic submission, for example, via Electronic 
Information Exchange, or CD-ROM. Electronic submissions must be made in 
a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information. Applications for affected individuals employed on October 
28, 1985, shall be submitted within 60 days of notification of 
Commission approval of the amended security plan.
    (2) Licensees who wish to secure NRC-U or NRC-R special nuclear 
material access authorizations for individuals in possession of an 
active NRC Q or L access authorization or other security clearance 
granted by another Federal agency based on an equivalent investigation 
shall submit a ``Security Acknowledgment'' (NRC Form 176) and a 
``Request for Access Authorization'' (NRC Form 237). NRC will process 
these requests by verifying the data on an NRC-cleared individual, or by 
contacting the Federal agency that granted the clearance, requesting 
certification of the security clearance, and determining the 
investigative basis and level of the clearance. Licensees may directly 
request the Federal agency that administered the security clearance, if 
other than NRC, to certify to

[[Page 278]]

the NRC that it has on file an active security clearance for an 
individual and to specify the investigative basis and level of the 
clearance.
    (b) Applications for special nuclear material access authorization 
for individuals, other than those qualifying under the provisions of 
Sec.11.15(a)(2), must be made on forms supplied by the Commission, 
including:
    (1) Questionnaire for National Security Positions (SF-86, Parts 1 
and 2);
    (2) Two completed standard fingerprint cards (FD-258);
    (3) Security Acknowledgment (NRC Form 176);
    (4) Other related forms where specified in accompanying instruction 
(NRC-254); and
    (5) A statement by the employer, prospective employer, or contractor 
identifying the job to be assigned to or assumed by the individual and 
the level of authorization needed, justified by appropriate reference to 
the licensee's security plan.
    (c)(1) Except as provided in paragraph (c)(2) of this section, NRC-U 
special nuclear material access authorizations must be renewed every 
five years from the date of issuance. Except as provided in paragraph 
(c)(3) of this section, NRC-R special nuclear material access 
authorizations must be renewed every ten years from the date of 
issuance. An application for renewal must be submitted at least 120 days 
before the expiration of the five-year period for NRC-U and ten-year 
period for NRC-R, respectively, and must include:
    (i) A statement by the licensee that at the time of application for 
renewal the individual's assigned or assumed job requires an NRC-U or an 
NRC-R special nuclear material access authorization, justified by 
appropriate reference to the licensee's security plan;
    (ii) The Questionnaire for National Security Positions (SF-86, Parts 
1 and 2);
    (iii) Two completed standard fingerprint cards (FD-258); and
    (iv) Other related forms specified in accompanying NRC instructions 
(NRC Form 254).
    (2) An exception to the time for submission of NRC-U special nuclear 
material access authorization renewal applications and the paperwork 
required is provided for individuals who have a current and active DOE-Q 
access authorization and are subject to DOE Reinvestigation Program 
requirements. For these individuals, the submission to DOE of the SF-86 
pursuant to DOE Reinvestigation Program requirements (generally every 
five years) will satisfy the NRC renewal submission and paperwork 
requirements even if less than five years has passed since the date of 
issuance or renewal of the NRC-U access authorization. Any NRC-U special 
nuclear material access authorization renewed in response to provisions 
of this paragraph will not be due for renewal until the date set by DOE 
for the next reinvestigation of the individual pursuant to DOE's 
Reinvestigation Program.
    (3) An exception to the time for submission of NRC-R special nuclear 
material access authorization renewal applications and the paperwork 
required is provided for individuals who have a current and active DOE-L 
or DOE-Q access authorization and are subject to DOE Reinvestigation 
Program requirements. For these individuals, the submission to DOE of 
the SF-86 pursuant to DOE Reinvestigation Program requirements will 
satisfy the NRC renewal submission and paperwork requirements even if 
less than ten years have passed since the date of issuance or renewal of 
the NRC-R access authorization. Any NRC-R special nuclear material 
access authorization renewed pursuant to this paragraph will not be due 
for renewal until the date set by DOE for the next reinvestigation of 
the individual pursuant to DOE's Reinvestigation Program.
    (4) Notwithstanding the provisions of paragraph (c)(2) of this 
section, the period of time for the initial and each subsequent NRC-U 
renewal application to NRC may not exceed seven years.
    (5) Notwithstanding the provisions of paragraph (c)(3) of this 
section, the period of time for the initial and each subsequent NRC-R 
renewal application to NRC may not exceed twelve years. Any individual 
who is subject to the DOE Reinvestigation Program requirements but, for 
administrative or other reasons, does not submit reinvestigation forms 
to DOE within seven years of the previous submission, for a NRC-

[[Page 279]]

U renewal or twelve years of the previous submission for a NRC-R 
renewal, shall submit a renewal application to NRC using the forms 
prescribed in paragraph (c)(1) of this section before the expiration of 
the seven year period for NRC-U or twelve year period for NRC-R renewal.
    (d) If at any time, due to new assignment or assumption of duties, a 
change in a special nuclear material access authorization level from NRC 
``R'' to ``U'' is required, the individual shall apply for a change of 
level of special nuclear material access authorization. The application 
must include a description of the new duties to be assigned or assumed, 
justified by appropriate reference to the licensee's security plan.
    (e) The Office of Personnel Management (OPM) bills the NRC for the 
cost of each background investigation conducted in support of an 
application for special nuclear material access authorization 
(application). The combined cost of the OPM investigation and the NRC's 
application processing overhead (NRC processing fee) are recovered 
through a material access authorization fee imposed on applicants for 
special nuclear material access authorization.
    (1) Each application for a special nuclear material access 
authorization, renewal, or change in level must be accompanied by a 
remittance, payable to the U.S. Nuclear Regulatory Commission, which is 
equal to the NRC material access authorization fee. This fee must be 
determined using the following formula: the OPM investigation billing 
rates on the day of NRC receipt of the application + the NRC processing 
fee = the NRC material access authorization fee. The NRC processing fee 
is determined by multiplying the OPM investigation billing rate on the 
day of NRC receipt of the application by 55.8 percent (i.e., OPM rate x 
55.8 percent).
    (2) Updated OPM investigation billing rates are published 
periodically in a Federal Investigations Notice (FIN) issued by the 
OPM's Federal Investigative Services. Copies of the current OPM 
investigation billing rates schedule can be obtained by contacting the 
NRC's Personnel Security Branch, Division of Facilities Security, Office 
of Administration by email to: Licensee_

Access_Authorization_Fee.Resource@

nrc.gov.
    (3) The NRC's Material Access Authorization Program (MAAP) is 
considered reimbursable work representing services provided to an 
organization for which the NRC is entitled payment. The NRC is 
authorized to receive and retain fees from licensees for services 
performed. The NRC's Office of the Chief Financial Officer periodically 
reviews the fees charged for MAAP and makes recommendations on revising 
those charges to reflect costs incurred by the NRC in providing those 
services. The reviews are performed using cost analysis techniques to 
determine the direct and indirect costs. Based on this review the MAAP 
fees are adjusted to reflect the current cost for the program. Copies of 
the current NRC material access authorization fee may be obtained by 
contacting the NRC's Personnel Security Branch, Division of Facilities 
Security, Office of Administration by email to: Licensee_Access_

[email protected]. Any change in the NRC's access 
authorization fees will be applicable to each access authorization 
request received on or after the effective date of the OPM's most 
recently published investigation billing rates schedule. Applicants 
shall calculate the access authorization fee according to the stated 
formula (i.e., OPM rate x 55.8 percent) and with reference to the 
following table:

----------------------------------------------------------------------------------------------------------------
                                                                       Plus the NRC's processing fee (rounded to
                                        Is the sum of the current OPM    the nearest dollar), which is equal to
 The NRC application fee for an access    investigation billing rate     the OPM investigation billing rate for
      authorization of type . . .        charged for an investigation     the type of investigation referenced
                                                of type . . .                     multiplied by . . .
----------------------------------------------------------------------------------------------------------------
i. NRC-R \1\..........................  NACLC--National Agency Check                                      55.8%
                                         with Law and Credit
                                         (Standard Service, Code C).
ii. NRC--R Based on Certification of    No fee assessed for most
 Comparable Investigation \2\.           applications.

[[Page 280]]

 
iii. NRC--R renewal \1\...............  NACLC--National Agency Check                                      55.8%
                                         with Law and Credit
                                         (Standard Service, Code C).
iv. NRC--U requiring single scope       SSBI--Single Scope Background                                     55.8%
 investigation.                          Investigation (Standard
                                         Service, Code C).
v. NRC--U requiring single scope        SSBI--Single Scope Background                                     55.8%
 investigation (expedited processing).   Investigation (Priority
                                         Handling, Code A).
vi. NRC--U based on certification of    No fee assessed for most
 comparable investigation \2\.           applications.
vii. NRC--U renewal \2\...............  SSBI-PR--Periodic                                                 55.8%
                                         Reinvestigation for SSBI
                                         (Standard Service, Code C).
----------------------------------------------------------------------------------------------------------------
\1\ If the NRC, having reviewed the available data, deems it necessary to perform a single scope investigation,
  the appropriate NRC-U fee will be assessed before the conduct of the investigation.
\2\ If the NRC determines, based on its review of available data, that a single scope investigation is
  necessary, the appropriate NRC-U fee will be assessed before the conduct of the investigation.

    (4) Certain applications from individuals having current Federal 
access authorizations may be processed expeditiously at no cost to the 
licensee because the Commission, at its discretion, may decide to accept 
the certification of access authorizations and investigative data from 
other Federal government agencies that grant personnel access 
authorizations.
    (f)(1) Any Federal employee, employee of a contractor of a Federal 
agency, licensee, or other person visiting an affected facility for the 
purpose of conducting official business, who possesses an active NRC or 
DOE-Q access authorization or an equivalent Federal security clearance 
granted by another Federal agency (``Top Secret'') based on a comparable 
single scope background investigation may be permitted, in accordance 
with Sec.11.11, the same level of unescorted access that an NRC-U 
special nuclear material access authorization would afford.
    (2) Any Federal employee, employee of a contractor of a Federal 
agency, licensee, or other person visiting an affected facility for the 
purpose of conducting official business, who possesses an active NRC or 
DOE-L access authorization or an equivalent security clearance granted 
by another Federal agency (``Secret'') based on a comparable or greater 
background investigation consisting of a national agency check with law 
and credit may be permitted, in accordance with Sec.11.11, the same 
level of unescorted access that an NRC-R special nuclear material access 
authorization would afford. An NRC or DOE-L access authorization or an 
equivalent security clearance (``Secret''), based on a background 
investigation or national agency check with credit granted or being 
processed by another Federal agency before January 1, 1998, is 
acceptable to meet this requirement.

[64 FR 15645, Apr. 1, 1999, as amended at 68 FR 62511, Nov. 5, 2003; 68 
FR 65765, Nov. 21, 2003; 68 FR 58800, Oct. 10, 2003; 72 FR 27410, May 
16, 2007; 74 FR 62680, Dec. 1, 2009; 77 FR 26152, May 3, 2012; 77 FR 
46257, Aug. 3, 2012; 80 FR 74978, Dec. 1, 2015]



Sec.11.16  Cancellation of request for special nuclear material access
authorization.

    When a request for an individual's access authorization is withdrawn 
or canceled, the licensee shall notify the Chief, Personnel Security 
Branch, NRC Division of Facilities and Security immediately, by 
telephone, so that the investigation may be discontinued. The caller 
shall provide the full name and date of birth of the individual, the 
date of request, and the type of access authorization originally 
requested (``U'' or ``R''). The licensee shall promptly submit written 
confirmation of the telephone notification to the Personnel Security 
Branch, NRC Division of Facilities and Security. A portion of the fee 
for the ``U'' special nuclear material access authorization may be 
refunded depending upon the status of the single scope investigation at 
the time of withdrawal or cancellation.

[64 FR 15647, Apr. 1, 1999]

[[Page 281]]

  Criteria for Determining Eligibility for Access to, or Control Over, 
                        Special Nuclear Material



Sec.11.21  Application of the criteria.

    (a) The decision to grant or deny special nuclear material access 
authorization is a comprehensive, common-sense judgment, made after 
consideration of all the relevant information, favorable or unfavorable, 
that to grant or deny special nuclear material access authorization is 
or is not inimical to the common defense and security and is or is not 
clearly consistent with the national interest.
    (b) To assist in making these determinations, on the basis of all 
the information in a particular case, there are set forth in Sec.10.11 
of this chapter a number of specific types of derogatory information. 
These criteria are not exhaustive but contain the principal types of 
derogatory information which in the opinion of the Commission create a 
question as to the individual's eligibility for special nuclear material 
access authorization. These criteria are subject to continuing review 
and may be revised from time to time as experience and circumstances may 
make desirable.
    (c) When the reports of an investigation of an individual contain 
information reasonably falling within one or more of the classes of 
derogatory information listed in Sec.10.11, it creates a question as 
to the individual's eligibility for special nuclear material access 
authorization. In these cases, the application of the criteria must be 
made in light of and with specific regard to whether the existence of 
the information supports a reasonable belief that the granting of a 
special nuclear material access authorization would be inimical to the 
common defense and security. The Director, Division of Facilities and 
Security, may authorize the granting of a special nuclear material 
access authorization on the basis of the information in the case or may 
authorize the conduct of an interview with the individual and, on the 
basis of the interview and other investigation as the Director deems 
appropriate, may authorize the granting of a special nuclear material 
access authorization. Otherwise, a question concerning the eligibility 
of an individual for a special nuclear material access authorization 
must be resolved in accordance with the procedures set forth in 
Sec. Sec.10.20 through 10.38 of this chapter.
    (d) In resolving a question concerning the eligibility or continued 
eligibility of an individual for a special nuclear material access 
authorization by action of the Hearing Examiner or a Personnel Security 
Review Panel, \3\ the following principle shall be applied by the 
Examiner and the Personnel Security Review Panel: Where there are 
sufficient grounds to establish a reasonable belief as to the truth of 
the information regarded as substantially derogatory and when the 
existence of this information supports a reasonable belief that granting 
access would be inimical to the common defense and security, this will 
be the basis for a recommendation for denying or revoking special 
nuclear material access authorization if not satisfactorily rebutted by 
the individual or shown to be mitigated by circumstance.
---------------------------------------------------------------------------

    \3\ The functions of the Hearing Examiner and the Personnel Security 
Review Panel are described in part 10 of this chapter.

[45 FR 76970, Nov. 21, 1980, as amended at 47 FR 38683, Sept. 2, 1982; 
64 FR 15647, Apr. 1, 1999]

                               Violations



Sec.11.30  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;

[[Page 282]]

    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55070, Nov. 24, 1992]



Sec.11.32  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all regulations in part 11 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 11 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.11.1, 11.3, 11.5, 11.7, 11.8, 11.9, 11.16, 11.21, 11.30, and 
11.32.

[57 FR 55070, Nov. 24, 1992]



PART 12_IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY
PROCEEDINGS--Table of Contents



                      Subpart A_General Provisions

Sec.
12.101 Purpose.
12.102 When the EAJA applies.
12.103 Proceedings covered.
12.104 Eligibility of applicants.
12.105 Standards for awards.
12.106 Allowable fees and expenses.
12.107 Rulemaking on maximum rates for attorney fees.
12.108 Awards against other agencies.
12.109 Decisionmaking authority.

             Subpart B_Information Required From Applicants

12.201 Contents of application.
12.202 Net worth exhibit.
12.203 Documentation of fees and expenses.
12.204 When an application may be filed.

            Subpart C_Procedures for Considering Applications

12.301 Filing and service of documents.
12.302 Answer to application.
12.303 Reply.
12.304 Comments by other parties.
12.305 Settlement.
12.306 Further proceedings.
12.307 Decision.
12.308 Agency review.
12.309 Judicial review.
12.310 Payment of award.

    Authority: 5 U.S.C. 504(c)(1).

    Source: 59 FR 23121, May 5, 1994, unless otherwise noted.



                      Subpart A_General Provisions



Sec.12.101  Purpose.

    The purpose of this part is to state the regulatory requirements for 
award of attorney fees to eligible individuals and entities in certain 
administrative proceedings before the Nuclear Regulatory Commission, in 
implementation of the Equal Access to Justice Act, 5 U.S.C. 504 (EAJA), 
which provides for the award of attorney fees and other expenses to 
parties to ``adversary adjudications'', as defined in 5 U.S.C. 
504(b)(1)(C). In general, an ``adversary adjudication'' is an 
adjudication that is required by statute to be determined on the record 
after opportunity for hearing before an agency of the United States and 
in which the position of the agency, or any component of the agency, is 
presented by an attorney or other representative who enters an 
appearance and participates in the proceeding. However, some agency 
adjudications are expressly excluded from coverage by 5 U.S.C. 504 
(e.g., an adjudication for the purpose of granting or renewing a 
license) even though they fall within this general definition, and 
certain appeals before an agency board of contract appeals and Program 
Fraud Civil Remedies Act hearings conducted under 31 U.S.C. ch. 38 are 
expressly covered.
    An eligible party may receive an award in an adversary adjudication 
when the party prevails over the Commission, unless the Commission's 
position was substantially justified or special circumstances make an 
award unjust. The regulations in this part describe the parties eligible 
for awards

[[Page 283]]

and the proceedings that are covered. They also explain how to apply for 
awards, and the procedures and standards that the Commission will use to 
make them.



Sec.12.102  When the EAJA applies.

    The EAJA applies to any covered adversary adjudication pending or 
commenced before the Commission on or after August 5, 1985.



Sec.12.103  Proceedings covered.

    (a) The EAJA applies to the following proceedings:
    (1) Hearings under the Program Fraud Civil Remedies Act (31 U.S.C. 
3801-12);
    (2) Any appeal of a decision made pursuant to section 6 of the 
Contract Disputes Act of 1978 (41 U.S.C. 605) before an agency board of 
contract appeals as provided in section 8 of that Act (41 U.S.C. 607); 
and
    (3) Adversary adjudications conducted by the Commission pursuant to 
any other statutory provision that requires a proceeding before the 
Nuclear Regulatory Commission to be so conducted as to fall within the 
meaning of ``adversary adjudication'' under 5 U.S.C. 504(b)(1)(C).
    (b) The Commission's failure to identify a type of proceeding as an 
adversary adjudication shall not preclude the filing of an application 
by a party who believes the proceeding is covered by the EAJA. Whether 
the proceeding is covered will then be an issue for resolution in 
proceedings on the application.
    (c) If a proceeding includes both matters covered by the EAJA and 
matters specifically excluded from coverage, any award made will include 
only fees and expenses related to covered issues.



Sec.12.104  Eligibility of applicants.

    (a) To be eligible for an award of attorney fees and other expenses 
under the EAJA, the applicant must be a party to the adversary 
adjudication for which it seeks an award. The term ``party'' is defined 
in 5 U.S.C. 551(3). The applicant must show that it meets all conditions 
of eligibility set out in this subpart and in subpart B.
    (b) The types of eligible applicants are as follows:
    (1) An individual with a net worth of not more than $2 million;
    (2) The sole owner of an unincorporated business who has a net worth 
of not more than $7 million, including both personal and business 
interests, and not more than 500 employees;
    (3) A charitable or other tax-exempt organization described in 
section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)) 
with not more than 500 employees;
    (4) A cooperative association as defined in section 15(a) of the 
Agricultural Marketing Act (12 U.S.C. 1141j(a)) with not more than 500 
employees; and
    (5) Any other partnership, corporation, association, unit of local 
government, or organization with a net worth of not more than $7 million 
and not more than 500 employees.
    (c) For the purpose of eligibility, the net worth and number of 
employees of an applicant shall be determined as of the date the 
proceeding was initiated.
    (d) An applicant who owns an unincorporated business will be 
considered as an ``individual'' rather than a ``sole owner of an 
unincorporated business'' if the issues on which the applicant prevails 
are related primarily to personal interests rather than to business 
interests.
    (e) The employees of an applicant include all persons who regularly 
perform services for remuneration for the applicant, under the 
applicant's direction and control. Part-time employees shall be included 
on a proportional basis.
    (f) The net worth and number of employees of the applicant and all 
of its affiliates shall be aggregated to determine eligibility. Any 
individual, corporation, or other entity that directly or indirectly 
controls or owns a majority of the voting shares or other interests of 
the applicant, or any corporation or other entity of which the applicant 
directly or indirectly owns or controls a majority of the voting shares 
or other interest, will be considered an affiliate for purposes of this 
part, unless the adjudicative officer determines that such treatment 
would be unjust and contrary to the purposes of the Act

[[Page 284]]

in light of the actual relationship between the affiliated entities. In 
addition, the adjudicative officer may determine that financial 
relationships of the applicant other than those described in this 
paragraph constitute special circumstances that would make an award 
unjust.
    (g) An applicant that participates in a proceeding primarily on 
behalf of one or more other persons or entities that would be ineligible 
is not itself eligible for an award.



Sec.12.105  Standards for awards.

    (a) A prevailing applicant may receive an award for fees and 
expenses incurred in connection with a proceeding or a significant and 
discrete substantive portion of the proceeding, unless the position of 
the Commission over which the applicant has prevailed was substantially 
justified. The position of the Commission includes, in addition to the 
position taken by the Commission in the adversary adjudication, the 
action or failure to act by the Commission upon which the adversary 
adjudication is based. The burden of proof that an award should not be 
made to a prevailing applicant because the Commission's position was 
substantially justified is on the Commission counsel.
    (b) An award will be reduced or denied if the applicant has unduly 
or unreasonably protracted the proceeding or if special circumstances 
make the award sought unjust.



Sec.12.106  Allowable fees and expenses.

    (a) Awards will be based on rates customarily charged by persons 
engaged in the business of acting as attorneys, agents, and expert 
witnesses, even if the services were made available without charge or at 
reduced rate to the applicant.
    (b) No award for the fee of an attorney or agent under this part may 
exceed $75.00 per hour. No award to compensate an expert witness may 
exceed the highest rate at which the Commission pays expert witnesses. 
However, an award may also include the reasonable expenses of the 
attorney, agent, or witness as a separate item, if the attorney, agent, 
or witness ordinarily charges clients separately for these expenses.
    (c) In determining the reasonableness of the fee sought for an 
attorney, agent, or expert witness, the adjudicative officer shall 
consider the following:
    (1) If the attorney, agent, or witness is in private practice, his 
or her customary fees for similar services, or, if an employee of the 
applicant, the fully allocated costs of the services;
    (2) The prevailing rate for similar services in the community in 
which the attorney, agent, or witness ordinarily performs services;
    (3) The time actually spent in the representation of the applicant;
    (4) The time reasonably spent in light of the difficulty or 
complexity of the issues in the proceeding; and
    (5) Other factors that bear on the value of the services provided.
    (d) The reasonable cost of any study, analysis, engineering report, 
test, project, or similar matter prepared on behalf of a party may be 
awarded, to the extent that the charge for the services does not exceed 
the prevailing rate for similar services, and the study or other matter 
was necessary for preparation of applicant's case.



Sec.12.107  Rulemaking on maximum rates for attorney fees.

    (a) If warranted by an increase in the cost of living or by special 
circumstances (such as limited availability of attorneys qualified to 
handle certain types of proceedings), the Commission may adopt 
regulations providing that attorney fees may be awarded at a rate higher 
than $75 per hour in some, or all of the types of proceedings covered by 
this part. The Commission will conduct any rulemaking proceedings for 
this purpose under the informal rulemaking procedures of the 
Administrative Procedure Act.
    (b) Any person may file with the Commission a petition for 
rulemaking to increase the maximum rate for attorney fees, in accordance 
with the requirements of 10 CFR 2.802. The petition should identify the 
rate the petitioner believes the Commission should establish and the 
types of proceedings in which the rate should be used. It

[[Page 285]]

should also explain fully the reasons why the higher rate is warranted. 
Within 90 days after the petition is filed, the Commission will 
determine whether it will initiate a rulemaking proceeding, deny the 
petition, or take other appropriate action on the petition. The 
Commission will act on the petition in accordance with 10 CFR 2.803.



Sec.12.108  Awards against other agencies.

    If an applicant is entitled to an award because it prevails over 
another agency of the United States that participates in a proceeding 
before the Commission and takes a position that is not substantially 
justified, the award or an appropriate portion of the award shall be 
made against that agency.



Sec.12.109  Decisionmaking authority.

    Unless otherwise ordered by the Commission in a particular 
proceeding, each application under this part shall be assigned for 
decision to the official or decisionmaking body that entered the 
decision in the adversary adjudication. That official or decisionmaking 
body is referred to in this part as the ``adjudicative officer.''



             Subpart B_Information Required From Applicants



Sec.12.201  Contents of application.

    (a) An application for an award of fees and expenses under the EAJA 
shall identify the applicant and the proceeding for which an award is 
sought. The application shall show that the applicant has prevailed and 
identify the position of the Commission or other agency that the 
applicant alleges was not substantially justified. Unless the applicant 
is an individual, the application shall also state the number of 
employees of the applicant and describe briefly the type and purpose of 
its organization or business.
    (b) The application shall also include a statement that the 
applicant's net worth does not exceed $2 million (if an individual) or 
$7 million (for all other applicants, including their affiliates). 
However, an applicant may omit this statement if:
    (1) The applicant attaches a copy of a ruling by the Internal 
Revenue Service that it qualifies as an organization described in 
section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)) or, 
in the case of a tax-exempt organization not required to obtain a ruling 
from the Internal Revenue Service on its exempt status, a statement that 
describes the basis for the applicant's belief that it qualifies under 
this section; or
    (2) The applicant states that it is a cooperative association as 
defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 
1141j(a)).
    (c) The application shall state the amount of fees and expenses for 
which an award is sought.
    (d) The application may also include any other matters that the 
applicant wishes the Commission to consider in determining whether, and 
in what amount, an award should be made.
    (e) The application shall be signed by the applicant or an 
authorized officer or attorney of the applicant. It shall also contain 
or be accompanied by a written verification under oath or under penalty 
of perjury that the information provided in the application is true and 
correct.



Sec.12.202  Net worth exhibit.

    (a) Each applicant, except a qualified tax-exempt organization or 
cooperative association must provide with its application a detailed 
exhibit showing the net worth of the applicant and any affiliates (as 
defined in Sec.12.104(f) of this part) when the proceeding was 
initiated. The exhibit may be in any form convenient to the applicant 
that provides full disclosure of the applicant's and its affiliates' 
assets and liabilities and is sufficient to determine whether the 
applicant qualifies under the standards in this part. The adjudicative 
officer may require an applicant to file additional information to 
determine its eligibility for an award.
    (b) Ordinarily, the net worth exhibit will be included in the public 
record of the proceeding. However, an applicant that objects to public 
disclosure of information in any portion of the exhibit and believes 
there are legal grounds for withholding it from disclosure may

[[Page 286]]

submit that portion of the exhibit directly to the adjudicative officer 
in a sealed envelope labeled ``Confidential Financial Information,'' 
accompanied by a motion to withhold the information from public 
disclosure. The motion shall describe the information sought to be 
withheld and explain, in detail, why it falls within one or more of the 
specific exemptions from mandatory disclosure under the Freedom of 
Information Act, 5 U.S.C. 552(b)(1)-(9), why public disclosure of the 
information would adversely affect the applicant, and why disclosure is 
not required in the public interest. The material in question shall be 
served on counsel representing the agency against which the applicant 
seeks an award, but need not be served on any other party to the 
proceeding. If the adjudicative officer finds that the information 
should not be withheld from disclosure, it shall be placed in the public 
record of the proceeding. Otherwise, any request to inspect or copy the 
exhibit shall be disposed of in accordance with the Commission's 
established procedures under the Freedom of Information Act, 10 CFR part 
9, subpart A.



Sec.12.203  Documentation of fees and expenses.

    The application shall be accompanied by full documentation of the 
fees and expenses, including the cost of any study, analysis, 
engineering report, test, project, or similar matter for which an award 
is sought. A separate itemized statement shall be submitted for each 
professional firm or individual whose services are covered by the 
application, showing the hours spent in connection with the proceeding 
by each individual, a description of the specific services performed, 
the rates at which each fee has been computed, any expenses for which 
reimbursement is sought, the total amount claimed, and the total amount 
paid or payable by the applicant or by any other person or entity for 
the services provided. The adjudicative officer may require the 
applicant to provide vouchers, receipts, logs, or other substantiation 
for any fees or expenses claimed, pursuant to Sec.12.306 of this part.



Sec.12.204  When an application may be filed.

    (a) An application may be filed whenever the applicant has prevailed 
in the proceeding or in a significant and discrete substantive portion 
of the proceeding, but in no case later than 30 days after the date on 
which a decision or order disposing of the merits of the proceeding or 
any other complete resolution of the proceeding, such as a settlement or 
voluntary dismissal, becomes final and unappealable, both within the NRC 
and to the courts.
    (b) If after the filing of an application for an award, review or 
reconsideration is sought or taken of a decision as to which an 
applicant believes it has prevailed, proceedings for the award of fees 
shall be stayed pending final disposition of the underlying controversy. 
When the United States appeals the underlying merits of an adversary 
adjudication to a court, no decision on an application for fees and 
other expenses in connection with that adversary adjudication shall be 
made until a final and unreviewable decision is rendered by the court on 
the appeal or until the underlying merits of the case have been finally 
determined pursuant to the appeal.



            Subpart C_Procedures for Considering Applications



Sec.12.301  Filing and service of documents.

    Any application for an award or other pleading or document related 
to an application shall be filed and served on all parties to the 
proceeding in the same manner as other pleadings in the proceeding, 
except as provided in Sec.12.202(b) for confidential financial 
information.



Sec.12.302  Answer to application.

    (a) Within 30 days after service of an application, counsel 
representing the NRC against which an award is sought may file an answer 
to the application. Unless the NRC counsel requests an extension of time 
for filing or files a statement of intent to negotiate under paragraph 
(b) of this section, failure to file an answer within the 30-day period

[[Page 287]]

may be treated as a consent to the award requested.
    (b) If the NRC counsel and the applicant believe that the issues in 
the fee application can be settled, they may jointly file a statement of 
their intent to negotiate a settlement. The filing of this statement 
shall extend the time for filing an answer for an additional 30 days, 
and further extensions may be granted by the adjudicative officer upon 
request by the NRC counsel and the applicant.
    (c) The answer shall explain in detail any objections to the award 
requested and identify the facts relied on in support of the NRC 
counsel's position. If the answer is based on any alleged facts not 
already in the record of the proceeding, the NRC counsel shall include 
with the answer either supporting affidavits or a request for further 
proceedings under Sec.12.306.



Sec.12.303  Reply.

    Within 15 days after service of an answer, the applicant may file a 
reply. If the reply is based on any alleged facts not already in the 
record of the proceeding, the applicant shall include with the reply 
either supporting affidavits or a request for further proceedings under 
Sec.12.306.



Sec.12.304  Comments by other parties.

    Any party to a proceeding other than the applicant and the NRC 
counsel may file comments on an application within 30 days after it is 
served, or on an answer within 15 days after it is served. A commenting 
party may not participate further in proceedings on the application 
unless the adjudicative officer determines that the public interest 
requires participation in order to permit full exploration of matters 
raised in the comments.



Sec.12.305  Settlement.

    The applicant and the NRC counsel may agree on a proposed settlement 
of the award before final action on the application, either in 
connection with a settlement of the underlying proceeding, or after the 
underlying proceeding has been concluded, in accordance with the NRC's 
standard settlement procedure. If a prevailing party and the NRC's 
counsel agree on a proposed settlement of an award before an application 
has been filed, the application shall be filed with the proposed 
settlement.



Sec.12.306  Further proceedings.

    (a) Ordinarily, the determination of an award will be made on the 
basis of the written record. However, on request of either the applicant 
or the NRC counsel, or on the adjudicative officer's own initiative, the 
adjudicative officer may order further proceedings, such as an informal 
conference, oral argument, additional written submissions or, as to 
issues other than substantial justification (such as the applicant's 
eligibility or substantiation of fees and expenses), pertinent discovery 
or an evidentiary hearing. Further proceedings shall be held only when 
necessary for full and fair resolution of the issues arising from the 
application, and shall be conducted as promptly as possible. Whether or 
not the position of the agency was substantially justified shall be 
determined on the basis of the administrative record, as a whole, which 
is made in the adversary adjudication for which fees and other expenses 
are sought.
    (b) A request that the adjudicative officer order further 
proceedings under this section shall specifically identify the 
information sought or the disputed issues and shall explain why the 
additional proceedings are necessary to resolve the issues.



Sec.12.307  Decision.

    (a) The adjudicative officer shall issue an initial decision on the 
application within 90 days after completion of proceedings on the 
application. If the adjudicative officer fails to issue an initial 
decision within 90 days, he or she shall notify the parties of the 
reason for the delay and shall set a new deadline.
    (b) The initial decision shall include written findings and 
conclusions on the applicant's eligibility and status as a prevailing 
party, and an explanation of the reasons for any difference between the 
amount requested and the amount awarded. The decision shall also 
include, if at issue, findings on whether the NRC's position was 
substantially justified, whether the applicant unduly

[[Page 288]]

protracted the proceedings, or whether special circumstances make an 
award unjust. If the applicant has sought an award against more than one 
agency, the decision shall allocate responsibility for payment of any 
award made among the agencies, and shall explain the reasons for the 
allocation made.



Sec.12.308  Agency review.

    (a) Either the applicant or the NRC counsel may seek review of the 
initial decision on the fee application, or the Commission may decide to 
review the decision on its own initiative, in accordance with the 
Commission's review procedures set out in 10 CFR 2.341. The filing of a 
petition for review is mandatory for a party to exhaust its 
administrative remedies before seeking judicial review. If neither the 
applicant nor NRC counsel seeks review and the Commission does not take 
review on its own initiative, the initial decision on the application 
shall become a final decision of the NRC 120 days after it is issued.
    (b) Notwithstanding anything to the contrary in any other part of 
the Commission's regulations, the initial decision shall be inoperative 
(i.e., the decision shall not be final and any award made shall not be 
paid) until the later of--
    (1) The expiration of the 120 day period provided in paragraph (a) 
of this section; or
    (2) If within the 120 day period provided in paragraph (a) of this 
section the Commission elects to review the decision, the Commission's 
issuance of a final decision on review of the initial decision.
    (c) Whether to review a decision on its own motion is a matter 
within the discretion of the Commission. If review is taken, the 
Commission will issue a final decision on the application or remand the 
application to the adjudicative officer for further proceedings.

[59 FR 23121, May 5, 1994, as amended at 77 FR 46599, Aug. 3, 2012]



Sec.12.309  Judicial review.

    Judicial review of final agency decisions on awards may be sought as 
provided in 5 U.S.C. 504(c)(2).



Sec.12.310  Payment of award.

    An applicant seeking payment of an award shall submit to the 
appropriate official of the paying agency a copy of the Commission's 
final decision granting the award, accompanied by a certification that 
the applicant will not seek review of the decision in the United States 
courts. Where the award is granted against the Commission, the applicant 
shall make the submission to the Director, Division of Accounting and 
Finance, Office of the Controller, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555. The NRC will pay the amount awarded to the 
applicant within 60 days.



PART 13_PROGRAM FRAUD CIVIL REMEDIES--Table of Contents



Sec.
13.1 Basis and purpose.
13.2 Definitions.
13.3 Basis for civil penalties and assessments.
13.4 Investigation.
13.5 Review by the reviewing official.
13.6 Prerequisites for issuing a complaint.
13.7 Complaint.
13.8 Service of complaint.
13.9 Answer.
13.10 Default upon failure to file an answer.
13.11 Referral of complaint and answer to the ALJ.
13.12 Notice of hearing.
13.13 Parties to the hearing.
13.14 Separation of functions.
13.15 Ex parte contacts.
13.16 Disqualification of reviewing official or ALJ.
13.17 Rights of parties.
13.18 Authority of the ALJ.
13.19 Prehearing conferences.
13.20 Disclosure of documents.
13.21 Discovery.
13.22 Exchange of witness lists, statements, and exhibits.
13.23 Subpoenas for attendance at hearing.
13.24 Protective order.
13.25 Fees.
13.26 Filing and service of papers.
13.27 Computation of time.
13.28 Motions.
13.29 Sanctions.
13.30 The hearing and burden of proof.
13.31 Determining the amount of penalties and assessments.
13.32 Location of hearing.
13.33 Witnesses.
13.34 Evidence.
13.35 The record.
13.36 Post-hearing briefs.

[[Page 289]]

13.37 Initial decision.
13.38 Reconsideration of initial decision.
13.39 Appeal to authority head.
13.40 Stays ordered by the Department of Justice.
13.41 Stay pending appeal.
13.42 Judicial review.
13.43 Collection of civil penalties and assessments.
13.44 Right to administrative offset.
13.45 Deposit in Treasury of United States.
13.46 Compromise or settlement.
13.47 Limitations.

    Authority: 31 U.S.C. 3801 through 3812; 44 U.S.C. 3504 note.
    Section 13.3 also issued under 28 U.S.C. 2461 note.
    Section 13.13 also issued under 31 U.S.C. 3730.

    Source: 56 FR 47135, Sept. 18, 1991, unless otherwise noted.



Sec.13.1  Basis and purpose.

    (a) Basis. This part implements the Program Fraud Civil Remedies Act 
of 1986, Public Law No. 99-509, Sec. Sec.6101-6104, 100 Stat. 1874 
(October 21, 1986) (31 U.S.C. 3801-3812). 31 U.S.C. 3809 requires each 
authority head to promulgate regulations necessary to implement the 
provisions of that Act.
    (b) Purpose. This part (1) establishes administrative procedures for 
imposing civil penalties and assessments against persons who make, 
submit, or present, or cause to be made, submitted, or presented, false, 
fictitious, or fraudulent claims or written statements to authorities or 
to their agents, and (2) specifies the hearing and appeal rights of 
persons subject to allegations of liability for such penalties and 
assessments.



Sec.13.2  Definitions.

    As used in this part:
    ALJ means an Administrative Law Judge in the authority appointed 
pursuant to 5 U.S.C. 3105 or detailed to the authority pursuant to 5 
U.S.C. 3344.
    Authority means the Nuclear Regulatory Commission.
    Authority head means the Commission of five members or a quorum 
thereof sitting as a body, as provided by section 201 of the Energy 
Reorganization Act of 1974 (88 Stat. 1242).
    Benefit means, in the context of ``statement'', anything of value, 
including but not limited to any advantage, preference, privilege, 
license, permit, favorable decision, ruling, status, or loan guarantee.
    Claim means any request, demand, or submission--
    (a) Made to the authority for property, services, or money 
(including money representing grants, loans, insurance, or benefits);
    (b) Made to a recipient of property, services, or money from the 
authority or to a party to a contract with the authority--
    (1) For property or services if the United States--
    (i) Provided such property or services;
    (ii) Provided any portion of the funds for the purchase of such 
property or services; or
    (iii) Will reimburse such recipient or party for the purchase of 
such property or services; or
    (2) For the payment of money (including money representing grants, 
loans, insurance, or benefits) if the United States--
    (i) Provided any portion of the money requested or demanded; or
    (ii) Will reimburse such recipient or party for any portion of the 
money paid on such request or demand; or
    (c) Made to the authority which has the effect of decreasing an 
obligation to pay or account for property, services, or money.
    Complaint means the administrative complaint served by the reviewing 
official on the defendant under Sec.13.7.
    Defendant means any person alleged in a complaint under Sec.13.7 
to be liable for a civil penalty or assessment under Sec.13.3.
    Digital ID certificate means a file stored on a participant's 
computer that contains the participant's name, e-mail address, and 
participant's digital signature, proves the participant's identity when 
filing documents and serving participants electronically through the E-
Filing system, and contains public keys, which allow for the encryption 
and decryption of documents so that the documents can be securely 
transferred over the Internet.
    Electronic acknowledgment means a communication transmitted 
electronically from the E-Filing system to the submitter confirming 
receipt of electronic filing and service.

[[Page 290]]

    Electronic Hearing Docket means the publicly available Web site 
which houses a visual presentation of the docket and a link to its 
files.
    E-Filing System means an electronic system that receives, stores, 
and distributes documents filed in proceedings for which an electronic 
hearing docket has been established.
    Government means the United States Government.
    Guidance for Electronic Submissions to the NRC means the document 
issued by the Commission that sets forth the transmission methods and 
formatting standards for filing and service under E-Filing. The document 
can be obtained by visiting the NRC's Web site at http://www.nrc.gov.
    Individual means a natural person.
    Initial decision means the written decision of the ALJ required by 
Sec.13.10 or Sec.13.37, and includes a revised initial decision 
issued following a remand or a motion for reconsideration.
    Investigating official means the Inspector General of the Nuclear 
Regulatory Commission or the Assistant Inspector General for 
Investigations, Office of the Inspector General.
    Knows or has reason to know means that a person, with respect to a 
claim or statement--
    (a) Has actual knowledge that the claim or statement is false, 
fictitious, or fraudulent;
    (b) Acts in deliberate ignorance of the truth or falsity of the 
claim or statement; or
    (c) Acts in reckless disregard of the truth or falsity of the claim 
or statement.
    Makes, wherever it appears, shall include the terms presents, 
submits, and causes to be made, presented, or submitted. As the context 
requires, making or made shall likewise include the corresponding forms 
of such terms.
    Optical Storage Media means any physical computer component that 
meets E-Filing Guidance standards for storing, saving, and accessing 
electronic documents.
    Participant means an individual or organization that has petitioned 
to intervene in a proceeding or requested a hearing but that has not yet 
been granted party status by an Atomic Safety and Licensing Board or 
other presiding officer. Participant also means a party to a proceeding 
and any interested State, local governmental body, or affected 
Federally-recognized Indian Tribe that seeks to participate in a 
proceeding in accordance with Sec.2.315(c). For the purpose of service 
of documents, the NRC staff is considered a participant even if not 
participating as a party.
    Person means any individual, partnership, corporation, association, 
or private organization and includes the plural of that term.
    Representative means any person designated by a party in writing.
    Reviewing official means the General Counsel of the Nuclear 
Regulatory Commission or his or her designee who is--
    (a) Not subject to supervision by, or required to report to, the 
investigating official;
    (b) Not employed in the organizational unit of the authority in 
which the investigating official is employed; and
    (c) Serving in a position for which the rate of basic pay is not 
less than the minimum rate of basic pay for grade GS-16 under the 
General Schedule.
    Statement means any representation, certification, affirmation, 
document, record, or accounting or bookkeeping entry made--
    (a) With respect to a claim or to obtain the approval or payment of 
a claim (including relating to eligibility to make a claim); or
    (b) With respect to (including relating to eligibility for)--
    (1) A contract with, or a bid or proposal for a contract with, or
    (2) A grant, loan, or benefit from,
    (i) The authority, or
    (ii) Any State, political subdivision of a State, or other party, if 
the United States government provides any portion of the money or 
property under such contract or for such grant, loan, or benefit, or if 
the Government will reimburse such State, political subdivision, or 
party for any portion of the

[[Page 291]]

money or property under such contract or for such grant, loan, or 
benefit.

[56 FR 47135, Sept. 18, 1991; 56 FR 49945, Oct. 2, 1991, as amended at 
62 FR 40427, July 29, 1997; 65 FR 59272, Oct. 4, 2000; 71 FR 15007, Mar. 
27, 2006; 72 FR 49152, Aug. 28, 2007; 72 FR 64529, Nov. 16, 2007]



Sec.13.3  Basis for civil penalties and assessments.

    (a) Claims. (1) Any person who makes a claim that the person knows 
or has reason to know--
    (i) Is false, fictitious, or fraudulent;
    (ii) Includes or is supported by any written statement which asserts 
a material fact which is false, fictitious, or fraudulent;
    (iii) Includes or is supported by any written statement that--
    (A) Omits a material fact;
    (B) Is false, fictitious, or fraudulent as a result of such 
omission; and
    (C) Is a statement in which the person making such statement has a 
duty to include such material fact; or
    (iv) Is for payment for the provision of property or services which 
the person has not provided as claimed, shall be subject, in addition to 
any other remedy that may be prescribed by law, to a civil penalty of 
not more than $11,181 for each such claim.
    (2) Each voucher, invoice, claim form, or other individual request 
or demand for property, services, or money constitutes a separate claim.
    (3) A claim shall be considered made to the authority, recipient, or 
party when such claim is actually made to an agent, fiscal intermediary 
or other entity, including any State or political subdivision thereof, 
acting for or on behalf of the authority, recipient, or party.
    (4) Each claim for property, services, or money is subject to a 
civil penalty regardless of whether such property, services, or money is 
actually delivered or paid.
    (5) If the Government has made any payment (including transferred 
property or provided services) on a claim, a person subject to a civil 
penalty under paragraph (a)(1) of this section shall also be subject to 
an assessment of not more than twice the amount of such claim or that 
portion thereof that is determined to be in violation of paragraph 
(a)(1) of this section. Such assessment shall be in lieu of damages 
sustained by the Government because of such claim.
    (b) Statements. (1) Any person who makes a written statement that--
    (i) The person knows or has reason to know--
    (A) Asserts a material fact which is false, fictitious, or 
fraudulent; or
    (B) Is false, fictitious, or fraudulent because it omits a material 
fact that the person making the statement has a duty to include in such 
statement; and
    (ii) Contains or is accompanied by an express certification or 
affirmation of the truthfulness and accuracy of the contents of the 
statement, shall be subject, in addition to any other remedy that may be 
prescribed by law, to a civil penalty of not more than $11,181 for each 
such statement.
    (2) Each written representation, certification, or affirmation 
constitutes a separate statement.
    (3) A statement shall be considered made to the authority when such 
statement is actually made to an agent, fiscal intermediary, or other 
entity, including any State or political subdivision thereof, acting for 
or on behalf of the authority.
    (c) No proof of specific intent to defraud is required to establish 
liability under this section.
    (d) In any case in which it is determined that more than one person 
is liable for making a claim or statement under this section, each such 
person may be held liable for a civil penalty under this section.
    (e) In any case in which it is determined that more than one person 
is liable for making a claim under this section on which the Government 
has made payment (including transferred property or provided services), 
an assessment may be imposed against any such person or jointly and 
severally against any combination of such persons.

[56 FR 47135, Sept. 18, 1991, as amended at 61 FR 53555, Oct. 11, 1996; 
62 FR 59275, Nov. 3, 1997; 65 FR 59273, Oct. 4, 2000; 71 FR 15007, Mar. 
27, 2006; 73 FR 54673, Sept. 23, 2008; 81 FR 43021, July 1, 2016; 82 FR 
8135, Jan. 24, 2017; 83 FR 1517, Jan. 12, 2018]

[[Page 292]]



Sec.13.4  Investigation.

    (a) If an investigating official concludes that a subpoena pursuant 
to the authority conferred by 31 U.S.C. 3804(a) is warranted--
    (1) The subpoena so issued shall notify the person to whom it is 
addressed of the authority under which the subpoena is issued and shall 
identify the records or documents sought;
    (2) The investigating official may designate a person to act on his 
or her behalf to receive the documents sought; and
    (3) The person receiving such subpoena shall be required to tender 
to the investigating official or the person designated to receive the 
documents a certification that the documents sought have been produced, 
or that such documents are not available and the reasons therefor, or 
that such documents, suitably identified, have been withheld based upon 
the assertion of an identified privilege.
    (b) If the investigating official concludes that an action under the 
Program Fraud Civil Remedies Act may be warranted, the investigating 
official shall submit a report containing the findings and conclusions 
of such investigation to the reviewing official. To the extent possible, 
before initiating an investigation or submitting a report involving a 
licensee false statement to the reviewing official, the investigating 
official shall consult with the Executive Director for Operations to 
ascertain whether any other agency action is under consideration, 
pending, or may be taken with regard to the licensee, and to allow for 
coordination between any action under this part and other enforcement 
action.
    (c) Nothing in this section shall preclude or limit an investigating 
official's discretion to refer allegations directly to the Department of 
Justice for suit under the False Claims Act or other civil relief, or to 
refer the matter to the Executive Director for Operations for 
enforcement action under the Atomic Energy Act, or to defer initiating 
an investigation or postpone a report or referral to the reviewing 
official to avoid interference with other enforcement action by the 
Commission or with a criminal investigation or prosecution.
    (d) Nothing in this section modifies any responsibility of an 
investigating official to report violations of criminal law to the 
Attorney General.



Sec.13.5  Review by the reviewing official.

    (a) If, based on the report of the investigating official under 
Sec.13.4(b), the reviewing official determines that there is adequate 
evidence to believe that a person is liable under Sec.13.3 of this 
part, the reviewing official shall transmit to the Attorney General a 
written notice of the reviewing official's intention to issue a 
complaint under Sec.13.7.
    (b) Such notice shall include--
    (1) A statement of the reviewing official's reasons for issuing a 
complaint;
    (2) A statement specifying the evidence that supports the 
allegations of liability;
    (3) A description of the claims or statements upon which the 
allegations of liability are based;
    (4) An estimate of the amount of money or the value of property, 
services, or other benefits requested or demanded in violation of Sec.
13.3 of this part;
    (5) A statement of any exculpatory or mitigating circumstances that 
may relate to the claims or statements known by the reviewing official 
or the investigating official; and
    (6) A statement that there is a reasonable prospect of collecting an 
appropriate amount of penalties and assessments.



Sec.13.6  Prerequisities for issuing a complaint.

    (a) The reviewing official may issue a complaint under Sec.13.7 
only if--
    (1) The Department of Justice approves the issuance of a complaint 
in a written statement described in 31 U.S.C. 3803(b)(1), and
    (2) In the case of allegations of liability under Sec.13.3(a) with 
respect to a claim, the reviewing official determines that, with respect 
to such claim or a group of related claims submitted at the same time 
such claim is submitted (as defined in paragraph (b) of this section), 
the amount of money or the value of property or services demanded or 
requested in violation of Sec.13.3(a) does not exceed $150,000.

[[Page 293]]

    (b) For the purposes of this section, a related group of claims 
submitted at the same time shall include only those claims arising from 
the same transaction (e.g., grant, loan, application, or contract) that 
are submitted simultaneously as part of a single request, demand, or 
submission.
    (c) Nothing in this section shall be construed to limit the 
reviewing official's authority to join in a single complaint against a 
person claims that are unrelated or were not submitted simultaneously, 
regardless of the amount of money, or the value of property or services, 
demanded or requested.

[56 FR 47135, Sept. 18, 1991; 56 FR 49945, Oct. 2, 1991]



Sec.13.7  Complaint.

    (a) On or after the date the Department of Justice approves the 
issuance of a complaint in accordance with 31 U.S.C. 3803(b)(1), the 
reviewing official may serve a complaint on the defendant, as provided 
in Sec.13.8.
    (b) The complaint shall state--
    (1) The allegations of liability against the defendant, including 
the statutory basis for liability, an identification of the claims or 
statements that are the basis for the alleged liability, and the reasons 
why liability allegedly arises from such claims or statements;
    (2) The maximum amount of penalties and assessments for which the 
defendant may be held liable;
    (3) Instructions for filing an answer to request a hearing, 
including a specific statement of the defendant's right to request a 
hearing by filing an answer and to be represented by a representative; 
and
    (4) That failure to file an answer within 30 days of service of the 
complaint will result in the imposition of the maximum amount of 
penalties and assessments without right to appeal, as provided in Sec.
13.10.
    (c) At the same time the reviewing official serves the complaint, he 
or she shall serve the defendant with a copy of these regulations.



Sec.13.8  Service of complaint.

    (a) Service of a complaint must be made by certified or registered 
mail or by delivery in any manner authorized by Rule 4(d) of the Federal 
Rules of Civil Procedure. Service is complete upon receipt.
    (b) Proof of service, stating the name and address of the person on 
whom the complaint was served, and the manner and date of service, may 
be made by--
    (1) Affidavit of the individual serving the complaint by delivery;
    (2) A United States Postal Service return receipt card acknowledging 
receipt; or
    (3) Written acknowledgment of receipt by the defendant or his or her 
representative.

[56 FR 47135, Sept. 18, 1991, as amended at 71 FR 15007, Mar. 27, 2006]



Sec.13.9  Answer.

    (a) The defendant may request a hearing by filing an answer with the 
reviewing official within thirty (30) days of service of the complaint. 
Service of an answer shall be made by electronically delivering a copy 
to the reviewing official in accordance with Sec.13.26. An answer 
shall be deemed a request for hearing.
    (b) In the answer, the defendant--
    (1) Shall admit or deny each of the allegations of liability made in 
the complaint;
    (2) Shall state any defense on which the defendant intends to rely;
    (3) May state any reasons why the defendant contends that the 
penalties and assessments should be less than the statutory maximum; and
    (4) Shall state the name, address, and telephone number of the 
person authorized by the defendant to act as defendant's representative, 
if any.
    (c) If the defendant is unable to file an answer meeting the 
requirements of paragraph (b) of this section within the time provided, 
the defendant may, before the expiration of 30 days from service of the 
complaint, file with the reviewing official a general answer denying 
liability and requesting a hearing, and a request for an extension of 
time within which to file an answer meeting the requirements of 
paragraph (b) of this section. The reviewing official shall file 
promptly with the ALJ the complaint, the general answer denying 
liability, and the request for an extension of time as provided in Sec.
13.11. For good cause shown, the ALJ may

[[Page 294]]

grant the defendant up to 30 additional days within which to file an 
answer meeting the requirements of paragraph (b) of this section.

[56 FR 47135, Sept. 18, 1991; 56 FR 64839, Dec. 12, 1991; 72 FR 49152, 
Aug. 28, 2007]



Sec.13.10  Default upon failure to file an answer.

    (a) If the defendant does not file an answer within the time 
prescribed in Sec.13.9(a), the reviewing official may refer the 
complaint to the ALJ.
    (b) Upon the referral of the complaint, the ALJ shall promptly serve 
on defendant in the manner prescribed in Sec.13.8 a notice that an 
initial decision will be issued under this section.
    (c) The ALJ shall assume the facts alleged in the complaint to be 
true, and, if such facts establish liability under Sec.13.3, the ALJ 
shall issue an initial decision imposing the maximum amount of penalties 
and assessments allowed under the statute.
    (d) Except as otherwise provided in this section, by failing to file 
a timely answer, the defendant waives any right to further review of the 
penalties and assessments imposed under paragraph (c) of this section 
and the initial decision shall become final and binding upon the parties 
30 days after it is issued.
    (e) If, before such an initial decision becomes final, the defendant 
files a motion with the ALJ seeking to reopen on the grounds that 
extraordinary circumstances prevented the defendant from filing an 
answer, the initial decision shall be stayed pending the ALJ's decision 
on the motion.
    (f) If, on such motion, the defendant can demonstrate extraordinary 
circumstances excusing the failure to file a timely answer, the ALJ 
shall withdraw the initial decision in paragraph (c) of this section if 
such a decision has been issued, and shall grant the defendant an 
opportunity to answer the complaint.
    (g) A decision of the ALJ denying a defendant's motion under 
paragraph (e) of this section is not subject to reconsideration under 
Sec.13.38.
    (h) The defendant may appeal to the authority head the decision 
denying a motion to reopen by filing a notice of appeal with the 
authority head within 15 days after the ALJ denies the motion. The 
timely filing of a notice of appeal shall stay the initial decision 
until the authority head decides the issue.
    (i) If the defendant files a timely notice of appeal with the 
authority head, the ALJ shall forward the record of the proceeding to 
the authority head.
    (j) The authority head shall decide expeditiously whether 
extraordinary circumstances excuse the defendant's failure to file a 
timely answer based solely on the record before the ALJ.
    (k) If the authority head decides that extraordinary circumstances 
excused the defendant's failure to file a timely answer, the authority 
head shall remand the case to the ALJ with instructions to grant the 
defendant an opportunity to answer.
    (l) If the authority head decides that the defendant's failure to 
file a timely answer is not excused, the authority head shall reinstate 
the initial decision of the ALJ, which shall become final and binding 
upon the parties 30 days after the authority head issues such decision.



Sec.13.11  Referral of complaint and answer to the ALJ.

    Upon receipt of an answer, the reviewing official shall file the 
complaint and answer with the ALJ.



Sec.13.12  Notice of hearing.

    (a) When the ALJ receives the complaint and answer, the ALJ shall 
promptly serve a notice of hearing upon the defendant in the manner 
prescribed by Sec.13.8. At the same time, the ALJ shall send a copy of 
such notice to the representative of the authority.
    (b) Such notice shall include--
    (1) The tentative time and place, and the nature of the hearing;
    (2) The legal authority and jurisdiction under which the hearing is 
to be held;
    (3) The matters of fact and law to be asserted;
    (4) A description of the procedures for the conduct of the hearing;
    (5) The name, address, and telephone number of the representative of 
the authority and of the defendant, if any; and

[[Page 295]]

    (6) Such other matters as the ALJ deems appropriate.



Sec.13.13  Parties to the hearing.

    (a) The parties to the hearing shall be the defendant and the 
authority.
    (b) Pursuant to 31 U.S.C. 3730(c)(5), a private plaintiff under the 
False Claims Act may participate in these proceedings to the extent 
authorized by the provisions of that Act.



Sec.13.14  Separation of functions.

    (a) The investigating official, the reviewing official, and any 
employee or agent of the authority who takes part in investigating, 
preparing, or presenting a particular case may not, in such case or a 
factually related case--
    (1) Participate in the hearing as the ALJ;
    (2) Participate or advise in the initial decision or the review of 
the initial decision by the authority head, except as a witness or a 
representative in public proceedings; or
    (3) Make the collection of penalties and assessments under 31 U.S.C. 
3806.
    (b) The ALJ shall not be responsible to, or subject to the 
supervision or direction of, the investigating official or the reviewing 
official.
    (c) Except as provided in paragraph (a) of this section, the 
representative for the Government may be employed anywhere in the 
authority, including in the offices of either the investigating official 
or the reviewing official.

[56 FR 47135, Sept. 18, 1991; 56 FR 64839, Dec. 12, 1991]



Sec.13.15  Ex parte contacts.

    No party or person (except employees of the ALJ's office) shall 
communicate in any way with the ALJ on any matter at issue in a case, 
unless on notice and opportunity for all parties to participate. This 
provision does not prohibit a person or party from inquiring about the 
status of a case or asking routine questions concerning administrative 
functions or procedures.



Sec.13.16  Disqualification of reviewing official or ALJ.

    (a) A reviewing official or ALJ in a particular case may disqualify 
himself or herself at any time.
    (b) A party may file with the ALJ a motion for disqualification of a 
reviewing official or an ALJ. Such motion shall be accompanied by an 
affidavit alleging personal bias or other reason for disqualification.
    (c) Such motion and affidavit shall be filed promptly upon the 
party's discovery of reasons requiring disqualification, or such 
objections, shall be deemed waived.
    (d) Such affidavit shall state specific facts that support the 
party's belief that personal bias or other reason for disqualification 
exists and the time and circumstances of the party's discovery of such 
facts. It shall be accompanied by a certificate of the representative of 
record that it is made in good faith.
    (e) Upon the filing of such a motion and affidavit, the ALJ shall 
proceed no further in the case until he or she resolves the matter of 
disqualification in accordance with paragraph (f) of this section.
    (f)(1) If the ALJ determines that a reviewing official is 
disqualified, the ALJ shall dismiss the complaint without prejudice.
    (2) If the ALJ disqualifies himself or herself, the case shall be 
reassigned promptly to another ALJ.
    (3) If the ALJ denies a motion to disqualify, the authority head may 
determine the matter only as part of its review of the initial decision 
upon appeal, if any.



Sec.13.17  Rights of parties.

    Except as otherwise limited by this part, all parties may--
    (a) Be accompanied, represented, and advised by a representative;
    (b) Participate in any conference held by the ALJ;
    (c) Conduct discovery;
    (d) Agree to stipulation of fact or law, which shall be made part of 
the record;
    (e) Present evidence relevant to the issues at the hearing;
    (f) Present and cross-examine witnesses;
    (g) Present oral arguments at the hearing as permitted by the ALJ; 
and
    (h) Submit written briefs and proposed findings of fact and 
conclusions of law after the hearing.

[[Page 296]]



Sec.13.18  Authority of the ALJ.

    (a) The ALJ shall conduct a fair and impartial hearing, avoid delay, 
maintain order, and assure that a record of the proceeding is made.
    (b) The ALJ has the authority to--
    (1) Set and change the date, time, and place of the hearing upon 
reasonable notice to the parties;
    (2) Continue or recess the hearing in whole or in part for a 
reasonable period of time;
    (3) Hold conferences to identify or simplify the issues, or to 
consider other matters that may aid in the expeditious disposition of 
the proceeding;
    (4) Administer oaths and affirmations;
    (5) Issue subpoenas requiring the attendance of witnesses and the 
production of documents at depositions or at hearings;
    (6) Rule on motions and other procedural matters;
    (7) Regulate the scope and timing of discovery;
    (8) Regulate the course of the hearing and the conduct of 
representatives and parties;
    (9) Examine witnesses;
    (10) Receive, rule on, exclude, or limit evidence;
    (11) Upon motion of a party, take official notice of facts;
    (12) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact;
    (13) Conduct any conference, argument, or hearing on motions in 
person or by telephone; and
    (14) Exercise such other authority as is necessary to carry out the 
responsibilities of the ALJ under this part.
    (c) The ALJ does not have the authority to find Federal statutes or 
regulations invalid.



Sec.13.19  Prehearing conferences.

    (a) The ALJ may schedule prehearing conferences as appropriate.
    (b) Upon the motion of any party, the ALJ shall schedule at least 
one prehearing conference at a reasonable time in advance of the 
hearing.
    (c) The ALJ may use prehearing conferences to discuss the following:
    (1) Simplification of the issues;
    (2) The necessity or desirability of amendments to the pleadings, 
including the need for a more definite statement;
    (3) Stipulations and admissions of fact or as to the contents and 
authenticity of documents;
    (4) Whether the parties can agree to submission of the case on a 
stipulated record;
    (5) Whether a party chooses to waive appearance at an oral hearing 
and to submit only documentary evidence (subject to the objection of 
other parties) and written argument;
    (6) Limitation of the number of witnesses;
    (7) Scheduling dates for the exchange of witness lists and of 
proposed exhibits;
    (8) Discovery;
    (9) The time and place for the hearing; and
    (10) Such other matters as may tend to expedite the fair and just 
disposition of the proceedings.
    (d) The ALJ may issue an order containing all matters agreed upon by 
the parties or ordered by the ALJ at a prehearing conference.



Sec.13.20  Disclosure of documents.

    (a) Upon written request to the reviewing official, the defendant 
may review any relevant and material documents, transcripts, records, 
and other materials that relate to the allegations set out in the 
complaint and upon which the findings and conclusions of the 
investigating official under Sec.13.4(b) are based, unless such 
documents are subject to a privilege under Federal law. Upon payment of 
fees for duplication, the defendant may obtain copies of such documents.
    (b) Upon written request to the reviewing official, the defendant 
also may obtain a copy of all exculpatory information in the possession 
of the reviewing official or investigating official relating to the 
allegations in the complaint, even if it is contained in a document that 
would otherwise be privileged. If the document would otherwise be 
privileged, only that portion containing exculpatory information must be 
disclosed.
    (c) The notice sent to the Attorney General from the reviewing 
official as

[[Page 297]]

described in Sec.13.5 is not discoverable under any circumstances.
    (d) The defendant may file a motion to compel disclosure of the 
documents subject to the provisions of this section. Such a motion may 
only be filed with the ALJ following the filing of an answer pursuant to 
Sec.13.9.



Sec.13.21  Discovery.

    (a) The following types of discovery are authorized:
    (1) Requests for production of documents for inspection and copying;
    (2) Requests for admissions of the authenticity of any relevant 
document or of the truth of any relevant fact;
    (3) Written interrogatories; and
    (4) Depositions.
    (b) For the purpose of this section and Sec. Sec.13.22 and 13.23, 
the term ``documents'' includes information, documents, reports, 
answers, records, accounts, papers, and other data and documentary 
evidence. Nothing contained herein shall be interpreted to require the 
creation of a document.
    (c) Unless mutually agreed to by the parties, discovery is available 
only as ordered by the ALJ. The ALJ shall regulate the timing of 
discovery.
    (d) Motions for discovery. (1) A party seeking discovery may file a 
motion with the ALJ. Such a motion shall be accompanied by a copy of the 
requested discovery, or in the case of depositions, a summary of the 
scope of the proposed deposition.
    (2) Within ten days of service, a party may file an opposition to 
the motion and/or a motion for protective order as provided in Sec.
13.24.
    (3) The ALJ may grant a motion for discovery only if he or she finds 
that the discovery sought--
    (i) Is necessary for the expeditious, fair, and reasonable 
consideration of the issues;
    (ii) Is not unduly costly or burdensome;
    (iii) Will not unduly delay the proceeding; and
    (iv) Does not seek privileged information.
    (4) The burden of showing that discovery should be allowed is on the 
party seeking discovery.
    (5) The ALJ may grant discovery subject to a protective order under 
Sec.13.24.
    (e) Depositions. (1) If a motion for deposition is granted, the ALJ 
shall issue a subpoena for the deponent, which may require the deponent 
to produce documents. The subpoena shall specify the time and place at 
which the deposition will be held.
    (2) The party seeking to depose shall serve the subpoena in the 
manner prescribed in Sec.13.8.
    (3) The deponent may file with the ALJ a motion to quash the 
subpoena or a motion for a protective order within ten days of service.
    (4) The party seeking to depose shall provide for the taking of a 
verbatim transcript of the deposition, which it shall make available to 
all other parties for inspection and copying.
    (f) Each party shall bear its own costs of discovery.



Sec.13.22  Exchange of witness lists, statements, and exhibits.

    (a) At least 15 days before the hearing or at such other times as 
may be ordered by the ALJ, the parties shall exchange witness lists, 
copies of prior statements of proposed witnesses, and copies of proposed 
hearing exhibits, including copies of any written statements that the 
party intends to offer in lieu of live testimony in accordance with 
Sec.13.33(b). At the time the above documents are exchanged, any party 
that intends to rely on the transcript of deposition testimony in lieu 
of live testimony at the hearing, if permitted by the ALJ, shall provide 
each party with a copy of the specific pages of the transcript it 
intends to introduce into evidence.
    (b) If a party objects, the ALJ shall not admit into evidence the 
testimony of any witness whose name does not appear on the witness list 
or any exhibit not provided to the opposing party as provided above 
unless the ALJ finds good cause for the failure or that there in no 
prejudice to the objecting party.
    (c) Unless another party objects within the time set by the ALJ, 
documents exchanged in accordance with paragraph (a) of this section 
shall be deemed to be authentic for the purpose of admissibility at the 
hearing.

[[Page 298]]



Sec.13.23  Subpoenas for attendance at hearing.

    (a) A party wishing to procure the appearance and testimony of any 
individual at the hearing may request that the ALJ issue a subpoena.
    (b) A subpoena requiring the attendance and testimony of an 
individual may also require the individual to produce documents at the 
hearing.
    (c) A party seeking a subpoena shall file a written request therefor 
not less than 15 days before the date fixed for the hearing unless 
otherwise allowed by the ALJ for good cause shown. Such request shall 
specify any documents to be produced and shall designate the witnesses 
and describe the address and location thereof with sufficient 
particularity to permit such witnesses to be found.
    (d) The subpoena shall specify the time and place at which the 
witness is to appear and any documents the witness is to produce.
    (e) The party seeking the subpoena shall serve it in the manner 
prescribed in Sec.13.8. A subpoena on a party or upon an individual 
under the control of a party may be served by first class mail.
    (f) A party or the individual to whom the subpoena is directed may 
file with the ALJ a motion to quash the subpoena within ten days after 
service or on or before the time specified in the subpoena for 
compliance if it is less than ten days after service.



Sec.13.24  Protective order.

    (a) A party or a prospective witness or deponent may file a motion 
for a protective order with respect to discovery sought by an opposing 
party or with respect to the hearing, seeking to limit the availability 
or disclosure of evidence.
    (b) In issuing a protective order, the ALJ may make any order which 
justice requires to protect a party or person from annoyance, 
embarrassment, oppression, or undue burden or expense, including one or 
more of the following:
    (1) That the discovery not be had;
    (2) That the discovery may be had only on specified terms and 
conditions, including a designation of the time or place;
    (3) That the discovery may be had only through a method of discovery 
other than that requested;
    (4) That certain matters not be inquired into, or that the scope of 
discovery be limited to certain matters;
    (5) That discovery be conducted with no one present except persons 
designated by the ALJ;
    (6) That the contents of discovery or evidence by sealed;
    (7) That a deposition after being sealed be opened only by order of 
the ALJ;
    (8) That a trade secret or other confidential research, development, 
commercial information, or facts pertaining to any criminal 
investigation, proceeding, or other administrative investigation not be 
disclosed or be disclosed only in a designated way; or
    (9) That the parties simultaneously file specified documents or 
information enclosed in sealed envelopes to be opened as directed by the 
ALJ.



Sec.13.25  Fees.

    The party requesting a subpoena shall pay the cost of the fees and 
mileage of any witness subpoenaed in the amounts that would be payable 
to a witness in a proceeding in United States District Court. A check 
for witness fees and mileage shall accompany the subpoena when served, 
except that when a subpoena is issued on behalf of the authority, a 
check for witness fees and mileage need not accompany the subpoena.



Sec.13.26  Filing and service of papers.

    (a) Filing. (1) Unless otherwise provided by order, all filings must 
be made as electronic submissions in a manner that enables the NRC to 
receive, read, authenticate, distribute, and archive the submission, and 
process and retrieve it a single page at a time. Detailed guidance on 
making electronic submissions may be found in the E-Filing Guidance and 
on the NRC Web site at http://www.nrc.gov/site-help/e-submittals.html. 
If a filing contains sections of information or electronic formats that 
may not be transmitted electronically for security or other reasons, 
portions not containing those sections will be transmitted 
electronically to the E-Filing system. In addition, optical

[[Page 299]]

storage media (OSM) containing the entire filing must be physically 
delivered or mailed. In such cases, the submitter does not need to apply 
to the Commission for an exemption to deviate from the requirements in 
paragraph (a) of this section.
    (2) Electronic transmission exemption. The ALJ may relieve a 
participant who is filing electronic documents of the transmission 
requirements in paragraph (a) of this section. Such a participant will 
file electronic documents by physically delivering or mailing an OSM 
containing the documents. The electronic formatting requirement in 
paragraph (a) of this section must be met.
    (3) Electronic document exemption. The ALJ may relieve a participant 
of both the electronic (computer file) formatting and transmission 
requirements in paragraph (a)(1) of this section. Such a participant 
will file paper documents physically or by mail to the Secretary, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: 
Rulemakings and Adjudications Staff. Filing by mail is complete upon 
deposit in the mail.
    (4) Requesting an exemption. A participant seeking an exemption 
under paragraphs (a)(2) or (a)(3) of this section must submit the 
exemption request with its first filing in the proceeding. In the 
request, the requestor must show good cause as to why it cannot file 
electronically. The filer may not change its formats and delivery 
methods for filing until a ruling on the exemption request is issued. 
Exemption requests submitted after the first filing in the proceeding 
will be granted only if the requestor shows that the interests of 
fairness so require.
    (5) Every pleading and document filed in the proceeding shall 
contain a caption setting forth the title of the action, the case number 
assigned by the presiding officer, and a designation of the document 
(e.g., motion to quash subpoena).
    (6) Filing is complete when the filer performs the last act that it 
must perform to submit a document, such as hitting the send/submit/
transmit button for an electronic transmission or depositing the 
document, in its entirety, in a mailbox.
    (b) Signatures. The original of each document must be signed by the 
participant or its authorized representative, or by an attorney having 
authority with respect to it. The document must state the capacity of 
the person signing; his or her address, phone number, and e-mail 
address; and the date of signature. The signature of a person signing a 
pleading or other similar document submitted by a participant is a 
representation that the document has been subscribed in the capacity 
specified with full authority, that he or she has read it and knows the 
contents, that to the best of his or her knowledge, information, and 
belief the statements made in it are true, and that it is not interposed 
for delay. The signature of a person signing an affidavit or similar 
document, which should be submitted in accord with the form outlined in 
28 U.S.C. 1746, is a representation that, under penalty of perjury, the 
document is true and correct to the best of that individual's knowledge 
and belief. If a document is not signed, or is signed with intent to 
defeat the purpose of this section, it may be struck.
    (1) An electronic document must be signed using a participant's or a 
participant representative's digital ID certificate. Additional 
signatures can be added to the electronic document, including to any 
affidavits that accompany the document, by a typed-in designation that 
indicates the signer understands and acknowledges that he or she is 
assenting to the representations in paragraph (d) of this section.
    (i) When signing an electronic document using a digital ID 
certificate, the signature page for the electronic document should 
contain a typed signature block that includes the phrase ``Signed 
(electronically) by'' typed onto the signature line; the name and the 
capacity of the person signing; the person's address, phone number, and 
e-mail address; and the date of signature.
    (ii) If additional individuals need to sign an electronic document, 
including any affidavits that accompany the document, these individuals 
must sign by inserting a typed signature block in the electronic 
document that includes the phrase ``Executed in Accord with 10 CFR 
2.304(d)'' or its equivalent typed on the signature line as well as the

[[Page 300]]

name and the capacity of the person signing; the person's address, phone 
number, and e-mail address; and the date of signature to the extent any 
of these items are different from the information provided for the 
digital ID certificate signer.
    (2) Paper documents must be signed in ink.
    (c) Service. A participant filing a document with the ALJ shall at 
the time of filing, serve a copy of such document on every other 
participant. Service upon any participant of any document other than 
those required to be served as prescribed in Sec.13.8 shall be made 
electronically to the E-Filing system. When a participant is represented 
by a representative, service shall be made upon such representative in 
lieu of the actual participant. Upon an order from the ALJ permitting 
alternative filing methods under paragraphs (a)(2) or (a)(3) of this 
section, service may be made by physical delivery or mail. As to each 
participant that cannot serve electronically, the ALJ shall require 
service by the most expeditious means permitted under this paragraph 
that are available to the participant, unless the ALJ finds that this 
requirement would impose undue burden or expense on the participant.
    (1) Unless otherwise provided in this paragraph, a participant will 
serve documents on the other participants by the same method that those 
participants filed.
    (2) A participant granted an exemption under paragraph (a)(2) of 
this section will serve the participants in the proceeding that filed 
electronically by physically delivering or mailing an OSM containing the 
electronic document.
    (3) A participant granted an exemption under paragraph (a)(3) will 
serve the other participants in the proceeding by physically delivering 
or mailing a paper copy.
    (4) A certificate of service stating the names and addresses of the 
persons served as well as the method and date of service must accompany 
any paper served upon participants to the proceeding.
    (5) Proof of service, which states the name and address of the 
person served as well as the method and date of service, may be made as 
required by law, by rule, or by order of the Commission.

[72 FR 49152, Aug. 28, 2007]



Sec.13.27  Computation of time.

    (a) In computing any period of time under this part or in an order 
issued thereunder, the time begins with the day following the act, 
event, or default, and includes the last day of the period, unless it is 
a Saturday or Sunday, a Federal legal holiday at the place where the 
action or event is to occur, or a day on which, because of emergency 
closure of the federal government in Washington, DC, NRC Headquarters 
does not open for business, in which event it includes the next day that 
is not a Saturday, Sunday, holiday or emergency closure.
    (b) When the period of time allowed is less than seven (7) days, 
intermediate Saturdays, Sundays, Federal legal holidays, and emergency 
closures shall be excluded from the computation.
    (c) Whenever an action is required within a prescribed period by a 
document served pursuant to Sec.13.26, no additional time is added to 
the prescribed period except in the following circumstances:
    (1) If a notice or document is served upon a participant, by first-
class mail only, three (3) calendar days will be added to the prescribed 
period for all the participants in the proceeding.
    (2) If a notice or document is served upon a participant, by express 
mail or other expedited service only, two (2) calendar days will be 
added to the prescribed period for all the participants in the 
proceeding.
    (3) If a document is to be served by multiple service methods, such 
as partially electronic and entirely on an OSM, the additional number of 
days is computed according to the service method used to deliver the 
entire document, excluding courtesy copies, to all of the other 
participants in the proceeding. The presiding officer may determine the 
calculation of additional days when a participant is not entitled to 
receive an entire filing served by multiple methods.
    (4) In mixed service proceedings where all participants are not 
using the same filing and service method, the

[[Page 301]]

number of days for service will be determined by the presiding officer 
based on considerations of fairness and efficiency. The same number of 
additional days will be added to the prescribed period for all the 
participants in the proceeding with the number of days being determined 
by the slowest method of service being used in the proceeding.
    (d) To be considered timely, a document must be served:
    (1) By 5 p.m. Eastern Time for a document served in person or by 
expedited service; and
    (2) By 11:59 p.m. Eastern Time for a document served by the E-Filing 
system.

[72 FR 49153, Aug. 28, 2007]



Sec.13.28  Motions.

    (a) Any application to the ALJ for an order or ruling shall be by 
motion. Motions shall state the relief sought, the authority relied 
upon, and the facts alleged, and shall be filed with the ALJ and served 
on all other parties.
    (b) Except for motions made during a prehearing conference or at the 
hearing, all motions shall be in writing. The ALJ may require that oral 
motions be reduced to writing.
    (c) Within 15 days after a written motion is served, or such other 
time as may be fixed by the ALJ, any party may file a response to such 
motion.
    (d) The ALJ may not grant a written motion before the time for 
filing responses thereto has expired, except upon consent of the parties 
or following a hearing on the motion, but may overrule or deny such 
motion without awaiting a response.
    (e) The ALJ shall make a reasonable effort to dispose of all 
outstanding motions prior to the beginning of the hearing.



Sec.13.29  Sanctions.

    (a) The ALJ may sanction a person, including any party or 
representative for--
    (1) Failing to comply with an order, rule, or procedure governing 
the proceeding;
    (2) Failing to prosecute or defend an action; or
    (3) Engaging in other misconduct that interferes with the speedy, 
orderly, or fair conduct of the hearing.
    (b) Any such sanction, including but not limited to those listed in 
paragraphs (c), (d), and (e) of this section, shall reasonably relate to 
the severity and nature of the failure or misconduct.
    (c) When a party fails to comply with an order, including an order 
for taking a deposition, the production of evidence within the party's 
control, or a request for admission, the ALJ may--
    (1) Draw an inference in favor of the requesting party with regard 
to the information sought;
    (2) In the case of requests for admission, deem each matter of which 
an admission is requested to be admitted;
    (3) Prohibit the party failing to comply with such order from 
introducing evidence concerning, or otherwise relying upon testimony 
relating to the information sought; and
    (4) Strike any part of the pleadings or other submissions of the 
party failing to comply with such request.
    (d) If a party fails to prosecute or defend an action under this 
part commenced by service of a notice of hearing, the ALJ may dismiss 
the action or may issue an initial decision imposing penalties and 
assessments.
    (e) The ALJ may refuse to consider any motion, request, response, 
brief or other document which is not filed in a timely fashion.



Sec.13.30  The hearing and burden of proof.

    (a) The ALJ shall conduct a hearing on the record in order to 
determine whether the defendant is liable for a civil penalty or 
assessment under Sec.13.3 and, if so, the appropriate amount of any 
such civil penalty or assessment considering any aggravating or 
mitigating factors.
    (b) The authority shall prove defendant's liability and any 
aggravating factors by a preponderance of the evidence.
    (c) The defendant shall prove any affirmative defenses and any 
mitigating factors by a preponderance of the evidence.
    (d) The hearing shall be open to the public unless otherwise ordered 
by the ALJ for good cause shown.

[[Page 302]]



Sec.13.31  Determining the amount of penalties and assessments.

    (a) In determining an appropriate amount of civil penalties and 
assessments, the ALJ and the authority head, upon appeal, should 
evaluate any circumstances that mitigate or aggravate the violation and 
should articulate in their opinions the reasons that support the 
penalties and assessments they impose. Because of the intangible costs 
of fraud, the expense of investigating such conduct, and the need to 
deter others who might be similarly tempted, ordinarily double damages 
and a significant civil penalty should be imposed.
    (b) Although not exhaustive, the following factors are among those 
that may influence the ALJ and the authority head in determining the 
amount of penalties and assessments to impose with respect to the 
misconduct (i.e., the false, fictitious, or fraudulent claims or 
statements) charged in the complaint:
    (1) The number of false, fictitious, or fraudulent claims or 
statements;
    (2) The time period over which such claims or statements were made;
    (3) The degree of the defendant's culpability with respect to the 
misconduct;
    (4) The amount of money or the value of the property, services, or 
benefit falsely claimed;
    (5) The value of the Government's actual loss as a result of the 
misconduct, including foreseeable consequential damages and the costs of 
investigation;
    (6) The relationship of the amount imposed as civil penalties to the 
amount of the Government's loss;
    (7) The potential or actual impact of the misconduct upon national 
defense, public health or safety, or public confidence in the management 
of Government programs and operations, including particularly the impact 
on the intended beneficiaries of such programs;
    (8) Whether the defendant has engaged in a pattern of the same or 
similar misconduct;
    (9) Whether the defendant attempted to conceal the misconduct;
    (10) The degree to which the defendant has involved others in the 
misconduct or in concealing it;
    (11) Where the misconduct of employees or agents is imputed to the 
defendant, the extent to which the defendant's practices fostered or 
attempted to preclude such misconduct;
    (12) Whether the defendant cooperated in or obstructed an 
investigation of the misconduct;
    (13) Whether the defendant assisted in identifying and prosecuting 
other wrongdoers;
    (14) The complexity of the program or transaction, and the degree of 
the defendant's sophistication with respect to it, including the extent 
of the defendant's prior participation in the program or in similar 
transactions;
    (15) Whether the defendant has been found, in any criminal, civil, 
or administrative proceeding to have engaged in similar misconduct or to 
have dealt dishonestly with the Government of the United States or of a 
State, directly or indirectly; and
    (16) The need to deter the defendant and others from engaging in the 
same or similar misconduct.
    (c) Nothing in this section shall be construed to limit the ALJ or 
the authority head from considering any other factors that in any given 
case may mitigate or aggravate the offense for which penalties and 
assessments are imposed.



Sec.13.32  Location of hearing.

    (a) The hearing may be held--
    (1) In any judicial district of the United States in which the 
defendant resides or transacts business;
    (2) In any judicial district of the United States in which the claim 
or statement in issue was made; or
    (3) In such other place as may be agreed upon by the defendant and 
the ALJ.
    (b) Each party shall have the opportunity to present argument with 
respect to the location of the hearing.
    (c) The hearing shall be held at the place and at the time ordered 
by the ALJ.



Sec.13.33  Witnesses.

    (a) Except as provided in paragraph (b) of this section, testimony 
at the hearing shall be given orally by witnesses under oath or 
affirmation.

[[Page 303]]

    (b) At the discretion of the ALJ, testimony may be admitted in the 
form of a written statement or deposition. Any such written statement 
must be provided to all other parties along with the last known address 
of such witness, in a manner which allows sufficient time for other 
parties to subpoena such witness for cross-examination at the hearing. 
Prior written statements of witnesses proposed to testify at the hearing 
and deposition transcripts shall be exchanged as provided in Sec.
13.22(a).
    (c) The ALJ shall exercise reasonable control over the mode and 
order of interrogating witnesses and presenting evidence so as to--
    (1) Make the interrogation and presentation effective for the 
ascertainment of the truth;
    (2) Avoid needless consumption of time; and
    (3) Protect witnesses from harassment or undue embarrassment.
    (d) The ALJ shall permit the parties to conduct such cross-
examination as may be required for a full and true disclosure of the 
facts.
    (e) At the discretion of the ALJ, a witness may be cross-examined on 
matters relevant to the proceeding without regard to the scope of his or 
her direct examination. To the extent permitted by the ALJ, cross-
examination on matters outside the scope of direct examination shall be 
conducted in the manner of direct examination and may proceed by leading 
questions only if the witness is a hostile witness, an adverse party, or 
a witness identified with an adverse party.
    (f) Upon motion of any party, the ALJ shall order witnesses excluded 
so that they cannot hear the testimony of other witnesses. This rule 
does not authorize exclusion of--
    (1) A party who is an individual;
    (2) In the case of a party that is not an individual, an officer or 
employee of the party appearing for the entity pro se or designated by 
the party's representative; or
    (3) An individual whose presence is shown by a party to be essential 
to the presentation of its case, including an individual employed by the 
Government engaged in assisting the representative for the Government.



Sec.13.34  Evidence.

    (a) The ALJ shall determine the admissibility of evidence.
    (b) Except as provided in this part, the ALJ shall not be bound by 
the Federal Rules of Evidence. However, the ALJ may apply the Federal 
Rules of Evidence where appropriate, e.g., to exclude unreliable 
evidence.
    (c) The ALJ shall exclude irrelevant and immaterial evidence.
    (d) Although relevant, evidence may be excluded if its probative 
value is substantially outweighed by the danger of unfair prejudice, 
confusion of the issues, or by considerations of undue delay or needless 
presentation of cumulative evidence.
    (e) Although relevant, evidence may be excluded if it is privileged 
under Federal law.
    (f) Evidence concerning offers of compromise or settlement shall be 
inadmissible to the extent provided in Rule 408 of the Federal Rules of 
Evidence.
    (g) The ALJ shall permit the parties to introduce rebuttal witnesses 
and evidence.
    (h) All documents and other evidence offered or taken for the record 
shall be open to examination by all parties, unless otherwise ordered by 
the ALJ pursuant to Sec.13.24.



Sec.13.35  The record.

    (a) The hearing will be recorded and transcribed. Transcripts may be 
obtained following the hearing from the ALJ at a cost not to exceed the 
actual cost of duplication.
    (b) The transcript of testimony, exhibits and other evidence 
admitted at the hearing, and all papers and requests filed in the 
proceeding constitute the record for the decision by the ALJ and the 
authority head.
    (c) The record may be inspected and copied (upon payment of a 
reasonable fee) by anyone, unless otherwise ordered by the ALJ pursuant 
to Sec.13.24.



Sec.13.36  Post-hearing briefs.

    The ALJ may require the parties to file post-hearing briefs. In any 
event, any party may file a post-hearing brief. The ALJ shall fix the 
time for filing such briefs, not to exceed 60 days from the date the 
parties receive the transcript of the hearing or, if applicable,

[[Page 304]]

the stipulated record. Such briefs may be accompanied by proposed 
findings of fact and conclusions of law. The ALJ may permit the parties 
to file reply briefs.



Sec.13.37  Initial decision.

    (a) The ALJ shall issue an initial decision based only on the 
record, which shall contain findings of fact, conclusions of law, and 
the amount of any penalties and assessments imposed.
    (b) The findings of fact shall include a finding on each of the 
following issues:
    (1) Whether the claims or statements identified in the complaint, or 
any portions thereof, violate Sec.13.3; and
    (2) If the person is liable for penalties or assessments, the 
appropriate amount of any such penalties or assessments considering any 
mitigating or aggravating factors that he or she finds in the case, such 
as those described in Sec.13.31.
    (c) The ALJ shall promptly serve the initial decision on all parties 
within 90 days after the time for submission of post-hearing briefs and 
reply briefs (if permitted) has expired. The ALJ shall at the same time 
serve all parties with a statement describing the right of any defendant 
determined to be liable for a civil penalty or assessment to file a 
motion for reconsideration with the ALJ or a notice of appeal with the 
authority head. If the ALJ fails to meet the deadline contained in this 
paragraph, he or she shall notify the parties of the reason for the 
delay and shall set a new deadline.
    (d) Unless the initial decision of the ALJ is timely appealed to the 
authority head, or a motion for reconsideration of the initial decision 
is timely filed, the initial decision shall constitute the final 
decision of the authority head and shall be final and binding on the 
parties 30 days after it is issued by the ALJ.



Sec.13.38  Reconsideration of initial decision.

    (a) Except as provided in paragraph (d) of this section, any party 
may file a motion for reconsideration of the initial decision within 20 
days of receipt of the initial decision. If service was made by mail, 
receipt will be presumed to be five days from the date of mailing in the 
absence of contrary proof.
    (b) Every such motion must set forth the matters claimed to have 
been erroneously decided and the nature of the alleged errors. Such 
motion shall be accompanied by a supporting brief.
    (c) Responses to such motions shall be allowed only upon request of 
the ALJ.
    (d) No party may file a motion for reconsideration of an initial 
decision that has been revised in response to a previous motion for 
reconsideration.
    (e) The ALJ may dispose of a motion for reconsideration by denying 
it or by issuing a revised initial decision.
    (f) If the ALJ denies a motion for reconsideration, the initial 
decision shall constitute the final decision of the authority head and 
shall be final and binding on the parties 30 days after the ALJ denies 
the motion, unless the initial decision is timely appealed to the 
authority head in accordance with Sec.13.39.
    (g) If the ALJ issues a revised initial decision, that decision 
shall constitute the final decision of the authority head and shall be 
final and binding on the parties 30 days after it is issued, unless it 
is timely appealed to the authority head in accordance with Sec.13.39.



Sec.13.39  Appeal to authority head.

    (a) Any defendant who has filed a timely answer and who is 
determined in an initial decision to be liable for a civil penalty or 
assessment may appeal such decision to the authority head by filing a 
notice of appeal with the authority head in accordance with this 
section.
    (b)(1) A notice of appeal may be filed at any time within 30 days 
after the ALJ issues an initial decision. However, if another party 
files a motion for reconsideration under Sec.13.38, consideration of 
the appeal shall be stayed automatically pending resolution of the 
motion for reconsideration.
    (2) If a motion for reconsideration is timely filed, a notice of 
appeal may be filed within 30 days after the ALJ denies the motion or 
issues a revised initial decision, whichever applies.
    (3) The authority head may extend the initial 30 day period for an 
additional 30 days if the defendant files

[[Page 305]]

with the authority head a request for an extension within the initial 30 
day period and shows good cause.
    (c) If the defendant files a timely notice of appeal with the 
authority head and the time for filing motions for reconsideration under 
Sec.13.38 has expired, the ALJ shall forward the record of the 
proceeding to the authority head.
    (d) A notice of appeal shall be accompanied by a written brief 
specifying exceptions to the initial decision and reasons supporting the 
exceptions.
    (e) The representative for the Government may file a brief in 
opposition to exceptions within 30 days of receiving the notice of 
appeal and accompanying brief.
    (f) There is no right to appear personally before the authority 
head.
    (g) There is no right to appeal any interlocutory ruling by the ALJ.
    (h) In reviewing the initial decision, the authority head shall not 
consider any objection that was not raised before the ALJ unless a 
demonstration is made of extraordinary circumstances causing the failure 
to raise the objection.
    (i) If any party demonstrates to the satisfaction of the authority 
head that additional evidence not presented at each hearing is material 
and that there were reasonable grounds for the failure to present such 
evidence at such hearing, the authority head shall remand the matter to 
the ALJ for consideration of such additional evidence.
    (j) The authority head may affirm, reduce, reverse, compromise, 
remand, or settle any penalty or assessment, determined by the ALJ in 
any initial decision.
    (k) The authority head shall promptly serve each party to the appeal 
with a copy of the decision of the authority head and a statement 
describing the right of any person determined to be liable for a penalty 
or assessment to seek judicial review.
    (l) Unless a petition for review is filed as provided in 31 U.S.C. 
3805 after a defendant has exhausted all administrative remedies under 
this part and within 60 days after the date on which the authority head 
serves the defendant with a copy of the authority head's decision, a 
determination that a defendant is liable under Sec.13.3 is final and 
is not subject to judicial review.



Sec.13.40  Stays ordered by the Department of Justice.

    If at any time the Attorney General or an Assistant Attorney General 
designated by the Attorney General transmits to the authority head a 
written finding that continuation of the administrative process 
described in this part with respect to a claim or statement may 
adversely affect any pending or potential criminal or civil action 
related to such claim or statement, the authority head shall stay the 
process immediately. The authority head may order the process resumed 
only upon receipt of the written authorization of the Attorney General.



Sec.13.41  Stay pending appeal.

    (a) An initial decision is stayed automatically pending disposition 
of a motion for reconsideration or of an appeal to the authority head.
    (b) No administrative stay is available following a final decision 
of the authority head.



Sec.13.42  Judicial review.

    Section 3805 of title 31, United States Code, authorizes judicial 
review by an appropriate United States District Court of a final 
decision of the authority head imposing penalties or assessments under 
this part and specifies the procedures for such review.



Sec.13.43  Collection of civil penalties and assessments.

    Sections 3806 and 3808(b) of title 31, United States Code, authorize 
actions for collection of civil penalties and assessments imposed under 
this part and specify the procedures for such actions.



Sec.13.44  Right to administrative offset.

    The amount of any penalty or assessment which has become final, or 
for which a judgment has been entered under Sec.13.42 or Sec.13.43, 
or any amount agreed upon in a compromise or settlement under Sec.
13.46, may be collected by administrative offset under 31 U.S.C. 3716, 
except that an administrative offset may not be made under this 
subsection against a refund of an overpayment of Federal taxes, then or 
later

[[Page 306]]

owing by the United States to the defendant.



Sec.13.45  Deposit in Treasury of United States.

    All amounts collected pursuant to this part shall be deposited as 
miscellaneous receipts in the Treasury of the United States, except as 
provided in 31 U.S.C. 3806(g).



Sec.13.46  Compromise or settlement.

    (a) Parties may make offers of compromise or settlement at any time.
    (b) The reviewing official has the exclusive authority to compromise 
or settle a case under this part at any time after the date on which the 
reviewing official is permitted to issue a complaint and before the date 
on which the ALJ issues an initial decision.
    (c) The authority head has exclusive authority to compromise or 
settle a case under this part at any time after the date on which the 
ALJ issues an initial decision, except during the pendency of any review 
under Sec.13.42 or during the pendancy of any action to collect 
penalties and assessments under Sec.13.43.
    (d) The Attorney General has exclusive authority to compromise or 
settle a case under this part during the pendancy of any review under 
Sec.13.42 or of any action to recover penalties and assessments under 
31 U.S.C. 3806.
    (e) The investigating officer may recommend settlement terms to the 
reviewing official, the authority head, or the Attorney General, as 
appropriate. The reviewing official may recommend settlement terms to 
the authority head, or the Attorney General, as appropriate.
    (f) Any compromise or settlement must be in writing.



Sec.13.47  Limitations.

    (a) The notice of hearing with respect to a claim or statement must 
be served in the manner specified in Sec.13.8 within 6 years after the 
date on which such claim or statement is made.
    (b) If the defendant fails to serve a timely answer, service of a 
notice under Sec.13.10(b) shall be deemed a notice of hearing for 
purposes of this section.
    (c) The statute of limitations may be extended by agreement of the 
parties.



PART 14_ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT--
Table of Contents



                            Subpart A_General

Sec.
14.1 Scope of regulations.
14.3 Limit on attorney fees; penalty.

              Subpart B_Filing Procedures and Requirements

14.11 Who may file a claim.
14.13 When is a claim presented to NRC.
14.15 Where to present a claim to NRC.
14.17 A claim must be presented to the appropriate agency.
14.19 When a claim is filed with more than one agency.
14.21 Filing a claim after an agency final denial.
14.23 Evidence and information to be submitted.
14.25 Amending a claim.
14.27 Time limit.

                Subpart C_Commission Action and Authority

14.31 Investigation.
14.33 Officials authorized to act.
14.35 Limitation on NRC's authority.
14.37 Final denial of claim.
14.39 Reconsideration of a claim.
14.41 Payment of approved claims.
14.43 Acceptance of payment constitutes release.

                       Subpart D_Employee Drivers

14.51 Procedures when employee drivers are sued.
14.53 Scope of employment report.
14.55 Removal of State court proceedings.
14.57 Suit against the United States exclusive remedy.

    Authority: 28 U.S.C. 2672, 2679; Atomic Energy Act of 1954, sec. 161 
(42 U.S.C. 2201); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 
5841); 28 CFR 14.11.

    Source: 47 FR 8983, Mar. 3, 1982, unless otherwise noted.



                            Subpart A_General



Sec.14.1  Scope of regulations.

    (a) The terms ``Nuclear Regulatory Commission'' and ``NRC'' as used 
in this part mean the agency established by section 201(a) of the Energy 
Reorganization Act of 1974, but do not include any contractor with the 
Nuclear Regulatory Commission.

[[Page 307]]

    (b) The regulations in this part supplement the Department of 
Justice's regulations in 28 CFR parts 14 and 15.
    (c) These regulations apply to administrative claims under the 
Federal Tort Claims Act, as amended, asserted on or after the effective 
date of this rule, for money damages against the United States for 
damage to or loss of property or personal injury or death caused by the 
negligent or wrongful act or omission of any employee of the NRC while 
acting within the scope of his or her office or employment, under 
circumstances where the United States, if a private person, would be 
liable to the claimant in accordance with the law of the place where the 
act or omission occurred.
    (d) These regulations also set forth the procedures when lawsuits 
are commenced against an employee of the NRC resulting from the 
operation of a motor vehicle while acting within the scope of his or her 
employment.



Sec.14.3  Limit on attorney fees; penalty.

    (a) An attorney may not charge or receive fees in excess of:
    (1) 25 percent of any judgment rendered under 28 U.S.C. 1346(b);
    (2) 25 percent of any settlement made under 28 U.S.C. 2677; or
    (3) 20 percent of any award, compromise, or settlement made under 28 
U.S.C. 2672.
    (b) Any attorney who charges or receives any amount in excess of 
that allowed under this section is subject to a fine of not more than 
$2,000 or imprisonment for not more than one year, or both. (28 U.S.C. 
2678)



              Subpart B_Filing Procedures and Requirements



Sec.14.11  Who may file a claim.

    (a) A claim for damage to or loss of property may be presented by 
the owner of the property interest which is the subject of the claim, 
his or her duly authorized agent, or his or her legal representative.
    (b) A claim for personal injury may be presented by the injured 
person, his or her duly authorized agent, or his or her legal 
representative.
    (c) A claim based on death may be presented by the executor or 
administrator of the decedent's estate, or by any other person legally 
entitled to assert the claim under applicable State law.
    (d) A claim for loss wholly compensated by an insurer with the 
rights of a subrogee may be presented by the insurer. A claim for loss 
partially compensated by an insurer with the rights of a subrogee may be 
presented by the insurer or the insured individually, to the extent of 
their respective interests, or jointly. Whenever an insurer presents a 
claim asserting the rights of a subrogee, the insurer shall present with 
the claim appropriate evidence that the insurer has the rights of a 
subrogee.
    (e) If a claim is presented by an agent or legal representative that 
person shall:
    (1) Present the claim in the name of the claimant;
    (2) Sign the claim;
    (3) Show the title or legal capacity of the person signing the 
claim; and
    (4) Include with the claim evidence of his or her authority to 
present a claim on behalf of the claimant as agent, executor, 
administrator, parent, guardian, or other representative.



Sec.14.13  When is a claim presented to NRC.

    For purposes of the provisions of 28 U.S.C. 2672, a claim is 
presented when NRC receives from a claimant, or the claimant's duly 
authorized agent or legal representative, an executed Standard Form 95 
or other written notification of an incident. An executed Standard Form 
95 or written notification must be accompanied by a claim for money 
damages in a sum certain for damage to or loss of property, personal 
injury, or death alleged to have occurred by reason of the incident.



Sec.14.15  Where to present a claim to NRC.

    A claimant shall mail or deliver the claim to the office of 
employment of the NRC employee whose negligent or wrongful act or 
omission is alleged to have caused the loss or injury. If the office of 
employment is not known, the claimant shall file the claim with the

[[Page 308]]

Office of the General Counsel, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555.

[47 FR 8983, Mar. 3, 1982, as amended at 51 FR 35999, Oct. 8, 1986]



Sec.14.17  A claim must be presented to the appropriate agency.

    A claimant shall present the claim to the Federal agency whose 
activities gave rise to the claim. If a claim is erroneously presented 
to the NRC, the NRC shall transfer it to the appropriate agency, if the 
proper agency can be identified from the claim, and shall advise the 
claimant of the transfer. If transfer is not feasible, the NRC shall 
return the claim to the claimant. The fact of transfer does not, in 
itself, preclude further transfer, return of the claim to the claimant, 
or other appropriate disposition of the claim. A claim shall be 
presented, as required by 28 U.S.C. 2401(b), as of the date it is 
received by the appropriate agency.



Sec.14.19  When a claim is filed with more than one agency.

    (a) If the NRC and one or more other Federal agencies is or may be 
involved in the events giving rise to the claim, and if the claim is 
filed with the NRC, the NRC shall contact all other affected agencies in 
order to designate the single agency which will investigate and decide 
the merits of the claim.
    (1) In the event that an agreed upon designation cannot be made by 
the affected agencies, the Department of Justice will be consulted and 
will designate a primary agency to investigate and decide the merits of 
the claim. If the NRC is designated as the primary agency, it shall 
notify the claimant that all future correspondence concerning the claim 
shall be directed to the NRC.
    (2) All involved Federal agencies can agree either to conduct their 
own administrative reviews and to coordinate the results or to have the 
investigations conducted by the primary agency. In either event, the 
primary agency is responsible for the final determination of the claim.
    (b) A claimant presenting a claim arising from an incident to more 
than one agency should identify each agency to which the claim is 
submitted at the time each claim is presented. If a claim arising from 
an incident is presented to more than one Federal agency without any 
indication that more than one agency is involved, and any one of the 
concerned Federal agencies takes final action on that claim, the final 
action is conclusive on the claims presented to the other agencies in 
regard to the time required for filing suit set forth in 28 U.S.C. 
2401(b). However, if NRC, as a subsequently involved Federal agency, 
desires to take further action with a view towards settling the claim, 
the NRC may treat the matter as a request for reconsideration of the 
final denial under 10 CFR 14.39, unless suit has been filed in the 
interim, and advise the claimant of the action.



Sec.14.21  Filing a claim after an agency final denial.

    If, after a final denial by another agency, the claimant files with 
the NRC a claim arising out of the same incident on which the claim 
filed with the other agency was based, the submission of the claim to 
NRC will not toll the requirement of 28 U.S.C. 2401(b) that suit must be 
filed within six months of the final denial by the other agency, unless 
the other agency specifically and explicitly treats the submission to 
NRC as a request for reconsideration under 10 CFR 14.39 and advises the 
claimant of the action.



Sec.14.23  Evidence and information to be submitted.

    (a) Death. In support of a claim based on death, the claimant may be 
required to submit the following evidence or information:
    (1) An authenticated death certificate or other competent evidence 
showing cause of death, date of death, and age of decedent.
    (2) Decedent's employment or occupation at time of death, including 
his or her monthly or yearly salary or earnings (if any), and the 
duration of his or her last employment or occupation.

[[Page 309]]

    (3) Full names, addresses, birth dates, kinship, and marital status 
of the decedent's survivors, including identification of those survivors 
who were dependent for support upon the decedent at the time of death.
    (4) Degree of support afforded by the decedent to each survivor 
dependent upon him or her for support at the time of death.
    (5) Decedent's general physical and mental condition before death.
    (6) Itemized bills for medical and burial expenses incurred by 
reason of the incident causing death, or itemized receipts of payment 
for these expenses.
    (7) If damages for pain and suffering prior to death are claimed, a 
physician's detailed statement specifying the injuries suffered, 
duration of pain and suffering, any drugs administered for pain, and the 
decedent's physical condition in the interval between injury and death.
    (8) Any other evidence or information which may have a bearing on 
either the responsibility of the United States for the death or the 
amount of damages claimed.
    (b) Personal injury. In support of a claim for personal injury, 
including pain and suffering, the claimant may be required to submit the 
following evidence or information:
    (1) A written report by the attending physician or dentist setting 
forth the nature and extent of the injury, nature and extent of 
treatment, any degree of temporary or permanent disability and 
prognosis, period of hospitalization, and any diminished earning 
capacity. In addition, the claimant may be required to submit to a 
physical or mental examination by a physician employed by the NRC or 
another Federal agency. The claimant may request in writing a copy of 
the report of the examining physician if the claimant has:
    (i) Furnished the report referred to in paragraph (a)(1) of this 
section on request; and
    (ii) Made or agrees to make available to the NRC all other reports 
of the claimant's physical or mental condition which have been or are 
made by any physician.
    (2) Itemized bills for medical, dental, and hospital expenses 
incurred, or itemized receipts of payment for these expenses.
    (3) If the prognosis reveals the necessity for future treatment, a 
statement of expected expenses for the treatment.
    (4) If a claim is made for loss of time from employment, a written 
statement from his or her employer showing actual time lost from 
employment, whether he or she is a full- or part-time employee, and 
wages or salary actually lost.
    (5) If a claim is made for loss of income and the claimant is self-
employed, documentary evidence showing the amount of earnings actually 
lost.
    (6) Any other evidence or information which may have a bearing on 
either the responsibility of the United States for the personal injury 
or the damages claimed.
    (c) Property damage. In support of a claim for damage to or loss of 
property, real or personal, the claimant may be required to submit the 
following evidence or information:
    (1) Proof of ownership of the property interest which is the subject 
of the claim.
    (2) A detailed statement of the amount claimed with respect to each 
item of property.
    (3) An itemized receipt of payment for necessary repairs or itemized 
written estimates of the cost of these repairs.
    (4) A statement listing date of purchase, purchase price, and 
salvage value, where repair is not economical.
    (5) Any other evidence or information which may have a bearing on 
either the responsibility of the United States for the injury to or loss 
of property or the damages claimed.



Sec.14.25  Amending a claim.

    The claimant may amend a claim presented in compliance with 10 CFR 
14.13 at any time prior to final agency action or prior to the exercise 
of the claimant's option under 28 U.S.C. 2675(a). The claimant or his or 
her duly authorized agent or legal representative shall sign each 
amendment and submit it in writing. Upon the timely filing of an 
amendment to a pending claim, the agency shall have six months in which 
to make a final disposition of the claim as amended and

[[Page 310]]

the claimant's option under 28 U.S.C. 2675(a) does not accrue until six 
months after the filing of an amendment.



Sec.14.27  Time limit.

    The claimant shall furnish evidence and information of the types 
described in 10 CFR 14.23, to the extent reasonably practicable, when 
the claim is initially presented. If the claimant fails to furnish 
sufficient evidence and information within six months after the claim 
was initially presented to enable NRC to adjust, determine, compromise 
and settle the claim, NRC may consider the claim a nullity.



                Subpart C_Commission Action and Authority



Sec.14.31  Investigation.

    The NRC may:
    (a) Require the claimant to furnish any evidence or information 
which is relevant to its consideration of the claim;
    (b) Examine the claimant; or
    (c) Investigate, or request any other Federal agency to investigate, 
a claim filed under this part.



Sec.14.33  Officials authorized to act.

    The General Counsel or the General Counsel's designee shall exercise 
the authority to adjust, determine, compromise and settle a claim under 
the provisions of 28 U.S.C. 2672.

[51 FR 35999, Oct. 8, 1986]



Sec.14.35  Limitation on NRC's authority.

    (a) The NRC shall effect an award, compromise, or settlement of a 
claim hereunder in excess of $25,000 only with the prior written 
approval of the Attorney General or his designee. For the purposes of 
this paragraph, a principal claim and any derivative or subrogated claim 
are treated as a single claim.
    (b) The NRC may adjust, determine, compromise, or settle a claim 
under this part only after consultation with the Department of Justice 
if, in the opinion of the Office of the General Counsel:
    (1) A new precedent or a new point of law is involved;
    (2) A question of policy is or may be involved;
    (3) The United States is or may be entitled to indemnity or 
contribution from a third party and the NRC is unable to adjust the 
third party claim; or
    (4) The compromise of a particular claim, as a practical matter, 
will or may control the disposition of a related claim in which the 
amount to be paid may exceed $25,000.
    (c) The NRC may adjust, determine, compromise, or settle a claim 
under this part only after consultation with the Department of Justice 
if the NRC is informed or is otherwise aware that the United States, or 
an employee, agent, or cost-plus contractor of the United States, is 
involved in litigation based on a claim arising out of the same incident 
or transaction.
    (d) When Department of Justice approval or consultation is required 
under this section or the advice of the Department of Justice is 
otherwise requested, the NRC shall direct the referral or request to the 
Assistant Attorney General, Civil Division, Department of Justice, in 
writing. The NRC shall ensure that the referral or request contains:
    (1) A short and concise statement of the facts and the reasons for 
the referral or request;
    (2) Copies of relevant portions of NRC's claim file; and
    (3) A statement of the recommendations or views of the NRC.

A referral or request to the Department of Justice may be made at any 
time after presentment of a claim to the NRC.

[47 FR 8983, Mar. 3, 1982, as amended at 51 FR 35999, Oct. 8, 1986]



Sec.14.37  Final denial of claim.

    The NRC shall send notice of a final denial of a claim in writing to 
the claimant, his or her attorney or legal representative, by certified 
or registered mail. The notification of final denial may include a 
statement of the reasons for the denial. The NRC shall include a 
statement in the notification of final denial that, if the claimant is 
dissatisfied with NRC's action, he or she may file suit in an 
appropriate U.S. District Court not later than 6 months

[[Page 311]]

after the date of mailing of the notification.



Sec.14.39  Reconsideration of a claim.

    Prior to the commencement of suit and prior to the expiration of the 
6-month period provided in 28 U.S.C. 2401(b), a claimant, or his or her 
duly authorized agent, or legal representative, may file a written 
request with the NRC for reconsideration of a final denial of a claim. 
Upon the timely filing of a request for reconsideration, the NRC shall 
have 6 months from the date of filing in which to make a final 
disposition of the claim, and the claimant's option under 28 U.S.C. 
2675(a) does not accrue until 6 months after the filing of a request for 
reconsideration. Final NRC action on a request for reconsideration shall 
be effected in accordance with the provisions of 10 CFR 14.37.



Sec.14.41  Payment of approved claims.

    (a) The NRC shall pay any award, compromise, or settlement in an 
amount of $2,500 or less made under the provisions of 28 U.S.C. 2672 out 
of the appropriations available to it. The NRC shall obtain payment of 
any award, compromise, or settlement in excess of $2,500 from the 
Department of the Treasury by forwarding Standard Form 1145 to the 
Payment Branch, Claims Group, General Accounting Office. If an award, 
compromise, or settlement is in excess of $25,000, Standard Form 1145 
must be accompanied by evidence that the award, compromise, or 
settlement has been approved by the Attorney General or the Attorney 
General's designee. When the use of Standard Form 1145 is required, it 
must be executed by the claimant or it must be accompanied by either a 
claims settlement agreement or a Standard Form 95 executed by the 
claimant.
    (b) If a claimant is represented by an attorney, the voucher for 
payment must designate both the claimant and his or her attorney as 
payees, and the check must be delivered to the attorney whose address 
appears on the voucher.



Sec.14.43  Acceptance of payment constitutes release.

    Acceptance by the claimant, his agent, or legal representative, of 
any award, compromise, or settlement made under the provisions of 28 
U.S.C. 2672 or 2677, is final and conclusive on the claimant, his or her 
agent or legal representative and any other person on whose behalf or 
for whose benefit the claim has been presented. Acceptance constitutes a 
complete release of any claim against the United States and against any 
employee of the Government whose act or omission gave rise to the claim.



                       Subpart D_Employee Drivers



Sec.14.51  Procedures when employee drivers are sued.

    (a) Any NRC employee against whom a civil action or proceeding is 
brought for damage to property, or for personal injury or death, on 
account of the employee's operation of a motor vehicle in the scope of 
his or her office or employment with the NRC, shall promptly deliver all 
process and pleadings served upon the employee, or an attested true 
copy, to the Office of the General Counsel. If the action is brought 
against an employee's estate, this procedure applies to the employee's 
personal representative.
    (b) In addition, upon the employee's receipt of any process or 
pleadings, or any prior information regarding the commencement of a 
civil action or proceeding, the employee shall immediately advise the 
Office of the General Counsel by telephone or telegraph.

[47 FR 8983, Mar. 3, 1982, as amended at 51 FR 35999, Oct. 8, 1986]



Sec.14.53  Scope of employment report.

    A report containing all data bearing upon the question whether the 
employee was acting within the scope of his or her office or employment 
will be furnished by the General Counsel or designee to the United 
States Attorney for the district encompassing the place where the civil 
action or proceeding is brought. A copy of the report also will be 
furnished to the Director of the Torts Branch, Civil Division, 
Department of Justice, at the earliest possible

[[Page 312]]

date, or within the time specified by the United States Attorney.

[51 FR 35999, Oct. 8, 1986]



Sec.14.55  Removal of State court proceedings.

    Upon a certification by the United States Attorney that the 
defendant employee was acting within the scope of his or her office or 
employment at the time of the incident out of which the suit arose, any 
civil action or proceeding commenced in a State court may be removed to 
the district court of the United States for the district and division 
encompassing the place where the action or proceeding is pending in 
accordance with 28 U.S.C. 2679.



Sec.14.57  Suit against United States exclusive remedy.

    The remedy against the United States provided by 28 U.S.C. 1346(b) 
and 2672 for damage to or loss of property or personal injury or death, 
resulting from the operation by an employee of the Government of any 
motor vehicle while acting within the scope of his or her office or 
employment, is exclusive of any other civil action or proceeding by 
reason of the same subject matter against the employee or his or her 
estate whose act or omission gave rise to the claim.



PART 15_DEBT COLLECTION PROCEDURES--Table of Contents



                   Subpart A_Application and Coverage

Sec.
15.1 Application.
15.2 Definitions.
15.3 Communications.
15.5 Claims that are covered.
15.7 Monetary limitation on NRC's authority.
15.8 Information collection requirements: OMB approval.
15.9 No private rights created.
15.11 Form of payment.
15.13 Subdivision of claims.

              Subpart B_Administrative Collection of Claims

15.20 Aggressive agency collection activity.
15.21 Written demands for payment.
15.23 Telephone or internet inquiries and investigations.
15.25 Personal interviews.
15.26 Reporting claims.
15.27 Contact with debtor's employing agency.
15.29 Suspension or revocation of license.
15.31 Disputed debts.
15.32 Contracting for collection services.
15.33 Collection by administrative offset.
15.35 Payments.
15.37 Interest, penalties, and administrative costs.
15.38 Use of credit reports.
15.39 Bankruptcy claims.

                     Subpart C_Compromise of a Claim

15.41 When a claim may be compromised.
15.43 Reasons for compromising a claim.
15.45 Consideration of tax consequences to the Government.
15.47 Finality of a compromise.
15.49 Mutual releases of the debtor and the Government.

        Subpart D_Suspension or Termination of Collection Action

15.51 When collection action may be suspended or terminated.
15.53 Reasons for suspending collection action.
15.55 Reasons for terminating collection action.
15.57 Termination of collection action.
15.59 Exception to termination.
15.60 Discharge of indebtedness; reporting requirements.

                      Subpart E_Referral of a Claim

15.61 Prompt referral.
15.65 Referral of a compromise offer.
15.67 Referral to the Department of Justice.

    Authority: Atomic Energy Act of 1954, secs. 161, 186 (42 U.S.C. 
2201, 2236); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 
5841); 5 U.S.C. 5514; 26 U.S.C. 6402; 31 U.S.C. 3701, 3713, 3716, 3719, 
3720A; 42 U.S.C. 664; 44 U.S.C. 3504 note; 31 CFR parts 900 through 904; 
31 CFR part 285; E.O. 12146, 44 FR 42657, 3 CFR, 1979 Comp., p. 409; 
E.O. 12988, 61 FR 4729, 3 CFR, 1996 Comp., p. 157.

    Source: 47 FR 7616, Feb. 22, 1982, unless otherwise noted.



                   Subpart A_Application and Coverage



Sec.15.1  Application.

    (a) This part applies to claims for the payment of debts owed to the 
United States Government in the form of money or property and; unless a 
different procedure is specified in a statute, regulation, or contract; 
prescribes procedures by which the NRC--

[[Page 313]]

    (1) Collects, compromises, suspends, offsets, and terminates 
collection action for claims;
    (2) Determines and collects interest and other charges on these 
claims; and
    (3) Refers unpaid claims over 180 days delinquent to Treasury for 
offset and collection and to the DOJ for litigation.
    (b) The following are examples of kinds of debts to which special 
statutory and administrative procedures apply:
    (1) A claim against an employee for erroneous payment of pay and 
allowances subject to waiver under 5 U.S.C. 5584 are covered by the 
provisions of 10 CFR part 16.
    (2) A claim against an applicant for, or a holder or former holder 
of, an NRC license involving the payment of civil penalties imposed by 
the NRC under 10 CFR 2.205.
    (3) A claim involved in a case pending before any Federal Contract 
Appeals Board or Grant Appeals Board. However, nothing in this part 
prevents negotiation and settlement of a claim pending before a Board.
    (c) The NRC is not limited to collection remedies contained in the 
revised Federal Claims Collection Standards (FCCS). The FCCS is not 
intended to impair common law remedies.

[47 FR 7616, Feb. 22, 1982, as amended at 55 FR 32377, Aug. 9, 1990; 56 
FR 51830, Oct. 16, 1991; 67 FR 30318, May 6, 2002]



Sec.15.2  Definitions.

    Administrative offset means withholding money payable by the United 
States Government to, or held by the Government for, a person to satisfy 
a debt the person owes the United States Government.
    Administrative wage garnishment is the process of withholding 
amounts from an employee's disposable pay and the paying of those 
amounts to a creditor in satisfaction of a withholding order.
    Claim and debt are used synonymously to refer to an amount of money, 
funds, or property that has been determined by an agency official to be 
owed to the United States from any person, organization, or entity, 
except another Federal agency. For the purposes of administrative offset 
under 31 U.S.C. 3716, the terms claim and debt include an amount of 
money, funds, or property owed by a person to a State (including past-
due support being enforced by a State), the District of Columbia, 
American Samoa, Guam, the United States Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, or the Commonwealth of Puerto Rico.
    Cross-servicing means that the Treasury or another debt collection 
center is taking appropriate debt collection action on behalf of one or 
more Federal agencies or a unit or subagency thereof.
    Delinquent. A debt is considered delinquent if it has not been paid 
by the date specified in the initial written demand for payment or 
applicable contractual agreement with the NRC unless other satisfactory 
payment arrangements have been made by that date. If the debtor fails to 
satisfy obligations under a payment agreement with the NRC after other 
payment arrangements have been made, the debt becomes a delinquent debt.
    Federal agencies include agencies of the executive, legislative, and 
judicial branches of the Government, including Government corporations.
    License means any license, permit, or other approval issued by the 
Commission.
    Payment in full means payment of the total debt due the United 
States, including any interest, penalty, and administrative costs of 
collection assessed against the debtor.
    Recoupment is a special method for adjusting debts arising under the 
same transaction or occurrence. For example, obligations arising under 
the same contract generally are subject to recoupment.
    Salary offset means an administrative offset to collect a debt under 
5 U.S.C. 5514 by deduction(s) at one or more officially established pay 
intervals from the current pay account of an employee without his/her 
consent.
    Tax refund offset means withholding or reducing a tax refund payment 
by an amount necessary to satisfy a debt owed by the payee(s) of a tax 
refund payment.
    Treasury as used in 10 CFR part 15 means the Department of the 
Treasury.

[[Page 314]]

    Withholding order means any order for withholding or garnishment of 
pay issued by an agency, or judicial or administrative body.

[55 FR 32377, Aug. 9, 1990, as amended at 56 FR 51830, Oct. 16, 1991; 67 
FR 30318, May 6, 2002]



Sec.15.3  Communications.

    Unless otherwise specified, communications concerning the 
regulations in this part may be addressed to the Secretary of the 
Nuclear Regulatory Commission and sent either by mail to the U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: 
Rulemakings and Adjudications Staff; by hand delivery to the NRC's 
offices at 11555 Rockville Pike, One White Flint North, Rockville, 
Maryland; or, where practicable, by electronic submission, for example, 
via Electronic Information Exchange, or CD-ROM. Electronic submissions 
must be made in a manner that enables the NRC to receive, read, 
authenticate, distribute, and archive the submission, and process and 
retrieve it a single page at a time. Detailed guidance on making 
electronic submissions can be obtained by visiting the NRC's Web site at 
http://www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information.

[68 FR 58801, Oct. 10, 2003, as amended at 74 FR 62680, Dec. 1, 2009; 80 
FR 74978, Dec. 1, 2015]



Sec.15.5  Claims that are covered.

    (a) These procedures generally apply to any claim for payment of a 
debt which:
    (1) Results from activities of the NRC, including fees imposed under 
part 170 and part 171; or
    (2) Is referred to the NRC for collection.
    (b) These procedures do not apply to:
    (1) A claim based on a civil monetary penalty for violation of a 
licensing requirement unless Sec.2.205 of this chapter provides 
otherwise;
    (2) A claim as to which there is an indication of fraud, the 
presentation of a false claim, or misrepresentation on the part of the 
debtor or any other party having an interest in the claim;
    (3) A claim based in whole or in part on conduct in violation of the 
antitrust laws;
    (4) A claim under the Internal Revenue Code of 1986.
    (5) A claim between Federal agencies. Federal agencies should 
attempt to resolve interagency claims as referenced in Executive Order 
12146 (3 CFR, 1980 Comp., pp. 409-412).
    (6) A claim once it becomes subject to salary offset under 5 U.S.C. 
5514. These claims are subject to the provisions of 10 CFR part 16.
    (7) A claim involving bankruptcy is covered by Title 11 of the 
United States Code.

[47 FR 7616, Feb. 22, 1982, as amended at 55 FR 32377, Aug. 9, 1990; 56 
FR 51830, Oct. 16, 1991; 67 FR 30318, May 6, 2002]



Sec.15.7  Monetary limitation on NRC's authority.

    The NRC's authority to compromise a claim, or to terminate or 
suspend collection action on a claim covered by these procedures, is 
limited by 31 U.S.C. 3711(a) to claims that--
    (a) Have not been referred to another Federal Agency for further 
collection actions; and
    (b) Do not exceed $100,000 (exclusive of interest, penalties, and 
administrative charges) or such higher amount as the Attorney General 
shall from time to time prescribe for purposes of compromise or 
suspension or termination of collection activity.

[47 FR 7616, Feb. 22, 1982, as amended at 55 FR 32378, Aug. 9, 1990; 67 
FR 30318, May 6, 2002]



Sec.15.8  Information collection requirements: OMB approval.

    This part contains no information collection requirements, and 
therefore, is not subject to the requirements of the Paperwork Reduction 
Act (44 U.S.C. 3501 et seq.).

[67 FR 30319, May 6, 2002]

[[Page 315]]



Sec.15.9  No private rights created.

    (a) The failure of NRC to include in this part any provision of the 
FCCS, 31 CFR Chapter IX, parts 900-904, does not prevent the NRC from 
applying these provisions.
    (b) A debtor may not use the failure of the NRC to comply with any 
provision of this part or of the Federal Claims Collections Standards as 
a defense.

[47 FR 7616, Feb. 22, 1982, as amended at 55 FR 32378, Aug. 9, 1990; 67 
FR 30319, May 6, 2002]



Sec.15.11  Form of payment.

    These procedures are directed primarily to the recovery of money on 
behalf of the Government. The NRC may demand:
    (a) The return of specific property; or
    (b) The performance of specific services.

[47 FR 7616, Feb. 22, 1982, as amended at 67 FR 30319, May 6, 2002]



Sec.15.13  Subdivision of claims.

    The NRC shall consider a debtor's liability arising from a 
particular transaction or contract as a single claim in determining 
whether the claim is less than the monetary limitation for the purpose 
of compromising or suspending or terminating collection action. A claim 
may not be subdivided to avoid the monetary limitation established by 31 
U.S.C. 3711(a)(2) and Sec.15.7.

[55 FR 32378, Aug. 9, 1990]



              Subpart B_Administrative Collection of Claims



Sec.15.20  Aggressive agency collection activity.

    (a) The NRC shall take aggressive action to collect all debts. These 
collection activities will be undertaken promptly and follow-up action 
will be taken as appropriate. These regulations do not require the 
Department of Justice, Department of the Treasury (Treasury), or any 
other Treasury-designated collection center to duplicate collection 
activities previously undertaken by NRC.
    (b) Debt referred or transferred to Treasury or to a Treasury-
designated debt collection center under the authority of 31 U.S.C. 
3711(g) must be serviced, collected, or compromised, or the collection 
action will be suspended or terminated, in accordance with the statutory 
requirements and authorities applicable to the collection of the debts.
    (c) The NRC shall cooperate with other agencies in their debt 
collection activities.
    (d) The NRC will consider referring debts that are less than 120 
days delinquent to Treasury or to a Treasury-designated debt collection 
center to accomplish efficient, cost-effective debt collection. 
Referrals to debt collection centers are at the discretion of, and for a 
time period acceptable to, Treasury.
    (e) The NRC shall transfer any debt that has been delinquent for 120 
days or more to Treasury so that it may take appropriate action to 
collect the debt or terminate collection actions. This requirement does 
not apply to any debt that--
    (1) Is in litigation or foreclosure;
    (2) Will be disposed of under an approved asset sale program;
    (3) Has been referred to a private collection contractor for a 
period of time acceptable to Treasury;
    (4) Is at a debt collection center for a period of time acceptable 
to Treasury;
    (5) Will be collected under internal offset procedures within 3 
years after the date the debt first became delinquent; or
    (6) Is exempt from this requirement based on a determination by 
Treasury that exemption for a certain class of debt is in the best 
interest of the United States.
    (f) Agencies operating Treasury-designated debt collection centers 
are authorized to charge a fee for services rendered regarding referred 
or transferred debts. The fee may be paid out of amounts collected and 
may be added to the debt as an administrative cost.

[67 FR 30319, May 6, 2002, as amended at 79 FR 66602, Nov. 10, 2014]



Sec.15.21  Written demands for payment.

    (a) The NRC shall make appropriate written demands upon the debtor 
for payment of money or the return of specific property in terms which 
specify:

[[Page 316]]

    (1) The basis of the indebtedness and the right of the debtor to 
seek review within the NRC;
    (2) The amount claimed;
    (3) A description of any property which is to be returned by a date 
certain;
    (4) The date on which payment is to be made (which is normally the 
date the initial written demand letter statement was mailed or hand 
delivered, unless otherwise specified by contractual agreement, 
established by Federal statute or regulation, or agreed to under a 
payment agreement);
    (5) The applicable standards for assessing interest, penalties, and 
administrative costs under 31 CFR 901.9;
    (6) The applicable policy for reporting the delinquent debt to 
consumer reporting agencies; and
    (7) The name, address, and phone number of a contact person or 
office within the NRC will be included with each demand letter.
    (b) The NRC shall normally send two demand letters to debtors. The 
initial demand letter will be followed approximately 30 days later with 
a second demand letter, unless circumstances indicate that alternative 
remedies better protect the Government's interest, that the debtor has 
explicitly refused to pay, or that sending a further demand letter is 
futile. Depending upon the circumstances, the first and second demand 
letters may--
    (1) Offer or seek to confer with the debtor;
    (2) State the amount of the interest and penalties that will be 
added on a daily basis as well as the administrative costs that will be 
added to the debt until the debt is paid; and
    (3) State that the authorized collection procedures include any 
procedure authorized in this part including:
    (i) Contacts with the debtor's employer when the debtor is employed 
by the Federal Government or is a member of the military establishment 
or the Coast Guard;
    (ii) The NRC may report debts to credit bureaus, refer debts to debt 
collection centers and collection agencies for cross-servicing 
(including wage garnishment), tax refund offset, administrative offset, 
and litigation. Any eligible debt that is delinquent for 180 days or 
more will be transferred to the Treasury for collection. Credit bureau 
reporting for transferred debts will be handled by Treasury or a 
Treasury-designated center.
    (iii) Possible reporting of the delinquent debt to consumer 
reporting agencies in accordance with the guidance and standards 
contained in 31 CFR 901.4.
    (iv) The suspension or revocation of a license or other remedy under 
Sec.15.29;
    (v) Installment payments possibly requiring security; and
    (vi) The right to refer the claim to DOJ for litigation.
    (c) The NRC shall normally send only one written demand to a debtor 
who is a current NRC employee. The procedure described in Sec.15.33 
and 10 CFR part 16 will be followed if full payment is not received 
either 30 days from the date the initial written demand was mailed or 
hand delivered. If the NRC cannot obtain full payment by following the 
procedures described in Sec.15.33 and 10 CFR part 16, the NRC may 
follow other collection procedures described in this subpart.
    (d) The failure to state in a letter of demand a matter described in 
Sec.15.21 is not a defense for a debtor and does not prevent the NRC 
from proceeding with respect to that matter.
    (e) When the NRC learns that a bankruptcy petition has been filed 
with respect to a debtor, the NRC will cease collection action 
immediately unless it has been determined that under 11 U.S.C. 362, the 
automatic stay has been lifted or is no longer in effect.

[47 FR 7616, Feb. 22, 1982, as amended at 55 FR 32378, Aug. 9, 1990; 56 
FR 51830, Oct. 16, 1991; 67 FR 30319, May 6, 2002]



Sec.15.23  Telephone or internet inquiries and investigations.

    (a) If a debtor has not responded to one or more demands, the NRC 
shall make reasonable efforts by telephone or internet to determine the 
debtor's intentions.
    (b) The NRC may undertake an investigation to locate a debtor if the 
whereabouts of a debtor is a problem, or if a debtor cannot be contacted 
by telephone.

[[Page 317]]

    (c) The NRC, under 15 U.S.C. 1681(f), may obtain consumer credit 
information from private firms, including the name, address, former 
addresses, place of employment, and former places of employment of a 
debtor.

[47 FR 7616, Feb. 22, 1982, as amended at 67 FR 30319, May 6, 2002]



Sec.15.25  Personal interviews.

    (a) The NRC may seek an interview with the debtor at the offices of 
the NRC when--
    (1) A matter involved in the claim needs clarification;
    (2) Information is needed concerning the debtor's circumstances; or
    (3) An agreement for payment might be negotiated.
    (b) The NRC shall grant an interview with a debtor upon the debtor's 
request. The NRC will not reimburse a debtor's interview expenses.

[47 FR 7616, Feb. 22, 1982, as amended at 55 FR 32378, Aug. 9, 1990]



Sec.15.26  Reporting claims.

    (a) In addition to assessing interest, penalties, and administrative 
costs under Sec.15.37, the NRC may report a debt that has been 
delinquent for 90 days to a consumer reporting agency if all the 
conditions of this paragraph are met.
    (1) The debtor has not--
    (i) Paid or agreed to pay the debt under a written payment plan that 
has been signed by the debtor and agreed to by the NRC; or
    (ii) Filed for review of the debt under Sec.15.26 (a)(2)(iv).
    (2) The NRC has included a notification in the second written demand 
(see Sec.15.21(b)) to the individual debtor stating--
    (i) That the payment of the debt is delinquent;
    (ii) That within not less than 60 days after the date of the 
notification, the NRC intends to disclose to a consumer reporting agency 
that the individual debtor is responsible for the debt;
    (iii) The specific information to be disclosed to the consumer 
reporting agency; and
    (iv) That the debtor has a right to a complete explanation of the 
debt (if that has not already been given), to dispute information in NRC 
records about the debt, and to request reconsideration of the debt by 
administrative appeal or review of the debt.
    (3) The NRC has reconsidered its initial decision on the debt when 
the debtor has requested a review under paragraph (a)(2)(iv) of this 
section.
    (4) The NRC has taken reasonable action to locate a debtor for whom 
the NRC does not have a current address to send the notification 
provided for in paragraph (a)(2) of this section.
    (b) If there is a substantial change in the condition or amount of 
the debt, the NRC shall--
    (1) Promptly disclose that fact(s) to each consumer reporting agency 
to which the original disclosure was made;
    (2) Promptly verify or correct information about a debt on request 
of a consumer reporting agency for verification of information disclosed 
by the NRC; and,
    (3) Obtain assurances from the consumer reporting agency that the 
agency is complying with all applicable Federal, state and local laws 
relating to its use of consumer credit information.
    (c) The information the NRC discloses to the consumer reporting 
agency is limited to--
    (1) Information necessary to establish the identity of the 
individual debtor, including name, address, and taxpayer identification 
number;
    (2) The amount, status, and history of the debt; and
    (3) The NRC activity under which the debt arose.

[55 FR 32378, Aug. 9, 1990, as amended at 67 FR 30319, May 6, 2002]



Sec.15.27  Contact with debtor's employing agency.

    If the debtor is employed by the Federal government or is a member 
of the military establishment or the Coast Guard, collection by offset 
must be accomplished in accordance with 5 U.S.C. 5514 and the provisions 
of 10 CFR part 16.

[56 FR 51830, Oct. 16, 1991]

[[Page 318]]



Sec.15.29  Suspension or revocation of license.

    In non-bankruptcy cases, the NRC may suspend or revoke any license, 
permit, or approval which the NRC has granted to the debtor for any 
inexcusable, prolonged, or repeated failure of the debtor to pay a 
delinquent debt. Before suspending or revoking any license, permit, or 
approval for failure to pay a debt, the NRC shall issue to the debtor 
(by certified mail) an order or a demand for information as to why the 
license, permit, or approval should not be suspended or revoked. The NRC 
shall allow the debtor no more than 30 days to pay the debt in full, 
including applicable interest, penalties, and administrative costs of 
collection of the delinquent debt. The NRC may revoke the license, 
permit, or approval at the end of this period. If a license is revoked 
under authority of this part, a new application, with appropriate fees, 
must be made to the NRC. The NRC may not consider an application unless 
all previous delinquent debts of the debtor to the NRC have been paid in 
full. The suspension or revocation of a license, permit, or approval is 
also applicable to Federal programs or activities that are administered 
by the states on behalf of the Federal Government to the extent that 
they affect the Federal Government's ability to collect money or funds 
owed by debtors. In bankruptcy cases, before advising the debtor of 
NRC's intention to suspend or revoke licenses, permits, or approvals, 
the NRC will seek legal advice from its Office of the General Counsel 
concerning the impact of the Bankruptcy Code which may restrict such 
action.

[67 FR 30320, May 6, 2002]



Sec.15.31  Disputed debts.

    (a) A debtor who disputes a debt shall explain why the debt is 
incorrect in fact or in law within 30 days from the date that the 
initial demand letter was mailed or hand-delivered. The debtor may 
support the explanation by affidavits, cancelled checks, or other 
relevant evidence.
    (b) If the debtor's arguments appear to have merit, the NRC may 
extend the interest waiver period as described in Sec.15.37(j) pending 
a final determination of the existence or amount of the debt.
    (c) The NRC may investigate the facts involved in the dispute and, 
if it considers it necessary, arrange for a conference at which the 
debtor may present evidence and any arguments in support of the debtor's 
position.

[47 FR 76716, Feb. 22, 1982, as amended at 55 FR 32379, Aug. 9, 1990]



Sec.15.32  Contracting for collection services.

    The NRC may contract for collection services in order to recover 
delinquent debts only if the debts are not subject to the DCIA 
requirement to transfer debts to Treasury for debt collection services, 
e.g. debts that are less than 180 days delinquent. However, the NRC 
retains the authority to resolve disputes, compromise claims, suspend or 
terminate collection action, and initiate enforced collection through 
litigation. When appropriate, the NRC shall contract for collection 
services in accordance with the guidance and standards contained in 31 
CFR chapter IX, parts 900-904.

[67 FR 30320, May 6, 2002]



Sec.15.33  Collection by administrative offset.

    (a) Application. (1) The NRC may administratively undertake 
collection by centralized offset on each claim which is liquidated or 
certain in amount in accordance with the guidance and standards in 31 
CFR Chapter IX, parts 900-904 and 5 U.S.C. 5514.
    (2) This section does not apply to:
    (i) Debts arising under the Social Security Act, except as provided 
in 42 U.S.C. 404;
    (ii) Payments made under the Social Security Act, except as provided 
for in 31 U.S.C. 3716(c) (see 31 CFR 285.4, Federal Benefit Offset);
    (iii) Debts arising under, or payments made under, the Internal 
Revenue Code (see 31 CFR 285.2, Tax Refund Offset) or the tariff laws of 
the United States;
    (iv) Offsets against Federal salaries to the extent these standards 
are inconsistent with regulations published to implement such offsets 
under 5 U.S.C. 5514 and 31 U.S.C. 3716 (see 5 CFR

[[Page 319]]

part 550, subpart K, and 31 CFR 285.7, Federal Salary Offset);
    (v) Offsets under 31 U.S.C. 3728 against a judgment obtained by a 
debtor against the United States;
    (vi) Offsets or recoupments under common law, State law, or Federal 
statutes specifically prohibiting offsets or recoupments of particular 
types of debts; or
    (vii) Offsets in the course of judicial proceedings, including 
bankruptcy.
    (3) Unless otherwise provided for by contract or law, debts or 
payments that are not subject to administrative offset under 31 U.S.C. 
3716 may be collected by administrative offset under the common law or 
their applicable statutory authority.
    (4) Unless otherwise provided by law, the NRC may not initiate 
administrative offset of payments under the authority of 31 U.S.C. 3716 
to collect a debt more than 10 years after the Government's right to 
collect the debt first accrued, unless facts material to the 
Government's right to collect the debt were not known and could not 
reasonably have been known to the NRC, or collection of ``approval'' 
fees has been deferred under 10 CFR part 170. If the collection of 
``approval'' fees has been deferred, the ten-year period begins to run 
at the end of the deferral period.
    (5) In bankruptcy cases, the NRC will seek legal advice from its 
Office of the General Counsel concerning the impact of the Bankruptcy 
Code on pending or contemplated collections by offset.
    (b) Mandatory centralized offset. (1) The NRC is required to refer 
past due, legally enforceable, nontax debts that are over 120 days 
delinquent to Treasury for collection by centralized administrative 
offset. A debt is legally enforceable if there has been a final NRC 
determination that the debt, in the amount stated, is due and there are 
no legal bars to collection action. Debts that are less than 120 days 
delinquent also may be referred to Treasury for this purpose.
    (2) The names and taxpayer identifying numbers (TINs) of debtors who 
owe debts referred to Treasury as described in paragraph (b)(1) of this 
section must be compared to the names and TINs on payments to be made by 
Federal disbursing officials. Federal disbursing officials include 
disbursing officials of Treasury, the Department of Defense, the United 
States Postal Service, other Government corporations, and disbursing 
officials of the United States designated by Treasury. When the name and 
TIN of a debtor match the name and TIN of a payee and all other 
requirements for offset have been met, the payment will be offset to 
satisfy the debt.
    (3) Federal disbursing officials will notify the debtor/payee in 
writing that an offset has occurred to satisfy, in part or in full, a 
past due, legally enforceable delinquent debt. The notice must include a 
description of the type and amount of the payment from which the offset 
was taken, the amount of offset that was taken, the identity of the 
creditor agency (NRC) requesting the offset, and a contact point within 
NRC who will respond to questions regarding the offset
    (c) NRC administrative offset. (1) Before referring a delinquent 
debt to Treasury for administrative offset, the NRC adopts the following 
administrative offset procedures:
    (i) Offsets may be initiated only after the debtor has been sent 
written notice of the type and amount of the debt, the intention of the 
NRC to use administrative offset to collect the debt, and an explanation 
of the debtor's rights under 31 U.S.C. 3716; and
    (ii) The debtor has been given--
    (A) The opportunity to inspect and copy NRC records related to the 
debt;
    (B) The opportunity for a review within the NRC of the determination 
of indebtedness; and
    (C) The opportunity to make a written agreement to repay the debt.
    (iii) The procedures set forth in paragraph (c)(1)(i) of this 
section may be omitted when--
    (A) The offset is in the nature of a recoupment;
    (B) The debt arises under a contract as set forth in Cecile 
Industries, Inc. v. Cheney, 995 F.2d 1052 (Fed. Cir. 1993) (notice and 
other procedural protections set forth in 31 U.S.C. 3716(a) do not 
supplant or restrict established procedures for contractual offsets 
accommodated by the Contracts Disputes Act); or

[[Page 320]]

    (C) The NRC first learns of the existence of the amount owed by the 
debtor when there is insufficient time before payment would be made to 
the debtor/payee to allow for prior notice and an opportunity for 
review. This applies to non-centralized offsets conducted under 
paragraph (d) of this section. When prior notice and an opportunity for 
review are omitted, the NRC shall give the debtor notice and an 
opportunity for review as soon as practicable and shall refund any money 
ultimately found not to have been owed to the NRC.
    (iv) When an agency previously has given a debtor any of the 
required notice and review opportunities with respect to a particular 
debt (31 CFR 901.2), the NRC need not duplicate the notice and review 
opportunities before administrative offset may be initiated.
    (2) When referring delinquent debts to Treasury, the NRC shall 
certify, in a form acceptable to Treasury, that:
    (i) The debt is past due and legally enforceable; and
    (ii) The NRC has complied with all due process requirements under 31 
U.S.C. 3716(a) and the NRC's regulations.
    (3) Payments that are prohibited by law from being offset are exempt 
from centralized administrative offset. The Treasury shall exempt 
payments under means-tested programs from centralized administrative 
offset when requested in writing by the head of the payment-certifying 
or authorizing agency. Also, the Treasury may exempt other classes of 
payments from centralized offset upon the written request of the head of 
the payment-certifying or authorizing agency.
    (4) Benefit payments made under the Social Security Act (42 U.S.C. 
301 et seq.), part B of the Black Lung Benefits Act (30 U.S.C. 921 et 
seq.), and any law administered by the Railroad Retirement Board (other 
than tier 2 benefits), may be offset only in accordance with Treasury 
regulations, issued in consultation with the Social Security 
Administration, the Railroad Retirement Board, and the Office of 
Management and Budget (31 CFR 285.4).
    (5) In accordance with 31 U.S.C. 3716(f), the Treasury may waive the 
provisions of the Computer Matching and Privacy Protection Act of 1988 
concerning matching agreements and post-match notification and 
verification (5 U.S.C. 552a(o) and (p)) for centralized administrative 
offset upon receipt of a certification from the NRC that the due process 
requirements enumerated in 31 U.S.C. 3716(a) have been met. The 
certification of a debt in accordance with paragraph (c)(2) of this 
section will satisfy this requirement. If a waiver is granted, only the 
Data Integrity Board of the Department of the Treasury is required to 
oversee any matching activities, in accordance with 31 U.S.C. 3716(g). 
This waiver authority does not apply to offsets conducted under 
paragraphs (c) and (d) of this section.
    (d) Non-centralized administrative offset. (1) Generally, non-
centralized administrative offsets are ad hoc case-by-case offsets that 
NRC would conduct, at its discretion, internally or in cooperation with 
the agency certifying or authorizing payments to the debtor. Unless 
otherwise prohibited by law, when centralized administrative offset is 
not available or appropriate, past due, legally enforceable, nontax 
delinquent debts may be collected through non-centralized administrative 
offset. In these cases, the NRC may make a request directly to a 
payment-authorizing agency to offset a payment due a debtor to collect a 
delinquent debt. For example, the NRC will request the Office of 
Personnel Management (OPM) to offset a Federal employee's lump sum 
payment upon leaving Government service to satisfy an unpaid advance.
    (2) Before requesting Treasury to conduct a non-centralized 
administrative offset, the NRC adopts the following procedures, which 
provide that such offsets may occur only after:
    (i) The debtor has been provided due process as set forth in 
paragraph (c)(1) of this section; and
    (ii) The Treasury has received written certification from NRC that 
the debtor owes the past due, legally enforceable delinquent debt in the 
amount stated, and that the NRC has fully complied with its regulations 
concerning administrative offset.
    (3) Treasury shall comply with offset requests by NRC to collect 
debts owed

[[Page 321]]

to the United States, unless the offset would not be in the best 
interests of the United States with respect to the Treasury's program, 
or would otherwise be contrary to law. Appropriate use should be made of 
the cooperative efforts of other agencies in effecting collection by 
administrative offset.
    (4) When collecting multiple debts by non-centralized administrative 
offset, the NRC will apply the recovered amounts to those debts in 
accordance with the best interests of the United States, as determined 
by the facts and circumstances of the particular case, particularly the 
applicable statute of limitations.
    (e) Requests to OPM to offset a debtor's anticipated or future 
benefit payment under the Civil Service Retirement and Disability Fund. 
Upon providing OPM written certification that a debtor has been afforded 
the procedures provided in paragraph (c)(1) of this section, the NRC 
will request OPM to offset a debtor's anticipated or future benefit 
payments under the Civil Service Retirement and Disability Fund (Fund) 
in accordance with regulations codified at 5 CFR 831.1801-831.1808. Upon 
receipt of such a request, OPM will identify and ``flag'' a debtor's 
account in anticipation of the time when the debtor requests, or becomes 
eligible to receive, payments from the Fund. This will satisfy any 
requirement that offset be initiated prior to the expiration of the time 
limitations referenced in paragraph (a)(4) of this section.
    (f) Review requirements. (1) For purposes of this section, whenever 
the NRC is required to afford a debtor a review within the agency, the 
NRC shall provide the debtor with a reasonable opportunity for an oral 
hearing in accordance with 10 CFR 16.9, when the debtor requests 
reconsideration of the debt, and the NRC determines that the question of 
the indebtedness cannot be resolved by review of the documentary 
evidence, for example, when the validity of the debt turns on an issue 
of credibility or veracity.
    (2) Unless otherwise required by law, an oral hearing under this 
section is not required to be a formal evidentiary hearing, although the 
NRC should carefully document all significant matters discussed at the 
hearing.
    (3) This section does not require an oral hearing with respect to 
debt collection systems in which a determination of indebtedness rarely 
involves issues of credibility or veracity, and the NRC has determined 
that review of the written record is ordinarily an adequate means to 
correct prior mistakes.
    (4) In those cases in which an oral hearing is not required by this 
section, the NRC shall accord the debtor a ``paper hearing,'' that is, a 
determination of the request for reconsideration based upon a review of 
the written record.

[67 FR 30320, May 6, 2002, as amended at 79 FR 66602, Nov. 10, 2014]



Sec.15.35  Payments.

    (a) Payment in full. The NRC shall make every effort to collect a 
claim in full before it becomes delinquent. If a claim is paid in one 
lump sum after it becomes delinquent, the NRC shall impose charges for 
interest, penalties, and administrative costs as specified in Sec.
15.37.
    (b) Payment by installment. If a debtor furnishes satisfactory 
evidence of inability to pay a claim in one lump sum, payment in regular 
installments may be arranged. Evidence may consist of a financial 
statement or a signed statement that the debtor's application for a loan 
to enable the debtor to pay the claim in full was rejected. Except for a 
claim described in 5 U.S.C. 5514 and codified in 10 CFR part 16, all 
installment payment arrangements must be in writing and require the 
payment of interest and administrative charges.
    (1) Installment note forms may be used. The written installment 
agreement must contain a provision accelerating the debt payment in the 
event the debtor defaults. If the debtor's financial statement discloses 
the ownership of assets which are free and clear of liens or security 
interests, or assets in which the debtor owns an equity, the debtor may 
be asked to secure the payment of an installment note by executing a 
Security Agreement and Financing Statement transferring to the United 
States a security interest in the asset until the debt is discharged.
    (2) If the debtor owes more than one debt, the NRC will apply the 
payment to the various debts in accordance with

[[Page 322]]

the best interests of the United States, as determined by the facts and 
circumstances of the particular case.
    (c) To whom payment is made. Payment of a debt is made by check, 
electronic transfer, draft, credit card, or money order and should be 
payable to the United States Nuclear Regulatory Commission, License Fee 
and Accounts Receivable Branch, P.O. Box 954514, St. Louis, MO. 63195-
4514, unless payment is--
    (1) Made pursuant to arrangements with DOJ;
    (2) Ordered by a Court of the United States; or
    (3) Otherwise directed in any other part of this chapter.

[47 FR 7616, Feb. 22, 1982, as amended at 52 FR 31610, Aug. 21, 1987; 54 
FR 53316, Dec. 28, 1989; 55 FR 32379, Aug. 9, 1990; 56 FR 51830, Oct. 
16, 1991; 63 FR 15743, Apr. 1, 1998; 67 FR 30322, May 6, 2002]



Sec.15.37  Interest, penalties, and administrative costs.

    (a) The NRC shall assess interest, penalties, and administrative 
costs on debts owed to the United States Government in accordance with 
the guidance provided under the FCCS, 31 CFR 901.9.
    (b) Before assessing any charges on delinquent debt, the NRC shall 
mail or hand-deliver a written notice to the debtor explaining its 
requirements concerning these charges under 31 CFR 901.2 and 901.9, 
except where these charges are included in a contractual or repayment 
agreement.
    (c) Interest begins to accrue from the date on which the initial 
written demand, advising the debtor of the interest requirements, is 
first mailed or hand delivered to the debtor unless a different date is 
specified in a statute, regulation, or contract.
    (d) The NRC shall assess interest based upon the rate of the current 
value of funds to the United States Treasury (the Treasury tax and loan 
account rate) prescribed for the current quarter and published in the 
Federal Register and the Treasury Financial Manual Bulletins, unless a 
different rate is prescribed by statute, regulation, or contract.
    (e) Interest is computed only on the principal of the debt and the 
interest rate remains fixed for the duration of the indebtedness, unless 
a debtor defaults on a repayment agreement and seeks to enter into a new 
agreement.
    (f) The NRC shall assess against a debtor charges to cover 
administrative costs incurred as a result of a delinquent debt. 
Administrative costs may include costs incurred in obtaining a credit 
report or in using a private debt collector, to the extent they are 
attributable to the delinquency.
    (g) The NRC shall assess a penalty charge of 6 percent a year on any 
portion of a debt that is delinquent for more than 90 days. The charge 
accrues retroactively to the date that the debt became delinquent.
    (h) Amounts received by the NRC as partial or installment payments 
are applied first to outstanding penalty and administrative cost 
charges, second to accrued interest, and third to outstanding principal.
    (i) The NRC shall waive collection of interest on the debt or any 
portion of the debt which is paid in full within 30 days after the date 
on which interest began to accrue.
    (j) The NRC may waive interest during the period a debt disputed 
under Sec.15.31 is under investigation or review by the NRC. However, 
this additional waiver is not automatic and must be requested before the 
expiration of the initial 30-day waiver period. The NRC may grant the 
additional waiver only when it finds merit in the explanation the debtor 
has submitted under Sec.15.31.
    (k) The NRC may waive the collection of interest, penalties, and 
administrative costs if it finds that one or more of the following 
conditions exist:
    (1) The debtor is unable to pay any significant sum toward the debt 
within a reasonable period of time;
    (2) Collection of interest, penalties, and administrative costs will 
jeopardize collection of the principal of the debt;
    (3) The NRC is unable to enforce collection in full within a 
reasonable time by enforced collection proceedings; or
    (4) Collection would be against equity and good conscience or not in 
the best interests of the United States, including the situation in 
which an administrative offset or installment payment agreement is in 
effect.

[[Page 323]]

    (l) The NRC is authorized to impose interest and related charges on 
debts not subject to 31 U.S.C. 3717, in accordance with common law.

[55 FR 32380, Aug. 9, 1990, as amended at 67 FR 30322, May 6, 2002]



Sec.15.38  Use of credit reports.

    The NRC may institute a credit investigation of the debtor at any 
time following receipt of knowledge of the debt in order to aid NRC in 
making appropriate determinations as to:
    (a) The collection and compromise of a debt;
    (b) The collection of interest, penalties, and administrative costs;
    (c) The use of administrative offset;
    (d) The use of other collection methods; and
    (e) The likelihood of collecting the debt.

[55 FR 32380, Aug. 9, 1990]



Sec.15.39  Bankruptcy claims.

    When the NRC learns that a bankruptcy petition has been filed with 
respect to a debtor, before proceeding with further collection action, 
the NRC will immediately seek legal advice from its Office of the 
General Counsel concerning the impact of the Bankruptcy Code on any 
pending or contemplated collection activities. Unless the NRC determines 
that the automatic stay imposed at the time of filing pursuant to 11 
U.S.C. 362 has been lifted or is no longer in effect, collection 
activity against the debtor will in most cases stop immediately.
    (a) After seeking legal advice from its Office of the General 
Counsel, a proof of claim usually will be filed with the bankruptcy 
court or the Trustee.
    (b) If the NRC is a secured creditor, it may seek relief from the 
automatic stay regarding its security, subject to the provisions and 
requirements of 11 U.S.C. 362.
    (c) Offset is stayed in most cases by the automatic stay. However, 
the NRC will seek legal advice from its Office of the General Counsel to 
determine whether its payments to the debtor and payments of other 
agencies available for offset may be frozen by the agency until relief 
from the automatic stay can be obtained from the bankruptcy court. The 
NRC will seek legal advice from its Office of the General Counsel to 
determine if recoupment is available.

[67 FR 30322, May 6, 2002]



                     Subpart C_Compromise of a Claim



Sec.15.41  When a claim may be compromised.

    (a) The NRC may compromise a claim not in excess of the monetary 
limitation if it has not been referred to DOJ for litigation.
    (b) Unless otherwise provided by law, when the principal balance of 
a debt, exclusive of interest, penalties, and administrative costs, 
exceeds $100,000 or any higher amount authorized by the Attorney 
General, the authority to accept the compromise rests with the DOJ. The 
NRC will evaluate the compromise offer, using the factors set forth in 
this part. If an offer to compromise any debt in excess of $100,000 is 
acceptable to the NRC, the NRC shall refer the debt to the Civil 
Division or other appropriate litigating division in the DOJ using a 
CCLR. The referral must include appropriate financial information and a 
recommendation for the acceptance of the compromise offer. DOJ approval 
is not required if the compromise offer is rejected by NRC.

[67 FR 30322, May 6, 2002]



Sec.15.43  Reasons for compromising a claim.

    A claim may be compromised for one or more of the reasons set forth 
below:
    (a) The full amount cannot be collected because:
    (1) The debtor is unable to pay the full amount within a reasonable 
time; or
    (2) The debtor refuses to pay the claim in full and the Government 
is unable to enforce collection in full within a reasonable time by 
enforced collection proceedings.
    (b) There is a real doubt concerning the Government's ability to 
prove its case in Court for the full amount claimed, either because of 
the legal issues involved or a bona fide dispute as to the facts.

[[Page 324]]

    (c) The cost of collecting the claim does not justify the enforced 
collection of the full amount. The NRC shall apply this reason for 
compromise in accordance with the guidance in 31 CFR 902.2.
    (d) The NRC shall determine the debtor's inability to pay, the 
Government's ability to enforce collection, and the amounts that are 
acceptable in compromise in accordance with the FCCS, 31 CFR part 902.
    (e) Compromises payable in installments are discouraged, but, if 
necessary, must be in the form of a legally enforceable agreement for 
the reinstatement of the prior indebtedness less sums paid thereon. The 
agreement also must provide that in the event of default--
    (1) The entire balance of the debt becomes immediately due and 
payable; and
    (2) The Government has the right to enforce any security interest.

[47 FR 7616, Feb. 22, 1982, as amended at 55 FR 32380, Aug. 9, 1990; 67 
FR 30322, May 6, 2002]



Sec.15.45  Consideration of tax consequences to the Government.

    (a) The NRC may accept a percentage of a debtor's profits or stock 
in a debtor corporation in compromise of a claim. In negotiating a 
compromise with a business concern, the NRC should consider requiring a 
waiver of tax-loss-carry-forward and tax-loss-carry-back rights of the 
debtor. For information on reporting requirements, see Sec.15.60.
    (b) When two or more debtors are jointly and severally liable, the 
NRC will pursue collection activity against all debtors, as appropriate. 
The NRC will not attempt to allocate the burden of payment between the 
debtors but will proceed to liquidate the indebtedness as quickly as 
possible. The NRC will ensure that a compromise agreement with one 
debtor does not release the NRC's claim against the remaining debtors. 
The amount of a compromise with one debtor shall not be considered a 
precedent or binding in determining the amount that will be required 
from other debtors jointly and severally liable on the claim.

[67 FR 30322, May 6, 2002]



Sec.15.47  Finality of a compromise.

    An offer of compromise must be in writing and signed by the debtor. 
An offer of compromise which is accepted by the NRC is final and 
conclusive on the debtor and on all officials, agencies, and courts of 
the United States, unless obtained by fraud, misrepresentation, the 
presentation of a false claim, or mutual mistake of fact.



Sec.15.49  Mutual releases of the debtor and the Government.

    (a) In all appropriate instances, a compromise that is accepted by 
NRC should be implemented by means of a mutual release.
    (1) The debtor is released from further non-tax liability on the 
compromised debt in consideration of payment in full of the compromised 
amount.
    (2) The Government and its officials, past and present, are released 
and discharged from any and all claims and causes of action arising from 
the same transaction held by the debtor.
    (b) If a mutual release is not executed when a debt is compromised, 
unless prohibited by law, the debtor is still deemed to have waived any 
and all claims and causes of action against the Government and its 
officials related to the transaction giving rise to the compromised 
debt.

[67 FR 30322, May 6, 2002]



        Subpart D_Suspension or Termination of Collection Action



Sec.15.51  When collection action may be suspended or terminated.

    The NRC may suspend or terminate collection action on a claim not in 
excess of the monetary limitation of $100,000 or such other amount as 
the Attorney General may direct, exclusive of interest, penalties, and 
administrative costs, after deducting the amount of partial payments or 
collections, if any of the debt has not been referred to the DOJ for 
litigation. If, after deducting the amount of any partial payments or 
collections, the principal amount of a debt exceeds $100,000, or such 
other amount as the Attorney General may direct, exclusive of interest, 
penalties, and administrative

[[Page 325]]

costs, the authority to suspend or terminate rests solely with the DOJ. 
If the NRC believes that suspension or termination of any debt in excess 
of $100,000 may be appropriate, the NRC shall refer the debt to the 
Civil Division or other appropriate litigating division in the DOJ, 
using the CCLR. The referral should specify the reasons for the NRC's 
recommendation. If, prior to referral to the DOJ, the NRC determines 
that a debt is plainly erroneous or clearly without legal merit, the NRC 
may terminate collection activity, regardless of the amount involved, 
without obtaining DOJ concurrence.

[67 FR 30323, May 6, 2002]



Sec.15.53  Reasons for suspending collection action.

    The NRC may suspend collection activity when:
    (a) The NRC cannot locate the debtor;
    (b) The debtor's financial condition is not expected to improve; or
    (c) The debtor has requested a waiver or review of the debt.
    (d) Based on the current financial condition of the debtor, the NRC 
may suspend collection activity on a debt when the debtor's future 
prospects justify retention of the debt for periodic review and 
collection activity and:
    (1) The applicable statute of limitations has not expired; or
    (2) Future collection can be effected by administrative offset, 
notwithstanding the expiration of the applicable statute of limitations 
for litigation of claims, with due regard to the 10-year limitation for 
administrative offset prescribed by 31 U.S.C. 3716(e)(1); or
    (3) The debtor agrees to pay interest on the amount of the debt on 
which collection will be suspended, and such suspension is likely to 
enhance the debtor's ability to pay the full amount of the principal of 
the debt with interest at a later date.
    (e)(1) The NRC shall suspend collection activity during the time 
required for consideration of the debtor's request for waiver or 
administrative review of the debt, if the statute under which the 
request is sought prohibits the NRC from collecting the debt during that 
time.
    (2) If the statute under which the request is sought does not 
prohibit collection activity pending consideration of the request, the 
NRC may use discretion, on a case-by-case basis, to suspend collection. 
Further, the NRC ordinarily should suspend collection action upon a 
request for waiver or review, if the NRC is prohibited by statute or 
regulation from issuing a refund of amounts collected prior to NRC 
consideration of the debtor's request. However, the NRC should not 
suspend collection when the NRC determines that the request for waiver 
or review is frivolous or was made primarily to delay collection.
    (f) When the NRC learns that a bankruptcy petition has been filed 
with respect to a debtor, in most cases, the collection activity on a 
debt must be suspended, pursuant to the provisions of 11 U.S.C. 362, 
1201, and 1301, unless the NRC can clearly establish that the automatic 
stay has been lifted or is no longer in effect. The NRC should seek 
legal advice immediately from its Office of the General Counsel and, if 
legally permitted, take the necessary steps to ensure that no funds or 
money are paid by the NRC to the debtor until relief from the automatic 
stay is obtained.

[67 FR 30323, May 6, 2002]



Sec.15.55  Reasons for terminating collection action.

    The NRC may terminate collection activity when:
    (a) The NRC is unable to collect any substantial amount through its 
own efforts or through the efforts of others;
    (b) The NRC is unable to locate the debtor;
    (c) Costs of collection are anticipated to exceed the amount 
recoverable,
    (d) The debt is legally without merit or enforcement of the debt is 
barred by any applicable statute of limitations;
    (e) The debt cannot be substantiated; or
    (f) The debt against the debtor has been discharged in bankruptcy.

[67 FR 30323, May 6, 2002]

[[Page 326]]



Sec.15.57  Termination of collection action.

    (a) Before terminating collection activity, the NRC should have 
pursued all appropriate means of collection and determined, based upon 
the results of the collection activity, that the debt is uncollectible. 
Termination of collection activity ceases active collection of the debt. 
The termination of collection activity does not preclude the NRC from 
retaining a record of the account for purposes of:
    (1) Selling the debt, if the Treasury determines that such sale is 
in the best interests of the United States;
    (2) Pursuing collection at a subsequent date in the event there is a 
change in the debtor's status or a new collection tool becomes 
available;
    (3) Offsetting against future income or assets not available at the 
time of termination of collection activity; or
    (4) Screening future applicants for prior indebtedness.
    (b) Generally, the NRC will terminate collection activity on a debt 
that has been discharged in bankruptcy, regardless of the amount. 
However, the NRC may continue collection activity, subject to the 
provisions of the Bankruptcy Code, for any payments provided under a 
plan of reorganization.

[67 FR 30323, May 6, 2002]



Sec.15.59  Exception to termination.

    When a significant enforcement policy is involved, or recovery of a 
judgment is a prerequisite to the imposition of administrative 
sanctions, the NRC may refer debts for litigation, although termination 
of collection activity may be appropriate.

[67 FR 30323, May 6, 2002]



Sec.15.60  Discharge of indebtedness; reporting requirements.

    (a) Before discharging a delinquent debt (also referred to as a 
close out of the debt), the NRC shall take all appropriate steps to 
collect the debt in accordance with 31 U.S.C. 3711(g), including, as 
applicable, administrative offset; tax refund offset; Federal salary 
offset; referral to Treasury, Treasury-designated debt collection 
centers, or private collection contractors; credit bureau reporting; 
wage garnishment; litigation; and foreclosure. Discharge of indebtedness 
is distinct from termination or suspension of collection activity under 
10 CFR 15.55 and 15.57 and is governed by the Internal Revenue Code. 
When collection action on a debt is suspended or terminated, the debt 
remains delinquent, and further collection action may be pursued at a 
later date. When the NRC discharges a debt in full or in part, further 
collection action is prohibited. Therefore, the NRC will make the 
determination that collection action is no longer warranted before 
discharging a debt. Before discharging a debt, the NRC must terminate 
debt collection action.
    (b) Section 3711(i), title 31, United States Code, requires agencies 
to sell a delinquent nontax debt upon termination of collection action 
if Treasury determines such a sale is in the best interests of the 
United States. Since the discharge of a debt precludes any further 
collection action (including the sale of a delinquent debt), the NRC may 
not discharge a debt until the requirements of 31 U.S.C. 3711(i) have 
been met.
    (c) Upon discharge of an indebtedness, the NRC shall report the 
discharge to the IRS in accordance with the requirements of 26 U.S.C. 
6050P and 26 CFR 1.6050P-1. The NRC may request Treasury or a Treasury-
designated debt collection center to file a discharge report to the IRS 
on the NRC's behalf.
    (d) When discharging a debt, the NRC shall request that litigation 
counsel release any liens of record securing the debt.

[67 FR 30323, May 6, 2002]



                      Subpart E_Referral of a Claim



Sec.15.61  Prompt referral.

    (a) The NRC shall promptly refer debts that are subject to 
aggressive collection activity (as described in subpart B of this part) 
and that cannot be compromised, or debts on which collection activity 
cannot be suspended or terminated, to DOJ for litigation. Debts for 
which the principal amount exceeds $1,000,000, or such other amount as 
the Attorney General may

[[Page 327]]

direct, exclusive of interest and penalties, must be referred to the 
Civil Division or other division responsible for litigating such debts 
at DOJ, Washington, DC. Debts for which the principal amount is 
$1,000,000 or less, or such other amount as the Attorney General may 
direct, exclusive of interest or penalties, must be referred to the 
DOJ's Nationwide Central Intake Facility, as required by the CCLR 
instructions. Debts will be referred as early as possible, consistent 
with the NRC's aggressive collection activity and well within the one 
year of the NRC's final determination of the fact and the amount of the 
debt.
    (b) DOJ has exclusive jurisdiction over the debts referred to in 
paragraph (a) of this section. The NRC shall terminate the use of any 
administrative collection activities to collect a debt when the debt is 
referred to DOJ. The NRC shall advise the DOJ of the collection 
activities it used and the results. The NRC shall refrain from having 
any contact with the debtor and shall direct all inquiries to DOJ. The 
NRC shall immediately notify DOJ of any payments credited to the 
debtor's account after the account has been referred to DOJ. DOJ shall 
notify NRC in a timely manner of any payments it receives from the 
debtor.

[67 FR 30324, May 6, 2002]



Sec.15.65  Referral of a compromise offer.

    The NRC may refer a debtor's firm written offer of compromise, which 
is substantial in amount, to the Civil Division or other appropriate 
litigating division in DOJ using a CCLR accompanied by supporting data 
and particulars concerning the debt.

[67 FR 30324, May 6, 2002]



Sec.15.67  Referral to the Department of Justice.

    (a) Unless excepted by DOJ, the NRC shall complete the CCLR 
accompanied by a Certificate of Indebtedness, to refer all 
administratively uncollectible claims to the DOJ for litigation.
    (b) The NRC shall indicate the actions it wishes DOJ to take 
regarding the referred claim on the CCLR.
    (c) Before referring a debt to DOJ for litigation, the NRC shall 
notify each person determined to be liable for the debt that, unless the 
debt can be collected administratively, litigation may be initiated. 
This notification must comply with Executive Order 12988 (3 CFR, 1996 
Comp., pp 157-163) and may be given as part of a demand letter or as a 
separate document.
    (d) The NRC shall preserve all files and records that DOJ may need 
to prove the claim in court.
    (e) The NRC may ordinarily not refer for litigation claims of less 
than $2,500, exclusive of interest, penalties, and administrative 
charges, or such other amount as the Attorney General shall from time to 
time prescribe.
    (f) The NRC may not refer claims of less than the minimum amount 
unless:
    (1) Litigation to collect a smaller claim is important to ensure 
compliance with NRC's policies and programs;
    (2) The claim is being referred solely to secure a judgment against 
the debtor, which will be filed as a lien against the debtor's property 
under 28 U.S.C. 3201 and returned to the NRC for enforcement, or
    (3) The debtor has the clear ability to pay the claim, and the 
Government effectively can enforce payment, with due regard for the 
exemptions available to the debtor under state and Federal law and the 
judicial remedies available to the Government.

[67 FR 30324, May 6, 2002]



PART 16_SALARY OFFSET PROCEDURES FOR COLLECTING DEBTS OWED BY FEDERAL
EMPLOYEES TO THE FEDERAL GOVERNMENT--Table of Contents



Sec.
16.1 Purpose and scope.
16.3 Definitions.
16.5 Application.
16.7 Notice requirements.
16.8 Information collection requirements: OMB approval.
16.9 Hearing.
16.11 Written decision.
16.13 Procedures for centralized administrative offset.
16.15 Procedures for internal salary offset.
16.17 Refunds.
16.19 Statute of limitations.
16.21 Non-waiver of rights.
16.23 Interest, penalties, and administrative charges.


[[Page 328]]


    Authority: Atomic Energy Act of 1954, sec. 161 (42 U.S.C. 2201), 
Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 31 U.S.C. 
3711, 3716, 3717, 3718; 5 U.S.C. 5514; Pub. L. 97-365, 96 Stat. 1749; 4 
CFR parts 101 through 105; 5 CFR 550.1101 through 550.1108.

    Source: 56 FR 51830, Oct. 16, 1991, unless otherwise noted.



Sec.16.1  Purpose and scope.

    (a) This part provides procedures for the collection by 
administrative offset of a Federal employee's salary without his/her 
consent to satisfy certain debts owed to the Federal Government. This 
part applies to all Federal employees who owe debts to the Nuclear 
Regulatory Commission (NRC) and to current employees of the NRC who owe 
debts to other Federal agencies. This part does not apply when the 
employee consents to recovery from his/her current pay account.
    (b) These procedures do not apply to debts or claims arising under:
    (1) The Internal Revenue Code of 1954, as amended, 26 U.S.C. 1 et 
seq.;
    (2) The tariff laws of the United States; or
    (3) Any case where a collection of a debt by salary offset is 
explicitly provided for or prohibited by another statute.
    (c) These procedures do not apply to any adjustment to pay arising 
out of an employee's selection of coverage or a change in coverage under 
a Federal benefits program requiring periodic deductions from pay if the 
amount to be recovered was accumulated over four pay periods or less.
    (d) These procedures do not preclude the compromise, suspension, or 
termination of collection action where appropriate under the standards 
implementing the revised Federal Claims Collection Standards (FCCS), 31 
U.S.C. 3711 et seq., 31 CFR chapter IX, parts 900 through 904.
    (e) This part does not preclude an employee from requesting waiver 
of an overpayment under 5 U.S.C. 5584, 10 U.S.C. 2774, or 32 U.S.C. 716 
or in any way questioning the amount or validity of the debt by 
submitting a subsequent claim to the NRC. This part does not preclude an 
employee from requesting a waiver pursuant to other statutory provisions 
applicable to the particular debt being collected.
    (f) The NRC is not limited to collection remedies contained in the 
revised FCCS. The FCCS is not intended to impair common law remedies.

[56 FR 51830, Oct. 16, 1991, as amended at 63 FR 15743, Apr. 1, 1998; 67 
FR 57507, Sept. 11, 2002]



Sec.16.3  Definitions.

    For the purposes of this part, the following definitions apply:
    Administrative charges are those amounts assessed by NRC to cover 
the costs of processing and handling delinquent debts due the 
Government.
    Administrative offset means withholding money payable by the United 
States Government to, or held by the Government for, a person to satisfy 
a debt the person owes the United States Government.
    Agency means any agency of the executive, legislative, and judicial 
branches of the Federal Government, including Government corporations.
    Centralized salary offset computer matching describes the 
computerized process used to match delinquent debt records with Federal 
salary payment records when the purpose of the match is to identify 
Federal employees who owe debt to the Federal Government.
    Creditor agency means the agency to which the debt is owed, 
including a debt collection center when acting in behalf of a creditor 
agency in matters pertaining to the collection of a debt.
    Debt and claim are used synonymously to refer to an amount of money, 
funds, or property that has been determined by an agency official to be 
owed to the United States from any person, organization, or entity, 
except another Federal agency. For the purposes of administrative offset 
under 31 U.S.C. 3716, the terms debt and claim include an amount of 
money, funds, or property owed by a person to a State (including past-
due support being enforced by a State), the District of Columbia, 
American Samoa, Guam, the United States Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, or the Commonwealth of Puerto Rico.
    Debt collection center means the Department of the Treasury or other 
Government agency or division designated by the Secretary of the 
Treasury with

[[Page 329]]

authority to collect debts on behalf of creditor agencies.
    Delinquent debt record refers to the information about a debt that 
an agency submits to Treasury when the agency refers the debt for 
collection by offset in accordance with the provision of 31 U.S.C. 3716.
    Disbursing official means an official who has authority to disburse 
Federal salary payments pursuant to 31 U.S.C. 3321 or another law.
    Disposable pay means that part of current basic pay, special pay, 
incentive pay, retired pay, retainer pay, or in the case of an employee 
not entitled to basic pay, other authorized pay remaining after the 
deduction of:
    (1) Any amount required by law to be withheld;
    (2) Amounts properly withheld for Federal, state or local income tax 
purposes;
    (3) Amounts deducted as health insurance premiums;
    (4) Amounts deducted as normal retirement contributions, not 
including amounts deducted for supplementary coverage; and
    (5) Amounts deducted as normal life insurance premiums not including 
amounts deducted for supplementary coverage.
    Employee is any individual employed by any agency of the executive, 
legislative, and judicial branches of the Federal Government, including 
Government corporations.
    FCCS means the Federal Claims Collection Standards jointly published 
by the Department of the Treasury and the Department of Justice at 31 
CFR Chapter IX, Parts 900 through 904.
    Hearing official means an individual responsible for conducting any 
hearing with respect to the existence or amount of a debt claimed or the 
repayment schedule if not established by written agreement between the 
employee and the NRC, and who renders a decision on the basis of this 
hearing.
    Paying agency means the agency that employs the individual who owes 
the debt and authorizes the payment of his/her current pay.
    Salary offset means an administrative offset to collect a debt under 
5 U.S.C. 5514 by deduction(s) at one or more officially established pay 
intervals from the current pay account of an employee without his or her 
consent.
    Treasury as used in 10 CFR part 16 means the Department of the 
Treasury.
    Waiver means the cancellation, remission, forgiveness, or non-
recovery of a debt allegedly owed by an employee to an agency as 
permitted or required by 5 U.S.C. 5584, 10 U.S.C. 2774, 32 U.S.C. 716, 5 
U.S.C. 8346(b), or any other law.

[56 FR 51830, Oct. 16, 1991, as amended at 67 FR 57507, Sept. 11, 2002]



Sec.16.5  Application.

    The regulations in this part are to be followed when:
    (a) The NRC is owed a debt by an individual currently employed by 
another Federal agency;
    (b) The NRC is owed a debt by an individual who is a current 
employee of the NRC; or
    (c) The NRC employs an individual who owes a debt to another Federal 
agency.



Sec.16.7  Notice requirements.

    (a) If the NRC is the creditor agency, deductions will not be made 
unless the NRC provides the employee with a signed written notice of the 
debt at least 30 days before salary offset commences. The notice will be 
delivered in person or by certified or registered mail, return receipt 
requested, with receipt returned as proof of delivery.
    (b) The written notice must contain:
    (1) A statement that the debt is owed and an explanation of its 
origin, nature, and amount;
    (2) The NRC's intention to collect the debt by deducting from the 
employee's current disposable pay account;
    (3) The amount and frequency of the intended deduction (stated as a 
fixed dollar amount or as a percentage of pay, not to exceed 15 percent 
of disposable pay) and the intention to continue the deduction until the 
debt is paid in full or otherwise resolved.
    (4) An explanation of interest, penalties, and administrative 
charges, including a statement that these charges will be assessed 
unless excused in accordance with the Federal Claims Collection 
Standards at 4 CFR parts 101-105;

[[Page 330]]

    (5) The employee's right to inspect and copy government records 
pertaining to the debt or, if the employee or his or her representative 
cannot personally inspect the records, to request and receive a copy of 
these records;
    (6) If not previously provided, the opportunity (under terms 
agreeable to the NRC) to establish a schedule for the voluntary 
repayment of the debt or to enter into a written agreement to establish 
a schedule for repayment of the debt in lieu of offset (31 CFR Chapter 
IX, 901.2). The agreement must be in writing, signed by the employee and 
the NRC, and documented in the NRC's files.
    (7) The employee's right to a hearing conducted by an official 
arranged for by the NRC (an administrative law judge, or alternatively, 
a hearing official not under the control of the head of the agency) if a 
petition is filed as prescribed in Sec.16.9;
    (8) The methods and time period for petitioning for hearings;
    (9) A statement that the timely filing of a petition for a hearing 
will stay the commencement of collection proceedings;
    (10) A statement that a final decision on the hearing will be issued 
not later than 60 days after the filing of the petition requesting the 
hearing unless the employee requests and the hearing official grants a 
delay in the proceedings;
    (11) A statement that knowingly false or frivolous statements, 
representations, or evidence may subject the employee to appropriate 
disciplinary procedures under chapter 75 of title 5, United States Code 
and 5 CFR part 752, penalties under the False Claims Act, sections 3729-
3731 of title 31, United States Code or other applicable statutory 
authority, or criminal penalties under section 286, 287, 1001 and 1002 
of title 18, United States Code or any other applicable statutory 
authority;
    (12) A statement of other rights and remedies available to the 
employee under statutes or regulations governing the program for which 
the collection is being made; and
    (13) Unless there are contractual or statutory provisions to the 
contrary, a statement that amounts paid on or deducted for the debt 
which are later waived or found not owed to the United States will be 
promptly refunded to the employee.

[56 FR 51830, Oct. 16, 1991, as amended at 67 FR 57508, Sept. 11, 2002]



Sec.16.8  Information collection requirements: OMB approval.

    This part contains no information collection requirements, and, 
therefore, is not subject to the requirements of the Paperwork Reduction 
Act (44 U.S.C. 3501 et. seq.).

[67 FR 57508, Sept. 11, 2002]



Sec.16.9  Hearing.

    (a) Request for hearing. (1) An employee shall file a petition for a 
hearing in accordance with the instructions outlined in the creditor 
agency's notice of offset.
    (2) If the NRC is the creditor agency, a hearing may be requested by 
filing a written petition stating why the employee disputes the 
existence or amount of the debt or the repayment schedule if it was not 
established by written agreement between the employee and the NRC. The 
employee shall sign the petition and fully identify and explain with 
reasonable specificity all the facts, evidence, and witnesses, if any, 
which the employee believes support his or her position. The petition 
for a hearing must be received no later than fifteen (15) calendar days 
after receipt of the notice of offset unless the employee can show that 
the delay in meeting the deadline date was because of circumstances 
beyond his or her control or because of failure to receive notice of the 
time limit (unless otherwise aware of it).
    (b) Hearing procedures. (1) The hearing will be presided over by a 
hearing official arranged by NRC (an administrative law judge or, 
alternatively, a hearing official not under the supervision or control 
of the head of the agency.)
    (2) The hearing must conform to procedures contained in the revised 
FCCS, 31 CFR Chapter IX, 901.3(e). The burden is on the employee to 
demonstrate either that the existence or the amount of the debt is in 
error or that the terms of the repayment schedule would result in undue 
financial hardship or would be against equity and good conscience.

[[Page 331]]

    (3) An employee is entitled to representation of his or her choice 
at any stage of the proceeding. NRC attorneys may not be provided as 
representatives for the debtor. The NRC will not compensate the debtor 
for representation expenses, including hourly fees for attorneys, travel 
expenses, and costs for reproducing documents.

[56 FR 51830, Oct. 16, 1991, as amended at 67 FR 57508, Sept. 11, 2002]



Sec.16.11  Written decision.

    (a) The hearing official will issue a written opinion no later than 
60 days after the hearing.
    (b) The written opinion must include:
    (1) A statement of the facts presented to demonstrate the nature and 
origin of the alleged debt;
    (2) The hearing official's analysis, findings, and conclusions;
    (3) The amount and validity of the debt; and
    (4) The repayment schedule, where appropriate.



Sec.16.13  Procedures for centralized administrative offset.

    (a) The NRC must notify Treasury of all debts that are delinquent as 
defined in the FCCS (over 180 days old) so that recovery may be made by 
centralized administrative offset. This includes those debts the NRC 
seeks to recover from the pay account of an employee of another agency 
via salary offset. The Treasury and other Federal disbursing officials 
will match payments, including Federal salary payments, against such 
debts. When a match occurs, and all the requirements for offset have 
been met, the payments will be offset to collect the debt. Prior to 
offset of the pay account of an employee, the NRC must comply with the 
requirements of 5 U.S.C. 5514, 5 CFR part 550, and 10 CFR part 15. 
Procedures for notifying Treasury of a debt for purposes of collection 
by centralized administrative offset are contained in 31 CFR part 285 
and 10 CFR 15.33. Procedures for internal salary offset are contained in 
Sec.16.15 of this chapter.
    (b) When the NRC determines that an employee of another Federal 
agency owes a delinquent debt to the NRC, the NRC will, as appropriate:
    (1) Arrange for a hearing upon the proper petitioning by the 
employee;
    (2) Provide the Federal employee with a notice and an opportunity to 
dispute the debt as contained in 5 U.S.C. 5514 and 10 CFR 15.26.
    (3) Submit the debt to Treasury for centralized administrative 
offset and certify in writing that the debtor has been afforded the 
legally required due process notification.
    (4) If collection must be made in installments, the NRC must advise 
the paying agency of the amount or percentage of disposable pay to be 
collected in each installment.
    (c) Offset amount. (1) The amount offset from a salary payment under 
this section shall be the lesser of:
    (i) The amount of the debt, including any interest, penalties, and 
administrative costs; or
    (ii) An amount up to 15 percent of the debtor's disposable pay.
    (2) Alternatively, the amount offset may be an amount agreed upon, 
in writing, by the debtor and the NRC.
    (3) Offsets will continue until the debt, including any interest, 
penalties, and administrative costs, is paid in full or otherwise 
resolved to the satisfaction of the NRC.
    (d) Priorities. (1) A levy pursuant to the Internal Revenue Code of 
1986 shall take precedence over other deductions under this section.
    (2) When a salary payment may be reduced to collect more than one 
debt, amounts offset under this section will be applied to a debt only 
after amounts offset have been applied to satisfy past due child support 
debt assigned to a State pursuant 26 U.S.C. 6402(c) and 31 CFR 
285.7(h)(2).
    (e) Notice. (1) Before offsetting a salary payment, the disbursing 
official, or the paying agency on behalf of the disbursing official, 
shall notify the Federal employee in writing of the date that deductions 
from salary will commence and of the amount of such deductions.
    (2)(i) When an offset occurs under this section, the disbursing 
official, or the paying agency on behalf of the disbursing official, 
shall notify the Federal employee in writing that an offset has occurred 
including:

[[Page 332]]

    (A) A description of the payment and the amount of the offset taken;
    (B) Identification of NRC as the agency requesting the offset; and,
    (C) A contact point within the NRC that will handle concerns 
regarding the offset.
    (ii) The information described in paragraphs (e)(2)(i)(B) and 
(e)(2)(i)(C) of this section does not need to be provided to the Federal 
employee when the offset occurs if such information was included in a 
prior notice from the disbursing official or paying agency.
    (3) The disbursing official will advise the NRC of the names, 
mailing addresses, and taxpayer identifying numbers of the debtors from 
whom amounts of past-due, legally enforceable debt were collected and of 
the amounts collected from each debtor. The disbursing official will not 
advise the NRC of the source of payment from which such amounts were 
collected.
    (f) Fees. Agencies that perform centralized salary offset computer 
matching services may charge a fee sufficient to cover the full cost of 
such services. In addition, Treasury or a paying agency acting on behalf 
of Treasury, may charge a fee sufficient to cover the full cost of 
implementing the administrative offset program. Treasury may deduct the 
fees from amounts collected by offset or may bill the NRC. Fees charged 
for offset shall be based on actual administrative offsets completed.
    (g) Disposition of amounts collected. The disbursing official 
conducting the offset will transmit amounts collected for debts, less 
fees charged under paragraph (f) of this section, to NRC. If an 
erroneous offset payment is made to the NRC, the disbursing official 
will notify the NRC that an erroneous offset payment has been made. The 
disbursing official may deduct the amount of the erroneous offset 
payment from future amounts payable to the NRC. Alternatively, upon the 
disbursing official's request, the NRC shall return promptly to the 
disbursing official or the affected payee an amount equal to the amount 
of the erroneous payment (without regard to whether any other amounts 
payable to the agency have been paid). The disbursing official and the 
NRC shall adjust the debtor records appropriately.

[67 FR 57508, Sept. 11, 2002]



Sec.16.15  Procedures for internal salary offset.

    (a) Deductions to liquidate an employee's debt will be by the method 
and in the amount stated in the NRC's notice of intention to offset as 
provided in Sec.16.7. Debts will be collected in one lump sum where 
possible. If the employee is financially unable to pay in one lump sum, 
collection must be made in installments.
    (b) Debts will be collected by deduction at officially established 
pay intervals from an employee's current pay account unless alternative 
arrangements for repayment are made.
    (c) Installment deductions will be made over a period not greater 
than the anticipated period of employment. The size of installment 
deductions must bear a reasonable relationship to the size of the debt 
and the employee's ability to pay. The deduction for the pay intervals 
for any period may not exceed 15% of disposable pay unless the employee 
has agreed in writing to a deduction of a greater amount.
    (d) Offset against any subsequent payment due an employee who 
retires or resigns or whose employment or period of active duty ends 
before collection of the debt is completed is provided for in accordance 
with 31 U.S.C. 3716. These payments include but are not limited to final 
salary payment or lump-sum leave due the employee from the paying agency 
as of the date of separation to the extent necessary to liquidate the 
debt.



Sec.16.17  Refunds.

    (a) The NRC will refund promptly any amounts deducted to satisfy 
debts owed to the NRC when the debt is waived, found not owed to the 
NRC, or when directed by an administrative or Judicial order.
    (b) The creditor agency will promptly return any amounts deducted by 
NRC to satisfy debts owed to the creditor agency when the debt is 
waived, found not owed, or when directed by an administrative or 
judicial order.

[[Page 333]]

    (c) Unless required or permitted by law or contract, refunds under 
this section may not bear interest.



Sec.16.19  Statute of limitations.

    If a debt has been outstanding for more than 10 years after the 
agency's right to collect the debt first accrued, the agency may not 
collect by salary offset unless facts material to the Government's right 
to collect were not known and could not reasonably have been known by 
the NRC official or officials who were charged with the responsibility 
for discovery and collection of the debts.



Sec.16.21  Non-waiver of rights.

    An employee's involuntary payment of all or any part of a debt 
collected under these regulations will not be construed as a waiver of 
any rights that the employee may have under 5 U.S.C. 5514 or any other 
provision of contract or law, unless there are statutes or contract(s) 
to the contrary.



Sec.16.23  Interest, penalties, and administrative charges.

    Charges may be assessed for interest, penalties, and administrative 
charges in accordance with the FCCS, 31 CFR Chapter IX, 901.9.

[67 FR 57509, Sept. 11, 2002]



PART 19_NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION
AND INVESTIGATIONS--Table of Contents



Sec.
19.1 Purpose.
19.2 Scope.
19.3 Definitions.
19.4 Interpretations.
19.5 Communications.
19.8 Information collection requirements: OMB approval.
19.11 Posting of notices to workers.
19.12 Instruction to workers.
19.13 Notifications and reports to individuals.
19.14 Presence of representatives of licensees and regulated entities, 
          and workers during inspections.
19.15 Consultation with workers during inspections.
19.16 Requests by workers for inspections.
19.17 Inspections not warranted; informal review.
19.18 Sequestration of witnesses and exclusion of counsel in interviews 
          conducted under subpoena.
19.20 Employee protection.
19.30 Violations.
19.31 Application for exemptions.
19.32 Discrimination prohibited.
19.40 Criminal penalties.

    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.

    Source: 38 FR 22217, Aug. 17, 1973, unless otherwise noted.



Sec.19.1  Purpose.

    The regulations in this part establish requirements for notices, 
instructions, and reports by licensees and regulated entities to 
individuals participating in NRC-licensed and regulated activities and 
options available to these individuals in connection with Commission 
inspections of licensees and regulated entities, and to ascertain 
compliance with the provisions of the Atomic Energy Act of 1954, as 
amended, titles II and IV of the Energy Reorganization Act of 1974, and 
regulations, orders, and licenses thereunder. The regulations in this 
part also establish the rights and responsibilities of the Commission 
and individuals during interviews compelled by subpoena as part of 
agency inspections or investigations under Section 161c of the Atomic 
Energy Act of 1954, as amended, on any matter within the Commission's 
jurisdiction.

[72 FR 49483, Aug. 28, 2007]



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, 39, 
40, 60, 61, 63, 70, or 72 of this chapter, including persons licensed to 
operate a production or utilization facility under parts 50 or 52 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

[[Page 334]]

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, and 54 
of this chapter;
    (3) All applicants for and holders of a standard design approval 
under subpart E of part 52 of this chapter; and
    (4) All applicants for a standard design certification under subpart 
B of part 52 of this chapter, and those (former) applicants whose 
designs have been certified under that subpart.
    (b) The regulations in this part regarding interviews of individuals 
under subpoena apply to all investigations and inspections within the 
jurisdiction of the NRC other than those involving NRC employees or NRC 
contractors. The regulations in this part do not apply to subpoenas 
issued under 10 CFR 2.702.

[72 FR 49484, Aug. 28, 2007]



Sec.19.3  Definitions.

    As used in this part:
    Act means the Atomic Energy Act of 1954, (68 Stat. 919) including 
any amendments thereto.
    Commission means the United States Nuclear Regulatory Commission.
    Exclusion means the removal of counsel representing multiple 
interests from an interview whenever the NRC official conducting the 
interview has concrete evidence that the presence of the counsel would 
obstruct and impede the particular investigation or inspection.
    License means a license issued under the regulations in parts 30 
through 36, 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 parts 50, 52, or 54 of this chapter.
    Licensee means the holder of such a license.
    Regulated activities means any activity carried on which is under 
the jurisdiction of the NRC under the Atomic Energy Act of 1954, as 
amended, or any title of the Energy Reorganization Act of 1972, as 
amended.
    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 of this chapter or a standard 
design certification under subpart B of part 52 of this chapter.
    Restricted area means an area, access to which is limited by the 
licensee for the purpose of protecting individuals against undue risks 
from exposure to radiation and radioactive materials. Restricted area 
does not include areas used as residential quarters, but separate rooms 
in a residential building may be set apart as a restricted area.
    Sequestration means the separation or isolation of witnesses and 
their attorneys from other witnesses and their attorneys during an 
interview conducted as part of an investigation, inspection, or other 
inquiry.
    Worker means an individual engaged in activities licensed or 
regulated by the Commission and controlled by a licensee or regulated 
entity, but does not include the licensee or regulated entity.

[38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 53 
FR 31680, Aug. 19, 1988; 55 FR 247, Jan. 4, 1990; 56 FR 23470, May 21, 
1991; 56 FR 65948, Dec. 19, 1991; 57 FR 61785, Dec. 29, 1992; 58 FR 
7736, Feb. 9, 1993; 66 FR 55789, Nov. 2, 2001; 69 FR 76600, Dec. 22, 
2004; 72 FR 49484, Aug. 28, 2007]



Sec.19.4  Interpretations.

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



Sec.19.5  Communications.

    Except where otherwise specified in this part, all communications 
and reports concerning the regulations in this part should be addressed 
to the Regional Administrator of the appropriate U.S. Nuclear Regulatory 
Commission Regional Office listed in Appendix D of part 20 of this 
chapter. Communications, reports, and applications may be delivered in 
person at the Commission's offices at One White

[[Page 335]]

Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland.

[67 FR 67098, Nov. 4, 2002]



Sec.19.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0044.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.19.13 and 19.16.

[62 FR 52185, Oct. 6, 1997]



Sec.19.11  Posting of notices to workers.

    (a) Each licensee (except for a holder of an early site permit under 
subpart A of part 52 of this chapter, or a holder of a manufacturing 
license under subpart F of part 52 of this chapter) shall post current 
copies of the following documents:
    (1) The regulations in this part and in part 20 of this chapter;
    (2) The license, license conditions, or documents incorporated into 
a license by reference, and amendments thereto;
    (3) The operating procedures applicable to licensed activities;
    (4) Any notice of violation involving radiological working 
conditions, proposed imposition of civil penalty, or order issued 
pursuant to subpart B of part 2 of this chapter, and any response from 
the licensee.
    (b) Each applicant for and holder of a standard design approval 
under subpart E of part 52 of this chapter, each applicant for an early 
site permit under subpart A of part 52 of this chapter, each applicant 
for a standard design certification under subpart B of part 52 of this 
chapter, and each applicant for and holder of a manufacturing license 
under subpart F of part 52 of this chapter shall post:
    (1) The regulations in this part;
    (2) The operating procedures applicable to the activities regulated 
by the NRC which are being conducted by the applicant or holder; and
    (3) Any notice of violation, proposed imposition of civil penalty, 
or order issued under subpart B of part 2 of this chapter, and any 
response from the applicant or holder.
    (c) [Reserved]
    (d) If posting of a document specified in paragraphs (a)(1), (2) or 
(3), or (b)(1) or (2) of this section is not practicable, the licensee 
or regulated entity may post a notice which describes the document and 
states where it may be examined.
    (e)(1) Each licensee, each applicant for a specific license, each 
applicant for or holder of a standard design approval under subpart E of 
part 52 of this chapter, each applicant for an early site permit under 
subpart A of part 52 of this chapter, and each applicant for a standard 
design certification under subpart B of part 52 of this chapter shall 
prominently post NRC Form 3, ``Notice to Employees,'' dated August 1997. 
Later versions of NRC Form 3 that supersede the August 1997 version 
shall replace the previously posted version within 30 days of receiving 
the revised NRC Form 3 from the Commission.
    (2) Additional copies of NRC Form 3 may be obtained by writing to 
the Regional Administrator of the appropriate U.S. Nuclear Regulatory 
Commission Regional Office listed in appendix D to part 20 of this 
chapter, via email to [email protected], or by visiting the NRC's 
online library at http://www.nrc.gov/reading-rm/doc-collections/forms/.
    (f) Documents, notices, or forms posted under this section shall 
appear in a sufficient number of places to permit individuals engaged in 
NRC-licensed or regulated activities to observe them on the way to or 
from any particular licensed or regulated activity location to which the 
document applies, shall be conspicuous, and shall be replaced if defaced 
or altered.
    (g) Commission documents posted under paragraphs (a)(4) or (b)(3) of 
this section shall be posted within 2 working days after receipt of the 
documents

[[Page 336]]

from the Commission; the licensee's or regulated entity's response, if 
any, shall be posted within 2 working days after dispatch by the 
licensee or regulated entity. These documents shall remain posted for a 
minimum of 5 working days or until action correcting the violation has 
been completed, whichever is later.

[38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 47 
FR 30454, July 14, 1982; 58 FR 52408, Oct. 8, 1993; 60 FR 24551, May 9, 
1995; 61 FR 6764, Feb. 22, 1996; 62 FR 48166, Sept. 15, 1997; 68 FR 
58801, Oct. 10, 2003; 72 FR 49484, Aug. 28, 2007; 73 FR 30457, May 28, 
2008; 79 FR 66602, Nov. 10, 2014]



Sec.19.12  Instruction to workers.

    (a) All individuals who in the course of employment are likely to 
receive in a year an occupational dose in excess of 100 mrem (1 mSv) 
shall be--
    (1) Kept informed of the storage, transfer, or use of radiation and/
or radioactive material;
    (2) Instructed in the health protection problems associated with 
exposure to radiation and/or radioactive material, in precautions or 
procedures to minimize exposure, and in the purposes and functions of 
protective devices employed;
    (3) Instructed in, and required to observe, to the extent within the 
workers control, the applicable provisions of Commission regulations and 
licenses for the protection of personnel from exposure to radiation and/
or radioactive material;
    (4) Instructed of their responsibility to report promptly to the 
licensee any condition which may lead to or cause a violation of 
Commission regulations and licenses or unnecessary exposure to radiation 
and/or radioactive material;
    (5) Instructed in the appropriate response to warnings made in the 
event of any unusual occurrence or malfunction that may involve exposure 
to radiation and/or radioactive material; and
    (6) Advised as to the radiation exposure reports which workers may 
request pursuant to Sec.19.13.
    (b) In determining those individuals subject to the requirements of 
paragraph (a) of this section, licensees must take into consideration 
assigned activities during normal and abnormal situations involving 
exposure to radiation and/or radioactive material which can reasonably 
be expected to occur during the life of a licensed facility. The extent 
of these instructions must be commensurate with potential radiological 
health protection problems present in the work place.

[60 FR 36043, July 13, 1995]



Sec.19.13  Notifications and reports to individuals.

    (a) Radiation exposure data for an individual, and the results of 
any measurements, analyses, and calculations of radioactive material 
deposited or retained in the body of an individual, shall be reported to 
the individual as specified in this section. The information reported 
shall include data and results obtained pursuant to Commission 
regulations, orders or license conditions, as shown in records 
maintained by the licensee pursuant to Commission regulations. Each 
notification and report shall: be in writing; include appropriate 
identifying data such as the name of the licensee, the name of the 
individual, the individual's social security number; include the 
individual's exposure information; and contain the following statement:

    This report is furnished to you under the provisions of the Nuclear 
Regulatory Commission regulation 10 CFR part 19. You should preserve 
this report for further reference.

    (b) Each licensee shall make dose information available to workers 
as shown in records maintained by the licensee under the provisions of 
10 CFR 20.2106. The licensee shall provide an annual report to each 
individual monitored under 10 CFR 20.1502 of the dose received in that 
monitoring year if:
    (1) The individual's occupational dose exceeds 1 mSv (100 mrem) TEDE 
or 1 mSv (100 mrem) to any individual organ or tissue; or
    (2) The individual requests his or her annual dose report.
    (c)(1) At the request of a worker formerly engaged in licensed 
activities controlled by the licensee, each licensee shall furnish to 
the worker a report of the worker's exposure to radiation and/or to 
radioactive material:

[[Page 337]]

    (i) As shown in records maintained by the licensee pursuant to Sec.
20.2106 for each year the worker was required to be monitored under the 
provisions of Sec.20.1502; and
    (ii) For each year the worker was required to be monitored under the 
monitoring requirements in effect prior to January 1, 1994.
    (2) This report must be furnished within 30 days from the time the 
request is made or within 30 days after the exposure of the individual 
has been determined by the licensee, whichever is later. This report 
must cover the period of time that the worker's activities involved 
exposure to radiation from radioactive material licensed by the 
Commission and must include the dates and locations of licensed 
activities in which the worker participated during this period.
    (d) When a licensee is required by Sec. Sec.20.2202, 20.2203 or 
20.2204 of this chapter to report to the Commission any exposure of an 
individual to radiation or radioactive material, the licensee shall also 
provide the individual a report on his or her exposure data included in 
the report to the Commission. This report must be transmitted no later 
than the transmittal to the Commission.
    (e) At the request of a worker who is terminating employment with 
the licensee that involved exposure to radiation or radioactive 
materials, during the current calendar quarter or the current year, each 
licensee shall provide at termination to each worker, or to the worker's 
designee, a written report regarding the radiation dose received by that 
worker from operations of the licensee during the current year or 
fraction thereof. If the most recent individual monitoring results are 
not available at that time, a written estimate of the dose must be 
provided together with a clear indication that this is an estimate.

[38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 44 
FR 32352, June 6, 1979; 58 FR 67658, Dec. 22, 1993; 59 FR 41642, Aug. 
15, 1994; 72 FR 68058, Dec. 4, 2007]



Sec.19.14  Presence of representatives of licensees and regulated
entities, and workers during inspections.

    (a) Each licensee, applicant for a license, applicant for or holder 
of a standard design approval under subpart E of part 52 of this 
chapter, applicant for an early site permit under subpart A of part 52 
of this chapter, and applicant for a standard design certification under 
subpart B of part 52 of this chapter shall afford to the Commission at 
all reasonable times opportunity to inspect materials, activities, 
facilities, premises, and records under the regulations in this chapter.
    (b) During an inspection, Commission inspectors may consult 
privately with workers as specified in Sec.19.15. The licensee, 
regulated entity, or the licensee's or regulated entity's representative 
may accompany Commission inspectors during other phases of an 
inspection.
    (c) If, at the time of inspection, an individual has been authorized 
by the workers to represent them during Commission inspections, the 
licensee or regulated entity shall notify the inspectors of such 
authorization and shall give the workers' representative an opportunity 
to accompany the inspectors during the inspection of physical working 
conditions.
    (d) Each workers' representative shall be routinely engaged in NRC-
licensed or regulated activities under control of the licensee or 
regulated entity, and shall have received instructions as specified in 
Sec.19.12.
    (e) Different representatives of licensees or regulated entities, 
and workers may accompany the inspectors during different phases of an 
inspection if there is no resulting interference with the conduct of the 
inspection. However, only one workers' representative at a time may 
accompany the inspectors.
    (f) With the approval of the licensee or regulated entity, and the 
workers' representative an individual who is not routinely engaged in 
licensed or regulated activities under control of the license or 
regulated entity (for example,

[[Page 338]]

a consultant to the licensee, the regulated entity, or the workers' 
representative), shall be afforded the opportunity to accompany 
Commission inspectors during the inspection of physical working 
conditions.
    (g) Notwithstanding the other provisions of this section, Commission 
inspectors are authorized to refuse to permit accompaniment by any 
individual who deliberately interferes with a fair and orderly 
inspection. With regard to areas containing information classified by an 
agency of the U.S. Government in the interest of national security, an 
individual who accompanies an inspector may have access to such 
information only if authorized to do so. With regard to any area 
containing proprietary information, the workers' representative for that 
area shall be an individual previously authorized by the licensee or 
regulated entity to enter that area.

[72 FR 49484, Aug. 28, 2007, as amended at 76 FR 72084, Nov. 22, 2011]



Sec.19.15  Consultation with workers during inspections.

    (a) Commission inspectors may consult privately with workers 
concerning matters of occupational radiation protection and other 
matters related to applicable provisions of Commission regulations and 
licenses to the extent the inspectors deem necessary for the conduct of 
an effective and thorough inspection.
    (b) During the course of an inspection any worker may bring 
privately to the attention of the inspectors, either orally or in 
writing, any past or present condition which he has reason to believe 
may have contributed to or caused any violation of the act, the 
regulations in this chapter, or license condition, or any unnecessary 
exposure of an individual to radiation from licensed radioactive 
material under the licensee's control. Any such notice in writing shall 
comply with the requirements of Sec.19.16(a).
    (c) The provisions of paragraph (b) of this section shall not be 
interpreted as authorization to disregard instructions pursuant to Sec.
19.12.



Sec.19.16  Requests by workers for inspections.

    (a) Any worker or representative of workers who believes that a 
violation of the Act, the regulations in this chapter, or license 
conditions exists or has occurred in license activities with regard to 
radiological working conditions in which the worker is engaged, may 
request an inspection by giving notice of the alleged violation to the 
Administrator of the appropriate Commission Regional Office, or to 
Commission inspectors. Any such notice shall be in writing, shall set 
forth the specific grounds for the notice, and shall be signed by the 
worker or representative of workers. A copy shall be provided the 
licensee by the Regional Office Administrator, or the inspector no later 
than at the time of inspection except that, upon the request of the 
worker giving such notice, his name and the name of individuals referred 
to therein shall not appear in such copy or on any record published, 
released or made available by the Commission, except for good cause 
shown.
    (b) If, upon receipt of such notice, the Regional Office 
Administrator determines that the complaint meets the requirements set 
forth in paragraph (a) of this section, and that there are reasonable 
grounds to believe that the alleged violation exists or has occurred, he 
shall cause an inspection to be made as soon as practicable, to 
determine if such alleged violation exists or has occurred. Inspections 
pursuant to this section need not be limited to matters referred to in 
the complaint.

[38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 47 
FR 30454, July 14, 1982; 52 FR 31610, Aug. 21, 1987]



Sec.19.17  Inspections not warranted; informal review.

    (a) If the Administrator of the appropriate Regional Office 
determines, with respect to a complaint under Sec.19.16, that an 
inspection is not warranted because there are no reasonable grounds to 
believe that a violation exists or has occurred, he shall notify the 
complainant in writing of such determination. The complainant may obtain 
review of this determination by submitting a written statement of 
position to the

[[Page 339]]

Executive Director for Operations, either by mail to the U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; by hand delivery to 
the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, 
where practicable, by electronic submission, for example, via Electronic 
Information Exchange, or CD-ROM. Electronic submissions must be made in 
a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information. The Executive Director for Operations will provide the 
licensee with a copy of such statement by certified mail, excluding, at 
the request of the complainant, the name of the complainant. The 
licensee may submit an opposing written statement of position with the 
Executive Director for Operations who will provide the complainant with 
a copy of such statement by certified mail. Upon the request of the 
complainant, the Executive Director for Operations or his designee may 
hold an informal conference in which the complainant and the licensee 
may orally present their views. An informal conference may also be held 
at the request of the licensee, but disclosure of the identity of the 
complainant will be made only following receipt of written authorization 
from the complainant. After considering all written and oral views 
presented, the Executive Director for Operations shall affirm, modify, 
or reverse the determination of the Administrator of the appropriate 
Regional Office and furnish the complainant and the licensee a written 
notification of his decision and the reason therefor.
    (b) If the Administrator of the appropriate Regional Office 
determines that an inspection is not warranted because the requirements 
of Sec.19.16(a) have not been met, he shall notify the complainant in 
writing of such determination. Such determination shall be without 
prejudice to the filing of a new complaint meeting the requirements of 
Sec.19.16(a).

[38 FR 22217, Aug. 17, 1973, as amended at 40 FR 8783, Mar. 3, 1975; 52 
FR 31610, Aug. 21, 1987; 67 FR 77652, Dec. 19, 2002; 68 FR 58801, Oct. 
10, 2003; 74 FR 62680, Dec. 1, 2009; 80 FR 74978, Dec. 1, 2015]



Sec.19.18  Sequestration of witnesses and exclusion of counsel 
in interviews conducted under subpoena.

    (a) All witnesses compelled by subpoena to submit to agency 
interviews shall be sequestered unless the official conducting the 
interviews permits otherwise.
    (b) Any witness compelled by subpoena to appear at an interview 
during an agency inquiry may be accompanied, represented, and advised by 
counsel of his or her choice. However, when the agency official 
conducting the inquiry determines, after consultation with the Office of 
the General Counsel, that the agency has concrete evidence that the 
presence of an attorney representing multiple interests would obstruct 
and impede the investigation or inspection, the agency official may 
prohibit that counsel from being present during the interview.
    (c) The interviewing official is to provide a witness whose counsel 
has been excluded under paragraph (b) of this section and the witness's 
counsel a written statement of the reasons supporting the decision to 
exclude. This statement, which must be provided no later than five 
working days after exclusion, must explain the basis for the counsel's 
exclusion. This statement must also advise the witness of the witness' 
right to appeal the exclusion decision and obtain an automatic stay of 
the effectiveness of the subpoena by filing a motion to quash the 
subpoena with the Commission within five days of receipt of this written 
statement.
    (d) Within five days after receipt of the written notification 
required in paragraph (c) of this section, a witness whose counsel has 
been excluded may appeal the exclusion decision by filing a motion to 
quash the subpoena with

[[Page 340]]

the Commission. The filing of the motion to quash will stay the 
effectiveness of the subpoena pending the Commission's decision on the 
motion.
    (e) If a witness' counsel is excluded under paragraph (b) of this 
section, the interview may, at the witness' request, either proceed 
without counsel or be delayed for a reasonable period of time to permit 
the retention of new counsel. The interview may also be rescheduled to a 
subsequent date established by the NRC, although the interview shall not 
be rescheduled by the NRC to a date that precedes the expiration of the 
time provided under Sec.19.18(d) for appeal of the exclusion of 
counsel, unless the witness consents to an earlier date.

[55 FR 247, Jan. 4, 1990, as amended at 56 FR 65948, Dec. 19, 1991; 57 
FR 61785, Dec. 29, 1992]



Sec.19.20  Employee protection.

    Employment discrimination by a licensee, a holder of a certificate 
of compliance issued under part 76 of this chapter or regulated entity 
subject to the requirements in this part as delineated in Sec.19.2(a), 
or a contractor or subcontractor of a licensee, a holder of a 
certificate of compliance issued under part 76 of this chapter, or 
regulated entity subject to the requirements in this part as delineated 
in Sec.19.2(a), against an employee for engaging in protected 
activities under this part or parts 30, 40, 50, 52, 54, 60, 61, 63, 70, 
72, 76, or 150 of this chapter is prohibited.

[72 FR 49485, Aug. 28, 2007]



Sec.19.30  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55071, Nov. 24, 1992]



Sec.19.31  Application for exemptions.

    The Commission may, upon application by any interested person or 
upon its own initiative, grant such exemptions from the requirements of 
the regulations in this part as it determines are authorized by law, 
will not result in undue hazard to life and property.

[72 FR 49485, Aug. 28, 2007]



Sec.19.32  Discrimination prohibited.

    No person shall on the grounds of sex be excluded from participation 
in, be denied a license, be denied the benefit of, or be subjected to 
discrimination under any program or activity carried on which is under 
the jurisdiction of the NRC under the Atomic Energy Act of 1954, as 
amended, or under any title of the Energy Reorganization Act of 1974, as 
amended. This provision will be enforced through agency provisions and 
regulations similar to those already established, with respect to racial 
and other discrimination, under Title VI of the Civil Rights Act of 
1964. This remedy is not exclusive, however, and will not prejudice or 
cut off any other legal remedies available to a discriminatee.

[72 FR 49485, Aug. 28, 2007]



Sec.19.40  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 19 are issued under one or more of sections 
161b, 161i,

[[Page 341]]

or 161o, except for the sections listed in paragraph (b) of this 
section.
    (b) The regulations in part 19 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.19.1, 19.2, 19.3, 19.4, 19.5, 19.8, 19.16, 19.17, 19.18, 
19.30, 19.31, and 19.40.

[57 FR 55071, Nov. 24, 1992]



PART 20_STANDARDS FOR PROTECTION AGAINST RADIATION--Table of Contents



                      Subpart A_General Provisions

Sec.
20.1001 Purpose.
20.1002 Scope.
20.1003 Definitions.
20.1004 Units of radiation dose.
20.1005 Units of radioactivity.
20.1006 Interpretations.
20.1007 Communications.
20.1008 Implementation.
20.1009 Information collection requirements: OMB approval.

                 Subpart B_Radiation Protection Programs

20.1101 Radiation protection programs.

                   Subpart C_Occupational Dose Limits

20.1201 Occupational dose limits for adults.
20.1202 Compliance with requirements for summation of external and 
          internal doses.
20.1203 Determination of external dose from airborne radioactive 
          material.
20.1204 Determination of internal exposure.
20.1205 [Reserved]
20.1206 Planned special exposures.
20.1207 Occupational dose limits for minors.
20.1208 Dose equivalent to an embryo/fetus.

  Subpart D_Radiation Dose Limits for Individual Members of the Public

20.1301 Dose limits for individual members of the public.
20.1302 Compliance with dose limits for individual members of the 
          public.

        Subpart E_Radiological Criteria for License Termination.

20.1401 General provisions and scope.
20.1402 Radiological criteria for unrestricted use.
20.1403 Criteria for license termination under restricted conditions.
20.1404 Alternate criteria for license termination.
20.1405 Public notification and public participation.
20.1406 Minimization of contamination.

                    Subpart F_Surveys and Monitoring

20.1501 General.
20.1502 Conditions requiring individual monitoring of external and 
          internal occupational dose.

 Subpart G_Control of Exposure From External Sources in Restricted Areas

20.1601 Control of access to high radiation areas.
20.1602 Control of access to very high radiation areas.

   Subpart H_Respiratory Protection and Controls To Restrict Internal 
                      Exposure in Restricted Areas

20.1701 Use of process or other engineering controls.
20.1702 Use of other controls.
20.1703 Use of individual respiratory protection equipment.
20.1704 Further restrictions on the use of respiratory protection 
          equipment.
20.1705 Application for use of higher assigned protection factors.

           Subpart I_Storage and Control of Licensed Material

20.1801 Security of stored material.
20.1802 Control of material not in storage.

                   Subpart J_Precautionary Procedures

20.1901 Caution signs.
20.1902 Posting requirements.
20.1903 Exceptions to posting requirements.
20.1904 Labeling containers.
20.1905 Exemptions to labeling requirements.
20.1906 Procedures for receiving and opening packages.

                        Subpart K_Waste Disposal

20.2001 General requirements.
20.2002 Method for obtaining approval of proposed disposal procedures.
20.2003 Disposal by release into sanitary sewerage.
20.2004 Treatment or disposal by incineration.
20.2005 Disposal of specific wastes.
20.2006 Transfer for disposal and manifests.
20.2007 Compliance with environmental and health protection regulations.
20.2008 Disposal of certain byproduct material.

                            Subpart L_Records

20.2101 General provisions.

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20.2102 Records of radiation protection programs.
20.2103 Records of surveys.
20.2104 Determination of prior occupational dose.
20.2105 Records of planned special exposures.
20.2106 Records of individual monitoring results.
20.2107 Records of dose to individual members of the public.
20.2108 Records of waste disposal.
20.2109 [Reserved]
20.2110 Form of records.

                            Subpart M_Reports

20.2201 Reports of theft or loss of licensed material.
20.2202 Notification of incidents.
20.2203 Reports of exposures, radiation levels, and concentrations of 
          radioactive material exceeding the constraints or limits.
20.2204 Reports of planned special exposures.
20.2205 Reports to individuals of exceeding dose limits.
20.2206 Reports of individual monitoring.
20.2207 Reports of transactions involving nationally tracked sources.

            Subpart N_Exemptions and Additional Requirements

20.2301 Applications for exemptions.
20.2302 Additional requirements.

                          Subpart O_Enforcement

20.2401 Violations.
20.2402 Criminal penalties.

Appendix A to Part 20--Assigned Protection Factors for Respirators
Appendix B to Part 20--Annual Limits on Intake (ALIs) and Derived Air 
          Concentrations (DACs) of Radionuclides for Occupational 
          Exposure; Effluent Concentrations; Concentrations for Release 
          to Sewerage
Appendix C to Part 20--Quantities of Licensed Material Requiring 
          Labeling
Appendix D to Part 20--United States Nuclear Regulatory Commission 
          Regional Offices
Appendix E to Part 20--Nationally Tracked Source Thresholds
Appendix F to Part 20 [Reserved]
Appendix G to Part 20--Requirements for Transfers of Low-Level 
          Radioactive Waste Intended for Disposal at Licensed Land 
          Disposal Facilities and Manifests

    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.



                      Subpart A_General Provisions

    Source: 56 FR 23391, May 21, 1991, unless otherwise noted.



Sec.20.1001  Purpose.

    (a) The regulations in this part establish standards for protection 
against ionizing radiation resulting from activities conducted under 
licenses issued by the Nuclear Regulatory Commission. These regulations 
are issued under the Atomic Energy Act of 1954, as amended, and the 
Energy Reorganization Act of 1974, as amended.
    (b) It is the purpose of the regulations in this part to control the 
receipt, possession, use, transfer, and disposal of licensed material by 
any licensee in such a manner that the total dose to an individual 
(including doses resulting from licensed and unlicensed radioactive 
material and from radiation sources other than background radiation) 
does not exceed the standards for protection against radiation 
prescribed in the regulations in this part. However, nothing in this 
part shall be construed as limiting actions that may be necessary to 
protect health and safety.



Sec.20.1002  Scope.

    The regulations in this part apply to persons licensed by the 
Commission to receive, possess, use, transfer, or dispose of byproduct, 
source, or special nuclear material or to operate a production or 
utilization facility under parts 30 through 36, 39, 40, 50, 52, 60, 61, 
63, 70, or 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. The limits in this part 
do not apply to doses due to background radiation, to exposure of 
patients to radiation for the purpose of medical diagnosis or therapy, 
to exposure from individuals administered radioactive material and 
released under Sec.35.75, or to exposure from

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voluntary participation in medical research programs.

[72 FR 49485, Aug. 28, 2007]



Sec.20.1003  Definitions.

    As used in this part:
    Absorbed dose means the energy imparted by ionizing radiation per 
unit mass of irradiated material. The units of absorbed dose are the rad 
and the gray (Gy).
    Accelerator-produced radioactive material means any material made 
radioactive by a particle accelerator.
    Act means the Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.), as 
amended.
    Activity is the rate of disintegration (transformation) or decay of 
radioactive material. The units of activity are the curie (Ci) and the 
becquerel (Bq).
    Adult means an individual 18 or more years of age.
    Airborne radioactive material means radioactive material dispersed 
in the air in the form of dusts, fumes, particulates, mists, vapors, or 
gases.
    Airborne radioactivity area means a room, enclosure, or area in 
which airborne radioactive materials, composed wholly or partly of 
licensed material, exist in concentrations--
    (1) In excess of the derived air concentrations (DACs) specified in 
appendix B, to Sec. Sec.20.1001-20.2401, or
    (2) To such a degree that an individual present in the area without 
respiratory protective equipment could exceed, during the hours an 
individual is present in a week, an intake of 0.6 percent of the annual 
limit on intake (ALI) or 12 DAC-hours.
    Air-purifying respirator means a respirator with an air-purifying 
filter, cartridge, or canister that removes specific air contaminants by 
passing ambient air through the air-purifying element.
    ALARA (acronym for ``as low as is reasonably achievable'') means 
making every reasonable effort to maintain exposures to radiation as far 
below the dose limits in this part as is practical consistent with the 
purpose for which the licensed activity is undertaken, taking into 
account the state of technology, the economics of improvements in 
relation to state of technology, the economics of improvements in 
relation to benefits to the public health and safety, and other societal 
and socioeconomic considerations, and in relation to utilization of 
nuclear energy and licensed materials in the public interest.
    Annual limit on intake (ALI) means the derived limit for the amount 
of radioactive material taken into the body of an adult worker by 
inhalation or ingestion in a year. ALI is the smaller value of intake of 
a given radionuclide in a year by the reference man that would result in 
a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed 
dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue. 
(ALI values for intake by ingestion and by inhalation of selected 
radionuclides are given in table 1, columns 1 and 2, of appendix B to 
Sec. Sec.20.1001-20.2401).
    Assigned protection factor (APF) means the expected workplace level 
of respiratory protection that would be provided by a properly 
functioning respirator or a class of respirators to properly fitted and 
trained users. Operationally, the inhaled concentration can be estimated 
by dividing the ambient airborne concentration by the APF.
    Atmosphere-supplying respirator means a respirator that supplies the 
respirator user with breathing air from a source independent of the 
ambient atmosphere, and includes supplied-air respirators (SARs) and 
self-contained breathing apparatus (SCBA) units.
    Background radiation means radiation from cosmic sources; naturally 
occurring radioactive material, including radon (except as a decay 
product of source or special nuclear material); and global fallout as it 
exists in the environment from the testing of nuclear explosive devices 
or from past nuclear accidents such as Chernobyl that contribute to 
background radiation and are not under the control of the licensee. 
``Background radiation'' does not include radiation from source, 
byproduct, or special nuclear materials regulated by the Commission.
    Bioassay (radiobioassay) means the determination of kinds, 
quantities or concentrations, and, in some cases, the locations of 
radioactive material in the

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human body, whether by direct measurement (in vivo counting) or by 
analysis and evaluation of materials excreted or removed from the human 
body.
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2) The tailings or wastes produced by the extraction or 
concentration of uranium or thorium from ore processed primarily for its 
source material content, including discrete surface wastes resulting 
from uranium solution extraction processes. Underground ore bodies 
depleted by these solution extraction operations do not constitute 
``byproduct material'' within this definition;
    (3)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 8, 
2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (4) Any discrete source of naturally occurring radioactive material, 
other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, the Secretary of Energy, the Secretary 
of Homeland Security, and the head of any other appropriate Federal 
agency, determines would pose a threat similar to the threat posed by a 
discrete source of radium-226 to the public health and safety or the 
common defense and security; and
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research activity.
    Class (or lung class or inhalation class) means a classification 
scheme for inhaled material according to its rate of clearance from the 
pulmonary region of the lung. Materials are classified as D, W, or Y, 
which applies to a range of clearance half-times: for Class D (Days) of 
less than 10 days, for Class W (Weeks) from 10 to 100 days, and for 
Class Y (Years) of greater than 100 days.
    Collective dose is the sum of the individual doses received in a 
given period of time by a specified population from exposure to a 
specified source of radiation.
    Commission means the Nuclear Regulatory Commission or its duly 
authorized representatives.
    Committed dose equivalent (HT,50) means the dose 
equivalent to organs or tissues of reference (T) that will be received 
from an intake of radioactive material by an individual during the 50-
year period following the intake.
    Committed effective dose equivalent (HE,50) is the sum of 
the products of the weighting factors applicable to each of the body 
organs or tissues that are irradiated and the committed dose equivalent 
to these organs or tissues (HE,50 = [Sigma] wT 
HT,50).
    Constraint (dose constraint) means a value above which specified 
licensee actions are required.
    Controlled area means an area, outside of a restricted area but 
inside the site boundary, access to which can be limited by the licensee 
for any reason.
    Critical Group means the group of individuals reasonably expected to 
receive the greatest exposure to residual radioactivity for any 
applicable set of circumstances.
    Declared pregnant woman means a woman who has voluntarily informed 
the licensee, in writing, of her pregnancy and the estimated date of 
conception. The declaration remains in effect until the declared 
pregnant woman withdraws the declaration in writing or is no longer 
pregnant.
    Decommission means to remove a facility or site safely from service 
and reduce residual radioactivity to a level that permits--
    (1) Release of the property for unrestricted use and termination of 
the license; or
    (2) Release of the property under restricted conditions and the 
termination of the license.

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    Deep-dose equivalent (Hd), which applies to external 
whole-body exposure, is the dose equivalent at a tissue depth of 1 cm 
(1000 mg/cm\2\).
    Demand respirator means an atmosphere-supplying respirator that 
admits breathing air to the facepiece only when a negative pressure is 
created inside the facepiece by inhalation.
    Department means the Department of Energy established by the 
Department of Energy Organization Act (Pub. L. 95-91, 91 Stat. 565, 42 
U.S.C. 7101 et seq.) to the extent that the Department, or its duly 
authorized representatives, exercises functions formerly vested in the 
U.S. Atomic Energy Commission, its Chairman, members, officers, and 
components and transferred to the U.S. Energy Research and Development 
Administration and to the Administrator thereof pursuant to sections 104 
(b), (c), and (d) of the Energy Reorganization Act of 1974 (Pub. L. 93-
438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the 
Secretary of Energy pursuant to section 301(a) of the Department of 
Energy Organization Act (Pub. L. 95-91, 91 Stat 565 at 577-578, 42 
U.S.C. 7151).
    Derived air concentration (DAC) means the concentration of a given 
radionuclide in air which, if breathed by the reference man for a 
working year of 2,000 hours under conditions of light work (inhalation 
rate 1.2 cubic meters of air per hour), results in an intake of one ALI. 
DAC values are given in table 1, column 3, of appendix B to Sec. Sec.
20.1001-20.2401.
    Derived air concentration-hour (DAC-hour) is the product of the 
concentration of radioactive material in air (expressed as a fraction or 
multiple of the derived air concentration for each radionuclide) and the 
time of exposure to that radionuclide, in hours. A licensee may take 
2,000 DAC-hours to represent one ALI, equivalent to a committed 
effective dose equivalent of 5 rems (0.05 Sv).
    Discrete source means a radionuclide that has been processed so that 
its concentration within a material has been purposely increased for use 
for commercial, medical, or research activities.
    Disposable respirator means a respirator for which maintenance is 
not intended and that is designed to be discarded after excessive 
breathing resistance, sorbent exhaustion, physical damage, or end-of-
service-life renders it unsuitable for use. Examples of this type of 
respirator are a disposable half-mask respirator or a disposable escape-
only self-contained breathing apparatus (SCBA).
    Distinguishable from background means that the detectable 
concentration of a radionuclide is statistically different from the 
background concentration of that radionuclide in the vicinity of the 
site or, in the case of structures, in similar materials using adequate 
measurement technology, survey, and statistical techniques.
    Dose or radiation dose is a generic term that means absorbed dose, 
dose equivalent, effective dose equivalent, committed dose equivalent, 
committed effective dose equivalent, or total effective dose equivalent, 
as defined in other paragraphs of this section.
    Dose equivalent (HT) means the product of the absorbed 
dose in tissue, quality factor, and all other necessary modifying 
factors at the location of interest. The units of dose equivalent are 
the rem and sievert (Sv).
    Dosimetry processor means an individual or organization that 
processes and evaluates individual monitoring equipment in order to 
determine the radiation dose delivered to the equipment.
    Effective dose equivalent (HE) is the sum of the products 
of the dose equivalent to the organ or tissue (HT) and the 
weighting factors (wT) applicable to each of the body organs 
or tissues that are irradiated (HE = [Sigma] wT 
HT).
    Embryo/fetus means the developing human organism from conception 
until the time of birth.
    Entrance or access point means any location through which an 
individual could gain access to radiation areas or to radioactive 
materials. This includes entry or exit portals of sufficient size to 
permit human entry, irrespective of their intended use.
    Exposure means being exposed to ionizing radiation or to radioactive 
material.
    External dose means that portion of the dose equivalent received 
from radiation sources outside the body.

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    Extremity means hand, elbow, arm below the elbow, foot, knee, or leg 
below the knee.
    Filtering facepiece (dust mask) means a negative pressure 
particulate respirator with a filter as an integral part of the 
facepiece or with the entire facepiece composed of the filtering medium, 
not equipped with elastomeric sealing surfaces and adjustable straps.
    Fit factor means a quantitative estimate of the fit of a particular 
respirator to a specific individual, and typically estimates the ratio 
of the concentration of a substance in ambient air to its concentration 
inside the respirator when worn.
    Fit test means the use of a protocol to qualitatively or 
quantitatively evaluate the fit of a respirator on an individual.
    Generally applicable environmental radiation standards means 
standards issued by the Environmental Protection Agency (EPA) under the 
authority of the Atomic Energy Act of 1954, as amended, that impose 
limits on radiation exposures or levels, or concentrations or quantities 
of radioactive material, in the general environment outside the 
boundaries of locations under the control of persons possessing or using 
radioactive material.
    Government agency means any executive department, commission, 
independent establishment, corporation wholly or partly owned by the 
United States of America, which is an instrumentality of the United 
States, or any board, bureau, division, service, office, officer, 
authority, administration, or other establishment in the executive 
branch of the Government.
    Gray [See Sec.20.1004].
    Helmet means a rigid respiratory inlet covering that also provides 
head protection against impact and penetration.
    High radiation area means an area, accessible to individuals, in 
which radiation levels from radiation sources external to the body could 
result in an individual receiving a dose equivalent in excess of 0.1 rem 
(1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 
centimeters from any surface that the radiation penetrates.
    Hood means a respiratory inlet covering that completely covers the 
head and neck and may also cover portions of the shoulders and torso.
    Individual means any human being.
    Individual monitoring means--
    (1) The assessment of dose equivalent by the use of devices designed 
to be worn by an individual;
    (2) The assessment of committed effective dose equivalent by 
bioassay (see Bioassay) or by determination of the time-weighted air 
concentrations to which an individual has been exposed, i.e., DAC-hours; 
or
    (3) The assessment of dose equivalent by the use of survey data.
    Individual monitoring devices (individual monitoring equipment) 
means devices designed to be worn by a single individual for the 
assessment of dose equivalent such as film badges, thermoluminescence 
dosimeters (TLDs), pocket ionization chambers, and personal (``lapel'') 
air sampling devices.
    Internal dose means that portion of the dose equivalent received 
from radioactive material taken into the body.
    Lens dose equivalent (LDE) applies to the external exposure of the 
lens of the eye and is taken as the dose equivalent at a tissue depth of 
0.3 centimeter (300 mg/cm\2\).
    License means a license issued under the regulations in parts 30 
through 36, 39, 40, 50, 60, 61, 63, 70, or 72 of this chapter.
    Licensed material means source material, special nuclear material, 
or byproduct material received, possessed, used, transferred or disposed 
of under a general or specific license issued by the Commission.
    Licensee means the holder of a license.
    Limits (dose limits) means the permissible upper bounds of radiation 
doses.
    Loose-fitting facepiece means a respiratory inlet covering that is 
designed to form a partial seal with the face.
    Lost or missing licensed material means licensed material whose 
location is unknown. It includes material that has been shipped but has 
not reached its destination and whose location cannot be readily traced 
in the transportation system.

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    Member of the public means any individual except when that 
individual is receiving an occupational dose.
    Minor means an individual less than 18 years of age.
    Monitoring (radiation monitoring, radiation protection monitoring) 
means the measurement of radiation levels, concentrations, surface area 
concentrations or quantities of radioactive material and the use of the 
results of these measurements to evaluate potential exposures and doses.
    Nationally tracked source is a sealed source containing a quantity 
equal to or greater than Category 1 or Category 2 levels of any 
radioactive material listed in Appendix E of this part. In this context 
a sealed source is defined as radioactive material that is sealed in a 
capsule or closely bonded, in a solid form and which is not exempt from 
regulatory control. It does not mean material encapsulated solely for 
disposal, or nuclear material contained in any fuel assembly, 
subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked 
sources are those containing radioactive material at a quantity equal to 
or greater than the Category 1 threshold. Category 2 nationally tracked 
sources are those containing radioactive material at a quantity equal to 
or greater than the Category 2 threshold but less than the Category 1 
threshold.
    Negative pressure respirator (tight fitting) means a respirator in 
which the air pressure inside the facepiece is negative during 
inhalation with respect to the ambient air pressure outside the 
respirator.
    Nonstochastic effect means health effects, the severity of which 
varies with the dose and for which a threshold is believed to exist. 
Radiation-induced cataract formation is an example of a nonstochastic 
effect (also called a deterministic effect).
    NRC means the Nuclear Regulatory Commission or its duly authorized 
representatives.
    Occupational dose means the dose received by an individual in the 
course of employment in which the individual's assigned duties involve 
exposure to radiation or to radioactive material from licensed and 
unlicensed sources of radiation, whether in the possession of the 
licensee or other person. Occupational dose does not include doses 
received from background radiation, from any medical administration the 
individual has received, from exposure to individuals administered 
radioactive material and released under Sec.35.75, from voluntary 
participation in medical research programs, or as a member of the 
public.
    Particle accelerator means any machine capable of accelerating 
electrons, protons, deuterons, or other charged particles in a vacuum 
and of discharging the resultant particulate or other radiation into a 
medium at energies usually in excess of 1 megaelectron volt. For 
purposes of this definition, ``accelerator'' is an equivalent term.
    Person means--
    (1) Any individual, corporation, partnership, firm, association, 
trust, estate, public or private institution, group, Government agency 
other than the Commission or the Department of Energy (except that the 
Department shall be considered a person within the meaning of the 
regulations in 10 CFR chapter I to the extent that its facilities and 
activities are subject to the licensing and related regulatory authority 
of the Commission under section 202 of the Energy Reorganization Act of 
1974 (88 Stat. 1244), the Uranium Mill Tailings Radiation Control Act of 
1978 (92 Stat. 3021), the Nuclear Waste Policy Act of 1982 (96 Stat. 
2201), and section 3(b)(2) of the Low-Level Radioactive Waste Policy 
Amendments Act of 1985 (99 Stat. 1842)), any State or any political 
subdivision of or any political entity within a State, any foreign 
government or nation or any political subdivision of any such government 
or nation, or other entity; and
    (2) Any legal successor, representative, agent, or agency of the 
foregoing.
    Planned special exposure means an infrequent exposure to radiation, 
separate from and in addition to the annual dose limits.
    Positive pressure respirator means a respirator in which the 
pressure inside the respiratory inlet covering exceeds the ambient air 
pressure outside the respirator.

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    Powered air-purifying respirator (PAPR) means an air-purifying 
respirator that uses a blower to force the ambient air through air-
purifying elements to the inlet covering.
    Pressure demand respirator means a positive pressure atmosphere-
supplying respirator that admits breathing air to the facepiece when the 
positive pressure is reduced inside the facepiece by inhalation.
    Public dose means the dose received by a member of the public from 
exposure to radiation or to radioactive material released by a licensee, 
or to any other source of radiation under the control of a licensee. 
Public dose does not include occupational dose or doses received from 
background radiation, from any medical administration the individual has 
received, from exposure to individuals administered radioactive material 
and released under Sec.35.75, or from voluntary participation in 
medical research programs.
    Qualitative fit test (QLFT) means a pass/fail fit test to assess the 
adequacy of respirator fit that relies on the individual's response to 
the test agent.
    Quality Factor (Q) means the modifying factor (listed in tables 
1004(b).1 and 1004(b).2 of Sec.20.1004) that is used to derive dose 
equivalent from absorbed dose.
    Quantitative fit test (QNFT) means an assessment of the adequacy of 
respirator fit by numerically measuring the amount of leakage into the 
respirator.
    Quarter means a period of time equal to one-fourth of the year 
observed by the licensee (approximately 13 consective weeks), providing 
that the beginning of the first quarter in a year coincides with the 
starting date of the year and that no day is omitted or duplicated in 
consecutive quarters.
    Rad (See Sec.20.1004).
    Radiation (ionizing radiation) means alpha particles, beta 
particles, gamma rays, x-rays, neutrons, high-speed electrons, high-
speed protons, and other particles capable of producing ions. Radiation, 
as used in this part, does not include non-ionizing radiation, such as 
radio- or microwaves, or visible, infrared, or ultraviolet light.
    Radiation area means an area, accessible to individuals, in which 
radiation levels could result in an individual receiving a dose 
equivalent in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 centimeters 
from the radiation source or from any surface that the radiation 
penetrates.
    Reference man means a hypothetical aggregation of human physical and 
physiological characteristics arrived at by international consensus. 
These characteristics may be used by researchers and public health 
workers to standardize results of experiments and to relate biological 
insult to a common base.
    Rem (See Sec.20.1004).
    Residual radioactivity means radioactivity in structures, materials, 
soils, groundwater, and other media at a site resulting from activities 
under the licensee's control. This includes radioactivity from all 
licensed and unlicensed sources used by the licensee, but excludes 
background radiation. It also includes radioactive materials remaining 
at the site as a result of routine or accidental releases of radioactive 
material at the site and previous burials at the site, even if those 
burials were made in accordance with the provisions of 10 CFR part 20.
    Respiratory protective device means an apparatus, such as a 
respirator, used to reduce the individual's intake of airborne 
radioactive materials.
    Restricted area means an area, access to which is limited by the 
licensee for the purpose of protecting individuals against undue risks 
from exposure to radiation and radioactive materials. Restricted area 
does not include areas used as residential quarters, but separate rooms 
in a residential building may be set apart as a restricted area.
    Sanitary sewerage means a system of public sewers for carrying off 
waste water and refuse, but excluding sewage treatment facilities, 
septic tanks, and leach fields owned or operated by the licensee.
    Self-contained breathing apparatus (SCBA) means an atmosphere-
supplying respirator for which the breathing air source is designed to 
be carried by the user.
    Shallow-dose equivalent (Hs), which applies to the 
external exposure of the skin of the whole body or the skin of an 
extremity, is taken as the dose

[[Page 349]]

equivalent at a tissue depth of 0.007 centimeter (7 mg/cm\2\).
    Site boundary means that line beyond which the land or property is 
not owned, leased, or otherwise controlled by the licensee.
    Source material means--
    (1) Uranium or thorium or any combination of uranium and thorium in 
any physical or chemical form; or
    (2) Ores that contain, by weight, one-twentieth of 1 percent (0.05 
percent), or more, of uranium, thorium, or any combination of uranium 
and thorium. Source material does not include special nuclear material.
    Special nuclear material means--
    (1) Plutonium, uranium-233, uranium enriched in the isotope 233 or 
in the isotope 235, and any other material that the Commission, pursuant 
to the provisions of section 51 of the Act, determines to be special 
nuclear material, but does not include source material; or
    (2) Any material artificially enriched by any of the foregoing but 
does not include source material.
    Stochastic effects means health effects that occur randomly and for 
which the probability of the effect occurring, rather than its severity, 
is assumed to be a linear function of dose without threshold. Hereditary 
effects and cancer incidence are examples of stochastic effects.
    Supplied-air respirator (SAR) or airline respirator means an 
atmosphere-supplying respirator for which the source of breathing air is 
not designed to be carried by the user.
    Survey means an evaluation of the radiological conditions and 
potential hazards incident to the production, use, transfer, release, 
disposal, or presence of radioactive material or other sources of 
radiation. When appropriate, such an evaluation includes a physical 
survey of the location of radioactive material and measurements or 
calculations of levels of radiation, or concentrations or quantities of 
radioactive material present.
    Tight-fitting facepiece means a respiratory inlet covering that 
forms a complete seal with the face.
    Total Effective Dose Equivalent (TEDE) means the sum of the 
effective dose equivalent (for external exposures) and the committed 
effective dose equivalent (for internal exposures).
    Unrestricted area means an area, access to which is neither limited 
nor controlled by the licensee.
    Uranium fuel cycle means the operations of milling of uranium ore, 
chemical conversion of uranium, isotopic enrichment of uranium, 
fabrication of uranium fuel, generation of electricity by a light-water-
cooled nuclear power plant using uranium fuel, and reprocessing of spent 
uranium fuel to the extent that these activities directly support the 
production of electrical power for public use. Uranium fuel cycle does 
not include mining operations, operations at waste disposal sites, 
transportation of radioactive material in support of these operations, 
and the reuse of recovered non-uranium special nuclear and byproduct 
materials from the cycle.
    User seal check (fit check) means an action conducted by the 
respirator user to determine if the respirator is properly seated to the 
face. Examples include negative pressure check, positive pressure check, 
irritant smoke check, or isoamyl acetate check.
    Very high radiation area means an area, accessible to individuals, 
in which radiation levels from radiation sources external to the body 
could result in an individual receiving an absorbed dose in excess of 
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1 
meter from any surface that the radiation penetrates.
    Note: At very high doses received at high dose rates, units of 
absorbed dose (e.g., rads and grays) are appropriate, rather than units 
of dose equivalent (e.g., rems and sieverts)).
    Waste means those low-level radioactive wastes containing source, 
special nuclear, or byproduct material that are acceptable for disposal 
in a land disposal facility. For the purposes of this definition, low-
level radioactive waste means radioactive waste not classified as high-
level radioactive waste, transuranic waste, spent nuclear fuel, or 
byproduct material as defined in paragraphs (2), (3), and (4) of the 
definition of Byproduct material set forth in this section.
    Week means 7 consecutive days starting on Sunday.
    Weighting factor wT, for an organ or tissue (T) is the 
proportion of the risk

[[Page 350]]

of stochastic effects resulting from irradiation of that organ or tissue 
to the total risk of stochastic effects when the whole body is 
irradiated uniformly. For calculating the effective dose equivalent, the 
values of wT are:

                      Organ Dose Weighting Factors
------------------------------------------------------------------------
                        Organ or tissue                             wT
------------------------------------------------------------------------
Gonads.........................................................     0.25
Breast.........................................................     0.15
Red bone marrow................................................     0.12
Lung...........................................................     0.12
Thyroid........................................................     0.03
Bone surfaces..................................................     0.03
Remainder......................................................      \1\
                                                                    0.30
Whole Body.....................................................      \2\
                                                                    1.00
------------------------------------------------------------------------
\1\ 0.30 results from 0.06 for each of 5 ``remainder'' organs (excluding
  the skin and the lens of the eye) that receive the highest doses.
\2\ For the purpose of weighting the external whole body dose (for
  adding it to the internal dose), a single weighting factor, wT = 1.0,
  has been specified. The use of other weighting factors for external
  exposure will be approved on a case-by-case basis until such time as
  specific guidance is issued.

    Whole body means, for purposes of external exposure, head, trunk 
(including male gonads), arms above the elbow, or legs above the knee.
    Working level (WL) is any combination of short-lived radon daughters 
(for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; 
and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-
212) in 1 liter of air that will result in the ultimate emission of 1.3 
x 10\5\ MeV of potential alpha particle energy.
    Working level month (WLM) means an exposure to 1 working level for 
170 hours (2,000 working hours per year/12 months per year = 
approximately 170 hours per month).
    Year means the period of time beginning in January used to determine 
compliance with the provisions of this part. The licensee may change the 
starting date of the year used to determine compliance by the licensee 
provided that the change is made at the beginning of the year and that 
no day is omitted or duplicated in consecutive years.

[56 FR 23391, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992; 58 
FR 7736, Feb. 9, 1993; 60 FR 36043, July 13, 1995; 60 FR 48625, Sept. 
20, 1995; 61 FR 65127, Dec. 10, 1996; 62 FR 4133, Jan. 29, 1997; 62 FR 
39087, July 21, 1997; 63 FR 39481, July 23, 1998; 64 FR 54556, Oct. 7, 
1999; 66 FR 55789, Nov. 2, 2001; 67 FR 16304, Apr. 5, 2002; 67 FR 20370, 
Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 71 FR 65707, Nov. 8, 2006; 72 
FR 55921, Oct. 1, 2007; 72 FR 68058, Dec. 4, 2007; 74 FR 62680, Dec. 1, 
2009]



Sec.20.1004  Units of radiation dose.

    (a) Definitions. As used in this part, the units of radiation dose 
are:
    Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an 
absorbed dose of 1 Joule/kilogram (100 rads).
    Rad is the special unit of absorbed dose. One rad is equal to an 
absorbed dose of 100 ergs/gram or 0.01 joule/kilogram (0.01 gray).
    Rem is the special unit of any of the quantities expressed as dose 
equivalent. The dose equivalent in rems is equal to the absorbed dose in 
rads multiplied by the quality factor (1 rem = 0.01 sievert).
    Sievert is the SI unit of any of the quantities expressed as dose 
equivalent. The dose equivalent in sieverts is equal to the absorbed 
dose in grays multiplied by the quality factor (1 Sv = 100 rems).
    (b) As used in this part, the quality factors for converting 
absorbed dose to dose equivalent are shown in table 1004(b).1.

    Table 1004(b).1--Quality Factors and Absorbed Dose Equivalencies
------------------------------------------------------------------------
                                                     Quality   Absorbed
                                                     factor   dose equal
                                                   ----------  to a unit
                 Type of radiation                               dose
                                                       (Q)    equivalent
                                                                  \a\
------------------------------------------------------------------------
X-, gamma, or beta radiation......................         1        1
Alpha particles, multiple-charged particles,              20        0.05
 fission fragments and heavy particles of unknown
 charge...........................................
Neutrons of unknown energy........................        10        0.1
High-energy protons...............................        10        0.1
------------------------------------------------------------------------
\a\ Absorbed dose in rad equal to 1 rem or the absorbed dose in gray
  equal to 1 sievert.

    (c) If it is more convenient to measure the neutron fluence rate 
than to determine the neutron dose equivalent rate in rems per hour or 
sieverts per

[[Page 351]]

hour, as provided in paragraph (b) of this section, 1 rem (0.01 Sv) of 
neutron radiation of unknown energies may, for purposes of the 
regulations in this part, be assumed to result from a total fluence of 
25 million neutrons per square centimeter incident upon the body. If 
sufficient information exists to estimate the approximate energy 
distribution of the neutrons, the licensee may use the fluence rate per 
unit dose equivalent or the appropriate Q value from table 1004(b).2 to 
convert a measured tissue dose in rads to dose equivalent in rems.

   Table 1004(b).2--Mean Quality Factors, Q, and Fluence per Unit Dose
                  Equivalent for Monoenergetic Neutrons
------------------------------------------------------------------------
                                                       Fluence per unit
                         Neutron energy    Quality   dose equivalent \b\
                              (MeV)         factor   (neutrons cm-2 rem
                                           \a\ (Q)            1)
------------------------------------------------------------------------
(thermal).............  2.5 x 10 -8             2     980 x 10 \6\
                        1 x 10 -7               2     980 x 10 \6\
                        1 x 10 -6               2     810 x 10 \6\
                        1 x 10 -5               2     810 x 10 \6\
                        1 x 10 -4               2     840 x 10 \6\
                        1 x 10 -3               2     980 x 10 \6\
                        1 x 10 -2               2.5  1010 x 10 \6\
                        1 x 10 -1               7.5   170 x 10 \6\
                        5 x 10 -1              11     39 x 10 \6\
                        1                      11     27 x 10 \6\
                        2.5                     9     29 x 10 \6\
                        5                       8     23 x 10 \6\
                        7                       7     24 x 10 \6\
                        10                      6.5   24 x 10 \6\
                        14                      7.5   17 x 10 \6\
                        20                      8     16 x 10 \6\
                        40                      7     14 x 10 \6\
                        60                      5.5   16 x 10 \6\
                        1 x 10 \2\              4     20 x 10 \6\
                        2 x 10 \2\              3.5   19 x 10 \6\
                        3 x 10 \2\              3.5   16 x 10 \6\
                        4 x 10 \2\              3.5   14 x 10 \6\
------------------------------------------------------------------------
\a\ Value of quality factor (Q) at the point where the dose equivalent
  is maximum in a 30-cm diameter cylinder tissue-equivalent phantom.
\b\ Monoenergetic neutrons incident normally on a 30-cm diameter
  cylinder tissue-equivalent phantom.



Sec.20.1005  Units of radioactivity.

    For the purposes of this part, activity is expressed in the special 
unit of curies (Ci) or in the SI unit of becquerels (Bq), or their 
multiples, or disintegrations (transformations) per unit of time.
    (a) One becquerel = 1 disintegration per second (s-1).
    (b) One curie = 3.7 x 10 \10\ disintegrations per second = 3.7 x 10 
\10\ becquerels = 2.22 x 10 \12\ disintegrations per minute.

[56 FR 23391, May 21, 1991; 56 FR 61352, Dec. 3, 1991]



Sec.20.1006  Interpretations.

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



Sec.20.1007  Communications.

    Unless otherwise specified, communications or reports concerning the 
regulations in this part should be addressed to the Executive Director 
for Operations (EDO), and sent either by mail to the U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; by hand delivery to 
the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, 
where practicable, by electronic submission, for example, via Electronic 
Information Exchange, or CD-ROM. Electronic submissions must be made in 
a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information.

[68 FR 58801, Oct. 10, 2003, as amended at 74 FR 62680, Dec. 1, 2009; 80 
FR 74979, Dec. 1, 2015]



Sec.20.1008  Implementation.

    (a) [Reserved]
    (b) The applicable section of Sec. Sec.20.1001-20.2402 must be 
used in lieu of requirements in the standards for protection against 
radiation in effect prior

[[Page 352]]

to January 1, 1994 \1\ that are cited in license conditions or technical 
specifications, except as specified in paragraphs (c), (d), and (e) of 
this section. If the requirements of this part are more restrictive than 
the existing license condition, then the licensee shall comply with this 
part unless exempted by paragraph (d) of this section.
---------------------------------------------------------------------------

    \1\ See Sec. Sec.20.1-20.602 codified as of January 1, 1993.
---------------------------------------------------------------------------

    (c) Any existing license condition or technical specification that 
is more restrictive than a requirement in Sec. Sec.20.1001-20.2402 
remains in force until there is a technical specification change, 
license amendment, or license renewal.
    (d) If a license condition or technical specification exempted a 
licensee from a requirement in the standards for protection against 
radiation in effect prior to January 1, 1994, \1\ it continues to exempt 
a licensee from the corresponding provision of Sec. Sec.20.1001-
20.2402.
    (e) If a license condition cites provisions in requirements in the 
standards for protection against radiation in effect prior to January 1, 
1994 \1\ and there are no corresponding provisions in Sec. Sec.
20.1001-20.2402, then the license condition remains in force until there 
is a technical specification change, license amendment, or license 
renewal that modifies or removes this condition.

[59 FR 41643, Aug. 15, 1994]



Sec.20.1009  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0014.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.20.1003, 20.1101, 20.1202, 20.1203, 
20.1204, 20.1206, 20.1208, 20.1301, 20.1302, 20.1403, 20.1404, 20.1406, 
20.1501, 20.1601, 20.1703, 20.1901, 20.1904, 20.1905, 20.1906, 20.2002, 
20.2004, 20.2005, 20.2006, 20.2102, 20.2103, 20.2104, 20.2105, 20.2106, 
20.2107, 20.2108, 20.2110, 20.2201, 20.2202, 20.2203, 20.2204, 20.2205, 
20.2206, 20.2207, 20.2301, and appendix G to this part.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec.20.2104, NRC Form 4 is approved under control number 
3150-0005.
    (2) In Sec. Sec.20.2106 and 20.2206, NRC Form 5 is approved under 
control number 3150-0006.
    (3) In Sec.20.2006 and appendix G to 10 CFR part 20, NRC Form 540 
and 540A is approved under control number 3150-0164.
    (4) In Sec.20.2006 and appendix G to 10 CFR part 20, NRC Form 541 
and 541A is approved under control number 3150-0166.
    (5) In Sec.20.2006 and appendix G to 10 CFR part 20, NRC Form 542 
and 542A is approved under control number 3150-0165.
    (6) In Sec.20.2207, NRC Form 748 is approved under control number 
3150-0202.

[63 FR 50128, Sept. 21, 1998, as amended at 67 FR 67099, Nov. 4, 2002; 
71 FR 65707, Nov. 8, 2006; 72 FR 55922, Oct. 1, 2007; 77 FR 39905, July 
6, 2012]



                 Subpart B_Radiation Protection Programs

    Source: 56 FR 23396, May 21, 1991, unless otherwise noted.



Sec.20.1101  Radiation protection programs.

    (a) Each licensee shall develop, document, and implement a radiation 
protection program commensurate with the scope and extent of licensed 
activities and sufficient to ensure compliance with the provisions of 
this part. (See Sec.20.2102 for recordkeeping requirements relating to 
these programs.)
    (b) The licensee shall use, to the extent practical, procedures and 
engineering controls based upon sound radiation protection principles to 
achieve

[[Page 353]]

occupational doses and doses to members of the public that are as low as 
is reasonably achievable (ALARA).
    (c) The licensee shall periodically (at least annually) review the 
radiation protection program content and implementation.
    (d) To implement the ALARA requirements of Sec.20.1101 (b), and 
notwithstanding the requirements in Sec.20.1301 of this part, a 
constraint on air emissions of radioactive material to the environment, 
excluding Radon-222 and its daughters, shall be established by licensees 
other than those subject to Sec.50.34a, such that the individual 
member of the public likely to receive the highest dose will not be 
expected to receive a total effective dose equivalent in excess of 10 
mrem (0.1 mSv) per year from these emissions. If a licensee subject to 
this requirement exceeds this dose constraint, the licensee shall report 
the exceedance as provided in Sec.20.2203 and promptly take 
appropriate corrective action to ensure against recurrence.

[56 FR 23396, May 21, 1991, as amended at 61 FR 65127, Dec. 10, 1996; 63 
FR 39482, July 23, 1998]



                   Subpart C_Occupational Dose Limits

    Source: 56 FR 23396, May 21, 1991, unless otherwise noted.



Sec.20.1201  Occupational dose limits for adults.

    (a) The licensee shall control the occupational dose to individual 
adults, except for planned special exposures under Sec.20.1206, to the 
following dose limits.
    (1) An annual limit, which is the more limiting of--
    (i) The total effective dose equivalent being equal to 5 rems (0.05 
Sv); or
    (ii) The sum of the deep-dose equivalent and the committed dose 
equivalent to any individual organ or tissue other than the lens of the 
eye being equal to 50 rems (0.5 Sv).
    (2) The annual limits to the lens of the eye, to the skin of the 
whole body, and to the skin of the extremities, which are:
    (i) A lens dose equivalent of 15 rems (0.15 Sv), and
    (ii) A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the 
whole body or to the skin of any extremity.
    (b) Doses received in excess of the annual limits, including doses 
received during accidents, emergencies, and planned special exposures, 
must be subtracted from the limits for planned special exposures that 
the individual may receive during the current year (see Sec.
20.1206(e)(1)) and during the individual's lifetime (see Sec.
20.1206(e)(2)).
    (c) When the external exposure is determined by measurement with an 
external personal monitoring device, the deep-dose equivalent must be 
used in place of the effective dose equivalent, unless the effective 
dose equivalent is determined by a dosimetry method approved by the NRC. 
The assigned deep-dose equivalent must be for the part of the body 
receiving the highest exposure. The assigned shallow-dose equivalent 
must be the dose averaged over the contiguous 10 square centimeters of 
skin receiving the highest exposure. The deep-dose equivalent, lens-dose 
equivalent, and shallow-dose equivalent may be assessed from surveys or 
other radiation measurements for the purpose of demonstrating compliance 
with the occupational dose limits, if the individual monitoring device 
was not in the region of highest potential exposure, or the results of 
individual monitoring are unavailable.
    (d) Derived air concentration (DAC) and annual limit on intake (ALI) 
values are presented in table 1 of appendix B to part 20 and may be used 
to determine the individual's dose (see Sec.20.2106) and to 
demonstrate compliance with the occupational dose limits.
    (e) In addition to the annual dose limits, the licensee shall limit 
the soluble uranium intake by an individual to 10 milligrams in a week 
in consideration of chemical toxicity (see footnote 3 of appendix B to 
part 20).
    (f) The licensee shall reduce the dose that an individual may be 
allowed to receive in the current year by the amount of occupational 
dose received while employed by any other person (see Sec.20.2104(e)).

[56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 63 
FR 39482, July 23, 1998; 67 FR 16304, Apr. 5, 2002; 72 FR 68059, Dec. 4, 
2007]

[[Page 354]]



Sec.20.1202  Compliance with requirements for summation of external
and internal doses.

    (a) If the licensee is required to monitor under both Sec. Sec.
20.1502 (a) and (b), the licensee shall demonstrate compliance with the 
dose limits by summing external and internal doses. If the licensee is 
required to monitor only under Sec.20.1502(a) or only under Sec.
20.1502(b), then summation is not required to demonstrate compliance 
with the dose limits. The licensee may demonstrate compliance with the 
requirements for summation of external and internal doses by meeting one 
of the conditions specified in paragraph (b) of this section and the 
conditions in paragraphs (c) and (d) of this section.
    (Note: The dose equivalents for the lens of the eye, the skin, and 
the extremities are not included in the summation, but are subject to 
separate limits.)
    (b) Intake by inhalation. If the only intake of radionuclides is by 
inhalation, the total effective dose equivalent limit is not exceeded if 
the sum of the deep-dose equivalent divided by the total effective dose 
equivalent limit, and one of the following, does not exceed unity:
    (1) The sum of the fractions of the inhalation ALI for each 
radionuclide, or
    (2) The total number of derived air concentration-hours (DAC-hours) 
for all radionuclides divided by 2,000, or
    (3) The sum of the calculated committed effective dose equivalents 
to all significantly irradiated \1\ organs or tissues (T) calculated 
from bioassay data using appropriate biological models and expressed as 
a fraction of the annual limit.
---------------------------------------------------------------------------

    \1\ An organ or tissue is deemed to be significantly irradiated if, 
for that organ or tissue, the product of the weighting factor, 
wT, and the committed dose equivalent, HT,50, per 
unit intake is greater than 10 percent of the maximum weighted value of 
HT,50, (i.e., WT HT,50) per unit intake 
for any organ or tissue.
---------------------------------------------------------------------------

    (c) Intake by oral ingestion. If the occupationally exposed 
individual also receives an intake of radionuclides by oral ingestion 
greater than 10 percent of the applicable oral ALI, the licensee shall 
account for this intake and include it in demonstrating compliance with 
the limits.
    (d) Intake through wounds or absorption through skin. The licensee 
shall evaluate and, to the extent practical, account for intakes through 
wounds or skin absorption.

    Note: The intake through intact skin has been included in the 
calculation of DAC for hydrogen-3 and does not need to be further 
evaluated.

[56 FR 23396, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992]



Sec.20.1203  Determination of external dose from airborne radioactive
material.

    Licensees shall, when determining the dose from airborne radioactive 
material, include the contribution to the deep-dose equivalent, lens 
dose equivalent, and shallow-dose equivalent from external exposure to 
the radioactive cloud (see appendix B to part 20, footnotes 1 and 2).
    Note: Airborne radioactivity measurements and DAC values should not 
be used as the primary means to assess the deep-dose equivalent when the 
airborne radioactive material includes radionuclides other than noble 
gases or if the cloud of airborne radioactive material is not relatively 
uniform. The determination of the deep-dose equivalent to an individual 
should be based upon measurements using instruments or individual 
monitoring devices.

[56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 63 
FR 39482, July 23, 1998]



Sec.20.1204  Determination of internal exposure.

    (a) For purposes of assessing dose used to determine compliance with 
occupational dose equivalent limits, the licensee shall, when required 
under Sec.20.1502, take suitable and timely measurements of--
    (1) Concentrations of radioactive materials in air in work areas; or
    (2) Quantities of radionuclides in the body; or
    (3) Quantities of radionuclides excreted from the body; or
    (4) Combinations of these measurements.
    (b) Unless respiratory protective equipment is used, as provided in 
Sec.20.1703, or the assessment of intake is based on bioassays, the 
licensee shall

[[Page 355]]

assume that an individual inhales radioactive material at the airborne 
concentration in which the individual is present.
    (c) When specific information on the physical and biochemical 
properties of the radionuclides taken into the body or the behavior or 
the material in an individual is known, the licensee may--
    (1) Use that information to calculate the committed effective dose 
equivalent, and, if used, the licensee shall document that information 
in the individual's record; and
    (2) Upon prior approval of the Commission, adjust the DAC or ALI 
values to reflect the actual physical and chemical characteristics of 
airborne radioactive material (e.g., aerosol size distribution or 
density); and
    (3) Separately assess the contribution of fractional intakes of 
Class D, W, or Y compounds of a given radionuclide (see appendix B to 
part 20) to the committed effective dose equivalent.
    (d) If the licensee chooses to assess intakes of Class Y material 
using the measurements given in Sec.20.1204(a)(2) or (3), the licensee 
may delay the recording and reporting of the assessments for periods up 
to 7 months, unless otherwise required by Sec. Sec.20.2202 or 20.2203, 
in order to permit the licensee to make additional measurements basic to 
the assessments.
    (e) If the identity and concentration of each radionuclide in a 
mixture are known, the fraction of the DAC applicable to the mixture for 
use in calculating DAC-hours must be either--
    (1) The sum of the ratios of the concentration to the appropriate 
DAC value (e.g., D, W, Y) from appendix B to part 20 for each radio-
nuclide in the mixture; or
    (2) The ratio of the total concentration for all radionuclides in 
the mixture to the most restrictive DAC value for any radionuclide in 
the mixture.
    (f) If the identity of each radionuclide in a mixture is known, but 
the concentration of one or more of the radionuclides in the mixture is 
not known, the DAC for the mixture must be the most restrictive DAC of 
any radionuclide in the mixture.
    (g) When a mixture of radionuclides in air exists, licensees may 
disregard certain radionuclides in the mixture if--
    (1) The licensee uses the total activity of the mixture in 
demonstrating compliance with the dose limits in Sec.20.1201 and in 
complying with the monitoring requirements in Sec.20.1502(b), and
    (2) The concentration of any radionuclide disregarded is less than 
10 percent of its DAC, and
    (3) The sum of these percentages for all of the radionuclides 
disregarded in the mixture does not exceed 30 percent.
    (h)(1) In order to calculate the committed effective dose 
equivalent, the licensee may assume that the inhalation of one ALI, or 
an exposure of 2,000 DAC-hours, results in a committed effective dose 
equivalent of 5 rems (0.05 Sv) for radionuclides that have their ALIs or 
DACs based on the committed effective dose equivalent.
    (2) When the ALI (and the associated DAC) is determined by the 
nonstochastic organ dose limit of 50 rems (0.5 Sv), the intake of 
radionuclides that would result in a committed effective dose equivalent 
of 5 rems (0.05 Sv) (the stochastic ALI) is listed in parentheses in 
table 1 of appendix B to part 20. In this case, the licensee may, as a 
simplifying assumption, use the stochastic ALIs to determine committed 
effective dose equivalent. However, if the licensee uses the stochastic 
ALIs, the licensee must also demonstrate that the limit in Sec.
20.1201(a)(1)(ii) is met.

[56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995]



Sec.20.1205  [Reserved]



Sec.20.1206  Planned special exposures.

    A licensee may authorize an adult worker to receive doses in 
addition to and accounted for separately from the doses received under 
the limits specified in Sec.20.1201 provided that each of the 
following conditions is satisfied--
    (a) The licensee authorizes a planned special exposure only in an 
exceptional situation when alternatives that might avoid the dose 
estimated to result from the planned special exposure are unavailable or 
impractical.

[[Page 356]]

    (b) The licensee (and employer if the employer is not the licensee) 
specifically authorizes the planned special exposure, in writing, before 
the exposure occurs.
    (c) Before a planned special exposure, the licensee ensures that the 
individuals involved are--
    (1) Informed of the purpose of the planned operation;
    (2) Informed of the estimated doses and associated potential risks 
and specific radiation levels or other conditions that might be involved 
in performing the task; and
    (3) Instructed in the measures to be taken to keep the dose ALARA 
considering other risks that may be present.
    (d) Prior to permitting an individual to participate in a planned 
special exposure, the licensee ascertains prior doses as required by 
Sec.20.2104(b) during the lifetime of the individual for each 
individual involved.
    (e) Subject to Sec.20.1201(b), the licensee does not authorize a 
planned special exposure that would cause an individual to receive a 
dose from all planned special exposures and all doses in excess of the 
limits to exceed--
    (1) The numerical values of any of the dose limits in Sec.
20.1201(a) in any year; and
    (2) Five times the annual dose limits in Sec.20.1201(a) during the 
individual's lifetime.
    (f) The licensee maintains records of the conduct of a planned 
special exposure in accordance with Sec.20.2105 and submits a written 
report in accordance with Sec.20.2204.
    (g) The licensee records the best estimate of the dose resulting 
from the planned special exposure in the individual's record and informs 
the individual, in writing, of the dose within 30 days from the date of 
the planned special exposure. The dose from planned special exposures is 
not to be considered in controlling future occupational dose of the 
individual under Sec.20.1201(a) but is to be included in evaluations 
required by Sec.20.1206 (d) and (e).

[56 FR 23396, May 21, 1991, as amended at 63 FR 39482, July 23, 1998]



Sec.20.1207  Occupational dose limits for minors.

    The annual occupational dose limits for minors are 10 percent of the 
annual dose limits specified for adult workers in Sec.20.1201.



Sec.20.1208  Dose equivalent to an embryo/fetus.

    (a) The licensee shall ensure that the dose equivalent to the 
embryo/fetus during the entire pregnancy, due to the occupational 
exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). 
(For recordkeeping requirements, see Sec.20.2106.)
    (b) The licensee shall make efforts to avoid substantial variation 
above a uniform monthly exposure rate to a declared pregnant woman so as 
to satisfy the limit in paragraph (a) of this section.
    (c) The dose equivalent to the embryo/fetus is the sum of--
    (1) The deep-dose equivalent to the declared pregnant woman; and
    (2) The dose equivalent to the embryo/fetus resulting from 
radionuclides in the embryo/fetus and radionuclides in the declared 
pregnant woman.
    (d) If the dose equivalent to the embryo/fetus is found to have 
exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, 
by the time the woman declares the pregnancy to the licensee, the 
licensee shall be deemed to be in compliance with paragraph (a) of this 
section if the additional dose equivalent to the embryo/fetus does not 
exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.

[56 FR 23396, May 21, 1991, as amended at 63 FR 39482, July 23, 1998]



  Subpart D_Radiation Dose Limits for Individual Members of the Public

    Source: 56 FR 23398, May 21, 1991, unless otherwise noted.



Sec.20.1301  Dose limits for individual members of the public.

    (a) Each licensee shall conduct operations so that--
    (1) The total effective dose equivalent to individual members of the 
public from the licensed operation does

[[Page 357]]

not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose 
contributions from background radiation, from any medical administration 
the individual has received, from exposure to individuals administered 
radioactive material and released under Sec.35.75, from voluntary 
participation in medical research programs, and from the licensee's 
disposal of radioactive material into sanitary sewerage in accordance 
with Sec.20.2003, and
    (2) The dose in any unrestricted area from external sources, 
exclusive of the dose contributions from patients administered 
radioactive material and released in accordance with Sec.35.75, does 
not exceed 0.002 rem (0.02 millisievert) in any one hour.
    (b) If the licensee permits members of the public to have access to 
controlled areas, the limits for members of the public continue to apply 
to those individuals.
    (c) Notwithstanding paragraph (a)(1) of this section, a licensee may 
permit visitors to an individual who cannot be released, under Sec.
35.75, to receive a radiation dose greater than 0.1 rem (1 mSv) if--
    (1) The radiation dose received does not exceed 0.5 rem (5 mSv); and
    (2) The authorized user, as defined in 10 CFR Part 35, has 
determined before the visit that it is appropriate.
    (d) A licensee or license applicant may apply for prior NRC 
authorization to operate up to an annual dose limit for an individual 
member of the public of 0.5 rem (5 mSv). The licensee or license 
applicant shall include the following information in this application:
    (1) Demonstration of the need for and the expected duration of 
operations in excess of the limit in paragraph (a) of this section;
    (2) The licensee's program to assess and control dose within the 0.5 
rem (5 mSv) annual limit; and
    (3) The procedures to be followed to maintain the dose as low as is 
reasonably achievable.
    (e) In addition to the requirements of this part, a licensee subject 
to the provisions of EPA's generally applicable environmental radiation 
standards in 40 CFR part 190 shall comply with those standards.
    (f) The Commission may impose additional restrictions on radiation 
levels in unrestricted areas and on the total quantity of radionuclides 
that a licensee may release in effluents in order to restrict the 
collective dose.

[56 FR 23398, May 21, 1991, as amended at 60 FR 48625, Sept. 20, 1995; 
62 FR 4133, Jan. 29, 1997; 67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 
9, 2002]



Sec.20.1302  Compliance with dose limits for individual members of
the public.

    (a) The licensee shall make or cause to be made, as appropriate, 
surveys of radiation levels in unrestricted and controlled areas and 
radioactive materials in effluents released to unrestricted and 
controlled areas to demonstrate compliance with the dose limits for 
individual members of the public in Sec.20.1301.
    (b) A licensee shall show compliance with the annual dose limit in 
Sec.20.1301 by--
    (1) Demonstrating by measurement or calculation that the total 
effective dose equivalent to the individual likely to receive the 
highest dose from the licensed operation does not exceed the annual dose 
limit; or
    (2) Demonstrating that--
    (i) The annual average concentrations of radioactive material 
released in gaseous and liquid effluents at the boundary of the 
unrestricted area do not exceed the values specified in table 2 of 
appendix B to part 20; and
    (ii) If an individual were continuously present in an unrestricted 
area, the dose from external sources would not exceed 0.002 rem (0.02 
mSv) in an hour and 0.05 rem (0.5 mSv) in a year.
    (c) Upon approval from the Commission, the licensee may adjust the 
effluent concentration values in appendix B to part 20, table 2, for 
members of the public, to take into account the actual physical and 
chemical characteristics of the effluents (e.g., aerosol size 
distribution, solubility, density, radioactive decay equilibrium, 
chemical form).

[56 FR 23398, May 21, 1991; 56 FR 61352, Dec. 3, 1991, as amended at 57 
FR 57878, Dec. 8, 1992; 60 FR 20185, Apr. 25, 1995]

[[Page 358]]



         Subpart E_Radiological Criteria for License Termination

    Source: 62 FR 39088, July 21, 1997, unless otherwise noted.



Sec.20.1401  General provisions and scope.

    (a) The criteria in this subpart apply to the decommissioning of 
facilities licensed under parts 30, 40, 50, 52, 60, 61, 63, 70, and 72 
of this chapter, and release of part of a facility or site for 
unrestricted use in accordance with Sec.50.83 of this chapter, as well 
as other facilities subject to the Commission's jurisdiction under the 
Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act 
of 1974, as amended. For high-level and low-level waste disposal 
facilities (10 CFR parts 60, 61, and 63), the criteria apply only to 
ancillary surface facilities that support radioactive waste disposal 
activities. The criteria do not apply to uranium and thorium recovery 
facilities already subject to appendix A to 10 CFR part 40 or the 
uranium solution extraction facilities.
    (b) The criteria in this subpart do not apply to sites which:
    (1) Have been decommissioned prior to the effective date of the rule 
in accordance with criteria identified in the Site Decommissioning 
Management Plan (SDMP) Action Plan of April 16, 1992 (57 FR 13389);
    (2) Have previously submitted and received Commission approval on a 
license termination plan (LTP) or decommissioning plan that is 
compatible with the SDMP Action Plan criteria; or
    (3) Submit a sufficient LTP or decommissioning plan before August 
20, 1998 and such LTP or decommissioning plan is approved by the 
Commission before August 20, 1999 and in accordance with the criteria 
identified in the SDMP Action Plan, except that if an EIS is required in 
the submittal, there will be a provision for day-for-day extension.
    (c) After a site has been decommissioned and the license terminated 
in accordance with the criteria in this subpart, or after part of a 
facility or site has been released for unrestricted use in accordance 
with Sec.50.83 of this chapter and in accordance with the criteria in 
this subpart, the Commission will require additional cleanup only, if 
based on new information, it determines that the criteria of this 
subpart were not met and residual radioactivity remaining at the site 
could result in significant threat to public health and safety.
    (d) When calculating TEDE to the average member of the critical 
group the licensee shall determine the peak annual TEDE dose expected 
within the first 1000 years after decommissioning.

[62 FR 39088, July 21, 1997, as amended at 66 FR 55789, Nov. 2, 2001; 68 
FR 19726, Apr. 22, 2003; 72 FR 49485, Aug. 28, 2007]



Sec.20.1402  Radiological criteria for unrestricted use.

    A site will be considered acceptable for unrestricted use if the 
residual radioactivity that is distinguishable from background radiation 
results in a TEDE to an average member of the critical group that does 
not exceed 25 mrem (0.25 mSv) per year, including that from groundwater 
sources of drinking water, and that the residual radioactivity has been 
reduced to levels that are as low as reasonably achievable (ALARA). 
Determination of the levels which are ALARA must take into account 
consideration of any detriments, such as deaths from transportation 
accidents, expected to potentially result from decontamination and waste 
disposal.



Sec.20.1403  Criteria for license termination under restricted conditions.

    A site will be considered acceptable for license termination under 
restricted conditions if:
    (a) The licensee can demonstrate that further reductions in residual 
radioactivity necessary to comply with the provisions of Sec.20.1402 
would result in net public or environmental harm or were not being made 
because the residual levels associated with restricted conditions are 
ALARA. Determination of the levels which are ALARA must take into 
account consideration of any detriments, such as traffic accidents, 
expected to potentially result from decontamination and waste disposal;
    (b) The licensee has made provisions for legally enforceable 
institutional

[[Page 359]]

controls that provide reasonable assurance that the TEDE from residual 
radioactivity distinguishable from background to the average member of 
the critical group will not exceed 25 mrem (0.25 mSv) per year;
    (c) The licensee has provided sufficient financial assurance to 
enable an independent third party, including a governmental custodian of 
a site, to assume and carry out responsibilities for any necessary 
control and maintenance of the site. Acceptable financial assurance 
mechanisms are--
    (1) Funds placed into a trust segregated from the licensee's assets 
and outside the licensee's administrative control, and in which the 
adequacy of the trust funds is to be assessed based on an assumed annual 
1 percent real rate of return on investment;
    (2) A statement of intent in the case of Federal, State, or local 
Government licensees, as described in Sec.30.35(f)(4) of this chapter; 
or
    (3) When a government entity is assuming custody and ownership of a 
site, an arrangement that is deemed acceptable by such governmental 
entity.
    (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. Sec.30.36(d), 40.42(d), 
50.82 (a) and (b), 70.38(d), or 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.
    (1) Licensees proposing to decommission by restricting use of the 
site shall seek advice from such affected parties regarding the 
following matters concerning the proposed decommissioning--
    (i) Whether provisions for institutional controls proposed by the 
licensee:
    (A) Will provide reasonable assurance that the TEDE from residual 
radioactivity distinguishable from background to the average member of 
the critical group will not exceed 25 mrem (0.25 mSv) TEDE per year;
    (B) Will be enforceable; and
    (C) Will not impose undue burdens on the local community or other 
affected parties.
    (ii) Whether the licensee has provided sufficient financial 
assurance to enable an independent third party, including a governmental 
custodian of a site, to assume and carry out responsibilities for any 
necessary control and maintenance of the site;
    (2) In seeking advice on the issues identified in Sec.
20.1403(d)(1), the licensee shall provide for:
    (i) Participation by representatives of a broad cross section of 
community interests who may be affected by the decommissioning;
    (ii) An opportunity for a comprehensive, collective discussion on 
the issues by the participants represented; and
    (iii) A publicly available summary of the results of all such 
discussions, including a description of the individual viewpoints of the 
participants on the issues and the extent of agreement or disagreement 
among the participants on the issues; and
    (e) Residual radioactivity at the site has been reduced so that if 
the institutional controls were no longer in effect, there is reasonable 
assurance that the TEDE from residual radioactivity distinguishable from 
background to the average member of the critical group is as low as 
reasonably achievable and would not exceed either--
    (1) 100 mrem (1 mSv) per year; or
    (2) 500 mrem (5 mSv) per year provided that the licensee--
    (i) Demonstrates that further reductions in residual radioactivity 
necessary to comply with the 100 mrem/y (1 mSv/y) value of paragraph 
(e)(1) of this section are not technically achievable, would be 
prohibitively expensive, or would result in net public or environmental 
harm;
    (ii) Makes provisions for durable institutional controls;
    (iii) Provides sufficient financial assurance to enable a 
responsible government entity or independent third

[[Page 360]]

party, including a governmental custodian of a site, both to carry out 
periodic rechecks of the site no less frequently than every 5 years to 
assure that the institutional controls remain in place as necessary to 
meet the criteria of Sec.20.1403(b) and to assume and carry out 
responsibilities for any necessary control and maintenance of those 
controls. Acceptable financial assurance mechanisms are those in 
paragraph (c) of this section.

[62 FR 39088, July 21, 1997, as amended at 76 FR 35564, July 17, 2011]



Sec.20.1404  Alternate criteria for license termination.

    (a) The Commission may terminate a license using alternate criteria 
greater than the dose criterion of Sec. Sec.20.1402, 20.1403(b), and 
20.1403(d)(1)(i)(A), if the licensee--
    (1) Provides assurance that public health and safety would continue 
to be protected, and that it is unlikely that the dose from all man-made 
sources combined, other than medical, would be more than the 1 mSv/y 
(100 mrem/y) limit of subpart D, by submitting an analysis of possible 
sources of exposure;
    (2) Has employed to the extent practical restrictions on site use 
according to the provisions of Sec.20.1403 in minimizing exposures at 
the site; and
    (3) Reduces doses to ALARA levels, taking into consideration any 
detriments such as traffic accidents expected to potentially result from 
decontamination and waste disposal.
    (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. Sec.30.36(d), 40.42(d), 50.82 (a) and (b), 
70.38(d), or 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:
    (i) Participation by representatives of a broad cross section of 
community interests who may be affected by the decommissioning;
    (ii) An opportunity for a comprehensive, collective discussion on 
the issues by the participants represented; and
    (iii) A publicly available summary of the results of all such 
discussions, including a description of the individual viewpoints of the 
participants on the issues and the extent of agreement and disagreement 
on the issues.
    (5) Has provided sufficient financial assurance in the form of a 
trust fund to enable an independent third party, including a 
governmental custodian of a site, to assume and carry out 
responsibilities for any necessary control and maintenance of the site.
    (b) The use of alternate criteria to terminate a license requires 
the approval of the Commission after consideration of the NRC staff's 
recommendations that will address any comments provided by the 
Environmental Protection Agency and any public comments submitted 
pursuant to Sec.20.1405.

[62 FR 39088, July 21, 1997, as amended at 76 FR 35564, July 17, 2011]



Sec.20.1405  Public notification and public participation.

    Upon the receipt of an LTP or decommissioning plan from the 
licensee, or a proposal by the licensee for release of a site pursuant 
to Sec. Sec.20.1403 or 20.1404, or whenever the Commission deems such 
notice to be in the public interest, the Commission shall:
    (a) Notify and solicit comments from:
    (1) Local and State governments in the vicinity of the site and any 
Indian Nation or other indigenous people that have treaty or statutory 
rights that could be affected by the decommissioning; and
    (2) The Environmental Protection Agency for cases where the licensee 
proposes to release a site pursuant to Sec.20.1404.
    (b) Publish a notice in the Federal Register and in a forum. such as 
local newspapers, letters to State of local organizations, or other 
appropriate forum, that is readily accessible to individuals in the 
vicinity of the site, and solicit comments from affected parties.

[[Page 361]]



Sec.20.1406  Minimization of contamination.

    (a) Applicants for licenses, other than early site permits and 
manufacturing licenses under part 52 of this chapter and renewals, whose 
applications are submitted after August 20, 1997, shall describe in the 
application how facility design and procedures for operation will 
minimize, to the extent practicable, contamination of the facility and 
the environment, facilitate eventual decommissioning, and minimize, to 
the extent practicable, the generation of radioactive waste.
    (b) Applicants for standard design certifications, standard design 
approvals, and manufacturing licenses under part 52 of this chapter, 
whose applications are submitted after August 20, 1997, shall describe 
in the application how facility design will minimize, to the extent 
practicable, contamination of the facility and the environment, 
facilitate eventual decommissioning, and minimize, to the extent 
practicable, the generation of radioactive waste.
    (c) Licensees shall, to the extent practical, conduct operations to 
minimize the introduction of residual radioactivity into the site, 
including the subsurface, in accordance with the existing radiation 
protection requirements in subpart B and radiological criteria for 
license termination in subpart E of this part.

[72 FR 49485, Aug. 28, 2007, as amended at 76 FR 35564, June 17, 2011]



                    Subpart F_Surveys and Monitoring

    Source: 56 FR 23398, May 21, 1991, unless otherwise noted.



Sec.20.1501  General.

    (a) Each licensee shall make or cause to be made, surveys of areas, 
including the subsurface, that--
    (1) May be necessary for the licensee to comply with the regulations 
in this part; and
    (2) Are reasonable under the circumstances to evaluate--
    (i) The magnitude and extent of radiation levels; and
    (ii) Concentrations or quantities of residual radioactivity; and
    (iii) The potential radiological hazards of the radiation levels and 
residual radioactivity detected.
    (b) Notwithstanding Sec.20.2103(a) of this part, 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. Sec.30.35(g), 40.36(f), 50.75(g), 70.25(g), or 72.30(d), as 
applicable.
    (c) The licensee shall ensure that instruments and equipment used 
for quantitative radiation measurements (e.g., dose rate and effluent 
monitoring) are calibrated periodically for the radiation measured.
    (d) All personnel dosimeters (except for direct and indirect reading 
pocket ionization chambers and those dosimeters used to measure the dose 
to the extremities) that require processing to determine the radiation 
dose and that are used by licensees to comply with Sec.20.1201, with 
other applicable provisions of this chapter, or with conditions 
specified in a license must be processed and evaluated by a dosimetry 
processor--
    (1) Holding current personnel dosimetry accreditation from the 
National Voluntary Laboratory Accreditation Program (NVLAP) of the 
National Institute of Standards and Technology; and
    (2) Approved in this accreditation process for the type of radiation 
or radiations included in the NVLAP program that most closely 
approximates the type of radiation or radiations for which the 
individual wearing the dosimeter is monitored.

[56 FR 23398, May 21, 1991, as amended at 63 FR 39482, July 23, 1998; 76 
FR 35564, June 17, 2011]



Sec.20.1502  Conditions requiring individual monitoring of external 
and internal occupational dose.

    Each licensee shall monitor exposures to radiation and radioactive 
material at levels sufficient to demonstrate compliance with the 
occupational dose limits of this part. As a minimum--

[[Page 362]]

    (a) Each licensee shall monitor occupational exposure to radiation 
from licensed and unlicensed radiation sources under the control of the 
licensee and shall supply and require the use of individual monitoring 
devices by--
    (1) Adults likely to receive, in 1 year from sources external to the 
body, a dose in excess of 10 percent of the limits in Sec.20.1201(a),
    (2) Minors likely to receive, in 1 year, from radiation sources 
external to the body, a deep dose equivalent in excess of 0.1 rem (1 
mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a 
shallow dose equivalent to the skin or to the extremities in excess of 
0.5 rem (5 mSv);
    (3) Declared pregnant women likely to receive during the entire 
pregnancy, from radiation sources external to the body, a deep dose 
equivalent in excess of 0.1 rem (1 mSv); \2\ and
---------------------------------------------------------------------------

    \2\ All of the occupational doses in Sec.20.1201 continue to be 
applicable to the declared pregnant worker as long as the embryo/fetus 
dose limit is not exceeded.
---------------------------------------------------------------------------

    (4) Individuals entering a high or very high radiation area.
    (b) Each licensee shall monitor (see Sec.20.1204) the occupational 
intake of radioactive material by and assess the committed effective 
dose equivalent to--
    (1) Adults likely to receive, in 1 year, an intake in excess of 10 
percent of the applicable ALI(s) in table 1, columns 1 and 2, of 
appendix B to Sec. Sec.20.1001-20.2402;
    (2) Minors likely to receive, in 1 year, a committed effective dose 
equivalent in excess of 0.1 rem (1 mSv); and
    (3) Declared pregnant women likely to receive, during the entire 
pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 
mSv).

[56 FR 23398, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 63 
FR 39482, July 23, 1998]



 Subpart G_Control of Exposure From External Sources in Restricted Areas

    Source: 56 FR 23398, May 21, 1991, unless otherwise noted.



Sec.20.1601  Control of access to high radiation areas.

    (a) The licensee shall ensure that each entrance or access point to 
a high radiation area has one or more of the following features--
    (1) A control device that, upon entry into the area, causes the 
level of radiation to be reduced below that level at which an individual 
might receive a deep-dose equivalent of 0.1 rem (1 mSv) in 1 hour at 30 
centimeters from the radiation source or from any surface that the 
radiation penetrates;
    (2) A control device that energizes a conspicuous visible or audible 
alarm signal so that the individual entering the high radiation area and 
the supervisor of the activity are made aware of the entry; or
    (3) Entryways that are locked, except during periods when access to 
the areas is required, with positive control over each individual entry.
    (b) In place of the controls required by paragraph (a) of this 
section for a high radiation area, the licensee may substitute 
continuous direct or electronic surveillance that is capable of 
preventing unauthorized entry.
    (c) A licensee may apply to the Commission for approval of 
alternative methods for controlling access to high radiation areas.
    (d) The licensee shall establish the controls required by paragraphs 
(a) and (c) of this section in a way that does not prevent individuals 
from leaving a high radiation area.
    (e) Control is not required for each entrance or access point to a 
room or other area that is a high radiation area solely because of the 
presence of radioactive materials prepared for transport and packaged 
and labeled in accordance with the regulations of the Department of 
Transportation provided that--
    (1) The packages do not remain in the area longer than 3 days; and
    (2) The dose rate at 1 meter from the external surface of any 
package does not exceed 0.01 rem (0.1 mSv) per hour.
    (f) Control of entrance or access to rooms or other areas in 
hospitals is not required solely because of the presence of patients 
containing radioactive material, provided that there are personnel in 
attendance who will take the

[[Page 363]]

necessary precautions to prevent the exposure of individuals to 
radiation or radioactive material in excess of the limits established in 
this part and to operate within the ALARA provisions of the licensee's 
radiation protection program.



Sec.20.1602  Control of access to very high radiation areas.

    In addition to the requirements in Sec.20.1601, the licensee shall 
institute additional measures to ensure that an individual is not able 
to gain unauthorized or inadvertent access to areas in which radiation 
levels could be encountered at 500 rads (5 grays) or more in 1 hour at 1 
meter from a radiation source or any surface through which the radiation 
penetrates.



   Subpart H_Respiratory Protection and Controls To Restrict Internal 
                      Exposure in Restricted Areas

    Source: 56 FR 23400, May 21, 1991, unless otherwise noted.



Sec.20.1701  Use of process or other engineering controls.

    The licensee shall use, to the extent practical, process or other 
engineering controls (e.g., containment, decontamination, or 
ventilation) to control the concentration of radioactive material in 
air.

[64 FR 54556, Oct. 7, 1999]



Sec.20.1702  Use of other controls.

    (a) When it is not practical to apply process or other engineering 
controls to control the concentrations of radioactive material in the 
air to values below those that define an airborne radioactivity area, 
the licensee shall, consistent with maintaining the total effective dose 
equivalent ALARA, increase monitoring and limit intakes by one or more 
of the following means--
    (1) Control of access;
    (2) Limitation of exposure times;
    (3) Use of respiratory protection equipment; or
    (4) Other controls.
    (b) If the licensee performs an ALARA analysis to determine whether 
or not respirators should be used, the licensee may consider safety 
factors other than radiological factors. The licensee should also 
consider the impact of respirator use on workers' industrial health and 
safety.

[64 FR 54556, Oct. 7, 1999]



Sec.20.1703  Use of individual respiratory protection equipment.

    If the licensee assigns or permits the use of respiratory protection 
equipment to limit the intake of radioactive material,
    (a) The licensee shall use only respiratory protection equipment 
that is tested and certified by the National Institute for Occupational 
Safety and Health (NIOSH) except as otherwise noted in this part.
    (b) If the licensee wishes to use equipment that has not been tested 
or certified by NIOSH, or for which there is no schedule for testing or 
certification, the licensee shall submit an application to the NRC for 
authorized use of this equipment except as provided in this part. The 
application must include evidence that the material and performance 
characteristics of the equipment are capable of providing the proposed 
degree of protection under anticipated conditions of use. This must be 
demonstrated either by licensee testing or on the basis of reliable test 
information.
    (c) The licensee shall implement and maintain a respiratory 
protection program that includes:
    (1) Air sampling sufficient to identify the potential hazard, permit 
proper equipment selection, and estimate doses;
    (2) Surveys and bioassays, as necessary, to evaluate actual intakes;
    (3) Testing of respirators for operability (user seal check for face 
sealing devices and functional check for others) immediately prior to 
each use;
    (4) Written procedures regarding--
    (i) Monitoring, including air sampling and bioassays;
    (ii) Supervision and training of respirator users;
    (iii) Fit testing;
    (iv) Respirator selection;
    (v) Breathing air quality;
    (vi) Inventory and control;

[[Page 364]]

    (vii) Storage, issuance, maintenance, repair, testing, and quality 
assurance of respiratory protection equipment;
    (viii) Recordkeeping; and
    (ix) Limitations on periods of respirator use and relief from 
respirator use;
    (5) Determination by a physician that the individual user is 
medically fit to use respiratory protection equipment:
    (i) Before the initial fitting of a face sealing respirator;
    (ii) Before the first field use of non-face sealing respirators, and
    (iii) Either every 12 months thereafter, or periodically at a 
frequency determined by a physician.
    (6) Fit testing, with fit factor =10 times the APF for 
negative pressure devices, and a fit factor =500 for any 
positive pressure, continuous flow, and pressure-demand devices, before 
the first field use of tight fitting, face-sealing respirators and 
periodically thereafter at a frequency not to exceed 1 year. Fit testing 
must be performed with the facepiece operating in the negative pressure 
mode.
    (d) The licensee shall advise each respirator user that the user may 
leave the area at any time for relief from respirator use in the event 
of equipment malfunction, physical or psychological distress, procedural 
or communication failure, significant deterioration of operating 
conditions, or any other conditions that might require such relief.
    (e) The licensee shall also consider limitations appropriate to the 
type and mode of use. When selecting respiratory devices the licensee 
shall provide for vision correction, adequate communication, low 
temperature work environments, and the concurrent use of other safety or 
radiological protection equipment. The licensee shall use equipment in 
such a way as not to interfere with the proper operation of the 
respirator.
    (f) Standby rescue persons are required whenever one-piece 
atmosphere-supplying suits, or any combination of supplied air 
respiratory protection device and personnel protective equipment are 
used from which an unaided individual would have difficulty extricating 
himself or herself. The standby persons must be equipped with 
respiratory protection devices or other apparatus appropriate for the 
potential hazards. The standby rescue persons shall observe or otherwise 
maintain continuous communication with the workers (visual, voice, 
signal line, telephone, radio, or other suitable means), and be 
immediately available to assist them in case of a failure of the air 
supply or for any other reason that requires relief from distress. A 
sufficient number of standby rescue persons must be immediately 
available to assist all users of this type of equipment and to provide 
effective emergency rescue if needed.
    (g) Atmosphere-supplying respirators must be supplied with 
respirable air of grade D quality or better as defined by the Compressed 
Gas Association in publication G-7.1, ``Commodity Specification for 
Air,'' 1997 and included in the regulations of the Occupational Safety 
and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E)). 
Grade D quality air criteria include--
    (1) Oxygen content (v/v) of 19.5-23.5%;
    (2) Hydrocarbon (condensed) content of 5 milligrams per cubic meter 
of air or less;
    (3) Carbon monoxide (CO) content of 10 ppm or less;
    (4) Carbon dioxide content of 1,000 ppm or less; and
    (5) Lack of noticeable odor.
    (h) The licensee shall ensure that no objects, materials or 
substances, such as facial hair, or any conditions that interfere with 
the face--facepiece seal or valve function, and that are under the 
control of the respirator wearer, are present between the skin of the 
wearer's face and the sealing surface of a tight-fitting respirator 
facepiece.
    (i) In estimating the dose to individuals from intake of airborne 
radioactive materials, the concentration of radioactive material in the 
air that is inhaled when respirators are worn is initially assumed to be 
the ambient concentration in air without respiratory protection, divided 
by the assigned protection factor. If the dose is later found to be 
greater than the estimated dose, the corrected value must be used. If 
the dose is later found to be

[[Page 365]]

less than the estimated dose, the corrected value may be used.

[64 FR 54557, Oct. 7, 1999, as amended at 67 FR 77652, Dec. 19, 2002]



Sec.20.1704  Further restrictions on the use of respiratory protection
equipment.

    The Commission may impose restrictions in addition to the provisions 
of Sec. Sec.20.1702, 20.1703, and Appendix A to Part 20, in order to:
    (a) Ensure that the respiratory protection program of the licensee 
is adequate to limit doses to individuals from intakes of airborne 
radioactive materials consistent with maintaining total effective dose 
equivalent ALARA; and
    (b) Limit the extent to which a licensee may use respiratory 
protection equipment instead of process or other engineering controls.

[64 FR 54557, Oct. 7, 1999]



Sec.20.1705  Application for use of higher assigned protection factors.

    The licensee shall obtain authorization from the Commission before 
using assigned protection factors in excess of those specified in 
Appendix A to part 20. The Commission may authorize a licensee to use 
higher assigned protection factors on receipt of an application that--
    (a) Describes the situation for which a need exists for higher 
protection factors; and
    (b) Demonstrates that the respiratory protection equipment provides 
these higher protection factors under the proposed conditions of use.

[64 FR 54557, Oct. 7, 1999]



           Subpart I_Storage and Control of Licensed Material

    Source: 56 FR 23401, May 21, 1991, unless otherwise noted.



Sec.20.1801  Security of stored material.

    The licensee shall secure from unauthorized removal or access 
licensed materials that are stored in controlled or unrestricted areas.



Sec.20.1802  Control of material not in storage.

    The licensee shall control and maintain constant surveillance of 
licensed material that is in a controlled or unrestricted area and that 
is not in storage.



                   Subpart J_Precautionary Procedures

    Source: 56 FR 23401, May 21, 1991, unless otherwise noted.



Sec.20.1901  Caution signs.

    (a) Standard radiation symbol. Unless otherwise authorized by the 
Commission, the symbol prescribed by this part shall use the colors 
magenta, or purple, or black on yellow background. The symbol prescribed 
by this part is the three-bladed design:

[[Page 366]]

[GRAPHIC] [TIFF OMITTED] TC02OC91.000

    (1) Cross-hatched area is to be magenta, or purple, or black, and
    (2) The background is to be yellow.
    (b) Exception to color requirements for standard radiation symbol. 
Notwithstanding the requirements of paragraph (a) of this section, 
licensees are authorized to label sources, source holders, or device 
components containing sources of licensed materials that are subjected 
to high temperatures, with conspicuously etched or stamped radiation 
caution symbols and without a color requirement.
    (c) Additional information on signs and labels. In addition to the 
contents of signs and labels prescribed in this part, the licensee may 
provide, on or near the required signs and labels, additional 
information, as appropriate, to make individuals aware of potential 
radiation exposures and to minimize the exposures.



Sec.20.1902  Posting requirements.

    (a) Posting of radiation areas. The licensee shall post each 
radiation area with a conspicuous sign or signs bearing the radiation 
symbol and the words ``CAUTION, RADIATION AREA.''
    (b) Posting of high radiation areas. The licensee shall post each 
high radiation area with a conspicuous sign or signs bearing the 
radiation symbol and the words ``CAUTION, HIGH RADIATION AREA'' or 
``DANGER, HIGH RADIATION AREA.''
    (c) Posting of very high radiation areas. The licensee shall post 
each very high radiation area with a conspicuous sign or signs bearing 
the radiation symbol and words ``GRAVE DANGER, VERY HIGH RADIATION 
AREA.''

[[Page 367]]

    (d) Posting of airborne radioactivity areas. The licensee shall post 
each airborne radioactivity area with a conspicuous sign or signs 
bearing the radiation symbol and the words ``CAUTION, AIRBORNE 
RADIOACTIVITY AREA'' or ``DANGER, AIRBORNE RADIOACTIVITY AREA.''
    (e) Posting of areas or rooms in which licensed material is used or 
stored. The licensee shall post each area or room in which there is used 
or stored an amount of licensed material exceeding 10 times the quantity 
of such material specified in appendix C to part 20 with a conspicuous 
sign or signs bearing the radiation symbol and the words ``CAUTION, 
RADIOACTIVE MATERIAL(S)'' or ``DANGER, RADIOACTIVE MATERIAL(S).''

[56 FR 23401, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995]



Sec.20.1903  Exceptions to posting requirements.

    (a) A licensee is not required to post caution signs in areas or 
rooms containing radioactive materials for periods of less than 8 hours, 
if each of the following conditions is met:
    (1) The materials are constantly attended during these periods by an 
individual who takes the precautions necessary to prevent the exposure 
of individuals to radiation or radioactive materials in excess of the 
limits established in this part; and
    (2) The area or room is subject to the licensee's control.
    (b) Rooms or other areas in hospitals that are occupied by patients 
are not required to be posted with caution signs pursuant to Sec.
20.1902 provided that the patient could be released from licensee 
control pursuant to Sec.35.75 of this chapter.
    (c) A room or area is not required to be posted with a caution sign 
because of the presence of a sealed source provided the radiation level 
at 30 centimeters from the surface of the source container or housing 
does not exceed 0.005 rem (0.05 mSv) per hour.
    (d) Rooms in hospitals or clinics that are used for teletherapy are 
exempt from the requirement to post caution signs under Sec.20.1902 
if--
    (1) Access to the room is controlled pursuant to 10 CFR 35.615; and
    (2) Personnel in attendance take necessary precautions to prevent 
the inadvertent exposure of workers, other patients, and members of the 
public to radiation in excess of the limits established in this part.

[56 FR 23401, May 21, 1991, as amended at 57 FR 39357, Aug. 31, 1992; 62 
FR 4133, Jan. 29, 1997; 63 FR 39482, July 23, 1998]



Sec.20.1904  Labeling containers.

    (a) The licensee shall ensure that each container of licensed 
material bears a durable, clearly visible label bearing the radiation 
symbol and the words ``CAUTION, RADIOACTIVE MATERIAL'' or ``DANGER, 
RADIOACTIVE MATERIAL.'' The label must also provide sufficient 
information (such as the radionuclide(s) present, an estimate of the 
quantity of radioactivity, the date for which the activity is estimated, 
radiation levels, kinds of materials, and mass enrichment) to permit 
individuals handling or using the containers, or working in the vicinity 
of the containers, to take precautions to avoid or minimize exposures.
    (b) Each licensee shall, prior to removal or disposal of empty 
uncontaminated containers to unrestricted areas, remove or deface the 
radioactive material label or otherwise clearly indicate that the 
container no longer contains radioactive materials.



Sec.20.1905  Exemptions to labeling requirements.

    A licensee is not required to label--
    (a) Containers holding licensed material in quantities less than the 
quantities listed in appendix C to part 20; or
    (b) Containers holding licensed material in concentrations less than 
those specified in table 3 of appendix B to part 20; or
    (c) Containers attended by an individual who takes the precautions 
necessary to prevent the exposure of individuals in excess of the limits 
established by this part; or
    (d) Containers when they are in transport and packaged and labeled 
in

[[Page 368]]

accordance with the regulations of the Department of Transportation, \3\ 
or
---------------------------------------------------------------------------

    \3\ Labeling of packages containing radioactive materials is 
required by the Department of Transportation (DOT) if the amount and 
type of radioactive material exceeds the limits for an excepted quantity 
or article as defined and limited by DOT regulations 49 CFR 173.403 (m) 
and (w) and 173.421-424.
---------------------------------------------------------------------------

    (e) Containers that are accessible only to individuals authorized to 
handle or use them, or to work in the vicinity of the containers, if the 
contents are identified to these individuals by a readily available 
written record (examples of containers of this type are containers in 
locations such as water-filled canals, storage vaults, or hot cells). 
The record must be retained as long as the containers are in use for the 
purpose indicated on the record; or
    (f) Installed manufacturing or process equipment, such as reactor 
components, piping, and tanks; or
    (g) Containers holding licensed material (other than sealed sources 
that are either specifically or generally licensed) at a facility 
licensed under Parts 50 or 52 of this chapter, not including non-power 
reactors, that are within an area posted under the requirements in Sec.
20.1902 if the containers are:
    (1) Conspicuously marked (such as by providing a system of color 
coding of containers) commensurate with the radiological hazard;
    (2) Accessible only to individuals who have sufficient instruction 
to minimize radiation exposure while handling or working in the vicinity 
of the containers; and
    (3) Subject to plant procedures to ensure they are appropriately 
labeled, as specified at Sec.20.1904 before being removed from the 
posted area.

[56 FR 23401, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 72 
FR 68059, Dec. 4, 2007]



Sec.20.1906  Procedures for receiving and opening packages.

    (a) Each licensee who expects to receive a package containing 
quantities of radioactive material in excess of a Type A quantity, as 
defined in Sec.71.4 and appendix A to part 71 of this chapter, shall 
make arrangements to receive--
    (1) The package when the carrier offers it for delivery; or
    (2) Notification of the arrival of the package at the carrier's 
terminal and to take possession of the package expeditiously.
    (b) Each licensee shall--
    (1) Monitor the external surfaces of a labeled \3a\ package for 
radioactive contamination unless the package contains only radioactive 
material in the form of a gas or in special form as defined in 10 CFR 
71.4;
---------------------------------------------------------------------------

    \3a\ Labeled with a Radioactive White I, Yellow II, or Yellow III 
label as specified in U.S. Department of Transportation regulations, 49 
CFR 172.403 and 172.436-440.
---------------------------------------------------------------------------

    (2) Monitor the external surfaces of a labeled \3a\ package for 
radiation levels unless the package contains quantities of radioactive 
material that are less than or equal to the Type A quantity, as defined 
in Sec.71.4 and appendix A to part 71 of this chapter; and
    (3) Monitor all packages known to contain radioactive material for 
radioactive contamination and radiation levels if there is evidence of 
degradation of package integrity, such as packages that are crushed, 
wet, or damaged.
    (c) The licensee shall perform the monitoring required by paragraph 
(b) of this section as soon as practical after receipt of the package, 
but not later than 3 hours after the package is received at the 
licensee's facility if it is received during the licensee's normal 
working hours, or not later than 3 hours from the beginning of the next 
working day if it is received after working hours.
    (d) The licensee shall immediately notify the final delivery carrier 
and the NRC Operations Center (301-816-5100), by telephone, when--
    (1) Removable radioactive surface contamination exceeds the limits 
of Sec.71.87(i) of this chapter; or
    (2) External radiation levels exceed the limits of Sec.71.47 of 
this chapter.
    (e) Each licensee shall--
    (1) Establish, maintain, and retain written procedures for safely 
opening packages in which radioactive material is received; and
    (2) Ensure that the procedures are followed and that due 
consideration is

[[Page 369]]

given to special instructions for the type of package being opened.
    (f) Licensees transferring special form sources in licensee-owned or 
licensee-operated vehicles to and from a work site are exempt from the 
contamination monitoring requirements of paragraph (b) of this section, 
but are not exempt from the survey requirement in paragraph (b) of this 
section for measuring radiation levels that is required to ensure that 
the source is still properly lodged in its shield.

[56 FR 23401, May 21, 1991, as amended at 57 FR 39357, Aug. 31, 1992; 60 
FR 20185, Apr. 25, 1995; 63 FR 39482, July 23, 1998]



                        Subpart K_Waste Disposal

    Source: 56 FR 23403, May 21, 1991, unless otherwise noted.



Sec.20.2001  General requirements.

    (a) A licensee shall dispose of licensed material only--
    (1) By transfer to an authorized recipient as provided in Sec.
20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 72 of 
this chapter;
    (2) By decay in storage; or
    (3) By release in effluents within the limits in Sec.20.1301; or
    (4) As authorized under Sec. Sec.20.2002, 20.2003, 20.2004, 
20.2005, or 20.2008.
    (b) A person must be specifically licensed to receive waste 
containing licensed material from other persons for:
    (1) Treatment prior to disposal; or
    (2) Treatment or disposal by incineration; or
    (3) Decay in storage; or
    (4) Disposal at a land disposal facility licensed under part 61 of 
this chapter; or
    (5) Disposal at a geologic repository under part 60 or part 63 of 
this chapter.

[56 FR 23403, May 21, 1991, as amended at 66 FR 55789, Nov. 2, 2001; 72 
FR 55922, Oct. 1, 2007]



Sec.20.2002  Method for obtaining approval of proposed disposal
procedures.

    A licensee or applicant for a license may apply to the Commission 
for approval of proposed procedures, not otherwise authorized in the 
regulations in this chapter, to dispose of licensed material generated 
in the licensee's activities. Each application shall include:
    (a) A description of the waste containing licensed material to be 
disposed of, including the physical and chemical properties important to 
risk evaluation, and the proposed manner and conditions of waste 
disposal; and
    (b) An analysis and evaluation of pertinent information on the 
nature of the environment; and
    (c) The nature and location of other potentially affected licensed 
and unlicensed facilities; and
    (d) Analyses and procedures to ensure that doses are maintained 
ALARA and within the dose limits in this part.



Sec.20.2003  Disposal by release into sanitary sewerage.

    (a) A licensee may discharge licensed material into sanitary 
sewerage if each of the following conditions is satisfied:
    (1) The material is readily soluble (or is readily dispersible 
biological material) in water; and
    (2) The quantity of licensed or other radioactive material that the 
licensee releases into the sewer in 1 month divided by the average 
monthly volume of water released into the sewer by the licensee does not 
exceed the concentration listed in table 3 of appendix B to part 20; and
    (3) If more than one radionuclide is released, the following 
conditions must also be satisfied:
    (i) The licensee shall determine the fraction of the limit in table 
3 of appendix B to part 20 represented by discharges into sanitary 
sewerage by dividing the actual monthly average concentration of each 
radionuclide released by the licensee into the sewer by the 
concentration of that radionuclide listed in table 3 of appendix B to 
part 20; and
    (ii) The sum of the fractions for each radionuclide required by 
paragraph (a)(3)(i) of this section does not exceed unity; and
    (4) The total quantity of licensed and other radioactive material 
that the licensee releases into the sanitary sewerage system in a year 
does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of 
carbon-14, and 1 curie (37 GBq) of all other radioactive materials 
combined.

[[Page 370]]

    (b) Excreta from individuals undergoing medical diagnosis or therapy 
with radioactive material are not subject to the limitations contained 
in paragraph (a) of this section.

[56 FR 23403, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995]



Sec.20.2004  Treatment or disposal by incineration.

    (a) A licensee may treat or dispose of licensed material by 
incineration only:
    (1) As authorized by paragraph (b) of this section; or
    (2) If the material is in a form and concentration specified in 
Sec.20.2005; or
    (3) As specifically approved by the Commission pursuant to Sec.
20.2002.
    (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 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 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. Sec.50.34 and 50.34a of this chapter associated 
with this incineration pursuant to Sec.50.71 of this chapter, as 
appropriate. The licensee shall also follow the procedures of Sec.
50.59 of this chapter with respect to such changes to the facility or 
procedures.
    (2) Solid residues produced in the process of incinerating waste 
oils must be disposed of as provided by Sec.20.2001.
    (3) The provisions of this section authorize onsite waste oil 
incineration under the terms of this section and supersede any provision 
in an individual plant license or technical specification that may be 
inconsistent.

[57 FR 57656, Dec. 7, 1992]



Sec.20.2005  Disposal of specific wastes.

    (a) A licensee may dispose of the following licensed material as if 
it were not radioactive:
    (1) 0.05 microcurie (1.85 kBq), or less, of hydrogen-3 or carbon-14 
per gram of medium used for liquid scintillation counting; and
    (2) 0.05 microcurie (1.85 kBq), or less, of hydrogen-3 or carbon-14 
per gram of animal tissue, averaged over the weight of the entire 
animal.
    (b) A licensee may not dispose of tissue under paragraph (a)(2) of 
this section in a manner that would permit its use either as food for 
humans or as animal feed.
    (c) The licensee shall maintain records in accordance with Sec.
20.2108.



Sec.20.2006  Transfer for disposal and manifests.

    (a) The requirements of this section and appendix G to 10 CFR part 
20 are designed to--
    (1) Control transfers of low-level radioactive waste by any waste 
generator, waste collector, or waste processor licensee, as defined in 
this part, who ships low-level waste either directly, or indirectly 
through a waste collector or waste processor, to a licensed low-level 
waste land disposal facility (as defined in part 61 of this chapter);
    (2) Establish a manifest tracking system; and
    (3) Supplement existing requirements concerning transfers and 
recordkeeping for those wastes.
    (b) Any licensee shipping radioactive waste intended for ultimate 
disposal at a licensed land disposal facility must document the 
information required on NRC's Uniform Low-Level Radioactive Waste 
Manifest and transfer this recorded manifest information to the intended 
consignee in accordance with appendix G to 10 CFR part 20.
    (c) Each shipment manifest must include a certification by the waste 
generator as specified in section II of appendix G to 10 CFR part 20.
    (d) Each person involved in the transfer for disposal and disposal 
of waste, including the waste generator, waste collector, waste 
processor, and disposal facility operator, shall comply with the

[[Page 371]]

requirements specified in section III of appendix G to 10 CFR part 20.
    (e) Any licensee shipping byproduct material as defined in 
paragraphs (3) and (4) of the definition of Byproduct material set forth 
in Sec.20.1003 intended for ultimate disposal at a land disposal 
facility licensed under part 61 of this chapter must document the 
information required on the NRC's Uniform Low-Level Radioactive Waste 
Manifest and transfer this recorded manifest information to the intended 
consignee in accordance with appendix G to this part.

[63 FR 50128, Sept. 21, 1998, as amended at 72 FR 55922, Oct. 1, 2007]



Sec.20.2007  Compliance with environmental and health protection
regulations.

    Nothing in this subpart relieves the licensee from complying with 
other applicable Federal, State, and local regulations governing any 
other toxic or hazardous properties of materials that may be disposed of 
under this subpart.



Sec.20.2008  Disposal of certain byproduct material.

    (a) Licensed material as defined in paragraphs (3) and (4) of the 
definition of Byproduct material set forth in Sec.20.1003 may be 
disposed of in accordance with part 61 of this chapter, even though it 
is not defined as low-level radioactive waste. Therefore, any licensed 
byproduct material being disposed of at a facility, or transferred for 
ultimate disposal at a facility licensed under part 61 of this chapter, 
must meet the requirements of Sec.20.2006.
    (b) A licensee may dispose of byproduct material, as defined in 
paragraphs (3) and (4) of the definition of Byproduct material set forth 
in Sec.20.1003, at a disposal facility authorized to dispose of such 
material in accordance with any Federal or State solid or hazardous 
waste law, including the Solid Waste Disposal Act, as authorized under 
the Energy Policy Act of 2005.

[72 FR 55922, Oct. 1, 2007]



                            Subpart L_Records

    Source: 56 FR 23404, May 21, 1991, unless otherwise noted.



Sec.20.2101  General provisions.

    (a) Each licensee shall use the units: curie, rad, rem, including 
multiples and subdivisions, and shall clearly indicate the units of all 
quantities on records required by this part.
    (b) In the records required by this part, the licensee may record 
quantities in SI units in parentheses following each of the units 
specified in paragraph (a) of this section. However, all quantities must 
be recorded as stated in paragraph (a) of this section.
    (c) Not withstanding the requirements of paragraph (a) of this 
section, when recording information on shipment manifests, as required 
in Sec.20.2006(b), information must be recorded in the International 
System of Units (SI) or in SI and units as specified in paragraph (a) of 
this section.
    (d) The licensee shall make a clear distinction among the quantities 
entered on the records required by this part (e.g., total effective dose 
equivalent, shallow-dose equivalent, lens dose equivalent, deep-dose 
equivalent, committed effective dose equivalent).

[56 FR 23404, May 21, 1991, as amended at 60 FR 15663, Mar. 27, 1995; 63 
FR 39483, July 23, 1998]



Sec.20.2102  Records of radiation protection programs.

    (a) Each licensee shall maintain records of the radiation protection 
program, including:
    (1) The provisions of the program; and
    (2) Audits and other reviews of program content and implementation.
    (b) The licensee shall retain the records required by paragraph 
(a)(1) of this section until the Commission terminates each pertinent 
license requiring the record. The licensee shall retain the records 
required by paragraph (a)(2) of this section for 3 years after the 
record is made.



Sec.20.2103  Records of surveys.

    (a) Each licensee shall maintain records showing the results of 
surveys and calibrations required by Sec. Sec.20.1501 and 20.1906(b). 
The licensee shall retain these records for 3 years after the record is 
made.

[[Page 372]]

    (b) The licensee shall retain each of the following records until 
the Commission terminates each pertinent license requiring the record:
    (1) Records of the results of surveys to determine the dose from 
external sources and used, in the absence of or in combination with 
individual monitoring data, in the assessment of individual dose 
equivalents. This includes those records of results of surveys to 
determine the dose from external sources and used, in the absence of or 
in combination with individual monitoring data, in the assessment of 
individual dose equivalents required under the standards for protection 
against radiation in effect prior to January 1, 1994; and
    (2) Records of the results of measurements and calculations used to 
determine individual intakes of radioactive material and used in the 
assessment of internal dose. This includes those records of the results 
of measurements and calculations used to determine individual intakes of 
radioactive material and used in the assessment of internal dose 
required under the standards for protection against radiation in effect 
prior to January 1, 1994; and
    (3) Records showing the results of air sampling, surveys, and 
bioassays required pursuant to Sec.20.1703(c)(1) and (2). This 
includes those records showing the results of air sampling, surveys, and 
bioassays required under the standards for protection against radiation 
in effect prior to January 1, 1994; and
    (4) Records of the results of measurements and calculations used to 
evaluate the release of radioactive effluents to the environment. This 
includes those records of the results of measurements and calculations 
used to evaluate the release of radioactive effluents to the environment 
required under the standards for protection against radiation in effect 
prior to January 1, 1994.

[56 FR 23404, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 66 
FR 64737, Dec. 14, 2001]



Sec.20.2104  Determination of prior occupational dose.

    (a) For each individual who is likely to receive an annual 
occupational dose requiring monitoring under Sec.20.1502, the licensee 
shall determine the occupational radiation dose received during the 
current year.
    (b) Prior to permitting an individual to participate in a planned 
special exposure, the licensee shall determine--
    (1) The internal and external doses from all previous planned 
special exposures; and
    (2) All doses in excess of the limits (including doses received 
during accidents and emergencies) received during the lifetime of the 
individual.
    (c) In complying with the requirements of paragraphs (a) or (b) of 
this section, a licensee may--
    (1) Accept, as a record of the occupational dose that the individual 
received during the current year, a written signed statement from the 
individual, or from the individual's most recent employer for work 
involving radiation exposure, that discloses the nature and the amount 
of any occupational dose that the individual may have received during 
the current year;
    (2) Accept, as the record of cumulative radiation dose, an up-to-
date NRC Form 4, or equivalent, signed by the individual and 
countersigned by an appropriate official of the most recent employer for 
work involving radiation exposure, or the individual's current employer 
(if the individual is not employed by the licensee); and
    (3) Obtain reports of the individual's dose equivalent(s) from the 
most recent employer for work involving radiation exposure, or the 
individual's current employer (if the individual is not employed by the 
licensee) by telephone, telegram, electronic media, or letter. The 
licensee shall request a written verification of the dose data if the 
authenticity of the transmitted report cannot be established.
    (d) The licensee shall record the exposure history of each 
individual, as required by paragraphs (a) or (b) of this section, on NRC 
Form 4, or other clear and legible record, including all of the 
information required by NRC Form 4. \4\

[[Page 373]]

The form or record must show each period in which the individual 
received occupational exposure to radiation or radioactive material and 
must be signed by the individual who received the exposure. For each 
period for which the licensee obtains reports, the licensee shall use 
the dose shown in the report in preparing the NRC Form 4. For any period 
in which the licensee does not obtain a report, the licensee shall place 
a notation on the NRC Form 4 indicating the periods of time for which 
data are not available.
---------------------------------------------------------------------------

    \4\ Licensees are not required to partition historical dose between 
external dose equivalent(s) and internal committed dose equivalent(s). 
Further, occupational exposure histories obtained and recorded on NRC 
Form 4 before January 1, 1994, might not have included effective dose 
equivalent, but may be used in the absence of specific information on 
the intake of radionuclides by the individual.
---------------------------------------------------------------------------

    (e) If the licensee is unable to obtain a complete record of an 
individual's current and previously accumulated occupational dose, the 
licensee shall assume--
    (1) In establishing administrative controls under Sec.20.1201(f) 
for the current year, that the allowable dose limit for the individual 
is reduced by 1.25 rems (12.5 mSv) for each quarter for which records 
were unavailable and the individual was engaged in activities that could 
have resulted in occupational radiation exposure; and
    (2) That the individual is not available for planned special 
exposures.
    (f) The licensee shall retain the records on NRC Form 4 or 
equivalent until the Commission terminates each pertinent license 
requiring this record. The licensee shall retain records used in 
preparing NRC Form 4 for 3 years after the record is made. This includes 
records required under the standards for protection against radiation in 
effect prior to January 1, 1994.

[56 FR 23404, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992; 60 
FR 20186, Apr. 25, 1995; 60 FR 36043, July 13, 1995; 72 FR 68059, Dec. 
4, 2007]



Sec.20.2105  Records of planned special exposures.

    (a) For each use of the provisions of Sec.20.1206 for planned 
special exposures, the licensee shall maintain records that describe--
    (1) The exceptional circumstances requiring the use of a planned 
special exposure; and
    (2) The name of the management official who authorized the planned 
special exposure and a copy of the signed authorization; and
    (3) What actions were necessary; and
    (4) Why the actions were necessary; and
    (5) How doses were maintained ALARA; and
    (6) What individual and collective doses were expected to result, 
and the doses actually received in the planned special exposure.
    (b) The licensee shall retain the records until the Commission 
terminates each pertinent license requiring these records.



Sec.20.2106  Records of individual monitoring results.

    (a) Recordkeeping requirement. Each licensee shall maintain records 
of doses received by all individuals for whom monitoring was required 
pursuant to Sec.20.1502, and records of doses received during planned 
special exposures, accidents, and emergency conditions. These records 
\5\ must include, when applicable--
---------------------------------------------------------------------------

    \5\ Assessments of dose equivalent and records made using units in 
effect before the licensee's adoption of this part need not be changed.
---------------------------------------------------------------------------

    (1) The deep-dose equivalent to the whole body, lens dose 
equivalent, shallow-dose equivalent to the skin, and shallow-dose 
equivalent to the extremities;
    (2) The estimated intake of radionuclides (see Sec.20.1202);
    (3) The committed effective dose equivalent assigned to the intake 
of radionuclides;
    (4) The specific information used to assess the committed effective 
dose equivalent pursuant to Sec.20.1204 (a) and (c), and when required 
by Sec.20.1502;
    (5) The total effective dose equivalent when required by Sec.
20.1202; and
    (6) The total of the deep-dose equivalent and the committed dose to 
the organ receiving the highest total dose.
    (b) Recordkeeping frequency. The licensee shall make entries of the 
records specified in paragraph (a) of this section at least annually.
    (c) Recordkeeping format. The licensee shall maintain the records 
specified in paragraph (a) of this section on NRC

[[Page 374]]

Form 5, in accordance with the instructions for NRC Form 5, or in clear 
and legible records containing all the information required by NRC Form 
5.
    (d) Privacy protection. The records required under this section 
should be protected from public disclosure because of their personal 
privacy nature. These records are protected by most State privacy laws 
and, when transferred to the NRC, are protected by the Privacy Act of 
1974, Public Law 93-579, 5 U.S.C. 552a, and the Commission's regulations 
in 10 CFR part 9.
    (e) The licensee shall maintain the records of dose to an embryo/
fetus with the records of dose to the declared pregnant woman. The 
declaration of pregnancy shall also be kept on file, but may be 
maintained separately from the dose records.
    (f) The licensee shall retain the required form or record until the 
Commission terminates each pertinent license requiring this record. This 
includes records required under the standards for protection against 
radiation in effect prior to January 1, 1994.

[56 FR 23404, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995; 63 
FR 39483, July 23, 1998]



Sec.20.2107  Records of dose to individual members of the public.

    (a) Each licensee shall maintain records sufficient to demonstrate 
compliance with the dose limit for individual members of the public (see 
Sec.20.1301).
    (b) The licensee shall retain the records required by paragraph (a) 
of this section until the Commission terminates each pertinent license 
requiring the record.



Sec.20.2108  Records of waste disposal.

    (a) Each licensee shall maintain records of the disposal of licensed 
materials made under Sec. Sec.20.2002, 20.2003, 20.2004, 20.2005, 10 
CFR part 61 and disposal by burial in soil, including burials authorized 
before January 28, 1981. \6\
---------------------------------------------------------------------------

    \6\ A previous Sec.20.304 permitted burial of small quantities of 
licensed materials in soil before January 28, 1981, without specific 
Commission authorization.
---------------------------------------------------------------------------

    (b) The licensee shall retain the records required by paragraph (a) 
of this section until the Commission terminates each pertinent license 
requiring the record. Requirements for disposition of these records, 
prior to license termination, are located in Sec. Sec.30.51, 40.61, 
70.51, and 72.80 for activities licensed under these parts.

[56 FR 23404, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995; 61 
FR 24673, May 16, 1996]



Sec.20.2109  [Reserved]



Sec.20.2110  Form of records.

    Each record required by this part must be legible throughout the 
specified retention period. The record may be the original or a 
reproduced copy or a microform provided that the copy or microform is 
authenticated by authorized personnel and that the microform is capable 
of producing a clear copy throughout the required retention period. The 
record may also be stored in electronic media with the capability for 
producing legible, accurate, and complete records during the required 
retention period. Records, such as letters, drawings, and 
specifications, must include all pertinent information, such as stamps, 
initials, and signatures. The licensee shall maintain adequate 
safeguards against tampering with and loss of records.



                            Subpart M_Reports

    Source: 56 FR 23406, May 21, 1991, unless otherwise noted.



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

    (a) Telephone reports. (1) Each licensee shall report by telephone 
as follows:
    (i) Immediately after its occurrence becomes known to the licensee, 
any lost, stolen, or missing licensed material in an aggregate quantity 
equal to or greater than 1,000 times the quantity specified in appendix 
C to part 20 under such circumstances that it appears to the licensee 
that an exposure could result to persons in unrestricted areas; or

[[Page 375]]

    (ii) Within 30 days after the occurrence of any lost, stolen, or 
missing licensed material becomes known to the licensee, all licensed 
material in a quantity greater than 10 times the quantity specified in 
appendix C to part 20 that is still missing at this time.
    (2) Reports must be made as follows:
    (i) Licensees having an installed Emergency Notification System 
shall make the reports to the NRC Operations Center in accordance with 
Sec.50.72 of this chapter, and
    (ii) All other licensees shall make reports by telephone to the NRC 
Operations Center (301-816-5100).
    (b) Written reports. (1) Each licensee required to make a report 
under paragraph (a) of this section shall, within 30 days after making 
the telephone report, make a written report setting forth the following 
information:
    (i) A description of the licensed material involved, including kind, 
quantity, and chemical and physical form; and
    (ii) A description of the circumstances under which the loss or 
theft occurred; and
    (iii) A statement of disposition, or probable disposition, of the 
licensed material involved; and
    (iv) Exposures of individuals to radiation, circumstances under 
which the exposures occurred, and the possible total effective dose 
equivalent to persons in unrestricted areas; and
    (v) Actions that have been taken, or will be taken, to recover the 
material; and
    (vi) Procedures or measures that have been, or will be, adopted to 
ensure against a recurrence of the loss or theft of licensed material.
    (2) Reports must be made as follows:
    (i) For holders of an operating license for a nuclear power plant, 
the events included in paragraph (b) of this section must be reported in 
accordance with the procedures described in Sec.50.73(b), (c), (d), 
(e), and (g) of this chapter and must include the information required 
in paragraph (b)(1) of this section, and
    (ii) All other licensees shall make reports to the Administrator of 
the appropriate NRC Regional Office listed in appendix D to part 20.
    (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. Sec.30.55(c), 37.57, 37.81, 40.64(c), 50.72, 50.73, 70.52, 
73.27(b), 73.67(e)(3)(vii), 73.67(g)(3)(iii), 73.71, or 150.19(c) of 
this chapter.
    (d) Subsequent to filing the written report, the licensee shall also 
report any additional substantive information on the loss or theft 
within 30 days after the licensee learns of such information.
    (e) The licensee shall prepare any report filed with the Commission 
pursuant to this section so that names of individuals who may have 
received exposure to radiation are stated in a separate and detachable 
part of the report.

[56 FR 23406, May 21, 1991, as amended at 58 FR 69220, Dec. 30, 1993; 60 
FR 20186, Apr. 25, 1995; 66 FR 64738, Dec. 14, 2001; 67 FR 3585, Jan. 
25, 2002; 78 FR 17006, Mar. 19, 2013]



Sec.20.2202  Notification of incidents.

    (a) Immediate notification. Notwithstanding any other requirements 
for notification, each licensee shall immediately report any event 
involving byproduct, source, or special nuclear material possessed by 
the licensee that may have caused or threatens to cause any of the 
following conditions--
    (1) An individual to receive--
    (i) A total effective dose equivalent of 25 rems (0.25 Sv) or more; 
or
    (ii) A lens dose equivalent of 75 rems (0.75 Sv) or more; or
    (iii) A shallow-dose equivalent to the skin or extremities of 250 
rads (2.5 Gy) or more; or
    (2) The release of radioactive material, inside or outside of a 
restricted area, so that, had an individual been present for 24 hours, 
the individual could have received an intake five times the annual limit 
on intake (the provisions of this paragraph do not apply to locations 
where personnel are not normally stationed during routine operations, 
such as hot-cells or process enclosures).
    (b) Twenty-four hour notification. Each licensee shall, within 24 
hours of discovery of the event, report any event involving loss of 
control of licensed material possessed by the licensee that may have 
caused, or threatens to cause, any of the following conditions:

[[Page 376]]

    (1) An individual to receive, in a period of 24 hours--
    (i) A total effective dose equivalent exceeding 5 rems (0.05 Sv); or
    (ii) A lens dose equivalent exceeding 15 rems (0.15 Sv); or
    (iii) A shallow-dose equivalent to the skin or extremities exceeding 
50 rems (0.5 Sv); or
    (2) The release of radioactive material, inside or outside of a 
restricted area, so that, had an individual been present for 24 hours, 
the individual could have received an intake in excess of one 
occupational annual limit on intake (the provisions of this paragraph do 
not apply to locations where personnel are not normally stationed during 
routine operations, such as hot-cells or process enclosures).
    (c) The licensee shall prepare any report filed with the Commission 
pursuant to this section so that names of individuals who have received 
exposure to radiation or radioactive material are stated in a separate 
and detachable part of the report.
    (d) Reports made by licensees in response to the requirements of 
this section must be made as follows:
    (1) Licensees having an installed Emergency Notification System 
shall make the reports required by paragraphs (a) and (b) of this 
section to the NRC Operations Center in accordance with 10 CFR 50.72; 
and
    (2) All other licensees shall make the reports required by 
paragraphs (a) and (b) of this section by telephone to the NRC 
Operations Center (301) 816-5100.
    (e) The provisions of this section do not include doses that result 
from planned special exposures, that are within the limits for planned 
special exposures, and that are reported under Sec.20.2204.

[56 FR 23406, May 21, 1991, as amended at 56 FR 40766, Aug. 16, 1991; 57 
FR 57879, Dec. 8, 1992; 59 FR 14086, Mar. 25, 1994; 63 FR 39483, July 
23, 1998]



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

    (a) Reportable events. In addition to the notification required by 
Sec.20.2202, each licensee shall submit a written report within 30 
days after learning of any of the following occurrences:
    (1) Any incident for which notification is required by Sec.
20.2202; or
    (2) Doses in excess of any of the following:
    (i) The occupational dose limits for adults in Sec.20.1201; or
    (ii) The occupational dose limits for a minor in Sec.20.1207; or
    (iii) The limits for an embryo/fetus of a declared pregnant woman in 
Sec.20.1208; or
    (iv) The limits for an individual member of the public in Sec.
20.1301; or
    (v) Any applicable limit in the license; or
    (vi) The ALARA constraints for air emissions established under Sec.
20.1101(d); or
    (3) Levels of radiation or concentrations of radioactive material 
in--
    (i) A restricted area in excess of any applicable limit in the 
license; or
    (ii) An unrestricted area in excess of 10 times any applicable limit 
set forth in this part or in the license (whether or not involving 
exposure of any individual in excess of the limits in Sec.20.1301); or
    (4) For licensees subject to the provisions of EPA's generally 
applicable environmental radiation standards in 40 CFR part 190, levels 
of radiation or releases of radioactive material in excess of those 
standards, or of license conditions related to those standards.
    (b) Contents of reports. (1) Each report required by paragraph (a) 
of this section must describe the extent of exposure of individuals to 
radiation and radioactive material, including, as appropriate:
    (i) Estimates of each individual's dose; and
    (ii) The levels of radiation and concentrations of radioactive 
material involved; and
    (iii) The cause of the elevated exposures, dose rates, or 
concentrations; and
    (iv) Corrective steps taken or planned to ensure against a 
recurrence, including the schedule for achieving conformance with 
applicable limits, ALARA constraints, generally applicable environmental 
standards, and associated license conditions.

[[Page 377]]

    (2) Each report filed pursuant to paragraph (a) of this section must 
include for each occupationally overexposed \1\ individual: the name, 
Social Security account number, and date of birth. The report must be 
prepared so that this information is stated in a separate and detachable 
part of the report and must be clearly labeled ``Privacy Act 
Information: Not for Public Disclosure.''
---------------------------------------------------------------------------

    \1\ With respect to the limit for the embryo/fetus (Sec.20.1208), 
the identifiers should be those of the declared pregnant woman.
---------------------------------------------------------------------------

    (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 in accordance with the procedures described in 
Sec. Sec.50.73(b), (c), (d), (e), and (g) of this chapter, and must 
include the information required by paragraph (b) of this section. 
Occurrences reported in accordance with Sec.50.73 of this chapter need 
not be reported by a duplicate report under paragraph (a) of this 
section.
    (d) All licensees, other than those holding an operating license or 
a combined license for a nuclear power plant, who make reports under 
paragraph (a) of this section shall submit the report in writing either 
by mail addressed to the U.S. Nuclear Regulatory Commission, ATTN: 
Document Control Desk, Washington, DC 20555-0001; by hand delivery to 
the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, 
where practicable, by electronic submission, for example, Electronic 
Information Exchange, or CD-ROM. Electronic submissions must be made in 
a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
A copy should be sent to the appropriate NRC Regional Office listed in 
appendix D to this part.

[56 FR 23406, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995; 61 
FR 65127, Dec. 10, 1996; 68 FR 14308, Mar. 25, 2003; 68 FR 58801, Oct. 
10, 2003; 72 FR 49486, Aug. 28, 2007; 74 FR 62680, Dec. 1, 2009; 80 FR 
74979, Dec. 1, 2015]



Sec.20.2204  Reports of planned special exposures.

    The licensee shall submit a written report to the Administrator of 
the appropriate NRC Regional Office listed in appendix D to part 20 
within 30 days following any planned special exposure conducted in 
accordance with Sec.20.1206, informing the Commission that a planned 
special exposure was conducted and indicating the date the planned 
special exposure occurred and the information required by Sec.20.2105.

[56 FR 23406, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995]



Sec.20.2205  Reports to individuals of exceeding dose limits.

    When a licensee is required by Sec. Sec.20.2203 or 20.2204 to 
report to the Commission any exposure of an identified occupationally 
exposed individual, or an identified member of the public, to radiation 
or radioactive material, the licensee shall also provide the individual 
a report on his or her exposure data included in the report to 
Commission. This report must be transmitted no later than the 
transmittal to the Commission.

[72 FR 68059, Dec. 4, 2007]



Sec.20.2206  Reports of individual monitoring.

    (a) This section applies to each person licensed by the Commission 
to--
    (1) Operate a nuclear reactor designed to produce electrical or heat 
energy pursuant to Sec.50.21(b) or Sec.50.22 of this chapter or a 
testing facility as defined in Sec.50.2 of this chapter; or
    (2) Possess or use byproduct material for purposes of radiography 
pursuant to parts 30 and 34 of this chapter; or
    (3) Possess or use at any one time, for purposes of fuel processing, 
fabricating, or reprocessing, special nuclear material in a quantity 
exceeding 5,000 grams of contained uranium-235, uranium-233, or 
plutonium, or any combination

[[Page 378]]

thereof pursuant to part 70 of this chapter; or
    (4) Possess high-level radioactive waste at a geologic repository 
operations area pursuant to part 60 or 63 of this chapter; or
    (5) Possess spent fuel in an independent spent fuel storage 
installation (ISFSI) pursuant to part 72 of this chapter; or
    (6) Receive radioactive waste from other persons for disposal under 
part 61 of this chapter; or
    (7) Possess or use at any time, for processing or manufacturing for 
distribution pursuant to parts 30, 32, 33 or 35 of this chapter, 
byproduct material in quantities exceeding any one of the following 
quantitites:

------------------------------------------------------------------------
                                                           Quantity of
                      Radionuclide                         radionuclide
                                                          \1\ in curies
------------------------------------------------------------------------
Cesium-137.............................................                1
Cobalt-60..............................................                1
Gold-198...............................................              100
Iodine-131.............................................                1
Iridium-192............................................               10
Krypton-85.............................................            1,000
Promethium-147.........................................               10
Techetium-99m..........................................            1,000
------------------------------------------------------------------------
\1\ The Commission may require as a license condition, or by rule,
  regulation, or order pursuant to Sec. 20.2302, reports from
  licensees who are licensed to use radionuclides not on this list, in
  quantities sufficient to cause comparable radiation levels.

    (b) Each licensee in a category listed in paragraph (a) of this 
section shall submit an annual report of the results of individual 
monitoring carried out by the licensee for each individual for whom 
monitoring was required by Sec.20.1502 during that year. The licensee 
may include additional data for individuals for whom monitoring was 
provided but not required. The licensee shall use Form NRC 5 or 
electronic media containing all the information required by Form NRC 5.
    (c) The licensee shall file the report required by Sec.20.2206(b), 
covering the preceding year, on or before April 30 of each year. The 
licensee shall submit the report to the REIRS Project Manager by an 
appropriate method listed in Sec.20.1007 or via the REIRS Web site at 
http://www.reirs.com.

[56 FR 23406, May 21, 1991, as amended at 56 FR 32072, July 15, 1991; 66 
FR 55789, Nov. 2, 2001; 68 FR 58802, Oct. 10, 2003]



Sec.20.2207  Reports of transactions involving nationally tracked 
sources.

    Each licensee who manufactures, transfers, receives, disassembles, 
or disposes of a nationally tracked source shall complete and submit a 
National Source Tracking Transaction Report as specified in paragraphs 
(a) through (e) of this section for each type of transaction.
    (a) Each licensee who manufactures a nationally tracked source shall 
complete and submit a National Source Tracking Transaction Report. The 
report must include the following information:
    (1) The name, address, and license number of the reporting licensee;
    (2) The name of the individual preparing the report;
    (3) The manufacturer, model, and serial number of the source;
    (4) The radioactive material in the source;
    (5) The initial source strength in becquerels (curies) at the time 
of manufacture; and
    (6) The manufacture date of the source.
    (b) Each licensee that transfers a nationally tracked source to 
another person shall complete and submit a National Source Tracking 
Transaction Report. The report must include the following information:
    (1) The name, address, and license number of the reporting licensee;
    (2) The name of the individual preparing the report;
    (3) The name and license number of the recipient facility and the 
shipping address;
    (4) The manufacturer, model, and serial number of the source or, if 
not available, other information to uniquely identify the source;
    (5) The radioactive material in the source;
    (6) The initial or current source strength in becquerels (curies);
    (7) The date for which the source strength is reported;
    (8) The shipping date;
    (9) The estimated arrival date; and
    (10) For nationally tracked sources transferred as waste under a 
Uniform Low-Level Radioactive Waste Manifest, the waste manifest number 
and

[[Page 379]]

the container identification of the container with the nationally 
tracked source.
    (c) Each licensee that receives a nationally tracked source shall 
complete and submit a National Source Tracking Transaction Report. The 
report must include the following information:
    (1) The name, address, and license number of the reporting licensee;
    (2) The name of the individual preparing the report;
    (3) The name, address, and license number of the person that 
provided the source;
    (4) The manufacturer, model, and serial number of the source or, if 
not available, other information to uniquely identify the source;
    (5) The radioactive material in the source;
    (6) The initial or current source strength in becquerels (curies);
    (7) The date for which the source strength is reported;
    (8) The date of receipt; and
    (9) For material received under a Uniform Low-Level Radioactive 
Waste Manifest, the waste manifest number and the container 
identification with the nationally tracked source.
    (d) Each licensee that disassembles a nationally tracked source 
shall complete and submit a National Source Tracking Transaction Report. 
The report must include the following information:
    (1) The name, address, and license number of the reporting licensee;
    (2) The name of the individual preparing the report;
    (3) The manufacturer, model, and serial number of the source or, if 
not available, other information to uniquely identify the source;
    (4) The radioactive material in the source;
    (5) The initial or current source strength in becquerels (curies);
    (6) The date for which the source strength is reported;
    (7) The disassemble date of the source.
    (e) Each licensee who disposes of a nationally tracked source shall 
complete and submit a National Source Tracking Transaction Report. The 
report must include the following information:
    (1) The name, address, and license number of the reporting licensee;
    (2) The name of the individual preparing the report;
    (3) The waste manifest number;
    (4) The container identification with the nationally tracked source.
    (5) The date of disposal; and
    (6) The method of disposal.
    (f) The reports discussed in paragraphs (a) through (e) of this 
section must be submitted by the close of the next business day after 
the transaction. A single report may be submitted for multiple sources 
and transactions. The reports must be submitted to the National Source 
Tracking System by using:
    (1) The on-line National Source Tracking System;
    (2) Electronically using a computer-readable format;
    (3) By facsimile;
    (4) By mail to the address on the National Source Tracking 
Transaction Report Form (NRC Form 748); or
    (5) By telephone with followup by facsimile or mail.
    (g) Each licensee shall correct any error in previously filed 
reports or file a new report for any missed transaction within 5 
business days of the discovery of the error or missed transaction. Such 
errors may be detected by a variety of methods such as administrative 
reviews or by physical inventories required by regulation. In addition, 
each licensee shall reconcile the inventory of nationally tracked 
sources possessed by the licensee against that licensee's data in the 
National Source Tracking System. The reconciliation must be conducted 
during the month of January in each year. The reconciliation process 
must include resolving any discrepancies between the National Source 
Tracking System and the actual inventory by filing the reports 
identified by paragraphs (a) through (e) of this section. By January 31 
of each year, each licensee must submit to the National Source Tracking 
System confirmation that the data in the National Source Tracking System 
is correct.
    (h) Each licensee that possesses Category 1 nationally tracked 
sources shall report its initial inventory of Category 1 nationally 
tracked sources

[[Page 380]]

to the National Source Tracking System by January 31, 2009. Each 
licensee that possesses Category 2 nationally tracked sources shall 
report its initial inventory of Category 2 nationally tracked sources to 
the National Source Tracking System by January 31, 2009. The information 
may be submitted by using any of the methods identified by paragraph 
(f)(1) through (f)(4) of this section. The initial inventory report must 
include the following information:
    (1) The name, address, and license number of the reporting licensee;
    (2) The name of the individual preparing the report;
    (3) The manufacturer, model, and serial number of each nationally 
tracked source or, if not available, other information to uniquely 
identify the source;
    (4) The radioactive material in the sealed source;
    (5) The initial or current source strength in becquerels (curies); 
and
    (6) The date for which the source strength is reported.

[71 FR 65707, Nov. 8, 2006, as amended at 72 FR 59163, Oct. 19, 2007]



            Subpart N_Exemptions and Additional Requirements

    Source: 56 FR 23408, May 21, 1991, unless otherwise noted.



Sec.20.2301  Applications for exemptions.

    The Commission may, upon application by a licensee or upon its own 
initiative, grant an exemption from the requirements of the regulations 
in this part if it determines the exemption is authorized by law and 
would not result in undue hazard to life or property.



Sec.20.2302  Additional requirements.

    The Commission may, by rule, regulation, or order, impose 
requirements on a licensee, in addition to those established in the 
regulations in this part, as it deems appropriate or necessary to 
protect health or to minimize danger to life or property.



                          Subpart O_Enforcement



Sec.20.2401  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107 or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section; and
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
Section 186 of the Atomic Energy Act of 1954, as amended.

[56 FR 23408, May 21, 1991; 56 FR 61352, Dec. 3, 1991, as amended at 57 
FR 55071, Nov. 24, 1992]



Sec.20.2402  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in Sec. Sec.20.1001 through 20.2402 are issued 
under one or more of sections 161b, 161i, or 161o, except for the 
sections listed in paragraph (b) this section.
    (b) The regulations in Sec. Sec.20.1001 through 20.2402 that are 
not issued under Sections 161b, 161i, or 161o for the purposes of 
Section 223 are as follows: Sec. Sec.20.1001, 20.1002, 20.1003, 
20.1004, 20.1005, 20.1006, 20.1007, 20.1008, 20.1009, 20.1405,

[[Page 381]]

20.1704, 20.1903, 20.1905, 20.2002, 20.2007, 20.2301, 20.2302, 20.2401, 
and 20.2402.

[57 FR 55071, Nov. 24, 1992, as amended at 62 FR 39089, July 21, 1997]



Sec. Appendix A to Part 20--Assigned Protection Factors for Respirators 
                                   \a\

------------------------------------------------------------------------
                                                               Assigned
                                          Operating mode      Protection
                                                                Factors
------------------------------------------------------------------------
I. Air Purifying Respirators
 [Particulate \b\ only] \c\:
    Filtering facepiece disposable    Negative Pressure.....       (\d\)
     \d\.
    Facepiece, half \e\.............  Negative Pressure.....          10
    Facepiece, full.................  Negative Pressure.....         100
    Facepiece, half.................  Powered air-purifying           50
                                       respirators.
    Facepiece, full.................  Powered air-purifying         1000
                                       respirators.
    Helmet/hood.....................  Powered air-purifying         1000
                                       respirators.
    Facepiece, loose-fitting........  Powered air-purifying           25
                                       respirators.
II. Atmosphere supplying respirators
 [particulate, gases and vapors
 \f\]:
    1. Air-line respirator:
        Facepiece, half.............  Demand................          10
        Facepiece, half.............  Continuous Flow.......          50
        Facepiece, half.............  Pressure Demand.......          50
        Facepiece, full.............  Demand................         100
        Facepiece, full.............  Continuous Flow.......        1000
        Facepiece, full.............  Pressure Demand.......        1000
        Helmet/hood.................  Continuous Flow.......        1000
        Facepiece, loose-fitting....  Continuous Flow.......          25
        Suit........................  Continuous Flow.......       (\g\)
    2. Self-contained breathing
     Apparatus (SCBA):
        Facepiece, full.............  Demand................     \h\ 100
        Facepiece, full.............  Pressure Demand.......  \i\ 10,000
        Facepiece, full.............  Demand, Recirculating.     \h\ 100
        Facepiece, full.............  Positive Pressure       \i\ 10,000
                                       Recirculating.
III. Combination Respirators:
    Any combination of air-purifying    Assigned protection factor for
     and atmosphere-supplying            type and mode of operation as
     respirators.                                listed above.
------------------------------------------------------------------------
\a\ These assigned protection factors apply only in a respiratory
  protection program that meets the requirements of this Part. They are
  applicable only to airborne radiological hazards and may not be
  appropriate to circumstances when chemical or other respiratory
  hazards exist instead of, or in addition to, radioactive hazards.
  Selection and use of respirators for such circumstances must also
  comply with Department of Labor regulations.
 Radioactive contaminants for which the concentration values in Table 1,
  Column 3 of Appendix B to Part 20 are based on internal dose due to
  inhalation may, in addition, present external exposure hazards at
  higher concentrations. Under these circumstances, limitations on
  occupancy may have to be governed by external dose limits.
\b\ Air purifying respirators with APF <100 must be equipped with
  particulate filters that are at least 95 percent efficient. Air
  purifying respirators with APF = 100 must be equipped with particulate
  filters that are at least 99 percent efficient. Air purifying
  respirators with APFs 100 must be equipped with particulate
  filters that are at least 99.97 percent efficient.
\c\ The licensee may apply to the Commission for the use of an APF
  greater than 1 for sorbent cartridges as protection against airborne
  radioactive gases and vapors (e.g., radioiodine).
\d\ Licensees may permit individuals to use this type of respirator who
  have not been medically screened or fit tested on the device provided
  that no credit be taken for their use in estimating intake or dose. It
  is also recognized that it is difficult to perform an effective
  positive or negative pressure pre-use user seal check on this type of
  device. All other respiratory protection program requirements listed
  in Sec. 20.1703 apply. An assigned protection factor has not been
  assigned for these devices. However, an APF equal to 10 may be used if
  the licensee can demonstrate a fit factor of at least 100 by use of a
  validated or evaluated, qualitative or quantitative fit test.
\e\ Under-chin type only. No distinction is made in this Appendix
  between elastomeric half-masks with replaceable cartridges and those
  designed with the filter medium as an integral part of the facepiece
  (e.g., disposable or reusable disposable). Both types are acceptable
  so long as the seal area of the latter contains some substantial type
  of seal-enhancing material such as rubber or plastic, the two or more
  suspension straps are adjustable, the filter medium is at least 95
  percent efficient and all other requirements of this Part are met.
\f\ The assigned protection factors for gases and vapors are not
  applicable to radioactive contaminants that present an absorption or
  submersion hazard. For tritium oxide vapor, approximately one-third of
  the intake occurs by absorption through the skin so that an overall
  protection factor of 3 is appropriate when atmosphere-supplying
  respirators are used to protect against tritium oxide. Exposure to
  radioactive noble gases is not considered a significant respiratory
  hazard, and protective actions for these contaminants should be based
  on external (submersion) dose considerations.
\g\ No NIOSH approval schedule is currently available for atmosphere
  supplying suits. This equipment may be used in an acceptable
  respiratory protection program as long as all the other minimum
  program requirements, with the exception of fit testing, are met
  (i.e., Sec. 20.1703).
\h\ The licensee should implement institutional controls to assure that
  these devices are not used in areas immediately dangerous to life or
  health (IDLH).
\i\ This type of respirator may be used as an emergency device in
  unknown concentrations for protection against inhalation hazards.
  External radiation hazards and other limitations to permitted exposure
  such as skin absorption shall be taken into account in these
  circumstances. This device may not be used by any individual who
  experiences perceptible outward leakage of breathing gas while wearing
  the device.


[64 FR 54558, Oct. 7, 1999; 64 FR 55524, Oct. 13, 1999]



 Sec. Appendix B to Part 20--Annual Limits on Intake (ALIs) and Derived 
 Air Concentrations (DACs) of Radionuclides for Occupational Exposure; 
     Effluent Concentrations; Concentrations for Release to Sewerage

                              Introduction

    For each radionuclide table 1 indicates the chemical form which is 
to be used for selecting the appropriate ALI or DAC value. The ALIs and 
DACs for inhalation are given for an aerosol with an activity median 
aerodynamic diameter (AMAD) of 1 [micro]m and for three classes (D,W,Y) 
of radioactive material, which refer to their retention (approximately 
days, weeks or years) in the pulmonary region of the lung. This 
classification applies to a range of clearance half-

[[Page 382]]

times of less than 10 days for D, for W from 10 to 100 days, and for Y 
greater than 100 days. The class (D, W, or Y) given in the column headed 
``Class'' applies only to the inhalation ALIs and DACs given in table 1, 
columns 2 and 3. Table 2 provides concentration limits for airborne and 
liquid effluents released to the general environment. Table 3 provides 
concentration limits for discharges to sanitary sewer systems.

                                Notation

    The values in tables 1, 2, and 3 are presented in the computer ``E'' 
notation. In this notation a value of 6E-02 represents a value of 6 x 
10-2 or 0.06, 6E + 2 represents 6 x 10\2\ or 600, and 6E + 0 
represents 6 x 10\0\ or 6.

                        Table 1 ``Occupational''

    Note that the columns in table 1, of this appendix captioned ``Oral 
Ingestion ALI,'' ``Inhalation ALI,'' and ``DAC,'' are applicable to 
occupational exposure to radioactive material.
    The ALIs in this appendix are the annual intakes of a given 
radionuclide by ``Reference Man'' which would result in either (1) a 
committed effective dose equivalent of 5 rems (stochastic ALI) or (2) a 
committed dose equivalent of 50 rems to an organ or tissue (non-
stochastic ALI). The stochastic ALIs were derived to result in a risk, 
due to irradiation of organs and tissues, comparable to the risk 
associated with deep dose equivalent to the whole body of 5 rems. The 
derivation includes multiplying the committed dose equivalent to an 
organ or tissue by a weighting factor, wT. This weighting 
factor is the proportion of the risk of stochastic effects resulting 
from irradiation of the organ or tissue, T, to the total risk of 
stochastic effects when the whole body is irradiated uniformly. The 
values of wT are listed under the definition of weighting 
factor in Sec.20.1003. The non-stochastic ALIs were derived to avoid 
non-stochastic effects, such as prompt damage to tissue or reduction in 
organ function.
    A value of wT = 0.06 is applicable to each of the five 
organs or tissues in the ``remainder'' category receiving the highest 
dose equivalents, and the dose equivalents of all other remaining 
tissues may be disregarded. The following parts of the GI tract--
stomach, small intestine, upper large intestine, and lower large 
intestine--are to be treated as four separate organs.
    Note that the dose equivalents for extremities (hands and forearms, 
feet and lower legs), skin, and lens of the eye are not considered in 
computing the committed effective dose equivalent, but are subject to 
limits that must be met separately.
    When an ALI is defined by the stochastic dose limit, this value 
alone, is given. When an ALI is determined by the non-stochastic dose 
limit to an organ, the organ or tissue to which the limit applies is 
shown, and the ALI for the stochastic limit is shown in parentheses. 
(Abbreviated organ or tissue designations are used: LLI wall = lower 
large intestine wall; St. wall = stomach wall; Blad wall = bladder wall; 
and Bone surf = bone surface.)
    The use of the ALIs listed first, the more limiting of the 
stochastic and non-stochastic ALIs, will ensure that non-stochastic 
effects are avoided and that the risk of stochastic effects is limited 
to an acceptably low value. If, in a particular situation involving a 
radionuclide for which the non-stochastic ALI is limiting, use of that 
non-stochastic ALI is considered unduly conservative, the licensee may 
use the stochastic ALI to determine the committed effective dose 
equivalent. However, the licensee shall also ensure that the 50-rem dose 
equivalent limit for any organ or tissue is not exceeded by the sum of 
the external deep dose equivalent plus the internal committed dose to 
that organ (not the effective dose). For the case where there is no 
external dose contribution, this would be demonstrated if the sum of the 
fractions of the nonstochastic ALIs (ALIns) that contribute 
to the committed dose equivalent to the organ receiving the highest dose 
does not exceed unity (i.e., [Sigma] (intake (in [micro]Ci) of each 
radionuclide/ALIns) <1.0). If there is an external deep dose 
equivalent contribution of Hd then this sum must be less than 
l-(Hd/50) instead of being <1.0.
    The derived air concentration (DAC) values are derived limits 
intended to control chronic occupational exposures. The relationship 
between the DAC and the ALI is given by: DAC = ALI(in [micro]Ci)/(2000 
hours per working year x 60 minutes/hour x 2 x 10\4\ ml per minute) = 
[ALI/2.4 x 10\9\] [micro]Ci/ml, where 2 x 10\4\ ml is the volume of air 
breathed per minute at work by ``Reference Man'' under working 
conditions of ``light work.''
    The DAC values relate to one of two modes of exposure: either 
external submersion or the internal committed dose equivalents resulting 
from inhalation of radioactive materials. Derived air concentrations 
based upon submersion are for immersion in a semi-infinite cloud of 
uniform concentration and apply to each radionuclide separately.
    The ALI and DAC values relate to exposure to the single radionuclide 
named, but also include contributions from the in-growth of any daughter 
radionuclide produced in the body by the decay of the parent. However, 
intakes that include both the parent and daughter radionuclides should 
be treated by the general method appropriate for mixtures.
    The value of ALI and DAC do not apply directly when the individual 
both ingests and inhales a radionuclide, when the individual is exposed 
to a mixture of radionuclides by either inhalation or ingestion or both, 
or

[[Page 383]]

when the individual is exposed to both internal and external radiation 
(see Sec.20.1202). When an individual is exposed to radioactive 
materials which fall under several of the translocation classifications 
(i.e., Class D, Class W, or Class Y) of the same radionuclide, the 
exposure may be evaluated as if it were a mixture of different 
radionuclides.
    It should be noted that the classification of a compound as Class D, 
W, or Y is based on the chemical form of the compound and does not take 
into account the radiological half-life of different radioisotopes. For 
this reason, values are given for Class D, W, and Y compounds, even for 
very short-lived radionuclides.

                                 Table 2

    The columns in table 2 of this appendix captioned ``Effluents,'' 
``Air,'' and ``Water,'' are applicable to the assessment and control of 
dose to the public, particularly in the implementation of the provisions 
of Sec.20.1302. The concentration values given in columns 1 and 2 of 
table 2 are equivalent to the radionuclide concentrations which, if 
inhaled or ingested continuously over the course of a year, would 
produce a total effective dose equivalent of 0.05 rem (50 millirem or 
0.5 millisieverts).
    Consideration of non-stochastic limits has not been included in 
deriving the air and water effluent concentration limits because non-
stochastic effects are presumed not to occur at the dose levels 
established for individual members of the public. For radionuclides, 
where the non-stochastic limit was governing in deriving the 
occupational DAC, the stochastic ALI was used in deriving the 
corresponding airborne effluent limit in table 2. For this reason, the 
DAC and airborne effluent limits are not always proportional as was the 
case in appendix B to Sec. Sec.20.1-20.601.
    The air concentration values listed in table 2, column 1, were 
derived by one of two methods. For those radionuclides for which the 
stochastic limit is governing, the occupational stochastic inhalation 
ALI was divided by 2.4 x 10 \9\ ml, relating the inhalation ALI to the 
DAC, as explained above, and then divided by a factor of 300. The factor 
of 300 includes the following components: a factor of 50 to relate the 
5-rem annual occupational dose limit to the 0.1-rem limit for members of 
the public, a factor of 3 to adjust for the difference in exposure time 
and the inhalation rate for a worker and that for members of the public; 
and a factor of 2 to adjust the occupational values (derived for adults) 
so that they are applicable to other age groups.
    For those radionuclides for which submersion (external dose) is 
limiting, the occupational DAC in table 1, column 3, was divided by 219. 
The factor of 219 is composed of a factor of 50, as described above, and 
a factor of 4.38 relating occupational exposure for 2,000 hours per year 
to full-time exposure (8,760 hours per year). Note that an additional 
factor of 2 for age considerations is not warranted in the submersion 
case.
    The water concentrations were derived by taking the most restrictive 
occupational stochastic oral ingestion ALI and dividing by 7.3 x 10\7\. 
The factor of 7.3 x 10\7\ (ml) includes the following components: the 
factors of 50 and 2 described above and a factor of 7.3 x 10\5\ (ml) 
which is the annual water intake of ``Reference Man.''
    Note 2 of this appendix provides groupings of radionuclides which 
are applicable to unknown mixtures of radionuclides. These groupings 
(including occupational inhalation ALIs and DACs, air and water effluent 
concentrations and sewerage) require demonstrating that the most 
limiting radionuclides in successive classes are absent. The limit for 
the unknown mixture is defined when the presence of one of the listed 
radionuclides cannot be definitely excluded either from knowledge of the 
radionuclide composition of the source or from actual measurements.

                       Table 3 ``Sewer Disposal''

    The monthly average concentrations for release to sanitary sewers 
are applicable to the provisions in Sec.20.2003. The concentration 
values were derived by taking the most restrictive occupational 
stochastic oral ingestion ALI and dividing by 7.3 x 10\6\ (ml). The 
factor of 7.3 x 10\6\ (ml) is composed of a factor of 7.3 x 10\5\ (ml), 
the annual water intake by ``Reference Man,'' and a factor of 10, such 
that the concentrations, if the sewage released by the licensee were the 
only source of water ingested by a reference man during a year, would 
result in a committed effective dose equivalent of 0.5 rem.

                            List of Elements
------------------------------------------------------------------------
                                                      Atomic
                  Name                   -------------------------------
                                                 Symbol            No.
------------------------------------------------------------------------
Actinium................................  Ac                          89
Aluminum................................  Al                          13
Americium...............................  Am                          95
Antimony................................  Sb                          51
Argon...................................  Ar                          18
Arsenic.................................  As                          33
Astatine................................  At                          85
Barium..................................  Ba                          56
Berkelium...............................  Bk                          97
Beryllium...............................  Be                           4
Bismuth.................................  Bi                          83
Bromine.................................  Br                          35
Cadmium.................................  Cd                          48
Calcium.................................  Ca                          20
Californium.............................  Cf                          98
Carbon..................................  C                            6
Cerium..................................  Ce                          58
Cesium..................................  Cs                          55
Chlorine................................  Cl                          17
Chromium................................  Cr                          24

[[Page 384]]

 
Cobalt..................................  Co                          27
Copper..................................  Cu                          29
Curium..................................  Cm                          96
Dysprosium..............................  Dy                          66
Einsteinium.............................  Es                          99
Erbium..................................  Er                          68
Europium................................  Eu                          63
Fermium.................................  Fm                         100
Fluorine................................  F                            9
Francium................................  Fr                          87
Gadolinium..............................  Gd                          64
Gallium.................................  Ga                          31
Germanium...............................  Ge                          32
Gold....................................  Au                          79
Hafnium.................................  Hf                          72
Holmium.................................  Ho                          67
Hydrogen................................  H                            1
Indium..................................  In                          49
Iodine..................................  I                           53
Iridium.................................  Ir                          77
Iron....................................  Fe                          26
Krypton.................................  Kr                          36
Lanthanum...............................  La                          57
Lead....................................  Pb                          82
Lutetium................................  Lu                          71
Magnesium...............................  Mg                          12
Manganese...............................  Mn                          25
Mendelevium.............................  Md                         101
Mercury.................................  Hg                          80
Molybdenum..............................  Mo                          42
Neodymium...............................  Nd                          60
Neptunium...............................  Np                          93
Nickel..................................  Ni                          28
Niobium.................................  Nb                          41
Nitrogen................................  N                            7
Osmium..................................  Os                          76
Oxygen..................................  O                            8
Palladium...............................  Pd                          46
Phosphorus..............................  P                           15
Platinum................................  Pt                          78
Plutonium...............................  Pu                          94
Polonium................................  Po                          84
Potassium...............................  K                           19
Praseodymium............................  Pr                          59
Promethium..............................  Pm                          61
Protactinium............................  Pa                          91
Radium..................................  Ra                          88
Radon...................................  Rn                          86
Rhenium.................................  Re                          75
Rhodium.................................  Rh                          45
Rubidium................................  Rb                          37
Ruthenium...............................  Ru                          44
Samarium................................  Sm                          62
Scandium................................  Sc                          21
Selenium................................  Se                          34
Silicon.................................  Si                          14
Silver..................................  Ag                          47
Sodium..................................  Na                          11
Strontium...............................  Sr                          38
Sulfur..................................  S                           16
Tantalum................................  Ta                          73
Technetium..............................  Tc                          43
Tellurium...............................  Te                          52
Terbium.................................  Tb                          65
Thallium................................  Tl                          81
Thorium.................................  Th                          90
Thulium.................................  Tm                          69
Tin.....................................  Sn                          50
Titanium................................  Ti                          22
Tungsten................................  W                           74
Uranium.................................  U                           92
Vanadium................................  V                           23
Xenon...................................  Xe                          54
Ytterbium...............................  Yb                          70
Yttrium.................................  Y                           39
Zinc....................................  Zn                          30
Zirconium...............................  Zr                          40
------------------------------------------------------------------------


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[56 FR 23409, May 21, 1991; 56 FR 61352, Dec. 3, 1991, as amended at 57 
FR 57879, Dec. 8, 1992. Redesignated at 58 FR 67659, Dec. 22, 1993, as 
amended at 71 FR 15007, Mar. 27, 2006; 72 FR 55922, Oct. 1, 2007; 75 FR 
73938, Nov. 30, 2010]

[[Page 438]]



    Sec. Appendix C to Part 20--Quantities \1\ of Licensed Material 
                           Requiring Labeling

------------------------------------------------------------------------
                                                               Quantity
                        Radionuclide                         ([micro]Ci)
------------------------------------------------------------------------
Hydrogen-3.................................................    1,000
Beryllium-7................................................    1,000
Beryllium-10...............................................        1
Carbon-11..................................................    1,000
Carbon-14..................................................      100
Fluorine-18................................................    1,000
Sodium-22..................................................       10
Sodium-24..................................................      100
Magnesium-28...............................................      100
Aluminum-26................................................       10
Silicon-31.................................................    1,000
Silicon-32.................................................        1
Phosphorus-32..............................................       10
Phosphorus-33..............................................      100
Sulfur-35..................................................      100
Chlorine-36................................................       10
Chlorine-38................................................    1,000
Chlorine-39................................................    1,000
Argon-39...................................................    1,000
Argon-41...................................................    1,000
Potassium-40...............................................      100
Potassium-42...............................................    1,000
Potassium-43...............................................    1,000
Potassium-44...............................................    1,000
Potassium-45...............................................    1,000
Calcium-41.................................................      100
Calcium-45.................................................      100
Calcium-47.................................................      100
Scandium-43................................................    1,000
Scandium-44m...............................................      100
Scandium-44................................................      100
Scandium-46................................................       10
Scandium-47................................................      100
Scandium-48................................................      100
Scandium-49................................................    1,000
Titanium-44................................................        1
Titanium-45................................................    1,000
Vanadium-47................................................    1,000
Vanadium-48................................................      100
Vanadium-49................................................    1,000
Chromium-48................................................    1,000
Chromium-49................................................    1,000
Chromium-51................................................    1,000
Manganese-51...............................................    1,000
Manganese-52m..............................................    1,000
Manganese-52...............................................      100
Manganese-53...............................................    1,000
Manganese-54...............................................      100
Manganese-56...............................................    1,000
Iron-52....................................................      100
Iron-55....................................................      100
Iron-59....................................................       10
Iron-60....................................................        1
Cobalt-55..................................................      100
Cobalt-56..................................................       10
Cobalt-57..................................................      100
Cobalt-58m.................................................    1,000
Cobalt-58..................................................      100
Cobalt-60m.................................................    1,000
Cobalt-60..................................................        1
Cobalt-61..................................................    1,000
Cobalt-62m.................................................    1,000
Nickel-56..................................................      100
Nickel-57..................................................      100
Nickel-59..................................................      100
Nickel-63..................................................      100
Nickel-65..................................................    1,000
Nickel-66..................................................       10
Copper-60..................................................    1,000
Copper-61..................................................    1,000
Copper-64..................................................    1,000
Copper-67..................................................    1,000
Zinc-62....................................................      100
Zinc-63....................................................    1,000
Zinc-65....................................................       10
Zinc-69m...................................................      100
Zinc-69....................................................    1,000
Zinc-71m...................................................    1,000
Zinc-72....................................................      100
Gallium-65.................................................    1,000
Gallium-66.................................................      100
Gallium-67.................................................    1,000
Gallium-68.................................................    1,000
Gallium-70.................................................    1,000
Gallium-72.................................................      100
Gallium-73.................................................    1,000
Germanium-66...............................................    1,000
Germanium-67...............................................    1,000
Germanium-68...............................................       10
Germanium-69...............................................    1,000
Germanium-71...............................................    1,000
Germanium-75...............................................    1,000
Germanium-77...............................................    1,000
Germanium-78...............................................    1,000
Arsenic-69.................................................    1,000
Arsenic-70.................................................    1,000
Arsenic-71.................................................      100
Arsenic-72.................................................      100
Arsenic-73.................................................      100
Arsenic-74.................................................      100
Arsenic-76.................................................      100
Arsenic-77.................................................      100
Arsenic-78.................................................    1,000
Selenium-70................................................    1,000
Selenium-73m...............................................    1,000
Selenium-73................................................      100
Selenium-75................................................      100
Selenium-79................................................      100
Selenium-81m...............................................    1,000
Selenium-81................................................    1,000
Selenium-83................................................    1,000
Bromine-74m................................................    1,000
Bromine-74.................................................    1,000
Bromine-75.................................................    1,000
Bromine-76.................................................      100
Bromine-77.................................................    1,000
Bromine-80m................................................    1,000
Bromine-80.................................................    1,000
Bromine-82.................................................      100
Bromine-83.................................................    1,000
Bromine-84.................................................    1,000
Krypton-74.................................................    1,000
Krypton-76.................................................    1,000
Krypton-77.................................................    1,000
Krypton-79.................................................    1,000
Krypton-81.................................................    1,000
Krypton-83m................................................    1,000
Krypton-85m................................................    1,000
Krypton-85.................................................    1,000
Krypton-87.................................................    1,000
Krypton-88.................................................    1,000
Rubidium-79................................................    1,000
Rubidium-81m...............................................    1,000
Rubidium-81................................................    1,000
Rubidium-82m...............................................    1,000
Rubidium-83................................................      100
Rubidium-84................................................      100
Rubidium-86................................................      100
Rubidium-87................................................      100
Rubidium-88................................................    1,000
Rubidium-89................................................    1,000
Strontium-80...............................................      100

[[Page 439]]

 
Strontium-81...............................................    1,000
Strontium-83...............................................      100
Strontium-85m..............................................    1,000
Strontium-85...............................................      100
Strontium-87m..............................................    1,000
Strontium-89...............................................       10
Strontium-90...............................................        0.1
Strontium-91...............................................      100
Strontium-92...............................................      100
Yttrium-86m................................................    1,000
Yttrium-86.................................................      100
Yttrium-87.................................................      100
Yttrium-88.................................................       10
Yttrium-90m................................................    1,000
Yttrium-90.................................................       10
Yttrium-91m................................................    1,000
Yttrium-91.................................................       10
Yttrium-92.................................................      100
Yttrium-93.................................................      100
Yttrium-94.................................................    1,000
Yttrium-95.................................................    1,000
Zirconium-86...............................................      100
Zirconium-88...............................................       10
Zirconium-89...............................................      100
Zirconium-93...............................................        1
Zirconium-95...............................................       10
Zirconium-97...............................................      100
Niobium-88.................................................    1,000
Niobium-89m (66 min).......................................    1,000
Niobium-89 (122 min).......................................    1,000
Niobium-90.................................................      100
Niobium-93m................................................       10
Niobium-94.................................................        1
Niobium-95m................................................      100
Niobium-95.................................................      100
Niobium-96.................................................      100
Niobium-97.................................................    1,000
Niobium-98.................................................    1,000
Molybdenum-90..............................................      100
Molybdenum-93m.............................................      100
Molybdenum-93..............................................       10
Molybdenum-99..............................................      100
Molybdenum-101.............................................    1,000
Technetium-93m.............................................    1,000
Technetium-93..............................................    1,000
Technetium-94m.............................................    1,000
Technetium-94..............................................    1,000
Technetium-96m.............................................    1,000
Technetium-96..............................................      100
Technetium-97m.............................................      100
Technetium-97..............................................    1,000
Technetium-98..............................................       10
Technetium-99m.............................................    1,000
Technetium-99..............................................      100
Technetium-101.............................................    1,000
Technetium-104.............................................    1,000
Ruthenium-94...............................................    1,000
Ruthenium-97...............................................    1,000
Ruthenium-103..............................................      100
Ruthenium-105..............................................    1,000
Ruthenium-106..............................................        1
Rhodium-99m................................................    1,000
Rhodium-99.................................................      100
Rhodium-100................................................      100
Rhodium-101m...............................................    1,000
Rhodium-101................................................       10
Rhodium-102m...............................................       10
Rhodium-102................................................       10
Rhodium-103m...............................................    1,000
Rhodium-105................................................      100
Rhodium-106m...............................................    1,000
Rhodium-107................................................    1,000
Palladium-100..............................................      100
Palladium-101..............................................    1,000
Palladium-103..............................................      100
Palladium-107..............................................       10
Palladium-109..............................................      100
Silver-102.................................................    1,000
Silver-103.................................................    1,000
Silver-104m................................................    1,000
Silver-104.................................................    1,000
Silver-105.................................................      100
Silver-106m................................................      100
Silver-106.................................................    1,000
Silver-108m................................................        1
Silver-110m................................................       10
Silver-111.................................................      100
Silver-112.................................................      100
Silver-115.................................................    1,000
Cadmium-104................................................    1,000
Cadmium-107................................................    1,000
Cadmium-109................................................        1
Cadmium-113m...............................................        0.1
Cadmium-113................................................      100
Cadmium-115m...............................................       10
Cadmium-115................................................      100
Cadmium-117m...............................................    1,000
Cadmium-117................................................    1,000
Indium-109.................................................    1,000
Indium-110 (69.1min.)......................................    1,000
Indium-110.................................................
  (4.9h)...................................................    1,000
Indium-111.................................................      100
Indium-112.................................................    1,000
Indium-113m................................................    1,000
Indium-114m................................................       10
Indium-115m................................................    1,000
Indium-115.................................................      100
Indium-116m................................................    1,000
Indium-117m................................................    1,000
Indium-117.................................................    1,000
Indium-119m................................................    1,000
Tin-110....................................................      100
Tin-111....................................................    1,000
Tin-113....................................................      100
Tin-117m...................................................      100
Tin-119m...................................................      100
Tin-121m...................................................      100
Tin-121....................................................    1,000
Tin-123m...................................................    1,000
Tin-123....................................................       10
Tin-125....................................................       10
Tin-126....................................................       10
Tin-127....................................................    1,000
Tin-128....................................................    1,000
Antimony-115...............................................    1,000
Antimony-116m..............................................    1,000
Antimony-116...............................................    1,000
Antimony-117...............................................    1,000
Antimony-118m..............................................    1,000
Antimony-119...............................................    1,000
Antimony-120 (16min.)......................................    1,000
Antimony-120 (5.76d).......................................      100
Antimony-122...............................................      100
Antimony-124m..............................................    1,000
Antimony-124...............................................       10
Antimony-125...............................................      100
Antimony-126m..............................................    1,000
Antimony-126...............................................      100
Antimony-127...............................................      100
Antimony-128 (10.4min.)....................................    1,000
Antimony-128 (9.01h).......................................      100
Antimony-129...............................................      100
Antimony-130...............................................    1,000
Antimony-131...............................................    1,000
Tellurium-116..............................................    1,000

[[Page 440]]

 
Tellurium-121m.............................................       10
Tellurium-121..............................................      100
Tellurium-123m.............................................       10
Tellurium-123..............................................      100
Tellurium-125m.............................................       10
Tellurium-127m.............................................       10
Tellurium-127..............................................    1,000
Tellurium-129m.............................................       10
Tellurium-129..............................................    1,000
Tellurium-131m.............................................       10
Tellurium-131..............................................      100
Tellurium-132..............................................       10
Tellurium-133m.............................................      100
Tellurium-133..............................................    1,000
Tellurium-134..............................................    1,000
Iodine-120m................................................    1,000
Iodine-120.................................................      100
Iodine-121.................................................    1,000
Iodine-123.................................................      100
Iodine-124.................................................       10
Iodine-125.................................................        1
Iodine-126.................................................        1
Iodine-128.................................................    1,000
Iodine-129.................................................        1
Iodine-130.................................................       10
Iodine-131.................................................        1
Iodine-132m................................................      100
Iodine-132.................................................      100
Iodine-133.................................................       10
Iodine-134.................................................    1,000
Iodine-135.................................................      100
Xenon-120..................................................    1,000
Xenon-121..................................................    1,000
Xenon-122..................................................    1,000
Xenon-123..................................................    1,000
Xenon-125..................................................    1,000
Xenon-127..................................................    1,000
Xenon-129m.................................................    1,000
Xenon-131m.................................................    1,000
Xenon-133m.................................................    1,000
Xenon-133..................................................    1,000
Xenon-135m.................................................    1,000
Xenon-135..................................................    1,000
Xenon-138..................................................    1,000
Cesium-125.................................................    1,000
Cesium-127.................................................    1,000
Cesium-129.................................................    1,000
Cesium-130.................................................    1,000
Cesium-131.................................................    1,000
Cesium-132.................................................      100
Cesium-134m................................................    1,000
Cesium-134.................................................       10
Cesium-135m................................................    1,000
Cesium-135.................................................      100
Cesium-136.................................................       10
Cesium-137.................................................       10
Cesium-138.................................................    1,000
Barium-126.................................................    1,000
Barium-128.................................................      100
Barium-131m................................................    1,000
Barium-131.................................................      100
Barium-133m................................................      100
Barium-133.................................................      100
Barium-135m................................................      100
Barium-139.................................................    1,000
Barium-140.................................................      100
Barium-141.................................................    1,000
Barium-142.................................................    1,000
Lanthanum-131..............................................    1,000
Lanthanum-132..............................................      100
Lanthanum-135..............................................    1,000
Lanthanum-137..............................................       10
Lanthanum-138..............................................      100
Lanthanum-140..............................................      100
Lanthanum-141..............................................      100
Lanthanum-142..............................................    1,000
Lanthanum-143..............................................    1,000
Cerium-134.................................................      100
Cerium-135.................................................      100
Cerium-137m................................................      100
Cerium-137.................................................    1,000
Cerium-139.................................................      100
Cerium-141.................................................      100
Cerium-143.................................................      100
Cerium-144.................................................        1
Praseodymium-136...........................................    1,000
Praseodymium-137...........................................    1,000
Praseodymium-138m..........................................    1,000
Praseodymium-139...........................................    1,000
Praseodymium-142m..........................................    1,000
Praseodymium-142...........................................      100
Praseodymium-143...........................................      100
Praseodymium-144...........................................    1,000
Praseodymium-145...........................................      100
Praseodymium-147...........................................    1,000
Neodymium-136..............................................    1,000
Neodymium-138..............................................      100
Neodymium-139m.............................................    1,000
Neodymium-139..............................................    1,000
Neodymium-141..............................................    1,000
Neodymium-147..............................................      100
Neodymium-149..............................................    1,000
Neodymium-151..............................................    1,000
Promethium-141.............................................    1,000
Promethium-143.............................................      100
Promethium-144.............................................       10
Promethium-145.............................................       10
Promethium-146.............................................        1
Promethium-147.............................................       10
Promethium-148m............................................       10
Promethium-148.............................................       10
Promethium-149.............................................      100
Promethium-150.............................................    1,000
Promethium-151.............................................      100
Samarium-141m..............................................    1,000
Samarium-141...............................................    1,000
Samarium-142...............................................    1,000
Samarium-145...............................................      100
Samarium-146...............................................        1
Samarium-147...............................................      100
Samarium-151...............................................       10
Samarium-153...............................................      100
Samarium-155...............................................    1,000
Samarium-156...............................................    1,000
Europium-145...............................................      100
Europium-146...............................................      100
Europium-147...............................................      100
Europium-148...............................................       10
Europium-149...............................................      100
Europium-150 (12.62h)......................................      100
Europium-150 (34.2y).......................................        1
Europium-152m..............................................      100
Europium-152...............................................        1
Europium-154...............................................        1
Europium-155...............................................       10
Europium-156...............................................      100
Europium-157...............................................      100
Europium-158...............................................    1,000
Gadolinium-145.............................................    1,000
Gadolinium-146.............................................       10
Gadolinium-147.............................................      100
Gadolinium-148.............................................        0.001
Gadolinium-149.............................................      100
Gadolinium-151.............................................       10
Gadolinium-152.............................................      100
Gadolinium-153.............................................       10

[[Page 441]]

 
Gadolinium-159.............................................      100
Terbium-147................................................    1,000
Terbium-149................................................      100
Terbium-150................................................    1,000
Terbium-151................................................      100
Terbium-153................................................    1,000
Terbium-154................................................      100
Terbium-155................................................    1,000
Terbium-156m (5.0h)........................................    1,000
Terbium-156m (24.4h).......................................    1,000
Terbium-156................................................      100
Terbium-157................................................       10
Terbium-158................................................        1
Terbium-160................................................       10
Terbium-161................................................      100
Dysprosium-155.............................................    1,000
Dysprosium-157.............................................    1,000
Dysprosium-159.............................................      100
Dysprosium-165.............................................    1,000
Dysprosium-166.............................................      100
Holmium-155................................................    1,000
Holmium-157................................................    1,000
Holmium-159................................................    1,000
Holmium-161................................................    1,000
Holmium-162m...............................................    1,000
Holmium-162................................................    1,000
Holmium-164m...............................................    1,000
Holmium-164................................................    1,000
Holmium-166m...............................................        1
Holmium-166................................................      100
Holmium-167................................................    1,000
Erbium-161.................................................    1,000
Erbium-165.................................................    1,000
Erbium-169.................................................      100
Erbium-171.................................................      100
Erbium-172.................................................      100
Thulium-162................................................    1,000
Thulium-166................................................      100
Thulium-167................................................      100
Thulium-170................................................       10
Thulium-171................................................       10
Thulium-172................................................      100
Thulium-173................................................      100
Thulium-175................................................    1,000
Ytterbium-162..............................................    1,000
Ytterbium-166..............................................      100
Ytterbium-167..............................................    1,000
Ytterbium-169..............................................      100
Ytterbium-175..............................................      100
Ytterbium-177..............................................    1,000
Ytterbium-178..............................................    1,000
Lutetium-169...............................................      100
Lutetium-170...............................................      100
Lutetium-171...............................................      100
Lutetium-172...............................................      100
Lutetium-173...............................................       10
Lutetium-174m..............................................       10
Lutetium-174...............................................       10
Lutetium-176m..............................................    1,000
Lutetium-176...............................................      100
Lutetium-177m..............................................       10
Lutetium-177...............................................      100
Lutetium-178m..............................................    1,000
Lutetium-178...............................................    1,000
Lutetium-179...............................................    1,000
Hafnium-170................................................      100
Hafnium-172................................................        1
Hafnium-173................................................    1,000
Hafnium-175................................................      100
Hafnium-177m...............................................    1,000
Hafnium-178m...............................................        0.1
Hafnium-179m...............................................       10
Hafnium-180m...............................................    1,000
Hafnium-181................................................       10
Hafnium-182m...............................................    1,000
Hafnium-182................................................        0.1
Hafnium-183................................................    1,000
Hafnium-184................................................      100
Tantalum-172...............................................    1,000
Tantalum-173...............................................    1,000
Tantalum-174...............................................    1,000
Tantalum-175...............................................    1,000
Tantalum-176...............................................      100
Tantalum-177...............................................    1,000
Tantalum-178...............................................    1,000
Tantalum-179...............................................      100
Tantalum-180m..............................................    1,000
Tantalum-180...............................................      100
Tantalum-182m..............................................    1,000
Tantalum-182...............................................       10
Tantalum-183...............................................      100
Tantalum-184...............................................      100
Tantalum-185...............................................    1,000
Tantalum-186...............................................    1,000
Tungsten-176...............................................    1,000
Tungsten-177...............................................    1,000
Tungsten-178...............................................    1,000
Tungsten-179...............................................    1,000
Tungsten-181...............................................    1,000
Tungsten-185...............................................      100
Tungsten-187...............................................      100
Tungsten-188...............................................       10
Rhenium-177................................................    1,000
Rhenium-178................................................    1,000
Rhenium-181................................................    1,000
Rhenium-182 (12.7h)........................................    1,000
Rhenium-182 (64.0h)........................................      100
Rhenium-184m...............................................       10
Rhenium-184................................................      100
Rhenium-186m...............................................       10
Rhenium-186................................................      100
Rhenium-187................................................    1,000
Rhenium-188m...............................................    1,000
Rhenium-188................................................      100
Rhenium-189................................................      100
Osmium-180.................................................    1,000
Osmium-181.................................................    1,000
Osmium-182.................................................      100
Osmium-185.................................................      100
Osmium-189m................................................    1,000
Osmium-191m................................................    1,000
Osmium-191.................................................      100
Osmium-193.................................................      100
Osmium-194.................................................        1
Iridium-182................................................    1,000
Iridium-184................................................    1,000
Iridium-185................................................    1,000
Iridium-186................................................      100
Iridium-187................................................    1,000
Iridium-188................................................      100
Iridium-189................................................      100
Iridium-190m...............................................    1,000
Iridium-190................................................      100
Iridium-192 (73.8d)........................................        1
Iridium-192m (1.4min.).....................................       10
Iridium-194m...............................................       10
Iridium-194................................................      100
Iridium-195m...............................................    1,000
Iridium-195................................................    1,000
Platinum-186...............................................    1,000
Platinum-188...............................................      100
Platinum-189...............................................    1,000
Platinum-191...............................................      100
Platinum-193m..............................................      100
Platinum-193...............................................    1,000
Platinum-195m..............................................      100

[[Page 442]]

 
Platinum-197m..............................................    1,000
Platinum-197...............................................      100
Platinum-199...............................................    1,000
Platinum-200...............................................      100
Gold-193...................................................    1,000
Gold-194...................................................      100
Gold-195...................................................       10
Gold-198m..................................................      100
Gold-198...................................................      100
Gold-199...................................................      100
Gold-200m..................................................      100
Gold-200...................................................    1,000
Gold-201...................................................    1,000
Mercury-193m...............................................      100
Mercury-193................................................    1,000
Mercury-194................................................        1
Mercury-195m...............................................      100
Mercury-195................................................    1,000
Mercury-197m...............................................      100
Mercury-197................................................    1,000
Mercury-199m...............................................    1,000
Mercury-203................................................      100
Thallium-194m..............................................    1,000
Thallium-194...............................................    1,000
Thallium-195...............................................    1,000
Thallium-197...............................................    1,000
Thallium-198m..............................................    1,000
Thallium-198...............................................    1,000
Thallium-199...............................................    1,000
Thallium-200...............................................    1,000
Thallium-201...............................................    1,000
Thallium-202...............................................      100
Thallium-204...............................................      100
Lead-195m..................................................    1,000
Lead-198...................................................    1,000
Lead-199...................................................    1,000
Lead-200...................................................      100
Lead-201...................................................    1,000
Lead-202m..................................................    1,000
Lead-202...................................................       10
Lead-203...................................................    1,000
Lead-205...................................................      100
Lead-209...................................................    1,000
Lead-210...................................................        0.01
Lead-211...................................................      100
Lead-212...................................................        1
Lead-214...................................................      100
Bismuth-200................................................    1,000
Bismuth-201................................................    1,000
Bismuth-202................................................    1,000
Bismuth-203................................................      100
Bismuth-205................................................      100
Bismuth-206................................................      100
Bismuth-207................................................       10
Bismuth-210m...............................................        0.1
Bismuth-210................................................        1
Bismuth-212................................................       10
Bismuth-213................................................       10
Bismuth-214................................................      100
Polonium-203...............................................    1,000
Polonium-205...............................................    1,000
Polonium-207...............................................    1,000
Polonium-210...............................................        0.1
Astatine-207...............................................      100
Astatine-211...............................................       10
Radon-220..................................................        1
Radon-222..................................................        1
Francium-222...............................................      100
Francium-223...............................................      100
Radium-223.................................................        0.1
Radium-224.................................................        0.1
Radium-225.................................................        0.1
Radium-226.................................................        0.1
Radium-227.................................................    1,000
Radium-228.................................................        0.1
Actinium-224...............................................        1
Actinium-225...............................................        0.01
Actinium-226...............................................        0.1
Actinium-227...............................................        0.001
Actinium-228...............................................        1
Thorium-226................................................       10
Thorium-227................................................        0.01
Thorium-228................................................        0.001
Thorium-229................................................        0.001
Thorium-230................................................        0.001
Thorium-231................................................      100
Thorium-232................................................      100
Thorium-234................................................       10
Thorium-natural............................................      100
Protactinium-227...........................................       10
Protactinium-228...........................................        1
Protactinium-230...........................................        0.1
Protactinium-231...........................................        0.001
Protactinium-232...........................................        1
Protactinium-233...........................................      100
Protactinium-234...........................................      100
Uranium-230................................................        0.01
Uranium-231................................................      100
Uranium-232................................................        0.001
Uranium-233................................................        0.001
Uranium-234................................................        0.001
Uranium-235................................................        0.001
Uranium-236................................................        0.001
Uranium-237................................................      100
Uranium-238................................................      100
Uranium-239................................................    1,000
Uranium-240................................................      100
Uranium-natural............................................      100
Neptunium-232..............................................      100
Neptunium-233..............................................    1,000
Neptunium-234..............................................      100
Neptunium-235..............................................      100
Neptunium-236 (1.15 x 10\5\ y).............................        0.001
Neptunium-236 (22.5h)......................................        1
Neptunium-237..............................................        0.001
Neptunium-238..............................................       10
Neptunium-239..............................................      100
Neptunium-240..............................................    1,000
Plutonium-234..............................................       10
Plutonium-235..............................................    1,000
Plutonium-236..............................................        0.001
Plutonium-237..............................................      100
Plutonium-238..............................................        0.001
Plutonium-239..............................................        0.001
Plutonium-240..............................................        0.001
Plutonium-241..............................................        0.01
Plutonium-242..............................................        0.001
Plutonium-243..............................................    1,000
Plutonium-244..............................................        0.001
Plutonium-245..............................................      100
Americium-237..............................................    1,000
Americium-238..............................................      100
Americium-239..............................................    1,000
Americium-240..............................................      100
Americium-241..............................................        0.001
Americium-242m.............................................        0.001
Americium-242..............................................       10
Americium-243..............................................        0.001
Americium-244m.............................................      100
Americium-244..............................................       10
Americium-245..............................................    1,000
Americium-246m.............................................    1,000
Americium-246..............................................    1,000
Curium-238.................................................      100
Curium-240.................................................        0.1
Curium-241.................................................        1

[[Page 443]]

 
Curium-242.................................................        0.01
Curium-243.................................................        0.001
Curium-244.................................................        0.001
Curium-245.................................................        0.001
Curium-246.................................................        0.001
Curium-247.................................................        0.001
Curium-248.................................................        0.001
Curium-249.................................................    1,000
Berkelium-245..............................................      100
Berkelium-246..............................................      100
Berkelium-247..............................................        0.001
Berkelium-249..............................................        0.1
Berkelium-250..............................................       10
Californium-244............................................      100
Californium-246............................................        1
Californium-248............................................        0.01
Californium-249............................................        0.001
Californium-250............................................        0.001
Californium-251............................................        0.001
Californium-252............................................        0.001
Californium-253............................................        0.1
Californium-254............................................        0.001
Any alpha emitting radionuclide not listed above or                0.001
 mixtures of alpha emitters of unknown composition.........
Einsteinium-250............................................      100
Einsteinium-251............................................      100
Einsteinium-253............................................        0.1
Einsteinium-254m...........................................        1
Einsteinium-254............................................        0.01
Fermium-252................................................        1
Fermium-253................................................        1
Fermium-254................................................       10
Fermium-255................................................        1
Fermium-257................................................        0.01
Mendelevium-257............................................       10
Mendelevium-258............................................        0.01
Any radionuclide other than alpha emitting radionuclides           0.01
 not listed above, or mixtures of beta emitters of unknown
 composition...............................................
------------------------------------------------------------------------
\1\ The quantities listed above were derived by taking \1/10\th of the
  most restrictive ALI listed in table 1, columns 1 and 2, of appendix B
  to Sec.Sec. 20.1001-20.2401 of this part, rounding to the nearest
  factor of 10, and arbitrarily constraining the values listed between
  0.001 and 1,000 [micro]Ci. Values of 100 [micro]Ci have been assigned
  for radionuclides having a radioactive half-life in excess of 10\9\
  years (except rhenium, 1000 [micro]Ci) to take into account their low
  specific activity.
Note: For purposes of Sec.Sec. 20.1902(e), 20.1905(a), and
  20.2201(a) where there is involved a combination of radionuclides in
  known amounts, the limit for the combination should be derived as
  follows: determine, for each radionuclide in the combination, the
  ratio between the quantity present in the combination and the limit
  otherwise established for the specific radionuclide when not in
  combination. The sum of such ratios for all radionuclides in the
  combination may not exceed ``1'' (i.e., ``unity'').


[56 FR 23465, May 21, 1991; 56 FR 61352, Dec. 3, 1991. Redesignated and 
amended at 58 FR 67659, Dec. 22, 1993; 60 FR 20186, Apr. 25, 1995]

   Appendix D to Part 20--United States Nuclear Regulatory Commission 
                            Regional Offices

----------------------------------------------------------------------------------------------------------------
                                               Address            Telephone (24 hour)             E-Mail
----------------------------------------------------------------------------------------------------------------
NRC Headquarters Operations Center...  USNRC, Division of       (301) 816-5100           [email protected]
                                        Incident Response       (301) 951-0550.........
                                        Operations,             (301) 816-5151 (fax)...
                                        Washington, DC 20555-
                                        0001.
Region I: Connecticut, Delaware,       USNRC, Region I, 2100    (610) 337-5000, (800)    RidsRgn1MailCenter@nrc.
 District of Columbia, Maine,           Renaissance Boulevard,   432-1156 TDD: (301)      gov
 Maryland, Massachusetts, New           Suite 100, King of       415-5575.
 Hampshire, New Jersey, New York,       Prussia, PA 19406-2713.
 Pennsylvania, Rhode Island, and
 Vermont.
Region II: Alabama, Florida, Georgia,  USNRC, Region II, 245    (404) 997-4000           RidsRgn2MailCenter@nrc.
 Kentucky, North Carolina, Puerto       Peachtree Center        (800) 877-8510.........   gov
 Rico, South Carolina, Tennessee,       Avenue, NE., Suite      TDD: (301) 415-5575....
 Virginia, Virgin Islands, and West     1200, Atlanta, GA
 Virginia.                              30303-1257..
Region III: Illinois, Indiana, Iowa,   USNRC, Region III, 2443  (630) 829-9500           RidsRgn3MailCenter@nrc.
 Michigan, Minnesota, Missouri, Ohio    Warrenville Road,       (800) 522-3025.........   gov
 and Wisconsin.                         Suite 210, Lisle, IL    TDD: (301) 415-5575....
                                        60532-4352.
Region IV: Alaska, Arizona, Arkansas,  US NRC, Region IV, 1600  (817) 860-8100           RidsRgn4MailCenter@nrc.
 California, Colorado, Hawaii, Idaho,   E. Lamar Blvd.,         (800) 952-9677.........   gov
 Kansas, Louisiana, Mississippi,        Arlington, TX 76011-    TDD: (301) 415-5575....
 Montana, Nebraska, Nevada, New         4511..
 Mexico, North Dakota, Oklahoma,
 Oregon, South Dakota, Texas, Utah,
 Washington, Wyoming, and the U.S.
 territories and possessions in the
 Pacific.
----------------------------------------------------------------------------------------------------------------


[68 FR 58802, Oct. 10, 2003, as amended at 71 FR 15007, Mar. 27, 2006; 
73 FR 30457, May 28, 2008; 75 FR 21980, Apr. 27, 2010; 76 FR 72084, Nov. 
22, 2011; 77 FR 39905, July 6, 2012; 79 FR 66602, Nov. 10, 2014]

[[Page 444]]



    Sec. Appendix E to Part 20-- Nationally Tracked Source Thresholds

    The Terabecquerel (TBq) values are the regulatory standard. The 
curie (Ci) values specified are obtained by converting from the TBq 
value. The curie values are provided for practical usefulness only and 
are rounded after conversion.

----------------------------------------------------------------------------------------------------------------
                                                    Category 1      Category 1      Category 2      Category 2
              Radioactive material                     (TBq)           (Ci)            (TBq)           (Ci)
----------------------------------------------------------------------------------------------------------------
Actinium-227....................................              20             540            0.2             5.4
Americium-241...................................              60           1,600            0.6            16
Americium-241/Be................................              60           1,600            0.6            16
Californium-252.................................              20             540            0.2             5.4
Cobalt-60.......................................              30             810            0.3             8.1
Curium-244......................................              50           1,400            0.5            14
Cesium-137......................................             100           2,700            1              27
Gadolinium-153..................................           1,000          27,000           10             270
Iridium-192.....................................              80           2,200            0.8            22
Plutonium-238...................................              60           1,600            0.6            16
Plutonium-239/Be................................              60           1,600            0.6            16
Polonium-210....................................              60           1,600            0.6            16
Promethium-147..................................          40,000       1,100,000          400          11,000
Radium-226......................................              40           1,100            0.4            11
Selenium-75.....................................             200           5,400            2              54
Strontium-90....................................           1,000          27,000           10             270
Thorium-228.....................................              20             540            0.2             5.4
Thorium-229.....................................              20             540            0.2             5.4
Thulium-170.....................................          20,000         540,000          200           5,400
Ytterbium-169...................................             300           8,100            3              81
----------------------------------------------------------------------------------------------------------------


[71 FR 65708, Nov. 8, 2006]



                  Sec. Appendix F to Part 20 [Reserved]



  Sec. Appendix G to Part 20--Requirements for Transfers of Low-Level 
   Radioactive Waste Intended for Disposal at Licensed Land Disposal 
                        Facilities and Manifests

                               I. Manifest

    A waste generator, collector, or processor who transports, or offers 
for transportation, low-level radioactive waste intended for ultimate 
disposal at a licensed low-level radioactive waste land disposal 
facility must prepare a Manifest (OMB Control Numbers 3150-0164, -0165, 
and -0166) reflecting information requested on applicable NRC Forms 540 
(Uniform Low-Level Radioactive Waste Manifest (Shipping Paper)) and 541 
(Uniform Low-Level Radioactive Waste Manifest (Container and Waste 
Description)) and, if necessary, on an applicable NRC Form 542 (Uniform 
Low-Level Radioactive Waste Manifest (Manifest Index and Regional 
Compact Tabulation)). NRC Forms 540 and 540A must be completed and must 
physically accompany the pertinent low-level waste shipment. Upon 
agreement between shipper and consignee, NRC Forms 541 and 541A and 542 
and 542A may be completed, transmitted, and stored in electronic media 
with the capability for producing legible, accurate, and complete 
records on the respective forms. Licensees are not required by NRC to 
comply with the manifesting requirements of this part when they ship:
    (a) LLW for processing and expect its return (i.e., for storage 
under their license) prior to disposal at a licensed land disposal 
facility;
    (b) LLW that is being returned to the licensee who is the ``waste 
generator'' or ``generator,'' as defined in this part; or
    (c) Radioactively contaminated material to a ``waste processor'' 
that becomes the processor's ``residual waste.''
    For guidance in completing these forms, refer to the instructions 
that accompany the forms. Copies of manifests required by this appendix 
may be legible carbon copies, photocopies, or computer printouts that 
reproduce the data in the format of the uniform manifest.
    NRC Forms 540, 540A, 541, 541A, 542 and 542A, and the accompanying 
instructions, in hard copy, may be obtained by writing or calling the 
Office of the Chief Information Officer, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, telephone (301) 415-7232, or by 
visiting the NRC's Web site at http://www.nrc.gov and selecting forms 
from the index found on the home page.
    This appendix includes information requirements of the Department of 
Transportation, as codified in 49 CFR part 172. Information on 
hazardous, medical, or other waste, required to meet Environmental 
Protection Agency regulations, as codified in 40 CFR parts 259, 261 or 
elsewhere, is not addressed in this section, and must be provided

[[Page 445]]

on the required EPA forms. However, the required EPA forms must 
accompany the Uniform Low-Level Radioactive Waste Manifest required by 
this chapter.
    As used in this appendix, the following definitions apply:
    Chelating agent has the same meaning as that given in Sec.61.2 of 
this chapter.
    Chemical description means a description of the principal chemical 
characteristics of a low-level radioactive waste.
    Computer-readable medium means that the regulatory agency's computer 
can transfer the information from the medium into its memory.
    Consignee means the designated receiver of the shipment of low-level 
radioactive waste.
    Decontamination facility means a facility operating under a 
Commission or Agreement State license whose principal purpose is 
decontamination of equipment or materials to accomplish recycle, reuse, 
or other waste management objectives, and, for purposes of this part, is 
not considered to be a consignee for LLW shipments.
    Disposal container means a container principally used to confine 
low-level radioactive waste during disposal operations at a land 
disposal facility (also see ``high integrity container''). Note that for 
some shipments, the disposal container may be the transport package.
    EPA identification number means the number received by a transporter 
following application to the Administrator of EPA as required by 40 CFR 
part 263.
    Generator means a licensee operating under a Commission or Agreement 
State license who (1) is a waste generator as defined in this part, or 
(2) is the licensee to whom waste can be attributed within the context 
of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (e.g., 
waste generated as a result of decontamination or recycle activities).
    High integrity container (HIC) means a container commonly designed 
to meet the structural stability requirements of Sec.61.56 of this 
chapter, and to meet Department of Transportation requirements for a 
Type A package.
    Land disposal facility has the same meaning as that given in Sec.
61.2 of this chapter.
    NRC Forms 540, 540A, 541, 541A, 542, and 542A are official NRC Forms 
referenced in this appendix. Licensees need not use originals of these 
NRC Forms as long as any substitute forms are equivalent to the original 
documentation in respect to content, clarity, size, and location of 
information. Upon agreement between the shipper and consignee, NRC Forms 
541 (and 541A) and NRC Forms 542 (and 542A) may be completed, 
transmitted, and stored in electronic media. The electronic media must 
have the capability for producing legible, accurate, and complete 
records in the format of the uniform manifest.
    Package means the assembly of components necessary to ensure 
compliance with the packaging requirements of DOT regulations, together 
with its radioactive contents, as presented for transport.
    Physical description means the items called for on NRC Form 541 to 
describe a low-level radioactive waste.
    Residual waste means low-level radioactive waste resulting from 
processing or decontamination activities that cannot be easily separated 
into distinct batches attributable to specific waste generators. This 
waste is attributable to the processor or decontamination facility, as 
applicable.
    Shipper means the licensed entity (i.e., the waste generator, waste 
collector, or waste processor) who offers low-level radioactive waste 
for transportation, typically consigning this type of waste to a 
licensed waste collector, waste processor, or land disposal facility 
operator.
    Shipping paper means NRC Form 540 and, if required, NRC Form 540A 
which includes the information required by DOT in 49 CFR part 172.
    Source material has the same meaning as that given in Sec.40.4 of 
this chapter.
    Special nuclear material has the same meaning as that given in Sec.
70.4 of this chapter.
    Uniform Low-Level Radioactive Waste Manifest or uniform manifest 
means the combination of NRC Forms 540, 541, and, if necessary, 542, and 
their respective continuation sheets as needed, or equivalent.
    Waste collector means an entity, operating under a Commission or 
Agreement State license, whose principal purpose is to collect and 
consolidate waste generated by others, and to transfer this waste, 
without processing or repackaging the collected waste, to another 
licensed waste collector, licensed waste processor, or licensed land 
disposal facility.
    Waste description means the physical, chemical and radiological 
description of a low-level radioactive waste as called for on NRC Form 
541.
    Waste generator means an entity, operating under a Commission or 
Agreement State license, who (1) possesses any material or component 
that contains radioactivity or is radioactively contaminated for which 
the licensee foresees no further use, and (2) transfers this material or 
component to a licensed land disposal facility or to a licensed waste 
collector or processor for handling or treatment prior to disposal. A 
licensee performing processing or decontamination services may be a 
``waste generator'' if the transfer of low-level radioactive waste from 
its facility is defined as ``residual waste.''
    Waste processor means an entity, operating under a Commission or 
Agreement State license, whose principal purpose is to process,

[[Page 446]]

repackage, or otherwise treat low-level radioactive material or waste 
generated by others prior to eventual transfer of waste to a licensed 
low-level radioactive waste land disposal facility.
    Waste type means a waste within a disposal container having a unique 
physical description (i.e., a specific waste descriptor code or 
description; or a waste sorbed on or solidified in a specifically 
defined media).

                        Information Requirements

                         A. General Information

    The shipper of the radioactive waste, shall provide the following 
information on the uniform manifest:
    1. The name, facility address, and telephone number of the licensee 
shipping the waste;
    2. An explicit declaration indicating whether the shipper is acting 
as a waste generator, collector, processor, or a combination of these 
identifiers for purposes of the manifested shipment; and
    3. The name, address, and telephone number, or the name and EPA 
identification number for the carrier transporting the waste.

                         B. Shipment Information

    The shipper of the radioactive waste shall provide the following 
information regarding the waste shipment on the uniform manifest:
    1. The date of the waste shipment;
    2. The total number of packages/disposal containers;
    3. The total disposal volume and disposal weight in the shipment;
    4. The total radionuclide activity in the shipment;
    5. The activity of each of the radionuclides H-3, C-14, Tc-99, and 
I-129 contained in the shipment; and
    6. The total masses of U-233, U-235, and plutonium in special 
nuclear material, and the total mass of uranium and thorium in source 
material.

               C. Disposal Container and Waste Information

    The shipper of the radioactive waste shall provide the following 
information on the uniform manifest regarding the waste and each 
disposal container of waste in the shipment:
    1. An alphabetic or numeric identification that uniquely identifies 
each disposal container in the shipment;
    2. A physical description of the disposal container, including the 
manufacturer and model of any high integrity container;
    3. The volume displaced by the disposal container;
    4. The gross weight of the disposal container, including the waste;
    5. For waste consigned to a disposal facility, the maximum radiation 
level at the surface of each disposal container;
    6. A physical and chemical description of the waste;
    7. The total weight percentage of chelating agent for any waste 
containing more than 0.1% chelating agent by weight, plus the identity 
of the principal chelating agent;
    8. The approximate volume of waste within a container;
    9. The sorbing or solidification media, if any, and the identity of 
the solidification media vendor and brand name;
    10. The identities and activities of individual radionuclides 
contained in each container, the masses of U-233, U-235, and plutonium 
in special nuclear material, and the masses of uranium and thorium in 
source material. For discrete waste types (i.e., activated materials, 
contaminated equipment, mechanical filters, sealed source/devices, and 
wastes in solidification/stabilization media), the identities and 
activities of individual radionuclides associated with or contained on 
these waste types within a disposal container shall be reported;
    11. The total radioactivity within each container; and
    12. For wastes consigned to a disposal facility, the classification 
of the waste pursuant to Sec.61.55 of this chapter. Waste not meeting 
the structural stability requirements of Sec.61.56(b) of this chapter 
must be identified.

                  D. Uncontainerized Waste Information

    The shipper of the radioactive waste shall provide the following 
information on the uniform manifest regarding a waste shipment delivered 
without a disposal container:
    1. The approximate volume and weight of the waste;
    2. A physical and chemical description of the waste;
    3. The total weight percentage of chelating agent if the chelating 
agent exceeds 0.1% by weight, plus the identity of the principal 
chelating agent;
    4. For waste consigned to a disposal facility, the classification of 
the waste pursuant to Sec.61.55 of this chapter. Waste not meeting the 
structural stability requirements of Sec.61.56(b) of this chapter must 
be identified;
    5. The identities and activities of individual radionuclides 
contained in the waste, the masses of U-233, U-235, and plutonium in 
special nuclear material, and the masses of uranium and thorium in 
source material; and
    6. For wastes consigned to a disposal facility, the maximum 
radiation levels at the surface of the waste.

[[Page 447]]

            E. Multi-Generator Disposal Container Information

    This section applies to disposal containers enclosing mixtures of 
waste originating from different generators. (Note: The origin of the 
LLW resulting from a processor's activities may be attributable to one 
or more ``generators'' (including ``waste generators'') as defined in 
this part). It also applies to mixtures of wastes shipped in an 
uncontainerized form, for which portions of the mixture within the 
shipment originate from different generators.
    1. For homogeneous mixtures of waste, such as incinerator ash, 
provide the waste description applicable to the mixture and the volume 
of the waste attributed to each generator.
    2. For heterogeneous mixtures of waste, such as the combined 
products from a large compactor, identify each generator contributing 
waste to the disposal container, and, for discrete waste types (i.e., 
activated materials, contaminated equipment, mechanical filters, sealed 
source/devices, and wastes in solidification/stabilization media), the 
identities and activities of individual radionuclides contained on these 
waste types within the disposal container. For each generator, provide 
the following:
    (a) The volume of waste within the disposal container;
    (b) A physical and chemical description of the waste, including the 
solidification agent, if any;
    (c) The total weight percentage of chelating agents for any disposal 
container containing more than 0.1% chelating agent by weight, plus the 
identity of the principal chelating agent;
    (d) The sorbing or solidification media, if any, and the identity of 
the solidification media vendor and brand name if the media is claimed 
to meet stability requirements in 10 CFR 61.56(b); and
    (e) Radionuclide identities and activities contained in the waste, 
the masses of U-233, U-235, and plutonium in special nuclear material, 
and the masses of uranium and thorium in source material if contained in 
the waste.

                            II. Certification

    An authorized representative of the waste generator, processor, or 
collector shall certify by signing and dating the shipment manifest that 
the transported materials are properly classified, described, packaged, 
marked, and labeled and are in proper condition for transportation 
according to the applicable regulations of the Department of 
Transportation and the Commission. A collector in signing the 
certification is certifying that nothing has been done to the collected 
waste which would invalidate the waste generator's certification.

                        III. Control and Tracking

    A. Any licensee who transfers radioactive waste to a land disposal 
facility or a licensed waste collector shall comply with the 
requirements in paragraphs A.1 through 9 of this section. Any licensee 
who transfers waste to a licensed waste processor for waste treatment or 
repackaging shall comply with the requirements of paragraphs A.4 through 
9 of this section. A licensee shall:
    1. Prepare all wastes so that the waste is classified according to 
Sec.61.55 and meets the waste characteristics requirements in Sec.
61.56 of this chapter;
    2. Label each disposal container (or transport package if potential 
radiation hazards preclude labeling of the individual disposal 
container) of waste to identify whether it is Class A waste, Class B 
waste, Class C waste, or greater then Class C waste, in accordance with 
Sec.61.55 of this chapter;
    3. Conduct a quality assurance program to assure compliance with 
Sec. Sec.61.55 and 61.56 of this chapter (the program must include 
management evaluation of audits);
    4. Prepare the NRC Uniform Low-Level Radioactive Waste Manifest as 
required by this appendix;
    5. Forward a copy or electronically transfer the Uniform Low-Level 
Radioactive Waste Manifest to the intended consignee so that either (i) 
receipt of the manifest precedes the LLW shipment or (ii) the manifest 
is delivered to the consignee with the waste at the time the waste is 
transferred to the consignee. Using both (i) and (ii) is also 
acceptable;
    6. Include NRC Form 540 (and NRC Form 540A, if required) with the 
shipment regardless of the option chosen in paragraph A.5 of this 
section;
    7. Receive acknowledgement of the receipt of the shipment in the 
form of a signed copy of NRC Form 540;
    8. Retain a copy of or electronically store the Uniform Low-Level 
Radioactive Waste Manifest and documentation of acknowledgement of 
receipt as the record of transfer of licensed material as required by 10 
CFR parts 30, 40, and 70 of this chapter; and
    9. For any shipments or any part of a shipment for which 
acknowledgement of receipt has not been received within the times set 
forth in this appendix, conduct an investigation in accordance with 
paragraph E of this appendix.
    B. Any waste collector licensee who handles only prepackaged waste 
shall:
    1. Acknowledge receipt of the waste from the shipper within one week 
of receipt by returning a signed copy of NRC Form 540;
    2. Prepare a new manifest to reflect consolidated shipments that 
meet the requirements of this appendix. The waste collector shall ensure 
that, for each container of waste

[[Page 448]]

in the shipment, the manifest identifies the generator of that container 
of waste;
    3. Forward a copy or electronically transfer the Uniform Low-Level 
Radioactive Waste Manifest to the intended consignee so that either: (i) 
Receipt of the manifest precedes the LLW shipment or (ii) the manifest 
is delivered to the consignee with the waste at the time the waste is 
transferred to the consignee. Using both (i) and (ii) is also 
acceptable;
    4. Include NRC Form 540 (and NRC Form 540A, if required) with the 
shipment regardless of the option chosen in paragraph B.3 of this 
section;
    5. Receive acknowledgement of the receipt of the shipment in the 
form of a signed copy of NRC Form 540;
    6. Retain a copy of or electronically store the Uniform Low-Level 
Radioactive Waste Manifest and documentation of acknowledgement of 
receipt as the record of transfer of licensed material as required by 10 
CFR parts 30, 40, and 70 of this chapter;
    7. For any shipments or any part of a shipment for which 
acknowledgement of receipt has not been received within the times set 
forth in this appendix, conduct an investigation in accordance with 
paragraph E of this appendix; and
    8. Notify the shipper and the Administrator of the nearest 
Commission Regional Office listed in appendix D of this part when any 
shipment, or part of a shipment, has not arrived within 60 days after 
receipt of an advance manifest, unless notified by the shipper that the 
shipment has been cancelled.
    C. Any licensed waste processor who treats or repackages waste 
shall:
    1. Acknowledge receipt of the waste from the shipper within one week 
of receipt by returning a signed copy of NRC Form 540;
    2. Prepare a new manifest that meets the requirements of this 
appendix. Preparation of the new manifest reflects that the processor is 
responsible for meeting these requirements. For each container of waste 
in the shipment, the manifest shall identify the waste generators, the 
preprocessed waste volume, and the other information as required in 
paragraph I.E. of this appendix;
    3. Prepare all wastes so that the waste is classified according to 
Sec.61.55 of this chapter and meets the waste characteristics 
requirements in Sec.61.56 of this chapter;
    4. Label each package of waste to identify whether it is Class A 
waste, Class B waste, or Class C waste, in accordance with Sec. Sec.
61.55 and 61.57 of this chapter;
    5. Conduct a quality assurance program to assure compliance with 
Sec. Sec.61.55 and 61.56 of this chapter (the program shall include 
management evaluation of audits);
    6. Forward a copy or electronically transfer the Uniform Low-Level 
Radioactive Waste Manifest to the intended consignee so that either: (i) 
Receipt of the manifest precedes the LLW shipment or (ii) the manifest 
is delivered to the consignee with the waste at the time the waste is 
transferred to the consignee. Using both (i) and (ii) is also 
acceptable;
    7. Include NRC Form 540 (and NRC Form 540A, if required) with the 
shipment regardless of the option chosen in paragraph C.6 of this 
section;
    8. Receive acknowledgement of the receipt of the shipment in the 
form of a signed copy of NRC Form 540;
    9. Retain a copy of or electronically store the Uniform Low-Level 
Radioactive Waste Manifest and documentation of acknowledgement of 
receipt as the record of transfer of licensed material as required by 10 
CFR parts 30, 40, and 70 of this chapter;
    10. For any shipment or any part of a shipment for which 
acknowledgement of receipt has not been received within the times set 
forth in this appendix, conduct an investigation in accordance with 
paragraph E of this appendix; and
    11. Notify the shipper and the Administrator of the nearest 
Commission Regional Office listed in appendix D of this part when any 
shipment, or part of a shipment, has not arrived within 60 days after 
receipt of an advance manifest, unless notified by the shipper that the 
shipment has been cancelled.
    D. The land disposal facility operator shall:
    1. Acknowledge receipt of the waste within one week of receipt by 
returning, as a minimum, a signed copy of NRC Form 540 to the shipper. 
The shipper to be notified is the licensee who last possessed the waste 
and transferred the waste to the operator. If any discrepancy exists 
between materials listed on the Uniform Low-Level Radioactive Waste 
Manifest and materials received, copies or electronic transfer of the 
affected forms must be returned indicating the discrepancy;
    2. Maintain copies of all completed manifests and electronically 
store the information required by 10 CFR 61.80(l) until the Commission 
terminates the license; and
    3. Notify the shipper and the Administrator of the nearest 
Commission Regional Office listed in appendix D of this part when any 
shipment, or part of a shipment, has not arrived within 60 days after 
receipt of an advance manifest, unless notified by the shipper that the 
shipment has been cancelled.
    E. Any shipment or part of a shipment for which acknowledgement is 
not received within the times set forth in this section must:
    1. Be investigated by the shipper if the shipper has not received 
notification or receipt within 20 days after transfer; and
    2. Be traced and reported. The investigation shall include tracing 
the shipment and filing a report with the nearest Commission Regional 
Office listed in appendix D to this

[[Page 449]]

part. Each licensee who conducts a trace investigation shall file a 
written report with the appropriate NRC Regional Office within 2 weeks 
of completion of the investigation.

[60 FR 15664, Mar. 27, 1995, as amended at 60 FR 25983, May 16, 1995; 68 
FR 58802, Oct. 10, 2003; 73 FR 30457, May 28, 2008; 80 FR 74979, Dec. 1, 
2015]



PART 21_REPORTING OF DEFECTS AND NONCOMPLIANCE--Table of Contents



                           General Provisions

Sec.
21.1 Purpose.
21.2 Scope.
21.3 Definitions.
21.4 Interpretations.
21.5 Communications.
21.6 Posting requirements.
21.7 Exemptions.
21.8 Information collection requirements: OMB approval.

                              Notification

21.21 Notification of failure to comply or existence of a defect and its 
          evaluation.

                          Procurement Documents

21.31 Procurement documents.

                          Inspections, Records

21.41 Inspections.
21.51 Maintenance and inspection of records.

                               Enforcement

21.61 Failure to notify.
21.62 Criminal penalties.

    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.

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

                           General Provisions



Sec.21.1  Purpose.

    The regulations in this part establish procedures and requirements 
for implementation of section 206 of the Energy Reorganization Act of 
1974. That section requires any individual director or responsible 
officer of a firm constructing, owning, operating or supplying the 
components of any facility or activity which is licensed or otherwise 
regulated pursuant to the Atomic Energy Act of 1954, as amended, or the 
Energy Reorganization Act of 1974, who obtains information reasonably 
indicating: (a) That the facility, activity or basic component supplied 
to such facility or activity fails to comply with the Atomic Energy Act 
of 1954, as amended, or any applicable rule, regulation, order, or 
license of the Commission relating to substantial safety hazards or (b) 
that the facility, activity, or basic component supplied to such 
facility or activity contains defects, which could create a substantial 
safety hazard, to immediately notify the Commission of such failure to 
comply or such defect, unless he has actual knowledge that the 
Commission has been adequately informed of such defect or failure to 
comply.



Sec.21.2  Scope.

    (a) The regulations in this part apply, except as specifically 
provided otherwise in parts 31, 34, 35, 39, 40, 60, 61, 63, 70, or part 
72 of this chapter, to:
    (1) Each individual, partnership, corporation, or other entity 
applying for or holding a license or permit under the regulations in 
this chapter to possess, use, or transfer within the United States 
source material, byproduct material, special nuclear material, and/or 
spent fuel and high-level radioactive waste, or to construct, 
manufacture, possess, own, operate, or transfer within the United 
States, any production or utilization facility or independent spent fuel 
storage installation (ISFSI) or monitored retrievable storage 
installation (MRS); and each director and responsible officer of such a 
licensee;
    (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 parts 50 or 52 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

[[Page 450]]

basic components for a facility or activity licensed, other than for 
export, under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or part 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 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 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 of this chapter; or supplying basic 
components with respect to a standard design approval under part 52 of 
this chapter;
    (b) For persons licensed to construct a facility under either a 
construction permit issued under Sec.50.23 of this chapter or a 
combined license under part 52 of this chapter (for the period of 
construction until the date that the Commission makes the finding under 
Sec.52.103(g) of this chapter), or to manufacture a facility under 
part 52 of this chapter, evaluation of potential defects and failures to 
comply and reporting of defects and failures to comply under Sec.
50.55(e) of this chapter satisfies each person's evaluation, 
notification, and reporting obligation to report defects and failures to 
comply under this part and the responsibility of individual directors 
and responsible officers of 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 or part 52 of this chapter, evaluation of potential defects and 
appropriate reporting of defects under Sec. Sec.50.72, 50.73, or Sec.
73.71 of this chapter, satisfies each person's evaluation, notification, 
and reporting obligation to report defects under this part, and the 
responsibility of individual directors and responsible officers of these 
licensees to report defects under Section 206 of the Energy 
Reorganization Act of 1974.
    (d) Nothing in these regulations should be deemed to preclude either 
an individual, a manufacturer, or a supplier of a commercial grade item 
(as defined in Sec.21.3) not subject to the regulations in this part 
from reporting to the Commission, a known or suspected defect or failure 
to comply and, as authorized by law, the identity of anyone so reporting 
will be withheld from disclosure. NRC regional offices and headquarters 
will accept collect telephone calls from individuals who wish to speak 
to NRC representatives concerning nuclear safety-related problems. The 
location and telephone numbers of the four regions (answered during 
regular working hours), are listed in appendix D to part 20 of this 
chapter. The telephone number of the NRC Operations Center (answered 24 
hours a day--including holidays) is (301) 816-5100.
    (e) The regulations in this part apply in accordance with 10 CFR 
76.60 to each individual, partnership, corporation, or other entity 
required to obtain a certificate of compliance or an approved compliance 
plan under part 76 of this chapter.

[56 FR 36089, July 31, 1991, as amended at 59 FR 14086, Mar. 25, 1994; 
59 FR 48959, Sept. 23, 1994; 60 FR 48373, Sept. 19, 1995; 66 FR 55790, 
Nov. 2, 2001; 72 FR 49486, Aug. 28, 2007]



Sec.21.3  Definitions.

    As used in this part:
    Basic component. (1)(i) When applied to nuclear power plants 
licensed under 10 CFR part 50 or part 52 of this chapter, basic 
component means a structure, system, or component, or part thereof that 
affects its safety function necessary to assure:
    (A) The integrity of the reactor coolant pressure boundary;
    (B) The capability to shut down the reactor and maintain it in a 
safe-shutdown condition; or
    (C) The capability to prevent or mitigate the consequences of 
accidents which could result in potential offsite

[[Page 451]]

exposures comparable to those referred to in Sec. Sec.50.34(a)(1), 
50.67(b)(2), or 100.11 of this chapter, as applicable.
    (ii) Basic components are items designed and manufactured under a 
quality assurance program complying with 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 under subpart C 
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 a structure, system, or component, 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. Sec.50.34(a)(1), 50.67(b)(2), or 100.11 
of this chapter, as applicable.
    (3) When applied to other facilities and other activities licensed 
under 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 
63, 70, 71, or 72 of this chapter, basic component means a structure, 
system, or component, or part thereof, that affects their safety 
function, that is directly procured by the licensee of a facility or 
activity subject to the regulations in this part and in which a defect 
or failure to comply with any applicable regulation in this chapter, 
order, or license issued by the Commission could create a substantial 
safety hazard.
    (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 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 pursuant to 10 CFR part 50, commercial grade item means a 
structure, system, or component, or part thereof that affects its safety 
function, that was not designed and manufactured as a basic component. 
Commercial grade items do not include items where the design and 
manufacturing process require in-process inspections and verifications 
to ensure that defects or failures to comply are identified and 
corrected (i.e., one or more critical characteristics of the item cannot 
be verified).
    (2) When applied to facilities and activities licensed pursuant to 
10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 
70, 71, or 72, commercial grade item means an item that is:
    (i) Not subject to design or specification requirements that are 
unique to those facilities or activities;
    (ii) Used in applications other than those facilities or activities; 
and
    (iii) To be ordered from the manufacturer/supplier on the basis of 
specifications set forth in the manufacturer's published product 
description (for example, a catalog).
    Commission means the Nuclear Regulatory Commission or its duly 
authorized representatives.
    Constructing or construction means the analysis, design, 
manufacture, fabrication, placement, erection, installation, 
modification, inspection, or testing of a facility or activity which is 
subject to the regulations in this part and consulting services related 
to the facility or activity that are safety related.
    Critical characteristics. When applied to nuclear power plants 
licensed pursuant to 10 CFR part 50, critical characteristics are those 
important design, material, and performance characteristics of a 
commercial grade item that, once verified, will provide reasonable 
assurance that the item will perform its intended safety function.
    Dedicating entity. When applied to nuclear power plants licensed 
pursuant to 10 CFR part 50, dedicating entity means the organization 
that performs the dedication process. Dedication may be performed by the 
manufacturer of

[[Page 452]]

the item, a third-party dedicating entity, or the licensee itself. The 
dedicating entity, pursuant to Sec.21.21(c) of this part, 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 10 CFR part 50, dedication is an acceptance process 
undertaken to provide reasonable assurance that a commercial grade item 
to be used as a basic component will perform its intended safety 
function and, in this respect, is deemed equivalent to an item designed 
and manufactured under a 10 CFR part 50, appendix B, quality assurance 
program. This assurance is achieved by identifying the critical 
characteristics of the item and verifying their acceptability by 
inspections, tests, or analyses performed by the purchaser or third-
party dedicating entity after delivery, supplemented as necessary by one 
or more of the following: commercial grade surveys; product inspections 
or witness at holdpoints at the manufacturer's facility, and analysis of 
historical records for acceptable performance. In all cases, the 
dedication process must be conducted in accordance with the applicable 
provisions of 10 CFR part 50, appendix B. The process is considered 
complete when the item is designated for use as a basic component.
    (2) When applied to facilities and activities licensed pursuant to 
10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 
70, 71, or 72, dedication occurs after receipt when that item is 
designated for use as a basic component.
    Defect means:
    (1) A deviation in a basic component delivered to a purchaser for 
use in a facility or an activity subject to the regulations in this part 
if, on the basis of an evaluation, the deviation could create a 
substantial safety hazard;
    (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 or part 52 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 
or part 52 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.
    Deviation means a departure from the technical requirements included 
in a procurement document, or specified in early site permit 
information, a standard design certification or standard design 
approval.
    Director means an individual, appointed or elected according to law, 
who is authorized to manage and direct the affairs of a corporation, 
partnership or other entity. In the case of an individual 
proprietorship, director means the individual.
    Discovery means the completion of the documentation first 
identifying the existence of a deviation or failure to comply 
potentially associated with a substantial safety hazard within the 
evaluation procedures discussed in Sec.21.21(a).
    Evaluation means the process of determining whether a particular 
deviation could create a substantial hazard or determining whether a 
failure to comply is associated with a substantial safety hazard.
    Notification means the telephonic communication to the NRC 
Operations Center or written transmittal of information to the NRC 
Document Control Desk.
    Operating or operation means the operation of a facility or the 
conduct of a licensed activity which is subject to the regulations in 
this part and consulting services related to operations that are safety 
related.

[[Page 453]]

    Procurement document means a contract that defines the requirements 
which facilities or basic components must meet in order to be considered 
acceptable by the purchaser.
    Responsible officer means the president, vice-president or other 
individual in the organization of a corporation, partnership, or other 
entity who is vested with executive authority over activities subject to 
this part.
    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 parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72 of this 
chapter.
    Supplying or supplies means contractually responsible for a basic 
component used or to be used in a facility or activity which is subject 
to the regulations in this part.

[42 FR 28893, June 6, 1977; 42 FR 36803, July 18, 1977, as amended at 43 
FR 48622, Oct. 19, 1978; 46 FR 58283, Dec. 1, 1981; 47 FR 57480, Dec. 
27, 1982; 56 FR 36089, July 31, 1991; 59 FR 5519, Feb. 7, 1994; 60 FR 
48373, Sept. 19, 1995; 61 FR 65171, Dec. 11, 1996; 64 FR 72000, Dec. 23, 
1999; 66 FR 55790, Nov. 2, 2001; 72 FR 49486, Aug. 28, 2007]



Sec.21.4  Interpretations.

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



Sec.21.5  Communications.

    Except where otherwise specified in this part, written 
communications and reports concerning the regulations in this part must 
be addressed to the NRC's Document Control Desk, and sent by mail to the 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand 
delivery to the NRC's offices at 11555 Rockville Pike, Rockville, 
Maryland; or, where practicable, by electronic submission, for example, 
Electronic Information Exchange, or CD-ROM. Electronic submissions must 
be made in a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information. In the case of a licensee or permit holder, a copy of the 
communication must also be sent to the appropriate Regional 
Administrator at the address specified in appendix D to part 20 of this 
chapter.

[72 FR 49487, Aug. 28, 2007, as amended at 74 FR 62680, Dec. 1, 2009; 80 
FR 74979, Dec. 1, 2015]



Sec.21.6  Posting requirements.

    (a)(1) Each individual, partnership, corporation, dedicating entity, 
or other entity subject to the regulations in this part shall post 
current copies of--
    (i) The regulations in this part;
    (ii) Section 206 of the Energy Reorganization Act of 1974; and
    (iii) Procedures adopted pursuant to the regulations in this part.
    (2) These documents must be posted in a conspicuous position on any 
premises within the United States where the activities subject to this 
part are conducted.
    (b) If posting of the regulations in this part or the procedures 
adopted pursuant to the regulations in this part is not practicable, the 
licensee or firm subject to the regulations in this part may, in 
addition to posting section 206, post a notice which describes the 
regulations/procedures, including the name of the individual to whom 
reports may be made, and states where they may be examined.
    (c) The effective date of this section has been deferred until 
January 6, 1978.

[42 FR 28893, June 6, 1977, as amended at 60 FR 48374, Sept. 19, 1995]

[[Page 454]]



Sec.21.7  Exemptions.

    The Commission may, upon application of any interested person or 
upon its own initiative, grant such exemptions from the requirements of 
the regulations in this part as it determines are authorized by law and 
will not endanger life or property or the common defense and security 
and are otherwise in the public interest. Suppliers of commercial grade 
items are exempt from the provisions of this part to the extent that 
they supply commercial grade items.

[42 FR 28893, June 6, 1977, as amended at 43 FR 48622, Oct. 19, 1978]



Sec.21.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0035.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.21.7, 21.21 and 21.51.

[62 FR 52185, Oct. 6, 1997]

                              Notification



Sec.21.21  Notification of failure to comply or existence of a defect
and its evaluation.

    (a) Each individual, corporation, partnership, dedicating entity, or 
other entity subject to the regulations in this part shall adopt 
appropriate procedures to--
    (1) Evaluate deviations and failures to comply to identify defects 
and failures to comply associated with substantial safety hazards as 
soon as practicable, and, except as provided in paragraph (a)(2) of this 
section, in all cases within 60 days of discovery, in order to identify 
a reportable defect or failure to comply that could create a substantial 
safety hazard, were it to remain uncorrected, and
    (2) Ensure that if an evaluation of an identified deviation or 
failure to comply potentially associated with a substantial safety 
hazard cannot be completed within 60 days from discovery of the 
deviation or failure to comply, an interim report is prepared and 
submitted to the Commission through a director or responsible officer or 
designated person as discussed in Sec.21.21(d)(5). The interim report 
should describe the deviation or failure to comply that is being 
evaluated and should also state when the evaluation will be completed. 
This interim report must be submitted in writing within 60 days of 
discovery of the deviation or failure to comply.
    (3) Ensure that a director or responsible officer subject to the 
regulations of this part is informed as soon as practicable, and, in all 
cases, within the 5 working days after completion of the evaluation 
described in paragraphs (a)(1) or (a)(2) of this section if the 
manufacture, construction, or operation of a facility or activity, a 
basic component supplied for such facility or activity, or the design 
certification or design approval under part 52 of this chapter--
    (i) Fails to comply with the Atomic Energy Act of 1954, as amended, 
or any applicable rule, regulation, order, or license of the Commission 
or standard design approval under part 52 of this chapter, relating to a 
substantial safety hazard, or
    (ii) Contains a defect.
    (b) If the deviation or failure to comply is discovered by a 
supplier of basic components, or services associated with basic 
components, and the supplier determines that it does not have the 
capability to perform the evaluation to determine if a defect exists, 
then the supplier must inform the purchasers or affected licensees 
within five working days of this determination so that the purchasers or 
affected licensees may evaluate the deviation or failure to comply, 
pursuant to Sec.21.21(a).
    (c) A dedicating entity is responsible for--

[[Page 455]]

    (1) Identifying and evaluating deviations and reporting defects and 
failures to comply associated with substantial safety hazards for 
dedicated items; and
    (2) Maintaining auditable records for the dedication process.
    (d)(1) A director or responsible officer subject to the regulations 
of this part or a person designated under Sec.21.21(d)(5) must notify 
the Commission when he or she obtains information reasonably indicating 
a failure to comply or a defect affecting--
    (i) The manufacture, construction or operation of a facility or an 
activity within the United States that is subject to the licensing 
requirements under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72 of 
this chapter and that is within his or her organization's 
responsibility; or
    (ii) A basic component that is within his or her organization's 
responsibility and is supplied for a facility or an activity within the 
United States that is subject to the licensing, design certification, or 
approval requirements under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 
72 of this chapter.
    (2) The notification to NRC of a failure to comply or of a defect 
under paragraph (d)(1) of this section and the evaluation of a failure 
to comply or a defect under paragraphs (a)(1) and (a)(2) of this 
section, are not required if the director or responsible officer has 
actual knowledge that the Commission has been notified in writing of the 
defect or the failure to comply.
    (3) Notification required by paragraph (d)(1) of this section must 
be made as follows--
    (i) Initial notification by facsimile, which is the preferred method 
of notification, to the NRC Operations Center at (301) 816-5151 or by 
telephone at (301) 816-5100 within two days following receipt of 
information by the director or responsible corporate officer under 
paragraph (a)(1) of this section, on the identification of a defect or a 
failure to comply. Verification that the facsimile has been received 
should be made by calling the NRC Operations Center. This paragraph does 
not apply to interim reports described in Sec.21.21(a)(2).
    (ii) Written notification to the NRC at the address specified in 
Sec.21.5 within 30 days following receipt of information by the 
director or responsible corporate officer under paragraph (a)(3) of this 
section, on the identification of a defect or a failure to comply.
    (4) The written report required by this paragraph shall include, but 
need not be limited to, the following information, to the extent known:
    (i) Name and address of the individual or individuals informing the 
Commission.
    (ii) Identification of the facility, the activity, or the basic 
component supplied for such facility or such activity within the United 
States which fails to comply or contains a defect.
    (iii) Identification of the firm constructing the facility or 
supplying the basic component which fails to comply or contains a 
defect.
    (iv) Nature of the defect or failure to comply and the safety hazard 
which is created or could be created by such defect or failure to 
comply.
    (v) The date on which the information of such defect or failure to 
comply was obtained.
    (vi) In the case of a basic component which contains a defect or 
fails to comply, the number and location of these components in use at, 
supplied for, being supplied for, or may be supplied for, manufactured, 
or being manufactured for one or more facilities or activities subject 
to the regulations in this part.
    (vii) The corrective action which has been, is being, or will be 
taken; the name of the individual or organization responsible for the 
action; and the length of time that has been or will be taken to 
complete the action.
    (viii) Any advice related to the defect or failure to comply about 
the facility, activity, or basic component that has been, is being, or 
will be given to purchasers or licensees.
    (ix) In the case of an early site permit, the entities to whom an 
early site permit was transferred.
    (5) The director or responsible officer may authorize an individual 
to provide the notification required by this paragraph, provided that, 
this shall not relieve the director or responsible officer of his or her 
responsibility under this paragraph.

[[Page 456]]

    (e) Individuals subject to this part may be required by the 
Commission to supply additional information related to a defect or 
failure to comply. Commission action to obtain additional information 
may be based on reports of defects from other reporting entities.

[42 FR 28893, June 6, 1977, as amended at 46 FR 58283, Dec. 1, 1981; 47 
FR 57480, Dec. 27, 1982; 52 FR 31611, Aug. 21, 1987; 56 FR 36089, July 
31, 1991; 59 FR 14086, Mar. 25, 1994; 60 FR 48374, Sept. 19, 1995; 66 FR 
55790, Nov. 2, 2001; 67 FR 77652, Dec. 19, 2002; 72 FR 49487, Aug. 28, 
2007]

                          Procurement Documents



Sec.21.31  Procurement documents.

    Each individual, corporation, partnership, dedicating entity, or 
other entity subject to the regulations in this part shall ensure that 
each procurement document for a facility, or a basic component issued by 
him, her or it on or after January 6, 1978, specifies, when applicable, 
that the provisions of 10 CFR part 21 apply.

[60 FR 48374, Sept. 19, 1995]

                          Inspections, Records



Sec.21.41  Inspections.

    Each individual, corporation, partnership, dedicating entity, or 
other entity subject to the regulations in this part shall permit the 
Commission to inspect records, premises, activities, and basic 
components as necessary to accomplish the purposes of this part.

[60 FR 48374, Sept. 19, 1995]



Sec.21.51  Maintenance and inspection of records.

    (a) Each individual, corporation, partnership, dedicating entity, or 
other entity subject to the regulations in this part shall prepare and 
maintain records necessary to accomplish the purposes of this part, 
specifically--
    (1) Retain evaluations of all deviations and failures to comply for 
a minimum of five years after the date of the evaluation;
    (2) Suppliers of basic components must retain any notifications sent 
to purchasers and affected licensees for a minimum of five years after 
the date of the notification.
    (3) Suppliers of basic components must retain a record of the 
purchasers of basic components for 10 years after delivery of the basic 
component or service associated with a basic component.
    (4) Applicants for standard design certification under subpart B of 
part 52 of this chapter and others providing a design which is the 
subject of a design certification, during and following Commission 
adoption of a final design certification rule for that design, shall 
retain any notifications sent to purchasers and affected licensees for a 
minimum of 5 years after the date of the notification, and retain a 
record of the purchasers for 15 years after delivery of design which is 
the subject of the design certification rule or service associated with 
the design.
    (5) Applicants for or holders of a standard design approval under 
subpart E of part 52 of this chapter and others providing a design which 
is the subject of a design approval shall retain any notifications sent 
to purchasers and affected licensees for a minimum of 5 years after the 
date of the notification, and retain a record of the purchasers for 15 
years after delivery of the design which is the subject of the design 
approval or service associated with the design.
    (b) Each individual, corporation, partnership, dedicating entity, or 
other entity subject to the regulations in this part shall permit the 
Commission the opportunity to inspect records pertaining to basic 
components that relate to the identification and evaluation of 
deviations, and the reporting of defects and failures to comply, 
including (but not limited to) any advice given to purchasers or 
licensees on the placement, erection, installation, operation, 
maintenance, modification, or inspection of a basic component.

[56 FR 36090, July 31, 1991, as amended at 60 FR 48374, Sept. 19, 1995; 
72 FR 49488, Aug. 28, 2007]

                               Enforcement



Sec.21.61  Failure to notify.

    (a) Any director or responsible officer of an entity (including 
dedicating entity) that is not otherwise subject to the deliberate 
misconduct provisions of

[[Page 457]]

this chapter but is subject to the regulations in this part who 
knowingly and consciously fails to provide the notice required as by 
Sec.21.21 shall be subject to a civil penalty equal to the amount 
provided by section 234 of the Atomic Energy Act of 1954, as amended.
    (b) Any NRC licensee or applicant for a license (including an 
applicant for, or holder of, a permit), applicant for a design 
certification under part 52 of this chapter during the pendency of its 
application, applicant for a design certification after Commission 
adoption of a final design certification rule for that design, or 
applicant for or holder of a standard design approval under part 52 of 
this chapter subject to the regulations in this part who fails to 
provide the notice required by Sec.21.21, or otherwise fails to comply 
with the applicable requirements of this part shall be subject to a 
civil penalty as provided by Section 234 of the Atomic Energy Act of 
1954, as amended.
    (c) The dedicating entity, pursuant to Sec.21.21(c) of this part, 
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. NRC enforcement action can 
be taken for failure to identify and evaluate deviations, failure to 
report defects and failures to comply, or failure to maintain auditable 
records.

[60 FR 48374, Sept. 19, 1995, as amended at 72 FR 49488, Aug. 28, 2007]



Sec.21.62  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 21 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 21 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.21.1, 21.2, 21.3, 21.4 21.5, 21.7, 21.8, 21.61, and 21.62.

[57 FR 55071, Nov. 24, 1992]



PART 25_ACCESS AUTHORIZATION--Table of Contents



                           General Provisions

Sec.
25.1 Purpose.
25.3 Scope.
25.5 Definitions.
25.7 Interpretations.
25.8 Information collection requirements: OMB approval.
25.9 Communications.
25.11 Specific exemptions.
25.13 Maintenance of records.

                          Access Authorizations

25.15 Access permitted under ``Q'' or ``L'' access authorization.
25.17 Approval for processing applicants for access authorization.
25.19 Processing applications.
25.21 Determination of initial and continued eligibility for access 
          authorization.
25.23 Notification of grant of access authorization.
25.25 Cancellation of requests for access authorization.
25.27 Reopening of cases in which requests for access authorizations are 
          canceled.
25.29 Reinstatement of access authorization.
25.31 Extensions and transfers of access authorizations.
25.33 Termination of access authorizations.

                            Classified Visits

25.35 Classified visits.

                               Violations

25.37 Violations.
25.39 Criminal penalties.

Appendix A to Part 25--Fees for NRC Access Authorization

    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.

    Source: 45 FR 14481, Mar. 5, 1980, unless otherwise noted.

                           General Provisions



Sec.25.1  Purpose.

    The regulations in this part establish procedures for granting, 
reinstating,

[[Page 458]]

extending, transferring, and terminating access authorizations of 
licensee personnel, licensee contractors or agents, and other persons 
(e.g., individuals involved in adjudicatory procedures as set forth in 
10 CFR part 2, subpart I) who may require access to classified 
information.

[62 FR 17687, Apr. 11, 1997]



Sec.25.3  Scope.

    The regulations in this part apply to licensees, certificate 
holders, and others who may require access to classified information 
related to a license, certificate, an application for a license or 
certificate, or other activities as the Commission may determine.

[70 FR 32227, June 2, 2005]



Sec.25.5  Definitions.

    Access authorization means an administrative determination that an 
individual (including a consultant) who is employed by or an applicant 
for employment with the NRC, NRC contractors, agents, licensees and 
certificate holders, or other person designated by the Executive 
Director for Operations, is eligible for a security clearance for access 
to classified information.
    Act means the Atomic Energy Act of 1954 (68 Stat. 919), as amended.
    Certificate holder means a facility operating under the provisions 
of parts 71 or 76 of this chapter.
    Classified information means either classified National Security 
Information, Restricted Data, or Formerly Restricted Data or any one of 
them. It is the generic term for information requiring protection in the 
interest of National Security whether classified under an Executive 
Order or the Atomic Energy Act.
    Classified National Security Information means information that has 
been determined under E.O. 13526, as amended, or any predecessor or 
successor order to require protection against unauthorized disclosure 
and that is so designated.
    Cognizant Security Agency (CSA) means agencies of the Executive 
Branch that have been authorized by E.O. 12829 to establish an 
industrial security program for the purpose of safeguarding classified 
information under the jurisdiction of those agencies when disclosed or 
released to U.S. industry. These agencies are the Department of Defense, 
the Department of Energy, the Central Intelligence Agency, and the 
Nuclear Regulatory Commission. A facility has a single CSA which 
exercises primary authority for the protection of classified information 
at the facility. The CSA for the facility provides security 
representation for other government agencies with security interests at 
the facility. The Secretary of Defense has been designated as Executive 
Agent for the National Industrial Security Program.
    Commission means the Nuclear Regulatory Commission or its duly 
authorized representatives.
    ``L'' access authorization means an access authorization granted by 
the Commission that is normally based on a national agency check with a 
law and credit investigation (NACLC) or an access national agency check 
and inquiries investigation (ANACI) conducted by the Office of Personnel 
Management.
    License means a license issued pursuant to 10 CFR parts 50, 52, 60, 
63, 70, or 72.
    Matter means documents or material.
    National Security Information means information that has been 
determined pursuant to Executive Order 12958, as amended, or any 
predecessor order to require protection against unauthorized disclosure 
and that is so designated.
    Need-to-know means a determination made by an authorized holder of 
classified information that a prospective recipient requires access to a 
specific classified information to perform or assist in a lawful and 
authorized governmental function under the cognizance of the Commission.
    Person means (1) any individual, corporation, partnership, firm, 
association, trust, estate, public or private institution, group, 
government agency other than the Commission or the Department of Energy 
(DOE), except that the DOE shall be considered a person to the extent 
that its facilities are subject to the licensing and related regulatory 
authority of the Commission pursuant to section 202 of the Energy 
Reorganization Act of 1974 and sections 104, 105 and 202 of the Uranium 
Mill

[[Page 459]]

Tailings Radiation Control Act of 1978, any State or any political 
subdivision of, or any political entity within a State, any foreign 
government or nation or any political subdivision of any such government 
or nation, or other entity; and (2) any legal successor, representative, 
agent, or agency of the foregoing.
    ``Q'' access authorization means an access authorization granted by 
the Commission normally based on a single scope background investigation 
conducted by the Office of Personnel Management, the Federal Bureau of 
Investigation, or other U.S. Government agency which conducts personnel 
security investigations.
    Restricted Data means all data concerning design, manufacture or 
utilization of atomic weapons, the production of special nuclear 
material, or the use of special nuclear material in the production of 
energy, but shall not include data declassified or removed from the 
Restricted Data category pursuant to section 142 of the Act.
    Visit authorization letters (VAL) means a letter, generated by a 
licensee, certificate holder or other organization under the 
requirements of 10 CFR parts 25 and/or 95, verifying the need-to-know 
and access authorization of an individual from that organization who 
needs to visit another authorized facility for the purpose of exchanging 
or acquiring classified information related to the license.

[45 FR 14481, Mar. 5, 1980, as amended at 46 FR 58283, Dec. 1, 1981; 47 
FR 38683, Sept. 2, 1982; 48 FR 24320, June 1, 1983; 50 FR 36984, Sept. 
11, 1985; 55 FR 11574, Mar. 29, 1990; 62 FR 17687, Apr. 11, 1997; 64 FR 
15647, Apr. 1, 1999; 70 FR 32227, June 2, 2005; 75 FR 73941, Nov. 30, 
2010]



Sec.25.7  Interpretations.

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



Sec.25.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0046.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.25.11, 25.17, 25.21, 25.23, 25.25, 25.27, 
25.29, 25.31, 25.33, and 25.35.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec. Sec.25.17(b), 25.21(c), 25.27(a), 25.29, and 25.31, 
NRC Form 237 is approved under control number 3150-0050.
    (2) In Sec. Sec.25.17(c), 25.21(c), 25.27(b), 25.29, and 25.31, 
SF-86 is approved under control number 3206-0007.
    (3) In Sec.25.21(b), NRC Form 354 is approved under control number 
3150-0026.
    (4) In Sec.25.33, NRC Form 136 is approved under control number 
3150-0049.
    (5) In Sec.25.35, NRC Form 277 is approved under control number 
3150-0051.

[49 FR 19624, May 9, 1984, as amended at 57 FR 3720, Jan. 31, 1992; 62 
FR 17687, Apr. 11, 1997; 62 FR 52185, Oct. 6, 1997]



Sec.25.9  Communications.

    Except where otherwise specified, communications and reports 
concerning the regulations in this part should be addressed to the 
Director, Division of Facilities and Security, Mail Stop T7-D57, and 
sent either by mail to the U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; by hand delivery to the NRC's offices at 
11555 Rockville Pike, Rockville, Maryland; or, where practicable, by 
electronic submission, for example, Electronic Information Exchange, or 
CD-

[[Page 460]]

ROM. Electronic submissions must be made in a manner that enables the 
NRC to receive, read, authenticate, distribute, and archive the 
submission, and process and retrieve it a single page at a time. 
Detailed guidance on making electronic submissions can be obtained by 
visiting the NRC's Web site at http://www.nrc.gov/site-help/e-
submittals.html; by e-mail to [email protected]; or by writing the 
Office of the Chief Information Officer, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001. The guidance discusses, among 
other topics, the formats the NRC can accept, the use of electronic 
signatures, and the treatment of nonpublic information.

[68 FR 58803, Oct. 10, 2003, as amended at 74 FR 62681, Dec. 1, 2009; 80 
FR 74979, Dec. 1, 2015]



Sec.25.11  Specific exemptions.

    The NRC may, upon application by any interested person or upon its 
own initiative, grant exemptions from the requirements of the 
regulations of this part, that are--
    (a) Authorized by law, will not present an undue risk to the public 
health and safety, and are consistent with the common defense and 
security; or
    (b) Coincidental with one or more of the following:
    (1) An application of the regulation in the particular circumstances 
conflicts with other NRC rules or requirements;
    (2) An application of the regulation in the particular circumstances 
would not serve the underlying purpose of the rule or is not necessary 
to achieve the underlying purpose of the rule;
    (3) When compliance would result in undue hardship or other costs 
that significantly exceed those contemplated when the regulation was 
adopted, or that significantly exceed those incurred by others similarly 
situated;
    (4) When the exemption would result in benefit to the common defense 
and security that compensates for any decrease in the security that may 
result from the grant of the exemption;
    (5) When the exemption would provide only temporary relief from the 
applicable regulation and the licensee or applicant has made good faith 
efforts to comply with the regulation;
    (6) When there is any other material circumstance present that was 
not considered when the regulation was adopted that would be in the 
public interest to grant an exemption. If this condition is relied on 
exclusively for satisfying paragraph (b) of this section, the exemption 
may not be granted until the Executive Director for Operations has 
consulted with the Commission.

[64 FR 15647, Apr. 1, 1999]



Sec.25.13  Maintenance of records.

    (a) Each licensee or organization employing individuals approved for 
personnel security access authorization under this part, shall maintain 
records as prescribed within the part. These records are subject to 
review and inspection by CSA representatives during security reviews.
    (b) Each record required by this part must be legible throughout the 
retention period specified by each Commission regulation. The record may 
be the original or a reproduced copy or a microform provided that the 
copy or microform is authenticated by authorized personnel and that the 
microform is capable of producing a clear copy throughout the required 
retention period. The record may also be stored in electronic media with 
the capability for producing legible, accurate, and complete records 
during the required retention period. Records such as letters, drawings, 
specifications, must include all pertinent information such as stamps, 
initials, and signatures. The licensee shall maintain adequate 
safeguards against tampering with and loss of records.

[45 FR 14481, Mar. 5, 1980, as amended at 53 FR 19245, May 27, 1988; 62 
FR 17687, Apr. 11, 1997]

                          Access Authorizations



Sec.25.15  Access permitted under ``Q'' or ``L'' access authorization.

    (a) A ``Q'' access authorization permits an individual access on a 
need-to-know basis to (1) Secret and Confidential Restricted Data and 
(2) Secret and

[[Page 461]]

Confidential National Security Information including intelligence 
information, CRYPTO (i.e., cryptographic information) or other 
classified communications security (COMSEC) information.
    (b) An ``L'' access authorization permits an individual access on a 
need-to-know basis to Confidential Restricted Data and Secret and 
Confidential National Security Information other than the categories 
specifically included in paragraph (a) of this section. In addition, 
access to certain Confidential COMSEC information is permitted as 
authorized by a National Communications Security Committee waiver dated 
February 14, 1985.
    (c) Each employee of the Commission is processed for one of the two 
levels of access authorization. Licensees and other persons will furnish 
National Security Information and/or Restricted Data to a Commission 
employee on official business when the employee has the appropriate 
level of NRC access authorization and need-to-know. Some individuals are 
permitted to begin NRC employment without an access authorization. 
However, no NRC employee shall be permitted access to any classified 
information until the appropriate level of access authorization has been 
granted to that employee by NRC.

[45 FR 14481, Mar. 5, 1980, as amended at 47 FR 9195, Mar. 4, 1982; 50 
FR 36984, Sept. 11, 1985]



Sec.25.17  Approval for processing applicants for access authorization.

    (a) Access authorizations must be requested for licensee employees 
or other persons (e.g., 10 CFR part 2, subpart I) who need access to 
classified information in connection with activities under 10 CFR parts 
50, 52, 54, 60, 63, 70, 72, or 76.
    (b) The request must be submitted to the facility CSA. If the NRC is 
the CSA, the procedures in Sec.25.17 (c) and (d) will be followed. If 
the NRC is not the CSA, the request will be submitted to the CSA in 
accordance with procedures established by the CSA. The NRC will be 
notified of the request by a letter that includes the name, Social 
Security number and level of access authorization.
    (c) The request must include a completed personnel security packet 
(see Sec.25.17(d)) and request form (NRC Form 237) signed by a 
licensee, licensee contractor official, or other authorized person.
    (d)(1) Each personnel security packet submitted must include the 
following completed forms:
    (i) Questionnaire for National Security Positions (SF-86, Parts 1 
and 2) (Part 2 is to be completed by the applicant and placed in a 
sealed envelope which is to be forwarded to NRC unopened. No licensee, 
licensee contractor official, or other person at a facility is permitted 
to review Part 2 information);
    (ii) Two standard fingerprint cards (FD-258);
    (iii) Security Acknowledgment (NRC Form 176); and
    (iv) Other related forms where specified in accompanying 
instructions (NRC Form 254).
    (2) Only a Security Acknowledgment (NRC Form 176) need be completed 
by any person possessing an active access authorization, or who is being 
processed for an access authorization, by another Federal agency. The 
active or pending access authorization must be at an equivalent level to 
that required by the NRC and be based on an adequate investigation of 
not more than five years old.
    (e) To avoid delays in processing requests for access 
authorizations, each security packet should be reviewed for completeness 
and correctness (including legibility of response on the forms) before 
submittal.
    (f) The Office of Personnel Management (OPM) bills the NRC for the 
cost of each background investigation conducted in support of an 
application for access authorization (application). The combined cost of 
the OPM investigation and the NRC's application processing overhead (NRC 
processing fee) are recovered through an access authorization fee 
imposed on applicants for access authorization.
    (1) Each application for access authorization, renewal, or change in 
level must be accompanied by a remittance, payable to the U.S. Nuclear 
Regulatory Commission, which is equal to the NRC access authorization 
fee. This fee must

[[Page 462]]

be determined using the following formula: the OPM investigation billing 
rates on the day of NRC receipt of the application + the NRC processing 
fee = the NRC access authorization fee. The NRC processing fee is 
determined by multiplying the OPM investigation billing rate on the day 
of NRC receipt of the application by 55.8 percent (i.e., OPM rate x 55.8 
percent).
    (2) Updated OPM investigation billing rates are published 
periodically in a Federal Investigations Notice (FIN) issued by the 
OPM's Federal Investigative Services. Copies of the current OPM 
investigation billing rates schedule can be obtained by contacting the 
NRC's Personnel Security Branch, Division of Facilities Security, Office 
of Administration by email to Licensee_

Access_Authorization_Fee.Resource@

nrc.gov
    (3) The NRC's Information Access Authority Program (IAAP) is 
considered reimbursable work representing services provided to an 
organization for which the NRC is entitled payment. The NRC is 
authorized to receive and retain fees from licensees for services 
performed. The NRC's Office of the Chief Financial Officer periodically 
reviews the fees charged for IAAP and makes recommendations on revising 
those charges to reflect costs incurred by the NRC in providing those 
services. The reviews are performed using cost analysis techniques to 
determine the direct and indirect costs. Based on this review the IAAP 
fees are adjusted to reflect the current cost for the program. Copies of 
the current NRC access authorization fee may be obtained by contacting 
the NRC's Personnel Security Branch, Division of Facilities Security, 
Office of Administration by email to: Licensee_Access_

[email protected]. Any change in the NRC's access 
authorization fee will be applicable to each access authorization 
request received on or after the effective date of the OPM's most 
recently published investigation billing rates schedule.
    (4) Certain applications from individuals having current Federal 
access authorizations may be processed more expeditiously and at less 
cost, because the Commission, at its discretion, may decide to accept 
the certification of access authorization and investigative data from 
other Federal Government agencies that grant personnel access 
authorizations.

[62 FR 17687, Apr. 11, 1997, as amended at 68 FR 62512, Nov. 5, 2003; 70 
FR 32227, June 2, 2005; 72 FR 27411, May 16, 2007; 77 FR 26153, May 3, 
2012; 77 FR 46258, Aug. 3, 2012]



Sec.25.19  Processing applications.

    Each application for an access authorization or access authorization 
renewal must be submitted to the CSA. If the NRC is the CSA, the 
application and its accompanying fee must be submitted to the NRC 
Division of Facilities and Security. If necessary, the NRC Division of 
Facilities and Security may obtain approval from the appropriate 
Commission office exercising licensing or regulatory authority before 
processing the access authorization or access authorization renewal 
request. If the applicant is disapproved for processing, the NRC 
Division of Facilities and Security shall notify the submitter in 
writing and return the original application (security packet) and its 
accompanying fee.

[64 FR 15648, Apr. 1, 1999]



Sec.25.21  Determination of initial and continued eligibility for
access authorization.

    (a) Following receipt by the CSA of the reports of the personnel 
security investigations, the record will be reviewed to determine that 
granting an access authorization or renewal of access authorization will 
not endanger the common defense and security and is clearly consistent 
with the national interest. If this determination is made, access 
authorization will be granted or renewed. If the NRC is the CSA, 
questions as to initial or continued eligibility will be determined in 
accordance with part 10 of chapter I. If another agency is the CSA, that 
agency will, under the requirements of the NISPOM, have established 
procedures at the facility to resolve questions as to initial or 
continued eligibility for access authorization. These questions will be 
determined in accordance with established CSA procedures already in 
effect for the facility.

[[Page 463]]

    (b) The CSA must be promptly notified of developments that bear on 
continued eligibility for access authorization throughout the period for 
which the authorization is active (e.g., persons who marry subsequent to 
the completion of a personnel security packet must report this change by 
submitting a completed NRC Form 354, ``Data Report on Spouse'' or 
equivalent CSA form).
    (c)(1) Except as provided in paragraph (c)(2) of this section, an 
NRC ``Q'' access authorization must be renewed every five years from the 
date of issuance. Except as provided in paragraph (c)(2) of this 
section, an NRC ``L'' access authorization must be renewed every ten 
years from the date of issuance. An application for renewal must be 
submitted at least 120 days before the expiration of the five-year 
period for a ``Q'' access authorization and the ten-year period for an 
``L'' access authorization, and must include:
    (i) A statement by the licensee or other person that the individual 
continues to require access to classified National Security Information 
or Restricted Data; and
    (ii) A personnel security packet as described in Sec.25.17(d).
    (2) Renewal applications and the required paperwork are not required 
for individuals who have a current and active access authorization from 
another Federal agency and who are subject to a reinvestigation program 
by that agency that is determined by the NRC to meet the NRC's 
requirements. (The DOE Reinvestigation Program has been determined to 
meet the NRC's requirements.) For these individuals, the submission of 
the SF-86 by the licensee or other person to the other Government agency 
pursuant to their reinvestigation requirements will satisfy the NRC's 
renewal submission and paperwork requirements, even if less than five 
years have passed since the date of issuance or renewal of the NRC ``Q'' 
access authorization, or if less than 10 years have passed since the 
date of issuance or renewal of the NRC ``L'' access authorization. Any 
NRC access authorization continued in response to the provisions of this 
paragraph will, thereafter, not be due for renewal until the date set by 
the other Government agency for the next reinvestigation of the 
individual pursuant to the other agency's reinvestigation program. 
However, the period of time for the initial and each subsequent NRC 
``Q'' renewal application to the NRC may not exceed seven years or, in 
the case of an NRC ``L'' renewal application, twelve years. Any 
individual who is subject to the reinvestigation program requirements of 
another Federal agency but, for administrative or other reasons, does 
not submit reinvestigation forms to that agency within seven years for a 
``Q'' renewal or twelve years for an ``L'' renewal of the previous 
submission, shall submit a renewal application to the NRC using the 
forms prescribed in Sec.25.17(d) before the expiration of the seven-
year period for a ``Q'' renewal or twelve-year period for an ``L'' 
renewal.
    (3) If the NRC is not the CSA, reinvestigation program procedures 
and requirements will be set by the CSA.

[62 FR 17688, Apr. 11, 1997, as amended at 64 FR 15648, Apr. 1, 1999]



Sec.25.23  Notification of grant of access authorization.

    The determination to grant or renew access authorization will be 
furnished in writing to the licensee or organization that initiated the 
request. Upon receipt of the notification of original grant of access 
authorization, the licensee or organization shall obtain, as a condition 
for grant of access authorization and access to classified information, 
an executed ``Classified Information Nondisclosure Agreement'' (SF-312) 
from the affected individual. The SF-312 is an agreement between the 
United States and an individual who is cleared for access to classified 
information. An employee issued an initial access authorization shall 
execute a SF-312 before being granted access to classified information. 
The licensee or other organization shall forward the executed SF-312 to 
the CSA for retention. If the employee refuses to execute the SF-312, 
the licensee or other organization shall deny the employee access to 
classified information and submit a report to the CSA. The SF-312 must 
be signed and dated by the employee and witnessed. The employee's and 
witness' signatures must bear the same date. The individual shall

[[Page 464]]

also be given a security orientation briefing in accordance with Sec.
95.33 of this chapter. Records of access authorization grant and renewal 
notification must be maintained by the licensee or other organization 
for three years after the access authorization has been terminated by 
the CSA. This information may also be furnished to other representatives 
of the Commission, to licensees, contractors, or other Federal agencies. 
Notifications of access authorization will not be given in writing to 
the affected individual except:
    (a) In those cases when the determination was made as a result of a 
Personnel Security Hearing or by a Personnel Security Review Panel ; or
    (b) When the individual also is the official designated by the 
licensee or other organization to whom written NRC notifications are 
forwarded.

[62 FR 17688, Apr. 11, 1997, as amended at 64 FR 15648, Apr. 1, 1999]



Sec.25.25  Cancellation of requests for access authorization.

    When a request for an individual's access authorization or renewal 
of an access authorization is withdrawn or canceled, the requestor shall 
notify the CSA immediately by telephone so that the single scope 
background investigation, national agency check with law and credit 
investigation, or other personnel security action may be discontinued. 
The requestor shall identify the full name and date of birth of the 
individual, the date of request, and the type of access authorization or 
access authorization renewal requested. The requestor shall confirm each 
telephone notification promptly in writing.

[64 FR 15648, Apr. 1, 1999]



Sec.25.27  Reopening of cases in which requests for access 
authorizations are canceled.

    (a) In conjunction with a new request for access authorization (NRC 
Form 237 or CSA equivalent) for individuals whose cases were previously 
canceled, new fingerprint cards (FD-257) in duplicate and a new Security 
Acknowledgment (NRC Form 176), or CSA equivalent, must be furnished to 
the CSA along with the request.
    (b) Additionally, if 90 days or more have elapsed since the date of 
the last Questionnaire for National Security Positions (SF-86), or CSA 
equivalent, the individual must complete a personnel security packet 
(see Sec.25.17(d)). The CSA, based on investigative or other needs, 
may require a complete personnel security packet in other cases as well. 
A fee, equal to the amount paid for an initial request, will be charged 
only if a new or updating investigation by the NRC is required.

[62 FR 17689, Apr. 11, 1997, as amended at 64 FR 15648, Apr. 1, 1999]



Sec.25.29  Reinstatement of access authorization.

    (a) An access authorization can be reinstated provided that:
    (1) No more than 24 months has lapsed since the date of termination 
of the clearance;
    (2) There has been no break in employment with the employer since 
the date of termination of the clearance;
    (3) There is no known adverse information;
    (4) The most recent investigation must not exceed 5 years (Top 
Secret, Q) or 10 years (Secret, L); and
    (5) The most recent investigation must meet or exceed the scope of 
the investigation required for the level of access authorization that is 
to be reinstated or granted.
    (b) An access authorization can be reinstated at the same, or lower, 
level by submission of a CSA-designated form to the CSA. The employee 
may not have access to classified information until receipt of written 
confirmation of reinstatement and an up-to-date personnel security 
packet will be furnished with the request for reinstatement of an access 
authorization. A new Security Acknowledgement will be obtained in all 
cases. Where personnel security packets are not required, a request for 
reinstatement must state the level of access authorization to be 
reinstated and the full name and date of birth of the individual to 
establish positive identification. A fee, equal to the amount paid for 
an initial request, will be charged only if a new or updating 
investigation by the NRC is required.

[62 FR 17689, Apr. 11, 1997]

[[Page 465]]



Sec.25.31  Extensions and transfers of access authorizations.

    (a) The NRC Division of Facilities and Security may, on request, 
extend the authorization of an individual who possesses an access 
authorization in connection with a particular employer or activity to 
permit access to classified information in connection with an assignment 
with another employer or activity.
    (b) The NRC Division of Facilities and Security may, on request, 
transfer an access authorization when an individual's access 
authorization under one employer or activity is terminated, 
simultaneously with the individual being granted an access authorization 
for another employer or activity.
    (c) Requests for an extension or transfer of an access authorization 
must state the full name of the person, date of birth, and level of 
access authorization. The Director, Division of Facilities and Security, 
may require a new personnel security packet (see Sec.25.17(c)) to be 
completed by the applicant. A fee, equal to the amount paid for an 
initial request, will be charged only if a new or updating investigation 
by the NRC is required.
    (d) The date of an extension or transfer of access authorization may 
not be used to determine when a request for renewal of access 
authorization is required. Access authorization renewal requests must be 
timely submitted, in accordance with Sec.25.21(c).

[45 FR 14481, Mar. 5, 1980, as amended at 48 FR 24320, June 1, 1983; 57 
FR 3721, Jan. 31, 1992; 62 FR 17689, Apr. 11, 1997; 64 FR 15648, Apr. 1, 
1999]



Sec.25.33  Termination of access authorizations.

    (a) Access authorizations will be terminated when:
    (1) An access authorization is no longer required;
    (2) An individual is separated from the employment or the activity 
for which he or she obtained an access authorization for a period of 90 
days or more; or
    (3) An individual, pursuant to 10 CFR part 10 or other CSA-approved 
adjudicatory standards, is no longer eligible for an access 
authorization.
    (b) A representative of the licensee or other organization that 
employs the individual whose access authorization will be terminated 
shall immediately notify the CSA when the circumstances noted in 
paragraph (a)(1) or (a)(2) of this section exist; inform the individual 
that his or her access authorization is being terminated, and the 
reason; and that he or she will be considered for reinstatement of an 
access authorization if he or she resumes work requiring the 
authorization.
    (c) When an access authorization is to be terminated, a 
representative of the licensee or other organization shall conduct a 
security termination briefing of the individual involved, explain the 
Security Termination Statement (NRC Form 136 or CSA approved form) and 
have the individual complete the form. The representative shall promptly 
forward the original copy of the completed Security Termination 
Statement to CSA.

[62 FR 17689, Apr. 11, 1997, as amended at 64 FR 15649, Apr. 1, 1999]

                            Classified Visits



Sec.25.35  Classified visits.

    (a) The number of classified visits must be held to a minimum. The 
licensee, certificate holder, applicant for a standard design 
certification under part 52 of this chapter (including an applicant 
after the Commission has adopted a final standard design certification 
rule under part 52 of this chapter), or other facility, or an applicant 
for or holder of a standard design approval under part 52 of this 
chapter shall determine that the visit is necessary and that the purpose 
of the visit cannot be achieved without access to, or disclosure of, 
classified information. All classified visits require advance 
notification to, and approval of, the organization to be visited. In 
urgent cases, visit information may be furnished by telephone and 
confirmed in writing.
    (b) Representatives of the Federal Government, when acting in their 
official capacities as inspectors, investigators, or auditors, may visit 
a licensee, certificate holder, or other facility without furnishing 
advanced notification, provided these representatives

[[Page 466]]

present appropriate Government credentials upon arrival. Normally, 
however, Federal representatives will provide advance notification in 
the form of an NRC Form 277, ``Request for Visit or Access Approval,'' 
with the ``need-to-know'' certified by the appropriate NRC office 
exercising licensing or regulatory authority and verification of an NRC 
access authorization by the Division of Facilities and Security.
    (c) The licensee, certificate holder, or others shall include the 
following information on all Visit Authorization Letters (VAL) which 
they prepare.
    (1) Visitor's name, address, and telephone number and certification 
of the level of the facility security clearance;
    (2) Name, date and place of birth, and citizenship of the individual 
intending to visit;
    (3) Certification of the proposed visitor's personnel clearance and 
any special access authorizations required for the visit;
    (4) Name of person(s) to be visited;
    (5) Purpose and sufficient justification for the visit to allow for 
a determination of the necessity of the visit; and
    (6) Date or period during which the VAL is to be valid.
    (d) Classified visits may be arranged for a 12 month period. The 
requesting facility shall notify all places honoring these visit 
arrangements of any change in the individual's status that will cause 
the visit request to be canceled before its normal termination date.
    (e) The responsibility for determining need-to-know in connection 
with a classified visit rests with the individual who will disclose 
classified information during the visit. The licensee, certificate 
holder or other facility shall establish procedures to ensure positive 
identification of visitors before the disclosure of any classified 
information.

[62 FR 17689, Apr. 11, 1997, as amended at 64 FR 15649, Apr. 1, 1999; 72 
FR 49488, Aug. 28, 2007]

                               Violations



Sec.25.37  Violations.

    (a) An injunction or other court order may be obtained to prohibit a 
violation of any provision of:
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) Any regulation or order issued under these Acts.
    (b) National Security Information is protected under the 
requirements and sanctions of Executive Order 13526, as amended, or any 
predecessor or successor orders.

[48 FR 24320, June 1, 1983, as amended at 57 FR 55072, Nov. 24, 1992; 64 
FR 15649, Apr. 1, 1999; 70 FR 32227, June 2, 2005; 75 FR 73941, Nov. 30, 
2010]



Sec.25.39  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 25 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 25 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.25.1, 25.3, 25.5, 25.7, 25.8, 25.9, 25.11, 25.19, 25.25, 
25.27, 25.29, 25.31, 25.37, and 25.39.

[57 FR 55072, Nov. 24, 1992]



[[Page 467]]

        Appendix A to Part 25--Fees for NRC Access Authorization

----------------------------------------------------------------------------------------------------------------
                                                                       Plus the NRC's processing fee (rounded to
                                        Is the sum of the current OPM    the nearest dollar), which is equal to
 The NRC application fee for an access    investigation billing rate     the OPM investigation billing rate for
      authorization of type . . .        charged for an investigation     the type of investigation referenced
                                                of type . . .                     multiplied by . . .
----------------------------------------------------------------------------------------------------------------
Initial ``L'' access authorization \1\  ANACI--Access National Agency                                     55.8%
                                         Check with Inquiries
                                         (Standard Service, Code C).
Reinstatement of ``L'' access           No fee assessed for most
 authorization \2\.                      applications.
Renewal of ``L'' access authorization   NACLC--National Agency Check                                     55.8%.
 \1\.                                    with Law and Credit
                                         (Standard Service, Code C).
Initial ``Q'' access authorization....  SSBI--Single Scope Background                                     55.8%
                                         Investigation (Standard
                                         Service, Code C).
Initial ``Q'' access authorization      SSBI--Single Scope Background                                     55.8%
 (expedited processing).                 Investigation (Priority
                                         Handling, Code A).
Reinstatement of ``Q'' access           No fee assessed for most
 authorization \2\.                      applications.
Renewal of ``Q'' access authorization   SSBI-PR--Periodic                                                 55.8%
 \1\.                                    Reinvestigation for SSBI
                                         (Standard Service, Code C).
----------------------------------------------------------------------------------------------------------------
\1\ If the NRC determines, based on its review of available data, that a single scope investigation is
  necessary, the appropriate fee for an Initial ``Q'' access authorization will be assessed before the conduct
  of investigation.
\2\ Full fee will only be charged if an investigation is required.


[77 FR 26153, May 3, 2012, as amended at 77 FR 46258, Aug. 3, 2012]



PART 26_FITNESS FOR DUTY PROGRAMS--Table of Contents



                   Subpart A_Administrative Provisions

Sec.
26.1 Purpose.
26.3 Scope.
26.4 FFD program applicability to categories of individuals.
26.5 Definitions.
26.7 Interpretations.
26.8 Information collection requirements: OMB approval.
26.9 Specific exemptions.
26.11 Communications.

                       Subpart B_Program Elements

26.21 Fitness-for-duty program.
26.23 Performance objectives.
26.25 [Reserved]
26.27 Written policy and procedures.
26.29 Training.
26.31 Drug and alcohol testing.
26.33 Behavioral observation.
26.35 Employee assistance programs.
26.37 Protection of information.
26.39 Review process for fitness-for-duty policy violations.
26.41 Audits and corrective action.

            Subpart C_Granting and Maintaining Authorization

26.51 Applicability.
26.53 General provisions.
26.55 Initial authorization.
26.57 Authorization update.
26.59 Authorization reinstatement.
26.61 Self-disclosure and employment history.
26.63 Suitable inquiry.
26.65 Pre-access drug and alcohol testing.
26.67 Random drug and alcohol testing of individuals who have applied 
          for authorization.
26.69 Authorization with potentially disqualifying fitness-for-duty 
          information.
26.71 Maintaining authorization.

        Subpart D_Management Actions and Sanctions To Be Imposed

26.73 Applicability.
26.75 Sanctions.
26.77 Management actions regarding possible impairment.

               Subpart E_Collecting Specimens for Testing

26.81 Purpose and applicability.
26.83 Specimens to be collected.
26.85 Collector qualifications and responsibilities.
26.87 Collection sites.
26.89 Preparing to collect specimens for testing.
26.91 Acceptable devices for conducting initial and confirmatory tests 
          for alcohol and methods of use.
26.93 Preparing for alcohol testing.
26.95 Conducting an initial test for alcohol using a breath specimen.
26.97 Conducting an initial test for alcohol using a specimen of oral 
          fluids.

[[Page 468]]

26.99 Determining the need for a confirmatory test for alcohol.
26.101 Conducting a confirmatory test for alcohol.
26.103 Determining a confirmed positive test result for alcohol.
26.105 Preparing for urine collection.
26.107 Collecting a urine specimen.
26.109 Urine specimen quantity.
26.111 Checking the acceptability of the urine specimen.
26.113 Splitting the urine specimen.
26.115 Collecting a urine specimen under direct observation.
26.117 Preparing urine specimens for storage and shipping.
26.119 Determining ``shy'' bladder.

                  Subpart F_Licensee Testing Facilities

26.121 Purpose.
26.123 Testing facility capabilities.
26.125 Licensee testing facility personnel.
26.127 Procedures.
26.129 Assuring specimen security, chain of custody, and preservation.
26.131 Cutoff levels for validity screening and initial validity tests.
26.133 Cutoff levels for drugs and drug metabolites.
26.135 Split specimens.
26.137 Quality assurance and quality control.
26.139 Reporting initial validity and drug test results.

 Subpart G_Laboratories Certified by the Department of Health and Human 
                                Services

26.151 Purpose.
26.153 Using certified laboratories for testing urine specimens.
26.155 Laboratory personnel.
26.157 Procedures.
26.159 Assuring specimen security, chain of custody, and preservation.
26.161 Cutoff levels for validity testing.
26.163 Cutoff levels for drugs and drug metabolites.
26.165 Testing split specimens and retesting single specimens.
26.167 Quality assurance and quality control.
26.168 Blind performance testing.
26.169 Reporting results.

Subpart H_Determining Fitness-for-Duty Policy Violations and Determining 
                                 Fitness

26.181 Purpose.
26.183 Medical review officer.
26.185 Determining a fitness-for-duty policy violation.
26.187 Substance abuse expert.
26.189 Determination of fitness.

                       Subpart I_Managing Fatigue.

26.201 Applicability.
26.203 General provisions.
26.205 Work hours.
26.207 Waivers and exceptions.
26.209 Self-declarations.
26.211 Fatigue assessments.

Subpart J [Reserved]

                 Subpart K_FFD Programs for Construction

26.401 General.
26.403 Written policy and procedures.
26.405 Drug and alcohol testing.
26.406 Fitness monitoring.
26.407 Behavioral observation.
26.409 Sanctions.
26.411 Protection of information.
26.413 Review process.
26.415 Audits.
26.417 Recordkeeping and reporting.
26.419 Suitability and fitness evaluations.

Subparts L-M [Reserved]

           Subpart N_Recordkeeping and Reporting Requirements

26.709 Applicability.
26.711 General provisions.
26.713 Recordkeeping requirements for licensees and other entities.
26.715 Recordkeeping requirements for collection sites, licensee testing 
          facilities, and laboratories certified by the Department of 
          Health and Human Services.
26.717 Fitness-for-duty program performance data.
26.719 Reporting requirements.

            Subpart O_Inspections, Violations, and Penalties

26.821 Inspections.
26.823 Violations.
26.825 Criminal penalties.

    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.

    Source: 73 FR 17176, Mar. 31, 2008, unless otherwise noted.



                   Subpart A_Administrative Provisions



Sec.26.1  Purpose.

    This part prescribes requirements and standards for the 
establishment, implementation, and maintenance of fitness-for-duty (FFD) 
programs.

[[Page 469]]



Sec.26.3  Scope.

    (a) Licensees who are authorized to operate a nuclear power reactor 
under 10 CFR 50.57, and holders of a combined license under 10 CFR Part 
52 after the Commission has made the finding under 10 CFR 52.103(g) 
shall comply with the requirements of this part, except for subpart K of 
this part. Licensees who receive their authorization to operate a 
nuclear power reactor under 10 CFR 50.57 after the date of publication 
of this final rule in the Federal Register and holders of a combined 
license under 10 CFR Part 52 after the Commission has made the finding 
under 10 CFR 52.103(g) shall implement the FFD program before the 
receipt of special nuclear material in the form of fuel assemblies.
    (b) Licensees who are authorized to possess, use, or transport 
formula quantities of strategic special nuclear material (SSNM) under 
Part 70 of this chapter, and any corporation, firm, partnership, limited 
liability company, association, or other organization who obtains a 
certificate of compliance or an approved compliance plan under Part 76 
of this chapter, only if the entity elects to engage in activities 
involving formula quantities of SSNM shall comply with the requirements 
of this part, except for subparts I and K of this part.
    (c) Before the receipt of special nuclear material in the form of 
fuel assemblies, the following licensees and other entities shall comply 
with the requirements of this part, except for subpart I of this part; 
and, no later than the receipt of special nuclear material in the form 
of fuel assemblies, the following licensees and other entities shall 
comply with the requirements of this part:
    (1) Combined license applicants (under Part 52 of this chapter) who 
have been issued a limited work authorization under Sec.50.10(e), if 
the limited work authorization authorizes the applicant to install the 
foundations, including the placement of concrete, for safety- and 
security-related structures, systems, and components (SSCs) under the 
limited work authorization;
    (2) Combined license holders (under Part 52 of this chapter) before 
the Commission has made the finding under Sec.52.103(g);
    (3) Construction permit applicants (under Part 50 of this chapter) 
who have been issued a limited work authorization under Sec.50.10(e), 
if the limited work authorization authorizes the applicant to install 
the foundations, including the placement of concrete, for safety- and 
security-related SSCs under the limited work authorization;
    (4) Construction permit holders (under Part 50 of this chapter); and
    (5) Early site permit holders who have been issued a limited work 
authorization under Sec.50.10(e), if the limited work authorization 
authorizes the early site permit holder to install the foundations, 
including the placement of concrete, for safety- and security-related 
SSCs under the limited work authorization.
    (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) 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.
    (e) This part does not apply to either spent fuel storage facility 
licensees or non-power reactor licensees who possess, use, or transport 
formula quantities of irradiated SSNM.



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 
subpart K of this part:
    (1) 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;
    (2) Performing health physics or chemistry duties required as a 
member of the onsite emergency response organization minimum shift 
complement;
    (3) Performing the duties of a fire brigade member who is 
responsible for understanding the effects of fire and fire

[[Page 470]]

suppressants on safe shutdown capability;
    (4) 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; and
    (5) Performing security duties as an armed security force officer, 
alarm station operator, response team leader, or watchman, hereinafter 
referred to as security personnel.
    (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 subpart K of this part.
    (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 requirement of this part, except Sec. Sec.26.205 through 26.209 
and subpart K of this part.
    (d) Any individual whose duties for the licensees and other entities 
in Sec.26.3(b) require him or her 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 and K of this part:
    (1) All persons who are granted unescorted access to Category IA 
material;
    (2) All persons who create or have access to procedures or records 
for safeguarding SSNM;
    (3) All persons who measure Category IA material;
    (4) All persons who transport or escort Category IA material; and
    (5) All persons who guard Category IA material.
    (e) When construction activities 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 and K of this 
part:
    (1) Serves as security personnel required by the NRC, until the 
licensees or other entities receive special nuclear material in the form 
of fuel assemblies, at which time individuals who serve as security 
personnel required by the NRC must meet the requirements applicable to 
security personnel in paragraph (a)(5) of this section;
    (2) Performs quality assurance, quality control, or quality 
verification activities related to safety- or security-related 
construction activities;
    (3) Based on a designation under Sec.26.406 by a licensee or other 
entity, monitors the fitness of the individuals specified in paragraph 
(f) of this section;
    (4) Witnesses or determines inspections, tests, and analyses 
certification required under Part 52 of this chapter;
    (5) Supervises or manages the construction of safety- or security-
related SSCs; or
    (6) Directs, as defined in Sec.26.5, or implements the access 
authorization program, including--
    (i) Having access to the information used by the licensee or other 
entity to make access authorization determinations, including 
information stored in electronic format;
    (ii) Making access authorization determinations;
    (iii) Issuing entry-control picture badges in accordance with access 
authorization determinations;
    (iv) Conducting background investigations or psychological 
assessments used by the licensee or other entity to make access 
authorization determinations, except that he or she shall be subject to 
behavioral observation only when he or she is present at the location 
where the nuclear power plant will be constructed and operated, and 
licensees and other entities may rely on a local hospital or other 
organization that meets the requirements of 49 CFR Part 40, ``Procedures 
for Department of Transportation Workplace Drug and Alcohol Testing 
Programs'' (65 FR 41944; August 9, 2001) to collect his or

[[Page 471]]

her specimens for drug and alcohol testing;
    (v) Adjudicating reviews or appeals of access authorization 
determinations;
    (vi) Auditing the access authorization program; or
    (vii) Performing any of the activities or having any of the duties 
listed in paragraph (e)(6) of this section for any C/V upon whom the 
licensee's or other entity's access authorization program will rely.
    (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 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 
and K 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 and K 
of this part, and, at the licensee's or other entity's discretion, 
subpart C of this part:
    (1) All persons who can link test results with the individual who 
was tested before an FFD policy violation determination is made, 
including, but not limited to the MRO;
    (2) All persons who make determinations of fitness;
    (3) All persons who make authorization decisions;
    (4) All persons involved in selecting or notifying individuals for 
testing; and
    (5) All persons involved in the collection or onsite testing of 
specimens.
    (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, 26.39, and the applicable requirements of subparts C, 
and E through H of this part.
    (i) The following individuals are not subject to an FFD program 
under this part:
    (1) Individuals who are not employed by a licensee or other entity 
in this part, who do not routinely provide FFD program services to a 
licensee or other entity in this part, and whose normal workplace is not 
at the licensee's or other entity's facility, but who may be called on 
to provide an FFD program service, including, but not limited to, 
collecting specimens for drug and alcohol testing, performing behavioral 
observation, or providing input to a determination of fitness. Such 
individuals may include, but are not limited to, hospital, employee 
assistance program (EAP) or substance abuse treatment facility 
personnel, or other medical professionals;
    (2) NRC employees, law enforcement personnel, or offsite emergency 
fire and medical response personnel while responding on site;
    (3) SSNM transporter personnel who are subject to U.S. Department of 
Transportation drug and alcohol FFD programs that require random testing 
for drugs and alcohol; and
    (4) The FFD program personnel of a program that is regulated by 
another Federal agency or State on which a licensee or other entity 
relies to meet the requirements of this part, as permitted under 
Sec. Sec.26.4(j), 26.31(b)(2), and 26.405(e), if the FFD program 
personnel are not employed by the licensee or other entity and their 
normal workplace is not at the licensee's or other entity's facility.
    (j) Individuals who are subject to this part and who are also 
subject to a program regulated by another Federal agency or State need 
be covered by only those elements of an FFD program that are not 
included in the Federal agency or State program, as long as all of the 
following conditions are met:
    (1) The individuals are subject to pre-access (or pre-employment), 
random, for-cause, and post-event testing for the drugs and drug 
metabolites specified in Sec.26.31(d)(1) at or below the cutoff levels 
specified in Sec.26.163(a)(1) for initial drug testing and in Sec.
26.163(b)(1) for confirmatory drug testing;

[[Page 472]]

    (2) The individuals are subject to pre-access (or pre-employment), 
random, for-cause, and post-event testing for alcohol at or below the 
cutoff levels specified in Sec.26.103(a) and breath specimens are 
subject to confirmatory testing, if required, with an EBT that meets the 
requirements specified in Sec.26.91;
    (3) Urine specimens are tested for validity and the presence of 
drugs and drug metabolites at a laboratory certified by the Department 
of Health and Human Services (HHS);
    (4) Training is provided to address the knowledge and abilities 
(KAs) listed in Sec.26.29(a)(1) through (a)(10); and
    (5) Provisions are made to ensure that the testing agency or 
organization notifies the licensee or other entity granting 
authorization of any FFD policy violation.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010]



Sec.26.5  Definitions.

    Acute fatigue means fatigue from causes (e.g., restricted sleep, 
sustained wakefulness, task demands) occurring within the past 24 hours.
    Adulterated specimen means a urine specimen that has been altered, 
as evidenced by test results showing either a substance that is not a 
normal constituent of urine or showing an abnormal concentration of an 
endogenous substance.
    Alertness means the ability to remain awake and sustain attention.
    Aliquot means a portion of a specimen that is used for testing. It 
is taken as a sample representing the whole specimen.
    Analytical run means the process of testing a group of urine 
specimens for validity or for the presence of drugs and/or drug 
metabolites. For the purposes of defining the periods within which 
performance testing must be conducted by any licensee testing facility 
or HHS-certified laboratory that continuously processes specimens, an 
analytical run is defined as no more than an 8-hour period. For a 
facility that analyzes specimens in batches, an analytical run is 
defined as a group of specimens that are handled and tested together.
    Authorization means that a licensee or other entity in Sec.26.3 
has determined that an individual has met the requirements of this part 
to be granted or maintain the types of access or perform the duties 
specified in Sec.26.4(a) through (e), and, at the licensee's or other 
entity's discretion, Sec.26.4(f) or (g).
    Best effort means documented actions that a licensee or other entity 
who is subject to subpart C of this part takes to obtain suitable 
inquiry and employment information in order to determine whether an 
individual may be granted authorization, when the primary source of 
information refuses or indicates an inability or unwillingness to 
provide the information within 3 business days of the request and the 
licensee or other entity relies on a secondary source to meet the 
requirement.
    Blood alcohol concentration (BAC) means the mass of alcohol in a 
volume of blood.
    Calibrator means a solution of known concentration which is used to 
define expected outcomes of a measurement procedure or to compare the 
response obtained with the response of a test specimen/sample. The 
concentration of the analyte of interest in the calibrator is known 
within limits ascertained during its preparation. Calibrators may be 
used to establish a cutoff concentration and/or a calibration curve over 
a range of interest.
    Category IA material means SSNM that is directly usable in the 
manufacture of a nuclear explosive device, except if the material meets 
any of the following criteria:
    (1) The dimensions are large enough (at least 2 meters in one 
dimension, greater than 1 meter in each of two dimensions, or greater 
than 25 centimeters in each of three dimensions) to preclude hiding the 
item on an individual;
    (2) The total weight of an encapsulated item of SSNM is such that it 
cannot be carried inconspicuously by one person (i.e., at least 50 
kilograms gross weight); or
    (3) The quantity of SSNM (less than 0.05 formula kilograms) in each 
container requires protracted diversions to accumulate 5 formula 
kilograms.

[[Page 473]]

    Chain of custody means procedures to account for the integrity of 
each specimen or aliquot by tracking its handling and storage from the 
point of specimen collection to final disposition of the specimen and 
its aliquots. ``Chain of custody'' and ``custody and control'' are 
synonymous and may be used interchangeably.
    Circadian variation in alertness and performance means the increases 
and decreases in alertness and cognitive/motor functioning caused by 
human physiological processes (e.g., body temperature, release of 
hormones) that vary on an approximately 24-hour cycle.
    Collection site means a designated place where individuals present 
themselves for the purpose of providing a specimen of their urine, oral 
fluids, and/or breath to be analyzed for the presence of drugs or 
alcohol.
    Collector means a person who is trained in the collection procedures 
of subpart E, instructs and assists a specimen donor at a collection 
site, and receives and makes an initial examination of the specimen(s) 
provided by the donor.
    Commission means the U.S. Nuclear Regulatory Commission (NRC) or its 
duly authorized representatives.
    Confirmatory drug or alcohol test means a second analytical 
procedure to identify the presence of alcohol or a specific drug or drug 
metabolite in a specimen. The purpose of a confirmatory test is to 
ensure the reliability and accuracy of an initial test result.
    Confirmatory validity test means a second test performed on a 
different aliquot of the original urine specimen to further support a 
validity test result.
    Confirmed test result means a test result that demonstrates that an 
individual has used drugs and/or alcohol in violation of the 
requirements of this part or has attempted to subvert the testing 
process by submitting an adulterated or substituted urine specimen. For 
drugs, adulterants, and substituted specimens, a confirmed test result 
is determined by the Medical Review Officer (MRO), after discussion with 
the donor subsequent to the MRO's receipt of a positive confirmatory 
drug test result from the HHS-certified laboratory and/or a confirmatory 
substituted or adulterated validity test result from the HHS-certified 
laboratory for that donor. For alcohol, a confirmed test result is based 
on a positive confirmatory alcohol test result from an evidential breath 
testing device (EBT) without MRO review of the test result.
    Constructing or construction activities mean, 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.
    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), who is providing work or services to a licensee or other 
entity covered in Sec.26.3(a) through (c), either by contract, 
purchase order, oral agreement, or other arrangement.
    Control means a sample used to monitor the status of an analysis to 
maintain its performance within predefined limits.
    Cumulative fatigue means the increase in fatigue over consecutive 
sleep-wake periods resulting from inadequate rest.
    Cutoff level means the concentration or decision criteria 
established for designating and reporting a test result as positive, of 
questionable validity (referring to validity screening or initial 
validity test results from a licensee testing facility), or adulterated, 
substituted, dilute, or invalid (referring to initial or confirmatory 
test results from an HHS-certified laboratory).
    Dilute specimen means a urine specimen with creatinine and specific 
gravity concentrations that are lower than expected for human urine.
    Directing means the exercise of control over a work activity by an 
individual who is directly involved in the execution of the work 
activity, and either makes technical decisions for that activity without 
subsequent technical review, or is ultimately responsible for the 
correct performance of that work activity.
    Donor means the individual from whom a specimen is collected.

[[Page 474]]

    Eight (8)-hour shift schedule means a schedule that averages not 
more than 9 hours per workday over the entire shift cycle.
    Employment action means a change in job responsibilities or removal 
from a job, or the employer-mandated implementation of a plan for 
substance abuse treatment in order to avoid a change in or removal from 
a job, because of the individual's use of drugs or alcohol.
    Fatigue means the degradation in an individual's cognitive and motor 
functioning resulting from inadequate rest.
    Formula quantity means SSNM in any combination in a quantity of 5000 
grams or more computed by the formula, grams = (grams contained U-235) + 
2.5 (grams U-233 + grams plutonium). This class of material is sometimes 
referred to as a Category I quantity of material.
    HHS-certified laboratory means a laboratory that is certified to 
perform urine drug testing under the Department of Health and Human 
Services Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (the HHS Guidelines), which were published in the Federal 
Register on April 11, 1988 (53 FR 11970), and as amended, June 9, 1994 
(59 FR 29908), November 13, 1998 (63 FR 63483), and April 13, 2004 (69 
FR 19643).
    Illegal drug means, for the purposes of this regulation, any drug 
that is included in Schedules I to V of section 202 of the Controlled 
Substances Act [21 U.S.C. 812], but not when used pursuant to a valid 
prescription or when used as otherwise authorized by law.
    Increased threat condition means an increase in the protective 
measure level, relative to the lowest protective measure level 
applicable to the site during the previous 60 days, as promulgated by an 
NRC Advisory.
    Initial drug test means a test to differentiate ``negative'' 
specimens from those that require confirmatory drug testing.
    Initial validity test means a first test used to determine whether a 
specimen is adulterated, dilute, substituted, or invalid, and may 
require confirmatory validity testing.
    Invalid result means the result reported by an HHS-certified 
laboratory for a specimen that contains an unidentified adulterant, 
contains an unidentified interfering substance, has an abnormal physical 
characteristic, contains inconsistent physiological constituents, or has 
an endogenous substance at an abnormal concentration that prevents the 
laboratory from completing testing or obtaining a valid drug test 
result.
    Legal action means a formal action taken by a law enforcement 
authority or court of law, including an arrest, an indictment, the 
filing of charges, a conviction, or the mandated implementation of a 
plan for substance abuse treatment in order to avoid a permanent record 
of an arrest or conviction, in response to any of the following 
activities:
    (1) The use, sale, or possession of illegal drugs;
    (2) The abuse of legal drugs or alcohol; or
    (3) The refusal to take a drug or alcohol test.
    Licensee testing facility means a drug and specimen validity testing 
facility that is operated by a licensee or other entity who is subject 
to this part to perform tests of urine specimens.
    Limit of detection (LOD) means the lowest concentration of an 
analyte that an analytical procedure can reliably detect, which could be 
significantly lower than the established cutoff levels.
    Limit of quantitation (LOQ) means the lowest concentration of an 
analyte at which the concentration of the analyte can be accurately 
determined under defined conditions.
    Maintenance means, for the purposes of Sec.26.4(a)(4), the 
following onsite maintenance activities: Modification, surveillance, 
post-maintenance testing, and corrective and preventive maintenance.
    Medical Review Officer (MRO) means a licensed physician who is 
responsible for receiving laboratory results generated by a Part 26 drug 
testing program and who has the appropriate medical training to properly 
interpret and evaluate an individual's drug and validity test results 
together with his or her medical history and any other relevant 
biomedical information.

[[Page 475]]

    Nominal means the limited flexibility that is permitted in meeting a 
scheduled due date for completing a recurrent activity that is required 
under this part, such as the nominal 12-month frequency required for FFD 
refresher training in Sec.26.29(c)(2) and the nominal 12-month 
frequency required for certain audits in Sec.26.41(c)(1). Completing a 
recurrent activity at a nominal frequency means that the activity may be 
completed within a period that is 25 percent longer or shorter than the 
period required in this part. The next scheduled due date would be no 
later than the current scheduled due date plus the required frequency 
for completing the activity.
    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), but is not 
licensed by the NRC.
    Oxidizing adulterant means a substance that acts alone or in 
combination with other substances to oxidize drugs or drug metabolites 
to prevent the detection of the drugs or drug metabolites, or a 
substance that affects the reagents in either the initial or 
confirmatory drug test. Examples of these agents include, but are not 
limited to, nitrites, pyridinium chlorochromate, chromium (VI), bleach, 
iodine/iodide, halogens, peroxidase, and peroxide.
    Positive result means, for drug testing, the result reported by a 
licensee testing facility or HHS-certified laboratory when a specimen 
contains a drug or drug metabolite equal to or greater than the cutoff 
concentration. A result reported by an HHS-certified laboratory that a 
specimen contains a drug or drug metabolite below the cutoff 
concentration is also a positive result when the laboratory has 
conducted the special analysis permitted in Sec.26.163(a)(2). For 
alcohol testing, a positive result means the result reported by a 
collection site when the BAC indicated by testing a specimen is equal to 
or greater than the cutoff concentrations established in this part.
    Potentially disqualifying FFD information means information 
demonstrating that an individual has--
    (1) Violated a licensee's or other entity's FFD policy;
    (2) Had authorization denied or terminated unfavorably under 
Sec. Sec.26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c), 
26.69(f), or 26.75(b) through (e);
    (3) Used, sold, or possessed illegal drugs;
    (4) Abused legal drugs or alcohol;
    (5) Subverted or attempted to subvert a drug or alcohol testing 
program;
    (6) Refused to take a drug or alcohol test;
    (7) Been subjected to a plan for substance abuse treatment (except 
for self-referral); or
    (8) Had legal action or employment action, as defined in this 
section, taken for alcohol or drug use.
    Protected area has the same meaning as in Sec.73.2(g) of this 
chapter: An area encompassed by physical barriers and to which access is 
controlled.
    Quality control sample means a sample used to evaluate whether an 
analytical procedure is operating within predefined tolerance limits. 
Calibrators, controls, negative samples, and blind performance test 
samples are collectively referred to as ``quality control samples'' and 
each is individually referred to as a ``sample.''
    Questionable validity means the results of validity screening or 
initial validity tests at a licensee testing facility indicating that a 
urine specimen may be adulterated, substituted, dilute, or invalid.
    Reviewing official means an employee of a licensee or other entity 
specified in Sec.26.3(a) through (c), 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) mean, for 
the purposes of this part, those structures, systems, and components 
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

[[Page 476]]

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 10 CFR 50.34(a)(1).
    Security-related SSCs mean, 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 (c)(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 (c)(2), respectively.
    Shift cycle means a series of consecutive work shifts and days off 
that is planned by the licensee or other entity to repeat regularly, 
thereby constituting a continuous shift schedule.
    Standard means a reference material of known purity or a solution 
containing a reference material at a known concentration.
    Strategic special nuclear material (SSNM) means uranium-235 
(contained in uranium enriched to 20 percent or more in the uranium-235 
isotope), uranium-233, or plutonium.
    Substance abuse means the use, sale, or possession of illegal drugs, 
or the abuse of prescription and over-the-counter drugs, or the abuse of 
alcohol.
    Substituted specimen means a specimen with creatinine and specific 
gravity values that are so diminished or so divergent that they are not 
consistent with normal human physiology.
    Subversion and subvert the testing process mean a willful act to 
avoid being tested or to bring about an inaccurate drug or alcohol test 
result for oneself or others at any stage of the testing process 
(including selection and notification of individuals for testing, 
specimen collection, specimen analysis, and test result reporting), and 
adulterating, substituting, or otherwise causing a specimen to provide 
an inaccurate test result.
    Supervises or manages means the exercise of control over a work 
activity by an individual who is not directly involved in the execution 
of the work activity, but who either makes technical decisions for that 
activity without subsequent technical review, or is ultimately 
responsible for the correct performance of that work activity.
    Ten (10)-hour shift schedule means a schedule that averages more 
than 9 hours, but not more than 11 hours, per workday over the entire 
shift cycle.
    Transporter means a general licensee, under 10 CFR 70.20(a), who is 
authorized to possess formula quantities of SSNM, in the regular course 
of carriage for another or storage incident thereto, and includes the 
driver or operator of any conveyance, and the accompanying guards or 
escorts.
    Twelve (12)-hour shift schedule means a schedule that averages more 
than 11 hours, but not more than 12 hours, per workday over the entire 
shift cycle.
    Unit outage means, for the purposes of this part, that the reactor 
unit is disconnected from the electrical grid.
    Validity screening test means a test to determine the need for 
initial validity testing of a urine specimen, using a non-instrumented 
test in which the endpoint result is obtained by visual evaluation (read 
by the human eye), or a test that is instrumented to the extent that 
results are machine-read.
    Validity screening test lot means a group of validity screening 
tests that were made from the same starting material.

[73 FR 17176, Mar. 31, 2008, as amended at 81 FR 86909, Dec. 2, 2016; 83 
FR 58464, Nov. 20, 2018]



Sec.26.7  Interpretations.

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



Sec.26.8  Information collection requirements: OMB approval.

    (a) The NRC has submitted the information collection requirements 
contained in this part for approval by the Office of Management and 
Budget (OMB), as required by the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.).

[[Page 477]]

The NRC may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. OMB has approved the information collection 
requirements contained in this part under control number 3150-0146.
    (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, 
26.155, 26.157, 26.159, 26.163, 26.165, 26.167, 26.168, 26.169, 26.183, 
26.185, 26.187, 26.189, 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, 26.711, 26.713, 
26.715, 26.717, 26.719, and 26.821.



Sec.26.9  Specific exemptions.

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



Sec.26.11  Communications.

    Except where otherwise specified in this part, all communications, 
applications, and reports concerning the regulations in this part must 
be sent either by mail addressed to ATTN: NRC Document Control Desk, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand 
delivery to the NRC's offices at 11555 Rockville Pike, Rockville, 
Maryland, between the hours of 8:15 a.m. and 4 p.m. eastern time; or, 
where practicable, by electronic submission, for example, via Electronic 
Information Exchange, e-mail, or CD-ROM. Electronic submissions must be 
made in a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information. Copies of all communications must be sent to the 
appropriate regional office and resident inspector (addresses for the 
NRC Regional Offices are listed in Appendix D to Part 20 of this 
chapter).

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 62681, Dec. 1, 2009; 80 
FR 74979, Dec. 1, 2015]



                       Subpart B_Program Elements



Sec.26.21  Fitness-for-duty program.

    The licensees and other entities specified in Sec.26.3(a) through 
(c) 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 meet the applicable requirements of this part.



Sec.26.23  Performance objectives.

    Fitness-for-duty programs must--
    (a) Provide reasonable assurance that individuals are trustworthy 
and reliable as demonstrated by the avoidance of substance abuse;
    (b) Provide reasonable assurance that individuals are not under the 
influence of any substance, legal or illegal, or mentally or physically 
impaired from any cause, which in any way adversely affects their 
ability to safely and competently perform their duties;
    (c) Provide reasonable measures for the early detection of 
individuals who are not fit to perform the duties that require them to 
be subject to the FFD program;
    (d) Provide reasonable assurance that the workplaces subject to this 
part are

[[Page 478]]

free from the presence and effects of illegal drugs and alcohol; and
    (e) Provide reasonable assurance that the effects of fatigue and 
degraded alertness on individuals' abilities to safely and competently 
perform their duties are managed commensurate with maintaining public 
health and safety.



Sec.26.25  [Reserved]



Sec.26.27  Written policy and procedures.

    (a) General. Each licensee and other entity shall establish, 
implement, and maintain written policies and procedures to meet the 
general performance objectives and applicable requirements of this part.
    (b) Policy. The FFD policy statement must be clear, concise, and 
readily available, in its most current form, to all individuals who are 
subject to the policy. Methods of making the statement readily available 
include, but are not limited to, posting the policy in multiple work 
areas, providing individuals with brochures, or allowing individuals to 
print the policy from a computer. The 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. At a minimum, the written policy statement 
must--
    (1) Describe the consequences of the following actions:
    (i) The use, sale, or possession of illegal drugs on or off site;
    (ii) The abuse of legal drugs and alcohol; and
    (iii) The misuse of prescription and over-the-counter drugs;
    (2) Describe the requirement that individuals who are notified that 
they have been selected for random testing must report to the collection 
site within the time period specified by the licensee or other entity;
    (3) Describe the actions that constitute a refusal to provide a 
specimen for testing, the consequences of a refusal to test, as well as 
the consequences of subverting or attempting to subvert the testing 
process;
    (4) Prohibit the consumption of alcohol, at a minimum--
    (i) Within an abstinence period of 5 hours preceding the 
individual's arrival at the licensee's or other entity's facility, 
except as permitted in Sec.26.27(c)(3); and
    (ii) During the period of any tour of duty;
    (5) 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;
    (6) Address other factors that could affect FFD, such as mental 
stress, fatigue, or illness, and the use of prescription and over-the-
counter medications that could cause impairment;
    (7) Provide a description of any program that is available to 
individuals who are seeking assistance in dealing with drug, alcohol, 
fatigue, or other problems that could adversely affect an individual's 
ability to safely and competently perform the duties that require an 
individual to be subject to this subpart;
    (8) Describe the consequences of violating the policy;
    (9) Describe the individual's responsibility to report legal 
actions, as defined in Sec.26.5;
    (10) Describe the responsibilities of managers, supervisors, and 
escorts to report FFD concerns; and
    (11) Describe the individual's responsibility to report FFD 
concerns.
    (c) Procedures. Each licensee and other entity shall prepare, 
implement, and maintain written procedures that describe the methods to 
be used in implementing the FFD policy and the requirements of this 
part. The procedures must--
    (1) Describe the methods and techniques to be used in testing for 
drugs and alcohol, including procedures for protecting the privacy and 
other rights (including due process) of an individual who provides a 
specimen, procedures for protecting the integrity of the specimen, and 
procedures used to ensure that the test results are valid and 
attributable to the correct individual;
    (2) Describe immediate and followup actions that will be taken, and 
the procedures to be used, in those cases in which individuals are 
determined to have--

[[Page 479]]

    (i) Been involved in the use, sale, or possession of illegal drugs;
    (ii) Consumed alcohol to excess before the mandatory pre-work 
abstinence period, or consumed any alcohol during the mandatory pre-work 
abstinence period or while on duty, as determined by a test that 
measures BAC;
    (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
    (v) Had legal action taken relating to drug or alcohol use, as 
defined in Sec.26.5;
    (3) Describe the process that the licensee or other entity will use 
to ensure that individuals who are called in to perform an unscheduled 
working tour are fit for duty. At a minimum--
    (i) The procedure must require the individual who is called in to 
state whether the individual considers himself or herself fit for duty 
and whether he or she has consumed alcohol within the pre-duty 
abstinence period stated in the policy;
    (ii) If the individual has consumed alcohol within this period and 
the individual is called in for an unscheduled working tour, including 
an unscheduled working tour to respond to an emergency, the procedure 
must--
    (A) Require a determination of fitness by breath alcohol analysis or 
other means;
    (B) Permit the licensee or other entity to assign the individual to 
duties that require him or her to be subject to this subpart, if the 
results of the determination of fitness indicate that the individual is 
fit to safely and competently perform his or her duties;
    (C) Prohibit the licensee or other entity from assigning the 
individual to duties that require him or her to be subject to this 
subpart, if the individual is not required to respond to an emergency 
and the results of the determination of fitness indicate that the 
individual may be impaired;
    (D) State that consumption of alcohol during the 5-hour abstinence 
period required in paragraph (b)(4)(i) of this section may not by itself 
preclude a licensee or other entity from using individuals who are 
needed to respond to an emergency. However, if the determination of 
fitness indicates that an individual who has been called in for an 
unscheduled working tour to respond to an emergency may be impaired, the 
procedure must require the establishment of controls and conditions 
under which the individual who has been called in can perform work, if 
necessary; and
    (E) State that no sanctions may be imposed on an individual who is 
called in to perform any unscheduled working tour for having consumed 
alcohol within the pre-duty abstinence period stated in the policy.
    (iii) If the individual reports that he or she considers himself or 
herself to be unfit for duty for other reasons, including illness, 
fatigue, or other potentially impairing conditions, and the individual 
is called in, the procedure must require the establishment of controls 
and conditions under which the individual can perform work, if 
necessary;
    (4) Describe the process to be followed if an individual's behavior 
raises a concern regarding the possible use, sale, or possession of 
illegal drugs on or off site; the possible possession or consumption of 
alcohol on site; or impairment from any cause which in any way could 
adversely affect the individual's ability to safely and competently 
perform his or her duties. The procedure must require that individuals 
who have an FFD concern about another individual's behavior shall 
contact the personnel designated in the procedures to report the 
concern.
    (d) Review. The NRC may, at any time, review the written policy and 
procedures to assure that they meet the performance objectives and 
requirements of this part.



Sec.26.29  Training.

    (a) Training content. Licensees and other entities shall ensure that 
the individuals who are subject to this subpart have the following KAs:
    (1) Knowledge of the policy and procedures that apply to the 
individual, the methods that will be used to implement them, and the 
consequences of violating the policy and procedures;

[[Page 480]]

    (2) Knowledge of the individual's role and responsibilities under 
the FFD program;
    (3) Knowledge of the roles and responsibilities of others, such as 
the MRO and the human resources, FFD, and EAP staffs;
    (4) Knowledge of the EAP services available to the individual;
    (5) Knowledge of the personal and public health and safety hazards 
associated with abuse of illegal and legal drugs and alcohol;
    (6) Knowledge of the potential adverse effects on job performance of 
prescription and over-the-counter drugs, alcohol, dietary factors, 
illness, mental stress, and fatigue;
    (7) Knowledge of the prescription and over-the-counter drugs and 
dietary factors that have the potential to affect drug and alcohol test 
results;
    (8) Ability to recognize illegal drugs and indications of the 
illegal use, sale, or possession of drugs;
    (9) Ability to observe and detect performance degradation, 
indications of impairment, or behavioral changes; and
    (10) Knowledge of the individual's responsibility to report an FFD 
concern and the ability to initiate appropriate actions, including 
referrals to the EAP and person(s) designated by the licensee or other 
entity to receive FFD concerns.
    (b) Comprehensive examination. Individuals who are subject to this 
subpart shall demonstrate the successful completion of training by 
passing a comprehensive examination that addresses the KAs in paragraph 
(a) of this section. The examination must include a comprehensive random 
sampling of all KAs with questions that test each KA, including at least 
one question for each KA. The minimum passing score required must be 80 
percent. Remedial training and testing are required for individuals who 
fail to answer correctly at least 80 percent of the test questions. The 
examination may be administered using a variety of media, including, but 
not limited to, hard-copy test booklets with separate answer sheets or 
computer-based questions.
    (c) Training administration. Licensees and other entities shall 
ensure that individuals who are subject to this subpart are trained, as 
follows:
    (1) Training must be completed before the licensee or other entity 
grants initial authorization, as defined in Sec.26.55, and must be 
current before the licensee or other entity grants an authorization 
update, as defined in Sec.26.57, or authorization reinstatement, as 
defined in Sec.26.59;
    (2) Individuals shall complete refresher training on a nominal 12-
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. Individuals who 
pass a comprehensive annual examination that meets the requirements in 
paragraph (b) of this section may forgo the refresher training; and
    (3) Initial and refresher training may be delivered using a variety 
of media (including, but not limited to, classroom lectures, required 
reading, video, or computer-based training systems). The licensee or 
other entity shall monitor the completion of training and provide a 
qualified instructor or designated subject matter expert to answer 
questions during the course of training.
    (d) Acceptance of training. Licensees and other entities may accept 
training of individuals who have been subject to another training 
program that meets the requirements of this section and who have, within 
the past 12 months, either had initial or refresher training, or have 
successfully passed a comprehensive examination that meets the 
requirements in paragraph (b) of this section.



Sec.26.31  Drug and alcohol testing.

    (a) General. To provide a means to deter and detect substance abuse, 
licensees and other entities who are subject to this part shall 
implement drug and alcohol testing programs for individuals who are 
subject to this subpart.
    (b) Assuring the honesty and integrity of FFD program personnel. (1) 
Licensees and other entities who are subject to this subpart shall 
carefully select and

[[Page 481]]

monitor FFD program personnel, as defined in Sec.26.4(g), based on the 
highest standards of honesty and integrity, and shall implement measures 
to ensure that these standards are maintained. The measures must ensure 
that the honesty and integrity of these individuals are not compromised 
and that FFD program personnel are not subject to influence attempts 
attributable to personal relationships with any individuals who are 
subject to testing, an undetected or untreated substance abuse problem, 
or other factors. At a minimum, these measures must include the 
following considerations:
    (i) Licensees and other entities shall complete appropriate 
background investigations, credit and criminal history checks, and 
psychological assessments of FFD program personnel before assignment to 
tasks directly associated with administration of the FFD program. The 
background investigations, credit and criminal history checks, and 
psychological assessments that are conducted to grant unescorted access 
authorization to individuals under a nuclear power plant licensee's 
access authorization program are acceptable to meet the requirements of 
this paragraph. The credit and criminal history checks and psychological 
assessments must be updated nominally every 5 years;
    (ii) Individuals who have personal relationships with a donor may 
not perform any assessment or evaluation procedures, including, but not 
limited to, determinations of fitness. These personal relationships may 
include, but are not limited to, supervisors, coworkers within the same 
work group, and relatives of the donor;
    (iii) Except if a directly observed collection is required, a 
collector who has a personal relationship with the donor may collect 
specimens from the donor only if the integrity of specimen collections 
in these instances is assured through the following means:
    (A) The collection must be monitored by an individual who does not 
have a personal relationship with the donor and who is designated by the 
licensee or other entity for this purpose, including, but not limited 
to, security force or quality assurance personnel; and
    (B) Individuals who are designated to monitor collections in these 
instances shall be trained to monitor specimen collections and the 
preparation of specimens for transfer or shipping under the requirements 
of this part;
    (iv) If a specimen must be collected under direct observation, the 
collector or an individual who serves as the observer, as permitted 
under Sec.26.115(e), may not have a personal relationship with the 
donor; and
    (v) FFD program personnel shall be subject to a behavioral 
observation program designed to assure that they continue to meet the 
highest standards of honesty and integrity. When an MRO and MRO staff 
are on site at a licensee's or other entity's facility, the MRO and MRO 
staff shall be subject to behavioral observation.
    (2) Licensees and other entities may rely on a local hospital or 
other organization that meets the requirements of 49 CFR Part 40, 
``Procedures for Department of Transportation Workplace Drug and Alcohol 
Testing Programs'' (65 FR 41944; August 9, 2001) to collect specimens 
for drug and alcohol testing from the FFD program personnel listed in 
Sec.26.4(g).
    (c) Conditions for testing. Licensees and other entities shall 
administer drug and alcohol tests to the individuals who are subject to 
this subpart under the following conditions:
    (1) Pre-access. In order to grant initial, updated, or reinstated 
authorization to an individual, as specified in subpart C of this part;
    (2) For cause. In response to an individual's observed behavior or 
physical condition indicating possible substance abuse or after 
receiving credible information that an individual is engaging in 
substance abuse, as defined in Sec.26.5;
    (3) Post-event. As soon as practical after an event involving a 
human error that was committed by an individual who is subject to this 
subpart, where the human error may have caused or contributed to the 
event. The licensee or other entity shall test the individual(s) who 
committed the error(s), and need not test individuals who were affected 
by the event whose actions likely did not cause or contribute to

[[Page 482]]

the event. The individual(s) who committed the human error(s) shall be 
tested if the event resulted in--
    (i) A significant illness or personal injury to the individual to be 
tested or another individual, which within 4 hours after the event is 
recordable under the Department of Labor standards contained in 29 CFR 
1904.7, ``General Recording Criteria,'' and subsequent amendments 
thereto, and 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 
physician or other licensed health care professional, even if it does 
not result in death, days away from work, restricted work or job 
transfer, medical treatment beyond first aid, or loss of consciousness;
    (ii) A radiation exposure or release of radioactivity in excess of 
regulatory limits; or
    (iii) Actual or potential substantial degradations of the level of 
safety of the plant;
    (4) Follow-up. As part of a follow-up plan to verify an individual's 
continued abstinence from substance abuse; and
    (5) Random. On a statistically random and unannounced basis, so that 
all individuals in the population subject to testing have an equal 
probability of being selected and tested.
    (d) General requirements for drug and alcohol testing--(1) 
Substances tested. At a minimum, licensees and other entities shall test 
for marijuana metabolite, cocaine metabolite, opiates (codeine, 
morphine, 6-acetylmorphine), amphetamines (amphetamine, 
methamphetamine), phencyclidine, adulterants, and alcohol.
    (i) In addition, licensees and other entities may consult with local 
law enforcement authorities, hospitals, and drug counseling services to 
determine whether other drugs with abuse potential are being used in the 
geographical locale of the facility and by the local workforce that may 
not be detected in the panel of drugs and drug metabolites specified in 
paragraph (d)(1) of this section.
    (A) When appropriate, the licensee or other entity may add other 
drugs identified under paragraph (d)(1)(i) of this section to the panel 
of substances for testing, but only if the additional drugs are listed 
in Schedules I through V of section 202 of the Controlled Substances Act 
[21 U.S.C. 812].
    (B) The licensee or other entity shall establish appropriate cutoff 
limits for these substances.
    (C) The licensee or other entity shall establish rigorous testing 
procedures for these substances that are consistent with the intent of 
this part, so that the MRO can evaluate the use of these substances.
    (D) The licensee or other entity may not conduct an analysis for any 
drug or drug metabolites except those identified in paragraph (d)(1) of 
this section unless the assay and cutoff levels to be used are certified 
in writing as scientifically sound and legally defensible by an 
independent, qualified forensic toxicologist who has no relationships 
with manufacturers of the assays or instruments to be used or the HHS-
certified laboratory that will conduct the testing for the licensee or 
other entity, which could be construed as a potential conflict of 
interest. The forensic toxicologist may not be an employee of the 
licensee or entity, and shall either be a Diplomate of the American 
Board of Forensic Toxicology or currently holds, has held, or is 
eligible to hold, the position of Responsible Person at an HHS-certified 
laboratory, as specified in Sec.26.155(a). All new assays and cutoff 
levels must be properly validated consistent with established forensic 
toxicological standards before implementation. Certification of the 
assay and cutoff levels is not required if the HHS Guidelines are 
revised to authorize use of the assay in testing for the additional drug 
or drug metabolites and the licensee or other entity uses the cutoff 
levels established in the HHS Guidelines for the drug or drug 
metabolites, or if the licensee or other entity received written 
approval of the NRC to test for the additional drug or drug metabolites 
before April 30, 2008.
    (ii) When conducting post-event, followup, and for-cause testing, as 
defined in Sec.26.31(c), licensees and other entities may test for any 
drugs listed on Schedules I through V of section 202 of the Controlled 
Substances Act [21 U.S.C. 812] that an individual is suspected of

[[Page 483]]

having abused, and may consider any drugs or metabolites so detected 
when determining appropriate action under subpart D of this part. If the 
drug or metabolites for which testing will be performed under this 
paragraph are not included in the FFD program's drug panel, the assay 
and cutoff levels to be used in testing for the additional drugs must be 
certified by a forensic toxicologist under paragraph (d)(1)(i)(D) of 
this section. Test results that fall below the established cutoff levels 
may not be considered when determining appropriate action under subpart 
D of this part, except if the specimen is dilute and the licensee or 
other entity has requested the HHS-certified laboratory to evaluate the 
specimen under Sec. Sec.26.163(a)(2) or 26.185(g)(3).
    (iii) The licensee or other entity shall document the additional 
drug(s) for which testing will be performed in written policies and 
procedures in which the substances for which testing will be performed 
are described.
    (2) Random testing. Random testing 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. At a minimum, the FFD program shall--
    (A) Take reasonable steps to either conceal from the workforce that 
collections will be performed during a scheduled collection period or 
create the appearance that specimens are being collected during a 
portion of each day on at least 4 days in each calendar week at each 
site. In the latter instance, the portions of each day and the days of 
the week must vary in a manner that cannot be predicted by donors; and
    (B) Collect specimens on an unpredictable schedule, including 
weekends, backshifts, and holidays, and at various times during a shift;
    (ii) At a minimum, be administered by the FFD program on a nominal 
weekly frequency;
    (iii) Require individuals who are selected for random testing to 
report to the collection site as soon as reasonably practicable after 
notification, within the time period specified in the FFD program 
policy;
    (iv) Ensure that all individuals in the population subject to 
testing have an equal probability of being selected and tested;
    (v) Require that individuals who are off site when selected for 
testing, or who are on site and are not reasonably available for testing 
when selected, shall be tested at the earliest reasonable and practical 
opportunity when both the donor and collectors are available to collect 
specimens for testing and without prior notification to the individual 
that he or she has been selected for testing;
    (vi) Provide that an individual completing a test is immediately 
eligible for another unannounced test; and
    (vii) 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.
    (3) Drug testing. (i) Testing of urine specimens for drugs and 
validity, except validity screening and initial drug and validity tests 
performed by licensee testing facilities under paragraph (d)(3)(ii) of 
this section, must be performed in a laboratory that is certified by HHS 
for that purpose, consistent with its standards and procedures for 
certification. Specimens sent to HHS-certified laboratories must be 
subject to initial validity and initial drug testing by the laboratory. 
Specimens that yield positive initial drug test results or are 
determined by initial validity testing to be of questionable validity 
must be subject to confirmatory testing by the laboratory, except for 
invalid specimens that cannot be tested. Licensees and other entities 
shall ensure that laboratories report results for all specimens sent for 
testing, including blind performance test samples.
    (ii) Licensees and other entities may conduct validity screening, 
initial validity, and initial drug tests of urine aliquots to determine 
which specimens are valid and negative and need no further testing, 
provided that the licensee's or other entity's staff possesses the 
necessary training and skills for

[[Page 484]]

the tasks assigned, the staff's qualifications are documented, and 
adequate quality controls for the testing are implemented.
    (iii) At a minimum, licensees and other entities shall apply the 
cutoff levels specified in Sec.26.163(a)(1) for initial drug testing 
at either the licensee testing facility or HHS-certified laboratory, and 
in Sec.26.163(b)(1) for confirmatory drug testing at the HHS-certified 
laboratory. At their discretion, licensees and other entities may 
implement programs with lower cutoff levels in testing for drugs and 
drug metabolites.
    (A) If a licensee or other entity implements lower cutoff levels, 
and the MRO determines that an individual has violated the FFD policy 
using the licensee's or other entity's more stringent cutoff levels, the 
individual shall be subject to all management actions and sanctions 
required by the licensee's or other entity's FFD policy and this part, 
as if the individual had a confirmed positive drug test result using the 
cutoff levels specified in this subpart. The licensee or other entity 
shall document the more stringent cutoff levels in any written policies 
and procedures in which cutoff levels for drug testing are described.
    (B) The licensee or other entity shall uniformly apply the cutoff 
levels listed in Sec.26.163(a)(1) for initial drug testing and in 
Sec.26.163(b)(1) for confirmatory drug testing, or any more stringent 
cutoff levels implemented by the FFD program, to all tests performed 
under this part and equally to all individuals who are tested under this 
part, except as permitted in Sec. Sec.26.31(d)(1)(ii), 26.163(a)(2), 
and 26.165(c)(2).
    (C) In addition, the scientific and technical suitability of any 
more stringent cutoff levels must be evaluated and certified, in 
writing, by a forensic toxicologist who meets the requirements set forth 
in Sec.26.31(d)(1)(i)(D). Certification of the more stringent cutoff 
levels is not required if the HHS Guidelines are revised to lower the 
cutoff levels for the drug or drug metabolites in Federal workplace drug 
testing programs and the licensee or other entity implements the cutoff 
levels published in the HHS Guidelines, or if the licensee or other 
entity received written approval of the NRC to test for lower cutoff 
levels before April 30, 2008.
    (4) Alcohol testing. Initial tests for alcohol must be administered 
by breath or oral fluids analysis using alcohol analysis devices that 
meet the requirements of Sec.26.91(a). If the initial test shows a BAC 
of 0.02 percent or greater, a confirmatory test for alcohol must be 
performed. The confirmatory test must be performed with an EBT that 
meets the requirements of Sec.26.91(b).
    (5) Medical conditions. (i) If an individual has a medical condition 
that makes collection of breath, oral fluids, or urine specimens 
difficult or hazardous, the MRO may authorize an alternative evaluation 
process, tailored to the individual case, to meet the requirements of 
this part for drug and alcohol testing. The alternative process must 
include measures to prevent subversion and achieve results that are 
comparable to those produced by urinalysis for drugs and breath analysis 
for alcohol.
    (ii) If an individual requires medical attention, including, but not 
limited to, an injured worker in an emergency medical facility who is 
required to have a post-event test, treatment may not be delayed to 
conduct drug and alcohol testing.
    (6) Limitations of testing. Specimens collected under NRC 
regulations may only be designated or approved for 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 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.

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38327, Aug. 3, 2009]



Sec.26.33  Behavioral observation.

    Licensees and other entities shall ensure that the individuals who 
are subject to this subpart are subject to behavioral observation. 
Behavioral observation must be performed by individuals who are trained 
under Sec.26.29 to detect behaviors that may indicate possible use, 
sale, or possession of illegal drugs; use or possession of alcohol on

[[Page 485]]

site or while on duty; or impairment from fatigue or any cause that, if 
left unattended, may constitute a risk to public health and safety or 
the common defense and security. Individuals who are subject to this 
subpart shall report any FFD concerns about other individuals to the 
personnel designated in the FFD policy.



Sec.26.35  Employee assistance programs.

    (a) Each licensee and other entity who is subject to this part shall 
maintain an EAP to strengthen the FFD program by offering confidential 
assessment, short-term counseling, referral services, and treatment 
monitoring to individuals who have problems that could adversely affect 
the individuals' abilities to safely and competently perform their 
duties. Employee assistance programs must be designed to achieve early 
intervention and provide for confidential assistance.
    (b) Licensees and other entities need not provide EAP services to a 
C/V's employees, including those whose work location is a licensee's or 
other entity's facility, or to individuals who have applied for, but 
have not yet been granted, authorization under subpart C of this part.
    (c) The EAP staff shall protect the identity and privacy of any 
individual (including those who have self-referred) seeking assistance 
from the EAP, except if the individual waives the right to privacy in 
writing or a determination is made that the individual's condition or 
actions pose or have posed an immediate hazard to himself or herself or 
others.
    (1) Licensees and other entities may not require the EAP to 
routinely report the names of individuals who self-refer to the EAP or 
the nature of the assistance the individuals sought.
    (2) If EAP personnel determine that an individual poses or has posed 
an immediate hazard to himself or herself or others, EAP personnel shall 
so inform FFD program management, and need not obtain a written waiver 
of the right to privacy from the individual. The individual conditions 
or actions that EAP personnel shall report to FFD program management 
include, but are not limited to, substantive reasons to believe that the 
individual--
    (i) Is likely to commit self-harm or harm to others;
    (ii) Has been impaired from using drugs or alcohol while in a work 
status and has a continuing substance abuse disorder that makes it 
likely he or she will be impaired while in a work status in the future; 
or
    (iii) Has ever engaged in any acts that would be reportable under 
Sec.26.719(b)(1) through (b)(3).
    (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 shall ensure that the requirements of Sec. Sec.26.69(d) and 
26.77(b) are implemented, as applicable.



Sec.26.37  Protection of information.

    (a) Each licensee or other entity who is subject to this subpart who 
collects personal information about an individual for the purpose of 
complying with this part, shall establish, use, and maintain a system of 
files and procedures that protects the individual's privacy.
    (b) Licensees and other entities shall obtain a signed consent that 
authorizes the disclosure of the personal information collected and 
maintained under this part before disclosing the personal information, 
except for disclosures to the following individuals:
    (1) The subject individual or his or her representative, when the 
individual has designated the representative in writing for specified 
FFD matters;
    (2) Assigned MROs and MRO staff;
    (3) NRC representatives;
    (4) Appropriate law enforcement officials under court order;
    (5) A licensee's or other entity's representatives who have a need 
to have access to the information to perform their assigned duties under 
the FFD program, including determinations of fitness, FFD program 
audits, or some human resources functions;
    (6) The presiding officer in a judicial or administrative proceeding 
that is initiated by the subject individual;
    (7) Persons deciding matters under review in Sec.26.39; and
    (8) Other persons pursuant to court order.

[[Page 486]]

    (c) Personal information that is collected under this subpart must 
be disclosed to other licensees and entities, including C/Vs, or their 
authorized representatives, who are legitimately seeking the information 
for authorization decisions as required by this part and who have 
obtained a signed release from the subject individual.
    (d) Upon receipt of a written request by the subject individual or 
his or her designated representative, the FFD program, including but not 
limited to, the collection site, HHS-certified laboratory, substance 
abuse expert (SAE), or MRO, possessing such records shall promptly 
provide copies of all FFD records pertaining to the individual, 
including, but not limited to, records pertaining to a determination 
that the individual has violated the FFD policy, drug and alcohol test 
results, MRO reviews, determinations of fitness, and management actions 
pertaining to the subject individual. The licensee or other entity shall 
obtain records related to the results of any relevant laboratory 
certification, review, or revocation-of-certification proceedings from 
the HHS-certified laboratory and provide them to the subject individual 
on request.
    (e) A licensee's or other entity's contracts with HHS-certified 
laboratories and C/Vs providing specimen collection services, and 
licensee testing facility procedures, must require test records to be 
maintained in confidence, except as provided in paragraphs (b), (c), and 
(d) of this section.
    (f) This section does not authorize the licensee or other entity to 
withhold evidence of criminal conduct from law enforcement officials.



Sec.26.39  Review process for fitness-for-duty policy violations.

    (a) Each licensee and other entity who is subject to this subpart 
shall establish procedures for the review of a determination that an 
individual who they employ or who has applied for authorization has 
violated the FFD policy. The review procedure must provide for an 
objective and impartial review of the facts related to the determination 
that the individual has violated the FFD policy.
    (b) The review procedure must provide notice to the individual of 
the grounds for the determination that the individual has violated the 
FFD policy, and must provide an opportunity for the individual to 
respond and submit additional relevant information.
    (c) The review procedure must ensure that the individual who 
conducts the review is not associated with the administration of the FFD 
program [see the description of FFD program personnel in Sec.26.4(g)]. 
Individuals who conduct the review may be management personnel.
    (d) If the review finds in favor of the individual, the licensee or 
other entity shall update the relevant records to reflect the outcome of 
the review and delete or correct all information the review found to be 
inaccurate.
    (e) When a C/V is administering an FFD program on which licensees 
and other entities rely, and the C/V determines that its employee, 
subcontractor, or applicant has violated its FFD policy, the C/V shall 
ensure that the review procedure required in this section is provided to 
the individual. Licensees and other entities who rely on a C/V's FFD 
program need not provide the review procedure required in this section 
to a C/V's employee, subcontractor, or applicant when the C/V is 
administering its own FFD program and the FFD policy violation was 
determined under the C/V's program.

[75 FR 73941, Nov. 30, 2010]



Sec.26.41  Audits and corrective action.

    (a) General. Each licensee and other entity who is subject to this 
subpart is responsible for the continuing effectiveness of the FFD 
program, including FFD program elements that are provided by C/Vs, the 
FFD programs of any C/Vs that are accepted by the licensee or other 
entity, any FFD program services that are provided to the C/V by a 
subcontractor, and the programs of the HHS-certified laboratories on 
whom the licensee or other entity and its C/Vs rely. Each licensee and 
other entity shall ensure that these programs are audited and that 
corrective actions are taken to resolve any problems identified.

[[Page 487]]

    (b) FFD program. Each licensee and other entity who is subject to 
this subpart shall ensure that the entire FFD program is audited as 
needed, but no less frequently than nominally every 24 months. Licensees 
and other entities are responsible for determining the appropriate 
frequency, scope, and depth of additional auditing activities within the 
nominal 24-month period based on the review of FFD program performance, 
including, but not limited to, the frequency, nature, and severity of 
discovered problems, testing errors, personnel or procedural changes, 
and previous audit findings.
    (c) C/Vs and HHS-certified laboratories. (1) FFD services that are 
provided to a licensee or other entity by C/V personnel who are off site 
or are not under the direct daily supervision or observation of the 
licensee's or other entity's personnel and HHS-certified laboratories 
must be audited on a nominal 12-month frequency.
    (2) Audits of HHS-certified laboratories that are conducted for 
licensees and other entities who are subject to this subpart need not 
duplicate areas inspected in the most recent HHS certification 
inspection. However, the licensee and other entity shall review the HHS 
certification inspection records and reports to identify any areas in 
which the licensee or other entity uses services that the HHS 
certification inspection did not address. The licensee or other entity 
shall ensure that any such areas are audited on a nominal 12-month 
frequency. Licensees and other entities need not audit organizations and 
professionals who may provide an FFD program service to the licensee or 
other entity, but who are not routinely involved in providing services 
to a licensee's or other entity's FFD program, as specified in Sec.
26.4(i)(1).
    (d) Contracts. (1) The contracts of licensees and other entities 
with C/Vs and HHS-certified laboratories must reserve the right to audit 
the C/V, the C/V's subcontractors providing FFD program services, and 
the HHS-certified laboratories at any time, including at unannounced 
times, as well as to review all information and documentation that is 
reasonably relevant to the audits.
    (2) Licensees' and other entities' contracts with C/Vs and HHS-
certified laboratories must also permit the licensee or other entity to 
obtain copies of and take away any documents, including reviews and 
inspections pertaining to a laboratory's certification by HHS, and any 
other data that may be needed to assure that the C/V, its 
subcontractors, or the HHS-certified laboratory are performing their 
functions properly and that staff and procedures meet applicable 
requirements. In a contract with a licensee or other entity who is 
subject to this subpart, an HHS-certified laboratory may reasonably 
limit the use and dissemination of any documents copied or taken away by 
the licensee's or other entity's auditors in order to ensure the 
protection of proprietary information and donors' privacy.
    (3) In addition, before awarding a contract, the licensee or other 
entity shall ensure completion of pre-award inspections and/or audits of 
the procedural aspects of the HHS-certified laboratory's drug-testing 
operations, except as provided in paragraph (g)(5) of this section.
    (e) Conduct of audits. Audits must focus on the effectiveness of the 
FFD program or program element(s), as appropriate, and must be conducted 
by individuals who are qualified in the subject(s) being audited. The 
individuals performing the audit of the FFD program or program 
element(s) shall be independent from both the subject FFD program's 
management and from personnel who are directly responsible for 
implementing the FFD program.
    (f) Audit results. The result of the audits, along with any 
recommendations, must be documented and reported to senior corporate and 
site management. Each audit report must identify conditions that are 
adverse to the proper performance of the FFD program, the cause of the 
condition(s), and recommended corrective actions. The licensee or other 
entity shall review the audit findings and take corrective actions, 
including re-auditing of the deficient areas where indicated, to 
preclude, within reason, repetition of the condition. The resolution of 
the audit findings and corrective actions must be documented.

[[Page 488]]

    (g) Sharing of audits. Licensees and other entities may jointly 
conduct audits, or may accept audits of C/Vs and HHS-certified 
laboratories that were conducted by other licensees and entities who are 
subject to this subpart, if the audit addresses the services obtained 
from the C/V or HHS-certified laboratory by each of the sharing 
licensees and other entities.
    (1) Licensees and other entities shall review audit records and 
reports to identify any areas that were not covered by the shared or 
accepted audit.
    (2) Licensees and other entities shall ensure that FFD program 
elements and services on which the licensee or entity relies are 
audited, if the program elements and services were not addressed in the 
shared audit.
    (3) Sharing licensees and other entities need not re-audit the same 
C/V or HHS-certified laboratory for the same period of time.
    (4) Each sharing licensee and other entity shall maintain a copy of 
the shared audit and HHS certification inspection records and reports, 
including findings, recommendations, and corrective actions.
    (5) If an HHS-certified laboratory loses its certification, in whole 
or in part, a licensee or other entity is permitted to immediately use 
another HHS-certified laboratory that has been audited within the 
previous 12 months by another NRC licensee or entity who is subject to 
this subpart. Within 3 months after the change, the licensee or other 
entity shall ensure that an audit is completed of any areas that have 
not been audited by another licensee or entity who is subject to this 
subpart within the past 12 months.

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38327, Aug. 3, 2009]



            Subpart C_Granting and Maintaining Authorization



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 meet the 
requirements of this subpart. Certain requirements in this subpart also 
apply to the individuals specified in Sec.26.4(h).



Sec.26.53  General provisions.

    (a) In order to grant authorization to an individual, a licensee or 
other entity shall ensure that the requirements in this subpart have 
been met for either initial authorization, authorization update, 
authorization reinstatement, or authorization with potentially 
disqualifying FFD information, as applicable.
    (b) For individuals who have previously held authorization under 
this part but whose authorization has since been favorably terminated, 
the licensee or other entity shall implement the requirements for either 
initial authorization, authorization update, or authorization 
reinstatement, based on the total number of days that the individual's 
authorization is interrupted, to include the day after the individual's 
last period of authorization was terminated and the intervening days 
until the day on which the licensee or other entity grants authorization 
to the individual. If potentially disqualifying FFD information is 
disclosed or discovered about an individual, licensees and other 
entities shall implement the applicable requirements in Sec.26.69 in 
order to grant or maintain an individual's authorization.
    (c) The licensee or other entity shall ensure that an individual has 
met the applicable FFD training requirements in Sec. Sec.26.29 and 
26.203(c) before granting authorization to the individual.
    (d) Licensees and other entities who are seeking to grant 
authorization to an individual who is maintaining authorization under 
another FFD program that is implemented by a licensee

[[Page 489]]

or entity who is subject to this subpart may rely on the transferring 
FFD program to satisfy the requirements of this subpart. The individual 
may maintain his or her authorization if he or she continues to be 
subject to either the receiving FFD program or the transferring FFD 
program, or a combination of elements from both programs that 
collectively satisfy the applicable requirements of this part. The 
receiving FFD program shall ensure that the program elements to which 
the individual is subject under the transferring FFD program remain 
current.
    (e) Licensees and other entities in Sec.26.3(a) through (c) may 
also rely on a C/V's FFD program or program elements when granting or 
maintaining the authorization of an individual who is or has been 
subject to the C/V's FFD program, if the C/V's program or program 
elements meet the applicable requirements of this part.
    (1) A C/V's FFD program may grant and maintain an individual's 
authorization, as defined in Sec.26.5, under the C/V's FFD program. 
However, only a licensee or other entity in Sec.26.3(a) through (c) 
may grant or maintain an individual's authorization to have the types of 
access or perform the duties specified in Sec.26.4(a) through (e) and 
(g), and, at the licensee's or other entity's discretion, Sec.26.4(f).
    (2) If a C/V's FFD program denies or unfavorably terminates an 
individual's authorization, and the individual is performing any duties 
for a licensee or other entity that are specified in Sec.26.4(a) 
through (e) and (g), or, at the licensee's or other entity's discretion, 
Sec.26.4(f), then the C/V shall inform the affected licensee or other 
entity of the denial or unfavorable termination. The licensee or other 
entity shall deny or unfavorably terminate the individual's 
authorization to perform those duties on the day that the licensee or 
other entity receives the information from the C/V, or implement the 
applicable process in Sec.26.69 to maintain the individual's 
authorization.
    (3) If an individual is maintaining authorization under a C/V's FFD 
program, a licensee or other entity in Sec.26.3(a) through (c) may 
grant authorization to the individual to have the types of access and 
perform the duties 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 
maintain his or her authorization, if the individual continues to be 
subject to either the receiving FFD program or a combination of elements 
from the receiving FFD program and the C/V's program that collectively 
satisfy the applicable requirements of this part. The receiving 
licensee's or other entity's FFD program shall ensure that the program 
elements to which the individual is subject under the C/V's FFD program 
remain current.
    (f) Licensees and other entities who are seeking to grant 
authorization to an individual who has been subject to an FFD program 
under subpart K may not rely on that program or its program elements to 
meet the requirements of this subpart, except if the program or program 
element(s) of the FFD program for construction satisfy the applicable 
requirements of this part.
    (g) The licensees and other entities specified in Sec.26.3(a) and, 
as applicable, (c) and (d), shall identify any violation of any 
requirement of this part to any licensee who has relied on or intends to 
rely on the FFD program element that is determined to be in violation of 
this part.
    (h) The licensees and other entities specified in Sec.26.3(a) and, 
as applicable, (c) and (d), may not initiate any actions under this 
subpart without the knowledge and written consent of the subject 
individual. The individual may withdraw his or her consent at any time. 
If an individual withdraws his or her consent, the licensee or other 
entity may not initiate any elements of the authorization process 
specified in this subpart that were not in progress at the time the 
individual withdrew his or her consent, but shall complete and document 
any elements that are in progress at the time consent is withdrawn. The 
licensee or other entity shall record the individual's application for 
authorization; his or her withdrawal of consent; the reason given by the 
individual for the withdrawal, if any; and any pertinent information 
gathered from the elements that were

[[Page 490]]

completed (e.g., the results of pre-access drug tests, information 
obtained from the suitable inquiry). The licensee or other entity to 
whom the individual has applied for authorization shall inform the 
individual that--
    (1) Withdrawal of his or her consent will withdraw the individual's 
current application for authorization under the licensee's or other 
entity's FFD program; and
    (2) Other licensees and entities will have access to information 
documenting the withdrawal as a result of the information sharing that 
is required under this part.
    (i) The licensees and other entities specified in Sec.26.3(a) and, 
as applicable, (c) and(d), shall inform, in writing, any individual who 
is applying for authorization that the following actions related to 
providing and sharing the personal information required under this 
subpart are sufficient cause for denial or unfavorable termination of 
authorization:
    (1) Refusal to provide written consent for the suitable inquiry;
    (2) Refusal to provide or the falsification of any personal 
information required under this part, including, but not limited to, the 
failure to report any previous denial or unfavorable termination of 
authorization;
    (3) Refusal to provide written consent for the sharing of personal 
information with other licensees or other entities required under this 
part; and
    (4) Failure to report any legal actions, as defined in Sec.26.5.



Sec.26.55  Initial authorization.

    (a) Before granting authorization to an individual who has never 
held authorization under this part or whose authorization has been 
interrupted for a period of 3 years or more and whose last period of 
authorization was terminated favorably, the licensee or other entity 
shall ensure that--
    (1) A self-disclosure has been obtained and reviewed under the 
applicable requirements of Sec.26.61;
    (2) A suitable inquiry has been completed under the applicable 
requirements of Sec.26.63;
    (3) The individual has been subject to pre-access drug and alcohol 
testing under the applicable requirements of Sec.26.65; and
    (4) The individual is subject to random drug and alcohol testing 
under the applicable requirements of Sec.26.67.
    (b) If potentially disqualifying FFD information is disclosed or 
discovered, the licensee or other entity may not grant authorization to 
the individual, except under Sec.26.69.



Sec.26.57  Authorization update.

    (a) Before granting authorization to an individual whose 
authorization has been interrupted for more than 365 days but less than 
3 years and whose last period of authorization was terminated favorably, 
the licensee or other entity shall ensure that--
    (1) A self-disclosure has been obtained and reviewed under the 
applicable requirements of Sec.26.61;
    (2) A suitable inquiry has been completed under the applicable 
requirements of Sec.26.63;
    (3) The individual has been subject to pre-access drug and alcohol 
testing under the applicable requirements of Sec.26.65; and
    (4) The individual is subject to random drug and alcohol testing 
under the applicable requirements of Sec.26.67.
    (b) If potentially disqualifying FFD information is disclosed or 
discovered, the licensee or other entity may not grant authorization to 
the individual, except under Sec.26.69.



Sec.26.59  Authorization reinstatement.

    (a) In order to grant authorization to an individual whose 
authorization has been interrupted for a period of more than 30 days but 
no more than 365 days and whose last period of authorization was 
terminated favorably, the licensee or other entity shall ensure that--
    (1) A self-disclosure has been obtained and reviewed under the 
applicable requirements of Sec.26.61;
    (2) A suitable inquiry has been completed under the requirements of 
Sec.26.63 within 5 business days of reinstating authorization. If the 
suitable inquiry is not completed within 5 business days due to 
circumstances that are outside of the licensee's or other entity's 
control and the licensee or other entity is

[[Page 491]]

not aware of any potentially disqualifying information regarding the 
individual within the past 5 years, the licensee or other entity may 
maintain the individual's authorization for an additional 5 business 
days. If the suitable inquiry is not completed within 10 business days 
of reinstating authorization, the licensee or other entity shall 
administratively withdraw the individual's authorization until the 
suitable inquiry is completed;
    (3) The individual has been subject to pre-access drug and alcohol 
testing under the applicable requirements of Sec.26.65; and
    (4) The individual is subject to random drug and alcohol testing 
under the applicable requirements of Sec.26.67.
    (b) If a licensee or other entity administratively withdraws an 
individual's authorization under paragraph (a)(2) of this section, and 
until the suitable inquiry is completed, the licensee or other entity 
may not record the administrative action to withdraw authorization as an 
unfavorable termination and may not disclose it in response to a 
suitable inquiry conducted under the provisions of Sec.26.63, a 
background investigation conducted under the provisions of this chapter, 
or any other inquiry or investigation. The individual may not be 
required to disclose the administrative action in response to requests 
for self-disclosure of potentially disqualifying FFD information, except 
if the individual's authorization was subsequently denied or terminated 
unfavorably by the licensee or other entity.
    (c) Before granting authorization to an individual whose 
authorization has been interrupted for a period of no more than 30 days 
and whose last period of authorization was terminated favorably, the 
licensee or other entity shall ensure that--
    (1) A self-disclosure has been obtained and reviewed under the 
applicable requirements of Sec.26.61;
    (2) The individual has been subject to pre-access drug and alcohol 
testing under the applicable requirements of Sec.26.65, if the 
individual's authorization was interrupted for more than 5 days; and
    (3) The individual is subject to random drug and alcohol testing 
under the applicable requirements of Sec.26.67.
    (d) If potentially disqualifying FFD information is disclosed or 
discovered, the licensee or other entity may not grant authorization to 
the individual, except under Sec.26.69.



Sec.26.61  Self-disclosure and employment history.

    (a) Before granting authorization, the licensee or other entity 
shall ensure that a written self-disclosure and employment history has 
been obtained from the individual who is applying for authorization, 
except as follows:
    (1) If an individual previously held authorization under this part, 
and the licensee or other entity has verified that the individual's last 
period of authorization was terminated favorably, and the individual has 
been subject to a behavioral observation program that includes arrest 
reporting, which meets the requirements of this part, throughout the 
period since the individual's last authorization was terminated, the 
granting licensee or other entity need not obtain the self-disclosure or 
employment history in order to grant authorization; and
    (2) If the individual's last period of authorization was terminated 
favorably within the past 30 days, the licensee or other entity need not 
obtain the employment history.
    (b) The written self-disclosure must--
    (1) State whether the individual has--
    (i) Violated a licensee's or other entity's FFD policy;
    (ii) Had authorization denied or terminated unfavorably under 
Sec. Sec.26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c), 
26.69(f), or 26.75(b) through (e);
    (iii) Used, sold, or possessed illegal drugs;
    (iv) Abused legal drugs or alcohol;
    (v) Subverted or attempted to subvert a drug or alcohol testing 
program;
    (vi) Refused to take a drug or alcohol test;
    (vii) Been subject to a plan for substance abuse treatment (except 
for self-referral); or
    (viii) Had legal action or employment action, as defined in Sec.
26.5, taken for alcohol or drug use;

[[Page 492]]

    (2) Address the specific type, duration, and resolution of any 
matter disclosed, including, but not limited to, the reason(s) for any 
unfavorable termination or denial of authorization; and
    (3) Address the shortest of the following periods:
    (i) The past 5 years;
    (ii) Since the individual's eighteenth birthday; or
    (iii) Since the individual's last period of authorization was 
terminated, if authorization was terminated favorably within the past 3 
years.
    (c) The individual shall provide a list of all employers, including 
the employer by whom the individual claims to have been employed on the 
day before he or she completes the employment history, if any, with 
dates of employment, for the shortest of the following periods:
    (1) The past 3 years;
    (2) Since the individual's eighteenth birthday; or
    (3) Since authorization was last terminated, if authorization was 
terminated favorably within the past 3 years.



Sec.26.63  Suitable inquiry.

    (a) In order to grant authorization, licensees and other entities 
shall ensure that a suitable inquiry has been conducted, on a best 
effort basis, to verify the individual's self-disclosed information and 
determine whether any potentially disqualifying FFD information is 
available, except if all of the following conditions are met:
    (1) The individual previously held authorization under this part;
    (2) The licensee or other entity has verified that the individual's 
last period of authorization was terminated favorably; and
    (3) The individual has been subject to a behavioral observation 
program that includes arrest reporting, which meets the requirements of 
this part, throughout the period of interruption.
    (b) To meet the suitable inquiry requirement, licensees and other 
entities may rely on the information that other licensees and entities 
who are subject to this subpart have gathered for previous periods of 
authorization. Licensees and other entities may also rely on those 
licensees' and entities' determinations of fitness that were conducted 
under Sec.26.189, as well as their reviews and resolutions of 
potentially disqualifying FFD information, for previous periods of 
authorization.
    (c) The licensee or other entity shall ensure that the suitable 
inquiry has been conducted, on a best effort basis, by questioning 
former employers, and the employer by whom the individual claims to have 
been employed on the day before he or she completes the employment 
history, if an employment history is required under Sec.26.61.
    (1) For the claimed employment period, the suitable inquiry must 
ascertain the reason for termination, eligibility for rehire, and other 
information that could reflect on the individual's fitness to be granted 
authorization.
    (2) If the claimed employment was military service, the licensee or 
other entity who is conducting the suitable inquiry shall request a 
characterization of service, reason for separation, and any disciplinary 
actions related to potentially disqualifying FFD information. If the 
individual's last duty station cannot provide this information, the 
licensee or other entity may accept a hand-carried copy of the DD 214 
presented by the individual which on face value appears to be 
legitimate. The licensee or other entity may also accept a copy of a DD 
214 provided by the custodian of military records.
    (3) If a company, previous employer, or educational institution to 
whom the licensee or other entity has directed a request for information 
refuses to provide information or indicates an inability or 
unwillingness to provide information within 3 business days of the 
request, the licensee or other entity shall document this refusal, 
inability, or unwillingness in the licensee's or other entity's record 
of the investigation, and obtain a confirmation of employment or 
educational enrollment and attendance from at least one alternate 
source, with suitable inquiry questions answered to the best of the 
alternate source's ability. This alternate source may not have been 
previously used by the licensee or other entity to obtain information 
about the individual's character. If the licensee or other entity uses 
an alternate

[[Page 493]]

source because employer information is not forthcoming within 3 business 
days of the request, the licensee or other entity need not delay 
granting authorization to wait for any employer response, but shall 
evaluate and document the response if it is received.
    (d) When any licensee or other entity in Sec.26.3(a) through (d) 
is legitimately seeking the information required for an authorization 
decision under this subpart and has obtained a signed release from the 
subject individual authorizing the disclosure of information, any 
licensee or other entity who is subject to this part shall disclose 
whether the subject individual's authorization was denied or terminated 
unfavorably as a result of a violation of an FFD policy and shall make 
available the information on which the denial or unfavorable termination 
of authorization was based, including, but not limited to, drug or 
alcohol test results, treatment and followup testing requirements or 
other results from a determination of fitness, and any other information 
that is relevant to an authorization decision.
    (e) In conducting a suitable inquiry, a licensee or other entity may 
obtain information and documents by electronic means, including, but not 
limited to, telephone, facsimile, or e-mail. The licensee or other 
entity shall make a record of the contents of the telephone call and 
shall retain that record, and any documents or electronic files obtained 
electronically, under Sec. Sec.26.711 and 26.713(a), (b), and (c), as 
applicable.
    (f) For individuals about whom no potentially disqualifying FFD 
information is known (or about whom potentially disqualifying FFD 
information is known, but it has been resolved by a licensee or other 
entity who is subject to this subpart) at the time at which the suitable 
inquiry is initiated, the licensee or other entity shall ensure that a 
suitable inquiry has been conducted as follows:
    (1) Initial authorization. The period of the suitable inquiry must 
be the past 3 years or since the individual's eighteenth birthday, 
whichever is shorter. For the 1-year period immediately preceding the 
date on which the individual applies for authorization, the licensee or 
other entity shall ensure that the suitable inquiry has been conducted 
with every employer, regardless of the length of employment. For the 
remaining 2-year period, the licensee or other entity shall ensure that 
the suitable inquiry has been conducted with the employer by whom the 
individual claims to have been employed the longest within each calendar 
month, if the individual claims employment during the given calendar 
month.
    (2) Authorization update. The period of the suitable inquiry must be 
the period since authorization was terminated. For the 1-year period 
immediately preceding the date on which the individual applies for 
authorization, the licensee or other entity shall ensure that the 
suitable inquiry has been conducted with every employer, regardless of 
the length of employment. For the remaining period since authorization 
was terminated, the licensee or other entity shall ensure that the 
suitable inquiry has been conducted with the employer by whom the 
individual claims to have been employed the longest within each calendar 
month, if the individual claims employment during the given calendar 
month.
    (3) Authorization reinstatement after an interruption of more than 
30 days. The period of the suitable inquiry must be the period since 
authorization was terminated. The licensee or other entity shall ensure 
that the suitable inquiry has been conducted with the employer by whom 
the individual claims to have been employed the longest within the 
calendar month, if the individual claims employment during the given 
calendar month.



Sec.26.65  Pre-access drug and alcohol testing.

    (a) Purpose. This section contains pre-access testing requirements 
for granting authorization to an individual who either has never held 
authorization or whose last period of authorization was terminated 
favorably and about whom no potentially disqualifying FFD information 
has been discovered or disclosed that was not previously reviewed and 
resolved by a licensee or other entity under the requirements of this 
subpart.

[[Page 494]]

    (b) Accepting tests conducted within the past 30 days. If an 
individual has negative results from drug and alcohol tests that were 
conducted under the requirements of this part before the individual 
applied for authorization from the licensee or other entity, and the 
specimens for such testing were collected within the 30-day period 
preceding the day on which the licensee or other entity grants 
authorization to the individual, the licensee or other entity may rely 
on the results of those drug and alcohol tests to meet the requirements 
for pre-access testing in this section.
    (c) Initial authorization and authorization update. Before granting 
authorization to an individual who has never held authorization or whose 
authorization has been interrupted for a period of more than 365 days, 
the licensee or other entity shall verify that the results of pre-access 
drug and alcohol tests, which must be performed within the 30-day period 
preceding the day the licensee or other entity grants authorization to 
the individual, are negative. The licensee or other entity need not 
conduct pre-access testing if--
    (1) The individual previously held authorization under this part and 
has been subject to a drug and alcohol testing program that includes 
random testing and a behavioral observation program that includes arrest 
reporting, which both meet the requirements of this part, from the date 
the individual's last authorization was terminated through the date the 
individual is granted authorization; or
    (2) The licensee or other entity relies on negative results from 
drug and alcohol tests that were conducted under the requirements of 
this part at any time before the individual applied for authorization, 
and the individual has remained subject to a drug and alcohol testing 
program that includes random testing and a behavioral observation 
program that includes arrest reporting, which both meet the requirements 
of this part, beginning on the date the drug and alcohol testing was 
conducted through the date the individual is granted authorization and 
thereafter.
    (d) Authorization reinstatement after an interruption of more than 
30 days. (1) To reinstate authorization for an individual whose 
authorization has been interrupted for a period of more than 30 days but 
no more than 365 days, except as permitted in paragraph (d)(2) of this 
section, the licensee or other entity shall--
    (i) Verify that the individual has negative results from alcohol 
testing and collect a specimen for drug testing within the 30-day period 
preceding the day the licensee reinstates the individual's 
authorization; and
    (ii) Verify that the drug test results are negative within 5 
business days of specimen collection or administratively withdraw 
authorization until the drug test results are received.
    (2) The licensee or other entity need not conduct pre-access testing 
of these individuals if--
    (i) The individual previously held authorization under this part and 
has been subject to a drug and alcohol testing program that includes 
random testing and a behavioral observation program that includes arrest 
reporting, which both meet the requirements of this part, beginning on 
the date the individual's last authorization was terminated through the 
date the individual is granted authorization; or
    (ii) The licensee or other entity relies on negative results from 
drug and alcohol tests that were conducted under the requirements of 
this part at any time before the individual applied for authorization, 
and the individual remains subject to a drug and alcohol testing program 
that includes random testing and a behavioral observation program that 
includes arrest reporting, which both meet the requirements of this 
part, beginning on the date the drug and alcohol testing was conducted 
through the date the individual is granted authorization.
    (e) Authorization reinstatement after an interruption of 30 or fewer 
days. (1) The licensee or other entity need not conduct pre-access 
testing before granting authorization to an individual whose 
authorization has been interrupted for 5 or fewer days. In addition, the 
licensee or other entity need not conduct pre-access testing if the 
individual has been subject to a drug and alcohol testing program that 
includes

[[Page 495]]

random testing and a behavioral observation program that includes arrest 
reporting, which both meet the requirements of this part, from the date 
the individual's last authorization was terminated through the date the 
individual is granted authorization.
    (2) In order to reinstate authorization for an individual whose 
authorization has been interrupted for a period of more than 5 days but 
not more than 30 days, except as permitted in paragraph (e)(1) of this 
section, the licensee or other entity shall take the following actions:
    (i) The licensee or other entity shall subject the individual to 
random selection for pre-access drug and alcohol testing at a one-time 
probability that is equal to or greater than the normal testing rate 
specified in Sec.26.31(d)(2)(vii) calculated for a 30-day period;
    (ii) If the individual is not selected for pre-access testing under 
paragraph (e)(2)(i) of this section, the licensee or other entity need 
not perform pre-access drug and alcohol tests; or
    (iii) If the individual is selected for pre-access testing under 
this paragraph, the licensee or other entity shall--
    (A) Verify that the individual has negative results from alcohol 
testing and collect a specimen for drug testing before reinstating 
authorization; and
    (B) Verify that the drug test results are negative within 5 business 
days of specimen collection or administratively withdraw authorization 
until negative drug test results are received.
    (f) Administrative withdrawal of authorization. If a licensee or 
other entity administratively withdraws an individual's authorization 
under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section, and until 
the drug test results are known, the licensee or other entity may not 
record the administrative action to withdraw authorization as an 
unfavorable termination. The individual may not be required to disclose 
the administrative action in response to requests for self-disclosure of 
potentially disqualifying FFD information, except if the individual's 
authorization was subsequently denied or terminated unfavorably by a 
licensee or entity. Immediately on receipt of negative test results, the 
licensee or other entity shall ensure that any matter that could link 
the individual to the temporary administrative action is eliminated from 
the donor's personnel record and other records.
    (g) Sanctions. If an individual has confirmed positive, adulterated, 
or substituted test results from any drug, validity, or alcohol tests 
that may be required in this section, the licensee or other entity 
shall, at a minimum and as appropriate--
    (1) Deny authorization to the individual, as required by Sec.
26.75(b), (d), (e)(2), or (g);
    (2) Terminate the individual's authorization, if it has been 
reinstated, under Sec.26.75(e)(1) or (f); or
    (3) Grant authorization to the individual under Sec.26.69.



Sec.26.67  Random drug and alcohol testing of individuals who have
applied for authorization.

    (a) When the licensee or other entity collects specimens from an 
individual for any pre-access testing that may be required under 
Sec. Sec.26.65 or 26.69, and thereafter, the licensee or other entity 
shall subject the individual to random testing under Sec.26.31(d)(2), 
except if--
    (1) The licensee or other entity does not grant authorization to the 
individual; or
    (2) The licensee or other entity relies on drug and alcohol tests 
that were conducted before the individual applied for authorization to 
meet the applicable requirements for pre-access testing. If the licensee 
or other entity relies on drug and alcohol tests that were conducted 
before the individual applied for authorization, the licensee or other 
entity shall subject the individual to random testing when the 
individual arrives at a licensee's or other entity's facility for in-
processing and thereafter.
    (b) If an individual is selected for one or more random tests after 
any applicable requirement for pre-access testing in Sec. Sec.26.65 or 
26.69 has been met, the licensee or other entity may grant authorization 
before random testing is completed, if the individual has met all other 
applicable requirements for authorization.
    (c) If an individual has confirmed positive, adulterated, or 
substituted

[[Page 496]]

test results from any drug, validity, or alcohol test required in this 
section, the licensee or other entity shall, at a minimum and as 
appropriate--
    (1) Deny authorization to the individual, as required by Sec.
26.75(b), (d), (e)(2), or (g);
    (2) Terminate the individual's authorization, if it has been 
granted, as required by Sec.26.75(e)(1) or (f); or
    (3) Grant authorization to the individual under Sec.26.69.



Sec.26.69  Authorization with potentially disqualifying fitness
-for-duty information.

    (a) Purpose. This section defines the management actions that 
licensees and other entities who are subject to this subpart shall take 
to grant or maintain, at the licensee's or other entity's discretion, 
the authorization of an individual who is in the following 
circumstances:
    (1) Potentially disqualifying FFD information within the past 5 
years has been disclosed or discovered about the individual by any 
means, including, but not limited to, the individual's self-disclosure, 
the suitable inquiry, drug and alcohol testing, the administration of 
any FFD program under this part, a self-report of a legal action, 
behavioral observation, or other sources of information, including, but 
not limited to, any background investigation or credit and criminal 
history check conducted under the requirements of this chapter; and
    (2) The potentially disqualifying FFD information has not been 
reviewed and favorably resolved by a previous licensee or other entity 
under this section.
    (b) Authorization after a first confirmed positive drug or alcohol 
test result or a 5-year denial of authorization. The requirements in 
this paragraph apply to individuals whose authorization was denied or 
terminated unfavorably for a first violation of an FFD policy involving 
a confirmed positive drug or alcohol test result and individuals whose 
authorization was denied for 5 years under Sec.26.75(c), (d), (e)(2), 
or (f). To grant, and subsequently maintain, the individual's 
authorization, the licensee or other entity shall--
    (1) Obtain and review a self-disclosure and employment history from 
the individual that addresses the shorter period of either the past 5 
years or since the individual's last period of authorization was 
terminated, and verify that the self-disclosure does not contain any 
previously undisclosed potentially disqualifying FFD information before 
granting authorization;
    (2) Complete a suitable inquiry with every employer by whom the 
individual claims to have been employed during the period addressed in 
the employment history obtained under paragraph (b)(1) of this section, 
and obtain and review any records that other licensees or entities who 
are subject to this part may have developed related to the unfavorable 
termination or denial of authorization;
    (3) If the individual was subject to a 5-year denial of 
authorization under this part, verify that he or she has abstained from 
substance abuse for at least the past 5 years;
    (4) Ensure that an SAE has conducted a determination of fitness and 
concluded that the individual is fit to safely and competently perform 
his or her duties.
    (i) If the individual's authorization was denied or terminated 
unfavorably for a first confirmed positive drug or alcohol test result, 
ensure that clinically appropriate treatment and followup testing plans 
have been developed by an SAE before granting authorization;
    (ii) If the individual was subject to a 5-year denial of 
authorization, ensure that any recommendations for treatment and 
followup testing from an SAE's determination of fitness are initiated 
before granting authorization; and
    (iii) Verify that the individual is in compliance with, and 
successfully completes, any followup testing and treatment plans.
    (5) Within 10 business days before granting authorization, perform a 
pre-access alcohol test, collect a specimen for drug testing under 
direct observation, and ensure that the individual is subject to random 
testing thereafter. Verify that the pre-access drug and alcohol test 
results are negative before granting authorization.

[[Page 497]]

    (6) If the individual's authorization was denied or terminated 
unfavorably for a first confirmed positive drug or alcohol test result 
and a licensee or other entity grants authorization to the individual, 
ensure that the individual is subject to unannounced testing at least 
quarterly for 3 calendar years after the date the individual is granted 
authorization. Both random and followup tests, as defined in Sec.
26.31(c), satisfy this requirement. Verify that the individual has 
negative test results from a minimum of 15 tests distributed over the 3-
year period, except as follows:
    (i) If the individual does not continuously hold authorization 
during the 3-year period, the licensee or other entity shall ensure that 
at least one unannounced test is conducted in any quarter during which 
the individual holds authorization;
    (ii) If the 15 tests are not completed within the 3-year period 
specified in this paragraph due to periods during which the individual 
does not hold authorization, the followup testing program may be 
extended up to 5 calendar years to complete the 15 tests;
    (iii) If the individual does not hold authorization during the 5-
year period a sufficient number of times or for sufficient periods of 
time to complete the 15 tests required in this paragraph, the licensee 
or other entity shall ensure that an SAE conducts a determination of 
fitness to assess whether further followup testing is required and 
implement the SAE's recommendations; and
    (7) Verify that any drug and alcohol tests required in this 
paragraph, and any other drug and alcohol tests that are conducted under 
this part since authorization was terminated or denied, yield results 
indicating no further drug abuse, as determined by the MRO after review, 
or alcohol abuse, as determined by the result of confirmatory alcohol 
testing.
    (c) Granting authorization with other potentially disqualifying FFD 
information. The requirements in this paragraph apply to an individual 
who has applied for authorization, and about whom potentially 
disqualifying FFD information has been discovered or disclosed that is 
not a first confirmed positive drug or alcohol test result or a 5-year 
denial of authorization. If potentially disqualifying FFD information is 
obtained about an individual by any means, including, but not limited 
to, the individual's self-disclosure, the suitable inquiry, the 
administration of any FFD program under this part, a self-report of a 
legal action, behavioral observation, or other sources of information, 
including, but not limited to, any background investigation or credit 
and criminal history check conducted under the requirements of this 
chapter, before granting authorization to the individual, the licensee 
or other entity shall--
    (1) Obtain and review a self-disclosure and employment history that 
addresses the shortest of the following periods:
    (i) The past 5 years;
    (ii) Since the individual's eighteenth birthday; or
    (iii) Since the individual's last period of authorization was 
terminated;
    (2) Complete a suitable inquiry with every employer by whom the 
individual claims to have been employed during the period addressed in 
the employment history required under paragraph (c)(1) of this section. 
If the individual held authorization within the past 5 years, obtain and 
review any records that other licensees or entities who are subject to 
this part may have developed with regard to potentially disqualifying 
FFD information about the individual from the past 5 years;
    (3) If the designated reviewing official determines that a 
determination of fitness is required, verify that a professional with 
the appropriate qualifications, as specified in Sec.26.189(a), has 
indicated that the individual is fit to safely and competently perform 
his or her duties;
    (4) Ensure that the individual is in compliance with, or has 
completed, any plans for treatment and drug and alcohol testing from the 
determination of fitness, which may include the collection of a urine 
specimen under direct observation; and
    (5) Verify that the results of pre-access drug and alcohol tests are 
negative before granting authorization, and that the individual is 
subject to random testing after the specimens have

[[Page 498]]

been collected for pre-access testing and thereafter.
    (d) Maintaining authorization with other potentially disqualifying 
FFD information. If an individual is authorized when other potentially 
disqualifying FFD information is disclosed or discovered, in order to 
maintain the individual's authorization, the licensee or other entity 
shall--
    (1) Ensure that the licensee's or other entity's designated 
reviewing official completes a review of the circumstances associated 
with the information;
    (2) If the designated reviewing official concludes that a 
determination of fitness is required, verify that a professional with 
the appropriate qualifications, as specified in Sec.26.189(a), has 
indicated that the individual is fit to safely and competently perform 
his or her duties; and
    (3) If the reviewing official determines that maintaining the 
individual's authorization is warranted, implement any recommendations 
for treatment and followup drug and alcohol testing from the 
determination of fitness, which may include the collection of urine 
specimens under direct observation, and ensure that the individual 
complies with and successfully completes the treatment plans.
    (e) Accepting followup testing and treatment plans from another FFD 
program. Licensees and other entities may rely on followup testing, 
treatment plans, and determinations of fitness that meet the 
requirements of Sec.26.189 and were conducted under the FFD program of 
another licensee or entity who is subject to this subpart.
    (1) If an individual leaves the FFD program in which a treatment 
and/or followup testing plan was required under paragraphs (b), (c), or 
(d) of this section, the licensee or other entity who imposed the 
treatment and/or followup testing plan shall ensure that information 
documenting the treatment and/or followup testing plan is identified to 
any subsequent licensee or other entity who seeks to grant authorization 
to the individual. If the individual is granted authorization by the 
same or another licensee or entity, the licensee or other entity who 
grants authorization to the individual shall ensure that any followup 
testing requirements are met and that the individual complies with any 
treatment plan, with accountability assumed by the granting licensee or 
other entity. If it is impractical for the individual to comply with a 
treatment plan that was developed under another FFD program because of 
circumstances that are outside of the individual's or licensee's or 
other entity's control (e.g., geographical distance, closure of a 
treatment facility), then the granting FFD program shall ensure that an 
SAE develops a comparable treatment plan, with accountability for 
monitoring the individual's compliance with the plan assumed by the 
granting licensee or other entity.
    (2) If the previous licensee or other entity determined that the 
individual successfully completed any required treatment and followup 
testing, and the individual's last period of authorization was 
terminated favorably, the receiving licensee or entity may rely on the 
previous determination of fitness and no further review or followup is 
required.
    (f) Sanctions. If an individual has confirmed positive, adulterated, 
or substituted test results from any drug, validity, or alcohol test 
required in this section, the licensee or other entity shall, at a 
minimum and as appropriate--
    (1) Deny authorization to the individual, as required by Sec.
26.75(b), (d), (e)(2), or (g); or
    (2) Terminate the individual's authorization, if it has been 
granted, as required by Sec.26.75(e)(1) or (f).

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009]



Sec.26.71  Maintaining authorization.

    (a) Individuals may maintain authorization under the following 
conditions:
    (1) The individual complies with the licensee's or other entity's 
FFD policies and procedures, as described in Sec.26.27, including the 
responsibility to report any legal actions, as defined in Sec.26.5;
    (2) The individual remains subject to a drug and alcohol testing 
program that meets the requirements of Sec.26.31, including random 
testing;

[[Page 499]]

    (3) The individual remains subject to a behavioral observation 
program that meets the requirements of Sec.26.33; and
    (4) The individual successfully completes required FFD training on 
the schedule specified in Sec.26.29(c).
    (b) If an authorized individual is not subject to an FFD program 
that meets the requirements of this section for more than 30 continuous 
days, then the licensee or other entity shall terminate the individual's 
authorization and the individual shall meet the requirements in this 
subpart, as applicable, to regain authorization.



        Subpart D_Management Actions and Sanctions To Be Imposed



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 meet 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.



Sec.26.75  Sanctions.

    (a) This section defines the minimum sanctions that licensees and 
other entities shall impose when an individual has violated the drug and 
alcohol provisions of an FFD policy. A licensee or other entity may 
impose more stringent sanctions, except as specified in paragraph (h) of 
this section.
    (b) Any act or attempted act to subvert the testing process, 
including, but not limited to, refusing to provide a specimen and 
providing or attempting to provide a substituted or adulterated 
specimen, for any test required under Sec.26.31(c) must result in the 
immediate unfavorable termination of the individual's authorization and 
permanent denial of authorization thereafter.
    (c) 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 nuclear power plant, within a facility 
that is licensed to possess or use formula quantities of SSNM, within a 
transporter's facility or vehicle, or while performing the duties that 
require the individual to be subject to this subpart shall immediately 
have his or her authorization unfavorably terminated and denied for a 
minimum of 5 years from the date of the unfavorable termination of 
authorization.
    (d) Any individual who resigns or withdraws his or her application 
for authorization before authorization is terminated or denied for a 
first violation of the FFD policy involving a confirmed positive drug or 
alcohol test result shall immediately have his or her authorization 
denied for a minimum of 5 years from the date of termination or denial. 
If an individual resigns or withdraws his or her application for 
authorization before his or her authorization is terminated or denied 
for any violation of the FFD policy, the licensee or other entity shall 
record the resignation or withdrawal, the nature of the violation, and 
the minimum sanction that would have been required under this section 
had the individual not resigned or withdrawn his or her application for 
authorization.
    (e) Lacking any other evidence to indicate the use, sale, or 
possession of illegal drugs or consumption of alcohol on site, a 
confirmed positive drug or alcohol test result must be presumed to be an 
indication of offsite drug or alcohol use in violation of the FFD 
policy.
    (1) The first violation of the FFD policy involving a confirmed 
positive drug or alcohol test result must, at a minimum, result in the 
immediate unfavorable termination of the individual's authorization for 
at least 14 days from the date of the unfavorable termination.
    (2) Any subsequent confirmed positive drug or alcohol test result, 
including during an assessment or treatment

[[Page 500]]

period, must result in the denial of authorization for a minimum of 5 
years from the date of denial.
    (f) Paragraph (e) of this section does not apply to the misuse of 
prescription and over-the-counter drugs, except if the MRO determines 
that misuse of the prescription or over-the-counter drug represents 
substance abuse. Sanctions for misuse of prescription and over-the-
counter drugs must be sufficient to deter misuse of those substances.
    (g) For individuals whose authorization was denied for 5 years under 
paragraphs (c), (d), (e)(2), or (f) of this section, any subsequent 
violation of the drug and alcohol provisions of an FFD policy must 
immediately result in permanent denial of authorization.
    (h) A licensee or other entity may not terminate an individual's 
authorization and may not subject the individual to other administrative 
action based solely on a positive test result from any initial drug 
test, other than positive initial test results for marijuana or cocaine 
metabolites from a specimen that is reported to be valid on the basis of 
either validity screening or initial validity testing performed at a 
licensee testing facility, unless other evidence, including information 
obtained under the process set forth in Sec.26.189, indicates that the 
individual is impaired or might otherwise pose a safety hazard. The 
licensee or other entity may not terminate an individual's authorization 
or subject an individual to any other administrative action under this 
section based on the results of validity screening or initial validity 
testing performed at a licensee testing facility indicating that a 
specimen is of questionable validity.
    (i) With respect to positive initial drug test results from a 
licensee testing facility for marijuana and cocaine metabolites from a 
valid specimen, licensee testing facility personnel may inform licensee 
or other entity management of the positive initial drug test result and 
the specific drugs or metabolites identified, and licensees or other 
entities may administratively withdraw the donor's authorization or take 
lesser administrative actions against the donor, provided that the 
licensee or other entity complies with the following conditions:
    (1) For the drug for which action will be taken, at least 85 percent 
of the specimens that were determined to be positive as a result of 
initial drug tests at the licensee testing facility during the past 12-
month data reporting period submitted to the NRC under Sec.26.717 were 
subsequently reported as positive by the HHS-certified laboratory as the 
result of confirmatory testing;
    (2) There is no loss of compensation or benefits to the donor during 
the period of temporary administrative action;
    (3) Immediately on receipt of a negative report from the HHS-
certified laboratory or MRO, any matter that could link the donor to the 
temporary administrative action is eliminated from the donor's personnel 
record and other records; and
    (4) Licensees and other entities may not disclose the temporary 
administrative action against an individual whose initial drug test 
result is not subsequently confirmed by the MRO as a violation of the 
FFD policy in response to a suitable inquiry conducted under the 
provisions of Sec.26.63, a background investigation conducted under 
the provisions of this chapter, or to any other inquiry or 
investigation.
    (i) To ensure that no records are retained, access to the system of 
files and records must be provided to personnel who are conducting 
reviews, inquiries into allegations, or audits under the provisions of 
Sec.26.41, and to NRC inspectors.
    (ii) The licensee or other entity shall provide the donor with a 
written statement that the records specified in Sec. Sec.26.713 and 
26.715 have not been retained with respect to the temporary 
administrative action and shall inform the donor in writing that the 
temporary administrative action that was taken will not be disclosed and 
need not be disclosed by the individual in response to requests for 
self-disclosure of potentially disqualifying FFD information.



Sec.26.77  Management actions regarding possible impairment.

    (a) This section defines management actions that licensees and other 
entities who are subject to this subpart

[[Page 501]]

must take when an individual who is subject to this subpart shows 
indications that he or she may not be fit to safely and competently 
perform his or her duties.
    (b) If an individual appears to be impaired or the individual's 
fitness is questionable, except as permitted under Sec. Sec.
26.27(c)(3), 26.207, and 26.209, the licensee or other entity shall take 
immediate action to prevent the individual from performing the duties 
that require him or her to be subject to this subpart.
    (1) If an observed behavior or physical condition creates a 
reasonable suspicion of possible substance abuse, the licensee or other 
entity shall perform drug and alcohol testing. The results must be 
negative before the individual returns to performing the duties that 
require the individual to be subject to this subpart. However, if the 
physical condition is the smell of alcohol with no other behavioral or 
physical indications of impairment, then only an alcohol test is 
required and the results must be negative before the individual returns 
to performing his or her duties.
    (2) If a licensee or C/V who is subject to subpart I of this part is 
certain that the observed behavior or physical condition is the result 
solely of fatigue, the licensee or C/V shall ensure that a fatigue 
assessment is conducted under Sec.26.211. If the results of the 
fatigue assessment confirm that the observed behavior or physical 
condition is the result solely of fatigue, the licensee or C/V need not 
perform drug and alcohol tests or implement the determination of fitness 
process otherwise required by Sec.26.189.
    (3) For other indications of possible impairment that do not create 
a reasonable suspicion of substance abuse (or fatigue, in the case of 
licensees and C/Vs who are subject to subpart I of this part), the 
licensee or other entity may permit the individual to return to 
performing his or her duties only after the impairing or questionable 
conditions are resolved and a determination of fitness indicates that 
the individual is fit to safely and competently perform his or her 
duties.
    (c) If a licensee or other entity has a reasonable belief that an 
NRC employee or NRC contractor may be under the influence of any 
substance, or is otherwise unfit for duty, the licensee or other entity 
may not deny access but shall escort the individual. In any such 
instance, the licensee or other entity shall immediately notify the 
appropriate Regional Administrator by telephone, followed by written 
notification (e.g., e-mail or fax) to document the oral notification. If 
the Regional Administrator cannot be reached, the licensee or other 
entity shall notify the NRC Operations Center.



               Subpart E_Collecting Specimens for Testing



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 
paragraph and under Sec. Sec.26.4(j) and 26.31(b)(2) and Subpart K.



Sec.26.83  Specimens to be collected.

    Except as permitted under Sec.26.31(d)(5), licensees and other 
entities who are subject to this subpart shall--
    (a) Collect either breath or oral fluids for initial tests for 
alcohol. Breath must be collected for confirmatory tests for alcohol; 
and
    (b) Collect only urine specimens for both initial and confirmatory 
tests for drugs.



Sec.26.85  Collector qualifications and responsibilities.

    (a) Urine collector qualifications. Urine collectors shall be 
knowledgeable of

[[Page 502]]

the requirements of this part and the FFD policy and procedures of the 
licensee or other entity for whom collections are performed, and shall 
keep current on any changes to urine collection procedures. Collectors 
shall receive qualification training that meets the requirements of this 
paragraph and demonstrate proficiency in applying the requirements of 
this paragraph before serving as a collector. At a minimum, 
qualification training must provide instruction on the following 
subjects:
    (1) All steps necessary to complete a collection correctly and the 
proper completion and transmission of the custody-and-control form;
    (2) Methods to address ``problem'' collections, including, but not 
limited to, collections involving ``shy bladder'' and attempts to tamper 
with a specimen;
    (3) How to correct problems in collections; and
    (4) The collector's responsibility for maintaining the integrity of 
the specimen collection and transfer process, carefully ensuring the 
modesty and privacy of the donor, and avoiding any conduct or remarks 
that might be construed as accusatorial or otherwise offensive or 
inappropriate.
    (b) Alcohol collector qualifications. Alcohol collectors shall be 
knowledgeable of the requirements of this part and the FFD policy and 
procedures of the licensee or other entity for whom collections are 
performed, and shall keep current on any changes to alcohol collection 
procedures. Collectors shall receive qualification training meeting the 
requirements of this paragraph and demonstrate proficiency in applying 
the requirements of this paragraph before serving as a collector. At a 
minimum, qualification training must provide instruction on the 
following subjects:
    (1) The alcohol testing requirements of this part;
    (2) Operation of the particular alcohol testing device(s) [i.e., the 
alcohol screening devices (ASDs) or EBTs] to be used, consistent with 
the most recent version of the manufacturers' instructions;
    (3) Methods to address ``problem'' collections, including, but not 
limited to, collections involving ``shy lung'' and attempts to tamper 
with a specimen;
    (4) How to correct problems in collections; and
    (5) The collector's responsibility for maintaining the integrity of 
the specimen collection process, carefully ensuring the privacy of the 
donor, and avoiding any conduct or remarks that might be construed as 
accusatorial or otherwise offensive or inappropriate.
    (c) Alternative collectors. A medical professional, technologist, or 
technician may serve as a collector without meeting the collector 
qualification requirements in paragraphs (a) or (b) of this section, as 
applicable, only if all of the following conditions are met:
    (1) A collector who meets the requirements of paragraphs (a) or (b) 
of this section cannot reasonably be made available at the time the 
collection must occur;
    (2) The individual is not employed by the licensee's or other 
entity's FFD program and his or her normal workplace is not at the 
licensee's or other entity's facility;
    (3) The individual does not routinely provide FFD program services 
to the licensee or other entity;
    (4) The individual is licensed or otherwise approved to practice in 
the jurisdiction in which the collection occurs; and
    (5) The individual is provided with detailed, clearly-illustrated, 
written instructions for collecting specimens under this subpart and 
follows those instructions.
    (d) Personnel available to testify at proceedings. The licensee or 
other entity shall ensure that qualified collection site personnel, when 
required, are available to testify in an administrative or disciplinary 
proceeding against an individual when that proceeding is based on 
positive drug or alcohol test results or adulterated or substituted test 
results from specimens collected by or under contract to the licensee or 
other entity.
    (e) Files. Collection site personnel files must include each 
individual's resume of training and experience; certification or 
license, if any; references;

[[Page 503]]

job descriptions; records of performance evaluations and advancement; 
incident reports, if any; results of tests to establish employee 
competency for the position he or she holds, including, but not limited 
to, certification that collectors are proficient in administering 
alcohol tests consistent with the most recent manufacturer's 
instructions for the instruments and devices used; and appropriate data 
to support determinations of honesty and integrity conducted under Sec.
26.31(b).



Sec.26.87  Collection sites.

    (a) Each FFD program must have one or more designated collection 
sites that have all necessary personnel, materials, equipment, 
facilities, and supervision to collect specimens for drug testing and to 
perform alcohol testing. Each collection site must provide for the 
collection, security, temporary storage, and shipping or transportation 
of urine specimens to a drug testing laboratory; the collection of oral 
fluids or breath specimens; and the security of alcohol testing devices 
and test results. A properly equipped mobile facility that meets the 
requirements of this section is an acceptable collection site.
    (b) The collection site must provide for the donor's visual privacy 
while the donor and collector are viewing the results of an alcohol 
test, and for individual privacy while the donor is submitting a urine 
specimen, except if a directly observed urine specimen collection is 
required. Unauthorized personnel may not be present for the specimen 
collection.
    (c) Contracts for collection site services must permit 
representatives of the NRC, licensee, or other entity to conduct 
unannounced inspections and audits and to obtain all information and 
documentation that is reasonably relevant to the inspections and audits.
    (d) Licensees and other entities shall take the following measures 
to prevent unauthorized access to the collection site that could 
compromise the integrity of the collection process or the specimens.
    (1) Unauthorized personnel may not be permitted in any part of the 
designated collection site where specimens are collected or stored;
    (2) A designated collection site must be secure. If a collection 
site is dedicated solely to specimen collection, it must be secure at 
all times. Methods of assuring security may include, but are not limited 
to, physical measures to control access, such as locked doors, alarms, 
or visual monitoring of the collection site when it is not occupied; and
    (3) If a collection site cannot be dedicated solely to collecting 
specimens, the portion of the facility that is used for specimen 
collection must be secured and, during the time period during which a 
specimen is being collected, a sign must be posted to indicate that 
access is permitted only for authorized personnel.
    (e) The following steps must be taken to deter the dilution and 
adulteration of urine specimens at the collection site:
    (1) Agents that color any source of standing water in the stall or 
room in which the donor will provide a specimen, including, but not 
limited to, the toilet bowl or tank, must be placed in the source of 
standing water, so that the reservoirs of water are neither yellow nor 
colorless;
    (2) There must be no other source of water (e.g., no shower or sink) 
in the enclosure where urination occurs, or the source of water must be 
rendered unusable; and
    (3) Chemicals or products that could be used to contaminate or 
otherwise alter the specimen must be removed from the collection site or 
secured. The collector shall inspect the enclosure in which urination 
will occur before each collection to ensure that no materials are 
available that could be used to subvert the testing process.
    (f) In the exceptional event that a designated collection site is 
inaccessible and there is an immediate requirement to collect a urine 
specimen, including, but not limited to, an event investigation, then 
the licensee or other entity may use a public rest room, onsite rest 
room, or hospital examining room according to the following procedures:
    (1) The facility must be secured by visual inspection to ensure that 
no unauthorized persons are present, and that undetected access (e.g., 
through a

[[Page 504]]

rear door not in the view of the collector) is impossible. Security 
during the collection may be maintained by restricting access to 
collection materials and specimens. In the case of a public rest room, a 
sign must be posted or an individual assigned to ensure that no 
unauthorized personnel are present during the entire collection 
procedure to avoid embarrassment of the donor and distraction of the 
collector.
    (2) If practical, a water coloring agent that meets the requirements 
of Sec.26.87(e)(1) must be placed in the toilet bowl to be used by the 
donor and in any other accessible source of standing water, including, 
but not limited to, the toilet tank. The collector shall instruct the 
donor not to flush the toilet.
    (3) A collector of the same gender as the donor shall accompany the 
donor into the area that will be used for specimen collection, but 
remain outside of the stall, if it is a multi-stalled rest room, or 
outside of the door to the room, if it is a single rest room, in which 
the donor will provide the specimen. If a collector of the same gender 
is not available, the collector shall select a same-gender person to 
accompany the donor. This person shall be instructed on the collection 
procedures specified in this subpart and his or her identity must be 
documented on the custody-and-control form.
    (4) After the collector has possession of the specimen, the 
collector shall inspect the toilet bowl and area to ensure that there is 
no evidence of a subversion attempt and shall then flush the toilet. The 
collector shall instruct the donor to participate with the collector in 
completing the chain-of-custody procedures.
    (5) If it is impractical to maintain continuous physical security of 
a collection site from the time a urine specimen is presented until the 
sealed container is transferred for shipment, the specimen must remain 
under the direct control of an individual who is authorized by the 
licensee or other entity until the specimen is prepared for transfer, 
storage, or shipping, as required by Sec.26.117. The authorized 
individual shall be instructed on his or her responsibilities for 
maintaining custody and control of the specimen and his or her custody 
of the specimen must be documented on the custody-and-control form.



Sec.26.89  Preparing to collect specimens for testing.

    (a) When an individual has been notified of a requirement for 
testing and does not appear at the collection site within the time 
period specified by FFD program procedures, the collector shall inform 
FFD program management that the individual has not reported for testing. 
FFD program management shall ensure that the necessary steps are taken 
to determine whether the individual's undue tardiness or failure to 
appear for testing constitutes a violation of the licensee's or other 
entity's FFD policy. If FFD program management determines that the undue 
tardiness or failure to report for testing represents an attempt to 
subvert the testing process, the licensee or other entity shall impose 
on the individual the sanctions in Sec.26.75(b). If FFD program 
management determines that the undue tardiness or failure to report does 
not represent a subversion attempt, the licensee or other entity may not 
impose sanctions but shall ensure that the individual is tested at the 
earliest reasonable and practical opportunity after locating the 
individual.
    (b) Donors shall provide acceptable identification before testing.
    (1) Acceptable identification includes photo-identification issued 
by a licensee or other entity who is subject to this part, or by the 
Federal, State, or local government. Licensees and other entities may 
not accept faxes or photocopies of identification.
    (2) If the donor cannot produce acceptable identification before any 
testing that is required under this part other than pre-access testing, 
the collector shall proceed with the test and immediately inform FFD 
program management that the donor did not present acceptable 
identification. When so informed, FFD program management shall contact 
the individual's supervisor to verify in-person the individual's 
identity, or, if the supervisor is not available, take other steps to 
establish the individual's identity and

[[Page 505]]

determine whether the lack of identification was an attempt to subvert 
the testing process. The donor may not leave the collection site except 
under supervision until his or her identity has been established.
    (3) If the donor is scheduled for pre-access testing and cannot 
produce acceptable identification, the collector may not proceed with 
the collection, and shall inform FFD program management that the 
individual did not present acceptable identification. When so informed, 
FFD program management will take the necessary steps to determine 
whether the lack of identification was an attempt to subvert the testing 
process.
    (4) The collector shall explain the testing procedure to the donor, 
show the donor the form(s) to be used, and ask the donor to sign a 
consent-to-testing form. The donor may not be required to list 
prescription medications or over-the-counter preparations that he or she 
has recently used.
    (c) The collector shall inform the donor that, if the donor refuses 
to cooperate in the specimen collection process (including, but not 
limited to, behaving in a confrontational manner that disrupts the 
testing process; admitting to the collector that he or she adulterated, 
diluted, or adulterated the specimen; is found to have a device, such as 
a prosthetic appliance, the purpose of which is to interfere with 
providing an actual urine specimen; or leaving the collection site 
before all of the collection procedures are completed), it will be 
considered a refusal to test, and sanctions for subverting the testing 
process will be imposed under Sec.26.75(b). If the donor refuses to 
cooperate in the collection procedures, the collector shall inform FFD 
program management to obtain guidance on the actions to be taken.
    (d) In order to promote the security of specimens, avoid distraction 
of the collector, and ensure against any confusion in the identification 
of specimens, a collector shall conduct only one collection procedure at 
any given time. For this purpose, a urine collection procedure is 
complete when the urine specimen container has been sealed and 
initialed, the chain-of-custody form has been executed, and the donor 
has departed the collection site.



Sec.26.91  Acceptable devices for conducting initial and confirmatory
tests for alcohol and methods of use.

    (a) Acceptable alcohol screening devices. Alcohol screening devices 
(ASDs), including devices that test specimens of oral fluids or breath, 
must be approved by the National Highway Traffic Safety Administration 
(NHTSA) and listed in the most current version of NHTSA's Conforming 
Products List (CPL) for such devices. An ASD that is listed in the NHTSA 
CPL may be used only for initial tests for alcohol, and may not be used 
for confirmatory tests.
    (b) Acceptable evidential breath testing devices. Evidential breath 
testing devices listed in the NHTSA CPL for evidential devices that meet 
the requirements of paragraph (c) of this section must be used to 
conduct confirmatory alcohol tests, and may be used to conduct initial 
alcohol tests. Note that, among the devices listed in the CPL for EBTs, 
only those devices listed without an asterisk (*) may be used for 
confirmatory alcohol testing under this subpart.
    (c) EBT capabilities. An EBT that is listed in the NHTSA CPL for 
evidential devices that has the following capabilities may be used for 
conducting initial alcohol tests and must be used for confirmatory 
alcohol tests under this subpart:
    (1) Provides a printed result of each breath test;
    (2) Assigns a unique number to each completed test, which the 
collector and donor can read before each test and which is printed on 
each copy of the test result;
    (3) Prints, on each copy of the test result, the manufacturer's name 
for the device, its serial number, and the time of the test;
    (4) Distinguishes alcohol from acetone at the 0.02 alcohol 
concentration level;
    (5) Tests an air blank; and
    (6) Permits performance of an external calibration check.

[[Page 506]]

    (d) Quality assurance and quality control of ASDs. (1) Licensees and 
other entities shall implement the most recent version of the quality 
assurance plan submitted to NHTSA for any ASD that is used for initial 
alcohol testing.
    (2) Licensees and other entities may not use an ASD that fails the 
specified quality control checks or that has passed its expiration date.
    (3) For ASDs that test breath specimens and meet EBT requirements 
for confirmatory testing, licensees and other entities shall also follow 
the device use and care requirements specified in paragraph (e) of this 
section.
    (e) Quality assurance and quality control of EBTs. (1) Licensees and 
other entities shall implement the most recent version of the 
manufacturer's instructions for the use and care of the EBT consistently 
with the quality assurance plan submitted to NHTSA for the EBT, 
including performing external calibration checks no less frequently than 
at the intervals specified in the manufacturer's instructions.
    (2) When conducting external calibration checks, licensees and other 
entities shall use only calibration devices appearing on NHTSA's CPL for 
``Calibrating Units for Breath Alcohol Tests.''
    (3) If an EBT fails an external check of calibration, the licensee 
or other entity shall take the EBT out of service. The EBT may not be 
used again for alcohol testing under this subpart until it is repaired 
and passes an external calibration check.
    (4) In order to ensure that confirmed positive alcohol test results 
are derived from an EBT that is calibrated, the licensee or other entity 
shall implement one of the following procedures:
    (i) If an EBT fails any external check of calibration, cancel every 
confirmed positive test result that was obtained using the EBT from any 
tests that were conducted after the EBT passed the last external 
calibration check; or
    (ii) After every confirmed positive test result obtained from using 
an EBT, conduct an external check of calibration of the EBT in the 
presence of the donor. If the EBT fails the external calibration check, 
cancel the donor's test result and conduct another initial and 
confirmatory test on a different EBT as soon as practicable.
    (5) Inspection, maintenance, and calibration of the EBT must be 
performed by its manufacturer or a maintenance representative or other 
individual who is certified either by the manufacturer or by a State 
health agency or other appropriate State agency.



Sec.26.93  Preparing for alcohol testing.

    (a) Immediately before collecting a specimen for alcohol testing, 
the collector shall--
    (1) Ask the donor whether he or she, in the past 15 minutes, has had 
anything to eat or drink, belched, or put anything into his or her mouth 
(including, but not limited to, a cigarette, breath mint, or chewing 
gum), and instruct the donor that he or she should avoid these 
activities during the collection process;
    (2) If the donor states that he or she has not engaged in the 
activities listed in paragraph (a)(1) of this section, alcohol testing 
may proceed;
    (3) If the donor states that he or she has engaged in any of the 
activities listed in paragraph (a)(1) of this section, inform the donor 
that a 15-minute waiting period is necessary to prevent an accumulation 
of mouth alcohol from leading to an artificially high reading;
    (4) Explain that it is to the donor's benefit to avoid the 
activities listed in paragraph (a)(1) of this section during the 
collection process;
    (5) Explain that the initial and confirmatory tests, if a 
confirmatory test is necessary, will be conducted at the end of the 
waiting period, even if the donor has not followed the instructions; and
    (6) Document that the instructions were communicated to the donor.
    (b) With the exception of the 15-minute waiting period, if 
necessary, the collector shall begin for-cause alcohol and/or drug 
testing as soon as reasonably practical after the decision is made that 
for-cause testing is required. When for-cause alcohol testing is 
required, alcohol testing may not be delayed by collecting a specimen 
for drug testing.

[[Page 507]]



Sec.26.95  Conducting an initial test for alcohol using a breath 
specimen.

    (a) The collector shall perform the initial breath test as soon as 
practical after the donor indicates that he or she has not engaged in 
the activities listed in Sec.26.93(a)(1) or after the 15-minute 
waiting period has elapsed, if required.
    (b) To perform the initial test, the collector shall--
    (1) Select, or allow the donor to select, an individually wrapped or 
sealed mouthpiece from the testing materials;
    (2) Open the individually wrapped or sealed mouthpiece in view of 
the donor and insert it into the device as required by the 
manufacturer's instructions;
    (3) Instruct the donor to blow steadily and forcefully into the 
mouthpiece for at least 6 seconds or until the device indicates that an 
adequate amount of breath has been obtained;
    (4) Show the donor the displayed or printed test result; and
    (5) Ensure that the test result record can be associated with the 
donor and is maintained secure.
    (c) Unless problems in administering the breath test require an 
additional collection, only one breath specimen may be collected for the 
initial test. If an additional collection(s) is required, the collector 
shall rely on the test result from the first successful collection to 
determine the need for confirmatory testing.



Sec.26.97  Conducting an initial test for alcohol using a specimen
of oral fluids.

    (a) To perform the initial test, the collector shall--
    (1) Check the expiration date on the device and show it to the donor 
(the device may not be used after its expiration date);
    (2) Open an individually wrapped or sealed package containing the 
device in the presence of the donor;
    (3) Offer the donor the choice of using the device or having the 
collector use it. If the donor chooses to use it, instruct the donor to 
insert the device into his or her mouth and use it in the manner 
described by the device's manufacturer;
    (4) If the donor chooses not to use the device, or in all cases when 
a new test is necessary because the device failed to activate, insert 
the device into the donor's mouth, and gather oral fluids in the manner 
described by the device's manufacturer (wear single-use examination or 
similar gloves while doing so and change them following each test); and
    (5) When the device is removed from the donor's mouth, follow the 
manufacturer's instructions regarding necessary next steps to ensure 
that the device has activated.
    (b) If the 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 shall--
    (1) Discard the device and conduct a new test using a new device. 
The new device must be one that has been under the collector's control 
before the test;
    (2) Record the reason for the new test;
    (3) Offer the donor the choice of using the device or having the 
collector use it unless the donor, in the opinion of the collector, was 
responsible for the new test needing to be conducted. If the collector 
concludes that the donor was responsible, then the collector shall use 
the device to conduct the test; and
    (4) Repeat the procedures in paragraph (a) of this section.
    (c) If the second collection attempt in paragraph (b) of this 
section could not be completed, the collector shall--
    (1) End the collection of oral fluids and document the reason(s) 
that the collection could not be completed; and
    (2) Immediately conduct another initial test using an EBT.
    (d) The collector shall read the result displayed on the device no 
sooner than the device's manufacturer instructs. In all cases, the 
collector shall read the result within 15 minutes of the test. The 
collector shall then show the device and its reading to the donor, 
record the result, and record that an ASD was used.
    (e) Devices, swabs, gloves, and other materials used in collecting 
oral fluids may not be re-used.

[[Page 508]]



Sec.26.99  Determining the need for a confirmatory test for alcohol.

    (a) If the initial test result is less than 0.02 percent BAC, the 
collector shall declare the test result as negative.
    (b) If the initial test result is 0.02 percent BAC or higher, the 
collector shall ensure that the time at which the test was concluded 
(i.e., the time at which the test result was known) is recorded and 
inform the donor that a confirmatory test for alcohol is required.



Sec.26.101  Conducting a confirmatory test for alcohol.

    (a) The confirmatory test must begin as soon as possible, but no 
more than 30 minutes after the conclusion of the initial test.
    (b) To complete the confirmatory test, the collector shall--
    (1) In the presence of the donor, conduct an air blank on the EBT 
before beginning the confirmatory test and show the result to the donor;
    (2) Verify that the reading is 0.00. If the reading is 0.00, the 
test may proceed. If not, then conduct another air blank;
    (3) If the reading on the second air blank is 0.00, the test may 
proceed. If the reading is greater than 0.00, take the EBT out of 
service and proceed with the test using another EBT. If an EBT is taken 
out of service for this reason, the EBT may not be used for further 
testing until it is found to be within tolerance limits on an external 
check of calibration;
    (4) Open an individually wrapped or sealed mouthpiece in view of the 
donor and insert it into the device as required by the manufacturer's 
instructions;
    (5) Read the unique test number displayed on the EBT, and ensure 
that the donor reads the same number;
    (6) Instruct the donor to blow steadily and forcefully into the 
mouthpiece for at least 6 seconds or until the device indicates that an 
adequate amount of breath has been obtained; and
    (7) Show the donor the result displayed on or printed by the EBT, 
record the result, and document the time at which the confirmatory test 
result was known.
    (c) Unless there are problems in administering the breath test that 
require an additional collection, the collector shall collect only one 
breath specimen for the confirmatory test. If an additional 
collection(s) is required because of problems in administering the 
breath test, the collector shall rely on the breath specimen from the 
first successful collection to determine the confirmatory test result. 
Collection procedures may not require collectors to calculate an average 
or otherwise combine results from two or more breath specimens to 
determine the confirmatory test result.
    (d) If an EBT that meets the requirements of Sec.26.91(b) and (c) 
was used for the initial alcohol test, the same EBT may be used for 
confirmatory testing.



Sec.26.103  Determining a confirmed positive test result for alcohol.

    (a) A confirmed positive test result for alcohol must be declared 
under any of the following conditions:
    (1) When the result of the confirmatory test for alcohol is 0.04 
percent BAC or higher;
    (2) When the result of the confirmatory test for alcohol is 0.03 
percent BAC or higher and the donor had been in a work status for at 
least 1 hour at the time the initial test was concluded (including any 
breaks for rest, lunch, dental/doctor appointments, etc.); or
    (3) When the result of the confirmatory test for alcohol is 0.02 
percent BAC or higher and the donor had been in a work status for at 
least 2 hours at the time the initial test was concluded (including any 
breaks for rest, lunch, dental/doctor appointments, etc.).
    (b) When the result of the confirmatory test for alcohol is equal to 
or greater than 0.01 percent BAC but less than 0.02 percent BAC and the 
donor has been in a work status for 3 hours or more at the time the 
initial test was concluded (including any breaks for rest, lunch, 
dental/doctor appointments, etc.), the collector shall declare the test 
result as negative and inform FFD program management. The licensee or 
other entity shall prohibit the donor from performing any duties that 
require the individual to be subject to this subpart and may not return 
the individual to performing such duties until a determination of 
fitness indicates that the donor is fit to safely

[[Page 509]]

and competently perform his or her duties.



Sec.26.105  Preparing for urine collection.

    (a) The collector shall ask the donor to remove any unnecessary 
outer garments, such as a coat or jacket, which might conceal items or 
substances that the donor could use to tamper with or adulterate his or 
her urine specimen. The collector shall ensure that all personal 
belongings such as a purse or briefcase remain with the outer garments 
outside of the room or stall in which the urine specimen is collected. 
The donor may retain his or her wallet.
    (b) The collector shall also ask the donor to empty his or her 
pockets and display the items in them to enable the collector to 
identify items that the donor could use to adulterate or substitute his 
or her urine specimen. The donor shall permit the collector to make this 
observation. If the donor refuses to show the collector the items in his 
or her pockets, this is considered a refusal to test. If an item is 
found that appears to have been brought to the collection site with the 
intent to adulterate or substitute the specimen, the collector shall 
contact the MRO or FFD program manager to determine whether a directly 
observed collection is required. If the item appears to have been 
inadvertently brought to the collection site, the collector shall secure 
the item and continue with the normal collection procedure. If the 
collector identifies nothing that the donor could use to adulterate or 
substitute the specimen, the donor may place the items back into his or 
her pockets.
    (c) The collector shall instruct the donor to wash and dry his or 
her hands before urinating.
    (d) After washing his or her hands, the donor shall remain in the 
presence of the collector and may not have access to any water fountain, 
faucet, soap dispenser, cleaning agent, or other materials that he or 
she could use to adulterate the urine specimen.
    (e) The collector may select, or allow the donor to select, an 
individually wrapped or sealed collection container from the collection 
kit materials. Either the collector or the donor, with both present, 
shall unwrap or break the seal of the collection container. With the 
exception of the collection container, the donor may not take anything 
from the collection kit into the room or stall used for urination.



Sec.26.107  Collecting a urine specimen.

    (a) The collector shall direct the donor to go into the room or 
stall used for urination, provide a specimen of the quantity that has 
been predetermined by the licensee or other entity, as defined in Sec.
26.109(a), not flush the toilet, and return with the specimen as soon as 
the donor has completed the void.
    (1) The donor shall provide his or her urine specimen in the privacy 
of a room, stall, or otherwise partitioned area (private area) that 
allows for individual privacy, except if a directly observed collection 
is required, as described in Sec.26.115;
    (2) Except in the case of a directly observed collection, no one may 
go with the donor into the room or stall in which the donor will provide 
his or her specimen; and
    (3) The collector may set a reasonable time limit for voiding.
    (b) The collector shall pay careful attention to the donor during 
the entire collection process to note any conduct that clearly indicates 
an attempt to tamper with a specimen (e.g., substitute urine is in plain 
view or an attempt to bring an adulterant or urine substitute into the 
private area used for urination). If any such conduct is detected, the 
collector shall document the conduct on the custody-and-control form and 
contact FFD program management to determine whether a directly observed 
collection is required, as described in Sec.26.115.
    (c) After the donor has provided the urine specimen and submitted it 
to the collector, the donor shall be permitted to wash his or her hands. 
The collector shall inspect the toilet bowl and room or stall in which 
the donor voided to identify any evidence of a subversion attempt, and 
then flush the toilet.



Sec.26.109  Urine specimen quantity.

    (a) Licensees and other entities who are subject to this subpart 
shall establish a predetermined quantity of urine that donors are 
requested to provide when submitting a specimen. At a minimum, the 
predetermined quantity

[[Page 510]]

must include 30 milliliters (mL) to ensure that a sufficient quantity of 
urine is available for initial and confirmatory validity and drug tests 
at an HHS-certified laboratory, and for retesting of an aliquot of the 
specimen if requested by the donor under Sec.26.165(b). The licensee's 
or other entity's predetermined quantity may include more than 30 mL, if 
the testing program follows split specimen procedures, tests for 
additional drugs, or performs initial testing at a licensee testing 
facility. Where collected specimens are to be split under the provisions 
of this subpart, the predetermined quantity must include an additional 
15 mL.
    (b) If the quantity of urine in the first specimen provided by the 
donor is less than 30 mL, the collector shall take the following steps:
    (1) The collector shall encourage the donor to drink a reasonable 
amount of liquid (normally, 8 ounces of water every 30 minutes, but not 
to exceed a maximum of 40 ounces over 3 hours) until the donor provides 
a specimen containing at least 30 mL. The collector shall provide the 
donor with a separate collection container for each successive specimen;
    (2) Once the donor provides a specimen of at least 30 mL, the 
collection must end. If the specimen quantity is at least 30 mL but is 
less than the licensee's or other entity's predetermined quantity, the 
licensee or other entity may not require the donor to provide additional 
specimens and may not impose any sanctions on the donor. If the donor 
provides a specimen of 30 mL or more, but the specimen quantity is less 
than the predetermined quantity, the collector shall forward the 
specimen to the HHS-certified laboratory for testing. If the donor 
provides a specimen of at least the predetermined quantity, the specimen 
may be processed under the FFD program's usual testing procedures;
    (3) If the donor has not provided a specimen of at least 30 mL 
within 3 hours of the first unsuccessful attempt to provide a specimen 
of the predetermined quantity, the collector shall discontinue the 
collection and notify the FFD program manager or MRO to initiate the 
``shy bladder'' procedures in Sec.26.119; and
    (4) Neither the donor nor the collector may combine specimens. The 
collector shall discard specimens of less than 30 mL, except if there is 
reason to believe that the donor has diluted, adulterated, substituted, 
or otherwise tampered with the specimen, based on the collector's 
observations of the donor's behavior during the collection process or 
the specimen's characteristics, as specified in Sec.26.111. If the 
collector has a reason to believe that a specimen that is 15 mL or more, 
but less than 30 mL, has been diluted, adulterated, substituted, or 
altered, the collector shall prepare the suspect specimen for shipping 
to the HHS-certified laboratory and contact FFD program management to 
determine whether a directly observed collection is required, as 
described in Sec.26.115.



Sec.26.111  Checking the acceptability of the urine specimen.

    (a) Immediately after the donor provides the urine specimen to the 
collector, including specimens of less than 30 mL but greater than 15 
mL, the collector shall measure the temperature of the specimen. The 
temperature-measuring device used must accurately reflect the 
temperature of the specimen and not contaminate the specimen. The time 
from urination to temperature measurement may not exceed 4 minutes. If 
the temperature of a urine specimen is outside the range of 90 [deg]F to 
100 [deg]F (32 [deg]C to 38 [deg]C), that is a reason to believe the 
donor may have altered or substituted the specimen.
    (b) Immediately after the donor provides a urine specimen, including 
specimens of less than 30 mL but equal to or greater than 15 mL, the 
collector shall also inspect the specimen to determine its color and 
clarity and look for any signs of contaminants or adulteration. The 
collector shall note any unusual findings on the custody-and-control 
form.
    (c) If there is reason to believe that the donor may have attempted 
to dilute, substitute, or adulterate the specimen based on specimen 
temperature or other observations made during the collection, the 
collector shall contact the designated FFD program manager,

[[Page 511]]

who may consult with the MRO, to determine whether the donor has 
attempted to subvert the testing process or whether other circumstances 
may explain the observations. The FFD program manager or MRO may require 
the donor to provide a second specimen as soon as possible under direct 
observation. In addition, the collector shall inform the donor that he 
or she may volunteer to submit a second specimen under direct 
observation to counter the reason to believe the donor may have altered 
or substituted the specimen.
    (d) Any specimen of 15 mL or more that the collector suspects has 
been diluted, substituted, or adulterated, and any specimen of 15 mL or 
more that has been collected under direct observation under paragraph 
(c) of this section, must be sent directly to the HHS-certified 
laboratory for initial and, if required, confirmatory testing, and may 
not be subject to initial testing at a licensee testing facility.
    (e) As much of the suspect specimen as possible must be preserved.
    (f) An acceptable specimen is free of any apparent contaminants, 
meets the required basic quantity of at least 30 mL, and is within the 
acceptable temperature range.



Sec.26.113  Splitting the urine specimen.

    (a) Licensees and other entities may, but are not required to, use 
split-specimen methods of collection.
    (b) If the urine specimen is to be split into two specimen bottles, 
hereinafter referred to as Bottle A and Bottle B, the collector shall 
take the following steps:
    (1) The collector shall instruct the donor to urinate into a 
specimen container;
    (2) The collector, in the presence of the donor and after 
determining specimen temperature as described in Sec.26.111(a), shall 
split the urine specimen. The collector shall pour 30 mL of urine into 
Bottle A and a minimum of 15 mL of urine into Bottle B. If the quantity 
of urine available for Bottle B is less than 15 mL, the collector shall 
pour the remaining urine into Bottle B and forward the specimens in 
Bottles A and B to the HHS-certified laboratory for drug and validity 
testing; and
    (3) The collector shall ask the donor to observe the splitting of 
the urine specimen and to maintain visual contact with both specimen 
bottles until the custody-and-control form(s) for both specimens are 
completed, the specimens are sealed, and the specimens and form(s) are 
prepared for secure storage or shipping.
    (c) Licensees and other entities may use aliquots of the specimen 
collected for validity screening and initial validity and drug testing 
at the licensee testing facility, as permitted under Sec.
26.31(d)(3)(ii), or to test for additional drugs, as permitted under 
Sec.26.31(d)(1)(i)(A), but only if sufficient urine is available for 
this testing after the specimen has been split into Bottle A and Bottle 
B.



Sec.26.115  Collecting a urine specimen under direct observation.

    (a) Procedures for collecting urine specimens must provide for the 
donor's privacy unless directed by this subpart or the MRO or FFD 
program manager determines that a directly observed collection is 
warranted. The following circumstances constitute the exclusive grounds 
for performing a directly observed collection:
    (1) The donor has presented, at this or a previous collection, a 
urine specimen that the HHS-certified laboratory reported as being 
substituted, adulterated, or invalid to the MRO and the MRO reported to 
the licensee or other entity that there is no adequate medical 
explanation for the result;
    (2) The donor has presented, at this collection, a urine specimen 
that falls outside the required temperature range;
    (3) The collector observes conduct clearly and unequivocally 
indicating an attempt to dilute, substitute, or adulterate the specimen; 
and
    (4) A directly observed collection is required under Sec.26.69.
    (b) Before collecting a urine specimen under direct observation, the 
collector shall obtain the agreement of the FFD program manager or MRO 
to obtain a urine specimen under direct observation. After obtaining 
agreement, the collector shall ensure that a

[[Page 512]]

specimen is collected under direct observation as soon as reasonably 
practicable.
    (c) The collector shall explain to the donor the reason for direct 
observation of the collection under paragraph (a) of this section.
    (d) The collector shall complete a new custody-and-control form for 
the specimen that is obtained from the directly observed collection. The 
collector shall record that the collection was observed and the 
reason(s) for the directly observed collection on the form.
    (e) The collector shall ensure that the observer is the same gender 
as the individual. A person of the opposite gender may not act as the 
observer under any conditions. The observer may be a different person 
from the collector and need not be a qualified collector.
    (f) If someone other than the collector is to observe the 
collection, the collector shall instruct the observer to follow the 
procedures in this paragraph. The individual who observes the collection 
shall follow these procedures:
    (1) The observer shall instruct the donor to adjust his or her 
clothing to ensure that the area of the donor's body between the waist 
and knees is exposed;
    (2) The observer shall watch the donor urinate into the collection 
container. Specifically, the observer shall watch the urine go from the 
donor's body into the collection container;
    (3) If the observer is not the collector, the observer may not take 
the collection container from the donor, but shall observe the specimen 
as the donor takes it to the collector; and
    (4) If the observer is not the collector, the collector shall record 
the observer's name on the custody-and-control form.
    (g) If a donor declines to allow a directly observed collection that 
is required or permitted under this section, the donor's refusal 
constitutes an act to subvert the testing process.
    (h) If a collector learns that a directly observed collection should 
have been performed but was not, the collector shall inform the FFD 
program manager, or his or her designee. The FFD program manager or 
designee shall ensure that a directly observed collection is immediately 
performed.



Sec.26.117  Preparing urine specimens for storage and shipping.

    (a) Both the donor and the collector shall keep the donor's urine 
specimen(s) in view at all times before the specimen(s) are sealed and 
labeled. If any specimen or aliquot is transferred to another container, 
the collector shall ask the donor to observe the transfer and sealing of 
the container with a tamper-evident seal.
    (b) Both the collector and the donor shall be present (at the same 
time) during the procedures outlined in this section.
    (c) The collector shall place an identification label securely on 
each container. The label must contain the date, the donor's specimen 
number, and any other identifying information provided or required by 
the FFD program. The collector shall also apply a tamper-evident seal on 
each container if it is separate from the label. The specimen bottle 
must be securely sealed to prevent undetected tampering.
    (d) The donor shall initial the identification label(s) on the 
specimen bottle(s) for the purpose of certifying that the specimen was 
collected from him or her. The collector shall also ask the donor to 
read and sign a statement on the custody-and-control form certifying 
that the specimen(s) identified as having been collected from the donor 
is, in fact, the specimen(s) that he or she provided.
    (e) The collector shall complete the custody-and-control form(s) and 
shall certify proper completion of the collection.
    (f) The specimens and chain-of-custody forms must be packaged for 
transfer to the HHS-certified laboratory or the licensee's testing 
facility. If the specimens are not immediately prepared for transfer, 
they must be appropriately safeguarded during temporary storage.
    (g) While any part of the chain-of-custody procedures is being 
performed, the specimens and custody documents must be under the control 
of the involved collector. The collector may not

[[Page 513]]

leave the collection site during the interval between presentation of 
the specimen by the donor and securing of the specimens with identifying 
labels bearing the donor's specimen identification numbers and seals 
initialed by the donor. If the involved collector momentarily leaves his 
or her workstation, the sealed specimens and custody-and-control forms 
must be secured or taken with him or her. If the collector is leaving 
for an extended period of time, the specimens must be packaged for 
transfer to the HHS-certified laboratory or the licensee testing 
facility and secured before the collector leaves the collection site.
    (h) The specimen(s) sealed in a shipping container must be 
immediately transferred, appropriately safeguarded during temporary 
storage, or kept under the personal control of an authorized individual 
until transferred. These minimum procedures apply to the transfer of 
specimens to licensee testing facilities from collection sites (except 
where co-located) as well as to the shipping of specimens to HHS-
certified laboratories. As an option, licensees and other entities may 
ship several specimens via courier in a locked or sealed shipping 
container.
    (i) Collection site personnel shall ensure that a custody-and-
control form is packaged with its associated urine specimen bottle. 
Unless a collection site and a licensee testing facility are co-located, 
the sealed and labeled specimen bottles, with their associated custody-
and-control forms that are being transferred from the collection site to 
the drug testing laboratory must be placed in a second, tamper-evident 
shipping container. The second container must be designed to minimize 
the possibility of damage to the specimen during shipment (e.g., 
specimen boxes, shipping bags, padded mailers, or bulk insulated 
shipping containers with that capability), so that the contents of the 
shipping containers are no longer accessible without breaking a tamper-
evident seal.
    (j) Collection site personnel shall arrange to transfer the 
collected specimens to the HHS-certified laboratory or the licensee 
testing facility. Licensees and other entities shall take appropriate 
and prudent actions to minimize false negative results from specimen 
degradation. Specimens that have not been shipped to the HHS-certified 
laboratory or the licensee testing facility within 24 hours of 
collection and any specimen that is suspected of having been 
substituted, adulterated, or tampered with in any way must be maintained 
cooled to not more than 6 [deg]C (42.8 [deg]F) until they are shipped to 
the HHS-certified laboratory. Specimens must be shipped from the 
collection site to the HHS-certified laboratory or the licensee testing 
facility as soon as reasonably practical but, except under unusual 
circumstances, the time between specimen shipment and receipt of the 
specimen at the licensee testing facility or HHS-certified laboratory 
should not exceed 2 business days.
    (k) Couriers, express carriers, and postal service personnel do not 
have direct access to the custody-and-control forms or the specimen 
bottles. Therefore, there is no requirement that such personnel document 
chain of custody on the custody-and-control forms during transit. 
Custody accountability of the shipping containers during shipment must 
be maintained by a tracking system provided by the courier, express 
carrier, or postal service.



Sec.26.119  Determining ``shy'' bladder.

    (a) When a donor has not provided a specimen of at least 30 mL 
within the 3 hours permitted for urine collection, FFD program personnel 
shall direct the donor to obtain, within 5 business days, an evaluation 
from a licensed physician who is acceptable to the MRO and has expertise 
in the medical issues raised by the donor's failure to provide a 
sufficient specimen. The MRO may perform this evaluation if the MRO has 
the appropriate expertise.
    (b) If another physician will perform the evaluation, the MRO shall 
provide the other physician with the following information and 
instructions:
    (1) The donor was required to take a drug test, but was unable to 
provide a sufficient quantity of urine to complete the test;
    (2) The potential consequences of refusing to take the required drug 
test; and

[[Page 514]]

    (3) The physician must agree to follow the requirements of 
paragraphs (c) through (f) of this section.
    (c) The physician who conducts this evaluation shall make one of the 
following determinations:
    (1) A medical condition has, or with a high degree of probability 
could have, precluded the donor from providing a sufficient amount of 
urine; or
    (2) There is an inadequate basis for determining that a medical 
condition has, or with a high degree of probability could have, 
precluded the donor from providing a sufficient quantity of urine.
    (d) For purposes of this section, a medical condition includes an 
ascertainable physiological condition (e.g., a urinary system 
dysfunction) or a medically documented pre-existing psychological 
disorder, but does not include unsupported assertions of ``situational 
anxiety'' or dehydration.
    (e) The physician who conducts this evaluation shall provide a 
written statement of his or her determination and the basis for it to 
the MRO. This statement may not include detailed information on the 
donor's medical condition beyond what is necessary to explain the 
determination.
    (f) If the physician who conducts this evaluation determines that 
the donor's medical condition is a serious and permanent or long-term 
disability that is highly likely to prevent the donor from providing a 
sufficient amount of urine for a very long or indefinite period of time, 
the physician shall set forth this determination and the reasons for it 
in the written statement to the MRO.
    (g) The MRO shall seriously consider and assess the information 
provided by the physician in deciding whether the donor has a medical 
condition that has, or with a high degree of probability could have, 
precluded the donor from providing a sufficient amount of urine, as 
follows:
    (1) If the MRO concurs with the physician's determination, then the 
MRO shall declare that the donor has not violated the FFD policy and the 
licensee or other entity shall take no further action with respect to 
the donor;
    (2) If the MRO determines that the medical condition has not, or 
with a high degree of probability could not have, precluded the donor 
from providing a sufficient amount of urine, then the MRO shall declare 
that there has been a refusal to test; or
    (3) If the MRO determines that the medical condition is highly 
likely to prevent the donor from providing a sufficient amount of urine 
for a very long or indefinite period of time, then the MRO shall 
authorize an alternative evaluation process, tailored to the individual 
case, for drug testing.



                  Subpart F_Licensee Testing Facilities



Sec.26.121  Purpose.

    This subpart contains requirements for facilities that are operated 
by licensees and other entities who are subject to this part to perform 
initial tests of urine specimens for validity, drugs, and drug 
metabolites.



Sec.26.123  Testing facility capabilities.

    Each licensee testing facility shall have the capability, at the 
same premises, to perform either validity screening tests or initial 
validity tests or both, and initial drug tests for each drug and drug 
metabolite for which testing is conducted.



Sec.26.125  Licensee testing facility personnel.

    (a) Each licensee testing facility shall have one or more 
individuals who are responsible for day-to-day operations and 
supervision of the testing technicians. The designated individual(s) 
shall have at least a bachelor's degree in the chemical or biological 
sciences, medical technology, or equivalent. He or she shall also have 
training and experience in the theory and practice of the procedures 
used in the licensee testing facility, and a thorough understanding of 
quality control practices and procedures, the review, interpretation, 
and reporting of test results, and proper remedial actions to be taken 
in response to detection of abnormal test or quality control results.
    (b) Other technicians or non-technical staff shall have the 
necessary training and skills for their assigned tasks. Technicians who 
perform urine

[[Page 515]]

specimen testing shall have documented proficiency in operating the 
testing instruments and devices used at the licensee testing facility.
    (c) Licensee testing facility personnel files must include each 
individual's resume of training and experience; certification or 
license, if any; references; job descriptions; records of performance 
evaluations and advancement; incident reports, if any; results of tests 
that establish employee competency for the position he or she holds, 
including, but not limited to, certification that personnel are 
proficient in conducting testing in accordance with manufacturer's most 
recent instructions for the instruments and devices used and tests for 
color blindness; and appropriate data to support determinations of 
honesty and integrity required by this part.



Sec.26.127  Procedures.

    (a) Licensee testing facilities shall develop, implement, and 
maintain clear and well-documented procedures for accession, shipment, 
and testing of urine specimens.
    (b) Written chain-of-custody procedures must describe the methods to 
be used to maintain control and accountability of specimens from receipt 
through completion of testing and reporting of results, during storage 
and shipping to the HHS-certified laboratory, and continuing until final 
disposition of the specimens.
    (c) Licensee testing facilities shall develop, implement, and 
maintain written standard operating procedures for each assay performed 
for drug and specimen validity testing. If a licensee testing facility 
performs validity screening tests, the licensee testing facility shall 
develop, implement, and maintain written standard operating procedures 
for each test. The procedures must include, but are not limited to, 
detailed descriptions of--
    (1) The principles of each test;
    (2) Preparation of reagents, standards, and controls;
    (3) Calibration procedures;
    (4) Derivation of results;
    (5) Linearity of the methods;
    (6) Sensitivity of the methods;
    (7) Cutoff values;
    (8) Mechanisms for reporting results;
    (9) Controls;
    (10) Criteria for unacceptable specimens and results;
    (11) Reagents and expiration dates; and
    (12) References.
    (d) Licensee testing facilities shall develop, implement, and 
maintain written procedures for instrument and test setup and normal 
operation, including the following:
    (1) A schedule for checking critical operating characteristics for 
all instruments and validity screening tests;
    (2) Tolerance limits for acceptable function checks; and
    (3) Instructions for major troubleshooting and repair.
    (e) Licensee testing facilities shall develop, implement, and 
maintain written procedures for remedial actions to be taken when 
systems, and instrumented and non-instrumented tests are out of 
acceptable limits or errors are detected. Each facility shall maintain 
documentation that these procedures are followed and that all necessary 
corrective actions are taken. In addition, each facility shall have 
systems in place to verify all stages of testing and reporting and to 
document the verification.



Sec.26.129  Assuring specimen security, chain of custody,
and preservation.

    (a) Each licensee testing facility must be secure at all times. Each 
licensee or other entity shall have sufficient security measures in 
place to control access to the licensee testing facility and to ensure 
that no unauthorized personnel handle specimens or gain access to the 
licensee testing facility's processes or areas where records are stored. 
Access to these secured areas must be limited to specifically authorized 
individuals whose authorization is documented. All authorized visitors 
and maintenance and service personnel shall be escorted at all times 
while in the licensee testing facility.
    (b) When specimens are received, licensee testing facility personnel 
shall inspect each package for evidence of possible tampering and shall 
compare

[[Page 516]]

information on the specimen containers within each package to the 
information on the accompanying custody-and-control forms. Licensee 
testing facility personnel shall attempt to resolve any discrepancies 
identified in the information on specimen bottles or on the accompanying 
custody-and-control forms. When resolving any discrepancies, licensee 
testing facility personnel shall obtain a memorandum for the record from 
the specimen collector involved in the discrepancy to document 
correction of the discrepancy. This memorandum must accompany the 
specimen(s) and custody-and-control forms to the HHS-certified 
laboratory if the specimen(s) must be transferred.
    (1) Indications of tampering with specimens in transit from the 
collection site, or at a licensee testing facility, must be reported to 
senior licensee or other entity management as soon as practical and no 
later than 8 hours after the indications are identified. In response to 
a report, licensee or other entity management personnel shall initiate 
an investigation to determine whether tampering has occurred.
    (i) If the investigation determines that tampering has occurred, 
licensee or other entity management shall ensure that corrective actions 
are taken.
    (ii) If there is reason to believe that the integrity or identity of 
a specimen is in question (as a result of tampering or discrepancies 
between the information on the specimen bottle and on the accompanying 
custody-and-control forms that cannot be resolved), the specimen may not 
be tested and the licensee or other entity shall ensure that another 
collection occurs as soon as reasonably practical, except if a split 
specimen collection was performed, either the Bottle A or Bottle B seal 
remains intact, and the intact specimen contains at least 15 mL of 
urine. In this instance, the licensee testing facility shall forward the 
intact specimen for testing to the HHS-certified laboratory and may not 
conduct any testing at the licensee testing facility.
    (2) The following are exclusive grounds requiring the MRO to cancel 
the testing of a donor's urine specimen:
    (i) The custody-and-control form does not contain information to 
identify the specimen collector and the collection site cannot provide 
conclusive evidence of the collector's identity;
    (ii) The identification numbers on the specimen bottle seal(s) do 
not match the identification numbers on the custody-and-control form;
    (iii) A specimen bottle seal is broken or shows evidence of 
tampering and an intact specimen, as specified in paragraph (b)(1)(ii) 
of this section, does not exist;
    (iv) The specimen appears to have leaked out of its sealed bottle 
and there is less than 15 mL remaining, and an intact specimen, as 
specified in paragraph (b)(1)(ii) of this section, does not exist; or
    (v) As required under Sec.26.165(f)(2).
    (c) The licensee testing facility shall retain specimen containers 
within the testing facility's accession area until all analyses have 
been completed. Testing facility personnel shall use aliquots of the 
specimen and licensee testing facility chain-of-custody forms, or other 
appropriate methods of tracking aliquot custody and control, when 
conducting validity screening and initial validity and drug tests. The 
original specimen bottles and the original custody-and-control forms 
must remain in secure storage. Licensee testing facility personnel may 
discard specimens and aliquots as soon as practical after validity 
screening or initial validity tests have demonstrated that the specimen 
appears valid and initial test results for drugs and drug metabolites 
are negative.
    (d) The licensee testing facility's procedure for tracking custody 
and control of specimens and aliquots must protect the identity of the 
donor, and provide documentation of the testing process and transfers of 
custody of the specimen and aliquots. Each time a specimen or aliquot is 
handled or transferred within the licensee testing facility, testing 
facility personnel shall document the date and purpose and every 
individual in the chain of custody must be identified.
    (e) Urine specimens identified as positive or of questionable 
validity at a licensee testing facility must be shipped to an HHS-
certified laboratory for testing as soon as reasonably practical.

[[Page 517]]

    (f) Licensee testing facility personnel shall take appropriate and 
prudent actions to minimize false negative results from specimen 
degradation. If validity screening or initial validity testing indicate 
that the specimen is of questionable validity, or initial drug test 
results are positive, or if a specimen has not been tested within 24 
hours of receipt at the licensee testing facility, then the facility 
shall maintain the specimen cooled to not more than 6 [deg]C (42.8 
[deg]F) until it is forwarded to the HHS-certified laboratory for 
further testing, if required. Split specimens in Bottle B that are 
associated with positive specimens or specimens of questionable validity 
in Bottle A must also be maintained cooled (as previously specified) 
until test results from the HHS-certified laboratory are known to be 
negative for Bottle A; until the MRO informs the licensee testing 
facility that Bottle B must be forwarded to an HHS-certified laboratory 
for testing; or until the specimen is moved to long-term, frozen 
storage, under Sec.26.135(c).
    (g) Licensee testing facility personnel shall ensure that the 
original custody-and-control form is packaged with its associated urine 
specimen bottle. Sealed and labeled specimen bottles, with their 
associated custody-and-control forms, being transferred from the 
licensee testing facility to the HHS-certified laboratory must be placed 
in a second, tamper-evident shipping container designed to minimize the 
possibility of damage to the specimen during shipment (e.g., specimen 
boxes, padded mailers, or bulk insulated shipping containers with that 
capability) so that the contents of the shipping containers are no 
longer accessible without breaking a tamper-evident seal.
    (h) Couriers, express carriers, and postal service personnel do not 
have direct access to the custody-and-control forms or the specimen 
bottles. Therefore, such personnel are not required to document chain of 
custody on the custody-and-control forms during transit. Custody 
accountability of the shipping containers during shipment must be 
maintained by a tracking system provided by the courier, express 
carrier, or postal service.



Sec.26.131  Cutoff levels for validity screening and initial validity
tests.

    (a) Each validity test result from the licensee testing facility 
must be based on performing either a validity screening test or an 
initial validity test, or both, on one or more aliquots of a urine 
specimen. The licensee testing facility shall forward any specimen that 
yields a questionable validity screening or initial validity test result 
to the HHS-certified laboratory for further testing. Licensee testing 
facilities need not perform validity screening tests before conducting 
initial validity tests of a specimen.
    (b) At a minimum, the licensee testing facility shall test each 
urine specimen for creatinine, pH, and one or more oxidizing 
adulterants. Licensees and other entities may not specify more stringent 
cutoff levels for validity screening and initial validity tests than 
those specified in this section. If tests or observations indicate one 
or more of the following from either a validity screening test or an 
initial validity test, the licensee testing facility shall forward the 
specimen to the HHS-certified laboratory for additional testing:
    (1) Creatinine is less than 20 milligrams (mg) per deciliter (dL);
    (2) The pH of the specimen is either less than 4.5 or equal to or 
greater than 9, using either a colorimetric pH test with a dynamic range 
of 2 to 12 or pH meter that is capable of measuring pH to one decimal 
place (for initial validity tests), or colorimetric pH tests, dipsticks, 
and pH paper (for pH validity screening tests) that have a narrow 
dynamic range;
    (3) Nitrite or other oxidant concentration is equal to or greater 
than 200 micrograms (mcg) per mL or equal to or greater than 200 mcg/mL 
nitrite-equivalents using either a nitrite colorimetric test or a 
general oxidant colorimetric test;
    (4) The possible presence of an oxidizing adulterant (e.g., chromium 
(VI), pyridine (pyridinium chlorochromate)) is determined using either a 
general oxidant colorimetric test (with a cutoff equal to or greater 
than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI) 
colorimetric test (chromium

[[Page 518]]

(VI) concentration equal to or greater than 50 mcg/mL);
    (5) The possible presence of halogen (e.g., bleach, iodine, 
fluoride) is determined using a general oxidant colorimetric test (with 
a cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or 
equal to or greater than 50 mcg/mL chromium (VI)-equivalents), a halogen 
colorimetric test (halogen concentration equal to or greater than the 
limit of detection (LOD)), or the odor of the specimen;
    (6) The possible presence of glutaraldehyde is determined using 
either an aldehyde test (aldehyde present) or the characteristic 
immunoassay response is observed on one or more drug immunoassay tests;
    (7) The possible presence of a surfactant is determined by using a 
surfactant colorimetric test with a cutoff equal to or greater than 100 
mcg/mL dodecylbenzene sulfonate-equivalent or a foam/shake test; or
    (8) The specimen shows evidence of adulterants, including, but not 
limited to, the following:
    (i) Abnormal physical characteristics;
    (ii) Reactions or responses characteristic of an adulterant obtained 
during the validity screening or initial test; or
    (iii) A possible unidentified interfering substance or adulterant, 
demonstrated by interference occurring on the immunoassay drug tests on 
two separate aliquots (i.e., valid immunoassay drug test results cannot 
be obtained).



Sec.26.133  Cutoff levels for drugs and drug metabolites.

    Subject to the provisions of Sec.26.31(d)(3)(iii), licensees and 
other entities may specify more stringent cutoff levels for drugs and 
drug metabolites than those in the table below and, in such cases, may 
report initial test results for only the more stringent cutoff levels. 
Otherwise, the following cutoff levels must be used for initial testing 
of urine specimens to determine whether they are negative for the 
indicated drugs and drug metabolites:

        Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                   Drug or metabolites                      [nanograms
                                                             (ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites...................................              50
Cocaine metabolites.....................................             300
Opiate metabolites......................................            2000
Phencyclidine (PCP).....................................              25
Amphetamines............................................            1000
------------------------------------------------------------------------



Sec.26.135  Split specimens.

    (a) If the FFD program follows split-specimen procedures, as 
described in Sec.26.113, the licensee testing facility shall analyze 
aliquots of the specimen for the licensee's or other entity's purposes 
as described in this part. Except as provided in paragraph (b) in this 
section, the licensee testing facility shall store Bottles A and B of 
the specimen in a secure manner until the facility has finished testing. 
If the initial validity and drug test results are negative and the 
specimen in Bottle A will not be forwarded to the HHS-certified 
laboratory, the licensee testing facility may discard both Bottle A and 
Bottle B. If any test results are positive or indicate that the specimen 
is of questionable validity, the licensee testing facility shall forward 
Bottle A to the HHS-certified laboratory for testing and shall retain 
Bottle B in secure storage, under the requirements of Sec.26.159(i), 
or may forward it to the HHS-certified laboratory for storage.
    (b) If the MRO confirms any positive, adulterated, or substituted 
result for a specimen in Bottle A, based on the results of confirmatory 
testing at an HHS-certified laboratory, and the licensee testing 
facility has elected to retain Bottle B of the specimen, and the donor 
requests testing of the specimen in Bottle B, as permitted under Sec.
26.165(b), the MRO shall ensure that Bottle B is forwarded to an HHS-
certified laboratory other than the laboratory that tested the specimen 
in Bottle A, under the procedures specified in Sec.26.165(b).
    (c) If the MRO confirms that the specimen in Bottle A is positive, 
adulterated, substituted, or invalid and the donor does not request that 
Bottle B be tested, the licensee or other entity shall ensure that 
Bottle B is maintained in long-term frozen storage (-20

[[Page 519]]

[deg]C (-4 [deg]F) or less) for a minimum of 1 year. If a licensee 
testing facility elects to retain the specimen in Bottle B, rather than 
forwarding it to the HHS-certified laboratory with Bottle A, the 
licensee testing facility shall ensure proper storage conditions in the 
event of a prolonged power failure. After the end of 1 year, the 
licensee or other entity may discard Bottle B, with the exception that 
the licensee testing facility shall retain any specimens under legal 
challenge, or as requested by the NRC, until the specimen is no longer 
needed.

[73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66602, Nov. 10, 2014]



Sec.26.137  Quality assurance and quality control.

    (a) Quality assurance program. Each licensee testing facility shall 
have a quality assurance program that encompasses all aspects of the 
testing process including, but not limited to, specimen acquisition, 
chain of custody, security and reporting of results, validity screening 
(if validity screening tests are performed), initial validity and drug 
testing, and validation of analytical procedures. Quality assurance 
procedures must be designed, implemented, and reviewed to monitor the 
conduct of each step of the process of validity testing and testing for 
drugs and drug metabolites.
    (b) Performance testing and quality control requirements for 
validity screening tests. (1) Licensee testing facilities may rely on 
validity screening tests to determine the need for initial tests of 
specimen validity either at the licensee testing facility or HHS-
certified laboratory. Licensees and other entities shall ensure that the 
HHS-certified laboratory is capable of conducting confirmatory testing 
for any adulterant for which the licensee testing facility conducts 
validity screening tests. Licensee testing facilities shall use only 
validity screening tests that meet the following criteria:
    (i) Either the test, by lot number, has been placed on the Substance 
Abuse and Mental Health Services Administration (SAMHSA) list of point-
of-collection tests that are approved for use in the Federal Workplace 
Drug Testing Program; or
    (ii) Before using the test, the licensee or other entity has ensured 
that the validity screening test, by lot number, effectively identifies 
specimens of questionable validity by meeting the following performance 
testing and quality control requirements:
    (A) The creatinine validity screening test must use a 20 mg/dL 
cutoff concentration;
    (B) A pH specimen validity screening test must be able to determine 
if pH is less than 4.5 and if pH is equal to or greater than 9; and
    (C) An oxidant validity screening test must be able to determine if 
an oxidant concentration is equal to or greater than a 200 mcg/mL 
nitrite-equivalent cutoff, and/or a chromium screening test must be able 
to determine concentrations equal to or greater than a 50 mcg/mL 
chromium(VI)-equivalent cutoff, and/or a halogen screening test must be 
able to determine the halogen concentration is equal to or greater than 
the LOD. Licensees and other entities who use validity screening tests 
for additional adulterants shall establish performance testing 
requirements to challenge the licensee testing facility and the HHS-
certified laboratory for the additional validity screening test(s);
    (D) The manufacturer has conducted validation studies to document 
the validity screening test's performance characteristics around each 
applicable cutoff specified in this section, using performance testing 
samples that have been formulated to challenge the validity screening 
test around the applicable cutoffs. These validation studies must 
demonstrate the validity screening test's ability to differentiate valid 
samples from those of questionable validity and the performance of the 
validity screening test(s) around the applicable cutoffs specified in 
this section; and
    (E) The licensee testing facility shall submit three consecutive 
sets of performance testing samples to the manufacturer, using 
performance testing samples that have been formulated to challenge the 
validity screening test around the applicable cutoffs specified in this 
paragraph and whose formulation levels have been confirmed by an HHS-
certified laboratory. For example,

[[Page 520]]

one set of performance testing samples used to challenge a creatinine 
validity screening test must include at least six samples formulated at 
different concentrations ranging from 0 to 20 mg/dL. A set of 
performance testing samples used to challenge a pH validity screening 
test must include at least six samples formulated with different pH 
levels that are equal to or less than 4.5, and six samples formulated 
with different pH levels that are equal to or greater than 9. And, a set 
of performance testing samples used to challenge an oxidizing adulterant 
validity screening test must include at least six samples to challenge 
each validity screening test used. The performance testing samples for 
oxidizing adulterants must contain nitrite and other oxidizing 
adulterant concentrations in a range of less than or equal to a 200 mcg/
mL nitrite-equivalent cutoff to a 500 mcg/mL nitrite-equivalent cutoff; 
chromium samples formulated in a range less than or equal to a 50 mcg/mL 
chromium(VI)-equivalent cutoff to 100 mcg/mL chromium(VI)-equivalent 
cutoff; or halogen samples formulated in a concentration at or near the 
LOD and 25 percent above the LOD. The results of analyzing the three 
consecutive sets of performance test samples for each validity screening 
test (i.e., creatinine, pH, nitrite and general oxidants, chromium, or 
halogen) must demonstrate that the validity screening test, by lot 
number, correctly identified at least 90 percent of the total validity 
performance test challenges on each of three sets of performance testing 
samples, and, for each individual specimen validity screening test, the 
test, by lot number, correctly identified at least 90 percent of the 
validity performance test challenges on each of three sets of 
performance testing samples; and
    (iii) After the licensee testing facility has placed a validity 
screening test in service, the licensee or other entity shall verify 
that the test, by lot number, remains on the SAMHSA-approved list. Or, 
if the SAMHSA-approved list is unavailable, the licensee or other entity 
shall ensure that the test continues to identify specimens of 
questionable validity, as demonstrated by documentation from the 
manufacturer that a set of validity screening tests from each lot in use 
by the licensee testing facility correctly identified at least 90 
percent of the total validity test challenges on a set of performance 
testing samples, and, for each individual specimen validity screening 
test, that the test, by lot number, correctly identified at least 90 
percent of the validity test challenges. This performance testing must 
be performed at a nominal annual frequency after the date on which the 
manufacturer completed the initial validation studies required under 
paragraph (b)(1)(ii)(D) of this section. The performance testing samples 
used must be formulated to challenge the validity screening test around 
the applicable cutoffs of this subpart.
    (2) In addition, licensee testing facility personnel who perform the 
validity screening tests shall conduct quality control testing of 
validity screening tests as follows:
    (i) At the beginning of any 8-hour period during which the licensee 
testing facility will perform validity screening tests, licensee testing 
facility personnel shall test a minimum of one quality control sample 
that is negative for each specific validity test to be performed (e.g., 
creatinine, pH, nitrites, chromium) during the 8-hour period, and one 
quality control sample that is formulated to challenge the validity 
screening test(s) around the cutoffs specified in this subpart for each 
specific validity test to be performed during the 8-hour period. The 
results of these quality control tests must be correct before any donor 
specimens may be tested.
    (ii) After screening every ten donor specimens during the 8-hour 
period, licensee testing facility personnel shall also challenge each 
validity screening test with at least one quality control sample that is 
formulated to challenge the validity screening test(s) around the 
cutoffs specified in this subpart. If fewer than ten donor specimens 
were screened during the 8-hour period or the number of donor specimens 
tested exceeds a multiple of ten but is less than the next multiple of 
ten (e.g., 24 donor specimens, 48 donor specimens), licensee testing 
facility personnel shall challenge each validity screening test at the 
end of the 8-hour period during

[[Page 521]]

which the validity screening tests were performed.
    (3) The licensee testing facility shall also submit at least one 
specimen out of every ten donor specimens that test negative using each 
validity screening test that the licensee testing facility uses to an 
HHS-certified laboratory as part of the licensee testing facility's 
quality assurance program.
    (4) Licensee testing facilities shall store specimen validity tests 
as specified by the manufacturer's instructions and may not use such 
tests after the manufacturer's expiration date.
    (c) Validity screening test results. If the results of a validity 
screening test indicate that the specimen is of questionable validity, 
the licensee testing facility may either perform initial validity 
testing or shall forward the specimen to the HHS-certified laboratory 
for further testing.
    (d) Quality control requirements for performing initial validity 
tests. Licensees and other entities shall ensure that the HHS-certified 
laboratory is capable of conducting confirmatory testing for any 
adulterant for which the licensee testing facility conducts initial 
validity tests.
    (1) Creatinine. Creatinine concentration must be measured to 1 
decimal place. The initial creatinine test must have a control in the 
range of 3 to 20 mg/dL and a control in the range of 21 to 25 mg/dL.
    (2) Requirements for performing initial pH tests are as follows:
    (i) Colorimetric pH tests must have a dynamic range of 2 to 12 and 
pH meters must be capable of measuring pH to one decimal place.
    (ii) An initial colorimetric pH test must have the following 
calibrators and controls:
    (A) One calibrator at 3;
    (B) One calibrator at 11;
    (C) One control in the range of 2 to 2.8;
    (D) One control in the range of 3.2 to 4;
    (E) One control in the range of 4.5 to 9;
    (F) One control in the range of 10 to 10.8; and
    (G) One control in the range of 11.2 to 12.
    (iii) If a pH screening test is not used, an initial pH meter test 
must have the following calibrators and controls:
    (A) One calibrator at 4;
    (B) One calibrator at 7;
    (C) One calibrator at 10;
    (D) One control in the range of 2 to 2.8;
    (E) One control in the range of 3.2 to 4;
    (F) One control in the range of 10 to 10.8; and
    (G) One control in the range of 11.2 to 12.
    (iv) If a pH screening test is used, an initial pH meter test must 
have the following calibrators and controls when the screening result 
indicates that the pH is below the lower decision point in use:
    (A) One calibrator at 4;
    (B) One calibrator at 7;
    (C) One control in the range of 2 to 2.8; and
    (D) One control in the range of 3.2 to 4.
    (v) If a pH screening test is used, an initial pH meter test must 
have the following calibrators and controls when the screening test 
result indicates that the pH is above the upper decision point in use:
    (A) One calibrator at 7;
    (B) One calibrator at 10;
    (C) One control in the range of 10 to 10.8; and
    (D) One control in the range of 11.2 to 12.
    (3) Oxidizing adulterants. Initial tests for oxidizing adulterants 
must include a calibrator at the appropriate cutoff concentration for 
the compound of interest, a control without the compound of interest 
(i.e., a certified negative control), and a control with at least one of 
the compounds of interest at a measurable concentration. For nitrite, 
the licensee testing facility shall have one control in the range of 200 
to 400 mcg/mL, one control in the range of 500 to 625 mcg/mL, and a 
control without nitrite (i.e., a certified negative control).
    (4) Other adulterants. Initial tests for other adulterants must 
include an appropriate calibrator, a control without the compound of 
interest (i.e., a certified negative control), and a control

[[Page 522]]

with the compound of interest at a measurable concentration.
    (5) Each analytical run performed to conduct initial validity 
testing shall include at least one quality control sample that appears 
to be a donor specimen to the licensee testing facility technicians.
    (6) The licensee testing facility shall also submit at least one 
specimen out of every 10 donor specimens that test negative on the 
initial validity tests performed by the licensee testing facility to an 
HHS-certified laboratory as part of the licensee testing facility's 
quality assurance program.
    (e) Quality control requirements for initial drug tests. (1) Any 
initial drug test performed by a licensee testing facility must use an 
immunoassay that meets the requirements of the Food and Drug 
Administration for commercial distribution. Licensee testing facilities 
may not use non-instrumented immunoassay testing devices that are 
pending HHS/SAMHSA review and approval for initial drug testing under 
this part. In addition, licensees and other entities may not take 
management actions on the basis of any drug test results obtained from 
non-instrumented devices that may be used for validity screening tests.
    (2) Licensee testing facilities shall discard negative specimens or 
may pool them for use in the licensee testing facility's internal 
quality control program after certification by an HHS-certified 
laboratory that the specimens are negative and valid. Licensee testing 
facilities may not retain any information linking donors to specimens 
that are pooled for use in the internal quality control program.
    (3) Licensee testing facilities may perform multiple initial drug 
tests for the same drug or drug class, provided that all tests meet the 
cutoffs and quality control requirements of this part. For example, a 
licensee testing facility may use immunoassay technique ``A'' for all 
drugs using the licensee's or other entity's cutoff levels, but 
specimens testing positive for amphetamines may also be tested using 
immunoassay technique ``B'' to eliminate any possible positives due to 
structural analogues; or, a valid analytical result cannot be obtained 
using immunoassay technique ``A'' and immunoassay technique ``B'' is 
used in an attempt to obtain a valid analytical result.
    (4) Licensee testing facilities need not assess their false positive 
testing rates for drugs, because all specimens that test as positive on 
the initial tests for drugs and drug metabolites must be forwarded to an 
HHS-certified laboratory for initial and confirmatory testing.
    (5) To ensure that the rate of false negative drug tests is kept to 
the minimum that the immunoassay technology supports, licensee testing 
facilities shall submit to the HHS-certified laboratory a minimum of 5 
percent (or at least one) of the donor specimens screened as negative 
from every analytical run.
    (6) A minimum of 10 percent of all specimens in each analytical run 
of specimens to be initially tested for drugs by the licensee testing 
facility must be quality control samples, which the licensee testing 
facility shall use for internal quality control purposes. (These samples 
are not forwarded to the HHS-certified laboratory for further testing, 
other than for performance testing of the samples.) Licensee testing 
facilities shall ensure that quality control samples that are positive 
for each drug and metabolite for which the FFD program conducts testing 
are included in at least one analytical run each calendar quarter. The 
quality control samples for each analytical run must include--
    (i) Sample(s) certified by an HHS-certified laboratory to contain no 
drugs or drug metabolites (i.e., negative urine samples);
    (ii) At least one positive control with drug(s) or drug 
metabolite(s) targeted at 25 percent above the cutoff;
    (iii) At least one positive control with drug(s) or drug 
metabolite(s) targeted at 25 percent below the cutoff;
    (iv) A sufficient number of calibrators to ensure and document the 
linearity of the assay method over time in the concentration area of the 
cutoff (after acceptable values are obtained for the known calibrators, 
those values will be used to calculate sample data); and

[[Page 523]]

    (v) At least one positive control, certified to be positive by an 
HHS-certified laboratory, which appears to be a donor specimen to the 
licensee testing facility technicians.
    (7) Licensee testing facilities shall document the implementation of 
procedures to ensure that carryover does not contaminate the testing of 
a donor's specimen.
    (f) Errors in testing. Each licensee testing facility shall 
investigate any testing errors or unsatisfactory performance discovered 
in the testing of quality control samples, in the testing of actual 
specimens, or through the processing of management reviews and/or MRO 
reviews, as well as any other errors or matters that could adversely 
reflect on the licensee testing facility's testing process.
    (1) Whenever possible, the investigation must determine relevant 
facts and identify the root cause(s) of the testing or process error.
    (2) The licensee testing facility shall take action to correct the 
cause(s) of any errors or unsatisfactory performance that are within the 
licensee testing facility's control.
    (3) If false negative results are obtained in any analytical run 
from testing the quality control samples specified in paragraphs (b), 
(d), and (e) of this section at the licensee testing facility, the 
licensee testing facility shall forward all donor specimens from that 
analytical run to the HHS-certified laboratory for additional testing 
and implement corrective actions before resuming testing of donor 
specimens for the drug(s), drug metabolite(s), adulterant(s), or other 
specimen characteristics (i.e., creatinine, pH) associated with the 
quality control sample that yielded the false negative result(s).
    (4) If a donor specimen that yielded negative validity or drug test 
results at the licensee testing facility yields positive, substituted, 
adulterated, or invalid results after confirmatory testing by the HHS-
certified laboratory under paragraphs (b)(3), (d)(6), or (e)(5) of this 
section, the licensee or other entity shall implement corrective actions 
before resuming testing of donor specimens for the drug(s), drug 
metabolite(s), adulterant(s), or other specimen characteristics (i.e., 
creatinine, pH) associated with the donor specimen that yielded the 
false negative result(s). In addition to resolving any technical, 
methodological, or administrative errors in the licensee testing 
facility's testing process, the licensee or other entity may re-collect 
and test specimens from any donor whose test results from the licensee 
testing facility may have been inaccurate.
    (5) A record of the investigative findings and the corrective 
actions taken, where applicable, must be dated and signed by the 
individuals who are responsible for the day-to-day management of the 
licensee testing facility and reported to appropriate levels of 
management.
    (g) Accuracy. Volumetric pipettes and measuring devices must be 
certified for accuracy or be checked by gravimetric, colorimetric, or 
other verification procedure. Automatic pipettes and dilutors must be 
checked for accuracy and reproducibility before being placed in service, 
and periodically thereafter.
    (h) Calibrators and controls. Calibrators and controls must be 
prepared using pure drug reference materials, stock standard solutions 
obtained from other laboratories, or standard solutions that are 
obtained from commercial manufacturers and are properly labeled as to 
content and concentration. Calibrators and controls may not be prepared 
from the same stock solution. The standards and controls must be labeled 
with the following dates: when received; when prepared or opened; when 
placed in service; and when scheduled for expiration.

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009]



Sec.26.139  Reporting initial validity and drug test results.

    (a) The licensee testing facility shall report as negative all 
specimens that are valid on the basis of validity screening or initial 
validity tests, or both, and are negative on the initial tests for drugs 
and drug metabolites. Except as permitted under Sec.26.75(h), positive 
test results from initial drug tests at the licensee testing facility 
may not be reported to licensee or other entity management. In addition, 
the licensee testing facility may not

[[Page 524]]

report results from validity screening or initial validity testing 
indicating that a specimen is of questionable validity or positive 
initial drug test results from specimens that are of questionable 
validity.
    (b) Except as provided in Sec. Sec.26.37 and 26.75(h), access to 
the results of initial tests must be limited to the licensee testing 
facility's staff, the MRO and MRO staff, the FFD program manager, and, 
when appropriate, EAP staff and the SAE.
    (c) The licensee testing facility shall provide qualified personnel, 
when required, to testify in an administrative or disciplinary 
proceeding against an individual when that proceeding is based on 
urinalysis results reported by the licensee testing facility.
    (d) The licensee testing facility shall prepare the information 
required for the annual report to the NRC, as required in Sec.26.717.
    (e) The data in the annual report to the NRC must be presented for 
either the cutoff levels specified in this part, or for more stringent 
cutoff levels, if the FFD program uses more stringent cutoff levels for 
drugs and drug metabolites. If the FFD program tests for drugs and drug 
metabolites that are not specified in Sec.26.31(d)(1), the summary 
must also include the number of positive test results and the cutoff 
levels used for those drugs and drug metabolites.
    (f) The designated FFD program official shall use the available 
information from the licensee testing facility's validity and drug test 
results, the results of quality control testing performed at the 
licensee testing facility, and the results from testing the quality 
control samples that the licensee testing facility submits to the HHS-
certified laboratory to evaluate continued testing program effectiveness 
and detect any local trends in drugs of abuse that may require 
management action or FFD program adjustments. FFD program adjustments 
may include, but are not limited to, training enhancements, procedure 
changes, the expansion of the FFD program's drug panel to include 
additional drugs to be tested, or changes in the types of assays, 
validity screening tests, or instruments used.



 Subpart G_Laboratories Certified by the Department of Health and Human 
                                Services



Sec.26.151  Purpose.

    This subpart contains requirements for the HHS-certified 
laboratories that licensees and other entities who are subject to this 
part use for testing urine specimens for validity and the presence of 
drugs and drug metabolites.



Sec.26.153  Using certified laboratories for testing urine specimens.

    (a) Licensees and other entities who are subject to this part shall 
use only laboratories certified under the Department of Health and Human 
Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing 
Programs [published in the Federal Register on April 11, 1988 (53 FR 
11970), and as amended, June 9, 1994 (59 FR 29908), November 13,1998 (63 
FR 63483), and April 13, 2004 (69 FR 19643)] for specimen validity and 
drug testing, except as permitted under Sec.26.31(d)(3)(ii). 
Information concerning the current certification status of laboratories 
is available from the Division of Workplace Programs, Center for 
Substance Abuse Prevention, Substance Abuse and Mental Health Services 
Administration, Room 815, 5600 Fishers Lane, Rockwall 2 Bldg., 
Rockville, Maryland 20857.
    (b) HHS-certified laboratories shall have the capability, at the 
same premises, to perform both initial and confirmatory tests for 
specimen validity and for each drug and drug metabolite for which the 
HHS-certified laboratory provides services to the licensee or other 
entity.
    (c) An HHS-certified laboratory may not subcontract and shall 
perform all work with its own personnel and equipment unless otherwise 
authorized by the licensee or other entity.
    (d) Licensees and other entities shall use only HHS-certified 
laboratories that agree to follow the same rigorous specimen testing, 
quality control, and chain-of-custody procedures when testing for more 
stringent cutoff levels as may be specified by licensees and other 
entities for the classes of drugs identified in this part, and for any 
other substances included in the licensees' or other entities' panels.

[[Page 525]]

    (e) Before awarding a contract to an HHS-certified laboratory, the 
licensee or other entity shall ensure that qualified personnel conduct a 
pre-award inspection and evaluation of the procedural aspects of the 
laboratory's drug testing operations. However, if an HHS-certified 
laboratory loses its certification, in whole or in part, a licensee or 
other entity may immediately begin using another HHS-certified 
laboratory that is being used by another licensee or entity who is 
subject to this part, as permitted by Sec.26.41(g)(5).
    (f) All contracts between licensees or other entities who are 
subject to this part and HHS-certified laboratories must require the 
laboratory to implement all applicable requirements of this part. At a 
minimum, licensees' and other entities' contracts with HHS-certified 
laboratories must include the following requirements:
    (1) Laboratory facilities shall comply with the applicable 
provisions of any State licensor requirements;
    (2) The laboratory shall make available qualified personnel to 
testify in an administrative or disciplinary proceeding against an 
individual when that proceeding is based on urinalysis results reported 
by the HHS-certified laboratory;
    (3) The laboratory shall maintain test records in confidence, 
consistent with the requirements of Sec.26.37, and use them with the 
highest regard for individual privacy.
    (4) Consistent with the principles established in section 503 of 
Public Law 100-71, any employee of a licensee or other entity who is the 
subject of a drug test (or his or her representative designated under 
Sec.26.37(d)) shall, on written request, have access to the 
laboratory's records related to his or her validity and drug test and 
any records related to the results of any relevant certification, 
review, or revocation-of-certification proceedings;
    (5) The laboratory may not enter into any relationship with the 
licensee's or other entity's MRO(s) that may be construed as a potential 
conflict of interest, including, but not limited to, the relationships 
described in Sec.26.183(b), and may not derive any financial benefit 
by having a licensee or other entity use a specific MRO; and
    (6) The laboratory shall permit representatives of the NRC and any 
licensee or other entity using the laboratory's services to inspect the 
laboratory at any time, including unannounced inspections.
    (g) If licensees or other entities use a form other than the current 
Federal custody-and-control form, licensees and other entities shall 
provide a memorandum to the laboratory explaining why a non-Federal form 
was used, but must ensure, at a minimum, that the form used contains all 
the required information on the Federal custody-and-control form.

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009]



Sec.26.155  Laboratory personnel.

    (a) Day-to-day management of the HHS-certified laboratory. HHS-
certified laboratories shall have a responsible person to assume 
professional, organizational, educational, and administrative 
responsibility for the laboratory's drug testing facilities.
    (1) This individual shall have documented scientific qualifications 
in analytical forensic toxicology. Minimum qualifications are as 
follows:
    (i) Certification by the appropriate State as a laboratory director 
in forensic or clinical laboratory toxicology; or
    (ii) A PhD in one of the natural sciences with an adequate 
undergraduate and graduate education in biology, chemistry, and 
pharmacology or toxicology; or
    (iii) Training and experience comparable to a Ph.D. in one of the 
natural sciences, such as a medical or scientific degree with additional 
training and laboratory/research experience in biology, chemistry, and 
pharmacology or toxicology; and
    (iv) In addition to the requirements in paragraphs (a)(1)(i) through 
(a)(1)(iii) of this section, the responsible person shall also have the 
following minimum qualifications:
    (A) Appropriate experience in analytical forensic toxicology 
including experience with the analysis of biological material for drugs 
of abuse; and

[[Page 526]]

    (B) Appropriate training and/or experience in forensic applications 
of analytical toxicology (e.g., publications, court testimony, research 
concerning analytical toxicology of drugs of abuse, or other factors 
that qualify the individual as an expert witness in forensic 
toxicology).
    (2) This individual shall be engaged in and responsible for the day-
to-day management of the testing laboratory, even if another individual 
has overall responsibility for an entire multi-specialty laboratory.
    (3) This individual shall be responsible for ensuring that there are 
enough personnel with adequate training and experience to supervise and 
conduct the work of the drug testing laboratory. He or she shall ensure 
the continued competency of laboratory personnel by documenting their 
in-service training, reviewing their work performance, and verifying 
their skills.
    (4) This individual shall be responsible for ensuring that the 
laboratory has a manual of standard operating procedures that are 
complete, up-to-date, available for personnel performing tests, and 
followed by those personnel. The procedures must be reviewed, signed, 
and dated by this responsible person whenever the procedures are first 
placed into use or changed or when a new individual assumes 
responsibility for management of the laboratory. This individual shall 
ensure that copies of all procedures and records of the dates on which 
they are in effect are maintained. (Specific contents of the procedures 
are described in Sec.26.157.)
    (5) This individual shall be responsible for maintaining a quality 
assurance program to assure the proper performance and reporting of all 
test results; maintaining acceptable analytical performance for all 
controls and standards; maintaining quality control testing; and 
assuring and documenting the validity, reliability, accuracy, precision, 
and performance characteristics of each test and test system.
    (6) This individual shall be responsible for taking all remedial 
actions that may be necessary to maintain satisfactory operation and 
performance of the laboratory in response to quality control systems not 
being within performance specifications, including errors in result 
reporting or in the analysis of performance testing results. This 
individual shall ensure that test results are not reported until all 
corrective actions have been taken and he or she can assure that the 
test results provided are accurate and reliable.
    (b) Certifying scientist. (1) HHS-certified laboratories shall have 
one or more certifying scientists who review all pertinent data and 
quality control results to certify the laboratory's test results.
    (2) A certifying scientist shall be an individual with at least a 
bachelor's degree in the chemical or biological sciences, medical 
technology, or an equivalent field who reviews all pertinent data and 
quality control results. The individual shall have training and 
experience in the theory and practice of all methods and procedures used 
in the laboratory, including a thorough understanding of chain-of-
custody procedures, quality control practices, and analytical procedures 
relevant to the results that the individual certifies. Relevant training 
and experience must also include the review, interpretation, and 
reporting of test results; maintenance of chain of custody; and proper 
remedial action to be taken in response to aberrant test or quality 
control results, or a determination that test systems are out of control 
limits.
    (3) A laboratory may designate certifying scientists who only 
certify results that are reported negative and certifying scientists who 
certify results that are reported both negative and adulterated, 
substituted, dilute, or invalid.
    (c) Day-to-day operations and supervision of analysts. HHS-certified 
laboratories shall assign one or more individuals who are responsible 
for day-to-day operations and supervision of the technical analysts. The 
designated individual(s) shall have at least a bachelor's degree in the 
chemical or biological sciences, medical technology, or an equivalent 
field. The individual(s) shall also have training and experience in the 
theory and practice of the procedures used in the laboratory, resulting 
in his or her thorough

[[Page 527]]

understanding of quality control practices and procedures; review, 
interpretation, and reporting of test results; maintenance of the chain 
of custody; and proper remedial actions to be taken in response to 
aberrant test or quality control results, or the finding that test 
systems are out of control limits.
    (d) Other personnel. Other technicians or nontechnical staff shall 
have the necessary training and skills for their assigned tasks.
    (e) Training. HHS-certified laboratories shall make available 
continuing education programs to meet the needs of laboratory personnel.
    (f) Files. At a minimum, each laboratory personnel file must include 
a r[eacute]sum[eacute], any professional certification(s) or license(s), 
a job description, and documentation to show that the individual has 
been properly trained to perform his or her job.



Sec.26.157  Procedures.

    (a) HHS-certified laboratories shall develop, implement, and 
maintain clear and well-documented procedures for accession, receipt, 
shipment, and testing of urine specimens.
    (b) Written chain-of-custody procedures must describe the methods to 
be used to maintain control and accountability of specimens from receipt 
through completion of testing and reporting of results, during storage 
and shipping to another HHS-certified laboratory, if required, and 
continuing until final disposition of specimens.
    (c) HHS-certified laboratories shall develop, implement, and 
maintain a written manual of standard operating procedures for each 
assay performed for licensees and other entities for drug and specimen 
validity testing. The procedures must include, but are not limited to, 
detailed descriptions of--
    (1) The principles of each test;
    (2) Preparation of reagents, standards, and controls;
    (3) Calibration procedures;
    (4) Derivation of results;
    (5) Linearity of methods;
    (6) Sensitivity of the methods;
    (7) Cutoff values;
    (8) Mechanisms for reporting results;
    (9) Controls;
    (10) Criteria for unacceptable specimens and results;
    (11) Reagents and expiration dates; and
    (12) References.
    (d) HHS-certified laboratories shall develop, implement, and 
maintain written procedures for instrument setup and normal operation, 
including the following:
    (1) A schedule for checking critical operating characteristics for 
all instruments;
    (2) Tolerance limits for acceptable function checks; and
    (3) Instructions for major troubleshooting and repair.
    (e) HHS-certified laboratories shall develop, implement, and 
maintain written procedures for remedial actions to be taken when errors 
are detected or systems are out of acceptable limits.

The laboratory shall maintain documentation that its personnel follow 
these procedures and take all necessary corrective actions. In addition, 
the laboratory shall have systems in place to verify all stages of 
testing and reporting and to document the verification.



Sec.26.159  Assuring specimen security, chain of custody, 
and preservation.

    (a) The HHS-certified laboratories performing services for licensees 
and other entities under this part shall be secure at all times. Each 
laboratory shall have in place sufficient security measures to control 
access to the premises and to ensure that no unauthorized personnel 
handle specimens or gain access to the laboratory processes or areas 
where records are stored. Access to these secured areas must be limited 
to specially authorized individuals whose authorization is documented. 
All authorized visitors, and maintenance and service personnel, shall be 
escorted at all times in the laboratory, except personnel who are 
authorized to conduct inspections and audits on behalf of licensees, 
other entities, the NRC, or the HHS Secretary, and emergency personnel 
(including but not limited to firefighters and medical rescue teams).

[[Page 528]]

    (b) When a shipment of specimens is received, laboratory personnel 
shall inspect each package for evidence of possible tampering and shall 
compare information on specimen bottles within each package to the 
information on the accompanying custody-and-control forms.
    (1) Any direct evidence of tampering or discrepancies in the 
information on the specimen bottles and the custody-and-control forms 
attached to the shipment must be reported to the licensee or other 
entity within 24 hours of the discovery and must be noted on the 
custody-and-control forms for each specimen contained in the package. 
When notified, the licensee or other entity shall ensure that an 
investigation is initiated to determine whether tampering has occurred.
    (i) If the investigation determines that tampering has occurred, the 
licensee or other entity shall ensure that corrective actions are taken.
    (ii) If the licensee or other entity has reason to question the 
integrity and identity of the specimens, the specimens may not be tested 
and the licensee or other entity shall ensure that another collection 
occurs as soon as reasonably practical, except if a split specimen 
collection was performed, either the Bottle A or Bottle B seal remains 
intact, and the intact specimen contains at least 15 mL of urine. In 
this instance, if the licensee testing facility has retained the 
specimen in Bottle B, the licensee testing facility shall forward the 
intact specimen for testing to the HHS-certified laboratory and may not 
conduct any testing at the licensee testing facility.
    (2) The following are exclusive grounds requiring the MRO to cancel 
the testing of a donor's urine specimen:
    (i) The custody-and-control form does not contain information to 
identify the specimen collector and the collection site cannot provide 
conclusive evidence of the collector's identity;
    (ii) The identification numbers on the specimen bottle seal(s) do 
not match the identification numbers on the custody-and-control form;
    (iii) A specimen bottle seal is broken or shows evidence of 
tampering and an intact specimen, as specified in paragraph (b)(1)(ii) 
of this section, does not exist;
    (iv) The specimen appears to have leaked out of its sealed bottle 
and there is less than 15 mL remaining, and an intact specimen, as 
specified in paragraph (b)(1)(ii) of this section, does not exist; or
    (v) As required under Sec.26.165(f)(2).
    (c) The HHS-certified laboratory shall retain specimen bottles 
within the laboratory's accession area until all analyses have been 
completed. Laboratory personnel shall use aliquots and laboratory 
internal custody-and-control forms when conducting initial and 
confirmatory tests. The original specimen and the original custody-and-
control form must remain in secure storage.
    (d) The laboratory's internal custody-and-control form must allow 
for identification of the donor, and documentation of the testing 
process and transfers of custody of the specimen.
    (e) Each time a specimen is handled or transferred within the 
laboratory, laboratory personnel shall document the date and purpose on 
the custody-and-control form and every individual in the chain shall be 
identified. Authorized technicians are responsible for each urine 
specimen or aliquot in their possession and shall sign and complete 
custody-and-control forms for those specimens or aliquots as they are 
received.
    (f) If a specimen is to be transferred to a second HHS-certified 
laboratory, laboratory personnel shall ensure that a copy of the 
custody-and-control form is packaged with the aliquot of a single 
specimen or Bottle B of a split specimen, as appropriate. Sealed and 
labeled specimen bottles and aliquots, with their associated custody-
and-control forms, being transferred from one laboratory to another must 
be placed in a second, tamper-evident shipping container designed to 
minimize the possibility of damage to the specimen during shipment 
(e.g., specimen boxes, padded mailers, or bulk insulated shipping 
containers with that capability) so that the contents of the shipping 
containers are inaccessible without breaking a tamper-evident seal.

[[Page 529]]

    (g) Couriers, express carriers, and postal service personnel do not 
have direct access to the custody-and-control forms or the specimen 
bottles. Therefore, such personnel are not required to document chain of 
custody on the custody-and-control forms during transit. Custody 
accountability of the shipping containers during shipment must be 
maintained by a tracking system provided by the courier, express 
carrier, or postal service.
    (h) Specimens that do not receive an initial test within 7 days of 
arrival at the laboratory must be placed in secure refrigeration units 
for short-term storage. Temperatures may not exceed 6 [deg]C (42.8 
[deg]F). The laboratory shall ensure proper storage conditions in the 
event of a prolonged power failure.
    (i) Long-term frozen storage at a temperature of -20 [deg]C (-4 
[deg]F) or less ensures that positive, adulterated, substituted, and 
invalid urine specimens and Bottle B of a split specimen will be 
available for any necessary retests. Unless otherwise authorized in 
writing by the licensee or other entity, laboratories shall retain and 
place in properly secured long-term frozen storage all specimens 
reported as positive, adulterated, substituted, or invalid. At a 
minimum, such specimens must be stored for 1 year. Within this 1-year 
period, a licensee, other entity, or the NRC may ask the laboratory to 
retain the specimen for an additional period of time. If no retention 
request is received, the laboratory may discard the specimen at the end 
of 1 year. However, the laboratory shall retain any specimens under 
review or legal challenge until they are no longer needed.
    (j) The laboratory shall discard a valid specimen that tests 
negative on initial or confirmatory drug tests or may pool such 
specimens for use in the laboratory's internal quality control program 
after certifying that the specimens are negative and valid. The 
laboratory may not retain any information linking donors to specimens 
that are pooled for use in the internal quality control program.

[73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66602, Nov. 10, 2014]



Sec.26.161  Cutoff levels for validity testing.

    (a) Validity test results. Each validity test result for a specimen 
that the HHS-certified laboratory reports to the MRO as adulterated, 
substituted, dilute, or invalid must be based on performing an initial 
validity test on one aliquot and a confirmatory validity test on a 
second aliquot. Licensees and other entities shall ensure that the HHS-
certified laboratory is capable of conducting, and conducts, 
confirmatory testing for at least one oxidizing adulterant and any other 
adulterants specified by the licensee's or other entity's testing 
program. If initial validity test results indicate that the specimen is 
valid under the criteria in paragraphs (c) through (f) of this section, 
the HHS-certified laboratory need not perform confirmatory validity 
testing of the specimen.
    (b) Initial validity testing. The HHS-certified laboratory shall 
perform initial validity testing of each specimen as follows:
    (1) Determine the creatinine concentration;
    (2) Determine the specific gravity of every specimen for which the 
creatinine concentration is less than 20 mg/dL;
    (3) Determine the pH;
    (4) Perform one or more initial validity tests for oxidizing 
adulterants; and
    (5) Perform additional validity tests, the choice of which depends 
on the observed indicators or characteristics below, when the following 
conditions are observed:
    (i) Abnormal physical characteristics;
    (ii) Reactions or responses characteristic of an adulterant obtained 
during initial or confirmatory drug tests (e.g., non-recovery of 
internal standards, unusual response); or
    (iii) Possible unidentified interfering substance or adulterant.
    (c) Results indicating an adulterated specimen. The laboratory shall 
report a specimen as adulterated when the specimen yields any one or 
more of the following validity testing results:
    (1) The pH is less than 3, or equal to or greater than 11, using 
either a pH meter or a colorimetric pH test for the initial test on the 
first aliquot and a

[[Page 530]]

pH meter for the confirmatory test on the second aliquot;
    (2) The nitrite concentration is equal to or greater than 500 mcg/mL 
using either a nitrite colorimetric test or a general oxidant 
colorimetric test for the initial test on the first aliquot and a 
different confirmatory test (e.g., multi-wavelength spectrophotometry, 
ion chromatography, capillary electrophoresis) on the second aliquot;
    (3) The presence of chromium (VI) is verified using either a general 
oxidant colorimetric test (with a cutoff equal to or greater than 50 
mcg/mL chromium (VI)-equivalents) or a chromium (VI) colorimetric test 
(chromium (VI) concentration equal to or greater than 50 mcg/mL) for the 
initial test on the first aliquot and a different confirmatory test 
(e.g., multi-wavelength spectrophotometry, ion chromatography, atomic 
absorption spectrophotometry, capillary electrophoresis, inductively 
coupled plasma-mass spectrometry) with the chromium (VI) concentration 
equal to or greater than the LOD of the confirmatory test on the second 
aliquot;
    (4) The presence of halogen (e.g., bleach, iodine, fluoride) is 
verified using either a general oxidant colorimetric test (with a cutoff 
equal to or greater than 200 mcg/mL nitrite-equivalents or a cutoff 
equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or a 
halogen colorimetric test (halogen concentration equal to or greater 
than the LOD) for the initial test on the first aliquot and a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, inductively coupled plasma-mass spectrometry) with a 
specific halogen concentration equal to or greater than the LOD of the 
confirmatory test on the second aliquot;
    (5) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the specimen yields the 
characteristic immunoassay response on one or more drug immunoassay 
tests for the initial test on the first aliquot and gas chromatography/
mass spectrometry (GC/MS) for the confirmatory test with the 
glutaraldehyde concentration equal to or greater than the LOD of the 
analysis on the second aliquot;
    (6) The presence of pyridine (pyridinium chlorochromate) is verified 
using either a general oxidant colorimetric test (with a cutoff equal to 
or greater than 200 mcg/mL nitrite-equivalents or a cutoff equal to or 
greater than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI) 
colorimetric test (chromium (VI) concentration equal to or greater than 
50 mcg/mL) for the initial test on the first aliquot and GC/MS for the 
confirmatory test with the pyridine concentration equal to or greater 
than the LOD of the analysis on the second aliquot;
    (7) The presence of a surfactant is verified by using a surfactant 
colorimetric test with a cutoff equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent for the initial test on the first 
aliquot and a different confirmatory test (e.g., multi-wavelength 
spectrophotometry) with a cutoff equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate equivalent on the second aliquot; or
    (8) The presence of any other adulterant not specified in paragraphs 
(c)(3) through (c)(7) of this section is verified using an initial test 
on the first aliquot and a different confirmatory test on the second 
aliquot.
    (d) Results indicating a substituted specimen. The laboratory shall 
report a specimen as substituted when the specimen's creatinine 
concentration is less than 2 mg/dL and its specific gravity is less than 
or equal to 1.0010, or equal to or greater than 1.0200, on both the 
initial and confirmatory creatinine tests (i.e., the same colorimetric 
test may be used to test both aliquots) and on both the initial and 
confirmatory specific gravity tests (i.e., a refractometer is used to 
test both aliquots) on two separate aliquots.
    (e) Results indicating a dilute specimen. The laboratory shall 
report a specimen as dilute when the specimen's creatinine concentration 
is equal to or greater than 2 mg/dL but less than 20 mg/dL and its 
specific gravity is greater than 1.0010 but less than 1.0030 on a single 
aliquot.
    (f) Results indicating an invalid specimen. The laboratory shall 
report a specimen as invalid when the laboratory obtains any one or more 
of the following validity testing results:

[[Page 531]]

    (1) Inconsistent creatinine concentration and specific gravity 
results are obtained (i.e., the creatinine concentration is less than 2 
mg/dL on both the initial and confirmatory creatinine tests and the 
specific gravity is greater than 1.0010 but less than 1.0200 on the 
initial and/or confirmatory specific gravity test, the specific gravity 
is less than or equal to 1.0010 on both the initial and confirmatory 
specific gravity tests and the creatinine concentration is equal to or 
greater than 2 mg/dL on either or both the initial or confirmatory 
creatinine tests);
    (2) The pH is equal to or greater than 3 and less than 4.5, or equal 
to or greater than 9 and less than 11, using either a colorimetric pH 
test or pH meter for the initial test and a pH meter for the 
confirmatory test on two separate aliquots;
    (3) The nitrite concentration is equal to or greater than 200 mcg/mL 
using a nitrite colorimetric test, or equal to or greater than the 
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric 
test for both the initial test and the confirmatory test, or, using 
either initial test, the nitrite concentration is equal to or greater 
than 200 mcg/mL but less than 500 mcg/mL using a different confirmatory 
test (e.g., multi-wavelength spectrophotometry, ion chromatography, 
capillary electrophoresis) on two separate aliquots;
    (4) The possible presence of chromium (VI) is determined using the 
same chromium (VI) colorimetric test with a cutoff equal to or greater 
than 50 mcg/mL chromium (VI) for both the initial test and the 
confirmatory test on two separate aliquots;
    (5) The possible presence of a halogen (e.g., bleach, iodine, 
fluoride) is determined using the same halogen colorimetric test with a 
cutoff equal to or greater than the LOD for both the initial test and 
the confirmatory test on two separate aliquots or relying on the odor of 
the specimen as the initial test;
    (6) The possible presence of glutaraldehyde is determined using the 
same aldehyde test (aldehyde present) or the characteristic immunoassay 
response is observed on one or more drug immunoassay tests for both the 
initial test and the confirmatory test on two separate aliquots;
    (7) The possible presence of an oxidizing adulterant is determined 
by using the same general oxidant colorimetric test (with cutoffs equal 
to or greater than 200 mcg/mL nitrite-equivalents, equal to or greater 
than 50 mcg/mL chromium (VI)-equivalents, or a halogen concentration 
equal to or greater than the LOD) for both the initial test and the 
confirmatory test on two separate aliquots;
    (8) The possible presence of a surfactant is determined using the 
same surfactant colorimetric test with a cutoff equal to or greater than 
100 mcg/mL dodecylbenzene sulfonate-equivalent for both the initial test 
and the confirmatory test on two separate aliquots or a foam/shake test 
for the initial test;
    (9) Interference occurs on the immunoassay drug tests on two 
separate aliquots (i.e., valid immunoassay drug test results cannot be 
obtained);
    (10) Interference with the drug confirmation assay occurs on at 
least two separate aliquots of the specimen, and the laboratory is 
unable to identify the interfering substance;
    (11) The physical appearance of the specimen indicates that testing 
may damage the laboratory's equipment; or
    (12) The physical appearances of Bottles A and B (when a split 
specimen collection is used) are clearly different, and either the test 
result for Bottle A indicated it is an invalid specimen or the specimen 
in Bottle A was screened negative for drugs, or both.
    (g) Additional testing by a second laboratory. If the presence of an 
interfering substance/adulterant is suspected that could make a test 
result invalid, but it cannot be identified (e.g., a new adulterant), 
laboratory personnel shall consult with the licensee's or other entity's 
MRO and, with the MRO's agreement, shall send the specimen to another 
HHS-certified laboratory that has the capability to identify the 
suspected substance.
    (h) More stringent validity test cutoff levels are prohibited. 
Licensees and other entities may not specify more stringent cutoff 
levels for validity tests than those specified in this section.

[[Page 532]]



Sec.26.163  Cutoff levels for drugs and drug metabolites.

    (a) Initial drug testing. (1) HHS-certified laboratories shall apply 
the following cutoff levels for initial testing of specimens to 
determine whether they are negative for the indicated drugs and drug 
metabolites, except if validity testing indicates that the specimen is 
dilute or the licensee or other entity has established more stringent 
cutoff levels:

        Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                   Drug or metabolites                      [nanograms
                                                             (ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites...................................              50
Cocaine metabolites.....................................             300
Opiate metabolites......................................            2000
Phencyclidine (PCP).....................................              25
Amphetamines............................................            1000
------------------------------------------------------------------------

    (2) At the licensee's or other entity's discretion, as documented in 
the FFD program policies and procedures, the licensee or other entity 
may require the HHS-certified laboratory to conduct special analyses of 
dilute specimens as follows:
    (i) If initial validity testing indicates that a specimen is dilute, 
the HHS-certified laboratory shall compare the responses of the dilute 
specimen to the cutoff calibrator in each of the drug classes;
    (ii) If any response is equal to or greater than 50 percent of the 
cutoff, the HHS-certified laboratory shall conduct confirmatory testing 
of the specimen down to the LOD for those drugs and/or drug metabolites; 
and
    (iii) The laboratory shall report the numerical values obtained from 
this special analysis to the MRO.
    (b) Confirmatory drug testing. (1) A specimen that is identified as 
positive on an initial drug test must be subject to confirmatory testing 
for the class(es) of drugs for which the specimen initially tested 
positive. The HHS-certified laboratory shall apply the confirmatory 
cutoff levels specified in this paragraph, except if the licensee or 
other entity requires the special analysis of dilute specimens permitted 
in paragraph (a)(2) of this section or the licensee or other entity has 
established more stringent cutoff levels.

     Confirmatory Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                                 Cutoff
                     Drug or metabolites                       level (ng/
                                                                  mL)
------------------------------------------------------------------------
Marijuana metabolite \1\.....................................         15
Cocaine metabolite \2\.......................................        150
Opiates:
    Morphine.................................................       2000
    Codeine..................................................       2000
    6-acetylmorphine \3\.....................................         10
Phencyclidine (PCP)..........................................         25
Amphetamines:
    Amphetamine..............................................        500
    Methamphetamine \4\......................................        500
------------------------------------------------------------------------
\1\ As delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ As benzoylecgonine.
\3\ Test for 6-AM when the confirmatory test shows a morphine
  concentration exceeding 2,000 ng/mL.
\4\ Specimen must also contain amphetamine at a concentration equal to
  or greater than 200 ng/mL.

    (2) Each confirmatory drug test must provide a quantitative result. 
When the concentration of a drug or metabolite exceeds the linear range 
of the standard curve, the laboratory may record the result as ``exceeds 
the linear range of the test'' or as ``equal to or greater than ,'' or may 
dilute an aliquot of the specimen to obtain an accurate quantitative 
result when the concentration is above the upper limit of the linear 
range.



Sec.26.165  Testing split specimens and retesting single specimens.

    (a) Testing split specimens. (1) If a specimen has been split into 
Bottle A and Bottle B at the collection site, and the specimen was not 
initially tested at a licensee testing facility, then the HHS-certified 
laboratory shall perform initial and confirmatory validity and drug 
testing, if required, of the specimen in Bottle A.
    (2) If a specimen was initially tested at a licensee testing 
facility and positive or questionable validity test results were 
obtained, then the HHS-certified laboratory shall perform initial and 
confirmatory testing, if required, of the specimen in Bottle A.
    (3) At the licensee's or other entity's discretion, Bottle B must 
either be forwarded to the HHS-certified laboratory or maintained in 
secure storage at the licensee testing facility, as required by Sec.
26.135(a) and (c), as applicable. If the specimen in Bottle A is free of 
any evidence of drugs or drug metabolites, and is a valid specimen, then 
the licensee

[[Page 533]]

testing facility or HHS-certified laboratory may discard the specimens 
in Bottles A and B.
    (b) Donor request to MRO for a retest of a single specimen or 
testing Bottle B of a split specimen. (1) For a confirmed positive, 
adulterated, or substituted result reported on a single specimen of 30 
mL or more, or a specimen in Bottle A of a split specimen which the 
donor submitted to the licensee or other entity, a donor may request 
(through the MRO) that an aliquot from the single specimen or the split 
(Bottle B) specimen be tested by a second HHS-certified laboratory to 
verify the result reported by the first laboratory. For an invalid test 
result, a donor may not request that an aliquot from the single specimen 
or the split specimen in Bottle B be tested by a second HHS-certified 
laboratory.
    (2) The MRO shall inform the donor that he or she may, within 3 
business days of notification by the MRO of the confirmed positive, 
adulterated, or substituted test result, request the retesting of an 
aliquot of the single specimen or the testing of the Bottle B split 
specimen. The MRO shall provide the donor with specific instructions for 
making this request (i.e., providing telephone numbers or other contact 
information). The MRO shall have the ability to receive the donor's 
calls at all times during the 3-day period (e.g., by use of an answering 
machine with a ``time stamp'' feature when there is no one in the MRO's 
office to answer the phone). The donor's request may be oral or in 
writing.
    (3) The donor shall provide his or her permission for retesting an 
aliquot of the single specimen or the testing of Bottle B. Neither the 
licensee, MRO, NRC, nor any other entity may order retesting of the 
single specimen or testing of the specimen in Bottle B without the 
donor's written permission, except as permitted in Sec.26.185(l).
    (4) If the donor has not requested a retest of an aliquot of a 
single specimen or a test of the split specimen (Bottle B) within 3 
business days, the donor may present to the MRO information documenting 
that serious injury, illness, lack of actual notice of the confirmed 
test result, inability to contact the MRO (e.g., there was no one in the 
MRO's office and the answering machine was not working), or other 
circumstances unavoidably prevented the donor from making a timely 
request. If the MRO concludes from the donor's information that there 
was a legitimate reason for the donor's failure to contact the MRO 
within the 3 business days permitted, the MRO shall direct the retesting 
of an aliquot of the single specimen or the test of the split specimen 
(Bottle B) take place, as if the donor had made a timely request.
    (5) As soon as reasonably practical and not more than 1 business day 
following the day of the donor's request, as permitted in paragraph 
(b)(3) or (b)(4) of this section, the MRO shall ensure that the HHS-
certified laboratory forwards an aliquot of a single specimen, or that 
the HHS-certified laboratory (or licensee testing facility, as 
appropriate) forwards Bottle B of a split specimen, to a second HHS-
certified laboratory that did not test the specimen in Bottle A.
    (6) The HHS-certified laboratory that retests an aliquot of a single 
specimen or tests the specimen in Bottle B shall provide quantitative 
test results to the MRO and the MRO shall provide them to the donor.
    (c) Retesting a specimen for drugs. (1) The second laboratory shall 
use its confirmatory drug test when retesting an aliquot of a single 
specimen or testing Bottle B of a split specimen for the drug(s) or drug 
metabolite(s) for which the first laboratory reported a positive 
result(s), including retesting specimens that have been subject to the 
special analysis permitted in Sec.26.163(a)(2).
    (2) Because some drugs or drug metabolites may deteriorate during 
storage, the retest by the second laboratory is not subject to a 
specific drug cutoff level, but must provide data sufficient to 
reconfirm the presence of the drug(s) or drug metabolite(s) down to the 
assay's LOD.
    (3) If the second laboratory fails to reconfirm the presence of the 
drug(s) or drug metabolite(s) for which the first laboratory reported a 
positive result(s), the second laboratory shall attempt to determine the 
reason for not reconfirming the first laboratory's findings by 
conducting specimen validity tests. The second laboratory shall conduct

[[Page 534]]

the same specimen validity tests it would conduct on a single specimen 
or the specimen in Bottle A of a split specimen.
    (4) The second laboratory shall report all results to the licensee's 
or other entity's MRO.
    (d) Retesting a specimen for adulterants. A second laboratory shall 
use the required confirmatory validity test and criteria in Sec.
26.161(c) to reconfirm an adulterant result when retesting an aliquot 
from a single specimen or when testing Bottle B of a split specimen. The 
second laboratory may only conduct the confirmatory validity test needed 
to reconfirm the adulterant result reported by the first laboratory.
    (e) Retesting a specimen for substitution. A second laboratory shall 
use its confirmatory creatinine and confirmatory specific gravity tests, 
when retesting an aliquot of a single specimen or testing Bottle B of a 
split specimen, to reconfirm that the creatinine concentration was less 
than 2 mg/dL and the specific gravity was less than or equal to 1.0010 
or equal to or greater than 1.0200. The second laboratory may only 
conduct the confirmatory creatinine and specific gravity tests to 
reconfirm the substitution result reported by the first laboratory.
    (f) Management actions and sanctions. (1) If the MRO confirms a 
positive, adulterated, or substituted test result(s) from the first HHS-
certified laboratory and the donor requests testing of Bottle B of a 
split specimen or retesting of an aliquot from a single specimen, the 
licensee or other entity shall administratively withdraw the 
individual's authorization on the basis of the first confirmed positive, 
adulterated, or substituted test result until the results of testing 
Bottle B or retesting an aliquot of the single specimen are available 
and have been reviewed by the MRO. If the MRO reports that the results 
of testing Bottle B or retesting the aliquot of a single specimen 
reconfirm any of the original positive, adulterated, or substituted test 
result(s), the licensee or other entity shall impose the appropriate 
sanctions specified in subpart D. If the results of testing Bottle B or 
retesting the aliquot of a single specimen are negative, the licensee or 
other entity--
    (i) May not impose any sanctions on the individual;
    (ii) Shall eliminate from the donor's personnel file and other 
records any matter that could link the individual to the temporary 
administrative action;
    (iii) May not disclose the temporary administrative action in 
response to a suitable inquiry conducted under the provisions of Sec.
26.63 or to any other inquiry or investigation required in this chapter. 
To ensure that no records have been retained, access to the system of 
files and records must be provided to personnel conducting reviews, 
inquiries into allegations, or audits under the provisions of Sec.
26.41, or to NRC inspectors; and
    (iv) Shall provide the tested individual with a written statement 
that the records specified in Sec. Sec.26.713 and 26.715 have not been 
retained and shall inform the individual in writing that the temporary 
administrative action that was taken will not be disclosed and need not 
be disclosed by the individual in response to requests for self-
disclosure of potentially disqualifying FFD information.
    (2) If a donor requests that Bottle B be tested or that an aliquot 
of a single specimen be retested, and either Bottle B or the single 
specimen are not available due to circumstances outside of the donor's 
control (including, but not limited to, circumstances in which there is 
an insufficient quantity of the single specimen or the specimen in 
Bottle B to permit retesting, either Bottle B or the original single 
specimen is lost in transit to the second HHS-certified laboratory, or 
Bottle B has been lost at the HHS-certified laboratory or licensee 
testing facility), the MRO shall cancel the test and inform the licensee 
or other entity that another collection is required under direct 
observation as soon as reasonably practical. The licensee or other 
entity shall eliminate from the donor's personnel and other records any 
matter that could link the donor to the original positive, adulterated, 
or substituted test result(s) and any temporary administrative action, 
and may not impose any sanctions on the donor for a cancelled test. If 
test results from

[[Page 535]]

the second specimen collected are positive, adulterated, or substituted 
and the MRO determines that the donor has violated the FFD policy, the 
licensee or other entity shall impose the appropriate sanctions 
specified in subpart D of this part, but may not consider the original 
confirmed positive, adulterated, or substituted test result in 
determining the appropriate sanctions.



Sec.26.167  Quality assurance and quality control.

    (a) Quality assurance program. Each HHS-certified laboratory shall 
have a quality assurance program that encompasses all aspects of the 
testing process, including, but not limited to, specimen accessioning, 
chain of custody, security and reporting of results, initial and 
confirmatory testing, certification of calibrators and controls, and 
validation of analytical procedures. The performance characteristics 
(e.g., accuracy, precision, LOD, limit of quantitation (LOQ), 
specificity) of each test must be validated and documented for each 
test. Validation of procedures must document that carryover does not 
affect the donor's specimen results. Periodic re-verification of 
analytical procedures is required. Quality assurance procedures must be 
designed, implemented, and reviewed to monitor the conduct of each step 
of the testing process.
    (b) Calibrators and controls required. Each analytical run of 
specimens for which an initial or confirmatory validity test, or an 
initial or confirmatory drug test, is being performed must include the 
appropriate calibrators and controls.
    (c) Quality control requirements for performing initial and 
confirmatory validity tests. (1) Requirements for performing creatinine 
tests:
    (i) The creatinine concentration must be measured to one decimal 
place on both the initial and the confirmatory creatinine tests;
    (ii) The initial creatinine test must have a calibrator at 2 mg/dL;
    (iii) The initial creatinine test must have a control in the range 
of 1 to 1.5 mg/dL, a control in the range of 3 to 20 mg/dL, and a 
control in the range of 21 to 25 mg/dL; and
    (iv) The confirmatory creatinine test (performed on those specimens 
with a creatinine concentration less than 2 mg/dL on the initial test) 
must have a calibrator at 2 mg/dL, a control in the range of 1.0 to 1.5 
mg/dL, and a control in the range of 3 to 4 mg/dL.
    (2) Requirements for performing specific gravity tests:
    (i) The refractometer must report and display the specific gravity 
to four decimal places, and must be interfaced with a laboratory 
information management system, or computer, and/or generate a hard copy 
or digital electronic display to document the numerical result;
    (ii) The initial and confirmatory specific gravity tests must have a 
calibrator or control at 1.0000; and
    (iii) The initial and confirmatory specific gravity tests must have 
the following controls:
    (A) One control targeted at 1.0020;
    (B) One control in the range of 1.0040 to 1.0180; and
    (C) One control equal to or greater than 1.0200 but not greater than 
1.0250.
    (3) Requirements for performing pH tests:
    (i) Colorimetric pH tests that have the dynamic range of 2 to 12 to 
support the 3 and 11 pH cutoffs and pH meters must be capable of 
measuring pH to one decimal place. Dipsticks, colorimetric pH tests, and 
pH paper that have a narrow dynamic range and do not support the 2 to 12 
pH cutoffs may be used only to determine whether initial validity tests 
must be performed;
    (ii) At a minimum, pH screening tests must have the following 
controls:
    (A) One control below the lower decision point in use;
    (B) One control between the decision points in use; and
    (C) One control above the upper decision point in use;
    (iii) If a pH screening test is not used, an initial pH meter test 
must have the following calibrators and controls:
    (A) One calibrator at 4;
    (B) One calibrator at 7;
    (C) One calibrator at 10;
    (D) One control in the range of 2 to 2.8;
    (E) One control in the range of 3.2 to 4;

[[Page 536]]

    (F) One control in the range of 10 to 10.8; and
    (G) One control in the range of 11.2 to 12;
    (iv) If a pH screening test is used, an initial or confirmatory pH 
meter test must have the following calibrators and controls when the 
screening result indicates that the pH is below the lower decision point 
in use:
    (A) One calibrator at 4;
    (B) One calibrator at 7;
    (C) One control in the range of 2 to 2.8; and
    (D) One control in the range of 3.2 to 4;
    (v) If a pH screening test is used, an initial or confirmatory pH 
meter test must have the following calibrators and controls when the 
screening result indicates that the pH is above the upper decision point 
in use:
    (A) One calibrator at 7;
    (B) One calibrator at 10;
    (C) One control in the range of 10 to 10.8; and
    (D) One control in the range of 11.2 to 12; and
    (vi) An initial colorimetric pH test must have the following 
calibrators and controls:
    (A) One calibrator at 3;
    (B) One calibrator at 11;
    (C) One control in the range of 2 to 2.8;
    (D) One control in the range of 3.2 to 4;
    (E) One control in the range of 4.5 to 9;
    (F) One control in the range of 10 to 10.8;
    (G) One control in the range of 11.2 to 12.
    (4) Requirements for performing oxidizing adulterant tests:
    (i) Initial tests for oxidizing adulterants must include a 
calibrator at the appropriate cutoff concentration for the compound of 
interest as specified in Sec.26.161(c) and (f), a control without the 
compound of interest (i.e., a certified negative control), and at least 
one control with one of the compounds of interest at a measurable 
concentration; and
    (ii) A confirmatory test for a specific oxidizing adulterant must 
use a different analytical method than that used for the initial test. 
Each confirmatory analytical run must include a calibrator at the 
appropriate cutoff concentration for the compound of interest as 
specified in Sec.26.161(c) and (f), a control without the compound of 
interest (i.e., a certified negative control), and a control with the 
compound of interest at a measurable concentration.
    (5) Requirements for performing nitrite tests: The initial and 
confirmatory nitrite tests must have a calibrator at the cutoff 
concentration, a control without nitrite (i.e., certified negative urine 
specimen), one control in the range of 200 to 400 mcg/mL, and one 
control in the range of 500 to 625 mcg/mL.
    (6) Requirements for performing ``other'' adulterant tests:
    (i) The initial and confirmatory tests for any ``other'' adulterant 
that may be identified in the future must satisfy the requirements in 
Sec.26.161(a);
    (ii) The confirmatory test for ``other'' adulterants must use a 
different analytical principle or chemical reaction than that used for 
the initial test; and
    (iii) The initial and confirmatory tests for ``other'' adulterants 
must include an appropriate calibrator, a control without the compound 
of interest (i.e., a certified negative control), and a control with the 
compound of interest at a measurable concentration.
    (d) Quality control requirements for performing initial drug tests. 
(1) Any initial drug test performed by an HHS-certified laboratory must 
use an immunoassay that meets the requirements of the Food and Drug 
Administration for commercial distribution. Non-instrumented immunoassay 
testing devices that are pending HHS/SAMHSA review and approval may not 
be used for initial drug testing under this part.
    (2) HHS-certified laboratories may perform multiple initial drug 
tests for the same drug or drug class, provided that all tests meet the 
cutoffs and quality control requirements of this part. For example, an 
HHS-certified laboratory may use immunoassay technique ``A'' for all 
drugs using the licensee's or other entity's cutoff levels, but 
specimens testing positive for amphetamines may also be tested using

[[Page 537]]

immunoassay technique ``B'' to eliminate any possible positives due to 
structural analogues; or, a valid analytical result cannot be obtained 
using immunoassay technique ``A'' and immunoassay technique ``B'' is 
used in an attempt to obtain a valid analytical result.
    (3) Quality control samples for each analytical run of specimens for 
initial testing must include--
    (i) Sample(s) certified to contain no drugs or drug metabolites 
(i.e., negative urine samples);
    (ii) At least one positive control with a drug(s) or drug 
metabolite(s) targeted at 25 percent above the cutoff;
    (iii) At least one positive control with a drug(s) or drug 
metabolite(s) targeted at 25 percent below the cutoff;
    (iv) A sufficient number of calibrators to ensure and document the 
linearity of the assay method over time in the concentration area of the 
cutoff (after acceptable values are obtained for the known calibrators, 
those values will be used to calculate sample data); and
    (v) At least one control that appears to be a donor specimen to the 
laboratory analysts.
    (4) A minimum of 10 percent of the total specimens in each 
analytical run must be quality control samples, as defined by paragraphs 
(d)(3)(i) through (iv) of this section.
    (e) Quality control requirements for performing confirmatory drug 
tests. (1) Confirmatory tests for drugs and drug metabolites must be 
performed using gas chromatography/mass spectrometry (GC/MS) or other 
confirmatory test methodologies that HHS-certified laboratories are 
permitted to use in Federal workplace drug testing programs for this 
purpose.
    (2) At least 10 percent of the samples in each analytical run of 
specimens must be calibrators and controls.
    (3) Each analytical run of specimens that are subjected to 
confirmatory testing must include--
    (i) Sample(s) certified to contain no drug (i.e., negative urine 
samples);
    (ii) Positive calibrator(s) and control(s) with a drug(s) or drug 
metabolite(s);
    (iii) At least one positive control with a drug(s) or drug 
metabolite(s) targeted at 25 percent above the cutoff; and
    (iv) At least one calibrator or control that is targeted at or below 
40 percent of the cutoff.
    (f) Errors in testing. The licensee or other entity shall ensure 
that the HHS-certified laboratory investigates any testing errors or 
unsatisfactory performance discovered in blind performance testing, as 
required under Sec.26.168, in the testing of actual specimens, or 
through the processing of reviews, as well as any other errors or 
matters that could adversely reflect on the testing process.
    (1) Whenever possible, the investigation must determine relevant 
facts and identify the root cause(s) of the testing or process error. 
The licensee or other entity, and the HHS-certified laboratory, shall 
take action to correct the causes of any errors or unsatisfactory 
performance that are within each entity's control. Sufficient records 
shall be maintained to furnish evidence of activities affecting quality. 
The licensee or other entity shall assure that the cause of the 
condition is determined and that corrective action is taken to preclude 
repetition. The identification of the significant condition, the cause 
of the condition, and the corrective action taken shall be documented 
and reported to appropriate levels of management.
    (2) If a false positive error occurs on a blind performance test 
sample or on a regular specimen, the licensee or other entity shall 
require the laboratory to take corrective action to minimize the 
occurrence of the particular error in the future. If there is reason to 
believe that the error could have been systematic, the licensee or other 
entity may also require review and re-analysis of previously run 
specimens.
    (3) If a false positive error occurs on a blind performance test 
sample and the error is determined to be technical or methodological, 
the licensee or other entity shall instruct the laboratory to provide 
all quality control data from the batch or analytical run of specimens 
that included a false positive sample. In addition, the licensee or 
other entity shall require the laboratory to retest all specimens that 
analyzed as positive for that drug or

[[Page 538]]

metabolite, or as adulterated, substituted, dilute, or invalid in 
validity testing, from the time of final resolution of the error back to 
the time of the last satisfactory performance test cycle. This retesting 
must be documented by a statement signed by the laboratory's responsible 
person. The licensee or other entity and the NRC also may require an 
onsite review of the laboratory, which may be conducted unannounced 
during any hours of operation of the laboratory.
    (g) Accuracy. Volumetric pipettes and measuring devices must be 
certified for accuracy or be checked by gravimetric, colorimetric, or 
other verification procedures. Automatic pipettes and dilutors must be 
checked for accuracy and reproducibility both before being placed in 
service and periodically thereafter.
    (h) Calibrators and controls. Laboratory calibrators and controls 
must be prepared using pure drug reference materials, stock standard 
solutions obtained from other laboratories, or standard solutions that 
are obtained from commercial manufacturers and are properly labeled as 
to content and concentration. Calibrators and controls may not be 
prepared from the same stock solution. The standards and controls must 
be labeled with the following dates: when received; when prepared or 
opened; when placed in service; and when scheduled for expiration.



Sec.26.168  Blind performance testing.

    (a) Each licensee and other entity shall submit blind performance 
test samples to the HHS-certified laboratory.
    (1) During the initial 90-day period of any contract with an HHS-
certified laboratory (not including rewritten or renewed contracts), 
each licensee or other entity shall submit blind performance test 
samples to each HHS-certified laboratory with whom it contracts in the 
amount of at least 20 percent of the total number of specimens submitted 
(up to a maximum of 100 blind performance test samples) or 30 blind 
performance test samples, whichever is greater.
    (2) Following the initial 90-day period, the number of blind 
performance test samples submitted per quarter must be a minimum of one 
percent of all specimens (up to a maximum of 100) or ten blind 
performance test samples, whichever is greater.
    (3) Both during the initial 90-day period and quarterly thereafter, 
licensees and other entities should attempt to submit blind performance 
test samples at a frequency that corresponds to the submission frequency 
for other specimens.
    (b) Approximately 60 percent of the blind performance test samples 
submitted to the laboratory must be positive for one or more drugs or 
drug metabolites per sample and submitted so that all of the drugs for 
which the FFD program is testing are included at least once each 
calendar quarter, except as follows:
    (1) Licensees and other entities shall submit blind performance test 
samples that are positive for marijuana metabolite at least two times 
each quarter; and
    (2) In at least two quarters each year, licensees and other entities 
shall submit an additional blind performance test sample that is 
positive for cocaine instead of the required sample that is positive for 
PCP.
    (c) The positive blind performance test samples must be positive for 
only those drugs for which the FFD program is testing and formulated at 
concentrations established in paragraph (g)(2) of this section.
    (d) To challenge the HHS-certified laboratory's ability to limit 
false negatives, approximately 10 percent of the blind performance test 
samples submitted to the laboratory each quarter must be formulated at 
the concentrations established in paragraph (g)(3) of this section.
    (e) To challenge the HHS-certified laboratory's ability to determine 
specimen validity, the licensee or other entity shall submit blind 
performance test samples each quarter that are appropriately 
adulterated, diluted, or substituted, in the amount of 20 percent of the 
specimens submitted that quarter or at least three samples per quarter 
(one each that is adulterated, diluted, or substituted), whichever is 
greater. These samples must be formulated at the concentrations 
established

[[Page 539]]

in paragraphs (g)(4) through (g)(6) of this section.
    (f) Approximately 10 percent of the blind performance test samples 
submitted to the laboratory each quarter must be negative, as specified 
in paragraph (g)(1) of this section.
    (g) Licensees and other entities shall use only blind performance 
test samples that have been certified by the supplier to be--
    (1) Negative. A negative blind performance test sample may not 
contain a measurable amount of a target drug analyte and must be 
certified by immunoassay and confirmatory testing;
    (2) Drug positive. These samples must contain a measurable amount of 
the target drug or analyte in concentrations ranging between 150 and 200 
percent of the initial cutoff values and be certified by immunoassay and 
confirmatory testing to contain one or more drug(s) or drug 
metabolite(s);
    (3) A false negative challenge. This blind performance test sample 
must contain a measurable amount of the target drug or analyte in 
concentrations ranging between 130 and 155 percent of the initial cutoff 
values;
    (4) Adulterated. The adulterated blind performance test sample must 
have a pH of less than or equal to 2, or greater than or equal to 12, or 
a nitrite or other oxidant concentration equal to or greater than 500 
mcg/mL, equal to or greater than 50 mcg/mL chromium (VI)-equivalents, or 
a halogen concentration equal to or greater than the LOD. Blind 
performance test samples for other adulterants must have adulterant 
concentrations equal to or greater than (or equal to or less than, as 
appropriate) the initial cutoff levels used by the licensee's or other 
entity's HHS-certified laboratory;
    (5) Dilute. The dilute blind performance test sample must contain a 
creatinine concentration that is equal to or greater than 5 mg/dL but 
less than 20 mg/dL, and the specific gravity must be greater than 1.0010 
but less than 1.0030; or
    (6) Substituted. The substituted blind performance test sample must 
contain less than 2 mg/dL of creatinine, and the specific gravity must 
be less than or equal to 1.0010, or equal to or greater than 1.0200.
    (h) In order to ensure that blind performance test samples continue 
to meet the criteria set forth in paragraph (g) of this section, 
licensees and other entities shall--
    (1) Ensure that all blind performance test sample lots are placed in 
service by the supplier only after confirmation by an HHS-certified 
laboratory, and for no more than 6 months;
    (2) Ensure that the supplier provides the expiration date for each 
blind performance test sample to ensure that each sample will have the 
expected value when it is submitted to and tested by a laboratory; and
    (3) At a minimum, require the supplier to check each open lot bi-
monthly (i.e., every two months) to ensure that samples remaining in the 
lot do not fall below 130 percent of the initial cutoff test 
concentration established by the assay manufacturer. Thus, for example, 
a lot that was certified by an HHS-certified laboratory at 155 percent 
of the manufacturer's assay cutoff level, and was reported by the 
licensee's or other entity's HHS-certified laboratory to be at or above 
130 percent of that standard is acceptable. A test that indicated a 
result below 130 percent of that standard would be unacceptable. 
Licensees and other entities shall discard blind performance test 
samples from any lot that is outside of these parameters and may not use 
any further samples from that lot.
    (i) Licensees and other entities shall ensure that each blind 
performance test sample is indistinguishable to laboratory personnel 
from a donor's specimen, as follows:
    (1) The licensee or other entity shall submit blind performance test 
samples to the laboratory using the same channels (i.e., from the 
licensee's or other entity's collection site or licensee testing 
facility, as appropriate) through which donors' specimens are sent to 
the laboratory;
    (2) The collector and licensee testing facility personnel, as 
appropriate, shall use a custody-and-control form, place fictional 
initials on the specimen bottles' labels/seals, and indicate for the

[[Page 540]]

MRO on the MRO's copy that the specimen is a blind performance test 
sample; and
    (3) The licensee or other entity shall ensure that all blind 
performance test samples include split samples, when the FFD program 
includes split specimen procedures.

[73 FR 17176, Mar. 31, 2008, as amended at 81 FR 86909, Dec. 2, 2016]



Sec.26.169  Reporting Results.

    (a) The HHS-certified laboratory shall report test results to the 
licensee's or other entity's MRO within 5 business days after receiving 
the specimen from the licensee or other entity. Before reporting any 
test result to the MRO, the laboratory's certifying scientist shall 
certify the result as correct. The report must identify the substances 
for which testing was performed; the results of the validity and drug 
tests; the cutoff levels for each; any indications of tampering, 
adulteration, or substitution that may be present; the specimen 
identification number assigned by the licensee or other entity; and the 
specimen identification number assigned by the laboratory.
    (b) If licensees or other entities specify cutoff levels for drugs 
or drug metabolites that are more stringent than those specified in this 
part, the laboratory need only conduct the more stringent tests and 
shall report the results of the initial and confirmatory tests only for 
the more stringent cutoff levels.
    (c) The HHS-certified laboratory shall report as negative all 
specimens that are negative on the initial or confirmatory drug and 
validity tests. Specimens that test as positive, adulterated, 
substituted, dilute, or invalid on the confirmatory analysis must be 
reported to the MRO as positive for a specific drug(s) or drug 
metabolite(s), or as meeting the criteria for an adulterated, 
substituted, dilute, or invalid specimen.
    (1) The laboratory shall report all positive, adulterated, 
substituted, dilute, and invalid test results for each specimen to the 
MRO. For example, a specimen may be both adulterated and positive for 
one or more specific drugs.
    (2) For a specimen that has a positive test result, the laboratory 
shall provide numerical values if the MRO requests such information. The 
MRO's request for positive confirmatory test results may be either a 
general request covering all such results or a specific case-by-case 
request. The laboratory shall routinely provide quantitative values for 
confirmatory opiate test results for morphine or codeine that are 
greater than or equal to 15,000 ng/mL, even if the MRO has not requested 
quantitative values for the test result.
    (3) For a specimen that has an adulterated or substituted test 
result, the laboratory shall provide the MRO with the numerical values 
that support the reported result. The MRO may not disclose the numerical 
values to the licensee or other entity, except as permitted in Sec.
26.37(b). If the numerical values for creatinine are below the LOD, the 
laboratory shall report to the MRO ``creatinine: none detected'' (i.e., 
substituted) along with the numerical values of the specific gravity 
test.
    (4) For a specimen that has an invalid result, the laboratory shall 
contact the MRO and both will decide whether testing by another 
certified laboratory would be useful in being able to report a positive 
or adulterated result. This contact may occur through any secure 
electronic means (e.g., telephone, fax, e-mail). If no further testing 
is necessary, the laboratory shall report the invalid result to the MRO.
    (5) When the concentration of a drug, metabolite, or adulterant 
exceeds the linear range of the standard curve, the laboratory may 
report to the MRO that the quantitative value ``exceeds the linear range 
of the test,'' that the quantitative value is ``equal to or greater than 
,'' 
or may report an accurate quantitative value above the upper limit of 
the linear range that was obtained by diluting an aliquot of the 
specimen.
    (d) The MRO and MRO staff may not disclose quantitative test results 
to a licensee or other entity, but shall report only whether the 
specimen was positive (and for which analyte), adulterated, substituted, 
dilute, invalid, or negative, except as permitted under

[[Page 541]]

Sec.26.37(b). This paragraph does not preclude either the HHS-
certified laboratory or the MRO from providing program performance data, 
as required under Sec.26.717.
    (e) The laboratory may transmit results to the MRO by various 
electronic means (e.g., teleprinters, facsimile, or computer) in a 
manner designed to ensure the confidentiality of the information. The 
laboratory may not provide results orally by telephone. The licensee or 
other entity, directly or through the HHS-certified laboratory, shall 
ensure the security of the data transmission and ensure only authorized 
access to any data transmission, storage, and retrieval system.
    (f) For negative test results, the HHS-certified laboratory may fax, 
courier, mail, or electronically transmit a computer-generated 
electronic report and/or a legible image or copy of the completed 
custody-and-control form to the MRO. However, for positive, adulterated, 
substituted, dilute, and invalid results, the laboratory shall fax, 
courier, mail, or electronically transmit a legible image or copy of the 
completed custody-and-control form to the MRO.
    (g) For a specimen that has a positive, adulterated, substituted, 
dilute, or invalid result, the laboratory shall retain the original 
custody-and-control form and transmit to the MRO a copy of the original 
custody-and-control form signed by a certifying scientist.
    (h) The HHS-certified laboratory shall provide to the licensee's or 
other entity's official responsible for coordination of the FFD program 
an annual statistical summary of urinalysis testing, which may not 
include any personal identifying information. To avoid sending data from 
which it is likely that information about a donor's test result can be 
readily inferred, the laboratory may not send a summary report if the 
licensee or other entity has fewer than 10 specimen test results in a 1-
year period. The summary report must include test results that were 
reported within the year period. The laboratory shall send the summary 
report to the licensee or other entity within 14 calendar days after the 
end of the 1-year period covered by the report. The statistics must be 
presented either for the cutoff levels specified in this part or for any 
more stringent cutoff levels that the licensee or other entity may 
specify. The HHS-certified laboratory shall make available quantitative 
results for all specimens tested when requested by the NRC, licensee, or 
other entity for whom the laboratory is performing drug-testing 
services. If the FFD program tests for additional drugs beyond those 
listed in Sec.26.31(d), the summary must include drug test results for 
the additional drugs. The summary report must contain the following 
information:
    (1) Total number of specimens received;
    (2) Number of specimens reported as--
    (i) Negative, and
    (ii) Negative and dilute;
    (3) Number of specimens reported as positive on confirmatory tests 
by drug or drug metabolite for which testing is conducted, including, 
but not limited to--
    (i) Marijuana metabolite;
    (ii) Cocaine metabolite;
    (iii) Opiates (total);
    (A) Codeine;
    (B) Morphine; and
    (C) 6-AM;
    (iv) Phencyclidine;
    (v) Amphetamines (total);
    (A) Amphetamine; and
    (B) Methamphetamine;
    (4) Total number of specimens reported as adulterated;
    (5) Total number of specimens reported as substituted;
    (6) Total number of specimens reported as positive and dilute 
[including an indication as to whether the specimen was subject to the 
special analysis permitted in Sec.26.163(a)(2)];
    (7) Total number of specimens reported as invalid; and
    (8) Number of specimens reported as rejected for testing and the 
reason for the rejection.



Subpart H_Determining Fitness-for-Duty Policy Violations and Determining 
                                 Fitness



Sec.26.181  Purpose.

    This subpart contains requirements for determining whether a donor 
has violated the FFD policy and for making a determination of fitness.

[[Page 542]]



Sec.26.183  Medical review officer.

    (a) Qualifications. The MRO shall be knowledgeable of this part and 
of the FFD policies of the licensees and other entities for whom the MRO 
provides services. The MRO shall be a physician holding either a Doctor 
of Medicine or Doctor of Osteopathy degree who is licensed to practice 
medicine by any State or Territory of the United States, the District of 
Columbia, or the Commonwealth of Puerto Rico. The MRO shall have passed 
an examination administered by a nationally-recognized MRO certification 
board or subspecialty board for medical practitioners in the field of 
medical review of Federally mandated drug tests.
    (b) Relationships. The MRO may be an employee of the licensee or 
other entity or a contractor. However, the MRO may not be an employee or 
agent of, or have any financial interest in, an HHS-certified laboratory 
or a contracted operator of a licensee testing facility for whom the MRO 
reviews drug test results. Additionally, the MRO may not derive any 
financial benefit by having the licensee or other entity use a specific 
drug testing laboratory or licensee testing facility operating 
contractor and may not have any agreement with such parties that may be 
construed as a potential conflict of interest. Examples of relationships 
between laboratories and MROs that create conflicts of interest, or the 
appearance of such conflicts, include, but are not limited to--
    (1) The laboratory employs an MRO who reviews test results produced 
by the laboratory;
    (2) The laboratory has a contract or retainer with the MRO for the 
review of test results produced by the laboratory;
    (3) The laboratory designates which MRO the licensee or other entity 
is to use, gives the licensee or other entity a slate of MROs from which 
to choose, or recommends certain MROs;
    (4) The laboratory gives the licensee or other entity a discount or 
other incentive to use a particular MRO;
    (5) The laboratory has its place of business co-located with that of 
an MRO or MRO staff who review test results produced by the laboratory; 
or
    (6) The laboratory permits an MRO, or an MRO's organization, to have 
a financial interest in the laboratory.
    (c) Responsibilities. The primary role of the MRO is to review and 
interpret positive, adulterated, substituted, invalid, and at the 
licensee's or other entity's discretion, dilute test results obtained 
through the licensee's or other entity's testing program and to identify 
any evidence of subversion of the testing process. The MRO is also 
responsible for identifying any issues associated with collecting and 
testing specimens, and for advising and assisting FFD program management 
in planning and overseeing the overall FFD program.
    (1) In carrying out these responsibilities, the MRO shall examine 
alternate medical explanations for any positive, adulterated, 
substituted, invalid, or, at the licensee's or other entity's 
discretion, dilute test result. This action may include, but is not 
limited to, conducting a medical interview with the donor, reviewing the 
donor's medical history, or reviewing any other relevant biomedical 
factors. The MRO shall review all medical records that the donor may 
make available when a positive, adulterated, substituted, invalid, or 
dilute test result could have resulted from responsible use of legally 
prescribed medication, a documented condition or disease state, or the 
demonstrated physiology of the donor.
    (2) The MRO may only consider the results of tests of specimens that 
are collected and processed under this part, including the results of 
testing split specimens, in making his or her determination, as long as 
those split specimens have been stored and tested under the procedures 
described in this part.
    (d) MRO staff. Individuals who provide administrative support to the 
MRO may be employees of a licensee or other entity, employees of the 
MRO, or employees of an organization with whom a licensee or other 
entity contracts for MRO services. Employees of a licensee or other 
entity who serve MRO staff functions may also perform other duties for 
the licensee or other entity and need not be under the direction of the 
MRO while performing those other duties.

[[Page 543]]

    (1) Direction of MRO staff activities. MROs shall be directly 
responsible for all administrative, technical, and professional 
activities of individuals who are serving MRO staff functions while they 
are performing those functions, and those functions must be under the 
MRO's direction.
    (i) The duties of MRO staff must be maintained independent from any 
other activity or interest of a licensee or other entity, in order to 
protect the integrity of the MRO function and donors' privacy.
    (ii) An MRO's responsibilities for directing MRO staff must include, 
but are not limited to, ensuring that--
    (A) The procedures being performed by MRO staff meet NRC regulations 
and HHS' and professional standards of practice;
    (B) Records and other donor personal information are maintained 
confidential by MRO staff and are not released to other individuals or 
entities, except as permitted under this part;
    (C) Data transmission is secure; and
    (D) Drug test results are reported to the licensee's or other 
entity's designated reviewing official only as required by this part.
    (iii) The MRO may not delegate any of his or her responsibilities 
for directing MRO staff to any other individual or entity, except 
another MRO.
    (2) MRO staff responsibilities. MRO staff may perform routine 
administrative support functions, including receiving test results, 
reviewing negative test results, and scheduling interviews for the MRO.
    (i) The staff under the direction of the MRO may receive, review, 
and report negative test results to the licensee's or other entity's 
designated representative.
    (ii) The staff reviews of positive, adulterated, substituted, 
invalid, and, at the licensee's or other entity's discretion, dilute 
test results must be limited to reviewing the custody-and-control form 
to determine whether it contains any errors that may require corrective 
action and to ensure that it is consistent with the information on the 
MRO's copy. The staff may resolve errors in custody-and-control forms 
that require corrective action(s), but shall forward the custody-and-
control forms to the MRO for review and approval of the resolution.
    (iii) The staff may not conduct interviews with donors to discuss 
positive, adulterated, substituted, invalid, or dilute test results nor 
request medical information from a donor. Only the MRO may request and 
review medical information related to a positive, adulterated, 
substituted, or invalid test result or other matter from a donor.
    (iv) Staff may not report nor discuss with any individuals other 
than the MRO and other MRO staff any positive, adulterated, substituted, 
invalid, or dilute test results received from the HHS-certified 
laboratory before those results have been reviewed and confirmed by the 
MRO. Any MRO staff discussions of confirmed positive, adulterated, 
substituted, invalid, or dilute test results must be limited to 
discussions only with the licensee's or other entity's FFD program 
personnel and may not reveal quantitative test results or any personal 
medical information about the donor that the MRO may have obtained in 
the course of reviewing confirmatory test results from the HHS-certified 
laboratory.

[73 FR 17176, Mar. 31, 2008, as amended at 83 FR 58464, Nov. 20, 2018]



Sec.26.185  Determining a fitness-for-duty policy violation.

    (a) MRO review required. A positive, adulterated, substituted, 
dilute, or invalid drug test result does not automatically identify an 
individual as having used drugs in violation of the NRC's regulations, 
or the licensee's or other entity's FFD policy, or as having attempted 
to subvert the testing process. An individual who has a detailed 
knowledge of possible alternate medical explanations is essential to the 
review of the results. The MRO shall review all positive, adulterated, 
substituted, and invalid test results from the HHS-certified laboratory 
to determine whether the donor has violated the FFD policy before 
reporting the results to the licensee's or other entity's designated 
representative.
    (b) Reporting of initial test results prohibited. Neither the MRO 
nor MRO staff may report positive, adulterated, substituted, dilute, or 
invalid initial test results that are received from the HHS-

[[Page 544]]

certified laboratory to the licensee or other entity.
    (c) Discussion with the donor. Before determining that a positive, 
adulterated, substituted, dilute, or invalid test result or other 
occurrence is an FFD policy violation and reporting it to the licensee 
or other entity, the MRO shall give the donor an opportunity to discuss 
the test result or other occurrence with the MRO, except as described in 
paragraph (d) of this section. After this discussion, if the MRO 
determines that a positive, adulterated, substituted, dilute, or invalid 
test result or other occurrence is an FFD policy violation, the MRO 
shall immediately notify the licensee's or other entity's designated 
representative.
    (d) Donor unavailability. The MRO may determine that a positive, 
adulterated, substituted, dilute, or invalid test result or other 
occurrence is an FFD policy violation without having discussed the test 
result or other occurrence directly with the donor in the following 
three circumstances:
    (1) The MRO has made and documented contact with the donor and the 
donor expressly declined the opportunity to discuss the test result or 
other occurrence that may constitute an FFD policy violation;
    (2) A representative of the licensee or other entity, or an MRO 
staff member, has successfully made and documented contact with the 
donor and has instructed him or her to contact the MRO, and more than 1 
business day has elapsed since the date on which the licensee's 
representative or MRO's staff member successfully contacted the donor; 
or
    (3) The MRO, after making all reasonable efforts and documenting the 
dates and time of those efforts, has been unable to contact the donor. 
Reasonable efforts include, at a minimum, three attempts, spaced 
reasonably over a 24-hour period, to reach the donor at the day and 
evening telephone numbers listed on the custody-and-control form.
    (e) Additional opportunity for discussion. If the MRO determines 
that the donor has violated the FFD policy without having discussed the 
positive, adulterated, substituted, dilute, or invalid test result or 
other occurrence directly with the donor, the donor may, on subsequent 
notification of the MRO determination and within 30 days of that 
notification, present to the MRO information documenting the 
circumstances, including, but not limited to, serious illness or injury, 
which unavoidably prevented the donor from being contacted by the MRO or 
a representative of the licensee or other entity, or from contacting the 
MRO in a timely manner. On the basis of this information, the MRO may 
reopen the procedure for determining whether the donor's test result or 
other occurrence is an FFD policy violation and permit the individual to 
present information related to the issue. The MRO may modify the initial 
determination based on an evaluation of the information provided.
    (f) Review of invalid specimens. (1) If the HHS-certified laboratory 
reports an invalid result, the MRO shall consult with the laboratory to 
determine whether additional testing by another HHS-certified laboratory 
may be useful in determining and reporting a positive or adulterated 
test result. If the MRO and the laboratory agree that further testing 
would be useful, the HHS-certified laboratory shall forward the specimen 
to a second laboratory for additional testing.
    (2) If the MRO and the laboratory agree that further testing would 
not be useful and there is no technical explanation for the result, the 
MRO shall contact the donor and determine whether there is an acceptable 
medical explanation for the invalid result. If there is an acceptable 
medical explanation, the MRO shall report to the licensee or other 
entity that the test result is not an FFD policy violation, but that a 
negative test result was not obtained. If the medical reason for the 
invalid result is, in the opinion of the MRO, a temporary condition, the 
licensee or other entity shall collect a second urine specimen from the 
donor as soon as reasonably practical and rely on the MRO's review of 
the test results from the second collection. The second specimen 
collected for the purposes of this paragraph may not be collected under 
direct observation. If the medical reason for the invalid result would 
similarly affect the testing of another urine specimen, the MRO may

[[Page 545]]

authorize an alternative method for drug testing. Licensees and other 
entities may not impose sanctions for an invalid test result due to a 
medical condition.
    (3) If the MRO and the laboratory agree that further testing would 
not be useful and there is no legitimate technical or medical 
explanation for the invalid test result, the MRO shall require that a 
second collection take place as soon as practical under direct 
observation. The licensee or other entity shall rely on the MRO's review 
of the test results from the directly observed collection.
    (g) Review of dilute specimens. (1) If the HHS-certified laboratory 
reports that a specimen is dilute and that drugs or drug metabolites 
were detected in the specimen at or above the cutoff levels specified in 
this part or the licensee's or other entity's more stringent cutoff 
levels, and the MRO determines that there is no legitimate medical 
explanation for the presence of the drugs or drug metabolites in the 
specimen, and a clinical examination, if required under paragraph (g)(4) 
of this section, has been conducted, the MRO shall determine that the 
drug test results are positive and that the donor has violated the FFD 
policy.
    (2) If the licensee or other entity requires the HHS-certified 
laboratory to conduct the special analysis of dilute specimens permitted 
in Sec.26.163(a)(2), the results of the special analysis are positive, 
the MRO determines that there is no legitimate medical explanation for 
the presence of the drug(s) or drug metabolite(s) in the specimen, and a 
clinical examination, if required under paragraph (g)(4) of this 
section, has been conducted under paragraph (j) of this section, the MRO 
shall determine whether the positive and dilute specimen is a refusal to 
test. If the MRO does not have sufficient reason to believe that the 
positive and dilute specimen is a subversion attempt, he or she shall 
determine that the drug test results are positive and that the donor has 
violated the FFD policy. When determining whether the donor has diluted 
the specimen in a subversion attempt, the MRO shall also consider the 
following circumstances, if applicable:
    (i) The donor has presented, at this or a previous collection, a 
urine specimen that the HHS-certified laboratory reported as being 
substituted, adulterated, or invalid to the MRO and the MRO determined 
that there is no adequate technical or medical explanation for the 
result;
    (ii) The donor has presented a urine specimen of 30 mL or more that 
falls outside the required temperature range, even if a subsequent 
directly observed collection was performed; or
    (iii) The collector observed conduct clearly and unequivocally 
indicating an attempt to dilute the specimen.
    (3) If a dilute specimen was collected under direct observation, the 
MRO may require the laboratory to conduct confirmatory testing at the 
LOD for any drugs or drug metabolites, as long as each drug class is 
evaluated as required by Sec.26.31(d)(1)(ii).
    (4) If the drugs detected in a dilute specimen are any opium, 
opiate, or opium derivative (e.g., morphine/codeine), or if the drugs or 
metabolites detected indicate the use of prescription or over-the-
counter medications, before determining that the donor has violated the 
FFD policy under paragraph (a) of this section, the MRO or his/her 
designee, who shall also be a licensed physician with knowledge of the 
clinical signs of drug abuse, shall conduct the clinical examination for 
abuse of these substances that is required in paragraph (j) of this 
section. An evaluation for clinical evidence of abuse is not required if 
the laboratory confirms the presence of 6-AM (i.e., the presence of this 
metabolite is proof of heroin use) in the dilute specimen.
    (5) An MRO review is not required for specimens that the HHS-
certified laboratory reports as negative and dilute. The licensee or 
other entity may not take any administrative actions or impose any 
sanctions on a donor who submits a negative and dilute specimen.
    (h) Review of substituted specimens. (1) If the HHS-certified 
laboratory reports a specimen as substituted (i.e., the creatinine 
concentration is less than 2 mg/dL and the specific gravity is less than 
or equal to 1.0010 or equal to or greater than 1.0200), the MRO shall 
contact the donor and offer the donor an opportunity to provide a 
legitimate medical

[[Page 546]]

explanation for the substituted result. The burden of proof resides 
solely with the donor, who must provide legitimate medical evidence 
within 5 business days that he or she produced the specimen for which 
the HHS-certified laboratory reported a substituted result. Any medical 
evidence must be submitted through a physician who is experienced and 
qualified in the medical issues involved, as verified by the MRO. Claims 
of excessive hydration, or claims based on unsubstantiated personal 
characteristics, including, but not limited to, race, gender, diet, and 
body weight, are not acceptable evidence without medical studies which 
demonstrate that the donor did produce the laboratory result.
    (2) If the MRO determines that there is no legitimate medical 
explanation for the substituted test result, the MRO shall report to the 
licensee or other entity that the specimen was substituted.
    (3) If the MRO determines that there is a legitimate medical 
explanation for the substituted test result and no drugs or drug 
metabolites were detected in the specimen, the MRO shall report to the 
licensee or other entity that no FFD policy violation has occurred.
    (i) Review of adulterated specimens. (1) If the HHS-certified 
laboratory reports a specimen as adulterated with a specific substance, 
the MRO shall contact the donor and offer the donor an opportunity to 
provide a legitimate medical explanation for the adulterated result. The 
burden of proof resides solely with the donor, who must provide 
legitimate medical evidence within 5 business days that he or she 
produced the adulterated result. Any medical evidence must be submitted 
through a physician experienced and qualified in the medical issues 
involved, as verified by the MRO.
    (2) If the MRO determines there is no legitimate medical explanation 
for the adulterated test result, the MRO shall report to the licensee or 
other entity that the specimen is adulterated.
    (3) If the MRO determines that there is a legitimate medical 
explanation for the adulterated test result and no drugs or drug 
metabolites were detected in the specimen, the MRO shall report to the 
licensee or other entity that no FFD policy violation has occurred.
    (j) Review for opiates, prescription and over-the-counter 
medications. (1) If the MRO determines that there is no legitimate 
medical explanation for a positive confirmatory test result for opiates 
and before the MRO determines that the test result is a violation of the 
FFD policy, the MRO or his/her designee, who shall also be a licensed 
physician with knowledge of the clinical signs of drug abuse, shall 
determine that there is clinical evidence, in addition to the positive 
confirmatory test result, that the donor has illegally used opium, an 
opiate, or an opium derivative (e.g., morphine/codeine). This 
requirement does not apply if the laboratory confirms the presence of 6-
AM (i.e., the presence of this metabolite is proof of heroin use), or 
the morphine or codeine concentration is equal to or greater than 15,000 
ng/mL and the donor does not present a legitimate medical explanation 
for the presence of morphine or codeine at or above this concentration. 
The MRO may not determine that the consumption of food products is a 
legitimate medical explanation for the presence of morphine or codeine 
at or above this concentration.
    (2) If the MRO determines that there is no legitimate medical 
explanation for a positive confirmatory test result for drugs other than 
opiates that are commonly prescribed or included in over-the-counter 
preparations (e.g., benzodiazepines in the first case, barbiturates in 
the second) and are listed in the licensee's or other entity's panel of 
substances to be tested, the MRO shall determine whether there is 
clinical evidence, in addition to the positive confirmatory test result, 
of abuse of any of these substances or their derivatives.
    (3) If the MRO determines that the donor has used another 
individual's prescription medication, including a medication containing 
opiates, and no clinical evidence of drug abuse is found, the MRO shall 
report to the licensee or other entity that the donor has misused a 
prescription medication. If the MRO determines that the donor has used 
another individual's prescription medication and clinical evidence of 
drug abuse is found, the MRO shall

[[Page 547]]

report to the licensee that the donor has violated the FFD policy.
    (4) In determining whether a legitimate medical explanation exists 
for a positive confirmatory test result for opiates or prescription or 
over-the-counter medications, the MRO may consider the use of a 
medication from a foreign country. The MRO shall exercise professional 
judgment consistently with the following principles:
    (i) There can be a legitimate medical explanation only with respect 
to a drug that is obtained legally in a foreign country;
    (ii) There can be a legitimate medical explanation only with respect 
to a drug that has a legitimate medical use. Use of a drug of abuse 
(e.g., heroin, PCP) or any other substance that cannot be viewed as 
having a legitimate medical use can never be the basis for a legitimate 
medical explanation, even if the drug is obtained legally in a foreign 
country; and
    (iii) Use of the drug can form the basis of a legitimate medical 
explanation only if it is used consistently with its proper and intended 
medical purpose.
    (5) The MRO may not consider consumption of food products, 
supplements, or other preparations containing substances that may result 
in a positive confirmatory drug test result, including, but not limited 
to supplements containing hemp products or coca leaf tea, as a 
legitimate medical explanation for the presence of drugs or drug 
metabolites in the urine specimen above the cutoff levels specified in 
Sec.26.163 or a licensee's or other entity's more stringent cutoff 
levels.
    (6) The MRO may not consider the use of any drug contained in 
Schedule I of section 202 of the Controlled Substances Act [21 U.S.C. 
812] as a legitimate medical explanation for a positive confirmatory 
drug test result, even if the drug may be legally prescribed and used 
under State law.
    (k) Results consistent with legitimate drug use. If the MRO 
determines that there is a legitimate medical explanation for a positive 
confirmatory drug test result, and that the use of a drug identified 
through testing was in the manner and at the dosage prescribed, and the 
results do not reflect a lack of reliability or trustworthiness, then 
the donor has not violated the licensee's or other entity's FFD policy. 
The MRO shall report to the licensee or other entity that no FFD policy 
violation has occurred. The MRO shall further evaluate the positive 
confirmatory test result and medical explanation to determine whether 
use of the drug and/or the medical condition poses a potential risk to 
public health and safety as a result of the individual being impaired 
while on duty. If the MRO determines that such a risk exists, he or she 
shall ensure that a determination of fitness is performed.
    (l) Retesting authorized. Should the MRO question the accuracy or 
scientific validity of a positive, adulterated, substituted, or invalid 
test result, only the MRO is authorized to order retesting of an aliquot 
of the original specimen or the analysis of any split specimen (Bottle 
B) in order to determine whether the FFD policy has been violated. 
Retesting must be performed by a second HHS-certified laboratory. The 
MRO is also the only individual who may authorize a reanalysis of an 
aliquot of the original specimen or an analysis of any split specimen 
(Bottle B) in response to a request from the donor tested.
    (m) Result scientifically insufficient. Based on the review of 
inspection and audit reports, quality control data, multiple specimens, 
and other pertinent results, the MRO may determine that a positive, 
adulterated, substituted or invalid test result is scientifically 
insufficient for further action and may declare that a drug or validity 
test result is not an FFD policy violation, but that a negative test 
result was not obtained. In this situation, the MRO may request 
retesting of the original specimen before making this decision. The MRO 
is neither expected nor required to request such retesting, unless in 
the sole opinion of the MRO, such retesting is warranted. The MRO may 
request that the reanalysis be performed by the same laboratory, or that 
an aliquot of the original specimen be sent for reanalysis to another 
HHS-certified laboratory. The licensee testing facility and the HHS-
certified laboratory shall assist in this review process, as requested 
by the

[[Page 548]]

MRO, by making available the individual(s) responsible for day-to-day 
management of the licensee testing facility or the HHS-certified 
laboratory, or other individuals who are forensic toxicologists or who 
have equivalent forensic experience in urine drug testing, to provide 
specific consultation as required by the MRO.
    (n) Evaluating results from a second laboratory. After a second 
laboratory tests an aliquot of a single specimen or the split (Bottle B) 
specimen, the MRO shall take the following actions if the second 
laboratory reports the following results:
    (1) If the second laboratory reconfirms any positive test results, 
the MRO may report an FFD policy violation to the licensee or other 
entity;
    (2) If the second laboratory reconfirms any adulterated, 
substituted, or invalid validity test results, the MRO may report an FFD 
policy violation to the licensee or other entity;
    (3) If the second laboratory does not reconfirm the positive test 
results, the MRO shall report that no FFD policy violation has occurred; 
or
    (4) If the second laboratory does not reconfirm the adulterated, 
substituted, or invalid validity test results, the MRO shall report that 
no FFD policy violation has occurred.
    (o) Re-authorization after a first violation for a positive test 
result. The MRO is responsible for reviewing drug test results from an 
individual whose authorization was terminated or denied for a first 
violation of the FFD policy involving a confirmed positive drug test 
result and who is being considered for re-authorization. In order to 
determine whether subsequent positive confirmatory drug test results 
represent new drug use or remaining metabolites from the drug use that 
initially resulted in the FFD policy violation, the MRO shall request 
from the HHS-certified laboratory, and the laboratory shall provide, 
quantitation of the test results and other information necessary to make 
the determination. If the drug for which the individual first tested 
positive was marijuana and the confirmatory assay for delta-9-
tetrahydrocannabinol-9-carboxylic acid yields a positive result, the MRO 
shall determine whether the confirmatory test result indicates further 
marijuana use since the first positive test result, or whether the test 
result is consistent with the level of delta-9-tetrahydrocannabinol-9-
carboxylic acid that would be expected if no further marijuana use had 
occurred. If the test result indicates that no further marijuana use has 
occurred since the first positive test result, then the MRO shall 
declare the drug test result as negative.
    (p) Time to complete MRO review. The MRO shall complete his or her 
review of positive, adulterated, substituted, and invalid test results 
and, in instances when the MRO determines that there is no legitimate 
medical explanation for the test result(s), notify the licensee's or 
other entity's designated representative within 10 business days of an 
initial positive, adulterated, substituted, or invalid test result. The 
MRO shall notify the licensee or other entity of the results of his or 
her review in writing and in a manner designed to ensure the 
confidentiality of the information.



Sec.26.187  Substance abuse expert.

    (a) Implementation. Any SAEs on whom licensees and other entities 
rely to make determinations of fitness under this part shall meet the 
requirements of this section. An MRO who meets the requirements of this 
section may serve as both an MRO and as an SAE.
    (b) Credentials. An SAE shall have at least one of the following 
credentials:
    (1) A licensed physician;
    (2) A licensed or certified social worker;
    (3) A licensed or certified psychologist;
    (4) A licensed or certified employee assistance professional; or
    (5) An alcohol and drug abuse counselor certified by the National 
Association of Alcoholism and Drug Abuse Counselors Certification 
Commission or by the International Certification Reciprocity Consortium/
Alcohol and Other Drug Abuse.
    (c) Basic knowledge. An SAE shall be knowledgeable in the following 
areas:
    (1) Demonstrated knowledge of and clinical experience in the 
diagnosis and

[[Page 549]]

treatment of alcohol and controlled-substance abuse disorders;
    (2) Knowledge of the SAE function as it relates to the public's 
interests in the duties performed by the individuals who are subject to 
this subpart; and
    (3) Knowledge of this part and any changes thereto.
    (d) Qualification training. SAEs shall receive qualification 
training on the following subjects:
    (1) Background, rationale, and scope of this part;
    (2) Key drug testing requirements of this part, including specimen 
collection, laboratory testing, MRO review, and problems in drug 
testing;
    (3) Key alcohol testing requirements of this part, including 
specimen collection, the testing process, and problems in alcohol tests;
    (4) SAE qualifications and prohibitions;
    (5) The role of the SAE in making determinations of fitness and the 
return-to-duty process, including the initial evaluation, referrals for 
education and/or treatment, the followup evaluation, continuing 
treatment recommendations, and the followup testing plan;
    (6) Procedures for SAE consultation and communication with licensees 
or other entities, MROs, and treatment providers;
    (7) Reporting and recordkeeping requirements of this part; and
    (8) Issues that SAEs confront in carrying out their duties under 
this part.
    (e) Continuing education. During each 3-year period following 
completion of initial qualification training, the SAE shall complete 
continuing education consisting of at least 12 continuing professional 
education hours relevant to performing SAE functions.
    (1) This continuing education must include material concerning new 
technologies, interpretations, recent guidance, rule changes, and other 
information about developments in SAE practice pertaining to this part, 
since the time the SAE met the qualification training requirements of 
this section.
    (2) Continuing education activities must include documented 
assessment tools to assist in determining that the SAE has learned the 
material.
    (f) Documentation. The SAE shall maintain documentation showing that 
he or she currently meets all requirements of this section. The SAE 
shall provide this documentation on request to NRC representatives, 
licensees, or other entities who are relying on or contemplating relying 
on the SAE's services, and to other individuals and entities, as 
required by Sec.26.37.
    (g) Responsibilities and prohibitions. The SAE shall evaluate 
individuals who have violated the substance abuse provisions of an FFD 
policy and make recommendations concerning education, treatment, return 
to duty, followup drug and alcohol testing, and aftercare. The SAE is 
not an advocate for the licensee or other entity, or the individual. The 
SAE's function is to protect public health and safety and the common 
defense and security by professionally evaluating the individual and 
recommending appropriate education/treatment, follow-up tests, and 
aftercare.
    (1) The SAE is authorized to make determinations of fitness in at 
least the following three circumstances:
    (i) When potentially disqualifying FFD information has been 
identified regarding an individual who has applied for authorization 
under this part;
    (ii) When an individual has violated the substance abuse provisions 
of a licensee's or other entity's FFD policy; and
    (iii) When an individual may be impaired by alcohol, prescription or 
over-the-counter medications, or illegal drugs.
    (2) After determining the best recommendation for assisting the 
individual, the SAE shall serve as a referral source to assist the 
individual's entry into an education and/or treatment program.
    (i) To prevent the appearance of a conflict of interest, the SAE may 
not refer an individual requiring assistance to his or her private 
practice or to a person or organization from whom the SAE receives 
payment or in which the SAE has a financial interest. The SAE is 
precluded from making referrals to entities with whom the SAE is 
financially associated.
    (ii) There are four exceptions to the prohibitions contained in the 
preceding paragraph. The SAE may refer an individual to any of the 
following providers

[[Page 550]]

of assistance, regardless of his or her relationship with them:
    (A) A public agency (e.g., treatment facility) operated by a state, 
county, or municipality;
    (B) A person or organization under contract to the licensee or other 
entity to provide alcohol or drug treatment and/or education services 
(e.g., the licensee's or other entity's contracted treatment provider);
    (C) The sole source of therapeutically appropriate treatment under 
the individual's health insurance program (e.g., the single substance 
abuse in-patient treatment program made available by the individual's 
insurance coverage plan); or
    (D) The sole source of therapeutically appropriate treatment 
reasonably available to the individual (e.g., the only treatment 
facility or education program reasonably located within the general 
commuting area).

[73 FR 17176, Mar. 31, 2008, as amended at 83 FR 58464, Nov. 20, 2018]



Sec.26.189  Determination of fitness.

    (a) A determination of fitness is the process entered when there are 
indications that an individual specified in Sec.26.4(a) through (e), 
and at the licensee's or other entity's discretion as specified in Sec.
26.4(f) and (g), may be in violation of the licensee's or other entity's 
FFD policy or is otherwise unable to safely and competently perform his 
or her duties. A determination of fitness must be made by a licensed or 
certified professional who is appropriately qualified and has the 
necessary clinical expertise, as verified by the licensee or other 
entity, to evaluate the specific fitness issues presented by the 
individual. A professional called on by the licensee or other entity may 
not perform a determination of fitness regarding fitness issues that are 
outside of his or her specific areas of expertise. The types of 
professionals and the fitness issues for which they are qualified to 
make determinations of fitness include, but are not limited to, the 
following:
    (1) An SAE who meets the requirements of Sec.26.187 may determine 
the fitness of an individual who may have engaged in substance abuse and 
shall determine an individual's fitness to be granted authorization 
following an unfavorable termination or denial of authorization under 
this part, but may not be qualified to assess the fitness of an 
individual who may have experienced mental illness, significant 
emotional stress, or other mental or physical conditions that may cause 
impairment but are unrelated to substance abuse, unless the SAE has 
additional qualifications for addressing those fitness issues;
    (2) A clinical psychologist may determine the fitness of an 
individual who may have experienced mental illness, significant 
emotional stress, or cognitive or psychological impairment from causes 
unrelated to substance abuse, but may not be qualified to assess the 
fitness of an individual who may have a substance abuse disorder, unless 
the psychologist is also an SAE;
    (3) A psychiatrist may determine the fitness of an individual who is 
taking psychoactive medications consistently with one or more valid 
prescription(s), but may not be qualified to assess potential impairment 
attributable to substance abuse, unless the psychiatrist has had 
specific training to diagnose and treat substance abuse disorders;
    (4) A physician may determine the fitness of an individual who may 
be ill, injured, fatigued, taking medications in accordance with one or 
more valid prescriptions, or using over-the-counter medications, but may 
not be qualified to assess the fitness of an individual who may have a 
substance abuse disorder, unless the physician is also an SAE; and
    (5) As a physician with specialized training, the MRO may determine 
the fitness of an individual who may have engaged in substance abuse or 
may be ill, injured, fatigued, taking medications under one or more 
valid prescriptions, and/or using over-the-counter medications, but may 
not be qualified to assess an individual's fitness to be granted 
authorization following an unfavorable termination or denial of 
authorization under this part, unless the MRO is also an SAE.
    (b) A determination of fitness must be made in at least the 
following circumstances:

[[Page 551]]

    (1) When there is an acceptable medical explanation for a positive, 
adulterated, substituted, or invalid test result, but there is a basis 
for believing that the individual could be impaired while on duty;
    (2) Before making return-to-duty recommendations after an 
individual's authorization has been terminated unfavorably or denied 
under a licensee's or other entity's FFD policy;
    (3) Before an individual is granted authorization when potentially 
disqualifying FFD information is identified that has not previously been 
evaluated by another licensee or entity who is subject to this subpart; 
and
    (4) When potentially disqualifying FFD information is otherwise 
identified and the licensee's or other entity's reviewing official 
concludes that a determination of fitness is warranted under Sec.
26.69.
    (c) A determination of fitness that is conducted for cause (i.e., 
because of observed behavior or a physical condition) must be conducted 
through face-to-face interaction between the subject individual and the 
professional making the determination. Electronic means of communication 
may not be used.
    (1) If there is neither conclusive evidence of an FFD policy 
violation nor a significant basis for concern that the individual may be 
impaired while on duty, then the individual must be determined to be fit 
for duty.
    (2) If there is no conclusive evidence of an FFD policy violation 
but there is a significant basis for concern that the individual may be 
impaired while on duty, then the subject individual must be determined 
to be unfit for duty. This result does not constitute a violation of 
this part nor of the licensee's or other entity's FFD policy, and no 
sanctions may be imposed. However, the professional who made the 
determination of fitness shall consult with the licensee's or other 
entity's management personnel to identify the actions required to ensure 
that any possible limiting condition does not represent a threat to 
workplace or public health and safety. Licensee or other entity 
management personnel shall implement the required actions. When 
appropriate, the subject individual may also be referred to the EAP.
    (d) Neither the individual nor licensees and other entities may seek 
a second determination of fitness if a determination of fitness under 
this part has already been performed by a qualified professional 
employed by or under contract to the licensee or other entity. After the 
initial determination of fitness has been made, the professional may 
modify his or her evaluation and recommendations based on new or 
additional information from other sources including, but not limited to, 
the subject individual, another licensee or entity, or staff of an 
education or treatment program. Unless the professional who made the 
initial determination of fitness is no longer employed by or under 
contract to the licensee or other entity, only that professional is 
authorized to modify the evaluation and recommendations. When reasonably 
practicable, licensees and other entities shall assist in arranging for 
consultation between the new professional and the professional who is no 
longer employed by or under contract to the licensee or other entity, to 
ensure continuity and consistency in the recommendations and their 
implementation.



                       Subpart I_Managing Fatigue



Sec.26.201  Applicability.

    The requirements in this subpart apply to the licensees and other 
entities identified in Sec.26.3(a), and, if applicable, (c) and (d). 
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).



Sec.26.203  General provisions.

    (a) Policy. Licensees shall 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.
26.27(b).
    (b) Procedures. In addition to the procedures required in Sec.
26.27(c), licensees shall develop, implement, and maintain procedures 
that--
    (1) Describe the process to be followed when any individual 
identified in

[[Page 552]]

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 examinations. Licensees shall add the following KAs 
to the content of the training that is required in Sec.26.29(a) and 
the comprehensive examination required in Sec.26.29(b):
    (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 shall 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 shall include the following information in 
a standard format in the annual FFD program performance report required 
under Sec.26.717:
    (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 shall 
report:
    (i) The number of instances when each applicable work hour control 
specified in Sec.26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and 
(d)(2)(ii), (d)(3)(i) through (d)(3)(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 (d)(1)(iii), (d)(2)(i) and 
(d)(2)(ii), (d)(3)(i) through (d)(3)(v), (d)(4) and (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 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).

[[Page 553]]

    (2) A summary of corrective actions, if any, resulting from the 
analyses of these data, including fatigue assessments.
    (f) Audits. Licensees shall audit the management of worker fatigue 
as required by Sec.26.41.

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43548, July 21, 2011]



Sec.26.205  Work hours.

    (a) Individuals subject to work hour controls. Any individual who 
performs duties identified in Sec.26.4(a)(1) through (a)(5) shall be 
subject to the requirements of this section.
    (b) Calculating work hours. For the purposes of this section, a 
licensee shall calculate the work hours of individuals who are subject 
to this section as the amount of time the individuals perform duties for 
the licensee. Except as permitted by paragraphs (b)(1) through (b)(5) of 
this section, the calculated work hours must include all time performing 
duties for the licensee, including all within-shift break times and rest 
periods during which there are no reasonable opportunities or 
accommodations appropriate for restorative sleep.
    (1) Shift turnover. Licensees may exclude shift turnover from the 
calculation of an individual's work hours. Shift turnover includes only 
those activities that are necessary to safely transfer information and 
responsibilities between two or more individuals between shifts. Shift 
turnover activities may include, but are not limited to, discussions of 
the status of plant equipment, and the status of ongoing activities, 
such as extended tests of safety systems and components. Licensees may 
not exclude work hours worked during turnovers between individuals 
within a shift period due to rotations or relief within a shift. 
Activities that licensees may not exclude from work hours calculations 
also include, but are not limited to, shift holdovers to cover for late 
arrivals of incoming shift members; early arrivals of individuals for 
meetings, training, or pre-shift briefings for special evolutions; and 
holdovers for interviews needed for event investigations.
    (2) Within-shift break and rest periods. Licensees may exclude from 
the calculation of an individual's work hours only that portion of a 
break or rest period during which there is a reasonable opportunity and 
accommodations for restorative sleep (e.g., a nap).
    (3) Beginning or resuming duties subject to work hour controls. If 
an individual begins or resumes performing for the licensee any of the 
duties listed in Sec.26.4(a) during the calculation period, the 
licensee shall include in the calculation of the individual's work hours 
all work hours worked for the licensee, including hours worked 
performing duties that are not listed in Sec.26.4(a), and control the 
individual's work hours under the requirements of paragraph (d) of this 
section.
    (4) Unannounced emergency preparedness exercises and drills. 
Licensees may exclude from the calculation of an individual's work hours 
the time the individual works unscheduled work hours for the purpose of 
participating in the actual conduct of an unannounced emergency 
preparedness exercise or drill.
    (5) Incidental duties performed off site. Licensees may exclude from 
the calculation of an individual's work hours unscheduled work performed 
off site (e.g., technical assistance provided by telephone from an 
individual's home), provided the total duration of the work does not 
exceed a nominal 30 minutes during any single break period. For the 
purposes of compliance with the minimum break requirements of Sec.
26.205(d)(2), and the minimum days off requirements of Sec.
26.205(d)(3) through (d)(5) or the maximum average work hours 
requirements of Sec.26.205(d)(7), such duties do not constitute work 
periods, work shifts, or hours worked.
    (c) Work hours scheduling. Licensees shall schedule the work hours 
of individuals who are subject to this section consistent with the 
objective of preventing impairment from fatigue due to the duration, 
frequency, or sequencing of successive shifts.
    (d) Work hour controls. Licensees shall control the work hours of 
individuals who are subject to this section.
    (1) Except as permitted in Sec.26.207, licensees shall ensure that 
any individual's work hours do not exceed the following limits:

[[Page 554]]

    (i) 16 work hours in any 24-hour period;
    (ii) 26 work hours in any 48-hour period; and
    (iii) 72 work hours in any 7-day period.
    (2) Licensees shall ensure that individuals have, at a minimum, the 
rest breaks specified in this paragraph. For the purposes of this 
subpart, a break is defined as an interval of time that falls between 
successive work periods, during which the individual does not perform 
any duties for the licensee other than one period of shift turnover at 
either the beginning or end of a shift but not both. Except as permitted 
in Sec.26.207, licensees shall ensure that individuals have, at a 
minimum--
    (i) A 10-hour break between successive work periods or an 8-hour 
break between successive work periods when a break of less than 10 hours 
is necessary to accommodate a crew's scheduled transition between work 
schedules or shifts; and
    (ii) A 34-hour break in any 9-day period.
    (3) Licensees shall either ensure that individuals have, at a 
minimum, the number of days off specified in this paragraph, or comply 
with the requirements for maximum average workhours in Sec.
26.205(d)(7). For the purposes of this section, a day off is defined as 
a calendar day during which an individual does not start a work shift. 
For the purposes of calculating the average number of days off required 
in this paragraph, the duration of the shift cycle may not exceed 6 
weeks.
    (i) Individuals who are working 8-hour shift schedules shall have at 
least 1 day off per week, averaged over the shift cycle;
    (ii) Individuals who are working 10-hour shift schedules shall have 
at least 2 days off per week, averaged over the shift cycle;
    (iii) Individuals who are working 12-hour shift schedules while 
performing the duties described in Sec.26.4(a)(1) through (a)(3) shall 
have at least 2.5 days off per week, averaged over the shift cycle;
    (iv) Individuals who are working 12-hour shift schedules while 
performing the duties described in Sec.26.4(a)(4) shall have at least 
2 days off per week, averaged over the shift cycle; and
    (v) Individuals who are working 12-hour shift schedules while 
performing the duties described in Sec.26.4(a)(5) shall have at least 
3 days off per week, averaged over the shift cycle.
    (4) During the first 60 days of a unit outage, licensees need not 
meet the requirements of Sec.26.205(d)(3) or (d)(7) for individuals 
specified in Sec.26.4(a)(1) through (a)(4), while those individuals 
are working on outage activities. However, the licensee shall ensure 
that the individuals specified in Sec.26.4(a)(1) through (a)(3) have 
at least 3 days off in each successive (i.e., non-rolling) 15-day period 
and that the individuals specified in Sec.26.4(a)(4) have at least 1 
day off in any 7-day period;
    (5) During the first 60 days of a unit outage, security system 
outage, or increased threat condition, licensees shall control the hours 
worked by individuals specified in Sec.26.4(a)(5) as follows:
    (i) During the first 60 days of a unit outage or a planned security 
system outage, licensees need not meet the requirements of Sec.
26.205(d)(3) or (d)(7). However, licensees shall ensure that these 
individuals have at least 4 days off in each successive (i.e., non-
rolling) 15-day period; and
    (ii) During the first 60 days of an unplanned security system outage 
or increased threat condition, licensees need not meet the requirements 
of Sec.26.205(d)(3), (d)(5)(i), or (d)(7).
    (6) The 60-day periods in paragraphs (d)(4) and (d)(5) of this 
section may be extended for each individual in 7-day increments for each 
non-overlapping 7-day period the individual has worked not more than 48 
hours during the unit or security system outage or increased threat 
condition, as applicable.
    (7) Licensees may, as an alternative to complying with the minimum 
days off requirements in Sec.26.205(d)(3), comply with the 
requirements for maximum average work hours in this paragraph.
    (i) Individuals may not work more than a weekly average of 54 hours, 
calculated using an averaging period of up to six (6) weeks, which 
advances by 7 consecutive calendar days at the finish of every averaging 
period.

[[Page 555]]

    (ii) For purposes of this section, when an individual's work shift 
starts at the end of a calendar day and concludes during the next 
calendar day, the licensee shall either consider the hours worked during 
that entire shift as if they were all worked on the day the shift 
started, or attribute the hours to the calendar days on which the hours 
were actually worked.
    (iii) Each licensee shall state, in its FFD policy and procedures 
required by Sec.26.27 and Sec.26.203(a) and (b), the work hour 
counting system in Sec.26.205(d)(7)(ii) the licensee is using.
    (8) Each licensee shall state, in its FFD policy and procedures 
required by Sec.26.27 and Sec.26.203(a) and (b), the requirements 
with which the licensee is complying: the minimum days off requirements 
in Sec.26.205(d)(3) or maximum average work hours requirements in 
Sec.26.205(d)(7).
    (e) Reviews. Licensees shall evaluate the effectiveness of their 
control of work hours of individuals who are subject to this section. 
Licensees shall conduct the reviews once per calendar year. If any plant 
or security system outages or increased threat conditions occurred since 
the licensee completed the most recent review, the licensee shall 
include in the review an evaluation of the control of work hours during 
the outages or increased threat conditions. Licensees shall complete the 
review within 30 days of the end of the review period. Licensees shall--
    (1) Review the actual work hours and performance of individuals who 
are subject to this section for consistency with the requirements of 
Sec.26.205(c). At a minimum, this review must address--
    (i) Individuals whose actual hours worked during the review period 
exceeded an average of 54 hours per week in any shift cycle while the 
individuals' work hours are subject to the requirements of Sec.
26.205(d)(3) or in any averaging period of up to 6 weeks, using the same 
averaging period durations that the licensee uses to control the 
individuals' work hours, while the individuals' work hours are subject 
to the requirements of Sec.26.205(d)(7);
    (ii) Individuals who were granted more than one waiver during the 
review period; and
    (iii) Individuals who were assessed for fatigue under Sec.26.211 
during the review period.
    (2) Review individuals' hours worked and the waivers under which 
work was performed to evaluate staffing adequacy for all jobs subject to 
the work hour controls of this section;
    (3) Document the methods used to conduct the review and the results 
of the review; and
    (4) Record, trend, and correct, under the licensee's corrective 
action program, any problems identified in maintaining control of work 
hours consistent with the specific requirements and performance 
objectives of this part.

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43548, July 21, 2011]



Sec.26.207  Waivers and exceptions.

    (a) Waivers. Licensees may grant a waiver of one or more of the work 
hour controls in Sec.26.205(d)(1) through (d)(5)(i) and (d)(7), as 
follows:
    (1) To grant a waiver, the licensee shall meet both of the following 
requirements:
    (i) An operations shift manager determines that the waiver is 
necessary to mitigate or prevent a condition adverse to safety, or a 
security shift manager determines that the waiver is necessary to 
maintain site security, or a site senior-level manager with requisite 
signature authority makes either determination; and
    (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 
Sec. Sec.26.29 and 26.203(c) 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

[[Page 556]]

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.
    (2) To the extent practicable, licensees shall rely on the granting 
of waivers only to address circumstances that could not have been 
reasonably controlled;
    (3) Licensees shall ensure that the timing of the face-to-face 
supervisory assessment that is required by paragraph (a)(1)(ii) of this 
section supports a valid assessment of the potential for worker fatigue 
during the time the individual will be performing work under the waiver. 
Licensees may not perform the face-to-face assessment more than 4 hours 
before the individual begins performing any work under the waiver; and
    (4) Licensees shall document the bases for individual waivers. The 
documented basis for a waiver must include a description of the 
circumstances that necessitate the waiver, a statement of the scope of 
work and time period for which the waiver is approved, and the bases for 
the determinations required in paragraphs (a)(1)(i) and (ii) of this 
section.
    (b) Force-on-force tactical exercises. For the purposes of 
compliance with the minimum days off requirements of Sec.26.205(d)(3) 
or the maximum average work hours requirements of Sec.26.205(d)(7), 
licensees may exclude shifts worked by security personnel during the 
actual conduct of NRC-evaluated force-on-force tactical exercises when 
calculating the individual's number of days off or hours worked, as 
applicable.
    (c) Common defense and security. When informed in writing by the NRC 
that the requirements of Sec.26.205, or any subset thereof, are waived 
for security personnel to ensure the common defense and security, 
licensees need not meet the specified requirements of Sec.26.205 for 
the duration of the period defined by the NRC.
    (d) Plant emergencies. Licensees need not meet the requirements of 
Sec.26.205(c) and (d) during declared emergencies, as defined in the 
licensee's emergency plan.

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43549, July 21, 2011]



Sec.26.209  Self-declarations.

    (a) If an individual is performing, or being assessed for, work 
under a waiver of one or more of the requirements contained in Sec.
26.205(d)(1) through (d)(5)(i) and (d)(7) and declares that, due to 
fatigue, he or she is unable to safely and competently perform his or 
her duties, the licensee shall immediately stop the individual from 
performing any duties listed in Sec.26.4(a), except if the individual 
is required to continue performing those duties under other requirements 
of this chapter. If the subject individual must continue performing the 
duties listed in Sec.26.4(a) until relieved, the licensee shall 
immediately take action to relieve the individual.
    (b) Following a self-declaration, as described in paragraph (a) of 
this section, the licensee--
    (1) May reassign the individual to duties other than those listed in 
Sec.26.4(a), but only if the results of a fatigue assessment, 
conducted under the requirements of Sec.26.211, indicate that the 
individual is fit to safely and competently perform those other duties; 
and
    (2) Shall permit or require the individual to take a break of at 
least 10 hours before the individual returns to performing any duties 
listed in Sec.26.4(a).

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43549, July 21, 2011]



Sec.26.211  Fatigue assessments.

    (a) Licensees shall ensure that fatigue assessments are conducted 
under the following conditions:
    (1) For cause. In addition to any other test or determination of 
fitness that may be required under Sec. Sec.26.31(c) and 26.77, 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

[[Page 557]]

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;
    (2) Self-declaration. A fatigue assessment must be conducted in 
response to an individual's self-declaration to his or her supervisor 
that he or she is not fit to safely and competently perform his or her 
duties for any part of a working tour because of fatigue, except if, 
following the self-declaration, the licensee permits or requires the 
individual to take a rest break of at least 10 hours before the 
individual returns to duty;
    (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). Licensees may not delay necessary medical treatment in 
order to conduct a fatigue assessment; and
    (4) Followup. If a fatigue assessment was conducted for cause or in 
response to a self-declaration, and the licensee returns the individual 
to duty following a break of less than 10 hours in duration, the 
licensee shall reassess the individual for fatigue as well as the need 
to implement controls and conditions before permitting the individual to 
resume performing any duties.
    (b) Only supervisors and FFD program personnel who are trained under 
Sec. Sec.26.29 and 26.203(c) may conduct a fatigue assessment. The 
fatigue assessment must be conducted face to face with the individual 
whose alertness may be impaired.
    (1) In the case of a fatigue assessment conducted for cause, the 
individual who observed the condition of impaired alertness may not 
conduct the fatigue assessment.
    (2) In the case of a post-event fatigue assessment, the individual 
who conducts the fatigue assessment may not have--
    (i) Performed or directed (on site) the work activities during which 
the event occurred;
    (ii) Performed, within 24 hours before the event occurred, a fatigue 
assessment of the individuals who were performing or directing (on site) 
the work activities during which the event occurred; and
    (iii) Evaluated or approved a waiver of one or more of the limits 
specified in Sec.26.205(d)(1) through (d)(5)(i) and (d)(7) for any of 
the individuals who were performing or directing (on site) the work 
activities during which the event occurred, if the event occurred while 
such individuals were performing work under that waiver.
    (c) A fatigue assessment must provide the information necessary for 
management decisions and actions in response to the circumstance that 
initiated the assessment.
    (1) At a minimum, the fatigue assessment must address the following 
factors:
    (i) Acute fatigue;
    (ii) Cumulative fatigue; and
    (iii) Circadian variations in alertness and performance.
    (2) Individuals shall provide complete and accurate information that 
may be required by the licensee to address the factors listed in 
paragraph (c)(1) of this section. Licensees shall limit any inquiries to 
obtaining from the subject individual only the personal information that 
may be necessary to assess the factors listed in paragraph (c)(1) of 
this section.
    (d) The licensee may not conclude that fatigue has not or will not 
degrade the individual's ability to safely and competently perform his 
or her duties solely on the basis that the individual's work hours have 
not exceeded any of the limits specified in Sec.26.205(d)(1), the 
individual has had the minimum breaks required in Sec.26.205(d)(2) or 
minimum days off required in Sec.26.205(d)(3) through (d)(5), as 
applicable, or the individual's hours worked have not exceeded the 
maximum average number of hours worked in Sec.26.205(d)(7).
    (e) Following a fatigue assessment, the licensee shall determine and 
implement the controls and conditions, if any, that are necessary to 
permit the individual to resume performing duties for the licensee, 
including the need for a break.

[[Page 558]]

    (f) Licensees shall document the results of any fatigue assessments 
conducted, the circumstances that necessitated the fatigue assessment, 
and any controls and conditions that were implemented.
    (g) Licensees shall also prepare an annual summary for each nuclear 
power plant site of instances of fatigue assessments that were conducted 
during the previous calendar year for any individual identified in Sec.
26.4(a) through (c). Each summary must include--
    (1) The conditions under which each fatigue assessment was conducted 
(i.e., self-declaration, for cause, post-event, followup);
    (2) A statement of whether or not the individual was working on 
outage activities at the time of the self-declaration or condition 
resulting in the fatigue assessment;
    (3) The category of duties the individual was performing, if the 
individual was performing the duties described in Sec.26.4(a)(1) 
through (a)(5) at the time of the self-declaration or condition 
resulting in the fatigue assessment; and
    (4) The management actions, if any, resulting from each fatigue 
assessment.

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43549, July 21, 2011]

Subpart J [Reserved]



                 Subpart K_FFD Program for Construction



Sec.26.401  General.

    (a) At the licensee's or other entity's discretion, a licensee or 
other entity in Sec.26.3(c) may establish, implement, and maintain an 
FFD program that meets the requirements of this subpart to apply to the 
individuals specified in Sec.26.4(f). If a licensee or other entity in 
Sec.26.3(c) does not elect to implement an FFD program that meets the 
requirements of this subpart, the individuals specified in Sec.26.4(f) 
shall be subject to an FFD program that meets the requirements of 
subparts A through H, N, and O of this part.
    (b) Entities who intend to implement an FFD program under this 
subpart shall submit a description of the FFD program and its 
implementation as part of the license, permit, or limited work 
authorization application.
    (c) Nothing in this subpart prohibits the licensees and other 
entities in Sec.26.3(c) from subjecting the individuals in Sec.
26.4(f) to an FFD program that meets all of the requirements of this 
part or FFD program elements that meet all of the applicable 
requirements of this part.



Sec.26.403  Written policy and procedures.

    (a) Licensees and other entities who implement an FFD program under 
this subpart shall ensure that a clear, concise, written FFD policy 
statement is provided to individuals who are subject to the program. The 
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.
    (b) Licensees and other entities shall develop, implement, and 
maintain written procedures that address the following topics:
    (1) The methods and techniques to be used in testing for drugs and 
alcohol, including procedures for protecting the privacy of an 
individual who provides a specimen, procedures for protecting the 
integrity of the specimen, and procedures used to ensure that the test 
results are valid and attributable to the correct individual;
    (2) The immediate and followup actions that will be taken, and the 
procedures to be used, in those cases in which individuals who are 
subject to the FFD program are determined to have--
    (i) Been involved in the use, sale, or possession of illegal drugs;
    (ii) Consumed alcohol to excess before or while constructing or 
directing the construction of safety- or security-related SSCs, as 
determined by a test that accurately measures BAC;
    (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

[[Page 559]]

    (v) Had legal action taken relating to drug or alcohol use.
    (3) The process 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 off site; the possible use or 
possession of alcohol while constructing or directing the construction 
of safety- or security-related SSCs; or impairment from any cause which 
in any way could adversely affect the individual's ability to safely and 
competently perform his or her duties.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010]



Sec.26.405  Drug and alcohol testing.

    (a) To provide means to deter and detect substance abuse, licensees 
and other entities who implement an FFD program under this subpart shall 
perform drug and alcohol testing that complies with the requirements of 
this section.
    (b) If the licensee or other entity elects to impose random testing 
for drugs and alcohol on the individuals identified in Sec.26.4(f), 
random testing must--
    (1) Be administered in a manner that provides reasonable assurance 
that individuals are unable to predict the time periods during which 
specimens will be collected;
    (2) Require individuals who are selected for random testing to 
report to the collection site as soon as reasonably practicable after 
notification, within the time period specified in the FFD program 
policy;
    (3) 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; and
    (4) Provide that an individual completing a test is immediately 
eligible for another random test.
    (c) Individuals identified in Sec.26.4(f) shall be subject to drug 
and alcohol testing under the following conditions:
    (1) Pre-assignment. Before assignment to construct or direct the 
construction of safety- or security-related SSCs;
    (2) For-cause. In response to an individual's observed behavior or 
physical condition indicating possible substance abuse or after 
receiving credible information that an individual is engaging in 
substance abuse, as defined in Sec.26.5;
    (3) Post-accident. As soon as practical after an event involving a 
human error that was committed by an individual specified in Sec.
26.4(f), where the human error may have caused or contributed to the 
accident. The licensee or other entity shall test the individual(s) who 
committed the error(s), and need not test individuals who were affected 
by the event but whose actions likely did not cause or contribute to the 
event. The individual(s) who committed the human error(s) shall be 
tested if the event resulted in--
    (i) A significant illness or personal injury to the individual to be 
tested or another individual, which within 4 hours after the event is 
recordable under the Department of Labor standards contained in 29 CFR 
1904.7, and subsequent amendments thereto, and 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 physician or other licensed health 
care professional, even if it does not result in death, days away from 
work, restricted work or job transfer, medical treatment beyond first 
aid, or loss of consciousness; or
    (ii) Significant damage, during construction, to any safety-or 
security-related SSC; and
    (4) Followup. As part of a followup plan to verify an individual's 
continued abstinence from substance abuse.
    (d) At a minimum, licensees and other entities shall test specimens 
for marijuana metabolite, cocaine metabolite, opiates (codeine, 
morphine, 6-acetylmorphine), amphetamines (amphetamine, 
methamphetamine), phencyclidine, adulterants, and alcohol at the cutoff 
levels specified in this part, or comparable cutoff levels if specimens 
other than urine are collected for drug testing. Urine specimens 
collected for drug testing must be subject to validity testing.
    (e) The specimen collection and drug and alcohol testing procedures 
of FFD programs under this subpart must protect the donor's privacy and 
the integrity of the specimen, and implement

[[Page 560]]

stringent quality controls to ensure that test results are valid and 
attributable to the correct individual. At the licensee's or other 
entity's discretion, specimen collections and alcohol testing may be 
conducted at a local hospital or other facility under the specimen 
collection and alcohol testing requirements of 49 CFR Part 40 and 
subsequent amendments thereto.
    (f) Testing of urine specimens for drugs and validity, except 
validity screening and initial drug and validity tests that may be 
performed by licensee testing facilities, must be performed in a 
laboratory that is certified by HHS for that purpose, consistent with 
its standards and procedures for certification. Any initial drug test 
performed by a licensee or other entity subject to this subpart must use 
an immunoassay that meets the requirements of the Food and Drug 
Administration for commercial distribution. Urine specimens that yield 
positive, adulterated, substituted, or invalid initial validity or drug 
test results must be subject to confirmatory testing by the HHS-
certified laboratory, except for invalid specimens that cannot be 
tested. Other specimens that yield positive initial drug test results 
must be subject to confirmatory testing by a laboratory that meets 
stringent quality control requirements that are comparable to those 
required for certification by the HHS.
    (g) Licensees and other entities shall provide for an MRO review of 
positive, adulterated, substituted, and invalid confirmatory drug and 
validity test results to determine whether the donor has violated the 
FFD policy, before reporting the results to the individual designated by 
the licensee or other entity to perform the suitability and fitness 
evaluations required under Sec.26.419.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010]



Sec.26.406  Fitness monitoring.

    (a) The requirements in this section apply only if a licensee or 
other entity does not elect to subject the individuals specified in 
Sec.26.4(f) to random testing for drugs and alcohol under Sec.
26.405(b).
    (b) Licensees and other entities shall implement a fitness 
monitoring program to deter substance abuse and detect indications of 
possible use, sale, or possession of illegal drugs; use or possession of 
alcohol while constructing or directing the construction of safety- or 
security-related SSCs; or impairment from any cause that if left 
unattended may result in a risk to public health and safety or the 
common defense and security.
    (c) Licensees and other entities shall establish procedures that 
monitors shall follow in response to the indications and actions 
specified in paragraph (b) of this section and train the monitors to 
implement the program.
    (d) Licensees and other entities shall ensure that the fitness of 
individuals specified in Sec.26.4(f) is monitored effectively while 
the individuals are constructing or directing the construction of 
safety- and security-related SSCs, commensurate with the potential risk 
to public health and safety and the common defense and security imposed 
by the construction activity. To achieve this objective, licensees and 
other entities shall consider the number and placement of monitors 
required, the necessary ratio of monitors to individuals specified in 
Sec.26.4(f), and the frequency with which the individuals specified in 
Sec.26.4(f) shall be monitored while constructing or directing the 
construction of each safety- or security-related SSC.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010]



Sec.26.407  Behavioral observation.

    While the individuals specified in Sec.26.4(f) are constructing or 
directing the construction of safety- or security-related SSCs, 
licensees and other entities shall ensure that these individuals are 
subject to behavioral observation, except if the licensee or other 
entity has implemented a fitness monitoring program under Sec.26.406.

[75 FR 73941, Nov. 30, 2010]



Sec.26.409  Sanctions.

    Licensees and other entities who implement an FFD program under this 
subpart shall establish sanctions for FFD policy violations that, at a 
minimum, prohibit the individuals specified in Sec.26.4(f) from being 
assigned to

[[Page 561]]

construct or direct the construction of safety- or security-related SSCs 
unless or until the licensee or other entity determines that the 
individual's condition or behavior does not pose a potential risk to 
public health and safety or the common defense and security.

[75 FR 73941, Nov. 30, 2010]



Sec.26.411  Protection of information.

    (a) Licensees and other entities who collect personal information 
about an individual for the purpose of complying with this subpart shall 
establish and maintain a system of files and procedures to protect the 
personal information. FFD programs must maintain and use such records 
with the highest regard for individual privacy.
    (b) Licensees and other entities shall obtain a signed consent that 
authorizes the disclosure of the personal information collected and 
maintained under this subpart before disclosing the personal 
information, except for disclosures to the individuals and entities 
specified in Sec.26.37(b)(1) through (b)(6), (b)(8), and persons 
deciding matters under review in Sec.26.413.



Sec.26.413  Review process.

    Licensees and other entities who implement an FFD program under this 
subpart shall establish and implement procedures for the review of a 
determination that an individual in Sec.26.4(f) 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.



Sec.26.415  Audits.

    (a) Licensees and other entities who implement an FFD program under 
this subpart shall ensure that audits are performed to assure the 
continuing effectiveness of the FFD program, including 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.
    (b) Each licensee and other entity shall ensure that these programs 
are audited at a frequency that assures their continuing effectiveness 
and that corrective actions are taken to resolve any problems 
identified. Licensees and entities may conduct joint audits, or accept 
audits of C/Vs conducted by others, so long as the audit addresses the 
relevant C/Vs' services.
    (c) Licensees and other entities need not audit HHS-certified 
laboratories or the specimen collection and alcohol testing services 
that meet the requirements of 49 CFR Part 40, ``Procedures for 
Department of Transportation Workplace Drug and Alcohol Testing 
Programs'' (65 FR 41944; August 9, 2001), on which licensees and other 
entities may rely to meet the drug and alcohol testing requirements of 
this subpart.



Sec.26.417  Recordkeeping and reporting.

    (a) Licensees and other entities who implement FFD programs under 
this subpart shall ensure that records pertaining to the administration 
of the 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.
    (b) Licensees and other entities shall 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 10 CFR 
73.71; and
    (2) Annual program performance reports for the FFD program.



Sec.26.419  Suitability and fitness evaluations.

    Licensees and other entities who implement FFD programs under this 
subpart shall develop, implement, and maintain procedures for evaluating 
whether to assign individuals to construct safety- and security-related 
SSCs. These procedures must provide reasonable assurance that the 
individuals are fit to safely and competently

[[Page 562]]

perform their duties, and are trustworthy and reliable, as demonstrated 
by the avoidance of substance abuse.

Subparts L-M [Reserved]



           Subpart N_Recordkeeping and Reporting Requirements



Sec.26.709  Applicability.

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



Sec.26.711  General provisions.

    (a) Each licensee and other entity shall maintain records and submit 
certain reports to the NRC. Records that are required by the regulations 
in this part must be retained for the period specified by the 
appropriate regulation. If a retention period is not otherwise 
specified, these records must be retained until the Commission 
terminates the facility's license, certificate, or other regulatory 
approval.
    (b) All records may be stored and archived electronically, provided 
that the method used to create the electronic records meets the 
following criteria:
    (1) Provides an accurate representation of the original records;
    (2) Prevents the alteration of any archived information and/or data 
once it has been committed to storage; and
    (3) Permits easy retrieval and re-creation of the original records.
    (c) The licensees and other entities specified in Sec.26.3(a) and, 
as applicable, (c) and (d), shall inform each individual of his or her 
right to review information about the individual that is collected and 
maintained under this part to assure its accuracy. Licensees and other 
entities shall provide the individual with an opportunity to correct any 
inaccurate or incomplete information that is documented by licensees and 
other entities about the individual.
    (d) Licensees and other entities shall ensure that only correct and 
complete information about individuals is retained and shared with other 
licensees and entities. If, for any reason, the shared information used 
for determining an individual's eligibility for authorization under this 
part changes or new information is developed about the individual, 
licensees and other entities shall correct or augment the shared 
information contained in the records. If the changed or developed 
information has implications for adversely affecting an individual's 
eligibility for authorization, a licensee and other entity specified in 
Sec.26.3(a) and, as applicable, (c) and (d), who has discovered the 
incorrect information, or develops new information, shall inform the 
reviewing official of any FFD program under which the individual is 
maintaining authorization of the updated information on the day of 
discovery. The reviewing official shall evaluate the information and 
take appropriate actions, which may include denial or unfavorable 
termination of the individual's authorization.



Sec.26.713  Recordkeeping requirements for licensees and other
entities.

    (a) Each licensee and other entity who is subject to this subpart 
shall retain the following records for at least 5 years after the 
licensee or other entity terminates or denies an individual's 
authorization or until the completion of all related legal proceedings, 
whichever is later:
    (1) Records of self-disclosures, employment histories, and suitable 
inquiries that are required under Sec. Sec.26.55, 26.57, 26.59, and 
26.69 that result in the granting of authorization;
    (2) Records pertaining to the determination of a violation of the 
FFD policy and related management actions;
    (3) Documentation of the granting and termination of authorization; 
and
    (4) Records of any determinations of fitness conducted under Sec.
26.189, including any recommendations for treatment and followup testing 
plans.
    (b) Each licensee and other entity who is subject to this subpart 
shall retain the following records for at least 3 years or until the 
completion of all related legal proceedings, whichever is later:
    (1) Records of FFD training and examinations conducted under Sec.
26.29; and
    (2) Records of audits, audit findings, and corrective actions taken 
under Sec.26.41.

[[Page 563]]

    (c) Licensees and other entities shall ensure the retention and 
availability of records pertaining to any 5-year denial of authorization 
under Sec.26.75(c), (d), or (e)(2) and any permanent denial of 
authorization under Sec.26.75(b) and (g) for at least 40 years or 
until, on application, the NRC determines that the records are no longer 
needed.
    (d) Licensees and other entities shall retain any superseded 
versions of the written FFD policy and procedures required under 
Sec. Sec.26.27, 26.39, and 26.203(b) for at least 5 years or until 
completion of all legal proceedings related to an FFD violation that may 
have occurred under the policy and procedures, whichever is later.
    (e) Licensees and other entities shall retain written agreements for 
the provision of services under this part for the life of the agreement 
or until completion of all legal proceedings related to an FFD policy 
violation that involved those services, whichever is later.
    (f) Licensees and other entities shall retain records of the 
background investigations, credit and criminal history checks, and 
psychological assessments of FFD program personnel, conducted under 
Sec.26.31(b)(1)(i), for the length of the individual's employment by 
or contractual relationship with the licensee or other entity, or until 
the completion of all related legal proceedings, whichever is later.
    (g) If a licensee's or other entity's FFD program includes tests for 
drugs in addition to those specified in this part, as permitted under 
Sec.26.31(d)(1), or uses more stringent cutoff levels than those 
specified in this part, as permitted under Sec.26.31(d)(3), the 
licensee or other entity shall retain documentation certifying the 
scientific and technical suitability of the assays and cutoff levels 
used, as required under Sec.26.31(d)(1)(i) and (d)(3)(iii)(C), 
respectively, for the time the FFD program follows these practices or 
until the completion of all related legal proceedings, whichever is 
later.



Sec.26.715  Recordkeeping requirements for collection sites, licensee
testing facilities, and laboratories certified by the Department of
Health and Human Services.
          

    (a) Collection sites providing services to licensees and other 
entities who are subject to this subpart, licensee testing facilities, 
and HHS-certified laboratories shall maintain and make available 
documentation of all aspects of the testing process for at least 2 years 
or until the completion of all legal proceedings related to a 
determination of an FFD violation, whichever is later. This 2-year 
period may be extended on written notification by the NRC or by any 
licensee or other entity for whom services are being provided.
    (b) Documentation that must be retained includes, but is not limited 
to, the following:
    (1) Personnel files, including training records, for all individuals 
who have been authorized to have access to specimens, but are no longer 
under contract to or employed by the collection site, licensee testing 
facility, or HHS-certified laboratory;
    (2) Chain-of-custody documents (other than forms recording specimens 
with negative test results and no FFD violations or anomalies, which may 
be destroyed after appropriate summary information has been recorded for 
program administration purposes);
    (3) Quality assurance and quality control records;
    (4) Superseded procedures;
    (5) All test data (including calibration curves and any calculations 
used in determining test results);
    (6) Test reports;
    (7) Records pertaining to performance testing;
    (8) Records pertaining to the investigation of testing errors or 
unsatisfactory performance discovered in quality control or blind 
performance testing, in the testing of actual specimens, or through the 
processing of appeals and MRO reviews, as well as any other errors or 
matters that could adversely reflect on the integrity of the testing 
process, investigation findings, and corrective actions taken, where 
applicable;
    (9) Performance records on certification inspections;

[[Page 564]]

    (10) Records of preventative maintenance on licensee testing 
facility instruments;
    (11) Records that summarize any test results that the MRO determined 
to be scientifically insufficient for further action;
    (12) Either printed or electronic copies of computer-generated data;
    (13) Records that document the dates, times of entry and exit, 
escorts, and purposes of entry of authorized visitors, maintenance 
personnel, and service personnel who have accessed secured areas of 
licensee testing facilities and HHS-certified laboratories; and
    (14) Records of the inspection, maintenance, and calibration of 
EBTs.



Sec.26.717  Fitness-for-duty program performance data.

    (a) Licensees and other entities shall collect and compile FFD 
program performance data for each FFD program that is subject to this 
subpart.
    (b) The FFD program performance data must include the following 
information:
    (1) The random testing rate;
    (2) Drugs for which testing is conducted and cutoff levels, 
including results of tests using lower cutoff levels, tests for drugs 
not included in the HHS panel, and any special analyses of dilute 
specimens permitted under Sec.26.163(a)(2);
    (3) Populations tested (i.e., individuals in applicant status, 
permanent licensee employees, C/Vs);
    (4) Number of tests administered and results of those tests sorted 
by population tested (i.e., individuals in applicant status, permanent 
licensee employees, C/Vs);
    (5) Conditions under which the tests were performed, as defined in 
Sec.26.31(c);
    (6) Substances identified;
    (7) Number of subversion attempts by type;
    (8) Summary of management actions; and
    (9) The information required under Sec.26.203(e)(1) and (e)(2).
    (c) Licensees and other entities who have a licensee-approved FFD 
program shall analyze the data at least annually and take appropriate 
actions to correct any identified program weaknesses. Records of the 
data, analyses, and corrective actions taken must be retained for at 
least 3 years or until the completion of any related legal proceedings, 
whichever is later.
    (d) Any licensee or other entity who terminates an individual's 
authorization or takes administrative action on the basis of the results 
of a positive initial drug test for marijuana or cocaine shall also 
report these test results in the annual summary by processing stage 
(i.e., initial testing at the licensee testing facility, testing at the 
HHS-certified laboratory, and MRO determinations). The report must also 
include the number of terminations and administrative actions taken 
against individuals for the reporting period.
    (e) Licensees and other entities shall submit the FFD program 
performance data (for January through December) to the NRC annually, 
before March 1 of the following year.
    (f) Licensees and other entities may submit the FFD program 
performance data in a consolidated report, as long as the report 
presents the data separately for each site.
    (g) Each C/V who maintains a licensee-approved drug and alcohol 
testing program is subject to the reporting requirements of this section 
and shall submit the required information either directly to the NRC or 
through the licensees or other entities to whom the C/V provided 
services during the year. Licensees, other entities, and C/Vs shall 
share information to ensure that the information is reported completely 
and is not duplicated in reports submitted to the NRC.

[73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66603, Nov. 10, 2014]



Sec.26.719  Reporting requirements.

    (a) Required reports. Each licensee and entity who is subject to 
this subpart shall inform the NRC of significant violations of the FFD 
policy, significant FFD program failures, and errors in drug and alcohol 
testing. These events must be reported under this section, rather than 
under the provisions of 10 CFR 73.71.
    (b) Significant FFD policy violations or programmatic failures. The 
following significant FFD policy violations and programmatic failures 
must be reported to

[[Page 565]]

the NRC Operations Center by telephone within 24 hours after the 
licensee or other entity discovers the violation:
    (1) The use, sale, distribution, possession, or presence of illegal 
drugs, or the consumption or presence of alcohol within a protected 
area;
    (2) Any acts by any person licensed under 10 CFR part 55 to operate 
a power reactor, as well as any acts by SSNM transporters, FFD program 
personnel, or any supervisory personnel who are authorized under this 
part, if such acts--
    (i) Involve the use, sale, or possession of a controlled substance;
    (ii) Result in a determination that the individual has violated the 
licensee's or other entity's FFD policy (including subversion as defined 
in Sec.26.5); or
    (iii) Involve the consumption of alcohol within a protected area or 
while performing the duties that require the individual to be subject to 
the FFD program;
    (3) Any intentional act that casts doubt on the integrity of the FFD 
program; and
    (4) Any programmatic failure, degradation, or discovered 
vulnerability of the FFD program that may permit undetected drug or 
alcohol use or abuse by individuals within a protected area, or by 
individuals who are assigned to perform duties that require them to be 
subject to the FFD program.
    (c) Drug and alcohol testing errors. (1) Within 30 days of 
completing an investigation of any testing errors or unsatisfactory 
performance discovered in performance testing at either a licensee 
testing facility or an HHS-certified laboratory, in the testing of 
quality control or actual specimens, or through the processing of 
reviews under Sec.26.39 and MRO reviews under Sec.26.185, as well as 
any other errors or matters that could adversely reflect on the 
integrity of the random selection or testing process, the licensee or 
other entity shall submit to the NRC a report of the incident and 
corrective actions taken or planned. If the error involves an HHS-
certified laboratory, the NRC shall ensure that HHS is notified of the 
finding.
    (2) If a false positive error occurs on a blind performance test 
sample submitted to an HHS-certified laboratory, the licensee or other 
entity shall notify the NRC within 24 hours after discovery of the 
error.
    (3) If a false negative error occurs on a quality assurance check of 
validity screening tests, as required in Sec.26.137(b), the licensee 
or other entity shall notify the NRC within 24 hours after discovery of 
the error.
    (d) Indicators of programmatic weaknesses. Licensees and other 
entities shall 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.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73942, Nov. 30, 2010]



            Subpart O_Inspections, Violations, and Penalties



Sec.26.821  Inspections.

    (a) Each licensee and other entity who is subject to this part shall 
permit duly authorized NRC representatives to inspect, copy, or take 
away copies of its records and to inspect its premises, activities, and 
personnel as may be necessary to accomplish the purposes of this part.
    (b) Written agreements between licensees or other entities and their 
C/Vs must clearly show that--
    (1) The licensee or other entity is responsible to the NRC for 
maintaining an effective FFD program under this part; and
    (2) Duly authorized NRC representatives may inspect, copy, or take 
away copies of any licensee's, other entity's, or C/V's documents, 
records, and reports related to implementation of the licensee's or 
other entity's FFD program under the scope of the contracted activities.



Sec.26.823  Violations.

    (a) An injunction or other court order may be obtained to prohibit a 
violation of any provision of--

[[Page 566]]

    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974; or
    (3) Any regulation or order issued under these Acts.
    (b) A court order may be obtained for the payment of a civil penalty 
imposed under section 234 of the Atomic Energy Act of 1954, for 
violations of--
    (1) Section 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Act;
    (2) Section 206 of the Energy Reorganization Act of 1974;
    (3) Any rule, regulation, or order issued under these sections;
    (4) Any term, condition, or limitation of any license issued under 
these sections; or
    (5) Any provisions for which a license may be revoked under section 
186 of the Atomic Energy Act of 1954.



Sec.26.825  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For the purposes of section 
223, all of the regulations in Part 26 are issued under one or more of 
sections 161b, 161i, or 161o, except for the sections listed in 
paragraph (b) of this section.
    (b) The regulations in Part 26 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, 26.823, and 26.825.



PART 30_RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL--Table of Contents



                           General Provisions

Sec.
30.1 Scope.
30.2 Resolution of conflict.
30.3 Activities requiring license.
30.4 Definitions.
30.5 Interpretations.
30.6 Communications.
30.7 Employee protection.
30.8 Information collection requirements: OMB approval.
30.9 Completeness and accuracy of information.
30.10 Deliberate misconduct.

                               Exemptions

30.11 Specific exemptions.
30.12 Persons using byproduct material under certain Department of 
          Energy and Nuclear Regulatory Commission contracts.
30.13 Carriers.
30.14 Exempt concentrations.
30.15 Certain items containing byproduct material.
30.18 Exempt quantities.
30.19 Self-luminous products containing tritium, krypton-85, or 
          promethium-147.
30.20 Gas and aerosol detectors containing byproduct material.
30.21 Radioactive drug: Capsules containing carbon-14 urea for ``in 
          vivo'' diagnostic use for humans.
30.22 Certain industrial devices.

                                Licenses

30.31 Types of licenses.
30.32 Application for specific licenses.
30.33 General requirements for issuance of specific licenses.
30.34 Terms and conditions of licenses.
30.35 Financial assurance and recordkeeping for decommissioning.
30.36 Expiration and termination of licenses and decommissioning of 
          sites and separate buildings or outdoor areas.
30.37 Application for renewal of licenses.
30.38 Application for amendment of licenses and registration 
          certificates.
30.39 Commission action on applications to renew or amend.
30.41 Transfer of byproduct material.

                Records, Inspections, Tests, and Reports

30.50 Reporting requirements.
30.51 Records.
30.52 Inspections.
30.53 Tests.
30.55 Tritium reports.

                               Enforcement

30.61 Modification and revocation of licenses and registration 
          certificates.
30.62 Right to cause the withholding or recall of byproduct material.
30.63 Violations.
30.64 Criminal penalties.

                                Schedules

30.70 Schedule A--Exempt concentrations.
30.71 Schedule B.
30.72 Schedule C--Quantities of radioactive materials requiring 
          consideration of the need for an emergency plan for responding 
          to a release.

Appendix A to Part 30--Criteria Relating to Use of Financial Tests and 
          Parent

[[Page 567]]

          Company Guarantees for Providing Reasonable Assurance of Funds 
          for Decommissioning
Appendix B to Part 30--Quantities of Licensed Material Requiring 
          Labeling
Appendix C to Part 30--Criteria Relating to Use of Financial Tests and 
          Self Guarantees for Providing Reasonable Assurance of Funds 
          for Decommissioning
Appendix D to Part 30--Criteria Relating to Use of Financial Tests and 
          Self-Guarantee for Providing Reasonable Assurance of Funds for 
          Decommissioning by Commercial Companies That Have No 
          Outstanding Rated Bonds
Appendix E to Part 30--Criteria Relating to Use of Financial Tests and 
          Self-Guarantee for Providing Reasonable Assurance of Funds For 
          Decommissioning by Nonprofit Colleges, Universities, and 
          Hospitals

    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.

    Editorial Note: Nomenclature changes to part 30 appear at 79 FR 
75739, Dec. 19, 2014.

                           General Provisions



Sec.30.1  Scope.

    This part prescribes rules applicable to all persons in the United 
States governing domestic licensing of byproduct material under the 
Atomic Energy Act of 1954, as amended (68 Stat. 919), and under title II 
of the Energy Reorganization Act of 1974 (88 Stat. 1242), and exemptions 
from the domestic licensing requirements permitted by Section 81 of the 
Act. This part also gives notice to all persons who knowingly provide to 
any licensee, applicant, certificate of registration holder, contractor, 
or subcontractor, components, equipment, materials, or other goods or 
services, that relate to a licensee's, applicant's or certificate of 
registration holder's activities subject to this part, that they may be 
individually subject to NRC enforcement action for violation of Sec.
30.10.

[63 FR 1895, Jan. 13, 1998]



Sec.30.2  Resolution of conflict.

    The requirements of this part are in addition to, and not in 
substitution for, other requirements of this chapter. In any conflict 
between the requirements in this part and a specific requirement in 
another part of the regulations in this chapter, the specific 
requirement governs.

[30 FR 8185, June 26, 1965]



Sec.30.3  Activities requiring license.

    (a) Except as provided in paragraphs (b)(2), (b)(3), (c)(2), and 
(c)(3) of this section and for persons exempt as provided in this part 
and part 150 of this chapter, no person shall manufacture, produce, 
transfer, receive, acquire, own, possess, or use byproduct material 
except as authorized in a specific or general license issued in 
accordance with the regulations in this chapter.
    (b)(1) The requirements, including provisions that are specific to 
licensees, in this part and parts 19, 20, 21, and 71 of this chapter, as 
well as the additional requirements for specific broad scope, industrial 
radiography, irradiator, or well logging uses in 10 CFR parts 33, 34, 
36, or 39, respectively, shall apply to Government agencies or Federally 
recognized Indian Tribes on November 30, 2007, when conducting 
activities under the authority provided by paragraphs (b)(2) and (b)(3) 
of this section.
    (2) A specifically licensed Government agency or Federally 
recognized Indian Tribe that possesses and uses accelerator-produced 
radioactive material or discrete sources of radium-226 for which a 
license amendment is required to authorize the activities in paragraph 
(a) of this section, may continue to use these materials for uses 
permitted under this part until the date of the NRC's final licensing 
determination, provided that the licensee submits an amendment 
application on or before June 2, 2008.
    (3) A Government agency or Federally recognized Indian Tribe that 
possesses and uses accelerator-produced radioactive material or discrete 
sources of radium-226 for which a specific license is required in 
paragraph (a) of this section, may continue to use such material for 
uses permitted under this part until the date of the NRC's final 
licensing determination provided

[[Page 568]]

that the agency or Indian Tribe submits an application for a license 
authorizing activities involving these materials on or before December 
1, 2008.
    (c)(1) The requirements, including provisions that are specific to 
licensees in this part and parts 19, 20, 21, and 71 of this chapter, as 
well as the additional requirements for specific broad scope, industrial 
radiography, irradiator, or well logging uses in 10 CFR parts 33, 34, 
36, or 39, respectively, shall apply to all persons, other than those 
included in paragraph (b)(1) of this section, on August 8, 2009, or 
earlier as noticed by the NRC, when conducting activities under the 
authority provided by paragraphs (c)(2) and (c)(3) of this section.
    (2) Except as provided in paragraph (b)(2) of this section, all 
other licensees, who possess and use accelerator-produced radioactive 
material or discrete sources of radium-226 for which a license amendment 
is required to authorize the activities in paragraph (a) of this 
section, may continue to use these materials for uses permitted under 
this part until the date of the NRC's final licensing determination, 
provided that the person submits an amendment application within 6 
months from the waiver expiration date of August 7, 2009 or within 6 
months from the date of an earlier termination of the waiver as noticed 
by the NRC, whichever date is earlier.
    (3) Except as provided in paragraph (b)(3) of this section, all 
other persons, who possess and use accelerator-produced radioactive 
material or discrete sources of radium-226 for which a specific license 
is required in paragraph (a) of this section, may continue to use such 
material for uses permitted under this part until the date of the NRC's 
final licensing determination, provided that the person submits a 
license application within 12 months from the waiver expiration date of 
August 7, 2009 or within 12 months from the date of an earlier 
termination of the waiver as noticed by the NRC, whichever date is 
earlier.
    (d) If a person or licensee is required to file an application for a 
license or amendment in accordance with paragraphs (b)(2), (b)(3), 
(c)(2), and (c)(3) of this section, but does not file for the license or 
amendment within the required time, the authority provided by paragraphs 
(b)(2), (b)(3), (c)(2), and (c)(3) of this section to receive or use the 
accelerator-produced radioactive material or discrete sources of radium-
226 shall expire with respect to the person's or licensee's authority to 
receive and use such byproduct material. This authority shall not expire 
with respect to the responsibility of the person or licensee regarding 
the possession of such byproduct material, the decommissioning 
(including financial assurance) of facilities, or the disposal of such 
byproduct material.

[72 FR 55924, Oct. 1, 2007]



Sec.30.4  Definitions.

    Accelerator-produced radioactive material means any material made 
radioactive by a particle accelerator.
    Act means the Atomic Energy Act of 1954 (68 Stat. 919), including 
any amendments thereto;
    Agreement State means any state with which the Atomic Energy 
Commission or the Nuclear Regulatory Commission has entered into an 
effective agreement under subsection 274b. of the Act. Non-agreement 
State means any other State;
    Alert means events may occur, are in progress, or have occurred that 
could lead to a release of radioactive material but that the release is 
not expected to require a response by offsite response organizations to 
protect persons offsite.
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 8, 
2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or

[[Page 569]]

after August 8, 2005, for use for a commercial, medical, or research 
activity; and
    (3) Any discrete source of naturally occurring radioactive material, 
other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, the Secretary of Energy, the Secretary 
of Homeland Security, and the head of any other appropriate Federal 
agency, determines would pose a threat similar to the threat posed by a 
discrete source of radium-226 to the public health and safety or the 
common defense and security; and
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research activity.
    Commencement of construction means taking any action defined as 
``construction'' or any other activity at the site of a facility subject 
to the regulations in this part that has a reasonable nexus to:
    (1) Radiological health and safety; or
    (2) Common defense and security.
    Commission means the Nuclear Regulatory Commission and its duly 
authorized representatives;
    Consortium means an association of medical use licensees and a PET 
radionuclide production facility in the same geographical area that 
jointly own or share in the operation and maintenance cost of the PET 
radionuclide production facility that produces PET radionuclides for use 
in producing radioactive drugs within the consortium for noncommercial 
distributions among its associated members for medical use. The PET 
radionuclide production facility within the consortium must be located 
at an educational institution or a Federal facility or a medical 
facility.
    Construction means the installation of foundations, or in-place 
assembly, erection, fabrication, or testing for any structure, system, 
or component of a facility or activity subject to the regulations in 
this part that are related to radiological safety or security. The term 
``construction'' does not include:
    (1) Changes for temporary use of the land for public recreational 
purposes;
    (2) Site exploration, including necessary borings to determine 
foundation conditions or other preconstruction monitoring to establish 
background information related to the suitability of the site, the 
environmental impacts of construction or operation, or the protection of 
environmental values;
    (3) Preparation of the site for construction of the facility, 
including clearing of the site, grading, installation of drainage, 
erosion and other environmental mitigation measures, and construction of 
temporary roads and borrow areas;
    (4) Erection of fences and other access control measures that are 
not related to the safe use of, or security of, radiological materials 
subject to this part;
    (5) Excavation;
    (6) Erection of support buildings (e.g., construction equipment 
storage sheds, warehouse and shop facilities, utilities, concrete mixing 
plants, docking and unloading facilities, and office buildings) for use 
in connection with the construction of the facility;
    (7) Building of service facilities (e.g., paved roads, parking lots, 
railroad spurs, exterior utility and lighting systems, potable water 
systems, sanitary sewerage treatment facilities, and transmission 
lines);
    (8) Procurement or fabrication of components or portions of the 
proposed facility occurring at other than the final, in-place location 
at the facility; or
    (9) Taking any other action that has no reasonable nexus to:
    (i) Radiological health and safety, or
    (ii) Common defense and security.
    Curie means that amount of radioactive material which disintegrates 
at the rate of 37 billion atoms per second;
    Cyclotron means a particle accelerator in which the charged 
particles travel in an outward spiral or circular path. A cyclotron 
accelerates charged particles at energies usually in excess of 10 
megaelectron volts and is commonly used for production of short half-
life radionuclides for medical use.
    Decommission means to remove a facility or site safely from service 
and reduce residual radioactivity to a level that permits--

[[Page 570]]

    (1) Release of the property for unrestricted use and termination of 
the license; or
    (2) Release of the property under restricted conditions and 
termination of the license.
    Dentist means an individual licensed by a State or Territory of the 
United States, the District of Columbia, or the Commonwealth of Puerto 
Rico to practice dentistry.
    Department and Department of Energy means the Department of Energy 
established by the Department of Energy Organization Act (Pub. L. 95-91, 
91 Stat. 565, 42 U.S.C. 7101 et seq.) to the extent that the Department, 
or its duly authorized representatives, exercises functions formerly 
vested in the U.S. Atomic Energy Commission, its Chairman, members, 
officers and components and transferred to the U.S. Energy Research and 
Development Administration and to the Administrator thereof pursuant to 
sections 104 (b), (c) and (d) of the Energy Reorganization Act of 1974 
(Pub. L. 93-438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and 
retransferred to the Secretary of Energy pursuant to section 301(a) of 
the Department of Energy Organization Act (Pub. L. 95-91, 91 Stat. 565 
at 577-578, 42 U.S.C. 7151).
    Discrete source means a radionuclide that has been processed so that 
its concentration within a material has been purposely increased for use 
for commercial, medical, or research activities.
    Effective dose equivalent means the sum of the products of the dose 
equivalent to the organ or tissue and the weighting factors applicable 
to each of the body organs or tissues that are irradiated. Weighting 
factors are: 0.25 for gonads, 0.15 for breast, 0.12 for red bone marrow, 
0.12 for lungs, 0.03 for thyroid, 0.03 for bone surface, and 0.06 for 
each of the other five organs receiving the highest dose equivalent.
    Government agency means any executive department, commission, 
independent establishment, corporation, wholly or partly owned by the 
United States of America which is an instrumentality of the United 
States, or any board, bureau, division, service, office, officer, 
authority, administration, or other establishment in the executive 
branch of the Government;
    License, except where otherwise specified means a license for by-
product material issued pursuant to the regulations in this part and 
parts 31 through 36 and 39 of this chapter;
    Medical use means the intentional internal or external 
administration of byproduct material or the radiation therefrom to 
patients or human research subjects under the supervision of an 
authorized user as defined in 10 CFR part 35.
    Microcurie means that amount of radioactive material which 
disintegrates at the rate of 37 thousand atoms per second;
    Millicurie means that amount of radioactive material which 
disintegrates at the rate of 37 million atoms per second;
    Particle accelerator means any machine capable of accelerating 
electrons, protons, deuterons, or other charged particles in a vacuum 
and of discharging the resultant particulate or other radiation into a 
medium at energies usually in excess of 1 megaelectron volt. For 
purposes of this definition, accelerator is an equivalent term.
    Person means: (1) Any individual, corporation, partnership, firm, 
association, trust, estate, public or private institution, group, 
Government agency other than the Commission or the Department, except 
that the Department shall be considered a person within the meaning of 
the regulations in this part to the extent that its facilities and 
activities are subject to the licensing and related regulatory authority 
of the Commission pursuant to section 202 of the Energy Reorganization 
Act of 1974 (88 Stat. 1244), any State or any political subdivision of 
or any political entity within a State, any foreign government or nation 
or any political subdivision of any such government or nation, or other 
entity; and (2) any legal successor, representative, agent, or agency of 
the foregoing;
    Physician means a medical doctor or doctor of osteopathy licensed by 
a State or Territory of the United States, the District of Columbia, or 
the Commonwealth of Puerto Rico to prescribe drugs in the practice of 
medicine;

[[Page 571]]

    Podiatrist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice podiatry.
    Principal activities, as used in this part, means activities 
authorized by the license which are essential to achieving the 
purpose(s) for which the license was issued or amended. Storage during 
which no licensed material is accessed for use or disposal and 
activities incidental to decontamination or decommissioning are not 
principal activities.
    Production facility means production facility as defined in the 
regulations contained in part 50 of this chapter;
    Research and development means: (1) Theoretical analysis, 
exploration, or experimentation; or (2) the extension of investigative 
findings and theories of a scientific or technical nature into practical 
application for experimental and demonstration purposes, including the 
experimental production and testing of models, devices, equipment, 
materials and processes. ``Research and development'' as used in this 
part and parts 31 through 35 does not include the internal or external 
administration of byproduct material, or the radiation therefrom, to 
human beings;
    Sealed source means any byproduct material that is encased in a 
capsule designed to prevent leakage or escape of the byproduct material;
    Site area emergency means events may occur, are in progress, or have 
occurred that could lead to a significant release of radioactive 
material and that could require a response by offsite response 
organizations to protect persons offsite.
    Source material means source material as defined in the regulations 
contained in part 40 of this chapter;
    Special nuclear material means special nuclear material as defined 
in the regulations contained in part 70 of this chapter;
    United States, when used in a geographical sense, includes Puerto 
Rico and all territories and possessions of the United States;
    Utilization facility means a utilization facility as defined in the 
regulations contained in part 50 of this chapter;

[30 FR 8185, June 26, 1965]

    Editorial Note: For Federal Register citations affecting Sec.30.4, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfoo.gov.



Sec.30.5  Interpretations.

    Except as specifically authorized by the Commission in writing, no 
interpretation of the meaning of the regulations in this part and parts 
31 through 36 and 39 by any officer or employee of the Commission other 
than a written interpretation by the General Counsel will be recognized 
to be binding upon the Commission.

[30 FR 8185, June 26, 1965, as amended at 43 FR 6921, Feb. 17, 1978; 52 
FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993]



Sec.30.6  Communications.

    (a) Unless otherwise specified or covered under the regional 
licensing program as provided in paragraph (b) of this section, any 
communication or report concerning the regulations in parts 30 through 
37 and 39 of this chapter and any application filed under these 
regulations may be submitted to the Commission as follows:
    (1) By mail addressed: ATTN: Document Control Desk, Director, Office 
of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001.
    (2) By hand delivery to the NRC's offices at 11555 Rockville Pike, 
Rockville, Maryland.
    (3) Where practicable, by electronic submission, for example, via 
Electronic Information Exchange, or CD-ROM. Electronic submissions must 
be made in a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information.

[[Page 572]]

    (b) The Commission has delegated to the four Regional Administrators 
licensing authority for selected parts of its decentralized licensing 
program for nuclear materials as described in paragraph (b)(1) of this 
section. Any communication, report, or application covered under this 
licensing program must be submitted to the appropriate Regional 
Administrator. The Administrators' jurisdictions and mailing addresses 
are listed in paragraph (b)(2) of this section.
    (1) The delegated licensing program includes authority to issue, 
renew, amend, cancel, modify, suspend, or revoke licenses for nuclear 
materials issued pursuant to 10 CFR parts 30 through 36, 39, 40, and 70 
to all persons for academic, medical, and industrial uses, with the 
following exceptions:
    (i) Activities in the fuel cycle and special nuclear material in 
quantities sufficient to constitute a critical mass in any room or area. 
This exception does not apply to license modifications relating to 
termination of special nuclear material licenses that authorize 
possession of larger quantities when the case is referred for action 
from NRC's Headquarters to the Regional Administrators.
    (ii) Health and safety design review of sealed sources and devices 
and approval, for licensing purposes, of sealed sources and devices.
    (iii) Processing of source material for extracting of metallic 
compounds (including Zirconium, Hafnium, Tantalum, Titanium, Niobium, 
etc.).
    (iv) Distribution of products containing radioactive material under 
Sec. Sec.32.11 through 32.30 and 40.52 of this chapter to persons 
exempt from licensing requirements.
    (v) New uses or techniques for use of byproducts, source, or special 
nuclear material.
    (2) Submissions. (i) Region I. The regional licensing program 
involves all Federal facilities in the region and non-Federal licensees 
in the following Region I non-Agreement States and the District of 
Columbia: Connecticut, Delaware, and Vermont. All mailed or hand-
delivered inquiries, communications, and applications for a new license 
or an amendment, renewal, or termination request of an existing license 
specified in paragraph (b)(1) of this section must use the following 
address: U.S. Nuclear Regulatory Commission, Region I, Nuclear Material 
Section B, Region I, 2100 Renaissance Boulevard, Suite 100, King of 
Prussia, PA 19406-2713; where email is appropriate it should be 
addressed to [email protected].
    (ii) Region II. The regional licensing program involves all Federal 
facilities in the region and non-Federal licensees in the following 
Region II non-Agreement States and territories: West Virginia, Puerto 
Rico, and the Virgin Islands. All mailed or hand-delivered inquiries, 
communications, and applications for a new license or an amendment, 
renewal, or termination request of an existing license specified in 
paragraph (b)(1) of this section must use the following address: U.S. 
Nuclear Regulatory Commission, Region I, Nuclear Material Section B, 
Region I, 2100 Renaissance Boulevard, Suite 100, King of Prussia, PA 
19406-2713; where email is appropriate it should be addressed to 
[email protected].
    (iii) Region III. (A) The regional licensing program for mining and 
milling involves all Federal facilities in the region, and non-Federal 
licensees in the Region III non-Agreement States of Indiana, Michigan, 
Missouri and the Region III Agreement States of Minnesota, Wisconsin, 
and Iowa. All mailed or hand-delivered inquiries, communications, and 
applications for a new license or an amendment, renewal, or termination 
request of an existing license specified in paragraph (b)(1) of this 
section must use the following address: U.S. Nuclear Regulatory 
Commission, Region III, Material Licensing Section, 2443 Warrenville 
Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it 
should be addressed to [email protected].
    (B) Otherwise, the regional licensing program involves all Federal 
facilities in the region and non-Federal licensees in the Region III 
non-Agreement States of Indiana, Michigan, and Missouri. All mailed or 
hand-delivered inquiries, communications, and applications for a new 
license or an amendment, renewal, or termination request of an existing 
license specified in paragraph (b)(1) of this section must use

[[Page 573]]

the following address: U.S. Nuclear Regulatory Commission, Region III, 
Material Licensing Section, 2443 Warrenville Road, Suite 210, Lisle, IL 
60532-4352; where e-mail is appropriate it should be addressed to 
[email protected].
    (iv) Region IV. (A) The regional licensing program for mining and 
milling involves all Federal facilities in the region, and non-Federal 
licensees in the Region IV non-Agreement States and territory of Alaska, 
Hawaii, Idaho, Montana, South Dakota, Wyoming and Guam and Region IV 
Agreement States of Oregon, California, Nevada, New Mexico, Louisiana, 
Mississippi, Arkansas, Oklahoma, Kansas, Nebraska, and North Dakota. All 
mailed or hand-delivered inquiries, communications, and applications for 
a new license or an amendment, renewal, or termination request of an 
existing license specified in paragraph (b)(1) of this section must use 
the following address: U.S. Nuclear Regulatory Commission, Region IV, 
Division of Nuclear Materials Safety, 1600 E. Lamar Blvd., Arlington, TX 
76011-4511; where email is appropriate, it should be addressed to 
[email protected].
    (B) Otherwise, the regional licensing program involves all Federal 
facilities in the region and non-Federal licensees in the following 
Region IV non-Agreement States and territory: Alaska, Hawaii, Idaho, 
Montana, South Dakota, Wyoming, and Guam. All mailed or hand-delivered 
inquiries, communications, and applications for a new license or an 
amendment, renewal, or termination request of an existing license 
specified in paragraph (b)(1) of this section must use the following 
address: U.S. Nuclear Regulatory Commission, Region IV, Division of 
Nuclear Materials Safety, 1600 E. Lamar Blvd., Arlington, TX 76011-4511; 
where email is appropriate, it should be addressed to 
[email protected].

    Editorial Note: For Federal Register citations affecting Sec.30.6, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfoo.gov.



Sec.30.7  Employee protection.

    (a) Discrimination by a Commission licensee, an applicant for a 
Commission license, or a contractor or subcontractor of a Commission 
licensee or applicant against an employee for engaging in certain 
protected activities is prohibited. Discrimination includes discharge 
and other actions that relate to compensation, terms, conditions, or 
privileges of employment. The protected activities are established in 
section 211 of the Energy Reorganization Act of 1974, as amended, and in 
general are related to the administration or enforcement of a 
requirement imposed under the Atomic Energy Act or the Energy 
Reorganization Act.
    (1) The protected activities include but are not limited to:
    (i) Providing the Commission or his or her employer information 
about alleged violations of either of the statutes named in paragraph 
(a) introductory text of this section or possible violations of 
requirements imposed under either of those statutes;
    (ii) Refusing to engage in any practice made unlawful under either 
of the statutes named in paragraph (a) introductory text or under these 
requirements if the employee has identified the alleged illegality to 
the employer;
    (iii) Requesting the Commission to institute action against his or 
her employer for the administration or enforcement of these 
requirements;
    (iv) Testifying in any Commission proceeding, or before Congress, or 
at any Federal or State proceeding regarding any provision (or proposed 
provision) of either of the statutes named in paragraph (a) introductory 
text.
    (v) Assisting or participating in, or is about to assist or 
participate in, these activities.
    (2) These activities are protected even if no formal proceeding is 
actually initiated as a result of the employee assistance or 
participation.
    (3) This section has no application to any employee alleging 
discrimination prohibited by this section who, acting without direction 
from his or her employer (or the employer's agent), deliberately causes 
a violation of any requirement of the Energy Reorganization Act of 1974, 
as amended, or the Atomic Energy Act of 1954, as amended.

[[Page 574]]

    (b) Any employee who believes that he or she has been discharged or 
otherwise discriminated against by any person for engaging in protected 
activities specified in paragraph (a)(1) of this section may seek a 
remedy for the discharge or discrimination through an administrative 
proceeding in the Department of Labor. The administrative proceeding 
must be initiated within 180 days after an alleged violation occurs. The 
employee may do this by filing a complaint alleging the violation with 
the Department of Labor, Employment Standards Administration, Wage and 
Hour Division. The Department of Labor may order reinstatement, back 
pay, and compensatory damages.
    (c) A violation of paragraphs (a), (e), or (f) of this section by a 
Commission licensee, an applicant for a Commission license, or a 
contractor or subcontractor of a Commission licensee or applicant may be 
grounds for--
    (1) Denial, revocation, or suspension of the license.
    (2) Imposition of a civil penalty on the licensee, applicant, or a 
contractor or subcontractor of the licensee or applicant.
    (3) Other enforcement action.
    (d) Actions taken by an employer, or others, which adversely affect 
an employee may be predicated upon nondiscriminatory grounds. The 
prohibition applies when the adverse action occurs because the employee 
has engaged in protected activities. An employee's engagement in 
protected activities does not automatically render him or her immune 
from discharge or discipline for legitimate reasons or from adverse 
action dictated by nonprohibited considerations.
    (e)(1) Each specific licensee, each applicant for a specific 
license, and each general licensee subject to part 19 shall prominently 
post the revision of NRC Form 3, ``Notice to Employees,'' referenced in 
10 CFR 19.11(e)(1).
    (2) The posting of NRC Form 3 must be at locations sufficient to 
permit employees protected by this section to observe a copy on the way 
to or from their place of work. Premises must be posted not later than 
30 days after an application is docketed and remain posted while the 
application is pending before the Commission, during the term of the 
license, and for 30 days following license termination.
    (3) Copies of NRC Form 3 may be obtained by writing to the Regional 
Administrator of the appropriate U.S. Nuclear Regulatory Commission 
Regional Office listed in appendix D to part 20 of this chapter, via 
email to [email protected], or by visiting the NRC's online library 
at http://www.nrc.gov/reading-rm/doc-collections/forms/.
    (f) No agreement affecting the compensation, terms, conditions, or 
privileges of employment, including an agreement to settle a complaint 
filed by an employee with the Department of Labor pursuant to section 
211 of the Energy Reorganization Act of 1974, as amended, may contain 
any provision which would prohibit, restrict, or otherwise discourage an 
employee from participating in protected activity as defined in 
paragraph (a)(1) of this section including, but not limited to, 
providing information to the NRC or to his or her employer on potential 
violations or other matters within NRC's regulatory responsibilities.

[58 FR 52408, Oct. 8, 1993, as amended at 60 FR 24551, May 9, 1995; 61 
FR 6764, Feb. 22, 1996; 68 FR 58803, Oct. 10, 2003; 72 FR 63973, Nov. 
14, 2007; 73 FR 30458, May 28, 2008; 79 FR 66603, Nov. 10, 2014; 83 FR 
58465, Nov. 20, 2018]



Sec.30.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0017.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.30.9, 30.11, 30.15, 30.19, 30.20, 30.32, 
30.34, 30.35, 30.36, 30.37, 30.38, 30.41, 30.50, 30.51, 30.55, and 
appendices A, C, D, and E to this part.

[[Page 575]]

    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec. Sec.30.32 and 30.37, NRC Form 313 is approved under 
control number 3150-0120.
    (2) In Sec.30.36, NRC Form 314 is approved under control number 
3150-0028.
    (3) In Sec.30.34, DOC/NRC Forms AP-1, AP-A, and associated forms 
are approved under control number 0694-0135.

[49 FR 19625, May 9, 1984, as amended at 59 FR 61780, Dec. 2, 1994; 62 
FR 52186, Oct. 6, 1997; 62 FR 63639, Dec. 2, 1997; 63 FR 29541, June 1, 
1998; 67 FR 67099, Nov. 4, 2002; 73 FR 78604, Dec. 23, 2008; 77 FR 
43689, July 25, 2012]



Sec.30.9  Completeness and accuracy of information.

    (a) Information provided to the Commission by an applicant for a 
license or by a licensee or information required by statute or by the 
Commission's regulations, orders, or license conditions to be maintained 
by the applicant or the licensee shall be complete and accurate in all 
material respects.
    (b) Each applicant or licensee shall notify the Commission of 
information identified by the applicant or licensee as having for the 
regulated activity a significant implication for public health and 
safety or common defense and security. An applicant or licensee violates 
this paragraph only if the applicant or licensee fails to notify the 
Commission of information that the applicant or licensee has identified 
as having a significant implication for public health and safety or 
common defense and security. Notification shall be provided to the 
Administrator of the appropriate Regional Office within two working days 
of identifying the information. This requirement is not applicable to 
information which is already required to be provided to the Commission 
by other reporting or updating requirements.

[52 FR 49371, Dec. 31, 1987]



Sec.30.10  Deliberate misconduct.

    (a) Any licensee, certificate of registration holder, applicant for 
a license or certificate of registration, employee of a licensee, 
certificate of registration holder or applicant; or any contractor 
(including a supplier or consultant), subcontractor, employee of a 
contractor or subcontractor of any licensee or certificate of 
registration holder or applicant for a license or certificate of 
registration, who knowingly provides to any licensee, applicant, 
certificate holder, contractor, or subcontractor, any components, 
equipment, materials, or other goods or services that relate to a 
licensee's, certificate holder's or applicant's activities in this part, 
may not:
    (1) Engage in deliberate misconduct that causes or would have 
caused, if not detected, a licensee, certificate of registration holder, 
or applicant to be in violation of any rule, regulation, or order; or 
any term, condition, or limitation of any license issued by the 
Commission; or
    (2) Deliberately submit to the NRC, a licensee, certificate of 
registration holder, an applicant, or a licensee's, certificate holder's 
or applicant's, contractor or subcontractor, information that the person 
submitting the information knows to be incomplete or inaccurate in some 
respect material to the NRC.
    (b) A person who violates paragraph (a)(1) or (a)(2) of this section 
may be subject to enforcement action in accordance with the procedures 
in 10 CFR part 2, subpart B.
    (c) For the purposes of paragraph (a)(1) of this section, deliberate 
misconduct by a person means an intentional act or omission that the 
person knows:
    (1) Would cause a licensee, certificate of registration holder or 
applicant to be in violation of any rule, regulation, or order; or any 
term, condition, or limitation, of any license issued by the Commission; 
or
    (2) Constitutes a violation of a requirement, procedure, 
instruction, contract, purchase order, or policy of a licensee, 
certificate of registration holder, applicant, contractor, or 
subcontractor.

[63 FR 1896, Jan. 13, 1998]

[[Page 576]]

                               Exemptions



Sec.30.11  Specific exemptions.

    (a) The Commission may, upon application of any interested person or 
upon its own initiative, grant such exemptions from the requirements of 
the regulations in this part and parts 31 through 36 and 39 of this 
chapter as it determines are authorized by law and will not endanger 
life or property or the common defense and security and are otherwise in 
the public interest.
    (b) Any licensee's activities are exempt from the requirements of 
this part to the extent that its activities are licensed under the 
requirements of part 72 of this chapter.
    (c) The Department of Energy is exempt from the requirements of this 
part to the extent that its activities are subject to the requirements 
of part 60 or 63 of this chapter.
    (d) Except as specifically provided in part 61 of this chapter, any 
licensee is exempt from the requirements of this part to the extent that 
its activities are subject to the requirements of part 61 of this 
chapter.

[37 FR 5746, Mar. 21, 1972, as amended at 39 FR 26279, July 18, 1974; 40 
FR 8784, Mar. 3, 1975; 43 FR 6921, Feb. 21, 1978; 45 FR 65530, Oct. 3, 
1980; 46 FR 13979, Feb. 25, 1981; 47 FR 57480, Dec. 27, 1982; 52 FR 
8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993; 66 FR 51838, Oct. 11, 
2001; 66 FR 55790, Nov. 2, 2001]



Sec.30.12  Persons using byproduct material under certain Department
of Energy and Nuclear Regulatory Commission contracts.

    Except to the extent that Department facilities or activities of the 
types subject to licensing pursuant to section 202 of the Energy 
Reorganization Act of 1974 are involved, any prime contractor of the 
Department is exempt from the requirements for a license set forth in 
sections 81 and 82 of the Act and from the regulations in this part to 
the extent that such contractor, under his prime contract with the 
Department manufactures, produces, transfers, receives, acquires, owns, 
possesses, or uses byproduct material for:
    (a) The performance of work for the Department at a United States 
Government-owned or controlled site, including the transportation of 
byproduct material to or from such site and the performance of contract 
services during temporary interruptions of such transportation;
    (b) Research in, or development, manufacture, storage, testing or 
transportation of, atomic weapons or components thereof; or
    (c) The use or operation of nuclear reactors or other nuclear 
devices in a United States Government-owned vehicle or vessel.

In addition to the foregoing exemptions and subject to the requirement 
for licensing of Department facilities and activities pursuant to 
section 202 of the Energy Reorganization Act of 1974, any prime 
contractor or subcontractor of the Department or the Commission is 
exempt from the requirements for a license set forth in sections 81 and 
82 of the Act and from the regulations in this part to the extent that 
such prime contractor or subcontractor manufacturers, produces, 
transfers, receives, acquires, owns, possesses, or uses byproduct 
material under his prime contract or subcontract when the Commission 
determines that the exemption of the prime contractor or subcontractor 
is authorized by law; and that, under the terms of the contract or 
subcontract, there is adequate assurance that the work thereunder can be 
accomplished without undue risk to the public health and safety.

[40 FR 8784, Mar. 3, 1975, as amended at 43 FR 6921, Feb. 17, 1978]



Sec.30.13  Carriers.

    Common and contract carriers, freight forwarders, warehousemen, and 
the U.S. Postal Service are exempt from the regulations in this part and 
parts 31 through 37 and 39 of this chapter and the requirements for a 
license set forth in section 81 of the Act to the extent that they 
transport or store byproduct material in the regular course of carriage 
for another or storage incident thereto.

[78 FR 17006, Mar. 19, 2013]



Sec.30.14  Exempt concentrations.

    (a) Except as provided in paragraphs (c) and (d) of this section, 
any person is exempt from the requirements for a license set forth in 
section 81 of the Act

[[Page 577]]

and from the regulations in this part and parts 31 through 36 and 39 of 
this chapter to the extent that such person receives, possesses, uses, 
transfers, owns or acquires products or materials containing byproduct 
material in concentrations not in excess of those listed in Sec.30.70.
    (b) This section shall not be deemed to authorize the import of 
byproduct material or products containing byproduct material.
    (c) A manufacturer, processor, or producer of a product or material 
is exempt from the requirements for a license set forth in section 81 of 
the Act and from the regulations in this part and parts 31 through 36 
and 39 of this chapter to the extent that this person transfers 
byproduct material contained in a product or material in concentrations 
not in excess of those specified in Sec.30.70 and introduced into the 
product or material by a licensee holding a specific license issued by 
the Commission expressly authorizing such introduction. This exemption 
does not apply to the transfer of byproduct material contained in any 
food, beverage, cosmetic, drug, or other commodity or product designed 
for ingestion or inhalation by, or application to, a human being.
    (d) No person may introduce byproduct material into a product or 
material knowing or having reason to believe that it will be transferred 
to persons exempt under this section or equivalent regulations of an 
Agreement State, except in accordance with a license issued under Sec.
32.11 of this chapter.

[30 FR 8185, June 26, 1965, as amended at 40 FR 8785, Mar. 3, 1975; 43 
FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 
1993; 72 FR 58486, Oct. 16, 2007]



Sec.30.15  Certain items containing byproduct material.

    (a) Except for persons who apply byproduct material to, or persons 
who incorporate byproduct material into, the following products, or 
persons who initially transfer for sale or distribution the following 
products containing byproduct material, any person is exempt from the 
requirements for a license set forth in section 81 of the Act and from 
the regulations in parts 20 and 30 through 36 and 39 of this chapter to 
the extent that such person receives, possesses, uses, transfers, owns, 
or acquires the following products:
    (1) Timepieces or hands or dials containing not more than the 
following specified quantities of byproduct material and not exceeding 
the following specified levels of radiation:
    (i) 25 millicuries of tritium per timepiece,
    (ii) 5 millicuries of tritium per hand,
    (iii) 15 millicuries of tritium per dial (bezels when used shall be 
considered as part of the dial),
    (iv) 100 microcuries of promethium 147 per watch or 200 microcuries 
of promethium 147 per any other timepiece,
    (v) 20 microcuries of promethium 147 per watch hand or 40 
microcuries of promethium 147 per other timepiece hand,
    (vi) 60 microcuries of promethium 147 per watch dial or 120 
microcuries of promethium 147 per other timepiece dial (bezels when used 
shall be considered as part of the dial),
    (vii) The levels of radiation from hands and dials containing 
promethium 147 will not exceed, when measured through 50 milligrams per 
square centimeter of absorber:
    (A) For wrist watches, 0.1 millirad per hour at 10 centimeters from 
any surface,
    (B) For pocket watches, 0.1 millirad per hour at 1 centimeter from 
any surface,
    (C) For any other timepiece, 0.2 millirad per hour at 10 centimeters 
from any surface.
    (viii) 0.037 megabecquerel (1 microcurie) of radium-226 per 
timepiece in intact timepieces manufactured prior to November 30, 2007.
    (2)(i) Static elimination devices which contain, as a sealed source 
or sources, byproduct material consisting of a total of not more than 
18.5 MBq (500 [micro]Ci) of polonium-210 per device.
    (ii) Ion generating tubes designed for ionization of air that 
contain, as a sealed source or sources, byproduct material consisting of 
a total of not more than 18.5 MBq (500 [micro]Ci) of polonium-210 per 
device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 
(tritium) per device.

[[Page 578]]

    (iii) Such devices authorized before October 23, 2012 for use under 
the general license then provided in Sec.31.3 and equivalent 
regulations of Agreement States and manufactured, tested, and labeled by 
the manufacturer in accordance with the specifications contained in a 
specific license issued by the Commission.
    (3) Balances of precision containing not more than 1 millicurie of 
tritium per balance or not more than 0.5 millicurie of tritium per 
balance part manufactured before December 17, 2007.
    (4) [Reserved]
    (5) Marine compasses containing not more than 750 millicuries of 
tritium gas and other marine navigational instruments containing not 
more than 250 millicuries of tritium gas manufactured before December 
17, 2007.
    (6) [Reserved]
    (7) Ionization chamber smoke detectors containing not more than 1 
microcurie ([micro]Ci) of americium-241 per detector in the form of a 
foil and designed to protect life and property from fires.
    (8) Electron tubes: Provided, That each tube does not contain more 
than one of the following specified quantities of byproduct material:
    (i) 150 millicuries of tritium per microwave receiver protector tube 
or 10 millicuries of tritium per any other electron tube;
    (ii) 1 microcurie of cobalt-60;
    (iii) 5 microcuries of nickel-63;
    (iv) 30 microcuries of krypton-85;
    (v) 5 microcuries of cesium-137;
    (vi) 30 microcuries of promethium-147;

And provided further, That the levels of radiation from each electron 
tube containing byproduct material do not exceed 1 millirad per hour at 
1 centimeter from any surface when measured through 7 milligrams per 
square centimeter of absorber. \1\
---------------------------------------------------------------------------

    \1\ For purposes of this paragraph ``electron tubes'' include spark 
gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, 
microwave tubes, indicator tubes, pickup tubes, radiation detection 
tubes, and any other completely sealed tube that is designed to conduct 
or control electrical currents.
---------------------------------------------------------------------------

    (9) Ionizing radiation measuring instruments containing, for 
purposes of internal calibration or standardization, one or more sources 
of byproduct material: Provided, That;
    (i) Each source contains no more than one exempt quantity set forth 
in Sec.30.71, Schedule B, and
    (ii) Each instrument contains no more than 10 exempt quantities. For 
purposes of this paragraph (a)(9), an instrument's source(s) may contain 
either one type or different types of radionuclides and an individual 
exempt quantity may be composed of fractional parts of one or more of 
the exempt quantities in Sec.30.71, Schedule B, provided that the sum 
of such fractions shall not exceed unity.
    (iii) For purposes of this paragraph (a)(9), 0.05 microcurie of 
americium-241 is considered an exempt quantity under Sec.30.71, 
Schedule B.
    (10) [Reserved]
    (b) Any person who desires to apply byproduct material to, or to 
incorporate byproduct material into, the products exempted in paragraph 
(a) of this section, or who desires to initially transfer for sale or 
distribution such products containing byproduct material, should apply 
for a specific license pursuant to Sec.32.14 of this chapter, which 
license states that the product may be distributed by the licensee to 
persons exempt from the regulations pursuant to paragraph (a) of this 
section.

[31 FR 5316, Apr. 2, 1966]

    Editorial Note: For Federal Register citations affecting Sec.
30.15, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfoo.gov.



Sec.30.18  Exempt quantities.

    (a) Except as provided in paragraphs (c) through (e) of this 
section, any person is exempt from the requirements for a license set 
forth in section 81 of the Act and from the regulations in parts 30 
through 34, 36, and 39 of this chapter to the extent that such person 
receives, possesses, uses, transfers, owns, or acquires byproduct 
material in individual quantities, each of which does not exceed the 
applicable quantity set forth in Sec.30.71, Schedule B.
    (b) Any person, who possesses byproduct material received or 
acquired before September 25, 1971, under the

[[Page 579]]

general license then provided in Sec.31.4 of this chapter or similar 
general license of a State, is exempt from the requirements for a 
license set forth in section 81 of the Act and from the regulations in 
parts 30 through 34, 36 and 39 of this chapter to the extent that this 
person possesses, uses, transfers, or owns byproduct material.
    (c) This section does not authorize for purposes of commercial 
distribution the production, packaging, repackaging, or transfer of 
byproduct material or the incorporation of byproduct material into 
products intended for commercial distribution.
    (d) No person may, for purposes of commercial distribution, transfer 
byproduct material in the individual quantities set forth in Sec.30.71 
Schedule B, knowing or having reason to believe that such quantities of 
byproduct material will be transferred to persons exempt under this 
section or equivalent regulations of an Agreement State, except in 
accordance with a license issued under Sec.32.18 of this chapter, 
which license states that the byproduct material may be transferred by 
the licensee to persons exempt under this section or the equivalent 
regulations of an Agreement State.
    (e) No person may, for purposes of producing an increased radiation 
level, combine quantities of byproduct material covered by this 
exemption so that the aggregate quantity exceeds the limits set forth in 
Sec.30.71, Schedule B, except for byproduct material combined within a 
device placed in use before May 3, 1999, or as otherwise permitted by 
the regulations in this part.

[35 FR 6427, Apr. 22, 1970, as amended at 36 FR 16898, Aug. 26, 1971; 43 
FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 
1993; 72 FR 55925, Oct. 1, 2007; 72 FR 58486, Oct. 16, 2007]



Sec.30.19  Self-luminous products containing tritium, krypton-85,
or promethium-147.

    (a) Except for persons who manufacture, process, produce, or 
initially transfer for sale or distribution self-luminous products 
containing tritium, krypton-85, or promethium-147, and except as 
provided in paragraph (c) of this section, any person is exempt from the 
requirements for a license set forth in section 81 of the Act and from 
the regulations in parts 20 and 30 through 36 and 39 of this chapter to 
the extent that such person receives, possesses, uses, transfers, owns, 
or acquires tritium, krypton-85, or promethium-147 in self-luminous 
products manufactured, processed, produced, or initially transferred in 
accordance with a specific license issued pursuant to Sec.32.22 of 
this chapter, which license authorizes the initial transfer of the 
product for use under this section.
    (b) Any person who desires to manufacture, process, or produce, or 
initially transfer for sale or distribution self-luminous products 
containing tritium, krypton-85, or promethium-147 for use under 
paragraph (a) of this section, should apply for a license under Sec.
32.22 of this chapter and for a certificate of registration in 
accordance with Sec.32.210 of this chapter.
    (c) The exemption in paragraph (a) of this section does not apply to 
tritium, krypton-85, or promethium-147 used in products primarily for 
frivolous purposes or in toys or adornments.

[34 FR 9026, June 6, 1969, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 
6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 
1993; 77 FR 43689, July 25, 2012]



Sec.30.20  Gas and aerosol detectors containing byproduct material.

    (a) Except for persons who manufacture, process, produce, or 
initially transfer for sale or distribution gas and aerosol detectors 
containing byproduct material, any person is exempt from the 
requirements for a license set forth in section 81 of the Act and from 
the regulations in parts 19, 20, 21, and 30 through 36 and 39 of this 
chapter to the extent that such person receives, possesses, uses, 
transfers, owns, or acquires byproduct material in gas and aerosol 
detectors designed to protect health, safety, or property, and 
manufactured, processed, produced, or initially transferred in 
accordance with a specific license issued under Sec.32.26 of this 
chapter, which license authorizes the initial transfer of the product 
for use under this section. This exemption also covers gas and aerosol 
detectors manufactured or distributed before November 30, 2007, in 
accordance with a specific license issued by a State under

[[Page 580]]

comparable provisions to Sec.32.26 of this chapter authorizing 
distribution to persons exempt from regulatory requirements.
    (b) Any person who desires to manufacture, process, or produce gas 
and aerosol detectors containing byproduct material, or to initially 
transfer such products for use under paragraph (a) of this section, 
should apply for a license under Sec.32.26 of this chapter and for a 
certificate of registration in accordance with Sec.32.210 of this 
chapter.

[77 FR 43689, July 25, 2012]



Sec.30.21  Radioactive drug: Capsules containing carbon-14 urea for
``in vivo'' diagnostic use for humans.

    (a) Except as provided in paragraphs (b) and (c) of this section, 
any person is exempt from the requirements for a license set forth in 
Section 81 of the Act and from the regulations in this part and part 35 
of this chapter provided that such person receives, possesses, uses, 
transfers, owns, or acquires capsules containing 37 kBq (1 [micro]Ci) 
carbon-14 urea (allowing for nominal variation that may occur during the 
manufacturing process) each, for ``in vivo'' diagnostic use for humans.
    (b) Any person who desires to use the capsules for research 
involving human subjects shall apply for and receive a specific license 
pursuant to part 35 of this chapter.
    (c) Any person who desires to manufacture, prepare, process, 
produce, package, repackage, or transfer for commercial distribution 
such capsules shall apply for and receive a specific license pursuant to 
Sec.32.21 of this chapter.
    (d) Nothing in this section relieves persons from complying with 
applicable FDA, other Federal, and State requirements governing receipt, 
administration, and use of drugs.

[62 FR 63640, Dec. 2, 1997]



Sec.30.22  Certain industrial devices.

    (a) Except for persons who manufacture, process, produce, or 
initially transfer for sale or distribution industrial devices 
containing byproduct material designed and manufactured for the purpose 
of detecting, measuring, gauging or controlling thickness, density, 
level, interface location, radiation, leakage, or qualitative or 
quantitative chemical composition, or for producing an ionized 
atmosphere, any person is exempt from the requirements for a license set 
forth in section 81 of the Act and from the regulations in parts 19, 20, 
21, 30 through 36, and 39 of this chapter to the extent that such person 
receives, possesses, uses, transfers, owns, or acquires byproduct 
material, in these certain detecting, measuring, gauging, or controlling 
devices and certain devices for producing an ionized atmosphere, and 
manufactured, processed, produced, or initially transferred in 
accordance with a specific license issued under Sec.32.30 of this 
chapter, which license authorizes the initial transfer of the device for 
use under this section. This exemption does not cover sources not 
incorporated into a device, such as calibration and reference sources.
    (b) Any person who desires to manufacture, process, produce, or 
initially transfer for sale or distribution industrial devices 
containing byproduct material for use under paragraph (a) of this 
section, should apply for a license under Sec.32.30 of this chapter 
and for a certificate of registration in accordance with Sec.32.210 of 
this chapter.

[77 FR 43689, July 25, 2012]

                                Licenses



Sec.30.31  Types of licenses.

    Licenses for byproduct material are of two types: General and 
specific.
    (a) The Commission issues a specific license to a named person who 
has filed an application for the license under the provisions of this 
part and parts 32 through 36, and 39.
    (b) A general license is provided by regulation, grants authority to 
a person for certain activities involving byproduct material, and is 
effective without the filing of an application with the Commission or 
the issuance of a licensing document to a particular person. However, 
registration with the Commission may be required by the particular 
general license.

[65 FR 79187, Dec. 18, 2000]

[[Page 581]]



Sec.30.32  Application for specific licenses.

    (a) A person may file an application on NRC Form 313, ``Application 
for Material License,'' in accordance with the instructions in Sec.
30.6 of this chapter. Information contained in previous applications, 
statements or reports filed with the Commission or the Atomic Energy 
Commission may be incorporated by reference, provided that the reference 
is clear and specific.
    (b) The Commission may at any time after the filing of the original 
application, and before the expiration of the license, require further 
statements in order to enable the Commission to determine whether the 
application should be granted or denied or whether a license should be 
modified or revoked.
    (c) Each application shall be signed by the applicant or licensee or 
a person duly authorized to act for and on his behalf.
    (d) An application for license filed pursuant to the regulations in 
this part and parts 32 through 35 of this chapter will be considered 
also as an application for licenses authorizing other activities for 
which licenses are required by the Act, provided that the application 
specifies the additional activities for which licenses are requested and 
complies with regulations of the Commission as to applications for such 
licenses.
    (e) Each application for a byproduct material license, other than a 
license exempted from part 170 of this chapter, shall be accompanied by 
the fee prescribed in Sec.170.31 of this chapter. No fee will be 
required to accompany an application for renewal or amendment of a 
license, except as provided in Sec.170.31 of this chapter.
    (f) An application for a license to receive and possess byproduct 
material for the conduct of any activity which the Commission has 
determined pursuant to subpart A of part 51 of this chapter will 
significantly affect the quality of the environment shall be filed at 
least 9 months prior to commencement of construction of the plant or 
facility in which the activity will be conducted and shall be 
accompanied by any Environmental Report required pursuant to subpart A 
of part 51 of this chapter.
    (g)(1) Except as provided in paragraphs (g)(2), (3), and (4) of this 
section, an application for a specific license to use byproduct material 
in the form of a sealed source or in a device that contains the sealed 
source must either--
    (i) Identify the source or device by manufacturer and model number 
as registered with the Commission under Sec.32.210 of this chapter, 
with an Agreement State, or for a source or a device containing radium-
226 or accelerator-produced radioactive material with a State under 
provisions comparable to Sec.32.210 of this chapter; or
    (ii) Contain the information identified in Sec.32.210(c) of this 
chapter.
    (2) For sources or devices manufactured before October 23, 2012 that 
are not registered with the Commission under Sec.32.210 of this 
chapter or with an Agreement State, and for which the applicant is 
unable to provide all categories of information specified in Sec.
32.210(c) of this chapter, the application must include:
    (i) All available information identified in Sec.32.210(c) of this 
chapter concerning the source, and, if applicable, the device; and
    (ii) Sufficient additional information to demonstrate that there is 
reasonable assurance that the radiation safety properties of the source 
or device are adequate to protect health and minimize danger to life and 
property. Such information must include a description of the source or 
device, a description of radiation safety features, the intended use and 
associated operating experience, and the results of a recent leak test.
    (3) For sealed sources and devices allowed to be distributed without 
registration of safety information in accordance with Sec.32.210(g)(1) 
of this chapter, the applicant may supply only the manufacturer, model 
number, and radionuclide and quantity.
    (4) If it is not feasible to identify each sealed source and device 
individually, the applicant may propose constraints on the number and 
type of sealed sources and devices to be used and the conditions under 
which they will be used, in lieu of identifying each sealed source and 
device.
    (h) As provided by Sec.30.35, certain applications for specific 
licenses filed

[[Page 582]]

under this part and parts 32 through 35 of this chapter must contain a 
proposed decommissioning funding plan or a certification of financial 
assurance for decommissioning. In the case of renewal applications 
submitted before July 27, 1990, this submittal may follow the renewal 
application but must be submitted on or before July 27, 1990.
    (i)(1) Each application to possess radioactive materials in unsealed 
form, on foils or plated sources, or sealed in glass in excess of the 
quantities in Sec.30.72, ``Schedule C--Quantities of Radioactive 
Materials Requiring Consideration of the Need for an Emergency Plan for 
Responding to a Release,'' must contain either:
    (i) An evaluation showing that the maximum dose to a person offsite 
due to a release of radioactive materials would not exceed 1 rem 
effective dose equivalent or 5 rems to the thyroid; or
    (ii) An emergency plan for responding to a release of radioactive 
material.
    (2) One or more of the following factors may be used to support an 
evaluation submitted under paragraph (i)(1)(i) of this section:
    (i) The radioactive material is physically separated so that only a 
portion could be involved in an accident;
    (ii) All or part of the radioactive material is not subject to 
release during an accident because of the way it is stored or packaged;
    (iii) The release fraction in the respirable size range would be 
lower than the release fraction shown Sec.30.72 due to the chemical or 
physical form of the material;
    (iv) The solubility of the radioactive material would reduce the 
dose received;
    (v) Facility design or engineered safety features in the facility 
would cause the release fraction to be lower than shown in Sec.30.72;
    (vi) Operating restrictions or procedures would prevent a release 
fraction as large as that shown in Sec.30.72; or
    (vii) Other factors appropriate for the specific facility.
    (3) An emergency plan for responding to a release of radioactive 
material submitted under paragraph (i)(1)(ii) of this section must 
include the following information:
    (i) Facility description. A brief description of the licensee's 
facility and area near the site.
    (ii) Types of accidents. An identification of each type of radio-
active materials accident for which protective actions may be needed.
    (iii) Classification of accidents. A classification system for 
classifying accidents as alerts or site area emergencies.
    (iv) Detection of accidents. Identification of the means of 
detecting each type of accident in a timely manner.
    (v) Mitigation of consequences. A brief description of the means and 
equipment for mitigating the consequences of each type of accident, 
including those provided to protect workers onsite, and a description of 
the program for maintaining the equipment.
    (vi) Assessment of releases. A brief description of the methods and 
equipment to assess releases of radioactive materials.
    (vii) Responsibilities. A brief description of the responsibilities 
of licensee personnel should an accident occur, including identification 
of personnel responsible for promptly notifying offsite response 
organizations and the NRC; also responsibilities for developing, 
maintaining, and updating the plan.
    (viii) Notification and coordination. A commitment to and a brief 
description of the means to promptly notify offsite response 
organizations and request offsite assistance, including medical 
assistance for the treatment of contaminated injured onsite workers when 
appropriate. A control point must be established. The notification and 
coordination must be planned so that unavailability of some personnel, 
parts of the facility, and some equipment will not prevent the 
notification and coordination. The licensee shall also commit to notify 
the NRC operations center immediately after notification of the 
appropriate offsite response organizations and not later than one hour 
after the licensee declares an emergency. \1\
---------------------------------------------------------------------------

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

---------------------------------------------------------------------------

[[Page 583]]

    (ix) Information to be communicated. A brief description of the 
types of information on facility status, radioactive releases, and 
recommended protective actions, if necessary, to be given to offsite 
response organizations and to the NRC.
    (x) Training. A brief description of the frequency, performance 
objectives and plans for the training that the licensee will provide 
workers on how to respond to an emergency including any special 
instructions and orientation tours the licensee would offer to fire, 
police, medical and other emergency personnel. The training shall 
familiarize personnel with site-specific emergency procedures. Also, the 
training shall thoroughly prepare site personnel for their 
responsibilities in the event of accident scenarios postulated as most 
probable for the specific site, including the use of team training for 
such scenarios.
    (xi) Safe shutdown. A brief description of the means of restoring 
the facility to a safe condition after an accident.
    (xii) Exercises. Provisions for conducting quarterly communications 
checks with offsite response organizations and biennial onsite exercises 
to test response to simulated emergencies. Quarterly communications 
checks with offsite response organizations must include the check and 
update of all necessary telephone numbers. The licensee shall invite 
offsite response organizations to participate in the biennial exercises. 
Participation of offsite response organizations in biennial exercises 
although recommended is not required. Exercises must use accident 
scenarios postulated as most probable for the specific site and the 
scenarios shall not be known to most exercise participants. The licensee 
shall critique each exercise using individuals not having direct 
implementation responsibility for the plan. Critiques of exercises must 
evaluate the appropriateness of the plan, emergency procedures, 
facilities, equipment, training of personnel, and overall effectiveness 
of the response. Deficiencies found by the critiques must be corrected.
    (xiii) Hazardous chemicals. A certification that the applicant has 
met its responsibilities under the Emergency Planning and Community 
Right-to-Know Act of 1986, title III, Pub. L. 99-499, if applicable to 
the applicant's activities at the proposed place of use of the byproduct 
material.
    (4) The licensee shall allow the offsite response organizations 
expected to respond in case of an accident 60 days to comment on the 
licensee's emergency plan before submitting it to NRC. The licensee 
shall provide any comments received within the 60 days to the NRC with 
the emergency plan.
    (j) An application from a medical facility, educational institution, 
or Federal facility to produce Positron Emission Tomography (PET) 
radioactive drugs for noncommercial transfer to licensees in its 
consortium authorized for medical use under part 35 of this chapter or 
equivalent Agreement State requirements shall include:
    (1) A request for authorization for the production of PET 
radionuclides or evidence of an existing license issued under part 30 of 
this chapter or Agreement State requirements for a PET radionuclide 
production facility within its consortium from which it receives PET 
radionuclides.
    (2) Evidence that the applicant is qualified to produce radioactive 
drugs for medical use by meeting one of the criteria in Sec.
32.72(a)(2) of this chapter.
    (3) Identification of individual(s) authorized to prepare the PET 
radioactive drugs if the applicant is a pharmacy, and documentation that 
each individual meets the requirements of an authorized nuclear 
pharmacist as specified in Sec.32.72(b)(2) of this chapter.
    (4) Information identified in Sec.32.72(a)(3) of this chapter on 
the PET drugs to be noncommercially transferred to members of its 
consortium.

[30 FR 8185, June 26, 1965, as amended at 36 FR 145, Jan. 6, 1971; 37 FR 
5747, Mar. 21, 1972; 43 FR 6922, Feb. 17, 1978; 49 FR 9403, Mar. 12, 
1984; 49 FR 27924, July 9, 1984; 52 FR 27786, July 24, 1987; 53 FR 
24044, June 27, 1988; 54 FR 14060, Apr. 7, 1989; 68 FR 58004, Oct. 10, 
2003; 72 FR 55925, Oct. 1, 2007; 73 FR 63570, Oct. 24, 2008; 77 FR 
43689, July 25, 2012; 79 FR 58671, Sept. 30, 2014]



Sec.30.33  General requirements for issuance of specific licenses.

    (a) An application for a specific license will be approved if:

[[Page 584]]

    (1) The application is for a purpose authorized by the Act;
    (2) The applicant's proposed equipment and facilities are adequate 
to protect health and minimize danger to life or property;
    (3) The applicant is qualified by training and experience to use the 
material for the purpose requested in such manner as to protect health 
and minimize danger to life or property;
    (4) The applicant satisfies any special requirements contained in 
parts 32 through 37 and 39 of this chapter; and
    (5) In the case of an application for a license to receive and 
possess byproduct material for the conduct of any activity which the NRC 
determines will significantly affect the quality of the environment, the 
Director, Office of Nuclear Material Safety and Safeguards or his/her 
designee, before commencement of construction of the plant or facility 
in which the activity will be conducted, on the basis of information 
filed and evaluations made pursuant to subpart A of part 51 of this 
chapter, has concluded, after weighing the environmental, economic, 
technical, and other benefits against environmental costs and 
considering available alternatives, that the action called for is the 
issuance of the proposed license, with any appropriate conditions to 
protect environmental values. Commencement of construction prior to such 
conclusion shall be grounds for denial of a license to receive and 
possess byproduct material in such plant or facility. Commencement of 
construction as defined in Sec.30.4 may include non-construction 
activities if the activity has a reasonable nexus to radiological safety 
and security.
    (b) Upon a determination that an application meets the requirements 
of the Act, and the regulations of the Commission, the Commission will 
issue a specific license authorizing the possession and use of byproduct 
material (Form NRC 374, ``Byproduct Material License'').

[30 FR 8185, June 26, 1965, as amended at 36 FR 12731, July 7, 1971; 37 
FR 5747, Mar. 21, 1972; 39 FR 26279, July 18, 1974; 43 FR 6922, Feb. 17, 
1978; 49 FR 9403, Mar. 12, 1984; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, 
Feb. 9, 1993; 73 FR 5717, Jan. 31, 2008; 76 FR 56962, Sept. 15, 2011; 78 
FR 17006, Mar. 19, 2013]



Sec.30.34  Terms and conditions of licenses.

    (a) Each license issued pursuant to the regulations in this part and 
the regulations in parts 31 through 36 and 39 of this chapter shall be 
subject to all the provisions of the Act, now or hereafter in effect, 
and to all valid rules, regulations and orders of the Commission.
    (b)(1) No license issued or granted pursuant to the regulations in 
this part and parts 31 through 36, and 39 nor any right under a license 
shall be transferred, assigned or in any manner disposed of, either 
voluntarily or involuntarily, directly or indirectly, through transfer 
of control of any license to any person, unless the Commission shall, 
after securing full information, find that the transfer is in accordance 
with the provisions of the Act and shall give its consent in writing.
    (2) An application for transfer of license must include:
    (i) The identity, technical and financial qualifications of the 
proposed transferee; and
    (ii) Financial assurance for decommissioning information required by 
Sec.30.35.
    (c) Each person licensed by the Commission pursuant to the 
regulations in this part and parts 31 through 36 and 39 shall confine 
his possession and use of the byproduct material to the locations and 
purposes authorized in the license. Except as otherwise provided in the 
license, a license issued pursuant to the regulations in this part and 
parts 31 through 36 and 39 of this chapter shall carry with it the right 
to receive, acquire, own, and possess byproduct material. Preparation 
for shipment and transport of byproduct material shall be in accordance 
with the provisions of part 71 of this chapter.
    (d) Each license issued pursuant to the regulations in this part and 
parts

[[Page 585]]

31 through 36 and 39 shall be deemed to contain the provisions set forth 
in section 183b.-d., inclusive, of the Act, whether or not these 
provisions are expressly set forth in the license.
    (e) The Commission may incorporate, in any license issued pursuant 
to the regulations in this part and parts 31 through 36 and 39, at the 
time of issuance, or thereafter by appropriate rule, regulation or 
order, such additional requirements and conditions with respect to the 
licensee's receipt, possession, use and transfer of byproduct material 
as it deems appropriate or necessary in order to:
    (1) Promote the common defense and security;
    (2) Protect health or to minimize danger to life or property;
    (3) Protect restricted data;
    (4) Require such reports and the keeping of such records, and to 
provide for such inspections of activities under the license as may be 
necessary or appropriate to effectuate the purposes of the Act and 
regulations thereunder.
    (f) Licensees required to submit emergency plans by Sec.30.32(i) 
shall follow the emergency plan approved by the Commission. The licensee 
may change the approved without Commission approval only if the changes 
do not decrease the effectiveness of the plan. The licensee shall 
furnish the change to the appropriate NRC Regional Office specified in 
Sec.30.6 and to affected offsite response organizations within six 
months after the change is made. Proposed changes that decrease, or 
potentially decrease, the effectiveness of the approved emergency plan 
may not be implemented without prior application to and prior approval 
by the Commission.
    (g) Each licensee preparing technetium-99m radiopharmaceuticals from 
molybdenum-99/technetium-99m generators or rubidium-82 from strontium-
82/rubidium-82 generators shall test the generator eluates for 
molybdenum-99 breakthrough or strontium-82 and strontium-85 
contamination, respectively, in accordance with Sec.35.204 of this 
chapter. The licensee shall record the results of each test and retain 
each record for 3 years after the record is made.
    (h)(1) Each general licensee that is required to register by Sec.
31.5(c)(13) of this chapter and each specific licensee shall notify the 
appropriate NRC Regional Administrator, in writing, immediately 
following the filing of a voluntary or involuntary petition for 
bankruptcy under any chapter of title 11 (Bankruptcy) of the United 
States Code by or against:
    (i) The licensee;
    (ii) An entity (as that term is defined in 11 U.S.C. 101(15) 
controlling the licensee or listing the license or licensee as property 
of the estate; or
    (iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of 
the licensee.
    (2) This notification must indicate:
    (i) The bankruptcy court in which the petition for bankruptcy was 
filed; and
    (ii) The date of the filing of the petition.
    (i) Security requirements for portable gauges. Each portable gauge 
licensee shall use a minimum of two independent physical controls that 
form tangible barriers to secure portable gauges from unauthorized 
removal, whenever portable gauges are not under the control and constant 
surveillance of the licensee.
    (j)(1) Authorization under Sec.30.32(j) to produce Positron 
Emission Tomography (PET) radioactive drugs for noncommercial transfer 
to medical use licensees in its consortium does not relieve the licensee 
from complying with applicable FDA, other Federal, and State 
requirements governing radioactive drugs.
    (2) Each licensee authorized under Sec.30.32(j) to produce PET 
radioactive drugs for noncommercial transfer to medical use licensees in 
its consortium shall:
    (i) Satisfy the labeling requirements in Sec.32.72(a)(4) of this 
chapter for each PET radioactive drug transport radiation shield and 
each syringe, vial, or other container used to hold a PET radioactive 
drug intended for noncommercial distribution to members of its 
consortium.
    (ii) Possess and use instrumentation to measure the radioactivity of 
the PET radioactive drugs intended for noncommercial distribution to 
members of its consortium and meet the

[[Page 586]]

procedural, radioactivity measurement, instrument test, instrument 
check, and instrument adjustment requirements in Sec.32.72(c) of this 
chapter.
    (3) A licensee that is a pharmacy authorized under Sec.30.32(j) to 
produce PET radioactive drugs for noncommercial transfer to medical use 
licensees in its consortium shall require that any individual that 
prepares PET radioactive drugs shall be:
    (i) an authorized nuclear pharmacist that meets the requirements in 
Sec.32.72(b)(2) of this chapter, or
    (ii) an individual under the supervision of an authorized nuclear 
pharmacist as specified in Sec.35.27 of this chapter.
    (4) A pharmacy, authorized under Sec.30.32(j) to produce PET 
radioactive drugs for noncommercial transfer to medical use licensees in 
its consortium that allows an individual to work as an authorized 
nuclear pharmacist, shall meet the requirements of Sec.32.72(b)(5) of 
this chapter.
    (k) As required by the Additional Protocol, each specific licensee 
authorized to possess and use byproduct material shall file with the 
Commission location information described in Sec.75.11 of this chapter 
on DOC/NRC Forms AP-1 and associated forms. The licensee shall also 
permit verification of this information by the International Atomic 
Energy Agency (IAEA) and shall take other action as may be necessary to 
implement the US/IAEA Safeguards Agreement, as described in part 75 of 
this chapter.

[30 FR 8185, June 26, 1965, as amended at 38 FR 33969, Dec. 10, 1973; 43 
FR 6922, Feb. 17, 1978; 48 FR 32328, July 15, 1983; 52 FR 1295, Jan. 12, 
1987; 52 FR 8241, Mar. 17, 1987; 53 FR 19245, May 27, 1988; 53 FR 23383, 
June 22, 1988; 54 FR 14061, Apr. 7, 1989; 58 FR 7736, Feb. 9, 1993; 59 
FR 61780, Dec. 2, 1994; 65 FR 79187, Dec. 18, 2000; 70 FR 2009, Jan. 12, 
2005; 72 FR 55926, Oct. 1, 2007; 73 FR 63570, Oct. 24, 2008; 73 FR 
78604, Dec. 23, 2008; 74 FR 7785, Feb. 20, 2009; 76 FR 35564, June 17, 
2011; 77 FR 39905, July 6, 2012; 79 FR 58671, Sept. 30, 2014]

    Effective Date Note: At 83 FR 33101, July 16, 2018, Sec.30.34 was 
amended by adding a third sentence to paragraph (g), effective Jan. 14, 
2019. For the convenience of the user, the added text is set forth as 
follows:



Sec.30.34  Terms and conditions of licenses.

                                * * * * *

    (g) * * * The licensee shall report the results of any test that 
exceeds the permissible concentration listed in Sec.35.204(a) of this 
chapter at the time of generator elution, in accordance with Sec.
35.3204 of this chapter.

                                * * * * *



Sec.30.35  Financial assurance and recordkeeping for decommissioning.

    (a)(1) Each applicant for a specific license authorizing the 
possession and use of unsealed byproduct material of half-life greater 
than 120 days and in quantities exceeding 10\5\ times the applicable 
quantities set forth in appendix B to part 30 shall submit a 
decommissioning funding plan as described in paragraph (e) of this 
section. The decommissioning funding plan must also be submitted when a 
combination of isotopes is involved if R divided by 10\5\ is greater 
than 1 (unity rule), where R is defined here as the sum of the ratios of 
the quantity of each isotope to the applicable value in appendix B to 
part 30.
    (2) Each holder of, or applicant for, any specific license 
authorizing the possession and use of sealed sources or plated foils of 
half-life greater than 120 days and in quantities exceeding 10\12\ times 
the applicable quantities set forth in appendix B to part 30 (or when a 
combination of isotopes is involved if R, as defined in Sec.
30.35(a)(1), divided by 10 \12\ is greater than 1), shall submit a 
decommissioning funding plan as described in paragraph (e) of this 
section. The decommissioning funding plan must be submitted to NRC by 
December 2, 2005.
    (b) Each applicant for a specific license authorizing possession and 
use of byproduct material of half-life greater than 120 days and in 
quantities specified in paragraph (d) of this section shall either--
    (1) Submit a decommissioning funding plan as described in paragraph 
(e) of this section; or
    (2) Submit a certification that financial assurance for 
decommissioning has been provided in the amount prescribed by paragraph 
(d) of this section using

[[Page 587]]

one of the methods described in paragraph (f) of this section. For an 
applicant, this certification may state that the appropriate assurance 
will be obtained after the application has been approved and the license 
issued but before the receipt of licensed material. If the applicant 
defers execution of the financial instrument until after the license has 
been issued, a signed original of the financial instrument obtained to 
satisfy the requirements of paragraph (f) of this section must be 
submitted to NRC before receipt of licensed material. If the applicant 
does not defer execution of the financial instrument, the applicant 
shall submit to NRC, as part of the certification, a signed original of 
the financial instrument obtained to satisfy the requirements of 
paragraph (f) of this section.
    (c)(1) Each holder of a specific license issued on or after July 27, 
1990, which is of a type described in paragraph (a) or (b) of this 
section, shall provide financial assurance for decommissioning in 
accordance with the criteria set forth in this section.
    (2) Each holder of a specific license issued before July 27, 1990, 
and of a type described in paragraph (a) of this section shall submit a 
decommissioning funding plan as described in paragraph (e) of this 
section or a certification of financial assurance for decommissioning in 
an amount at least equal to $1,125,000 in accordance with the criteria 
set forth in this section. If the licensee submits the certification of 
financial assurance rather than a decommissioning funding plan, the 
licensee shall include a decommissioning funding plan in any application 
for license renewal.
    (3) Each holder of a specific license issued before July 27, 1990, 
and of a type described in paragraph (b) of this section shall submit, 
on or before July 27, 1990, a decommissioning funding plan as described, 
in paragraph (e) of this section, or a certification of financial 
assurance for decommissioning in accordance with the criteria set forth 
in this section.
    (4) Any licensee who has submitted an application before July 27, 
1990, for renewal of license in accordance with Sec.30.37 shall 
provide financial assurance for decommissioning in accordance with 
paragraphs (a) and (b) of this section. This assurance must be submitted 
when this rule becomes effective November 24, 1995.
    (5) Waste collectors and waste processors, as defined in 10 CFR part 
20, Appendix G, must provide financial assurance in an amount based on a 
decommissioning funding plan as described in paragraph (e) of this 
section. The decommissioning funding plan must include the cost of 
disposal of the maximum amount (curies) of radioactive material 
permitted by license, and the cost of disposal of the maximum quantity, 
by volume, of radioactive material which could be present at the 
licensee's facility at any time, in addition to the cost to remediate 
the licensee's site to meet the license termination criteria of 10 CFR 
part 20. The decommissioning funding plan must be submitted by December 
2, 2005.
    (6) If, in surveys made under 10 CFR 20.1501(a), residual 
radioactivity in the facility and environment, including the subsurface, 
is detected at levels that would, if left uncorrected, prevent the site 
from meeting the 10 CFR 20.1402 criteria for unrestricted use, the 
licensee must submit a decommissioning funding plan within one year of 
when the survey is completed.
    (d) Table of required amounts of financial assurance for 
decommissioning by quantity of material. Licensees required to submit 
the $1,125,000 amount must do so by December 2, 2004. Licensees required 
to submit the $113,000 or $225,000 amount must do so by June 2, 2005. 
Licensees having possession limits exceeding the upper bounds of this 
table must base financial assurance on a decommissioning funding plan.

------------------------------------------------------------------------
 
------------------------------------------------------------------------
Greater than 10\4\ but less than or equal to 10\5\ times      $1,125,000
 the applicable quantities of appendix B to part 30 in
 unsealed form. (For a combination of isotopes, if R, as
 defined in Sec. 30.35(a)(1), divided by 10\4\ is greater
 than 1 but R divided by 10\5\ is less than or equal to 1).
Greater than 10\3\ but less than or equal to 10\4\ times         225,000
 the applicable quantities of appendix B to part 30 in
 unsealed form. (For a combination of isotopes, if R, as
 defined in Sec. 30.35(a)(1), divided by 10\3\ is greater
 than 1 but R divided by 10\4\ is less than or equal to 1).

[[Page 588]]

 
Greater than 10\10\ but less than or equal to 10\12\ times       113,000
 the applicable quantities of appendix B to part 30 in
 sealed sources or plated foils. (For a combination of
 isotopes, if R, as defined in Sec. 30.35(a)(1), divided
 by 10\10\ is greater than, 1, but R divided by 10\12\ is
 less than or equal to 1)..................................
------------------------------------------------------------------------

    (e)(1) Each decommissioning funding plan must be submitted for 
review and approval and must contain --
    (i) A detailed cost estimate for decommissioning, in an amount 
reflecting:
    (A) The cost of an independent contractor to perform all 
decommissioning activities;
    (B) The cost of meeting the 10 CFR 20.1402 criteria for unrestricted 
use, provided that, if the applicant or licensee can demonstrate its 
ability to meet the provisions of 10 CFR 20.1403, the cost estimate may 
be based on meeting the 10 CFR 20.1403 criteria;
    (C) The volume of onsite subsurface material containing residual 
radioactivity that will require remediation to meet the criteria for 
license termination; and
    (D) An adequate contingency factor.
    (ii) Identification of and justification for using the key 
assumptions contained in the DCE;
    (iii) A description of the method of assuring funds for 
decommissioning from paragraph (f) of this section, including means for 
adjusting cost estimates and associated funding levels periodically over 
the life of the facility;
    (iv) A certification by the licensee that financial assurance for 
decommissioning has been provided in the amount of the cost estimate for 
decommissioning; and
    (v) A signed original of the financial instrument obtained to 
satisfy the requirements of paragraph (f) of this section (unless a 
previously submitted and accepted financial instrument continues to 
cover the cost estimate for decommissioning).
    (2) At the time of license renewal and at intervals not to exceed 3 
years, the decommissioning funding plan must be resubmitted with 
adjustments as necessary to account for changes in costs and the extent 
of contamination. If the amount of financial assurance will be adjusted 
downward, this can not be done until the updated decommissioning funding 
plan is approved. The decommissioning funding plan must update the 
information submitted with the original or prior approved plan, and must 
specifically consider the effect of the following events on 
decommissioning costs:
    (i) Spills of radioactive material producing additional residual 
radioactivity in onsite subsurface material;
    (ii) Waste inventory increasing above the amount previously 
estimated;
    (iii) Waste disposal costs increasing above the amount previously 
estimated;
    (iv) Facility modifications;
    (v) Changes in authorized possession limits;
    (vi) Actual remediation costs that exceed the previous cost 
estimate;
    (vii) Onsite disposal; and
    (viii) Use of a settling pond.
    (f) The financial instrument must include the licensee's name, 
license number, and docket number, and the name, address, and other 
contact information of the issuer, and, if a trust is used, the trustee. 
When any of the foregoing information changes, the licensee must, within 
30 days, submit financial instruments reflecting such changes. The 
financial instrument submitted must be a signed original or signed 
original duplicate, except where a copy of the signed original is 
specifically permitted. Financial assurance for decommissioning must be 
provided by one or more of the following methods:
    (1) Prepayment. Prepayment is the deposit before the start of 
operation into an account segregated from licensee assets and outside 
the licensee's administrative control of cash or liquid assets such that 
the amount of funds would be sufficient to pay decommissioning costs. 
Prepayment must be made into a trust account, and the trustee and the 
trust must be acceptable to the Commission.
    (2) A surety method, insurance, or other guarantee method. These 
methods guarantee that decommissioning costs will be paid. A surety 
method may be in the form of a surety bond, or letter of credit. A 
parent company guarantee of funds for decommissioning costs based on a 
financial test may be used if the

[[Page 589]]

guarantee and test are as contained in Appendix A to this part. For 
commercial corporations that issue bonds, a guarantee of funds by the 
applicant or licensee for decommissioning costs based on a financial 
test may be used if the guarantee and test are as contained in Appendix 
C to this part. For commercial companies that do not issue bonds, a 
guarantee of funds by the applicant or licensee for decommissioning 
costs may be used if the guarantee and test are as contained in Appendix 
D to this part. For nonprofit entities, such as colleges, universities, 
and nonprofit hospitals, a guarantee of funds by the applicant or 
licensee may be used if the guarantee and test are as contained in 
Appendix E to this part. Except for an external sinking fund, a parent 
company guarantee or a guarantee by the applicant or licensee may not be 
used in combination with any other financial methods used to satisfy the 
requirements of this section. A guarantee by the applicant or licensee 
may not be used in any situation where the applicant or licensee has a 
parent company holding majority control of the voting stock of the 
company. Any surety method or insurance used to provide financial 
assurance for decommissioning must contain the following conditions:
    (i) The surety method or insurance must be open-ended or, if written 
for a specified term, such as five years, must be renewed automatically 
unless 90 days or more prior to the renewal date, the issuer notifies 
the Commission, the beneficiary, and the licensee of its intention not 
to renew. The surety method or insurance must also provide that the full 
face amount be paid to the beneficiary automatically prior to the 
expiration without proof of forfeiture if the licensee fails to provide 
a replacement acceptable to the Commission within 30 days after receipt 
of notification of cancellation.
    (ii) The surety method or insurance must be payable to a trust 
established for decommissioning costs. The trustee and trust must be 
acceptable to the Commission. An acceptable trustee includes an 
appropriate State or Federal government agency or an entity which has 
the authority to act as a trustee and whose trust operations are 
regulated and examined by a Federal or State agency.
    (iii) The surety method or insurance must remain in effect until the 
Commission has terminated the license.
    (3) An external sinking fund in which deposits are made at least 
annually, coupled with a surety method, insurance, or other guarantee 
method, the value of which may decrease by the amount being accumulated 
in the sinking fund. An external sinking fund is a fund established and 
maintained by setting aside funds periodically in an account segregated 
from licensee assets and outside the licensee's administrative control 
in which the total amount of funds would be sufficient to pay 
decommissioning costs at the time termination of operation is expected. 
An external sinking fund must be in the form of a trust. If the other 
guarantee method is used, no surety or insurance may be combined with 
the external sinking fund. The surety, insurance, or other guarantee 
provisions must be as stated in paragraph (f)(2) of this section.
    (4) In the case of Federal, State, or local government licensees, a 
statement of intent containing a cost estimate for decommissioning or an 
amount based on the table in paragraph (d) of this section, and 
indicating that funds for decommissioning will be obtained when 
necessary.
    (5) When a government entity is assuming custody and ownership of a 
site, an arrangement that is deemed acceptable by such government 
entity.
    (g) Each person licensed under this part or parts 32 through 36 and 
39 of this chapter shall keep records of information important to the 
decommissioning of a facility in an identified location until the site 
is released for unrestricted use. Before licensed activities are 
transferred or assigned in accordance with Sec.30.34(b), licensees 
shall transfer all records described in this paragraph to the new 
licensee. In this case, the new licensee will be responsible for 
maintaining these records until the license is terminated. If records 
important to the decommissioning of a facility are kept for other 
purposes, reference to these records

[[Page 590]]

and their locations may be used. Information the Commission considers 
important to decommissioning consists of--
    (1) Records of spills or other unusual occurrences involving the 
spread of contamination in and around the facility, equipment, or site. 
These records may be limited to instances when contamination remains 
after any cleanup procedures or when there is reasonable likelihood that 
contaminants may have spread to inaccessible areas as in the case of 
possible seepage into porous materials such as concrete. These records 
must include any known information on identification of involved 
nuclides, quantities, forms, and concentrations.
    (2) As-built drawings and modifications of structures and equipment 
in restricted areas where radioactive materials are used and/or stored, 
and of locations of possible inaccessible contamination such as buried 
pipes which may be subject to contamination. If required drawings are 
referenced, each relevant document need not be indexed individually. If 
drawings are not available, the licensee shall substitute appropriate 
records of available information concerning these areas and locations.
    (3) Except for areas containing only sealed sources (provided the 
sources have not leaked or no contamination remains after any leak) or 
byproduct materials having only half-lives of less than 65 days, a list 
contained in a single document and updated every 2 years, of the 
following:
    (i) All areas designated and formerly designated restricted areas as 
defined in 10 CFR 20.1003 (For requirements prior to January 1, 1994, 
see 10 CFR 20.3 as contained in the CFR edition revised as of January 1, 
1993.);
    (ii) All areas outside of restricted areas that require 
documentation under Sec.30.35(g)(1).
    (iii) All areas outside of restricted areas where current and 
previous wastes have been buried as documented under 10 CFR 20.2108; and
    (iv) All areas outside of restricted areas that contain material 
such that, if the license expired, the licensee would be required to 
either decontaminate the area to meet the criteria for decommissioning 
in 10 CFR part 20, subpart E, or apply for approval for disposal under 
10 CFR 20.2002.
    (4) Records of the cost estimate performed for the decommissioning 
funding plan or of the amount certified for decommissioning, and records 
of the funding method used for assuring funds if either a funding plan 
or certification is used.
    (h) In providing financial assurance under this section, each 
licensee must use the financial assurance funds only for decommissioning 
activities and each licensee must monitor the balance of funds held to 
account for market variations. The licensee must replenish the funds, 
and report such actions to the NRC, as follows:
    (1) If, at the end of a calendar quarter, the fund balance is below 
the amount necessary to cover the cost of decommissioning, but is not 
below 75 percent of the cost, the licensee must increase the balance to 
cover the cost, and must do so within 30 days after the end of the 
calendar quarter.
    (2) If, at any time, the fund balance falls below 75 percent of the 
amount necessary to cover the cost of decommissioning, the licensee must 
increase the balance to cover the cost, and must do so within 30 days of 
the occurrence.
    (3) Within 30 days of taking the actions required by paragraph 
(h)(1) or (h)(2) of this section, the licensee must provide a written 
report of such actions to the Director, Office of Nuclear Material 
Safety and Safeguards , and state the new balance of the fund.

[53 FR 24044, June 27, 1988, as amended at 56 FR 23471, May 21, 1991; 58 
FR 39633, July 26, 1993; 58 FR 67659, Dec. 22, 1993; 58 FR 68730, Dec. 
29, 1993; 59 FR 1618, Jan. 12, 1994; 60 FR 38238, July 26, 1995; 61 FR 
24673, May 16, 1996; 62 FR 39090, July 21, 1997; 63 FR 29541, June 1, 
1998; 68 FR 57335, Oct. 3, 2003; 76 FR 35564, June 17, 2011]



Sec.30.36  Expiration and termination of licenses and decommissioning
of sites and separate buildings or outdoor areas.

    (a) Each specific license expires at the end of the day on the 
expiration date stated in the license, unless the licensee has filed an 
application for renewal under Sec.30.37 not less than 30 days before 
the expiration date stated in the existing license. If an application 
for

[[Page 591]]

renewal has been filed at least 30 days before the expiration date 
stated in the existing license, the existing license expires at the end 
of the day on which the Commission makes a final determination to deny 
the renewal application or, if the determination states an expiration 
date, the expiration date stated in the determination.
    (b) Each specific license revoked by the Commission expires at the 
end of the day on the date of the Commission's final determination to 
revoke the license, or on the expiration date stated in the 
determination, or as otherwise provided by Commission Order.
    (c) Each specific license continues in effect, beyond the expiration 
date if necessary, with respect to possession of byproduct material 
until the Commission notifies the licensee in writing that the license 
is terminated. During this time, the licensee shall--
    (1) Limit actions involving byproduct material to those related to 
decommissioning; and
    (2) Continue to control entry to restricted areas until they are 
suitable for release in accordance with NRC requirements.
    (d) Within 60 days of the occurrence of any of the following, 
consistent with the administrative directions in Sec.30.6, each 
licensee shall provide notification to the NRC in writing of such 
occurrence, and either begin decommissioning its site, or any separate 
building or outdoor area that contains residual radioactivity so that 
the building or outdoor area is suitable for release in accordance with 
NRC requirements, or submit within 12 months of notification a 
decommissioning plan, if required by paragraph (g)(1) of this section, 
and begin decommissioning upon approval of that plan if--
    (1) The license has expired pursuant to paragraph (a) or (b) of this 
section; or
    (2) The licensee has decided to permanently cease principal 
activities, as defined in this part, at the entire site or in any 
separate building or outdoor area that contains residual radioactivity 
such that the building or outdoor area is unsuitable for release in 
accordance with NRC requirements; or
    (3) No principal activities under the license have been conducted 
for a period of 24 months; or
    (4) No principal activities have been conducted for a period of 24 
months in any separate building or outdoor area that contains residual 
radioactivity such that the building or outdoor area is unsuitable for 
release in accordance with NRC requirements.
    (e) Coincident with the notification required by paragraph (d) of 
this section, the licensee shall maintain in effect all decommissioning 
financial assurances established by the licensee pursuant to Sec.30.35 
in conjunction with a license issuance or renewal or as required by this 
section. The amount of the financial assurance must be increased, or may 
be decreased, as appropriate, to cover the detailed cost estimate for 
decommissioning established pursuant to paragraph (g)(4)(v) of this 
section.
    (1) Any licensee who has not provided financial assurance to cover 
the detailed cost estimate submitted with the decommissioning plan shall 
do so when this rule becomes effective November 24, 1995.
    (2) Following approval of the decommissioning plan, a licensee may 
reduce the amount of the financial assurance as decommissioning proceeds 
and radiological contamination is reduced at the site with the approval 
of the Commission.
    (f) The Commission may grant a request to extend the time periods 
established in paragraph (d) if the Commission determines that this 
relief is not detrimental to the public health and safety and is 
otherwise in the public interest. The request must be submitted no later 
than 30 days before notification pursuant to paragraph (d) of this 
section. The schedule for decommissioning set forth in paragraph (d) of 
this section may not commence until the Commission has made a 
determination on the request.
    (g)(1) A decommissioning plan must be submitted if required by 
license condition or if the procedures and activities necessary to carry 
out decommissioning of the site or separate building or outdoor area 
have not been previously approved by the Commission

[[Page 592]]

and these procedures could increase potential health and safety impacts 
to workers or to the public, such as in any of the following cases:
    (i) Procedures would involve techniques not applied routinely during 
cleanup or maintenance operations;
    (ii) Workers would be entering areas not normally occupied where 
surface contamination and radiation levels are significantly higher than 
routinely encountered during operation;
    (iii) Procedures could result in significantly greater airborne 
concentrations of radioactive materials than are present during 
operation; or
    (iv) Procedures could result in significantly greater releases of 
radioactive material to the environment than those associated with 
operation.
    (2) The Commission may approve an alternate schedule for submittal 
of a decommissioning plan required pursuant to paragraph (d) of this 
section if the Commission determines that the alternative schedule is 
necessary to the effective conduct of decommissioning operations and 
presents no undue risk from radiation to the public health and safety 
and is otherwise in the public interest.
    (3) Procedures such as those listed in paragraph (g)(1) of this 
section with potential health and safety impacts may not be carried out 
prior to approval of the decommissioning plan.
    (4) The proposed decommissioning plan for the site or separate 
building or outdoor area must include:
    (i) A description of the conditions of the site or separate building 
or outdoor area sufficient to evaluate the acceptability of the plan;
    (ii) A description of planned decommissioning activities;
    (iii) A description of methods used to ensure protection of workers 
and the environment against radiation hazards during decommissioning;
    (iv) A description of the planned final radiation survey; and
    (v) An updated detailed cost estimate for decommissioning, 
comparison of that estimate with present funds set aside for 
decommissioning, and a plan for assuring the availability of adequate 
funds for completion of decommissioning.
    (vi) For decommissioning plans calling for completion of 
decommissioning later than 24 months after plan approval, the plan shall 
include a justification for the delay based on the criteria in paragraph 
(i) of this section.
    (5) The proposed decommissioning plan will be approved by the 
Commission if the information therein demonstrates that the 
decommissioning will be completed as soon as practicable and that the 
health and safety of workers and the public will be adequately 
protected.
    (h)(1) Except as provided in paragraph (i) of this section, 
licensees shall complete decommissioning of the site or separate 
building or outdoor area as soon as practicable but no later than 24 
months following the initiation of decommissioning.
    (2) Except as provided in paragraph (i) of this section, when 
decommissioning involves the entire site, the licensee shall request 
license termination as soon as practicable but no later than 24 months 
following the initiation of decommissioning.
    (i) The Commission may approve a request for an alternative schedule 
for completion of decommissioning of the site or separate building or 
outdoor area, and license termination if appropriate, if the Commission 
determines that the alternative is warranted by consideration of the 
following:
    (1) Whether it is technically feasible to complete decommissioning 
within the allotted 24-month period;
    (2) Whether sufficient waste disposal capacity is available to allow 
completion of decommissioning within the allotted 24-month period;
    (3) Whether a significant volume reduction in wastes requiring 
disposal will be achieved by allowing short-lived radionuclides to 
decay;
    (4) Whether a significant reduction in radiation exposure to workers 
can be achieved by allowing short-lived radionuclides to decay; and
    (5) Other site-specific factors which the Commission may consider 
appropriate on a case-by-case basis, such as the regulatory requirements 
of other government agencies, lawsuits, groundwater treatment 
activities, monitored

[[Page 593]]

natural groundwater restoration, actions that could result in more 
environmental harm than deferred cleanup, and other factors beyond the 
control of the licensee.
    (j) As the final step in decommissioning, the licensee shall--
    (1) Certify the disposition of all licensed material, including 
accumulated wastes, by submitting a completed NRC Form 314 or equivalent 
information; and
    (2) Conduct a radiation survey of the premises where the licensed 
activities were carried out and submit a report of the results of this 
survey, unless the licensee demonstrates in some other manner that the 
premises are suitable for release in accordance with the criteria for 
decommissioning in 10 CFR part 20, subpart E. The licensee shall, as 
appropriate--
    (i) Report levels of gamma radiation in units of millisieverts 
(microroentgen) per hour at one meter from surfaces, and report levels 
of radioactivity, including alpha and beta, in units of megabecquerels 
(disintegrations per minute or microcuries) per 100 square centimeters--
removable and fixed--for surfaces, megabecquerels (microcuries) per 
milliliter for water, and becquerels (picocuries) per gram for solids 
such as soils or concrete; and
    (ii) Specify the survey instrument(s) used and certify that each 
instrument is properly calibrated and tested.
    (k) Specific licenses, including expired licenses, will be 
terminated by written notice to the licensee when the Commission 
determines that:
    (1) Byproduct material has been properly disposed;
    (2) Reasonable effort has been made to eliminate residual 
radioactive contamination, if present; and
    (3)(i) A radiation survey has been performed which demonstrates that 
the premises are suitable for release in accordance with the criteria 
for decommissioning in 10 CFR part 20, subpart E; or
    (ii) Other information submitted by the licensee is sufficient to 
demonstrate that the premises are suitable for release in accordance 
with the criteria for decommissioning in 10 CFR part 20, subpart E.
    (4) Records required by Sec.30.51 (d) and (f) have been received.

[59 FR 36034, July 15, 1994, as amended at 60 FR 38238, July 26, 1995; 
61 FR 1114, Jan. 16, 1996; 61 FR 24673, May 16, 1996; 61 FR 29637, June 
12, 1996; 62 FR 39090, July 21, 1997; 73 FR 42673, July 23, 2008; 81 FR 
86909, Dec. 2, 2016]



Sec.30.37  Application for renewal of licenses.

    Application for renewal of a specific license must be filed on NRC 
Form 313 and in accordance with Sec.30.32.

[75 FR 73942, Nov. 30, 2010]



Sec.30.38  Application for amendment of licenses and registration 
certificates.

    Applications for amendment of a license must be filed in accordance 
with Sec.30.32 and must specify the respects in which the licensee 
desires its license to be amended and the grounds for the amendment. 
Applications for amendment of sealed source and device registration 
certificates must be filed in accordance with Sec.32.210 of this 
chapter and any other applicable provisions and must specify the 
respects in which the certificate holder desires its certificate to be 
amended and the grounds for the amendment.

[77 FR 43690, July 25, 2012]



Sec.30.39  Commission action on applications to renew or amend.

    In considering an application to renew or amend a license or to 
amend a sealed source or device registration certificate, the Commission 
will apply the applicable criteria set forth in Sec.30.33 and parts 32 
through 36 and 39 of this chapter.

[77 FR 43690, July 25, 2012]



Sec.30.41  Transfer of byproduct material.

    (a) No licensee shall transfer byproduct material except as 
authorized pursuant to this section.
    (b) Except as otherwise provided in his license and subject to the 
provisions of paragraphs (c) and (d) of this section, any licensee may 
transfer byproduct material:
    (1) To the Department;

[[Page 594]]

    (2) To the agency in any Agreement State which regulates radioactive 
material pursuant to an agreement under section 274 of the Act;
    (3) To any person exempt from the licensing requirements of the Act 
and regulations in this part, to the extent permitted under such 
exemption;
    (4) To any person in an Agreement State, subject to the jurisdiction 
of that State, who has been exempted from the licensing requirements and 
regulations of that State, to the extent permitted under such exemption;
    (5) To any person authorized to receive such byproduct material 
under terms of a specific license or a general license or their 
equivalents issued by the Atomic Energy Commission, the Commission, or 
an Agreement State;
    (6) To a person abroad pursuant to an export license issued under 
part 110 of this chapter; or
    (7) As otherwise authorized by the Commission in writing.
    (c) Before transferring byproduct material to a specific licensee of 
the Commission or an Agreement State or to a general licensee who is 
required to register with the Commission or with an Agreement State 
prior to receipt of the byproduct material, the licensee transferring 
the material shall verify that the transferee's license authorizes the 
receipt of the type, form, and quantity of byproduct material to be 
transferred.
    (d) The following methods for the verification required by paragraph 
(c) of this section are acceptable:
    (1) The transferor may have in his possession, and read, a current 
copy of the transferee's specific license or registration certificate;
    (2) The transferor may have in his possession a written 
certification by the transferee that he is authorized by license or 
registration certificate to receive the type, form, and quantity of 
byproduct material to be transferred, specifying the license or 
registration certificate number, issuing agency and expiration date;
    (3) For emergency shipments the transferor may accept oral 
certification by the transferee that he is authorized by license or 
registration certificate to receive the type, form, and quantity of 
byproduct material to be transferred, specifying the license or 
registration certificate number, issuing agency and expiration date: 
Provided, That the oral certification is confirmed in writing within 10 
days;
    (4) The transferor may obtain other sources of information compiled 
by a reporting service from official records of the Commission or the 
licensing agency of an Agreement State as to the identity of licensees 
and the scope and expiration dates of licenses and registration; or
    (5) When none of the methods of verification described in paragraphs 
(d)(1) to (4) of this section are readily available or when a transferor 
desires to verify that information received by one of such methods is 
correct or up-to-date, the transferor may obtain and record confirmation 
from the Commission or the licensing agency of an Agreement State that 
the transferee is licensed to receive the byproduct material.

[38 FR 33969, Dec. 10, 1973, as amended at 40 FR 8785, Mar. 3, 1975; 43 
FR 6922, Feb. 17, 1978]

                Records, Inspections, Tests, and Reports



Sec.30.50  Reporting requirements.

    (a) Immediate report. Each licensee shall notify the NRC as soon as 
possible but not later than 4 hours after the discovery of an event that 
prevents immediate protective actions necessary to avoid exposures to 
radiation or radioactive materials that could exceed regulatory limits 
or releases of licensed material that could exceed regulatory limits 
(events may include fires, explosions, toxic gas releases, etc.).
    (b) Twenty-four hour report. Each licensee shall notify the NRC 
within 24 hours after the discovery of any of the following events 
involving licensed material:
    (1) An unplanned contamination event that:
    (i) Requires access to the contaminated area, by workers or the 
public, to be restricted for more than 24 hours by imposing additional 
radiological controls or by prohibiting entry into the area;

[[Page 595]]

    (ii) Involves a quantity of material greater than five times the 
lowest annual limit on intake specified in appendix B of Sec. Sec.
20.1001-20.2401 of 10 CFR part 20 for the material; and
    (iii) Has access to the area restricted for a reason other than to 
allow isotopes with a half-life of less than 24 hours to decay prior to 
decontamination.
    (2) An event in which equipment is disabled or fails to function as 
designed when:
    (i) The equipment is required by regulation or license condition to 
prevent releases exceeding regulatory limits, to prevent exposures to 
radiation and radioactive materials exceeding regulatory limits, or to 
mitigate the consequences of an accident;
    (ii) The equipment is required to be available and operable when it 
is disabled or fails to function; and
    (iii) No redundant equipment is available and operable to perform 
the required safety function.
    (3) An event that requires unplanned medical treatment at a medical 
facility of an individual with spreadable radioactive contamination on 
the individual's clothing or body.
    (4) An unplanned fire or explosion damaging any licensed material or 
any device, container, or equipment containing licensed material when:
    (i) The quantity of material involved is greater than five times the 
lowest annual limit on intake specified in appendix B of Sec. Sec.
20.1001-20.2401 of 10 CFR part 20 for the material; and
    (ii) The damage affects the integrity of the licensed material or 
its container.
    (c) Preparation and submission of reports. Reports made by licensees 
in response to the requirements of this section must be made as follows:
    (1) Licensees shall make reports required by paragraphs (a) and (b) 
of this section by telephone to the NRC Operations Center. \1\ To the 
extent that the information is available at the time of notification, 
the information provided in these reports must include:
---------------------------------------------------------------------------

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

    (i) The caller's name and call back telephone number;
    (ii) A description of the event, including date and time;
    (iii) The exact location of the event;
    (iv) The isotopes, quantities, and chemical and physical form of the 
licensed material involved; and
    (v) Any personnel radiation exposure data available.
    (2) Written report. Each licensee who makes a report required by 
paragraph (a) or (b) of this section shall submit a written follow-up 
report within 30 days of the initial report. Written reports prepared 
pursuant to other regulations may be submitted to fulfill this 
requirement if the reports contain all of the necessary information and 
the appropriate distribution is made. These written reports must be sent 
to the NRC using an appropriate method listed in Sec.30.6(a); and a 
copy must be sent to the appropriate NRC Regional office listed in 
appendix D to part 20 of this chapter. The reports must include the 
following:
    (i) A description of the event, including the probable cause and the 
manufacturer and model number (if applicable) of any equipment that 
failed or malfunctioned;
    (ii) The exact location of the event;
    (iii) The isotopes, quantities, and chemical and physical form of 
the licensed material involved;
    (iv) Date and time of the event;
    (v) Corrective actions taken or planned and the results of any 
evaluations or assessments; and
    (vi) The extent of exposure of individuals to radiation or to 
radioactive materials without identification of individuals by name.
    (3) The provisions of Sec.30.50 do not apply to licensees subject 
to the notification requirements in Sec.50.72. They do apply to those 
part 50 licensees possessing material licensed under part 30, who are 
not subject to the notification requirements in Sec.50.72.

[56 FR 40767, Aug. 16, 1991, as amended at 59 FR 14086, Mar. 25, 1994; 
68 FR 58804, Oct. 10, 2003]



Sec.30.51  Records.

    (a) Each person who receives byproduct material pursuant to a 
license issued pursuant to the regulations in this part and parts 31 
through 36 of this chapter shall keep records showing the

[[Page 596]]

receipt, transfer, and disposal of the byproduct material as follows:
    (1) The licensee shall retain each record of receipt of byproduct 
material as long as the material is possessed and for three years 
following transfer or disposal of the material.
    (2) The licensee who transferred the material shall retain each 
record of transfer for three years after each transfer unless a specific 
requirement in another part of the regulations in this chapter dictates 
otherwise.
    (3) The licensee who disposed of the material shall retain each 
record of disposal of byproduct material until the Commission terminates 
each license that authorizes disposal of the material.
    (b) The licensee shall retain each record that is required by the 
regulations in this part and parts 31 through 36 of this chapter or by 
license condition for the period specified by the appropriate regulation 
or license condition. If a retention period is not otherwise specified 
by regulation or license condition, the record must be retained until 
the Commission terminates each license that authorizes the activity that 
is subject to the recordkeeping requirement.
    (c)(1) Records which must be maintained pursuant to this part and 
parts 31 through 36 of this chapter may be the original or a reproduced 
copy or microform if such reproduced copy or microform is duly 
authenticated by authorized personnel and the microform is capable of 
producing a clear and legible copy after storage for the period 
specified by Commission regulations. The record may also be stored in 
electronic media with the capability for producing legible, accurate, 
and complete records during the required retention period. Records such 
as letters, drawings, specifications, must include all pertinent 
information such as stamps, initials, and signatures. The licensee shall 
maintain adequate safeguards against tampering with and loss of records.
    (2) If there is a conflict between the Commission's regulations in 
this part and parts 31 through 36 and 39 of this chapter, license 
condition, or other written Commission approval or authorization 
pertaining to the retention period for the same type of record, the 
retention period specified in the regulations in this part and parts 31 
through 36 and 39 of this chapter for such records shall apply unless 
the Commission, pursuant to Sec.30.11, has granted a specific 
exemption from the record retention requirements specified in the 
regulations in this part or parts 31 through 36 and 39 of this chapter.
    (d) Prior to license termination, each licensee authorized to 
possess radioactive material with a half-life greater than 120 days, in 
an unsealed form, shall forward the following records to the appropriate 
NRC Regional Office:
    (1) Records of disposal of licensed material made under Sec. Sec.
20.2002 (including burials authorized before January 28, 1981 \1\), 
20.2003, 20.2004, 20.2005; and
---------------------------------------------------------------------------

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

    (2) Records required by Sec.20.2103(b)(4).
    (e) If licensed activities are transferred or assigned in accordance 
with Sec.30.34(b), each licensee authorized to possess radioactive 
material, with a half-life greater than 120 days, in an unsealed form, 
shall transfer the following records to the new licensee and the new 
licensee will be responsible for maintaining these records until the 
license is terminated:
    (1) Records of disposal of licensed material made under Sec. Sec.
20.2002 (including burials authorized before January 28, 1981 \1\), 
20.2003, 20.2004, 20.2005; and
    (2) Records required by Sec.20.2103(b)(4).
    (f) Prior to license termination, each licensee shall forward the 
records required by Sec.30.35(g) to the appropriate NRC Regional 
Office.

[41 FR 18301, May 5, 1976, as amended at 43 FR 6922, Feb. 17, 1978; 52 
FR 8241, Mar. 17, 1987; 53 FR 19245, May 27, 1988; 58 FR 7736, Feb. 9, 
1993; 61 FR 24673, May 16, 1996]



Sec.30.52  Inspections.

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

[[Page 597]]

    (b) Each licensee shall make available to the Commission for 
inspection, upon reasonable notice, records kept by him pursuant to the 
regulations in this chapter.

[30 FR 8185, June 26, 1965]



Sec.30.53  Tests.

    Each licensee shall perform, or permit the Commission to perform, 
such tests as the Commission deems appropriate or necessary for the 
administration of the regulations in this part and parts 31 through 36 
and 39 of this chapter, including tests of:
    (a) Byproduct material;
    (b) Facilities wherein byproduct material is utilized or stored;
    (c) Radiation detection and monitoring instruments; and
    (d) Other equipment and devices used in connection with the 
utilization or storage of byproduct material.

[30 FR 8185, June 26, 1965, as amended at 43 FR 6922, Feb. 17, 1978; 52 
FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993]



Sec.30.55  Tritium reports.

    (a)-(b) [Reserved]
    (c) Except as specified in paragraph (d) of this section, each 
licensee who is authorized to possess tritium shall report promptly to 
the appropriate NRC Regional Office listed in appendix D of part 20 of 
this chapter by telephone and telegraph, mailgram, or facsimile any 
incident in which an attempt has been made or is believed to have been 
made to commit a theft or unlawful diversion of more than 10 curies of 
such material at any one time or more than 100 curies of such material 
in any one calendar year. The initial report shall be followed within a 
period of fifteen (15) days by a written report submitted to the 
appropriate NRC Regional Office which sets forth the details of the 
incident and its consequences. Copies of such written report shall be 
sent to the Director, Office of Nuclear Material Safety and Safeguards , 
using an appropriate method listed in Sec.30.6(a). Subsequent to the 
submission of the written report required by this paragraph, the 
licensee shall promptly inform the Office of Nuclear Material Safety and 
Safeguards by means of a written report of any substantive additional 
information, which becomes available to the licensee, concerning an 
attempted or apparent theft or unlawful diversion of tritium.
    (d) The reports described in this section are not required for 
tritium possessed pursuant to a general license provided in part 31 of 
this chapter or for tritium contained in spent fuel.

[37 FR 9208, May 6, 1972, as amended at 38 FR 1271, Jan. 11, 1973; 38 FR 
2330, Jan. 24, 1973; 41 FR 16446, Apr. 19, 1976; 43 FR 6922, Feb. 17, 
1978; 46 FR 55085, Nov. 6, 1981; 49 FR 24707, June 15, 1984; 52 FR 
31611, Aug. 21, 1987; 68 FR 58804, Oct. 10, 2003; 73 FR 5718, Jan. 31, 
2008]

                               Enforcement



Sec.30.61  Modification and revocation of licenses and registration
certificates.

    (a) The terms and conditions of each license and registration 
certificate issued under the regulations in this part and parts 31 
through 36 and 39 of this chapter shall be subject to amendment, 
revision, or modification by reason of amendments to the Act, or by 
reason of rules, regulations, and orders issued in accordance with the 
terms of the Act.
    (b) Any license or registration certificate may be revoked, 
suspended, or modified, in whole or in part, for any material false 
statement in the application or in any statement of fact required under 
section 182 of the Act, or because of conditions revealed by such 
application or statement of fact or any report, record, or inspection or 
other means that would warrant the Commission to refuse to grant a 
license or registration certificate on an original application, or for 
violation of, or failure to observe any of the terms and provisions of 
the Act or of any rule, regulation, or order of the Commission.
    (c) Except in cases of willfulness or those in which the public 
health, interest, or safety requires otherwise, no license or 
registration certificate shall be modified, suspended, or revoked 
unless, before the institution of proceedings therefor, facts or conduct 
that may warrant such action shall have been called to the attention of 
the licensee or certificate holder in writing and the licensee or 
certificate holder shall have been given an opportunity

[[Page 598]]

to demonstrate or achieve compliance with all lawful requirements.

[77 FR 43690, July 25, 2012]



Sec.30.62  Right to cause the withholding or recall of byproduct
material.

    The Commission may cause the withholding or recall of byproduct 
material from any licensee who is not equipped to observe or fails to 
observe such safety standards to protect health as may be established by 
the Commission, or who uses such materials in violation of law or 
regulation of the Commission, or in a manner other than as disclosed in 
the application therefor or approved by the Commission.

[30 FR 8185, June 26, 1965, as amended at 40 FR 8785, Mar. 3, 1975]



Sec.30.63  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55072, Nov. 24, 1992]



Sec.30.64  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 30 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 30 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.30.1, 30.2, 30.4, 30.5, 30.6, 30.8, 30.11, 30.12, 30.13, 
30.15, 30.31, 30.32, 30.33, 30.37, 30.38, 30.39, 30.61, 30.62, 30.63, 
30.64, 30.70, 30.71, and 30.72.

[57 FR 55072, Nov. 24, 1992, as amended at 73 FR 42673, July 23, 2008]

                                Schedules



Sec.30.70  Schedule A--Exempt concentrations.

                                      [See footnotes at end of this table]
----------------------------------------------------------------------------------------------------------------
                                                                         Col. I                  Col. II
                                                               -------------------------------------------------
       Element (atomic number)                 Isotope                                       Liquid and solid
                                                                   Gas concentration     concentration [micro]Ci/
                                                                    [micro]Ci/ml \1\              ml \2\
----------------------------------------------------------------------------------------------------------------
Antimony (51)........................  Sb 122.................  .......................  3 x 10-4
                                       Sb 124.................  .......................  2 x 10-4
                                       Sb 125.................  .......................  1 x 10-3
Argon (18)...........................  A 37...................  1 x 10-3...............
                                       A 41...................  4 x 10-7...............
Arsenic (33).........................  As 73..................  .......................  5 x 10-3
                                       As 74..................  .......................  5 x 10-4
                                       As 76..................  .......................  2 x 10-4
                                       As 77..................  .......................  8 x 10-4
Barium (56)..........................  Ba 131.................  .......................  2 x 10-3
                                       Ba 140.................  .......................  3 x 10-4
Beryllium (4)........................  Be 7...................  .......................  2 x 10-2
Bismuth (83).........................  Bi 206.................  .......................  4 x 10-4

[[Page 599]]

 
Bromine (35).........................  Br 82..................  4 x 10-7...............  3 x 10-3
Cadmium (48).........................  Cd 109.................  .......................  2 x 10-3
                                       Cd 115m................  .......................  3 x 10-4
                                       Cd 115.................  .......................  3 x 10-4
Calcium (20).........................  Ca 45..................  .......................  9 x 10-5
                                       Ca 47..................  .......................  5 x 10-4
Carbon (6)...........................  C 14...................  1 x 10-6...............  8 x 10-3
Cerium (58)..........................  Ce 141.................  .......................  9 x 10-4
                                       Ce 143.................  .......................  4 x 10-4
                                       Ce 144.................  .......................  1 x 10-4
Cesium (55)..........................  Cs 131.................  .......................  2 x 10-2
                                       Cs 134m................  .......................  6 x 10-2
                                       Cs 134.................  .......................  9 x 10-5
Chlorine (17)........................  Cl 38..................  9 x 10-7...............  4 x 10-3
Chromium (24)........................  Cr 51..................  .......................  2 x 10-2
Cobalt (27)..........................  Co 57..................  .......................  5 x 10-3
                                       Co 58..................  .......................  1 x 10-3
                                       Co 60..................  .......................  5 x 10-4
Copper (29)..........................  Cu 64..................  .......................  3 x 10-3
Dysprosium (66)......................  Dy 165.................  .......................  4 x 10-3
                                       Dy 166.................  .......................  4 x 10-4
Erbium (68)..........................  Er 169.................  .......................  9 x 10-4
                                       Er 171.................  .......................  1 x 10-3
Europium (63)........................  Eu 152.................  .......................  6 x 10-4
                                       (T/2 = 9.2 Hrs)........
                                       Eu 155.................  .......................  2 x 10-3
Fluorine (9).........................  F 18...................  2 x 10-6...............  8 x 10-3
Gadolinium (64)......................  Gd 153.................  .......................  2 x 10-3
                                       Gd 159.................  .......................  8 x 10-4
Gallium (31).........................  Ga 72..................  .......................  4 x 10-4
Germanium (32).......................  Ge 71..................  .......................  2 x 10-2
Gold (79)............................  Au 196.................  .......................  2 x 10-3
                                       Au 198.................  .......................  5 x 10-4
                                       Au 199.................  .......................  2 x 10-3
Hafnium (72).........................  Hf 181.................  .......................  7 x 10-4
Hydrogen (1).........................  H 3....................  5 x 10-6...............  3 x 10-2
Indium (49)..........................  In 113m................  .......................  1 x 10-2
                                       In 114m................  .......................  2 x 10-4
Iodine (53)..........................  I 126..................  3 x 10-9...............  2 x 10-5
                                       I 131..................  3 x 10-9...............  2 x 10-5
                                       I 132..................  8 x 10-8...............  6 x 10-4
                                       I 133..................  1 x 10-8...............  7 x 10-5
                                       I 134..................  2 x 10-7...............  1 x 10-3
Iridium (77).........................  Ir 190.................  .......................  2 x 10-3
                                       Ir 192.................  .......................  4 x 10-4
                                       Ir 194.................  .......................  3 x 10-4
Iron (26)............................  Fe 55..................  .......................  8 x 10-3
                                       Fe 59..................  .......................  6 x 10-4
Krypton (36).........................  Kr 85m.................  1 x 10-6...............
                                       Kr 85..................  3 x 10-6...............
Lanthanum (57).......................  La 140.................  .......................  2 x 10-4
Lead (82)............................  Pb 203.................  .......................  4 x 10-3
Lutetium (71)........................  Lu 177.................  .......................  1 x 10-3
Manganese (25).......................  Mn 52..................  .......................  3 x 10-4
                                       Mn 54..................  .......................  1 x 10-3
                                       Mn 56..................  .......................  1 x 10-3
Mercury (80).........................  Hg 197m................  .......................  2 x 10-3
                                       Hg 197.................  .......................  3 x 10-3
                                       Hg 203.................  .......................  2 x 10-4
Molybdenum (42)......................  Mo 99..................  .......................  2 x 10-3
Neodymium (60).......................  Nd 147.................  .......................  6 x 10-4
                                       Nd 149.................  .......................  3 x 10-3
Nickel (28)..........................  Ni 65..................  .......................  1 x 10-3
Niobium (Columbium) (41).............  Nb 95..................  .......................  1 x 10-3
                                       Nb 97..................  .......................  9 x 10-3
Osmium (76)..........................  Os 185.................  .......................  7 x 10-4
                                       Os 191m................  .......................  3 x 10-2
                                       Os 191.................  .......................  2 x 10-3
                                       Os 193.................  .......................  6 x 10-4

[[Page 600]]

 
Palladium (46).......................  Pd 103.................  .......................  3 x 10-3
                                       Pd 109.................  .......................  9 x 10-4
Phosphorus (15)......................  P 32...................  .......................  2 x 10-4
Platinum (78)........................  Pt 191.................  .......................  1 x 10-3
                                       Pt 193m................  .......................  1 x 10-2
                                       Pt 197m................  .......................  1 x 10-2
                                       Pt 197.................  .......................  1 x 10-3
Potassium (19).......................  K 42...................  .......................  3 x 10-3
Praseodymium (59)....................  Pr 142.................  .......................  3 x 10-4
                                       Pr 143.................  .......................  5 x 10-4
Promethium (61)......................  Pm 147.................  .......................  2 x 10-3
                                       Pm 149.................  .......................  4 x 10-4
Rhenium (75).........................  Re 183.................  .......................  6 x 10-3
                                       Re 186.................  .......................  9 x 10-4
                                       Re 188.................  .......................  6 x 10-4
Rhodium (45).........................  Rh 103m................  .......................  1 x 10-1
                                       Rh 105.................  .......................  1 x 10-3
Rubidium (37)........................  Rb 86..................  .......................  7 x 10-4
Ruthenium (44).......................  Ru 97..................  .......................  4 x 10-4
                                       Ru 103.................  .......................  8 x 10-4
                                       Ru 105.................  .......................  1 x 10-3
                                       Ru 106.................  .......................  1 x 10-4
Samarium (62)........................  Sm 153.................  .......................  8 x 10-4
Scandium (21)........................  Sc 46..................  .......................  4 x 10-4
                                       Sc 47..................  .......................  9 x 10-4
                                       Sc 48..................  .......................  3 x 10-4
Selenium (34)........................  Se 75..................  .......................  3 x 10-3
Silicon (14).........................  Si 31..................  .......................  9 x 10-3
Silver (47)..........................  Ag 105.................  .......................  1 x 10-3
                                       Ag 110m................  .......................  3 x 10-4
                                       Ag 111.................  .......................  4 x 10-4
Sodium (11)..........................  Na 24..................  .......................  2 x 10-3
Strontium (38).......................  Sr 85..................  .......................  1 x 10-4
                                       Sr 89..................  .......................  1 x 10-4
                                       Sr 91..................  .......................  7 x 10-4
                                       Sr 92..................  .......................  7 x 10-4
Sulfur (16)..........................  S 35...................  9 x 10-8...............  6 x 10-4
Tantalum (73)........................  Ta 182.................  .......................  4 x 10-4
Technetium (43)......................  Tc 96m.................  .......................  1 x 10-1
                                       Tc 96..................  .......................  1 x 10-3
Tellurium (52).......................  Te 125m................  .......................  2 x 10-3
                                       Te 127m................  .......................  6 x 10-4
                                       Te 127.................  .......................  3 x 10-3
                                       Te 129m................  .......................  3 x 10-4
                                       Te 131m................  .......................  6 x 10-4
                                       Te 132.................  .......................  3 x 10-4
Terbium (65).........................  Tb 160.................  .......................  4 x 10-4
Thallium (81)........................  Tl 200.................  .......................  4 x 10-3
                                       Tl 201.................  .......................  3 x 10-3
                                       Tl 202.................  .......................  1 x 10-3
                                       Tl 204.................  .......................  1 x 10-3
Thulium (69).........................  Tm 170.................  .......................  5 x 10-4
                                       Tm 171.................  .......................  5 x 10-3
Tin (50).............................  Sn 113.................  .......................  9 x 10-4
                                       Sn 125.................  .......................  2 x 10-4
Tungsten (Wolfram) (74)..............  W 181..................  .......................  4 x 10-3
                                       W 187..................  .......................  7 x 10-4
Vanadium (23)........................  V 48...................  .......................  3 x 10-4
Xenon (54)...........................  Xe 131m................  4 x 10-6...............
                                       Xe 133.................  3 x 10-6...............
                                       Xe 135.................  1 x 10-6...............
Ytterbium (70).......................  Yb 175.................  .......................  1 x 10-3
Yttrium (39).........................  Y 90...................  .......................  2 x 10-4
                                       Y 91m..................  .......................  3 x 10-2
                                       Y 91...................  .......................  3 x 10-4
                                       Y 92...................  .......................  6 x 10-4
                                       Y 93...................  .......................  3 x 10-4
Zinc (30)............................  Zn 65..................  .......................  1 x 10-3
                                       Zn 69m.................  .......................  7 x 10-4

[[Page 601]]

 
                                       Zn 69..................  .......................  2 x 10-2
Zirconium (40).......................  Zr 95..................  .......................  6 x 10-4
                                       Zr 97..................  .......................  2 x 10-4
Beta and/or gamma emitting byproduct   .......................  1 x 10-10..............  1 x 10-6
 material not listed above with half-
 life less than 3 years.
----------------------------------------------------------------------------------------------------------------
Footnotes to Schedule A:
\1\ Values are given only for those materials normally used as gases.
\2\ [micro]Ci/gm for solids.
 Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in
  Schedule A, the activity stated is that of the parent isotope and takes into account the daughters.
 For purposes of Sec. 30.14 where there is involved a combination of isotopes, the limit for the combination
  should be derived as follows:
Determine for each isotope in the product the ratio between the concentration present in the product and the
  exempt concentration established in Schedule A for the specific isotope when not in combination. The sum of
  such ratios may not exceed ``1'' (i.e., unity).
Example:

[GRAPHIC] [TIFF OMITTED] TC14NO91.021


[30 FR 8185, June 26, 1965, as amended at 35 FR 3982, Mar. 3, 1970; 38 
FR 29314, Oct. 24, 1973; 59 FR 5520, Feb. 7, 1994]



Sec.30.71  Schedule B.

------------------------------------------------------------------------
                     Byproduct material                      Microcuries
------------------------------------------------------------------------
Antimony 122 (Sb 122)......................................          100
Antimony 124 (Sb 124)......................................           10
Antimony 125 (Sb 125)......................................           10
Arsenic 73 (As 73).........................................          100
Arsenic 74 (As 74).........................................           10
Arsenic 76 (As 76).........................................           10
Arsenic 77 (As 77).........................................          100
Barium 131 (Ba 131)........................................           10
Barium 133 (Ba 133)........................................           10
Barium 140 (Ba 140)........................................           10
Bismuth 210 (Bi 210).......................................            1
Bromine 82 (Br 82).........................................           10
Cadmium 109 (Cd 109).......................................           10
Cadmium 115m (Cd 115m).....................................           10
Cadmium 115 (Cd 115).......................................          100
Calcium 45 (Ca 45).........................................           10
Calcium 47 (Ca 47).........................................           10
Carbon 14 (C 14)...........................................          100
Cerium 141 (Ce 141)........................................          100
Cerium 143 (Ce 143)........................................          100
Cerium 144 (Ce 144)........................................            1
Cesium 129 (Cs 129)........................................          100
Cesium 131 (Cs 131)........................................        1,000
Cesium 134m (Cs 134m)......................................          100
Cesium 134 (Cs 134)........................................            1
Cesium 135 (Cs 135)........................................           10
Cesium 136 (Cs 136)........................................           10
Cesium 137 (Cs 137)........................................           10
Chlorine 36 (C1 36)........................................           10
Chlorine 38 (Cl 38)........................................           10
Chromium 51 (Cr 51)........................................        1,000
Cobalt 57 (Co 57)..........................................          100
Cobalt 58m (Co 58m)........................................           10
Cobalt 58 (Co 58)..........................................           10
Cobalt 60 (Co 60)..........................................            1
Copper 64 (Cu 64)..........................................          100
Dysprosium 165 (Dy 165)....................................           10
Dysprosium 166 (Dy 166)....................................          100
Erbium 169 (Er 169)........................................          100
Erbium 171 (Er 171)........................................          100
Europium 152 9.2 h (Eu 152 9.2 h)..........................          100
Europium 152 13 yr (Eu 152 13 yr)..........................            1
Europium 154 (Eu 154)......................................            1
Europium 155 (Eu 155)......................................           10
Fluorine 18 (F 18).........................................        1,000
Gadolinium 153 (Gd 153)....................................           10
Gadolinium 159 (Gd 159)....................................          100
Gallium 67 (Ga 67).........................................          100
Gallium 72 (Ga 72).........................................           10
Germanium 68 (Ge 68).......................................           10
Germanium 71 (Ge 71).......................................          100
Gold 195 (Au 195)..........................................           10
Gold 198 (Au 198)..........................................          100
Gold 199 (Au 199)..........................................          100
Hafnium 181 (Hf 181).......................................           10
Holmium 166 (Ho 166).......................................          100
Hydrogen 3 (H 3)...........................................        1,000
Indium 111 (In 111)........................................          100
Indium 113m (In 113m)......................................          100
Indium 114m (In 114m)......................................           10
Indium 115m (In 115m)......................................          100
Indium 115 (In 115)........................................           10
Iodine 123 (I 123).........................................          100
Iodine 125 (I 125).........................................            1
Iodine 126 (I 126).........................................            1
Iodine 129 (I 129).........................................          0.1
Iodine 131 (I 131).........................................            1
Iodine 132 (I 132).........................................           10
Iodine 133 (I 133).........................................            1
Iodine 134 (I 134).........................................           10
Iodine 135 (I 135).........................................           10
Iridium 192 (Ir 192).......................................           10
Iridium 194 (Ir 194).......................................          100
Iron 52 (Fe 52)............................................           10
Iron 55 (Fe 55)............................................          100
Iron 59 (Fe 59)............................................           10
Krypton 85 (Kr 85).........................................          100
Krypton 87 (Kr 87).........................................           10
Lanthanum 140 (La 140).....................................           10
Lutetium 177 (Lu 177)......................................          100

[[Page 602]]

 
Manganese 52 (Mn 52).......................................           10
Manganese 54 (Mn 54).......................................           10
Manganese 56 (Mn 56).......................................           10
Mercury 197m (Hg 197m).....................................          100
Mercury 197 (Hg 197).......................................          100
Mercury 203 (Hg 203).......................................           10
Molybdenum 99 (Mo 99)......................................          100
Neodymium 147 (Nd 147).....................................          100
Neodymium 149 (Nd 149).....................................          100
Nickel 59 (Ni 59)..........................................          100
Nickel 63 (Ni 63)..........................................           10
Nickel 65 (Ni 65)..........................................          100
Niobium 93m (Nb 93m).......................................           10
Niobium 95 (Nb 95).........................................           10
Niobium 97 (Nb 97).........................................           10
Osmium 185 (Os 185)........................................           10
Osmium 191m (Os 191m)......................................          100
Osmium 191 (Os 191)........................................          100
Osmium 193 (Os 193)........................................          100
Palladium 103 (Pd 103).....................................          100
Palladium 109 (Pd 109).....................................          100
Phosphorus 32 (P 32).......................................           10
Platinum 191 (Pt 191)......................................          100
Platinum 193m (Pt 193m)....................................          100
Platinum 193 (Pt 193)......................................          100
Platinum 197m (Pt 197m)....................................          100
Platinum 197 (Pt 197)......................................          100
Polonium 210 (Po 210)......................................          0.1
Potassium 42 (K 42)........................................           10
Potassium 43 (K 43)........................................           10
Praseodymium 142 (Pr 142)..................................          100
Praseodymium 143 (Pr 143)..................................          100
Promethium 147 (Pm 147)....................................           10
Promethium 149 (Pm 149)....................................           10
Rhenium 186 (Re 186).......................................          100
Rhenium 188 (Re 188).......................................          100
Rhodium 103m (Rh 103m).....................................          100
Rhodium 105 (Rh 105).......................................          100
Rubidium 81 (Rb 81)........................................           10
Rubidium 86 (Rb 86)........................................           10
Rubidium 87 (Rb 87)........................................           10
Ruthenium 97 (Ru 97).......................................          100
Ruthenium 103 (Ru 103).....................................           10
Ruthenium 105 (Ru 105).....................................           10
Ruthenium 106 (Ru 106).....................................            1
Samarium 151 (Sm 151)......................................           10
Samarium 153 (Sm 153)......................................          100
Scandium 46 (Sc 46)........................................           10
Scandium 47 (Sc 47)........................................          100
Scandium 48 (Sc 48)........................................           10
Selenium 75 (Se 75)........................................           10
Silicon 31 (Si 31).........................................          100
Silver 105 (Ag 105)........................................           10
Silver 110m (Ag 110m)......................................            1
Silver 111 (Ag 111)........................................          100
Sodium 22 (Na 22)..........................................           10
Sodium 24 (Na 24)..........................................           10
Strontium 85 (Sr 85).......................................           10
Strontium 89 (Sr 89).......................................            1
Strontium 90 (Sr 90).......................................          0.1
Strontium 91 (Sr 91).......................................           10
Strontium 92 (Sr 92).......................................           10
Sulphur 35 (S 35)..........................................          100
Tantalum 182 (Ta 182)......................................           10
Technetium 96 (Tc 96)......................................           10
Technetium 97m (Tc 97m)....................................          100
Technetium 97 (Tc 97)......................................          100
Technetium 99m (Tc 99m)....................................          100
Technetium 99 (Tc 99)......................................           10
Tellurium 125m (Te 125m)...................................           10
Tellurium 127m (Te 127m)...................................           10
Tellurium 127 (Te 127).....................................          100
Tellurium 129m (Te 129m)...................................           10
Tellurium 129 (Te 129).....................................          100
Tellurium 131m (Te 131m)...................................           10
Tellurium 132 (Te 132).....................................           10
Terbium 160 (Tb 160).......................................           10
Thallium 200 (Tl 200)......................................          100
Thallium 201 (Tl 201)......................................          100
Thallium 202 (Tl 202)......................................          100
Thallium 204 (Tl 204)......................................           10
Thulium 170 (Tm 170).......................................           10
Thulium 171 (Tm 171).......................................           10
Tin 113 (Sn 113)...........................................           10
Tin 125 (Sn 125)...........................................           10
Tungsten 181 (W 181).......................................           10
Tungsten 185 (W 185).......................................           10
Tungsten 187 (W 187).......................................          100
Vanadium 48 (V 48).........................................           10
Xenon 131m (Xe 131m).......................................        1,000
Xenon 133 (Xe 133).........................................          100
Xenon 135 (Xe 135).........................................          100
Ytterbium 175 (Yb 175).....................................          100
Yttrium 87 (Y 87)..........................................           10
Yttrium 88 (Y 88)..........................................           10
Yttrium 90 (Y 90)..........................................           10
Yttrium 91 (Y 91)..........................................           10
Yttrium 92 (Y 92)..........................................          100
Yttrium 93 (Y 93)..........................................          100
Zinc 65 (Zn 65)............................................           10
Zinc 69m (Zn 69m)..........................................          100
Zinc 69 (Zn 69)............................................        1,000
Zirconium 93 (Zr 93).......................................           10
Zirconium 95 (Zr 95).......................................           10
Zirconium 97 (Zr 97).......................................           10
Any byproduct material not listed above other than alpha             0.1
 emitting byproduct material...............................
------------------------------------------------------------------------


[35 FR 6427, Apr. 22, 1970, as amended at 36 FR 16898, Aug. 26, 1971; 59 
FR 5519, Feb. 7, 1994; 72 FR 55926, Oct. 1, 2007]



Sec.30.72  Schedule C--Quantities of radioactive materials requiring 
consideration of the need for an emergency plan for responding to
a release.

------------------------------------------------------------------------
                                                      Release   Quantity
              Radioactive material \1\               fraction   (curies)
------------------------------------------------------------------------
Actinium-228.......................................    0.001       4,000
Americium-241......................................     .001           2
Americium-242......................................     .001           2
Americium-243......................................     .001           2
Antimony-124.......................................     .01        4,000
Antimony-126.......................................     .01        6,000
Barium-133.........................................     .01       10,000
Barium-140.........................................     .01       30,000
Bismuth-207........................................     .01        5,000
Bismuth-210........................................     .01          600
Cadmium-109........................................     .01        1,000
Cadmium-113........................................     .01           80
Calcium-45.........................................     .01       20,000
Californium-252....................................     .001   9 (20 mg)
Carbon-14 (non-carbon dioxide).....................     .01       50,000
Cerium-141.........................................     .01       10,000
Cerium-144.........................................     .01          300
Cesium-134.........................................     .01        2,000
Cesium-137.........................................     .01        3,000
Chlorine-36........................................     .5           100
Chromium-51........................................     .01      300,000
Cobalt-60..........................................     .001       5,000
Copper-64..........................................     .01      200,000
Curium-242.........................................     .001          60
Curium-243.........................................     .001           3

[[Page 603]]

 
Curium-244.........................................     .001           4
Curium-245.........................................     .001           2
Europium-152.......................................     .01          500
Europium-154.......................................     .01          400
Europium-155.......................................     .01        3,000
Germanium-68.......................................     .01        2,000
Gadolinium-153.....................................     .01        5,000
Gold-198...........................................     .01       30,000
Hafnium-172........................................     .01          400
Hafnium-181........................................     .01        7,000
Holmium-166m.......................................     .01          100
Hydrogen-3.........................................     .5        20,000
Iodine-125.........................................     .5            10
Iodine-131.........................................     .5            10
Indium-114m........................................     .01        1,000
Iridium-192........................................     .001      40,000
Iron-55............................................     .01       40,000
Iron-59............................................     .01        7,000
Krypton-85.........................................    1.0     6,000,000
Lead-210...........................................     .01            8
Manganese-56.......................................     .01       60,000
Mercury-203........................................     .01       10,000
Molybdenum-99......................................     .01       30,000
Neptunium-237......................................     .001           2
Nickel-63..........................................     .01       20,000
Niobium-94.........................................     .01          300
Phosphorus-32......................................     .5           100
Phosphorus-33......................................     .5         1,000
Polonium-210.......................................     .01           10
Potassium-42.......................................     .01        9,000
Promethium-145.....................................     .01        4,000
Promethium-147.....................................     .01        4,000
Radium-226.........................................    0.001         100
Ruthenium-106......................................     .01          200
Samarium-151.......................................     .01        4,000
Scandium-46........................................     .01        3,000
Selenium-75........................................     .01       10,000
Silver-110m........................................     .01        1,000
Sodium-22..........................................     .01        9,000
Sodium-24..........................................     .01       10,000
Strontium-89.......................................     .01        3,000
Strontium-90.......................................     .01           90
Sulfur-35..........................................     .5           900
Technitium-99......................................     .01       10,000
Technitium-99m.....................................     .01      400,000
Tellurium-127m.....................................     .01        5,000
Tellurium-129m.....................................     .01        5,000
Terbium-160........................................     .01        4,000
Thulium-170........................................     .01        4,000
Tin-113............................................     .01       10,000
Tin-123............................................     .01        3,000
Tin-126............................................     .01        1,000
Titanium-44........................................     .01          100
Vanadium-48........................................     .01        7,000
Xenon-133..........................................    1.0       900,000
Yttrium-91.........................................     .01        2,000
Zinc-65............................................     .01        5,000
Zirconium-93.......................................     .01          400
Zirconium-95.......................................     .01        5,000
Any other beta-gamma emitter.......................     .01       10,000
Mixed fission products.............................     .01        1,000
Mixed corrosion products...........................     .01       10,000
Contaminated equipment beta-gamma..................     .001      10,000
Irradiated material, any form other than solid          .01        1,000
 noncombustible....................................
Irradiated material, solid noncombustible..........     .001      10,000
Mixed radioactive waste, beta-gamma................     .01        1,000
Packaged mixed waste, beta-gamma \4\...............     .001      10,000
Any other alpha emitter............................     .001           2
Contaminated equipment, alpha......................     .0001         20
Packaged waste, alpha \4\..........................     .0001         20
Combinations of radioactive materials listed above
 \1\...............................................
------------------------------------------------------------------------
\1\ For combinations of radioactive materials, consideration of the need
  for an emergency plan is required if the sum of the ratios of the
  quantity of each radioactive material authorized to the quantity
  listed for that material in Schedule C exceeds one.
\2\ Waste packaged in Type B containers does not require an emergency
  plan.


[54 FR 14061, Apr. 7, 1989, as amended at 61 FR 9902, Mar. 12, 1996; 72 
FR 55926, Oct. 1, 2007]





Sec. Appendix A to Part 30--Criteria Relating to Use of Financial Tests 
  and Parent Company Guarantees for Providing Reasonable Assurance of 
                        Funds for Decommissioning

                             I. Introduction

    An applicant or licensee may provide reasonable assurance of the 
availability of funds for decommissioning based on obtaining a parent 
company guarantee that funds will be available for decommissioning costs 
and on a demonstration that the parent company passes a financial test. 
This appendix establishes criteria for passing the financial test and 
for obtaining the parent company guarantee.

                           II. Financial Test

    A. To pass the financial test, the parent company must meet the 
criteria of either paragraph A.1 or A.2 of this section. For purposes of 
applying the Appendix A criteria, tangible net worth must be calculated 
to exclude all intangible assets and the net book value of the nuclear 
facility and site, and total net worth, which may include intangible 
assets, must be calculated to exclude the net book value and goodwill of 
the nuclear facility and site.
    1. The parent company must have:
    (i) Two of the following three ratios: A ratio of total liabilities 
to total net worth less than 2.0; a ratio of the sum of net income plus 
depreciation, depletion, and amortization to total liabilities greater 
than 0.1; and a ratio of current assets to current liabilities greater 
than 1.5; and
    (ii) Net working capital and tangible net worth each at least six 
times the amount of decommissioning funds being assured by a parent 
company guarantee for the total of all nuclear facilities or parts 
thereof (or prescribed amount if a certification is used); and
    (iii) Tangible net worth of at least $21 million; and

[[Page 604]]

    (iv) Assets located in the United States amounting to at least 90 
percent of the total assets or at least six times the current 
decommissioning cost estimates for the total of all facilities or parts 
thereof (or prescribed amount if a certification is used), or, for a 
power reactor licensee, at least six times the amount of decommissioning 
funds being assured by a parent company guarantee for the total of all 
reactor units or parts thereof.
    2. The parent company must have:
    (i) A current rating for its most recent uninsured, 
uncollateralized, and unencumbered bond issuance of AAA, AA, A, or BBB 
(including adjustments of + and -) as issued by Standard and Poor's or 
Aaa, Aa, A, or Baa (including adjustment of 1, 2, or 3) as issued by 
Moody's; and
    (ii) Total net worth at least six times the amount of 
decommissioning funds being assured by a parent company guarantee for 
the total of all nuclear facilities or parts thereof (or prescribed 
amount if a certification is used); and
    (iii) Tangible net worth of at least $21 million; and
    (iv) Assets located in the United States amounting to at least 90 
percent of the total assets or at least six times the current 
decommissioning cost estimates for the total of all facilities or parts 
thereof (or prescribed amount if a certification is used), or, for a 
power reactor licensee, at least six times the amount of decommissioning 
funds being assured by a parent company guarantee for the total of all 
reactor units or parts thereof.
    B. The parent company's independent certified public accountant must 
compare the data used by the parent company in the financial test, which 
is derived from the independently audited, year-end financial statements 
for the latest fiscal year, with the amounts in such financial 
statement. The accountant must evaluate the parent company's off-balance 
sheet transactions and provide an opinion on whether those transactions 
could materially adversely affect the parent company's ability to pay 
for decommissioning costs. The accountant must verify that a bond 
rating, if used to demonstrate passage of the financial test, meets the 
requirements of paragraph A of this section. In connection with the 
auditing procedure, the licensee must inform the NRC within 90 days of 
any matters coming to the auditor's attention which cause the auditor to 
believe that the data specified in the financial test should be adjusted 
and that the company no longer passes the test.
    C.1. After the initial financial test, the parent company must 
annually pass the test and provide documentation of its continued 
eligibility to use the parent company guarantee to the Commission within 
90 days after the close of each succeeding fiscal year.
    2. If the parent company no longer meets the requirements of 
paragraph A of this section, the licensee must send notice to the 
Commission of intent to establish alternate financial assurance as 
specified in the Commission's regulations. The notice must be sent by 
certified mail within 90 days after the end of the fiscal year for which 
the year end financial data show that the parent company no longer meets 
the financial test requirements. The licensee must provide alternate 
financial assurance within 120 days after the end of such fiscal year.

                      III. Parent Company Guarantee

    The terms of a parent company guarantee which an applicant or 
licensee obtains must provide that:
    A. The parent company guarantee will remain in force unless the 
guarantor sends notice of cancellation by certified mail to the licensee 
and the Commission. Cancellation may not occur, however, during the 120 
days beginning on the date of receipt of the notice of cancellation by 
both the licensee and the Commission, as evidenced by the return 
receipts.
    B. If the licensee fails to provide alternate financial assurance as 
specified in the Commission's regulations within 90 days after receipt 
by the licensee and Commission of a notice of cancellation of the parent 
company guarantee from the guarantor, the guarantor will provide 
alternative financial assurance that meets the provisions of the 
Commission's regulations in the name of the licensee.
    C. The parent company guarantee and financial test provisions must 
remain in effect until the Commission has terminated the license, 
accepted in writing the parent company's alternate financial assurances, 
or accepted in writing the licensee's financial assurances.
    D. A standby trust to protect public health and safety and the 
environment must be established for decommissioning costs before the 
parent company guarantee agreement is submitted. The trustee and trust 
must be acceptable to the Commission. An acceptable trustee includes an 
appropriate State or Federal Government agency or an entity which has 
the authority to act as a trustee, whose trust operations are regulated 
and examined by a Federal or State agency. The Commission has the right 
to change the trustee. An acceptable trust will meet the regulatory 
criteria established in these regulations that govern the issuance of 
the license for which the guarantor has accepted the obligation to pay 
for decommissioning costs.
    E. The guarantor must agree that it would be subject to Commission 
orders to make payments under the guarantee agreement.
    F. The guarantor must agree that if the guarantor admits in writing 
its inability to pay its debts generally, or makes a general

[[Page 605]]

assignment for the benefit of creditors, or any proceeding is instituted 
by or against the guarantor seeking to adjudicate it as bankrupt or 
insolvent, or seeking dissolution, liquidation, winding-up, 
reorganization, arrangement, adjustment, protection, relief or 
composition of it or its debts under any law relating to bankruptcy, 
insolvency, or reorganization or relief of debtors, or seeking the entry 
of an order for relief or the appointment of a receiver, trustee, 
custodian, or other similar official for the guarantor or for any 
substantial part of its property, or the guarantor takes any action to 
authorize or effect any of the actions stated in this paragraph, then 
the Commission may:
    1. Declare that the financial assurance guaranteed by the parent 
company guarantee agreement is immediately due and payable to the 
standby trust set up to protect the public health and safety and the 
environment, without diligence, presentment, demand, protest or any 
other notice of any kind, all of which are expressly waived by 
guarantor; and
    2. Exercise any and all of its other rights under applicable law.
    G. 1. The guarantor must agree to notify the NRC, in writing, 
immediately following the filing of a voluntary or involuntary petition 
for bankruptcy under any chapter of title 11 (Bankruptcy) of the United 
States Code, or the occurrence of any other event listed in paragraph F 
of this Appendix, by or against:
    (i) The guarantor;
    (ii) The licensee;
    (iii) An entity (as that term is defined in 11 U.S.C. 101(14)) 
controlling the licensee or listing the license or licensee as property 
of the estate; or
    (iv) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of 
the licensee.
    2. This notification must include:
    (i) A description of the event, including major creditors, the 
amounts involved, and the actions taken to assure that the amount of 
funds guaranteed by the parent company guarantee for decommissioning 
will be transferred to the standby trust as soon as possible;
    (ii) If a petition of bankruptcy was filed, the identity of the 
bankruptcy court in which the petition for bankruptcy was filed; and
    (iii) The date of filing of any petitions.

[53 FR 24046, June 27, 1988, as amended at 63 FR 50479, Sept. 22, 1998; 
76 FR 35565, June 17, 2011]



    Sec. Appendix B to Part 30--Quantities \1\ of Licensed Material 
                           Requiring Labeling

------------------------------------------------------------------------
                          Material                           Microcuries
------------------------------------------------------------------------
Americium-241..............................................          .01
Antimony-122...............................................          100
Antimony-124...............................................           10
Antimony-125...............................................           10
Arsenic-73.................................................          100
Arsenic-74.................................................           10
Arsenic-76.................................................           10
Arsenic-77.................................................          100
Barium-131.................................................           10
Barium-133.................................................           10
Barium-140.................................................           10
Bismuth-210................................................            1
Bromine-82.................................................           10
Cadmium-109................................................           10
Cadmium-115m...............................................           10
Cadmium-115................................................          100
Calcium-45.................................................           10
Calcium-47.................................................           10
Carbon-14..................................................          100
Cerium-141.................................................          100
Cerium-143.................................................          100
Cerium-144.................................................            1
Cesium-131.................................................        1,000
Cesium-134m................................................          100
Cesium-134.................................................            1
Cesium-135.................................................           10
Cesium-136.................................................           10
Cesium-137.................................................           10
Chlorine-36................................................           10
Chlorine-38................................................           10
Chromium-51................................................        1,000
Cobalt-58m.................................................           10
Cobalt-58..................................................           10
Cobalt-60..................................................            1
Copper-64..................................................          100
Dysprosium-165.............................................           10
Dysprosium-166.............................................          100
Erbium-169.................................................          100
Erbium-171.................................................          100
Europium-152 9.2 h.........................................          100
Europium-152 13 yr.........................................            1
Europium-154...............................................            1
Europium-155...............................................           10
Fluorine-18................................................        1,000
Gadolinium-153.............................................           10
Gadolinium-159.............................................          100
Gallium-72.................................................           10
Germanium-71...............................................          100
Gold-198...................................................          100
Gold-199...................................................          100
Hafnium-181................................................           10
Holmium-166................................................          100
Hydrogen-3.................................................        1,000
Indium-113m................................................          100
Indium-114m................................................           10
Indium-115m................................................          100
Indium-115.................................................           10
Iodine-125.................................................            1
Iodine-126.................................................            1
Iodine-129.................................................          0.1
Iodine-131.................................................            1
Iodine-132.................................................           10
Iodine-133.................................................            1
Iodine-134.................................................           10
Iodine-135.................................................           10
Iridium-192................................................           10
Iridium-194................................................          100
Iron-55....................................................          100
Iron-59....................................................           10

[[Page 606]]

 
Krypton-85.................................................          100
Krypton-87.................................................           10
Lanthanum-140..............................................           10
Lutetium-177...............................................          100
Manganese-52...............................................           10
Manganese-54...............................................           10
Manganese-56...............................................           10
Mercury-197m...............................................          100
Mercury-197................................................          100
Mercury-203................................................           10
Molybdenum-99..............................................          100
Neodymium-147..............................................          100
Neodymium-149..............................................          100
Nickel-59..................................................          100
Nickel-63..................................................           10
Nickel-65..................................................          100
Niobium-93m................................................           10
Niobium-95.................................................           10
Niobium-97.................................................           10
Osmium-185.................................................           10
Osmium-191m................................................          100
Osmium-191.................................................          100
Osmium-193.................................................          100
Palladium-103..............................................          100
Palladium-109..............................................          100
Phosphorus-32..............................................           10
Platinum-191...............................................          100
Platinum-193m..............................................          100
Platinum-193...............................................          100
Platinum-197m..............................................          100
Platinum-197...............................................          100
Plutonium-239..............................................          .01
Polonium-210...............................................          0.1
Potassium-42...............................................           10
Praseodymium-142...........................................          100
Praseodymium-143...........................................          100
Promethium-147.............................................           10
Promethium-149.............................................           10
Radium-226.................................................          .01
Rhenium-186................................................          100
Rhenium-188................................................          100
Rhodium-103m...............................................          100
Rhodium-105................................................          100
Rubidium-86................................................           10
Rubidium-87................................................           10
Ruthenium-97...............................................          100
Ruthenium-103..............................................           10
Ruthenium-105..............................................           10
Ruthenium-106..............................................            1
Samarium-151...............................................           10
Samarium-153...............................................          100
Scandium-46................................................           10
Scandium-47................................................          100
Scandium-48................................................           10
Selenium-75................................................           10
Silicon-31.................................................          100
Silver-105.................................................           10
Silver-110m................................................            1
Silver-111.................................................          100
Sodium-24..................................................           10
Strontium-85...............................................           10
Strontium-89...............................................            1
Strontium-90...............................................          0.1
Strontium-91...............................................           10
Strontium-92...............................................           10
Sulphur-35.................................................          100
Tantalum-182...............................................           10
Technetium-96..............................................           10
Technetium-97m.............................................          100
Technetium-97..............................................          100
Technetium-99m.............................................          100
Technetium-99..............................................           10
Tellurium-125m.............................................           10
Tellurium-127m.............................................           10
Tellurium-127..............................................          100
Tellurium-129m.............................................           10
Tellurium-129..............................................          100
Tellurium-131m.............................................           10
Tellurium-132..............................................           10
Terbium-160................................................           10
Thallium-200...............................................          100
Thallium-201...............................................          100
Thallium-202...............................................          100
Thallium-204...............................................           10
Thorium (natural) \1\......................................          100
Thulium-170................................................           10
Thulium-171................................................           10
Tin-113....................................................           10
Tin-125....................................................           10
Tungsten-181...............................................           10
Tungsten-185...............................................           10
Tungsten-187...............................................          100
Uranium (natural) \2\......................................          100
Uranium-233................................................          .01
Uranium-234--Uranium-235...................................          .01
Vanadium-48................................................           10
Xenon-131m.................................................        1,000
Xenon-133..................................................          100
Xenon-135..................................................          100
Ytterbium-175..............................................          100
Yttrium-90.................................................           10
Yttrium-91.................................................           10
Yttrium-92.................................................          100
Yttrium-93.................................................          100
Zinc-65....................................................           10
Zinc-69m...................................................          100
Zinc-69....................................................        1,000
Zirconium-93...............................................           10
Zirconium-95...............................................           10
Zirconium-97...............................................           10
Any alpha emitting radionuclide not listed above or                  .01
 mixtures of alpha emitters of unknown composition.........
Any radionuclide other than alpha emitting radionuclides,             .1
 not listed above or mixtures of beta emitters of unknown
 composition...............................................
------------------------------------------------------------------------
\1\ Based on alpha disintegration rate of Th-232, Th-230 and their
  daughter products.
\2\ Based on alpha disintegration rate of U-238, U-234, and U-235.

    Note: For purposes of Sec.20.303, where there is involved a 
combination of isotopes in known amounts, the limit for the combination 
should be derived as follows: Determine, for each isotope in the 
combination, the ratio between the quantity present in the combination 
and the limit otherwise established for the specific isotope when not in 
combination. The sum of such ratios for all the isotopes in the 
combination may not exceed ``1'' (i.e., ``unity'').

[35 FR 6425, Apr. 22, 1970, as amended at 36 FR 16898, Aug. 26, 1971; 38 
FR 29314, Oct. 24, 1973; 39 FR 23991, June 28, 1974; 45 FR 71763, Oct. 
30, 1980. Redesignated at 56 FR 23391, May 21, 1991, and further 
redesignated at 58 FR 67659, Dec. 22, 1993]

[[Page 607]]



Sec. Appendix C to Part 30--Criteria Relating to Use of Financial Tests 
  and Self Guarantees for Providing Reasonable Assurance of Funds for 
                             Decommissioning

                             I. Introduction

    An applicant or licensee may provide reasonable assurance of the 
availability of funds for decommissioning based on furnishing its own 
guarantee that funds will be available for decommissioning costs and on 
a demonstration that the company passes the financial test of Section II 
of this appendix. The terms of the self-guarantee are in Section III of 
this appendix. This appendix establishes criteria for passing the 
financial test for the self guarantee and establishes the terms for a 
self-guarantee.

                           II. Financial Test

    A. To pass the financial test a company must meet all of the 
criteria set forth in this section. For purposes of applying the 
Appendix C criteria, tangible net worth must be calculated to exclude 
all intangible assets and the net book value of the nuclear facility and 
site, and total net worth, which may include intangible assets, must be 
calculated to exclude the net book value and goodwill of the nuclear 
facility and site. These criteria include:
    (1) Tangible net worth of at least $21 million, and total net worth 
at least 10 times the amount of decommissioning funds being assured by a 
self-guarantee for all decommissioning activities for which the company 
is responsible as self-guaranteeing licensee and as parent-guarantor for 
the total of all nuclear facilities or parts thereof (or the current 
amount required if certification is used).
    (2) Assets located in the United States amounting to at least 90 
percent of total assets or at least 10 times the amount of 
decommissioning funds being assured by a self-guarantee, for all 
decommissioning activities for which the company is responsible as self-
guaranteeing licensee and as parent-guarantor for the total of all 
nuclear facilities or parts thereof (or the current amount required if 
certification is used).
    (3) A current rating for its most recent uninsured, 
uncollateralized, and unencumbered bond issuance of AAA, AA, or A 
(including adjustments of + and -) as issued by Standard and Poor's, or 
Aaa, Aa, or A (including adjustments of 1, 2, or 3) as issued by 
Moody's.
    B. To pass the financial test, a company must meet all of the 
following additional requirements:
    (1) The company must have at least one class of equity securities 
registered under the Securities Exchange Act of 1934.
    (2) The company's independent certified public accountant must 
compare the data used by the company in the financial test, which is 
derived from the independently audited, year-end financial statements 
for the latest fiscal year, with the amounts in such financial 
statement. The accountant must evaluate the company's off-balance sheet 
transactions and provide an opinion on whether those transactions could 
materially adversely affect the company's ability to pay for 
decommissioning costs. The accountant must verify that a bond rating, if 
used to demonstrate passage of the financial test, meets the 
requirements of Section II, paragraph A of this appendix. In connection 
with the auditing procedure, the licensee must inform the NRC within 90 
days of any matters coming to the auditor's attention which cause the 
auditor to believe that the data specified in the financial test should 
be adjusted and that the company no longer passes the test.
    (3) After the initial financial test, the company must annually pass 
the test and provide documentation of its continued eligibility to use 
the self-guarantee to the Commission within 90 days after the close of 
each succeeding fiscal year.
    C. If the licensee no longer meets the requirements of Section II.A. 
of this appendix, the licensee must send immediate notice to the 
Commission of its intent to establish alternate financial assurance as 
specified in the Commission's regulations within 120 days of such 
notice.

                       III. Company Self-Guarantee

    The terms of a self-guarantee which an applicant or licensee 
furnishes must provide that:
    A. The guarantee will remain in force unless the licensee sends 
notice of cancellation by certified mail to the Commission. Cancellation 
may not occur, however, during the 120 days beginning on the date of 
receipt of the notice of cancellation by the Commission, as evidenced by 
the return receipt.
    B. The licensee shall provide alternative financial assurance as 
specified in the Commission's regulations within 90 days following 
receipt by the Commission of a notice of cancellation of the guarantee.
    C. The guarantee and financial test provisions must remain in effect 
until the Commission has terminated the license or until another 
financial assurance method acceptable to the Commission has been put in 
effect by the licensee.
    D. The licensee will promptly forward to the Commission and the 
licensee's independent auditor all reports covering the latest fiscal 
year filed by the licensee with the Securities and Exchange Commission 
pursuant to the requirements of section 13 of the Securities and 
Exchange Act of 1934.

[[Page 608]]

    E. (1) If, at any time, the licensee's most recent bond issuance 
ceases to be rated in any category of ``A-'' and above by Standard and 
Poor's or in any category of ``A3'' and above by Moody's, the licensee 
will notify the Commission in writing within 20 days after publication 
of the change by the rating service.
    (2) If the licensee's most recent bond issuance ceases to be rated 
in any category of A or above by both Standard and Poor's and Moody's, 
the licensee no longer meets the requirements of Section II.A. of this 
appendix.
    F. The applicant or licensee must provide to the Commission a 
written guarantee (a written commitment by a corporate officer) which 
states that the licensee will fund and carry out the required 
decommissioning activities or, upon issuance of an order by the 
Commission, the licensee will fund the standby trust in the amount 
guaranteed by the self-guarantee agreement.
    G. (1) A standby trust to protect public health and safety and the 
environment must be established for decommissioning costs before the 
self-guarantee agreement is submitted.
    (2) The trustee and trust must be acceptable to the Commission. An 
acceptable trustee includes an appropriate State or Federal Government 
agency or an entity which has the authority to act as a trustee and 
whose trust operations are regulated and examined by a Federal or State 
agency. The Commission has the right to change the trustee. An 
acceptable trust will meet the regulatory criteria established in these 
regulations that govern the issuance of the license for which the 
guarantor has accepted the obligation to pay for decommissioning costs.
    H. The guarantor must agree that if the guarantor admits in writing 
its inability to pay its debts generally, or makes a general assignment 
for the benefit of creditors, or any proceeding is instituted by or 
against the guarantor seeking to adjudicate it as bankrupt or insolvent, 
or seeking dissolution, liquidation, winding-up, reorganization, 
arrangement, adjustment, protection, relief or composition of it or its 
debts under any law relating to bankruptcy, insolvency, or 
reorganization or relief of debtors, or seeking the entry of an order 
for relief or the appointment of a receiver, trustee, custodian, or 
other similar official for the guarantor or for any substantial part of 
its property, or the guarantor takes any action to authorize or effect 
any of the actions stated in this paragraph, then the Commission may:
    (1) Declare that the financial assurance guaranteed by the self-
guarantee agreement is immediately due and payable to the standby trust 
set up to protect the public health and safety and the environment, 
without diligence, presentment, demand, protest or any other notice of 
any kind, all of which are expressly waived by guarantor; and
    (2) Exercise any and all of its other rights under applicable law.
    I. The guarantor must notify the NRC, in writing, immediately 
following the occurrence of any event listed in paragraph H of this 
appendix, and must include a description of the event, including major 
creditors, the amounts involved, and the actions taken to assure that 
the amount of funds guaranteed by the self-guarantee agreement for 
decommissioning will be transferred to the standby trust as soon as 
possible.

[58 FR 68730, Dec. 29, 1993; 59 FR 1618, Jan. 12, 1994, as amended at 63 
FR 50479, Sept. 22, 1998; 76 FR 35566, June 17, 2011]



Sec. Appendix D to Part 30--Criteria Relating to Use of Financial Tests 
   and Self-Guarantee for Providing Reasonable Assurance of Funds for 
 Decommissioning by Commercial Companies That Have No Outstanding Rated 
                                  Bonds

                             I. Introduction

    An applicant or licensee may provide reasonable assurance of the 
availability of funds for decommissioning based on furnishing its own 
guarantee that funds will be available for decommissioning costs and on 
a demonstration that the company passes the financial test of Section II 
of this appendix. The terms of the self-guarantee are in Section III of 
this appendix. This appendix establishes criteria for passing the 
financial test for the self-guarantee and establishes the terms for a 
self-guarantee.

                           II. Financial Test

    A. To pass the financial test a company must meet all of the 
criteria set forth in this section. For purposes of applying the 
Appendix D criteria, tangible net worth must be calculated to exclude 
all intangible assets and the net book value of the nuclear facility and 
site, and total net worth, which may include intangible assets, must be 
calculated to exclude the net book value and goodwill of the nuclear 
facility and site. These criteria include:
    (1) Tangible net worth of at least $21 million, and total net worth 
of at least 10 times the amount of decommissioning funds being assured 
by a self-guarantee for all decommissioning activities for which the 
company is responsible as self-guaranteeing licensee and as parent-
guarantor for the total of all nuclear facilities or parts thereof (or 
the current amount required if certification is used).

[[Page 609]]

    (2) Assets located in the United States amounting to at least 90 
percent of total assets or at least 10 times the total current 
decommissioning cost estimate (or the current amount required if 
certification is used) for all decommissioning activities for which the 
company is responsible as self-guaranteeing licensee and as parent-
guarantor.
    (3) A ratio of cash flow divided by total liabilities greater than 
0.15 and a ratio of total liabilities divided by total net worth less 
than 1.5.
    B. In addition, to pass the financial test, a company must meet all 
of the following requirements:
    (1) The company's independent certified public accountant must 
compare the data used by the company in the financial test, which is 
derived from the independently audited, year-end financial statements 
for the latest fiscal year, with the amounts in such financial 
statement. The accountant must evaluate the company's off-balance sheet 
transactions and provide an opinion on whether those transactions could 
materially adversely affect the company's ability to pay for 
decommissioning costs. In connection with the auditing procedure, the 
licensee must inform the NRC within 90 days of any matters coming to the 
auditor's attention which cause the auditor to believe that the data 
specified in the financial test should be adjusted and that the company 
no longer passes the test.
    (2) After the initial financial test, the company must annually pass 
the test and provide documentation of its continued eligibility to use 
the self-guarantee to the Commission within 90 days after the close of 
each succeeding fiscal year.
    (3) If the licensee no longer meets the requirements of paragraph 
II.A of this appendix, the licensee must send notice to the NRC of 
intent to establish alternative financial assurance as specified in NRC 
regulations. The notice must be sent by certified mail, return receipt 
requested, within 90 days after the end of the fiscal year for which the 
year end financial data show that the licensee no longer meets the 
financial test requirements. The licensee must provide alternative 
financial assurance within 120 days after the end of such fiscal year.

                       III. Company Self-Guarantee

    The terms of a self-guarantee which an applicant or licensee 
furnishes must provide that:
    A. The guarantee shall remain in force unless the licensee sends 
notice of cancellation by certified mail, return receipt requested, to 
the NRC. Cancellation may not occur until an alternative financial 
assurance mechanism is in place.
    B. The licensee shall provide alternative financial assurance as 
specified in the regulations within 90 days following receipt by the NRC 
of a notice of cancellation of the guarantee.
    C. The guarantee and financial test provisions must remain in effect 
until the Commission has terminated the license or until another 
financial assurance method acceptable to the Commission has been put in 
effect by the licensee.
    D. The applicant or licensee must provide to the Commission a 
written guarantee (a written commitment by a corporate officer) which 
states that the licensee will fund and carry out the required 
decommissioning activities or, upon issuance of an order by the 
Commission, the licensee will fund the standby trust in the amount of 
the current cost estimates for decommissioning.
    E. A standby trust to protect public health and safety and the 
environment must be established for decommissioning costs before the 
self-guarantee agreement is submitted. The trustee and trust must be 
acceptable to the Commission. An acceptable trustee includes an 
appropriate State or Federal Government agency or an entity which has 
the authority to act as a trustee and whose trust operations are 
regulated and examined by a Federal or State agency. The Commission will 
have the right to change the trustee. An acceptable trust will meet the 
regulatory criteria established in the part of these regulations that 
governs the issuance of the license for which the guarantor has accepted 
the obligation to pay for decommissioning costs.
    F. The guarantor must agree that if the guarantor admits in writing 
its inability to pay its debts generally, or makes a general assignment 
for the benefit of creditors, or any proceeding is instituted by or 
against the guarantor seeking to adjudicate it as bankrupt or insolvent, 
or seeking dissolution, liquidation, winding-up, reorganization, 
arrangement, adjustment, protection, relief or composition of it or its 
debts under any law relating to bankruptcy, insolvency, or 
reorganization or relief of debtors, or seeking the entry of an order 
for relief or the appointment of a receiver, trustee, custodian, or 
other similar official for the guarantor or for any substantial part of 
its property, or the guarantor takes any action to authorize or effect 
any of the actions stated in this paragraph, then the Commission may:
    (1) Declare that the financial assurance guaranteed by the self-
guarantee agreement is immediately due and payable to the standby trust 
set up to protect the public health and safety and the environment, 
without diligence, presentment, demand, protest or any other notice of 
any kind, all of which are expressly waived by guarantor; and
    (2) Exercise any and all of its other rights under applicable law.
    G. The guarantor must notify the NRC, in writing, immediately 
following the occurrence of any event listed in paragraph F of

[[Page 610]]

this appendix, and must include a description of the event, including 
major creditors, the amounts involved, and the actions taken to assure 
that the amount of funds guaranteed by the self-guarantee agreement for 
decommissioning will be transferred to the standby trust as soon as 
possible.

[63 FR 29542, June 1, 1998, as amended at 76 FR 35567, June 17, 2011]



Sec. Appendix E to Part 30--Criteria Relating to Use of Financial Tests 
   and Self-Guarantee For Providing Reasonable Assurance of Funds For 
   Decommissioning by Nonprofit Colleges, Universities, and Hospitals

                             I. Introduction

    An applicant or licensee may provide reasonable assurance of the 
availability of funds for decommissioning based on furnishing its own 
guarantee that funds will be available for decommissioning costs and on 
a demonstration that the applicant or licensee passes the financial test 
of Section II of this appendix. The terms of the self-guarantee are in 
Section III of this appendix. This appendix establishes criteria for 
passing the financial test for the self-guarantee and establishes the 
terms for a self-guarantee.

                           II. Financial Test

    A. For colleges and universities, to pass the financial test a 
college or university must meet either the criteria in Paragraph 
II.A.(1) or the criteria in Paragraph II.A.(2) of this appendix.
    (1) For applicants or licensees that issue bonds, a current rating 
for its most recent uninsured, uncollateralized, and unencumbered bond 
issuance of AAA, AA, or A (including adjustments of + or -) as issued by 
Standard and Poor's (S&P) or Aaa, Aa, or A (including adjustments of 1, 
2, or 3) as issued by Moody's.
    (2) For applicants or licensees that do not issue bonds, 
unrestricted endowment consisting of assets located in the United States 
of at least $50 million, or at least 30 times the total current 
decommissioning cost estimate (or the current amount required if 
certification is used), whichever is greater, for all decommissioning 
activities for which the college or university is responsible as a self-
guaranteeing licensee.
    B. For hospitals, to pass the financial test a hospital must meet 
either the criteria in Paragraph II.B.(1) or the criteria in Paragraph 
II.B.(2) of this appendix:
    (1) For applicants or licensees that issue bonds, a current rating 
for its most recent uninsured, uncollateralized, and unencumbered bond 
issuance of AAA, AA, or A (including adjustments of + or -) as issued by 
Standard and Poor's or Aaa, Aa, or A (including adjustments of 1, 2, or 
3) as issued by Moody's.
    (2) For applicants or licensees that do not issue bonds, all the 
following tests must be met:
    (a) (Total Revenues less total expenditures) divided by total 
revenues must be equal to or greater than 0.04.
    (b) Long term debt divided by net fixed assets must be less than or 
equal to 0.67.
    (c) (Current assets and depreciation fund) divided by current 
liabilities must be greater than or equal to 2.55.
    (d) Operating revenues must be at least 100 times the total current 
decommissioning cost estimate (or the current amount required if 
certification is used) for all decommissioning activities for which the 
hospital is responsible as a self-guaranteeing license.
    C. In addition, to pass the financial test, a licensee must meet all 
the following requirements:
    (1) The licensee's independent certified public accountant must 
compare the data used by the licensee in the financial test, which is 
derived from the independently audited, year-end financial statements 
for the latest fiscal year, with the amounts in such financial 
statement. The accountant must evaluate the licensee's off-balance sheet 
transactions and provide an opinion on whether those transactions could 
materially adversely affect the licensee's ability to pay for 
decommissioning costs. The accountant must verify that a bond rating, if 
used to demonstrate passage of the financial test, meets the 
requirements of Section II of this appendix. In connection with the 
auditing procedure, the licensee must inform the NRC within 90 days of 
any matters coming to the auditor's attention which cause the auditor to 
believe that the data specified in the financial test should be adjusted 
and that the licensee no longer passes the test.
    (2) After the initial financial test, the licensee must repeat 
passage of the test and provide documentation of its continued 
eligibility to use the self-guarantee to the Commission within 90 days 
after the close of each succeeding fiscal year.
    (3) If the licensee no longer meets the requirements of Section I of 
this appendix, the licensee must send notice to the NRC of its intent to 
establish alternative financial assurance as specified in NRC 
regulations. The notice must be sent by certified mail, return receipt 
requested, within 90 days after the end of the fiscal year for which the 
year end financial data show that the licensee no longer meets the 
financial test requirements. The licensee must provide alternate 
financial assurance within 120 days after the end of such fiscal year.

[[Page 611]]

                           III. Self-Guarantee

    The terms of a self-guarantee which an applicant or licensee 
furnishes must provide that--
    A. The guarantee shall remain in force unless the licensee sends 
notice of cancellation by certified mail, and/or return receipt 
requested, to the Commission. Cancellation may not occur unless an 
alternative financial assurance mechanism is in place.
    B. The licensee shall provide alternative financial assurance as 
specified in the Commission's regulations within 90 days following 
receipt by the Commission of a notice of cancellation of the guarantee.
    C. The guarantee and financial test provisions must remain in effect 
until the Commission has terminated the license or until another 
financial assurance method acceptable to the Commission has been put in 
effect by the licensee.
    D. The applicant or licensee must provide to the Commission a 
written guarantee (a written commitment by a corporate officer or 
officer of the institution) which states that the licensee will fund and 
carry out the required decommissioning activities or, upon issuance of 
an order by the Commission, the licensee will fund the standby trust in 
the amount of the current cost estimates for decommissioning.
    E. (1) If, at any time, the licensee's most recent bond issuance 
ceases to be rated in any category of ``A'' or above by either Standard 
and Poor's or Moody's, the licensee shall notify the Commission in 
writing within 20 days after publication of the change by the rating 
service.
    (2) If the licensee's most recent bond issuance ceases to be rated 
in any category of ``A-'' and above by Standard and Poor's or in any 
category of ``A3'' and above by Moody's, the licensee no longer meets 
the requirements of Section II.A. of this appendix.
    F. (1) A standby trust to protect public health and safety and the 
environment must be established for decommissioning costs before the 
self-guarantee agreement is submitted.
    (2) The trustee and trust must be acceptable to the Commission. An 
acceptable trustee includes an appropriate State or Federal Government 
agency or an entity which has the authority to act as a trustee and 
whose trust operations are regulated and examined by a Federal or State 
agency. The Commission has the right to change the trustee. An 
acceptable trust will meet the regulatory criteria established in the 
part of these regulations that governs the issuance of the license for 
which the guarantor has accepted the obligation to pay for 
decommissioning costs.
    G. The guarantor must agree that if the guarantor admits in writing 
its inability to pay its debts generally, or makes a general assignment 
for the benefit of creditors, or any proceeding is instituted by or 
against the guarantor seeking to adjudicate it as bankrupt or insolvent, 
or seeking dissolution, liquidation, winding-up, reorganization, 
arrangement, adjustment, protection, relief or composition of it or its 
debts under any law relating to bankruptcy, insolvency, or 
reorganization or relief of debtors, or seeking the entry of an order 
for relief or the appointment of a receiver, trustee, custodian, or 
other similar official for guarantor or for any substantial part of its 
property, or the guarantor takes any action to authorize or effect any 
of the actions stated in this paragraph, then the Commission may:
    (1) Declare that the financial assurance guaranteed by the self-
guarantee agreement is immediately due and payable to the standby trust 
set up to protect the public health and safety and the environment, 
without diligence, presentment, demand, protest or any other notice of 
any kind, all of which are expressly waived by guarantor; and
    (2) Exercise any and all of its other rights under applicable law.
    H. The guarantor must notify the NRC, in writing, immediately 
following the occurrence of any event listed in paragraph G of this 
appendix, and must include a description of the event, including major 
creditors, the amounts involved, and the actions taken to assure that 
the amount of funds guaranteed by the self-guarantee agreement for 
decommissioning will be transferred to the standby trust as soon as 
possible.

[63 FR 29542, June 1, 1998, as amended at 76 FR 35568, June 17, 2011]



PART 31_GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL--
Table of Contents



Sec.
31.1 Purpose and scope.
31.2 Terms and conditions.
31.3 [Reserved]
31.4 Information collection requirements: OMB approval.
31.5 Certain detecting, measuring, gauging, or controlling devices and 
          certain devices for producing light or an ionized atmosphere.
31.6 General license to install devices generally licensed in Sec.
          31.5.
31.7 Luminous safety devices for use in aircraft.
31.8 Americium-241 and radium-226 in the form of calibration or 
          reference sources.
31.9 General license to own byproduct material.
31.10 General license for strontium 90 in ice detection devices.

[[Page 612]]

31.11 General license for use of byproduct material for certain in vitro 
          clinical or laboratory testing.
31.12 General license for certain items and self-luminous products 
          containing radium-226.
31.13-31.20 [Reserved]
31.21 Maintenance of records.
31.22 Violations.
31.23 Criminal penalties.

    Authority: Atomic Energy Act of 1954, secs. 81, 161, 183, 223, 234, 
274 (42 U.S.C. 2111, 2201, 2233, 2273, 2282, 2021); Energy 
Reorganization Act of 1974, secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 
5846); 44 U.S.C. 3504 note.

    Editorial Note: Nomenclature changes to part 31 appear at 79 FR 
75739, Dec. 19, 2014.



Sec.31.1  Purpose and scope.

    This part establishes general licenses for the possession and use of 
byproduct material and a general license for ownership of byproduct 
material. Specific provisions of 10 CFR Part 30 are applicable to 
general licenses established by this part. These provisions are 
specified in Sec.31.2 or in the particular general license.

[65 FR 79187, Dec. 18, 2000]



Sec.31.2  Terms and conditions.

    The general licenses provided in this part are subject to the 
general provisions of Part 30 of this chapter (Sec. Sec.30.1 through 
30.10), the provisions of Sec. Sec.30.14(d), 30.34(a) to (e), 30.41, 
30.50 to 30.53, 30.61 to 30.63, and Parts 19, 20, and 21, of this 
chapter \1\ unless indicated otherwise in the specific provision of the 
general license.
---------------------------------------------------------------------------

    \1\ Attention is directed particularly to the provisions of Part 20 
of this chapter concerning labeling of containers.

[65 FR 79187, Dec. 18, 2000]



Sec.31.3  [Reserved]



Sec.31.4  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0016.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.31.5, 31.8, 31.11, and 31.12.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec.31.11. NRC Form 483 is approved under control number 
3150-0038.
    (2) [Reserved]

[62 FR 52186, Oct. 6, 1997, as amended at 67 FR 67099, Nov. 4, 2002; 72 
FR 55926, Oct. 1, 2007]



Sec.31.5  Certain detecting, measuring, gauging, or controlling devices
and certain devices for producing light or an ionized atmosphere. \2\
---------------------------------------------------------------------------

    \2\ Persons possessing byproduct material in devices under a general 
license in Sec.31.5 before January 15, 1975, may continue to possess, 
use, or transfer that material in accordance with the labeling 
requirements of Sec.31.5 in effect on January 14, 1975.
---------------------------------------------------------------------------

    (a) A general license is hereby issued to commercial and industrial 
firms and research, educational and medical institutions, individuals in 
the conduct of their business, and Federal, State or local government 
agencies to acquire, receive, possess, use or transfer, in accordance 
with the provisions of paragraphs (b), (c) and (d) of this section, 
byproduct material contained in devices designed and manufactured for 
the purpose of detecting, measuring, gauging or controlling thickness, 
density, level, interface location, radiation, leakage, or qualitative 
or quantitative chemical composition, or for producing light or an 
ionized atmosphere.
    (b)(1) The general license in paragraph (a) of this section applies 
only to byproduct material contained in devices which have been 
manufactured or initially transferred and labeled in accordance with the 
specifications contained in--

[[Page 613]]

    (i) A specific license issued under Sec.32.51 of this chapter; or
    (ii) An equivalent specific license issued by an Agreement State; or
    (iii) An equivalent specific license issued by a State with 
provisions comparable to Sec.32.51 of this chapter.
    (2) The devices must have been received from one of the specific 
licensees described in paragraph (b)(1) of this section or through a 
transfer made under paragraph (c)(9) of this section.
    (c) Any person who acquires, receives, possesses, uses or transfers 
byproduct material in a device pursuant to the general license in 
paragraph (a) of this section:
    (1) Shall assure that all labels affixed to the device at the time 
of receipt and bearing a statement that removal of the label is 
prohibited are maintained thereon and shall comply with all instructions 
and precautions provided by such labels;
    (2) Shall assure that the device is tested for leakage of 
radioactive material and proper operation of the on-off mechanism and 
indicator, if any, at no longer than six-month intervals or at such 
other intervals as are specified in the label; however:
    (i) Devices containing only krypton need not be tested for leakage 
of radioactive material, and
    (ii) Devices containing only tritium or not more than 100 
microcuries of other beta and/or gamma emitting material or 10 
microcuries of alpha emitting material and devices held in storage in 
the original shipping container prior to initial installation need not 
be tested for any purpose;
    (3) Shall assure that the tests required by paragraph (c)(2) of this 
section and other testing, installation, servicing, and removal from 
installation involving the radioactive materials, its shielding or 
containment, are performed:
    (i) In accordance with the instructions provided by the labels; or
    (ii) By a person holding a specific license pursuant to parts 30 and 
32 of this chapter or from an Agreement State to perform such 
activities;
    (4) Shall maintain records showing compliance with the requirements 
of paragraphs (c)(2) and (c)(3) of this section. The records must show 
the results of tests. The records also must show the dates of 
performance of, and the names of persons performing, testing, 
installing, servicing, and removing from the installation radioactive 
material and its shielding or containment. The licensee shall retain 
these records as follows:
    (i) Each record of a test for leakage or radioactive material 
required by paragraph (c)(2) of this section must be retained for three 
years after the next required leak test is performed or until the sealed 
source is transferred or disposed of.
    (ii) Each record of a test of the on-off mechanism and indicator 
required by paragraph (c)(2) of this section must be retained for three 
years after the next required test of the on-off mechanism and indicator 
is performed or until the sealed source is transferred or disposed of.
    (iii) Each record that is required by paragraph (c)(3) of this 
section must be retained for three years from the date of the recorded 
event or until the device is transferred or disposed of.
    (5) Shall immediately suspend operation of the device if there is a 
failure of, or damage to, or any indication of a possible failure of or 
damage to, the shielding of the radioactive material or the on-off 
mechanism or indicator, or upon the detection of 185 bequerel (0.005 
microcurie) or more removable radioactive material. The device may not 
be operated until it has been repaired by the manufacturer or other 
person holding a specific license to repair such devices that was issued 
under parts 30 and 32 of this chapter or by an Agreement State. The 
device and any radioactive material from the device may only be disposed 
of by transfer to a person authorized by a specific license to receive 
the byproduct material in the device or as otherwise approved by the 
Commission. A report containing a brief description of the event and the 
remedial action taken; and, in the case of detection of 0.005 microcurie 
or more removable radioactive material or failure of or damage to a 
source likely to result in contamination of the premises or the 
environs, a plan for ensuring that the premises and environs are 
acceptable for unrestricted use, must be

[[Page 614]]

furnished to the Director, Office of Nuclear Material Safety and 
Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001 within 30 days. Under these circumstances, the criteria 
set out in Sec.20.1402 of this chapter, ``Radiological criteria for 
unrestricted use,'' may be applicable, as determined by the Commission 
on a case-by-case basis;
    (6) Shall not abandon the device containing byproduct material;
    (7) Shall not export the device containing byproduct material except 
in accordance with part 110 of this chapter;
    (8)(i) Shall transfer or dispose of the device containing byproduct 
material only by export as provided by paragraph (c)(7) of this section, 
by transfer to another general licensee as authorized in paragraph 
(c)(9) of this section, or to a person authorized to receive the device 
by a specific license issued under parts 30 and 32 of this chapter, or 
part 30 of this chapter that authorizes waste collection, or equivalent 
regulations of an Agreement State, or as otherwise approved under 
paragraph (c)(8)(iii) of this section.
    (ii) Shall, within 30 days after the transfer of a device to a 
specific licensee or export, furnish a report to the Director, Office of 
Nuclear Material Safety and Safeguards , ATTN: Document Control Desk/
GLTS, using an appropriate method listed in Sec.30.6(a) of this 
chapter. The report must contain--
    (A) The identification of the device by manufacturer's (or initial 
transferor's) name, model number, and serial number;
    (B) The name, address, and license number of the person receiving 
the device (license number not applicable if exported); and
    (C) The date of the transfer.
    (iii) Shall obtain written NRC approval before transferring the 
device to any other specific licensee not specifically identified in 
paragraph (c)(8)(i) of this section; however, a holder of a specific 
license may transfer a device for possession and use under its own 
specific license without prior approval, if, the holder:
    (A) Verifies that the specific license authorizes the possession and 
use, or applies for and obtains an amendment to the license authorizing 
the possession and use;
    (B) Removes, alters, covers, or clearly and unambiguously augments 
the existing label (otherwise required by paragraph (c)(1) of this 
section) so that the device is labeled in compliance with Sec.20.1904 
of this chapter; however the manufacturer, model number, and serial 
number must be retained;
    (C) Obtains the manufacturer's or initial transferor's information 
concerning maintenance that would be applicable under the specific 
license (such as leak testing procedures); and
    (D) Reports the transfer under paragraph (c)(8)(ii) of this section.
    (9) Shall transfer the device to another general licensee only if--
    (i) The device remains in use at a particular location. In this 
case, the transferor shall give the transferee a copy of this section, a 
copy of Sec.31.2, 30.51, 20.2201, and 20.2202 of this chapter, and any 
safety documents identified in the label of the device. Within 30 days 
of the transfer, the transferor shall report to the Director, Office of 
Nuclear Material Safety and Safeguards , ATTN: Document Control Desk/
GLTS, using an appropriate method listed in Sec.30.6(a) of this 
chapter--
    (A) The manufacturer's (or initial transferor's) name;
    (B) The model number and the serial number of the device 
transferred;
    (C) The transferee's name and mailing address for the location of 
use; and
    (D) The name, title, and phone number of the responsible individual 
identified by the transferee in accordance with paragraph (c)(12) of 
this section to have knowledge of and authority to take actions to 
ensure compliance with the appropriate regulations and requirements; or
    (ii) The device is held in storage by an intermediate person in the 
original shipping container at its intended location of use prior to 
initial use by a general licensee.
    (10) Shall comply with the provisions of Sec. Sec.20.2201, and 
20.2202 of this chapter for reporting radiation incidents, theft or loss 
of licensed material, but shall be exempt from the other requirements of 
parts 19, 20, and 21, of this chapter.

[[Page 615]]

    (11) Shall respond to written requests from the Nuclear Regulatory 
Commission to provide information relating to the general license within 
30 calendar days of the date of the request, or other time specified in 
the request. If the general licensee cannot provide the requested 
information within the allotted time, it shall, within that same time 
period, request a longer period to supply the information by providing 
the Director, Office of Nuclear Material Safety and Safeguards , by an 
appropriate method listed in Sec.30.6(a) of this chapter, a written 
justification for the request.
    (12) Shall appoint an individual responsible for having knowledge of 
the appropriate regulations and requirements and the authority for 
taking required actions to comply with appropriate regulations and 
requirements. The general licensee, through this individual, shall 
ensure the day-to-day compliance with appropriate regulations and 
requirements. This appointment does not relieve the general licensee of 
any of its responsibility in this regard.
    (13)(i) Shall register, in accordance with paragraphs (c)(13)(ii) 
and (iii) of this section, devices containing at least 370 
megabecquerels (10 millicuries) of cesium-137, 3.7 megabecquerels (0.1 
millicurie) of strontium-90, 37 megabecquerels (1 millicurie) of cobalt-
60, 3.7 megabecquerels (0.1 millicurie) of radium-226, or 37 
megabecquerels (1 millicurie) of americium-241 or any other transuranic 
(i.e., element with atomic number greater than uranium (92)), based on 
the activity indicated on the label. Each address for a location of use, 
as described under paragraph (c)(13)(iii)(D) of this section, represents 
a separate general licensee and requires a separate registration and 
fee.
    (ii) If in possession of a device meeting the criteria of paragraph 
(c)(13)(i) of this section, shall register these devices annually with 
the Commission and shall pay the fee required by Sec.170.31 of this 
chapter. Registration must be done by verifying, correcting, and/or 
adding to the information provided in a request for registration 
received from the Commission. The registration information must be 
submitted to the NRC within 30 days of the date of the request for 
registration or as otherwise indicated in the request. In addition, a 
general licensee holding devices meeting the criteria of paragraph 
(c)(13)(i) of this section is subject to the bankruptcy notification 
requirement in Sec.30.34(h) of this chapter.
    (iii) In registering devices, the general licensee shall furnish the 
following information and any other information specifically requested 
by the Commission--
    (A) Name and mailing address of the general licensee.
    (B) Information about each device: the manufacturer (or initial 
transferor), model number, serial number, the radioisotope and activity 
(as indicated on the label).
    (C) Name, title, and telephone number of the responsible person 
designated as a representative of the general licensee under paragraph 
(c)(12) of this section.
    (D) Address or location at which the device(s) are used and/or 
stored. For portable devices, the address of the primary place of 
storage.
    (E) Certification by the responsible representative of the general 
licensee that the information concerning the device(s) has been verified 
through a physical inventory and checking of label information.
    (F) Certification by the responsible representative of the general 
licensee that they are aware of the requirements of the general license.
    (iv) Persons generally licensed by an Agreement State with respect 
to devices meeting the criteria in paragraph (c)(13)(i) of this section 
are not subject to registration requirements if the devices are used in 
areas subject to NRC jurisdiction for a period less than 180 days in any 
calendar year. The Commission will not request registration information 
from such licensees.
    (14) Shall report changes to the mailing address for the location of 
use (including change in name of general licensee) to the Director, 
Office of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days 
of the effective date of

[[Page 616]]

the change. For a portable device, a report of address change is only 
required for a change in the device's primary place of storage.
    (15) May not hold devices that are not in use for longer than 2 
years. If devices with shutters are not being used, the shutter must be 
locked in the closed position. The testing required by paragraph (c)(2) 
of this section need not be performed during the period of storage only. 
However, when devices are put back into service or transferred to 
another person, and have not been tested within the required test 
interval, they must be tested for leakage before use or transfer and the 
shutter tested before use. Devices kept in standby for future use are 
excluded from the two-year time limit if the general licensee performs 
quarterly physical inventories of these devices while they are in 
standby.
    (d) The general license in paragraph (a) of this section does not 
authorize the manufacture or import of devices containing byproduct 
material.

[39 FR 43532, Dec. 16, 1974, as amended at 40 FR 8785, Mar. 3, 1975; 40 
FR 14085, Mar. 28, 1975; 42 FR 25721, May 19, 1977; 42 FR 28896, June 6, 
1977; 43 FR 6922, Feb. 17, 1978; 53 FR 19246, May 27, 1988; 56 FR 23471, 
May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, Dec. 22, 1993; 64 
FR 42275, Aug. 4, 1999; 65 FR 79188, Dec. 18, 2000; 68 FR 58804, Oct. 
10, 2003; 72 FR 55926, Oct. 1, 2007; 72 FR 58486, Oct. 16, 2007; 73 FR 
5718, Jan. 31, 2008; 73 FR 42673, July 23, 2008]



Sec.31.6  General license to install devices generally licensed in
Sec.31.5.

    Any person who holds a specific license issued by an Agreement State 
authorizing the holder to manufacture, install, or service a device 
described in Sec.31.5 within such Agreement State is hereby granted a 
general license to install and service such device in any non-Agreement 
State and a general license to install and service such device in 
offshore waters, as defined in Sec.150.3(f) of this chapter: Provided, 
That:
    (a) [Reserved]
    (b) The device has been manufactured, labeled, installed, and 
serviced in accordance with applicable provisions of the specific 
license issued to such person by the Agreement State.
    (c) Such person assures that any labels required to be affixed to 
the device under regulations of the Agreement State which licensed 
manufacture of the device bear a statement that removal of the label is 
prohibited.

[30 FR 8189, June 26, 1965, as amended at 30 FR 10947, Aug. 24, 1965; 39 
FR 43533, Dec. 16, 1974; 46 FR 44151, Sept. 3, 1981]



Sec.31.7  Luminous safety devices for use in aircraft.

    (a) A general license is hereby issued to own, receive, acquire, 
possess, and use tritium or promethium-147 contained in luminous safety 
devices for use in aircraft, provided each device contains not more than 
10 curies of tritium or 300 millicuries of promethium-147 and that each 
device has been manufactured, assembled or initially transferred in 
accordance with a license issued under the provisions of Sec.32.53 of 
this chapter or manufactured or assembled in accordance with a specific 
license issued by an Agreement State which authorizes manufacture or 
assembly of the device for distribution to persons generally licensed by 
the Agreement State.
    (b) Persons who own, receive, acquire, possess or use luminous 
safety devices pursuant to the general license in this section are 
exempt from the requirements of parts 19, 20, and 21, of this chapter, 
except that they shall comply with the provisions of Sec. Sec.20.2201, 
and 20.2202 of this chapter.
    (c) This general license does not authorize the manufacture, 
assembly, repair or import of luminous safety devices containing tritium 
or promethium-147.
    (d) This general license does not authorize the export of luminous 
safety devices containing tritium or promethium-147.
    (e) This general license does not authorize the ownership, receipt, 
acquisition, possession or use of promethium-147 contained in instrument 
dials.

[30 FR 8189, June 26, 1965, as amended at 33 FR 6463, Apr. 27, 1968; 38 
FR 22220, Aug. 17, 1973; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 
1978; 56 FR 23471, May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, 
Dec. 22, 1993]

[[Page 617]]



Sec.31.8  Americium-241 and radium-226 in the form of calibration 
or reference sources.

    (a) A general license is issued to those persons listed in this 
section to own, receive, acquire, possess, use, and transfer, in 
accordance with the provisions of paragraphs (b) and (c) of this 
section, americium-241 or radium-226 in the form of calibration or 
reference sources:
    (1) Any person in a non-Agreement State who holds a specific license 
issued under this chapter which authorizes receipt, possession, use, and 
transfer of byproduct material, source material, or special nuclear 
material; and
    (2) Any Government agency, as defined in Sec.30.4 of this chapter, 
which holds a specific license issued under this chapter which 
authorizes it to receive, possess, use, and transfer byproduct material, 
source material, or special nuclear material.
    (b) The general license in paragraph (a) of this section applies 
only to calibration or reference sources which have been manufactured or 
initially transferred in accordance with the specifications contained in 
a specific license issued under Sec.32.57 of this chapter or in 
accordance with the specifications contained in a specific license 
issued to the manufacturer by an Agreement State which authorizes 
manufacture of the sources for distribution to persons generally 
licensed by the Agreement State, or in accordance with a specific 
license issued by a State with comparable provisions to Sec.32.57.
    (c) The general license in paragraph (a) of this section is subject 
to the provisions of Sec. Sec.30.14(d), 30.34 (a) to (e), and 30.50 to 
30.63 of this chapter, and to the provisions of parts 19, 20, and 21, of 
this chapter. In addition, persons who own, receive, acquire, possess, 
use, and transfer one or more calibration or reference sources under 
this general license:
    (1) Shall not possess at any one time, at any one location of 
storage or use, more than 0.185 megabecquerel (5 microcuries) of 
americium-241 or 0.185 megabecquerel (5 microcuries) of radium-226 in 
such sources;
    (2) Shall not receive, possess, use, or transfer a source unless the 
source, or the storage container, bears a label which includes the 
following statement or a substantially similar statement which contains 
the information called for in the following statement: \1\
---------------------------------------------------------------------------

    \1\ Sources generally licensed under this section before January 19, 
1975, may bear labels authorized by the regulations in effect on January 
1, 1975. Sources containing radium-226 generally licensed under this 
section and manufactured before November 30, 2007 shall be labeled in 
accordance with the applicable State regulations at the time of 
manufacture or import.
---------------------------------------------------------------------------

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

CAUTION--RADIOACTIVE MATERIAL--THIS SOURCE CONTAINS AMERICIUM-241 [or 
RADIUM-226, as appropriate]. DO NOT TOUCH RADIOACTIVE PORTION OF THIS 
SOURCE.

________________________________________________________________________

(Name of manufacturer or initial transferor)

    (3) Shall not transfer, abandon, or dispose of a source except by 
transfer to a person authorized by a license issued under this chapter 
or by an Agreement State to receive the source.
    (4) Shall store a source, except when the source is being used, in a 
closed container adequately designed and constructed to contain 
americium-241 or radium-226 which might otherwise escape during storage.
    (5) Shall not use a source for any purpose other than the 
calibration of radiation detectors or the standardization of other 
sources.
    (d) This general license does not authorize the manufacture or 
import of calibration or reference sources containing americium-241 or 
radium-226.
    (e) This general license does not authorize the export of 
calibration or reference sources containing americium-241 or radium-226.

[72 FR 55927, Oct. 1, 2007]

[[Page 618]]



Sec.31.9  General license to own byproduct material.

    A general license is hereby issued to own byproduct material without 
regard to quantity. Notwithstanding any other provision of this chapter, 
a general licensee under this paragraph is not authorized to 
manufacture, produce, transfer, receive, possess, use, import or export 
byproduct material, except as authorized in a specific license.

[30 FR 8189, June 26, 1965]



Sec.31.10  General license for strontium 90 in ice detection devices.

    (a) A general license is hereby issued to own, receive, acquire, 
possess, use, and transfer strontium 90 contained in ice detection 
devices, provided each device contains not more than fifty microcuries 
of strontium 90 and each device has been manufactured or initially 
transferred in accordance with the specifications contained in a license 
issued pursuant to Sec.32.61 of this chapter or in accordance with the 
specifications contained in a specific license issued to the 
manufacturer by an Agreement State which authorizes manufacture of the 
ice detection devices for distribution to persons generally licensed by 
the Agreement State.
    (b) Persons who own, receive, acquire, possess, use, or transfer 
strontium 90 contained in ice detection devices pursuant to the general 
license in paragraph (a) of this section:
    (1) Shall, upon occurrence of visually observable damage, such as a 
bend or crack or discoloration from overheating, to the device, 
discontinue use of the device until it has been inspected, tested for 
leakage and repaired by a person holding a specific license pursuant to 
part 30 or 32 of this chapter or from an Agreement State to manufacture 
or service such devices; or shall dispose of the device pursuant to the 
provisions of Sec.20.2001.
    (2) Shall assure that all labels affixed to the device at the time 
of receipt, and which bear a statement which prohibits removal of the 
labels, are maintained thereon;
    (3) Are exempt from the requirements of parts 19, 20, and 21, of 
this chapter except that such persons shall comply with the provisions 
of Sec. Sec.20.2001, 20.2201, and 20.2202 of this chapter.
    (c) The general license does not authorize the manufacture, 
assembly, disassembly, repair, or import of strontium 90 in ice 
detection devices.

[30 FR 9905, Aug. 10, 1965, as amended at 38 FR 22220, Aug. 17, 1973; 40 
FR 8785, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 
1978; 56 FR 23471, May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, 
Dec. 22, 1993]



Sec.31.11  General license for use of byproduct material for certain
in vitro clinical or laboratory testing.

    (a) A general license is hereby issued to any physician, 
veterinarian in the practice of veterinary medicine, clinical laboratory 
or hospital to receive, acquire, possess, transfer, or use, for any of 
the following stated tests, in accordance with the provisions of 
paragraphs (b), (c), (d), (e), and (f) of this section, the following 
byproduct materials in prepackaged units:
    (1) Iodine-125, in units not exceeding 10 microcuries each for use 
in in vitro clinical or laboratory tests not involving internal or 
external administration of byproduct material, or the radiation 
therefrom, to human beings or animals.
    (2) Iodine-131, in units not exceeding 10 microcuries each for use 
in in vitro clinical or laboratory tests not involving internal or 
external administration of byproduct material, or the radiation 
therefrom, to human beings or animals.
    (3) Carbon-14, in units not exceeding 10 microcuries each for use in 
in vitro clinical or laboratory tests not involving internal or external 
administration of byproduct material, or the radiation therefrom, to 
human beings or animals.
    (4) Hydrogen-3 (tritium), in units not exceeding 50 microcuries each 
for use in in vitro clinical or laboratory tests not involving internal 
or external administration of byproduct material, or the radiation 
therefrom, to human beings or animals.
    (5) Iron-59, in units not exceeding 20 microcuries each for use in 
in vitro clinical or laboratory tests not involving internal or external 
administration of byproduct material, or the radiation

[[Page 619]]

therefrom, to human beings, or animals.
    (6) Selenium-75, in units not exceeding 10 microcuries each for use 
in in vitro clinical or laboratory tests not involving internal or 
external administration of byproduct material, or the radiation 
therefrom, to human beings or animals.
    (7) Mock Iodine-125 reference or calibration sources, in units not 
exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of 
americium-241 each for use in in vitro clinical or laboratory tests not 
involving internal or external administration of byproduct material, or 
the radiation therefrom, to human beings or animals.
    (8) Cobalt-57, in units not exceeding 0.37 megabecquerel (10 
microcuries) each for use in in vitro clinical or laboratory tests not 
involving internal or external administration of byproduct material, or 
the radiation therefrom, to human beings or animals.
    (b) A person shall not receive, acquire, possess, use, or transfer 
byproduct material under the general license established by paragraph 
(a) of this section unless that person:
    (1) Has filed NRC Form 483, ``Registration Certificate--In Vitro 
Testing with Byproduct Material Under General License,'' with the 
Director, Office of Nuclear Material Safety and Safeguards , by an 
appropriate method listed in Sec.30.6(a) of this chapter, and has 
received from the Commission a validated copy of NRC Form 483 with a 
registration number assigned; or
    (2) Has a license that authorizes the medical use of byproduct 
material that was issued under part 35 of this chapter.
    (c) A person who receives, acquires, possesses, or uses byproduct 
material pursuant to the general license established by paragraph (a) of 
this section shall comply with the following:
    (1) The general licensee shall not possess at any one time, under 
the general license in paragraph (a) of this section, at any one 
location of storage or use, a total amount of iodine-125, iodine-131, 
selenium-75, cobalt-57 and/or iron-59 in excess of 7.4 megabecquerels 
(200 microcuries).
    (2) The general licensee shall store the byproduct material, until 
used, in the original shipping container or in a container providing 
equivalent radiation protection.
    (3) The general licensee shall use the byproduct material only for 
the uses authorized by paragraph (a) of this section.
    (4) The general licensee shall not transfer the byproduct material 
except by transfer to a person authorized to receive it by a license 
pursuant to this chapter or from an Agreement State, nor transfer the 
byproduct material in any manner other than in the unopened, labeled 
shipping container as received from the supplier.
    (5) The general licensee shall dispose of the Mock Iodine-125 
reference or calibration sources described in paragraph (a)(7) of this 
section as required by Sec.20.2001.
    (d) The general licensee shall not receive, acquire, possess, or use 
byproduct material pursuant to paragraph (a) of this section:
    (1) Except as prepackaged units which are labeled in accordance with 
the provisions of a specific license issued under the provisions of 
Sec.32.71 of this chapter or in accordance with the provisions of a 
specific license issued by an Agreement State, or before November 30, 
2007, and the provisions of a specific license issued by a State with 
comparable provisions to Sec.32.71 that authorize manufacture and 
distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), 
selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for distribution to 
persons generally licensed by the Agreement State or the State with 
comparable provisions to Sec.32.71.
    (2) Unless the following statement, or a substantially similar 
statement which contains the information called for in the following 
statement, appears on a label affixed to each prepackaged unit or 
appears in a leaflet or brochure which accompanies the package: \1\
---------------------------------------------------------------------------

    \1\ Labels authorized by the regulations in effect on September 26, 
1979, may be used until one year from September 27, 1979.

    This radioactive material may be received, acquired, possessed, and 
used only by physicians, veterinarians in the practice of veterinary 
medicine, clinical laboratories or hospitals and only for in vitro 
clinical or laboratory tests not involving internal or external

[[Page 620]]

administration of the material, or the radiation therefrom, to human 
beings or animals. Its receipt, acquisition, possession, use, and 
transfer are subject to the regulations and a general license of the 
U.S. Nuclear Regulatory Commission or of a State with which the 
Commission has entered into an agreement for the exercise of regulatory 
---------------------------------------------------------------------------
authority.

________________________________________________________________________
(Name of Manufacturer)

    (e) The registrant possessing or using byproduct materials under the 
general license of paragraph (a) of this section shall report in writing 
to the Director, Office of Nuclear Material Safety and Safeguards , any 
changes in the information furnished by him in the ''Registration 
Certificate--In Vitro Testing With Byproduct Material Under General 
License.'' Form NRC-483. The report shall be furnished within 30 days 
after the effective date of such change.
    (f) Any person using byproduct material pursuant to the general 
license of paragraph (a) of this section is exempt from the requirements 
of parts 19, 20, and 21, of this chapter with respect to byproduct 
materials covered by that general license, except that such persons 
using the Mock Iodine-125 described in paragraph (a)(7) of this section 
shall comply with the provisions of Sec. Sec.20.2001, 20.2201, and 
20.2202.

[33 FR 16553, Nov. 14, 1968]

    Editorial Note: For Federal Register citations affecting Sec.
31.11, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfoo.gov.



Sec.31.12  General license for certain items and self-luminous
products containing radium-226.

    (a) A general license is hereby issued to any person to acquire, 
receive, possess, use, or transfer, in accordance with the provisions of 
paragraphs (b), (c), and (d) of this section, radium-226 contained in 
the following products manufactured prior to November 30, 2007.
    (1) Antiquities originally intended for use by the general public. 
For the purposes of this paragraph, antiquities mean products originally 
intended for use by the general public and distributed in the late 19th 
and early 20th centuries, such as radium emanator jars, revigators, 
radium water jars, radon generators, refrigerator cards, radium bath 
salts, and healing pads.
    (2) Intact timepieces containing greater than 0.037 megabecquerel (1 
microcurie), nonintact timepieces, and timepiece hands and dials no 
longer installed in timepieces.
    (3) Luminous items installed in air, marine, or land vehicles.
    (4) All other luminous products, provided that no more than 100 
items are used or stored at the same location at any one time.
    (5) Small radium sources containing no more than 0.037 megabecquerel 
(1 microcurie) of radium-226. For the purposes of this paragraph, 
``small radium sources'' means discrete survey instrument check sources, 
sources contained in radiation measuring instruments, sources used in 
educational demonstrations (such as cloud chambers and spinthariscopes), 
electron tubes, lightning rods, ionization sources, static eliminators, 
or as designated by the NRC.
    (b) Persons who acquire, receive, possess, use, or transfer 
byproduct material under the general license issued in paragraph (a) of 
this section are exempt from the provisions of 10 CFR parts 19, 20, and 
21, and Sec.30.50 and 30.51 of this chapter, to the extent that the 
receipt, possession, use, or transfer of byproduct material is within 
the terms of the general license; provided, however, that this exemption 
shall not be deemed to apply to any such person specifically licensed 
under this chapter.
    (c) Any person who acquires, receives, possesses, uses, or transfers 
byproduct material in accordance with the general license in paragraph 
(a) of this section:
    (1) Shall notify the NRC should there be any indication of possible 
damage to the product so that it appears it could result in a loss of 
the radioactive material. A report containing a brief description of the 
event, and the remedial action taken, must be furnished to the Director 
of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001 within 30 days.
    (2) Shall not abandon products containing radium-226. The product, 
and

[[Page 621]]

any radioactive material from the product, may only be disposed of 
according to Sec.20.2008 of this chapter or by transfer to a person 
authorized by a specific license to receive the radium-226 in the 
product or as otherwise approved by the NRC.
    (3) Shall not export products containing radium-226 except in 
accordance with part 110 of this chapter.
    (4) Shall dispose of products containing radium-226 at a disposal 
facility authorized to dispose of radioactive material in accordance 
with any Federal or State solid or hazardous waste law, including the 
Solid Waste Disposal Act, as authorized under the Energy Policy Act of 
2005, by transfer to a person authorized to receive radium-226 by a 
specific license issued under part 30 of this chapter, or equivalent 
regulations of an Agreement State, or as otherwise approved by the NRC.
    (5) Shall respond to written requests from the NRC to provide 
information relating to the general license within 30 calendar days of 
the date of the request, or other time specified in the request. If the 
general licensee cannot provide the requested information within the 
allotted time, it shall, within that same time period, request a longer 
period to supply the information by providing the Director of the Office 
of Nuclear Material Safety and Safeguards, by an appropriate method 
listed in Sec.30.6(a) of this chapter, a written justification for the 
request.
    (d) The general license in paragraph (a) of this section does not 
authorize the manufacture, assembly, disassembly, repair, or import of 
products containing radium-226, except that timepieces may be 
disassembled and repaired.

[72 FR 55927, Oct. 1, 2007]



Sec. Sec.31.13-31.20  [Reserved]



Sec.31.21  Maintenance of records.

    Each record required by this part must be legible throughout the 
retention period specified by each Commission regulation. The record may 
be the original or a reproduced copy or a microform provided that the 
copy or microform is authenticated by authorized personnel and that the 
microform is capable of producing a clear copy throughout the required 
retention period. The record may also be stored in electronic media with 
the capability for producing legible, accurate, and complete records 
during the required retention period. Records such as letters, drawings, 
specifications, must include all pertinent information such as letters, 
stamps, initials, and signatures. The licensee shall maintain adequate 
safeguards against tampering with and loss of records.

[53 FR 19246, May 27, 1988. Redesignated at 72 FR 55927, Oct. 1, 2007]



Sec.31.22  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55072, Nov. 24, 1992. Redesignated at 72 FR 55927, Oct. 1, 2007]



Sec.31.23  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223,

[[Page 622]]

all the regulations in part 31 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 31 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.31.1, 31.2, 31.4, 31.9, 31.22, and 31.23.

[57 FR 55073, Nov. 24, 1992. Redesignated at 72 FR 55927, Oct. 1, 2007, 
and amended at 77 FR 43690, July 25, 2012]



PART 32_SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN
ITEMS CONTAINING BYPRODUCT MATERIAL--Table of Contents



Sec.
32.1 Purpose and scope.
32.2 Definitions.
32.3 Maintenance of records.
32.8 Information collection requirements: OMB approval.

                Subpart A_Exempt Concentrations and Items

32.11 Introduction of byproduct material in exempt concentrations into 
          products or materials, and transfer of ownership or 
          possession: Requirements for license.
32.12 Same: Records and material transfer reports.
32.13 Same: Prohibition of introduction.
32.14 Certain items containing byproduct material; requirements for 
          license to apply or initially transfer.
32.15 Same: Quality assurance, prohibition of transfer, and labeling.
32.16 Certain items containing byproduct material: Records and reports 
          of transfer.
32.18 Manufacture, distribution and transfer of exempt quantities of 
          byproduct material: Requirements for license.
32.19 Same: Conditions of licenses.
32.20 Same: Records and material transfer reports.
32.21 Radioactive drug: Manufacture, preparation, or transfer for 
          commercial distribution of capsules containing carbon-14 urea 
          each for ``in vivo'' diagnostic use for humans to persons 
          exempt from licensing; Requirements for a license.
32.21a Same: Conditions of license.
32.22 Self-luminous products containing tritium, krypton-85 or 
          promethium-147: Requirements for license to manufacture, 
          process, produce, or initially transfer.
32.23 Same: Safety criteria.
32.24 Same: Table of organ doses.
32.25 Conditions of licenses issued under Sec.32.22: Quality control, 
          labeling, and reports of transfer.
32.26 Gas and aerosol detectors containing byproduct material: 
          Requirements for license to manufacture, process, produce, or 
          initially transfer.
32.27 Same: Safety criteria.
32.28 Same: Table of organ doses.
32.29 Conditions of licenses issued under Sec.32.26: Quality control, 
          labeling, and reports of transfer.
32.30 Certain industrial devices containing byproduct material: 
          Requirements for license to manufacture, process, produce, or 
          initially transfer.
32.31 Certain industrial devices containing byproduct material: Safety 
          criteria.
32.32 Conditions of licenses issued under Sec.32.30: Quality control, 
          labeling, and reports of transfer.

                   Subpart B_Generally Licensed Items

32.51 Byproduct material contained in devices for use under Sec.31.5; 
          requirements for license to manufacture or initially transfer.
32.51a Same: Conditions of licenses.
32.52 Same: Material transfer reports and records.
32.53 Luminous safety devices for use in aircraft: Requirements for 
          license to manufacture, assemble, repair or initially 
          transfer.
32.54 Same: Labeling of devices.
32.55 Same: Quality assurance, prohibition of transfer.
32.56 Same: Material transfer reports.
32.57 Calibration or reference sources containing americium-241 or 
          radium-226: Requirements for license to manufacture or 
          initially transfer.
32.58 Same: Labeling of devices.
32.59 Same: Leak testing of each source.
32.60 [Reserved]
32.61 Ice detection devices containing strontium-90; requirements for 
          license to manufacture or initially transfer.
32.62 Same: Quality assurance; prohibition of transfer.
32.71 Manufacture and distribution of byproduct material for certain in 
          vitro clinical or laboratory testing under general license.

                  Subpart C_Specifically Licensed Items

32.72 Manufacture, preparation, or transfer for commercial distribution 
          of radioactive drugs containing byproduct material for medical 
          use under part 35.
32.74 Manufacture and distribution of sources or devices containing 
          byproduct material for medical use.
32.201 Serialization of nationally tracked sources.

[[Page 623]]

             Subpart D_Sealed Source and Device Registration

32.210 Registration of product information.
32.211 Inactivation of certificates of registration of sealed sources 
          and devices.

                          Subpart E_Violations

32.301 Violations.
32.303 Criminal penalties.

    Authority: Atomic Energy Act of 1954, secs. 81, 161, 170H, 181, 182, 
183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2210h, 2231, 2232, 2233, 2273, 
2282, 2021); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 
5841); 44 U.S.C. 3504 note.

    Editorial Note: Nomenclature changes to part 32 appear at 79 FR 
75739, Dec. 19, 2014.



Sec.32.1  Purpose and scope.

    (a)(1) This part prescribes requirements for the issuance of 
specific licenses to persons who manufacture or initially transfer items 
containing byproduct material for sale or distribution to:
    (i) Persons exempted from the licensing requirements of part 30 of 
this chapter, or equivalent regulations of an Agreement State, or
    (ii) Persons generally licensed under part 31 of this chapter or 
equivalent regulations of an Agreement State.
    (iii) Persons licensed under part 35 of this chapter.
    (2) This part prescribes requirements for the issuance of specific 
licenses to persons who introduce byproduct material into a product or 
material owned by or in the possession of a licensee or another, and 
regulations governing holders of such licenses.
    (3) This part prescribes certain requirements governing holders of 
licenses to manufacture or distribute items containing byproduct 
material.
    (4) This part describes procedures and prescribes requirements for 
the issuance of certificates of registration (covering radiation safety 
information about a product) to manufacturers or initial transferors of 
sealed sources or devices containing sealed sources.
    (b) The provisions and requirements of this part are in addition to, 
and not in substitution for, other requirements of this chapter. In 
particular, the provisions of part 30 of this chapter apply to 
applications, licenses and certificates of registration subject to this 
part, and the provisions of part 37 of this chapter apply to 
applications and licenses subject to this part.
    (c)(1) The requirements in this part, including provisions that are 
specific to licensees, shall apply to Government agencies and Federally 
recognized Indian Tribes with respect to accelerator-produced 
radioactive material or discrete sources of radium-226 on November 30, 
2007 except that the agency or Tribe may continue to manufacture or 
initially transfer items containing accelerator-produced radioactive 
material or discrete sources of radium-226 for sale or distribution to 
persons exempted from the licensing requirements of part 30 of this 
chapter, and to persons generally licensed under part 31 of this 
chapter, and radioactive drugs and sources and devices to medical use 
licensees, until the date of the NRC's final licensing determination, 
provided that the agency or Tribe submits a new license application for 
these activities on or before December 1, 2008 or an amendment 
application for these activities on or before June 2, 2008.
    (2) The requirements in this part, including provisions that are 
specific to licensees, shall apply to all persons other than those 
included in paragraph (c)(1) of this section with respect to 
accelerator-produced radioactive material or discrete sources of radium-
226 on August 8, 2009, or earlier as noticed by the NRC, except that 
these persons may continue to manufacture or initially transfer items 
containing accelerator-produced radioactive material or discrete sources 
of radium-226 for sale or distribution to persons exempted from the 
licensing requirements of part 30 of this chapter, and to persons 
generally licensed under part 31 of this chapter, and to sell or 
manufacture radioactive drugs and sources and devices to medical use 
licensees until the date of the NRC's final licensing determination, 
provided that the person submits a license application within 12 months 
from the waiver expiration date of August 7, 2009 or within 12 months 
from the date of an earlier termination of the waiver as noticed by the 
NRC, whichever is earlier; or that the person submits an amendment 
request within 6 months from the waiver expiration

[[Page 624]]

date of August 7, 2009 or within 6 months from the date of an earlier 
termination of the waiver as noticed by the NRC, whichever date is 
earlier.

[30 FR 8192, June 26, 1965, as amended at 52 FR 27786, July 24, 1987; 63 
FR 1896, Jan. 13, 1998; 72 FR 55928, Oct. 1, 2007; 77 FR 43690, July 25, 
2012; 78 FR 17006, Mar. 19, 2013; 80 FR 74979, Dec. 1, 2015]



Sec.32.2  Definitions.

    As used in this part:
    Committed dose for the purposes of this part means the radiation 
dose that will accumulate over time as a result of retention in the body 
of radioactive material. Committed dose is a generic term for internal 
dose and must be calculated by summing the projected dose over the 50 
years after intake for all irradiated organs or tissues multiplying the 
doses to individual organs and tissues by applicable tissue weighting 
factors.
    Dose commitment means the total radiation dose to a part of the body 
that will result from retention in the body of radioactive material. For 
purposes of estimating the dose commitment, it is assumed that from the 
time of intake the period of exposure to retained material will not 
exceed 50 years.
    Lot Tolerance Percent Defective means, expressed in percent 
defective, the poorest quality in an individual inspection lot that 
should be accepted.
    Nationally tracked source is a sealed source containing a quantity 
equal to or greater than Category 1 or Category 2 levels of any 
radioactive material listed in Appendix E to part 20 of this Chapter. In 
this context a sealed source is defined as radioactive material that is 
sealed in a capsule or closely bonded, in a solid form and which is not 
exempt from regulatory control. It does not mean material encapsulated 
solely for disposal, or nuclear material contained in any fuel assembly, 
subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked 
sources are those containing radioactive material at a quantity equal to 
or greater than the Category 1 threshold. Category 2 nationally tracked 
sources are those containing radioactive material at a quantity equal to 
or greater than the Category 2 threshold but less than the Category 1 
threshold.
    Sealed Source and Device Registry means the national registry that 
contains all the registration certificates, generated by both the NRC 
and the Agreement States, that summarize the radiation safety 
information for the sealed sources and devices and describe the 
licensing and use conditions approved for the product.

[34 FR 6653, Apr. 18, 1969, as amended at 39 FR 22129, June 20, 1974; 71 
FR 65708, Nov. 8, 2006; 77 FR 43690, July 25, 2012]



Sec.32.3  Maintenance of records.

    Each record required by this part must be legible throughout the 
retention period specified by each Commission regulation. The record may 
be the original or a reproduced copy of a microform provided that the 
copy or microform is authenticated by authorized personnel and that the 
microform is capable of producing a clear copy throughout the required 
retention period. The record may also be stored in electronic media with 
the capability for producing legible, accurate, and complete records 
during the required retention period. Records such as letters, drawings, 
specifications, must include all pertinent information such as stamps, 
initials, and signatures. The licensee shall maintain adequate 
safeguards against tampering with and loss of records.

[53 FR 19246, May 27, 1988]



Sec.32.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0001.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.32.11, 32.12, 32.14, 32.15, 32.16, 32.18, 
32.19, 32.20, 32.21, 32.21a,

[[Page 625]]

32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.30, 32.31, 32.32, 32.51, 
32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 
32.71, 32.72, 32.74, 32.201, 32.210, and 32.211.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec.32.11, NRC Form 313 is approved under control number 
3150-0120.
    (2) [Reserved]

[49 FR 19625, May 9, 1984, as amended at 59 FR 61780, Dec. 2, 1994; 62 
FR 52186, Oct. 6, 1997; 62 FR 63640, Dec. 2, 1997; 71 FR 65708, Nov. 8, 
2006; 72 FR 58486, Oct. 16, 2007; 77 FR 43691, July 25, 2012]



                Subpart A_Exempt Concentrations and Items



Sec.32.11  Introduction of byproduct material in exempt concentrations
into products or materials, and transfer of ownership or possession:
Requirements for license.
          

    An application for a specific license on Form NRC-313 authorizing 
the introduction of byproduct material into a product or material owned 
by or in the possession of the licensee or another and the transfer of 
ownership or possession of the product or material containing the 
byproduct material will be approved if the applicant:
    (a) Satisfies the general requirements specified in Sec.30.33 of 
this chapter; provided, however, that the requirements of Sec.
30.33(a)(2) and (3) do not apply to an application for a license to 
introduce byproduct material into a product or material owned by or in 
the possession of the licensee or another and the transfer of ownership 
or possession of the product or material containing the byproduct 
material, if the possession and use of the byproduct material to be 
introduced is authorized by a license issued by an Agreement State;
    (b) Provides a description of the product or material into which the 
byproduct material will be introduced, intended use of the byproduct 
material and the product or material into which it is introduced, method 
of introduction, initial concentration of the byproduct material in the 
product or material, control methods to assure that no more than the 
specified concentration is introduced into the product or material, 
estimated time interval between introduction and transfer of the product 
or material, and estimated concentration of the radioisotopes in the 
product or material at the time of transfer; and
    (c) Provides reasonable assurance that the concentrations of 
byproduct material at the time of transfer will not exceed the 
concentrations in Sec.30.70 of this chapter, that reconcentration of 
the byproduct material in concentrations exceeding those in Sec.30.70 
is not likely, that use of lower concentrations is not feasible, and 
that the product or material is not likely to be incorporated in any 
food, beverage, cosmetic, drug or other commodity or product designed 
for ingestion or inhalation by, or application to, a human being.

[30 FR 8192, June 26, 1965, as amended at 49 FR 19625, May 9, 1984; 72 
FR 58487, Oct. 16, 2007]



Sec.32.12  Same: Records and material transfer reports.

    (a) Each person licensed under Sec.32.11 shall maintain records of 
transfer of byproduct material and file a report with the Director of 
the Office of Nuclear Material Safety and Safeguards by an appropriate 
method listed in Sec.30.6(a) of this chapter, including in the 
address: ATTN: Document Control Desk/Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the byproduct material is 
transferred for use under Sec.30.14 of this chapter or equivalent 
regulations of an Agreement State.
    (b) The report must identify the:
    (1) Type and quantity of each product or material into which 
byproduct material has been introduced during the reporting period;
    (2) Name and address of the person who owned or possessed the 
product or

[[Page 626]]

material, into which byproduct material has been introduced, at the time 
of introduction;
    (3) The type and quantity of radionuclide introduced into each 
product or material; and
    (4) The initial concentrations of the radionuclide in the product or 
material at time of transfer of the byproduct material by the licensee.
    (c)(1) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first report 
after December 17, 2007, the licensee shall separately include data for 
transfers in prior years not previously reported to the Commission or to 
an Agreement State.
    (2) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.32.11 shall file a report for the current 
calendar year within 30 days after ceasing distribution.
    (d) If no transfers of byproduct material have been made under Sec.
32.11 during the reporting period, the report must so indicate.
    (e) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.

[72 FR 58487, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 
FR 42673, July 23, 2008]



Sec.32.13  Same: Prohibition of introduction.

    No person may introduce byproduct material into a product or 
material knowing or having reason to believe that it will be transferred 
to persons exempt under Sec.30.14 of this chapter or equivalent 
regulations of an Agreement State, except in accordance with a license 
issued under Sec.32.11.

[72 FR 58487, Oct. 16, 2007]



Sec.32.14  Certain items containing byproduct material; requirements
for license to apply or initially transfer.

    An application for a specific license to apply byproduct material 
to, or to incorporate byproduct material into, the products specified in 
Sec.30.15 of this chapter or to initially transfer for sale or 
distribution such products containing byproduct material for use 
pursuant to Sec.30.15 of this chapter will be approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter;
    (b) The applicant submits sufficient information regarding the 
product pertinent to evaluation of the potential radiation exposure, 
including:
    (1) Chemical and physical form and maximum quantity of byproduct 
material in each product;
    (2) Details of construction and design of each product;
    (3) The method of containment or binding of the byproduct material 
in the product;
    (4) Except for electron tubes and ionization chamber smoke detectors 
and timepieces containing promethium-147 or tritium in the form of 
gaseous tritium light sources, procedures for and results of prototype 
testing to demonstrate that the byproduct material will not become 
detached from the product and that the byproduct material will not be 
released to the environment under the most severe conditions likely to 
be encountered in normal use of the product;
    (5) In the case of ionizing radiation measuring instruments and 
timepieces containing tritium in the form of paint, quality control 
procedures to be followed in the fabrication of production lots of the 
product and the quality control standards the product will be required 
to meet;
    (6) The proposed method of labeling or marking each unit, except 
timepieces or hands or dials containing tritium or promethium-147, and 
its container with the identification of the manufacturer or initial 
transferor of the product and the byproduct material in the product;
    (7) For products for which limits on levels of radiation are 
specified in Sec.30.15 of this chapter, the radiation level and the 
method of measurement;
    (8) Any additional information, including experimental studies and 
tests, required by the Commission to facilitate a determination of the 
safety of the product.
    (c) Each product will contain no more than the quantity of byproduct 
material specified for that product in

[[Page 627]]

Sec.30.15 of this chapter. The levels of radiation from each product 
containing byproduct material will not exceed the limits specified for 
that product in Sec.30.15 of this chapter.
    (d) The Commission determines that the byproduct material is 
properly contained in the product under the most severe conditions that 
are likely to be encountered in normal use and handling.

[31 FR 5316, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 43 
FR 6922, Feb. 17, 1978; 63 FR 32971, June 17, 1998; 72 FR 58487, Oct. 
16, 2007; 77 FR 43691, July 25, 2012]



Sec.32.15  Same: Quality assurance, prohibition of transfer, 
and labeling.

    (a) Each person licensed under Sec.32.14 for products for which 
quality control procedures are required shall:
    (1) Maintain quality assurance systems in the manufacture of the 
part or product, or the installation of the part into the product, in a 
manner sufficient to provide reasonable assurance that the safety-
related components of the distributed products are capable of performing 
their intended functions;
    (2) Subject inspection lots to acceptance sampling procedures, by 
procedures specified in the license issued under Sec.32.14, to provide 
at least 95 percent confidence that the Lot Tolerance Percent Defective 
of 5.0 percent will not be exceeded; and
    (3) Visually inspect each unit in inspection lots. Any unit which 
has an observable physical defect that could adversely affect 
containment of the byproduct material must be considered a defective 
unit.
    (b) No person licensed under Sec.32.14 shall transfer to other 
persons for use under Sec.30.15 of this chapter or equivalent 
regulations of an Agreement State:
    (1) Any part or product tested and found defective under the 
criteria and procedures specified in the license issued under Sec.
32.14, unless the defective part or product has been repaired or 
reworked, retested, and found by an independent inspector to meet the 
applicable acceptance criteria; or
    (2) Any part or product contained within any lot that has been 
sampled and rejected as a result of the procedures in paragraph (a)(2) 
of this section, unless:
    (i) A procedure for defining sub-lot size, independence, and 
additional testing procedures is contained in the license issued under 
Sec.32.14; and
    (ii) Each individual sub-lot is sampled, tested, and accepted in 
accordance with the procedures specified in paragraphs (a)(2) and 
(b)(2)(i) of this section and any other criteria that may be required as 
a condition of the license issued under Sec.32.14.
    (c) [Reserved]
    (d)(1) Label or mark each unit, except timepieces or hands or dials 
containing tritium or promethium-147, and its container so that the 
manufacturer or initial transferor of the product and the byproduct 
material in the product can be identified.
    (2) For ionization chamber smoke detectors, label or mark each 
detector and its point-of-sale package so that:
    (i) Each detector has a durable, legible, readily visible label or 
marking on the external surface of the detector containing:
    (A) The following statement: ``CONTAINS RADIOACTIVE MATERIAL'';
    (B) The name of the radionuclide (``americium-241'' or ``Am-241'') 
and the quantity of activity; and
    (C) An identification of the person licensed under Sec.32.14 to 
transfer the detector for use under Sec.30.15(a)(7) of this chapter or 
equivalent regulations of an Agreement State.
    (ii) The labeling or marking specified in paragraph (d)(2)(i) of 
this section is located where it will be readily visible when the 
detector is removed from its mounting.
    (iii) The external surface of the point-of-sale package has a 
legible, readily visible label or marking containing:
    (A) The name of the radionuclide and quantity of activity;
    (B) An identification of the person licensed under Sec.32.14 to 
transfer the detector for use under Sec.30.15(a)(7) or equivalent 
regulations of an Agreement State; and
    (C) The following or a substantially similar statement: ``THIS 
DETECTOR CONTAINS RADIOACTIVE MATERIAL. THE PURCHASER IS EXEMPT

[[Page 628]]

FROM ANY REGULATORY REQUIREMENTS.''
    (iv) Each detector and point-of-sale package is provided with such 
other information as may be required by the Commission.

[31 FR 5317, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 39 
FR 22129, June 20, 1974; 43 FR 6922, Feb. 17, 1978; 72 FR 58487, Oct. 
16, 2007; 73 FR 42673, July 23, 2008; 77 FR 43691, July 25, 2012]



Sec.32.16  Certain items containing byproduct material: Records 
and reports of transfer.

    (a) Each person licensed under Sec.32.14 shall maintain records of 
all transfers of byproduct material and file a report with the Director 
of the Office of Nuclear Material Safety and Safeguards by an 
appropriate method listed in Sec.30.6(a) of this chapter, including in 
the address: ATTN: Document Control Desk/Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the products are transferred for 
use under Sec.30.15 of this chapter, giving the specific paragraph 
designation, or equivalent regulations of an Agreement State.
    (b) The report must include the following information on products 
transferred to other persons for use under Sec.30.15 or equivalent 
regulations of an Agreement State:
    (1) A description or identification of the type of each product and 
the model number(s), if applicable;
    (2) For each radionuclide in each type of product and each model 
number, if applicable, the total quantity of the radionuclide; and
    (3) The number of units of each type of product transferred during 
the reporting period by model number, if applicable.
    (c)(1) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first report 
after December 17, 2007, the licensee shall separately include data for 
transfers in prior years not previously reported to the Commission.
    (2) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.32.14 shall file a report for the current 
calendar year within 30 days after ceasing distribution.
    (d) If no transfers of byproduct material have been made under Sec.
32.14 during the reporting period, the report must so indicate.
    (e) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.

[72 FR 58487, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 
FR 42673, July 23, 2008]



Sec.32.18  Manufacture, distribution and transfer of exempt quantities
of byproduct material: Requirements for license.

    An application for a specific license to manufacture, process, 
produce, package, repackage, or transfer quantities of byproduct 
material for commercial distribution to persons exempt pursuant to Sec.
30.18 of this chapter or the equivalent regulations of an Agreement 
State will be approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter: Provided, however, That the requirements of 
Sec.30.33(a) (2) and (3) of this chapter do not apply to an 
application for a license to transfer byproduct material manufactured, 
processed, produced, packaged, or repackaged pursuant to a license 
issued by an Agreement State;
    (b) The byproduct material is not contained in any food, beverage, 
cosmetic, drug, or other commodity designed for ingestion or inhalation 
by, or application to, a human being;
    (c) The byproduct material is in the form of processed chemical 
elements, compounds, or mixtures, tissue samples, bioassay samples, 
counting standards, plated or encapsulated sources, or similar 
substances, identified as radioactive and to be used for its radioactive 
properties, but is not incorporated into any manufactured or assembled 
commodity, product, or device intended for commercial distribution; and
    (d) The applicant submits copies of prototype labels and brochures 
and the

[[Page 629]]

Commission approves such labels and brochures.

[35 FR 6428, Apr. 22, 1970, as amended at 43 FR 6922, Feb. 17, 1978]



Sec.32.19  Same: Conditions of licenses.

    Each license issued under Sec.32.18 is subject to the following 
conditions:
    (a) No more than 10 exempt quantities set forth in Sec.30.71, 
Schedule B of this chapter shall be sold or transferred in any single 
transaction. For purposes of this requirement, an individual exempt 
quantity may be composed of fractional parts of one or more of the 
exempt quantities in Sec.30.71, Schedule B of this chapter, provided 
that the sum of such fractions shall not exceed unity.
    (b) Each quantity of byproduct material set forth in Sec.30.71, 
Schedule B of this chapter shall be separately and individually 
packaged. No more than 10 such packaged exempt quantities shall be 
contained in any outer package for transfer to persons exempt pursuant 
to Sec.30.18 of this chapter. The outer package shall be such that the 
dose rate at the external surface of the package does not exceed 0.5 
millirem per hour.
    (c) The immediate container of each quantity or separately packaged 
fractional quantity of byproduct material shall bear a durable, legible 
label which (1) identifies the radioisotope and the quantity of 
radioactivity, and (2) bears the words ``Radioactive Material.''
    (d) In addition to the labeling information required by paragraph 
(c) of this section, the label affixed to the immediate container, or an 
accompanying brochure, shall also (1) state that the contents are exempt 
from NRC or Agreement State licensing requirements; (2) bear the words 
``Radioactive Material--Not for Human Use--Introduction Into Foods, 
Beverages, Cosmetics, Drugs, or Medicinals, or Into Products 
Manufactured for Commercial Distribution is Prohibited--Exempt 
Quantities Should Not be Combined''; and (3) set forth appropriate 
additional radiation safety precautions and instructions relating to the 
handling, use, storage, and disposal of the radioactive material.

[35 FR 6428, Apr. 22, 1970]



Sec.32.20  Same: Records and material transfer reports.

    (a) Each person licensed under Sec.32.18 shall maintain records of 
transfer of material identifying, by name and address, each person to 
whom byproduct material is transferred for use under Sec.30.18 of this 
chapter or the equivalent regulations of an Agreement State and stating 
the kinds, quantities, and physical form of byproduct material 
transferred.
    (b) The licensee shall file a summary report with the Director of 
the Office of Nuclear Material Safety and Safeguards by an appropriate 
method listed in Sec.30.6(a) of this chapter, including in the 
address: ATTN: Document Control Desk/Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the materials are transferred for 
use under Sec.30.18 or equivalent regulations of an Agreement State.
    (c) For each radionuclide in each physical form, the report shall 
indicate the total quantity of each radionuclide and the physical form, 
transferred under the specific license.
    (d)(1) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first report 
after December 17, 2007, the licensee shall separately include the total 
quantity of each radionuclide transferred for transfers in prior years 
not previously reported to the Commission.
    (2) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.32.18 shall file a report for the current 
calendar year within 30 days after ceasing distribution.
    (e) If no transfers of byproduct material have been made under Sec.
32.18 during the reporting period, the report must so indicate.
    (f) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a summary report to the 
Commission.

[72 FR 58488, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 
FR 42673, July 23, 2008]

[[Page 630]]



Sec.32.21  Radioactive drug: Manufacture, preparation, or transfer for
commercial distribution of capsules containing carbon-14 urea each for
``in vivo'' diagnostic use for humans to persons exempt from licensing; 
 Requirements for a license.

    (a) An application for a specific license to manufacture, prepare, 
process, produce, package, repackage, or transfer for commercial 
distribution capsules containing 37 kBq (1 [micro]Ci) carbon-14 urea 
(allowing for nominal variation that may occur during the manufacturing 
process) each for ``in vivo'' diagnostic use, to persons exempt from 
licensing under Sec.30.21 of this chapter or the equivalent 
regulations of an Agreement State will be approved if:
    (1) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter, provided that the requirements of Sec.
30.33(a) (2) and (3) of this chapter do not apply to an application for 
a license to transfer byproduct material manufactured, prepared, 
processed, produced, packaged, or repackaged pursuant to a license 
issued by an Agreement State;
    (2) The applicant meets the requirements under Sec.32.72(a)(2) of 
this part;
    (3) The applicant provides evidence that each capsule contains 37 
kBq (1 [micro]Ci) carbon-14 urea (allowing for nominal variation that 
may occur during the manufacturing process);
    (4) The carbon-14 urea is not contained in any food, beverage, 
cosmetic, drug (except as described in this section) or other commodity 
designed for ingestion or inhalation by, or topical application to, a 
human being;
    (5) The carbon-14 urea is in the form of a capsule, identified as 
radioactive, and to be used for its radioactive properties, but is not 
incorporated into any manufactured or assembled commodity, product, or 
device intended for commercial distribution; and
    (6) The applicant submits copies of prototype labels and brochures 
and the NRC approves these labels and brochures.
    (b) Nothing in this section relieves the licensee from complying 
with applicable FDA, other Federal, and State requirements governing 
drugs.

[62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001]



Sec.32.21a  Same: Conditions of license.

    Each license issued under Sec.32.21 of this part is subject to the 
following conditions:
    (a) The immediate container of the capsule(s) must bear a durable, 
legible label which:
    (1) Identifies the radioisotope, the physical and chemical form, the 
quantity of radioactivity of each capsule at a specific date; and
    (2) Bears the words ``Radioactive Material.''
    (b) In addition to the labeling information required by paragraph 
(a) of this section, the label affixed to the immediate container, or an 
accompanying brochure also must:
    (1) State that the contents are exempt from NRC or Agreement State 
licensing requirements; and
    (2) Bears the words ``Radioactive Material. For ``In Vivo'' 
Diagnostic Use Only. This Material Is Not To Be Used for Research 
Involving Human Subjects and Must Not Be Introduced into Foods, 
Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products 
Manufactured for Commercial Distribution. This Material May Be Disposed 
of in Ordinary Trash.''

[62 FR 63640, Dec. 2, 1997]



Sec.32.22  Self-luminous products containing tritium, krypton-85 
or promethium-147: Requirements for license to manufacture, process,
produce, or initially transfer.
          

    (a) An application for a specific license to manufacture, process, 
or produce self-luminous products containing tritium, krypton-85, or 
promethium-147, or to initially transfer such products for use pursuant 
to Sec.30.19 of this chapter or equivalent regulations of an Agreement 
State, will be approved if:
    (1) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter: Provided, however, That the requirements of 
Sec.30.33(a) (2) and (3) do not apply to an application for a license 
to transfer tritium, krypton-85, or promethium-147 in self-luminous 
products manufactured, processed, or produced pursuant to a license 
issued by an Agreement State.
    (2) The applicant submits sufficient information relating to the 
design,

[[Page 631]]

manufacture, prototype testing, quality control procedures, labeling or 
marking, and conditions of handling, storage, use, and disposal of the 
self-luminous product to demonstrate that the product will meet the 
safety criteria set forth in Sec.32.23. The information should 
include:
    (i) A description of the product and its intended use or uses.
    (ii) The type and quantity of byproduct material in each unit.
    (iii) Chemical and physical form of the byproduct material in the 
product and changes in chemical and physical form that may occur during 
the useful life of the product.
    (iv) Solubility in water and body fluids of the forms of the 
byproduct material identified in paragraphs (a)(2) (iii) and (xii) of 
this section.
    (v) Details of construction and design of the product as related to 
containment and shielding of the byproduct material and other safety 
features under normal and severe conditions of handling, storage, use, 
and disposal of the product.
    (vi) Maximum external radiation levels at 5 and 25 centimeters from 
any external surface of the product, averaged over an area not to exceed 
10 square centimeters, and the method of measurement.
    (vii) Degree of access of human beings to the product during normal 
handling and use.
    (viii) Total quantity of byproduct material expected to be 
distributed in the product annually.
    (ix) The expected useful life of the product.
    (x) The proposed method of labeling or marking each unit with 
identification of the manufacturer or initial transferor of the product 
and the byproduct material in the product.
    (xi) Procedures for prototype testing of the product to demonstrate 
the effectiveness of the containment, shielding, and other safety 
features under both normal and severe conditions of handling, storage, 
use, and disposal of the product.
    (xii) Results of the prototype testing of the product, including any 
change in the form of the byproduct material contained in the product, 
the extent to which the byproduct material may be released to the 
environment, any increase in external radiation levels, and any other 
changes in safety features.
    (xiii) The estimated external radiation doses and dose commitments 
relevant to the safety criteria in Sec.32.23 and the basis for such 
estimates.
    (xiv) A determination that the probabilities with respect to the 
doses referred to in Sec.32.23(d) meet the criteria of that paragraph.
    (xv) Quality control procedures to be followed in the fabrication of 
production lots of the product and the quality control standards the 
product will be required to meet.
    (xvi) Any additional information, including experimental studies and 
tests, required by the Commission.
    (3)(i) The Commission determines that the product meets the safety 
criteria in Sec.32.23; and
    (ii) The product has been evaluated by the NRC and registered in the 
Sealed Source and Device Registry.
    (b) Notwithstanding the provisions of paragraph (a) of this section, 
the Commission may deny an application for a specific license under this 
section if the end uses of the product cannot be reasonably foreseen.

[34 FR 9026, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 77 
FR 43691, July 25, 2012]



Sec.32.23  Same: Safety criteria.

    An applicant for a license under Sec.32.22 shall demonstrate that 
the product is designed and will be manufactured so that:
    (a) In normal use and disposal of a single exempt unit, it is 
unlikely that the external radiation dose in any one year, or the dose 
commitment resulting from the intake of radioactive material in any one 
year, to a suitable sample of the group of individuals expected to be 
most highly exposed to radiation or radioactive material from the 
product will exceed the dose to the appropriate organ as specified in 
Column I of the table in Sec.32.24 of this part.
    (b) In normal handling and storage of the quantities of exempt units 
likely to accumulate in one location during marketing, distribution, 
installation, and servicing of the product, it is unlikely that the 
external radiation dose

[[Page 632]]

in any one year, or the dose commitment resulting from the intake of 
radioactive material in any one year, to a suitable sample of the group 
of individuals expected to be most highly exposed to radiation or 
radioactive material from the product will exceed the dose to the 
appropriate organ as specified in Column II of the table in Sec.32.24.
    (c) It is unlikely that there will be a significant reduction in the 
effectiveness of the containment, shielding, or other safety features of 
the product from wear and abuse likely to occur in normal handling and 
use of the product during its useful life.
    (d) \1\ In use and disposal of a single exempt unit, or in handling 
and storage of the quantities of exempt units likely to accumulate in 
one location during marketing, distribution, installation, and servicing 
of the product, the probability is low that the containment, shielding, 
or other safety features of the product would fail under such 
circumstances that a person would receive an external radiation dose or 
dose commitment in excess of the dose to the appropriate organ as 
specified in Column III of the table in Sec.32.24, and the probability 
is negligible that a person would receive an external radiation dose or 
dose commitment in excess of the dose to the appropriate organ as 
specified in Column IV of the table in Sec.32.24.
---------------------------------------------------------------------------

    \1\ It is the intent of this paragraph that as the magnitude of the 
potential dose increases above that permitted under normal conditions, 
the probability that any individual will receive such a dose must 
decrease. The probabilities have been expressed in general terms to 
emphasize the approximate nature of the estimates which are to be made. 
The following values may be used as guides in estimating compliance with 
the criteria:
    Low--not more than one such failure per year for each 10,000 exempt 
units distributed.
    Negligible--not more than one such failure per year for each 1 
million exempt units distributed.

[34 FR 9027, June 6, 1969]



Sec.32.24  Same: Table of organ doses.

------------------------------------------------------------------------
                                          Column  Column  Column  Column
              Part of body                   I      II      III     IV
                                           (rem)   (rem)   (rem)   (rem)
------------------------------------------------------------------------
Whole body; head and trunk: active blood-  0.001    0.01     0.5      15
 forming organs; gonads: or lens of eye.
Hands and forearms; feet and ankles;       0.015    0.15     7.5     200
 localized areas of skin averaged over
 areas no larger than 1 square
 centimeter.............................
Other organs............................   0.003    0.03     1.5      50
------------------------------------------------------------------------


[34 FR 9329, June 13, 1969]



Sec.32.25  Conditions of licenses issued under Sec.32.22: Quality
control, labeling, and reports of transfer.

    Each person licensed under Sec.32.22 shall:
    (a) Carry out adequate control procedures in the manufacture of the 
product to assure that each production lot meets the quality control 
standards approved by the Commission;
    (b) Label or mark each unit so that the manufacturer, processor, 
producer, or initial transferor of the product and the byproduct 
material in the product can be identified; and
    (c) Maintain records of all transfers and file a report with the 
Director of the Office of Nuclear Material Safety and Safeguards by an 
appropriate method listed in Sec.30.6(a) of this chapter, including in 
the address: ATTN: Document Control Desk/Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the products are transferred for 
use under Sec.30.19 of this chapter or equivalent regulations of an 
Agreement State.
    (3) The report must include the following information on products 
transferred to other persons for use under Sec.30.19 or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each product and 
the model number(s);
    (ii) For each radionuclide in each type of product and each model 
number, the total quantity of the radionuclide;

[[Page 633]]

    (iii) The number of units of each type of product transferred during 
the reporting period by model number.
    (4)(i) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first report 
after December 17, 2007, the licensee shall separately include data for 
transfers in prior years not previously reported to the Commission.
    (ii) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.32.22 shall file a report for the current 
calendar year within 30 days after ceasing distribution.
    (5) If no transfers of byproduct material have been made under Sec.
32.22 during the reporting period, the report must so indicate.
    (6) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.

[34 FR 9027, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 48 
FR 12334, Mar. 24, 1983; 68 FR 58804, Oct. 10, 2003; 72 FR 58488, Oct. 
16, 2007; 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]



Sec.32.26  Gas and aerosol detectors containing byproduct material:
Requirements for license to manufacture, process, produce, 
or initially transfer.

    An application for a specific license to manufacture, process, or 
produce gas and aerosol detectors containing byproduct material and 
designed to protect health, safety, or property, or to initially 
transfer such products for use under Sec.30.20 of this chapter or 
equivalent regulations of an Agreement State, will be approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter: Provided, however, That the requirements of 
Sec.30.33(a) (2) and (3) do not apply to an application for a license 
to transfer byproduct material in gas and aerosol detectors 
manufactured, processed or produced pursuant to a license issued by an 
Agreement State.
    (b) The applicant submits sufficient information relating to the 
design, manufacture, prototype testing, quality control procedures, 
labeling or marking, and conditions of handling, storage, use, and 
disposal of the gas and aerosol detector to demonstrate that the product 
will meet the safety criteria set forth in Sec.32.27. The information 
should include:
    (1) A description of the product and its intended use or uses;
    (2) The type and quantity of byproduct material in each unit;
    (3) Chemical and physical form of the byproduct material in the 
product and changes in chemical and physical form that may occur during 
the useful life of the product;
    (4) Solubility in water and body fluids of the forms of the 
byproduct material identified in paragraphs (b) (3) and (12) of this 
section;
    (5) Details of construction and design of the product as related to 
containment and shielding of the byproduct material and other safety 
features under normal and severe conditions of handling, storage, use, 
and disposal of the product;
    (6) Maximum external radiation levels at 5 and 25 centimeters from 
any external surface of the product, averaged over an area not to exceed 
10 square centimeters, and the method of measurement;
    (7) Degree of access of human beings to the product during normal 
handling and use;
    (8) Total quantity of byproduct material expected to be distributed 
in the product annually;
    (9) The expected useful life of the product;
    (10) The proposed methods of labeling or marking the detector and 
its point-of-sale package to satisfy the requirements of Sec.32.29(b);
    (11) Procedures for prototype testing of the product to demonstrate 
the effectiveness of the containment, shielding, and other safety 
features under both normal and severe conditions of handling, storage, 
use, and disposal of the product;
    (12) Results of the prototype testing of the product, including any 
change in the form of the byproduct material contained in the product, 
the extent to which the byproduct material may be released to the 
environment, any increase in external radiation levels, and any other 
changes in safety features;

[[Page 634]]

    (13) The estimated external radiation doses and dose commitments 
relevant to the safety criteria in Sec.32.27 and the basis for such 
estimates;
    (14) A determination that the probabilities with respect to the 
doses referred to in Sec.32.27(c) meet the criteria of that paragraph;
    (15) Quality control procedures to be followed in the fabrication of 
production lots of the product and the quality control standards the 
product will be required to meet; and
    (16) Any additional information, including experimental studies and 
tests, required by the Commission.
    (c)(1) The Commission determines that the product meets the safety 
criteria in Sec.32.27; and
    (2) The product has been evaluated by the NRC and registered in the 
Sealed Source and Device Registry.

[34 FR 6653, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 
FR 38342, June 9, 1980; 77 FR 43691, July 25, 2012]



Sec.32.27  Same: Safety criteria.

    An applicant for a license under Sec.32.26 shall demonstrate that 
the product is designed and will be manufactured so that:
    (a) In normal use and disposal of a single exempt unit, and in 
normal handling and storage of the quantities of exempt units likely to 
accumulate in one location during marketing, distribution, installation, 
and servicing of the product, it is unlikely that the external radiation 
dose in any one year, or the dose commitment resulting from the intake 
of radioactive material in any one year, to a suitable sample of the 
group of individuals expected to be most highly exposed to radiation or 
radioactive material from the product will exceed the dose to the 
appropriate organ as specified in Column I of the table in Sec.32.28.
    (b) It is unlikely that there will be a significant reduction in the 
effectiveness of the containment, shielding, or other safety features of 
the product from wear and abuse likely to occur in normal handling and 
use of the product during its useful life.
    (c) In use and disposal of a single exempt unit and in handling and 
storage of the quantities of exempt units likely to accumulate in one 
location during marketing, distribution, installation, and servicing of 
the product, the probability is low that the containment, shielding, or 
other safety features of the product would fail under such circumstances 
that a person would receive an external radiation dose or dose 
commitment in excess of the dose to the appropriate organ as specified 
in Column II of the table in Sec.32.28, and the probability is 
negligible that a person would receive an external radiation dose or 
dose commitment in excess of the dose to the appropriate organ as 
specified in Column III of the table in Sec.32.28. \1\
---------------------------------------------------------------------------

    \1\ It is the intent of this paragraph that as the magnitude of the 
potential dose increases above that permitted under normal conditions, 
the probability that any individual will receive such a dose must 
decrease. The probabilities have been expressed in general terms to 
emphasize the approximate nature of the estimates which are to be made. 
The following values may be used as guides in estimating compliance with 
the criteria:
    Low--not more than one such failure per year for each 10,000 exempt 
units distributed.
    Negligible--not more than one such failure per year for each one 
million exempt units distributed.

[34 FR 6654, Apr. 18, 1969]



Sec.32.28  Same: Table of organ doses.

------------------------------------------------------------------------
                                                         Column   Column
                 Part of body                   Column     II      III
                                               I (rem)   (rem)    (rem)
------------------------------------------------------------------------
Whole body; head and trunk; active blood-        0.005      0.5       15
 forming organs; gonads; or lens of eye......
Hands and forearms; feet and ankles;             0.075      7.5      200
 localized areas of skin averaged over areas
 no larger than 1 square centimeter..........
Other organs.................................    0.015      1.5       50
------------------------------------------------------------------------


[34 FR 6654, Apr. 18, 1969]



Sec.32.29  Conditions of licenses issued under Sec.32.26: Quality
control, labeling, and reports of transfer.

    Each person licensed under Sec.32.26 shall:
    (a) Carry out adequate control procedures in the manufacture of the 
product to assure that each production lot meets the quality control 
standards approved by the Commission;
    (b) Label or mark each detector and its point-of-sale package so 
that:

[[Page 635]]

    (1) Each detector has a durable, legible, readily visible label or 
marking on the external surface of the detector containing:
    (i) The following statement: ``CONTAINS RADIOACTIVE MATERIAL'';
    (ii) The name of the radionuclide and quantity of activity; and
    (iii) An identification of the person licensed under Sec.32.26 to 
transfer the detector for use pursuant to Sec.30.20 of this chapter or 
equivalent regulations of an Agreement State.
    (2) The labeling or marking specified in paragraph (b)(1) of this 
section is located where its will be readily visible when the detector 
is removed from its mounting.
    (3) The external surface of the point-of-sale package has a legible, 
readily visible label or marking containing:
    (i) The name of the radionuclide and quantity of activity;
    (ii) An identification of the person licensed under Sec.32.26 to 
transfer the detector for use pursuant to Sec.30.20 of this chapter or 
equivalent regulations of an Agreement State; and
    (iii) The following or a substantially similar statement:

    THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN 
MANUFACTURED IN COMPLIANCE WITH U.S. NRC SAFETY CRITERIA IN 10 CFR 
32.27. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.

    (4) Each detector and point-of-sale package is provided with such 
other information as may be required by the Commission; and
    (c) Maintain records of all transfers and file a report with the 
Director of the Office of Nuclear Material Safety and Safeguards by an 
appropriate method listed in Sec.30.6(a) of this chapter, including in 
the address: ATTN: Document Control Desk/Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the products are transferred for 
use under Sec.30.20 of this chapter or equivalent regulations of an 
Agreement State.
    (3) The report must include the following information on products 
transferred to other persons for use under Sec.30.20 or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each product and 
the model number(s);
    (ii) For each radionuclide in each type of product and each model 
number, the total quantity of the radionuclide;
    (iii) The number of units of each type of product transferred during 
the reporting period by model number.
    (4)(i) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first report 
after December 17, 2007, the licensee shall separately include data for 
transfers in prior years not previously reported to the Commission.
    (ii) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.32.26 shall file a report for the current 
calendar year within 30 days after ceasing distribution.
    (5) If no transfers of byproduct material have been made under Sec.
32.26 during the reporting period, the report must so indicate.
    (6) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.

[34 FR 6654, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 
FR 38342, June 9, 1980; 48 FR 12334, Mar. 24, 1983; 72 FR 58488, Oct. 
16, 2007; 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]



Sec.32.30  Certain industrial devices containing byproduct material:
Requirements for license to manufacture, process, produce, or 
initially transfer.

    An application for a specific license to manufacture, process, 
produce, or initially transfer for sale or distribution devices 
containing byproduct material for use under Sec.30.22 of this chapter 
or equivalent regulations of an Agreement State will be approved if:
    (a) The applicant satisfies the general requirements of Sec.30.33 
of this chapter: However, the requirements of Sec.30.33(a)(2) and (3) 
do not apply to an

[[Page 636]]

application for a license to transfer byproduct material in such 
industrial devices manufactured, processed, or produced under a license 
issued by an Agreement State;
    (b) The applicant submits sufficient information relating to the 
design, manufacture, prototype testing, quality control procedures, 
labeling or marking, and conditions of handling, storage, use, and 
disposal of the industrial devices to demonstrate that the device will 
meet the safety criteria set forth in Sec.32.31. The information 
should include:
    (1) A description of the device and its intended use or uses;
    (2) The type and quantity of byproduct material in each unit;
    (3) Chemical and physical form of the byproduct material in the 
device and changes in chemical and physical form that may occur during 
the useful life of the device;
    (4) Solubility in water and body fluids of the forms of the 
byproduct material identified in paragraphs (b)(3) and (b)(12) of this 
section;
    (5) Details of construction and design of the device as related to 
containment and shielding of the byproduct material and other safety 
features under normal and severe conditions of handling, storage, use, 
and disposal of the device;
    (6) Maximum external radiation levels at 5 and 30 centimeters from 
any external surface of the device, averaged over an area not to exceed 
10 square centimeters, and the method of measurement;
    (7) Degree of access of human beings to the device during normal 
handling and use;
    (8) Total quantity of byproduct material expected to be distributed 
in the devices annually;
    (9) The expected useful life of the device;
    (10) The proposed methods of labeling or marking the device and its 
point-of-sale package to satisfy the requirements of Sec.32.32(b);
    (11) Procedures for prototype testing of the device to demonstrate 
the effectiveness of the containment, shielding, and other safety 
features under both normal and severe conditions of handling, storage, 
use, and disposal of the device;
    (12) Results of the prototype testing of the device, including any 
change in the form of the byproduct material contained in the device, 
the extent to which the byproduct material may be released to the 
environment, any increase in external radiation levels, and any other 
changes in safety features;
    (13) The estimated external radiation doses and committed doses 
resulting from the intake of byproduct material in any one year relevant 
to the safety criteria in Sec.32.31 and the basis for these estimates;
    (14) A determination that the probabilities with respect to the 
doses referred to in Sec.32.31(a)(4) meet the criteria of that 
paragraph;
    (15) Quality control procedures to be followed in the fabrication of 
production lots of the devices and the quality control standards the 
devices will be required to meet; and
    (16) Any additional information, including experimental studies and 
tests, required by the Commission.
    (c)(1) The Commission determines that the device meets the safety 
criteria in Sec.32.31.
    (2) The device is unlikely to be routinely used by members of the 
general public in a non-occupational environment.
    (3) The device has been registered in the Sealed Source and Device 
Registry.

[77 FR 43691, July 25, 2012]



Sec.32.31  Certain industrial devices containing byproduct material:
Safety criteria.

    (a) An applicant for a license under Sec.32.30 shall demonstrate 
that the device is designed and will be manufactured so that:
    (1) In normal use, handling, and storage of the quantities of exempt 
units likely to accumulate in one location, including during marketing, 
distribution, installation, and servicing of the device, it is unlikely 
that the external radiation dose in any one year, or the committed dose 
resulting from the intake of radioactive material in any one year, to a 
suitable sample of the group of individuals expected to be most

[[Page 637]]

highly exposed to radiation or radioactive material from the device will 
exceed 200 [micro]Sv (20 mrem).
    (2) It is unlikely that the external radiation dose in any one year, 
or the committed dose resulting from the intake of radioactive material 
in any one year, to a suitable sample of the group of individuals 
expected to be most highly exposed to radiation or radioactive material 
from disposal of the quantities of units likely to accumulate in the 
same disposal site will exceed 10 [micro]Sv (1 mrem).
    (3) It is unlikely that there will be a significant reduction in the 
effectiveness of the containment, shielding, or other safety features of 
the device from wear and abuse likely to occur in normal handling and 
use of the device during its useful life.
    (4) In use, handling, storage, and disposal of the quantities of 
exempt units likely to accumulate in one location, including during 
marketing, distribution, installation, and servicing of the device, the 
probability is low that the containment, shielding, or other safety 
features of the device would fail under such circumstances that a person 
would receive an external radiation dose or committed dose in excess of 
5 mSv (500 mrem), and the probability is negligible that a person would 
receive an external radiation dose or committed dose of 100 mSv (10 rem) 
or greater.\1\
---------------------------------------------------------------------------

    \1\ It is the intent of this paragraph that as the magnitude of the 
potential dose increases above that permitted under normal conditions, 
the probability that any individual will receive such a dose must 
decrease. The probabilities have been expressed in general terms to 
emphasize the approximate nature of the estimates that are to be made. 
The following values may be used as guides in estimating compliance with 
the criteria: Low--not more than one such failure/incident per year for 
each 10,000 exempt units distributed. Negligible--not more than one such 
failure/incident per year for each one million exempt units distributed.
---------------------------------------------------------------------------

    (b) An applicant for a license under Sec.32.30 shall demonstrate 
that, even in unlikely scenarios of misuse, including those resulting in 
direct exposure to the unshielded source removed from the device for 
1,000 hours at an average distance of 1 meter and those resulting in 
dispersal and subsequent intake of 10-4 of the quantity of 
byproduct material (or in the case of tritium, an intake of 10 percent), 
a person will not receive an external radiation dose or committed dose 
in excess of 100 mSv (10 rem), and, if the unshielded source is small 
enough to fit in a pocket, that the dose to localized areas of skin 
averaged over areas no larger than 1 square centimeter from carrying the 
unshielded source in a pocket for 80 hours will not exceed 2 Sv (200 
rem).

[77 FR 43692, July 25, 2012]



Sec.32.32  Conditions of licenses issued under Sec.32.30: Quality
control, labeling, and reports of transfer.

    Each person licensed under Sec.32.30 shall:
    (a) Carry out adequate control procedures in the manufacture of the 
device to ensure that each production lot meets the quality control 
standards approved by the Commission;
    (b) Label or mark each device and its point-of-sale package so that:
    (1) Each item has a durable, legible, readily visible label or 
marking on the external surface of the device containing:
    (i) The following statement: ``CONTAINS RADIOACTIVE MATERIAL'';
    (ii) The name of the radionuclide(s) and quantity(ies) of activity;
    (iii) An identification of the person licensed under Sec.32.30 to 
transfer the device for use under Sec.30.22 of this chapter or 
equivalent regulations of an Agreement State; and
    (iv) Instructions and precautions necessary to assure safe 
installation, operation, and servicing of the device (documents such as 
operating and service manuals may be identified in the label and used to 
provide this information).
    (2) The external surface of the point-of-sale package has a legible, 
readily visible label or marking containing:
    (i) The name of the radionuclide and quantity of activity;
    (ii) An identification of the person licensed under Sec.32.30 to 
transfer the device for use under Sec.30.22 of this chapter or 
equivalent regulations of an Agreement State; and
    (iii) The following or a substantially similar statement: ``THIS 
DEVICE

[[Page 638]]

CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE 
WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN 10 CFR 32.31. 
THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.''
    (3) Each device and point-of-sale package contains such other 
information as may be required by the Commission; and
    (c) Maintain records of all transfers and file a report with the 
Director of the Office of Nuclear Material Safety and Safeguards by an 
appropriate method listed in Sec.30.6(a) of this chapter, including in 
the address: ATTN: Document Control Desk/Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the devices are transferred for 
use under Sec.30.22 of this chapter or equivalent regulations of an 
Agreement State.
    (3) The report must include the following information on devices 
transferred to other persons for use under Sec.30.22 or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each device and 
the model number(s);
    (ii) For each radionuclide in each type of device and each model 
number, the total quantity of the radionuclide; and
    (iii) The number of units of each type of device transferred during 
the reporting period by model number.
    (4)(i) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year.
    (ii) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.32.30 shall file a report for the current 
calendar year within 30 days after ceasing distribution.
    (5) If no transfers of byproduct material have been made under Sec.
32.30 during the reporting period, the report must so indicate.
    (6) The licensee shall maintain the record of a transfer for a 
period of one year after the transfer is included in a report to the 
Commission.

[77 FR 43692, July 25, 2012]



                   Subpart B_Generally Licensed Items



Sec.32.51  Byproduct material contained in devices for use under 
Sec.31.5; requirements for license to manufacture, or initially
transfer.

    (a) An application for a specific license to manufacture, or 
initially transfer devices containing byproduct material to persons 
generally licensed under Sec.31.5 of this chapter or equivalent 
regulations of an Agreement State will be approved if:
    (1) The applicant satisfies the general requirements of Sec.30.33 
of this chapter;
    (2) The applicant submits sufficient information relating to the 
design, manufacture, prototype testing, quality control, labels, 
proposed uses, installation, servicing, leak testing, operating and 
safety instructions, and potential hazards of the device to provide 
reasonable assurance that:
    (i) The device can be safely operated by persons not having training 
in radiological protection;
    (ii) Under ordinary conditions of handling, storage, and use of the 
device, the byproduct material contained in the device will not be 
released or inadvertently removed from the device, and it is unlikely 
that any person will receive in 1 year a dose in excess of 10 percent of 
the annual limits specified in Sec.20.1201(a) of this chapter; and
    (iii) Under accident conditions (such as fire and explosion) 
associated with handling, storage and use of the device, it is unlikely 
that any person would receive an external radiation dose or dose 
commitment in excess of the dose to the appropriate organ as specified 
in Column IV of the table in Sec.32.24.
    (3) Each device bears a durable, legible, clearly visible label or 
labels approved by the Commission which contain in a clearly identified 
and separate statement:
    (i) Instructions and precautions necessary to assure safe 
installation, operation, and servicing of the device (documents such as 
operating and service manuals may be identified in the label and used to 
provide this information);

[[Page 639]]

    (ii) The requirements, or lack of requirement, for leak testing, or 
for testing any on-off mechanism and indicator, including the maximum 
time interval for such testing, and the identification of radioactive 
material by isotope, quantity of radioactivity, and date of 
determination of the quantity; and
    (iii) The information called for in the following statement in the 
same or substantially similar form: \1\
---------------------------------------------------------------------------

    \1\ Devices licensed under Sec.32.51 prior to January 19, 1975 may 
bear labels authorized by the regulations in effect on January 1, 1975.

    The receipt, possession, use, and transfer of this device Model ____ 
\2\, Serial No.___ \2\, are subject to a general license or the 
equivalent and the regulations of the U.S. NRC or of a State with which 
the NRC has entered into an agreement for the exercise of regulatory 
authority. This label shall be maintained on the device in a legible 
condition. Removal of this label is prohibited.
---------------------------------------------------------------------------

    \2\ The model, serial number, and the name of the manufacturer, or 
initial transferor may be omitted from this label provided the 
information is elsewhere specified in labeling affixed to the device.
---------------------------------------------------------------------------

                      CAUTION--RADIOACTIVE MATERIAL

________________________________________________________________________
(Name of manufacturer, or initial transferor) \2\

    (4) Each device having a separable source housing that provides the 
primary shielding for the source also bears, on the source housing, a 
durable label containing the device model number and serial number, the 
isotope and quantity, the words, ``Caution-Radioactive Material,'' the 
radiation symbol described in Sec.20.1901 of this chapter, and the 
name of the manufacturer or initial distributor.
    (5) Each device meeting the criteria of Sec.31.5(c)(13)(i) of this 
chapter, bears a permanent (e.g., embossed, etched, stamped, or 
engraved) label affixed to the source housing if separable, or the 
device if the source housing is not separable, that includes the words, 
``Caution-Radioactive Material,'' and, if practicable, the radiation 
symbol described in Sec.20.1901 of this chapter.
    (6) The device has been registered in the Sealed Source and Device 
Registry.
    (b) In the event the applicant desires that the device be required 
to be tested at intervals longer than six months, either for proper 
operation of the on-off mechanism and indicator, if any, or for leakage 
of radioactive material or for both, he shall include in this 
application sufficient information to demonstrate that such longer 
interval is justified by performance characteristics of the device or 
similar devices, and by design features which have a significant bearing 
on the probability or consequences of leakage of radioactive material 
from the device or failure of the on-off mechanism and indicator. In 
determining the acceptable interval for the test for leakage of 
radioactive material, the Commission will consider information which 
includes, but is not limited to:
    (1) Primary containment (source capsule);
    (2) Protection of primary containment;
    (3) Method of sealing containment;
    (4) Containment construction materials;
    (5) Form of contained radioactive material;
    (6) Maximum temperature withstood during prototype tests;
    (7) Maximum pressure withstood during prototype tests;
    (8) Maximum quantity of contained radioactive material;
    (9) Radiotoxicity of contained radioactive material; and
    (10) Operating experience with identical devices or similarly 
designed and constructed devices.
    (c) In the event the applicant desires that the general licensee 
under Sec.31.5 of this chapter, or under equivalent regulations of an 
Agreement State, be authorized to install the device, collect the sample 
to be analyzed by a specific licensee for leakage of radioactive 
material, service the device, test the on-off mechanism and indicator, 
or remove the device from installation, the applicant shall include in 
the application written instructions to be followed by the general 
licensee, estimated calendar quarter doses associated with such activity 
or activities, and the bases for these estimates. The submitted 
information must demonstrate that performance of this activity or 
activities by an individual untrained in radiological protection, in 
addition to

[[Page 640]]

other handling, storage, and use of devices under the general license, 
is unlikely to cause that individual to receive a dose in excess of 10 
percent of the annual limits specified in Sec.20.1201(a) of this 
chapter.

[39 FR 43533, Dec. 16, 1974, as amended at 40 FR 8785, Mar. 3, 1975; 42 
FR 25721, May 19, 1977; 43 FR 6923, Feb. 17, 1978; 58 FR 67660, Dec. 22, 
1993; 59 FR 5520, Feb. 7, 1994; 65 FR 79189, Dec. 18, 2000; 77 FR 43693, 
July 25, 2012]



Sec.32.51a  Same: Conditions of licenses.

    (a) If a device containing byproduct material is to be transferred 
for use under the general license contained in Sec.31.5 of this 
chapter, each person that is licensed under Sec.32.51 shall provide 
the information specified in this paragraph to each person to whom a 
device is to be transferred. This information must be provided before 
the device may be transferred. In the case of a transfer through an 
intermediate person, the information must also be provided to the 
intended user prior to initial transfer to the intermediate person. The 
required information includes--
    (1) A copy of the general license contained in Sec.31.5 of this 
chapter; if paragraphs (c)(2) through (4) or (c)(13) of Sec.31.5 do 
not apply to the particular device, those paragraphs may be omitted.
    (2) A copy of Sec. Sec.31.2, 30.51, 20.2201, and 20.2202 of this 
chapter;
    (3) A list of the services that can only be performed by a specific 
licensee;
    (4) Information on acceptable disposal options including estimated 
costs of disposal; and
    (5) An indication that NRC's policy is to issue high civil penalties 
for improper disposal.
    (b) If byproduct material is to be transferred in a device for use 
under an equivalent general license of an Agreement State, each person 
that is licensed under Sec.32.51 shall provide the information 
specified in this paragraph to each person to whom a device is to be 
transferred. This information must be provided before the device may be 
transferred. In the case of a transfer through an intermediate person, 
the information must also be provided to the intended user prior to 
initial transfer to the intermediate person. The required information 
includes--
    (1) A copy of the Agreement State's regulations equivalent to 
Sec. Sec.31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter or a 
copy of Sec. Sec.31.5, 31.2, 30.51, 20.2201, and 20.2202 of this 
chapter. If a copy of the NRC regulations is provided to a prospective 
general licensee in lieu of the Agreement State's regulations, it shall 
be accompanied by a note explaining that use of the device is regulated 
by the Agreement State; if certain paragraphs of the regulations do not 
apply to the particular device, those paragraphs may be omitted.
    (2) A list of the services that can only be performed by a specific 
licensee;
    (3) Information on acceptable disposal options including estimated 
costs of disposal; and
    (4) The name or title, address, and phone number of the contact at 
the Agreement State regulatory agency from which additional information 
may be obtained.
    (c) An alternative approach to informing customers may be proposed 
by the licensee for approval by the Commission.
    (d) Each device that is transferred after February 19, 2002 must 
meet the labeling requirements in Sec.32.51(a)(3) through (5).
    (e) If a notification of bankruptcy has been made under Sec.
30.34(h) or the license is to be terminated, each person licensed under 
Sec.32.51 shall provide, upon request, to the NRC and to any 
appropriate Agreement State, records of final disposition required under 
Sec.32.52(c).

[65 FR 79189, Dec. 18, 2000; 65 FR 80991, Dec. 22, 2000]



Sec.32.52  Same: material transfer reports and records.

    Each person licensed under Sec.32.51 to initially transfer devices 
to generally licensed persons shall comply with the requirements of this 
section.
    (a) The person shall report to the Director, Office of Nuclear 
Material Safety and Safeguards , ATTN: GLTS, by an appropriate method 
listed in Sec.30.6(a) of this chapter, all transfers of such devices 
to persons for use under the general license in Sec.31.5 of this 
chapter and all receipts of devices from persons licensed under Sec.
31.5 of this chapter. The

[[Page 641]]

report must be submitted on a quarterly basis on NRC Form 653--
``Transfers of Industrial Devices Report'' or in a clear and legible 
report containing all of the data required by the form.
    (1) The required information for transfers to general licensees 
includes--
    (i) The identity of each general licensee by name and mailing 
address for the location of use; if there is no mailing address for the 
location of use, an alternate address for the general licensee shall be 
submitted along with information on the actual location of use.
    (ii) The name, title, and phone number of the person identified by 
the general licensee as having knowledge of and authority to take 
required actions to ensure compliance with the appropriate regulations 
and requirements;
    (iii) The date of transfer;
    (iv) The type, model number, and serial number of the device 
transferred; and
    (v) The quantity and type of byproduct material contained in the 
device.
    (2) If one or more intermediate persons will temporarily possess the 
device at the intended place of use before its possession by the user, 
the report must include the same information for both the intended user 
and each intermediate person, and clearly designate the intermediate 
person(s).
    (3) For devices received from a Sec.31.5 general licensee, the 
report must include the identity of the general licensee by name and 
address, the type, model number, and serial number of the device 
received, the date of receipt, and, in the case of devices not initially 
transferred by the reporting licensee, the name of the manufacturer or 
initial transferor.
    (4) If the licensee makes changes to a device possessed by a Sec.
31.5 general licensee, such that the label must be changed to update 
required information, the report must identify the general licensee, the 
device, and the changes to information on the device label.
    (5) The report must cover each calendar quarter, must be filed 
within 30 days of the end of the calendar quarter, and must clearly 
indicate the period covered by the report.
    (6) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (7) If no transfers have been made to or from persons generally 
licensed under Sec.31.5 of this chapter during the reporting period, 
the report must so indicate.
    (b) The person shall report all transfers of devices to persons for 
use under a general license in an Agreement State's regulations that are 
equivalent to Sec.31.5 of this chapter and all receipts of devices 
from general licensees in the Agreement State's jurisdiction to the 
responsible Agreement State agency. The report must be submitted on Form 
653--``Transfers of Industrial Devices Report'' or in a clear and 
legible report containing all of the data required by the form.
    (1) The required information for transfers to general licensees 
includes--
    (i) The identity of each general licensee by name and mailing 
address for the location of use; if there is no mailing address for the 
location of use, an alternate address for the general licensee shall be 
submitted along with information on the actual location of use.
    (ii) The name, title, and phone number of the person identified by 
the general licensee as having knowledge of and authority to take 
required actions to ensure compliance with the appropriate regulations 
and requirements;
    (iii) The date of transfer;
    (iv) The type, model number, and serial number of the device 
transferred; and
    (v) The quantity and type of byproduct material contained in the 
device.
    (2) If one or more intermediate persons will temporarily possess the 
device at the intended place of use before its possession by the user, 
the report must include the same information for both the intended user 
and each intermediate person, and clearly designate the intermediate 
person(s).
    (3) For devices received from a general licensee, the report must 
include the identity of the general licensee by name and address, the 
type, model number, and serial number of the device received, the date 
of receipt, and,

[[Page 642]]

in the case of devices not initially transferred by the reporting 
licensee, the name of the manufacturer or initial transferor.
    (4) If the licensee makes changes to a device possessed by a general 
licensee, such that the label must be changed to update required 
information, the report must identify the general licensee, the device, 
and the changes to information on the device label.
    (5) The report must cover each calendar quarter, must be filed 
within 30 days of the end of the calendar quarter, and must clearly 
indicate the period covered by the report.
    (6) The report must clearly identify the specific licensee 
submitting the report and must include the license number of the 
specific licensee.
    (7) If no transfers have been made to or from a particular Agreement 
State during the reporting period, this information shall be reported to 
the responsible Agreement State agency upon request of the agency.
    (c) The person shall maintain all information concerning transfers 
and receipts of devices that supports the reports required by this 
section. Records required by this paragraph must be maintained for a 
period of 3 years following the date of the recorded event.

[65 FR 79189, Dec. 18, 2000, as amended at 68 FR 58805, Oct. 10, 2003; 
73 FR 5719, Jan. 31, 2008]



Sec.32.53  Luminous safety devices for use in aircraft: Requirements
for license to manufacture, assemble, repair or initially transfer.

    An application for a specific license to manufacture, assemble, 
repair or initially transfer luminous safety devices containing tritium 
or promethium-147 for use in aircraft, for distribution to persons 
generally licensed under Sec.31.7 of this chapter, will be approved 
if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter;
    (b) The applicant submits sufficient information regarding each 
device pertinent to evaluation of the potential radiation exposure, 
including:
    (1) Chemical and physical form and maximum quantity of tritium or 
promethium-147 in each device;
    (2) Details of construction and design;
    (3) Details of the method of binding or containing the tritium or 
promethium-147;
    (4) Procedures for and results of prototype testing to demonstrate 
that the tritium or promethium-147 will not be released to the 
environment under the most severe conditions likely to be encountered in 
normal use;
    (5) Quality assurance procedures to be followed that are sufficient 
to ensure compliance with Sec.32.55;
    (6) Any additional information, including experimental studies and 
tests, required by the Commission to facilitate a determination of the 
safety of the device.
    (c) Each device will contain no more than 10 curies of tritium or 
300 millicuries of promethium-147. The levels of radiation from each 
device containing promethium-147 will not exceed 0.5 millirad per hour 
at 10 centimeters from any surface when measured through 50 milligrams 
per square centimeter of absorber.
    (d) The Commission determines that:
    (1) The method of incorporation and binding of the tritium or 
promethium-147 in the device is such that the tritium or promethium-147 
will not be released under the most severe conditions which are likely 
to be encountered in normal use and handling of the device;
    (2) The tritium or promethium-147 is incorporated or enclosed so as 
to preclude direct physical contact by any person with it;
    (3) The device is so designed that it cannot easily be disassembled; 
and
    (4) Prototypes of the device have been subjected to and have 
satisfactorily passed the tests required by paragraph (e) of this 
section.
    (e) The applicant shall subject at least five prototypes of the 
device to tests as follows:
    (1) The devices are subjected to tests that adequately take into 
account the individual, aggregate, and cumulative effects of 
environmental conditions expected in service that could adversely affect 
the effective containment of tritium or promethium-147, such as

[[Page 643]]

temperature, moisture, absolute pressure, water immersion, vibration, 
shock, and weathering.
    (2) The devices are inspected for evidence of physical damage and 
for loss of tritium or promethium-147, after each stage of testing, 
using methods of inspection adequate for determining compliance with the 
criteria in paragraph (e)(3) of this section.
    (3) Device designs are rejected for which the following has been 
detected for any unit:
    (i) A leak resulting in a loss of 0.1 percent or more of the 
original amount of tritium or promethium-147 from the device; or
    (ii) Surface contamination of tritium or promethium-147 on the 
device of more than 2,200 disintegrations per minute per 100 square 
centimeters of surface area; or
    (iii) Any other evidence of physical damage.
    (f) The device has been registered in the Sealed Source and Device 
Registry.

[30 FR 8192, June 26, 1965, as amended at 33 FR 6463, Apr. 27, 1968; 43 
FR 6923, Feb. 17, 1978; 77 FR 43693, July 25, 2012]



Sec.32.54  Same: Labeling of devices.

    (a) A person licensed under Sec.32.53 to manufacture, assemble, or 
initially transfer devices containing tritium or promethium-147 for 
distribution to persons generally licensed under Sec.31.7 of this 
chapter shall, except as provided in paragraph (b) of this section, 
affix to each device a label containing the radiation symbol prescribed 
by Sec.20.1901 of this chapter, such other information as may be 
required by the Commission including disposal instructions when 
appropriate, and the following or a substantially similar statement 
which contains the information called for in the following statement: 
\1\
---------------------------------------------------------------------------

    \1\ Devices licensed under Sec.32.53 prior to January 19, 1975 may 
bear labels authorized by the regulations in effect on January 1, 1975.

    The receipt, possession, use, and transfer of this device, Model* 
_______, Serial No.* ___, containing ______ (Identity and quantity of 
radioactive material) are subject to a general license or the equivalent 
and the regulations of the U.S. NRC or of a State with which the NRC has 
entered into an agreement for the exercise of regulatory authority. Do 
not remove this label.

                      CAUTION--RADIOACTIVE MATERIAL

________________________________________________________________________
(Name of manufacturer, assembler, or initial transferor.)*
    *The model, serial number, and name of manufacturer, assembler, or 
initial transferor may be omitted from this label provided they are 
elsewhere specified in labeling affixed to the device.

    (b) If the Commission determines that it is not feasible to affix a 
label to the device containing all the information called for in 
paragraph (a) of this section, it may waive the requirements of that 
paragraph and require in lieu thereof that:
    (1) A label be affixed to the device identifying:
    (i) The manufacturer, assembler, or initial transferor; and
    (ii) The type of radioactive material; and
    (2) A leaflet bearing the following information be enclosed in or 
accompany the container in which the device is shipped:
    (i) The name of the manufacturer, assembler, or initial transferor,
    (ii) The type and quantity of radioactive material,
    (iii) The model number,
    (iv) A statement that the receipt, possession, use, and transfer of 
the device are subject to a general license or the equivalent and the 
regulations of the U.S. NRC or of an Agreement State, and
    (v) Such other information as may be required by the Commission, 
including disposal instructions when appropriate.

[33 FR 16331, Nov. 7, 1968, as amended at 40 FR 8785, Mar. 3, 1975; 43 
FR 6923, Feb. 17, 1978; 63 FR 39483, July 23, 1998]



Sec.32.55  Same: Quality assurance, prohibition of transfer.

    (a) Each person licensed under Sec.32.53 shall visually inspect 
each device and shall reject any that has an observable physical defect 
that could adversely affect containment of the tritium or promethium-
147.
    (b) Each person licensed under Sec.32.53 shall:
    (1) Maintain quality assurance systems in the manufacture of the 
luminous safety device in a manner sufficient to provide reasonable 
assurance that the safety-related components of

[[Page 644]]

the distributed devices are capable of performing their intended 
functions; and
    (2) Subject inspection lots to acceptance sampling procedures, by 
procedures specified in paragraph (c) of this section and in the license 
issued under Sec.32.53, to provide at least 95 percent confidence that 
the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.
    (c) The licensee shall subject each inspection lot to:
    (1) Tests that adequately take into account the individual, 
aggregate, and cumulative effects of environmental conditions expected 
in service that could adversely affect the effective containment of 
tritium or promethium-147, such as absolute pressure and water 
immersion.
    (2) Inspection for evidence of physical damage, containment failure, 
or for loss of tritium or promethium-147 after each stage of testing, 
using methods of inspection adequate for applying the following criteria 
for defective:
    (i) A leak resulting in a loss of 0.1 percent or more of the 
original amount of tritium or promethium-147 from the device;
    (ii) Levels of radiation in excess of 5 microgray (0.5 millirad) per 
hour at 10 centimeters from any surface when measured through 50 
milligrams per square centimeter of absorber, if the device contains 
promethium-147; and
    (iii) Any other criteria specified in the license issued under Sec.
32.53.
    (d) No person licensed under Sec.32.53 shall transfer to persons 
generally licensed under Sec.31.7 of this chapter, or under an 
equivalent general license of an Agreement State:
    (1) Any luminous safety device tested and found defective under any 
condition of a license issued under Sec.32.53, or paragraph (b) of 
this section, unless the defective luminous safety device has been 
repaired or reworked, retested, and determined by an independent 
inspector to meet the applicable acceptance criteria; or
    (2) Any luminous safety device contained within any lot that has 
been sampled and rejected as a result of the procedures in paragraph 
(b)(2) of this section, unless:
    (i) A procedure for defining sub-lot size, independence, and 
additional testing procedures is contained in the license issued under 
Sec.32.53; and
    (ii) Each individual sub-lot is sampled, tested, and accepted in 
accordance with paragraphs (b)(2) and (d)(2)(i) of this section and any 
other criteria that may be required as a condition of the license issued 
under Sec.32.53.

[77 FR 43693, July 25, 2012]



Sec.32.56  Same: Material transfer reports.

    (a) Each person licensed under Sec.32.53 shall file an annual 
report with the Director, Office of Nuclear Material Safety and 
Safeguards , ATTN: Document Control Desk/GLTS, by an appropriate method 
listed in Sec.30.6(a) of this chapter, which must state the total 
quantity of tritium or promethium-147 transferred to persons generally 
licensed under Sec.31.7 of this chapter. The report must identify each 
general licensee by name, state the kinds and numbers of luminous 
devices transferred, and specify the quantity of tritium or promethium-
147 in each kind of device. Each report must cover the year ending June 
30 and must be filed within thirty (30) days thereafter. If no transfers 
have been made to persons generally licensed under Sec.31.7 of this 
chapter during the reporting period, the report must so indicate.
    (b) Each person licensed under Sec.32.53 shall report annually all 
transfers of devices to persons for use under a general license in an 
Agreement State's regulations that are equivalent to Sec.31.7 of this 
chapter to the responsible Agreement State agency. The report must state 
the total quantity of tritium or promethium-147 transferred, identify 
each general licensee by name, state the kinds and numbers of luminous 
devices transferred, and specify the quantity of tritium or promethium-
147 in each kind of device. If no transfers have been made to a 
particular Agreement State during the reporting period, this information 
must be reported to the responsible Agreement State agency upon request 
of the agency.

[77 FR 43694, July 25, 2012]

[[Page 645]]



Sec.32.57  Calibration or reference sources containing americium-241
or radium-226: Requirements for license to manufacture or initially
transfer.

    An application for a specific license to manufacture or initially 
transfer calibration or reference sources containing americium-241 or 
radium-226, for distribution to persons generally licensed under Sec.
31.8 of this chapter, will be approved if:
    (a) The applicant satisfies the general requirements of Sec.30.33 
of this chapter;
    (b) The applicant submits sufficient information regarding each type 
of calibration or reference source pertinent to evaluation of the 
potential radiation exposure, including:
    (1) Chemical and physical form and maximum quantity of americium 241 
or radium-226 in the source;
    (2) Details of construction and design;
    (3) Details of the method of incorporation and binding of the 
americium-241 or radium-226 in the source;
    (4) Procedures for and results of prototype testing of sources, 
which are designed to contain more than 0.005 microcurie of americium-
241 or radium-226, to demonstrate that the americium-241 or radium-226 
contained in each source will not be released or be removed from the 
source under normal conditions of use;
    (5) Details of quality control procedures to be followed in 
manufacture of the source;
    (6) Description of labeling to be affixed to the source or the 
storage container for the source;
    (7) Any additional information, including experimental studies and 
tests, required by the Commission to facilitate a determination of the 
safety of the source.
    (c) Each source will contain no more than 5 microcuries of 
americium-241 or radium-226.
    (d) The Commission determines, with respect to any type of source 
containing more than 0.005 microcurie of americium-241 or radium-226, 
that:
    (1) The method of incorporation and binding of the americium-241 or 
radium-226 in the source is such that the americium-241 or radium-226 
will not be released or be removed from the source under normal 
conditions of use and handling of the source; and
    (2) The source has been subjected to and has satisfactorily passed 
appropriate tests required by paragraph (e) of this section.
    (e) The applicant shall subject at least five prototypes of each 
source that is designed to contain more than 0.185 kilobecquerel (0.005 
microcurie) of americium-241 or radium-226 to tests as follows:
    (1) The initial quantity of radioactive material deposited on each 
source is measured by direct counting of the source.
    (2) The sources are subjected to tests that adequately take into 
account the individual, aggregate, and cumulative effects of 
environmental conditions expected in service that could adversely affect 
the effective containment or binding of americium-241 or radium-226, 
such as physical handling, moisture, and water immersion.
    (3) The sources are inspected for evidence of physical damage and 
for loss of americium-241 or radium-226, after each stage of testing, 
using methods of inspection adequate for determining compliance with the 
criteria in paragraph (e)(4) of this section.
    (4) Source designs are rejected for which the following has been 
detected for any unit: Removal of more than 0.185 kilobecquerel (0.005 
microcurie) of americium-241 or radium-226 from the source or any other 
evidence of physical damage.

[30 FR 8192, June 26, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 72 
FR 55928, Oct. 1, 2007; 73 FR 42674, July 23, 2008; 77 FR 43694, July 
25, 2012]



Sec.32.58  Same: Labeling of devices.

    Each person licensed under Sec.32.57 shall affix to each source, 
or storage container for the source, a label which shall contain 
sufficient information relative to safe use and storage of the source 
and shall include the following statement or a substantially similar

[[Page 646]]

statement which contains the information called for in the following 
statement: \1\
---------------------------------------------------------------------------

    \1\ Sources licensed under Sec.32.57 before January 19, 1975, may 
bear labels authorized by the regulations in effect on January 1, 1975.
---------------------------------------------------------------------------

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

CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241 (or 
RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE

________________________________________________________________________

(Name of manufacturer or initial transferor)

[72 FR 55929, Oct. 1, 2007]



Sec.32.59  Same: Leak testing of each source.

    Each person licensed under Sec.32.57 shall perform a dry wipe test 
upon each source containing more than 3.7 kilobecquerels (0.1 
microcurie) of americium-241 or radium-226 before transferring the 
source to a general licensee under Sec.31.8 of this chapter or under 
equivalent regulations of an Agreement State. This test must be 
performed by wiping the entire radioactive surface of the source with a 
filter paper with the application of moderate finger pressure. The 
radioactivity on the filter paper must be measured using methods capable 
of detecting 0.185 kilobecquerel (0.005 microcurie) of americium-241 or 
radium-226. If a source has been shown to be leaking or losing more than 
0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 by 
the methods described in this section, the source must be rejected and 
must not be transferred to a general licensee under Sec.31.8 of this 
chapter, or equivalent regulations of an Agreement State.

[77 FR 43694, July 25, 2012]



Sec.32.60  [Reserved]



Sec.32.61  Ice detection devices containing strontium-90;
requirements for license to manufacture or initially transfer.

    An application for a specific license to manufacture or initially 
transfer ice detection devices containing strontium-90 for distribution 
to persons generally licensed under Sec.31.10 of this chapter will be 
approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter;
    (b) The applicant submits sufficient information regarding each type 
of device pertinent to evaluation of the potential radiation exposure, 
including:
    (1) Chemical and physical form and maximum quantity of strontium-90 
in the device;
    (2) Details of construction and design of the source of radiation 
and its shielding;
    (3) Radiation profile of a prototype device;
    (4) Procedures for and results of prototype testing of devices to 
demonstrate that the strontium-90 contained in each device will not be 
released or be removed from the device under the most severe conditions 
likely to be encountered in normal handling and use;
    (5) Details of quality control procedures to be followed in 
manufacture of the device;
    (6) Description of labeling to be affixed to the device;
    (7) Instructions for handling and installation of the device;
    (8) Any additional information, including experimental studies and 
tests, required by the Commission to facilitate a determination of the 
safety of the device;
    (c) Each device will contain no more than 50 microcuries of 
strontium-90 in an insoluble form;
    (d) Each device will bear durable, legible labeling which includes 
the radiation caution symbol prescribed by Sec.20.1901(a) of this 
chapter, a statement that the device contains strontium-90 and the 
quantity thereof, instructions for disposal and statements that the 
device may be possessed pursuant to a general license, that the 
manufacturer

[[Page 647]]

or civil authorities should be notified if the device is found, that 
removal of the labeling is prohibited and that disassembly and repair of 
the device may be performed only by a person holding a specific license 
to manufacture or service such devices;
    (e) The Commission determines that:
    (1) The method of incorporation and binding of the strontium-90 in 
the device is such that the strontium-90 will not be released from the 
device under the most severe conditions which are likely to be 
encountered in normal use and handling of the device;
    (2) The strontium-90 is incorporated or enclosed so as to preclude 
direct physical contact by any individual with it and is shielded so 
that no individual will receive a radiation exposure to a major portion 
of his body in excess of 0.5 rem in a year under ordinary circumstances 
of use;
    (3) The device is so designed that it cannot be easily disassembled;
    (4) Prototypes of the device have been subjected to and have 
satisfactorily passed the tests required by paragraph (f) of this 
section.
    (5) Quality control procedures have been established to satisfy the 
requirements of Sec.32.62.
    (f) The applicant shall subject at least five prototypes of the 
device to tests as follows:
    (1) The devices are subjected to tests that adequately take into 
account the individual, aggregate, and cumulative effects of 
environmental conditions expected in service that could adversely affect 
the effective containment of strontium-90, such as temperature, 
moisture, absolute pressure, water immersion, vibration, shock, and 
weathering.
    (2) The devices are inspected for evidence of physical damage and 
for loss of strontium-90 after each stage of testing, using methods of 
inspection adequate for determining compliance with the criteria in 
paragraph (f)(3) of this section.
    (3) Device designs are rejected for which the following has been 
detected for any unit:
    (i) A leak resulting in a loss of 0.1 percent or more of the 
original amount of strontium-90 from the device; or
    (ii) Surface contamination of strontium-90 on the device of more 
than 2,200 disintegrations per minute per 100 square centimeters of 
surface area; or
    (iii) Any other evidence of physical damage.
    (g) The device has been registered in the Sealed Source and Device 
Registry.

[30 FR 9905, Aug. 10, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 56 
FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 77 FR 43694, July 
25, 2012]



Sec.32.62  Same: Quality assurance; prohibition of transfer.

    (a) Each person licensed under Sec.32.61 shall visually inspect 
each device and shall reject any which has an observable physical defect 
that could affect containment of the strontium-90.
    (b) Each person licensed under Sec.32.61 shall test each device 
for possible loss of strontium-90 or for contamination by wiping with 
filter paper an area of at least 100 square centimeters on the outside 
surface of the device, or by wiping the entire surface area if it is 
less than 100 square centimeters. The detection on the filter paper of 
more than 2,200 disintegrations per minute of radioactive material per 
100 square centimeters of surface wiped shall be cause for rejection of 
the tested device.
    (c) Each person licensed under Sec.32.61 shall:
    (1) Maintain quality assurance systems in the manufacture of the ice 
detection device containing strontium-90 in a manner sufficient to 
provide reasonable assurance that the safety-related components of the 
distributed devices are capable of performing their intended functions; 
and
    (2) Subject inspection lots to acceptance sampling procedures, by 
procedures specified in paragraph (d) of this section and in the license 
issued under Sec.32.61, to provide at least 95 percent confidence that 
the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.
    (d) Each person licensed under Sec.32.61 shall subject each 
inspection lot to:
    (1) Tests that adequately take into account the individual, 
aggregate, and cumulative effects of environmental conditions expected 
in service that

[[Page 648]]

could possibly affect the effective containment of strontium-90, such as 
absolute pressure and water immersion.
    (2) Inspection for evidence of physical damage, containment failure, 
or for loss of strontium-90 after each stage of testing, using methods 
of inspection adequate to determine compliance with the following 
criteria for defective: A leak resulting in a loss of 0.1 percent or 
more of the original amount of strontium-90 from the device and any 
other criteria specified in the license issued under Sec.32.61.
    (e) No person licensed under Sec.32.61 shall transfer to persons 
generally licensed under Sec.31.10 of this chapter, or under an 
equivalent general license of an Agreement State:
    (1) Any ice detection device containing strontium-90 tested and 
found defective under the criteria specified in a license issued under 
Sec.32.61, unless the defective ice detection device has been repaired 
or reworked, retested, and determined by an independent inspector to 
meet the applicable acceptance criteria; or
    (2) Any ice detection device containing strontium-90 contained 
within any lot that has been sampled and rejected as a result of the 
procedures in paragraph (c)(2) of this section, unless:
    (i) A procedure for defining sub-lot size, independence, and 
additional testing procedures is contained in the license issued under 
Sec.32.61; and
    (ii) Each individual sub-lot is sampled, tested, and accepted in 
accordance with paragraphs (c)(2) and (e)(2)(i) of this section and any 
other criteria as may be required as a condition of the license issued 
under Sec.32.61.

[30 FR 9905, Aug. 10, 1965, as amended at 39 FR 22130, June 20, 1974; 39 
FR 26397, July 19, 1974; 43 FR 6923, Feb. 17, 1978; 77 FR 43694, July 
25, 2012]



Sec.32.71  Manufacture and distribution of byproduct material 
for certain in vitro clinical or laboratory testing under general
license.

    An application for a specific license to manufacturer or distribute 
byproduct material for use under the general license of Sec.31.11 of 
this chapter will be approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter.
    (b) The byproduct material is to be prepared for distribution in 
prepackaged units of:
    (1) Iodine-125 in units not exceeding 10 microcuries each.
    (2) Iodine-131 in units not exceeding 10 microcuries each.
    (3) Carbon-14 in units not exceeding 10 microcuries each.
    (4) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each.
    (5) Iron-59 in units not exceeding 20 microcuries each.
    (6) Selenium-75 in units not exceeding 10 microcuries each.
    (7) Mock Iodine-125 in units not exceeding 0.05 microcurie of 
iodine-129 and 0.005 microcurie of americium-241 each.
    (8) Cobalt-57 in units not exceeding 0.37 megabecquerel (10 
microcuries) each.
    (c) Each prepackaged unit bears a durable, clearly visible label:
    (1) Identifying the radioactive contents as to chemical form and 
radionuclide, and indicating that the amount of radioactivity does not 
exceed 0.37 megabecquerel (10 microcuries) of iodine-131, iodine-125, 
selenium-75, or carbon-14; 1.85 megabecquerels (50 microcuries) of 
hydrogen-3 (tritium); or 0.74 megabecquerel (20 microcuries) of iron-59; 
or Mock Iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 
microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of 
americium-241 each; or cobalt-57 in units not exceeding 0.37 
megabecquerel (10 microcuries); and
    (2) Displaying the radiation caution symbol described in Sec.
20.1901(a) of this chapter and the words, ``Caution, Radioactive 
Material'', and ``Not for Internal or External Use in Humans or 
Animals.''
    (d) The following statement, or a substantially similar statement 
which contains the information called for in the following statement, 
appears on a label affixed to each prepackaged unit

[[Page 649]]

or appears in a leaflet or brochure which accompanies the package: \1\
---------------------------------------------------------------------------

    \1\ Labels authorized by the regulations in effect on September 26, 
1979, may be used until one year from September 27, 1979.

    The radioactive material may be received, acquired, possessed, and 
used only by physicians, veterinarians in the practice of veterinary 
medicine, clinical laboratories or hospitals and only for in vitro 
clinical or laboratory tests not involving internal or external 
administration of the material, or the radiation therefrom, to human 
beings or animals. Its receipt, acquisition, possession, use, and 
transfer are subject to the regulations and a general license of the 
U.S. Nuclear Regulatory Commission or of a State with which the 
Commission has entered into an agreement for the exercise of regulatory 
authority.
________________________________________________________________________
(Name of Manufacturer)

    (e) The label affixed to the unit, or the leaflet or brochure which 
accompanies the package, contains adequate information as to the 
precautions to be observed in handling and storing such byproduct 
material. In the case of the Mock Iodine-125 reference or calibration 
source, the information accompanying the source must also contain 
directions to the licensee regarding the waste disposal requirements set 
out in Sec.20.2001.

[33 FR 16553, Nov. 14, 1968, as amended at 38 FR 34110, Dec. 11, 1973; 
39 FR 26148, July 17, 1974; 40 FR 8786, Mar. 3, 1975; 42 FR 21604, Apr. 
28, 1977; 42 FR 26987, May 26, 1977; 44 FR 50325, Aug. 28, 1979; 56 FR 
23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 72 FR 55929, Oct. 1, 
2007]



                  Subpart C_Specifically Licensed Items



Sec.32.72  Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35.

    (a) An application for a specific license to manufacture, prepare, 
or transfer for commercial distribution radioactive drugs containing 
byproduct material for use by persons authorized pursuant to part 35 of 
this chapter will be approved if:
    (1) The applicant satisfies the general requirements specified in 10 
CFR 30.33;
    (2) The applicant submits evidence that the applicant is at least 
one of the following:
    (i) Registered with the U.S. Food and Drug Administration (FDA) as 
the owner or operator of a drug establishment that engages in the 
manufacture, preparation, propagation, compounding, or processing of a 
drug under 21 CFR 207.20(a);
    (ii) Registered or licensed with a state agency as a drug 
manufacturer;
    (iii) Licensed as a pharmacy by a State Board of Pharmacy;
    (iv) Operating as a nuclear pharmacy within a Federal medical 
institution; or
    (v) A Positron Emission Tomography (PET) drug production facility 
registered with a State agency.
    (3) The applicant submits information on the radionuclide; the 
chemical and physical form; the maximum activity per vial, syringe, 
generator, or other container of the radioactive drug; and the shielding 
provided by the packaging to show it is appropriate for the safe 
handling and storage of the radioactive drugs by medical use licensees; 
and
    (4) The applicant satisfies the following labeling requirements:
    (i) A label is affixed to each transport radiation shield, whether 
it is constructed of lead, glass, plastic, or other material, of a 
radioactive drug to be transferred for commercial distribution. The 
label must include the radiation symbol and the words ``CAUTION, 
RADIOACTIVE MATERIAL'' or ``DANGER, RADIOACTIVE MATERIAL''; the name of 
the radioactive drug or its abbreviation; and the quantity of 
radioactivity at a specified date and time. For radioactive drugs with a 
half life greater than 100 days, the time may be omitted.
    (ii) A label is affixed to each syringe, vial, or other container 
used to hold a radioactive drug to be transferred for commercial 
distribution. The label must include the radiation symbol and the words 
``CAUTION, RADIOACTIVE MATERIAL'' or ``DANGER, RADIOACTIVE MATERIAL'' 
and an identifier that ensures that the syringe, vial, or other 
container can be correlated with the information on the transport 
radiation shield label.

[[Page 650]]

    (b) A licensee described by paragraph (a)(2)(iii) or (iv) of this 
section:
    (1) May prepare radioactive drugs for medical use, as defined in 10 
CFR 35.2, provided that the radioactive drug is prepared by either an 
authorized nuclear pharmacist, as specified in paragraphs (b)(2) and 
(b)(4) of this section, or an individual under the supervision of an 
authorized nuclear pharmacist as specified in 10 CFR 35.27.
    (2) May allow a pharmacist to work as an authorized nuclear 
pharmacist if:
    (i) This individual qualifies as an authorized nuclear pharmacist as 
defined in 10 CFR 35.2,
    (ii) This individual meets the requirements specified in Sec.
35.55(b) and 35.59 of this chapter, and the licensee has received an 
approved license amendment identifying this individual as an authorized 
nuclear pharmacist; or
    (iii) This individual is designated as an authorized nuclear 
pharmacist in accordance with paragraph (b)(4) of this section.
    (3) The actions authorized in paragraphs (b)(1) and (b)(2) of this 
section are permitted in spite of more restrictive language in license 
conditions.
    (4) May designate a pharmacist (as defined in Sec.35.2 of this 
chapter) as an authorized nuclear pharmacist if:
    (i) The individual was a nuclear pharmacist preparing only 
radioactive drugs containing accelerator-produced radioactive material, 
and
    (ii) The individual practiced at a pharmacy at a Government agency 
or Federally recognized Indian Tribe before November 30, 2007 or at all 
other pharmacies before August 8, 2009, or an earlier date as noticed by 
the NRC.
    (5) Shall provide to the Commission:
    (i) A copy of each individual's certification by a specialty board 
whose certification process has been recognized by the Commission or an 
Agreement State as specified in Sec.35.55(a) of this chapter with the 
written attestation signed by a preceptor as required by Sec.
35.55(b)(2) of this chapter; or
    (ii) The Commission or Agreement State license, or
    (iii) Commission master materials licensee permit, or
    (iv) The permit issued by a licensee or Commission master materials 
permittee of broad scope or the authorization from a commercial nuclear 
pharmacy authorized to list its own authorized nuclear pharmacist, or
    (v) Documentation that only accelerator-produced radioactive 
materials were used in the practice of nuclear pharmacy at a Government 
agency or Federally recognized Indian Tribe before November 30, 2007 or 
at all other locations of use before August 8, 2009, or an earlier date 
as noticed by the NRC; and
    (vi) A copy of the State pharmacy licensure or registration, no 
later than 30 days after the date that the licensee allows, under 
paragraphs (b)(2)(i) and (b)(2)(iii) of this section, the individual to 
work as an authorized nuclear pharmacist.
    (c) A licensee shall possess and use instrumentation to measure the 
radioactivity of radioactive drugs. The licensee shall have procedures 
for use of the instrumentation. The licensee shall measure, by direct 
measurement or by combination of measurements and calculations, the 
amount of radioactivity in dosages of alpha-, beta-, or photon-emitting 
radioactive drugs prior to transfer for commercial distribution. In 
addition, the licensee shall:
    (1) Perform tests before initial use, periodically, and following 
repair, on each instrument for accuracy, linearity, and geometry 
dependence, as appropriate for the use of the instrument; and make 
adjustments when necessary; and
    (2) Check each instrument for constancy and proper operation at the 
beginning of each day of use.
    (d) Nothing in this section relieves the licensee from complying 
with applicable FDA, other Federal, and State requirements governing 
radioactive drugs.

[59 FR 61780, Dec. 2, 1994; 59 FR 65244, Dec. 19, 1994, as amended at 60 
FR 324, Jan. 4, 1995; 67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 
2002; 67 FR 77652, Dec. 19, 2002; 71 FR 15007, Mar. 27, 2006; 72 FR 
45150, Aug. 13, 2007; 72 FR 55929, Oct. 1, 2007]

    Effective Date Note: At 83 FR 33101, July 16, 2018, Sec.32.72 was 
amended by revising paragraphs (a)(4) introductory text and (b)(5)(i); 
redesignating paragraph (d) as paragraph (e); and adding a new paragraph 
(d), effective Jan. 14, 2019. For the convenience of the user,

[[Page 651]]

the added and revised text is set forth as follows:



Sec.32.72  Manufacture, preparation, or transfer for commercial 
          distribution of radioactive drugs containing byproduct 
          material for medical use under part 35.

    (a) * * *
    (4) The applicant commits to the following labeling requirements:

                                * * * * *

    (b) * * *
    (5) * * *
    (i) A copy of each individual's certification by a specialty board 
whose certification process has been recognized by the Commission or an 
Agreement State as specified in Sec.35.55(a) of this chapter; or

                                * * * * *

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

                                * * * * *



Sec.32.74  Manufacture and distribution of sources or devices 
containing byproduct material for medical use.

    (a) An application for a specific license to manufacture and 
distribute sources and devices containing byproduct material to persons 
licensed under part 35 of this chapter for use as a calibration, 
transmission, or reference source or for the uses listed in Sec. Sec.
35.400, 35.500, 35.600, and 35.1000 of this chapter will be approved if:
    (1) The applicant satisfies the general requirements in Sec.30.33 
of this chapter;
    (2) The applicant submits sufficient information regarding each type 
of source or device pertinent to an evaluation of its radiation safety, 
including:
    (i) The byproduct material contained, its chemical and physical 
form, and amount;
    (ii) Details of design and construction of the source or device;
    (iii) Procedures for, and results of, prototype tests to demonstrate 
that the source or device will maintain its integrity under stresses 
likely to be encountered in normal use and accidents;
    (iv) For devices containing byproduct material, the radiation 
profile of a prototype device;
    (v) Details of quality control procedures to assure that production 
sources and devices meet the standards of the design and prototype 
tests;
    (vi) Procedures and standards for calibrating sources and devices;
    (vii) Legend and methods for labeling sources and devices as to 
their radioactive content;
    (viii) Instructions for handling and storing the source or device 
from the radiation safety standpoint; these instructions are to be 
included on a durable label attached to the source or device or attached 
to a permanent storage container for the source or device: Provided, 
That instructions which are too lengthy for such label may be summarized 
on the label and printed in detail on a brochure which is referenced on 
the label;
    (3) The label affixed to the source or device, or to the permanent 
storage container for the source or device, contains information on the 
radionuclide, quantity and date of assay, and a statement that the U.S. 
Nuclear Regulatory Commission has approved distribution of the (name of 
source or device) to persons licensed to use byproduct material 
identified in Sec. Sec.35.65, 35.400, 35.500, and 35.600 as 
appropriate, and to persons who hold an equivalent license issued by an 
Agreement State. However, labels worded in accordance with requirements 
that were in place on March 30, 1987 may be used until March 30, 1989.
    (4) The source or device has been registered in the Sealed Source 
and Device Registry.
    (b)(1) In the event the applicant desires that the source or device 
be required to be tested for leakage of radioactive material at 
intervals longer than six months, he shall include in his application 
sufficient information to demonstrate that such longer interval is 
justified by performance characteristics of the source or device or 
similar sources or devices and by design features that have a 
significant bearing on the probability or consequences of leakage of 
radioactive material from the source.
    (2) In determining the acceptable interval for test of leakage of 
radioactive material, the Commission will consider

[[Page 652]]

information that includes, but is not limited to:
    (i) Primary containment (source capsule);
    (ii) Protection of primary containment;
    (iii) Method of sealing containment;
    (iv) Containment construction materials;
    (v) Form of contained radioactive material;
    (vi) Maximum temperature withstood during prototype tests;
    (vii) Maximum pressure withstood during prototype tests;
    (viii) Maximum quantity of contained radioactive material;
    (ix) Radiotoxicity of contained radioactive material;
    (x) Operating experience with identical sources or devices or 
similarly designed and constructed sources or devices.
    (c) If an application is filed pursuant to paragraph (a) of this 
section on or before October 15, 1974, for a license to manufacture and 
distribute a source or device that was distributed commercially on or 
before August 16, 1974, the applicant may continue the distribution of 
such source or device to group licensees until the Commission issues the 
license or notifies the applicant otherwise.

[39 FR 26149, July 17, 1974, as amended at 51 FR 36967, Oct. 16, 1986; 
62 FR 59276, Nov. 3, 1997; 67 FR 20370, Apr. 24, 2002; 71 FR 15008, Mar. 
27, 2006; 72 FR 45150, Aug. 13, 2007; 77 FR 43695, July 25, 2012]



Sec.32.201  Serialization of nationally tracked sources.

    Each licensee who manufactures a nationally tracked source after 
February 6, 2007 shall assign a unique serial number to each nationally 
tracked source. Serial numbers must be composed only of alpha-numeric 
characters.

[71 FR 65709, Nov. 8, 2006]



             Subpart D_Sealed Source and Device Registration



Sec.32.210  Registration of product information.

    (a) Any manufacturer or initial distributor of a sealed source or 
device containing a sealed source may submit a request to the NRC for 
evaluation of radiation safety information about its product and for its 
registration.
    (b) The request for review must be sent to the NRC's Office of 
Nuclear Material Safety and Safeguards, ATTN: SSDR by an appropriate 
method listed in Sec.30.6(a) of this chapter.
    (c) The request for review of a sealed source or a device must 
include sufficient information about the design, manufacture, prototype 
testing, quality control program, labeling, proposed uses and leak 
testing and, for a device, the request must also include sufficient 
information about installation, service and maintenance, operating and 
safety instructions, and its potential hazards, to provide reasonable 
assurance that the radiation safety properties of the source or device 
are adequate to protect health and minimize danger to life and property.
    (d) The NRC normally evaluates a sealed source or a device using 
radiation safety criteria in accepted industry standards. If these 
standards and criteria do not readily apply to a particular case, the 
NRC formulates reasonable standards and criteria with the help of the 
manufacturer or distributor. The NRC shall use criteria and standards 
sufficient to ensure that the radiation safety properties of the device 
or sealed source are adequate to protect health and minimize danger to 
life and property. Subpart A of this part includes specific criteria 
that apply to certain exempt products and subpart B includes specific 
criteria applicable to certain generally licensed devices. Subpart C 
includes specific provisions that apply to certain specifically licensed 
items.
    (e) After completion of the evaluation, the Commission issues a 
certificate of registration to the person making the request. The 
certificate of registration acknowledges the availability of the 
submitted information for inclusion in an application for a specific 
license proposing use of the product, or concerning use under an 
exemption from licensing or general license as applicable for the 
category of certificate.
    (f) The person submitting the request for evaluation and 
registration of safety information about the product shall

[[Page 653]]

manufacture and distribute the product in accordance with--
    (1) The statements and representations, including quality control 
program, contained in the request; and
    (2) The provisions of the registration certificate.
    (g) Authority to manufacture or initially distribute a sealed source 
or device to specific licensees may be provided in the license without 
the issuance of a certificate of registration in the following cases:
    (1) Calibration and reference sources containing no more than:
    (i) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or
    (ii) 0.37 MBq (10 [micro]Ci), for alpha emitting radionuclides; or
    (2) The intended recipients are qualified by training and experience 
and have sufficient facilities and equipment to safely use and handle 
the requested quantity of radioactive material in any form in the case 
of unregistered sources or, for registered sealed sources contained in 
unregistered devices, are qualified by training and experience and have 
sufficient facilities and equipment to safely use and handle the 
requested quantity of radioactive material in unshielded form, as 
specified in their licenses; and
    (i) The intended recipients are licensed under part 33 of this 
chapter or comparable provisions of an Agreement State; or
    (ii) The recipients are authorized for research and development; or
    (iii) The sources and devices are to be built to the unique 
specifications of the particular recipient and contain no more than 740 
GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.
    (h) After the certificate is issued, the Commission may conduct an 
additional review as it determines is necessary to ensure compliance 
with current regulatory standards. In conducting its review, the 
Commission will complete its evaluation in accordance with criteria 
specified in this section. The Commission may request such additional 
information as it considers necessary to conduct its review and the 
certificate holder shall provide the information as requested.

[52 FR 27786, July 24, 1987, as amended at 60 FR 24551, May 9, 1995; 68 
FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 31, 2008; 77 FR 43695, July 
25, 2012]



Sec.32.211  Inactivation of certificates of registration of sealed 
sources and devices.

    (a) A certificate holder who no longer manufactures or initially 
transfers any of the sealed source(s) or device(s) covered by a 
particular certificate issued by the Commission shall request 
inactivation of the registration certificate. Such a request must be 
made to the NRC's Office of Nuclear Material Safety and Safeguards, 
ATTN: SSDR by an appropriate method listed in Sec.30.6(a) of this 
chapter and must normally be made no later than two years after initial 
distribution of all of the source(s) or device(s) covered by the 
certificate has ceased. However, if the certificate holder determines 
that an initial transfer was in fact the last initial transfer more than 
two years after that transfer, the certificate holder shall request 
inactivation of the certificate within 90 days of this determination and 
briefly describe the circumstances of the delay.
    (b) If a distribution license is to be terminated in accordance with 
Sec.30.36 of this chapter, the licensee shall request inactivation of 
its registration certificates associated with that distribution license 
before the Commission will terminate the license. Such a request for 
inactivation of certificate(s) must indicate that the license is being 
terminated and include the associated specific license number.
    (c) A specific license to manufacture or initially transfer a source 
or device covered only by an inactivated certificate no longer 
authorizes the licensee to initially transfer such sources or devices 
for use. Servicing of devices must be in accordance with any conditions 
in the certificate, including in the case of an inactive certificate.

[77 FR 43695, July 25, 2012]

[[Page 654]]



                          Subpart E_Violations



Sec.32.301  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55073, Nov. 24, 1992]



Sec.32.303  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 32 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 32 that are not issued under subsections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.32.1, 32.2, 32.8, 32.11, 32.14, 32.18, 32.21, 32.22, 32.23, 
32.24, 32.26, 32.27, 32.28, 32.30, 32.31, 32.51, 32.53, 32.57, 32.61, 
32.71, 32.72, 32.74, 32.301, and 32.303.

[57 FR 55073, Nov. 24, 1992, as amended at 59 FR 61781, Dec. 2, 1994; 73 
FR 42674, July 23, 2008; 77 FR 43696, July 25, 2012]



PART 33_SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT
MATERIAL--Table of Contents



Sec.
33.1 Purpose and scope.
33.8 Information collection requirements: OMB approval.

                    Specific Licenses of Broad Scope

33.11 Types of specific licenses of broad scope.
33.12 Applications for specific licenses of broad scope.
33.13 Requirements for the issuance of a Type A specific license of 
          broad scope.
33.14 Requirements for the issuance of a Type B specific license of 
          broad scope.
33.15 Requirements for the issuance of a Type C specific license of 
          broad scope.
33.16 Application for other specific licenses.
33.17 Conditions of specific licenses of broad scope.

                               Violations

33.21 Violations.
33.23 Criminal penalties.

                                Schedules

33.100 Schedule A.

    Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182, 183, 
223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282, 
2021); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 
U.S.C. 3504 note.

    Source: 33 FR 14579, Sept. 28, 1968, unless otherwise noted.



Sec.33.1  Purpose and scope.

    This part prescribes requirements for the issuance of specific 
licenses of broad scope for byproduct material (``broad licenses'') and 
certain regulations governing holders of such licenses. The provisions 
and requirements of this part are in addition to, and not in 
substitution for, other requirements of this chapter. In particular, the 
provisions of parts 30 and 37 of this chapter apply to applications and 
licenses subject to this part.

[78 FR 17006, Mar. 19, 2013]



Sec.33.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management

[[Page 655]]

and Budget (OMB) for approval as required by the Paperwork Reduction Act 
(44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a 
person is not required to respond to, a collection of information unless 
it displays a currently valid OMB control number. OMB has approved the 
information collection requirements contained in this part under control 
number 3150-0015.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.33.12, 33.13, 33.14 and 33.15.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec.33.12, NRC Form 313 is approved under control number 
3150-0120.
    (2) [Reserved]

[49 FR 19625, May 9, 1984, as amended at 62 FR 52186, Oct. 6, 1997; 67 
FR 67099, Nov. 4, 2002]

                    Specific Licenses of Broad Scope



Sec.33.11  Types of specific licenses of broad scope.

    (a) A ``Type A specific license of broad scope'' is a specific 
license authorizing receipt, acquisition, ownership, possession, use, 
and transfer of any chemical or physical form of the byproduct material 
specified in the license, but not exceeding quantities specified in the 
license, for purposes authorized by the Act. The quantities specified 
are usually in the multicurie range.
    (b) A ``Type B specific license of broad scope'' is a specific 
license authorizing receipt, acquisition, ownership, possession, use, 
and transfer of any chemical or physical form of byproduct material 
specified in Sec.33.100, Schedule A, of this part for purposes 
authorized by the Act. The possession limit for a Type B broad license, 
if only one radionuclide is possessed thereunder, is the quantity 
specified for that radionuclide in Sec.33.100, Schedule A, Column I. 
If two or more radionuclides are possessed thereunder, the possession 
limit for each is determined as follows: For each radionuclide, 
determine the ratio of the quantity possessed to the applicable quantity 
specified in Sec.33.100, Schedule A, Column I, for that radionuclide. 
The sum of the ratios for all radionuclides possessed under the license 
shall not exceed unity.
    (c) A ``Type C specific license of broad scope'' is a specific 
license authorizing receipt, acquisition, ownership, possession, use, 
and transfer of any chemical or physical form of byproduct material 
specified in Sec.33.100, Schedule A, for purposes authorized by the 
Act. The possession limit for a Type C broad license, if only one 
radionuclide is possessed thereunder, is the quantity specified for that 
radionuclide in Sec.33.100, Schedule A, Column II. If two or more 
radionuclides are possessed thereunder, the possession limit is 
determined for each as follows: For each radionuclide determine the 
ratio of the quantity possessed to the applicable quantity specified in 
Sec.33.100, Schedule A, Column II, for that radionuclide. The sum of 
the ratios for all radionuclides possessed under the license shall not 
exceed unity.

(Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); 
sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841))

[33 FR 14579, Sept. 28, 1968, as amended at 43 FR 6923, Feb. 17, 1978]



Sec.33.12  Applications for specific licenses of broad scope.

    A person may file an application for specific license of broad scope 
on NRC Form 313, ``Application for Material License,'' in accordance 
with the provisions of Sec.30.32 of this chapter.

[68 FR 58805, Oct. 10, 2003]



Sec.33.13  Requirements for the issuance of a Type A specific license
of broad scope.

    An application for a Type A specific license of broad scope will be 
approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter;
    (b) The applicant has engaged in a reasonable number of activities 
involving the use of byproduct material; and

[[Page 656]]

    (c) The applicant has established administrative controls and 
provisions relating to organization and management, procedures, record 
keeping, material control, and accounting and management review that are 
necessary to assure safe operations, including:
    (1) The establishment of a radiation safety committee composed of 
such persons as a radiological safety officer, a representative of 
management, and persons trained and experienced in the safe use of 
radioactive materials;
    (2) The appointment of a radiological safety officer who is 
qualified by training and experience in radiation protection, and who is 
available for advice and assistance on radiological safety matters; and
    (3) The establishment of appropriate administrative procedures to 
assure:
    (i) Control of procurement and use of byproduct material;
    (ii) Completion of safety evaluations of proposed uses of byproduct 
material which take into consideration such matters as the adequacy of 
facilities and equipment, training and experience of the user, and the 
operating or handling procedures; and
    (iii) Review, approval, and recording by the radiation safety 
committee of safety evaluations of proposed uses prepared in accordance 
with paragraph (c)(3)(ii) of this section prior to use of the byproduct 
material.



Sec.33.14  Requirements for the issuance of a Type B specific license
of broad scope.

    An application for a Type B specific license of broad scope will be 
approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter; and
    (b) The applicant has established administrative controls and 
provisions relating to organization and management, procedures, record 
keeping, material control and accounting, and management review that are 
necessary to assure safe operations, including:
    (1) The appointment of a radiological safety officer who is 
qualified by training and experience in radiation protection, and who is 
available for advice and assistance on radiological safety matters; and
    (2) The establishment of appropriate administrative procedures to 
assure:
    (i) Control of procurement and use of byproduct material;
    (ii) Completion of safety evaluations of proposed uses of byproduct 
material which take into consideration such matters as the adequacy of 
facilities and equipment, training and experience of the user, and the 
operating or handling procedures; and
    (iii) Review, approval, and recording by the radiological safety 
officer of safety evaluations of proposed uses prepared in accordance 
with paragraph (b)(2)(ii) of this section prior to use of the byproduct 
material.



Sec.33.15  Requirements for the issuance of a Type C specific license
of broad scope.

    An application for a Type C specific license of broad scope will be 
approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter; and
    (b) The applicant submits a statement that byproduct material will 
be used only by, or under the direct supervision of, individuals who 
have received:
    (1) A college degree at the bachelor level, or equivalent training 
and experience, in the physical or biological sciences or in 
engineering; and
    (2) At least 40 hours of training and experience in the safe 
handling of radioactive materials, and in the characteristics of 
ionizing radiation, units of radiation dose and quantities, radiation 
detection instrumentation, and biological hazards of exposure to 
radiation appropriate to the type and forms of byproduct material to be 
used; and
    (c) The applicant has established administrative controls and 
provisions relating to procurement of byproduct material, procedures, 
record keeping, material control and accounting, and management review 
necessary to assure safe operations.



Sec.33.16  Application for other specific licenses.

    An application filed pursuant to part 30 of this chapter for a 
specific license other than one of broad scope will be

[[Page 657]]

considered by the Commission as an application for a specific license of 
broad scope under this part if the requirements of the applicable 
sections of this part are satisfied.



Sec.33.17  Conditions of specific licenses of broad scope.

    (a) Unless specifically authorized pursuant to other parts of this 
chapter, persons licensed under this part shall not:
    (1) Conduct tracer studies in the environment involving direct 
release of byproduct material;
    (2) Receive, acquire, own, possess, use, transfer, or import devices 
containing 100,000 curies or more of byproduct material in sealed 
sources used for irradiation of materials;
    (3) Conduct activities for which a specific license issued by the 
Commission under part 32, 34, or 35 of this chapter is required; or
    (4) Add or cause the addition of byproduct material to any food, 
beverage, cosmetic, drug, or other product designed for ingestion or 
inhalation by, or application to, a human being.
    (b) Each Type A specific license of broad scope issued under this 
part shall be subject to the condition that byproduct material possessed 
under the license may only be used by, or under the direct supervision 
of, individuals approved by the licensee's radiation safety committee.
    (c) Each Type B specific license of broad scope issued under this 
part shall be subject to the condition that byproduct material possessed 
under the license may only be used by, or under the direct supervision 
of, individuals approved by the licensee's radiological safety officer.
    (d) Each Type C specific license of broad scope issued under this 
part shall be subject to the condition that byproduct material possessed 
under the license may only be used by, or under the direct supervision 
of, individuals who satisfy the requirements of Sec.33.15 of this 
part.

                               Violations



Sec.33.21  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55073, Nov. 24, 1992]



Sec.33.23  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 33 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 33 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.33.1, 33.8, 33.11, 33.12, 33.13, 33.14, 33.15, 33.16, 33.21, 
33.23 and 33.100.

[57 FR 55073, Nov. 24, 1992]

[[Page 658]]

                                Schedules



Sec.33.100  Schedule A.

------------------------------------------------------------------------
                                                       Col. I    Col. II
                 Byproduct material                    curies    curies
------------------------------------------------------------------------
Antimony-122........................................         1      0.01
Antimony-124........................................         1       .01
Antimony-125........................................         1       .01
Arsenic-73..........................................        10        .1
Arsenic-74..........................................         1       .01
Arsenic-76..........................................         1       .01
Arsenic-77..........................................        10        .1
Barium-131..........................................        10        .1
Barium-140..........................................         1       .01
Beryllium-7.........................................        10       0.1
Bismuth-210.........................................        .1      .001
Bromine-82..........................................        10        .1
Cadmium-109.........................................         1       .01
Cadmium-115m........................................         1       .01
Cadmium-115.........................................        10        .1
Calcium-45..........................................         1       .01
Calcium-47..........................................        10        .1
Carbon-14...........................................       100        1.
Cerium-141..........................................        10        .1
Cerium-143..........................................        10        .1
Cerium-144..........................................        .1      .001
Cesium-131..........................................       100        1.
Cesium-134m.........................................       100        1.
Cesium-134..........................................        .1      .001
Cesium-135..........................................         1       .01
Cesium-136..........................................        10        .1
Cesium-137..........................................        .1      .001
Chlorine-36.........................................         1       .01
Chlorine-38.........................................       100        1.
Chromium-51.........................................       100        1.
Cobalt-57...........................................        10       0.1
Cobalt-58m..........................................       100        1.
Cobalt-58...........................................         1       .01
Cobalt-60...........................................        .1      .001
Copper-64...........................................        10        .1
Dysprosium-165......................................       100        1.
Dysprosium-166......................................        10        .1
Erbium-169..........................................        10        .1
Erbium-171..........................................        10        .1
Europium-152 9.2 h..................................        10        .1
Europium-152 13 y...................................        .1      .001
Europium-154........................................        .1      .001
Europium-155........................................         1       .01
Fluorine-18.........................................       100        1.
Gadolinium-153......................................         1       .01
Gadolinium-159......................................        10        .1
Gallium-72..........................................        10        .1
Germanium-71........................................       100         1
Gold-198............................................        10        .1
Gold-199............................................        10        .1
Hafnium-181.........................................         1       .01
Holmium-166.........................................        10        .1
Hydrogen-3..........................................       100         1
Indium-113m.........................................       100         1
Indium-114m.........................................         1       .01
Indium-115m.........................................       100         1
Indium-115..........................................         1       .01
Iodine-125..........................................        .1      .001
Iodine-126..........................................        .1      .001
Iodine-129..........................................        .1       .01
Iodine-131..........................................        .1      .001
Iodine-132..........................................        10        .1
Iodine-133..........................................         1       .01
Iodine-134..........................................        10        .1
Iodine-135..........................................         1       .01
Iridium-192.........................................         1       .01
Iridium-194.........................................        10        .1
Iron-55.............................................        10        .1
Iron-59.............................................         1       .01
Krypton-85..........................................       100         1
Krypton-87..........................................        10        .1
Lanthanum-140.......................................         1       .01
Lutetium-177........................................        10        .1
Manganese-52........................................         1       .01
Manganese-54........................................         1       .01
Manganese-56........................................        10        .1
Mercury-197m........................................        10        .1
Mercury-197.........................................        10        .1
Mercury-203.........................................         1       .01
Molybdenum-99.......................................        10        .1
Neodymium-147.......................................        10        .1
Neodymium-149.......................................        10        .1
Nickel-59...........................................        10        .1
Nickel-63...........................................         1       .01
Nickel-65...........................................        10        .1
Niobium-93m.........................................         1       .01
Niobium-95..........................................         1       .01
Niobium-97..........................................       100        1.
Osmium-185..........................................         1       .01
Osmium-191m.........................................       100        1.
Osmium-191..........................................        10        .1
Osmium-193..........................................        10        .1
Palladium-103.......................................        10        .1
Palladium-109.......................................        10        .1
Phosphorus-32.......................................         1       .01
Platinum-191........................................        10        .1
Platinum-193m.......................................       100        1.
Platinum-193........................................        10        .1
Platinum-197m.......................................       100         1
Platinum-197........................................        10        .1
Polonium-210........................................       .01     .0001
Potassium-42........................................         1       .01
Praseodymium-142....................................        10        .1
Praseodymium-143....................................        10        .1
Promethium-147......................................         1       .01
Promethium-149......................................        10        .1
Radium-226..........................................      0.01    0.0001
Rhenium-186.........................................        10        .1
Rhenium-188.........................................        10        .1
Rhodium-103m........................................     1,000       10.
Rhodium-105.........................................        10        .1
Rubidium-86.........................................         1       .01
Rubidium-87.........................................         1       .01
Ruthenium-97........................................       100        1.
Ruthenium-103.......................................         1       .01
Ruthenium-105.......................................        10        .1
Ruthenium-106.......................................        .1      .001
Samarium-151........................................         1       .01
Samarium-153........................................        10        .1
Scandium-46.........................................         1       .01
Scandium-47.........................................        10        .1
Scandium-48.........................................         1       .01
Selenium-75.........................................         1       .01
Silicon-31..........................................        10        .1
Silver-105..........................................         1       .01
Silver-110m.........................................        .1      .001
Silver-111..........................................        10        .1
Sodium-22...........................................       0.1     0.001
Sodium-24...........................................         1       .01
Strontium-85m.......................................     1,000       10.
Strontium-85........................................         1       .01
Strontium-89........................................         1       .01
Strontium-90........................................       .01     .0001
Strontium-91........................................        10        .1
Strontium-92........................................        10        .1
Sulphur-35..........................................        10        .1
Tantalum-182........................................         1       .01
Technetium-96.......................................        10        .1
Technetium-97m......................................        10        .1
Technetium-97.......................................        10        .1
Technetium-99m......................................       100        1.
Technetium-99.......................................         1       .01

[[Page 659]]

 
Tellurium-125m......................................         1       .01
Tellurium-127m......................................         1       .01
Tellurium-127.......................................        10        .1
Tellurium-129m......................................         1       .01
Tellurium-129.......................................       100         1
Tellurium-131m......................................        10        .1
Tellurium-132.......................................         1       .01
Terbium-160.........................................         1       .01
Thallium-200........................................        10        .1
Thallium-201........................................        10        .1
Thallium-202........................................        10        .1
Thallium-204........................................         1       .01
Thulium-170.........................................         1       .01
Thulium-171.........................................         1       .01
Tin-113.............................................         1       .01
Tin-125.............................................         1       .01
Tungsten-181........................................         1       .01
Tungsten-185........................................         1       .01
Tungsten-187........................................        10        .1
Vanadium-48.........................................         1       .01
Xenon-131m..........................................     1,000       10.
Xenon-133...........................................       100        1.
Xenon-135...........................................       100        1.
Ytterbium-175.......................................        10        .1
Yttrium-90..........................................         1       .01
Yttrium-91..........................................         1       .01
Yttrium-92..........................................        10        .1
Yttrium-93..........................................         1       .01
Zinc-65.............................................         1       .01
Zinc-69m............................................        10        .1
Zinc-69.............................................       100        1.
Zirconium-93........................................         1       .01
Zirconium-95........................................         1       .01
Zirconium-97........................................         1       .01
Any byproduct material other than alpha emitting            .1      .001
 byproduct material not listed above................
------------------------------------------------------------------------


(Sec. 201, Pub. L. 93-438; 88 Stat. 1242 (42 U.S.C. 5841))

[33 FR 14579, Sept. 28, 1968, as amended at 72 FR 55930, Oct. 1, 2007]



PART 34_LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY 
REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
34.1 Purpose and scope.
34.3 Definitions.
34.5 Interpretations.
34.8 Information collection requirements: OMB approval.

                 Subpart B_Specific Licensing Provisions

34.11 Application for a specific license.
34.13 Specific license for industrial radiography.

                           Subpart C_Equipment

34.20 Performance requirements for industrial radiography equipment.
34.21 Limits on external radiation levels from storage containers and 
          source changers.
34.23 Locking of radiographic exposure devices, storage containers, and 
          source changers.
34.25 Radiation survey instruments.
34.27 Leak testing and replacement of sealed sources.
34.29 Quarterly inventory.
34.31 Inspection and maintenance of radiographic exposure devices, 
          transport and storage containers, associated equipment, source 
          changers, and survey instruments.
34.33 Permanent radiographic installations.
34.35 Labeling, storage, and transportation.

                 Subpart D_Radiation Safety Requirements

34.41 Conducting industrial radiographic operations.
34.42 Radiation Safety Officer for industrial radiography.
34.43 Training.
34.45 Operating and emergency procedures.
34.46 Supervision of radiographers' assistants.
34.47 Personnel monitoring.
34.49 Radiation surveys.
34.51 Surveillance.
34.53 Posting.

                  Subpart E_Recordkeeping Requirements

34.61 Records of the specific license for industrial radiography.
34.63 Records of the receipt and transfer of sealed sources.
34.65 Records of radiation survey instruments.
34.67 Records of leak testing of sealed sources and devices containing 
          depleted uranium.
34.69 Records of quarterly inventory.
34.71 Utilization logs.
34.73 Records of inspection and maintenance of radiographic exposure 
          devices, transport and storage containers, associated 
          equipment, source changers, and survey instruments.
34.75 Records of alarm system and entrance control checks at permanent 
          radiographic installations.
34.79 Records of training and certification.
34.81 Copies of operating and emergency procedures.
34.83 Records of personnel monitoring procedures.
34.85 Records of radiation surveys.
34.87 Form of records.
34.89 Location of documents and records.

[[Page 660]]

                         Subpart F_Notifications

34.101 Notifications.

                          Subpart G_Exemptions

34.111 Applications for exemptions.

                          Subpart H_Violations

34.121 Violations.
34.123 Criminal penalties.

Appendix A to Part 34--Radiographer Certification

    Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182, 183, 
223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282, 
2021); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 
5841, 5846); 44 U.S.C. 3504 note.

    Source: 62 FR 28963, May 28, 1997, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 34 appear at 79 FR 
75739, Dec. 19, 2014.



                      Subpart A_General Provisions



Sec.34.1  Purpose and scope.

    This part prescribes requirements for the issuance of licenses for 
the use of sealed sources containing byproduct material and radiation 
safety requirements for persons using these sealed sources in industrial 
radiography. The provisions and requirements of this part are in 
addition to, and not in substitution for, other requirements of this 
chapter. In particular, the requirements and provisions of parts 19, 20, 
21, 30, 37, 71, 150, 170, and 171 of this chapter apply to applications 
and licenses subject to this part. This rule does not apply to medical 
uses of byproduct material.

[78 FR 17006, Mar. 19, 2013]



Sec.34.3  Definitions.

    ALARA (acronym for ``as low as is reasonably achievable'') means 
making every reasonable effort to maintain exposures to radiation as far 
below the dose limits specified in 10 CFR part 20 as is practical 
consistent with the purpose for which the licensed activity is 
undertaken, taking into account the state of technology, the economics 
of improvements in relation to state of technology, the economics of 
improvements in relation to benefits to the public health and safety, 
and other societal and socioeconomic considerations, and in relation to 
utilization of nuclear energy and licensed materials in the public 
interest.
    Annual refresher safety training means a review conducted or 
provided by the licensee for its employees on radiation safety aspects 
of industrial radiography. The review may include, as appropriate, the 
results of internal inspections, new procedures or equipment, new or 
revised regulations, accidents or errors that have been observed, and 
should also provide opportunities for employees to ask safety questions.
    Associated equipment means equipment that is used in conjunction 
with a radiographic exposure device to make radiographic exposures that 
drives, guides, or comes in contact with the source, (e.g., guide tube, 
control tube, control (drive) cable, removable source stop, ``J'' tube 
and collimator when it is used as an exposure head.
    Becquerel (Bq) means one disintegration per second.
    Certifying Entity means an independent certifying organization 
meeting the requirements in appendix A of this part or an Agreement 
State meeting the requirements in appendix A, parts II and III of this 
part.
    Collimator means a radiation shield that is placed on the end of the 
guide tube or directly onto a radiographic exposure device to restrict 
the size of the radiation beam when the sealed source is cranked into 
position to make a radiographic exposure.
    Control (drive) cable means the cable that is connected to the 
source assembly and used to drive the source to and from the exposure 
location.
    Control drive mechanism means a device that enables the source 
assembly to be moved to and from the exposure device.
    Control tube means a protective sheath for guiding the control 
cable. The control tube connects the control drive mechanism to the 
radiographic exposure device.
    Exposure head means a device that locates the gamma radiography 
sealed source in the selected working position. (An exposure head is 
also known as a source stop.)

[[Page 661]]

    Field station means a facility where licensed material may be stored 
or used and from which equipment is dispatched.
    Gray means the SI unit of absorbed dose. One gray is equal to an 
absorbed dose of 1 Joule/kilogram. It is also equal to 100 rads.
    Guide tube (Projection sheath) means a flexible or rigid tube (i.e., 
``J'' tube) for guiding the source assembly and the attached control 
cable from the exposure device to the exposure head. The guide tube may 
also include the connections necessary for attachment to the exposure 
device and to the exposure head.
    Hands-on experience means experience in all of those areas 
considered to be directly involved in the radiography process.
    Independent certifying organization means an independent 
organization that meets all of the criteria of appendix A to this part.
    Industrial radiography (radiography) means an examination of the 
structure of materials by nondestructive methods, utilizing ionizing 
radiation to make radiographic images.
    Lay-barge radiography means industrial radiography performed on any 
water vessel used for laying pipe.
    Offshore platform radiography means industrial radiography conducted 
from a platform over a body of water.
    Permanent radiographic installation means an enclosed shielded room, 
cell, or vault, not located at a temporary jobsite, in which radiography 
is performed.
    Practical Examination means a demonstration through practical 
application of the safety rules and principles in industrial radiography 
including use of all appropriate equipment and procedures.
    Radiation Safety Officer for industrial radiography means an 
individual with the responsibility for the overall radiation safety 
program on behalf of the licensee and who meets the requirements of 
Sec.34.42.
    Radiographer means any individual who performs or who, in attendance 
at the site where the sealed source or sources are being used, 
personally supervises industrial radiographic operations and who is 
responsible to the licensee for assuring compliance with the 
requirements of the Commission's regulations and the conditions of the 
license.
    Radiographer certification means written approval received from a 
certifying entity stating that an individual has satisfactorily met 
certain established radiation safety, testing, and experience criteria.
    Radiographer's assistant means any individual who under the direct 
supervision of a radiographer, uses radiographic exposure devices, 
sealed sources or related handling tools, or radiation survey 
instruments in industrial radiography.
    Radiographic exposure device (also called a camera, or a projector) 
means any instrument containing a sealed source fastened or contained 
therein, in which the sealed source or shielding thereof may be moved, 
or otherwise changed, from a shielded to unshielded position for 
purposes of making a radiographic exposure.
    Radiographic operations means all activities associated with the 
presence of radioactive sources in a radiographic exposure device during 
use of the device or transport (except when being transported by a 
common or contract transport), to include surveys to confirm the 
adequacy of boundaries, setting up equipment and any activity inside 
restricted area boundaries.
    S-tube means a tube through which the radioactive source travels 
when inside a radiographic exposure device.
    Sealed source means any byproduct material that is encased in a 
capsule designed to prevent leakage or escape of the byproduct material.
    Shielded position means the location within the radiographic 
exposure device or source changer where the sealed source is secured and 
restricted from movement.
    Sievert means the SI unit of any of the quantities expressed as dose 
equivalent. The dose equivalent in sieverts is equal to the absorbed 
dose in grays multiplied by the quality factor (1 Sv = 100 rems).
    Source assembly means an assembly that consists of the sealed source 
and a connector that attaches the source to the control cable. The 
source assembly

[[Page 662]]

may also include a stop ball used to secure the source in the shielded 
position.
    Source changer means a device designed and used for replacement of 
sealed sources in radiographic exposure devices, including those also 
used for transporting and storage of sealed sources.
    Storage area means any location, facility, or vehicle which is used 
to store or to secure a radiographic exposure device, a storage 
container, or a sealed source when it is not in use and which is locked 
or has a physical barrier to prevent accidental exposure, tampering 
with, or unauthorized removal of the device, container, or source.
    Storage container means a container in which sealed sources are 
secured and stored.
    Temporary jobsite means a location where radiographic operations are 
conducted and where licensed material may be stored other than those 
location(s) of use authorized on the license.
    Underwater radiography means industrial radiography performed when 
the radiographic exposure device and/or related equipment are beneath 
the surface of the water.



Sec.34.5  Interpretations.

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



Sec.34.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may nor conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0007.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.34.13, 34.20, 34.25, 34.27, 34.29, 34.31, 
34.33, 34.35, 34.41, 34.42, 34.43, 34.45, 34.47, 34.49, 34.61, 34.63, 
34.65, 34.67, 34.69, 34.71, 34.73, 34.75, 34.79, 34.81, 34.83, 34.85, 
34.87, 34.89, 34.101, and appendix A.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. The information collection requirements 
and the control numbers under which it is approved are as follows:
    (1) In Sec.34.11, NRC Form 313 is approved under control number 
3150-0120.
    (2) [Reserved]

[62 FR 52186, Oct. 6, 1997, as amended at 75 FR 73942, Nov. 30, 2010]



                 Subpart B_Specific Licensing Provisions



Sec.34.11  Application for a specific license.

    A person may file an application for specific license for use of 
sealed sources in industrial radiography on NRC Form 313, ``Application 
for Material License,'' in accordance with the provisions of Sec.30.32 
of this chapter.

[68 FR 58805, Oct. 10, 2003]



Sec.34.13  Specific license for industrial radiography.

    An application for a specific license for the use of licensed 
material in industrial radiography will be approved if the applicant 
meets the following requirements:
    (a) The applicant satisfies the general requirements specified in 
Sec.30.33 of this chapter for byproduct material, as appropriate, and 
any special requirements contained in this part.
    (b) The applicant submits an adequate program for training 
radiographers and radiographers' assistants that meets the requirements 
of Sec.34.43.
    (1) After May 28, 1999, a license applicant need not describe its 
initial training and examination program for radiographers in the 
subjects outlined in Sec.34.43(g).
    (2) From June 27, 1997 to May 28, 1999 a license applicant may 
affirm that all

[[Page 663]]

individuals acting as industrial radiographers will be certified in 
radiation safety by a certifying entity before commencing duty as 
radiographers. This affirmation substitutes for a description of its 
initial training and examination program for radiographers in the 
subjects outlined in Sec.34.43(g).
    (c) The applicant submits procedures for verifying and documenting 
the certification status of radiographers and for ensuring that the 
certification of individuals acting as radiographers remains valid.
    (d) The applicant submits written operating and emergency procedures 
as described in Sec.34.45.
    (e) The applicant submits a description of a program for inspections 
of the job performance of each radiographer and radiographers' assistant 
at intervals not to exceed 6 months as described in Sec.34.43(e).
    (f) The applicant submits a description of the applicant's overall 
organizational structure as it applies to the radiation safety 
responsibilities in industrial radiography, including specified 
delegation of authority and responsibility.
    (g) The applicant identifies and lists the qualifications of the 
individual(s) designated as the RSO (Sec.34.42) and potential 
designees responsible for ensuring that the licensee's radiation safety 
program is implemented in accordance with approved procedures.
    (h) If an applicant intends to perform leak testing of sealed 
sources or exposure devices containing depleted uranium (DU) shielding, 
the applicant must describe the procedures for performing and the 
qualifications of the person(s) authorized to do the leak testing. If 
the applicant intends to analyze its own wipe samples, the application 
must include a description of the procedures to be followed. The 
description must include the--
    (1) Instruments to be used;
    (2) Methods of performing the analysis; and
    (3) Pertinent experience of the person who will analyze the wipe 
samples.
    (i) If the applicant intends to perform ``in-house'' calibrations of 
survey instruments the applicant must describe methods to be used and 
the relevant experience of the person(s) who will perform the 
calibrations. All calibrations must be performed according to the 
procedures described and at the intervals prescribed in Sec.34.25.
    (j) The applicant identifies and describes the location(s) of all 
field stations and permanent radiographic installations.
    (k) The applicant identifies the locations where all records 
required by this part and other parts of this chapter will be 
maintained.



                           Subpart C_Equipment



Sec.34.20  Performance requirements for industrial radiography 
equipment.

    Equipment used in industrial radiographic operations must meet the 
following minimum criteria:
    (a)(1) Each radiographic exposure device, source assembly or sealed 
source, and all associated equipment must meet the requirements 
specified in American National Standards Institute, N432-1980 
``Radiological Safety for the Design and Construction of Apparatus for 
Gamma Radiography,'' (published as NBS Handbook 136, issued January 
1981). This publication has been approved for incorporation by reference 
by the Director of the Federal Register in accordance with 5 U.S.C. 
552(a)and 1 CFR part 51. This publication may be purchased from the 
American National Standards Institute, Inc., 25 West 43rd Street, New 
York, New York 10036; Telephone: (212) 642-4900. Copies of the document 
are available for inspection at the Nuclear Regulatory Commission 
Library, 11545 Rockville Pike, Rockville, Maryland 20852. A copy of the 
document is also on file at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (2) Engineering analysis may be submitted by an applicant or 
licensee to demonstrate the applicability of previously performed 
testing on similar individual radiography equipment components. Upon 
review, the Commission may find this an acceptable alternative

[[Page 664]]

to actual testing of the component pursuant to the above referenced 
standard.
    (b) In addition to the requirements specified in paragraph (a) of 
this section, the following requirements apply to radiographic exposure 
devices, source changers, source assemblies and sealed sources.
    (1) The licensee shall ensure that each radiographic exposure device 
has attached to it a durable, legible, clearly visible label bearing 
the--
    (i) Chemical symbol and mass number of the radionuclide in the 
device;
    (ii) Activity and the date on which this activity was last measured;
    (iii) Model (or product code) and serial number of the sealed 
source;
    (iv) Manufacturer's identity of the sealed source; and
    (v) Licensee's name, address, and telephone number.
    (2) Radiographic exposure devices intended for use as Type B 
transport containers must meet the applicable requirements of 10 CFR 
part 71.
    (3) Modification of radiographic exposure devices, source changers, 
and source assemblies and associated equipment is prohibited, unless the 
design of any replacement component,including source holder, source 
assembly, controls or guide tubes would not compromise the design safety 
features of the system.
    (c) In addition to the requirements specified in paragraphs (a) and 
(b) of this section, the following requirements apply to radiographic 
exposure devices, source assemblies, and associated equipment that allow 
the source to be moved out of the device for radiographic operations or 
to source changers.
    (1) The coupling between the source assembly and the control cable 
must be designed in such a manner that the source assembly will not 
become disconnected if cranked outside the guide tube. The coupling must 
be such that it cannot be unintentionally disconnected under normal and 
reasonably foreseeable abnormal conditions.
    (2) The device must automatically secure the source assembly when it 
is cranked back into the fully shielded position within the device. This 
securing system may only be released by means of a deliberate operation 
on the exposure device.
    (3) The outlet fittings, lock box, and drive cable fittings on each 
radiographic exposure device must be equipped with safety plugs or 
covers which must be installed during storage and transportation to 
protect the source assembly from water, mud, sand or other foreign 
matter.
    (4)(i) Each sealed source or source assembly must have attached to 
it or engraved on it, a durable, legible, visible label with the words: 
``DANGER--RADIOACTIVE.''
    (ii) The label may not interfere with the safe operation of the 
exposure device or associated equipment.
    (5) The guide tube must be able to withstand a crushing test that 
closely approximates the crushing forces that are likely to be 
encountered during use, and be able to withstand a kinking resistance 
test that closely approximates the kinking forces that are likely to be 
encountered during use.
    (6) Guide tubes must be used when moving the source out of the 
device.
    (7) An exposure head or similar device designed to prevent the 
source assembly from passing out of the end of the guide tube must be 
attached to the outermost end of the guide tube during industrial 
radiography operations.
    (8) The guide tube exposure head connection must be able to 
withstand the tensile test for control units specified in ANSI N432-
1980.
    (9) Source changers must provide a system for ensuring that the 
source will not be accidentally withdrawn from the changer when 
connecting or disconnecting the drive cable to or from a source 
assembly.
    (d) All radiographic exposure devices and associated equipment in 
use after January 10, 1996, must comply with the requirements of this 
section.
    (e) Notwithstanding paragraph (a)(1) of this section, equipment used 
in industrial radiographic operations need not comply with Sec.
8.9.2(c) of the Endurance Test in American National Standards Institute 
N432-1980, if the prototype equipment has been tested using a torque 
value representative of the torque that an individual using the 
radiography equipment can realistically

[[Page 665]]

exert on the lever or crankshaft of the drive mechanism.

[62 FR 28963, May 28, 1997, as amended at 69 FR 18803, Apr. 9, 2004; 77 
FR 39906, July 6, 2012]



Sec.34.21  Limits on external radiation levels from storage containers
and source changers.

    The maximum exposure rate limits for storage containers and source 
changers are 2 millisieverts (200 millirem) per hour at any exterior 
surface, and 0.1 millisieverts (10 millirem) per hour at 1 meter from 
any exterior surface with the sealed source in the shielded position.



Sec.34.23  Locking of radiographic exposure devices, storage 
containers and source changers.

    (a) Each radiographic exposure device must have a lock or outer 
locked container designed to prevent unauthorized or accidental removal 
of the sealed source from its shielded position. The exposure device 
and/or its container must be kept locked (and if a keyed-lock, with the 
key removed at all times) when not under the direct surveillance of a 
radiographer or a radiographer's assistant except at permanent 
radiographic installations as stated in Sec.34.51. In addition, during 
radiographic operations the sealed source assembly must be secured in 
the shielded position each time the source is returned to that position.
    (b) Each sealed source storage container and source changer must 
have a lock or outer locked container designed to prevent unauthorized 
or accidental removal of the sealed source from its shielded position. 
Storage containers and source changers must be kept locked (and if a 
keyed-lock, with the key removed at all times) when containing sealed 
sources except when under the direct surveillance of a radiographer or a 
radiographer's assistant.



Sec.34.25  Radiation survey instruments.

    (a) The licensee shall keep sufficient calibrated and operable 
radiation survey instruments at each location where radioactive material 
is present to make the radiation surveys required by this part and by 10 
CFR part 20 of this chapter. Instrumentation required by this section 
must be capable of measuring a range from 0.02 millisieverts (2 
millirems) per hour through 0.01 sievert (1 rem) per hour.
    (b) The licensee shall have each radiation survey instrument 
required under paragraph (a) of this section calibrated--
    (1) At intervals not to exceed 6 months and after instrument 
servicing, except for battery changes;
    (2) For linear scale instruments, at two points located 
approximately one-third and two-thirds of full-scale on each scale; for 
logarithmic scale instruments, at mid-range of each decade, and at two 
points of at least one decade; and for digital instruments, at 3 points 
between 0.02 and 10 millisieverts (2 and 1000 millirems) per hour; and
    (3) So that an accuracy within plus or minus 20 percent of the 
calibration source can be demonstrated at each point checked.
    (c) The licensee shall maintain records of the results of the 
instrument calibrations in accordance with Sec.34.65.



Sec.34.27  Leak testing and replacement of sealed sources.

    (a) The replacement of any sealed source fastened to or contained in 
a radiographic exposure device and leak testing of any sealed source 
must be performed by persons authorized to do so by the NRC or an 
Agreement State.
    (b) The opening, repair, or modification of any sealed source must 
be performed by persons specifically authorized to do so by the 
Commission or an Agreement State.
    (c) Testing and recordkeeping requirements. (1) Each licensee who 
uses a sealed source shall have the source tested for leakage at 
intervals not to exceed 6 months. The leak testing of the source must be 
performed using a method approved by the Commission or by an Agreement 
State. The wipe sample should be taken from the nearest accessible point 
to the sealed source where contamination might accumulate. The wipe 
sample must be analyzed for radioactive contamination. The analysis must 
be capable of detecting the presence of 185 Bq (0.005 microcurie) of 
radioactive material on

[[Page 666]]

the test sample and must be performed by a person specifically 
authorized by the Commission or an Agreement State to perform the 
analysis.
    (2) The licensee shall maintain records of the leak tests in 
accordance with Sec.34.67.
    (3) Unless a sealed source is accompanied by a certificate from the 
transferor that shows that it has been leak tested within 6 months 
before the transfer, it may not be used by the licensee until tested for 
leakage. Sealed sources that are in storage and not in use do not 
require leak testing, but must be tested before use or transfer to 
another person if the interval of storage exceeds 6 months.
    (d) Any test conducted pursuant to paragraph (c) of this section 
which reveals the presence of 185 Bq (0.005 microcurie) or more of 
removable radioactive material must be considered evidence that the 
sealed source is leaking. The licensee shall immediately withdraw the 
equipment involved from use and shall have it decontaminated and 
repaired or disposed of in accordance with Commission regulations. A 
report must be filed with the Director, Office of Nuclear Material 
Safety and Safeguards , by an appropriate method listed in Sec.30.6(a) 
of this chapter, the report to be filed within 5 days of any test with 
results that exceed the threshold in this paragraph (d), and to describe 
the equipment involved, the test results, and the corrective action 
taken. A copy of the report must be sent to the Administrator of the 
appropriate Nuclear Regulatory Commission's Regional Office listed in 
appendix D of 10 CFR part 20 of this chapter ``Standards for Protection 
Against Radiation.''
    (e) Each exposure device using depleted uranium (DU) shielding and 
an ``S'' tube configuration must be tested for DU contamination at 
intervals not to exceed 12 months. The analysis must be capable of 
detecting the presence of 185 Bq (0.005 microcuries) of radioactive 
material on the test sample and must be performed by a person 
specifically authorized by the Commission or an Agreement State to 
perform the analysis. Should such testing reveal the presence of 185 Bq 
(0.005 microcuries) or more of removable DU contamination, the exposure 
device must be removed from use until an evaluation of the wear on the 
S-tube has been made. Should the evaluation reveal that the S-tube is 
worn through, the device may not be used again. DU shielded devices do 
not have to be tested for DU contamination while in storage and not in 
use. Before using or transferring such a device however, the device must 
be tested for DU contamination if the interval of storage exceeded 12 
months. A record of the DU leak-test must be made in accordance with 
Sec.34.67. Licensees will have until June 27, 1998, to comply with the 
DU leak-testing requirements of this paragraph.

[62 FR 28963, May 28, 1997, as amended at 63 FR 37061, July 9, 1998; 67 
FR 77652, Dec. 19, 2002; 68 FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 
31, 2008]



Sec.34.29  Quarterly inventory.

    (a) Each licensee shall conduct a quarterly physical inventory to 
account for all sealed sources and for devices containing depleted 
uranium received and possessed under this license.
    (b) The licensee shall maintain records of the quarterly inventory 
in accordance with Sec.34.69.



Sec.34.31  Inspection and maintenance of radiographic exposure 
devices, transport and storage containers, associated equipment,
source changers, and survey instruments.
          

    (a) The licensee shall perform visual and operability checks on 
survey meters, radiographic exposure devices, transport and storage 
containers, associated equipment and source changers before use on each 
day the equipment is to be used to ensure that the equipment is in good 
working condition, that the sources are adequately shielded, and that 
required labeling is present. Survey instrument operability must be 
performed using check sources or other appropriate means. If equipment 
problems are found, the equipment must be removed from service until 
repaired.
    (b) Each licensee shall have written procedures for:
    (1) Inspection and routine maintenance of radiographic exposure 
devices, source changers, associated equipment, transport and storage 
containers, and

[[Page 667]]

survey instruments at intervals not to exceed 3 months or before the 
first use thereafter to ensure the proper functioning of components 
important to safety. Replacement components shall meet design 
specifications. If equipment problems are found, the equipment must be 
removed from service until repaired.
    (2) Inspection and maintenance necessary to maintain the Type B 
packaging used to transport radioactive materials. The inspection and 
maintenance program must include procedures to assure that Type B 
packages are shipped and maintained in accordance with the certificate 
of compliance or other approval.
    (c) Records of equipment problems and of any maintenance performed 
under paragraphs (a) and (b) of this section must be made in accordance 
with Sec.34.73.



Sec.34.33  Permanent radiographic installations.

    (a) Each entrance that is used for personnel access to the high 
radiation area in a permanent radiographic installation must have 
either:
    (1) An entrance control of the type described in Sec.20.1601(a)(1) 
of this chapter that reduces the radiation level upon entry into the 
area, or
    (2) Both conspicuous visible and audible warning signals to warn of 
the presence of radiation. The visible signal must be actuated by 
radiation whenever the source is exposed. The audible signal must be 
actuated when an attempt is made to enter the installation while the 
source is exposed.
    (b) The alarm system must be tested for proper operation with a 
radiation source each day before the installation is used for 
radiographic operations. The test must include a check of both the 
visible and audible signals. Entrance control devices that reduce the 
radiation level upon entry (designated in paragraph (a)(1) of this 
section) must be tested monthly. If an entrance control device or an 
alarm is operating improperly, it must be immediately labeled as 
defective and repaired within 7 calendar days. The facility may continue 
to be used during this 7-day period, provided the licensee implements 
the continuous surveillance requirements of Sec.34.51 and uses an 
alarming ratemeter. Test records for entrance controls and audible and 
visual alarm must be maintained in accordance with Sec.34.75.



Sec.34.35  Labeling, storage, and transportation.

    (a) The licensee may not use a source changer or a container to 
store licensed material unless the source changer or the storage 
container has securely attached to it a durable, legible, and clearly 
visible label bearing the standard trefoil radiation caution symbol 
conventional colors, i.e., magenta, purple or black on a yellow 
background, having a minimum diameter of 25 mm, and the wording

CAUTION*
RADIOACTIVE MATERIAL
NOTIFY CIVIL AUTHORITIES (or ``NAME OF COMPANY'')
*____ or ``DANGER''

    (b) The licensee may not transport licensed material unless the 
material is packaged, and the package is labeled, marked, and 
accompanied with appropriate shipping papers in accordance with 
regulations set out in 10 CFR part 71.
    (c) Locked radiographic exposure devices and storage containers must 
be physically secured to prevent tampering or removal by unauthorized 
personnel. The licensee shall store licensed material in a manner which 
will minimize danger from explosion or fire.
    (d) The licensee shall lock and physically secure the transport 
package containing licensed material in the transporting vehicle to 
prevent accidental loss, tampering, or unauthorized removal of the 
licensed material from the vehicle.



                 Subpart D_Radiation Safety Requirements



Sec.34.41  Conducting industrial radiographic operations.

    (a) Whenever radiography is performed at a location other than a 
permanent radiographic installation, the radiographer must be 
accompanied by at least one other qualified radiographer or an 
individual who has at a minimum met the requirements of

[[Page 668]]

Sec.34.43(c). The additional qualified individual shall observe the 
operations and be capable of providing immediate assistance to prevent 
unauthorized entry. Radiography may not be performed if only one 
qualified individual is present.
    (b) All radiographic operations conducted at locations of use 
authorized on the license must be conducted in a permanent radiographic 
installation, unless specifically authorized by the Commission.
    (c) A licensee may conduct lay-barge, offshore platform, or 
underwater radiography only if procedures have been approved by the 
Commission or by an Agreement State.
    (d) Licensees will have until June 27, 1998, to meet the 
requirements for having two qualified individuals present at locations 
other than a permanent radiographic installation as specified in 
paragraph (a) of this section.

[62 FR 28963, May 28, 1997, as amended at 63 FR 37061, July 9, 1998]



Sec.34.42  Radiation Safety Officer for industrial radiography.

    The RSO shall ensure that radiation safety activities are being 
performed in accordance with approved procedures and regulatory 
requirements in the daily operation of the licensee's program.
    (a) The minimum qualifications, training, and experience for RSOs 
for industrial radiography are as follows:
    (1) Completion of the training and testing requirements of Sec.
34.43(a);
    (2) 2000 hours of hands-on experience as a qualified radiographer in 
industrial radiographic operations; and
    (3) Formal training in the establishment and maintenance of a 
radiation protection program.
    (b) The Commission will consider alternatives when the RSO has 
appropriate training and/or experience in the field of ionizing 
radiation, and in addition, has adequate formal training with respect to 
the establishment and maintenance of a radiation safety protection 
program.
    (c) The specific duties and authorities of the RSO include, but are 
not limited to:
    (1) Establishing and overseeing all operating, emergency, and ALARA 
procedures as required by 10 CFR part 20 of this chapter, and reviewing 
them regularly to ensure that the procedures in use conform to current 
10 CFR part 20 procedures, conform to other NRC regulations and to the 
license conditions.
    (2) Overseeing and approving all phases of the training program for 
radiographic personnel, ensuring that appropriate and effective 
radiation protection practices are taught;
    (3) Ensuring that required radiation surveys and leak tests are 
performed and documented in accordance with the regulations, including 
any corrective measures when levels of radiation exceed established 
limits;
    (4) Ensuring that personnel monitoring devices are calibrated and 
used properly by occupationally-exposed personnel, that records are kept 
of the monitoring results, and that timely notifications are made as 
required by Sec.20.2203 of this chapter; and
    (5) Ensuring that operations are conducted safely and to assume 
control for instituting corrective actions including stopping of 
operations when necessary.
    (d) Licensees will have until June 27, 1999, to meet the 
requirements of paragraph (a) or (b) of this section.

[62 FR 28963, May 28, 1997, as amended at 63 FR 37061, July 9, 1998]



Sec.34.43  Training.

    (a) The licensee may not permit any individual to act as a 
radiographer until the individual--
    (1) Has received training in the subjects in paragraph (g) of this 
section, in addition to a minimum of 2 months of on-the-job training, 
and is certified through a radiographer certification program by a 
certifying entity in accordance with the criteria specified in appendix 
A of this part. (An independent organization that would like to be 
recognized as a certifying entity shall submit its request to the 
Director, Office of Nuclear Material Safety and Safeguards, by an 
appropriate method listed in Sec.30.6(a) of this chapter.); or
    (2) The licensee may, until June 27, 1999, allow an individual who 
has not met the requirements of paragraph (a)(1) of this section, to act 
as a

[[Page 669]]

radiographer after the individual has received training in the subjects 
outlined in paragraph (g) of this section and demonstrated an 
understanding of these subjects by successful completion of a written 
examination that was previously submitted to and approved by the 
Commission.
    (b) In addition, the licensee may not permit any individual to act 
as a radiographer until the individual--
    (1) Has received copies of and instruction in the requirements 
described in NRC regulations contained in this part; in Sec. Sec.30.7, 
30.9, and 30.10 of this chapter; in the applicable sections of 10 CFR 
parts 19 and 20, of this chapter, in applicable DOT regulations as 
referenced in 10 CFR part 71, in the NRC license(s) under which the 
radiographer will perform industrial radiography, and the licensee's 
operating and emergency procedures;
    (2) Has demonstrated understanding of the licensee's license and 
operating and emergency procedures by successful completion of a written 
or oral examination covering this material.
    (3) Has received training in the use of the licensee's radiographic 
exposure devices, sealed sources, in the daily inspection of devices and 
associated equipment, and in the use of radiation survey instruments.
    (4) Has demonstrated understanding of the use of radiographic 
exposure devices, sources, survey instruments and associated equipment 
described in paragraphs (b)(1) and (b)(3) of this section by successful 
completion of a practical examination covering this material.
    (c) The licensee may not permit any individual to act as a 
radiographer's assistant until the individual--
    (1) Has received copies of and instruction in the requirements 
described in NRC regulations contained in this part, in Sec. Sec.30.7, 
30.9, and 30.10 of this chapter, in the applicable sections of 10 CFR 
parts 19 and 20 of this chapter, in applicable DOT regulations as 
referenced in 10 CFR part 71, in the NRC license(s) under which the 
radiographer's assistant will perform industrial radiography, and the 
licensee's operating and emergency procedures;
    (2) Has developed competence to use, under the personal supervision 
of the radiographer, the radiographic exposure devices, sealed sources, 
associated equipment, and radiation survey instruments that the 
assistant will use; and
    (3) Has demonstrated understanding of the instructions provided 
under (c)(1) of this section by successfully completing a written test 
on the subjects covered and has demonstrated competence in the use of 
hardware described in (c)(2) of this section by successful completion of 
a practical examination on the use of such hardware.
    (d) The licensee shall provide annual refresher safety training for 
each radiographer and radiographer's assistant at intervals not to 
exceed 12 months.
    (e) Except as provided in paragraph (e)(4), the RSO or designee 
shall conduct an inspection program of the job performance of each 
radiographer and radiographer's assistant to ensure that the 
Commission's regulations, license requirements, and the applicant's 
operating and emergency procedures are followed. The inspection program 
must:
    (1) Include observation of the performance of each radiographer and 
radiographer's assistant during an actual industrial radiographic 
operation, at intervals not to exceed 6 months; and
    (2) Provide that, if a radiographer or a radiographer's assistant 
has not participated in an industrial radiographic operation for more 
than 6 months since the last inspection, the radiographer must 
demonstrate knowledge of the training requirements of Sec.34.43(b)(3) 
and the radiographer's assistant must re-demonstrate knowledge of the 
training requirements of Sec.34.43(c)(2) by a practical examination 
before these individuals can next participate in a radiographic 
operation.
    (3) The Commission may consider alternatives in those situations 
where the individual serves as both radiographer and RSO.
    (4) In those operations where a single individual serves as both 
radiographer and RSO, and performs all radiography operations, an 
inspection program is not required.
    (f) The licensee shall maintain records of the above training to 
include

[[Page 670]]

certification documents, written and practical examinations, refresher 
safety training and inspections of job performance in accordance with 
Sec.34.79.
    (g) The licensee shall include the following subjects required in 
paragraph (a) of this section:
    (1) Fundamentals of radiation safety including--
    (i) Characteristics of gamma radiation;
    (ii) Units of radiation dose and quantity of radioactivity;
    (iii) Hazards of exposure to radiation;
    (iv) Levels of radiation from licensed material; and
    (v) Methods of controlling radiation dose (time, distance, and 
shielding);
    (2) Radiation detection instruments including--
    (i) Use, operation, calibration, and limitations of radiation survey 
instruments;
    (ii) Survey techniques; and
    (iii) Use of personnel monitoring equipment;
    (3) Equipment to be used including--
    (i) Operation and control of radiographic exposure equipment, remote 
handling equipment, and storage containers, including pictures or models 
of source assemblies (pigtails).
    (ii) Storage, control, and disposal of licensed material; and
    (iii) Inspection and maintenance of equipment.
    (4) The requirements of pertinent Federal regulations; and
    (5) Case histories of accidents in radiography.
    (h) Licensees will have until June 27, 1998, to comply with the 
additional training requirements specified in paragraphs (b)(1) and 
(c)(1) of this section.
    (i) Licensees will have until June 27, 1999 to comply with the 
certification requirements specified in paragraph (a)(1) of this 
section. Records of radiographer certification maintained in accordance 
with Sec.34.79(a) provide appropriate affirmation of certification 
requirements specified in paragraph (a)(1) of this section.

[62 FR 28963, May 28, 1997, as amended at 63 FR 37061, July 9, 1998; 68 
FR 58805, Oct. 10, 2003, 73 FR 5720, Jan. 31, 2008]



Sec.34.45  Operating and emergency procedures.

    (a) Operating and emergency procedures must include, as a minimum, 
instructions in the following:
    (1) Appropriate handling and use of licensed sealed sources and 
radiographic exposure devices so that no person is likely to be exposed 
to radiation doses in excess of the limits established in 10 CFR part 20 
of this chapter ``Standards for Protection Against Radiation'';
    (2) Methods and occasions for conducting radiation surveys;
    (3) Methods for controlling access to radiographic areas;
    (4) Methods and occasions for locking and securing radiographic 
exposure devices, transport and storage containers and sealed sources;
    (5) Personnel monitoring and the use of personnel monitoring 
equipment;
    (6) Transporting sealed sources to field locations, including 
packing of radiographic exposure devices and storage containers in the 
vehicles, placarding of vehicles when needed, and control of the sealed 
sources during transportation (refer to 49 CFR parts 171-173);
    (7) The inspection, maintenance, and operability checks of 
radiographic exposure devices, survey instruments, transport containers, 
and storage containers;
    (8) Steps that must be taken immediately by radiography personnel in 
the event a pocket dosimeter is found to be off-scale or an alarm 
ratemeter alarms unexpectedly.
    (9) The procedure(s) for identifying and reporting defects and 
noncompliance, as required by 10 CFR part 21 of this chapter;
    (10) The procedure for notifying proper persons in the event of an 
accident;
    (11) Minimizing exposure of persons in the event of an accident;
    (12) Source recovery procedure if licensee will perform source 
recovery;
    (13) Maintenance of records.
    (b) The licensee shall maintain copies of current operating and 
emergency procedures in accordance with Sec. Sec.34.81 and 34.89.

[[Page 671]]



Sec.34.46  Supervision of radiographers' assistants.

    Whenever a radiographer's assistant uses radiographic exposure 
devices, associated equipment or sealed sources or conducts radiation 
surveys required by Sec.34.49(b) to determine that the sealed source 
has returned to the shielded position after an exposure, the assistant 
shall be under the personal supervision of a radiographer. The personal 
supervision must include:
    (a) The radiographer's physical presence at the site where the 
sealed sources are being used;
    (b) The availability of the radiographer to give immediate 
assistance if required; and
    (c) The radiographer's direct observation of the assistant's 
performance of the operations referred to in this section.



Sec.34.47  Personnel monitoring.

    (a) The licensee may not permit any individual to act as a 
radiographer or a radiographer's assistant unless, at all times during 
radiographic operations, each individual wears, on the trunk of the 
body, a direct reading dosimeter, an operating alarm ratemeter, and a 
personnel dosimeter that is processed and evaluated by an accredited 
National Voluntary Laboratory Accreditation Program (NVLAP) processor. 
At permanent radiography installations where other appropriate alarming 
or warning devices are in routine use, the wearing of an alarming 
ratemeter is not required.
    (1) Pocket dosimeters must have a range from zero to 2 millisieverts 
(200 millirems) and must be recharged at the start of each shift. 
Electronic personal dosimeters may only be used in place of ion-chamber 
pocket dosimeters.
    (2) Each personnel dosimeter must be assigned to and worn only by 
one individual.
    (3) Film badges must be replaced at periods not to exceed one month 
and other personnel dosimeters processed and evaluated by an accredited 
NVLAP processor must be replaced at periods not to exceed three months.
    (4) After replacement, each personnel dosimeter must be processed as 
soon as possible.
    (b) Direct reading dosimeters such as pocket dosimeters or 
electronic personal dosimeters, must be read and the exposures recorded 
at the beginning and end of each shift, and records must be maintained 
in accordance with Sec.34.83.
    (c) Pocket dosimeters, or electronic personal dosimeters, must be 
checked at periods not to exceed 12 months for correct response to 
radiation, and records must be maintained in accordance with Sec.
34.83. Acceptable dosimeters must read within plus or minus 20 percent 
of the true radiation exposure.
    (d) If an individual's pocket chamber is found to be off-scale, or 
if his or her electronic personal dosimeter reads greater than 2 
millisieverts (200 millirems), and the possibility of radiation exposure 
cannot be ruled out as the cause, the individual's personnel dosimeter 
must be sent for processing within 24 hours. In addition, the individual 
may not resume work associated with licensed material use until a 
determination of the individual's radiation exposure has been made. This 
determination must be made by the RSO or the RSO's designee. The results 
of this determination must be included in the records maintained in 
accordance with Sec.34.83.
    (e) If the personnel dosimeter that is required by paragraph (a) of 
this section is lost or damaged, the worker shall cease work immediately 
until a replacement personnel dosimeter meeting the requirements in 
paragraph (a) is provided and the exposure is calculated for the time 
period from issuance to loss or damage of the personnel dosimeter. The 
results of the calculated exposure and the time period for which the 
personnel dosimeter was lost or damaged must be included in the records 
maintained in accordance with Sec.34.83.
    (f) Dosimetry reports received from the accredited NVLAP personnel 
dosimeter processor must be retained in accordance with Sec.34.83.
    (g) Each alarm ratemeter must--
    (1) Be checked to ensure that the alarm functions properly (sounds) 
before using at the start of each shift;
    (2) Be set to give an alarm signal at a preset dose rate of 5 mSv/hr 
(500 mrem/hr); with an accuracy of plus or

[[Page 672]]

minus 20 percent of the true radiation dose rate;
    (3) Require special means to change the preset alarm function; and
    (4) Be calibrated at periods not to exceed 12 months for correct 
response to radiation. The licensee shall maintain records of alarm 
ratemeter calibrations in accordance with Sec.34.83.

[62 FR 28963, May 28, 1997, as amended at 65 FR 63751, Oct. 24, 2000]



Sec.34.49  Radiation surveys.

    The licensee shall:
    (a) Conduct surveys with a calibrated and operable radiation survey 
instrument that meets the requirements of Sec.34.25.
    (b) Using a survey instrument meeting the requirements of paragraph 
(a) of this section, conduct a survey of the radiographic exposure 
device and the guide tube after each exposure when approaching the 
device or the guide tube. The survey must determine that the sealed 
source has returned to its shielded position before exchanging films, 
repositioning the exposure head, or dismantling equipment.
    (c) Conduct a survey of the radiographic exposure device with a 
calibrated radiation survey instrument any time the source is exchanged 
and whenever a radiographic exposure device is placed in a storage area 
(as defined in Sec.34.3), to ensure that the sealed source is in its 
shielded position.
    (d) Maintain records in accordance with Sec.34.85.



Sec.34.51  Surveillance.

    During each radiographic operation the radiographer, or the other 
individual present, as required by Sec.34.41, shall maintain 
continuous direct visual surveillance of the operation to protect 
against unauthorized entry into a high radiation area, as defined in 10 
CFR part 20 of this chapter, except at permanent radiographic 
installations where all entryways are locked and the requirements of 
Sec.34.33 are met.



Sec.34.53  Posting.

    All areas in which industrial radiography is being performed must be 
conspicuously posted as required by Sec.20.1902(a) and (b) of this 
chapter. Exceptions listed in Sec.20.1903 of this chapter do not apply 
to industrial radiographic operations.

[62 FR 28963, May 28, 1997, as amended at 66 FR 64738, Dec. 14, 2001]



                  Subpart E_Recordkeeping Requirements



Sec.34.61  Records of the specific license for industrial 
radiography.

    Each licensee shall maintain a copy of its license, license 
conditions, documents incorporated by reference, and amendments to each 
of these items until superseded by new documents approved by the 
Commission, or until the Commission terminates the license.



Sec.34.63  Records of receipt and transfer of sealed sources.

    (a) Each licensee shall maintain records showing the receipts and 
transfers of sealed sources and devices using DU for shielding and 
retain each record for 3 years after it is made.
    (b) These records must include the date, the name of the individual 
making the record, radionuclide, number of becquerels (curies) or mass 
(for DU), and manufacturer, model, and serial number of each sealed 
source and/or device, as appropriate.



Sec.34.65  Records of radiation survey instruments.

    Each licensee shall maintain records of the calibrations of its 
radiation survey instruments that are required under Sec.34.25 and 
retain each record for 3 years after it is made.



Sec.34.67  Records of leak testing of sealed sources and devices
containing depleted uranium.

    Each licensee shall maintain records of leak test results for sealed 
sources and for devices containing DU. The results must be stated in 
units of becquerels (microcuries). The licensee shall retain each record 
for 3 years after it is made or until the source in storage is removed.



Sec.34.69  Records of quarterly inventory.

    (a) Each licensee shall maintain records of the quarterly inventory 
of sealed sources and of devices containing depleted uranium as required

[[Page 673]]

by Sec.34.29 and retain each record for 3 years after it is made.
    (b) The record must include the date of the inventory, name of the 
individual conducting the inventory, radionuclide, number of becquerels 
(curies) or mass (for DU) in each device, location of sealed source and/
or devices, and manufacturer, model, and serial number of each sealed 
source and/or device, as appropriate.



Sec.34.71  Utilization logs.

    (a) Each licensee shall maintain utilization logs showing for each 
sealed source the following information:
    (1) A description, including the make, model, and serial number of 
the radiographic exposure device or transport or storage container in 
which the sealed source is located;
    (2) The identity and signature of the radiographer to whom assigned; 
and
    (3) The plant or site where used and dates of use, including the 
dates removed and returned to storage.
    (b) The licensee shall retain the logs required by paragraph (a) of 
this section for 3 years after the log is made.



Sec.34.73  Records of inspection and maintenance of radiographic
exposure devices, transport and storage containers, associated 
equipment, source changers, and survey instruments.
          

    (a) Each licensee shall maintain records specified in Sec.34.31 of 
equipment problems found in daily checks and quarterly inspections of 
radiographic exposure devices, transport and storage containers, 
associated equipment, source changers, and survey instruments; and 
retain each record for 3 years after it is made.
    (b) The record must include the date of check or inspection, name of 
inspector, equipment involved, any problems found, and what repair and/
or maintenance, if any, was done.



Sec.34.75  Records of alarm system and entrance control checks at
permanent radiographic installations.

    Each licensee shall maintain records of alarm system and entrance 
control device tests required under Sec.34.33 and retain each record 
for 3 years after it is made.



Sec.34.79  Records of training and certification.

    Each licensee shall maintain the following records (of training and 
certification) for 3 years after the record is made:
    (a) Records of training of each radiographer and each radiographer's 
assistant. The record must include radiographer certification documents 
and verification of certification status, copies of written tests, dates 
of oral and practical examinations, and names of individuals conducting 
and receiving the oral and practical examinations; and
    (b) Records of annual refresher safety training and semi-annual 
inspections of job performance for each radiographer and each 
radiographer's assistant. The records must list the topics discussed 
during the refresher safety training, the dates the annual refresher 
safety training was conducted, and names of the instructors and 
attendees. For inspections of job performance, the records must also 
include a list showing the items checked and any non-compliances 
observed by the RSO.



Sec.34.81  Copies of operating and emergency procedures.

    Each licensee shall maintain a copy of current operating and 
emergency procedures until the Commission terminates the license. 
Superseded material must be retained for 3 years after the change is 
made.



Sec.34.83  Records of personnel monitoring procedures.

    Each licensee shall maintain the following exposure records 
specified in Sec.34.47:
    (a) Direct reading dosimeter readings and yearly operability checks 
required by Sec.34.47 (b) and (c) for 3 years after the record is 
made.
    (b) Records of alarm ratemeter calibrations for 3 years after the 
record is made.
    (c) Personnel dosimeter results received from the accredited NVLAP 
processor until the Commission terminates the license.
    (d) Records of estimates of exposures as a result of: off-scale 
personal direct reading dosimeters, or lost or damaged

[[Page 674]]

personnel dosimeters until the Commission terminates the license.

[62 FR 28963, May 28, 1997, as amended at 65 FR 63752, Oct. 24, 2000]



Sec.34.85  Records of radiation surveys.

    Each licensee shall maintain a record of each exposure device survey 
conducted before the device is placed in storage as specified in Sec.
34.49(c), if that survey is the last one performed in the workday. Each 
record must be maintained for 3 years after it is made.



Sec.34.87  Form of records.

    Each record required by this part must be legible throughout the 
specified retention period. The record may be the original or a 
reproduced copy or a microform provided that the copy or microform is 
authenticated by authorized personnel and that the microform is capable 
of reproducing a clear copy throughout the required retention period. 
The record may also be stored in electronic media with the capability 
for producing legible, accurate, and complete records during the 
required retention period. Records, such as letters, drawings, and 
specifications, must include all pertinent information, such as stamps, 
initials, and signatures. The licensee shall maintain adequate 
safeguards against tampering with and loss of records.



Sec.34.89  Location of documents and records.

    (a) Each licensee shall maintain copies of records required by this 
part and other applicable parts of this chapter at the location 
specified in Sec.34.13(k).
    (b) Each licensee shall also maintain copies of the following 
documents and records sufficient to demonstrate compliance at each 
applicable field station and each temporary jobsite;
    (1) The license authorizing the use of licensed material;
    (2) A copy of 10 CFR parts 19, 20, and 34 of NRC regulations;
    (3) Utilization records for each radiographic exposure device 
dispatched from that location as required by Sec.34.71.
    (4) Records of equipment problems identified in daily checks of 
equipment as required by Sec.34.73(a);
    (5) Records of alarm system and entrance control checks required by 
Sec.34.75, if applicable;
    (6) Records of direct reading dosimeters such as pocket dosimeter 
and/or electronic personal dosimeters readings as required by Sec.
34.83;
    (7) Operating and emergency procedures required by Sec.34.81;
    (8) Evidence of the latest calibration of the radiation survey 
instruments in use at the site, as required by Sec.34.65;
    (9) Evidence of the latest calibrations of alarm ratemeters and 
operability checks of pocket dosimeters and/or electronic personal 
dosimeters as required by Sec.34.83;
    (10) Latest survey records required by Sec.34.85;
    (11) The shipping papers for the transportation of radioactive 
materials required by Sec.71.5 of this chapter; and
    (12) When operating under reciprocity pursuant to Sec.150.20 of 
this chapter, a copy of the Agreement State license authorizing the use 
of licensed materials.



                         Subpart F_Notifications



Sec.34.101  Notifications.

    (a) In addition to the reporting requirements specified in Sec.
30.50 and under other sections of this chapter, such as Sec.21.21, 
each licensee shall send a written report to the NRC's Office of Nuclear 
Material Safety and Safeguards, by an appropriate method listed in Sec.
30.6(a) of this chapter, within 30 days of the occurrence of any of the 
following incidents involving radiographic equipment:
    (1) Unintentional disconnection of the source assembly from the 
control cable;
    (2) Inability to retract the source assembly to its fully shielded 
position and secure it in this position; or
    (3) Failure of any component (critical to safe operation of the 
device) to properly perform its intended function;
    (b) The licensee shall include the following information in each 
report submitted under paragraph (a) of this section, and in each report 
of overexposure submitted under 10 CFR 20.2203 which involves failure of 
safety components of radiography equipment:

[[Page 675]]

    (1) A description of the equipment problem;
    (2) Cause of each incident, if known;
    (3) Name of the manufacturer and model number of equipment involved 
in the incident;
    (4) Place, date, and time of the incident;
    (5) Actions taken to establish normal operations;
    (6) Corrective actions taken or planned to prevent recurrence; and
    (7) Qualifications of personnel involved in the incident.
    (c) Any licensee conducting radiographic operations or storing 
radioactive material at any location not listed on the license for a 
period in excess of 180 days in a calendar year, shall notify the 
appropriate NRC regional office listed in Sec.30.6(b)(2) of this 
chapter prior to exceeding the 180 days.

[62 FR 28963, May 28, 1997, as amended at 67 FR 3585, Jan. 25, 2002; 68 
FR 58805, Oct. 10, 2003; 73 FR 5720, Jan. 31, 2008; 83 FR 30287, June 
28, 2018]



                          Subpart G_Exemptions



Sec.34.111  Applications for exemptions.

    The Commission may, upon application of any interested person or 
upon its own initiative, grant an exemption from the requirements of the 
regulations in this part if it determines the exemption is authorized by 
law and would not endanger life or property or the common defense and 
security and is otherwise in the public interest.



                          Subpart H_Violations



Sec.34.121  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to these Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under Section 234 of the Atomic Energy Act;
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section.
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.



Sec.34.123  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1952, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under one 
or more of Sec. Sec.161b, 161i, or 161o of the Act. For purposes of 
Section 223, all the regulations in 10 CFR part 34 are issued under one 
or more of Sec. Sec.161b, 161i, or 161o, except for the sections 
listed in paragraph (b) of this section.
    (b) The regulations in 10 CFR part 34 that are not issued under 
sections 161b, 161i, or 161o for the purposes of Section 223 are as 
follows: Sec. Sec.34.1, 34.3, 34.5, 34.8, 34.11, 34.13, 34.111, 
34.121, 34.123.



         Sec. Appendix A to Part 34--Radiographer Certification

       I. Requirements for an Independent Certifying Organization

    An independent certifying organization shall:
    1. Be an organization such as a society or association, whose 
members participate in, or have an interest in, the fields of industrial 
radiography;
    2. Make its membership available to the general public nationwide 
that is not restricted because of race, color, religion, sex, age, 
national origin or disability;
    3. Have a certification program open to nonmembers, as well as 
members;
    4. Be an incorporated, nationally recognized organization, that is 
involved in setting national standards of practice within its fields of 
expertise;
    5. Have an adequate staff, a viable system for financing its 
operations, and a policy-and decision-making review board;

[[Page 676]]

    6. Have a set of written organizational by-laws and policies that 
provide adequate assurance of lack of conflict of interest and a system 
for monitoring and enforcing those by-laws and policies;
    7. Have a committee, whose members can carry out their 
responsibilities impartially, to review and approve the certification 
guidelines and procedures, and to advise the organization's staff in 
implementing the certification program;
    8. Have a committee, whose members can carry out their 
responsibilities impartially, to review complaints against certified 
individuals and to determine appropriate sanctions;
    9. Have written procedures describing all aspects of its 
certification program, maintain records of the current status of each 
individual's certification and the administration of its certification 
program;
    10. Have procedures to ensure that certified individuals are 
provided due process with respect to the administration of its 
certification program, including the process of becoming certified and 
any sanctions imposed against certified individuals;
    11. Have procedures for proctoring examinations, including 
qualifications for proctors. These procedures must ensure that the 
individuals proctoring each examination are not employed by the same 
company or corporation (or a wholly-owned subsidiary of such company or 
corporation) as any of the examinees;
    12. Exchange information about certified individuals with the 
Commission and other independent certifying organizations and/or 
Agreement States and allow periodic review of its certification program 
and related records; and
    13. Provide a description to the Commission of its procedures for 
choosing examination sites and for providing an appropriate examination 
environment.

               II. Requirements for Certification Programs

    All certification programs must:
    1. Require applicants for certification to (a) receive training in 
the topics set forth in Sec.34.43(g) or equivalent Agreement State 
regulations, and (b) satisfactorily complete a written examination 
covering these topics;
    2. Require applicants for certification to provide documentation 
that demonstrates that the applicant has: (a) received training in the 
topics set forth in Sec.34.43(g) or equivalent Agreement State 
regulations; (b) satisfactorily completed a minimum period of on-the-job 
training; and (c) has received verification by an Agreement State or a 
NRC licensee that the applicant has demonstrated the capability of 
independently working as a radiographer;
    3. Include procedures to ensure that all examination questions are 
protected from disclosure;
    4. Include procedures for denying an application, revoking, 
suspending, and reinstating a certificate;
    5. Provide a certification period of not less than 3 years nor more 
than 5 years;
    6. Include procedures for renewing certifications and, if the 
procedures allow renewals without examination, require evidence of 
recent full-time employment and annual refresher training.
    7. Provide a timely response to inquiries, by telephone or letter, 
from members of the public, about an individual's certification status.

               III. Requirements for Written Examinations

    All examinations must be:
    1. Designed to test an individual's knowledge and understanding of 
the topics listed in Sec.34.43(g) or equivalent Agreement State 
requirements;
    2. Written in a multiple-choice format;
    3. Have test items drawn from a question bank containing 
psychometrically valid questions based on the material in Sec.
34.43(g).



PART 35_MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents



                      Subpart A_General Information

Sec.
35.1 Purpose and scope.
35.2 Definitions.
35.5 Maintenance of records.
35.6 Provisions for the protection of human research subjects.
35.7 FDA, other Federal, and State requirements.
35.8 Information collection requirements: OMB approval.
35.10 Implementation.
35.11 License required.
35.12 Application for license, amendment, or renewal.
35.13 License amendments.
35.14 Notifications.
35.15 Exemptions regarding Type A specific licenses of broad scope.
35.18 License issuance.
35.19 Specific exemptions.

              Subpart B_General Administrative Requirements

35.24 Authority and responsibilities for the radiation protection 
          program.
35.26 Radiation protection program changes.
35.27 Supervision.
35.40 Written directives.

[[Page 677]]

35.41 Procedures for administrations requiring a written directive.
35.49 Suppliers for sealed sources or devices for medical use.
35.50 Training for Radiation Safety Officer.
35.51 Training for an authorized medical physicist.
35.55 Training for an authorized nuclear pharmacist.
35.57 Training for experienced Radiation Safety Officer, teletherapy or 
          medical physicist, authorized medical physicist, authorized 
          user, nuclear pharmacist, and authorized nuclear pharmacist.
35.59 Recentness of training.

                Subpart C_General Technical Requirements

35.60 Possession, use, and calibration of instruments used to measure 
          the activity of unsealed byproduct material.
35.61 Calibration of survey instruments.
35.63 Determination of dosages of unsealed byproduct material for 
          medical use.
35.65 Authorization for calibration, transmission, and reference 
          sources.
35.67 Requirements for possession of sealed sources and brachytherapy 
          sources.
35.69 Labeling of vials and syringes.
35.70 Surveys of ambient radiation exposure rate.
35.75 Release of individuals containing unsealed byproduct material or 
          implants containing byproduct material.
35.80 Provision of mobile medical service.
35.92 Decay-in-storage.

  Subpart D_Unsealed Byproduct Material_Written Directive Not Required

35.100 Use of unsealed byproduct material for uptake, dilution, and 
          excretion studies for which a written directive is not 
          required.
35.190 Training for uptake, dilution, and excretion studies.
35.200 Use of unsealed byproduct material for imaging and localization 
          studies for which a written directive is not required.
35.204 Permissible molybdenum-99, strontium-82, and strontium-85 
          concentrations.
35.290 Training for imaging and localization studies.

    Subpart E_Unsealed Byproduct Material_Written Directive Required

35.300 Use of unsealed byproduct material for which a written directive 
          is required.
35.310 Safety instruction.
35.315 Safety precautions.
35.390 Training for use of unsealed byproduct material for which a 
          written directive is required.
35.392 Training for the oral administration of sodium iodide I-131 
          requiring a written directive in quantities less than or equal 
          to 1.22 Gigabecquerels (33 millicuries).
35.394 Training for the oral administration of sodium iodide I-131 
          requiring a written directive in quantities greater than 1.22 
          Gigabecquerels (33 millicuries).
35.396 Training for the parenteral administration of unsealed byproduct 
          material requiring a written directive.

                     Subpart F_Manual Brachytherapy

35.400 Use of sources for manual brachytherapy.
35.404 Surveys after source implant and removal.
35.406 Brachytherapy sources accountability.
35.410 Safety instruction.
35.415 Safety precautions.
35.432 Calibration measurements of brachytherapy sources.
35.433 Decay of strontium-90 sources for ophthalmic treatments.
35.457 Therapy-related computer systems.
35.490 Training for use of manual brachytherapy sources.
35.491 Training for ophthalmic use of strontium-90.

                 Subpart G_Sealed Sources for Diagnosis

35.500 Use of sealed sources for diagnosis.
35.590 Training for use of sealed sources for diagnosis.

 Subpart H_Photon Emitting Remote Afterloader Units, Teletherapy Units, 
                and Gamma Stereotactic Radiosurgery Units

35.600 Use of a sealed source in a remote afterloader unit, teletherapy 
          unit, or gamma stereotactic radiosurgery unit.
35.604 Surveys of patients and human research subjects treated with a 
          remote afterloader unit.
35.605 Installation, maintenance, adjustment, and repair.
35.610 Safety procedures and instructions for remote afterloader units, 
          teletherapy units, and gamma stereotactic radiosurgery units.
35.615 Safety precautions for remote afterloader units, teletherapy 
          units, and gamma stereotactic radiosurgery units.
35.630 Dosimetry equipment.
35.632 Full calibration measurements on teletherapy units.
35.633 Full calibration measurements on remote afterloader units.
35.635 Full calibration measurements on gamma stereotactic radiosurgery 
          units.
35.642 Periodic spot-checks for teletherapy units.

[[Page 678]]

35.643 Periodic spot-checks for remote afterloader units.
35.645 Periodic spot-checks for gamma stereotactic radiosurgery units.
35.647 Additional technical requirements for mobile remote afterloader 
          units.
35.652 Radiation surveys.
35.655 Five-year inspection for teletherapy and gamma stereotactic 
          radiosurgery units.
35.657 Therapy-related computer systems.
35.690 Training for use of remote afterloader units, teletherapy units, 
          and gamma stereotactic radiosurgery units.

Subparts I-J [Reserved]

  Subpart K_Other Medical Uses of Byproduct Material or Radiation From 
                           Byproduct Material

35.1000 Other medical uses of byproduct material or radiation from 
          byproduct material.

                            Subpart L_Records

35.2024 Records of authority and responsibilities for radiation 
          protection programs.
35.2026 Records of radiation protection program changes.
35.2040 Records of written directives.
35.2041 Records for procedures for administrations requiring a written 
          directive.
35.2060 Records of calibrations of instruments used to measure the 
          activity of unsealed byproduct materials.
35.2061 Records of radiation survey instrument calibrations.
35.2063 Records of dosages of unsealed byproduct material for medical 
          use.
35.2067 Records of leaks tests and inventory of sealed sources and 
          brachytherapy sources.
35.2070 Records of surveys for ambient radiation exposure rate.
35.2075 Records of the release of individuals containing unsealed 
          byproduct material or implants containing byproduct material.
35.2080 Records of mobile medical services.
35.2092 Records of decay-in-storage.
35.2204 Records of molybdenum-99, strontium-82, and strontium-85 
          concentrations.
35.2310 Records of safety instruction.
35.2404 Records of surveys after source implant and removal.
35.2406 Records of brachytherapy source accountability.
35.2432 Records of calibration measurements of brachytherapy sources.
35.2433 Records of decay of strontium-90 sources for ophthalmic 
          treatments.
35.2605 Records of installation, maintenance, adjustment, and repair of 
          remote afterloader units, teletherapy units, and gamma 
          stereotactic radiosurgery units.
35.2610 Records of safety procedures.
35.2630 Records of dosimetry equipment used with remote afterloader 
          units, teletherapy units, and gamma stereotactic radiosurgery 
          units.
35.2632 Records of teletherapy, remote afterloader, and gamma 
          stereotactic radiosurgery full calibrations.
35.2642 Records of periodic spot-checks for teletherapy units.
35.2643 Records of periodic spot-checks for remote afterloader units.
35.2645 Records of periodic spot-checks for gamma stereotactic 
          radiosurgery units.
35.2647 Records of additional technical requirements for mobile remote 
          afterloader units.
35.2652 Records of surveys of therapeutic treatment units.
35.2655 Records of 5-year inspection for teletherapy and gamma 
          stereotactic radiosurgery units.

                            Subpart M_Reports

35.3045 Report and notification of a medical event.
35.3047 Report and notification of a dose to an embryo/fetus or a 
          nursing child.
35.3067 Report of a leaking source.
35.3204 Report and notification for an eluate exceeding permissible 
          molybdenum-99, strontium-82, and strontium-85 concentrations.

                          Subpart N_Enforcement

35.4001 Violations.
35.4002 Criminal penalties.

    Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182, 183, 
223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282, 
2021); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 
5841, 5846); 44 U.S.C. 3504 note.

    Source: 67 FR 20370, Apr. 24, 2002, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 35 appear at 79 FR 
75739, Dec. 19, 2014.



                      Subpart A_General Information



Sec.35.1  Purpose and scope.

    This part contains the requirements and provisions for the medical 
use of byproduct material and for issuance of specific licenses 
authorizing the medical use of this material. These requirements and 
provisions provide for the radiation safety of workers, the general 
public, patients, and human research subjects. The requirements and

[[Page 679]]

provisions of this part are in addition to, and not in substitution for, 
others in this chapter. The requirements and provisions of parts 19, 20, 
21, 30, 37, 71, 170, and 171 of this chapter apply to applicants and 
licensees subject to this part unless specifically exempted.

[78 FR 17006, Mar. 19, 2013]



Sec.35.2  Definitions.

    Address of use means the building or buildings that are identified 
on the license and where byproduct material may be received, prepared, 
used, or stored.
    Agreement State means any State with which the Commission or the 
Atomic Energy Commission has entered into an effective agreement under 
subsection 274b of the Atomic Energy Act of 1954, as amended.
    Area of use means a portion of an address of use that has been set 
aside for the purpose of receiving, preparing, using, or storing 
byproduct material.
    Authorized medical physicist means an individual who--
    (1) Meets the requirements in Sec. Sec.35.51(a) and 35.59; or
    (2) Is identified as an authorized medical physicist or teletherapy 
physicist on--
    (i) A specific medical use license issued by the Commission or 
Agreement State;
    (ii) A medical use permit issued by a Commission master material 
licensee;
    (iii) A permit issued by a Commission or Agreement State broad scope 
medical use licensee; or
    (iv) A permit issued by a Commission master material license broad 
scope medical use permittee.
    Authorized nuclear pharmacist means a pharmacist who--
    (1) Meets the requirements in Sec. Sec.35.55(a) and 35.59; or
    (2) Is identified as an authorized nuclear pharmacist on--
    (i) A specific license issued by the Commission or Agreement State 
that authorizes medical use or the practice of nuclear pharmacy;
    (ii) A permit issued by a Commission master material licensee that 
authorizes medical use or the practice of nuclear pharmacy;
    (iii) A permit issued by a Commission or Agreement State broad scope 
medical use licensee that authorizes medical use or the practice of 
nuclear pharmacy; or
    (iv) A permit issued by a Commission master material license broad 
scope medical use permittee that authorizes medical use or the practice 
of nuclear pharmacy; or
    (3) Is identified as an authorized nuclear pharmacist by a 
commercial nuclear pharmacy that has been authorized to identify 
authorized nuclear pharmacists; or
    (4) Is designated as an authorized nuclear pharmacist in accordance 
with Sec.32.72(b)(4).
    Authorized user means a physician, dentist, or podiatrist who--
    (1) Meets the requirements in Sec. Sec.35.59 and 35.190(a), 
35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 
35.690(a); or
    (2) Is identified as an authorized user on--
    (i) A Commission or Agreement State license that authorizes the 
medical use of byproduct material;
    (ii) A permit issued by a Commission master material licensee that 
is authorized to permit the medical use of byproduct material;
    (iii) A permit issued by a Commission or Agreement State specific 
licensee of broad scope that is authorized to permit the medical use of 
byproduct material; or
    (iv) A permit issued by a Commission master material license broad 
scope permittee that is authorized to permit the medical use of 
byproduct material.
    Brachytherapy means a method of radiation therapy in which sources 
are used to deliver a radiation dose at a distance of up to a few 
centimeters by surface, intracavitary, intraluminal, or interstitial 
application.
    Brachytherapy source means a radioactive source or a manufacturer-
assembled source train or a combination of these sources that is 
designed to deliver a therapeutic dose within a distance of a few 
centimeters.
    Client's address means the area of use or a temporary job site for 
the purpose of providing mobile medical service in accordance with Sec.
35.80.
    Cyclotron means a particle accelerator in which the charged 
particles travel in an outward spiral or circular

[[Page 680]]

path. A cyclotron accelerates charged particles at energies usually in 
excess of 10 megaelectron volts and is commonly used for production of 
short half-life radionuclides for medical use.
    Dedicated check source means a radioactive source that is used to 
assure the constant operation of a radiation detection or measurement 
device over several months or years.
    Dentist means an individual licensed by a State or Territory of the 
United States, the District of Columbia, or the Commonwealth of Puerto 
Rico to practice dentistry.
    High dose-rate remote afterloader, as used in this part, means a 
brachytherapy device that remotely delivers a dose rate in excess of 12 
gray (1200 rads) per hour at the point or surface where the dose is 
prescribed.
    Low dose-rate remote afterloader, as used in this part, means a 
brachytherapy device that remotely delivers a dose rate of less than or 
equal to 2 gray (200 rads) per hour at the point or surface where the 
dose is prescribed.
    Management means the chief executive officer or other individual 
having the authority to manage, direct, or administer the licensee's 
activities, or those persons' delegate or delegates.
    Manual brachytherapy, as used in this part, means a type of 
brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) 
are manually placed topically on or inserted either into the body 
cavities that are in close proximity to a treatment site or directly 
into the tissue volume.
    Medical event means an event that meets the criteria in Sec.
35.3045(a) or (b).
    Medical institution means an organization in which more than one 
medical discipline is practiced.
    Medical use means the intentional internal or external 
administration of byproduct material or the radiation from byproduct 
material to patients or human research subjects under the supervision of 
an authorized user.
    Medium dose-rate remote afterloader, as used in this part, means a 
brachytherapy device that remotely delivers a dose rate of greater than 
2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 
rads) per hour at the point or surface where the dose is prescribed.
    Mobile medical service means the transportation of byproduct 
material to and its medical use at the client's address.
    Output means the exposure rate, dose rate, or a quantity related in 
a known manner to these rates from a brachytherapy source or a 
teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit 
for a specified set of exposure conditions.
    Patient intervention means actions by the patient or human research 
subject, whether intentional or unintentional, such as dislodging or 
removing treatment devices or prematurely terminating the 
administration.
    Pharmacist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice pharmacy.
    Physician means a medical doctor or doctor of osteopathy licensed by 
a State or Territory of the United States, the District of Columbia, or 
the Commonwealth of Puerto Rico to prescribe drugs in the practice of 
medicine.
    Podiatrist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice podiatry.
    Positron Emission Tomography (PET) radionuclide production facility 
is defined as a facility operating a cyclotron or accelerator for the 
purpose of producing PET radionuclides.
    Preceptor means an individual who provides, directs, or verifies 
training and experience required for an individual to become an 
authorized user, an authorized medical physicist, an authorized nuclear 
pharmacist, or a Radiation Safety Officer.
    Prescribed dosage means the specified activity or range of activity 
of unsealed byproduct material as documented--
    (1) In a written directive; or
    (2) In accordance with the directions of the authorized user for 
procedures performed pursuant to Sec. Sec.35.100 and 35.200.
    Prescribed dose means--

[[Page 681]]

    (1) For gamma stereotactic radiosurgery, the total dose as 
documented in the written directive;
    (2) For teletherapy, the total dose and dose per fraction as 
documented in the written directive;
    (3) For manual brachytherapy, either the total source strength and 
exposure time or the total dose, as documented in the written directive; 
or
    (4) For remote brachytherapy afterloaders, the total dose and dose 
per fraction as documented in the written directive.
    Pulsed dose-rate remote afterloader, as used in this part, means a 
special type of remote afterloading brachytherapy device that uses a 
single source capable of delivering dose rates in the ``high dose-rate'' 
range, but--
    (1) Is approximately one-tenth of the activity of typical high dose-
rate remote afterloader sources; and
    (2) Is used to simulate the radiobiology of a low dose-rate 
treatment by inserting the source for a given fraction of each hour.
    Radiation Safety Officer means an individual who--
    (1) Meets the requirements in Sec. Sec.35.50(a) or (c)(1) and 
35.59; or
    (2) Is identified as a Radiation Safety Officer on--
    (i) A specific medical use license issued by the Commission or 
Agreement State; or
    (ii) A medical use permit issued by a Commission master material 
licensee.
    Sealed source means any byproduct material that is encased in a 
capsule designed to prevent leakage or escape of the byproduct material.
    Sealed Source and Device Registry means the national registry that 
contains all the registration certificates, generated by both NRC and 
the Agreement States, that summarize the radiation safety information 
for the sealed sources and devices and describe the licensing and use 
conditions approved for the product.
    Stereotactic radiosurgery means the use of external radiation in 
conjunction with a stereotactic guidance device to very precisely 
deliver a therapeutic dose to a tissue volume.
    Structured educational program means an educational program designed 
to impart particular knowledge and practical education through 
interrelated studies and supervised training.
    Teletherapy, as used in this part, means a method of radiation 
therapy in which collimated gamma rays are delivered at a distance from 
the patient or human research subject.
    Temporary job site means a location where mobile medical services 
are conducted other than those location(s) of use authorized on the 
license.
    Therapeutic dosage means a dosage of unsealed byproduct material 
that is intended to deliver a radiation dose to a patient or human 
research subject for palliative or curative treatment.
    Therapeutic dose means a radiation dose delivered from a source 
containing byproduct material to a patient or human research subject for 
palliative or curative treatment.
    Treatment site means the anatomical description of the tissue 
intended to receive a radiation dose, as described in a written 
directive.
    Type of use means use of byproduct material under Sec. Sec.35.100, 
35.200, 35.300, 35.400, 35.500, 35.600, or 35.1000.
    Unit dosage means a dosage prepared for medical use for 
administration as a single dosage to a patient or human research subject 
without any further manipulation of the dosage after it is initially 
prepared.
    Written directive means an authorized user's written order for the 
administration of byproduct material or radiation from byproduct 
material to a specific patient or human research subject, as specified 
in Sec.35.40.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 
69 FR 55737, Sept. 16, 2004; 70 FR 16361, Mar. 30, 2005; 71 FR 15008, 
Mar. 27, 2006; 72 FR 45151, Aug. 13, 2007; 72 FR 55930, Oct. 1, 2007]

    Effective Date Note: At 83 FR 33102, July 16, 2018, Sec.35.2 was 
amended by adding in alphabetical order definitions for Associate 
Radiation Safety Officer and Ophthalmic physicist and revising the 
definition of Preceptor, effective Jan. 14, 2019. For the convenience of 
the user, the added and revised text is set forth as follows:



Sec.35.2  Definitions.

                                * * * * *

    Associate Radiation Safety Officer means an individual who--

[[Page 682]]

    (1) Meets the requirements in Sec. Sec.35.50 and 35.59; and
    (2) Is currently identified as an Associate Radiation Safety Officer 
for the types of use of byproduct material for which the individual has 
been assigned duties and tasks by the Radiation Safety Officer on--
    (i) A specific medical use license issued by the Commission or an 
Agreement State; or
    (ii) A medical use permit issued by a Commission master material 
licensee.

                                * * * * *

    Ophthalmic physicist means an individual who--
    (1) Meets the requirements in Sec. Sec.35.433(a)(2) and 35.59; and
    (2) Is identified as an ophthalmic physicist on a--
    (i) Specific medical use license issued by the Commission or an 
Agreement State;
    (ii) Permit issued by a Commission or Agreement State broad scope 
medical use licensee;
    (iii) Medical use permit issued by a Commission master material 
licensee; or
    (iv) Permit issued by a Commission master material licensee broad 
scope medical use permittee.

                                * * * * *

    Preceptor means an individual who provides, directs, or verifies 
training and experience required for an individual to become an 
authorized user, an authorized medical physicist, an authorized nuclear 
pharmacist, a Radiation Safety Officer, or an Associate Radiation Safety 
Officer.

                                * * * * *



Sec.35.5  Maintenance of records.

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



Sec.35.6  Provisions for the protection of human research subjects.

    (a) A licensee may conduct research involving human research 
subjects only if it uses the byproduct materials specified on its 
license for the uses authorized on its license.
    (b) If the research is conducted, funded, supported, or regulated by 
another Federal agency that has implemented the Federal Policy for the 
Protection of Human Subjects (Federal Policy), the licensee shall, 
before conducting research--
    (1) Obtain review and approval of the research from an 
``Institutional Review Board,'' as defined and described in the Federal 
Policy; and
    (2) Obtain ``informed consent,'' as defined and described in the 
Federal Policy, from the human research subject.
    (c) If the research will not be conducted, funded, supported, or 
regulated by another Federal agency that has implemented the Federal 
Policy, the licensee shall, before conducting research, apply for and 
receive a specific amendment to its NRC medical use license. The 
amendment request must include a written commitment that the licensee 
will, before conducting research--
    (1) Obtain review and approval of the research from an 
``Institutional Review Board,'' as defined and described in the Federal 
Policy; and
    (2) Obtain ``informed consent'', as defined and described in the 
Federal Policy, from the human research subject.
    (d) Nothing in this section relieves licensees from complying with 
the other requirements in this part.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002]



Sec.35.7  FDA, other Federal, and State requirements.

    Nothing in this part relieves the licensee from complying with 
applicable FDA, other Federal, and State requirements governing 
radioactive drugs or devices.



Sec.35.8  Information collection requirements: OMB approval.

    (a) The Commission has submitted the information collection 
requirements contained in this part to the Office of Management and 
Budget (OMB)

[[Page 683]]

for approval as required by the Paperwork Reduction Act (44 U.S.C. 
3501et seq.). The NRC may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays a 
currently valid OMB control number. OMB has approved the information 
collection requirements in this part under control number 3150-0010.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.35.6, 35.12, 35.13, 35.14, 35.19, 35.24, 
35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.63, 
35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.190, 35.204, 35.290, 
35.310, 35.315, 35.390, 35.392, 35.394, 35.396, 35.404, 35.406, 35.410, 
35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 
35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 
35.652, 35.655, 35.690, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 
35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 
35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 
35.2630, 35.2632, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 
35.3045, 35.3047 and 35.3067.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec.35.12, NRC Form 313, including NRC Form 313A, which 
licensees may use to provide supplemental information, is approved under 
control number 3150-0120.
    (2) [Reserved]

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006]

    Effective Date Note: At 83 FR 33102, July 16, 2018, Sec.35.8 was 
amended by revising paragraph (b), effective Jan. 14, 2019. For the 
convenience of the user, the revised text is set forth as follows:



Sec.35.8  Information collection requirements: OMB approval.

                                * * * * *

    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.35.6, 35.12, 35.13, 35.14, 35.19, 35.24, 
35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.63, 
35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.190, 35.204, 35.290, 
35.310, 35.315, 35.390, 35.392, 35.394, 35.396, 35.404, 35.406, 35.410, 
35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 
35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 
35.652, 35.655, 35.690, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 
35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 
35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 
35.2630, 35.2632, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 
35.3045, 35.3047, 35.3067, and 35.3204.

                                * * * * *



Sec.35.10  Implementation.

    (a) A Government agency or a Federally recognized Indian Tribe that 
possesses and uses accelerator-produced radioactive material or discrete 
sources of radium-226 for which a specific medical use license is 
required by the Atomic Energy Act of 1954, as amended, must comply with 
the requirements of this part, including provisions that are specific to 
licensees, on November 30, 2007. All other persons who possess and use 
accelerator-produced radioactive material or discrete sources of radium-
226 for which a specific medical use license is required, must comply 
with the requirements of this part, including provisions that are 
specific to licensees, on August 8, 2009, or earlier as noticed by the 
NRC.
    (b)-(c) [Reserved]
    (d) If a license condition exempted a licensee from a provision of 
Part 35 on October 24, 2002, then the license condition continues to 
exempt the licensee from the requirements in the corresponding provision 
of Sec. Sec.35.1-35.4002.
    (e) When a requirement in this part differs from the requirement in 
an existing license condition, the requirement in this part shall 
govern.
    (f) A licensee shall continue to comply with any license condition 
that requires it to implement procedures required by Sec. Sec.35.610, 
35.642, 35.643, and 35.645 until there is a license amendment or renewal 
that modifies the license condition.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006; 
72 FR 55930, Oct. 1, 2007]

[[Page 684]]



Sec.35.11  License required.

    (a) A person may manufacture, produce, acquire, receive, possess, 
prepare, use, or transfer byproduct material for medical use only in 
accordance with a specific license issued by the Commission or an 
Agreement State, or as allowed in paragraph (b) or (c) of this section.
    (b) A specific license is not needed for an individual who--
    (1) Receives, possesses, uses, or transfers byproduct material in 
accordance with the regulations in this chapter under the supervision of 
an authorized user as provided in Sec.35.27, unless prohibited by 
license condition; or
    (2) Prepares unsealed byproduct material for medical use in 
accordance with the regulations in this chapter under the supervision of 
an authorized nuclear pharmacist or authorized user as provided in Sec.
35.27, unless prohibited by license condition.
    (c)(1) A Government agency or a Federally recognized Indian Tribe, 
that possesses and uses accelerator-produced radioactive material or 
discrete sources of radium-226 for which a specific medical use license 
is required in paragraph (a) of this section, may continue to use such 
materials for medical uses until the date of the NRC's final licensing 
determination, provided that the person submits a medical use license 
application on or before December 1, 2008.
    (2) Except as provided in paragraph (c)(1) of this section, all 
other persons, who possess and use accelerator-produced radioactive 
material or discrete sources of radium-226 for which a specific medical 
use license is required in paragraph (a) of this section, may continue 
to use this type of material for medical uses permitted under this part 
until the date of the NRC's final licensing determination, provided that 
the person submits a medical use license application within 12 months 
from the waiver expiration date of August 7, 2009 or within 12 months 
from the date of an earlier termination of the waiver as noticed by the 
NRC, whichever date is earlier.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55930, Oct. 1, 2006]



Sec.35.12  Application for license, amendment, or renewal.

    (a) An application must be signed by the applicant's or licensee's 
management.
    (b) An application for a license for medical use of byproduct 
material as described in Sec. Sec.35.100, 35.200, 35.300, 35.400, 
35.500, 35.600, and 35.1000 must be made by--
    (1) Filing an original and one copy of NRC Form 313, ``Application 
for Material License,'' that includes the facility diagram, equipment, 
and training and experience qualifications of the Radiation Safety 
Officer, authorized user(s), authorized medical physicist(s), and 
authorized nuclear pharmacist(s); and
    (2) Submitting procedures required by Sec. Sec.35.610, 35.642, 
35.643, and 35.645, as applicable.
    (c) A request for a license amendment or renewal must be made by--
    (1) Submitting an original and one copy of either--
    (i) NRC Form 313, ``Application for Material License''; or
    (ii) A letter requesting the amendment or renewal; and
    (2) Submitting procedures required by Sec. Sec.35.610, 35.642, 
35.643, and 35.645, as applicable.
    (d) In addition to the requirements in paragraphs (b) and (c) of 
this section, an application for a license or amendment for medical use 
of byproduct material as described in Sec.35.1000 must also include 
information regarding any radiation safety aspects of the medical use of 
the material that is not addressed in Subparts A through C of this part.
    (1) The applicant shall also provide specific information on--
    (i) Radiation safety precautions and instructions;
    (ii) Methodology for measurement of dosages or doses to be 
administered to patients or human research subjects; and
    (iii) Calibration, maintenance, and repair of instruments and 
equipment necessary for radiation safety.
    (2) The applicant or licensee shall also provide any other 
information requested by the Commission in its review of the 
application.

[[Page 685]]

    (e) An applicant that satisfies the requirements specified in Sec.
33.13 of this chapter may apply for a Type A specific license of broad 
scope.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002]

    Effective Date Note: At 83 FR 33102, July 16, 2018, Sec.35.12 was 
amended by revising paragraphs (b)(1), (c)(1) introductory text, 
(c)(1)(ii), and (d), effective Jan. 14, 2019. For the convenience of the 
user, the revised text is set forth as follows:



Sec.35.12  Application for license, amendment, or renewal.

                                * * * * *

    (b) * * *
    (1) Filing an original NRC Form 313, ``Application for Material 
License,'' that includes the facility diagram, equipment, and training 
and experience qualifications of the Radiation Safety Officer, Associate 
Radiation Safety Officer(s), authorized user(s), authorized medical 
physicist(s), ophthalmic physicist(s), and authorized nuclear 
pharmacist(s); and

                                * * * * *

    (c) * * *
    (1) Submitting an original of either--

                                * * * * *

    (ii) A letter containing all information required by NRC Form 313; 
and

                                * * * * *

    (d) In addition to the requirements in paragraphs (b) and (c) of 
this section, an application for a license or amendment for medical use 
of byproduct material as described in Sec.35.1000 must also include:
    (1) Any additional aspects of the medical use of the material that 
are applicable to radiation safety that are not addressed in, or differ 
from, subparts A through C, L, and M of this part;
    (2) Identification of and commitment to follow the applicable 
radiation safety program requirements in subparts D through H of this 
part that are appropriate for the specific Sec.35.1000 medical use;
    (3) Any additional specific information on--
    (i) Radiation safety precautions and instructions;
    (ii) Methodology for measurement of dosages or doses to be 
administered to patients or human research subjects; and
    (iii) Calibration, maintenance, and repair of instruments and 
equipment necessary for radiation safety; and
    (4) Any other information requested by the Commission in its review 
of the application.

                                * * * * *



Sec.35.13  License amendments.

    A licensee shall apply for and must receive a license amendment--
    (a) Before it receives, prepares, or uses byproduct material for a 
type of use that is permitted under this part, but is not authorized on 
the licensee's current license issued under this part; except that--
    (1) A Government agency or a Federally recognized Indian Tribe 
licensee who possesses and uses accelerator-produced radioactive 
material or discrete sources of radium-226 may continue to use such 
material for medical uses permitted under this part until the date of 
the NRC's final licensing determination, provided that the licensee 
submits an amendment application on or before June 2, 2008.
    (2) Except as provided in paragraph (a)(1) of this section, all 
other licensees who possess and use accelerator-produced radioactive 
material or discrete sources of radium-226 may continue to use those 
materials for medical uses permitted under this part until the date of 
the NRC's final licensing determination, provided that the person 
submits a medical use license amendment request within 6 months from the 
waiver expiration date of August 7, 2009 or within 6 months from the 
date of an earlier termination of the waiver as noticed by the NRC, 
whichever date is earlier.
    (b) Before it permits anyone to work as an authorized user, 
authorized nuclear pharmacist, or authorized medical physicist under the 
license, except--
    (1) For an authorized user, an individual who meets the requirements 
in Sec. Sec.35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 
35.394(a), 35.490(a), 35.590(a), and 35.690(a);
    (2) For an authorized nuclear pharmacist, an individual who meets 
the requirements in Sec. Sec.35.55(a) and 35.59;
    (3) For an authorized medical physicist, an individual who meets the 
requirements in Sec. Sec.35.51(a) and (c) and 35.59;

[[Page 686]]

    (4) An individual who is identified as an authorized user, an 
authorized nuclear pharmacist, or authorized medical physicist--
    (i) On a Commission or Agreement State license or other equivalent 
permit or license recognized by NRC that authorizes the use of byproduct 
material in medical use or in the practice of nuclear pharmacy;
    (ii) On a permit issued by a Commission or Agreement State specific 
license of broad scope that is authorized to permit the use of byproduct 
material in medical use or in the practice of nuclear pharmacy;
    (iii) On a permit issued by a Commission master material licensee 
that is authorized to permit the use of byproduct material in medical 
use or in the practice of nuclear pharmacy; or
    (iv) By a commercial nuclear pharmacy that has been authorized to 
identify authorized nuclear pharmacists.
    (5) A physician, podiatrist, or dentist who used only accelerator-
produced radioactive materials, discrete sources of radium-226, or both, 
for medical uses or a nuclear pharmacist who used only accelerator-
produced radioactive materials in the practice of nuclear pharmacy at a 
Government agency or Federally recognized Indian Tribe before November 
30, 2007 or at all other locations of use before August 8, 2009, or an 
earlier date as noticed by the NRC, and for only those materials and 
uses performed before these dates.
    (c) Before it changes Radiation Safety Officers, except as provided 
in Sec.35.24(c);
    (d) Before it receives byproduct material in excess of the amount or 
in a different form, or receives a different radionuclide than is 
authorized on the license;
    (e) Before it adds to or changes the areas of use identified in the 
application or on the license, including areas used in accordance with 
either Sec.35.100 or Sec.35.200 if the change includes addition or 
relocation of either an area where PET radionuclides are produced or a 
PET radioactive drug delivery line from the PET radionuclide/PET 
radioactive drug production area. Other areas of use where byproduct 
material is used only in accordance with either Sec.35.100 or Sec.
35.200 are exempt;
    (f) Before it changes the address(es) of use identified in the 
application or on the license; and
    (g) Before it revises procedures required by Sec. Sec.35.610, 
35.642, 35.643, and 35.645, as applicable, where such revision reduces 
radiation safety.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006; 
72 FR 55930, Oct. 1, 2007]

    Effective Date Note: At 83 FR 33102, July 16, 2018, Sec.35.13 was 
amended by revising paragraph (b); redesignating paragraphs (d) through 
(g) as paragraphs (e) through (h); adding new paragraph (d); revising 
newly redesignated paragraphs (g) and (h); and adding paragraph (i), 
effective Jan. 14, 2019. For the convenience of the user, the added and 
revised text is set forth as follows:



Sec.35.13  License amendments.

                                * * * * *

    (b) Before it permits anyone to work as an authorized user, 
authorized medical physicist, ophthalmic physicist, or authorized 
nuclear pharmacist under the license, except--
    (1) For an authorized user, an individual who meets the requirements 
in Sec. Sec.35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 
35.394(a), 35.490(a), 35.590(a), and 35.690(a);
    (2) For an authorized nuclear pharmacist, an individual who meets 
the requirements in Sec. Sec.35.55(a) and 35.59;
    (3) For an authorized medical physicist, an individual who meets the 
requirements in Sec. Sec.35.51(a) and 35.59;
    (4) An individual who is identified as an authorized user, an 
authorized nuclear pharmacist, authorized medical physicist, or an 
ophthalmic physicist--

                                * * * * *

    (d) Before it permits anyone to work as an Associate Radiation 
Safety Officer, or before the Radiation Safety Officer assigns duties 
and tasks to an Associate Radiation Safety Officer that differ from 
those for which this individual is authorized on the license;

                                * * * * *

    (g) Before it changes the address(es) of use identified in the 
application or on the license;
    (h) Before it revises procedures required by Sec. Sec.35.610, 
35.642, 35.643, and 35.645, as applicable, where such revision reduces 
radiation safety; and
    (i) Before it receives a sealed source from a different manufacturer 
or of a different model number than authorized by its license unless the 
sealed source is used for manual

[[Page 687]]

brachytherapy, is listed in the Sealed Source and Device Registry, and 
is in a quantity and for an isotope authorized by the license.



Sec.35.14  Notifications.

    (a) A licensee shall provide the Commission a copy of the board 
certification and the written attestation(s), signed by a preceptor, the 
Commission or Agreement State license, the permit issued by a Commission 
master material licensee, the permit issued by a Commission or Agreement 
State licensee of broad scope, the permit issued by a Commission master 
material license broad scope permittee, or documentation that only 
accelerator-produced radioactive materials, discrete sources of radium-
226, or both, were used for medical use or in the practice of nuclear 
pharmacy at a Government agency or Federally recognized Indian Tribe 
before November 30, 2007 or at all other locations of use before August 
8, 2009, or an earlier date as noticed by the NRC, and for each 
individual no later than 30 days after the date that the licensee 
permits the individual to work as an authorized user, an authorized 
nuclear pharmacist, or an authorized medical physicist, under Sec.
35.13(b). For individuals permitted to work under Sec.35.13(b)(4), 
within the same 30-day time frame, the licensee shall also provide, as 
appropriate, verification of completion of;
    (1) Any additional case experience required in Sec.
35.390(b)(1)(ii)(G) for an authorized user under Sec.35.300;
    (2) Any additional training required in Sec.35.690(c) for an 
authorized user under Sec.35.600; and
    (3) Any additional training required in Sec.35.51(c) for an 
authorized medical physicist.
    (b) A licensee shall notify the Commission no later than 30 days 
after:
    (1) An authorized user, an authorized nuclear pharmacist, a 
Radiation Safety Officer, or an authorized medical physicist permanently 
discontinues performance of duties under the license or has a name 
change;
    (2) The licensee permits an authorized user or an individual 
qualified to be a Radiation Safety Officer, under Sec. Sec.35.50 and 
35.59, to function as a temporary Radiation Safety Officer and to 
perform the functions of a Radiation Safety Officer in accordance with 
Sec.35.24(c).
    (3) The licensee's mailing address changes;
    (4) The licensee's name changes, but the name change does not 
constitute a transfer of control of the license as described in Sec.
30.34(b) of this chapter; or
    (5) The licensee has added to or changed the areas of use identified 
in the application or on the license where byproduct material is used in 
accordance with either Sec.35.100 or Sec.35.200 if the change does 
not include addition or relocation of either an area where PET 
radionuclides are produced or a PET radioactive drug delivery line from 
the PET radionuclide/PET radioactive drug production area.
    (c) The licensee shall send the documents required in this section 
to the appropriate address identified in Sec.30.6 of this chapter.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 58805, Oct. 10, 2003; 
70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006; 72 FR 55931, 
Oct. 1, 2007]

    Effective Date Note: At 83 FR 33103, July 16, 2018, Sec.35.14 was 
amended by revising paragraphs (a) and (b), effective Jan. 14, 2019. For 
the convenience of the user, the revised text is set forth as follows:



Sec.35.14  Notifications.

    (a) A licensee shall provide the Commission, no later than 30 days 
after the date that the licensee permits an individual to work under the 
provisions of Sec.35.13(b) as an authorized user, authorized medical 
physicist, ophthalmic physicist, or authorized nuclear pharmacist--
    (1) A copy of the board certification and, as appropriate, 
verification of completion of:
    (i) Training for the authorized medical physicist under Sec.
35.51(c);
    (ii) Any additional case experience required in Sec.
35.390(b)(1)(ii)(G) for an authorized user under Sec.35.300; or
    (iii) Device specific training in Sec.35.690(c) for the authorized 
user under Sec.35.600; or
    (2) A copy of the Commission or Agreement State license, the permit 
issued by a Commission master material licensee, the permit issued by a 
Commission or Agreement State licensee of broad scope, the permit issued 
by a Commission master material license broad scope permittee, or 
documentation that only accelerator-produced radioactive materials, 
discrete sources of radium-226, or both, were used for medical use or in 
the practice of nuclear pharmacy at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007, or at all other 
locations of

[[Page 688]]

use before August 8, 2009, or an earlier date as noticed by the NRC for 
each individual whom the licensee permits to work under the provisions 
of this section.
    (b) A licensee shall notify the Commission no later than 30 days 
after:
    (1) An authorized user, an authorized nuclear pharmacist, a 
Radiation Safety Officer, an Associate Radiation Safety Officer, an 
authorized medical physicist, or ophthalmic physicist permanently 
discontinues performance of duties under the license or has a name 
change;
    (2) The licensee permits an individual qualified to be a Radiation 
Safety Officer under Sec. Sec.35.50 and 35.59 to function as a 
temporary Radiation Safety Officer and to perform the functions of a 
Radiation Safety Officer in accordance with Sec.35.24(c);
    (3) The licensee's mailing address changes;
    (4) The licensee's name changes, but the name change does not 
constitute a transfer of control of the license as described in Sec.
30.34(b) of this chapter;
    (5) The licensee has added to or changed the areas of use identified 
in the application or on the license where byproduct material is used in 
accordance with either Sec.35.100 or Sec.35.200 if the change does 
not include addition or relocation of either an area where PET 
radionuclides are produced or a PET radioactive drug delivery line from 
the PET radionuclide/PET radioactive drug production area; or
    (6) The licensee obtains a sealed source for use in manual 
brachytherapy from a different manufacturer or with a different model 
number than authorized by its license for which it did not require a 
license amendment as provided in Sec.35.13(i). The notification must 
include the manufacturer and model number of the sealed source, the 
isotope, and the quantity per sealed source.

                                * * * * *



Sec.35.15  Exemptions regarding Type A specific licenses of broad
scope.

    A licensee possessing a Type A specific license of broad scope for 
medical use, issued under Part 33 of this chapter, is exempt from--
    (a) The provisions of Sec.35.12(d) regarding the need to file an 
amendment to the license for medical use of byproduct material, as 
described in Sec.35.1000;
    (b) The provisions of Sec.35.13(b);
    (c) The provisions of Sec.35.13(e) regarding additions to or 
changes in the areas of use at the addresses identified in the 
application or on the license;
    (d) The provisions of Sec.35.14(a);
    (e) The provisions of Sec.35.14(b)(1) for an authorized user, an 
authorized nuclear pharmacist, or an authorized medical physicist;
    (f) The provisions of Sec.35.14(b)(5).
    (g) The provisions of Sec.35.49(a).

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55931, Oct. 1, 2007]

    Effective Date Note: At 83 FR 33103, July 16, 2018, Sec.35.15 was 
amended by revising paragraphs (c) and (e), effective Jan. 14, 2019. For 
the convenience of the user, the revised text is set forth as follows:



Sec.35.15  Exemptions regarding Type A specific licenses of broad 
          scope.

                                * * * * *

    (c) The provisions of Sec.35.13(f) regarding additions to or 
changes in the areas of use at the addresses identified in the 
application or on the license;

                                * * * * *

    (e) The provisions of Sec.35.14(b)(1) for an authorized user, an 
authorized nuclear pharmacist, an authorized medical physicist, or an 
ophthalmic physicist;

                                * * * * *



Sec.35.18  License issuance.

    (a) The Commission shall issue a license for the medical use of 
byproduct material if--
    (1) The applicant has filed NRC Form 313 ``Application for Material 
License'' in accordance with the instructions in Sec.35.12;
    (2) The applicant has paid any applicable fee as provided in Part 
170 of this chapter;
    (3) The Commission finds the applicant equipped and committed to 
observe the safety standards established by the Commission in this 
Chapter for the protection of the public health and safety; and
    (4) The applicant meets the requirements of Part 30 of this chapter.
    (b) The Commission shall issue a license for mobile medical service 
if the applicant:
    (1) Meets the requirements in paragraph (a) of this section; and
    (2) Assures that individuals or human research subjects to whom 
unsealed byproduct material or radiation from implants containing 
byproduct material will be administered may be released

[[Page 689]]

following treatment in accordance with Sec.35.75.



Sec.35.19  Specific exemptions.

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



              Subpart B_General Administrative Requirements



Sec.35.24  Authority and responsibilities for the radiation protection program.

    (a) In addition to the radiation protection program requirements of 
Sec.20.1101 of this chapter, a licensee's management shall approve in 
writing--
    (1) Requests for a license application, renewal, or amendment before 
submittal to the Commission;
    (2) Any individual before allowing that individual to work as an 
authorized user, authorized nuclear pharmacist, or authorized medical 
physicist; and
    (3) Radiation protection program changes that do not require a 
license amendment and are permitted under Sec.35.26;
    (b) A licensee's management shall appoint a Radiation Safety 
Officer, who agrees, in writing, to be responsible for implementing the 
radiation protection program. The licensee, through the Radiation Safety 
Officer, shall ensure that radiation safety activities are being 
performed in accordance with licensee-approved procedures and regulatory 
requirements.
    (c) For up to 60 days each year, a licensee may permit an authorized 
user or an individual qualified to be a Radiation Safety Officer, under 
Sec. Sec.35.50 and 35.59, to function as a temporary Radiation Safety 
Officer and to perform the functions of a Radiation Safety Officer, as 
provided in paragraph (g) of this section, if the licensee takes the 
actions required in paragraphs (b), (e), (g), and (h) of this section 
and notifies the Commission in accordance with Sec.35.14(b).
    (d) A licensee may simultaneously appoint more than one temporary 
Radiation Safety Officer in accordance with paragraph (c) of this 
section, if needed to ensure that the licensee has a temporary Radiation 
Safety Officer that satisfies the requirements to be a Radiation Safety 
Officer for each of the different types of uses of byproduct material 
permitted by the license.
    (e) A licensee shall establish the authority, duties, and 
responsibilities of the Radiation Safety Officer in writing.
    (f) Licensees that are authorized for two or more different types of 
uses of byproduct material under Subparts E, F, and H of this part, or 
two or more types of units under Subpart H of this part, shall establish 
a Radiation Safety Committee to oversee all uses of byproduct material 
permitted by the license. The Committee must include an authorized user 
of each type of use permitted by the license, the Radiation Safety 
Officer, a representative of the nursing service, and a representative 
of management who is neither an authorized user nor a Radiation Safety 
Officer. The Committee may include other members the licensee considers 
appropriate.
    (g) A licensee shall provide the Radiation Safety Officer sufficient 
authority, organizational freedom, time, resources, and management 
prerogative, to--
    (1) Identify radiation safety problems;
    (2) Initiate, recommend, or provide corrective actions;
    (3) Stop unsafe operations; and,
    (4) Verify implementation of corrective actions.
    (h) A licensee shall retain a record of actions taken under 
paragraphs (a), (b), and (e) of this section in accordance with Sec.
35.2024.

    Effective Date Note: At 83 FR 33103, July 16, 2018, Sec.35.24 was 
amended by revising paragraphs (b) and (c), effective Jan. 14, 2019. For 
the convenience of the user, the revised text is set forth as follows:



Sec.35.24  Authority and responsibilities for the radiation protection 
          program.

                                * * * * *

    (b) A licensee's management shall appoint a Radiation Safety Officer 
who agrees, in writing, to be responsible for implementing

[[Page 690]]

the radiation protection program. The licensee, through the Radiation 
Safety Officer, shall ensure that radiation safety activities are being 
performed in accordance with licensee-approved procedures and regulatory 
requirements. A licensee's management may appoint, in writing, one or 
more Associate Radiation Safety Officers to support the Radiation Safety 
Officer. The Radiation Safety Officer, with written agreement of the 
licensee's management, must assign the specific duties and tasks to each 
Associate Radiation Safety Officer. These duties and tasks are 
restricted to the types of use for which the Associate Radiation Safety 
Officer is listed on a license. The Radiation Safety Officer may 
delegate duties and tasks to the Associate Radiation Safety Officer but 
shall not delegate the authority or responsibilities for implementing 
the radiation protection program.
    (c) For up to 60 days each year, a licensee may permit an individual 
qualified to be a Radiation Safety Officer, under Sec. Sec.35.50 and 
35.59, to function as a temporary Radiation Safety Officer and to 
perform the functions of a Radiation Safety Officer, as provided in 
paragraph (g) of this section, if the licensee takes the actions 
required in paragraphs (b), (e), (g), and (h) of this section and 
notifies the Commission in accordance with Sec.35.14(b).

                                * * * * *



Sec.35.26  Radiation protection program changes.

    (a) A licensee may revise its radiation protection program without 
Commission approval if--
    (1) The revision does not require a license amendment under Sec.
35.13;
    (2) The revision is in compliance with the regulations and the 
license ;
    (3) The revision has been reviewed and approved by the Radiation 
Safety Officer and licensee management; and
    (4) The affected individuals are instructed on the revised program 
before the changes are implemented.
    (b) A licensee shall retain a record of each change in accordance 
with Sec.35.2026.



Sec.35.27  Supervision.

    (a) A licensee that permits the receipt, possession, use, or 
transfer of byproduct material by an individual under the supervision of 
an authorized user, as allowed by Sec.35.11(b)(1), shall--
    (1) In addition to the requirements in Sec.19.12 of this chapter, 
instruct the supervised individual in the licensee's written radiation 
protection procedures, written directive procedures, regulations of this 
chapter, and license conditions with respect to the use of byproduct 
material; and
    (2) Require the supervised individual to follow the instructions of 
the supervising authorized user for medical uses of byproduct material, 
written radiation protection procedures established by the licensee, 
written directive procedures, regulations of this chapter, and license 
conditions with respect to the medical use of byproduct material.
    (b) A licensee that permits the preparation of byproduct material 
for medical use by an individual under the supervision of an authorized 
nuclear pharmacist or physician who is an authorized user, as allowed by 
Sec.35.11(b)(2), shall--
    (1) In addition to the requirements in Sec.19.12 of this chapter, 
instruct the supervised individual in the preparation of byproduct 
material for medical use, as appropriate to that individual's 
involvement with byproduct material; and
    (2) Require the supervised individual to follow the instructions of 
the supervising authorized user or authorized nuclear pharmacist 
regarding the preparation of byproduct material for medical use, written 
radiation protection procedures established by the licensee, the 
regulations of this chapter, and license conditions.
    (c) A licensee that permits supervised activities under paragraphs 
(a) and (b) of this section is responsible for the acts and omissions of 
the supervised individual.



Sec.35.40  Written directives.

    (a) A written directive must be dated and signed by an authorized 
user before the administration of I-131 sodium iodide greater than 1.11 
megabecquerels (MBq) (30 microcuries ([micro]Ci)), any therapeutic 
dosage of unsealed byproduct material or any therapeutic dose of 
radiation from byproduct material.
    (1) If, because of the emergent nature of the patient's condition, a 
delay in order to provide a written directive would jeopardize the 
patient's health, an oral directive is acceptable. The information 
contained in the oral directive must be documented as soon as

[[Page 691]]

possible in writing in the patient's record. A written directive must be 
prepared within 48 hours of the oral directive.
    (b) The written directive must contain the patient or human research 
subject's name and the following information--
    (1) For any administration of quantities greater than 1.11 MBq (30 
[micro]Ci) of sodium iodide I-131: the dosage;
    (2) For an administration of a therapeutic dosage of unsealed 
byproduct material other than sodium iodide I-131: the radioactive drug, 
dosage, and route of administration;
    (3) For gamma stereotactic radiosurgery: the total dose, treatment 
site, and values for the target coordinate settings per treatment for 
each anatomically distinct treatment site;
    (4) For teletherapy: the total dose, dose per fraction, number of 
fractions, and treatment site;
    (5) For high dose-rate remote afterloading brachytherapy: the 
radionuclide, treatment site, dose per fraction, number of fractions, 
and total dose; or
    (6) For all other brachytherapy, including low, medium, and pulsed 
dose rate remote afterloaders:
    (i) Before implantation: treatment site, the radionuclide, and dose; 
and
    (ii) After implantation but before completion of the procedure: the 
radionuclide, treatment site, number of sources, and total source 
strength and exposure time (or the total dose).
    (c) A written revision to an existing written directive may be made 
if the revision is dated and signed by an authorized user before the 
administration of the dosage of unsealed byproduct material, the 
brachytherapy dose, the gamma stereotactic radiosurgery dose, the 
teletherapy dose, or the next fractional dose.
    (1) If, because of the patient's condition, a delay in order to 
provide a written revision to an existing written directive would 
jeopardize the patient's health, an oral revision to an existing written 
directive is acceptable. The oral revision must be documented as soon as 
possible in the patient's record. A revised written directive must be 
signed by the authorized user within 48 hours of the oral revision.
    (d) The licensee shall retain a copy of the written directive in 
accordance with Sec.35.2040.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 68 FR 75389, 
Dec. 31, 2003]

    Effective Date Note: At 83 FR 33103, July 16, 2018, Sec.35.40 was 
amended by revising paragraph (b)(5); redesignating paragraph (b)(6) as 
paragraph (b)(7); adding new paragraph (b)(6); revising newly 
redesignated paragraph (b)(7); redesignating paragraph (c) introductory 
text as paragraph (c)(1); and redesignating paragraph (c)(1) as 
paragraph (c)(2), effective Jan. 14, 2019. For the convenience of the 
user, the added and revised text is set forth as follows:



Sec.35.40  Written directives.

                                * * * * *

    (b) * * *
    (5) For high dose-rate remote afterloading brachytherapy: The 
radionuclide, treatment site, dose per fraction, number of fractions, 
and total dose;
    (6) For permanent implant brachytherapy:
    (i) Before implantation: The treatment site, the radionuclide, and 
the total source strength; and
    (ii) After implantation but before the patient leaves the post-
treatment recovery area: The treatment site, the number of sources 
implanted, the total source strength implanted, and the date; or
    (7) For all other brachytherapy, including low, medium, and pulsed 
dose rate remote afterloaders:
    (i) Before implantation: The treatment site, radionuclide, and dose; 
and
    (ii) After implantation but before completion of the procedure: The 
radionuclide; treatment site; number of sources; total source strength 
and exposure time (or the total dose); and date.

                                * * * * *



Sec.35.41  Procedures for administrations requiring a written
directive.

    (a) For any administration requiring a written directive, the 
licensee shall develop, implement, and maintain written procedures to 
provide high confidence that:
    (1) The patient's or human research subject's identity is verified 
before each administration; and
    (2) Each administration is in accordance with the written directive.
    (b) At a minimum, the procedures required by paragraph (a) of this 
section must address the following items that

[[Page 692]]

are applicable to the licensee's use of byproduct material--
    (1) Verifying the identity of the patient or human research subject;
    (2) Verifying that the administration is in accordance with the 
treatment plan, if applicable, and the written directive;
    (3) Checking both manual and computer-generated dose calculations; 
and
    (4) Verifying that any computer-generated dose calculations are 
correctly transferred into the consoles of therapeutic medical units 
authorized by Sec. Sec.35.600 or 35.1000.
    (c) A licensee shall retain a copy of the procedures required under 
paragraph (a) in accordance with Sec.35.2041.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 45151, Aug. 13, 2007]

    Effective Date Note: At 83 FR 33104, July 16, 2018, Sec.35.41 was 
amended by revising paragraphs (b)(3) and (4) and adding paragraphs 
(b)(5) and (6), effective Jan. 14, 2019. For the convenience of the 
user, the added and revised text is set forth as follows:



Sec.35.41  Procedures for administrations requiring a written 
          directive.

                                * * * * *

    (b) * * *
    (3) Checking both manual and computer-generated dose calculations;
    (4) Verifying that any computer-generated dose calculations are 
correctly transferred into the consoles of therapeutic medical units 
authorized by Sec. Sec.35.600 or 35.1000;
    (5) Determining if a medical event, as defined in Sec.35.3045, has 
occurred; and
    (6) Determining, for permanent implant brachytherapy, within 60 
calendar days from the date the implant was performed, the total source 
strength administered outside of the treatment site compared to the 
total source strength documented in the post-implantation portion of the 
written directive, unless a written justification of patient 
unavailability is documented.

                                * * * * *



Sec.35.49  Suppliers for sealed sources or devices for medical use.

    For medical use, a licensee may only use--
    (a) Sealed sources or devices manufactured, labeled, packaged, and 
distributed in accordance with a license issued under 10 CFR Part 30 and 
10 CFR 32.74 of this chapter or equivalent requirements of an Agreement 
State;
    (b) Sealed sources or devices non-commercially transferred from a 
Part 35 licensee or an Agreement State medical use licensee.
    (c) Teletherapy sources manufactured and distributed in accordance 
with a license issued under 10 CFR Part 30 or the equivalent 
requirements of an Agreement State.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006]



Sec.35.50  Training for Radiation Safety Officer.

    Except as provided in Sec.35.57, the licensee shall require an 
individual fulfilling the responsibilities of the Radiation Safety 
Officer as provided in Sec.35.24 to be an individual who--
    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State and who 
meets the requirements in paragraphs (d) and (e) of this section. (The 
names of board certifications which have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page.) 
To have its certification process recognized, a specialty board shall 
require all candidates for certification to:
    (1)(i) Hold a bachelor's or graduate degree from an accredited 
college or university in physical science or engineering or biological 
science with a minimum of 20 college credits in physical science;
    (ii) Have 5 or more years of professional experience in health 
physics (graduate training may be substituted for no more than 2 years 
of the required experience) including at least 3 years in applied health 
physics; and
    (iii) Pass an examination administered by diplomates of the 
specialty board, which evaluates knowledge and competence in radiation 
physics and instrumentation, radiation protection, mathematics 
pertaining to the use and measurement of radioactivity, radiation 
biology, and radiation dosimetry; or
    (2)(i) Hold a master's or doctor's degree in physics, medical 
physics, other

[[Page 693]]

physical science, engineering, or applied mathematics from an accredited 
college or university;
    (ii) Have 2 years of full-time practical training and/or supervised 
experience in medical physics--
    (A) Under the supervision of a medical physicist who is certified in 
medical physics by a specialty board recognized by the Commission or an 
Agreement State; or
    (B) In clinical nuclear medicine facilities providing diagnostic 
and/or therapeutic services under the direction of physicians who meet 
the requirements for authorized users in Sec. Sec.35.57, 35.290, or 
35.390; and
    (iii) Pass an examination, administered by diplomates of the 
specialty board, that assesses knowledge and competence in clinical 
diagnostic radiological or nuclear medicine physics and in radiation 
safety; or
    (b)(1) Has completed a structured educational program consisting of 
both:
    (i) 200 hours of classroom and laboratory training in the following 
areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Radiation biology; and
    (E) Radiation dosimetry; and
    (ii) One year of full-time radiation safety experience under the 
supervision of the individual identified as the Radiation Safety Officer 
on a Commission or Agreement State license or permit issued by a 
Commission master material licensee that authorizes similar type(s) of 
use(s) of byproduct material involving the following--
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of instruments 
used to determine the activity of dosages, survey meters, and 
instruments used to measure radionuclides;
    (C) Securing and controlling byproduct material;
    (D) Using administrative controls to avoid mistakes in the 
administration of byproduct material;
    (E) Using procedures to prevent or minimize radioactive 
contamination and using proper decontamination procedures;
    (F) Using emergency procedures to control byproduct material; and
    (G) Disposing of byproduct material; or
    (2) [Reserved]
    (c)(1) Is a medical physicist who has been certified by a specialty 
board whose certification process has been recognized by the Commission 
or an Agreement State under Sec.35.51(a) and has experience in 
radiation safety for similar types of use of byproduct material for 
which the licensee is seeking the approval of the individual as 
Radiation Safety Officer and who meets the requirements in paragraphs 
(d) and (e) of this section; or
    (2) Is an authorized user, authorized medical physicist, or 
authorized nuclear pharmacist identified on the licensee's license and 
has experience with the radiation safety aspects of similar types of use 
of byproduct material for which the individual has Radiation Safety 
Officer responsibilities; and,
    (d) Has obtained written attestation, signed by a preceptor 
Radiation Safety Officer, that the individual has satisfactorily 
completed the requirements in paragraph (e) and in paragraphs (a)(1)(i) 
and (a)(1)(ii) or (a)(2)(i) and (a)(2)(ii) or (b)(1) or (c)(1) or (c)(2) 
of this section, and has achieved a level of radiation safety knowledge 
sufficient to function independently as a Radiation Safety Officer for a 
medical use licensee; and
    (e) Has training in the radiation safety, regulatory issues, and 
emergency procedures for the types of use for which a licensee seeks 
approval. This training requirement may be satisfied by completing 
training that is supervised by a Radiation Safety Officer, authorized 
medical physicist, authorized nuclear pharmacist, or authorized user, as 
appropriate, who is authorized for the type(s) of use for which the 
licensee is seeking approval.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16361, Mar. 30, 2005; 
71 FR 1926, Jan. 12, 2006; 71 FR 15008, Mar. 27, 2006; 74 FR 33904, July 
14, 2009; 76 FR 72085, Nov. 22, 2011]

    Effective Date Note: At 83 FR 33104, July 16, 2018, Sec.35.50 was 
revised, effective Jan. 14,

[[Page 694]]

2019. For the convenience of the user, the revised text is set forth as 
follows:



Sec.35.50  Training for Radiation Safety Officer and Associate 
          Radiation Safety Officer.

    Except as provided in Sec.35.57, the licensee shall require an 
individual fulfilling the responsibilities of the Radiation Safety 
Officer or an individual assigned duties and tasks as an Associate 
Radiation Safety Officer as provided in Sec.35.24 to be an individual 
who--
    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State and who 
meets the requirements in paragraph (d) of this section. The names of 
board certifications that have been recognized by the Commission or an 
Agreement State are posted on the NRC's Medical Uses Licensee Toolkit 
web page. To have its certification process recognized, a specialty 
board shall require all candidates for certification to:
    (1)(i) Hold a bachelor's or graduate degree from an accredited 
college or university in physical science or engineering or biological 
science with a minimum of 20 college credits in physical science;
    (ii) Have 5 or more years of professional experience in health 
physics (graduate training may be substituted for no more than 2 years 
of the required experience) including at least 3 years in applied health 
physics; and
    (iii) Pass an examination administered by diplomates of the 
specialty board, which evaluates knowledge and competence in radiation 
physics and instrumentation, radiation protection, mathematics 
pertaining to the use and measurement of radioactivity, radiation 
biology, and radiation dosimetry; or
    (2)(i) Hold a master's or doctor's degree in physics, medical 
physics, other physical science, engineering, or applied mathematics 
from an accredited college or university;
    (ii) Have 2 years of full-time practical training and/or supervised 
experience in medical physics--
    (A) Under the supervision of a medical physicist who is certified in 
medical physics by a specialty board recognized by the Commission or an 
Agreement State; or
    (B) In clinical nuclear medicine facilities providing diagnostic or 
therapeutic services under the direction of physicians who meet the 
requirements for authorized users in Sec. Sec.35.57, 35.290, or 
35.390; and
    (iii) Pass an examination, administered by diplomates of the 
specialty board, that assesses knowledge and competence in clinical 
diagnostic radiological or nuclear medicine physics and in radiation 
safety; or
    (b)(1) Has completed a structured educational program consisting of 
both:
    (i) 200 hours of classroom and laboratory training in the following 
areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Radiation biology; and
    (E) Radiation dosimetry; and
    (ii) One year of full-time radiation safety experience under the 
supervision of the individual identified as the Radiation Safety Officer 
on a Commission or an Agreement State license or permit issued by a 
Commission master material licensee that authorizes similar type(s) of 
use(s) of byproduct material. An Associate Radiation Safety Officer may 
provide supervision for those areas for which the Associate Radiation 
Safety Officer is authorized on a Commission or an Agreement State 
license or permit issued by a Commission master material licensee. The 
full-time radiation safety experience must involve the following--
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of instruments 
used to determine the activity of dosages, survey meters, and 
instruments used to measure radionuclides;
    (C) Securing and controlling byproduct material;
    (D) Using administrative controls to avoid mistakes in the 
administration of byproduct material;
    (E) Using procedures to prevent or minimize radioactive 
contamination and using proper decontamination procedures;
    (F) Using emergency procedures to control byproduct material; and
    (G) Disposing of byproduct material; and
    (2) This individual must obtain a written attestation, signed by a 
preceptor Radiation Safety Officer or Associate Radiation Safety Officer 
who has experience with the radiation safety aspects of similar types of 
use of byproduct material for which the individual is seeking approval 
as a Radiation Safety Officer or an Associate Radiation Safety Officer. 
The written attestation must state that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and (d) 
of this section, and is able to independently fulfill the radiation 
safety-related duties as a Radiation Safety Officer or as an Associate 
Radiation Safety Officer for a medical use license; or
    (c)(1) Is a medical physicist who has been certified by a specialty 
board whose certification process has been recognized by the Commission 
or an Agreement State under Sec.35.51(a), has experience with the 
radiation safety aspects of similar types of use of byproduct material 
for which the licensee seeks the approval of the individual as Radiation 
Safety Officer or an Associate Radiation Safety Officer, and meets the 
requirements in paragraph (d) of this section; or
    (2) Is an authorized user, authorized medical physicist, or 
authorized nuclear pharmacist identified on a Commission or an Agreement 
State license, a permit issued by

[[Page 695]]

a Commission master material licensee, a permit issued by a Commission 
or an Agreement State licensee of broad scope, or a permit issued by a 
Commission master material license broad scope permittee, has experience 
with the radiation safety aspects of similar types of use of byproduct 
material for which the licensee seeks the approval of the individual as 
the Radiation Safety Officer or Associate Radiation Safety Officer, and 
meets the requirements in paragraph (d) of this section; or
    (3) Has experience with the radiation safety aspects of the types of 
use of byproduct material for which the individual is seeking 
simultaneous approval both as the Radiation Safety Officer and the 
authorized user on the same new medical use license or new medical use 
permit issued by a Commission master material license. The individual 
must also meet the requirements in paragraph (d) of this section.
    (d) Has training in the radiation safety, regulatory issues, and 
emergency procedures for the types of use for which a licensee seeks 
approval. This training requirement may be satisfied by completing 
training that is supervised by a Radiation Safety Officer, an Associate 
Radiation Safety Officer, authorized medical physicist, authorized 
nuclear pharmacist, or authorized user, as appropriate, who is 
authorized for the type(s) of use for which the licensee is seeking 
approval.



Sec.35.51  Training for an authorized medical physicist.

    Except as provided in Sec.35.57, the licensee shall require the 
authorized medical physicist to be an individual who--
    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State and who 
meets the requirements in paragraphs (b)(2) and (c) of this section. 
(The names of board certifications which have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page.) 
To have its certification process recognized, a specialty board shall 
require all candidates for certification to:
    (1) Hold a master's or doctor's degree in physics, medical physics, 
other physical science, engineering, or applied mathematics from an 
accredited college or university;
    (2) Have 2 years of full-time practical training and/or supervised 
experience in medical physics--
    (i) Under the supervision of a medical physicist who is certified in 
medical physics by a specialty board recognized by the Commission or an 
Agreement State; or
    (ii) In clinical radiation facilities providing high-energy, 
external beam therapy (photons and electrons with energies greater than 
or equal to 1 million electron volts) and brachytherapy services under 
the direction of physicians who meet the requirements in Sec.35.57, 
35.490, or 35.690; and
    (3) Pass an examination, administered by diplomates of the specialty 
board, that assesses knowledge and competence in clinical radiation 
therapy, radiation safety, calibration, quality assurance, and treatment 
planning for external beam therapy, brachytherapy, and stereotactic 
radiosurgery; or
    (b)(1) Holds a master's or doctor's degree in physics, medical 
physics, other physical science, engineering, or applied mathematics 
from an accredited college or university; and has completed 1 year of 
full-time training in medical physics and an additional year of full-
time work experience under the supervision of an individual who meets 
the requirements for an authorized medical physicist for the type(s) of 
use for which the individual is seeking authorization. This training and 
work experience must be conducted in clinical radiation facilities that 
provide high-energy, external beam therapy (photons and electrons with 
energies greater than or equal to 1 million electron volts) and 
brachytherapy services and must include:
    (i) Performing sealed source leak tests and inventories;
    (ii) Performing decay corrections;
    (iii) Performing full calibration and periodic spot checks of 
external beam treatment units, stereotactic radiosurgery units, and 
remote afterloading units as applicable; and
    (iv) Conducting radiation surveys around external beam treatment 
units, stereotactic radiosurgery units, and remote afterloading units as 
applicable; and
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c) and (a)(1) 
and (a)(2), or (b)(1)

[[Page 696]]

and (c) of this section, and has achieved a level of competency 
sufficient to function independently as an authorized medical physicist 
for each type of therapeutic medical unit for which the individual is 
requesting authorized medical physicist status. The written attestation 
must be signed by a preceptor authorized medical physicist who meets the 
requirements in Sec. Sec.35.51, 35.57, or equivalent Agreement State 
requirements for an authorized medical physicist for each type of 
therapeutic medical unit for which the individual is requesting 
authorized medical physicist status; and
    (c) Has training for the type(s) of use for which authorization is 
sought that includes hands-on device operation, safety procedures, 
clinical use, and the operation of a treatment planning system. This 
training requirement may be satisfied by satisfactorily completing 
either a training program provided by the vendor or by training 
supervised by an authorized medical physicist authorized for the type(s) 
of use for which the individual is seeking authorization.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002, as amended at 70 
FR 16362, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006; 74 FR 33904, July 
14, 2009]

    Effective Date Note: At 83 FR 33105, July 16, 2018, Sec.35.51 was 
amended by revising paragraphs (a) introductory text, (a)(2)(i), and 
(b)(2), effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:



Sec.35.51  Training for an authorized medical physicist.

                                * * * * *

    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State and who 
meets the requirements in paragraph (c) of this section. The names of 
board certifications that have been recognized by the Commission or an 
Agreement State are posted on the NRC's Medical Uses Licensee Toolkit 
web page. To have its certification process recognized, a specialty 
board shall require all candidates for certification to:

                                * * * * *

    (2) * * *
    (i) Under the supervision of a medical physicist who is certified in 
medical physics by a specialty board whose certification process has 
been recognized under this section by the Commission or an Agreement 
State; or

                                * * * * *

    (b) * * *
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and (c) 
of this section, and is able to independently fulfill the radiation 
safety-related duties as an authorized medical physicist for each type 
of therapeutic medical unit for which the individual is requesting 
authorized medical physicist status. The written attestation must be 
signed by a preceptor authorized medical physicist who meets the 
requirements in Sec.35.51, Sec.35.57, or equivalent Agreement State 
requirements for an authorized medical physicist for each type of 
therapeutic medical unit for which the individual is requesting 
authorized medical physicist status.

                                * * * * *



Sec.35.55  Training for an authorized nuclear pharmacist.

    Except as provided in Sec.35.57, the licensee shall require the 
authorized nuclear pharmacist to be a pharmacist who--
    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State and who 
meets the requirements in paragraph (b)(2) of this section. (The names 
of board certifications which have been recognized by the Commission or 
an Agreement State will be posted on the NRC's Web page.) To have its 
certification process recognized, a specialty board shall require all 
candidates for certification to:
    (1) Have graduated from a pharmacy program accredited by the 
American Council on Pharmaceutical Education (ACPE) or have passed the 
Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;
    (2) Hold a current, active license to practice pharmacy;
    (3) Provide evidence of having acquired at least 4000 hours of 
training/experience in nuclear pharmacy practice. Academic training may 
be substituted for no more than 2000 hours of the required training and 
experience; and
    (4) Pass an examination in nuclear pharmacy administered by 
diplomates

[[Page 697]]

of the specialty board, that assesses knowledge and competency in 
procurement, compounding, quality assurance, dispensing, distribution, 
health and safety, radiation safety, provision of information and 
consultation, monitoring patient outcomes, research and development; or
    (b)(1) Has completed 700 hours in a structured educational program 
consisting of both:
    (i) 200 hours of classroom and laboratory training in the following 
areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) Supervised practical experience in a nuclear pharmacy 
involving--
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of instruments 
used to determine the activity of dosages, survey meters, and, if 
appropriate, instruments used to measure alpha- or beta-emitting 
radionuclides;
    (C) Calculating, assaying, and safely preparing dosages for patients 
or human research subjects;
    (D) Using administrative controls to avoid medical events in the 
administration of byproduct material; and
    (E) Using procedures to prevent or minimize radioactive 
contamination and using proper decontamination procedures; and
    (2) Has obtained written attestation, signed by a preceptor 
authorized nuclear pharmacist, that the individual has satisfactorily 
completed the requirements in paragraphs (a)(1), (a)(2), and (a)(3) or 
(b)(1) of this section and has achieved a level of competency sufficient 
to function independently as an authorized nuclear pharmacist.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16362, Mar. 30, 2005]

    Effective Date Note: At 83 FR 33105, July 16, 2018, Sec.35.55 was 
amended by revising paragraphs (a) introductory text and (b)(2), 
effective Jan. 14, 2019. For the convenience of the user, the revised 
text is set forth as follows:



Sec.35.55  Training for an authorized nuclear pharmacist.

                                * * * * *

    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State. The names 
of board certifications that have been recognized by the Commission or 
an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit 
web page. To have its certification process recognized, a specialty 
board shall require all candidates for certification to:

                                * * * * *

    (b) * * *
    (2) Has obtained written attestation, signed by a preceptor 
authorized nuclear pharmacist, that the individual has satisfactorily 
completed the requirements in paragraph (b)(1) of this section and is 
able to independently fulfill the radiation safety-related duties as an 
authorized nuclear pharmacist.



Sec.35.57  Training for experienced Radiation Safety Officer, 
teletherapy or medical physicist, authorized medical physicist,
authorized user, nuclear pharmacist, and authorized nuclear
pharmacist.
          

    (a)(1) An individual identified as a Radiation Safety Officer, a 
teletherapy or medical physicist, or a nuclear pharmacist on a 
Commission or Agreement State license or a permit issued by a Commission 
or Agreement State broad scope licensee or master material license 
permit or by a master material license permittee of broad scope before 
October 24, 2002, need not comply with the training requirements of 
Sec. Sec.35.50, 35.51, or 35.55, respectively.
    (2) An individual identified as a Radiation Safety Officer, an 
authorized medical physicist, or an authorized nuclear pharmacist on a 
Commission or Agreement State license or a permit issued by a Commission 
or Agreement State broad scope licensee or master material license 
permit or by a master material license permittee of broad scope between 
October 24, 2002 and April 29, 2005 need not comply with the training 
requirements of Sec. Sec.35.50, 35.51, or 35.55, respectively.
    (3) A Radiation Safety Officer, a medical physicist, or a nuclear 
pharmacist, who used only accelerator-produced radioactive materials, 
discrete sources of

[[Page 698]]

radium-226, or both, for medical uses or in the practice of nuclear 
pharmacy at a Government agency or Federally recognized Indian Tribe 
before November 30, 2007 or at all other locations of use before August 
8, 2009, or an earlier date as noticed by the NRC, need not comply with 
the training requirements of Sec.35.50, Sec.35.51 or Sec.35.55, 
respectively, when performing the same uses. A nuclear pharmacist, who 
prepared only radioactive drugs containing accelerator-produced 
radioactive materials, or a medical physicist, who used only 
accelerator-produced radioactive materials, at the locations and time 
period identified in this paragraph, qualifies as an authorized nuclear 
pharmacist or an authorized medical physicist, respectively, for those 
materials and uses performed before these dates, for purposes of this 
chapter.
    (b)(1) Physicians, dentists, or podiatrists identified as authorized 
users for the medical use of byproduct material on a license issued by 
the Commission or Agreement State, a permit issued by a Commission 
master material licensee, a permit issued by a Commission or Agreement 
State broad scope licensee, or a permit issued by a Commission master 
material license broad scope permittee before October 24, 2002, who 
perform only those medical uses for which they were authorized on that 
date need not comply with the training requirements of Subparts D 
through H of this part.
    (2) Physicians, dentists, or podiatrists identified as authorized 
users for the medical use of byproduct material on a license issued by 
the Commission or Agreement State, a permit issued by a Commission 
master material licensee, a permit issued by a Commission or Agreement 
State broad scope licensee, or a permit issued by a Commission master 
material license broad scope permittee who perform only those medical 
uses for which they were authorized between October 24, 2002 and April 
29, 2005, need not comply with the training requirements of Subparts D 
through H of this part.
    (3) Physicians, dentists, or podiatrists who used only accelerator-
produced radioactive materials, discrete sources of radium-226, or both, 
for medical uses performed at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007 or at all other 
locations of use before August 8, 2009, or an earlier date as noticed by 
the NRC, need not comply with the training requirements of subparts D 
through H of this part when performing the same medical uses. A 
physician, dentist, or podiatrist, who used only accelerator-produced 
radioactive materials, discrete sources of radium-226, or both, for 
medical uses at the locations and time period identified in this 
paragraph, qualifies as an authorized user for those materials and uses 
performed before these dates, for purposes of this chapter.
    (c) Individuals who need not comply with training requirements as 
described in this section may serve as preceptors for, and supervisors 
of, applicants seeking authorization on NRC licenses for the same uses 
for which these individuals are authorized.

[70 FR 16363, Mar. 30, 2005, as amended at 72 FR 55931, Oct. 1, 2007; 74 
FR 33905, July 14, 2009]

    Effective Date Note: At 83 FR 33105, July 16, 2018, Sec.35.57 was 
amended by revising paragraphs (a) and (b), effective Jan. 14, 2019. For 
the convenience of the user, the revised text is set forth as follows:



Sec.35.57  Training for experienced Radiation Safety Officer, 
          teletherapy or medical physicist, authorized medical 
          physicist, authorized user, nuclear pharmacist, and
          authorized nuclear pharmacist.

    (a)(1) An individual identified on a Commission or an Agreement 
State license or a permit issued by a Commission or an Agreement State 
broad scope licensee or master material license permit or by a master 
material license permittee of broad scope as a Radiation Safety Officer, 
a teletherapy or medical physicist, an authorized medical physicist, a 
nuclear pharmacist or an authorized nuclear pharmacist on or before 
January 14, 2019 need not comply with the training requirements of Sec.
35.50, Sec.35.51, or Sec.35.55, respectively, except the Radiation 
Safety Officers and authorized medical physicists identified in this 
paragraph must meet the training requirements in Sec.35.50(d) or Sec.
35.51(c), as appropriate, for any material or uses for which they were 
not authorized prior to this date.
    (2) Any individual certified by the American Board of Health Physics 
in Comprehensive Health Physics; American Board of Radiology; American 
Board of Nuclear Medicine; American Board of Science in Nuclear 
Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; 
American Board

[[Page 699]]

of Medical Physics in radiation oncology physics; Royal College of 
Physicians and Surgeons of Canada in nuclear medicine; American 
Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear 
Medicine on or before October 24, 2005, need not comply with the 
training requirements of Sec.35.50 to be identified as a Radiation 
Safety Officer or as an Associate Radiation Safety Officer on a 
Commission or an Agreement State license or Commission master material 
license permit for those materials and uses that these individuals 
performed on or before October 24, 2005.
    (3) Any individual certified by the American Board of Radiology in 
therapeutic radiological physics, Roentgen ray and gamma ray physics, x-
ray and radium physics, or radiological physics, or certified by the 
American Board of Medical Physics in radiation oncology physics, on or 
before October 24, 2005, need not comply with the training requirements 
for an authorized medical physicist described in Sec.35.51, for those 
materials and uses that these individuals performed on or before October 
24, 2005.
    (4) A Radiation Safety Officer, a medical physicist, or a nuclear 
pharmacist, who used only accelerator-produced radioactive materials, 
discrete sources of radium-226, or both, for medical uses or in the 
practice of nuclear pharmacy at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007, or at all other 
locations of use before August 8, 2009, or an earlier date as noticed by 
the NRC, need not comply with the training requirements of Sec.35.50, 
Sec.35.51 or Sec.35.55, respectively, when performing the same uses. 
A nuclear pharmacist, who prepared only radioactive drugs containing 
accelerator-produced radioactive materials, or a medical physicist, who 
used only accelerator-produced radioactive materials, at the locations 
and during the time period identified in this paragraph, qualifies as an 
authorized nuclear pharmacist or an authorized medical physicist, 
respectively, for those materials and uses performed before these dates, 
for the purposes of this chapter.
    (b)(1) Physicians, dentists, or podiatrists identified as authorized 
users for the medical use of byproduct material on a license issued by 
the Commission or an Agreement State, a permit issued by a Commission 
master material licensee, a permit issued by a Commission or an 
Agreement State broad scope licensee, or a permit issued by a Commission 
master material license broad scope permittee on or before January 14, 
2019, who perform only those medical uses for which they were authorized 
on or before that date need not comply with the training requirements of 
subparts D through H of this part.
    (2) Physicians, dentists, or podiatrists not identified as 
authorized users for the medical use of byproduct material on a license 
issued by the Commission or an Agreement State, a permit issued by a 
Commission master material licensee, a permit issued by a Commission or 
an Agreement State broad scope licensee, or a permit issued by a 
Commission master material license of broad scope on or before October 
24, 2005, need not comply with the training requirements of subparts D 
through H of this part for those materials and uses that these 
individuals performed on or before October 24, 2005, as follows:
    (i) For uses authorized under Sec.35.100 or Sec.35.200, or oral 
administration of sodium iodide I-131 requiring a written directive for 
imaging and localization purposes, a physician who was certified on or 
before October 24, 2005, in nuclear medicine by the American Board of 
Nuclear Medicine; diagnostic radiology by the American Board of 
Radiology; diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology; nuclear medicine by the Royal College of Physicians 
and Surgeons of Canada; or American Osteopathic Board of Nuclear 
Medicine in nuclear medicine;
    (ii) For uses authorized under Sec.35.300, a physician who was 
certified on or before October 24, 2005, by the American Board of 
Nuclear Medicine; the American Board of Radiology in radiology, 
therapeutic radiology, or radiation oncology; nuclear medicine by the 
Royal College of Physicians and Surgeons of Canada; or the American 
Osteopathic Board of Radiology after 1984;
    (iii) For uses authorized under Sec.35.400 or Sec.35.600, a 
physician who was certified on or before October 24, 2005, in radiology, 
therapeutic radiology or radiation oncology by the American Board of 
Radiology; radiation oncology by the American Osteopathic Board of 
Radiology; radiology, with specialization in radiotherapy, as a British 
``Fellow of the Faculty of Radiology'' or ``Fellow of the Royal College 
of Radiology''; or therapeutic radiology by the Canadian Royal College 
of Physicians and Surgeons; and
    (iv) For uses authorized under Sec.35.500, a physician who was 
certified on or before October 24, 2005, in radiology, diagnostic 
radiology, therapeutic radiology, or radiation oncology by the American 
Board of Radiology; nuclear medicine by the American Board of Nuclear 
Medicine; diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology; or nuclear medicine by the Royal College of 
Physicians and Surgeons of Canada.
    (3) Physicians, dentists, or podiatrists who used only accelerator-
produced radioactive materials, discrete sources of radium-226, or both, 
for medical uses performed at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007, or at all other 
locations of use before August 8, 2009, or an earlier date as noticed by 
the NRC, need not comply with the training requirements of subparts D 
through H of this part when performing the same medical uses. A

[[Page 700]]

physician, dentist, or podiatrist, who used only accelerator-produced 
radioactive materials, discrete sources of radium-226, or both, for 
medical uses at the locations and time period identified in this 
paragraph, qualifies as an authorized user for those materials and uses 
performed before these dates, for the purposes of this chapter.

                                * * * * *



Sec.35.59  Recentness of training.

    The training and experience specified in Subparts B, D, E, F, G, and 
H of this part must have been obtained within the 7 years preceding the 
date of application or the individual must have had related continuing 
education and experience since the required training and experience was 
completed.

[71 FR 15008, Mar. 27, 2006]



                Subpart C_General Technical Requirements



Sec.35.60  Possession, use, and calibration of instruments used
to measure the activity of unsealed byproduct material.

    (a) For direct measurements performed in accordance with Sec.
35.63, a licensee shall possess and use instrumentation to measure the 
activity of unsealed byproduct material before it is administered to 
each patient or human research subject.
    (b) A licensee shall calibrate the instrumentation required in 
paragraph (a) of this section in accordance with nationally recognized 
standards or the manufacturer's instructions.
    (c) A licensee shall retain a record of each instrument calibration 
required by this section in accordance with Sec.35.2060.



Sec.35.61  Calibration of survey instruments.

    (a) A licensee shall calibrate the survey instruments used to show 
compliance with this part and 10 CFR Part 20 before first use, annually, 
and following a repair that affects the calibration. A licensee shall--
    (1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per 
hour with a radiation source;
    (2) Calibrate two separated readings on each scale or decade that 
will be used to show compliance; and
    (3) Conspicuously note on the instrument the date of calibration.
    (b) A licensee may not use survey instruments if the difference 
between the indicated exposure rate and the calculated exposure rate is 
more than 20 percent.
    (c) A licensee shall retain a record of each survey instrument 
calibration in accordance with Sec.35.2061.



Sec.35.63  Determination of dosages of unsealed byproduct material
for medical use.

    (a) A licensee shall determine and record the activity of each 
dosage before medical use.
    (b) For a unit dosage, this determination must be made by--
    (1) Direct measurement of radioactivity; or
    (2) A decay correction, based on the activity or activity 
concentration determined by--
    (i) A manufacturer or preparer licensed under Sec.32.72 of this 
chapter or equivalent Agreement State requirements; or
    (ii) An NRC or Agreement State licensee for use in research in 
accordance with a Radioactive Drug Research Committee-approved protocol 
or an Investigational New Drug (IND) protocol accepted by FDA; or
    (iii) A PET radioactive drug producer licensed under Sec.30.32(j) 
of this chapter or equivalent Agreement State requirements.
    (c) For other than unit dosages, this determination must be made 
by--
    (1) Direct measurement of radioactivity;
    (2) Combination of measurement of radioactivity and mathematical 
calculations; or
    (3) Combination of volumetric measurements and mathematical 
calculations, based on the measurement made by:
    (i) A manufacturer or preparer licensed under Sec.32.72 of this 
chapter or equivalent Agreement State requirements; or
    (ii) A PET radioactive drug producer licensed under Sec.30.32(j) 
of this chapter

[[Page 701]]

or equivalent Agreement State requirements.
    (d) Unless otherwise directed by the authorized user, a licensee may 
not use a dosage if the dosage does not fall within the prescribed 
dosage range or if the dosage differs from the prescribed dosage by more 
than 20 percent.
    (e) A licensee shall retain a record of the dosage determination 
required by this section in accordance with Sec.35.2063.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55931, Oct. 1, 2007]



Sec.35.65  Authorization for calibration, transmission, and reference
sources.

    Any person authorized by Sec.35.11 for medical use of byproduct 
material may receive, possess, and use any of the following byproduct 
material for check, calibration, transmission, and reference use.
    (a) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, 
manufactured and distributed by a person licensed under Sec.32.74 of 
this chapter or equivalent Agreement State regulations.
    (b) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, 
redistributed by a licensee authorized to redistribute the sealed 
sources manufactured and distributed by a person licensed under Sec.
32.74 of this chapter or equivalent Agreement State regulations, 
providing the redistributed sealed sources are in the original packaging 
and shielding and are accompanied by the manufacturer's approved 
instructions.
    (c) Any byproduct material with a half-life not longer than 120 days 
in individual amounts not to exceed 0.56 GBq (15 mCi).
    (d) Any byproduct material with a half-life longer than 120 days in 
individual amounts not to exceed the smaller of 7.4 MBq (200 [micro]Ci) 
or 1000 times the quantities in Appendix B of Part 30 of this chapter.
    (e) Technetium-99m in amounts as needed.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15009, Mar. 27, 2006]

    Effective Date Note: At 83 FR 33106, July 16, 2018, Sec.35.65 was 
revised, effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:



Sec.35.65  Authorization for calibration, transmission, and reference 
          sources.

    (a) Any person authorized by Sec.35.11 for medical use of 
byproduct material may receive, possess, and use any of the following 
byproduct material for check, calibration, transmission, and reference 
use:
    (1) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, 
manufactured and distributed by a person licensed under Sec.32.74 of 
this chapter or equivalent Agreement State regulations;
    (2) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, 
redistributed by a licensee authorized to redistribute the sealed 
sources manufactured and distributed by a person licensed under Sec.
32.74 of this chapter or equivalent Agreement State regulations, 
providing the redistributed sealed sources are in the original packaging 
and shielding and are accompanied by the manufacturer's approved 
instructions;
    (3) Any byproduct material with a half-life not longer than 120 days 
in individual amounts not to exceed 0.56 GBq (15 mCi);
    (4) Any byproduct material with a half-life longer than 120 days in 
individual amounts not to exceed the smaller of 7.4 MBq (200 [micro]CI) 
or 1000 times the quantities in appendix B of part 30 of this chapter; 
or
    (5) Technetium-99m in amounts as needed.
    (b) Byproduct material in sealed sources authorized by this 
provision shall not be:
    (1) Used for medical use as defined in Sec.35.2 except in 
accordance with the requirements in Sec.35.500; or
    (2) Combined (i.e., bundled or aggregated) to create an activity 
greater than the maximum activity of any single sealed source authorized 
under this section.
    (c) A licensee using calibration, transmission, and reference 
sources in accordance with the requirements in paragraph (a) or (b) of 
this section need not list these sources on a specific medical use 
license.



Sec.35.67  Requirements for possession of sealed sources 
and brachytherapy sources.

    (a) A licensee in possession of any sealed source or brachytherapy 
source shall follow the radiation safety and handling instructions 
supplied by the manufacturer.
    (b) A licensee in possession of a sealed source shall--
    (1) Test the source for leakage before its first use unless the 
licensee has a certificate from the supplier indicating that the source 
was tested within 6 months before transfer to the licensee; and
    (2) Test the source for leakage at intervals not to exceed 6 months 
or at

[[Page 702]]

other intervals approved by the Commission or an Agreement State in the 
Sealed Source and Device Registry.
    (c) To satisfy the leak test requirements of this section, the 
licensee shall measure the sample so that the leak test can detect the 
presence of 185 Bq (0.005 [micro]Ci) of radioactive material in the 
sample.
    (d) A licensee shall retain leak test records in accordance with 
Sec.35.2067(a).
    (e) If the leak test reveals the presence of 185 Bq (0.005 
[micro]Ci) or more of removable contamination, the licensee shall--
    (1) Immediately withdraw the sealed source from use and store, 
dispose, or cause it to be repaired in accordance with the requirements 
in parts 20 and 30 of this chapter; and
    (2) File a report within 5 days of the leak test in accordance with 
Sec.35.3067.
    (f) A licensee need not perform a leak test on the following 
sources:
    (1) Sources containing only byproduct material with a half-life of 
less than 30 days;
    (2) Sources containing only byproduct material as a gas;
    (3) Sources containing 3.7 MBq (100 [micro]Ci) or less of beta or 
gamma-emitting material or 0.37 MBq (10 [micro]Ci) or less of alpha-
emitting material;
    (4) Seeds of iridium-192 encased in nylon ribbon; and
    (5) Sources stored and not being used. However, the licensee shall 
test each such source for leakage before any use or transfer unless it 
has been leak tested within 6 months before the date of use or transfer.
    (g) A licensee in possession of sealed sources or brachytherapy 
sources, except for gamma stereotactic radiosurgery sources, shall 
conduct a semi-annual physical inventory of all such sources in its 
possession. The licensee shall retain each inventory record in 
accordance with Sec.35.2067(b).



Sec.35.69  Labeling of vials and syringes.

    Each syringe and vial that contains unsealed byproduct material must 
be labeled to identify the radioactive drug. Each syringe shield and 
vial shield must also be labeled unless the label on the syringe or vial 
is visible when shielded.



Sec.35.70  Surveys of ambient radiation exposure rate.

    (a) In addition to the surveys required by Part 20 of this chapter, 
a licensee shall survey with a radiation detection survey instrument at 
the end of each day of use. A licensee shall survey all areas where 
unsealed byproduct material requiring a written directive was prepared 
for use or administered.
    (b) A licensee does not need to perform the surveys required by 
paragraph (a) of this section in an area(s) where patients or human 
research subjects are confined when they cannot be released under Sec.
35.75.
    (c) A licensee shall retain a record of each survey in accordance 
with Sec.35.2070.



Sec.35.75  Release of individuals containing unsealed byproduct 
material or implants containing byproduct material.

    (a) A licensee may authorize the release from its control of any 
individual who has been administered unsealed byproduct material or 
implants containing byproduct material if the total effective dose 
equivalent to any other individual from exposure to the released 
individual is not likely to exceed 5 mSv (0.5 rem). \1\
---------------------------------------------------------------------------

    \1\ The current revision of NUREG-1556, Vol. 9, ``Consolidated 
Guidance About Materials Licenses: Program-Specific Guidance About 
Medical Licenses'' describes methods for calculating doses to other 
individuals and contains tables of activities not likely to cause doses 
exceeding 5 mSv (0.5 rem).
---------------------------------------------------------------------------

    (b) A licensee shall provide the released individual, or the 
individual's parent or guardian, with instructions, including written 
instructions, on actions recommended to maintain doses to other 
individuals as low as is reasonably achievable if the total effective 
dose equivalent to any other individual is likely to exceed 1 mSv (0.1 
rem). If the total effective dose equivalent to a nursing infant or 
child could exceed 1 mSv (0.1 rem) assuming there were no interruption 
of breast-feeding, the instructions must also include--
    (1) Guidance on the interruption or discontinuation of breast-
feeding; and
    (2) Information on the potential consequences, if any, of failure to 
follow the guidance.

[[Page 703]]

    (c) A licensee shall maintain a record of the basis for authorizing 
the release of an individual in accordance with Sec.35.2075(a).
    (d) The licensee shall maintain a record of instructions provided to 
a breast-feeding female in accordance with Sec.35.2075(b).

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16363, Mar. 30, 2005; 
72 FR 45151, Aug. 13, 2007]



Sec.35.80  Provision of mobile medical service.

    (a) A licensee providing mobile medical service shall--
    (1) Obtain a letter signed by the management of each client for 
which services are rendered that permits the use of byproduct material 
at the client's address and clearly delineates the authority and 
responsibility of the licensee and the client;
    (2) Check instruments used to measure the activity of unsealed 
byproduct material for proper function before medical use at each 
client's address or on each day of use, whichever is more frequent. At a 
minimum, the check for proper function required by this paragraph must 
include a constancy check;
    (3) Check survey instruments for proper operation with a dedicated 
check source before use at each client's address; and
    (4) Before leaving a client's address, survey all areas of use to 
ensure compliance with the requirements in Part 20 of this chapter.
    (b) A mobile medical service may not have byproduct material 
delivered from the manufacturer or the distributor to the client unless 
the client has a license allowing possession of the byproduct material. 
Byproduct material delivered to the client must be received and handled 
in conformance with the client's license.
    (c) A licensee providing mobile medical services shall retain the 
letter required in paragraph (a)(1) and the record of each survey 
required in paragraph (a)(4) of this section in accordance with Sec.
35.2080(a) and (b), respectively.



Sec.35.92  Decay-in-storage.

    (a) A licensee may hold byproduct material with a physical half-life 
of less than or equal to 120 days for decay-in-storage before disposal 
without regard to its radioactivity if it--
    (1) Monitors byproduct material at the surface before disposal and 
determines that its radioactivity cannot be distinguished from the 
background radiation level with an appropriate radiation detection 
survey meter set on its most sensitive scale and with no interposed 
shielding; and
    (2) Removes or obliterates all radiation labels, except for 
radiation labels on materials that are within containers and that will 
be managed as biomedical waste after they have been released from the 
licensee.
    (b) A licensee shall retain a record of each disposal permitted 
under paragraph (a) of this section in accordance with Sec.35.2092.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 45151, Aug. 13, 2007]



  Subpart D_Unsealed Byproduct Material_Written Directive Not Required



Sec.35.100  Use of unsealed byproduct material for uptake, dilution,
and excretion studies for which a written directive is not required.

    Except for quantities that require a written directive under Sec.
35.40(b), a licensee may use any unsealed byproduct material prepared 
for medical use for uptake, dilution, or excretion studies that is--
    (a) Obtained from:
    (1) A manufacturer or preparer licensed under Sec.32.72 of this 
chapter or equivalent Agreement State requirements; or
    (2) A PET radioactive drug producer licensed under Sec.30.32(j) of 
this chapter or equivalent Agreement State requirements; or
    (b) Excluding production of PET radionuclides, prepared by:
    (1) An authorized nuclear pharmacist;
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec. Sec.35.290, or 35.390 and 
35.290(c)(1)(ii)(G); or

[[Page 704]]

    (3) An individual under the supervision, as specified in Sec.
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this 
section or the physician who is an authorized user in paragraph (b)(2) 
of this section; or
    (c) Obtained from and prepared by an NRC or Agreement State licensee 
for use in research in accordance with a Radioactive Drug Research 
Committee-approved protocol or an Investigational New Drug (IND) 
protocol accepted by FDA; or
    (d) Prepared by the licensee for use in research in accordance with 
a Radioactive Drug Research Committee-approved application or an 
Investigational New Drug (IND) protocol accepted by FDA.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 
71 FR 15009, Mar. 27, 2006; 72 FR 55931, Oct. 1, 2007]



Sec.35.190  Training for uptake, dilution, and excretion studies.

    Except as provided in Sec.35.57, the licensee shall require an 
authorized user of unsealed byproduct material for the uses authorized 
under Sec.35.100 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State and 
who meets the requirements in paragraph (c)(2) of this section. (The 
names of board certifications which have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page.) 
To have its certification process recognized, a specialty board shall 
require all candidates for certification to:
    (1) Complete 60 hours of training and experience in basic 
radionuclide handling techniques and radiation safety applicable to the 
medical use of unsealed byproduct material for uptake, dilution, and 
excretion studies as described in paragraphs (c)(1)(i) through 
(c)(1)(ii)(F) of this section; and
    (2) Pass an examination, administered by diplomates of the specialty 
board, that assesses knowledge and competence in radiation safety, 
radionuclide handling, and quality control; or
    (b) Is an authorized user under Sec. Sec.35.290, 35.390, or 
equivalent Agreement State requirements; or
    (c)(1) Has completed 60 hours of training and experience, including 
a minimum of 8 hours of classroom and laboratory training, in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material for uptake, dilution, and excretion studies. 
The training and experience must include--
    (i) Classroom and laboratory training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec.35.57, 35.190, 35.290, 35.390, 
or equivalent Agreement State requirements, involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (E) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (F) Administering dosages of radioactive drugs to patients or human 
research subjects; and
    (2) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.35.57, 35.190, 
35.290, or 35.390, or equivalent Agreement State requirements, that the 
individual has satisfactorily completed the requirements in paragraph 
(a)(1) or (c)(1) of this section and has achieved a level of competency 
sufficient to function independently as an

[[Page 705]]

authorized user for the medical uses authorized under Sec.35.100.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 
69 FR 55738, Sept. 16, 2004; 70 FR 16363, Mar. 30, 2005; 71 FR 15009, 
Mar. 27, 2006; 72 FR 45151, Aug. 13, 2007; 74 FR 33905, July 14, 2009]

    Effective Date Note: At 83 FR 33106, July 16, 2018, Sec.35.190 was 
amended by revising (a) introductory text and (c)(2), effective Jan. 14, 
2019. For the convenience of the user, the revised text is set forth as 
follows:



Sec.35.190  Training for uptake, dilution, and excretion studies.

                                * * * * *

    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State. The 
names of board certifications that have been recognized by the 
Commission or an Agreement State are posted on the NRC's Medical Uses 
Licensee Toolkit web page. To have its certification process recognized, 
a specialty board shall require all candidates for certification to:

                                * * * * *

    (c) * * *
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (c)(1) of this 
section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized 
under Sec.35.100. The attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in Sec.
35.57, Sec.35.190, Sec.35.290, or Sec.35.390, or equivalent 
Agreement State requirements; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec.35.57, Sec.35.190, Sec.35.290, or Sec.
35.390, or equivalent Agreement State requirements, and concurs with the 
attestation provided by the residency program director. The residency 
training program must be approved by the Residency Review Committee of 
the Accreditation Council for Graduate Medical Education or the Royal 
College of Physicians and Surgeons of Canada or the Council on 
Postdoctoral Training of the American Osteopathic Association and must 
include training and experience specified in paragraph (c)(1) of this 
section.



Sec.35.200  Use of unsealed byproduct material for imaging and 
localization studies for which a written directive is not required.

    Except for quantities that require a written directive under Sec.
35.40(b), a licensee may use any unsealed byproduct material prepared 
for medical use for imaging and localization studies that is--
    (a) Obtained from:
    (1) A manufacturer or preparer licensed under Sec.32.72 of this 
chapter or equivalent Agreement State requirements; or
    (2) A PET radioactive drug producer licensed under Sec.30.32(j) of 
this chapter or equivalent Agreement State requirements; or
    (b) Excluding production of PET radionuclides, prepared by:
    (1) An authorized nuclear pharmacist;
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec.35.290, or 35.390 and 
35.290(c)(1)(ii)(G); or
    (3) An individual under the supervision, as specified in Sec.
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this 
section or the physician who is an authorized user in paragraph (b)(2) 
of this section;
    (c) Obtained from and prepared by an NRC or Agreement State licensee 
for use in research in accordance with a Radioactive Drug Research 
Committee-approved protocol or an Investigational New Drug (IND) 
protocol accepted by FDA; or
    (d) Prepared by the licensee for use in research in accordance with 
a Radioactive Drug Research Committee-approved application or an 
Investigational New Drug (IND) protocol accepted by FDA.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 
71 FR 15009, Mar. 27, 2006; 72 FR 55932, Oct. 1, 2007]



Sec.35.204  Permissible molybdenum-99, strontium-82, and strontium-85
concentrations.

    (a) A licensee may not administer to humans a radiopharmaceutical 
that contains:
    (1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel 
of

[[Page 706]]

technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of 
technetium-99m); or
    (2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel 
of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per 
millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of 
strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 
microcurie of strontium-85 per millicurie of rubidium-82).
    (b) A licensee that uses molybdenum-99/technetium-99m generators for 
preparing a technetium-99m radiopharmaceutical shall measure the 
molybdenum-99 concentration of the first eluate after receipt of a 
generator to demonstrate compliance with paragraph (a) of this section.
    (c) A licensee that uses a strontium-82/rubidium-82 generator for 
preparing a rubidium-82 radiopharmaceutical shall, before the first 
patient use of the day, measure the concentration of radionuclides 
strontium-82 and strontium-85 to demonstrate compliance with paragraph 
(a) of this section.
    (d) If a licensee is required to measure the molybdenum-99 
concentration or strontium-82 and strontium-85 concentrations, the 
licensee shall retain a record of each measurement in accordance with 
Sec.35.2204.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55932, Oct. 1, 2007]

    Effective Date Note: At 83 FR 33107, July 16, 2018, Sec.35.204 was 
amended by revising paragraph (b) and adding paragraph (e), effective 
Jan. 14, 2019. For the convenience of the user, the added and revised 
text is set forth as follows:



Sec.35.204  Permissible molybdenum-99, strontium-82, and strontium-85 
          concentrations.

                                * * * * *

    (b) A licensee that uses molybdenum-99/technetium-99m generators for 
preparing a technetium-99m radiopharmaceutical shall measure the 
molybdenum-99 concentration in each eluate from a generator to 
demonstrate compliance with paragraph (a) of this section.

                                * * * * *

    (e) The licensee shall report any measurement that exceeds the 
limits in paragraph (a) of this section at the time of generator 
elution, in accordance with Sec.35.3204.



Sec.35.290  Training for imaging and localization studies.

    Except as provided in Sec.35.57, the licensee shall require an 
authorized user of unsealed byproduct material for the uses authorized 
under Sec.35.200 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State and 
who meets the requirements in paragraph (c)(2) of this section. (The 
names of board certifications which have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page.) 
To have its certification process recognized, a specialty board shall 
require all candidates for certification to:
    (1) Complete 700 hours of training and experience in basic 
radionuclide handling techniques and radiation safety applicable to the 
medical use of unsealed byproduct material for imaging and localization 
studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(G) of 
this section; and
    (2) Pass an examination, administered by diplomates of the specialty 
board, which assesses knowledge and competence in radiation safety, 
radionuclide handling, and quality control; or
    (b) Is an authorized user under Sec.35.390 and meets the 
requirements in Sec.35.290(c)(1)(ii)(G), or equivalent Agreement State 
requirements; or
    (c)(1) Has completed 700 hours of training and experience, including 
a minimum of 80 hours of classroom and laboratory training, in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material for imaging and localization studies. The 
training and experience must include, at a minimum--
    (i) Classroom and laboratory training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use;
    (E) Radiation biology; and
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec.35.57,

[[Page 707]]

35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State 
requirements, involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (E) Using procedures to safely contain spilled radioactive material 
and using proper decontamination procedures;
    (F) Administering dosages of radioactive drugs to patients or human 
research subjects; and
    (G) Eluting generator systems appropriate for preparation of 
radioactive drugs for imaging and localization studies, measuring and 
testing the eluate for radionuclidic purity, and processing the eluate 
with reagent kits to prepare labeled radioactive drugs; and
    (2) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.35.57, 35.290, 
or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State 
requirements, that the individual has satisfactorily completed the 
requirements in paragraph (a)(1) or (c)(1) of this section and has 
achieved a level of competency sufficient to function independently as 
an authorized user for the medical uses authorized under Sec. Sec.
35.100 and 35.200.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16364, Mar. 30, 2005; 
71 FR 15009, Mar. 27, 2006; 72 FR 45151, Aug. 13, 2007; 74 FR 33905, 
July 14, 2009]

    Effective Date Note: At 83 FR 33107, July 16, 2018, Sec.35.290 was 
amended by revising paragraphs (a) introductory text, (c)(1)(ii) 
introductory text, and (c)(2), effective Jan. 14, 2019. For the 
convenience of the user, the revised text is set forth as follows:



Sec.35.290  Training for imaging and localization studies.

                                * * * * *

    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State. The 
names of board certifications that have been recognized by the 
Commission or an Agreement State are posted on the NRC's Medical Uses 
Licensee Toolkit web page. To have its certification process recognized, 
a specialty board shall require all candidates for certification to:

                                * * * * *

    (c)(1) * * *
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec.35.57, Sec.35.290, or Sec. Sec.
35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State 
requirements. An authorized nuclear pharmacist who meets the 
requirements in Sec.35.55 or Sec.35.57 may provide the supervised 
work experience for paragraph (c)(1)(ii)(G) of this section. Work 
experience must involve--

                                * * * * *

    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (c)(1) of this 
section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized 
under Sec. Sec.35.100 and 35.200. The attestation must be obtained 
from either:
    (i) A preceptor authorized user who meets the requirements in Sec.
35.57, Sec.35.290, or Sec. Sec.35.390 and 35.290(c)(1)(ii)(G), or 
equivalent Agreement State requirements; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec.35.57, Sec.35.290, or Sec. Sec.35.390 and 
35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, and 
concurs with the attestation provided by the residency program director. 
The residency training program must be approved by the Residency Review 
Committee of the Accreditation Council for Graduate Medical Education or 
the Royal College of Physicians and Surgeons of Canada or the Council on 
Postdoctoral Training of the American Osteopathic Association and must 
include training and experience specified in paragraph (c)(1) of this 
section.

[[Page 708]]



    Subpart E_Unsealed Byproduct Material_Written Directive Required



Sec.35.300  Use of unsealed byproduct material for which a written
directive is required.

    A licensee may use any unsealed byproduct material prepared for 
medical use and for which a written directive is required that is--
    (a) Obtained from:
    (1) A manufacturer or preparer licensed under Sec.32.72 of this 
chapter or equivalent Agreement State requirements; or
    (2) A PET radioactive drug producer licensed under Sec.30.32(j) of 
this chapter or equivalent Agreement State requirements; or
    (b) Excluding production of PET radionuclides, prepared by:
    (1) An authorized nuclear pharmacist;
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec. Sec.35.290, 35.390, or
    (3) An individual under the supervision, as specified in Sec.
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this 
section or the physician who is an authorized user in paragraph (b)(2) 
of this section; or
    (c) Obtained from and prepared by an NRC or Agreement State licensee 
for use in research in accordance with an Investigational New Drug (IND) 
protocol accepted by FDA; or
    (d) Prepared by the licensee for use in research in accordance with 
an Investigational New Drug (IND) protocol accepted by FDA.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 
71 FR 15009, Mar. 27, 2006; 72 FR 55932, Oct. 1, 2007]

    Effective Date Note: At 83 FR 33107, July 16, 2018, Sec.35.300 was 
amended by revising the introductory text, effective Jan. 14, 2019. For 
the convenience of the user, the revised text is set forth as follows:



Sec.35.300  Use of unsealed byproduct material for which a written 
          directive is required.

    A licensee may use any unsealed byproduct material identified in 
Sec.35.390(b)(1)(ii)(G) prepared for medical use and for which a 
written directive is required that is--

                                * * * * *



Sec.35.310  Safety instruction.

    In addition to the requirements of Sec.19.12 of this chapter,
    (a) A licensee shall provide radiation safety instruction, initially 
and at least annually, to personnel caring for patients or human 
research subjects who cannot be released under Sec.35.75. To satisfy 
this requirement, the instruction must be commensurate with the duties 
of the personnel and include--
    (1) Patient or human research subject control;
    (2) Visitor control, including--
    (i) Routine visitation to hospitalized individuals in accordance 
with Sec.20.1301(a)(1) of this chapter; and
    (ii) Visitation authorized in accordance with Sec.20.1301(c) of 
this chapter;
    (3) Contamination control;
    (4) Waste control; and
    (5) Notification of the Radiation Safety Officer, or his or her 
designee, and an authorized user if the patient or the human research 
subject has a medical emergency or dies.
    (b) A licensee shall retain a record of individuals receiving 
instruction in accordance with Sec.35.2310.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003]



Sec.35.315  Safety precautions.

    (a) For each patient or human research subject who cannot be 
released under Sec.35.75, a licensee shall--
    (1) Quarter the patient or the human research subject either in--
    (i) A private room with a private sanitary facility; or
    (ii) A room, with a private sanitary facility, with another 
individual who also has received therapy with unsealed byproduct 
material and who also cannot be released under Sec.35.75;
    (2) Visibly post the patient's or the human research subject's room 
with a ``Radioactive Materials'' sign.
    (3) Note on the door or in the patient's or human research subject's 
chart where and how long visitors may stay in the patient's or the human 
research subject's room; and
    (4) Either monitor material and items removed from the patient's or 
the human research subject's room to determine that their radioactivity 
cannot be distinguished from the natural

[[Page 709]]

background radiation level with a radiation detection survey instrument 
set on its most sensitive scale and with no interposed shielding, or 
handle the material and items as radioactive waste.
    (b) A licensee shall notify the Radiation Safety Officer, or his or 
her designee, and an authorized user as soon as possible if the patient 
or human research subject has a medical emergency or dies.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19325, Apr. 21, 2003]



Sec.35.390  Training for use of unsealed byproduct material for which
a written directive is required.

    Except as provided in Sec.35.57, the licensee shall require an 
authorized user of unsealed byproduct material for the uses authorized 
under Sec.35.300 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State and 
who meets the requirements in paragraphs (b)(1)(ii)(G) and (b)(2) of 
this section. (Specialty boards whose certification processes have been 
recognized by the Commission or an Agreement State will be posted on the 
NRC's Web page.) To be recognized, a specialty board shall require all 
candidates for certification to:
    (1) Successfully complete residency training in a radiation therapy 
or nuclear medicine training program or a program in a related medical 
specialty. These residency training programs must include 700 hours of 
training and experience as described in paragraphs (b)(1)(i) through 
(b)(1)(ii)(E) of this section. Eligible training programs must be 
approved by the Residency Review Committee of the Accreditation Council 
for Graduate Medical Education, the Royal College of Physicians and 
Surgeons of Canada, or the Committee on Post-Graduate Training of the 
American Osteopathic Association; and
    (2) Pass an examination, administered by diplomates of the specialty 
board, which tests knowledge and competence in radiation safety, 
radionuclide handling, quality assurance, and clinical use of unsealed 
byproduct material for which a written directive is required; or
    (b)(1) Has completed 700 hours of training and experience, including 
a minimum of 200 hours of classroom and laboratory training, in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material requiring a written directive. The training 
and experience must include--
    (i) Classroom and laboratory training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec.35.57, 35.390, or equivalent 
Agreement State requirements. A supervising authorized user, who meets 
the requirements in Sec.35.390(b), must also have experience in 
administering dosages in the same dosage category or categories (i.e., 
Sec.35.390(b)(1)(ii)(G)) as the individual requesting authorized user 
status. The work experience must involve--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages, and performing checks for proper 
operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (E) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures;
    (F) [Reserved]
    (G) Administering dosages of radioactive drugs to patients or human 
research subjects involving a minimum of three cases in each of the 
following categories for which the individual is requesting authorized 
user status--
    (1) Oral administration of less than or equal to 1.22 gigabecquerels 
(33

[[Page 710]]

millicuries) of sodium iodide I-131, for which a written directive is 
required;
    (2) Oral administration of greater than 1.22 gigabecquerels (33 
millicuries) of sodium iodide I-131 \2\;
---------------------------------------------------------------------------

    \2\ Experience with at least 3 cases in Category (G)(2) also 
satisfies the requirement in Category (G)(1).
---------------------------------------------------------------------------

    (3) Parenteral administration of any beta emitter, or a photon-
emitting radionuclide with a photon energy less than 150 keV, for which 
a written directive is required; and/or
    (4) Parenteral administration of any other radionuclide, for which a 
written directive is required; and
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (a)(1) and 
(b)(1)(ii)(G) or (b)(1) of this section, and has achieved a level of 
competency sufficient to function independently as an authorized user 
for the medical uses authorized under Sec.35.300. The written 
attestation must be signed by a preceptor authorized user who meets the 
requirements in Sec. Sec.35.57, 35.390, or equivalent Agreement State 
requirements. The preceptor authorized user, who meets the requirements 
in Sec.35.390(b) must have experience in administering dosages in the 
same dosage category or categories (i.e., Sec.35.390(b)(1)(ii)(G)) as 
the individual requesting authorized user status.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 
70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 74 FR 33905, 
July 14, 2009]

    Effective Date Note: At 83 FR 33107, July 16, 2018, Sec.35.390 was 
amended by revising paragraphs (a) introductory text, (b)(1)(ii)(G), and 
(b)(2), effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:



Sec.35.390  Training for use of unsealed byproduct material for which 
          a written directive is required.

                                * * * * *

    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State and 
who meets the requirements in paragraphs (b)(1)(ii)(G) of this section. 
The names of board certifications that have been recognized by the 
Commission or an Agreement State are posted on the NRC's Medical Uses 
Licensee Toolkit web page. To be recognized, a specialty board shall 
require all candidates for certification to:

                                * * * * *

    (b)(1) * * *
    (ii) * * *
    (G) Administering dosages of radioactive drugs to patients or human 
research subjects from the three categories in this paragraph. 
Radioactive drugs containing radionuclides in categories not included in 
this paragraph are regulated under Sec.35.1000. This work experience 
must involve a minimum of three cases in each of the following 
categories for which the individual is requesting authorized user 
status--
    (1) Oral administration of less than or equal to 1.22 gigabecquerels 
(33 millicuries) of sodium iodide I-131, for which a written directive 
is required;
    (2) Oral administration of greater than 1.22 gigabecquerels (33 
millicuries) of sodium iodide I-131; \2\
---------------------------------------------------------------------------

    \2\ Experience with at least three cases in Category (G)(2) also 
satisfies the requirement in Category (G)(1).
---------------------------------------------------------------------------

    (3) Parenteral administration of any radioactive drug that contains 
a radionuclide that is primarily used for its electron emission, beta 
radiation characteristics, alpha radiation characteristics, or photon 
energy of less than 150 keV, for which a written directive is required; 
and
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (b)(1) of this 
section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized 
under Sec.35.300 for which the individual is requesting authorized 
user status. The attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in Sec.
35.57, Sec.35.390, or equivalent Agreement State requirements and has 
experience in administering dosages in the same dosage category or 
categories as the individual requesting authorized user status; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec.35.57, Sec.35.390, or equivalent Agreement State 
requirements, has experience in administering dosages in the same dosage 
category or categories as the individual requesting authorized user 
status, and concurs with the attestation provided by the residency 
program director. The residency training program must be approved by the

[[Page 711]]

Residency Review Committee of the Accreditation Council for Graduate 
Medical Education or the Royal College of Physicians and Surgeons of 
Canada or the Council on Postdoctoral Training of the American 
Osteopathic Association and must include training and experience 
specified in paragraph (b)(1) of this section.

                                * * * * *



Sec.35.392  Training for the oral administration of sodium iodide
I-131 requiring a written directive in quantities less than or equal
to 1.22 gigabecquerels (33 millicuries).
          

    Except as provided in Sec.35.57, the licensee shall require an 
authorized user for the oral administration of sodium iodide I-131 
requiring a written directive in quantities less than or equal to 1.22 
Gigabecquerels (33 millicuries), to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraphs (c)(1) and (c)(2) 
of this section and whose certification process has been recognized by 
the Commission or an Agreement State and who meets the requirements in 
paragraph (c)(3) of this section. (The names of board certifications 
which have been recognized by the Commission or an Agreement State will 
be posted on the NRC's Web page.); or
    (b) Is an authorized user under Sec.35.390 for uses listed in 
Sec.35.390(b)(1)(ii)(G)(1) or (2), Sec.35.394, or equivalent 
Agreement State requirements; or
    (c)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to the medical use of sodium iodide I-
131 for procedures requiring a written directive. The training must 
include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec.35.57, 35.390, 35.392, 35.394, 
or equivalent Agreement State requirements. A supervising authorized 
user who meets the requirements in Sec.35.390(b) must also have 
experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2). The work experience 
must involve--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
    (iii) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (iv) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (v) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research subjects, 
that includes at least 3 cases involving the oral administration of less 
than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide 
I-131; and
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section, and has achieved a level of competency 
sufficient to function independently as an authorized user for medical 
uses authorized under Sec.35.300. The written attestation must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. Sec.35.57, 35.390, 35.392, 35.394, or equivalent Agreement State 
requirements. A preceptor authorized user, who meets the requirement in 
Sec.35.390(b), must also have experience in administering dosages as 
specified in Sec. Sec.35.390(b)(1)(ii)(G)(1) or 
35.390(b)(1)(ii)(G)(2).

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 
70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 74 FR 33905, 
July 14, 2009]

    Effective Date Note: At 83 FR 33108, July 16, 2018, Sec.35.392 was 
amended by revising paragraphs (a) and (c)(3), effective Jan. 14, 2019. 
For the convenience of the user, the revised text is set forth as 
follows:

[[Page 712]]



Sec.35.392  Training for the oral administration of sodium iodide I-
          131 requiring a written directive in quantities less than or 
          equal to 1.22 gigabecquerels (33 millicuries).

                                * * * * *

    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraphs (c)(1) and (2) of 
this section and whose certification process has been recognized by the 
Commission or an Agreement State. The names of board certifications that 
have been recognized by the Commission or an Agreement State are posted 
on the NRC's Medical Uses Licensee Toolkit web page; or

                                * * * * *

    (c) * * *
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and (2) 
of this section, and is able to independently fulfill the radiation 
safety-related duties as an authorized user for oral administration of 
less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium 
iodide I-131 for medical uses authorized under Sec.35.300. The 
attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in Sec.
35.57, Sec.35.390, Sec.35.392, Sec.35.394, or equivalent Agreement 
State requirements and has experience in administering dosages as 
specified in Sec.35.390(b)(1)(ii)(G)(1) or (2); or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec.35.57, Sec.35.390, Sec.35.392, Sec.35.394, 
or equivalent Agreement State requirements, has experience in 
administering dosages as specified in Sec.35.390(b)(1)(ii)(G)(1) or 
(2), and concurs with the attestation provided by the residency program 
director. The residency training program must be approved by the 
Residency Review Committee of the Accreditation Council for Graduate 
Medical Education or the Royal College of Physicians and Surgeons of 
Canada or the Council on Postdoctoral Training of the American 
Osteopathic Association and must include training and experience 
specified in paragraphs (c)(1) and (2) of this section.



Sec.35.394  Training for the oral administration of sodium iodide
I-131 requiring a written directive in quantities greater than 1.22
gigabecquerels (33 millicuries).
          

    Except as provided in Sec.35.57, the licensee shall require an 
authorized user for the oral administration of sodium iodide I-131 
requiring a written directive in quantities greater than 1.22 
Gigabecquerels (33 millicuries), to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraphs (c)(1) and (c)(2) 
of this section, and whose certification has been recognized by the 
Commission or an Agreement State, and who meets the requirements in 
paragraph (c)(3) of this section. (The names of board certifications 
which have been recognized by the Commission or an Agreement State will 
be posted on the NRC's Web page.); or
    (b) Is an authorized user under Sec.35.390 for uses listed in 
Sec.35.390(b)(1)(ii)(G)(2) or equivalent Agreement State requirements; 
or
    (c)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to the medical use of sodium iodide I-
131 for procedures requiring a written directive. The training must 
include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec.35.57, 35.390, 35.394, or 
equivalent Agreement State requirements. A supervising authorized user, 
who meets the requirements in Sec.35.390(b), must also have experience 
in administering dosages as specified in Sec.35.390(b)(1)(ii)(G)(2). 
The work experience must involve--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
    (iii) Calculating, measuring, and safely preparing patient or human 
research subject dosages;

[[Page 713]]

    (iv) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (v) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research subjects, 
that includes at least 3 cases involving the oral administration of 
greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-
131; and
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section, and has achieved a level of competency 
sufficient to function independently as an authorized user for medical 
uses authorized under Sec.35.300. The written attestation must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. Sec.35.57, 35.390, 35.394, or equivalent Agreement State 
requirements. A preceptor authorized user, who meets the requirements in 
Sec.35.390(b), must also have experience in administering dosages as 
specified in Sec.35.390(b)(1)(ii)(G)(2).

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 
70 FR 16365, Mar. 30, 2005; 71 FR 15010, Mar. 27, 2006; 74 FR 33905, 
July 14, 2009]

    Effective Date Note: At 83 FR 33108, July 16, 2018, Sec.35.394 was 
amended by revising paragraphs (a) and (c)(3), effective Jan. 14, 2019. 
For the convenience of the user, the revised text is set forth as 
follows:



Sec.35.394  Training for the oral administration of sodium iodide I-
          131 requiring a written directive in quantities greater than 
          1.22 gigabecquerels (33 millicuries).

                                * * * * *

    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraphs (c)(1) and (2) of 
this section, and whose certification has been recognized by the 
Commission or an Agreement State. The names of board certifications that 
have been recognized by the Commission or an Agreement State are posted 
on the NRC's Medical Uses Licensee Toolkit web page; or

                                * * * * *

    (c) * * *
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and (2) 
of this section, and is able to independently fulfill the radiation 
safety-related duties as an authorized user for oral administration of 
greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 
for medical uses authorized under Sec.35.300. The attestation must be 
obtained from either:
    (i) A preceptor authorized user who meets the requirements in Sec.
35.57, Sec.35.390, Sec.35.394, or equivalent Agreement State 
requirements, and has experience in administering dosages as specified 
in Sec.35.390(b)(1)(ii)(G)(2); or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec.35.57, Sec.35.390, Sec.35.394, or equivalent 
Agreement State requirements, has experience in administering dosages as 
specified in Sec.35.390(b)(1)(ii)(G)(2), and concurs with the 
attestation provided by the residency program director. The residency 
training program must be approved by the Residency Review Committee of 
the Accreditation Council for Graduate Medical Education or the Royal 
College of Physicians and Surgeons of Canada or the Council on 
Postdoctoral Training of the American Osteopathic Association and must 
include training and experience specified in paragraphs (c)(1) and (2) 
of this section.



Sec.35.396  Training for the parenteral administration of unsealed
byproduct material requiring a written directive.

    Except as provided in Sec.35.57, the licensee shall require an 
authorized user for the parenteral administration requiring a written 
directive, to be a physician who--
    (a) Is an authorized user under Sec.35.390 for uses listed in 
Sec. Sec.35.390(b)(1)(ii)(G)(3) or 35.390(b)(1)(ii)(G)(4), or 
equivalent Agreement State requirements; or
    (b) Is an authorized user under Sec. Sec.35.490, 35.690, or 
equivalent Agreement State requirements and who meets the requirements 
in paragraph (d) of this section; or
    (c) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State 
under Sec. Sec.35.490 or 35.690, and who meets the requirements in 
paragraph (d) of this section.
    (d)(1) Has successfully completed 80 hours of classroom and 
laboratory

[[Page 714]]

training, applicable to parenteral administrations, for which a written 
directive is required, of any beta emitter, or any photon-emitting 
radionuclide with a photon energy less than 150 keV, and/or parenteral 
administration of any other radionuclide for which a written directive 
is required. The training must include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec.35.57, 35.390, 35.396, or 
equivalent Agreement State requirements, in the parenteral 
administration, for which a written directive is required, of any beta 
emitter, or any photon-emitting radionuclide with a photon energy less 
than 150 keV, and/or parenteral administration of any other radionuclide 
for which a written directive is required. A supervising authorized user 
who meets the requirements in Sec.35.390 must have experience in 
administering dosages as specified in Sec. Sec.35.390(b)(1)(ii)(G)(3) 
and/or 35.390(b)(1)(ii)(G)(4). The work experience must involve--
    (i) Ordering, receiving, and unpacking radioactive materials safely, 
and performing the related radiation surveys;
    (ii) Performing quality control procedures on instruments used to 
determine the activity of dosages, and performing checks for proper 
operation of survey meters;
    (iii) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (iv) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (v) Using procedures to contain spilled byproduct material safely, 
and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research subjects, 
that include at least 3 cases involving the parenteral administration, 
for which a written directive is required, of any beta emitter, or any 
photon-emitting radionuclide with a photon energy less than 150 keV and/
or at least 3 cases involving the parenteral administration of any other 
radionuclide, for which a written directive is required; and
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (b) or (c) of 
this section, and has achieved a level of competency sufficient to 
function independently as an authorized user for the parenteral 
administration of unsealed byproduct material requiring a written 
directive. The written attestation must be signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.35.57, 35.390, 
35.396, or equivalent Agreement State requirements. A preceptor 
authorized user, who meets the requirements in Sec.35.390, must have 
experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4).

[70 FR 16365, Mar. 30, 2005, as amended at 71 FR 15010, Mar. 27, 2006; 
74 FR 33906, July 14, 2009]

    Effective Date Note: At 83 FR 33108, July 16, 2018, Sec.35.396 was 
revised, effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:



Sec.35.396  Training for the parenteral administration of unsealed 
          byproduct material requiring a written directive.

    (a) Except as provided in Sec.35.57, the licensee shall require an 
authorized user for the parenteral administration requiring a written 
directive, to be a physician who--
    (1) Is an authorized user under Sec.35.390 for uses listed in 
Sec.35.390(b)(1)(ii)(G)(3), or equivalent Agreement State 
requirements; or
    (2) Is an authorized user under Sec.35.490, Sec.35.690, or 
equivalent Agreement State requirements, and who meets the requirements 
in paragraph (b) of this section; or
    (3) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State 
under Sec.35.490 or Sec.35.690, and who meets the requirements in 
paragraph (b) of this section.
    (b) The physician--
    (1) Has successfully completed 80 hours of classroom and laboratory 
training, applicable to parenteral administrations listed in Sec.
35.390(b)(1)(ii)(G)(3). The training must include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;

[[Page 715]]

    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized user 
who meets the requirements in Sec.35.57, Sec.35.390, Sec.35.396, 
or equivalent Agreement State requirements, in the parenteral 
administrations listed in Sec.35.390(b)(1)(ii)(G)(3). A supervising 
authorized user who meets the requirements in Sec.35.390, Sec.
35.396, or equivalent Agreement State requirements, must have experience 
in administering dosages in the same category or categories as the 
individual requesting authorized user status. The work experience must 
involve--
    (i) Ordering, receiving, and unpacking radioactive materials safely, 
and performing the related radiation surveys;
    (ii) Performing quality control procedures on instruments used to 
determine the activity of dosages, and performing checks for proper 
operation of survey meters;
    (iii) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (iv) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (v) Using procedures to contain spilled byproduct material safely, 
and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research subjects, 
that include at least three cases of the parenteral administrations as 
specified in Sec.35.390(b)(1)(ii)(G)(3); and
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and (2) 
of this section, and is able to independently fulfill the radiation 
safety-related duties as an authorized user for the parenteral 
administration of unsealed byproduct material requiring a written 
directive. The attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in Sec.
35.57, Sec.35.390, Sec.35.396, or equivalent Agreement State 
requirements. A preceptor authorized user who meets the requirements in 
Sec.35.390, Sec.35.396, or equivalent Agreement State requirements, 
must have experience in administering dosages in the same category or 
categories as the individual requesting authorized user status; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec.35.57, Sec.35.390, Sec.35.396, or equivalent 
Agreement State requirements, has experience in administering dosages in 
the same dosage category or categories as the individual requesting 
authorized user status, and concurs with the attestation provided by the 
residency program director. The residency training program must be 
approved by the Residency Review Committee of the Accreditation Council 
for Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Council on Postdoctoral Training of the 
American Osteopathic Association and must include training and 
experience specified in paragraphs (b)(1) and (2) of this section.



                     Subpart F_Manual Brachytherapy



Sec.35.400  Use of sources for manual brachytherapy.

    A licensee shall use only brachytherapy sources for therapeutic 
medical uses:
    (a) As approved in the Sealed Source and Device Registry; or
    (b) In research in accordance with an active Investigational Device 
Exemption (IDE) application accepted by the FDA provided the 
requirements of Sec.35.49(a) are met.

    Effective Date Note: At 83 FR 33109, July 16, 2018, Sec.35.400 was 
revised, effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:



Sec.35.400  Use of sources for manual brachytherapy.

    A licensee must use only brachytherapy sources:
    (a) Approved in the Sealed Source and Device Registry for manual 
brachytherapy medical use. The manual brachytherapy sources may be used 
for manual brachytherapy uses that are not explicitly listed in the 
Sealed Source and Device Registry, but must be used in accordance with 
the radiation safety conditions and limitations described in the Sealed 
Source and Device Registry; or
    (b) In research to deliver therapeutic doses for medical use in 
accordance with an active Investigational Device Exemption (IDE) 
application accepted by the U.S. Food and Drug Administration provided 
the requirements of Sec.35.49(a) are met.



Sec.35.404  Surveys after source implant and removal.

    (a) Immediately after implanting sources in a patient or a human 
research subject, the licensee shall make a survey to locate and account 
for all sources that have not been implanted.
    (b) Immediately after removing the last temporary implant source 
from a patient or a human research subject, the licensee shall make a 
survey of the patient or the human research subject

[[Page 716]]

with a radiation detection survey instrument to confirm that all sources 
have been removed.
    (c) A licensee shall retain a record of the surveys required by 
paragraphs (a) and (b) of this section in accordance with Sec.35.2404.



Sec.35.406  Brachytherapy sources accountability.

    (a) A licensee shall maintain accountability at all times for all 
brachytherapy sources in storage or use.
    (b) As soon as possible after removing sources from a patient or a 
human research subject, a licensee shall return brachytherapy sources to 
a secure storage area.
    (c) A licensee shall maintain a record of the brachytherapy source 
accountability in accordance with Sec.35.2406.



Sec.35.410  Safety instruction.

    In addition to the requirements of Sec.19.12 of this chapter,
    (a) The licensee shall provide radiation safety instruction, 
initially and at least annually, to personnel caring for patients or 
human research subjects who are receiving brachytherapy and cannot be 
released under Sec.35.75. To satisfy this requirement, the instruction 
must be commensurate with the duties of the personnel and include the--
    (1) Size and appearance of the brachytherapy sources;
    (2) Safe handling and shielding instructions;
    (3) Patient or human research subject control;
    (4) Visitor control, including both:
    (i) Routine visitation of hospitalized individuals in accordance 
with Sec.20.1301(a)(1) of this chapter; and
    (ii) Visitation authorized in accordance with Sec.20.1301(c) of 
this chapter; and
    (5) Notification of the Radiation Safety Officer, or his or her 
designee, and an authorized user if the patient or the human research 
subject has a medical emergency or dies.
    (b) A licensee shall retain a record of individuals receiving 
instruction in accordance with Sec.35.2310.



Sec.35.415  Safety precautions.

    (a) For each patient or human research subject who is receiving 
brachytherapy and cannot be released under Sec.35.75, a licensee 
shall--
    (1) Not quarter the patient or the human research subject in the 
same room as an individual who is not receiving brachytherapy;
    (2) Visibly post the patient's or human research subject's room with 
a ``Radioactive Materials'' sign; and
    (3) Note on the door or in the patient's or human research subject's 
chart where and how long visitors may stay in the patient's or human 
research subject's room.
    (b) A licensee shall have applicable emergency response equipment 
available near each treatment room to respond to a source--
    (1) Dislodged from the patient; and
    (2) Lodged within the patient following removal of the source 
applicators.
    (c) A licensee shall notify the Radiation Safety Officer, or his or 
her designee, and an authorized user as soon as possible if the patient 
or human research subject has a medical emergency or dies.



Sec.35.432  Calibration measurements of brachytherapy sources.

    (a) Before the first medical use of a brachytherapy source on or 
after October 24, 2002, a licensee shall have--
    (1) Determined the source output or activity using a dosimetry 
system that meets the requirements of Sec.35.630(a);
    (2) Determined source positioning accuracy within applicators; and
    (3) Used published protocols currently accepted by nationally 
recognized bodies to meet the requirements of paragraphs (a)(1) and 
(a)(2) of this section.
    (b) Instead of a licensee making its own measurements as required in 
paragraph (a) of this section, the licensee may use measurements 
provided by the source manufacturer or by a calibration laboratory 
accredited by the American Association of Physicists in Medicine that 
are made in accordance with paragraph (a) of this section.
    (c) A licensee shall mathematically correct the outputs or 
activities determined in paragraph (a) of this section

[[Page 717]]

for physical decay at intervals consistent with 1 percent physical 
decay.
    (d) A licensee shall retain a record of each calibration in 
accordance with Sec.35.2432.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19325, Apr. 21, 2003]



Sec.35.433  Decay of strontium-90 sources for ophthalmic treatments.

    (a) Only an authorized medical physicist shall calculate the 
activity of each strontium-90 source that is used to determine the 
treatment times for ophthalmic treatments. The decay must be based on 
the activity determined under Sec.35.432.
    (b) A licensee shall retain a record of the activity of each 
strontium-90 source in accordance with Sec.35.2433.

    Effective Date Note: At 83 FR 33109, July 16, 2018, Sec.35.433 was 
revised, effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:



Sec.35.433  Strontium-90 sources for ophthalmic treatments.

    (a) Licensees who use strontium-90 for ophthalmic treatments must 
ensure that certain activities as specified in paragraph (b) of this 
section are performed by either:
    (1) An authorized medical physicist; or
    (2) An individual who:
    (i) is identified as an ophthalmic physicist on a specific medical 
use license issued by the Commission or an Agreement State; permit 
issued by a Commission or Agreement State broad scope medical use 
licensee; medical use permit issued by a Commission master material 
licensee; or permit issued by a Commission master material licensee 
broad scope medical use permittee; and
    (ii) holds a master's or doctor's degree in physics, medical 
physics, other physical sciences, engineering, or applied mathematics 
from an accredited college or university; and
    (iii) has successfully completed 1 year of full-time training in 
medical physics and an additional year of full-time work experience 
under the supervision of a medical physicist; and
    (iv) Has documented training in:
    (A) The creation, modification, and completion of written 
directives;
    (B) Procedures for administrations requiring a written directive; 
and
    (C) Performing the calibration measurements of brachytherapy sources 
as detailed in Sec.35.432.
    (b) The individuals who are identified in paragraph (a) of this 
section must:
    (1) Calculate the activity of each strontium-90 source that is used 
to determine the treatment times for ophthalmic treatments. The decay 
must be based on the activity determined under Sec.35.432; and
    (2) Assist the licensee in developing, implementing, and maintaining 
written procedures to provide high confidence that the administration is 
in accordance with the written directive. These procedures must include 
the frequencies that the individual meeting the requirements in 
paragraph (a) of this section will observe treatments, review the 
treatment methodology, calculate treatment time for the prescribed dose, 
and review records to verify that the administrations were in accordance 
with the written directives.
    (c) Licensees must retain a record of the activity of each 
strontium-90 source in accordance with Sec.35.2433.



Sec.35.457  Therapy-related computer systems.

    The licensee shall perform acceptance testing on the treatment 
planning system of therapy-related computer systems in accordance with 
published protocols accepted by nationally recognized bodies. At a 
minimum, the acceptance testing must include, as applicable, 
verification of:
    (a) The source-specific input parameters required by the dose 
calculation algorithm;
    (b) The accuracy of dose, dwell time, and treatment time 
calculations at representative points;
    (c) The accuracy of isodose plots and graphic displays; and
    (d) The accuracy of the software used to determine sealed source 
positions from radiographic images.



Sec.35.490  Training for use of manual brachytherapy sources.

    Except as provided in Sec.35.57, the licensee shall require an 
authorized user of a manual brachytherapy source for the uses authorized 
under Sec.35.400 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State, and 
who meets the requirements in paragraph (b)(3) of this section. (The 
names of board certifications which have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page.) 
To have its certification process

[[Page 718]]

recognized, a specialty board shall require all candidates for 
certification to:
    (1) Successfully complete a minimum of 3 years of residency training 
in a radiation oncology program approved by the Residency Review 
Committee of the Accreditation Council for Graduate Medical Education or 
the Royal College of Physicians and Surgeons of Canada or the Committee 
on Post-Graduate Training of the American Osteopathic Association; and
    (2) Pass an examination, administered by diplomates of the specialty 
board, that tests knowledge and competence in radiation safety, 
radionuclide handling, treatment planning, quality assurance, and 
clinical use of manual brachytherapy; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide handling techniques applicable to the use of manual 
brachytherapy sources that includes--
    (i) 200 hours of classroom and laboratory training in the following 
areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (D) Radiation biology; and
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec. Sec.35.57, 35.490, 
or equivalent Agreement State requirements at a medical institution, 
involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Checking survey meters for proper operation;
    (C) Preparing, implanting, and removing brachytherapy sources;
    (D) Maintaining running inventories of material on hand;
    (E) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (F) Using emergency procedures to control byproduct material; and
    (2) Has completed 3 years of supervised clinical experience in 
radiation oncology, under an authorized user who meets the requirements 
in Sec. Sec.35.57, 35.490, or equivalent Agreement State requirements, 
as part of a formal training program approved by the Residency Review 
Committee for Radiation Oncology of the Accreditation Council for 
Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Committee on Postdoctoral Training of the 
American Osteopathic Association. This experience may be obtained 
concurrently with the supervised work experience required by paragraph 
(b)(1)(ii) of this section; and
    (3) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.35.57, 35.490, 
or equivalent Agreement State requirements, that the individual has 
satisfactorily completed the requirements in paragraph (a)(1), or 
paragraphs (b)(1) and (b)(2), of this section and has achieved a level 
of competency sufficient to function independently as an authorized user 
of manual brachytherapy sources for the medical uses authorized under 
Sec.35.400.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16366, Mar. 30, 2005; 
71 FR 15010, Mar. 27, 2006; 74 FR 33906, July 14, 2009]

    Effective Date Note: At 83 FR 33109, July 16, 2018, Sec.35.490 was 
amended by revising paragraphs (a) introductory text, (b)(1)(ii) 
introductory text, and (b)(3), effective Jan. 14, 2019. For the 
convenience of the user, the revised text is set forth as follows:



Sec.35.490  Training for use of manual brachytherapy sources.

                                * * * * *

    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State. The 
names of board certifications that have been recognized by the 
Commission or an Agreement State are posted on the NRC's Medical Uses 
Licensee Toolkit web page. To have its certification process recognized, 
a specialty board shall require all candidates for certification to:

                                * * * * *

    (b)(1) * * *
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec.35.57, Sec.35.490, 
or equivalent Agreement State requirements, at a

[[Page 719]]

medical facility authorized to use byproduct materials under Sec.
35.400, involving--

                                * * * * *

    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and (2) 
of this section and is able to independently fulfill the radiation 
safety-related duties as an authorized user of manual brachytherapy 
sources for the medical uses authorized under Sec.35.400. The 
attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in Sec.
35.57, Sec.35.490, or equivalent Agreement State requirements; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec.35.57, Sec.35.490, or equivalent Agreement State 
requirements, and concurs with the attestation provided by the residency 
program director. The residency training program must be approved by the 
Residency Review Committee of the Accreditation Council for Graduate 
Medical Education or the Royal College of Physicians and Surgeons of 
Canada or the Council on Postdoctoral Training of the American 
Osteopathic Association and must include training and experience 
specified in paragraphs (b)(1) and (2) of this section.



Sec.35.491  Training for ophthalmic use of strontium-90.

    Except as provided in Sec.35.57, the licensee shall require the 
authorized user of strontium-90 for ophthalmic radiotherapy to be a 
physician who--
    (a) Is an authorized user under Sec.35.490 or equivalent Agreement 
State requirements; or
    (b)(1) Has completed 24 hours of classroom and laboratory training 
applicable to the medical use of strontium-90 for ophthalmic 
radiotherapy. The training must include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology; and
    (2) Supervised clinical training in ophthalmic radiotherapy under 
the supervision of an authorized user at a medical institution, clinic, 
or private practice that includes the use of strontium-90 for the 
ophthalmic treatment of five individuals. This supervised clinical 
training must involve--
    (i) Examination of each individual to be treated;
    (ii) Calculation of the dose to be administered;
    (iii) Administration of the dose; and
    (iv) Follow up and review of each individual's case history; and
    (3) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.35.57, 35.490, 
35.491, or equivalent Agreement State requirements, that the individual 
has satisfactorily completed the requirements in paragraph (b) of this 
section and has achieved a level of competency sufficient to function 
independently as an authorized user of strontium-90 for ophthalmic use.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19326, Apr. 21, 2003; 
71 FR 15011, Mar. 27, 2006; 74 FR 33906, July 14, 2009]

    Effective Date Note: At 83 FR 33109, July 16, 2018, Sec.35.491 was 
amended by revising paragraph (b)(3), effective Jan. 14, 2019. For the 
convenience of the user, the revised text is set forth as follows:



Sec.35.491  Training for ophthalmic use of strontium-90.

                                * * * * *

    (b) * * *
    (3) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec.35.57, Sec.35.490, 
Sec.35.491, or equivalent Agreement State requirements, that the 
individual has satisfactorily completed the requirements in paragraphs 
(b)(1) and (2) of this section and is able to independently fulfill the 
radiation safety-related duties as an authorized user of strontium-90 
for ophthalmic use.



                 Subpart G_Sealed Sources for Diagnosis



Sec.35.500  Use of sealed sources for diagnosis.

    A licensee shall use only sealed sources for diagnostic medical uses 
as approved in the Sealed Source and Device Registry.

    Effective Date Note: At 83 FR 33110, July 16, 2018, Sec.35.500 was 
revised, effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:

[[Page 720]]



Sec.35.500  Use of sealed sources and medical devices for diagnosis.

    (a) A licensee must use only sealed sources that are not in medical 
devices for diagnostic medical uses if the sealed sources are approved 
in the Sealed Source and Device Registry for diagnostic medicine. The 
sealed sources may be used for diagnostic medical uses that are not 
explicitly listed in the Sealed Source and Device Registry but must be 
used in accordance with the radiation safety conditions and limitations 
described in the Sealed Source and Device Registry.
    (b) A licensee must only use medical devices containing sealed 
sources for diagnostic medical uses if both the sealed sources and 
medical devices are approved in the Sealed Source and Device Registry 
for diagnostic medical uses. The diagnostic medical devices may be used 
for diagnostic medical uses that are not explicitly listed in the Sealed 
Source and Device Registry but must be used in accordance with the 
radiation safety conditions and limitations described in the Sealed 
Source and Device Registry.
    (c) Sealed sources and devices for diagnostic medical uses may be 
used in research in accordance with an active Investigational Device 
Exemption (IDE) application accepted by the U.S. Food and Drug 
Administration provided the requirements of Sec.35.49(a) are met.



Sec.35.590  Training for use of sealed sources for diagnosis.

    Except as provided in Sec.35.57, the licensee shall require the 
authorized user of a diagnostic sealed source for use in a device 
authorized under Sec.35.500 to be a physician, dentist, or podiatrist 
who--
    (a) Is certified by a specialty board whose certification process 
includes all of the requirements in paragraphs (b) and (c) of this 
section and whose certification has been recognized by the Commission or 
an Agreement State. (The names of board certifications which have been 
recognized by the Commission or an Agreement State will be posted on the 
NRC's Web page.); or
    (b) Has completed 8 hours of classroom and laboratory training in 
basic radionuclide handling techniques specifically applicable to the 
use of the device. The training must include--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection;
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology; and
    (c) Has completed training in the use of the device for the uses 
requested.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16366, Mar. 30, 2005]

    Effective Date Note: At 83 FR 33110, July 16, 2018, Sec.35.590 was 
revised, effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:



Sec.35.590  Training for use of sealed sources and medical devices for 
          diagnosis.

    Except as provided in Sec.35.57, the licensee shall require the 
authorized user of a diagnostic sealed source or a device authorized 
under Sec.35.500 to be a physician, dentist, or podiatrist who--
    (a) Is certified by a specialty board whose certification process 
includes all of the requirements in paragraphs (c) and (d) of this 
section and whose certification has been recognized by the Commission or 
an Agreement State. The names of board certifications that have been 
recognized by the Commission or an Agreement State are posted on the 
NRC's Medical Uses Licensee Toolkit web page; or
    (b) Is an authorized user for uses listed in Sec.35.200 or 
equivalent Agreement State requirements; or
    (c) Has completed 8 hours of classroom and laboratory training in 
basic radionuclide handling techniques specifically applicable to the 
use of the device. The training must include--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection;
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology; and
    (d) Has completed training in the use of the device for the uses 
requested.



 Subpart H_Photon Emitting Remote Afterloader Units, Teletherapy Units, 
                and Gamma Stereotactic Radiosurgery Units



Sec.35.600  Use of a sealed source in a remote afterloader unit,
teletherapy unit, or gamma stereotactic radiosurgery unit.

    A licensee shall use sealed sources in photon emitting remote 
afterloader units, teletherapy units, or gamma stereotactic radiosurgery 
units for therapeutic medical uses:
    (a) As approved in the Sealed Source and Device Registry; or
    (b) In research in accordance with an active Investigational Device 
Exemption (IDE) application accepted by the

[[Page 721]]

FDA provided the requirements of Sec.35.49(a) are met.

    Effective Date Note: At 83 FR 33110, July 16, 2018, Sec.35.600 was 
revised, effective Jan. 14, 2019. For the convenience of the user, the 
revised text is set forth as follows:



Sec.35.600  Use of a sealed source in a remote afterloader unit, 
          teletherapy unit, or gamma stereotactic radiosurgery unit.

    (a) A licensee must only use sealed sources:
    (1) Approved and as provided for in the Sealed Source and Device 
Registry in photon emitting remote afterloader units, teletherapy units, 
or gamma stereotactic radiosurgery units to deliver therapeutic doses 
for medical uses: or
    (2) In research involving photon-emitting remote afterloader units, 
teletherapy units, or gamma stereotactic radiosurgery units in 
accordance with an active Investigational Device Exemption (IDE) 
application accepted by the U.S. Food and Drug Administration provided 
the requirements of Sec.35.49(a) are met.
    (b) A licensee must use photon-emitting remote afterloader units, 
teletherapy units, or gamma stereotactic radiosurgery units:
    (1) Approved in the Sealed Source and Device Registry to deliver a 
therapeutic dose for medical use. These devices may be used for 
therapeutic medical treatments that are not explicitly provided for in 
the Sealed Source and Device Registry, but must be used in accordance 
with radiation safety conditions and limitations described in the Sealed 
Source and Device Registry; or
    (2) In research in accordance with an active Investigational Device 
Exemption (IDE) application accepted by the FDA provided the 
requirements of Sec.35.49(a) are met.



Sec.35.604  Surveys of patients and human research subjects treated
with a remote afterloader unit.

    (a) Before releasing a patient or a human research subject from 
licensee control, a licensee shall survey the patient or the human 
research subject and the remote afterloader unit with a portable 
radiation detection survey instrument to confirm that the source(s) has 
been removed from the patient or human research subject and returned to 
the safe shielded position.
    (b) A licensee shall retain a record of these surveys in accordance 
with Sec.35.2404.



Sec.35.605  Installation, maintenance, adjustment, and repair.

    (a) Only a person specifically licensed by the Commission or an 
Agreement State shall install, maintain, adjust, or repair a remote 
afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery 
unit that involves work on the source(s) shielding, the source(s) 
driving unit, or other electronic or mechanical component that could 
expose the source(s), reduce the shielding around the source(s), or 
compromise the radiation safety of the unit or the source(s).
    (b) Except for low dose-rate remote afterloader units, only a person 
specifically licensed by the Commission or an Agreement State shall 
install, replace, relocate, or remove a sealed source or source 
contained in other remote afterloader units, teletherapy units, or gamma 
stereotactic radiosurgery units.
    (c) For a low dose-rate remote afterloader unit, only a person 
specifically licensed by the Commission or an Agreement State or an 
authorized medical physicist shall install, replace, relocate, or remove 
a sealed source(s) contained in the unit.
    (d) A licensee shall retain a record of the installation, 
maintenance, adjustment, and repair of remote afterloader units, 
teletherapy units, and gamma stereotactic radiosurgery units in 
accordance with Sec.35.2605.



Sec.35.610  Safety procedures and instructions for remote afterloader
units, teletherapy units, and gamma stereotactic radiosurgery units.

    (a) A licensee shall--
    (1) Secure the unit, the console, the console keys, and the 
treatment room when not in use or unattended;
    (2) Permit only individuals approved by the authorized user, 
Radiation Safety Officer, or authorized medical physicist to be present 
in the treatment room during treatment with the source(s);
    (3) Prevent dual operation of more than one radiation producing 
device in a treatment room if applicable; and
    (4) Develop, implement, and maintain written procedures for 
responding to an abnormal situation when the operator is unable to place 
the source(s) in the shielded position, or remove the patient or human 
research subject from the radiation field with controls from

[[Page 722]]

outside the treatment room. These procedures must include--
    (i) Instructions for responding to equipment failures and the names 
of the individuals responsible for implementing corrective actions;
    (ii) The process for restricting access to and posting of the 
treatment area to minimize the risk of inadvertent exposure; and
    (iii) The names and telephone numbers of the authorized users, the 
authorized medical physicist, and the Radiation Safety Officer to be 
contacted if the unit or console operates abnormally.
    (b) A copy of the procedures required by paragraph (a)(4) of this 
section must be physically located at the unit console.
    (c) A licensee shall post instructions at the unit console to inform 
the operator of--
    (1) The location of the procedures required by paragraph (a)(4) of 
this section; and
    (2) The names and telephone numbers of the authorized users, the 
authorized medical physicist, and the Radiation Safety Officer to be 
contacted if the unit or console operates abnormally.
    (d) A licensee shall provide instruction, initially and at least 
annually, to all individuals who operate the unit, as appropriate to the 
individual's assigned duties, in--
    (1) The procedures identified in paragraph (a)(4) of this section; 
and
    (2) The operating procedures for the unit.
    (e) A licensee shall ensure that operators, authorized medical 
physicists, and authorized users participate in drills of the emergency 
procedures, initially and at least annually.
    (f) A licensee shall retain a record of individuals receiving 
instruction required by paragraph (d) of this section, in accordance 
with Sec.35.2310.
    (g) A licensee shall retain a copy of the procedures required by 
Sec. Sec.35.610(a)(4) and (d)(2) in accordance with Sec.35.2610.

    Effective Date Note: At 83 FR 33110, July 16, 2018, Sec.35.610 was 
amended by revising paragraphs (d) and (g), effective Jan. 14, 2019. For 
the convenience of the user, the revised text is set forth as follows:



Sec.35.610  Safety procedures and instructions for remote afterloader 
          units, teletherapy units, and gamma stereotactic radiosurgery 
          units.

                                * * * * *

    (d)(1) Prior to the first use for patient treatment of a new unit or 
an existing unit with a manufacturer upgrade that affects the operation 
and safety of the unit, a licensee shall ensure that vendor operational 
and safety training is provided to all individuals who will operate the 
unit. The vendor operational and safety training must be provided by the 
device manufacturer or by an individual certified by the device 
manufacturer to provide the operational and safety training.
    (2) A licensee shall provide operational and safety instructions 
initially and at least annually to all individuals who operate the unit 
at the facility, as appropriate to the individual's assigned duties. The 
instructions shall include instruction in--
    (i) The procedures identified in paragraph (a)(4) of this section; 
and
    (ii) The operating procedures for the unit.

                                * * * * *

    (g) A licensee shall retain a copy of the procedures required by 
paragraphs (a)(4) and (d)(2)(ii) of this section in accordance with 
Sec.35.2610.



Sec.35.615  Safety precautions for remote afterloader units, 
teletherapy units, and gamma stereotactic radiosurgery units.

    (a) A licensee shall control access to the treatment room by a door 
at each entrance.
    (b) A licensee shall equip each entrance to the treatment room with 
an electrical interlock system that will--
    (1) Prevent the operator from initiating the treatment cycle unless 
each treatment room entrance door is closed;
    (2) Cause the source(s) to be shielded when an entrance door is 
opened; and
    (3) Prevent the source(s) from being exposed following an interlock 
interruption until all treatment room entrance doors are closed and the 
source(s) on-off control is reset at the console.
    (c) A licensee shall require any individual entering the treatment 
room to assure, through the use of appropriate radiation monitors, that 
radiation levels have returned to ambient levels.

[[Page 723]]

    (d) Except for low-dose remote afterloader units, a licensee shall 
construct or equip each treatment room with viewing and intercom systems 
to permit continuous observation of the patient or the human research 
subject from the treatment console during irradiation.
    (e) For licensed activities where sources are placed within the 
patient's or human research subject's body, a licensee shall only 
conduct treatments which allow for expeditious removal of a decoupled or 
jammed source.
    (f) In addition to the requirements specified in paragraphs (a) 
through (e) of this section, a licensee shall--
    (1) For medium dose-rate and pulsed dose-rate remote afterloader 
units, require--
    (i) An authorized medical physicist and either an authorized user or 
a physician, under the supervision of an authorized user, who has been 
trained in the operation and emergency response for the unit to be 
physically present during the initiation of all patient treatments 
involving the unit; and
    (ii) An authorized medical physicist and either an authorized user 
or an individual, under the supervision of an authorized user, who has 
been trained to remove the source applicator(s) in the event of an 
emergency involving the unit, to be immediately available during 
continuation of all patient treatments involving the unit.
    (2) For high dose-rate remote afterloader units, require--
    (i) An authorized user and an authorized medical physicist to be 
physically present during the initiation of all patient treatments 
involving the unit; and
    (ii) An authorized medical physicist and either an authorized user 
or a physician, under the supervision of an authorized user, who has 
been trained in the operation and emergency response for the unit, to be 
physically present during continuation of all patient treatments 
involving the unit.
    (3) For gamma stereotactic radiosurgery units, require an authorized 
user and an authorized medical physicist to be physically present 
throughout all patient treatments involving the unit.
    (4) Notify the Radiation Safety Officer, or his/her designee, and an 
authorized user as soon as possible if the patient or human research 
subject has a medical emergency or dies.
    (g) A licensee shall have applicable emergency response equipment 
available near each treatment room to respond to a source--
    (1) Remaining in the unshielded position; or
    (2) Lodged within the patient following completion of the treatment.



Sec.35.630  Dosimetry equipment.

    (a) Except for low dose-rate remote afterloader sources where the 
source output or activity is determined by the manufacturer, a licensee 
shall have a calibrated dosimetry system available for use. To satisfy 
this requirement, one of the following two conditions must be met.
    (1) The system must have been calibrated using a system or source 
traceable to the National Institute of Standards and Technology (NIST) 
and published protocols accepted by nationally recognized bodies; or by 
a calibration laboratory accredited by the American Association of 
Physicists in Medicine (AAPM). The calibration must have been performed 
within the previous 2 years and after any servicing that may have 
affected system calibration; or
    (2) The system must have been calibrated within the previous 4 
years. Eighteen to thirty months after that calibration, the system must 
have been intercompared with another dosimetry system that was 
calibrated within the past 24 months by NIST or by a calibration 
laboratory accredited by the AAPM. The results of the intercomparison 
must indicate that the calibration factor of the licensee's system had 
not changed by more than 2 percent. The licensee may not use the 
intercomparison result to change the calibration factor. When 
intercomparing dosimetry systems to be used for calibrating sealed 
sources for therapeutic units, the licensee shall use a comparable unit 
with beam attenuators or collimators, as applicable, and sources of the 
same radionuclide as the source used at the licensee's facility.
    (b) The licensee shall have a dosimetry system available for use for 
spot-

[[Page 724]]

check output measurements, if applicable. To satisfy this requirement, 
the system may be compared with a system that has been calibrated in 
accordance with paragraph (a) of this section. This comparison must have 
been performed within the previous year and after each servicing that 
may have affected system calibration. The spot-check system may be the 
same system used to meet the requirement in paragraph (a) of this 
section.
    (c) The licensee shall retain a record of each calibration, 
intercomparison, and comparison in accordance with Sec.35.2630.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19326, Apr. 21, 2003]



Sec.35.632  Full calibration measurements on teletherapy units.

    (a) A licensee authorized to use a teletherapy unit for medical use 
shall perform full calibration measurements on each teletherapy unit--
    (1) Before the first medical use of the unit; and
    (2) Before medical use under the following conditions:
    (i) Whenever spot-check measurements indicate that the output 
differs by more than 5 percent from the output obtained at the last full 
calibration corrected mathematically for radioactive decay;
    (ii) Following replacement of the source or following reinstallation 
of the teletherapy unit in a new location;
    (iii) Following any repair of the teletherapy unit that includes 
removal of the source or major repair of the components associated with 
the source exposure assembly; and
    (3) At intervals not exceeding 1 year.
    (b) To satisfy the requirement of paragraph (a) of this section, 
full calibration measurements must include determination of--
    (1) The output within 3 percent for the range 
of field sizes and for the distance or range of distances used for 
medical use;
    (2) The coincidence of the radiation field and the field indicated 
by the light beam localizing device;
    (3) The uniformity of the radiation field and its dependence on the 
orientation of the useful beam;
    (4) Timer accuracy and linearity over the range of use;
    (5) On-off error; and
    (6) The accuracy of all distance measuring and localization devices 
in medical use.
    (c) A licensee shall use the dosimetry system described in Sec.
35.630(a) to measure the output for one set of exposure conditions. The 
remaining radiation measurements required in paragraph (b)(1) of this 
section may be made using a dosimetry system that indicates relative 
dose rates.
    (d) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols 
accepted by nationally recognized bodies.
    (e) A licensee shall mathematically correct the outputs determined 
in paragraph (b)(1) of this section for physical decay for intervals not 
exceeding 1 month for cobalt-60, 6 months for cesium-137, or at 
intervals consistent with 1 percent decay for all other nuclides.
    (f) Full calibration measurements required by paragraph (a) of this 
section and physical decay corrections required by paragraph (e) of this 
section must be performed by the authorized medical physicist.
    (g) A licensee shall retain a record of each calibration in 
accordance with Sec.35.2632.



Sec.35.633  Full calibration measurements on remote afterloader units.

    (a) A licensee authorized to use a remote afterloader unit for 
medical use shall perform full calibration measurements on each unit--
    (1) Before the first medical use of the unit;
    (2) Before medical use under the following conditions:
    (i) Following replacement of the source or following reinstallation 
of the unit in a new location outside the facility; and
    (ii) Following any repair of the unit that includes removal of the 
source or major repair of the components associated with the source 
exposure assembly; and
    (3) At intervals not exceeding 1 quarter for high dose-rate, medium 
dose-rate, and pulsed dose-rate remote

[[Page 725]]

afterloader units with sources whose half-life exceeds 75 days; and
    (4) At intervals not exceeding 1 year for low dose-rate remote 
afterloader units.
    (b) To satisfy the requirement of paragraph (a) of this section, 
full calibration measurements must include, as applicable, determination 
of:
    (1) The output within 5 percent;
    (2) Source positioning accuracy to within 1 
millimeter;
    (3) Source retraction with backup battery upon power failure;
    (4) Length of the source transfer tubes;
    (5) Timer accuracy and linearity over the typical range of use;
    (6) Length of the applicators; and
    (7) Function of the source transfer tubes, applicators, and transfer 
tube-applicator interfaces.
    (c) A licensee shall use the dosimetry system described in Sec.
35.630(a) to measure the output.
    (d) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols 
accepted by nationally recognized bodies.
    (e) In addition to the requirements for full calibrations for low 
dose-rate remote afterloader units in paragraph (b) of this section, a 
licensee shall perform an autoradiograph of the source(s) to verify 
inventory and source(s) arrangement at intervals not exceeding 1 
quarter.
    (f) For low dose-rate remote afterloader units, a licensee may use 
measurements provided by the source manufacturer that are made in 
accordance with paragraphs (a) through (e) of this section.
    (g) A licensee shall mathematically correct the outputs determined 
in paragraph (b)(1) of this section for physical decay at intervals 
consistent with 1 percent physical decay.
    (h) Full calibration measurements required by paragraph (a) of this 
section and physical decay corrections required by paragraph (g) of this 
section must be performed by the authorized medical physicist.
    (i) A licensee shall retain a record of each calibration in 
accordance with Sec.35.2632.



Sec.35.635  Full calibration measurements on gamma stereotactic 
radiosurgery units.

    (a) A licensee authorized to use a gamma stereotactic radiosurgery 
unit for medical use shall perform full calibration measurements on each 
unit--
    (1) Before the first medical use of the unit;
    (2) Before medical use under the following conditions--
    (i) Whenever spot-check measurements indicate that the output 
differs by more than 5 percent from the output obtained at the last full 
calibration corrected mathematically for radioactive decay;
    (ii) Following replacement of the sources or following 
reinstallation of the gamma stereotactic radiosurgery unit in a new 
location; and
    (iii) Following any repair of the gamma stereotactic radiosurgery 
unit that includes removal of the sources or major repair of the 
components associated with the source assembly; and
    (3) At intervals not exceeding 1 year, with the exception that 
relative helmet factors need only be determined before the first medical 
use of a helmet and following any damage to a helmet.
    (b) To satisfy the requirement of paragraph (a) of this section, 
full calibration measurements must include determination of--
    (1) The output within 3 percent;
    (2) Relative helmet factors;
    (3) Isocenter coincidence;
    (4) Timer accuracy and linearity over the range of use;
    (5) On-off error;
    (6) Trunnion centricity;
    (7) Treatment table retraction mechanism, using backup battery power 
or hydraulic backups with the unit off;
    (8) Helmet microswitches;
    (9) Emergency timing circuits; and
    (10) Stereotactic frames and localizing devices (trunnions).
    (c) A licensee shall use the dosimetry system described in Sec.
35.630(a) to measure the output for one set of exposure conditions. The 
remaining radiation measurements required in paragraph (b)(1) of this 
section may be made using a dosimetry system that indicates relative 
dose rates.

[[Page 726]]

    (d) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols 
accepted by nationally recognized bodies.
    (e) A licensee shall mathematically correct the outputs determined 
in paragraph (b)(1) of this section at intervals not exceeding 1 month 
for cobalt-60 and at intervals consistent with 1 percent physical decay 
for all other radionuclides.
    (f) Full calibration measurements required by paragraph (a) of this 
section and physical decay corrections required by paragraph (e) of this 
section must be performed by the authorized medical physicist.
    (g) A licensee shall retain a record of each calibration in 
accordance with Sec.35.2632.



Sec.35.642  Periodic spot-checks for teletherapy units.

    (a) A licensee authorized to use teletherapy units for medical use 
shall perform output spot-checks on each teletherapy unit once in each 
calendar month that include determination of--
    (1) Timer accuracy, and timer linearity over the range of use;
    (2) On-off error;
    (3) The coincidence of the radiation field and the field indicated 
by the light beam localizing device;
    (4) The accuracy of all distance measuring and localization devices 
used for medical use;
    (5) The output for one typical set of operating conditions measured 
with the dosimetry system described in Sec.35.630(b); and
    (6) The difference between the measurement made in paragraph (a)(5) 
of this section and the anticipated output, expressed as a percentage of 
the anticipated output (i.e., the value obtained at last full 
calibration corrected mathematically for physical decay).
    (b) A licensee shall perform measurements required by paragraph (a) 
of this section in accordance with written procedures established by the 
authorized medical physicist. That individual need not actually perform 
the spot-check measurements.
    (c) A licensee shall have the authorized medical physicist review 
the results of each spot-check within 15 days. The authorized medical 
physicist shall notify the licensee as soon as possible in writing of 
the results of each spot-check.
    (d) A licensee authorized to use a teletherapy unit for medical use 
shall perform safety spot-checks of each teletherapy facility once in 
each calendar month and after each source installation to assure proper 
operation of--
    (1) Electrical interlocks at each teletherapy room entrance;
    (2) Electrical or mechanical stops installed for the purpose of 
limiting use of the primary beam of radiation (restriction of source 
housing angulation or elevation, carriage or stand travel and operation 
of the beam on-off mechanism);
    (3) Source exposure indicator lights on the teletherapy unit, on the 
control console, and in the facility;
    (4) Viewing and intercom systems;
    (5) Treatment room doors from inside and outside the treatment room; 
and
    (6) Electrically assisted treatment room doors with the teletherapy 
unit electrical power turned off.
    (e) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning system.
    (f) A licensee shall retain a record of each spot-check required by 
paragraphs (a) and (d) of this section, and a copy of the procedures 
required by paragraph (b), in accordance with Sec.35.2642.



Sec.35.643  Periodic spot-checks for remote afterloader units.

    (a) A licensee authorized to use a remote afterloader unit for 
medical use shall perform spot-checks of each remote afterloader 
facility and on each unit--
    (1) Before the first use of a high dose-rate, medium dose-rate, or 
pulsed dose-rate remote afterloader unit on a given day;
    (2) Before each patient treatment with a low dose-rate remote 
afterloader unit; and
    (3) After each source installation.
    (b) A licensee shall perform the measurements required by paragraph

[[Page 727]]

(a) of this section in accordance with written procedures established by 
the authorized medical physicist. That individual need not actually 
perform the spot check measurements.
    (c) A licensee shall have the authorized medical physicist review 
the results of each spot-check within 15 days. The authorized medical 
physicist shall notify the licensee as soon as possible in writing of 
the results of each spot-check.
    (d) To satisfy the requirements of paragraph (a) of this section, 
spot-checks must, at a minimum, assure proper operation of--
    (1) Electrical interlocks at each remote afterloader unit room 
entrance;
    (2) Source exposure indicator lights on the remote afterloader unit, 
on the control console, and in the facility;
    (3) Viewing and intercom systems in each high dose-rate, medium 
dose-rate, and pulsed dose-rate remote afterloader facility;
    (4) Emergency response equipment;
    (5) Radiation monitors used to indicate the source position;
    (6) Timer accuracy;
    (7) Clock (date and time) in the unit's computer; and
    (8) Decayed source(s) activity in the unit's computer.
    (e) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning system.
    (f) A licensee shall retain a record of each check required by 
paragraph (d) of this section and a copy of the procedures required by 
paragraph (b) of this section in accordance with Sec.35.2643.



Sec.35.645  Periodic spot-checks for gamma stereotactic radiosurgery
units.

    (a) A licensee authorized to use a gamma stereotactic radiosurgery 
unit for medical use shall perform spot-checks of each gamma 
stereotactic radiosurgery facility and on each unit--
    (1) Monthly;
    (2) Before the first use of the unit on a given day; and
    (3) After each source installation.
    (b) A licensee shall--
    (1) Perform the measurements required by paragraph (a) of this 
section in accordance with written procedures established by the 
authorized medical physicist. That individual need not actually perform 
the spot check measurements.
    (2) Have the authorized medical physicist review the results of each 
spot-check within 15 days. The authorized medical physicist shall notify 
the licensee as soon as possible in writing of the results of each spot-
check.
    (c) To satisfy the requirements of paragraph (a)(1) of this section, 
spot-checks must, at a minimum--
    (1) Assure proper operation of--
    (i) Treatment table retraction mechanism, using backup battery power 
or hydraulic backups with the unit off;
    (ii) Helmet microswitches;
    (iii) Emergency timing circuits; and
    (iv) Stereotactic frames and localizing devices (trunnions).
    (2) Determine--
    (i) The output for one typical set of operating conditions measured 
with the dosimetry system described in Sec.35.630(b);
    (ii) The difference between the measurement made in paragraph 
(c)(2)(i) of this section and the anticipated output, expressed as a 
percentage of the anticipated output (i.e., the value obtained at last 
full calibration corrected mathematically for physical decay);
    (iii) Source output against computer calculation;
    (iv) Timer accuracy and linearity over the range of use;
    (v) On-off error; and
    (vi) Trunnion centricity.
    (d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of 
this section, spot-checks must assure proper operation of--
    (1) Electrical interlocks at each gamma stereotactic radiosurgery 
room entrance;
    (2) Source exposure indicator lights on the gamma stereotactic 
radiosurgery unit, on the control console, and in the facility;
    (3) Viewing and intercom systems;
    (4) Timer termination;
    (5) Radiation monitors used to indicate room exposures; and

[[Page 728]]

    (6) Emergency off buttons.
    (e) A licensee shall arrange for the repair of any system identified 
in paragraph (c) of this section that is not operating properly as soon 
as possible.
    (f) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning system.
    (g) A licensee shall retain a record of each check required by 
paragraphs (c) and (d) and a copy of the procedures required by 
paragraph (b) of this section in accordance with Sec.35.2645.



Sec.35.647  Additional technical requirements for mobile remote after
loader units.

    (a) A licensee providing mobile remote afterloader service shall--
    (1) Check survey instruments before medical use at each address of 
use or on each day of use, whichever is more frequent; and
    (2) Account for all sources before departure from a client's address 
of use.
    (b) In addition to the periodic spot-checks required by Sec.
35.643, a licensee authorized to use mobile afterloaders for medical use 
shall perform checks on each remote afterloader unit before use at each 
address of use. At a minimum, checks must be made to verify the 
operation of--
    (1) Electrical interlocks on treatment area access points;
    (2) Source exposure indicator lights on the remote afterloader unit, 
on the control console, and in the facility;
    (3) Viewing and intercom systems;
    (4) Applicators, source transfer tubes, and transfer tube-applicator 
interfaces;
    (5) Radiation monitors used to indicate room exposures;
    (6) Source positioning (accuracy); and
    (7) Radiation monitors used to indicate whether the source has 
returned to a safe shielded position.
    (c) In addition to the requirements for checks in paragraph (b) of 
this section, a licensee shall ensure overall proper operation of the 
remote afterloader unit by conducting a simulated cycle of treatment 
before use at each address of use.
    (d) If the results of the checks required in paragraph (b) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning system.
    (e) A licensee shall retain a record of each check required by 
paragraph (b) of this section in accordance with Sec.35.2647.



Sec.35.652  Radiation surveys.

    (a) In addition to the survey requirement in Sec.20.1501 of this 
chapter, a person licensed under this subpart shall make surveys to 
ensure that the maximum radiation levels and average radiation levels 
from the surface of the main source safe with the source(s) in the 
shielded position do not exceed the levels stated in the Sealed Source 
and Device Registry.
    (b) The licensee shall make the survey required by paragraph (a) of 
this section at installation of a new source and following repairs to 
the source(s) shielding, the source(s) driving unit, or other electronic 
or mechanical component that could expose the source, reduce the 
shielding around the source(s), or compromise the radiation safety of 
the unit or the source(s).
    (c) A licensee shall retain a record of the radiation surveys 
required by paragraph (a) of this section in accordance with Sec.
35.2652.



Sec.35.655  Five-year inspection for teletherapy and gamma 
stereotactic radiosurgery units.

    (a) A licensee shall have each teletherapy unit and gamma 
stereotactic radiosurgery unit fully inspected and serviced during 
source replacement or at intervals not to exceed 5 years, whichever 
comes first, to assure proper functioning of the source exposure 
mechanism.
    (b) This inspection and servicing may only be performed by persons 
specifically licensed to do so by the Commission or an Agreement State.
    (c) A licensee shall keep a record of the inspection and servicing 
in accordance with Sec.35.2655.

    Effective Date Note: At 83 FR 33110, July 16, 2018, Sec.35.655 was 
amended by revising the

[[Page 729]]

section heading and paragraph (a), effective Jan. 14, 2019. For the 
convenience of the user, the revised text is set forth as follows:



Sec.35.655  Full-inspection servicing for teletherapy and gamma 
          stereotactic radiosurgery units.

    (a) A licensee shall have each teletherapy unit and gamma 
stereotactic radiosurgery unit fully inspected and serviced during each 
source replacement to assure proper functioning of the source exposure 
mechanism and other safety components. The interval between each full-
inspection servicing shall not exceed 5 years for each teletherapy unit 
and shall not exceed 7 years for each gamma stereotactic radiosurgery 
unit.

                                * * * * *



Sec.35.657  Therapy-related computer systems.

    The licensee shall perform acceptance testing on the treatment 
planning system of therapy-related computer systems in accordance with 
published protocols accepted by nationally recognized bodies. At a 
minimum, the acceptance testing must include, as applicable, 
verification of:
    (a) The source-specific input parameters required by the dose 
calculation algorithm;
    (b) The accuracy of dose, dwell time, and treatment time 
calculations at representative points;
    (c) The accuracy of isodose plots and graphic displays;
    (d) The accuracy of the software used to determine sealed source 
positions from radiographic images; and
    (e) The accuracy of electronic transfer of the treatment delivery 
parameters to the treatment delivery unit from the treatment planning 
system.



Sec.35.690  Training for use of remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units.

    Except as provided in Sec.35.57, the licensee shall require an 
authorized user of a sealed source for a use authorized under Sec.
35.600 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State and 
who meets the requirements in paragraphs (b)(3) and (c) of this section. 
(The names of board certifications which have been recognized by the 
Commission or an Agreement State will be posted on the NRC's web page.) 
To have its certification process recognized, a specialty board shall 
require all candidates for certification to:
    (1) Successfully complete a minimum of 3 years of residency training 
in a radiation therapy program approved by the Residency Review 
Committee of the Accreditation Council for Graduate Medical Education or 
the Royal College of Physicians and Surgeons of Canada or the Committee 
on Post-Graduate Training of the American Osteopathic Association; and
    (2) Pass an examination, administered by diplomates of the specialty 
board, which tests knowledge and competence in radiation safety, 
radionuclide handling, treatment planning, quality assurance, and 
clinical use of stereotactic radiosurgery, remote afterloaders and 
external beam therapy; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide techniques applicable to the use of a sealed source in a 
therapeutic medical unit that includes--
    (i) 200 hours of classroom and laboratory training in the following 
areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (D) Radiation biology; and
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec. Sec.35.57, 35.690, 
or equivalent Agreement State requirements at a medical institution, 
involving--
    (A) Reviewing full calibration measurements and periodic spot-
checks;
    (B) Preparing treatment plans and calculating treatment doses and 
times;
    (C) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (D) Implementing emergency procedures to be followed in the event of 
the abnormal operation of the medical unit or console;
    (E) Checking and using survey meters; and

[[Page 730]]

    (F) Selecting the proper dose and how it is to be administered; and
    (2) Has completed 3 years of supervised clinical experience in 
radiation therapy, under an authorized user who meets the requirements 
in Sec. Sec.35.57, 35.690, or equivalent Agreement State requirements, 
as part of a formal training program approved by the Residency Review 
Committee for Radiation Oncology of the Accreditation Council for 
Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Committee on Postdoctoral Training of the 
American Osteopathic Association. This experience may be obtained 
concurrently with the supervised work experience required by paragraph 
(b)(1)(ii) of this section; and
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (a)(1) or 
paragraphs (b)(1) and (b)(2), and paragraph (c), of this section, and 
has achieved a level of competency sufficient to function independently 
as an authorized user of each type of therapeutic medical unit for which 
the individual is requesting authorized user status. The written 
attestation must be signed by a preceptor authorized user who meets the 
requirements in Sec. Sec.35.57, 35.690, or equivalent Agreement State 
requirements for an authorized user for each type of therapeutic medical 
unit for which the individual is requesting authorized user status; and
    (c) Has received training in device operation, safety procedures, 
and clinical use for the type(s) of use for which authorization is 
sought. This training requirement may be satisfied by satisfactory 
completion of a training program provided by the vendor for new users or 
by receiving training supervised by an authorized user or authorized 
medical physicist, as appropriate, who is authorized for the type(s) of 
use for which the individual is seeking authorization.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16366, Mar. 30, 2005; 
71 FR 15011, Mar. 27, 2006; 74 FR 33906, July 14, 2009]

    Effective Date Note: At 83 FR 33110, July 16, 2018, Sec.35.690 was 
amended by revising paragraphs (a) introductory text, (b)(1)(ii) 
introductory text, and (b)(3), effective Jan. 14, 2019. For the 
convenience of the user, the revised text is set forth as follows:



Sec.35.690  Training for use of remote afterloader units, teletherapy 
          units, and gamma stereotactic radiosurgery units.

                                * * * * *

    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State and 
who meets the requirements in paragraph (c) of this section. The names 
of board certifications that have been recognized by the Commission or 
an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit 
web page. To have its certification process recognized, a specialty 
board shall require all candidates for certification to:

                                * * * * *

    (b)(1) * * *
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec.35.57, Sec.35.690, 
or equivalent Agreement State requirements, at a medical facility that 
is authorized to use byproduct materials in Sec.35.600, involving--

                                * * * * *

    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and (2) 
and (c) of this section; and is able to independently fulfill the 
radiation safety-related duties as an authorized user of each type of 
therapeutic medical unit for which the individual is requesting 
authorized user status. The attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in Sec.
35.57, Sec.35.690, or equivalent Agreement State requirements for the 
type(s) of therapeutic medical unit for which the individual is 
requesting authorized user status; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec.35.57, Sec.35.690, or equivalent Agreement State 
requirements, for the type(s) of therapeutic medical unit for which the 
individual is requesting authorized user status, and concurs with the 
attestation provided by the residency program director. The residency 
training program must be approved by the Residency Review Committee of 
the Accreditation Council for Graduate Medical Education or the Royal 
College of Physicians and Surgeons of Canada or the Council on 
Postdoctoral Training of the

[[Page 731]]

American Osteopathic Association and must include training and 
experience specified in paragraphs (b)(1) and (2) of this section.

                                * * * * *

Subparts I-J [Reserved]



  Subpart K_Other Medical Uses of Byproduct Material or Radiation From 
                           Byproduct Material



Sec.35.1000  Other medical uses of byproduct material or radiation
from byproduct material.

    A licensee may use byproduct material or a radiation source approved 
for medical use which is not specifically addressed in subparts D 
through H of this part if--
    (a) The applicant or licensee has submitted the information required 
by Sec.35.12(b) through (d); and
    (b) The applicant or licensee has received written approval from the 
Commission in a license or license amendment and uses the material in 
accordance with the regulations and specific conditions the Commission 
considers necessary for the medical use of the material.



                            Subpart L_Records



Sec.35.2024  Records of authority and responsibilities for radiation
protection programs.

    (a) A licensee shall retain a record of actions taken by the 
licensee's management in accordance with Sec.35.24(a) for 5 years. The 
record must include a summary of the actions taken and a signature of 
licensee management.
    (b) The licensee shall retain a copy of both authority, duties, and 
responsibilities of the Radiation Safety Officer as required by Sec.
35.24(e), and a signed copy of each Radiation Safety Officer's agreement 
to be responsible for implementing the radiation safety program, as 
required by Sec.35.24(b), for the duration of the license. The records 
must include the signature of the Radiation Safety Officer and licensee 
management.

    Effective Date Note: At 83 FR 33111, July 16, 2018, Sec.35.2024 
was amended by adding paragraph (c), effective Jan. 14, 2019. For the 
convenience of the user, the added text is set forth as follows:



Sec.35.2024  Records of authority and responsibilities for radiation 
          protection programs.

                                * * * * *

    (c) For each Associate Radiation Safety Officer appointed under 
Sec.35.24(b), the licensee shall retain, for 5 years after the 
Associate Radiation Safety Officer is removed from the license, a copy 
of the written document appointing the Associate Radiation Safety 
Officer signed by the licensee's management.



Sec.35.2026  Records of radiation protection program changes.

    A licensee shall retain a record of each radiation protection 
program change made in accordance with Sec.35.26(a) for 5 years. The 
record must include a copy of the old and new procedures; the effective 
date of the change; and the signature of the licensee management that 
reviewed and approved the change.



Sec.35.2040  Records of written directives.

    A licensee shall retain a copy of each written directive as required 
by Sec.35.40 for 3 years.



Sec.35.2041  Records for procedures for administrations requiring
a written directive

    A licensee shall retain a copy of the procedures required by Sec.
35.41(a) for the duration of the license.



Sec.35.2060  Records of calibrations of instruments used to measure
the activity of unsealed byproduct material.

    A licensee shall maintain a record of instrument calibrations 
required by Sec.35.60 for 3 years. The records must include the model 
and serial number of the instrument, the date of the calibration, the 
results of the calibration, and the name of the individual who performed 
the calibration.



Sec.35.2061  Records of radiation survey instrument calibrations.

    A licensee shall maintain a record of radiation survey instrument 
calibrations required by Sec.35.61 for 3 years. The record must 
include the model and serial number of the instrument, the date

[[Page 732]]

of the calibration, the results of the calibration, and the name of the 
individual who performed the calibration.



Sec.35.2063  Records of dosages of unsealed byproduct material for medical use.

    (a) A licensee shall maintain a record of dosage determinations 
required by Sec.35.63 for 3 years.
    (b) The record must contain--
    (1) The radiopharmaceutical;
    (2) The patient's or human research subject's name, or 
identification number if one has been assigned;
    (3) The prescribed dosage, the determined dosage, or a notation that 
the total activity is less than 1.1 MBq (30 [micro]Ci);
    (4) The date and time of the dosage determination; and
    (5) The name of the individual who determined the dosage.



Sec.35.2067  Records of leaks tests and inventory of sealed sources
and brachytherapy sources.

    (a) A licensee shall retain records of leak tests required by Sec.
35.67(b) for 3 years. The records must include the model number, and 
serial number if one has been assigned, of each source tested; the 
identity of each source by radionuclide and its estimated activity; the 
results of the test; the date of the test; and the name of the 
individual who performed the test.
    (b) A licensee shall retain records of the semi-annual physical 
inventory of sealed sources and brachytherapy sources required by Sec.
35.67(g) for 3 years. The inventory records must contain the model 
number of each source, and serial number if one has been assigned, the 
identity of each source by radionuclide and its nominal activity, the 
location of each source, and the name of the individual who performed 
the inventory.



Sec.35.2070  Records of surveys for ambient radiation exposure rate.

    A licensee shall retain a record of each survey required by Sec.
35.70 for 3 years. The record must include the date of the survey, the 
results of the survey, the instrument used to make the survey, and the 
name of the individual who performed the survey.



Sec.35.2075  Records of the release of individuals containing 
unsealed byproduct material or implants containing byproduct 
material.

    (a) A licensee shall retain a record of the basis for authorizing 
the release of an individual in accordance with Sec.35.75, if the 
total effective dose equivalent is calculated by--
    (1) Using the retained activity rather than the activity 
administered;
    (2) Using an occupancy factor less than 0.25 at 1 meter;
    (3) Using the biological or effective half-life; or
    (4) Considering the shielding by tissue.
    (b) A licensee shall retain a record that the instructions required 
by Sec.35.75(b) were provided to a breast-feeding female if the 
radiation dose to the infant or child from continued breast-feeding 
could result in a total effective dose equivalent exceeding 5 mSv (0.5 
rem).
    (c) The records required by paragraphs (a) and (b) of this section 
must be retained for 3 years after the date of release of the 
individual.



Sec.35.2080  Records of mobile medical services.

    (a) A licensee shall retain a copy of each letter that permits the 
use of byproduct material at a client's address, as required by Sec.
35.80(a)(1). Each letter must clearly delineate the authority and 
responsibility of the licensee and the client and must be retained for 3 
years after the last provision of service.
    (b) A licensee shall retain the record of each survey required by 
Sec.35.80(a)(4) for 3 years. The record must include the date of the 
survey, the results of the survey, the instrument used to make the 
survey, and the name of the individual who performed the survey.



Sec.35.2092  Records of decay-in-storage.

    A licensee shall maintain records of the disposal of licensed 
materials, as required by Sec.35.92, for 3 years. The record must 
include the date of the disposal, the survey instrument used, the 
background radiation level, the radiation level measured at the surface 
of each waste container, and the name of

[[Page 733]]

the individual who performed the survey.



Sec.35.2204  Records of molybdenum-99, strontium-82, and strontium-85
concentrations.

    A licensee shall maintain a record of the molybdenum-99 
concentration or strontium-82 and strontium-85 concentration tests 
required by Sec.35.204(b) and (c) for 3 years. The record must 
include:
    (a) For each measured elution of technetium-99m, the ratio of the 
measures expressed as kilobecquerel of molybdenum-99 per megabecquerel 
of technetium-99m (or microcuries of molybdenum per millicurie of 
technetium), the time and date of the measurement, and the name of the 
individual who made the measurement; or
    (b) For each measured elution of rubidium-82, the ratio of the 
measures expressed as kilobecquerel of strontium-82 per megabecquerel of 
rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium), 
kilobecquerel of strontium-85 per megabecquerel of rubidium-82 (or 
microcuries of strontium-85 per millicurie of rubidium), the time and 
date of the measurement, and the name of the individual who made the 
measurement.

[72 FR 55932, Oct. 1, 2007]



Sec.35.2310  Records of safety instruction.

    A licensee shall maintain a record of safety instructions required 
by Sec. Sec.35.310, 35.410, and 35.610 for 3 years. The record must 
include a list of the topics covered, the date of the instruction, the 
name(s) of the attendee(s), and the name(s) of the individual(s) who 
provided the instruction.

    Effective Date Note: At 83 FR 33111, July 16, 2018, Sec.35.2310 
was revised, effective Jan. 14, 2019. For the convenience of the user, 
the revised text is set forth as follows:



Sec.35.2310  Records of safety instruction.

    A licensee shall maintain a record of safety instructions required 
by Sec. Sec.35.310 and 35.410 and the operational and safety 
instructions required by Sec.35.610 for 3 years. The record must 
include a list of the topics covered, the date of the instruction, the 
name(s) of the attendee(s), and the name(s) of the individual(s) who 
provided the instruction.



Sec.35.2404  Records of surveys after source implant and removal.

    A licensee shall maintain a record of the surveys required by 
Sec. Sec.35.404 and 35.604 for 3 years. Each record must include the 
date and results of the survey, the survey instrument used, and the name 
of the individual who made the survey.



Sec.35.2406  Records of brachytherapy source accountability.

    (a) A licensee shall maintain a record of brachytherapy source 
accountability required by Sec.35.406 for 3 years.
    (b) For temporary implants, the record must include--
    (1) The number and activity of sources removed from storage, the 
time and date they were removed from storage, the name of the individual 
who removed them from storage, and the location of use; and
    (2) The number and activity of sources returned to storage, the time 
and date they were returned to storage, and the name of the individual 
who returned them to storage.
    (c) For permanent implants, the record must include--
    (1) The number and activity of sources removed from storage, the 
date they were removed from storage, and the name of the individual who 
removed them from storage;
    (2) The number and activity of sources not implanted, the date they 
were returned to storage, and the name of the individual who returned 
them to storage; and
    (3) The number and activity of sources permanently implanted in the 
patient or human research subject.



Sec.35.2432  Records of calibration measurements of brachytherapy
sources.

    (a) A licensee shall maintain a record of the calibrations of 
brachytherapy sources required by Sec.35.432 for 3 years after the 
last use of the source.
    (b) The record must include--
    (1) The date of the calibration;
    (2) The manufacturer's name, model number, and serial number for the 
source and the instruments used to calibrate the source;
    (3) The source output or activity;
    (4) The source positioning accuracy within the applicators; and

[[Page 734]]

    (5) The name of the individual, the source manufacturer, or the 
calibration laboratory that performed the calibration.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19326, Apr. 21, 2003]



Sec.35.2433  Records of decay of strontium-90 sources for ophthalmic
treatments.

    (a) A licensee shall maintain a record of the activity of a 
strontium-90 source required by Sec.35.433 for the life of the source.
    (b) The record must include--
    (1) The date and initial activity of the source as determined under 
Sec.35.432; and
    (2) For each decay calculation, the date and the source activity as 
determined under Sec.35.433.



Sec.35.2605  Records of installation, maintenance, adjustment,
and repair of remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units.
          

    A licensee shall retain a record of the installation, maintenance, 
adjustment, and repair of remote afterloader units, teletherapy units, 
and gamma stereotactic radiosurgery units as required by Sec.35.605 
for 3 years. For each installation, maintenance, adjustment and repair, 
the record must include the date, description of the service, and 
name(s) of the individual(s) who performed the work.



Sec.35.2610  Records of safety procedures.

    A licensee shall retain a copy of the procedures required by 
Sec. Sec.35.610(a)(4) and (d)(2) until the licensee no longer 
possesses the remote afterloader, teletherapy unit, or gamma 
stereotactic radiosurgery unit.



Sec.35.2630  Records of dosimetry equipment used with remote
afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units.

    (a) A licensee shall retain a record of the calibration, 
intercomparison, and comparisons of its dosimetry equipment done in 
accordance with Sec.35.630 for the duration of the license.
    (b) For each calibration, intercomparison, or comparison, the record 
must include--
    (1) The date;
    (2) The manufacturer's name, model numbers and serial numbers of the 
instruments that were calibrated, intercompared, or compared as required 
by paragraphs (a) and (b) of Sec.35.630;
    (3) The correction factor that was determined from the calibration 
or comparison or the apparent correction factor that was determined from 
an intercomparison; and
    (4) The names of the individuals who performed the calibration, 
intercomparison, or comparison.



Sec.35.2632  Records of teletherapy, remote afterloader, and gamma
stereotactic radiosurgery full calibrations.

    (a) A licensee shall maintain a record of the teletherapy unit, 
remote afterloader unit, and gamma stereotactic radiosurgery unit full 
calibrations required by Sec. Sec.35.632, 35.633, and 35.635 for 3 
years.
    (b) The record must include--
    (1) The date of the calibration;
    (2) The manufacturer's name, model number, and serial number of the 
teletherapy, remote afterloader, and gamma stereotactic radiosurgery 
unit(s), the source(s), and the instruments used to calibrate the 
unit(s);
    (3) The results and an assessment of the full calibrations;
    (4) The results of the autoradiograph required for low dose-rate 
remote afterloader units; and
    (5) The signature of the authorized medical physicist who performed 
the full calibration.



Sec.35.2642  Records of periodic spot-checks for teletherapy units.

    (a) A licensee shall retain a record of each periodic spot-check for 
teletherapy units required by Sec.35.642 for 3 years.
    (b) The record must include--
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number of the 
teletherapy unit, source and instrument used to measure the output of 
the teletherapy unit;
    (3) An assessment of timer linearity and constancy;
    (4) The calculated on-off error;
    (5) A determination of the coincidence of the radiation field and 
the

[[Page 735]]

field indicated by the light beam localizing device;
    (6) The determined accuracy of each distance measuring and 
localization device;
    (7) The difference between the anticipated output and the measured 
output;
    (8) Notations indicating the operability of each entrance door 
electrical interlock, each electrical or mechanical stop, each source 
exposure indicator light, and the viewing and intercom system and doors; 
and
    (9) The name of the individual who performed the periodic spot-check 
and the signature of the authorized medical physicist who reviewed the 
record of the spot-check.
    (c) A licensee shall retain a copy of the procedures required by 
Sec.35.642(b) until the licensee no longer possesses the teletherapy 
unit.



Sec.35.2643  Records of periodic spot-checks for remote afterloader
units.

    (a) A licensee shall retain a record of each spot-check for remote 
afterloader units required by Sec.35.643 for 3 years.
    (b) The record must include, as applicable--
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number for the 
remote afterloader unit and source;
    (3) An assessment of timer accuracy;
    (4) Notations indicating the operability of each entrance door 
electrical interlock, radiation monitors, source exposure indicator 
lights, viewing and intercom systems, and clock and decayed source 
activity in the unit's computer; and
    (5) The name of the individual who performed the periodic spot-check 
and the signature of the authorized medical physicist who reviewed the 
record of the spot-check.
    (c) A licensee shall retain a copy of the procedures required by 
Sec.35.643(b) until the licensee no longer possesses the remote 
afterloader unit.



Sec.35.2645  Records of periodic spot-checks for gamma stereotactic
radiosurgery units.

    (a) A licensee shall retain a record of each spot-check for gamma 
stereotactic radiosurgery units required by Sec.35.645 for 3 years.
    (b) The record must include--
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number for the 
gamma stereotactic radiosurgery unit and the instrument used to measure 
the output of the unit;
    (3) An assessment of timer linearity and accuracy;
    (4) The calculated on-off error;
    (5) A determination of trunnion centricity;
    (6) The difference between the anticipated output and the measured 
output;
    (7) An assessment of source output against computer calculations;
    (8) Notations indicating the operability of radiation monitors, 
helmet microswitches, emergency timing circuits, emergency off buttons, 
electrical interlocks, source exposure indicator lights, viewing and 
intercom systems, timer termination, treatment table retraction 
mechanism, and stereotactic frames and localizing devices (trunnions); 
and
    (9) The name of the individual who performed the periodic spot-check 
and the signature of the authorized medical physicist who reviewed the 
record of the spot-check.
    (c) A licensee shall retain a copy of the procedures required by 
Sec.35.645(b) until the licensee no longer possesses the gamma 
stereotactic radiosurgery unit.



Sec.35.2647  Records of additional technical requirements for mobile
remote afterloader units.

    (a) A licensee shall retain a record of each check for mobile remote 
afterloader units required by Sec.35.647 for 3 years.
    (b) The record must include--
    (1) The date of the check;
    (2) The manufacturer's name, model number, and serial number of the 
remote afterloader unit;
    (3) Notations accounting for all sources before the licensee departs 
from a facility;
    (4) Notations indicating the operability of each entrance door 
electrical interlock, radiation monitors, source exposure indicator 
lights, viewing and intercom system, applicators, source

[[Page 736]]

transfer tubes, and transfer tube applicator interfaces, and source 
positioning accuracy; and
    (5) The signature of the individual who performed the check.



Sec.35.2652  Records of surveys of therapeutic treatment units.

    (a) A licensee shall maintain a record of radiation surveys of 
treatment units made in accordance with Sec.35.652 for the duration of 
use of the unit.
    (b) The record must include--
    (1) The date of the measurements;
    (2) The manufacturer's name, model number and serial number of the 
treatment unit, source, and instrument used to measure radiation levels;
    (3) Each dose rate measured around the source while the unit is in 
the off position and the average of all measurements; and
    (4) The signature of the individual who performed the test.



Sec.35.2655  Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units.

    (a) A licensee shall maintain a record of the 5-year inspections for 
teletherapy and gamma stereotactic radiosurgery units required by Sec.
35.655 for the duration of use of the unit.
    (b) The record must contain--
    (1) The inspector's radioactive materials license number;
    (2) The date of inspection;
    (3) The manufacturer's name and model number and serial number of 
both the treatment unit and source;
    (4) A list of components inspected and serviced, and the type of 
service; and
    (5) The signature of the inspector.

    Effective Date Note: At 83 FR 33111, July 16, 2018, Sec.35.2655 
was amended by revising the section heading and paragraph (a), effective 
Jan. 14, 2019. For the convenience of the user, the revised text is set 
forth as follows:



Sec.35.2655  Records of full-inspection servicing for teletherapy and 
          gamma stereotactic radiosurgery units.

    (a) A licensee shall maintain a record of the full-inspection 
servicing for teletherapy and gamma stereotactic radiosurgery units 
required by Sec.35.655 for the duration of the use of the unit.

                                * * * * *



                            Subpart M_Reports



Sec.35.3045  Report and notification of a medical event.

    (a) A licensee shall report any event, except for an event that 
results from patient intervention, in which the administration of 
byproduct material or radiation from byproduct material results in--
    (1) A dose that differs from the prescribed dose or dose that would 
have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) 
effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 
Sv (50 rem) shallow dose equivalent to the skin; and
    (i) The total dose delivered differs from the prescribed dose by 20 
percent or more;
    (ii) The total dosage delivered differs from the prescribed dosage 
by 20 percent or more or falls outside the prescribed dosage range; or
    (iii) The fractionated dose delivered differs from the prescribed 
dose, for a single fraction, by 50 percent or more.
    (2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 
0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose 
equivalent to the skin from any of the following--
    (i) An administration of a wrong radioactive drug containing 
byproduct material;
    (ii) An administration of a radioactive drug containing byproduct 
material by the wrong route of administration;
    (iii) An administration of a dose or dosage to the wrong individual 
or human research subject;
    (iv) An administration of a dose or dosage delivered by the wrong 
mode of treatment; or
    (v) A leaking sealed source.
    (3) A dose to the skin or an organ or tissue other than the 
treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and 
50 percent or more of the dose expected from the administration defined 
in the written directive (excluding, for permanent implants, seeds that 
were implanted in the correct site but migrated outside the treatment 
site).
    (b) A licensee shall report any event resulting from intervention of 
a patient or human research subject in

[[Page 737]]

which the administration of byproduct material or radiation from 
byproduct material results or will result in unintended permanent 
functional damage to an organ or a physiological system, as determined 
by a physician.
    (c) The licensee shall notify by telephone the NRC Operations Center 
\3\ no later than the next calendar day after discovery of the medical 
event.
---------------------------------------------------------------------------

    \3\ The commercial telephone number of the NRC Operations Center is 
(301) 816-5100.
---------------------------------------------------------------------------

    (d) By an appropriate method listed in Sec.30.6(a) of this 
chapter, the licensee shall submit a written report to the appropriate 
NRC Regional Office listed in Sec.30.6 of this chapter within 15 days 
after discovery of the medical event.
    (1) The written report must include--
    (i) The licensee's name;
    (ii) The name of the prescribing physician;
    (iii) A brief description of the event;
    (iv) Why the event occurred;
    (v) The effect, if any, on the individual(s) who received the 
administration;
    (vi) What actions, if any, have been taken or are planned to prevent 
recurrence; and
    (vii) Certification that the licensee notified the individual (or 
the individual's responsible relative or guardian), and if not, why not.
    (2) The report may not contain the individual's name or any other 
information that could lead to identification of the individual.
    (e) The licensee shall provide notification of the event to the 
referring physician and also notify the individual who is the subject of 
the medical event no later than 24 hours after its discovery, unless the 
referring physician personally informs the licensee either that he or 
she will inform the individual or that, based on medical judgment, 
telling the individual would be harmful. The licensee is not required to 
notify the individual without first consulting the referring physician. 
If the referring physician or the affected individual cannot be reached 
within 24 hours, the licensee shall notify the individual as soon as 
possible thereafter. The licensee may not delay any appropriate medical 
care for the individual, including any necessary remedial care as a 
result of the medical event, because of any delay in notification. To 
meet the requirements of this paragraph, the notification of the 
individual who is the subject of the medical event may be made instead 
to that individual's responsible relative or guardian. If a verbal 
notification is made, the licensee shall inform the individual, or 
appropriate responsible relative or guardian, that a written description 
of the event can be obtained from the licensee upon request. The 
licensee shall provide such a written description if requested.
    (f) Aside from the notification requirement, nothing in this section 
affects any rights or duties of licensees and physicians in relation to 
each other, to individuals affected by the medical event, or to that 
individual's responsible relatives or guardians.
    (g) A licensee shall:
    (1) Annotate a copy of the report provided to the NRC with the:
    (i) Name of the individual who is the subject of the event; and
    (ii) Social security number or other identification number, if one 
has been assigned, of the individual who is the subject of the event; 
and
    (2) Provide a copy of the annotated report to the referring 
physician, if other than the licensee, no later than 15 days after the 
discovery of the event.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 58805, Oct. 10, 2003; 
76 FR 72085, Nov. 22, 2011]

    Effective Date Note: At 83 FR 33111, July 16, 2018, Sec.35.3045 
was amended by revising paragraph (a), effective Jan. 14, 2019. For the 
convenience of the user, the revised text is set forth as follows:



Sec.35.3045  Report and notification of a medical event.

    (a) A licensee shall report any event as a medical event, except for 
an event that results from patient intervention, in which--
    (1) The administration of byproduct material or radiation from 
byproduct material, except permanent implant brachytherapy, results in--
    (i) A dose that differs from the prescribed dose or dose that would 
have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) 
effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 
Sv (50 rem) shallow dose equivalent to the skin; and

[[Page 738]]

    (A) The total dose delivered differs from the prescribed dose by 20 
percent or more;
    (B) The total dosage delivered differs from the prescribed dosage by 
20 percent or more or falls outside the prescribed dosage range; or
    (C) The fractionated dose delivered differs from the prescribed dose 
for a single fraction, by 50 percent or more.
    (ii) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 
0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose 
equivalent to the skin from any of the following--
    (A) An administration of a wrong radioactive drug containing 
byproduct material or the wrong radionuclide for a brachytherapy 
procedure;
    (B) An administration of a radioactive drug containing byproduct 
material by the wrong route of administration;
    (C) An administration of a dose or dosage to the wrong individual or 
human research subject;
    (D) An administration of a dose or dosage delivered by the wrong 
mode of treatment; or
    (E) A leaking sealed source.
    (iii) A dose to the skin or an organ or tissue other than the 
treatment site that exceeds by:
    (A) 0.5 Sv (50 rem) or more the expected dose to that site from the 
procedure if the administration had been given in accordance with the 
written directive prepared or revised before administration; and
    (B) 50 percent or more the expected dose to that site from the 
procedure if the administration had been given in accordance with the 
written directive prepared or revised before administration.
    (2) For permanent implant brachytherapy, the administration of 
byproduct material or radiation from byproduct material (excluding 
sources that were implanted in the correct site but migrated outside the 
treatment site) that results in--
    (i) The total source strength administered differing by 20 percent 
or more from the total source strength documented in the post-
implantation portion of the written directive;
    (ii) The total source strength administered outside of the treatment 
site exceeding 20 percent of the total source strength documented in the 
post-implantation portion of the written directive; or
    (iii) An administration that includes any of the following:
    (A) The wrong radionuclide;
    (B) The wrong individual or human research subject;
    (C) Sealed source(s) implanted directly into a location 
discontiguous from the treatment site, as documented in the post-
implantation portion of the written directive; or
    (D) A leaking sealed source resulting in a dose that exceeds 0.5 Sv 
(50 rem) to an organ or tissue.

                                * * * * *



Sec.35.3047  Report and notification of a dose to an embryo/fetus
or a nursing child.

    (a) A licensee shall report any dose to an embryo/fetus that is 
greater than 50 mSv (5 rem) dose equivalent that is a result of an 
administration of byproduct material or radiation from byproduct 
material to a pregnant individual unless the dose to the embryo/fetus 
was specifically approved, in advance, by the authorized user.
    (b) A licensee shall report any dose to a nursing child that is a 
result of an administration of byproduct material to a breast-feeding 
individual that--
    (1) Is greater than 50 mSv (5 rem) total effective dose equivalent; 
or
    (2) Has resulted in unintended permanent functional damage to an 
organ or a physiological system of the child, as determined by a 
physician.
    (c) The licensee shall notify by telephone the NRC Operations Center 
no later than the next calendar day after discovery of a dose to the 
embryo/fetus or nursing child that requires a report in paragraphs (a) 
or (b) in this section.
    (d) By an appropriate method listed in Sec.30.6(a) of this 
chapter, the licensee shall submit a written report to the appropriate 
NRC Regional Office listed in Sec.30.6 of this chapter within 15 days 
after discovery of a dose to the embryo/fetus or nursing child that 
requires a report in paragraphs (a) or (b) in this section.
    (1) The written report must include--
    (i) The licensee's name;
    (ii) The name of the prescribing physician;
    (iii) A brief description of the event;
    (iv) Why the event occurred;
    (v) The effect, if any, on the embryo/fetus or the nursing child;
    (vi) What actions, if any, have been taken or are planned to prevent 
recurrence; and
    (vii) Certification that the licensee notified the pregnant 
individual or mother (or the mother's or child's responsible relative or 
guardian), and if not, why not.

[[Page 739]]

    (2) The report must not contain the individual's or child's name or 
any other information that could lead to identification of the 
individual or child.
    (e) The licensee shall provide notification of the event to the 
referring physician and also notify the pregnant individual or mother, 
both hereafter referred to as the mother, no later than 24 hours after 
discovery of an event that would require reporting under paragraph (a) 
or (b) of this section, unless the referring physician personally 
informs the licensee either that he or she will inform the mother or 
that, based on medical judgment, telling the mother would be harmful. 
The licensee is not required to notify the mother without first 
consulting with the referring physician. If the referring physician or 
mother cannot be reached within 24 hours, the licensee shall make the 
appropriate notifications as soon as possible thereafter. The licensee 
may not delay any appropriate medical care for the embryo/fetus or for 
the nursing child, including any necessary remedial care as a result of 
the event, because of any delay in notification. To meet the 
requirements of this paragraph, the notification may be made to the 
mother's or child's responsible relative or guardian instead of the 
mother. If a verbal notification is made, the licensee shall inform the 
mother, or the mother's or child's responsible relative or guardian, 
that a written description of the event can be obtained from the 
licensee upon request. The licensee shall provide such a written 
description if requested.
    (f) A licensee shall:
    (1) Annotate a copy of the report provided to the NRC with the:
    (i) Name of the pregnant individual or the nursing child who is the 
subject of the event; and
    (ii) Social security number or other identification number, if one 
has been assigned, of the pregnant individual or the nursing child who 
is the subject of the event; and
    (2) Provide a copy of the annotated report to the referring 
physician, if other than the licensee, no later than 15 days after the 
discovery of the event.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 58805, Oct. 10, 2003]



Sec.35.3067  Report of a leaking source.

    A licensee shall file a report within 5 days if a leak test required 
by Sec.35.67 reveals the presence of 185 Bq (0.005 [micro]Ci) or more 
of removable contamination. The report must be filed with the 
appropriate NRC Regional Office listed in Sec.30.6 of this chapter, by 
an appropriate method listed in Sec.30.6(a) of this chapter, with a 
copy to the Director, Office of Nuclear Material Safety and Safeguards. 
The written report must include the model number and serial number, if 
assigned, of the leaking source; the radionuclide and its estimated 
activity; the results of the test; the date of the test; and the action 
taken.

[73 FR 5720, Jan. 31, 2008]



Sec.35.3204  Report and notification for an eluate exceeding 
permissible molybdenum-99, strontium-82, and strontium-85 
concentrations.

    (a) The licensee shall notify by telephone the NRC Operations Center 
and the distributor of the generator within 7 calendar days after 
discovery that an eluate exceeded the permissible concentration listed 
in Sec.35.204(a) at the time of generator elution. The telephone 
report to the NRC must include the manufacturer, model number, and 
serial number (or lot number) of the generator; the results of the 
measurement; the date of the measurement; whether dosages were 
administered to patients or human research subjects, when the 
distributor was notified, and the action taken.
    (b) By an appropriate method listed in Sec.30.6(a) of this 
chapter, the licensee shall submit a written report to the appropriate 
NRC Regional Office listed in Sec.30.6 of this chapter within 30 
calendar days after discovery of an eluate exceeding the permissible 
concentration at the time of generator elution. The written report must 
include the action taken by the licensee; the patient dose assessment; 
the methodology used to make this dose assessment if the eluate was 
administered to patients or human research subjects; and the probable

[[Page 740]]

cause and an assessment of failure in the licensee's equipment, 
procedures or training that contributed to the excessive readings if an 
error occurred in the licensee's breakthrough determination; and the 
information in the telephone report as required by paragraph (a) of this 
section.

[83 FR 33111, July 16, 2018]

    Effective Date Note: At 83 FR 33111, July 16, 2018, Sec.35.3204 
was added, effective Jan. 14, 2019.



                          Subpart N_Enforcement



Sec.35.4001  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued under those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under Section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued under the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
Section 186 of the Atomic Energy Act of 1954, as amended.



Sec.35.4002  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of Section 223, 
all the regulations in 10 CFR part 35 are issued under one or more of 
sections 161b, 161i, or 161o, except for the sections listed in 
paragraph (b) of this section.
    (b) The regulations in 10 CFR part 35 that are not issued under 
subsections 161b, 161i, or 161o for the purposes of Section 223 are as 
follows: Sec. Sec.35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19, 
35.65, 35.100, 35.200, 35.300, 35.4001, and 35.4002.



PART 36_LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
--Table of Contents



                      Subpart A_General Provisions

Sec.
36.1 Purpose and scope.
36.2 Definitions.
36.5 Interpretations.
36.8 Information collection requirements: OMB approval.

                Subpart B_Specific Licensing Requirements

36.11 Application for a specific license.
36.13 Specific licenses for irradiators.
36.15 Commencement of construction.
36.17 Applications for exemptions.
36.19 Request for written statements.

      Subpart C_Design and Performance Requirements for Irradiators

36.21 Performance criteria for sealed sources.
36.23 Access control.
36.25 Shielding.
36.27 Fire protection.
36.29 Radiation monitors.
36.31 Control of source movement.
36.33 Irradiator pools.
36.35 Source rack protection.
36.37 Power failures.
36.39 Design requirements.
36.41 Construction monitoring and acceptance testing.

                   Subpart D_Operation of Irradiators

36.51 Training.
36.53 Operating and emergency procedures.
36.55 Personnel monitoring.
36.57 Radiation surveys.
36.59 Detection of leaking sources.
36.61 Inspection and maintenance.
36.63 Pool water purity.
36.65 Attendance during operation.
36.67 Entering and leaving the radiation room.
36.69 Irradiation of explosive or flammable materials.

                            Subpart E_Records

36.81 Records and retention periods.

[[Page 741]]

36.83 Reports.

                          Subpart F_Enforcement

36.91 Violations.
36.93 Criminal penalties.

    Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182, 183, 
223, 234, 274 (42 U.S.C. 2111, 2112, 2201, 2231, 2233, 2273, 2282, 
2021); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 
5841, 5846); 44 U.S.C. 3504 note.

    Source: 58 FR 7728, Feb. 9, 1993, unless otherwise noted.



                      Subpart A_General Provisions



Sec.36.1  Purpose and scope.

    (a) This part contains requirements for the issuance of a license 
authorizing the use of sealed sources containing radioactive materials 
in irradiators used to irradiate objects or materials using gamma 
radiation. This part also contains radiation safety requirements for 
operating irradiators. The requirements of this part are in addition to 
other requirements of this chapter. In particular, the provisions of 
parts 19, 20, 21, 30, 37, 71, 170, and 171 of this chapter apply to 
applications and licenses subject to this part. Nothing in this part 
relieves the licensee from complying with other applicable Federal, 
State and local regulations governing the siting, zoning, land use, and 
building code requirements for industrial facilities.
    (b) The regulations in this part apply to panoramic irradiators that 
have either dry or wet storage of the radioactive sealed sources and to 
underwater irradiators in which both the source and the product being 
irradiated are under water. Irradiators whose dose rates exceed 5 grays 
(500 rads) per hour at 1 meter from the radioactive sealed sources in 
air or in water, as applicable for the irradiator type, are covered by 
this part.
    (c) The regulations in this part do not apply to self-contained dry-
source-storage irradiators (those in which both the source and the area 
subject to irradiation are contained within a device and are not 
accessible by personnel), medical radiology or teletherapy, radiography 
(the irradiation of materials for nondestructive testing purposes), 
gauging, or open-field (agricultural) irradiations.

[58 FR 7728, Feb. 9, 1993, as amended at 78 FR 17007, Mar. 19, 2013]



Sec.36.2  Definitions.

    Annually means either (1) at intervals not to exceed 1 year or (2) 
once per year, at about the same time each year (plus or minus 1 month).
    Commencement of construction means taking any action defined as 
``construction'' or any other activity at the site of a facility subject 
to the regulations in this part that has a reasonable nexus to:
    (1) Radiological health and safety; or
    (2) Common defense and security.
    Construction means the installation of foundations, or in-place 
assembly, erection, fabrication, or testing for any structure, system, 
or component of a facility or activity subject to the regulations in 
this part that are related to radiological safety or security. The term 
``construction'' does not include:
    (1) Changes for temporary use of the land for public recreational 
purposes;
    (2) Site exploration, including necessary borings to determine 
foundation conditions or other preconstruction monitoring to establish 
background information related to the suitability of the site, the 
environmental impacts of construction or operation, or the protection of 
environmental values;
    (3) Preparation of the site for construction of the facility, 
including clearing of the site, grading, installation of drainage, 
erosion and other environmental mitigation measures, and construction of 
temporary roads and borrow areas;
    (4) Erection of fences and other access control measures that are 
not related to the safe use of, or security of, radiological materials 
subject to this part;
    (5) Excavation;
    (6) Erection of support buildings (e.g., construction equipment 
storage sheds, warehouse and shop facilities, utilities, concrete mixing 
plants, docking and unloading facilities, and office buildings) for use 
in connection with the construction of the facility;
    (7) Building of service facilities (e.g., paved roads, parking lots, 
railroad

[[Page 742]]

spurs, exterior utility and lighting systems, potable water systems, 
sanitary sewerage treatment facilities, and transmission lines);
    (8) Procurement or fabrication of components or portions of the 
proposed facility occurring at other than the final, in-place location 
at the facility; or
    (9) Taking any other action that has no reasonable nexus to:
    (i) Radiological health and safety, or
    (ii) Common defense and security.
    Doubly encapsulated sealed source means a sealed source in which the 
radioactive material is sealed within a capsule and that capsule is 
sealed within another capsule.
    Irradiator means a facility that uses radioactive sealed sources for 
the irradiation of objects or materials and in which radiation dose 
rates exceeding 5 grays (500 rads) per hour exist at 1 meter from the 
sealed radioactive sources in air or water, as applicable for the 
irradiator type, but does not include irradiators in which both the 
sealed source and the area subject to irradiation are contained within a 
device and are not accessible to personnel.
    Irradiator operator means an individual who has successfully 
completed the training and testing described in Sec.36.51 and is 
authorized by the terms of the license to operate the irradiator without 
a supervisor present.
    Panoramic dry-source-storage irradiator means an irradiator in which 
the irradiations occur in air in areas potentially accessible to 
personnel and in which the sources are stored in shields made of solid 
materials. The term includes beam-type dry-source-storage irradiators in 
which only a narrow beam of radiation is produced for performing 
irradiations.
    Panoramic irradiator means an irradiator in which the irradiations 
are done in air in areas potentially accessible to personnel. The term 
includes beam-type irradiators.
    Panoramic wet-source-storage irradiator means an irradiator in which 
the irradiations occur in air in areas potentially accessible to 
personnel and in which the sources are stored under water in a storage 
pool.
    Pool irradiator means any irradiator at which the sources are stored 
or used in a pool of water including panoramic wet-source-storage 
irradiators and underwater irradiators.
    Product conveyor system means a system for moving the product to be 
irradiated to, from, and within the area where irradiation takes place.
    Radiation room means a shielded room in which irradiations take 
place. Underwater irradiators do not have radiation rooms.
    Radiation safety officer means an individual with responsibility for 
the overall radiation safety program at the facility.
    Sealed source means any byproduct material that is used as a source 
of radiation and is encased in a capsule designed to prevent leakage or 
escape of the byproduct material.
    Seismic area means any area where the probability of a horizontal 
acceleration in rock of more than 0.3 times the acceleration of gravity 
in 250 years is greater than 10 percent, as designated by the U.S. 
Geological Survey.
    Underwater irradiator means an irradiator in which the sources 
always remain shielded under water and humans do not have access to the 
sealed sources or the space subject to irradiation without entering the 
pool.

[58 FR 7728, Feb. 9, 1993, as amended at 76 FR 56963, Sept. 15, 2011]



Sec.36.5  Interpretations.

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



Sec.36.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501et seq.). The NRC

[[Page 743]]

may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number. OMB has approved the information collection requirements 
contained in this part under control number 3150-0158.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.36.11, 36.13, 36.17, 36.19, 36.21, 36.53, 
36.69, 36.81, and 36.83.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec.36.11, NRC Form 313 is approved under control number 
3150-0120.
    (2) [Reserved]

[58 FR 7728, Feb. 9, 1993, as amended at 62 FR 52187, Oct. 6, 1997]



                Subpart B_Specific Licensing Requirements



Sec.36.11  Application for a specific license.

    A person, as defined in Sec.30.4 of this chapter, may file an 
application for a specific license authorizing the use of sealed sources 
in an irradiator on Form NRC 313, ``Application for Material License.'' 
Each application for a license, other than a license exempted from part 
170 of this chapter, must be accompanied by the fee prescribed in Sec.
170.31 of this chapter. The application and one copy must be sent to the 
appropriate NRC Regional Office listed in appendix D to part 20 of this 
chapter.



Sec.36.13  Specific licenses for irradiators.

    The Commission will approve an application for a specific license 
for the use of licensed material in an irradiator if the applicant meets 
the requirements contained in this section.
    (a) The applicant shall satisfy the general requirements specified 
in Sec. Sec.30.33(a)(1)-(4) and 30.33(b) of this chapter and the 
requirements contained in this part.
    (b) The application must describe the training provided to 
irradiator operators including--
    (1) Classroom training;
    (2) On-the-job or simulator training;
    (3) Safety reviews;
    (4) Means employed by the applicant to test each operator's 
understanding of the Commission's regulations and licensing requirements 
and the irradiator operating and emergency procedures; and
    (5) Minimum training and experience of personnel who may provide 
training.
    (c) The application must include an outline of the written operating 
and emergency procedures listed in Sec.36.53 that describes the 
radiation safety aspects of the procedures.
    (d) The application must describe the organizational structure for 
managing the irradiator, specifically the radiation safety 
responsibilities and authorities of the radiation safety officer and 
those management personnel who have important radiation safety 
responsibilities or authorities. In particular, the application must 
specify who, within the management structure, has the authority to stop 
unsafe operations. The application must also describe the training and 
experience required for the position of radiation safety officer.
    (e) The application must include a description of the access control 
systems required by Sec.36.23, the radiation monitors required by 
Sec.36.29, the method of detecting leaking sources required by Sec.
36.59 including the sensitivity of the method, and a diagram of the 
facility that shows the locations of all required interlocks and 
radiation monitors.
    (f) If the applicant intends to perform leak testing of dry-source-
storage sealed sources, the applicant shall establish procedures for 
leak testing and submit a description of these procedures to the 
Commission. The description must include the--
    (1) Instruments to be used;
    (2) Methods of performing the analysis; and
    (3) Pertinent experience of the individual who analyzes the samples.
    (g) If licensee personnel are to load or unload sources, the 
applicant shall describe the qualifications and training

[[Page 744]]

of the personnel and the procedures to be used. If the applicant intends 
to contract for source loading or unloading at its facility, the loading 
or unloading must be done by an organization specifically authorized by 
the Commission or an Agreement State to load or unload irradiator 
sources.
    (h) The applicant shall describe the inspection and maintenance 
checks, including the frequency of the checks required by Sec.36.61.

[58 FR 7728, Feb. 9, 1993, as amended at 76 FR 56963, Sept. 15, 2011]



Sec.36.15  Commencement of construction.

    Commencement of construction of a new irradiator may not occur prior 
to the submission to the NRC of both an application for a license for 
the irradiator and the fee required by Sec.170.31 of this chapter. Any 
activities undertaken prior to the issuance of a license are entirely at 
the risk of the applicant and have no bearing on the issuance of a 
license with respect to the requirements of the Atomic Energy Act of 
1954 (Act), as amended, and rules, regulations, and orders issued under 
the Act. Commencement of construction as defined in Sec.36.2 may 
include non-construction activities if the activity has a reasonable 
nexus to radiological safety and security.

[76 FR 56963, Sept. 15, 2011]



Sec.36.17  Applications for exemptions.

    (a) The Commission may, upon application of any interested person or 
upon its own initiative, grant any exemptions from the requirements in 
this part that it determines are authorized by law and will not endanger 
life or property or the common defense and security and are otherwise in 
the public interest.
    (b) Any application for a license or for amendment of a license 
authorizing use of a teletherapy-type unit for irradiation of materials 
or objects may include proposed alternatives for the requirements of 
this part. The Commission will approve the proposed alternatives if the 
applicant provides adequate rationale for the proposed alternatives and 
demonstrates that they are likely to provide an adequate level of safety 
for workers and the public.



Sec.36.19  Request for written statements.

    (a) After the filing of the original application, the Commission may 
request further information necessary to enable the Commission to 
determine whether the application should be granted or denied.
    (b) Each license is issued with the condition that the licensee 
will, at any time before expiration of the license, upon the 
Commission's request, submit written statements to enable the Commission 
to determine whether the license should be modified, suspended, or 
revoked.



      Subpart C_Design and Performance Requirements for Irradiators



Sec.36.21  Performance criteria for sealed sources.

    (a) Requirements. Sealed sources installed after July 1, 1993:
    (1) Must have a certificate of registration issued under 10 CFR 
32.210;
    (2) Must be doubly encapsulated;
    (3) Must use radioactive material that is as nondispersible as 
practical and that is as insoluble as practical if the source is used in 
a wet-source-storage or wet-source-change irradiator;
    (4) Must be encapsulated in a material resistant to general 
corrosion and to localized corrosion, such as 316L stainless steel or 
other material with equivalent resistance if the sources are for use in 
irradiator pools; and
    (5) In prototype testing of the sealed source, must have been leak 
tested and found leak-free after each of the tests described in 
paragraphs (b) through (g) of this section.
    (b) Temperature. The test source must be held at -40 [deg]C for 20 
minutes, 600 [deg]C for 1 hour, and then be subjected to a thermal shock 
test with a temperature drop from 600 [deg]C to 20 [deg]C within 15 
seconds.
    (c) Pressure. The test source must be twice subjected for at least 5 
minutes to an external pressure (absolute) of 2 million newtons per 
square meter.
    (d) Impact. A 2-kilogram steel weight, 2.5 centimeters in diameter, 
must be

[[Page 745]]

dropped from a height of 1 meter onto the test source.
    (e) Vibration. The test source must be subjected 3 times for 10 
minutes each to vibrations sweeping from 25 hertz to 500 hertz with a 
peak amplitude of 5 times the acceleration of gravity. In addition, each 
test source must be vibrated for 30 minutes at each resonant frequency 
found.
    (f) Puncture. A 50-gram weight and pin, 0.3-centimeter pin diameter, 
must be dropped from a height of 1 meter onto the test source.
    (g) Bend. If the length of the source is more than 15 times larger 
than the minimum cross-sectional dimension, the test source must be 
subjected to a force of 2000 newtons at its center equidistant from two 
support cylinders, the distance between which is 10 times the minimum 
cross-sectional dimension of the source.



Sec.36.23  Access control.

    (a) Each entrance to a radiation room at a panoramic irradiator must 
have a door or other physical barrier to prevent inadvertent entry of 
personnel if the sources are not in the shielded position. Product 
conveyor systems may serve as barriers as long as they reliably and 
consistently function as a barrier. It must not be possible to move the 
sources out of their shielded position if the door or barrier is open. 
Opening the door or barrier while the sources are exposed must cause the 
sources to return promptly to their shielded position. The personnel 
entrance door or barrier must have a lock that is operated by the same 
key used to move the sources. The doors and barriers must not prevent 
any individual in the radiation room from leaving.
    (b) In addition, each entrance to a radiation room at a panoramic 
irradiator must have an independent backup access control to detect 
personnel entry while the sources are exposed. Detection of entry while 
the sources are exposed must cause the sources to return to their fully 
shielded position and must also activate a visible and audible alarm to 
make the individual entering the room aware of the hazard. The alarm 
must also alert at least one other individual who is onsite of the 
entry. That individual shall be trained on how to respond to the alarm 
and prepared to promptly render or summon assistance.
    (c) A radiation monitor must be provided to detect the presence of 
high radiation levels in the radiation room of a panoramic irradiator 
before personnel entry. The monitor must be integrated with personnel 
access door locks to prevent room access when radiation levels are high. 
Attempted personnel entry while the monitor measures high radiation 
levels, must activate the alarm described in paragraph (b) of this 
section. The monitor may be located in the entrance (normally referred 
to as the maze) but not in the direct radiation beam.
    (d) Before the sources move from their shielded position in a 
panoramic irradiator, the source control must automatically activate 
conspicuous visible and audible alarms to alert people in the radiation 
room that the sources will be moved from their shielded position. The 
alarms must give individuals enough time to leave the room before the 
sources leave the shielded position.
    (e) Each radiation room at a panoramic irradiator must have a 
clearly visible and readily accessible control that would allow an 
individual in the room to make the sources return to their fully 
shielded position.
    (f) Each radiation room of a panoramic irradiator must contain a 
control that prevents the sources from moving from the shielded position 
unless the control has been activated and the door or barrier to the 
radiation room has been closed within a preset time after activation of 
the control.
    (g) Each entrance to the radiation room of a panoramic irradiator 
and each entrance to the area within the personnel access barrier of an 
underwater irradiator must be posted as required by 10 CFR 20.1902. 
Radiation postings for panoramic irradiators must comply with the 
posting requirements of 10 CFR 20.1902, except that signs may be 
removed, covered, or otherwise made inoperative when the sources are 
fully shielded.
    (h) If the radiation room of a panoramic irradiator has roof plugs 
or other

[[Page 746]]

movable shielding, it must not be possible to operate the irradiator 
unless the shielding is in its proper location. This requirement may be 
met by interlocks that prevent operation if shielding is not placed 
properly or by an operating procedure requiring inspection of shielding 
before operating.
    (i) Underwater irradiators must have a personnel access barrier 
around the pool which must be locked to prevent access when the 
irradiator is not attended. Only operators and facility management may 
have access to keys to the personnel access barrier. There must be an 
intrusion alarm to detect unauthorized entry when the personnel access 
barrier is locked. Activation of the intrusion alarm must alert an 
individual (not necessarily onsite) who is prepared to respond or summon 
assistance.

[58 FR 7728, Feb. 9, 1993, as amended at 63 FR 39483, July 23, 1998]



Sec.36.25  Shielding.

    (a) The radiation dose rate in areas that are normally occupied 
during operation of a panoramic irradiator may not exceed 0.02 
millisievert (2 millirems) per hour at any location 30 centimeters or 
more from the wall of the room when the sources are exposed. The dose 
rate must be averaged over an area not to exceed 100 square centimeters 
having no linear dimension greater than 20 cm. Areas where the radiation 
dose rate exceeds 0.02 millisievert (2 millirems) per hour must be 
locked, roped off, or posted.
    (b) The radiation dose at 30 centimeters over the edge of the pool 
of a pool irradiator may not exceed 0.02 millisievert (2 millirems) per 
hour when the sources are in the fully shielded position.
    (c) The radiation dose rate at 1 meter from the shield of a dry-
source-storage panoramic irradiator when the source is shielded may not 
exceed 0.02 millisievert (2 millirems) per hour and at 5 centimeters 
from the shield may not exceed 0.2 millisievert (20 millirems) per hour.



Sec.36.27  Fire protection.

    (a) The radiation room at a panoramic irradiator must have heat and 
smoke detectors. The detectors must activate an audible alarm. The alarm 
must be capable of alerting a person who is prepared to summon 
assistance promptly. The sources must automatically become fully 
shielded if a fire is detected.
    (b) The radiation room at a panoramic irradiator must be equipped 
with a fire extinguishing system capable of extinguishing a fire without 
the entry of personnel into the room. The system for the radiation room 
must have a shut-off valve to control flooding into unrestricted areas.



Sec.36.29  Radiation monitors.

    (a) Irradiators with automatic product conveyor systems must have a 
radiation monitor with an audible alarm located to detect loose 
radioactive sources that are carried toward the product exit. If the 
monitor detects a source, an alarm must sound and product conveyors must 
stop automatically. The alarm must be capable of alerting an individual 
in the facility who is prepared to summon assistance. Underwater 
irradiators in which the product moves within an enclosed stationary 
tube are exempt from the requirements of this paragraph.
    (b) Underwater irradiators that are not in a shielded radiation room 
must have a radiation monitor over the pool to detect abnormal radiation 
levels. The monitor must have an audible alarm and a visible indicator 
at entrances to the personnel access barrier around the pool. The 
audible alarm may have a manual shut-off. The alarm must be capable of 
alerting an individual who is prepared to respond promptly.



Sec.36.31  Control of source movement.

    (a) The mechanism that moves the sources of a panoramic irradiator 
must require a key to actuate. Actuation of the mechanism must cause an 
audible signal to indicate that the sources are leaving the shielded 
position. Only one key may be in use at any time, and only operators or 
facility management may possess it. The key must be attached to a 
portable radiation survey meter by a chain or cable. The lock for source 
control must be designed so that the key may not be removed if the 
sources are in an unshielded position.

[[Page 747]]

The door to the radiation room must require the same key.
    (b) The console of a panoramic irradiator must have a source 
position indicator that indicates when the sources are in the fully 
shielded position, when they are in transit, and when the sources are 
exposed.
    (c) The control console of a panoramic irradiator must have a 
control that promptly returns the sources to the shielded position.
    (d) Each control for a panoramic irradiator must be clearly marked 
as to its function.



Sec.36.33  Irradiator pools.

    (a) For licenses initially issued after July 1, 1993, irradiator 
pools must either:
    (1) Have a water-tight stainless steel liner or a liner 
metallurgically compatible with other components in the pool; or
    (2) Be constructed so that there is a low likelihood of substantial 
leakage and have a surface designed to facilitate decontamination. In 
either case, the licensee shall have a method to safely store the 
sources during repairs of the pool.
    (b) For licenses initially issued after July 1, 1993, irradiator 
pools must have no outlets more than 0.5 meter below the normal low 
water level that could allow water to drain out of the pool. Pipes that 
have intakes more than 0.5 meter below the normal low water level and 
that could act as siphons must have siphon breakers to prevent the 
siphoning of pool water.
    (c) A means must be provided to replenish water losses from the 
pool.
    (d) A visible indicator must be provided in a clearly visible 
location to indicate if the pool water level is below the normal low 
water level or above the normal high water level.
    (e) Irradiator pools must be equipped with a purification system 
designed to be capable of maintaining the water during normal operation 
at a conductivity of 20 microsiemens per centimeter or less and with a 
clarity so that the sources can be seen clearly.
    (f) A physical barrier, such as a railing or cover, must be used 
around or over irradiator pools during normal operation to prevent 
personnel from accidentally falling into the pool. The barrier may be 
removed during maintenance, inspection, and service operations.
    (g) If long-handled tools or poles are used in irradiator pools, the 
radiation dose rate on the handling areas of the tools may not exceed 
0.02 millisievert (2 millirems) per hour.



Sec.36.35  Source rack protection.

    If the product to be irradiated moves on a product conveyor system, 
the source rack and the mechanism that moves the rack must be protected 
by a barrier or guides to prevent products and product carriers from 
hitting or touching the rack or mechanism.



Sec.36.37  Power failures.

    (a) If electrical power at a panoramic irradiator is lost for longer 
than 10 seconds, the sources must automatically return to the shielded 
position.
    (b) The lock on the door of the radiation room of a panoramic 
irradiator may not be deactivated by a power failure.
    (c) During a power failure, the area of any irradiator where sources 
are located may be entered only when using an operable and calibrated 
radiation survey meter.



Sec.36.39  Design requirements.

    Irradiators whose construction begins after July 1, 1993, must meet 
the design requirements of this section.
    (a) Shielding. For panoramic irradiators, the licensee shall design 
shielding walls to meet generally accepted building code requirements 
for reinforced concrete and design the walls, wall penetrations, and 
entranceways to meet the radiation shielding requirements of Sec.
36.25. If the irradiator will use more than 2 x 10\17\ becquerels (5 
million curies) of activity, the licensee shall evaluate the effects of 
heating of the shielding walls by the irradiator sources.
    (b) Foundations. For panoramic irradiators, the licensee shall 
design the foundation, with consideration given to soil characteristics, 
to ensure it is adequate to support the weight of the facility shield 
walls.

[[Page 748]]

    (c) Pool integrity. For pool irradiators, the licensee shall design 
the pool to assure that it is leak resistant, that it is strong enough 
to bear the weight of the pool water and shipping casks, that a dropped 
cask would not fall on sealed sources, that all outlets or pipes meet 
the requirements of Sec.36.33(b), and that metal components are 
metallurgically compatible with other components in the pool.
    (d) Water handling system. For pool irradiators, the licensee shall 
verify that the design of the water purification system is adequate to 
meet the requirements of Sec.36.33(e). The system must be designed so 
that water leaking from the system does not drain to unrestricted areas 
without being monitored.
    (e) Radiation monitors. For all irradiators, the licensee shall 
evaluate the location and sensitivity of the monitor to detect sources 
carried by the product conveyor system as required by Sec.36.29(a). 
The licensee shall verify that the product conveyor is designed to stop 
before a source on the product conveyor would cause a radiation 
overexposure to any person. For pool irradiators, if the licensee uses 
radiation monitors to detect contamination under Sec.36.59(b), the 
licensee shall verify that the design of radiation monitoring systems to 
detect pool contamination includes sensitive detectors located close to 
where contamination is likely to concentrate.
    (f) Source rack. For pool irradiators, the licensee shall verify 
that there are no crevices on the source or between the source and 
source holder that would promote corrosion on a critical area of the 
source. For panoramic irradiators, the licensee shall determine that 
source rack drops due to loss of power will not damage the source rack 
and that source rack drops due to failure of cables (or alternate means 
of support) will not cause loss of integrity of sealed sources. For 
panoramic irradiators, the licensee shall review the design of the 
mechanism that moves the sources to assure that the likelihood of a 
stuck source is low and that, if the rack sticks, a means exists to free 
it with minimal risk to personnel.
    (g) Access control. For panoramic irradiators, the licensee shall 
verify from the design and logic diagram that the access control system 
will meet the requirements of Sec.36.23.
    (h) Fire protection. For panoramic irradiators, the licensee shall 
verify that the number, location, and spacing of the smoke and heat 
detectors are appropriate to detect fires and that the detectors are 
protected from mechanical and radiation damage. The licensee shall 
verify that the design of the fire extinguishing system provides the 
necessary discharge patterns, densities, and flow characteristics for 
complete coverage of the radiation room and that the system is protected 
from mechanical and radiation damage.
    (i) Source return. For panoramic irradiators, the licensee shall 
verify that the source rack will automatically return to the fully 
shielded position if offsite power is lost for more than 10 seconds.
    (j) Seismic. For panoramic irradiators to be built in seismic areas, 
the licensee shall design the reinforced concrete radiation shields to 
retain their integrity in the event of an earthquake by designing to the 
seismic requirements of an appropriate source such as American Concrete 
Institute Standard ACI 318-89, ``Building Code Requirements for 
Reinforced Concrete,'' Chapter 21, ``Special Provisions for Seismic 
Design,'' or local building codes, if current.
    (k) Wiring. For panoramic irradiators, the licensee shall verify 
that electrical wiring and electrical equipment in the radiation room 
are selected to minimize failures due to prolonged exposure to 
radiation.



Sec.36.41  Construction monitoring and acceptance testing.

    The requirements of this section must be met for irradiators whose 
construction begins after July 1, 1993. The requirements must be met 
prior to loading sources.
    (a) Shielding. For panoramic irradiators, the licensee shall monitor 
the construction of the shielding to

[[Page 749]]

verify that its construction meets design specifications and generally 
accepted building code requirements for reinforced concrete.
    (b) Foundations. For panoramic irradiators, the licensee shall 
monitor the construction of the foundations to verify that their 
construction meets design specifications.
    (c) Pool integrity. For pool irradiators, the licensee shall verify 
that the pool meets design specifications and shall test the integrity 
of the pool. The licensee shall verify that outlets and pipes meet the 
requirements of Sec.36.33(b).
    (d) Water handling system. For pool irradiators, the licensee shall 
verify that the water purification system, the conductivity meter, and 
the water level indicators operate properly.
    (e) Radiation monitors. For all irradiators, the licensee shall 
verify the proper operation of the monitor to detect sources carried on 
the product conveyor system and the related alarms and interlocks 
required by Sec.36.29(a). For pool irradiators, the licensee shall 
verify the proper operation of the radiation monitors and the related 
alarm if used to meet Sec.36.59(b). For underwater irradiators, the 
licensee shall verify the proper operation of the over-the-pool monitor, 
alarms, and interlocks required by Sec.36.29(b).
    (f) Source rack. For panoramic irradiators, the licensee shall test 
the movement of the source racks for proper operation prior to source 
loading; testing must include source rack lowering due to simulated loss 
of power. For all irradiators with product conveyor systems, the 
licensee shall observe and test the operation of the conveyor system to 
assure that the requirements in Sec.36.35 are met for protection of 
the source rack and the mechanism that moves the rack; testing must 
include tests of any limit switches and interlocks used to protect the 
source rack and mechanism that moves the rack from moving product 
carriers.
    (g) Access control. For panoramic irradiators, the licensee shall 
test the completed access control system to assure that it functions as 
designed and that all alarms, controls, and interlocks work properly.
    (h) Fire protection. For panoramic irradiators, the licensee shall 
test the ability of the heat and smoke detectors to detect a fire, to 
activate alarms, and to cause the source rack to automatically become 
fully shielded. The licensee shall test the operability of the fire 
extinguishing system.
    (i) Source return. For panoramic irradiators, the licensee shall 
demonstrate that the source racks can be returned to their fully 
shielded positions without offsite power.
    (j) Computer systems. For panoramic irradiators that use a computer 
system to control the access control system, the licensee shall verify 
that the access control system will operate properly if offsite power is 
lost and shall verify that the computer has security features that 
prevent an irradiator operator from commanding the computer to override 
the access control system when it is required to be operable.
    (k) Wiring. For panoramic irradiators, the licensee shall verify 
that the electrical wiring and electrical equipment that were installed 
meet the design specifications.



                   Subpart D_Operation of Irradiators



Sec.36.51  Training.

    (a) Before an individual is permitted to operate an irradiator 
without a supervisor present, the individual must be instructed in:
    (1) The fundamentals of radiation protection applied to irradiators 
(including the differences between external radiation and radioactive 
contamination, units of radiation dose, NRC dose limits, why large 
radiation doses must be avoided, how shielding and access controls 
prevent large doses, how an irradiator is designed to prevent 
contamination, the proper use of survey meters and personnel dosimeters, 
other radiation safety features of an irradiator, and the basic function 
of the irradiator);
    (2) The requirements of parts 19 and 36 of NRC regulations that are 
relevant to the irradiator;
    (3) The operation of the irradiator;

[[Page 750]]

    (4) Those operating and emergency procedures listed in Sec.36.53 
that the individual is responsible for performing; and
    (5) Case histories of accidents or problems involving irradiators.
    (b) Before an individual is permitted to operate an irradiator 
without a supervisor present, the individual shall pass a written test 
on the instruction received consisting primarily of questions based on 
the licensee's operating and emergency procedures that the individual is 
responsible for performing and other operations necessary to safely 
operate the irradiator without supervision.
    (c) Before an individual is permitted to operate an irradiator 
without a supervisor present, the individual must have received on-the-
job training or simulator training in the use of the irradiator as 
described in the license application. The individual shall also 
demonstrate the ability to perform those portions of the operating and 
emergency procedures that he or she is to perform.
    (d) The licensee shall conduct safety reviews for irradiator 
operators at least annually. The licensee shall give each operator a 
brief written test on the information. Each safety review must include, 
to the extent appropriate, each of the following--
    (1) Changes in operating and emergency procedures since the last 
review, if any;
    (2) Changes in regulations and license conditions since the last 
review, if any;
    (3) Reports on recent accidents, mistakes, or problems that have 
occurred at irradiators, if any;
    (4) Relevant results of inspections of operator safety performance;
    (5) Relevant results of the facility's inspection and maintenance 
checks; and
    (6) A drill to practice an emergency or abnormal event procedure.
    (e) The licensee shall evaluate the safety performance of each 
irradiator operator at least annually to ensure that regulations, 
license conditions, and operating and emergency procedures are followed. 
The licensee shall discuss the results of the evaluation with the 
operator and shall instruct the operator on how to correct any mistakes 
or deficiencies observed.
    (f) Individuals who will be permitted unescorted access to the 
radiation room of the irradiator or the area around the pool of an 
underwater irradiator, but who have not received the training required 
for operators and the radiation safety officer, shall be instructed and 
tested in any precautions they should take to avoid radiation exposure, 
any procedures or parts of procedures listed in Sec.36.53 that they 
are expected to perform or comply with, and their proper response to 
alarms required in this part. Tests may be oral.
    (g) Individuals who must be prepared to respond to alarms required 
by Sec. Sec.36.23(b), 36.23(i), 36.27(a), 36.29(a), 36.29(b), and 
36.59(b) shall be trained and tested on how to respond. Each individual 
shall be retested at least once a year. Tests may be oral.



Sec.36.53  Operating and emergency procedures.

    (a) The licensee shall have and follow written operating procedures 
for--
    (1) Operation of the irradiator, including entering and leaving the 
radiation room;
    (2) Use of personnel dosimeters;
    (3) Surveying the shielding of panoramic irradiators;
    (4) Monitoring pool water for contamination while the water is in 
the pool and before release of pool water to unrestricted areas;
    (5) Leak testing of sources;
    (6) Inspection and maintenance checks required by Sec.36.61;
    (7) Loading, unloading, and repositioning sources, if the operations 
will be performed by the licensee; and
    (8) Inspection of movable shielding required by Sec.36.23(h), if 
applicable.
    (b) The licensee shall have and follow emergency or abnormal event 
procedures, appropriate for the irradiator type, for--
    (1) Sources stuck in the unshielded position;
    (2) Personnel overexposures;
    (3) A radiation alarm from the product exit portal monitor or pool 
monitor;
    (4) Detection of leaking sources, pool contamination, or alarm 
caused by contamination of pool water;

[[Page 751]]

    (5) A low or high water level indicator, an abnormal water loss, or 
leakage from the source storage pool;
    (6) A prolonged loss of electrical power;
    (7) A fire alarm or explosion in the radiation room;
    (8) An alarm indicating unauthorized entry into the radiation room, 
area around pool, or another alarmed area;
    (9) Natural phenomena, including an earthquake, a tornado, flooding, 
or other phenomena as appropriate for the geographical location of the 
facility; and
    (10) The jamming of automatic conveyor systems.
    (c) The licensee may revise operating and emergency procedures 
without Commission approval only if all of the following conditions are 
met:
    (1) The revisions do not reduce the safety of the facility,
    (2) The revisions are consistent with the outline or summary of 
procedures submitted with the license application,
    (3) The revisions have been reviewed and approved by the radiation 
safety officer, and
    (4) The users or operators are instructed and tested on the revised 
procedures before they are put into use.



Sec.36.55  Personnel monitoring.

    (a) Irradiator operators shall wear a personnel dosimeter that is 
processed and evaluated by an accredited National Voluntary Laboratory 
Accreditation Program (NVLAP) processor while operating a panoramic 
irradiator or while in the area around the pool of an underwater 
irradiator. The personnel dosimeter processor must be accredited for 
high energy photons in the normal and accident dose ranges (see 10 CFR 
20.1501(c)). Each personnel dosimeter must be assigned to and worn by 
only one individual. Film badges must be processed at least monthly, and 
other personnel dosimeters must be processed at least quarterly.
    (b) Other individuals who enter the radiation room of a panoramic 
irradiator shall wear a dosimeter, which may be a pocket dosimeter. For 
groups of visitors, only two people who enter the radiation room are 
required to wear dosimeters. If pocket dosimeters are used to meet the 
requirements of this paragraph, a check of their response to radiation 
must be done at least annually. Acceptable dosimeters must read within 
plus or minus 30 percent of the true radiation dose.

[58 FR 7728, Feb. 9, 1993, as amended at 65 FR 63752, Oct. 24, 2000]



Sec.36.57  Radiation surveys.

    (a) A radiation survey of the area outside the shielding of the 
radiation room of a panoramic irradiator must be conducted with the 
sources in the exposed position before the facility starts to operate. A 
radiation survey of the area above the pool of pool irradiators must be 
conducted after the sources are loaded but before the facility starts to 
operate. Additional radiation surveys of the shielding must be performed 
at intervals not to exceed 3 years and before resuming operation after 
addition of new sources or any modification to the radiation room 
shielding or structure that might increase dose rates.
    (b) If the radiation levels specified in Sec.36.25 are exceeded, 
the facility must be modified to comply with the requirements in Sec.
36.25.
    (c) Portable radiation survey meters must be calibrated at least 
annually to an accuracy of 20 percent for the 
gamma energy of the sources in use. The calibration must be done at two 
points on each scale or, for digital instruments, at one point per 
decade over the range that will be used. Portable radiation survey 
meters must be of a type that does not saturate and read zero at high 
radiation dose rates.
    (d) Water from the irradiator pool, other potentially contaminated 
liquids, and sediments from pool vacuuming must be monitored for 
radioactive contamination before release to unrestricted areas. 
Radioactive concentrations must not exceed those specified in 10 CFR 
part 20, table 2, column 2 or table 3 of appendix B, ``Annual Limits on 
Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for 
Occupational Exposure; Effluent Concentrations; Concentrations for 
Release to Sewerage.''
    (e) Before releasing resins for unrestricted use, they must be 
monitored

[[Page 752]]

before release in an area with a background level less than 0.5 
microsievert (0.05 millirem) per hour. The resins may be released only 
if the survey does not detect radiation levels above background 
radiation levels. The survey meter used must be capable of detecting 
radiation levels of 0.5 microsievert (0.05 millirem) per hour.



Sec.36.59  Detection of leaking sources.

    (a) Each dry-source-storage sealed source must be tested for leakage 
at intervals not to exceed 6 months using a leak test kit or method 
approved by the Commission or an Agreement State. In the absence of a 
certificate from a transferor that a test has been made within the 6 
months before the transfer, the sealed source may not be used until 
tested. The test must be capable of detecting the presence of 200 
becquerels (0.005 microcurie) of radioactive material and must be 
performed by a person approved by the Commission or an Agreement State 
to perform the test.
    (b) For pool irradiators, sources may not be put into the pool 
unless the licensee tests the sources for leaks or has a certificate 
from a transferor that leak test has been done within the 6 months 
before the transfer. Water from the pool must be checked for 
contamination each day the irradiator operates. The check may be done 
either by using a radiation monitor on a pool water circulating system 
or by analysis of a sample of pool water. If a check for contamination 
is done by analysis of a sample of pool water, the results of the 
analysis must be available within 24 hours. If the licensee uses a 
radiation monitor on a pool water circulating system, the detection of 
above normal radiation levels must activate an alarm. The alarm set-
point must be set as low as practical, but high enough to avoid false 
alarms. The licensee may reset the alarm set-point to a higher level if 
necessary to operate the pool water purification system to clean up 
contamination in the pool if specifically provided for in written 
emergency procedures.
    (c) If a leaking source is detected, the licensee shall arrange to 
remove the leaking source from service and have it decontaminated, 
repaired, or disposed of by an NRC or Agreement State licensee that is 
authorized to perform these functions. The licensee shall promptly check 
its personnel, equipment, facilities, and irradiated product for 
radioactive contamination. No product may be shipped until the product 
has been checked and found free of contamination. If a product has been 
shipped that may have been inadvertently contaminated, the licensee 
shall arrange to locate and survey that product for contamination. If 
any personnel are found to be contaminated, decontamination must be 
performed promptly. If contaminated equipment, facilities, or products 
are found, the licensee shall arrange to have them decontaminated or 
disposed of by an NRC or Agreement State licensee that is authorized to 
perform these functions. If a pool is contaminated, the licensee shall 
arrange to clean the pool until the contamination levels do not exceed 
the appropriate concentration in table 2, column 2, appendix B to part 
20. (See 10 CFR 30.50 for reporting requirements.)

[58 FR 7728, Feb. 9, 1993, as amended at 58 FR 67660, Dec. 22, 1993]



Sec.36.61  Inspection and maintenance.

    (a) The licensee shall perform inspection and maintenance checks 
that include, as a minimum, each of the following at the frequency 
specified in the license or license application:
    (1) Operability of each aspect of the access control system required 
by Sec.36.23.
    (2) Functioning of the source position indicator required by Sec.
36.31(b).
    (3) Operability of the radiation monitor for radioactive 
contamination in pool water required by Sec.36.59(b) using a radiation 
check source, if applicable.
    (4) Operability of the over-pool radiation monitor at underwater 
irradiators as required by Sec.36.29(b).
    (5) Operability of the product exit monitor required by Sec.
36.29(a).
    (6) Operability of the emergency source return control required by 
Sec.36.31(c).
    (7) Leak-tightness of systems through which pool water circulates 
(visual inspection).

[[Page 753]]

    (8) Operability of the heat and smoke detectors and extinguisher 
system required by Sec.36.27 (but without turning extinguishers on).
    (9) Operability of the means of pool water replenishment required by 
Sec.36.33(c).
    (10) Operability of the indicators of high and low pool water levels 
required by Sec.36.33(d).
    (11) Operability of the intrusion alarm required by Sec.36.23(i), 
if applicable.
    (12) Functioning and wear of the system, mechanisms, and cables used 
to raise and lower sources.
    (13) Condition of the barrier to prevent products from hitting the 
sources or source mechanism as required by Sec.36.35.
    (14) Amount of water added to the pool to determine if the pool is 
leaking.
    (15) Electrical wiring on required safety systems for radiation 
damage.
    (16) Pool water conductivity measurements and analysis as required 
by Sec.36.63(b).
    (b) Malfunctions and defects found during inspection and maintenance 
checks must be repaired without undue delay.



Sec.36.63  Pool water purity.

    (a) Pool water purification system must be run sufficiently to 
maintain the conductivity of the pool water below 20 microsiemens per 
centimeter under normal circumstances. If pool water conductivity rises 
above 20 microsiemens per centimeter, the licensee shall take prompt 
actions to lower the pool water conductivity and shall take corrective 
actions to prevent future recurrences.
    (b) The licensee shall measure the pool water conductivity 
frequently enough, but no less than weekly, to assure that the 
conductivity remains below 20 microsiemens per centimeter. Conductivity 
meters must be calibrated at least annually.



Sec.36.65  Attendance during operation.

    (a) Both an irradiator operator and at least one other individual, 
who is trained on how to respond and prepared to promptly render or 
summon assistance if the access control alarm sounds, shall be present 
onsite:
    (1) Whenever the irradiator is operated using an automatic product 
conveyor system; and
    (2) Whenever the product is moved into or out of the radiation room 
when the irradiator is operated in a batch mode.
    (b) At a panoramic irradiator at which static irradiations (no 
movement of the product) are occurring, a person who has received the 
training on how to respond to alarms described in Sec.36.51(g) must be 
onsite.
    (c) At an underwater irradiator, an irradiator operator must be 
present at the facility whenever the product is moved into or out of the 
pool. Individuals who move the product into or out of the pool of an 
underwater irradiator need not be qualified as irradiator operators; 
however, they must have received the training described in Sec.36.51 
(f) and (g). Static irradiations may be performed without a person 
present at the facility.



Sec.36.67  Entering and leaving the radiation room.

    (a) Upon first entering the radiation room of a panoramic irradiator 
after an irradiation, the irradiator operator shall use a survey meter 
to determine that the source has returned to its fully shielded 
position. The operator shall check the functioning of the survey meter 
with a radiation check source prior to entry.
    (b) Before exiting from and locking the door to the radiation room 
of a panoramic irradiator prior to a planned irradiation, the irradiator 
operator shall:
    (1) Visually inspect the entire radiation room to verify that no one 
else is in it; and
    (2) Activate a control in the radiation room that permits the 
sources to be moved from the shielded position only if the door to the 
radiation room is locked within a preset time after setting the control.
    (c) During a power failure, the area around the pool of an 
underwater irradiator may not be entered without using an operable and 
calibrated radiation survey meter unless the over-the-

[[Page 754]]

pool monitor required by Sec.36.29(b) is operating with backup power.



Sec.36.69  Irradiation of explosive or flammable materials.

    (a) Irradiation of explosive material is prohibited unless the 
licensee has received prior written authorization from the Commission. 
Authorization will not be granted unless the licensee can demonstrate 
that detonation of the explosive would not rupture the sealed sources, 
injure personnel, damage safety systems, or cause radiation 
overexposures of personnel.
    (b) Irradiation of more than small quantities of flammable material 
(flash point below 140 [deg]F) is prohibited in panoramic irradiators 
unless the licensee has received prior written authorization from the 
Commission. Authorization will not be granted unless the licensee can 
demonstrate that a fire in the radiation room could be controlled 
without damage to sealed sources or safety systems and without radiation 
overexposures of personnel.



                            Subpart E_Records



Sec.36.81  Records and retention periods.

    The licensee shall maintain the following records at the irradiator 
for the periods specified.
    (a) A copy of the license, license conditions, documents 
incorporated into a license by reference, and amendments thereto until 
superseded by new documents or until the Commission terminates the 
license for documents not superseded.
    (b) Records of each individual's training, tests, and safety reviews 
provided to meet the requirements of Sec.36.51 (a), (b), (c), (d), 
(f), and (g) until 3 years after the individual terminates work.
    (c) Records of the annual evaluations of the safety performance of 
irradiator operators required by Sec.36.51(e) for 3 years after the 
evaluation.
    (d) A copy of the current operating and emergency procedures 
required by Sec.36.53 until superseded or the Commission terminates 
the license. Records of the radiation safety officer's review and 
approval of changes in procedures as required by Sec.36.53(c)(3) 
retained for 3 years from the date of the change.
    (e) Evaluations of personnel dosimeters required by Sec.36.55 
until the Commission terminates the license.
    (f) Records of radiation surveys required by Sec.36.57 for 3 years 
from the date of the survey.
    (g) Records of radiation survey meter calibrations required by Sec.
36.57 and pool water conductivity meter calibrations required by Sec.
36.63(b) until 3 years from the date of calibration.
    (h) Records of the results of leak tests required by Sec.36.59(a) 
and the results of contamination checks required by Sec.36.59(b) for 3 
years from the date of each test.
    (i) Records of inspection and maintenance checks required by Sec.
36.61 for 3 years.
    (j) Records of major malfunctions, significant defects, operating 
difficulties or irregularities, and major operating problems that 
involve required radiation safety equipment for 3 years after repairs 
are completed.
    (k) Records of the receipt, transfer and disposal, of all licensed 
sealed sources as required by Sec. Sec.30.51 and 30.41.
    (l) Records on the design checks required by Sec.36.39 and the 
construction control checks as required by Sec.36.41 until the license 
is terminated. The records must be signed and dated. The title or 
qualification of the person signing must be included.
    (m) Records related to decommissioning of the irradiator as required 
by Sec.30.35(g).

[58 FR 7728, Feb. 9, 1993, as amended at 65 FR 63752, Oct. 24, 2000]



Sec.36.83  Reports.

    (a) In addition to the reporting requirements in other parts of NRC 
regulations, the licensee shall report the following events if not 
reported under other parts of NRC regulations:
    (1) Source stuck in an unshielded position.
    (2) Any fire or explosion in a radiation room.
    (3) Damage to the source racks.
    (4) Failure of the cable or drive mechanism used to move the source 
racks.
    (5) Inoperability of the access control system.
    (6) Detection of radiation source by the product exit monitor.

[[Page 755]]

    (7) Detection of radioactive contamination attributable to licensed 
radioactive material.
    (8) Structural damage to the pool liner or walls.
    (9) Abnormal water loss or leakage from the source storage pool.
    (10) Pool water conductivity exceeding 100 microsiemens per 
centimeter.
    (b) The report must include a telephone report within 24 hours as 
described in Sec.30.50(c)(1), and a written report within 30 days as 
described in Sec.30.50(c)(2).



                          Subpart F_Enforcement



Sec.36.91  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.



Sec.36.93  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 36 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 36 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.36.1, 36.2, 36.5, 36.8, 36.11, 36.13, 36.17, 36.19, 36.91, 
and 36.93.



PART 37_PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES
OF RADIOACTIVE MATERIAL--Table of Contents



                      Subpart A_General Provisions

Sec.
37.1 Purpose.
37.3 Scope.
37.5 Definitions.
37.7 Communications.
37.9 Interpretations.
37.11 Specific exemptions.
37.13 Information collection requirements: OMB approval.

     Subpart B_Background Investigations and Access Control Program

37.21 Personnel access authorization requirements for category 1 or 
          category 2 quantities of radioactive material.
37.23 Access authorization program requirements.
37.25 Background investigations.
37.27 Requirements for criminal history records checks of individuals 
          granted unescorted access to category 1 or category 2 
          quantities of radioactive material.
37.29 Relief from fingerprinting, identification, and criminal history 
          records checks and other elements of background investigations 
          for designated categories of individuals permitted unescorted 
          access to certain radioactive materials.
37.31 Protection of information.
37.33 Access authorization program review.

          Subpart C_Physical Protection Requirements During Use

37.41 Security program.
37.43 General security program requirements.
37.45 LLEA coordination.
37.47 Security zones.
37.49 Monitoring, detection, and assessment.
37.51 Maintenance and testing.
37.53 Requirements for mobile devices.
37.55 Security program review.
37.57 Reporting of events.

[[Page 756]]

                Subpart D_Physical Protection in Transit

37.71 Additional requirements for transfer of category 1 and category 2 
          quantities of radioactive material.
37.73 Applicability of physical protection of category 1 and category 2 
          quantities of radioactive material during transit.
37.75 Preplanning and coordination of shipment of category 1 or category 
          2 quantities of radioactive material.
37.77 Advance notification of shipment of category 1 quantities of 
          radioactive material.
37.79 Requirements for physical protection of category 1 and category 2 
          quantities of radioactive material during shipment.
37.81 Reporting of events.

Subpart E [Reserved]

                            Subpart F_Records

37.101 Form of records.
37.103 Record retention.

                          Subpart G_Enforcement

37.105 Inspections.
37.107 Violations.
37.109 Criminal penalties.

Appendix A to Part 37--Category 1 and Category 2 Radioactive Materials

    Authority: Atomic Energy Act of 1954, secs. 11, 53, 81, 103, 104, 
147, 148, 149, 161, 182, 183, 223, 234, 274 (42 U.S.C. 2014, 2073, 2111, 
2133, 2134, 2167, 2168, 2169, 2201, 2232, 2233, 2273, 2282, 2021); 
Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 
5842); 44 U.S.C. 3504 note.

    Source: 78 FR 17007, Mar. 19, 2013, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 37 appear at 79 FR 
75739, Dec. 19, 2014.



                      Subpart A_General Provisions



Sec.37.1  Purpose.

    This part has been established to provide the requirements for the 
physical protection program for any licensee that possesses an 
aggregated category 1 or category 2 quantity of radioactive material 
listed in Appendix A to this part. These requirements provide reasonable 
assurance of the security of category 1 or category 2 quantities of 
radioactive material by protecting these materials from theft or 
diversion. Specific requirements for access to material, use of 
material, transfer of material, and transport of material are included. 
No provision of this part authorizes possession of licensed material.



Sec.37.3  Scope.

    (a) Subparts B and C of this part apply to any person who, under the 
regulations in this chapter, possesses or uses at any site, an 
aggregated category 1 or category 2 quantity of radioactive material.
    (b) Subpart D of this part applies to any person who, under the 
regulations of this chapter:
    (1) Transports or delivers to a carrier for transport in a single 
shipment, a category 1 or category 2 quantity of radioactive material; 
or
    (2) Imports or exports a category 1 or category 2 quantity of 
radioactive material; the provisions only apply to the domestic portion 
of the transport.



Sec.37.5  Definitions.

    As used in this part:
    Access control means a system for allowing only approved individuals 
to have unescorted access to the security zone and for ensuring that all 
other individuals are subject to escorted access.
    Act means the Atomic Energy Act of 1954 (68 Stat. 919), including 
any amendments thereto.
    Aggregated means accessible by the breach of a single physical 
barrier that would allow access to radioactive material in any form, 
including any devices that contain the radioactive material, when the 
total activity equals or exceeds a category 2 quantity of radioactive 
material.
    Agreement State means any state with which the Atomic Energy 
Commission or the U.S. Nuclear Regulatory Commission has entered into an 
effective agreement under subsection 274b. of the Act. Non-agreement 
State means any other State.
    Approved individual means an individual whom the licensee has 
determined to be trustworthy and reliable for unescorted access in 
accordance with subpart B of this part and who has completed the 
training required by Sec.37.43(c).
    Background investigation means the investigation conducted by a 
licensee or applicant to support the determination of trustworthiness 
and reliability.

[[Page 757]]

    Becquerel (Bq) means one disintegration per second.
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2) The tailings or wastes produced by the extraction or 
concentration of uranium or thorium from ore processed primarily for its 
source material content, including discrete surface wastes resulting 
from uranium solution extraction processes. Underground ore bodies 
depleted by these solution extraction operations do not constitute 
``byproduct material'' within this definition;
    (3)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 8, 
2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (4) Any discrete source of naturally occurring radioactive material, 
other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, the Secretary of Energy, the Secretary 
of Homeland Security, and the head of any other appropriate Federal 
agency, determines would pose a threat similar to the threat posed by a 
discrete source of radium-226 to the public health and safety or the 
common defense and security; and
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research activity.
    Carrier means a person engaged in the transportation of passengers 
or property by land or water as a common, contract, or private carrier, 
or by civil aircraft.
    Category 1 quantity of radioactive material means a quantity of 
radioactive material meeting or exceeding the category 1 threshold in 
Table 1 of Appendix A to this part. This is determined by calculating 
the ratio of the total activity of each radionuclide to the category 1 
threshold for that radionuclide and adding the ratios together. If the 
sum is equal to or exceeds 1, the quantity would be considered a 
category 1 quantity. Category 1 quantities of radioactive material do 
not include the radioactive material contained in any fuel assembly, 
subassembly, fuel rod, or fuel pellet.
    Category 2 quantity of radioactive material means a quantity of 
radioactive material meeting or exceeding the category 2 threshold but 
less than the category 1 threshold in Table 1 of Appendix A to this 
part. This is determined by calculating the ratio of the total activity 
of each radionuclide to the category 2 threshold for that radionuclide 
and adding the ratios together. If the sum is equal to or exceeds 1, the 
quantity would be considered a category 2 quantity. Category 2 
quantities of radioactive material do not include the radioactive 
material contained in any fuel assembly, subassembly, fuel rod, or fuel 
pellet.
    Commission means the U.S. Nuclear Regulatory Commission or its duly 
authorized representatives.
    Curie means that amount of radioactive material which disintegrates 
at the rate of 37 billion atoms per second.
    Diversion means the unauthorized movement of radioactive material 
subject to this part to a location different from the material's 
authorized destination inside or outside of the site at which the 
material is used or stored.
    Escorted access means accompaniment while in a security zone by an 
approved individual who maintains continuous direct visual surveillance 
at all times over an individual who is not approved for unescorted 
access.
    Fingerprint orders means the orders issued by the U.S. Nuclear 
Regulatory Commission or the legally binding requirements issued by 
Agreement States that require fingerprints and criminal history records 
checks for individuals with unescorted access to category 1 and category 
2 quantities of radioactive material or safeguards information-modified 
handling.

[[Page 758]]

    Government agency means any executive department, commission, 
independent establishment, corporation, wholly or partly owned by the 
United States of America which is an instrumentality of the United 
States, or any board, bureau, division, service, office, officer, 
authority, administration, or other establishment in the executive 
branch of the Government.
    License, except where otherwise specified, means a license for 
byproduct material issued pursuant to the regulations in parts 30 
through 36 and 39 of this chapter;
    License issuing authority means the licensing agency that issued the 
license, i.e. the U.S. Nuclear Regulatory Commission or the appropriate 
agency of an Agreement State;
    Local law enforcement agency (LLEA) means a public or private 
organization that has been approved by a federal, state, or local 
government to carry firearms and make arrests, and is authorized and has 
the capability to provide an armed response in the jurisdiction where 
the licensed category 1 or category 2 quantity of radioactive material 
is used, stored, or transported.
    Lost or missing licensed material means licensed material whose 
location is unknown. It includes material that has been shipped but has 
not reached its destination and whose location cannot be readily traced 
in the transportation system.
    Mobile device means a piece of equipment containing licensed 
radioactive material that is either mounted on wheels or casters, or 
otherwise equipped for moving without a need for disassembly or 
dismounting; or designed to be hand carried. Mobile devices do not 
include stationary equipment installed in a fixed location.
    Movement control center means an operations center that is remote 
from transport activity and that maintains position information on the 
movement of radioactive material, receives reports of attempted attacks 
or thefts, provides a means for reporting these and other problems to 
appropriate agencies and can request and coordinate appropriate aid.
    No-later-than arrival time means the date and time that the shipping 
licensee and receiving licensee have established as the time at which an 
investigation will be initiated if the shipment has not arrived at the 
receiving facility. The no-later-than-arrival time may not be more than 
6 hours after the estimated arrival time for shipments of category 2 
quantities of radioactive material.
    Person means--
    (1) Any individual, corporation, partnership, firm, association, 
trust, estate, public or private institution, group, Government agency 
other than the Commission or the DOE (except that the Department shall 
be considered a person within the meaning of the regulations in 10 CFR 
chapter I to the extent that its facilities and activities are subject 
to the licensing and related regulatory authority of the Commission 
under section 202 of the Energy Reorganization Act of 1974 (88 Stat. 
1244), the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 
3021), the Nuclear Waste Policy Act of 1982 (96 Stat. 2201), and section 
3(b)(2) of the Low-Level Radioactive Waste Policy Amendments Act of 1985 
(99 Stat. 1842), any State or any political subdivision of or any 
political entity within a State, any foreign government or nation or any 
political subdivision of any such government or nation, or other entity; 
and
    (2) Any legal successor, representative, agent, or agency of the 
foregoing.
    Reviewing official means the individual who shall make the 
trustworthiness and reliability determination of an individual to 
determine whether the individual may have, or continue to have, 
unescorted access to the category 1 or category 2 quantities of 
radioactive materials that are possessed by the licensee.
    Sabotage means deliberate damage, with malevolent intent, to a 
category 1 or category 2 quantity of radioactive material, a device that 
contains a category 1 or category 2 quantity of radioactive material, or 
the components of the security system.
    Safe haven means a readily recognizable and readily accessible site 
at which security is present or from which, in the event of an 
emergency, the transport crew can notify and wait for the local law 
enforcement authorities.

[[Page 759]]

    Security zone means any temporary or permanent area determined and 
established by the licensee for the physical protection of category 1 or 
category 2 quantities of radioactive material.
    State means a State of the United States, the District of Columbia, 
the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American 
Samoa, and the Commonwealth of the Northern Mariana Islands.
    Telemetric position monitoring system means a data transfer system 
that captures information by instrumentation and/or measuring devices 
about the location and status of a transport vehicle or package between 
the departure and destination locations.
    Trustworthiness and reliability are characteristics of an individual 
considered dependable in judgment, character, and performance, such that 
unescorted access to category 1 or category 2 quantities of radioactive 
material by that individual does not constitute an unreasonable risk to 
the public health and safety or security. A determination of 
trustworthiness and reliability for this purpose is based upon the 
results from a background investigation.
    Unescorted access means solitary access to an aggregated category 1 
or category 2 quantity of radioactive material or the devices that 
contain the material.
    United States, when used in a geographical sense, includes Puerto 
Rico and all territories and possessions of the United States.



Sec.37.7  Communications.

    Except where otherwise specified or covered under the regional 
licensing program as provided in Sec.30.6(b) of this chapter, all 
communications and reports concerning the regulations in this part may 
be sent as follows:
    (a) By mail addressed to: ATTN: Document Control Desk; Director, 
Office of Nuclear Reactor Regulation; Director, Office of New Reactors; 
or Director, Office of Nuclear Material Safety and Safeguards, as 
appropriate, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001;
    (b) By hand delivery to the NRC's offices at 11555 Rockville Pike, 
Rockville, Maryland 20852;
    (c) Where practicable, by electronic submission, for example, 
Electronic Information Exchange, or CD-ROM. Electronic submissions must 
be made in a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by email to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information.

[78 FR 17007, Mar. 19, 2013, as amended at 79 FR 75740, Dec. 19, 2014; 
80 FR 74979, Dec. 1, 2015; 83 FR 58722, Nov. 21, 2018]



Sec.37.9  Interpretations.

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



Sec.37.11  Specific exemptions.

    (a) The Commission may, upon application of any interested person or 
upon its own initiative, grant such exemptions from the requirements of 
the regulations in this part as it determines are authorized by law and 
will not endanger life or property or the common defense and security, 
and are otherwise in the public interest.
    (b) Any licensee's NRC-licensed activities are exempt from the 
requirements of subparts B and C of this part to the extent that its 
activities are included in a security plan required by part 73 of this 
chapter.
    (c) A licensee that possesses radioactive waste that contains 
category 1 or category 2 quantities of radioactive material is exempt 
from the requirements of subparts B, C, and D of this part. Except that 
any radioactive waste that contains discrete sources,

[[Page 760]]

ion-exchange resins, or activated material that weighs less than 2,000 
kg (4,409 lbs) is not exempt from the requirements of this part. The 
licensee shall implement the following requirements to secure the 
radioactive waste:
    (1) Use continuous physical barriers that allow access to the 
radioactive waste only through established access control points;
    (2) Use a locked door or gate with monitored alarm at the access 
control point;
    (3) Assess and respond to each actual or attempted unauthorized 
access to determine whether an actual or attempted theft, sabotage, or 
diversion occurred; and
    (4) Immediately notify the LLEA and request an armed response from 
the LLEA upon determination that there was an actual or attempted theft, 
sabotage, or diversion of the radioactive waste that contains category 1 
or category 2 quantities of radioactive material.



Sec.37.13  Information collection requirements: OMB approval.

    (a) The U.S. Nuclear Regulatory Commission has submitted the 
information collection requirements contained in this part to the Office 
of Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. The 
OMB has approved the information collection requirements contained in 
this part under control number 3150-0214.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.37.11, 37.21, 37.23, 37.25, 37.27, 37.29, 
37.31, 37.33, 37.41, 37.43, 37.45, 37.49, 37.51, 37.55, 37.57, 37.71, 
37.75, 37.77, 37.79, and 37.81.



  Subpart B_Background Investigations and Access Authorization Program



Sec.37.21  Personnel access authorization requirements for category
1 or category 2 quantities of radioactive material.

    (a) General. (1) Each licensee that possesses an aggregated quantity 
of radioactive material at or above the category 2 threshold shall 
establish, implement, and maintain its access authorization program in 
accordance with the requirements of this subpart.
    (2) An applicant for a new license and each licensee that would 
become newly subject to the requirements of this subpart upon 
application for modification of its license shall implement the 
requirements of this subpart, as appropriate, before taking possession 
of an aggregated category 1 or category 2 quantity of radioactive 
material.
    (3) Any licensee that has not previously implemented the Security 
Orders or been subject to the provisions of this subpart B shall 
implement the provisions of this subpart B before aggregating 
radioactive material to a quantity that equals or exceeds the category 2 
threshold.
    (b) General performance objective. The licensee's access 
authorization program must ensure that the individuals specified in 
paragraph (c)(1) of this section are trustworthy and reliable.
    (c) Applicability. (1) Licensees shall subject the following 
individuals to an access authorization program:
    (i) Any individual whose assigned duties require unescorted access 
to category 1 or category 2 quantities of radioactive material or to any 
device that contains the radioactive material; and
    (ii) Reviewing officials.
    (2) Licensees need not subject the categories of individuals listed 
in Sec.37.29(a)(1) through (13) to the investigation elements of the 
access authorization program.
    (3) Licensees shall approve for unescorted access to category 1 or 
category 2 quantities of radioactive material only those individuals 
with job duties that require unescorted access to category 1 or category 
2 quantities of radioactive material.

[[Page 761]]

    (4) Licensees may include individuals needing access to safeguards 
information-modified handling under part 73 of this chapter in the 
access authorization program under this subpart B.



Sec.37.23  Access authorization program requirements.

    (a) Granting unescorted access authorization. (1) Licensees shall 
implement the requirements of this subpart for granting initial or 
reinstated unescorted access authorization.
    (2) Individuals who have been determined to be trustworthy and 
reliable shall also complete the security training required by Sec.
37.43(c) before being allowed unescorted access to category 1 or 
category 2 quantities of radioactive material.
    (b) Reviewing officials. (1) Reviewing officials are the only 
individuals who may make trustworthiness and reliability determinations 
that allow individuals to have unescorted access to category 1 or 
category 2 quantities of radioactive materials possessed by the 
licensee.
    (2) Each licensee shall name one or more individuals to be reviewing 
officials. After completing the background investigation on the 
reviewing official, the licensee shall provide under oath or 
affirmation, a certification that the reviewing official is deemed 
trustworthy and reliable by the licensee. Provide oath or affirmation 
certifications to the ATTN: Document Control Desk; Director, Office of 
Nuclear Material Safety and Safeguards. The fingerprints of the named 
reviewing official must be taken by a law enforcement agency, Federal or 
State agencies that provide fingerprinting services to the public, or 
commercial fingerprinting services authorized by a State to take 
fingerprints. The licensee shall recertify that the reviewing official 
is deemed trustworthy and reliable every 10 years in accordance with 
Sec.37.25(c).
    (3) Reviewing officials must be permitted to have unescorted access 
to category 1 or category 2 quantities of radioactive materials or 
access to safeguards information or safeguards information-modified 
handling, if the licensee possesses safeguards information or safeguards 
information-modified handling.
    (4) Reviewing officials cannot approve other individuals to act as 
reviewing officials.
    (5) A reviewing official does not need to undergo a new background 
investigation before being named by the licensee as the reviewing 
official if:
    (i) The individual has undergone a background investigation that 
included fingerprinting and an FBI criminal history records check and 
has been determined to be trustworthy and reliable by the licensee; or
    (ii) The individual is subject to a category listed in Sec.
37.29(a).
    (c) Informed consent. (1) Licensees may not initiate a background 
investigation without the informed and signed consent of the subject 
individual. This consent must include authorization to share personal 
information with other individuals or organizations as necessary to 
complete the background investigation. Before a final adverse 
determination, the licensee shall provide the individual with an 
opportunity to correct any inaccurate or incomplete information that is 
developed during the background investigation. Licensees do not need to 
obtain signed consent from those individuals that meet the requirements 
of Sec.37.25(b). A signed consent must be obtained prior to any 
reinvestigation.
    (2) The subject individual may withdraw his or her consent at any 
time. Licensees shall inform the individual that:
    (i) If an individual withdraws his or her consent, the licensee may 
not initiate any elements of the background investigation that were not 
in progress at the time the individual withdrew his or her consent; and
    (ii) The withdrawal of consent for the background investigation is 
sufficient cause for denial or termination of unescorted access 
authorization.
    (d) Personal history disclosure. Any individual who is applying for 
unescorted access authorization shall disclose the

[[Page 762]]

personal history information that is required by the licensee's access 
authorization program for the reviewing official to make a determination 
of the individual's trustworthiness and reliability. Refusal to provide, 
or the falsification of, any personal history information required by 
this subpart is sufficient cause for denial or termination of unescorted 
access.
    (e) Determination basis. (1) The reviewing official shall determine 
whether to permit, deny, unfavorably terminate, maintain, or 
administratively withdraw an individual's unescorted access 
authorization based on an evaluation of all of the information collected 
to meet the requirements of this subpart.
    (2) The reviewing official may not permit any individual to have 
unescorted access until the reviewing official has evaluated all of the 
information collected to meet the requirements of this subpart and 
determined that the individual is trustworthy and reliable. The 
reviewing official may deny unescorted access to any individual based on 
information obtained at any time during the background investigation.
    (3) The licensee shall document the basis for concluding whether or 
not there is reasonable assurance that an individual is trustworthy and 
reliable.
    (4) The reviewing official may terminate or administratively 
withdraw an individual's unescorted access authorization based on 
information obtained after the background investigation has been 
completed and the individual granted unescorted access authorization.
    (5) Licensees shall maintain a list of persons currently approved 
for unescorted access authorization. When a licensee determines that a 
person no longer requires unescorted access or meets the access 
authorization requirement, the licensee shall remove the person from the 
approved list as soon as possible, but no later than 7 working days, and 
take prompt measures to ensure that the individual is unable to have 
unescorted access to the material.
    (f) Procedures. Licensees shall develop, implement, and maintain 
written procedures for implementing the access authorization program. 
The procedures must include provisions for the notification of 
individuals who are denied unescorted access. The procedures must 
include provisions for the review, at the request of the affected 
individual, of a denial or termination of unescorted access 
authorization. The procedures must contain a provision to ensure that 
the individual is informed of the grounds for the denial or termination 
of unescorted access authorization and allow the individual an 
opportunity to provide additional relevant information.
    (g) Right to correct and complete information. (1) Prior to any 
final adverse determination, licensees shall provide each individual 
subject to this subpart with the right to complete, correct, and explain 
information obtained as a result of the licensee's background 
investigation. Confirmation of receipt by the individual of this 
notification must be maintained by the licensee for a period of 1 year 
from the date of the notification.
    (2) If, after reviewing his or her criminal history record, an 
individual believes that it is incorrect or incomplete in any respect 
and wishes to change, correct, update, or explain anything in the 
record, the individual may initiate challenge procedures. These 
procedures include direct application by the individual challenging the 
record to the law enforcement agency that contributed the questioned 
information or a direct challenge as to the accuracy or completeness of 
any entry on the criminal history record to the Federal Bureau of 
Investigation, Criminal Justice Information Services (CJIS) Division, 
ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as 
set forth in 28 CFR 16.30 through 16.34. In the latter case, the Federal 
Bureau of Investigation (FBI) will forward the challenge to the agency 
that submitted the data, and will request that the agency verify or 
correct the challenged entry. Upon receipt of an official communication 
directly from the agency that contributed the original information, the 
FBI Identification Division makes any changes necessary in accordance 
with the information supplied by that agency. Licensees must provide at 
least 10 days for an individual to initiate action to

[[Page 763]]

challenge the results of an FBI criminal history records check after the 
record being made available for his or her review. The licensee may make 
a final adverse determination based upon the criminal history records 
only after receipt of the FBI's confirmation or correction of the 
record.
    (h) Records. (1) The licensee shall retain documentation regarding 
the trustworthiness and reliability of individual employees for 3 years 
from the date the individual no longer requires unescorted access to 
category 1 or category 2 quantities of radioactive material.
    (2) The licensee shall retain a copy of the current access 
authorization program procedures as a record for 3 years after the 
procedure is no longer needed. If any portion of the procedure is 
superseded, the licensee shall retain the superseded material for 3 
years after the record is superseded.
    (3) The licensee shall retain the list of persons approved for 
unescorted access authorization for 3 years after the list is superseded 
or replaced.

[78 FR 17007, Mar. 19, 2013, as amended at 80 FR 45843, Aug. 3, 2015; 83 
FR 30287, June 28, 2018]



Sec.37.25  Background investigations.

    (a) Initial investigation. Before allowing an individual unescorted 
access to category 1 or category 2 quantities of radioactive material or 
to the devices that contain the material, licensees shall complete a 
background investigation of the individual seeking unescorted access 
authorization. The scope of the investigation must encompass at least 
the 7 years preceding the date of the background investigation or since 
the individual's eighteenth birthday, whichever is shorter. The 
background investigation must include at a minimum:
    (1) Fingerprinting and an FBI identification and criminal history 
records check in accordance with Sec.37.27;
    (2) Verification of true identity. Licensees shall verify the true 
identity of the individual who is applying for unescorted access 
authorization to ensure that the applicant is who he or she claims to 
be. A licensee shall review official identification documents (e.g., 
driver's license; passport; government identification; certificate of 
birth issued by the state, province, or country of birth) and compare 
the documents to personal information data provided by the individual to 
identify any discrepancy in the information. Licensees shall document 
the type, expiration, and identification number of the identification 
document, or maintain a photocopy of identifying documents on file in 
accordance with Sec.37.31. Licensees shall certify in writing that the 
identification was properly reviewed, and shall maintain the 
certification and all related documents for review upon inspection;
    (3) Employment history verification. Licensees shall complete an 
employment history verification, including military history. Licensees 
shall verify the individual's employment with each previous employer for 
the most recent 7 years before the date of application;
    (4) Verification of education. Licensees shall verify that the 
individual participated in the education process during the claimed 
period;
    (5) Character and reputation determination. Licensees shall complete 
reference checks to determine the character and reputation of the 
individual who has applied for unescorted access authorization. Unless 
other references are not available, reference checks may not be 
conducted with any person who is known to be a close member of the 
individual's family, including but not limited to the individual's 
spouse, parents, siblings, or children, or any individual who resides in 
the individual's permanent household. Reference checks under this 
subpart must be limited to whether the individual has been and continues 
to be trustworthy and reliable;
    (6) The licensee shall also, to the extent possible, obtain 
independent information to corroborate that provided by the individual 
(e.g., seek references not supplied by the individual); and
    (7) If a previous employer, educational institution, or any other 
entity with which the individual claims to have been engaged fails to 
provide information or indicates an inability or unwillingness to 
provide information within a time frame deemed appropriate by the 
licensee but at least after 10 business days of the request or if the

[[Page 764]]

licensee is unable to reach the entity, the licensee shall document the 
refusal, unwillingness, or inability in the record of investigation; and 
attempt to obtain the information from an alternate source.
    (b) Grandfathering. (1) Individuals who have been determined to be 
trustworthy and reliable for unescorted access to category 1 or category 
2 quantities of radioactive material under the Fingerprint Orders may 
continue to have unescorted access to category 1 and category 2 
quantities of radioactive material without further investigation. These 
individuals shall be subject to the reinvestigation requirement.
    (2) Individuals who have been determined to be trustworthy and 
reliable under the provisions of part 73 of this chapter or the security 
orders for access to safeguards information, safeguards information-
modified handling, or risk-significant material may have unescorted 
access to category 1 and category 2 quantities of radioactive material 
without further investigation. The licensee shall document that the 
individual was determined to be trustworthy and reliable under the 
provisions of part 73 of this chapter or a security order. Security 
order, in this context, refers to any order that was issued by the NRC 
that required fingerprints and an FBI criminal history records check for 
access to safeguards information, safeguards information-modified 
handling, or risk significant material such as special nuclear material 
or large quantities of uranium hexafluoride. These individuals shall be 
subject to the reinvestigation requirement.
    (c) Reinvestigations. Licensees shall conduct a reinvestigation 
every 10 years for any individual with unescorted access to category 1 
or category 2 quantities of radioactive material. The reinvestigation 
shall consist of fingerprinting and an FBI identification and criminal 
history records check in accordance with Sec.37.27. The 
reinvestigations must be completed within 10 years of the date on which 
these elements were last completed.



Sec.37.27  Requirements for criminal history records checks of
individuals granted unescorted access to category 1 or category 
2 quantities of radioactive material.
          

    (a) General performance objective and requirements. (1) Except for 
those individuals listed in Sec.37.29 and those individuals 
grandfathered under Sec.37.25(b), each licensee subject to the 
provisions of this subpart shall fingerprint each individual who is to 
be permitted unescorted access to category 1 or category 2 quantities of 
radioactive material. Licensees shall transmit all collected 
fingerprints to the Commission for transmission to the FBI. The licensee 
shall use the information received from the FBI as part of the required 
background investigation to determine whether to grant or deny further 
unescorted access to category 1 or category 2 quantities of radioactive 
materials for that individual.
    (2) The licensee shall notify each affected individual that his or 
her fingerprints will be used to secure a review of his or her criminal 
history record, and shall inform him or her of the procedures for 
revising the record or adding explanations to the record.
    (3) Fingerprinting is not required if a licensee is reinstating an 
individual's unescorted access authorization to category 1 or category 2 
quantities of radioactive materials if:
    (i) The individual returns to the same facility that granted 
unescorted access authorization within 365 days of the termination of 
his or her unescorted access authorization; and
    (ii) The previous access was terminated under favorable conditions.
    (4) Fingerprints do not need to be taken if an individual who is an 
employee of a licensee, contractor, manufacturer, or supplier has been 
granted unescorted access to category 1 or category 2 quantities of 
radioactive material, access to safeguards information, or safeguards 
information-modified handling by another licensee, based upon a 
background investigation conducted under this subpart, the Fingerprint 
Orders, or part 73 of this chapter. An existing criminal history records

[[Page 765]]

check file may be transferred to the licensee asked to grant unescorted 
access in accordance with the provisions of Sec.37.31(c).
    (5) Licensees shall use the information obtained as part of a 
criminal history records check solely for the purpose of determining an 
individual's suitability for unescorted access authorization to category 
1 or category 2 quantities of radioactive materials, access to 
safeguards information, or safeguards information-modified handling.
    (b) Prohibitions. (1) Licensees may not base a final determination 
to deny an individual unescorted access authorization to category 1 or 
category 2 quantities of radioactive material solely on the basis of 
information received from the FBI involving:
    (i) An arrest more than 1 year old for which there is no information 
of the disposition of the case; or
    (ii) An arrest that resulted in dismissal of the charge or an 
acquittal.
    (2) Licensees may not use information received from a criminal 
history records check obtained under this subpart in a manner that would 
infringe upon the rights of any individual under the First Amendment to 
the Constitution of the United States, nor shall licensees use the 
information in any way that would discriminate among individuals on the 
basis of race, religion, national origin, gender, or age.
    (c) Procedures for processing of fingerprint checks. (1) For the 
purpose of complying with this subpart, licensees shall use an 
appropriate method listed in Sec.37.7 to submit to the U.S. Nuclear 
Regulatory Commission, Director, Division of Facilities and Security, 
11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop TWB-05 
B32M, Rockville, Maryland 20852, one completed, legible standard 
fingerprint card (Form FD-258, ORIMDNRCOOOZ), electronic fingerprint 
scan or, where practicable, other fingerprint record for each individual 
requiring unescorted access to category 1 or category 2 quantities of 
radioactive material. Copies of these forms may be obtained by writing 
the Office of the Chief Information Officer, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, by calling 1-630-829-9565, or by 
email to [email protected]. Guidance on submitting electronic 
fingerprints can be found at http://www.nrc.gov/site-help/e-
submittals.html.
    (2) Fees for the processing of fingerprint checks are due upon 
application. Licensees shall submit payment with the application for the 
processing of fingerprints through corporate check, certified check, 
cashier's check, money order, or electronic payment, made payable to 
``U.S. NRC.'' (For guidance on making electronic payments, contact the 
Security Branch, Division of Facilities and Security at 301-492-3531.) 
Combined payment for multiple applications is acceptable. The Commission 
publishes the amount of the fingerprint check application fee on the 
NRC's public Web site. (To find the current fee amount, go to the 
Electronic Submittals page at http://www.nrc.gov/site-help/e-
submittals.html and see the link for the Criminal History Program under 
Electronic Submission Systems.)
    (3) The Commission will forward to the submitting licensee all data 
received from the FBI as a result of the licensee's application(s) for 
criminal history records checks.

[78 FR 17007, Mar. 19, 2013, as amended at 80 FR 74979, Dec. 1, 2015]



Sec.37.29  Relief from fingerprinting, identification, and criminal
history records checks and other elements of background investigations
for designated categories of individuals permitted unescorted access
to certain radioactive materials.
          

    (a) Fingerprinting, and the identification and criminal history 
records checks required by section 149 of the Atomic Energy Act of 1954, 
as amended, and other elements of the background investigation are not 
required for the following individuals prior to granting unescorted 
access to category 1 or category 2 quantities of radioactive materials:
    (1) An employee of the Commission or of the Executive Branch of the 
U.S. Government who has undergone fingerprinting for a prior U.S. 
Government criminal history records check;
    (2) A Member of Congress;
    (3) An employee of a member of Congress or Congressional committee 
who has undergone fingerprinting for a

[[Page 766]]

prior U.S. Government criminal history records check;
    (4) The Governor of a State or his or her designated State employee 
representative;
    (5) Federal, State, or local law enforcement personnel;
    (6) State Radiation Control Program Directors and State Homeland 
Security Advisors or their designated State employee representatives;
    (7) Agreement State employees conducting security inspections on 
behalf of the NRC under an agreement executed under section 274.i. of 
the Atomic Energy Act;
    (8) Representatives of the International Atomic Energy Agency (IAEA) 
engaged in activities associated with the U.S./IAEA Safeguards Agreement 
who have been certified by the NRC;
    (9) Emergency response personnel who are responding to an emergency;
    (10) Commercial vehicle drivers for road shipments of category 1 and 
category 2 quantities of radioactive material;
    (11) Package handlers at transportation facilities such as freight 
terminals and railroad yards;
    (12) Any individual who has an active Federal security clearance, 
provided that he or she makes available the appropriate documentation. 
Written confirmation from the agency/employer that granted the Federal 
security clearance or reviewed the criminal history records check must 
be provided to the licensee. The licensee shall retain this 
documentation for a period of 3 years from the date the individual no 
longer requires unescorted access to category 1 or category 2 quantities 
of radioactive material; and
    (13) Any individual employed by a service provider licensee for 
which the service provider licensee has conducted the background 
investigation for the individual and approved the individual for 
unescorted access to category 1 or category 2 quantities of radioactive 
material. Written verification from the service provider must be 
provided to the licensee. The licensee shall retain the documentation 
for a period of 3 years from the date the individual no longer requires 
unescorted access to category 1 or category 2 quantities of radioactive 
material.
    (b) Fingerprinting, and the identification and criminal history 
records checks required by section 149 of the Atomic Energy Act of 1954, 
as amended, are not required for an individual who has had a favorably 
adjudicated U.S. Government criminal history records check within the 
last 5 years, under a comparable U.S. Government program involving 
fingerprinting and an FBI identification and criminal history records 
check provided that he or she makes available the appropriate 
documentation. Written confirmation from the agency/employer that 
reviewed the criminal history records check must be provided to the 
licensee. The licensee shall retain this documentation for a period of 3 
years from the date the individual no longer requires unescorted access 
to category 1 or category 2 quantities of radioactive material. These 
programs include, but are not limited to:
    (1) National Agency Check;
    (2) Transportation Worker Identification Credentials (TWIC) under 49 
CFR part 1572;
    (3) Bureau of Alcohol, Tobacco, Firearms, and Explosives background 
check and clearances under 27 CFR part 555;
    (4) Health and Human Services security risk assessments for 
possession and use of select agents and toxins under 42 CFR part 73;
    (5) Hazardous Material security threat assessment for hazardous 
material endorsement to commercial drivers license under 49 CFR part 
1572; and
    (6) Customs and Border Protection's Free and Secure Trade (FAST) 
Program.

[78 FR 17007, Mar. 19, 2013, as amended at 79 FR 58671, Sept. 30, 2014]



Sec.37.31  Protection of information.

    (a) Each licensee who obtains background information on an 
individual under this subpart shall establish and maintain a system of 
files and written procedures for protection of the record and the 
personal information from unauthorized disclosure.
    (b) The licensee may not disclose the record or personal information 
collected and maintained to persons other

[[Page 767]]

than the subject individual, his or her representative, or to those who 
have a need to have access to the information in performing assigned 
duties in the process of granting or denying unescorted access to 
category 1 or category 2 quantities of radioactive material, safeguards 
information, or safeguards information-modified handling. No individual 
authorized to have access to the information may disseminate the 
information to any other individual who does not have a need to know.
    (c) The personal information obtained on an individual from a 
background investigation may be provided to another licensee:
    (1) Upon the individual's written request to the licensee holding 
the data to disseminate the information contained in his or her file; 
and
    (2) The recipient licensee verifies information such as name, date 
of birth, social security number, gender, and other applicable physical 
characteristics.
    (d) The licensee shall make background investigation records 
obtained under this subpart available for examination by an authorized 
representative of the NRC to determine compliance with the regulations 
and laws.
    (e) The licensee shall retain all fingerprint and criminal history 
records (including data indicating no record) received from the FBI, or 
a copy of these records if the individual's file has been transferred, 
on an individual for 3 years from the date the individual no longer 
requires unescorted access to category 1 or category 2 quantities of 
radioactive material.



Sec.37.33  Access authorization program review.

    (a) Each licensee shall be responsible for the continuing 
effectiveness of the access authorization program. Each licensee shall 
ensure that access authorization programs are reviewed to confirm 
compliance with the requirements of this subpart and that comprehensive 
actions are taken to correct any noncompliance that is identified. The 
review program shall evaluate all program performance objectives and 
requirements. Each licensee shall periodically (at least annually) 
review the access program content and implementation.
    (b) The results of the reviews, along with any recommendations, must 
be documented. Each review report must identify conditions that are 
adverse to the proper performance of the access authorization program, 
the cause of the condition(s), and, when appropriate, recommend 
corrective actions, and corrective actions taken. The licensee shall 
review the findings and take any additional corrective actions necessary 
to preclude repetition of the condition, including reassessment of the 
deficient areas where indicated.
    (c) Review records must be maintained for 3 years.



          Subpart C_Physical Protection Requirements During Use



Sec.37.41  Security program.

    (a) Applicability. (1) Each licensee that possesses an aggregated 
category 1 or category 2 quantity of radioactive material shall 
establish, implement, and maintain a security program in accordance with 
the requirements of this subpart.
    (2) An applicant for a new license and each licensee that would 
become newly subject to the requirements of this subpart upon 
application for modification of its license shall implement the 
requirements of this subpart, as appropriate, before taking possession 
of an aggregated category 1 or category 2 quantity of radioactive 
material.
    (3) Any licensee that has not previously implemented the Security 
Orders or been subject to the provisions of subpart C shall provide 
written notification to the NRC regional office specified in Sec.30.6 
of this chapter at least 90 days before aggregating radioactive material 
to a quantity that equals or exceeds the category 2 threshold.
    (b) General performance objective. Each licensee shall establish, 
implement, and maintain a security program that is designed to monitor 
and, without delay, detect, assess, and respond to an actual or 
attempted unauthorized access to category 1 or category 2 quantities of 
radioactive material.

[[Page 768]]

    (c) Program features. Each licensee's security program must include 
the program features, as appropriate, described in Sec. Sec.37.43, 
37.45, 37.47, 37.49, 37.51, 37.53, and 37.55.



Sec.37.43  General security program requirements.

    (a) Security plan. (1) Each licensee identified in Sec.37.41(a) 
shall develop a written security plan specific to its facilities and 
operations. The purpose of the security plan is to establish the 
licensee's overall security strategy to ensure the integrated and 
effective functioning of the security program required by this subpart. 
The security plan must, at a minimum:
    (i) Describe the measures and strategies used to implement the 
requirements of this subpart; and
    (ii) Identify the security resources, equipment, and technology used 
to satisfy the requirements of this subpart.
    (2) The security plan must be reviewed and approved by the 
individual with overall responsibility for the security program.
    (3) A licensee shall revise its security plan as necessary to ensure 
the effective implementation of Commission requirements. The licensee 
shall ensure that:
    (i) The revision has been reviewed and approved by the individual 
with overall responsibility for the security program; and
    (ii) The affected individuals are instructed on the revised plan 
before the changes are implemented.
    (4) The licensee shall retain a copy of the current security plan as 
a record for 3 years after the security plan is no longer required. If 
any portion of the plan is superseded, the licensee shall retain the 
superseded material for 3 years after the record is superseded.
    (b) Implementing procedures. (1) The licensee shall develop and 
maintain written procedures that document how the requirements of this 
subpart and the security plan will be met.
    (2) The implementing procedures and revisions to these procedures 
must be approved in writing by the individual with overall 
responsibility for the security program.
    (3) The licensee shall retain a copy of the current procedure as a 
record for 3 years after the procedure is no longer needed. Superseded 
portions of the procedure must be retained for 3 years after the record 
is superseded.
    (c) Training. (1) Each licensee shall conduct training to ensure 
that those individuals implementing the security program possess and 
maintain the knowledge, skills, and abilities to carry out their 
assigned duties and responsibilities effectively. The training must 
include instruction in:
    (i) The licensee's security program and procedures to secure 
category 1 or category 2 quantities of radioactive material, and in the 
purposes and functions of the security measures employed;
    (ii) The responsibility to report promptly to the licensee any 
condition that causes or may cause a violation of Commission 
requirements;
    (iii) The responsibility of the licensee to report promptly to the 
local law enforcement agency and licensee any actual or attempted theft, 
sabotage, or diversion of category 1 or category 2 quantities of 
radioactive material; and
    (iv) The appropriate response to security alarms.
    (2) In determining those individuals who shall be trained on the 
security program, the licensee shall consider each individual's assigned 
activities during authorized use and response to potential situations 
involving actual or attempted theft, diversion, or sabotage of category 
1 or category 2 quantities of radioactive material. The extent of the 
training must be commensurate with the individual's potential 
involvement in the security of category 1 or category 2 quantities of 
radioactive material.
    (3) Refresher training must be provided at a frequency not to exceed 
12 months and when significant changes have been made to the security 
program. This training must include:
    (i) Review of the training requirements of paragraph (c) of this 
section and any changes made to the security program since the last 
training;
    (ii) Reports on any relevant security issues, problems, and lessons 
learned;
    (iii) Relevant results of NRC inspections; and

[[Page 769]]

    (iv) Relevant results of the licensee's program review and testing 
and maintenance.
    (4) The licensee shall maintain records of the initial and refresher 
training for 3 years from the date of the training. The training records 
must include dates of the training, topics covered, a list of licensee 
personnel in attendance, and related information.
    (d) Protection of information. (1) Licensees authorized to possess 
category 1 or category 2 quantities of radioactive material shall limit 
access to and unauthorized disclosure of their security plan, 
implementing procedures, and the list of individuals that have been 
approved for unescorted access.
    (2) Efforts to limit access shall include the development, 
implementation, and maintenance of written policies and procedures for 
controlling access to, and for proper handling and protection against 
unauthorized disclosure of, the security plan, implementing procedures, 
and the list of individuals that have been approved for unescorted 
access.
    (3) Before granting an individual access to the security plan, 
implementing procedures, or the list of individuals that have been 
approved for unescorted access, licensees shall:
    (i) Evaluate an individual's need to know the security plan, 
implementing procedures, or the list of individuals that have been 
approved for unescorted access; and
    (ii) If the individual has not been authorized for unescorted access 
to category 1 or category 2 quantities of radioactive material, 
safeguards information, or safeguards information-modified handling, the 
licensee must complete a background investigation to determine the 
individual's trustworthiness and reliability. A trustworthiness and 
reliability determination shall be conducted by the reviewing official 
and shall include the background investigation elements contained in 
Sec.37.25(a)(2) through (a)(7).
    (4) Licensees need not subject the following individuals to the 
background investigation elements for protection of information:
    (i) The categories of individuals listed in Sec.37.29(a)(1) 
through (13); or
    (ii) Security service provider employees, provided written 
verification that the employee has been determined to be trustworthy and 
reliable, by the required background investigation in Sec.37.25(a)(2) 
through (a)(7), has been provided by the security service provider.
    (5) The licensee shall document the basis for concluding that an 
individual is trustworthy and reliable and should be granted access to 
the security plan, implementing procedures, or the list of individuals 
that have been approved for unescorted access.
    (6) Licensees shall maintain a list of persons currently approved 
for access to the security plan, implementing procedures, or the list of 
individuals that have been approved for unescorted access. When a 
licensee determines that a person no longer needs access to the security 
plan, implementing procedures, or the list of individuals that have been 
approved for unescorted access, or no longer meets the access 
authorization requirements for access to the information, the licensee 
shall remove the person from the approved list as soon as possible, but 
no later than 7 working days, and take prompt measures to ensure that 
the individual is unable to obtain the security plan, implementing 
procedures, or the list of individuals that have been approved for 
unescorted access.
    (7) When not in use, the licensee shall store its security plan, 
implementing procedures, and the list of individuals that have been 
approved for unescorted access in a manner to prevent unauthorized 
access. Information stored in nonremovable electronic form must be 
password protected.
    (8) The licensee shall retain as a record for 3 years after the 
document is no longer needed:
    (i) A copy of the information protection procedures; and
    (ii) The list of individuals approved for access to the security 
plan, implementing procedures, or the list of individuals that have been 
approved for unescorted access.

[78 FR 17007, Mar. 19, 2013, as amended at 79 FR 58671, Sept. 30, 2014; 
83 FR 30287, June 28, 2018]

[[Page 770]]



Sec.37.45  LLEA coordination.

    (a) A licensee subject to this subpart shall coordinate, to the 
extent practicable, with an LLEA for responding to threats to the 
licensee's facility, including any necessary armed response. The 
information provided to the LLEA must include:
    (1) A description of the facilities and the category 1 and category 
2 quantities of radioactive materials along with a description of the 
licensee's security measures that have been implemented to comply with 
this subpart; and
    (2) A notification that the licensee will request a timely armed 
response by the LLEA to any actual or attempted theft, sabotage, or 
diversion of category 1 or category 2 quantities of material.
    (b) The licensee shall notify the appropriate NRC regional office 
listed in Sec.30.6(b)(2) of this chapter within 3 business days if:
    (1) The LLEA has not responded to the request for coordination 
within 60 days of the coordination request; or
    (2) The LLEA notifies the licensee that the LLEA does not plan to 
participate in coordination activities.
    (c) The licensee shall document its efforts to coordinate with the 
LLEA. The documentation must be kept for 3 years.
    (d) The licensee shall coordinate with the LLEA at least every 12 
months, or when changes to the facility design or operation adversely 
affect the potential vulnerability of the licensee's material to theft, 
sabotage, or diversion.

[78 FR 17007, Mar. 19, 2013, as amended at 83 FR 30288, June 28, 2018]



Sec.37.47  Security zones.

    (a) Licensees shall ensure that all aggregated category 1 and 
category 2 quantities of radioactive material are used or stored within 
licensee-established security zones. Security zones may be permanent or 
temporary.
    (b) Temporary security zones must be established as necessary to 
meet the licensee's transitory or intermittent business activities, such 
as periods of maintenance, source delivery, and source replacement.
    (c) Security zones must, at a minimum, allow unescorted access only 
to approved individuals through:
    (1) Isolation of category 1 and category 2 quantities of radioactive 
materials by the use of continuous physical barriers that allow access 
to the security zone only through established access control points. A 
physical barrier is a natural or man-made structure or formation 
sufficient for the isolation of the category 1 or category 2 quantities 
of radioactive material within a security zone; or
    (2) Direct control of the security zone by approved individuals at 
all times; or
    (3) A combination of continuous physical barriers and direct 
control.
    (d) For category 1 quantities of radioactive material during periods 
of maintenance, source receipt, preparation for shipment, installation, 
or source removal or exchange, the licensee shall, at a minimum, provide 
sufficient individuals approved for unescorted access to maintain 
continuous surveillance of sources in temporary security zones and in 
any security zone in which physical barriers or intrusion detection 
systems have been disabled to allow such activities.
    (e) Individuals not approved for unescorted access to category 1 or 
category 2 quantities of radioactive material must be escorted by an 
approved individual when in a security zone.



Sec.37.49  Monitoring, detection, and assessment.

    (a) Monitoring and detection. (1) Licensees shall establish and 
maintain the capability to continuously monitor and detect without delay 
all unauthorized entries into its security zones. Licensees shall 
provide the means to maintain continuous monitoring and detection 
capability in the event of a loss of the primary power source, or 
provide for an alarm and response in the event of a loss of this 
capability to continuously monitor and detect unauthorized entries.
    (2) Monitoring and detection must be performed by:
    (i) A monitored intrusion detection system that is linked to an 
onsite or offsite central monitoring facility; or

[[Page 771]]

    (ii) Electronic devices for intrusion detection alarms that will 
alert nearby facility personnel; or
    (iii) A monitored video surveillance system; or
    (iv) Direct visual surveillance by approved individuals located 
within the security zone; or
    (v) Direct visual surveillance by a licensee designated individual 
located outside the security zone.
    (3) A licensee subject to this subpart shall also have a means to 
detect unauthorized removal of the radioactive material from the 
security zone. This detection capability must provide:
    (i) For category 1 quantities of radioactive material, immediate 
detection of any attempted unauthorized removal of the radioactive 
material from the security zone. Such immediate detection capability 
must be provided by:
    (A) Electronic sensors linked to an alarm; or
    (B) Continuous monitored video surveillance; or
    (C) Direct visual surveillance.
    (ii) For category 2 quantities of radioactive material, weekly 
verification through physical checks, tamper indicating devices, use, or 
other means to ensure that the radioactive material is present.
    (b) Assessment. Licensees shall immediately assess each actual or 
attempted unauthorized entry into the security zone to determine whether 
the unauthorized access was an actual or attempted theft, sabotage, or 
diversion.
    (c) Personnel communications and data transmission. For personnel 
and automated or electronic systems supporting the licensee's 
monitoring, detection, and assessment systems, licensees shall:
    (1) Maintain continuous capability for personnel communication and 
electronic data transmission and processing among site security systems; 
and
    (2) Provide an alternative communication capability for personnel, 
and an alternative data transmission and processing capability, in the 
event of a loss of the primary means of communication or data 
transmission and processing. Alternative communications and data 
transmission systems may not be subject to the same failure modes as the 
primary systems.
    (d) Response. Licensees shall immediately respond to any actual or 
attempted unauthorized access to the security zones, or actual or 
attempted theft, sabotage, or diversion of category 1 or category 2 
quantities of radioactive material at licensee facilities or temporary 
job sites. For any unauthorized access involving an actual or attempted 
theft, sabotage, or diversion of category 1 or category 2 quantities of 
radioactive material, the licensee's response shall include requesting, 
without delay, an armed response from the LLEA.



Sec.37.51  Maintenance and testing.

    (a) Each licensee subject to this subpart shall implement a 
maintenance and testing program to ensure that intrusion alarms, 
associated communication systems, and other physical components of the 
systems used to secure or detect unauthorized access to radioactive 
material are maintained in operable condition and are capable of 
performing their intended function when needed. The equipment relied on 
to meet the security requirements of this part must be inspected and 
tested for operability and performance at the manufacturer's suggested 
frequency. If there is no suggested manufacturer's suggested frequency, 
the testing must be performed at least annually, not to exceed 12 
months.
    (b) The licensee shall maintain records on the maintenance and 
testing activities for 3 years.



Sec.37.53  Requirements for mobile devices.

    Each licensee that possesses mobile devices containing category 1 or 
category 2 quantities of radioactive material must:
    (a) Have two independent physical controls that form tangible 
barriers to secure the material from unauthorized removal when the 
device is not under direct control and constant surveillance by the 
licensee; and
    (b) For devices in or on a vehicle or trailer, unless the health and 
safety requirements for a site prohibit the disabling of the vehicle, 
the licensee shall utilize a method to disable the vehicle

[[Page 772]]

or trailer when not under direct control and constant surveillance by 
the licensee. Licensees shall not rely on the removal of an ignition key 
to meet this requirement.



Sec.37.55  Security program review.

    (a) Each licensee shall be responsible for the continuing 
effectiveness of the security program. Each licensee shall ensure that 
the security program is reviewed to confirm compliance with the 
requirements of this subpart and that comprehensive actions are taken to 
correct any noncompliance that is identified. The review must include 
the radioactive material security program content and implementation. 
Each licensee shall periodically (at least annually) review the security 
program content and implementation.
    (b) The results of the review, along with any recommendations, must 
be documented. Each review report must identify conditions that are 
adverse to the proper performance of the security program, the cause of 
the condition(s), and, when appropriate, recommend corrective actions, 
and corrective actions taken. The licensee shall review the findings and 
take any additional corrective actions necessary to preclude repetition 
of the condition, including reassessment of the deficient areas where 
indicated.
    (c) The licensee shall maintain the review documentation for 3 
years.



Sec.37.57  Reporting of events.

    (a) The licensee shall immediately notify the LLEA after determining 
that an unauthorized entry resulted in an actual or attempted theft, 
sabotage, or diversion of a category 1 or category 2 quantity of 
radioactive material. As soon as possible after initiating a response, 
but not at the expense of causing delay or interfering with the LLEA 
response to the event, the licensee shall notify the NRC's Operations 
Center (301-816-5100). In no case shall the notification to the NRC be 
later than 4 hours after the discovery of any attempted or actual theft, 
sabotage, or diversion.
    (b) The licensee shall assess any suspicious activity related to 
possible theft, sabotage, or diversion of category 1 or category 2 
quantities of radioactive material and notify the LLEA as appropriate. 
As soon as possible but not later than 4 hours after notifying the LLEA, 
the licensee shall notify the NRC's Operations Center (301-816-5100).
    (c) The initial telephonic notification required by paragraph (a) of 
this section must be followed within a period of 30 days by a written 
report submitted to the NRC by an appropriate method listed in Sec.
37.7. The report must include sufficient information for NRC analysis 
and evaluation, including identification of any necessary corrective 
actions to prevent future instances.



                Subpart D_Physical Protection in Transit



Sec.37.71  Additional requirements for transfer of category 1 and
category 2 quantities of radioactive material.

    A licensee transferring a category 1 or category 2 quantity of 
radioactive material to a licensee of the Commission or an Agreement 
State shall meet the license verification provisions listed below 
instead of those listed in Sec.30.41(d) of this chapter:
    (a) Any licensee transferring category 1 quantities of radioactive 
material to a licensee of the Commission or an Agreement State, prior to 
conducting such transfer, shall verify with the NRC's license 
verification system or the license issuing authority that the 
transferee's license authorizes the receipt of the type, form, and 
quantity of radioactive material to be transferred and that the licensee 
is authorized to receive radioactive material at the location requested 
for delivery. If the verification is conducted by contacting the license 
issuing authority, the transferor shall document the verification. For 
transfers within the same organization, the licensee does not need to 
verify the transfer.
    (b) Any licensee transferring category 2 quantities of radioactive 
material to a licensee of the Commission or an Agreement State, prior to 
conducting such transfer, shall verify with the NRC's license 
verification system or the license issuing authority that the 
transferee's license authorizes the receipt of the type, form, and 
quantity

[[Page 773]]

of radioactive material to be transferred. If the verification is 
conducted by contacting the license issuing authority, the transferor 
shall document the verification. For transfers within the same 
organization, the licensee does not need to verify the transfer.
    (c) In an emergency where the licensee cannot reach the license 
issuing authority and the license verification system is nonfunctional, 
the licensee may accept a written certification by the transferee that 
it is authorized by license to receive the type, form, and quantity of 
radioactive material to be transferred. The certification must include 
the license number, current revision number, issuing agency, expiration 
date, and for a category 1 shipment the authorized address. The licensee 
shall keep a copy of the certification. The certification must be 
confirmed by use of the NRC's license verification system or by 
contacting the license issuing authority by the end of the next business 
day.
    (d) The transferor shall keep a copy of the verification 
documentation as a record for 3 years.



Sec.37.73  Applicability of physical protection of category 1 and
category 2 quantities of radioactive material during transit.

    (a) For shipments of category 1 quantities of radioactive material, 
each shipping licensee shall comply with the requirements for physical 
protection contained in Sec. Sec.37.75(a) and (e); 37.77; 37.79(a)(1), 
(b)(1), and (c); and 37.81(a), (c), (e), (g) and (h).
    (b) For shipments of category 2 quantities of radioactive material, 
each shipping licensee shall comply with the requirements for physical 
protection contained in Sec. Sec.37.75(b) through (e); 37.79(a)(2), 
(a)(3), (b)(2), and (c); and 37.81(b), (d), (f), (g), and (h). For those 
shipments of category 2 quantities of radioactive material that meet the 
criteria of Sec.71.97(b) of this chapter, the shipping licensee shall 
also comply with the advance notification provisions of Sec.71.97 of 
this chapter.
    (c) The shipping licensee shall be responsible for meeting the 
requirements of this subpart unless the receiving licensee has agreed in 
writing to arrange for the in-transit physical protection required under 
this subpart.
    (d) Each licensee that imports or exports category 1 quantities of 
radioactive material shall comply with the requirements for physical 
protection during transit contained in Sec. Sec.37.75(a)(2) and (e); 
37.77; 37.79(a)(1), (b)(1), and (c); and 37.81(a), (c), (e), (g), and 
(h) for the domestic portion of the shipment.
    (e) Each licensee that imports or exports category 2 quantities of 
radioactive material shall comply with the requirements for physical 
protection during transit contained in Sec. Sec.37.79(a)(2), (a)(3), 
and (b)(2); and 37.81(b), (d), (f), (g), and (h) for the domestic 
portion of the shipment.



Sec.37.75  Preplanning and coordination of shipment of category 1
or category 2 quantities of radioactive material.

    (a) Each licensee that plans to transport, or deliver to a carrier 
for transport, licensed material that is a category 1 quantity of 
radioactive material outside the confines of the licensee's facility or 
other place of use or storage shall:
    (1) Preplan and coordinate shipment arrival and departure times with 
the receiving licensee;
    (2) Preplan and coordinate shipment information with the governor or 
the governor's designee of any State through which the shipment will 
pass to:
    (i) Discuss the State's intention to provide law enforcement 
escorts; and
    (ii) Identify safe havens; and
    (3) Document the preplanning and coordination activities.
    (b) Each licensee that plans to transport, or deliver to a carrier 
for transport, licensed material that is a category 2 quantity of 
radioactive material outside the confines of the licensee's facility or 
other place of use or storage shall coordinate the shipment no-later-
than arrival time and the expected shipment arrival with the receiving 
licensee. The licensee shall document the coordination activities.
    (c) Each licensee who receives a shipment of a category 2 quantity 
of radioactive material shall confirm receipt of the shipment with the 
originator. If the shipment has not arrived by the

[[Page 774]]

no-later-than arrival time, the receiving licensee shall notify the 
originator.
    (d) Each licensee, who transports or plans to transport a shipment 
of a category 2 quantity of radioactive material, and determines that 
the shipment will arrive after the no-later-than arrival time provided 
pursuant to paragraph (b) of this section, shall promptly notify the 
receiving licensee of the new no-later-than arrival time.
    (e) The licensee shall retain a copy of the documentation for 
preplanning and coordination and any revision thereof, as a record for 3 
years.



Sec.37.77  Advance notification of shipment of category 1 quantities
of radioactive material.

    As specified in paragraphs (a) and (b) of this section, each 
licensee shall provide advance notification to the NRC and the governor 
of a State, or the governor's designee, of the shipment of licensed 
material in a category 1 quantity, through or across the boundary of the 
State, before the transport, or delivery to a carrier for transport of 
the licensed material outside the confines of the licensee's facility or 
other place of use or storage.
    (a) Procedures for submitting advance notification. (1) The 
notification must be made to the NRC and to the office of each 
appropriate governor or governor's designee. The contact information, 
including telephone and mailing addresses, of governors and governors' 
designees, is available on the NRC's Web site at  https://scp.nrc.gov/
special/designee.pdf. A list of the contact information is also 
available upon request from the Director, Division of Materials Safety, 
Security, State, and Tribal Programs , Office of Nuclear Material Safety 
and Safeguards., U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001. Notifications to the NRC must be to the NRC's Director, 
Office of Nuclear Security and Incident Response, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001. The notification to 
the NRC may be made by email to [email protected] or by fax to 
301-816-5151.
    (2) A notification delivered by mail must be postmarked at least 7 
days before transport of the shipment commences at the shipping 
facility.
    (3) A notification delivered by any means other than mail must reach 
NRC at least 4 days before the transport of the shipment commences and 
must reach the office of the governor or the governor's designee at 
least 4 days before transport of a shipment within or through the State.
    (b) Information to be furnished in advance notification of shipment. 
Each advance notification of shipment of category 1 quantities of 
radioactive material must contain the following information, if 
available at the time of notification:
    (1) The name, address, and telephone number of the shipper, carrier, 
and receiver of the category 1 radioactive material;
    (2) The license numbers of the shipper and receiver;
    (3) A description of the radioactive material contained in the 
shipment, including the radionuclides and quantity;
    (4) The point of origin of the shipment and the estimated time and 
date that shipment will commence;
    (5) The estimated time and date that the shipment is expected to 
enter each State along the route;
    (6) The estimated time and date of arrival of the shipment at the 
destination; and
    (7) A point of contact, with a telephone number, for current 
shipment information.
    (c) Revision notice. (1) The licensee shall provide any information 
not previously available at the time of the initial notification, as 
soon as the information becomes available but not later than 
commencement of the shipment, to the governor of the State or the 
governor's designee and to the NRC's Director, Office and Incident 
Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
    (2) A licensee shall promptly notify the governor of the State or 
the governor's designee of any changes to the information provided in 
accordance with paragraphs (b) and (c)(1) of this section. The licensee 
shall also immediately notify the NRC's Director, Office of Nuclear 
Security and Incident Response, U.S. Nuclear Regulatory

[[Page 775]]

Commission, Washington, DC 20555-0001 of any such changes.
    (d) Cancellation notice. Each licensee who cancels a shipment for 
which advance notification has been sent shall send a cancellation 
notice to the governor of each State or to the governor's designee 
previously notified and to the NRC's Director, Office of Nuclear 
Security and Incident Response, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001. The licensee shall send the cancellation 
notice before the shipment would have commenced or as soon thereafter as 
possible. The licensee shall state in the notice that it is a 
cancellation and identify the advance notification that is being 
cancelled.
    (e) Records. The licensee shall retain a copy of the advance 
notification and any revision and cancellation notices as a record for 3 
years.
    (f) Protection of information. State officials, State employees, and 
other individuals, whether or not licensees of the Commission or an 
Agreement State, who receive schedule information of the kind specified 
in Sec.37.77(b) shall protect that information against unauthorized 
disclosure as specified in Sec.37.43(d) of this part.

[78 FR 17007, Mar. 19, 2013; 78 FR 31821, May 28, 2013; 79 FR 58671, 
Sept. 30, 2014; 80 FR 74979, Dec. 1, 2015; 83 FR 30288, June 28, 2018; 
83 FR 58723, Nov. 21, 2018]



Sec.37.79  Requirements for physical protection of category 1 and
category 2 quantities of radioactive material during shipment.

    (a) Shipments by road. (1) Each licensee who transports, or delivers 
to a carrier for transport, in a single shipment, a category 1 quantity 
of radioactive material shall:
    (i) Ensure that movement control centers are established that 
maintain position information from a remote location. These control 
centers must monitor shipments 24 hours a day, 7 days a week, and have 
the ability to communicate immediately, in an emergency, with the 
appropriate law enforcement agencies.
    (ii) Ensure that redundant communications are established that allow 
the transport to contact the escort vehicle (when used) and movement 
control center at all times. Redundant communications may not be subject 
to the same interference factors as the primary communication.
    (iii) Ensure that shipments are continuously and actively monitored 
by a telemetric position monitoring system or an alternative tracking 
system reporting to a movement control center. A movement control center 
must provide positive confirmation of the location, status, and control 
over the shipment. The movement control center must be prepared to 
promptly implement preplanned procedures in response to deviations from 
the authorized route or a notification of actual, attempted, or 
suspicious activities related to the theft, loss, or diversion of a 
shipment. These procedures will include, but not be limited to, the 
identification of and contact information for the appropriate LLEA along 
the shipment route.
    (iv) Provide an individual to accompany the driver for those highway 
shipments with a driving time period greater than the maximum number of 
allowable hours of service in a 24-hour duty day as established by the 
Department of Transportation Federal Motor Carrier Safety 
Administration. The accompanying individual may be another driver.
    (v) Develop written normal and contingency procedures to address:
    (A) Notifications to the communication center and law enforcement 
agencies;
    (B) Communication protocols. Communication protocols must include a 
strategy for the use of authentication codes and duress codes and 
provisions for refueling or other stops, detours, and locations where 
communication is expected to be temporarily lost;
    (C) Loss of communications; and
    (D) Responses to an actual or attempted theft or diversion of a 
shipment.
    (vi) Each licensee who makes arrangements for the shipment of 
category 1 quantities of radioactive material shall ensure that drivers, 
accompanying personnel, and movement control center personnel have 
access to the normal and contingency procedures.

[[Page 776]]

    (2) Each licensee that transports category 2 quantities of 
radioactive material shall maintain constant control and/or surveillance 
during transit and have the capability for immediate communication to 
summon appropriate response or assistance.
    (3) Each licensee who delivers to a carrier for transport, in a 
single shipment, a category 2 quantity of radioactive material shall:
    (i) Use carriers that have established package tracking systems. An 
established package tracking system is a documented, proven, and 
reliable system routinely used to transport objects of value. In order 
for a package tracking system to maintain constant control and/or 
surveillance, the package tracking system must allow the shipper or 
transporter to identify when and where the package was last and when it 
should arrive at the next point of control.
    (ii) Use carriers that maintain constant control and/or surveillance 
during transit and have the capability for immediate communication to 
summon appropriate response or assistance; and
    (iii) Use carriers that have established tracking systems that 
require an authorized signature prior to releasing the package for 
delivery or return.
    (b) Shipments by rail. (1) Each licensee who transports, or delivers 
to a carrier for transport, in a single shipment, a category 1 quantity 
of radioactive material shall:
    (i) Ensure that rail shipments are monitored by a telemetric 
position monitoring system or an alternative tracking system reporting 
to the licensee, third-party, or railroad communications center. The 
communications center shall provide positive confirmation of the 
location of the shipment and its status. The communications center shall 
implement preplanned procedures in response to deviations from the 
authorized route or to a notification of actual, attempted, or 
suspicious activities related to the theft or diversion of a shipment. 
These procedures will include, but not be limited to, the identification 
of and contact information for the appropriate LLEA along the shipment 
route.
    (ii) Ensure that periodic reports to the communications center are 
made at preset intervals.
    (2) Each licensee who transports, or delivers to a carrier for 
transport, in a single shipment, a category 2 quantity of radioactive 
material shall:
    (i) Use carriers that have established package tracking systems. An 
established package tracking system is a documented, proven, and 
reliable system routinely used to transport objects of value. In order 
for a package tracking system to maintain constant control and/or 
surveillance, the package tracking system must allow the shipper or 
transporter to identify when and where the package was last and when it 
should arrive at the next point of control.
    (ii) Use carriers that maintain constant control and/or surveillance 
during transit and have the capability for immediate communication to 
summon appropriate response or assistance; and
    (iii) Use carriers that have established tracking systems that 
require an authorized signature prior to releasing the package for 
delivery or return.
    (c) Investigations. Each licensee who makes arrangements for the 
shipment of category 1 quantities of radioactive material shall 
immediately conduct an investigation upon the discovery that a category 
1 shipment is lost or missing. Each licensee who makes arrangements for 
the shipment of category 2 quantities of radioactive material shall 
immediately conduct an investigation, in coordination with the receiving 
licensee, of any shipment that has not arrived by the designated no-
later-than arrival time.



Sec.37.81  Reporting of events.

    (a) The shipping licensee shall notify the appropriate LLEA and the 
NRC's Operations Center (301-816-5100) within 1 hour of its 
determination that a shipment of category 1 quantities of radioactive 
material is lost or missing. The appropriate LLEA would be the law 
enforcement agency in the area of the shipment's last confirmed 
location. During the investigation required by Sec.37.79(c), the 
shipping licensee will provide agreed upon updates to the NRC's 
Operations Center on the status of the investigation.

[[Page 777]]

    (b) The shipping licensee shall notify the NRC's Operations Center 
(301-816-5100) within 4 hours of its determination that a shipment of 
category 2 quantities of radioactive material is lost or missing. If, 
after 24 hours of its determination that the shipment is lost or 
missing, the radioactive material has not been located and secured, the 
licensee shall immediately notify the NRC's Operations Center.
    (c) The shipping licensee shall notify the designated LLEA along the 
shipment route as soon as possible upon discovery of any actual or 
attempted theft or diversion of a shipment or suspicious activities 
related to the theft or diversion of a shipment of a category 1 quantity 
of radioactive material. As soon as possible after notifying the LLEA, 
the licensee shall notify the NRC's Operations Center (301-816-5100) 
upon discovery of any actual or attempted theft or diversion of a 
shipment, or any suspicious activity related to the shipment of category 
1 radioactive material.
    (d) The shipping licensee shall notify the NRC's Operations Center 
(301-816-5100) as soon as possible upon discovery of any actual or 
attempted theft or diversion of a shipment, or any suspicious activity 
related to the shipment, of a category 2 quantity of radioactive 
material.
    (e) The shipping licensee shall notify the NRC's Operations Center 
(301-816-5100) and the LLEA as soon as possible upon recovery of any 
lost or missing category 1 quantities of radioactive material.
    (f) The shipping licensee shall notify the NRC's Operations Center 
(301-816-5100) as soon as possible upon recovery of any lost or missing 
category 2 quantities of radioactive material.
    (g) The initial telephonic notification required by paragraphs (a) 
through (d) of this section must be followed within a period of 30 days 
by a written report submitted to the NRC by an appropriate method listed 
in Sec.37.7. A written report is not required for notifications on 
suspicious activities required by paragraphs (c) and (d) of this 
section. The report must set forth the following information:
    (1) A description of the licensed material involved, including kind, 
quantity, and chemical and physical form;
    (2) A description of the circumstances under which the loss or theft 
occurred;
    (3) A statement of disposition, or probable disposition, of the 
licensed material involved;
    (4) Actions that have been taken, or will be taken, to recover the 
material; and
    (5) Procedures or measures that have been, or will be, adopted to 
ensure against a recurrence of the loss or theft of licensed material.
    (h) Subsequent to filing the written report, the licensee shall also 
report any additional substantive information on the loss or theft 
within 30 days after the licensee learns of such information.

[78 FR 17007, Mar. 19, 2013, as amended at 83 FR 58723, Nov. 21, 2018]

Subpart E [Reserved]



                            Subpart F_Records



Sec.37.101  Form of records.

    Each record required by this part must be legible throughout the 
retention period specified by each Commission regulation. The record may 
be the original or a reproduced copy or a microform, provided that the 
copy or microform is authenticated by authorized personnel and that the 
microform is capable of producing a clear copy throughout the required 
retention period. The record may also be stored in electronic media with 
the capability for producing legible, accurate, and complete records 
during the required retention period. Records such as letters, drawings, 
and specifications, must include all pertinent information such as 
stamps, initials, and signatures. The licensee shall maintain adequate 
safeguards against tampering with and loss of records.



Sec.37.103  Record retention.

    Licensees shall maintain the records that are required by the 
regulations in this part for the period specified by the appropriate 
regulation. If a retention period is not otherwise specified, these 
records must be retained until the

[[Page 778]]

Commission terminates the facility's license. All records related to 
this part may be destroyed upon Commission termination of the facility 
license.



                          Subpart G_Enforcement



Sec.37.105  Inspections.

    (a) Each licensee shall afford to the Commission at all reasonable 
times opportunity to inspect category 1 or category 2 quantities of 
radioactive material and the premises and facilities wherein the nuclear 
material is used, produced, or stored.
    (b) Each licensee shall make available to the Commission for 
inspection, upon reasonable notice, records kept by the licensee 
pertaining to its receipt, possession, use, acquisition, import, export, 
or transfer of category 1 or category 2 quantities of radioactive 
material.



Sec.37.107  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended:
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
Section 186 of the Atomic Energy Act of 1954, as amended.



Sec.37.109  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in this part 37 are issued under one or more of 
sections 161b, 161i, or 161o, except for the sections listed in 
paragraph (b) of this section.
    (b) The regulations in this part 37 that are not issued under 
sections 161b, 161i, or 161o for the purposes of section 223 are as 
follows: Sec. Sec.37.1, 37.3, 37.5, 37.7, 37.9, 37.11, 37.13, 37.107, 
and 37.109.



   Sec. Appendix A to Part 37--Category 1 and Category 2 Radioactive 
                                Materials

              Table 1--Category 1 and Category 2 Threshold

    The terabecquerel (TBq) values are the regulatory standard. The 
curie (Ci) values specified are obtained by converting from the TBq 
value. The curie values are provided for practical usefulness only.

----------------------------------------------------------------------------------------------------------------
                                                    Category 1      Category 1      Category 2      Category 2
              Radioactive material                     (TBq)           (Ci)            (TBq)           (Ci)
----------------------------------------------------------------------------------------------------------------
Americium-241...................................              60           1,620             0.6            16.2
Americium-241/Be................................              60           1,620             0.6            16.2
Californium-252.................................              20             540             0.2            5.40
Cobalt-60.......................................              30             810             0.3            8.10
Curium-244......................................              50           1,350             0.5            13.5
Cesium-137......................................             100           2,700               1            27.0
Gadolinium-153..................................           1,000          27,000              10             270
Iridium-192.....................................              80           2,160             0.8            21.6
Plutonium-238...................................              60           1,620             0.6            16.2
Plutonium-239/Be................................              60           1,620             0.6            16.2
Promethium-147..................................          40,000       1,080,000             400          10,800
Radium-226......................................              40           1,080             0.4            10.8
Selenium-75.....................................             200           5,400               2            54.0
Strontium-90....................................           1,000          27,000              10             270
Thulium-170.....................................          20,000         540,000             200           5,400

[[Page 779]]

 
Ytterbium-169...................................             300           8,100               3            81.0
----------------------------------------------------------------------------------------------------------------

    Note: Calculations Concerning Multiple Sources or Multiple 
Radionuclides
    The ''sum of fractions'' methodology for evaluating combinations of 
multiple sources or multiple radionuclides is to be used in determining 
whether a location meets or exceeds the threshold and is thus subject to 
the requirements of this part.
    I. If multiple sources of the same radionuclide and/or multiple 
radionuclides are aggregated at a location, the sum of the ratios of the 
total activity of each of the radionuclides must be determined to verify 
whether the activity at the location is less than the category 1 or 
category 2 thresholds of Table 1, as appropriate. If the calculated sum 
of the ratios, using the equation below, is greater than or equal to 
1.0, then the applicable requirements of this part apply.
    II. First determine the total activity for each radionuclide from 
Table 1. This is done by adding the activity of each individual source, 
material in any device, and any loose or bulk material that contains the 
radionuclide. Then use the equation below to calculate the sum of the 
ratios by inserting the total activity of the applicable radionuclides 
from Table 1 in the numerator of the equation and the corresponding 
threshold activity from Table 1 in the denominator of the equation. 
Calculations must be performed in metric values (i.e., TBq) and the 
numerator and denominator values must be in the same units.
R1 = total activity for radionuclide 1
R2 = total activity for radionuclide 2
RN = total activity for radionuclide n
AR1 = activity threshold for radionuclide 1
AR2 = activity threshold for radionuclide 2
ARN = activity threshold for radionuclide n
[GRAPHIC] [TIFF OMITTED] TR19MR13.000



PART 39_LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING
--Table of Contents



                      Subpart A_General Provisions

Sec.
39.1 Purpose and scope.
39.2 Definitions.
39.5 Interpretations.
39.8 Information collection requirements: OMB approval.

                Subpart B_Specific Licensing Requirements

39.11 Application for a specific license.
39.13 Specific licenses for well logging.
39.15 Agreement with well owner or operator.
39.17 Request for written statements.

                           Subpart C_Equipment

39.31 Labels, security, and transportation precautions.
39.33 Radiation detection instruments.
39.35 Leak testing of sealed sources.
39.37 Physical inventory.
39.39 Records of material use.
39.41 Design and performance criteria for sources.
39.43 Inspection, maintenance, and opening of a source or source holder.
39.45 Subsurface tracer studies.
39.47 Radioactive markers.
39.49 Uranium sinker bars.
39.51 Use of a sealed source in a well without surface casing.
39.53 Energy compensation source.
39.55 Tritium neutron generator target sources.

                 Subpart D_Radiation Safety Requirements

39.61 Training.
39.63 Operating and emergency procedures.
39.65 Personnel monitoring.
39.67 Radiation surveys.
39.69 Radioactive contamination control.

               Subpart E_Security, Records, Notifications

39.71 Security.
39.73 Documents and records required at field stations.
39.75 Documents and records required at temporary jobsites.
39.77 Notification of incidents and lost sources; abandonment procedures 
          for irretrievable sources.

[[Page 780]]

                          Subpart F_Exemptions

39.91 Applications for exemptions.

                          Subpart G_Enforcement

39.101 Violations.
39.103 Criminal penalties.

    Authority: Atomic Energy Act of 1954, secs. 53, 57, 62, 63, 65, 69, 
81, 161, 181, 182, 183, 223, 234 (42 U.S.C. 2073, 2077, 2092, 2093, 
2095, 2099, 2111, 2112, 2201, 2232, 2233, 2273, 2282); Energy 
Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); 44 
U.S.C. 3504 note.

    Source: 52 FR 8234, Mar. 17, 1987, unless otherwise noted.



                      Subpart A_General Provisions



Sec.39.1  Purpose and scope.

    (a) This part prescribes requirements for the issuance of a license 
authorizing the use of licensed materials including sealed sources, 
radioactive tracers, radioactive markers, and uranium sinker bars in 
well logging in a single well. This part also prescribes radiation 
safety requirements for persons using licensed materials in these 
operations. The provisions and requirements of this part are in addition 
to, and not in substitution for, other requirements of this chapter. In 
particular, the provisions of parts 19, 20, 21, 30, 37, 40, 70, 71, and 
150 of this chapter apply to applicants and licensees subject to this 
part.
    (b) The requirements set out in this part do not apply to the 
issuance of a license authorizing the use of licensed material in tracer 
studies involving multiple wells, such as field flooding studies, or to 
the use of sealed sources auxiliary to well logging but not lowered into 
wells.

[52 FR 8234, Mar. 17, 1987, as amended at 78 FR 17020, Mar. 19, 2013]



Sec.39.2  Definitions.

    Energy compensation source (ECS) means a small sealed source, with 
an activity not exceeding 3.7 MBq [100 microcuries], used within a 
logging tool, or other tool components, to provide a reference standard 
to maintain the tool's calibration when in use.
    Field station means a facility where licensed material may be stored 
or used and from which equipment is dispatched to temporary jobsites.
    Fresh water aquifer, for the purpose of this part, means a geologic 
formation that is capable of yielding fresh water to a well or spring.
    Injection tool means a device used for controlled subsurface 
injection of radioactive tracer material.
    Irretrievable well logging source means any sealed source containing 
licensed material that is pulled off or not connected to the wireline 
that suspends the source in the well and for which all reasonable effort 
at recovery has been expended.
    Licensed material means byproduct, source, or special nuclear 
material received, processed, used, or transferred under a license 
issued by the Commission under the regulations in this chapter.
    Logging assistant means any individual who, under the personal 
supervision of a logging supervisor, handles sealed sources or tracers 
that are not in logging tools or shipping containers or who performs 
surveys required by Sec.39.67.
    Logging supervisor means an individual who uses licensed material or 
provides personal supervision in the use of licensed material at a 
temporary jobsite and who is responsible to the licensee for assuring 
compliance with the requirements of the Commission's regulations and the 
conditions of the license.
    Logging tool means a device used subsurface to perform well logging.
    Personal supervision means guidance and instruction by a logging 
supervisor, who is physically present at a temporary jobsite, who is in 
personal contact with logging assistants, and who can give immediate 
assistance.
    Radioactive marker means licensed material used for depth 
determination or direction orientation. For purposes of this part, this 
term includes radioactive collar markers and radioactive iron nails.
    Safety review means a periodic review provided by the licensee for 
its employees on radiation safety aspects of well logging. The review 
may include, as appropriate, the results of internal inspections, new 
procedures or equipment, accidents or errors that have been observed, 
and opportunities for employees to ask safety questions.

[[Page 781]]

    Sealed source means any licensed material that is encased in a 
capsule designed to prevent leakage or escape of the licensed material.
    Source holder means a housing or assembly into which a sealed source 
is placed to facilitate the handling and use of the source in well 
logging.
    Subsurface tracer study means the release of unsealed license 
material or a substance labeled with licensed material in a single well 
for the purpose of tracing the movement or position of the material or 
substance in the well or adjacent formation.
    Surface casing for protecting fresh water aquifers means a pipe or 
tube used as a lining in a well to isolate fresh water aquifers from the 
well.
    Temporary jobsite means a place where licensed materials are present 
for the purpose of performing well logging or subsurface tracer studies.
    Tritium neutron generator target source means a tritium source used 
within a neutron generator tube to produce neutrons for use in well 
logging applications.
    Uranium sinker bar means a weight containing depleted uranium used 
to pull a logging tool toward the bottom of a well.
    Well means a drilled hole in which well logging may be performed. As 
used in this part, ``well'' includes drilled holes for the purpose of 
oil, gas, mineral, groundwater, or geological exploration.
    Well logging means all operations involving the lowering and raising 
of measuring devices or tools which contain licensed material or are 
used to detect licensed materials in wells for the purpose of obtaining 
information about the well or adjacent formations which may be used in 
oil, gas, mineral, groundwater, or geological exploration.

[52 FR 8234, Mar. 17, 1987, as amended at 65 FR 20344, Apr. 17, 2000]



Sec.39.5  Interpretations.

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



Sec.39.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S. 3501 et seq.) The NRC may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has 
approved the information collection requirements contained in this part 
under control number 3150-0130.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.39.11, 39.13, 39.15, 39.17, 39.31, 39.33, 
39.35, 39.37, 39.39, 39.43, 39.51, 39.61, 39.63, 39.65, 39.67, 39.73, 
39.75, 39.77, and 39.91.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec.39.11, NRC Form 313 is approved under control 3150-
0120.
    (2) [Reserved]

[62 FR 52187, Oct. 6, 1997, as amended at 67 FR 67099, Nov. 4, 2002]



                Subpart B_Specific Licensing Requirements



Sec.39.11  Application for a specific license.

    A person, as defined in Sec.30.4 of this chapter, shall file an 
application for a specific license authorizing the use of licensed 
material in well logging on Form NRC 313, ``Application for Material 
License.'' Each application for a license, other than a license exempted 
from part 170 of this chapter, must be accompanied by the fee prescribed 
in Sec.170.31 of this chapter. The application must be sent to the 
appropriate NRC Regional Office listed in appendix D of part 20 of this 
chapter.

[[Page 782]]



Sec.39.13  Specific licenses for well logging.

    The Commission will approve an application for a specific license 
for the use of licensed material in well logging if the applicant meets 
the following requirements:
    (a) The applicant shall satisfy the general requirements specified 
in Sec.30.33 of this chapter for byproduct material, in Sec.40.32 of 
this chapter for source material, and in Sec.70.23 of this chapter for 
special nuclear material, as appropriate, and any special requirements 
contained in this part.
    (b) The applicant shall develop a program for training logging 
supervisors and logging assistants and submit to the Commission a 
description of this program which specifies the--
    (1) Initial training;
    (2) On-the-job training;
    (3) Annual safety reviews provided by the licensee;
    (4) Means the applicant will use to demonstrate the logging 
supervisor's knowledge and understanding of and ability to comply with 
the Commission's regulations and licensing requirements and the 
applicant's operating and emergency procedures; and
    (5) Means the applicant will use to demonstrate the logging 
assistant's knowledge and understanding of and ability to comply with 
the applicant's operating and emergency procedures.
    (c) The applicant shall submit to the Commission written operating 
and emergency procedures as described in Sec.39.63 or an outline or 
summary of the procedures that includes the important radiation safety 
aspects of the procedures.
    (d) The applicant shall establish and submit to the Commission its 
program for annual inspections of the job performance of each logging 
supervisor to ensure that the Commission's regulations, license 
requirements, and the applicant's operating and emergency procedures are 
followed. Inspection records must be retained for 3 years after each 
annual internal inspection.
    (e) The applicant shall submit a description of its overall 
organizational structure as it applies to the radiation safety 
responsibilities in well logging, including specified delegations of 
authority and responsibility.
    (f) If an applicant wants to perform leak testing of sealed sources, 
the applicant shall identify the manufacturers and the model numbers of 
the leak test kits to be used. If the applicant wants to analyze its own 
wipe samples, the applicant shall establish procedures to be followed 
and submit a description of these procedures to the Commission. The 
description must include the--
    (1) Instruments to be used;
    (2) Methods of performing the analysis; and
    (3) Pertinent experience of the person who will analyze the wipe 
samples.

[52 FR 8234, Mar. 17, 1987, as amended at 76 FR 56963, Sept. 15, 2011]



Sec.39.15  Agreement with well owner or operator.

    (a) A licensee may perform well logging with a sealed source only 
after the licensee has a written agreement with the employing well owner 
or operator. This written agreement must identify who will meet the 
following requirements:
    (1) If a sealed source becomes lodged in the well, a reasonable 
effort will be made to recover it.
    (2) A person may not attempt to recover a sealed source in a manner 
which, in the licensee's opinion, could result in its rupture.
    (3) The radiation monitoring required in Sec.39.69(a) will be 
performed.
    (4) If the environment, any equipment, or personnel are contaminated 
with licensed material, they must be decontaminated before release from 
the site or release for unrestricted use; and
    (5) If the sealed source is classified as irretrievable after 
reasonable efforts at recovery have been expended, the following 
requirements must be implemented within 30 days:
    (i) Each irretrievable well logging source must be immobilized and 
sealed in place with a cement plug.
    (ii) A means to prevent inadvertent intrusion on the source, unless 
the source is not accessible to any subsequent drilling operations; and
    (iii) A permanent identification plaque, constructed of long lasting 
material such as stainless steel, brass, bronze, or monel, must be 
mounted at

[[Page 783]]

the surface of the well, unless the mounting of the plaque is not 
practical. The size of the plaque must be at least 17 cm [7 inches] 
square and 3 mm [\1/8\-inch] thick. The plaque must contain--
    (A) The word ``CAUTION'';
    (B) The radiation symbol (the color requirement in Sec.20.1901(a) 
need not be met);
    (C) The date the source was abandoned;
    (D) The name of the well owner or well operator, as appropriate;
    (E) The well name and well identification number(s) or other 
designation;
    (F) An identification of the sealed source(s) by radionuclide and 
quantity;
    (G) The depth of the source and depth to the top of the plug; and
    (H) An appropriate warning, such as, ``DO NOT RE-ENTER THIS WELL.''
    (b) The licensee shall retain a copy of the written agreement for 3 
years after the completion of the well logging operation.
    (c) A licensee may apply, pursuant to Sec.39.91, for Commission 
approval, on a case-by-case basis, of proposed procedures to abandon an 
irretrievable well logging source in a manner not otherwise authorized 
in paragraph (a)(5) of this section.
    (d) A written agreement between the licensee and the well owner or 
operator is not required if the licensee and the well owner or operator 
are part of the same corporate structure or otherwise similarly 
affiliated. However, the licensee shall still otherwise meet the 
requirements in paragraphs (a)(1) through (a)(5).

[52 FR 8234, Mar. 17, 1987, as amended at 56 FR 23472, May 21, 1991; 58 
FR 67660, Dec. 22, 1993; 65 FR 20344, Apr. 17, 2000]



Sec.39.17  Request for written statements.

    Each license is issued with the condition that the licensee will, at 
any time before expiration of the license, upon the Commission's 
request, submit written statements, signed under oath or affirmation, to 
enable the Commission to determine whether or not the license should be 
modified, suspended, or revoked.



                           Subpart C_Equipment



Sec.39.31  Labels, security, and transportation precautions.

    (a) Labels. (1) The licensee may not use a source, source holder, or 
logging tool that contains licensed material unless the smallest 
component that is transported as a separate piece of equipment with the 
licensed material inside bears a durable, legible, and clearly visible 
marking or label. The marking or label must contain the radiation symbol 
specified in Sec.20.1901(a), without the conventional color 
requirements, and the wording ``DANGER (or CAUTION) RADIOACTIVE 
MATERIAL.''
    (2) The licensee may not use a container to store licensed material 
unless the container has securely attached to it a durable, legible, and 
clearly visible label. The label must contain the radiation symbol 
specified in Sec.20.1901(a) of this chapter and the wording ``CAUTION 
(or DANGER), RADIOACTIVE MATERIAL, NOTIFY CIVIL AUTHORITIES (or NAME OF 
COMPANY).''
    (3) The licensee may not transport licensed material unless the 
material is packaged, labeled, marked, and accompanied with appropriate 
shipping papers in accordance with regulations set out in 10 CFR part 
71.
    (b) Security precautions during storage and transportation. (1) The 
licensee shall store each source containing licensed material in a 
storage container or transportation package. The container or package 
must be locked and physically secured to prevent tampering or removal of 
licensed material from storage by unauthorized personnel. The licensee 
shall store licensed material in a manner which will minimize danger 
from explosion or fire.
    (2) The licensee shall lock and physically secure the transport 
package containing licensed material in the transporting vehicle to 
prevent accidental loss, tampering, or unauthorized removal of the 
licensed material from the vehicle.

[52 FR 8234, Mar. 17, 1987, as amended at 56 FR 23472, May 21, 1991; 58 
FR 67660, Dec. 22, 1993]

[[Page 784]]



Sec.39.33  Radiation detection instruments.

    (a) The licensee shall keep a calibrated and operable radiation 
survey instrument capable of detecting beta and gamma radiation at each 
field station and temporary jobsite to make the radiation surveys 
required by this part and by part 20 of this chapter. To satisfy this 
requirement, the radiation survey instrument must be capable of 
measuring 0.001 mSv (0.1 mrem) per hour through at least 0.5 mSv (50 
mrem) per hour.
    (b) The licensee shall have available additional calibrated and 
operable radiation detection instruments sensitive enough to detect the 
low radiation and contamination levels that could be encountered if a 
sealed source ruptured. The licensee may own the instruments or may have 
a procedure to obtain them quickly from a second party.
    (c) The licensee shall have each radiation survey instrument 
required under paragraph (a) of this section calibrated--
    (1) At intervals not to exceed 6 months and after instrument 
servicing;
    (2) For linear scale instruments, at two points located 
approximately \1/3\ and \2/3\ of full-scale on each scale; for 
logarithmic scale instruments, at midrange of each decade, and at two 
points of at least one decade; and for digital instruments, at 
appropriate points; and
    (3) So that an accuracy within plus or minus 20 percent of the 
calibration standard can be demonstrated on each scale.
    (d) The licensee shall retain calibration records for a period of 3 
years after the date of calibration for inspection by the Commission.

[52 FR 8234, Mar. 17, 1987, as amended at 63 FR 39483, July 23, 1998]



Sec.39.35  Leak testing of sealed sources.

    (a) Testing and recordkeeping requirements. Each licensee who uses a 
sealed source shall have the source tested for leakage periodically. The 
licensee shall keep a record of leak test results in units of 
microcuries and retain the record for inspection by the Commission for 3 
years after the leak test is performed.
    (b) Method of testing. The wipe of a sealed source must be performed 
using a leak test kit or method approved by the Commission or an 
Agreement State. The wipe sample must be taken from the nearest 
accessible point to the sealed source where contamination might 
accumulate. The wipe sample must be analyzed for radioactive 
contamination. The analysis must be capable of detecting the presence of 
185 Bq [0.005 microcuries] of radioactive material on the test sample 
and must be performed by a person approved by the Commission or an 
Agreement State to perform the analysis.
    (c) Test frequency. (1) Each sealed source (except an energy 
compensation source (ECS)) must be tested at intervals not to exceed 6 
months. In the absence of a certificate from a transferor that a test 
has been made within the 6 months before the transfer, the sealed source 
may not be used until tested.
    (2) Each ECS that is not exempt from testing in accordance with 
paragraph (e) of this section must be tested at intervals not to exceed 
3 years. In the absence of a certificate from a transferor that a test 
has been made within the 3 years before the transfer, the ECS may not be 
used until tested.
    (d) Removal of leaking source from service. (1) If the test 
conducted pursuant to paragraphs (a) and (b) of this section reveals the 
presence of 185 Bq [0.005 microcuries] or more of removable radioactive 
material, the licensee shall remove the sealed source from service 
immediately and have it decontaminated, repaired, or disposed of by an 
NRC or Agreement State licensee that is authorized to perform these 
functions. The licensee shall check the equipment associated with the 
leaking source for radioactive contamination and, if contaminated, have 
it decontaminated or disposed of by an NRC or Agreement State licensee 
that is authorized to perform these functions.
    (2) The licensee shall submit a report to the appropriate NRC 
Regional Office listed in appendix D of part 20 of this chapter, within 
5 days of receiving the test results. The report must describe the 
equipment involved in the leak, the test results, any contamination 
which resulted from the leaking source, and

[[Page 785]]

the corrective actions taken up to the time the report is made.
    (e) Exemptions from testing requirements. The following sealed 
sources are exempt from the periodic leak test requirements set out in 
paragraphs (a) through (d) of this section:
    (1) Hydrogen-3 (tritium) sources;
    (2) Sources containing licensed material with a half-life of 30 days 
or less;
    (3) Sealed sources containing licensed material in gaseous form;
    (4) Sources of beta- or gamma-emitting radioactive material with an 
activity of 3.7 MBq [100 microcuries] or less; and
    (5) Sources of alpha- or neutron-emitting radioactive material with 
an activity of 0.37 MBq [10 microcuries] or less.

[52 FR 8234, Mar. 17, 1987, as amended at 65 FR 20344, Apr. 17, 2000]



Sec.39.37  Physical inventory.

    Each licensee shall conduct a semi-annual physical inventory to 
account for all licensed material received and possessed under the 
license. The licensee shall retain records of the inventory for 3 years 
from the date of the inventory for inspection by the Commission. The 
inventory must indicate the quantity and kind of licensed material, the 
location of the licensed material, the date of the inventory, and the 
name of the individual conducting the inventory. Physical inventory 
records may be combined with leak test records.



Sec.39.39  Records of material use.

    (a) Each licensee shall maintain records for each use of licensed 
material showing--
    (1) The make, model number, and a serial number or a description of 
each sealed source used;
    (2) In the case of unsealed licensed material used for subsurface 
tracer studies, the radionuclide and quantity of activity used in a 
particular well and the disposition of any unused tracer materials;
    (3) The identity of the logging supervisor who is responsible for 
the licensed material and the identity of logging assistants present; 
and
    (4) The location and date of use of the licensed material.
    (b) The licensee shall make the records required by paragraph (a) of 
this section available for inspection by the Commission. The licensee 
shall retain the records for 3 years from the date of the recorded 
event.



Sec.39.41  Design and performance criteria for sources.

    (a) A licensee may use a sealed source for use in well logging 
applications if--
    (1) The sealed source is doubly encapsulated;
    (2) The sealed source contains licensed material whose chemical and 
physical forms are as insoluble and nondispersible as practical; and
    (3) Meets the requirements of paragraph (b), (c), or (d) of this 
section.
    (b) For a sealed source manufactured on or before July 14, 1989, a 
licensee may use the sealed source, for use in well logging applications 
if it meets the requirements of USASI N5.10-1968, ``Classification of 
Sealed Radioactive Sources,'' or the requirements in paragraph (c) or 
(d) of this section.
    (c) For a sealed source manufactured after July 14, 1989, a licensee 
may use the sealed source, for use in well logging applications if it 
meets the oil-well logging requirements of ANSI/HPS N43.6-1997, ``Sealed 
Radioactive Sources--Classification.''
    (d) For a sealed source manufactured after July 14, 1989, a licensee 
may use the sealed source, for use in well logging applications, if--
    (1) The sealed source's prototype has been tested and found to 
maintain its integrity after each of the following tests:
    (i) Temperature. The test source must be held at -40 [deg]C for 20 
minutes, 600 [deg]C for 1 hour, and then be subject to a thermal shock 
test with a temperature drop from 600 [deg]C to 20 [deg]C within 15 
seconds.
    (ii) Impact test. A 5 kg steel hammer, 2.5 cm in diameter, must be 
dropped from a height of 1 m onto the test source.
    (iii) Vibration test. The test source must be subject to a vibration 
from 25 Hz to 500 Hz at 5 g amplitude for 30 minutes.
    (iv) Puncture test. A 1 gram hammer and pin, 0.3 cm pin diameter, 
must be

[[Page 786]]

dropped from a height of 1 m onto the test source.
    (v) Pressure test. The test source must be subject to an external 
pressure of 1.695 x 10\7\ pascals [24,600 pounds per square inch 
absolute].
    (e) The requirements in paragraphs (a), (b), (c), and (d) of this 
section do not apply to sealed sources that contain licensed material in 
gaseous form.
    (f) The requirements in paragraphs (a), (b), (c), and (d) of this 
section do not apply to energy compensation sources (ECS). ECSs must be 
registered with the Commission under Sec.32.210 of this chapter or 
with an Agreement State.

[65 FR 20345, Apr. 17, 2000]



Sec.39.43  Inspection, maintenance, and opening of a source 
or source holder.

    (a) Each licensee shall visually check source holders, logging 
tools, and source handling tools, for defects before each use to ensure 
that the equipment is in good working condition and that required 
labeling is present. If defects are found, the equipment must be removed 
from service until repaired, and a record must be made listing: the date 
of check, name of inspector, equipment involved, defects found, and 
repairs made. These records must be retained for 3 years after the 
defect is found.
    (b) Each licensee shall have a program for semiannual visual 
inspection and routine maintenance of source holders, logging tools, 
injection tools, source handling tools, storage containers, transport 
containers, and uranium sinker bars to ensure that the required labeling 
is legible and that no physical damage is visible. If defects are found, 
the equipment must be removed from service until repaired, and a record 
must be made listing: date, equipment involved, inspection and 
maintenance operations performed, any defects found, and any actions 
taken to correct the defects. These records must be retained for 3 years 
after the defect is found.
    (c) Removal of a sealed source from a source holder or logging tool, 
and maintenance on sealed sources or holders in which sealed sources are 
contained may not be performed by the licensee unless a written 
procedure developed pursuant to Sec.39.63 has been approved either by 
the Commission pursuant to Sec.39.13(c) or by an Agreement State.
    (d) If a sealed source is stuck in the source holder, the licensee 
may not perform any operation, such as drilling, cutting, or chiseling, 
on the source holder unless the licensee is specifically approved by the 
Commission or an Agreement State to perform this operation.
    (e) The opening, repair, or modification of any sealed source must 
be performed by persons specifically approved to do so by the Commission 
or an Agreement State.



Sec.39.45  Subsurface tracer studies.

    (a) The licensee shall require all personnel handling radioactive 
tracer material to use protective gloves and, if required by the 
license, other protective clothing and equipment. The licensee shall 
take precautions to avoid ingestion or inhalation of radioactive tracer 
material and to avoid contamination of field stations and temporary 
jobsites.
    (b) A licensee may not knowingly inject licensed material into fresh 
water aquifers unless specifically authorized to do so by the 
Commission.



Sec.39.47  Radioactive markers.

    The licensee may use radioactive markers in wells only if the 
individual markers contain quantities of licensed material not exceeding 
the quantities specified in Sec.30.71 of this chapter. The use of 
markers is subject only to the requirements of Sec.39.37.



Sec.39.49  Uranium sinker bars.

    The licensee may use a uranium sinker bar in well logging 
applications only if it is legibly impressed with the words ``CAUTION--
RADIOACTIVE-DEPLETED URANIUM'' and ``NOTIFY CIVIL AUTHORITIES (or 
COMPANY NAME) IF FOUND.''

[65 FR 20345, Apr. 17, 2000]



Sec.39.51  Use of a sealed source in a well without a surface casing.

    The licensee may use a sealed source in a well without a surface 
casing for

[[Page 787]]

protecting fresh water aquifers only if the licensee follows a procedure 
for reducing the probability of the source becoming lodged in the well. 
The procedure must be approved by the Commission pursuant to Sec.
39.13(c) or by an Agreement State.



Sec.39.53  Energy compensation source.

    The licensee may use an energy compensation source (ECS) which is 
contained within a logging tool, or other tool components, only if the 
ECS contains quantities of licensed material not exceeding 3.7 MBq [100 
microcuries].
    (a) For well logging applications with a surface casing for 
protecting fresh water aquifers, use of the ECS is only subject to the 
requirements of Sec. Sec.39.35, 39.37 and 39.39.
    (b) For well logging applications without a surface casing for 
protecting fresh water aquifers, use of the ECS is only subject to the 
requirements of Sec. Sec.39.15, 39.35, 39.37, 39.39, 39.51, and 39.77.

[65 FR 20345, Apr. 17, 2000]



Sec.39.55  Tritium neutron generator target sources.

    (a) Use of a tritium neutron generator target source, containing 
quantities not exceeding 1,110 GBg [30 curies] and in a well with a 
surface casing to protect fresh water aquifers, is subject to the 
requirements of this part except Sec. Sec.39.15, 39.41, and 39.77.
    (b) Use of a tritium neutron generator target source, containing 
quantities exceeding 1,110 GBg [30 curies] or in a well without a 
surface casing to protect fresh water aquifers, is subject to the 
requirements of this part except Sec.39.41.

[68 FR 75390, Dec. 31, 2003]



                 Subpart D_Radiation Safety Requirements



Sec.39.61  Training.

    (a) The licensee may not permit an individual to act as a logging 
supervisor until that person--
    (1) Has completed training in the subjects outlined in paragraph (e) 
of this section;
    (2) Has received copies of, and instruction in--
    (i) The NRC regulations contained in the applicable sections of 
parts 19, 20, and 39 of this chapter;
    (ii) The NRC license under which the logging supervisor will perform 
well logging; and
    (iii) The licensee's operating and emergency procedures required by 
Sec.39.63;
    (3) Has completed on-the-job training and demonstrated competence in 
the use of licensed materials, remote handling tools, and radiation 
survey instruments by a field evaluation; and
    (4) Has demonstrated understanding of the requirements in paragraphs 
(a) (1) and (2) of this section by successfully completing a written 
test.
    (b) The licensee may not permit an individual to act as a logging 
assistant until that person--
    (1) Has received instruction in applicable sections of parts 19 and 
20 of this chapter;
    (2) Has received copies of, and instruction in, the licensee's 
operating and emergency procedures required by Sec.39.63;
    (3) Has demonstrated understanding of the materials listed in 
paragraphs (b) (1) and (2) of this section by successfully completing a 
written or oral test; and
    (4) Has received instruction in the use of licensed materials, 
remote handling tools, and radiation survey instruments, as appropriate 
for the logging assistant's intended job responsibilities.
    (c) The licensee shall provide safety reviews for logging 
supervisors and logging assistants at least once during each calendar 
year.
    (d) The licensee shall maintain a record on each logging 
supervisor's and logging assistant's training and annual safety review. 
The training records must include copies of written tests and dates of 
oral tests given after July 14, 1987. The training records must be 
retained until 3 years following the termination of employment. Records 
of annual safety reviews must list the topics discussed and be retained 
for 3 years.
    (e) The licensee shall include the following subjects in the 
training required in paragraph (a)(1) of this section:

[[Page 788]]

    (1) Fundamentals of radiation safety including--
    (i) Characteristics of radiation;
    (ii) Units of radiation dose and quantity of radioactivity;
    (iii) Hazards of exposure to radiation;
    (iv) Levels of radiation from licensed material;
    (v) Methods of controlling radiation dose (time, distance, and 
shielding); and
    (vi) Radiation safety practices, including prevention of 
contamination, and methods of decontamination.
    (2) Radiation detection instruments including--
    (i) Use, operation, calibration, and limitations of radiation survey 
instruments;
    (ii) Survey techniques; and
    (iii) Use of personnel monitoring equipment;
    (3) Equipment to be used including--
    (i) Operation of equipment, including source handling equipment and 
remote handling tools;
    (ii) Storage, control, and disposal of licensed material; and
    (iii) Maintenance of equipment.
    (4) The requirements of pertinent Federal regulations. And
    (5) Case histories of accidents in well logging.



Sec.39.63  Operating and emergency procedures.

    Each licensee shall develop and follow written operating and 
emergency procedures that cover--
    (a) The handling and use of licensed materials including the use of 
sealed sources in wells without surface casing for protecting fresh 
water aquifers, if appropriate;
    (b) The use of remote handling tools for handling sealed sources and 
radioactive tracer material except low-activity calibration sources;
    (c) Methods and occasions for conducting radiation surveys, 
including surveys for detecting contamination, as required by Sec.
39.67(c)-(e);
    (d) Minimizing personnel exposure including exposures from 
inhalation and ingestion of licensed tracer materials;
    (e) Methods and occasions for locking and securing stored licensed 
materials;
    (f) Personnel monitoring and the use of personnel monitoring 
equipment;
    (g) Transportation of licensed materials to field stations or 
temporary jobsites, packaging of licensed materials for transport in 
vehicles, placarding of vehicles when needed, and physically securing 
licensed materials in transport vehicles during transportation to 
prevent accidental loss, tampering, or unauthorized removal;
    (h) Picking up, receiving, and opening packages containing licensed 
materials, in accordance with Sec.20.1906 of this chapter;
    (i) For the use of tracers, decontamination of the environment, 
equipment, and personnel;
    (j) Maintenance of records generated by logging personnel at 
temporary jobsites;
    (k) The inspection and maintenance of sealed sources, source 
holders, logging tools, injection tools, source handling tools, storage 
containers, transport containers, and uranium sinker bars as required by 
Sec.39.43;
    (l) Identifying and reporting to NRC defects and noncompliance as 
required by part 21 of this chapter;
    (m) Actions to be taken if a sealed source is lodged in a well;
    (n) Notifying proper persons in the event of an accident; and
    (o) Actions to be taken if a sealed source is ruptured including 
actions to prevent the spread of contamination and minimize inhalation 
and ingestion of licensed materials and actions to obtain suitable 
radiation survey instruments as required by Sec.39.33(b).

[52 FR 8234, Mar. 17, 1987, as amended at 67 FR 77652, Dec. 19, 2002]



Sec.39.65  Personnel monitoring.

    (a) The licensee may not permit an individual to act as a logging 
supervisor or logging assistant unless that person wears, at all times 
during the handling of licensed radioactive materials, a personnel 
dosimeter that is processed and evaluated by an accredited National 
Voluntary Laboratory Accreditation Program (NVLAP) processor. Each 
personnel dosimeter must be assigned to and worn by only one individual. 
Film badges must be replaced at least monthly and other personnel 
dosimeters replaced at least quarterly.

[[Page 789]]

After replacement, each personnel dosimeter must be promptly processed.
    (b) The licensee shall provide bioassay services to individuals 
using licensed materials in subsurface tracer studies if required by the 
license.
    (c) The licensee shall retain records of personnel dosimeters 
required by paragraph (a) of this section and bioassay results for 
inspection until the Commission authorizes disposition of the records.

[52 FR 8234, Mar. 17, 1987, as amended at 65 FR 63752, Oct. 24, 2000]



Sec.39.67  Radiation surveys.

    (a) The licensee shall make radiation surveys, including but not 
limited to the surveys required under paragraphs (b) through (e) of this 
section, of each area where licensed materials are used and stored.
    (b) Before transporting licensed materials, the licensee shall make 
a radiation survey of the position occupied by each individual in the 
vehicle and of the exterior of each vehicle used to transport the 
licensed materials.
    (c) If the sealed source assembly is removed from the logging tool 
before departure from the temporary jobsite, the licensee shall confirm 
that the logging tool is free of contamination by energizing the logging 
tool detector or by using a survey meter.
    (d) If the licensee has reason to believe that, as a result of any 
operation involving a sealed source, the encapsulation of the sealed 
source could be damaged by the operation, the licensee shall conduct a 
radiation survey, including a contamination survey, during and after the 
operation.
    (e) The licensee shall make a radiation survey at the temporary 
jobsite before and after each subsurface tracer study to confirm the 
absence of contamination.
    (f) The results of surveys required under paragraphs (a) through (e) 
of this section must be recorded and must include the date of the 
survey, the name of the individual making the survey, the identification 
of the survey, instrument used, and the location of the survey. The 
licensee shall retain records of surveys for inspection by the 
Commission for 3 years after they are made.



Sec.39.69  Radioactive contamination control.

    (a) If the licensee detects evidence that a sealed source has 
ruptured or licensed materials have caused contamination, the licensee 
shall initiate immediately the emergency procedures required by Sec.
39.63.
    (b) If contamination results from the use of licensed material in 
well logging, the licensee shall decontaminate all work areas, 
equipment, and unrestricted areas.
    (c) During efforts to recover a sealed source lodged in the well, 
the licensee shall continuously monitor, with an appropriate radiation 
detection instrument or a logging tool with a radiation detector, the 
circulating fluids from the well, if any, to check for contamination 
resulting from damage to the sealed source.



               Subpart E_Security, Records, Notifications



Sec.39.71  Security.

    (a) A logging supervisor must be physically present at a temporary 
jobsite whenever licensed materials are being handled or are not stored 
and locked in a vehicle or storage place. The logging supervisor may 
leave the jobsite in order to obtain assistance if a source becomes 
lodged in a well.
    (b) During well logging, except when radiation sources are below 
ground or in shipping or storage containers, the logging supervisor or 
other individual designated by the logging supervisor shall maintain 
direct surveillance of the operation to prevent unauthorized entry into 
a restricted area, as defined in Sec.20.1003 of this chapter.

[52 FR 8234, Mar. 17, 1987, as amended at 63 FR 39483, July 23, 1998]



Sec.39.73  Documents and records required at field stations.

    Each licensee shall maintain the following documents and records at 
the field station:
    (a) A copy of parts 19, 20, and 39 of NRC regulations;
    (b) The license authorizing the use of licensed material;
    (c) Operating and emergency procedures required by Sec.39.63;

[[Page 790]]

    (d) The record of radiation survey instrument calibrations required 
by Sec.39.33;
    (e) The record of leak test results required by Sec.39.35;
    (f) Physical inventory records required by Sec.39.37;
    (g) Utilization records required by Sec.39.39;
    (h) Records of inspection and maintenance required by Sec.39.43;
    (i) Training records required by Sec.39.61(d); and
    (j) Survey records required by Sec.39.67.



Sec.39.75  Documents and records required at temporary jobsites.

    Each licensee conducting operations at a temporary jobsite shall 
maintain the following documents and records at the temporary jobsite 
until the well logging operation is completed:
    (a) Operating and emergency procedures required by Sec.39.63.
    (b) Evidence of latest calibration of the radiation survey 
instruments in use at the site required by Sec.39.33.
    (c) Latest survey records required by Sec. Sec.39.67 (b), (c), and 
(e).
    (d) The shipping papers for the transportation of radioactive 
materials required by Sec.71.5 of this chapter; and
    (e) When operating under reciprocity pursuant to Sec.150.20 of 
this chapter, a copy of the Agreement State license authorizing use of 
licensed materials.



Sec.39.77  Notification of incidents and lost sources; abandonment
procedures for irretrievable sources.

    (a) The licensee shall immediately notify the appropriate NRC 
Regional Office by telephone and subsequently, within 30 days, by 
confirmation in writing, using an appropriate method listed in Sec.
30.6(a) of this chapter, if the licensee knows or has reason to believe 
that a sealed source has been ruptured. The written confirmation must 
designate the well or other location, describe the magnitude and extent 
of the escape of licensed materials, assess the consequences of the 
rupture, and explain efforts planned or being taken to mitigate these 
consequences.
    (b) The licensee shall notify the Commission of the theft or loss of 
radioactive materials, radiation overexposures, excessive levels and 
concentrations of radiation, and certain other accidents as required by 
Sec. Sec.20.2201-20.2202, Sec.20.2203 and Sec.30.50 of this 
chapter.
    (c) If a sealed source becomes lodged in a well, and when it becomes 
apparent that efforts to recover the sealed source will not be 
successful, the licensee shall--
    (1) Notify the appropriate NRC Regional Office by telephone of the 
circumstances that resulted in the inability to retrieve the source 
and--
    (i) Obtain NRC approval to implement abandonment procedures; or
    (ii) That the licensee implemented abandonment before receiving NRC 
approval because the licensee believed there was an immediate threat to 
public health and safety; and
    (2) Advise the well owner or operator, as appropriate, of the 
abandonment procedures under Sec.39.15 (a) or (c); and
    (3) Either ensure that abandonment procedures are implemented within 
30 days after the sealed source has been classified as irretrievable or 
request an extension of time if unable to complete the abandonment 
procedures.
    (d) The licensee shall, within 30 days after a sealed source has 
been classified as irretrievable, make a report in writing to the 
appropriate NRC Regional Office. The licensee shall send a copy of the 
report to each appropriate State or Federal agency that issued permits 
or otherwise approved of the drilling operation. The report must contain 
the following information:
    (1) Date of occurrence;
    (2) A description of the irretrievable well logging source involved 
including the radionuclide and its quantity, chemical, and physical 
form;
    (3) Surface location and identification of the well;
    (4) Results of efforts to immobilize and seal the source in place;
    (5) A brief description of the attempted recovery effort;
    (6) Depth of the source;
    (7) Depth of the top of the cement plug;
    (8) Depth of the well;
    (9) The immediate threat to public health and safety justification 
for implementing abandonment if prior NRC

[[Page 791]]

approval was not obtained in accordance with paragraph (c)(1)(ii) of 
this section;
    (10) Any other information, such as a warning statement, contained 
on the permanent identification plaque; and
    (11) State and Federal agencies receiving copy of this report.

[52 FR 8234, Mar. 17, 1987, as amended at 56 FR 64980, Dec. 13, 1991; 58 
FR 67660, Dec. 22, 1993; 65 FR 20345, Apr. 17, 2000; 68 FR 58806, Oct. 
10, 2003]



                          Subpart F_Exemptions



Sec.39.91  Applications for exemptions.

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



                          Subpart G_Enforcement



Sec.39.101  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55074, Nov. 24, 1992]



Sec.39.103  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 39 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 39 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.39.1, 39.2, 39.5, 39.8, 39.13, 39.91, 39.101, and 39.103.

[57 FR 55074, Nov. 24, 1992]



PART 40_DOMESTIC LICENSING OF SOURCE MATERIAL--Table of Contents



                           General Provisions

Sec.
40.1 Purpose.
40.2 Scope.
40.2a Coverage of inactive tailings sites.
40.3 License requirements.
40.4 Definitions.
40.5 Communications.
40.6 Interpretations.
40.7 Employee protection.
40.8 Information collection requirements: OMB approval.
40.9 Completeness and accuracy of information.
40.10 Deliberate misconduct.

                               Exemptions

40.11 Persons using source material under certain Department of Energy 
          and Nuclear Regulatory Commission contracts.
40.12 Carriers.
40.13 Unimportant quantities of source material.
40.14 Specific exemptions.

                            General Licenses

40.20 Types of licenses.
40.21 General license to receive title to source or byproduct material.
40.22 Small quantities of source material.
40.23 General license for carriers of transient shipments of natural 
          uranium other than in the form of ore or ore residue.
40.24 [Reserved]

[[Page 792]]

40.25 General license for use of certain industrial products or devices.
40.26 General license for possession and storage of byproduct material 
          as defined in this part.
40.27 General license for custody and long-term care of residual 
          radioactive material disposal sites.
40.28 General license for custody and long-term care of uranium or 
          thorium byproduct materials disposal sites.

                          License Applications

40.31 Application for specific licenses.
40.32 General requirements for issuance of specific licenses.
40.33 Issuance of a license for a uranium enrichment facility.
40.34 Special requirements for issuance of specific licenses.
40.35 Conditions of specific licenses issued pursuant to Sec.40.34.
40.36 Financial assurance and recordkeeping for decommissioning.
40.38 Ineligibility of certain applicants.

                                Licenses

40.41 Terms and conditions of licenses.
40.42 Expiration and termination of licenses and decommissioning of 
          sites and separate buildings or outdoor areas.
40.43 Renewal of licenses.
40.44 Amendment of licenses at request of licensee.
40.45 Commission action on applications to renew or amend.
40.46 Inalienability of licenses.

                       Transfer of Source Material

40.51 Transfer of source or byproduct material.
40.52 Certain items containing source material; requirements for license 
          to apply or initially transfer.
40.53 Conditions for licenses issued for initial transfer of certain 
          items containing source material: Quality control, labeling, 
          and records and reports.
40.54 Requirements for license to initially transfer source material for 
          use under the `small quantities of source material' general 
          license.
40.55 Conditions of licenses to initially transfer source material for 
          use under the `small quantities of source material' general 
          license: Quality control, labeling, safety instructions, and 
          records and reports.
40.56 Restrictions on the use of Australian-obligated source material.

                    Records, Reports, and Inspections

40.60 Reporting requirements.
40.61 Records.
40.62 Inspections.
40.63 Tests.
40.64 Reports.
40.65 Effluent monitoring reporting requirements.
40.66 Requirements for advance notice of export shipments of natural 
          uranium.
40.67 Requirement for advance notice for importation of natural uranium 
          from countries that are not party to the Convention on the 
          Physical Protection of Nuclear Material.

                 Modification and Revocation of Licenses

40.71 Modification and revocation of licenses.

                               Enforcement

40.81 Violations.
40.82 Criminal penalties.

Appendix A to Part 40--Criteria Relating to the Operation of Uranium 
          Mills and the Disposition of Tailings or Wastes Produced by 
          the Extraction or Concentration of Source Material From Ores 
          Processed Primarily From Their Source Material Content

    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.

    Source: 26 FR 284, Jan. 14, 1961, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 40 appear at 79 FR 
75740, Dec. 19, 2014.

                           General Provisions



Sec.40.1  Purpose.

    (a) The regulations in this part establish procedures and criteria 
for the issuance of licenses to receive title to, receive, possess, use, 
transfer, or deliver source and byproduct materials, as defined in this 
part, and establish and provide for the terms and conditions upon which 
the Commission will issue such licenses. (Additional requirements 
applicable to natural and depleted uranium at enrichment facilities are 
set forth in Sec.70.22 of this chapter.) These regulations also 
provide for the disposal of byproduct material and for the long-term 
care and custody of byproduct material and residual radioactive 
material. The regulations in this part also establish certain 
requirements for the physical protection of

[[Page 793]]

import, export, and transient shipments of natural uranium. (Additional 
requirements applicable to the import and export of natural uranium are 
set forth in part 110 of this chapter.)
    (b) The regulations contained in this part are issued under the 
Atomic Energy Act of 1954, as amended (68 Stat. 919), title II of the 
Energy Reorganization Act of 1974, as amended (88 Stat. 1242), and 
titles I and II of the Uranium Mill Tailings Radiation Control Act of 
1978, as amended (42 U.S.C. 7901).

[55 FR 45597, Oct. 30, 1990, as amended at 56 FR 55997, Oct. 31, 1991]



Sec.40.2  Scope.

    Except as provided in Sec. Sec.40.11 to 40.14, inclusive, the 
regulations in this part apply to all persons in the United States. This 
part also gives notice to all persons who knowingly provide to any 
licensee, applicant, contractor, or subcontractor, components, 
equipment, materials, or other goods or services, that relate to a 
licensee's or applicant's activities subject to this part, that they may 
be individually subject to NRC enforcement action for violation of Sec.
40.10.

[63 FR 1896, Jan. 13, 1998]



Sec.40.2a  Coverage of inactive tailings sites.

    (a) Prior to the completion of the remedial action, the Commission 
will not require a license pursuant to 10 CFR chapter I for possession 
of residual radioactive materials as defined in this part that are 
located at a site where milling operations are no longer active, if the 
site is covered by the remedial action program of title I of the Uranium 
Mill Tailings Radiation Control Act of 1978, as amended. The Commission 
will exert its regulatory role in remedial actions primarily through 
concurrence and consultation in the execution of the remedial action 
pursuant to title I of the Uranium Mill Tailings Radiation Control Act 
of 1978, as amended. After remedial actions are completed, the 
Commission will license the long-term care of sites, where residual 
radioactive materials are disposed, under the requirements set out in 
Sec.40.27.
    (b) The Commission will regulate byproduct material as defined in 
this part that is located at a site where milling operations are no 
longer active, if such site is not covered by the remedial action 
program of title I of the Uranium Mill Tailings Radiation Control Act of 
1978. The criteria in appendix A of this part will be applied to such 
sites.

[45 FR 65531, Oct. 3, 1980, as amended at 55 FR 45598, Oct. 30, 1990]



Sec.40.3  License requirements.

    A person subject to the regulations in this part may not receive 
title to, own, receive, possess, use, transfer, provide for long-term 
care, deliver or dispose of byproduct material or residual radioactive 
material as defined in this part or any source material after removal 
from its place of deposit in nature, unless authorized in a specific or 
general license issued by the Commission under the regulations in this 
part.

[55 FR 45598, Oct. 30, 1990]



Sec.40.4  Definitions.

    Act means the Atomic Energy Act of 1954 (68 Stat. 919), including 
any amendments thereto;
    Agreement State means any State with which the Atomic Energy 
Commission or the Nuclear Regulatory Commission has entered into an 
effective agreement under subsection 274b. of the Atomic Energy Act of 
1954, as amended.
    Alert means events may occur, are in progress, or have occurred that 
could lead to a release of radioactive material but that the release is 
not expected to require a response by offsite response organizations to 
protect persons offsite.
    Byproduct Material means the tailings or wastes produced by the 
extraction or concentration of uranium or thorium from any ore processed 
primarily for its source material content, including discrete surface 
wastes resulting from uranium solution extraction processes. Underground 
ore bodies depleted by such solution extraction operations do not 
constitute ``byproduct material'' within this definition.
    With the exception of ``byproduct material'' as defined in section 
11e. of the Act, other terms defined in section

[[Page 794]]

11 of the Act shall have the same meaning when used in the regulations 
in this part.
    Commencement of construction means taking any action defined as 
``construction'' or any other activity at the site of a facility subject 
to the regulations in this part that has a reasonable nexus to:
    (1) Radiological health and safety; or
    (2) Common defense and security.
    Commission means the Nuclear Regulatory Commission or its duly 
authorized representatives.
    Construction means the installation of wells associated with 
radiological operations (e.g., production, injection, or monitoring well 
networks associated with in-situ recovery or other facilities), the 
installation of foundations, or in-place assembly, erection, 
fabrication, or testing for any structure, system, or component of a 
facility or activity subject to the regulations in this part that are 
related to radiological safety or security. The term ``construction'' 
does not include:
    (1) Changes for temporary use of the land for public recreational 
purposes;
    (2) Site exploration, including necessary borings to determine 
foundation conditions or other preconstruction monitoring to establish 
background information related to the suitability of the site, the 
environmental impacts of construction or operation, or the protection of 
environmental values;
    (3) Preparation of the site for construction of the facility, 
including clearing of the site, grading, installation of drainage, 
erosion and other environmental mitigation measures, and construction of 
temporary roads and borrow areas;
    (4) Erection of fences and other access control measures that are 
not related to the safe use of, or security of, radiological materials 
subject to this part;
    (5) Excavation;
    (6) Erection of support buildings (e.g., construction equipment 
storage sheds, warehouse and shop facilities, utilities, concrete mixing 
plants, docking and unloading facilities, and office buildings) for use 
in connection with the construction of the facility;
    (7) Building of service facilities (e.g., paved roads, parking lots, 
railroad spurs, exterior utility and lighting systems, potable water 
systems, sanitary sewerage treatment facilities, and transmission 
lines);
    (8) Procurement or fabrication of components or portions of the 
proposed facility occurring at other than the final, in-place location 
at the facility; or
    (9) Taking any other action that has no reasonable nexus to:
    (i) Radiological health and safety, or
    (ii) Common defense and security.
    Corporation means the United States Enrichment Corporation (USEC), 
or its successor, a Corporation that is authorized by statute to lease 
the gaseous diffusion enrichment plants in Paducah, Kentucky, and 
Piketon, Ohio, from the Department of Energy, or any person authorized 
to operate one or both of the gaseous diffusion plants, or other 
facilities, pursuant to a plan for the privatization of USEC that is 
approved by the President.
    Decommission means to remove a facility or site safely from service 
and reduce residual radioactivity to a level that permits--
    (1) Release of the property for unrestricted use and termination of 
the license; or
    (2) Release of the property under restricted conditions and 
termination of the license.
    Department and Department of Energy means the Department of Energy 
established by the Department of Energy Organization Act (Pub. L. 95-91, 
91 Stat. 565, 42 U.S.C. 7101 et seq.) to the extent that the Department, 
or its duly authorized representatives, exercises functions formerly 
vested in the U.S. Atomic Energy Commission, its Chairman, members, 
officers and components and transferred to the U.S. Energy Research and 
Development Administration and to the Administrator thereof pursuant to 
sections 104 (b), (c) and (d) of the Energy Reorganization Act of 1974 
(Pub. L. 93-438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and 
retransferred to the Secretary of Energy pursuant to section 301(a) of 
the Department of Energy Organization Act (Pub. L. 95-91, 91 Stat. 565 
at 577-578, 42 U.S.C. 7151).
    Depleted uranium means the source material uranium in which the 
isotope uranium-235 is less than 0.711 weight

[[Page 795]]

percent of the total uranium present. Depleted uranium does not include 
special nuclear material.
    Effective kilogram means (1) for the source material uranium in 
which the uranium isotope uranium-235 is greater than 0.005 (0.5 weight 
percent) of the total uranium present: 10,000 kilograms, and (2) for any 
other source material: 20,000 kilograms.
    Foreign obligations means the commitments entered into by the U.S. 
Government under Atomic Energy Act (AEA) section 123 agreements for 
cooperation in the peaceful uses of atomic energy. Imports and exports 
of material or equipment pursuant to such agreements are subject to 
these commitments, which in some cases involve an exchange of 
information on imports, exports, retransfers with foreign governments, 
peaceful end-use assurances, and other conditions placed on the transfer 
of the material or equipment. The U.S. Government informs the licensee 
of obligations attached to material.
    Government agency means any executive department, commission, 
independent establishment, corporation, wholly or partly owned by the 
United States of America which is an instrumentality of the United 
States, or any board, bureau, division, service, office, officer, 
authority, administration, or other establishment in the executive 
branch of the Government.
    License, except where otherwise specified, means a license issued 
pursuant to the regulations in this part.
    Persons means: (1) Any individual, corporation, partnership, firm, 
association, trust, estate, public or private institution, group, 
Government agency other than the Commission or the Department of Energy 
except that the Department of Energy shall be considered a person within 
the meaning of the regulations in this part to the extent that its 
facilities and activities are subject to the licensing and related 
regulatory authority of the Commission pursuant to section 202 of the 
Energy Reorganization Act of 1974 (88 Stat. 1244) and the Uranium Mill 
Tailings Radiation Control Act of 1978 (92 Stat. 3021), any State or any 
political subdivision of, or any political entity within a State, any 
foreign government or nation or any subdivision of any such government 
or nation, or other entity; and (2) any legal successor, representative, 
agent or agency of the foregoing.
    Pharmacist means an individual registered by a state or territory of 
the United States, the District of Columbia or the Commonwealth of 
Puerto Rico to compound and dispense drugs, prescriptions and poisons.
    Physician means a medical doctor or doctor of osteopathy licensed by 
a State or Territory of the United States, the District of Columbia, or 
the Commonwealth of Puerto Rico to prescribe drugs in the practice of 
medicine.
    Principal activities, as used in this part, means activities 
authorized by the license which are essential to achieving the 
purpose(s) for which the license was issued or amended. Storage during 
which no licensed material is accessed for use or disposal and 
activities incidental to decontamination or decommissioning are not 
principal activities.
    Reconciliation means the process of evaluating and comparing 
licensee reports required under this part to the projected material 
balances generated by the Nuclear Materials Management and Safeguards 
System. This process is considered complete when the licensee resolves 
any differences between the reported and projected balances, including 
those listed for foreign obligated materials.
    Residual radioactive material means: (1) Waste (which the Secretary 
of Energy determines to be radioactive) in the form of tailings 
resulting from the processing of ores for the extraction of uranium and 
other valuable constituents of the ores; and (2) other waste (which the 
Secretary of Energy determines to be radioactive) at a processing site 
which relates to such processing, including any residual stock of 
unprocessed ores or low-grade materials. This term is used only with 
respect to materials at sites subject to remediation under title I of 
the Uranium Mill Tailings Radiation Control Act of 1978, as amended.
    Site area emergency means events may occur, are in progress, or have 
occurred that could lead to a significant release of radioactive 
material and that could

[[Page 796]]

require a response by offsite response organizations to protect persons 
offsite.
    Source Material means: (1) Uranium or thorium, or any combination 
thereof, in any physical or chemical form or (2) ores which contain by 
weight one-twentieth of one percent (0.05%) or more of: (i) Uranium, 
(ii) thorium or (iii) any combination thereof. Source material does not 
include special nuclear material.
    Special nuclear material means: (1) Plutonium, uranium 233, uranium 
enriched in the isotope 233 or in the isotope 235, and any other 
material which the Commission, pursuant to the provisions of section 51 
of the Act, determines to be special nuclear material; or (2) any 
material artificially enriched by any of the foregoing.
    Transient shipment means a shipment of nuclear material, originating 
and terminating in foreign countries, on a vessel or aircraft that stops 
at a United States port.
    United States, when used in a geographical sense, includes Puerto 
Rico and all territories and possessions of the United States.
    Unrefined and unprocessed ore means ore in its natural form prior to 
any processing, such as grinding, roasting or beneficiating, or 
refining. Processing does not include sieving or encapsulation of ore or 
preparation of samples for laboratory analysis.
    Uranium enrichment facility means:
    (1) Any facility used for separating the isotopes of uranium or 
enriching uranium in the isotope 235, except laboratory scale facilities 
designed or used for experimental or analytical purposes only; or
    (2) Any equipment or device, or important component part especially 
designed for such equipment or device, capable of separating the 
isotopes of uranium or enriching uranium in the isotope 235.
    Uranium Milling means any activity that results in the production of 
byproduct material as defined in this part.

[26 FR 284, Jan. 14, 1961]

    Editorial Note: For Federal Register citations affecting Sec.40.4, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfoo.gov.



Sec.40.5  Communications.

    (a) Unless otherwise specified or covered under the regional 
licensing program as provided in paragraph (b) of this section, any 
communication or report concerning the regulations in this part and any 
application filed under these regulations may be submitted to the 
Commission as follows:
    (1) By mail addressed: ATTN: Document Control Desk, Director, Office 
of Nuclear Material Safety and Safeguards, or Director, Office of 
Nuclear Security, or Director, Office of Nuclear Security and Incident 
Response, as appropriate, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001.
    (2) By hand delivery to the NRC's offices at 11555 Rockville Pike, 
Rockville, Maryland.
    (3) Where practicable, by electronic submission, for example, via 
Electronic Information Exchange, or CD-ROM. Electronic submissions must 
be made in a manner that enables the NRC to receive, read, authenticate, 
distribute, and archive the submission, and process and retrieve it a 
single page at a time. Detailed guidance on making electronic 
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/e-submittals.html; by e-mail to 
[email protected]; or by writing the Office of the Chief Information 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 
The guidance discusses, among other topics, the formats the NRC can 
accept, the use of electronic signatures, and the treatment of nonpublic 
information.
    (b) The Commission has delegated to the four Regional Administrators 
licensing authority for selected parts of its decentralized licensing 
program for nuclear materials as described in paragraph (b)(1) of this 
section. Any communication, report, or application covered under this 
licensing program must be submitted to the appropriate Regional 
Administrator. The administrators' jurisdictions and mailing addresses 
are listed in paragraph (b)(2) of this section.

[[Page 797]]

    (1) The delegated licensing program includes authority to issue, 
renew, amend, cancel, modify, suspend, or revoke licenses for nuclear 
materials issued pursuant to 10 CFR parts 30 through 36, 39, 40, and 70 
to all persons for academic, medical, and industrial uses, with the 
following exceptions:
    (i) Activities in the fuel cycle and special nuclear material in 
quantities sufficient to constitute a critical mass in any room or area. 
This exception does not apply to license modifications relating to 
termination of special nuclear material licenses that authorize 
possession of larger quantities when the case is referred for action 
from NRC's Headquarters to the Regional Administrators.
    (ii) Health and safety design review of sealed sources and devices 
and approval, for licensing purposes, of sealed sources and devices.
    (iii) Processing of source material for extracting of metallic 
compounds (including Zirconium, Hafnium, Tantalum, Titanium, Niobium, 
etc.).
    (iv) Distribution of products containing radioactive material under 
Sec. Sec.32.11 through 32.30 and 40.52 of this chapter to persons 
exempt from licensing requirements.
    (v) New uses or techniques for use of byproduct, source, or special 
nuclear material.
    (vi) Uranium enrichment facilities.
    (2) Submissions.--(i) Region I. The regional licensing program 
involves all Federal facilities in the region and non-Federal licensees 
in the following Region I non-Agreement States and the District of 
Columbia: Connecticut, Delaware, and Vermont. All mailed or hand-
delivered inquiries, communications, and applications for a new license 
or an amendment or renewal of an existing license specified in paragraph 
(b)(1) of this section must use the following address: U.S. Nuclear 
Regulatory Commission, Region I, Nuclear Material Section B, Region I, 
2100 Renaissance Boulevard, Suite 100, King of Prussia, PA 19406-2713; 
where email is appropriate it should be addressed to 
[email protected].
    (ii) Region II. The regional licensing program involves all Federal 
facilities in the region and non-Federal licensees in the following 
Region II non-Agreement States and territories: West Virginia, Puerto 
Rico, and the Virgin Islands. All mailed or hand-delivered inquiries, 
communications, and applications for a new license or an amendment or 
renewal of an existing license specified in paragraph (b)(1) of this 
section must use the following address: U.S. Nuclear Regulatory 
Commission, Region I, Nuclear Material Section B, Region I, 2100 
Renaissance Boulevard, Suite 100, King of Prussia, PA 19406-2713; where 
email is appropriate it should be addressed to 
[email protected].
    (iii) Region III. (A) The regional licensing program for mining and 
milling involves all Federal facilities in the region, and non-Federal 
licensees in the Region III non-Agreement States of Indiana, Michigan, 
Missouri and Region III Agreement States of Minnesota, Wisconsin, and 
Iowa. All mailed or hand-delivered inquiries, communications, and 
applications for a new license or an amendment, renewal, or termination 
request of an existing license specified in paragraph (b)(1) of this 
section must use the following address: U.S. Nuclear Regulatory 
Commission, Region III, Material Licensing Section, 2443 Warrenville 
Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it 
should be addressed to [email protected].
    (B) Otherwise, the regional licensing program involves all Federal 
facilities in the region and non-Federal licensees in the following 
Region III non-Agreement States: Indiana, Michigan, and Missouri. All 
mailed or hand-delivered inquiries, communications, and applications for 
a new license or an amendment, or renewal of an existing license 
specified in paragraph (b)(1) of this section must use the following 
address: U.S. Nuclear Regulatory Commission, Region III, Material 
Licensing Section, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-
4352; where e-mail is appropriate it should be addressed to 
[email protected]. Outside of this jurisdiction, 
concerning the licensing program involving mining and milling, the 
Agreement States of Illinois and Ohio should be contacted.

[[Page 798]]

    (iv) Region IV. (A) The regional licensing program for mining and 
milling involves all Federal facilities in the region, and non-Federal 
licensees in the Region IV non-Agreement States and territory of Alaska, 
Hawaii, Idaho, Montana, South Dakota, Wyoming and Guam and Region IV 
Agreement States of Oregon, California, Nevada, New Mexico, Louisiana, 
Mississippi, Arkansas, Oklahoma, Kansas, Nebraska, and North Dakota. All 
mailed or hand-delivered inquiries, communications, and applications for 
a new license or an amendment or renewal of an existing license 
specified in paragraph (b)(1) of this section must use the following 
address: U.S. Nuclear Regulatory Commission, Region IV, Division of 
Nuclear Materials Safety, 1600 E. Lamar Blvd., Arlington, TX 76011-4511; 
where email is appropriate, it should be addressed to 
[email protected].
    (B) Otherwise, the regional licensing program involves all Federal 
facilities in the region and non-Federal licensees in the following 
Region IV non-Agreement States and territory: Alaska, Hawaii, Idaho, 
Montana, South Dakota, Wyoming, and Guam. All mailed or hand-delivered 
inquiries, communications, and applications for a new license or an 
amendment or renewal of an existing license specified in paragraph 
(b)(1) of this section must use the following address: U.S. Nuclear 
Regulatory Commission, Region IV, Division of Nuclear Materials Safety, 
1600 E. Lamar Blvd., Arlington, TX 76011-4511; where email is 
appropriate, it should be addressed to [email protected].

[48 FR 16031, Apr. 14, 1983]

    Editorial Note: For Federal Register citations affecting Sec.40.5, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfoo.gov.



Sec.40.6  Interpretations.

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



Sec.40.7  Employee protection.

    (a) Discrimination by a Commission licensee, an applicant for a 
Commission license, or a contractor or subcontractor of a Commission 
licensee or applicant against an employee for engaging in certain 
protected activities is prohibited. Discrimination includes discharge 
and other actions that relate to compensation, terms, conditions, or 
privileges of employment. The protected activities are established in 
section 211 of the Energy Reorganization Act of 1974, as amended, and in 
general are related to the administration or enforcement of a 
requirement imposed under the Atomic Energy Act or the Energy 
Reorganization Act.
    (1) The protected activities include but are not limited to:
    (i) Providing the Commission or his or her employer information 
about alleged violations of either of the statutes named in paragraph 
(a) introductory text of this section or possible violations of 
requirements imposed under either of those statutes;
    (ii) Refusing to engage in any practice made unlawful under either 
of the statutes named in paragraph (a) introductory text or under these 
requirements if the employee has identified the alleged illegality to 
the employer;
    (iii) Requesting the Commission to institute action against his or 
her employer for the administration or enforcement of these 
requirements;
    (iv) Testifying in any Commission proceeding, or before Congress, or 
at any Federal or State proceeding regarding any provision (or proposed 
provision) of either of the statutes named in paragraph (a) introductory 
text.
    (v) Assisting or participating in, or is about to assist or 
participate in, these activities.
    (2) These activities are protected even if no formal proceeding is 
actually initiated as a result of the employee assistance or 
participation.
    (3) This section has no application to any employee alleging 
discrimination prohibited by this section who, acting without direction 
from his or her employer (or the employer's agent), deliberately causes 
a violation of any requirement of the Energy Reorganization Act of 1974, 
as amended, or the

[[Page 799]]

Atomic Energy Act of 1954, as amended.
    (b) Any employee who believes that he or she has been discharged or 
otherwise discriminated against by any person for engaging in protected 
activities specified in paragraph (a)(1) of this section may seek a 
remedy for the discharge or discrimination through an administrative 
proceeding in the Department of Labor. The administrative proceeding 
must be initiated within 180 days after an alleged violation occurs. The 
employee may do this by filing a complaint alleging the violation with 
the Department of Labor, Employment Standards Administration, Wage and 
Hour Division. The Department of Labor may order reinstatement, back 
pay, and compensatory damages.
    (c) A violation of paragraphs (a), (e), or (f) of this section by a 
Commission licensee, an applicant for a Commission license, or a 
contractor or subcontractor of a Commission licensee or applicant may be 
grounds for--
    (1) Denial, revocation, or suspension of the license.
    (2) Imposition of a civil penalty on the licensee, applicant, or a 
contractor or subcontractor of the licensee or applicant.
    (3) Other enforcement action.
    (d) Actions taken by an employer, or others, which adversely affect 
an employee may be predicated upon nondiscriminatory grounds. The 
prohibition applies when the adverse action occurs because the employee 
has engaged in protected activities. An employee's engagement in 
protected activities does not automatically render him or her immune 
from discharge or discipline for legitimate reasons or from adverse 
action dictated by nonprohibited considerations.
    (e)(1) Each specific licensee, each applicant for a specific 
license, and each general licensee subject to part 19 shall prominently 
post the revision of NRC Form 3, ``Notice to Employees'', referenced in 
10 CFR 19.11(e)(1).
    (2) The posting of NRC Form 3 must be at locations sufficient to 
permit employees protected by this section to observe a copy on the way 
to or from their place of work. Premises must be posted not later than 
30 days after an application is docketed and remain posted while the 
application is pending before the Commission, during the term of the 
license, and for 30 days following license termination.
    (3) Copies of NRC Form 3 may be obtained by writing to the Regional 
Administrator of the appropriate U.S. Nuclear Regulatory Commission 
Regional Office listed in appendix D to part 20 of this chapter, via 
email to [email protected], or by visiting the NRC's online library 
at http://www.nrc.gov/reading-rm/doc-collections/forms/.
    (f) No agreement affecting the compensation, terms, conditions, or 
privileges of employment, including an agreement to settle a complaint 
filed by an employee with the Department of Labor pursuant to section 
211 of the Energy Reorganization Act of 1974, may contain any provision 
which would prohibit, restrict, or otherwise discourage an employee from 
participating in protected activity as defined in paragraph (a)(1) of 
this section including, but not limited to, providing information to the 
NRC or to his or her employer on potential violations or other matters 
within NRC's regulatory responsibilities.

[58 FR 52409, Oct. 8, 1993, as amended at 60 FR 24551, May 9, 1995; 61 
FR 6765, Feb. 22, 1996; 68 FR 58806, Oct. 10, 2003; 72 FR 63973, Nov. 
14, 2007; 73 FR 30458, May 28, 2008; 79 FR 66603, Nov. 10, 2014; 83 FR 
58465, Nov. 20, 2018]



Sec.40.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0020.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.40.9, 40.22, 40.23, 40.25, 40.26, 40.27, 
40.31, 40.34, 40.35, 40.36, 40.41, 40.42, 40.43, 40.44, 40.51, 40.52, 
40.53, 40.54,

[[Page 800]]

40.55, 40.60, 40.61, 40.64, 40.65, 40.66, 40.67, and appendix A to this 
part.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec. Sec.40.31, 40.43, 40.44, and appendix A, NRC Form 313 
is approved under control number 3150-0120.
    (2) In Sec.40.31, DOC/NRC Forms AP-1, AP-A, and associated forms 
are approved under control numbers 0694-0135.
    (3) In Sec.40.31, Forms N-71 and associated forms are approved 
under control number 3150-0056.
    (4) In Sec.40.42, NRC Form 314 is approved under control number 
3150-0028.
    (5) In Sec.40.64, DOE/NRC Form 741 is approved under control 
number 3150-0003.
    (6) In Sec. Sec.40.25 and 40.35, NRC Form 244 is approved under 
control number 3150-0031.

[49 FR 19626, May 9, 1984, as amended at 56 FR 40768, Aug. 16, 1991; 58 
FR 68731, Dec. 29, 1993; 62 FR 52187, Oct. 6, 1997; 73 FR 78604, Dec. 
23, 2008; 77 FR 39906, July 6, 2012; 78 FR 32338, May 29, 2013]



Sec.40.9  Completeness and accuracy of information.

    (a) Information provided to the Commission by an applicant for a 
license or by a licensee or information required by statute or by the 
Commission's regulations, orders, or license conditions to be maintained 
by the applicant or the licensee shall be complete and accurate in all 
material respects.
    (b) Each applicant or licensee shall notify the Commission of 
information identified by the applicant or licensee as having for the 
regulated activity a significant implication for public health and 
safety or common defense and security. An applicant or licensee violates 
this paragraph only if the applicant or licensee fails to notify the 
Commission of information that the applicant or licensee has identified 
as having a significant implication for public health and safety or 
common defense and security. Notification shall be provided to the 
Administrator of the appropriate Regional Office within two working days 
of identifying the information. This requirement is not applicable to 
information which is already required to be provided to the Commission 
by other reporting or undating requirements.

[52 FR 49371, Dec. 31, 1987]



Sec.40.10  Deliberate misconduct.

    (a) Any licensee, applicant for a license, employee of a licensee or 
applicant; or any contractor (including a supplier or consultant), 
subcontractor, employee of a contractor or subcontractor of any licensee 
or applicant for a license, who knowingly provides to any licensee, 
applicant, contractor, or subcontractor, any components, equipment, 
materials, or other goods or services that relate to a licensee's or 
applicant's activities in this part, may not:
    (1) Engage in deliberate misconduct that causes or would have 
caused, if not detected, a licensee or applicant to be in violation of 
any rule, regulation, or order; or any term, condition, or limitation of 
any license issued by the Commission; or
    (2) Deliberately submit to the NRC, a licensee, an applicant, or a 
licensee's or applicant's contractor or subcontractor, information that 
the person submitting the information knows to be incomplete or 
inaccurate in some respect material to the NRC.
    (b) A person who violates paragraph (a)(1) or (a)(2) of this section 
may be subject to enforcement action in accordance with the procedures 
in 10 CFR part 2, subpart B.
    (c) For the purposes of paragraph (a)(1) of this section, deliberate 
misconduct by a person means an intentional act or omission that the 
person knows:
    (1) Would cause a licensee or applicant to be in violation of any 
rule, regulation, or order; or any term, condition, or limitation, of 
any license issued by the Commission; or
    (2) Constitutes a violation of a requirement, procedure, 
instruction, contract, purchase order, or policy of a licensee, 
applicant, contractor, or subcontractor.

[63 FR 1896, Jan. 13, 1998]

[[Page 801]]

                               Exemptions



Sec.40.11  Persons using source material under certain Department
of Energy and Nuclear Regulatory Commission contracts.

    Except to the extent that Department facilities or activities of the 
types subject to licensing pursuant to section 202 of the Energy 
Reorganization Act of 1974 or the Uranium Mill Tailings Radiation 
Control Act of 1978 are involved, any prime contractor of the Department 
is exempt from the requirements for a license set forth in sections 62, 
63, and 64 of the Act and from the regulations in this part to the 
extent that such contractor, under his prime contract with the 
Department, receives, possesses, uses, transfers or delivers source 
material for: (a) The performance of work for the Department at a United 
States Government-owned or controlled site, including the transportation 
of source material to or from such site and the performance of contract 
services during temporary interruptions of such transportation; (b) 
research in, or development, manufacture, storage, testing or 
transportation of, atomic weapons or components thereof; or (c) the use 
or operation of nuclear reactors or other nuclear devices in a United 
States Government-owned vehicle or vessel. In addition to the foregoing 
exemptions, and subject to the requirement for licensing of Department 
facilities and activities pursuant to section 202 of the Energy 
Reorganization Act of 1974 or the Uranium Mill Tailings Radiation 
Control Act of 1980, any prime contractor or subcontractor of the 
Department or the Commission is exempt from the requirements for a 
license set forth in sections 62, 63, and 64 of the Act and from the 
regulations in this part to the extent that such prime contractor or 
subcontractor receives, possesses, uses, transfers or delivers source 
material under his prime contract or subcontract when the Commission 
determines that the exemption of the prime contractor or subcontractor 
is authorized by law; and that, under the terms of the contract or 
subcontract, there is adequate assurance that the work thereunder can be 
accomplished without undue risk to the public health and safety.

[40 FR 8787, Mar. 3, 1975, as amended at 43 FR 6923, Feb. 17, 1978; 45 
FR 65531, Oct. 3, 1980]



Sec.40.12  Carriers.

    (a) Except as specified in paragraph (b) of this section, common and 
contract carriers, freight forwarders, warehousemen, and the U.S. Postal 
Service are exempt from the regulations in this part and the 
requirements for a license set forth in section 62 of the Act to the 
extent that they transport or store source material in the regular 
course of the carriage for another or storage incident thereto.
    (b) The exemption in paragraph (a) of this section does not apply to 
a person who possesses a transient shipment (as defined in Sec.
40.4(r)), an import shipment, or an export shipment of natural uranium 
in an amount exceeding 500 kilograms, unless the shipment is in the form 
of ore or ore residue.

[52 FR 9651, Mar. 26, 1987]



Sec.40.13  Unimportant quantities of source material.

    (a) Any person is exempt from the regulations in this part and from 
the requirements for a license set forth in section 62 of the Act to the 
extent that such person receives, possesses, uses, transfers or delivers 
source material in any chemical mixture, compound, solution, or alloy in 
which the source material is by weight less than one-twentieth of 1 
percent (0.05 percent) of the mixture, compound, solution or alloy. The 
exemption contained in this paragraph does not apply to Australian-
obligated source material, nor does it include byproduct materials as 
defined in this part.
    (b) Any person is exempt from the regulations in this part and from 
the requirements for a license set forth in section 62 of the act to the 
extent that such person receives, possesses, uses, or transfers 
unrefined and unprocessed ore containing source material; provided, 
that, except as authorized in a specific license, such person shall not 
refine or process such ore.
    (c) Any person is exempt from the requirements for a license set 
forth in

[[Page 802]]

section 62 of the Act and from the regulations in this part and parts 
19, 20, and 21 of this chapter to the extent that such person receives, 
possesses, uses, or transfers:
    (1) Any quantities of thorium contained in (i) incandescent gas 
mantles, (ii) vacuum tubes, (iii) welding rods, (iv) electric lamps for 
illuminating purposes: Provided, That each lamp does not contain more 
than 50 milligrams of thorium, (v) germicidal lamps, sunlamps, and lamps 
for outdoor or industrial lighting: Provided, That each lamp does not 
contain more than 2 grams of thorium, (vi) rare earth metals and 
compounds, mixtures, and products containing not more than 0.25 percent 
by weight thorium, uranium, or any combination of these, or (vii) 
personnel neutron dosimeters: Provided, That each dosimeter does not 
contain more than 50 milligrams of thorium.
    (2) Source material contained in the following products:
    (i) Glazed ceramic tableware manufactured before August 27, 2013, 
provided that the glaze contains not more than 20 percent by weight 
source material;
    (ii) Piezoelectric ceramic containing not more than 2 percent by 
weight source material;
    (iii) Glassware containing not more than 2 percent by weight source 
material or, for glassware manufactured before August 27, 2013, 10 
percent by weight source material; but not including commercially 
manufactured glass brick, pane glass, ceramic tile, or other glass or 
ceramic used in construction;
    (iv) Glass enamel or glass enamel frit containing not more than 10 
percent by weight source material imported or ordered for importation 
into the United States, or initially distributed by manufacturers in the 
United States, before July 25, 1983. \1\
---------------------------------------------------------------------------

    \1\ On July 25, 1983, the exemption of glass enamel or glass enamel 
frit was suspended. The exemption was eliminated on September 11, 1984.
---------------------------------------------------------------------------

    (3) Photographic film, negatives, and prints containing uranium or 
thorium;
    (4) Any finished product or part fabricated of, or containing 
tungsten or magnesium-thorium alloys, provided that the thorium content 
of the alloy does not exceed 4 percent by weight and that the exemption 
contained in this subparagraph shall not be deemed to authorize the 
chemical, physical or metallurgical treatment or processing of any such 
product or part; and
    (5) Uranium contained in counterweights installed in aircraft, 
rockets, projectiles, and missiles, or stored or handled in connection 
with installation or removal of such counterweights: Provided, That:
    (i) Each counterweight has been impressed with the following legend 
clearly legible through any plating or other covering: ``Depleted 
Uranium''; \2\
---------------------------------------------------------------------------

    \2\ The requirements specified in paragraphs (c)(5)(i) and (ii) of 
this section need not be met by counterweights manufactured prior to 
Dec. 31, 1969, provided that such counterweights were manufactured under 
a specific license issued by the Atomic Energy Commission and were 
impressed with the legend required by Sec.40.13(c)(5)(ii) in effect on 
June 30, 1969.
---------------------------------------------------------------------------

    (ii) Each counterweight is durably and legibly labeled or marked 
with the identification of the manufacturer, and the statement: 
``Unauthorized Alterations Prohibited''; \2\ and
    (iii) The exemption contained in this paragraph shall not be deemed 
to authorize the chemical, physical, or metallurgical treatment or 
processing of any such counterweights other than repair or restoration 
of any plating or other covering.
    (iv) Consistent with Sec.40.56, the counterweights are not 
manufactured for a military purpose using Australian-obligated source 
material.
    (6) Natural or depleted uranium metal used as shielding constituting 
part of any shipping container: Provided, That:
    (i) The shipping container is conspicuously and legibly impressed 
with the legend ``CAUTION--RADIOACTIVE SHIELDING--URANIUM''; and
    (ii) The uranium metal is encased in mild steel or equally fire 
resistant metal of minimum wall thickness of one-eighth inch (3.2 mm).
    (7) Thorium or uranium contained in or on finished optical lenses 
and mirrors, provided that each lens or mirror does not contain more 
than 10 percent by weight thorium or uranium or, for lenses manufactured 
before August 27,

[[Page 803]]

2013, 30 percent by weight of thorium; and that the exemption contained 
in this paragraph does not authorize either:
    (i) The shaping, grinding or polishing of such lens or mirror or 
manufacturing processes other than the assembly of such lens or mirror 
into optical systems and devices without any alteration of the lens or 
mirror; or
    (ii) The receipt, possession, use, or transfer of uranium or thorium 
contained in contact lenses, or in spectacles, or in eyepieces in 
binoculars or other optical instruments.
    (8) Thorium contained in any finished aircraft engine part 
containing nickel-thoria alloy, Provided, That:
    (i) The thorium is dispersed in the nickel-thoria alloy in the form 
of finely divided thoria (thorium dioxide); and
    (ii) The thorium content in the nickel-thoria alloy does not exceed 
4 percent by weight.
    (9) The exemptions in this paragraph (c) do not authorize the 
manufacture of any of the products described.
    (10) No person may initially transfer for sale or distribution a 
product containing source material to persons exempt under this 
paragraph (c), or equivalent regulations of an Agreement State, unless 
authorized by a license issued under Sec.40.52 to initially transfer 
such products for sale or distribution.
    (i) Persons initially distributing source material in products 
covered by the exemptions in this paragraph (c) before August 27, 2013, 
without specific authorization may continue such distribution for 1 year 
beyond this date. Initial distribution may also be continued until the 
Commission takes final action on a pending application for license or 
license amendment to specifically authorize distribution submitted no 
later than 1 year beyond this date.
    (ii) Persons authorized to manufacture, process, or produce these 
materials or products containing source material by an Agreement State, 
and persons who import finished products or parts, for sale or 
distribution must be authorized by a license issued under Sec.40.52 
for distribution only and are exempt from the requirements of parts 19 
and 20 of this chapter, and Sec.40.32(b) and (c).

[26 FR 284, Jan. 14, 1961]

    Editorial Note: For Federal Register citations affecting Sec.
40.13, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfoo.gov.



Sec.40.14  Specific exemptions.

    (a) The Commission may, upon application of any interested person or 
upon its own initiative, grant such exemptions from the requirements of 
the regulation in this part as it determines are authorized by law and 
will not endanger life or property or the common defense and security 
and are otherwise in the public interest.
    (b) [Reserved]
    (c) The Department of Energy is exempt from the requirements of this 
part to the extent that its activities are subject to the requirements 
of part 60 or 63 of this chapter.
    (d) Except as specifically provided in part 61 of this chapter any 
licensee is exempt from the requirements of this part to the extent that 
its activities are subject to the requirements of part 61 of this 
chapter.

[37 FR 5747, Mar. 21, 1972, as amended at 39 FR 26279, July 18, 1974; 40 
FR 8787, Mar. 3, 1975; 45 FR 65531, Oct. 3, 1980; 46 FR 13979, Feb. 25, 
1981; 47 FR 57481, Dec. 27, 1982; 66 FR 55790, Nov. 2, 2001]

                            General Licenses



Sec.40.20  Types of licenses.

    (a) Licenses for source material and byproduct material are of two 
types: general and specific. Licenses for long-term care and custody of 
residual radioactive material at disposal sites are general licenses. 
The general licenses provided in this part are effective without the 
filing of applications with the Commission or the issuance of licensing 
documents to particular persons. Specific licenses are issued to named 
persons upon applications filed pursuant to the regulations in this 
part.
    (b) Section 40.27 contains a general license applicable for custody 
and long-term care of residual radioactive material at uranium mill 
tailings disposal sites remediated under title I of the

[[Page 804]]

Uranium Mill Tailings Radiation Control Act of 1978, as amended.
    (c) Section 40.28 contains a general license applicable for custody 
and long-term care of byproduct material at uranium or thorium mill 
tailings disposal sites under title II of the Uranium Mill Tailings 
Radiation Control Act of 1978, as amended.

[55 FR 45598, Oct. 30, 1990]



Sec.40.21  General license to receive title to source or byproduct
material.

    A general license is hereby issued authorizing the receipt of title 
to source or byproduct material, as defined in this part, without regard 
to quantity. This general license does not authorize any person to 
receive, possess, deliver, use, or transfer source or byproduct 
material.

[45 FR 65531, Oct. 3, 1980]



Sec.40.22  Small quantities of source material.

    (a) A general license is hereby issued authorizing commercial and 
industrial firms; research, educational, and medical institutions; and 
Federal, State, and local government agencies to receive, possess, use, 
and transfer uranium and thorium, in their natural isotopic 
concentrations and in the form of depleted uranium, for research, 
development, educational, commercial, or operational purposes in the 
following forms and quantities:
    (1) No more than 1.5 kg (3.3 lb) of uranium and thorium in 
dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time. 
Any material processed by the general licensee that alters the chemical 
or physical form of the material containing source material must be 
accounted for as a dispersible form. A person authorized to possess, 
use, and transfer source material under this paragraph may not receive 
more than a total of 7 kg (15.4 lb) of uranium and thorium in any one 
calendar year. Persons possessing source material in excess of these 
limits as of August 27, 2013, may continue to possess up to 7 kg (15.4 
lb) of uranium and thorium at any one time for one year beyond this 
date, or until the Commission takes final action on a pending 
application submitted on or before August 27, 2014, for a specific 
license for such material; and receive up to 70 kg (154 lb) of uranium 
or thorium in any one calendar year until December 31, 2014, or until 
the Commission takes final action on a pending application submitted on 
or before August 27, 2014, for a specific license for such material; and
    (2) No more than a total of 7 kg (15.4 lb) of uranium and thorium at 
any one time. A person authorized to possess, use, and transfer source 
material under this paragraph may not receive more than a total of 70 kg 
(154 lb) of uranium and thorium in any one calendar year. A person may 
not alter the chemical or physical form of the source material possessed 
under this paragraph unless it is accounted for under the limits of 
paragraph (a)(1) of this section; or
    (3) No more than 7 kg (15.4 lb) of uranium, removed during the 
treatment of drinking water, at any one time. A person may not remove 
more than 70 kg (154 lb) of uranium from drinking water during a 
calendar year under this paragraph; or
    (4) No more than 7 kg (15.4 lb) of uranium and thorium at 
laboratories for the purpose of determining the concentration of uranium 
and thorium contained within the material being analyzed at any one 
time. A person authorized to possess, use, and transfer source material 
under this paragraph may not receive more than a total of 70 kg (154 lb) 
of source material in any one calendar year.
    (b) Any person who receives, possesses, uses, or transfers source 
material in accordance with the general license in paragraph (a) of this 
section:
    (1) Is prohibited from administering source material, or the 
radiation therefrom, either externally or internally, to human beings 
except as may be authorized by the NRC in a specific license.
    (2) Shall not abandon such source material. Source material may be 
disposed of as follows:
    (i) A cumulative total of 0.5 kg (1.1 lb) of source material in a 
solid, non-dispersible form may be transferred each calendar year, by a 
person authorized to receive, possess, use, and transfer source material 
under this general

[[Page 805]]

license to persons receiving the material for permanent disposal. The 
recipient of source material transferred under the provisions of this 
paragraph is exempt from the requirements to obtain a license under this 
part to the extent the source material is permanently disposed. This 
provision does not apply to any person who is in possession of source 
material under a specific license issued under this chapter; or
    (ii) In accordance with Sec.20.2001 of this chapter.
    (3) Is subject to the provisions in Sec. Sec.40.1 through 40.10, 
40.41(a) through (e), 40.46, 40.51, 40.56, 40.60 through 40.63, 40.71, 
and 40.81.
    (4) Shall respond to written requests from the NRC to provide 
information relating to the general license within 30 calendar days of 
the date of the request, or other time specified in the request. If the 
person cannot provide the requested information within the allotted 
time, the person shall, within that same time period, request a longer 
period to supply the information by providing the Director of the Office 
of Nuclear Material Safety and Safeguards, using an appropriate method 
listed in Sec.40.5(a), a written justification for the request;
    (5) Shall not export such source material except in accordance with 
part 110 of this chapter.
    (c) Any person who receives, possesses, uses, or transfers source 
material in accordance with paragraph (a) of this section shall conduct 
activities so as to minimize contamination of the facility and the 
environment. When activities involving such source material are 
permanently ceased at any site, if evidence of significant contamination 
is identified, the general licensee shall notify the Director of the 
Office of Nuclear Material Safety and Safeguards by an appropriate 
method listed in Sec.40.5(a) about such contamination and may consult 
with the NRC as to the appropriateness of sampling and restoration 
activities to ensure that any contamination or residual source material 
remaining at the site where source material was used under this general 
license is not likely to result in exposures that exceed the limits in 
Sec.20.1402 of this chapter.
    (d) Any person who receives, possesses, uses, or transfers source 
material in accordance with the general license granted in paragraph (a) 
of this section is exempt from the provisions of parts 19, 20, and 21 of 
this chapter to the extent that such receipt, possession, use, and 
transfer are within the terms of this general license, except that such 
person shall comply with the provisions of Sec. Sec.20.1402 and 
20.2001 of this chapter to the extent necessary to meet the provisions 
of paragraphs (b)(2) and (c) of this section. However, this exemption 
does not apply to any person who also holds a specific license issued 
under this chapter.
    (e) No person may initially transfer or distribute source material 
to persons generally licensed under paragraph (a)(1) or (2) of this 
section, or equivalent regulations of an Agreement State, unless 
authorized by a specific license issued in accordance with Sec.40.54 
or equivalent provisions of an Agreement State. This prohibition does 
not apply to analytical laboratories returning processed samples to the 
client who initially provided the sample. Initial distribution of source 
material to persons generally licensed by paragraph (a) of this section 
before August 27, 2013, without specific authorization may continue for 
1 year beyond this date. Distribution may also be continued until the 
Commission takes final action on a pending application for license or 
license amendment to specifically authorize distribution submitted on or 
before August 27, 2014.

[78 FR 32339, May 29, 2013]



Sec.40.23  General license for carriers of transient shipments of
natural uranium other than in the form of ore or ore residue.

    (a) A general license is hereby issued to any person to possess a 
transient shipment of natural uranium, other than in the form of ore or 
ore residue, in amounts exceeding 500 kilograms.
    (b)(1) Persons generally licensed under paragraph (a) of this 
section, who plan to carry a transient shipment with scheduled stops at 
a United States port, shall notify the Director Office of Nuclear 
Security and Incident Response, using an appropriate method listed in 
Sec.40.5. The notification must be

[[Page 806]]

in writing and must be received at least 10 days before transport of the 
shipment commences at the shipping facility.
    (2) The notification must include the following information:
    (i) Location of all scheduled stops in United States territory;
    (ii) Arrival and departure times for all scheduled stops in United 
States territory;
    (iii) The type of transport vehicle;
    (iv) A physical description of the shipment;
    (v) The numbers and types of containers;
    (vi) The name and telephone number of the carrier's representatives 
at each stopover location in the United States territory;
    (vii) A listing of the modes of shipments, transfer points, and 
routes to be used;
    (viii) The estimated date and time that shipment will commence and 
that each nation (other than the United States) along the route is 
scheduled to be entered;
    (ix) For shipment between countries that are not party to the 
Convention on the Physical Protection of Nuclear Material (i.e., not 
listed in appendix F to part 73 of this chapter), a certification that 
arrangements have been made to notify the Director, Office of Nuclear 
Security and Incident Response when the shipment is received at the 
destination facility.
    (c) Persons generally licensed under this section making unscheduled 
stops at United States ports, immediately after the decision to make an 
unscheduled stop, shall provide to the Director, Division of Physical 
and Cyber Security Policy the information required under paragraph (b) 
of this section.
    (d) A licensee who needs to amend a notification may do so by 
telephoning the Division of Physical and Cyber Security Policy at (301) 
287-3598.

[52 FR 9651, Mar. 26, 1987, as amended at 53 FR 4110, Feb. 12, 1988; 60 
FR 24551, May 9, 1995; 68 FR 58806, Oct. 10, 2003; 74 FR 62681, Dec. 1, 
2009; 83 FR 58723, Nov. 21, 2018]



Sec.40.24  [Reserved]



Sec.40.25  General license for use of certain industrial products
or devices.

    (a) A general license is hereby issued to receive, acquire, possess, 
use, or transfer, in accordance with the provisions of paragraphs (b), 
(c), (d), and (e) of this section, depleted uranium contained in 
industrial products or devices for the purpose of providing a 
concentrated mass in a small volume of the product or device.
    (b) The general license in paragraph (a) of this section applies 
only to industrial products or devices which have been manufactured or 
initially transferred in accordance with a specific license issued 
pursuant to Sec.40.34 (a) of this part or in accordance with a 
specific license issued by an Agreement State which authorizes 
manufacture of the products or devices for distribution to persons 
generally licensed by the Agreement State.
    (c)(1) Persons who receive, acquire, possess, or use depleted 
uranium pursuant to the general license established by paragraph (a) of 
this section shall file NRC Form 244, ``Registration Certificate--Use of 
Depleted Uranium Under General License,'' with the Director, Office of 
Nuclear Material Safety and Safeguards, by an appropriate method listed 
in Sec.40.5, with a copy to the appropriate NRC Regional 
Administrator. The form shall be submitted within 30 days after the 
first receipt or acquisition of such depleted uranium. The registrant 
shall furnish on NRC Form 244 the following information and such other 
information as may be required by that form:
    (i) Name and address of the registrant;
    (ii) A statement that the registrant has developed and will maintain 
procedures designed to establish physical control over the depleted 
uranium described in paragraph (a) of this section and designed to 
prevent transfer of such depleted uranium in any form, including metal 
scrap, to persons not authorized to receive the depleted uranium; and
    (iii) Name and/or title, address, and telephone number of the 
individual duly authorized to act for and on behalf of the registrant in 
supervising the

[[Page 807]]

procedures identified in paragraph (c)(1)(ii) of this section.
    (2) The registrant possessing or using depleted uranium under the 
general license established by paragraph (a) of this section shall 
report in writing to the Director, Office of Nuclear Material Safety and 
Safeguards, with a copy to the Regional Administrator of the appropriate 
U.S. Nuclear Regulatory Commission Regional Office listed in appendix D 
of part 20 of this chapter, any changes in information furnished by him 
in the NRC Form 244 ``Registration Certificate--Use of Depleted Uranium 
Under General License.'' The report shall be submitted within 30 days 
after the effective date of such change.
    (d) A person who receives, acquires, possesses, or uses depleted 
uranium pursuant to the general license established by paragraph (a) of 
this section:
    (1) Shall not introduce such depleted uranium, in any form, into a 
chemical, physical, or metallurgical treatment or process, except a 
treatment or process for repair or restoration of any plating or other 
covering of the depleted uranium.
    (2) Shall not abandon such depleted uranium.
    (3) Shall transfer or dispose of such depleted uranium only by 
transfer in accordance with the provisions of Sec.40.51 of this part. 
In the case where the transferee receives the depleted uranium pursuant 
to the general license established by paragraph (a) of this section, the 
transferor shall furnish the transferee a copy of this section and a 
copy of Form NRC 244. In the case where the transferee receives the 
depleted uranium pursuant to a general license contained in an Agreement 
State's regulation equivalent to this section, the transferor shall 
furnish the transferee a copy of this section and a copy of Form NRC 244 
accompanied by a note explaining that use of the product or device is 
regulated by the Agreement State under requirements substantially the 
same as those in this section.
    (4) Within 30 days of any transfer, shall report in writing to the 
Director, Office of Nuclear Material Safety and Safeguards, with a copy 
to the Regional Administrator of the appropriate U.S. Nuclear Regulatory 
Commission Regional Office listed in appendix D of part 20 of this 
chapter, the name and address of the person receiving the source 
material pursuant to such transfer.
    (e) Any person receiving, acquiring, possessing, using, or 
transferring depleted uranium pursuant to the general license 
established by paragraph (a) of this section is exempt from the 
requirements of parts 19, 20 and 21 of this chapter with respect to the 
depleted uranium covered by that general license.

[41 FR 53331, Dec. 6, 1976, as amended at 42 FR 28896, June 6, 1977; 43 
FR 6923, Feb. 17, 1978; 43 FR 52202, Nov. 9, 1978; 52 FR 31611, Aug. 21, 
1987; 60 FR 24551, May 9, 1995; 68 FR 58807, Oct. 10, 2003; 73 FR 5720, 
Jan. 31, 2008]



Sec.40.26  General license for possession and storage of byproduct
material as defined in this part.

    (a) A general license is hereby issued to receive title to, own, or 
possess byproduct material as defined in this part without regard to 
form or quantity.
    (b) The general license in paragraph (a) of this section applies 
only: In the case of licensees of the Commission, where activities that 
result in the production of byproduct material are authorized under a 
specific license issued by the Commission pursuant to this part, to 
byproduct material possessed or stored at an authorized disposal 
containment area or transported incident to such authorized activity: 
Provided, That authority to receive title to, own, or possess byproduct 
material under this general license shall terminate when the specific 
license for source material expires, is renewed, or is amended to 
include a specific license for byproduct material as defined in this 
part.
    (c) The general license in paragraph (a) of this section is subject 
to:
    (1) The provisions of parts 19, 20, 21, and Sec. Sec.40.1, 40.2a, 
40.3, 40.4, 40.5, 40.6, 40.41, 40.46, 40.60, 40.61, 40.62, 40.63, 40.65, 
40.71, and 40.81 of part 40 of this chapter; and
    (2) The documentation of daily inspections of tailings or waste 
retention systems and the immediate notification of the appropriate NRC 
regional office as indicated in appendix D to

[[Page 808]]

part 20 of this chapter, or the Director, Office of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555, of any failure in a tailings or waste retention system that 
results in a release of tailings or waste into unrestricted areas, or of 
any unusual conditions (conditions not contemplated in the design of the 
retention system) that if not corrected could lead to failure of the 
system and result in a release of tailings or waste into unrestricted 
areas; and any additional requirements the Commission may by order deem 
necessary. The licensee shall retain this documentation of each daily 
inspection as a record for three years after each inspection is 
documented.
    (d) The general license in paragraph (a) of this section shall 
expire nine months from the effective date of this subparagraph unless 
an applicable licensee has submitted, pursuant to the provisions of 
Sec.40.31 of this part, an application for license renewal or 
amendment which includes a detailed program for meeting the technical 
and financial criteria contained in appendix A of this part.

[44 FR 50014, Aug. 24, 1979, as amended at 45 FR 12377, Feb. 26, 1980; 
45 FR 65531, Oct. 3, 1980; 53 FR 19248, May 27, 1988; 56 FR 40768, Aug. 
16, 1991; 73 FR 5720, Jan. 31, 2008]



Sec.40.27  General license for custody and long-term care of residual
radioactive material disposal sites.

    (a) A general license is issued for the custody of and long-term 
care, including monitoring, maintenance, and emergency measures 
necessary to protect public health and safety and other actions 
necessary to comply with the standards promulgated under section 275(a) 
of the Atomic Energy Act of 1954, as amended, for disposal sites under 
title I of the Uranium Mill Tailings Radiation Control Act of 1978, as 
amended. The license is available only to the Department of Energy, or 
another Federal agency designated by the President to provide long-term 
care. The purpose of this general license is to ensure that uranium mill 
tailings disposal sites will be cared for in such a manner as to protect 
the public health, safety, and the environment after remedial action has 
been completed.
    (b) The general license in paragraph (a) of this section becomes 
effective when the Commission accepts a site Long-Term Surveillance Plan 
(LTSP) that meets the requirements of this section, and when the 
Commission concurs with the Department of Energy's determination of 
completion of remedial action at each disposal site. There is no 
termination of this general license. The LTSP may incorporate by 
reference information contained in documents previously submitted to the 
Commission if the references to the individual incorporated documents 
are clear and specific. Each LTSP must include--
    (1) A legal description of the disposal site to be licensed, 
including documentation on whether land and interests are owned by the 
United States or an Indian Tribe. If the site is on Indian land, then, 
as specified in the Uranium Mill Tailings Radiation Control Act of 1978, 
as amended, the Indian Tribe and any person holding any interest in the 
land shall execute a waiver releasing the United States of any liability 
or claim by the Tribe or person concerning or arising from the remedial 
action and holding the United States harmless against any claim arising 
out of the performance of the remedial action;
    (2) A detailed description, which can be in the form of a reference, 
of the final disposal site conditions, including existing groundwater 
characterization and any necessary groundwater protection activities or 
strategies. This description must be detailed enough so that future 
inspectors will have a baseline to determine changes to the site and 
when these changes are serious enough to require maintenance or repairs. 
If the disposal site has continuing aquifer restoration requirements, 
then the licensing process will be completed in two steps. The first 
step includes all items other than groundwater restoration. Groundwater 
monitoring, which would be addressed in the LTSP, may still be required 
in this first step to assess performance of the tailings disposal units. 
When the Commission concurs with the completion of groundwater 
restoration, the licensee shall assess the need to modify the LTSP and 
report results to the

[[Page 809]]

Commission. If the proposed modifications meet the requirements of this 
section, the LTSP will be considered suitable to accommodate the second 
step.
    (3) A description of the long-term surveillance program, including 
proposed inspection frequency and reporting to the Commission (as 
specified in appendix A, criterion 12 of this part), frequency and 
extent of groundwater monitoring if required, appropriate constituent 
concentration limits for groundwater, inspection personnel 
qualifications, inspection procedures, recordkeeping and quality 
assurance procedures;
    (4) The criteria for follow-up inspections in response to 
observations from routine inspections or extreme natural events; and
    (5) The criteria for instituting maintenance or emergency measures.
    (c) The long-term care agency under the general license established 
by paragraph (a) of this section shall--
    (1) Implement the LTSP as described in paragraph (b) of this 
section;
    (2) Care for the disposal site in accordance with the provisions of 
the LTSP;
    (3) Notify the Commission of any changes to the LTSP; the changes 
may not conflict with the requirements of this section;
    (4) Guarantee permanent right-of-entry to Commission representatives 
for the purpose of periodic site inspections; and
    (5) Notify the Commission prior to undertaking any significant 
construction, actions, or repairs related to the disposal site, even if 
the action is required by a State or another Federal agency.
    (d) As specified in the Uranium Mill Tailings Radiation Control Act 
of 1978, as amended, the Secretary of the Interior, with the concurrence 
of the Secretary of Energy and the Commission, may sell or lease any 
subsurface mineral rights associated with land on which residual 
radioactive materials are disposed. In such cases, the Commission shall 
grant a license permitting use of the land if it finds that the use will 
not disturb the residual radioactive materials or that the residual 
radioactive materials will be restored to a safe and environmentally 
sound condition if they are disturbed by the use.
    (e) The general license in paragraph (a) of this section is exempt 
from parts 19, 20, and 21 of this chapter, unless significant 
construction, actions, or repairs are required. If these types of 
actions are to be undertaken, the licensee shall explain to the 
Commission which requirements from these parts apply for the actions and 
comply with the appropriate requirements.

[55 FR 45598, Oct. 30, 1990, as amended at 81 FR 86909, Dec. 2, 2016]



Sec.40.28  General license for custody and long-term care of uranium
or thorium byproduct materials disposal sites.

    (a) A general license is issued for the custody of and long-term 
care, including monitoring, maintenance, and emergency measures 
necessary to protect the public health and safety and other actions 
necessary to comply with the standards in this part for uranium or 
thorium mill tailings sites closed under title II of the Uranium Mill 
Tailings Radiation Control Act of 1978, as amended. The licensee will be 
the Department of Energy, another Federal agency designated by the 
President, or a State where the disposal site is located. The purpose of 
this general license is to ensure that uranium and thorium mill tailings 
disposal sites will be cared for in such a manner as to protect the 
public health, safety, and the environment after closure.
    (b) The general license in paragraph (a) of this section becomes 
effective when the Commission terminates, or concurs in an Agreement 
State's termination of, the current specific license and a site Long-
Term Surveillance Plan (LTSP) meeting the requirements of this section 
has been accepted by the Commission. There is no termination of this 
general license. If the LTSP has not been formally received by the NRC 
prior to termination of the current specific license, the Commission may 
issue a specific order to the intended custodial agency to ensure 
continued control and surveillance of the disposal site to protect the 
public health, safety, and the environment. The Commission will not 
unnecessarily delay the

[[Page 810]]

termination of the specific license solely on the basis that an 
acceptable LTSP has not been received. The LTSP may incorporate by 
reference information contained in documents previously submitted to the 
Commission if the references to the individual incorporated documents 
are clear and specific. Each LTSP must include--
    (1) A legal description of the disposal site to be transferred 
(unless transfer is exempted under provisions of the Atomic Energy Act, 
Sec.83(b)(1)(A)) and licensed;
    (2) A detailed description, which can be in the form of a reference 
of the final disposal site conditions, including existing groundwater 
characterization. This description must be detailed enough so that 
future inspectors will have a baseline to determine changes to the site 
and when these changes are serious enough to require maintenance or 
repairs;
    (3) A description of the long-term surveillance program, including 
proposed inspection frequency and reporting to the Commission (as 
specified in appendix A, Criterion 12 of this part), frequency and 
extent of groundwater monitoring if required, appropriate constituent 
concentration limits for groundwater, inspection personnel 
qualifications, inspection procedures, recordkeeping and quality 
assurance procedures;
    (4) The criteria for follow-up inspections in response to 
observations from routine inspections or extreme natural events; and
    (5) The criteria for instituting maintenance or emergency measures.
    (c) The long-term care agency who has a general license established 
by paragraph (a) of this section shall--
    (1) Implement the LTSP as described in paragraph (b) of this 
section;
    (2) Care for the disposal site in accordance with the provisions of 
the LTSP;
    (3) Notify the Commission of any changes to the LTSP; the changes 
may not conflict with the requirements of this section;
    (4) Guarantee permanent right-of-entry to Commission representatives 
for the purpose of periodic site inspections; and
    (5) Notify the Commission prior to undertaking any significant 
construction, actions, or repairs related to the disposal site, even if 
the action is required by a State or another Federal agency.
    (d) Upon application, the Commission may issue a specific license, 
as specified in the Uranium Mill Tailings Radiation Control Act of 1978, 
as amended, permitting the use of surface and/or subsurface estates 
transferred to the United States or a State. Although an application may 
be received from any person, if permission is granted, the person who 
transferred the land to DOE or the State shall receive the right of 
first refusal with respect to this use of the land. The application must 
demonstrate that--
    (1) The proposed action does not endanger the public health, safety, 
welfare, or the environment;
    (2) Whether the proposed action is of a temporary or permanent 
nature, the site would be maintained and/or restored to meet 
requirements in appendix A of this part for closed sites; and
    (3) Adequate financial arrangements are in place to ensure that the 
byproduct materials will not be disturbed, or if disturbed that the 
applicant is able to restore the site to a safe and environmentally 
sound condition.
    (e) The general license in paragraph (a) of this section is exempt 
from parts 19, 20, and 21 of this chapter, unless significant 
construction, actions, or repairs are required. If these types of 
actions are to be undertaken, the licensee shall explain to the 
Commission which requirements from these parts apply for the actions and 
comply with the appropriate requirements.
    (f) In cases where the Commission determines that transfer of title 
of land used for disposal of any byproduct materials to the United 
States or any appropriate State is not necessary to protect the public 
health, safety or welfare or to minimize or eliminate danger to life or 
property (Atomic Energy Act, Sec.83(b)(1)(A)), the Commission will 
consider specific modifications of the custodial agency's LTSP 
provisions on a case-by-case basis.

[55 FR 45599, Oct. 30, 1990, as amended at 81 FR 86909, Dec. 2, 2016]

[[Page 811]]

                          License Applications



Sec.40.31  Application for specific licenses.

    (a) A person may file an application for specific license on NRC 
Form 313, ``Application for Material License,'' in accordance with the 
instructions in Sec.40.5 of this chapter. Information contained in 
previous applications, statements or reports filed with the Commission 
may be incorporated by reference provided that the reference is clear 
and specific.
    (b) The Commission may at any time after the filing of the original 
application, and before the expiration of the license, require further 
statements in order to enable the Commission to determine whether the 
application should be granted or denied or whether a license should be 
modified or revoked. All applications and statements shall be signed by 
the applicant or licensee or a person duly authorized to act for and on 
his behalf.
    (c) Applications and documents submitted to the Commission in 
connection with applications will be made available for public 
inspection in accordance with the provisions of the regulations 
contained in parts 2 and 9 of this chapter.
    (d) An application for a license filed pursuant to the regulations 
in this part will be considered also as an application for licenses 
authorizing other activities for which licenses are required by the Act: 
Provided, That the application specifies the additional activities for 
which licenses are requested and complies with regulations of the 
Commission as to applications for such licenses.
    (e) Each application for a source material license, other than a 
license exempted from part 170 of this chapter, shall be accompanied by 
the fee prescribed in Sec.170.31 of this chapter. No fee will be 
required to accompany an application for renewal or amendment of a 
license, except as provided in Sec.170.31 of this chapter.
    (f) An application for a license to possess and use source material 
for uranium milling, production of uranium hexafluoride, or for the 
conduct of any other activity which the Commission has determined 
pursuant to subpart A of part 51 of this chapter will significantly 
affect the quality of the environment shall be filed at least 9 months 
prior to commencement of construction of the plant or facility in which 
the activity will be conducted and shall be accompanied by any 
Environmental Report required pursuant to subpart A of part 51 of this 
chapter.
    (g) An applicant for a license to possess and use source material, 
or the recipient of such a license shall report information to the 
Commission as follows:
    (1) In response to a written request by the Commission, a uranium or 
thorium processing plant, and any other applicant for a license to 
possess and use source material, shall submit facility information 
described in Sec.75.10 of this chapter on Form N-71 and associated 
forms and site information on DOC/NRC Form AP-A, and associated forms;
    (2) As required by the Additional Protocol, a uranium or thorium 
processing plant, and any other applicant for a license to possess and 
use source material, shall submit location information described in 
Sec.75.11 of this chapter on DOC/NRC Form AP-1 and associated forms; 
shall permit verification of this information by the International 
Atomic Energy Agency (IAEA); and shall take other actions as may be 
necessary to implement the US/IAEA Safeguards Agreement, as described in 
part 75 of this chapter; or
    (3) As required by the Additional Protocol, an ore processing plant 
or a facility using or storing ore concentrates or other impure source 
materials shall submit the information described in Sec.75.11 of this 
chapter, as appropriate, on DOC/NRC Form AP-1 and associated forms; 
shall permit verification of this information by the International 
Atomic Energy Agency (IAEA); and shall take other actions as may be 
necessary to implement the US/IAEA Safeguards Agreement, as described in 
part 75 of this chapter.
    (h) An application for a license to receive, possess, and use source 
material for uranium or thorium milling or byproduct material, as 
defined in this part, at sites formerly associated with such milling 
shall contain proposed

[[Page 812]]

written specifications relating to milling operations and the 
disposition of the byproduct material to achieve the requirements and 
objectives set forth in appendix A of this part. Each application must 
clearly demonstrate how the requirements and objectives set forth in 
appendix A of this part have been addressed. Failure to clearly 
demonstrate how the requirements and objectives in appendix A have been 
addressed shall be grounds for refusing to accept an application.
    (i) As provided by Sec.40.36, certain applications for specific 
licenses filed under this part must contain a proposed decommissioning 
funding plan or a certification of financial assurance for 
decommissioning. In the case of renewal applications submitted before 
July 27, 1990, this submittal may follow the renewal application but 
must be submitted on or before July 27, 1990.
    (j)(1) Each application to possess uranium hexafluoride in excess of 
50 kilograms in a single container or 1000 kilograms total must contain 
either:
    (i) An evaluation showing that the maximum intake of uranium by a 
member of the public due to a release would not exceed 2 milligrams; or
    (ii) An emergency plan for responding to the radiological hazards of 
an accidental release of source material and to any associated chemical 
hazards directly incident thereto.
    (2) One or more of the following factors may be used to support an 
evaluation submitted under paragraph (j)(1)(i) of this section:
    (i) All or part of the radioactive material is not subject to 
release during an accident because of the way it is stored or packaged;
    (ii) Facility design or engineered safety features in the facility 
would reduce the amount of the release; or
    (iii) Other factors appropriate for the specific facility.
    (3) An emergency plan submitted under paragraph (j)(1)(ii) of this 
section must include the following:
    (i) Facility description. A brief description of the licensee's 
facility and area near the site.
    (ii) Types of accidents. An identification of each type of accident 
for which protective actions may be needed.
    (iii) Classification of accidents. A classification system for 
classifying accidents as alerts or site area emergencies.
    (iv) Detection of accidents. Identification of the means of 
detecting each type of radioactive materials accident in a timely 
manner.
    (v) Mitigation of consequences. A brief description of the means and 
equipment for mitigating the consequences of each type of accident, 
including those provided to protect workers onsite, and a description of 
the program for maintaining the equipment.
    (vi) Assessment of releases. A brief description of the methods and 
equipment to assess releases of radioactive materials.
    (vii) Responsibilities. A brief description of the responsibilities 
of licensee personnel should an accident occur, including identification 
of personnel responsible for promptly notifying offsite response 
organizations and the NRC; also responsibilities for developing, 
maintaining, and updating the plan.
    (viii) Notification and coordination. A commitment to and a brief 
description of the means to promptly notify offsite response 
organizations and request offsite assistance, including medical 
assistance for the treatment of contaminated injured onsite workers when 
appropriate. A control point must be established. The notification and 
coordination must be planned so that unavailability of some personnel, 
parts of the facility, and some equipment will not prevent the 
notification and coordination. The licensee shall also commit to notify 
the NRC operations center immediately after notification of the offsite 
response organizations and not later than one hour after the licensee 
declares an emergency. \1\
---------------------------------------------------------------------------

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

    (ix) Information to be communicated. A brief description of the 
types of information on facility status, radioactive releases, and 
recommended protective actions, if necessary, to be given to offsite 
response organizations and to the NRC.

[[Page 813]]

    (x) Training. A brief description of the frequency, performance 
objectives and plans for the training that the licensee will provide 
workers on how to respond to an emergency including any special 
instructions and orientation tours the licensee would offer to fire, 
police, medical and other emergency personnel. The training shall 
familiarize personnel with site-specific emergency procedures. Also, the 
training shall thoroughly prepare site personnel for their 
responsibilities in the event of accident scenarios postulated as most 
probable for the specific site, including the use of team training for 
such scenarios.
    (xi) Safe shutdown. A brief description of the means of restoring 
the facility to a safe condition after an accident.
    (xii) Exercises. Provisions for conducting quarterly communications 
checks with offsite response organizations and biennial onsite exercises 
to test response to simulated emergencies. Quarterly communications 
checks with offsite response organizations must include the check and 
update of all necessary telephone numbers. The licensee shall invite 
offsite response organizations to participate in the biennial exercises. 
Participation of offsite response organizations in biennial exercises 
although recommended is not required. Exercises must use accident 
scenarios postulated as most probable for the specific site and the 
scenarios shall not be known to most exercise participants. The licensee 
shall critique each exercise using individuals not having direct 
implementation responsibility for the plan. Critiques of exercises must 
evaluate the appropriateness of the plan, emergency procedures, 
facilities, equipment, training of personnel, and overall effectiveness 
of the response. Deficiencies found by the critiques must be corrected.
    (xiii) Hazardous chemicals. A certification that the application has 
met its responsibilities under the Emergency Planning and Community 
Right-to-Know Act of 1986, title III, Pub. L. 99-499, if applicable to 
the applicant's activities at the proposed place of the use of the 
source material.
    (4) The licensee shall allow the offsite response organizations 
expected to respond in case of an accident 60 days to comment on the 
licensee's emergency plan before submitting it to the NRC. The licensee 
shall provide any comments received within the 60 days to the NRC with 
the emergency plan.
    (k) A license application for a uranium enrichment facility must be 
accompanied by an Environmental Report required under subpart A of part 
51 of this chapter.
    (l) A license application that involves the use of source material 
in a uranium enrichment facility must include the applicant's provisions 
for liability insurance.
    (m) Each applicant for a license for the possession of source 
material at a facility for the production or conversion of uranium 
hexafluoride shall protect Safeguards Information against unauthorized 
disclosure in accordance with the requirements in Sec. Sec.73.21 and 
73.22 of this chapter, as applicable. Each applicant for a license for 
source material shall protect Safeguards Information against 
unauthorized disclosure in accordance with the requirements in Sec.
73.21 and the requirements of Sec.73.22 or Sec.73.23 of this 
chapter, as applicable.

[26 FR 284, Jan. 14, 1961, as amended at 31 FR 4669, Mar. 19, 1966; 34 
FR 19546, Dec. 11, 1969; 36 FR 145, Jan. 6, 1971; 37 FR 5748, Mar. 21, 
1972; 46 FR 13497, Feb. 23, 1981; 49 FR 9403, Mar. 12, 1984; 49 FR 
19626, May 9, 1984; 49 FR 21699, May 23, 1984; 49 FR 27924, July 9, 
1984; 53 FR 24047, June 27, 1988; 54 FR 14061, Apr. 7, 1989; 57 FR 
18390, Apr. 30, 1992; 68 FR 58807, Oct. 10, 2003; 73 FR 63570, Oct. 24, 
2008; 73 FR 78604, Dec. 23, 2008]



Sec.40.32  General requirements for issuance of specific licenses.

    An application for a specific license will be approved if:
    (a) The application is for a purpose authorized by the Act; and
    (b) The applicant is qualified by reason of training and experience 
to use the source material for the purpose requested in such manner as 
to protect health and minimize danger to life or property; and
    (c) The applicant's proposed equipment, facilities and procedures 
are adequate to protect health and minimize danger to life or property; 
and
    (d) The issuance of the license will not be inimical to the common 
defense

[[Page 814]]

and security or to the health and safety of the public; and
    (e) In the case of an application for a license for a uranium 
enrichment facility, or for a license to possess and use source and 
byproduct material for uranium milling, production of uranium 
hexafluoride, or for the conduct of any other activity which the NRC 
determines will significantly affect the quality of the environment, the 
Director, Office of Nuclear Material Safety and Safeguardsor his/her 
designee, before commencement of construction, on the basis of 
information filed and evaluations made pursuant to subpart A of part 51 
of this chapter, has concluded, after weighing the environmental, 
economic, technical and other benefits against environmental costs and 
considering available alternatives, that the action called for is the 
issuance of the proposed license, with any appropriate conditions to 
protect environmental values. Commencement of construction prior to this 
conclusion is grounds for denial of a license to possess and use source 
and byproduct material in the plant or facility. Commencement of 
construction as defined in Sec.40.4 may include non-construction 
activities if the activity has a reasonable nexus to radiological safety 
and security.
    (f) The applicant satisfies any applicable special requirements 
contained in Sec. Sec.40.34, 40.52, and 40.54.
    (g) If the proposed activity involves use of source material in a 
uranium enrichment facility, the applicant has satisfied the applicable 
provisions of part 140 of this chapter.

[26 FR 284, Jan. 14, 1961, as amended at 36 FR 12731, July 7, 1971; 40 
FR 8787, Mar. 3, 1975; 41 FR 53332, Dec. 6, 1976; 43 FR 6924, Feb. 17, 
1978; 49 FR 9403, Mar. 12, 1984; 57 FR 18390, Apr. 30, 1992; 73 FR 5721, 
Jan. 31, 2008; 76 FR 56964, Sept. 15, 2011; 78 FR 32340, May 29, 2013]



Sec.40.33  Issuance of a license for a uranium enrichment facility.

    (a) The Commission will hold a hearing pursuant to 10 CFR part 2, 
subparts A, G, and I, on each application with regard to the licensing 
of the construction and operation of a uranium enrichment facility. The 
Commission will publish public notice of the hearing in the Federal 
Register at least 30 days before the hearing.
    (b) A license for a uranium enrichment facility may not be issued 
before the hearing is completed and a decision issued on the 
application.

[57 FR 18391, Apr. 30, 1992]



Sec.40.34  Special requirements for issuance of specific licenses.

    (a) An application for a specific license to manufacture industrial 
products and devices containing depleted uranium, or to initially 
transfer such products or devices, for use pursuant to Sec.40.25 of 
this part or equivalent regulations of an Agreement State, will be 
approved if:
    (1) The applicant satisfies the general requirements specified in 
Sec.40.32;
    (2) The applicant submits sufficient information relating to the 
design, manufacture, prototype testing, quality control procedures, 
labeling or marking, proposed uses, and potential hazards of the 
industrial product or device to provide reasonable assurance that 
possession, use, or transfer of the depleted uranium in the product or 
device is not likely to cause any individual to receive in 1 year a 
radiation dose in excess of 10 percent of the annual limits specified in 
Sec.20.1201(a) of this chapter; and
    (3) The applicant submits sufficient information regarding the 
industrial product or device and the presence of depleted uranium for a 
mass-volume application in the product or device to provide reasonable 
assurance that unique benefits will accrue to the public because of the 
usefulness of the product or device.
    (b) In the case of an industrial product or device whose unique 
benefits are questionable, the Commission will approve an application 
for a specific license under this paragraph only if the product or 
device is found to combine a high degree of utility and low probability 
of uncontrolled disposal and dispersal of significant quantities of 
depleted uranium into the environment.
    (c) The Commission may deny an applicant for a specific license 
under this

[[Page 815]]

paragraph if the end uses of the industrial product or device cannot be 
reasonably foreseen.

[41 FR 53332, Dec. 6, 1976, as amended at 43 FR 6924, Feb. 17, 1978; 58 
FR 67661, Dec. 22, 1993; 59 FR 41643, Aug. 15, 1994]



Sec.40.35  Conditions of specific licenses issued pursuant 
to Sec.40.34.

    Each person licensed pursuant to Sec.40.34 shall:
    (a) Maintain the level of quality control required by the license in 
the manufacture of the industrial product or device, and in the 
installation of the depleted uranium into the product or device;
    (b) Label or mark each unit to: (1) Identify the manufacturer or 
initial transferor of the product or device and the number of the 
license under which the product or device was manufactured or initially 
transferred, the fact that the product or device contains depleted 
uranium, and the quantity of depleted uranium in each product or device; 
and (2) state that the receipt, possession, use, and transfer of the 
product or device are subject to a general license or the equivalent and 
the regulations of the U.S. NRC or of an Agreement State;
    (c) Assure that the depleted uranium before being installed in each 
product or device has been impressed with the following legend clearly 
legible through any plating or other covering: ``Depleted Uranium'';
    (d)(1) Furnish a copy of the general license contained in Sec.
40.25 and a copy of Form NRC 244 to each person to whom he transfers 
source material in a product or device for use pursuant to the general 
license contained in Sec.40.25; or
    (2) Furnish a copy of the general license contained in the Agreement 
State's regulation equivalent to Sec.40.25 and a copy of the Agreement 
State's certificate, or alternately, furnish a copy of the general 
license contained in Sec.40.25 and a copy of Form NRC 244 to each 
person to whom he transfers source material in a product or device for 
use pursuant to the general license of an Agreement State. If a copy of 
the general license in Sec.40.25 and a copy of Form NRC 244 are 
furnished to such person, they shall be accompanied by a note explaining 
that use of the product or device is regulated by the Agreement State 
under requirements substantially the same as those in Sec.40.25; and
    (e)(1) Report to the Director, Office of Nuclear Material Safety and 
Safeguards, by an appropriate method listed in Sec.40.5, all transfers 
of industrial products or devices to persons for use under the general 
license in Sec.40.25. Such report shall identify each general licensee 
by name and address, an individual by name and/or position who may 
constitute a point of contact between the Commission and the general 
licensee, the type and model number of device transferred, and the 
quantity of depleted uranium contained in the product or device. The 
report shall be submitted within 30 days after the end of each calendar 
quarter in which such a product or device is transferred to the 
generally licensed person. If no transfers have been made to persons 
generally licensed under Sec.40.25 during the reporting period, the 
report shall so indicate;
    (2) Report to the responsible Agreement State Agency all transfers 
of industrial products or devices to persons for use under the general 
license in the Agreement State's regulation equivalent to Sec.40.25. 
Such report shall identify each general licensee by name and address, an 
individual by name and/or position who may constitute a point of contact 
between the Agency and the general licensee, the type and model number 
of device transferred, and the quantity of depleted uranium contained in 
the product or device. The report shall be submitted within 30 days 
after the end of each calendar quarter in which such product or device 
is transferred to the generally licensed person. If no transfers have 
been made to a particular Agreement State during the reporting period, 
this information shall be reported to the responsible Agreement State 
Agency;
    (3) Keep records showing the name, address, and a point of contact 
for each general license to whom he or she transfers depleted uranium in 
industrial products or devices for use pursuant to the general license 
provided in Sec.40.25 or equivalent regulations of an Agreement State. 
The records must be

[[Page 816]]

retained for three years from the date of transfer and must show the 
date of each transfer, the quantity of depleted uranium in each product 
or device transferred, and compliance with the report requirements of 
this section.
    (f) Licensees required to submit emergency plans by Sec.
40.31(j)(1)-(4) shall follow the emergency plan approved by the 
Commission. The licensee may change the plan without Commission approval 
if the changes do not decrease the effectiveness of the plan. The 
licensee shall furnish the change to the Director, Office of Nuclear 
Material Safety and Safeguards, by an appropriate method listed in Sec.
40.5, and to affected offsite response organizations, within six months 
after the change is made. Proposed changes that decrease the 
effectiveness of the approved emergency plan may not be implemented 
without application to and prior approval by the Commission.

[41 FR 53332, Dec. 6, 1976, as amended at 43 FR 6924, Feb. 17, 1978; 52 
FR 31611, Aug. 21, 1987; 53 FR 19248, May 27, 1988; 54 FR 14062, Apr. 7, 
1989; 68 FR 58807, Oct. 10, 2003; 73 FR 5721, Jan. 31, 2008; 82 FR 
52825, Nov. 15, 2017]



Sec.40.36  Financial assurance and recordkeeping for decommissioning.

    Except for licenses authorizing the receipt, possession, and use of 
source material for uranium or thorium milling, or byproduct material at 
sites formerly associated with such milling, for which financial 
assurance requirements are set forth in appendix A of this part, 
criteria for providing financial assurance for decommissioning are as 
follows:
    (a) Each applicant for a specific license authorizing the possession 
and use of more than 100 mCi of source material in a readily dispersible 
form shall submit a decommissioning funding plan as described in 
paragraph (d) of this section.
    (b) Each applicant for a specific license authorizing possession and 
use of quantities of source material greater than 10 mCi but less than 
or equal to 100 mCi in a readily dispersible form shall either--
    (1) Submit a decommissioning funding plan as described in paragraph 
(d) of this section; or
    (2) Submit a certification that financial assurance for 
decommissioning has been provided in the amount of $225,000 by June 2, 
2005 using one of the methods described in paragraph (e) of this 
section. For an applicant, this certification may state that the 
appropriate assurance will be obtained after the application has been 
approved and the license issued but before the receipt of licensed 
material. If the applicant defers execution of the financial instrument 
until after the license has been issued, a signed original of the 
financial instrument obtained to satisfy the requirements of paragraph 
(e) of this section must be submitted to NRC prior to receipt of 
licensed material. If the applicant does not defer execution of the 
financial instrument, the applicant shall submit to NRC, as part of the 
certification, a signed original of the financial instrument obtained to 
satisfy the requirements of paragraph (e) of this section.
    (c)(1) Each holder of a specific license issued on or after July 27, 
1990, which is covered by paragraph (a) or (b) of this section, shall 
provide financial assurance for decommissioning in accordance with the 
criteria set forth in this section.
    (2) Each holder of a specific license issued before July 27, 1990, 
and of a type described in paragraph (a) of this section shall submit a 
decommissioning funding plan as described in paragraph (d) of this 
section or a certification of financial assurance for decommissioning in 
an amount at least equal to $1,125,000 in accordance with the criteria 
set forth in this section. If the licensee submits the certification of 
financial assurance rather than a decommissioning funding plan, the 
licensee shall include a decommissioning funding plan in any application 
for license renewal. Licensees required to submit the $1,125,000 amount 
must do so by December 2, 2004.
    (3) Each holder of a specific license issued before July 27, 1990, 
and of a type described in paragraph (b) of this section shall submit, 
on or before July 27, 1990, a decommissioning funding plan, as described 
in paragraph (d) of this section, or a certification of financial 
assurance for decommissioning in

[[Page 817]]

accordance with the criteria set forth in this section.
    (4) Any licensee who has submitted an application before July 27, 
1990, for renewal of license in accordance with Sec.40.43 shall 
provide financial assurance for decommissioning in accordance with 
paragraphs (a) and (b) of this section. This assurance must be submitted 
when this rule becomes effective November 24, 1995.
    (5) If, in surveys made under 10 CFR 20.1501(a), residual 
radioactivity in the facility and environment, including the subsurface, 
is detected at levels that would, if left uncorrected, prevent the site 
from meeting the 10 CFR 20.1402 criteria for unrestricted use, the 
licensee must submit a decommissioning funding plan within one year of 
when the survey is completed.
    (d)(1) Each decommissioning funding plan must be submitted for 
review and approval and must contain--
    (i) A detailed cost estimate for decommissioning, in an amount 
reflecting:
    (A) The cost of an independent contractor to perform all 
decommissioning activities;
    (B) The cost of meeting the 10 CFR 20.1402 criteria for unrestricted 
use, provided that, if the applicant or licensee can demonstrate its 
ability to meet the provisions of 10 CFR 20.1403, the cost estimate may 
be based on meeting the 10 CFR 20.1403 criteria;
    (C) The volume of onsite subsurface material containing residual 
radioactivity that will require remediation; and
    (D) An adequate contingency factor.
    (ii) Identification of and justification for using the key 
assumptions contained in the DCE;
    (iii) A description of the method of assuring funds for 
decommissioning from paragraph (e) of this section, including means for 
adjusting cost estimates and associated funding levels periodically over 
the life of the facility;
    (iv) A certification by the licensee that financial assurance for 
decommissioning has been provided in the amount of the cost estimate for 
decommissioning; and
    (v) A signed original, or if permitted, a copy, of the financial 
instrument obtained to satisfy the requirements of paragraph (e) of this 
section (unless a previously submitted and accepted financial instrument 
continues to cover the cost estimate for decommissioning).
    (2) At the time of license renewal and at intervals not to exceed 3 
years, the decommissioning funding plan must be resubmitted with 
adjustments as necessary to account for changes in costs and the extent 
of contamination. If the amount of financial assurance will be adjusted 
downward, this can not be done until the updated decommissioning funding 
plan is approved. The decommissioning funding plan must update the 
information submitted with the original or prior approved plan, and must 
specifically consider the effect of the following events on 
decommissioning costs:
    (i) Spills of radioactive material producing additional residual 
radioactivity in onsite subsurface material;
    (ii) Waste inventory increasing above the amount previously 
estimated;
    (iii) Waste disposal costs increasing above the amount previously 
estimated;
    (iv) Facility modifications;
    (v) Changes in authorized possession limits;
    (vi) Actual remediation costs that exceed the previous cost 
estimate;
    (vii) Onsite disposal; and
    (viii) Use of a settling pond.
    (e) The financial instrument must include the licensee's name, 
license number, and docket number; and the name, address, and other 
contact information of the issuer, and, if a trust is used, the trustee. 
When any of the foregoing information changes, the licensee must, within 
30 days, submit financial instruments reflecting such changes. The 
financial instrument submitted must be a signed original or signed 
original duplicate, except where a copy is specifically permitted. 
Financial assurance for decommissioning must be provided by one or more 
of the following methods:
    (1) Prepayment. Prepayment is the deposit before the start of 
operation into an account segregated from licensee assets and outside 
the licensee's administrative control of cash or liquid assets such that 
the amount of funds

[[Page 818]]

would be sufficient to pay decommissioning costs. Prepayment must be 
made into a trust account, and the trustee and the trust must be 
acceptable to the Commission.
    (2) A surety method, insurance, or other guarantee method. These 
methods guarantee that decommissioning costs will be paid. A surety 
method may be in the form of a surety bond, or letter of credit. A 
parent company guarantee of funds for decommissioning costs based on a 
financial test may be used if the guarantee and test are as contained in 
appendix A to part 30 of this chapter. For commercial corporations that 
issue bonds, a guarantee of funds by the applicant or licensee for 
decommissioning costs based on a financial test may be used if the 
guarantee and test are as contained in appendix C to part 30 of this 
chapter. For commercial companies that do not issue bonds, a guarantee 
of funds by the applicant or licensee for decommissioning costs may be 
used if the guarantee and test are as contained in appendix D to part 30 
of this chapter. For nonprofit entities, such as colleges, universities, 
and nonprofit hospitals, a guarantee of funds by the applicant or 
licensee may be used if the guarantee and test are as contained in 
appendix E to part 30 of this chapter. Except for an external sinking 
fund, a parent company guarantee or guarantee by the applicant or 
licensee may not be used in combination with any other financial methods 
used to satisfy the requirements of this section. A guarantee by the 
applicant or licensee may not be used in any situation where the 
applicant or licensee has a parent company holding majority control of 
the voting stock of the company. Any surety method or insurance used to 
provide financial assurance for decommissioning must contain the 
following conditions:
    (i) The surety method or insurance must be open-ended or, if written 
for a specified term, such as five years, must be renewed automatically 
unless 90 days or more prior to the renewal date, the issuer notifies 
the Commission, the beneficiary, and the licensee of its intention not 
to renew. The surety method or insurance must also provide that the full 
face amount be paid to the beneficiary automatically prior to the 
expiration without proof of forfeiture if the licensee fails to provide 
a replacement acceptable to the Commission within 30 days after receipt 
of notification of cancellation.
    (ii) The surety method or insurance must be payable to a trust 
established for decommissioning costs. The trustee and trust must be 
acceptable to the Commission. An acceptable trustee includes an 
appropriate State or Federal government agency or an entity which has 
the authority to act as a trustee and whose trust operations are 
regulated and examined by a Federal or State agency.
    (iii) The surety method or insurance must remain in effect until the 
Commission has terminated the license.
    (3) An external sinking fund in which deposits are made at least 
annually, coupled with a surety method, insurance, or other guarantee 
method, the value of which may decrease by the amount being accumulated 
in the sinking fund. An external sinking fund is a fund established and 
maintained by setting aside funds periodically in an account segregated 
from licensee assets and outside the licensee's administrative control 
in which the total amount of funds would be sufficient to pay 
decommissioning costs at the time termination of operation is expected. 
An external sinking fund must be in the form of a trust. If the other 
guarantee method is used, no surety or insurance may be combined with 
the external sinking fund. The surety, insurance, or other guarantee 
provisions must be as stated in paragraph (e)(2) of this section.
    (4) In the case of Federal, State, or local government licensees, a 
statement of intent containing a cost estimate for decommissioning or an 
amount based on paragraph (b) of this section, and indicating that funds 
for decommissioning will be obtained when necessary.
    (5) When a government entity is assuming custody and ownership of a 
site, an arrangement that is deemed acceptable by such government 
entity.
    (f) Each person licensed under this part shall keep records of 
information important to the decommissioning of a facility in an 
identified location until the site is released for unrestricted use.

[[Page 819]]

Before licensed activities are transferred or assigned in accordance 
with Sec.40.41(b) licensees shall transfer all records described in 
this paragraph to the new licensee. In this case, the new licensee will 
be responsible for maintaining these records until the license is 
terminated. If records important to the decommissioning of a facility 
are kept for other purposes, reference to these records and their 
locations may be used. Information the Commission considers important to 
decommissioning consists of--
    (1) Records of spills or other unusual occurrences involving the 
spread of contamination in and around the facility, equipment, or site. 
These records may be limited to instances when contamination remains 
after any cleanup procedures or when there is reasonable likelihood that 
contaminants may have spread to inaccessible areas as in the case of 
possible seepage into porous materials such as concrete. These records 
must include any known information on identification of involved 
nuclides, quantities, forms, and concentrations.
    (2) As-built drawings and modifications of structures and equipment 
in restricted areas where radioactive materials are used and/or stored, 
and of locations of possible inaccessible contamination such as buried 
pipes which may be subject to contamination. If required drawings are 
referenced, each relevant document need not be indexed individually. If 
drawings are not available, the licensee shall substitute appropriate 
records of available information concerning these areas and locations.
    (3) Except for areas containing depleted uranium used only for 
shielding or as penetrators in unused munitions, a list contained in a 
single document and updated every 2 years, of the following:
    (i) All areas designated and formerly designated as restricted areas 
as defined under 10 CFR 20.1003;
    (ii) All areas outside of restricted areas that require 
documentation under Sec.40.36(f)(1);
    (iii) All areas outside of restricted areas where current and 
previous wastes have been buried as documented under 10 CFR 20.2108; and
    (iv) All areas outside of restricted areas that contain material 
such that, if the license expired, the licensee would be required to 
either decontaminate the area to meet the criteria for decommissioning 
in 10 CFR part 20, subpart E, or apply for approval for disposal under 
10 CFR 20.2002.
    (4) Records of the cost estimate performed for the decommissioning 
funding plan or of the amount certified for decommissioning, and records 
of the funding method used for assuring funds if either a funding plan 
or certification is used.
    (g) In providing financial assurance under this section, each 
licensee must use the financial assurance funds only for decommissioning 
activities and each licensee must monitor the balance of funds held to 
account for market variations. The licensee must replenish the funds, 
and report such actions to the NRC, as follows:
    (1) If, at the end of a calendar quarter, the fund balance is below 
the amount necessary to cover the cost of decommissioning, but is not 
below 75 percent of the cost, the licensee must increase the balance to 
cover the cost, and must do so within 30 days after the end of the 
calendar quarter.
    (2) If, at any time, the fund balance falls below 75 percent of the 
amount necessary to cover the cost of decommissioning, the licensee must 
increase the balance to cover the cost, and must do so within 30 days of 
the occurrence.
    (3) Within 30 days of taking the actions required by paragraph 
(g)(1) or (g)(2) of this section, the licensee must provide a written 
report of such actions to the Director, Office of Nuclear Material 
Safety and Safeguards, and state the new balance of the fund.

[53 FR 24047, June 27, 1988, as amended at 58 FR 39633, July 26, 1993; 
58 FR 67661, Dec. 22, 1993; 58 FR 68731, Dec. 29, 1993; 59 FR 1618, Jan. 
12, 1994; 60 FR 38238, July 26, 1995; 61 FR 24674, May 16, 1996; 62 FR 
39090, July 21, 1997; 63 FR 29543, June 1, 1998; 68 FR 57336, Oct. 3, 
2003; 76 FR 35568, June 17, 2011; 78 FR 34247, June 7, 2013; 78 FR 
75450, Dec. 12, 2013]



Sec.40.38  Ineligibility of certain applicants.

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

[[Page 820]]

    (a) The Corporation is owned, controlled, or dominated by an alien, 
a foreign corporation, or a foreign government; or
    (b) The issuance of such a license would be inimical to--
    (1) The common defense and security of the United States; or
    (2) The maintenance of a reliable and economical domestic source of 
enrichment services.

[62 FR 6669, Feb. 12, 1997]

                                Licenses



Sec.40.41  Terms and conditions of licenses.

    (a) Each license issued pursuant to the regulations in this part 
shall be subject to all the provisions of the act, now or hereafter in 
effect, and to all rules, regulations and orders of the Commission.
    (b) Neither the license nor any right under the license shall be 
assigned or otherwise transferred in violation of the provisions of the 
Act.
    (c) Each person licensed by the Commission pursuant to the 
regulations in this part shall confine his possession and use of source 
or byproduct material to the locations and purposes authorized in the 
license. Except as otherwise provided in the license, a license issued 
pursuant to the regulations in this part shall carry with it the right 
to receive, possess, and use source or byproduct material. Preparation 
for shipment and transport of source or byproduct material shall be in 
accordance with the provisions of part 71 of this chapter.
    (d) Each license issued pursuant to the regulations in this part 
shall be deemed to contain the provisions set forth in sections 183b.-
d., of the Act, whether or not said provisions are expressly set forth 
in the license.
    (e) The Commission may incorporate in any license at the time of 
issuance, or thereafter, by appropriate rule, regulation or order, such 
additional requirements and conditions with respect to the licensee's 
receipt, possession, use, and transfer of source or byproduct material 
as it deems appropriate or necessary in order to:
    (1) Promote the common defense and security;
    (2) Protect health or to minimize danger of life or property;
    (3) Protect restricted data;
    (4) Require such reports and the keeping of such records, and to 
provide for such inspections of activities under the license as may be 
necessary or appropriate to effectuate the purposes of the act and 
regulations thereunder.
    (f)(1) Each licensee shall notify the appropriate NRC Regional 
Administrator, in writing, immediately following the filing of a 
voluntary or involuntary petition for bankruptcy under any chapter of 
title 11 (Bankruptcy) of the United States Code by or against:
    (i) The licensee;
    (ii) An entity (as that term is defined in 11 U.S.C. 101(14)) 
controlling the licensee or listing the license or licensee as property 
of the estate; or
    (iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of 
the licensee.
    (2) This notification must indicate:
    (i) The bankruptcy court in which the petition for bankruptcy was 
filed; and
    (ii) The date of the filing of the petition.
    (g) No person may commence operation of a uranium enrichment 
facility until the Commission verifies through inspection that the 
facility has been constructed in accordance with the requirements of the 
license. The Commission shall publish notice of the inspection results 
in the Federal Register.
    (h) Each licensee shall ensure that Safeguards Information is 
protected against unauthorized disclosure in accordance with the 
requirements in Sec.73.21 and the requirements of Sec.73.22 or Sec.
73.23 of this chapter, as applicable.

[26 FR 284, Jan. 14, 1961, as amended at 31 FR 15145, Dec. 2, 1966; 45 
FR 65531, Oct. 3, 1980; 48 FR 32328, July 15, 1983; 52 FR 1295, Jan. 12, 
1987; 57 FR 18391, Apr. 30, 1992; 73 FR 63571, Oct. 24, 2008]



Sec.40.42  Expiration and termination of licenses and decommissioning
of sites and separate buildings or outdoor areas.

    (a) Each specific license expires at the end of the day on the 
expiration date stated in the license unless the licensee has filed an 
application for renewal under Sec.40.43 not less than 30 days

[[Page 821]]

before the expiration date stated in the existing license. If an 
application for renewal has been filed at least 30 days before the 
expiration date stated in the existing license, the existing license 
expires at the end of the day on which the Commission makes a final 
determination to deny the renewal application or, if the determination 
states an expiration date, the expiration date stated in the 
determination.
    (b) Each specific license revoked by the Commission expires at the 
end of the day on the date of the Commission's final determination to 
revoke the license, or on the expiration date stated in the 
determination, or as otherwise provided by Commission Order.
    (c) Each specific license continues in effect, beyond the expiration 
date if necessary, with respect to possession of source material until 
the Commission notifies the licensee in writing that the license is 
terminated. During this time, the licensee shall--
    (1) Limit actions involving source material to those related to 
decommissioning; and
    (2) Continue to control entry to restricted areas until they are 
suitable for release in accordance with NRC requirements;
    (d) Within 60 days of the occurrence of any of the following, 
consistent with the administrative directions in Sec.40.5, each 
licensee shall provide notification to the NRC in writing and either 
begin decommissioning its site, or any separate building or outdoor area 
that contains residual radioactivity, so that the building or outdoor 
area is suitable for release in accordance with NRC requirements, or 
submit within 12 months of notification a decommissioning plan, if 
required by paragraph (g)(1) of this section, and begin decommissioning 
upon approval of that plan if--
    (1) The license has expired pursuant to paragraph (a) or (b) of this 
section; or
    (2) The licensee has decided to permanently cease principal 
activities, as defined in this part, at the entire site or in any 
separate building or outdoor area; or
    (3) No principal activities under the license have been conducted 
for a period of 24 months; or
    (4) No principal activities have been conducted for a period of 24 
months in any separate building or outdoor area that contains residual 
radioactivity such that the building or outdoor area is unsuitable for 
release in accordance with NRC requirements.
    (e) Coincident with the notification required by paragraph (d) of 
this section, the licensee shall maintain in effect all decommissioning 
financial assurances established by the licensee pursuant to Sec.40.36 
in conjunction with a license issuance or renewal or as required by this 
section. The amount of the financial assurance must be increased, or may 
be decreased, as appropriate, to cover the detailed cost estimate for 
decommissioning established pursuant to paragraph (g)(4)(v) of this 
section.
    (1) Any licensee who has not provided financial assurance to cover 
the detailed cost estimate submitted with the decommissioning plan shall 
do so when this rule becomes effective November 24, 1995.
    (2) Following approval of the decommissioning plan, a licensee may 
reduce the amount of the financial assurance as decommissioning proceeds 
and radiological contamination is reduced at the site with the approval 
of the Commission.
    (f) The Commission may grant a request to delay or postpone 
initiation of the decommissioning process if the Commission determines 
that such relief is not detrimental to the public health and safety and 
is otherwise in the public interest. The request must be submitted no 
later than 30 days before notification pursuant to paragraph (d) of this 
section. The schedule for decommissioning set forth in paragraph (d) of 
this section may not commence until the Commission has made a 
determination on the request.
    (g)(1) A decommissioning plan must be submitted if required by 
license condition or if the procedures and activities necessary to carry 
out decommissioning of the site or separate building or outdoor area 
have not been previously approved by the Commission and these procedures 
could increase potential health and safety impacts to workers or to the 
public, such as in any of the following cases:

[[Page 822]]

    (i) Procedures would involve techniques not applied routinely during 
cleanup or maintenance operations;
    (ii) Workers would be entering areas not normally occupied where 
surface contamination and radiation levels are significantly higher than 
routinely encountered during operation;
    (iii) Procedures could result in significantly greater airborne 
concentrations of radioactive materials than are present during 
operation; or
    (iv) Procedures could result in significantly greater releases of 
radioactive material to the environment than those associated with 
operation.
    (2) The Commission may approve an alternate schedule for submittal 
of a decommissioning plan required pursuant to paragraph (d) of this 
section if the Commission determines that the alternative schedule is 
necessary to the effective conduct of decommissioning operations and 
presents no undue risk from radiation to the public health and safety 
and is otherwise in the public interest.
    (3) The procedures listed in paragraph (g)(1) of this section may 
not be carried out prior to approval of the decommissioning plan.
    (4) The proposed decommissioning plan for the site or separate 
building or outdoor area must include:
    (i) A description of the conditions of the site or separate building 
or outdoor area sufficient to evaluate the acceptability of the plan;
    (ii) A description of planned decommissioning activities;
    (iii) A description of methods used to ensure protection of workers 
and the environment against radiation hazards during decommissioning;
    (iv) A description of the planned final radiation survey; and
    (v) An updated detailed cost estimate for decommissioning, 
comparison of that estimate with present funds set aside for 
decommissioning, and a plan for assuring the availability of adequate 
funds for completion of decommissioning.
    (vi) For decommissioning plans calling for completion of 
decommissioning later than 24 months after plan approval, a 
justification for the delay based on the criteria in paragraph (i) of 
this section.
    (5) The proposed decommissioning plan will be approved by the 
Commission if the information therein demonstrates that the 
decommissioning will be completed as soon as practicable and that the 
health and safety of workers and the public will be adequately 
protected.
    (h)(1) Except as provided in paragraph (i) of this section, 
licensees shall complete decommissioning of the site or separate 
building or outdoor area as soon as practicable but no later than 24 
months following the initiation of decommissioning.
    (2) Except as provided in paragraph (i) of this section, when 
decommissioning involves the entire site, the licensee shall request 
license termination as soon as practicable but no later than 24 months 
following the initiation of decommissioning.
    (i) The Commission may approve a request for an alternate schedule 
for completion of decommissioning of the site or separate building or 
outdoor area, and license termination if appropriate, if the Commission 
determines that the alternative is warranted by consideration of the 
following:
    (1) Whether it is technically feasible to complete decommissioning 
within the allotted 24-month period;
    (2) Whether sufficient waste disposal capacity is available to allow 
completion of decommissioning within the allotted 24-month period;
    (3) Whether a significant volume reduction in wastes requiring 
disposal will be achieved by allowing short-lived radionuclides to 
decay;
    (4) Whether a significant reduction in radiation exposure to workers 
can be achieved by allowing short-lived radionuclides to decay; and
    (5) Other site-specific factors which the Commission may consider 
appropriate on a case-by-case basis, such as the regulatory requirements 
of other government agencies, lawsuits, groundwater treatment 
activities, monitored natural groundwater restoration, actions that 
could result in more environmental harm than deferred cleanup, and other 
factors beyond the control of the licensee.
    (j) As the final step in decommissioning, the licensee shall--

[[Page 823]]

    (1) Certify the disposition of all licensed material, including 
accumulated wastes, by submitting a completed NRC Form 314 or equivalent 
information; and
    (2) Conduct a radiation survey of the premises where the licensed 
activities were carried out and submit a report of the results of this 
survey, unless the licensee demonstrates in some other manner that the 
premises are suitable for release in accordance with the criteria for 
decommissioning in 10 CFR part 20, subpart E or, for uranium milling 
(uranium and thorium recovery) facilities, Criterion 6(6) of Appendix A 
to this part. The licensee shall, as appropriate--
    (i) Report levels of gamma radiation in units of millisieverts 
(microroentgen) per hour at one meter from surfaces, and report levels 
of radioactivity, including alpha and beta, in units of megabecquerels 
(disintegrations per minute or microcuries) per 100 square centimeters 
removable and fixed for surfaces, megabecquerels (microcuries) per 
milliliter for water, and becquerels (picocuries) per gram for solids 
such as soils or concrete; and
    (ii) Specify the survey instrument(s) used and certify that each 
instrument is properly calibrated and tested.
    (k) Specific licenses, including expired licenses, will be 
terminated by written notice to the licensee when the Commission 
determines that:
    (1) Source material has been properly disposed;
    (2) Reasonable effort has been made to eliminate residual 
radioactive contamination, if present; and
    (3)(i) A radiation survey has been performed which demonstrates that 
the premises are suitable for release in accordance with the criteria 
for decommissioning in 10 CFR part 20, subpart E or, for (uranium and 
thorium recovery) facilities, Criterion 6(6) of Appendix A to this part; 
or
    (ii) Other information submitted by the licensee is sufficient to 
demonstrate that the premises are suitable for release in accordance 
with the criteria for decommissioning in 10 CFR part 20, subpart E or, 
for uranium milling (uranium and thorium recovery) facilities, Criterion 
6(6) of Appendix A to this part.
    (4) Records required by Sec.40.61 (d) and (f) have been received.
    (l) Specific licenses for uranium and thorium milling are exempt 
from paragraphs (d)(4), (g) and (h) of this section with respect to 
reclamation of tailings impoundments and/or waste disposal areas.

[59 FR 36035, July 15, 1994, as amended at 60 FR 38239, July 26, 1995; 
61 FR 1114, Jan. 16, 1996; 61 FR 24674, May 16, 1996; 61 FR 29637, June 
12, 1996; 62 FR 39090, July 21, 1997; 66 FR 64738, Dec. 14, 2001; 68 FR 
75390, Dec. 31, 2003; 73 FR 42674, July 23, 2008; 81 FR 86909, Dec. 2, 
2016]



Sec.40.43  Renewal of licenses.

    Application for renewal of a specific license must be filed on NRC 
Form 313 and in accordance with Sec.40.31.

[75 FR 73943, Nov. 30, 2010]



Sec.40.44  Amendment of licenses at request of licensee.

    Applications for amendment of a license shall be filed on NRC Form 
313 in accordance with Sec.40.31 and shall specify the respects in 
which the licensee desires the license to be amended and the grounds for 
such amendment.

[49 FR 19627, May 9, 1984, as amended at 56 FR 40768, Aug. 16, 1991]



Sec.40.45  Commission action on applications to renew or amend.

    In considering an application by a licensee to renew or amend his 
license the Commission will apply the applicable criteria set forth in 
Sec.40.32.

[26 FR 284, Jan. 14, 1961, as amended at 43 FR 6924, Feb. 17, 1978]



Sec.40.46  Inalienability of licenses.

    (a) No license issued or granted pursuant to the regulations in this 
part shall be transferred, assigned or in any manner disposed of, either 
voluntarily or involuntarily, directly or indirectly, through transfer 
of control of any license to any person, unless the Commission shall 
after securing full information, find that the transfer is in accordance 
with the provisions of this act, and shall give its consent in writing.
    (b) An application for transfer of license must include:

[[Page 824]]

    (1) The identity, technical and financial qualifications of the 
proposed transferee; and
    (2) Financial assurance for decommissioning information required by 
Sec.40.36 or Appendix A to this part, as applicable.

[26 FR 284, Jan. 14, 1961, as amended at 76 FR 35569, June 17, 2011]

                       Transfer of Source Material



Sec.40.51  Transfer of source or byproduct material.

    (a) No licensee shall transfer source or byproduct material except 
as authorized pursuant to this section.
    (b) Except as otherwise provided in his license and subject to the 
provisions of paragraphs (c) and (d) of this section, any licensee may 
transfer source or byproduct material:
    (1) To the Department of Energy;
    (2) To the agency in any Agreement State which regulates radioactive 
materials pursuant to an agreement with the Commission or the Atomic 
Energy Commission under section 274 of the Act;
    (3) To any person exempt from the licensing requirements of the Act 
and regulations in this part, to the extent permitted under such 
exemption;
    (4) To any person in an Agreement State subject to the jurisdiction 
of that State who has been exempted from the licensing requirements and 
regulations of that State, to the extent permitted under such 
exemptions;
    (5) To any person authorized to receive such source or byproduct 
material under terms of a specific license or a general license or their 
equivalents issued by the Commission or an Agreement State;
    (6) To any person abroad pursuant to an export license issued under 
part 110 of this chapter; or
    (7) As otherwise authorized by the commission in writing.
    (c) Before transferring source or byproduct material to a specific 
licensee of the Commission or an Agreement State or to a general 
licensee who is required to register with the Commission or with an 
Agreement State prior to receipt of the source or byproduct material, 
the licensee transferring the material shall verify that the 
transferee's license authorizes receipt of the type, form, and quantity 
of source or byproduct material to be transferred.
    (d) The following methods for the verification required by paragraph 
(c) of this section are acceptable:
    (1) The transferor may have in his possession, and read, a current 
copy of the transferee's specific license or registration certificate;
    (2) The transferor may have in his possession a written 
certification by the transferee that he is authorized by license or 
registration certificate to receive the type, form, and quantity of 
source or byproduct material to be transferred, specifying the license 
or registration certification number, issuing agency and expiration 
date;
    (3) For emergency shipments the transferor may accept oral 
certification by the transferee that he is authorized by license or 
registration certificate to receive the type, form, and quantity of 
source or byproduct material to be transferred, specifying the license 
or registration certificate number, issuing agency and expiration date: 
Provided, That the oral certification is confirmed in writing within 10 
days;
    (4) The transferor may obtain other sources of information compiled 
by a reporting service from official records of the Commission or the 
licensing agency of an Agreement State as to the identity of licensees 
and the scope and expiration dates of licenses and registrations; or
    (5) When none of the methods of verification described in paragraphs 
(d)(1) to (4) of this section are readily available or when a transferor 
desires to verify that information received by one of such methods is 
correct or up-to-date, the transferor may obtain and record confirmation 
from the Commission or the licensing agency of an Agreement State that 
the transferee is licensed to receive the source or byproduct material.

[45 FR 65532, Oct. 3, 1980]

[[Page 825]]



Sec.40.52  Certain items containing source material; requirements for
license to apply or initially transfer.

    An application for a specific license to apply source material to, 
incorporate source material into, manufacture, process, or produce the 
products specified in Sec.40.13(c) or to initially transfer for sale 
or distribution any products containing source material for use under 
Sec.40.13(c) or equivalent provisions of an Agreement State will be 
approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.40.32. However, the requirements of Sec.40.32(b) and (c) do not 
apply to an application for a license to transfer products manufactured, 
processed, or produced in accordance with a license issued by an 
Agreement State or to the import of finished products or parts.
    (b) The applicant submits sufficient information regarding the 
product pertinent to the evaluation of the potential radiation 
exposures, including:
    (1) Chemical and physical form and maximum quantity of source 
material in each product;
    (2) Details of construction and design of each product, if 
applicable. For coated lenses, this must include a description of 
manufacturing methods that will ensure that the coatings are unlikely to 
be removed under the conditions expected to be encountered during 
handling and use;
    (3) For products with applicable quantity or concentration limits, 
quality control procedures to be followed in the fabrication of 
production lots of the product and the quality control standards the 
product will be required to meet;
    (4) The proposed method of labeling or marking each unit, and/or its 
container with the identification of the manufacturer or initial 
transferor of the product and the source material in the product; and
    (5) The means of providing radiation safety precautions and 
instructions relating to handling, use, and storage of products to be 
used under Sec.40.13(c)(1)(i) and (c)(1)(iii).
    (c) Each product will contain no more than the quantity or the 
concentration of source material specified for that product in Sec.
40.13(c).

[78 FR 32340, May 29, 2013]



Sec.40.53  Conditions for licenses issued for initial transfer of
certain items containing source material: Quality control, labeling,
and records and reports.
          

    (a) Each person licensed under Sec.40.52 shall ensure that the 
quantities or concentrations of source material do not exceed any 
applicable limit in Sec.40.13(c).
    (b) Each person licensed under Sec.40.52 shall ensure that each 
product is labeled as provided in the specific exemption under Sec.
40.13(c) and as required by their license. Those distributing products 
to be used under Sec.40.13(c)(1)(i) and (iii) or equivalent 
regulations of an Agreement State shall provide radiation safety 
precautions and instructions relating to handling, use, and storage of 
these products as specified in the license.
    (c)(1) Each person licensed under Sec.40.52 shall file a report 
with the Director, Office of Nuclear Material Safety and Safeguards by 
an appropriate method listed in Sec.40.5(a), including in the address: 
ATTN: Document Control Desk/Exempt Distribution.
    (2) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee and indicate that the products are transferred for use under 
Sec.40.13(c), giving the specific paragraph designation, or equivalent 
regulations of an Agreement State.
    (3) The report must include the following information on products 
transferred to other persons for use under Sec.40.13(c) or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each product and 
the model number(s), if applicable;
    (ii) For each type of source material in each type of product and 
each model number, if applicable, the total quantity of the source 
material; and
    (iii) The number of units of each type of product transferred during 
the reporting period by model number, if applicable.
    (4) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year.

[[Page 826]]

Licensees who permanently discontinue activities authorized by the 
license issued under Sec.40.52 shall file a report for the current 
calendar year within 30 days after ceasing distribution.
    (5) If no transfers of source material have been made to persons 
exempt under Sec.40.13(c) or the equivalent regulations of an 
Agreement State, during the reporting period, the report must so 
indicate.
    (6) The licensee shall maintain all information concerning transfers 
that support the reports required by this section for 1 year after each 
transfer is included in a report to the Commission.

[78 FR 32340, May 29, 2013]



Sec.40.54  Requirements for license to initially transfer source
material for use under the `small quantities of source material' 
general license.

    An application for a specific license to initially transfer source 
material for use under Sec.40.22, or equivalent regulations of an 
Agreement State, will be approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.40.32; and
    (b) The applicant submits adequate information on, and the 
Commission approves the methods to be used for quality control, 
labeling, and providing safety instructions to recipients.

[78 FR 32340, May 29, 2013]



Sec.40.55  Conditions of licenses to initially transfer source 
material for use under the `small quantities of source material' 
general license: Quality control, labeling, safety instructions,
and records and reports.
          

    (a) Each person licensed under Sec.40.54 shall label the immediate 
container of each quantity of source material with the type of source 
material and quantity of material and the words, ``radioactive 
material.''
    (b) Each person licensed under Sec.40.54 shall ensure that the 
quantities and concentrations of source material are as labeled and 
indicated in any transfer records.
    (c) Each person licensed under Sec.40.54 shall provide the 
information specified in this paragraph to each person to whom source 
material is transferred for use under Sec.40.22 or equivalent 
provisions in Agreement State regulations. This information must be 
transferred before the source material is transferred for the first time 
in each calendar year to the particular recipient. The required 
information includes:
    (1) A copy of Sec. Sec.40.22 and 40.51, or relevant equivalent 
regulations of the Agreement State.
    (2) Appropriate radiation safety precautions and instructions 
relating to handling, use, storage, and disposal of the material.
    (d) Each person licensed under Sec.40.54 shall report transfers as 
follows:
    (1) File a report with the Director, Office of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555. The report shall include the following information:
    (i) The name, address, and license number of the person who 
transferred the source material;
    (ii) For each general licensee under Sec.40.22 or equivalent 
Agreement State provisions to whom greater than 50 grams (0.11 lb) of 
source material has been transferred in a single calendar quarter, the 
name and address of the general licensee to whom source material is 
distributed; a responsible agent, by name and/or position and phone 
number, of the general licensee to whom the material was sent; and the 
type, physical form, and quantity of source material transferred; and
    (iii) The total quantity of each type and physical form of source 
material transferred in the reporting period to all such generally 
licensed recipients.
    (2) File a report with each responsible Agreement State agency that 
identifies all persons, operating under provisions equivalent to Sec.
40.22, to whom greater than 50 grams (0.11 lb) of source material has 
been transferred within a single calendar quarter. The report shall 
include the following information specific to those transfers made to 
the Agreement State being reported to:
    (i) The name, address, and license number of the person who 
transferred the source material; and
    (ii) The name and address of the general licensee to whom source 
material

[[Page 827]]

was distributed; a responsible agent, by name and/or position and phone 
number, of the general licensee to whom the material was sent; and the 
type, physical form, and quantity of source material transferred.
    (iii) The total quantity of each type and physical form of source 
material transferred in the reporting period to all such generally 
licensed recipients within the Agreement State.
    (3) Submit each report by January 31 of each year covering all 
transfers for the previous calendar year. If no transfers were made to 
persons generally licensed under Sec.40.22 or equivalent Agreement 
State provisions during the current period, a report shall be submitted 
to the Commission indicating so. If no transfers have been made to 
general licensees in a particular Agreement State during the reporting 
period, this information shall be reported to the responsible Agreement 
State agency upon request of the agency.
    (e) Each person licensed under Sec.40.54 shall maintain all 
information that supports the reports required by this section 
concerning each transfer to a general licensee for a period of 1 year 
after the event is included in a report to the Commission or to an 
Agreement State agency.

[78 FR 32340, May 29, 2013]



Sec.40.56  Restrictions on the use of Australian-obligated source
material.

    (a) In accordance with Article 8 of the Agreement between the 
Government of Australia and the Government of the United States of 
America Concerning Peaceful Uses of Nuclear Energy, dated 2010, 
Australian-obligated source material shall not be used for military 
purposes. As used in this section, ``military purposes'' includes, but 
is not limited to, the production of tritium for use in nuclear 
explosive devices; military nuclear propulsion; munitions, including 
depleted uranium munitions; and other direct military non-nuclear 
applications. ``Military purposes'' does not include the supply of 
electricity to a military base from any power network; the production of 
radioisotopes to be used for medical purposes in military hospitals; and 
such other similar purposes.
    (b) Licensees are prohibited from receiving, processing, 
transferring, or otherwise using Australian-obligated source material 
for military purposes.

[76 FR 69122, Nov. 8, 2011. Redesignated at 76 FR 78805, Dec. 20, 2011]

                    Records, Reports, and Inspections



Sec.40.60  Reporting requirements.

    (a) Immediate report. Each licensee shall notify the NRC as soon as 
possible but not later than 4 hours after the discovery of an event that 
prevents immediate protective actions necessary to avoid exposures to 
radiation or radioactive materials that could exceed regulatory limits 
or releases of licensed material that could exceed regulatory limits 
(events may include fires, explosions, toxic gas releases, etc.).
    (b) Twenty-four hour report. Each licensee shall notify the NRC 
within 24 hours after the discovery of any of the following events 
involving licensed material:
    (1) An unplanned contamination event that:
    (i) Requires access to the contaminated area, by workers or the 
public, to be restricted for more than 24 hours by imposing additional 
radiological controls or by prohibiting entry into the area;
    (ii) Involves a quantity of material greater than five times the 
lowest annual limit on intake specified in appendix B of Sec. Sec.
20.1001-20.2401 of 10 CFR part 20 for the material; and
    (iii) Has access to the area restricted for a reason other than to 
allow isotopes with a half-life of less than 24 hours to decay prior to 
decontamination.
    (2) An event in which equipment is disabled or fails to function as 
designed when:
    (i) The equipment is required by regulation or license condition to 
prevent releases exceeding regulatory limits, to prevent exposures to 
radiation and radioactive materials exceeding regulatory limits, or to 
mitigate the consequences of an accident;
    (ii) The equipment is required to be available and operable when it 
is disabled or fails to function; and

[[Page 828]]

    (iii) No redundant equipment is available and operable to perform 
the required safety function.
    (3) An event that requires unplanned medical treatment at a medical 
facility of an individual with spreadable radioactive contamination on 
the individual's clothing or body.
    (4) An unplanned fire or explosion damaging any licensed material or 
any device, container, or equipment containing licensed material when:
    (i) The quantity of material involved is greater than five times the 
lowest annual limit on intake specified in appendix B of Sec. Sec.
20.1001-20.2401 of 10 CFR part 20 for the material; and
    (ii) The damage affects the integrity of the licensed material or 
its container.
    (c) Preparation and submission of reports. Reports made by licensees 
in response to the requirements of this section must be made as follows:
    (1) Licensees shall make reports required by paragraphs (a) and (b) 
of this section by telephone to the NRC Operations Center. \1\ To the 
extent that the information is available at the time of notification, 
the information provided in these reports must include:
---------------------------------------------------------------------------

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

    (i) The caller's name and call back telephone number;
    (ii) A description of the event, including date and time;
    (iii) The exact location of the event;
    (iv) The isotopes, quantities, and chemical and physical form of the 
licensed material involved; and
    (v) Any personnel radiation exposure data available.
    (2) Written report. Each licensee who makes a report required by 
paragraph (a) or (b) of this section shall submit a written follow-up 
report within 30 days of the initial report. Written reports prepared 
pursuant to other regulations may be submitted to fulfill this 
requirement if the reports contain all of the necessary information and 
the appropriate distribution is made. These written reports must be sent 
to the NRC's Document Control Desk by an appropriate method listed in 
Sec.40.5, with a copy to the appropriate NRC regional office listed in 
appendix D to part 20 of this chapter. The reports must include the 
following:
    (i) A description of the event, including the probable cause and the 
manufacturer and model number (if applicable) of any equipment that 
failed or malfunctioned;
    (ii) The exact location of the event;
    (iii) The isotopes, quantities, and chemical and physical form of 
the licensed material involved;
    (iv) Date and time of the event;
    (v) Corrective actions taken or planned and the results of any 
evaluations or assessments; and
    (vi) The extent of exposure of individuals to radiation or to 
radioactive materials without identification of individuals by name.
    (3) The provisions of Sec.40.60 do not apply to licensees subject 
to the notification requirements in Sec.50.72. They do apply to those 
part 50 licensees possessing material licensed under part 40 who are not 
subject to the notification requirements in Sec.50.72.

[56 FR 40768, Aug. 16, 1991, as amended at 59 FR 14086, Mar. 25, 1994; 
68 FR 58807, Oct. 10, 2003]



Sec.40.61  Records.

    (a) Each person who receives source or byproduct material pursuant 
to a license issued pursuant to the regulations in this part shall keep 
records showing the receipt, transfer, and disposal of this source or 
byproduct material as follows:
    (1) The licensee shall retain each record of receipt of source or 
byproduct material as long as the material is possessed and for three 
years following transfer or disposition of the source or byproduct 
material.
    (2) The licensee who transferred the material shall retain each 
record of transfer of source or byproduct material until the Commission 
terminates each license that authorizes the activity that is subject to 
the recordkeeping requirement.
    (3) The licensee shall retain each record of disposal of source or 
byproduct material until the Commission terminates each license that 
authorizes the activity that is subject to the recordkeeping 
requirement.
    (4) If source or byproduct material is combined or mixed with other 
licensed

[[Page 829]]

material and subsequently treated in a manner that makes direct 
correlation of a receipt record with a transfer, export, or disposition 
record impossible, the licensee may use evaluative techniques (such as 
first-in-first-out), to make the records that are required by this part 
account for 100 percent of the material received.
    (b) The licensee shall retain each record that is required by the 
regulations in this part or by license condition for the period 
specified by the appropriate regulation or license condition. If a 
retention period is not otherwise specified by regulation or license 
condition, each record must be maintained until the Commission 
terminates the license that authorizes the activity that is subject to 
the recordkeeping requirement.
    (c)(1) Records which must be maintained pursuant to this part may be 
the original or reproduced copy or microform if the reproduced copy or 
microform is duly authenticated by authorized personnel and the 
microform is capable of producing a clear and legible copy after storage 
for the period specified by Commission regulations. The record may also 
be stored in electronic media with the capability for producing legible, 
accurate, and complete records during the required retention period. 
Records such as letters, drawings, specifications, must include all 
pertinent information such as stamps, initials, and signatures. The 
licensee shall maintain adequate safeguards against tampering with and 
loss of records.
    (2) If there is a conflict between the Commission's regulations in 
this part, license condition, or other written Commission approval or 
authorization pertaining to the retention period for the same type of 
record, the retention period specified in the regulations in this part 
for such records shall apply unless the Commission, pursuant to Sec.
40.14 of this part, has granted a specific exemption from the record 
retention requirements specified in the regulations in this part.
    (d) Prior to license termination, each licensee authorized to 
possess source material, in an unsealed form, shall forward the 
following records to the appropriate NRC Regional Office:
    (1) Records of disposal of licensed material made under Sec.
20.2002 (including burials authorized before January 28, 1981 \1\), 
20.2003, 20.2004, 20.2005; and
---------------------------------------------------------------------------

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

    (2) Records required by Sec.20.2103(b)(4).
    (e) If licensed activities are transferred or assigned in accordance 
with Sec.40.41(b), each licensee authorized to possess source 
material, in an unsealed form, shall transfer the following records to 
the new licensee and the new licensee will be responsible for 
maintaining these records until the license is terminated:
    (1) Records of disposal of licensed material made under Sec.
20.2002 (including burials authorized before January 28, 1981 \1\), 
20.2003, 20.2004, 20.2005; and
    (2) Records required by Sec.20.2103(b)(4).
    (f) Prior to license termination, each licensee shall forward the 
records required by Sec.40.36(f) to the appropriate NRC Regional 
Office.

[45 FR 65532, Oct. 3, 1980, as amended at 53 FR 19248, May 27, 1988; 61 
FR 24674, May 16, 1996; 80 FR 45843, Aug. 3, 2015]



Sec.40.62  Inspections.

    (a) Each licensee shall afford to the Commission at all reasonable 
times opportunity to inspect source or byproduct material and the 
premises and facilities wherein source or byproduct material is used or 
stored.
    (b) Each licensee shall make available to the Commission for 
inspection, upon reasonable notice, records kept by him pursuant to the 
regulations in this chapter.

[45 FR 65532, Oct. 3, 1980]



Sec.40.63  Tests.

    Each licensee shall perform, or permit the Commission to perform, 
such tests as the Commission deems appropriate or necessary for the 
administration of the regulations in this part, including tests of:
    (a) Source or byproduct material;
    (b) Facilities wherein source or byproduct material is utilized or 
stored;

[[Page 830]]

    (c) Radiation detection and monitoring instruments; and
    (d) Other equipment and devices used in connection with the 
utilization and storage of source or byproduct material.

[45 FR 65533, Oct. 3, 1980]



Sec.40.64  Reports.

    (a) Except as specified in paragraphs (d) and (e) of this section, 
each specific licensee who transfers, receives, or adjusts the inventory 
in any manner, of uranium or thorium source material with foreign 
obligations by one kilogram or more; or who imports or exports one 
kilogram or more of uranium or thorium source material; or who uses one 
kilogram or more of any uranium or thorium source material in enrichment 
services, downblending uranium that has an initial enrichment of the 
U\235\ isotope of 10 percent or more, or in the fabrication of mixed-
oxide fuels, shall complete a Nuclear Material Transaction Report in 
computer-readable format as specified in the instructions in NUREG/BR-
0006 and NMMSS Report D-24, ``Personal Computer Data Input for NRC 
Licensees.'' Each licensee who exports one kilogram or more of uranium 
or thorium source material shall complete in the format listed above the 
licensee's portion of the Nuclear Material Transaction Report unless 
there is indication of loss, theft, or diversion as discussed under 
paragraph (d) of this section, in which case both the licensee's and the 
foreign facility's information must be reported. Licensees who import 
one kilogram or more of uranium or thorium source material shall 
complete the supplier's and the licensee's portion of the Nuclear 
Material Transaction Report. Copies of the instructions may be obtained 
either by writing the U.S. Nuclear Regulatory Commission, Division of 
Fuel Cycle Safety, Safeguards, and Environmental Review, Washington, DC 
20555-0001, or by e-mail to [email protected]. Each licensee who 
transfers the material shall submit a Nuclear Material Transaction 
Report in computer-readable format as specified in the instructions no 
later than the close of business the next working day. Each licensee who 
receives the material shall submit a Nuclear Material Transaction Report 
in computer-readable format in accordance with instructions within ten 
(10) days after the material is received. The Commission's copy of the 
report must be submitted to the address specified in the instructions. 
These prescribed computer-readable forms replace the DOE/NRC Form 741 
previously submitted in paper form.
    (b) Except as specified in paragraphs (d) and (e) of this section, 
each licensee who:
    (1) Possesses, or had possessed in the previous reporting period, at 
any one time and location, one kilogram or more of uranium or thorium 
source material with foreign obligations as defined in this part, shall 
document holdings as of September 30 of each year and submit to the 
Commission within 30 days, a statement of its source material inventory 
with foreign obligations as defined in this part. Alternatively, this 
information may be submitted with the licensee's material status reports 
on special nuclear material filed under part 72 or 74 of this chapter, 
as a statement of its source material inventory with foreign obligations 
as defined in this part. This statement must be submitted to the address 
specified in the reporting instructions in NUREG/BR-0007, and include 
the Reporting Identification Symbol (RIS) assigned by the Commission to 
the licensee.
    (2) Possesses, or had possessed in the previous reporting period, 
one kilogram or more of uranium or thorium source material pursuant to 
the operation of enrichment services, downblending uranium that has an 
initial enrichment of the U\235\ isotope of 10 percent or more, or in 
the fabrication of mixed-oxide fuels shall complete and submit, in 
computer-readable format, Material Balance and Physical Inventory 
Listing Reports concerning all source material that the licensee has 
received, produced, possessed, transferred, consumed, disposed of, or 
lost. Reports must be submitted for each Reporting Identification Symbol 
(RIS) account including all holding accounts. Each licensee shall 
prepare and submit these reports as specified in the instructions in 
NUREG/BR-0007 and

[[Page 831]]

NMMSS Report D-24, ``Personal Computer Data Input for NRC Licensees.'' 
These reports must document holdings as of September 30 of each year and 
must be submitted to the Commission within 30 days. Alternatively, these 
reports may be submitted with the licensee's material status reports on 
special nuclear material filed under parts 72 or 74 of this chapter. 
Copies of the reporting instructions may be obtained either by writing 
to the U.S. Nuclear Regulatory Commission, Division of Fuel Cycle 
Safety, Safeguards, and Environmental Review, Washington, DC 20555-0001, 
or by e-mail to [email protected]. Each licensee required to report 
material balance, inventory, and/or foreign obligation information, as 
detailed in this part, shall resolve any discrepancies identified during 
the report review and reconciliation process within 30 calendar days of 
notification of a discrepancy identified by the NRC.
    (c)(1) Except as specified in paragraph (d) of this section, each 
licensee who is authorized to possess uranium or thorium pursuant to a 
specific license shall notify the NRC Headquarters Operations Center by 
telephone, at the numbers listed in appendix A of part 73 of this 
chapter, of any incident in which an attempt has been made or is 
believed to have been made to commit a theft or unlawful diversion of 
more than 6.8 kilograms (kg) [15 pounds] of such material at any one 
time or more than 68 kg [150 pounds] of such material in any one 
calendar year.
    (2) The licensee shall notify the NRC as soon as possible, but 
within 4 hours, of discovery of any incident in which an attempt has 
been made or is believed to have been made to commit a theft or unlawful 
diversion of such material.
    (3) The initial notification shall be followed within a period of 
sixty (60) days by a written followup notification submitted in 
accordance with Sec.40.5.
    (4) Subsequent to the submission of the written followup 
notification required by this paragraph, the licensee shall promptly 
update the written followup notification, in accordance with this 
paragraph, with any substantive additional information, which becomes 
available to the licensee, concerning an attempted or apparent theft or 
unlawful diversion of source material.
    (d) The reports described in paragraphs (a), (b), and (c) of this 
section are not required for:
    (1) Processed ores containing less than five (5) percent of uranium 
or thorium, or any combination of uranium or thorium, by dry weight;
    (2) Thorium contained in magnesium-thorium and tungsten-thorium 
alloys, if the thorium content in the alloys does not exceed 4 percent 
by weight;
    (3) Chemical catalysts containing uranium depleted in the U-235 
isotope to 0.4 percent or less, if the uranium content of the catalyst 
does not exceed 15 percent by weight; or
    (4) Any source material contained in non-nuclear end use devices or 
components, including but not limited to permanently installed 
shielding, teletherapy, radiography, X-ray, accelerator devices, or 
munitions.
    (e) Any licensee who is required to submit inventory change reports 
and material status reports pursuant to part 75 of this chapter 
(pertaining to implementation of the US/IAEA Safeguards Agreement) shall 
prepare and submit such reports only as provided in Sec. Sec.75.34 and 
75.35 of this chapter (instead of as provided in paragraphs (a) and (b) 
of this section).

[35 FR 12195, July 30, 1970, as amended at 36 FR 10938, June 5, 1971; 38 
FR 1272, Jan. 11, 1973; 38 FR 2330, Jan. 24, 1973; 40 FR 8787, Mar. 3, 
1975; 41 FR 16446, Apr. 19, 1976; 45 FR 50710, July 31, 1980; 49 FR 
24707, June 15, 1984; 51 FR 9766, Mar. 21, 1986; 52 FR 31611, Aug. 21, 
1987; 59 FR 35620, July 13, 1994; 68 FR 10364, Mar. 5, 2003; 68 FR 
58807, Oct. 10, 2003; 73 FR 32461, June 9, 2008; 74 FR 62681, Dec. 1, 
2009; 83 FR 58723, Nov. 21, 2018]



Sec.40.65  Effluent monitoring reporting requirements.

    (a) Each licensee authorized to possess and use source material in 
uranium milling, in production of uranium hexafluoride, or in a uranium 
enrichment facility shall:
    (1) Within 60 days after January 1, 1976 and July 1, 1976, and 
within 60 days after January 1 and July 1 of each year thereafter, 
submit a report to the Director, Office of Nuclear Material Safety and 
Safeguards, using an appropriate method listed in Sec.40.5, with a

[[Page 832]]

copy to the appropriate NRC Regional Office shown in appendix D to part 
20 of this chapter; the report must specify the quantity of each of the 
principal radionuclides released to unrestricted areas in liquid and in 
gaseous effluents during the previous six months of operation, and such 
other information as the Commission may require to estimate maximum 
potential annual radiation doses to the public resulting from effluent 
releases. If quantities of radioactive materials released during the 
reporting period are significantly above the licensee's design 
objectives previously reviewed as part of the licensing action, the 
report shall cover this specifically. On the basis of such reports and 
any additional information the Commission may obtain from the licensee 
or others, the Commission may from time to time require the licensee to 
take such action as the Commission deems appropriate.
    (2) [Reserved]
    (b) [Reserved]

[40 FR 53230, Nov. 17, 1975, as amended at 41 FR 21627, May 27, 1976; 42 
FR 25721, May 19, 1977; 52 FR 31611, Aug. 21, 1987; 57 FR 18391, Apr. 
30, 1992; 68 FR 58807, Oct. 10, 2003; 73 FR 5721, Jan. 31, 2008]



Sec.40.66  Requirements for advance notice of export shipments 
of natural uranium.

    (a) Each licensee authorized to export natural uranium, other than 
in the form of ore or ore residue, in amounts exceeding 500 kilograms, 
shall notify the Director, Office of Nuclear Security and Incident 
Response, by an appropriate method listed in Sec.40.5.
    The notification must be in writing and must be received at least 10 
days before transport of the shipment commences at the shipping 
facility.
    (b) The notification must include the following information:
    (1) The name(s), address(es), and telephone number(s) of the 
shipper, receiver, and carrier(s);
    (2) A physical description of the shipment;
    (3) A listing of the mode(s) of shipment, transfer points, and 
routes to be used;
    (4) The estimated date and time that shipment will commence and that 
each nation (other than the United States) along the route is scheduled 
to be entered; and
    (5) A certification that arrangements have been made to notify the 
Director, Office of Nuclear Security and Incident Response when the 
shipment is received at the receiving facility.
    (c) A licensee who needs to amend a notification may do so by 
telephoning the Director, Office of Nuclear Security and Incident 
Response, at the numbers for the NRC Headquarters Operations Center 
listed in Appendix A to part 73 of this chapter.

[52 FR 9651, Mar. 26, 1987, as amended at 53 FR 4110, Feb. 12, 1988; 60 
FR 24551, May 9, 1995; 68 FR 58808, Oct. 10, 2003; 69 FR 76600, Dec. 22, 
2004; 74 FR 62681, Dec. 1, 2009; 83 FR 58723, Nov. 21, 2018]



Sec.40.67  Requirement for advance notice for importation of natural
uranium from countries that are not party to the Convention on the
Physical Protection of Nuclear Material.
          

    (a) Each licensee authorized to import natural uranium, other than 
in the form of ore or ore residue, in amounts exceeding 500 kilograms, 
from countries not party to the Convention on the Physical Protection of 
Nuclear Material (see appendix F to Part 73 of this chapter) shall 
notify the Director, Office of Nuclear Security and Incident Response, 
using an appropriate method listed in Sec.40.5. The notification must 
be in writing and must be received at least 10 days before transport of 
the shipment commences at the shipping facility.
    (b) The notification must include the following information:
    (1) The name(s), address(es), and telephone number(s) of the 
shipper, receiver, and carrier(s);
    (2) A physical description of the shipment;
    (3) A listing of the mode(s) of shipment, transfer points, and 
routes to be used;
    (4) The estimated date and time that shipment will commence and that 
each nation along the route is scheduled to be entered.
    (c) The licensee shall notify the Director, Office of Nuclear 
Security and Incidence Response by telephone at (301) 816-5100 when the 
shipment is received in the receiving facility.

[[Page 833]]

    (d) A licensee who needs to amend a notification may do so by 
telephoning the Director, Office of Nuclear Security and Incidence 
Response at (301) 816-5100.

[52 FR 9652, Mar. 26, 1987, as amended at 53 FR 4110, Feb. 12, 1988; 60 
FR 24551, May 9, 1995; 68 FR 58808, Oct. 10, 2003; 69 FR 76600, Dec. 22, 
2004; 74 FR 62681, Dec. 1, 2009; 83 FR 58723, Nov. 21, 2018]

                 Modification and Revocation of Licenses



Sec.40.71  Modification and revocation of licenses.

    (a) The terms and conditions of each license shall be subject to 
amendment, revision, or modification by reason of amendments to the Act, 
or by reason of rules, regulations, or orders issued in accordance with 
the Act.
    (b) Any license may be revoked, suspended, or modified, in whole or 
in part, for any material false statement in the application or any 
statement of fact required under section 182 of the Act, or because of 
conditions revealed by such application or statement of fact or any 
report, record, or inspection or other means which would warrant the 
Commission to refuse to grant a license on an original application, or 
for violation of, or failure to observe any of, the terms and conditions 
of the Act, or the license, or of any rule, regulation or order of the 
Commission.
    (c) Except in cases of willfulness or those in which the public 
health, interest or safety requires otherwise, no license shall be 
modified, suspended, or revoked unless, prior to the institution of 
proceedings therefor, facts or conduct which may warrant such action 
shall have been called to the attention of the licensee in writing and 
the licensee shall have been accorded opportunity to demonstrate or 
achieve compliance with all lawful requirements.

[26 FR 284, Jan. 14, 1961, as amended at 35 FR 11460, July 17, 1970; 48 
FR 32328, July 15, 1983]

                               Enforcement



Sec.40.81  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55074, Nov. 24, 1992]



Sec.40.82  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 40 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in part 40 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.40.1, 40.2, 40.2a, 40.4, 40.5, 40.6, 40.8, 40.11, 40.12, 
40.13, 40.14, 40.20, 40.21, 40.31, 40.32, 40.34, 40.43, 40.44, 40.45, 
40.52, 40.54, 40.71, 40.81, and 40.82.

[57 FR 55075, Nov. 24, 1992, as amended at 78 FR 32341, May 29, 2013]

[[Page 834]]



   Sec. Appendix A to Part 40--Criteria Relating to the Operation of 
Uranium Mills and the Disposition of Tailings or Wastes Produced by the 
   Extraction or Concentration of Source Material From Ores Processed 
               Primarily for Their Source Material Content

    Introduction. Every applicant for a license to possess and use 
source material in conjunction with uranium or thorium milling, or 
byproduct material at sites formerly associated with such milling, is 
required by the provisions of Sec.40.31(h) to include in a license 
application proposed specifications relating to milling operations and 
the disposition of tailings or wastes resulting from such milling 
activities. This appendix establishes technical, financial, ownership, 
and long-term site surveillance criteria relating to the siting, 
operation, decontamination, decommissioning, and reclamation of mills 
and tailings or waste systems and sites at which such mills and systems 
are located. As used in this appendix, the term ``as low as is 
reasonably achievable'' has the same meaning as in Sec.20.1003 of this 
chapter.
    In many cases, flexibility is provided in the criteria to allow 
achieving an optimum tailings disposal program on a site-specific basis. 
However, in such cases the objectives, technical alternatives and 
concerns which must be taken into account in developing a tailings 
program are identified. As provided by the provisions of Sec.40.31(h) 
applications for licenses must clearly demonstrate how the criteria have 
been addressed.
    The specifications must be developed considering the expected full 
capacity of tailings or waste systems and the lifetime of mill 
operations. Where later expansions of systems or operations may be 
likely (for example, where large quantities of ore now marginally 
uneconomical may be stockpiled), the amenability of the disposal system 
to accommodate increased capacities without degradation in long-term 
stability and other performance factors must be evaluated.
    Licensees or applicants may propose alternatives to the specific 
requirements in this appendix. The alternative proposals may take into 
account local or regional conditions, including geology, topography, 
hydrology, and meterology. The Commission may find that the proposed 
alternatives meet the Commission's requirements if the alternatives will 
achieve a level of stabilization and containment of the sites concerned, 
and a level of protection for public health, safety, and the environment 
from radiological and nonradiological hazards associated with the sites, 
which is equivalent to, to the extent practicable, or more stringent 
than the level which would be achieved by the requirements of this 
appendix and the standards promulgated by the Environmental Protection 
Agency in 40 CFR part 192, subparts D and E.
    All site specific licensing decisions based on the criteria in this 
appendix or alternatives proposed by licensees or applicants will take 
into account the risk to the public health and safety and the 
environment with due consideration to the economic costs involved and 
any other factors the Commission determines to be appropriate. In 
implementing this appendix, the Commission will consider ``practicable'' 
and ``reasonably achievable'' as equivalent terms. Decisions involved 
these terms will take into account the state of technology, and the 
economics of improvements in relation to benefits to the public health 
and safety, and other societal and socioeconomic considerations, and in 
relation to the utilization of atomic energy in the public interest.
    The following definitions apply to the specified terms as used in 
this appendix:
    Aquifer means a geologic formation, group of formations, or part of 
a formation capable of yielding a significant amount of groundwater to 
wells or springs. Any saturated zone created by uranium or thorium 
recovery operations would not be considered an aquifer unless the zone 
is or potentially is (1) hydraulically interconnected to a natural 
aquifer, (2) capable of discharge to surface water, or (3) reasonably 
accessible because of migration beyond the vertical projection of the 
boundary of the land transferred for long-term government ownership and 
care in accordance with Criterion 11 of this appendix.
    As expeditiously as practicable considering technological 
feasibility, for the purposes of Criterion 6A, means as quickly as 
possible considering: the physical characteristics of the tailings and 
the site; the limits of available technology; the need for consistency 
with mandatory requirements of other regulatory programs; and factors 
beyond the control of the licensee. The phrase permits consideration of 
the cost of compliance only to the extent specifically provided for by 
use of the term available technology.
    Available technology means technologies and methods for emplacing a 
final radon barrier on uranium mill tailings piles or impoundments. This 
term shall not be construed to include extraordinary measures or 
techniques that would impose costs that are grossly excessive as 
measured by practice within the industry (or one that is reasonably 
analogous), (such as, by way of illustration only, unreasonable 
overtime, staffing, or transportation requirements, etc., considering 
normal practice in the industry; laser fusion of soils, etc.), provided 
there is reasonable progress toward emplacement of the final radon 
barrier. To determine grossly excessive costs, the relevant baseline 
against

[[Page 835]]

which cost shall be compared is the cost estimate for tailings 
impoundment closure contained in the licensee's approved reclamation 
plan, but costs beyond these estimates shall not automatically be 
considered grossly excessive.
    Closure means the activities following operations to decontaminate 
and decommission the buildings and site used to produce byproduct 
materials and reclaim the tailings and/or waste disposal area.
    Closure plan means the Commission approved plan to accomplish 
closure.
    Compliance period begins when the Commission sets secondary 
groundwater protection standards and ends when the owner or operator's 
license is terminated and the site is transferred to the State or 
Federal agency for long-term care.
    Dike means an embankment or ridge of either natural or man-made 
materials used to prevent the movement of liquids, sludges, solids or 
other materials.
    Disposal area means the area containing byproduct materials to which 
the requirements of Criterion 6 apply.
    Existing portion means that land surface area of an existing surface 
impoundment on which significant quantities of uranium or thorium 
byproduct materials had been placed prior to September 30, 1983.
    Factors beyond the control of the licensee means factors proximately 
causing delay in meeting the schedule in the applicable reclamation plan 
for the timely emplacement of the final radon barrier notwithstanding 
the good faith efforts of the licensee to complete the barrier in 
compliance with paragraph (1) of Criterion 6A. These factors may 
include, but are not limited to--
    (1) Physical conditions at the site;
    (2) Inclement weather or climatic conditions;
    (3) An act of God;
    (4) An act of war;
    (5) A judicial or administrative order or decision, or change to the 
statutory, regulatory, or other legal requirements applicable to the 
licensee's facility that would preclude or delay the performance of 
activities required for compliance;
    (6) Labor disturbances;
    (7) Any modifications, cessation or delay ordered by State, Federal, 
or local agencies;
    (8) Delays beyond the time reasonably required in obtaining 
necessary government permits, licenses, approvals, or consent for 
activities described in the reclamation plan proposed by the licensee 
that result from agency failure to take final action after the licensee 
has made a good faith, timely effort to submit legally sufficient 
applications, responses to requests (including relevant data requested 
by the agencies), or other information, including approval of the 
reclamation plan; and
    (9) An act or omission of any third party over whom the licensee has 
no control.
    Final radon barrier means the earthen cover (or approved alternative 
cover) over tailings or waste constructed to comply with Criterion 6 of 
this appendix (excluding erosion protection features).
    Groundwater means water below the land surface in a zone of 
saturation. For purposes of this appendix, groundwater is the water 
contained within an aquifer as defined above.
    Leachate means any liquid, including any suspended or dissolved 
components in the liquid, that has percolated through or drained from 
the byproduct material.
    Licensed site means the area contained within the boundary of a 
location under the control of persons generating or storing byproduct 
materials under a Commission license.
    Liner means a continuous layer of natural or man-made materials, 
beneath or on the sides of a surface impoundment which restricts the 
downward or lateral escape of byproduct material, hazardous 
constituents, or leachate.
    Milestone means an action or event that is required to occur by an 
enforceable date.
    Operation means that a uranium or thorium mill tailings pile or 
impoundment is being used for the continued placement of byproduct 
material or is in standby status for such placement. A pile or 
impoundment is in operation from the day that byproduct material is 
first placed in the pile or impoundment until the day final closure 
begins.
    Point of compliance is the site specific location in the uppermost 
aquifer where the groundwater protection standard must be met.
    Reclamation plan, for the purposes of Criterion 6A, means the plan 
detailing activities to accomplish reclamation of the tailings or waste 
disposal area in accordance with the technical criteria of this 
appendix. The reclamation plan must include a schedule for reclamation 
milestones that are key to the completion of the final radon barrier 
including as appropriate, but not limited to, wind blown tailings 
retrieval and placement on the pile, interim stabilization (including 
dewatering or the removal of freestanding liquids and recontouring), and 
final radon barrier construction. (Reclamation of tailings must also be 
addressed in the closure plan; the detailed reclamation plan may be 
incorporated into the closure plan.)
    Surface impoundment means a natural topographic depression, man-made 
excavation, or diked area, which is designed to hold an accumulation of 
liquid wastes or wastes containing free liquids, and which is not an 
injection well.
    Uppermost aquifer means the geologic formation nearest the natural 
ground surface that is an aquifer, as well as lower aquifers

[[Page 836]]

that are hydraulically interconnected with this aquifer within the 
facility's property boundary.

                          I. Technical Criteria

    Criterion 1--The general goal or broad objective in siting and 
design decisions is permanent isolation of tailings and associated 
contaminants by minimizing disturbance and dispersion by natural forces, 
and to do so without ongoing maintenance. For practical reasons, 
specific siting decisions and design standards must involve finite times 
(e.g., the longevity design standard in Criterion 6). The following site 
features which will contribute to such a goal or objective must be 
considered in selecting among alternative tailings disposal sites or 
judging the adequacy of existing tailings sites:
    Remoteness from populated areas;
    Hydrologic and other natural conditions as they contribute to 
continued immobilization and isolation of contaminants from groundwater 
sources; and
    Potential for minimizing erosion, disturbance, and dispersion by 
natural forces over the long term.
    The site selection process must be an optimization to the maximum 
extent reasonably achievable in terms of these features.
    In the selection of disposal sites, primary emphasis must be given 
to isolation of tailings or wastes, a matter having long-term impacts, 
as opposed to consideration only of short-term convenience or benefits, 
such as minimization of transportation or land acquisition costs. While 
isolation of tailings will be a function of both site and engineering 
design, overriding consideration must be given to siting features given 
the long-term nature of the tailings hazards.
    Tailings should be disposed of in a manner that no active 
maintenance is required to preserve conditions of the site.
    Criterion 2--To avoid proliferation of small waste disposal sites 
and thereby reduce perpetual surveillance obligations, byproduct 
material from in situ extraction operations, such as residues from 
solution evaporation or contaminated control processes, and wastes from 
small remote above ground extraction operations must be disposed of at 
existing large mill tailings disposal sites; unless, considering the 
nature of the wastes, such as their volume and specific activity, and 
the costs and environmental impacts of transporting the wastes to a 
large disposal site, such offsite disposal is demonstrated to be 
impracticable or the advantages of onsite burial clearly outweigh the 
benefits of reducing the perpetual surveillance obligations.
    Criterion 3--The ``prime option'' for disposal of tailings is 
placement below grade, either in mines or specially excavated pits (that 
is, where the need for any specially constructed retention structure is 
eliminated). The evaluation of alternative sites and disposal methods 
performed by mill operators in support of their proposed tailings 
disposal program (provided in applicants' environmental reports) must 
reflect serious consideration of this disposal mode. In some instances, 
below grade disposal may not be the most environmentally sound approach, 
such as might be the case if a groundwater formation is relatively close 
to the surface or not very well isolated by overlying soils and rock. 
Also, geologic and topographic conditions might make full below grade 
burial impracticable: For example, bedrock may be sufficiently near the 
surface that blasting would be required to excavate a disposal pit at 
excessive cost, and more suitable alternative sites are not available. 
Where full below grade burial is not practicable, the size of retention 
structures, and size and steepness of slopes associated exposed 
embankments must be minimized by excavation to the maximum extent 
reasonably achievable or appropriate given the geologic and hydrologic 
conditions at a site. In these cases, it must be demonstrated that an 
above grade disposal program will provide reasonably equivalent 
isolation of the tailings from natural erosional forces.
    Criterion 4--The following site and design criteria must be adhered 
to whether tailings or wastes are disposed of above or below grade.
    (a) Upstream rainfall catchment areas must be minimized to decrease 
erosion potential and the size of the floods which could erode or wash 
out sections of the tailings disposal area.
    (b) Topographic features should provide good wind protection.
    (c) Embankment and cover slopes must be relatively flat after final 
stabilization to minimize erosion potential and to provide conservative 
factors of safety assuring long-term stability. The broad objective 
should be to contour final slopes to grades which are as close as 
possible to those which would be provided if tailings were disposed of 
below grade; this could, for example, lead to slopes of about 10 
horizontal to 1 vertical (10h:1v) or less steep. In general, slopes 
should not be steeper than about 5h:1v. Where steeper slopes are 
proposed, reasons why a slope less steep than 5h:1v would be 
impracticable should be provided, and compensating factors and 
conditions which make such slopes acceptable should be identified.
    (d) A full self-sustaining vegetative cover must be established or 
rock cover employed to reduce wind and water erosion to negligible 
levels.
    Where a full vegetative cover is not likely to be self-sustaining 
due to climatic or other conditions, such as in semi-arid and arid 
regions, rock cover must be employed on slopes of the impoundment 
system. The NRC will consider relaxing this requirement for

[[Page 837]]

extremely gentle slopes such as those which may exist on the top of the 
pile.
    The following factors must be considered in establishing the final 
rock cover design to avoid displacement of rock particles by human and 
animal traffic or by natural process, and to preclude undercutting and 
piping:
    Shape, size, composition, and gradation of rock particles (excepting 
bedding material average particles size must be at least cobble size or 
greater);
    Rock cover thickness and zoning of particles by size; and
    Steepness of underlying slopes.
    Individual rock fragments must be dense, sound, and resistant to 
abrasion, and must be free from cracks, seams, and other defects that 
would tend to unduly increase their destruction by water and frost 
actions. Weak, friable, or laminated aggregate may not be used.
    Rock covering of slopes may be unnecessary where top covers are very 
thick (on the order of 10 m or greater); impoundment slopes are very 
gentle (on the order of 10 h:1v or less); bulk cover materials have 
inherently favorable erosion resistance characteristics; and, there is 
negligible drainage catchment area upstream of the pile and good wind 
protection as described in points (a) and (b) of this Criterion.
    Furthermore, all impoundment surfaces must be contoured to avoid 
areas of concentrated surface runoff or abrupt or sharp changes in slope 
gradient. In addition to rock cover on slopes, areas toward which 
surface runoff might be directed must be well protected with substantial 
rock cover (rip rap). In addition to providing for stability of the 
impoundment system itself, overall stability, erosion potential, and 
geomorphology of surrounding terrain must be evaluated to assure that 
there are not ongoing or potential processes, such as gully erosion, 
which would lead to impoundment instability.
    (e) The impoundment may not be located near a capable fault that 
could cause a maximum credible earthquake larger than that which the 
impoundment could reasonably be expected to withstand. As used in this 
criterion, the term ``capable fault'' has the same meaning as defined in 
section III(g) of appendix A of 10 CFR part 100. The term ``maximum 
credible earthquake'' means that earthquake which would cause the 
maximum vibratory ground motion based upon an evaluation of earthquake 
potential considering the regional and local geology and seismology and 
specific characteristics of local subsurface material.
    (f) The impoundment, where feasible, should be designed to 
incorporate features which will promote deposition. For example, design 
features which promote deposition of sediment suspended in any runoff 
which flows into the impoundment area might be utilized; the object of 
such a design feature would be to enhance the thickness of cover over 
time.
    Criterion 5--Criteria 5A-5D and new Criterion 13 incorporate the 
basic groundwater protection standards imposed by the Environmental 
Protection Agency in 40 CFR part 192, subparts D and E (48 FR 45926; 
October 7, 1983) which apply during operations and prior to the end of 
closure. Groundwater monitoring to comply with these standards is 
required by Criterion 7A.
    5A(1)--The primary groundwater protection standard is a design 
standard for surface impoundments used to manage uranium and thorium 
byproduct material. Unless exempted under paragraph 5A(3) of this 
criterion, surface impoundments (except for an existing portion) must 
have a liner that is designed, constructed, and installed to prevent any 
migration of wastes out of the impoundment to the adjacent subsurface 
soil, groundwater, or surface water at any time during the active life 
(including the closure period) of the impoundment. The liner may be 
constructed of materials that may allow wastes to migrate into the liner 
(but not into the adjacent subsurface soil, groundwater, or surface 
water) during the active life of the facility, provided that impoundment 
closure includes removal or decontamination of all waste residues, 
contaminated containment system components (liners, etc.), contaminated 
subsoils, and structures and equipment contaminated with waste and 
leachate. For impoundments that will be closed with the liner material 
left in place, the liner must be constructed of materials that can 
prevent wastes from migrating into the liner during the active life of 
the facility.
    5A(2)--The liner required by paragraph 5A(1) above must be--
    (a) Constructed of materials that have appropriate chemical 
properties and sufficient strength and thickness to prevent failure due 
to pressure gradients (including static head and external hydrogeologic 
forces), physical contact with the waste or leachate to which they are 
exposed, climatic conditions, the stress of installation, and the stress 
of daily operation;
    (b) Placed upon a foundation or base capable of providing support to 
the liner and resistance to pressure gradients above and below the liner 
to prevent failure of the liner due to settlement, compression, or 
uplift; and
    (c) Installed to cover all surrounding earth likely to be in contact 
with the wastes or leachate.
    5A(3)--The applicant or licensee will be exempted from the 
requirements of paragraph 5A(1) of this criterion if the Commission 
finds, based on a demonstration by the applicant or licensee, that 
alternate design and operating practices, including the closure plan, 
together with site characteristics will

[[Page 838]]

prevent the migration of any hazardous constituents into groundwater or 
surface water at any future time. In deciding whether to grant an 
exemption, the Commission will consider--
    (a) The nature and quantity of the wastes;
    (b) The proposed alternate design and operation;
    (c) The hydrogeologic setting of the facility, including the 
attenuative capacity and thickness of the liners and soils present 
between the impoundment and groundwater or surface water; and
    (d) All other factors which would influence the quality and mobility 
of the leachate produced and the potential for it to migrate to 
groundwater or surface water.
    5A(4)--A surface impoundment must be designed, constructed, 
maintained, and operated to prevent overtopping resulting from normal or 
abnormal operations, overfilling, wind and wave actions, rainfall, or 
run-on; from malfunctions of level controllers, alarms, and other 
equipment; and from human error.
    5A(5)--When dikes are used to form the surface impoundment, the 
dikes must be designed, constructed, and maintained with sufficient 
structural integrity to prevent massive failure of the dikes. In 
ensuring structural integrity, it must not be presumed that the liner 
system will function without leakage during the active life of the 
impoundment.
    5B(1)--Uranium and thorium byproduct materials must be managed to 
conform to the following secondary groundwater protection standard: 
Hazardous constituents entering the groundwater from a licensed site 
must not exceed the specified concentration limits in the uppermost 
aquifer beyond the point of compliance during the compliance period. 
Hazardous constituents are those constituents identified by the 
Commission pursuant to paragraph 5B(2) of this criterion. Specified 
concentration limits are those limits established by the Commission as 
indicated in paragraph 5B(5) of this criterion. The Commission will also 
establish the point of compliance and compliance period on a site 
specific basis through license conditions and orders. The objective in 
selecting the point of compliance is to provide the earliest practicable 
warning that the impoundment is releasing hazardous constituents to the 
groundwater. The point of compliance must be selected to provide prompt 
indication of groundwater contamination on the hydraulically 
downgradient edge of the disposal area. The Commission shall identify 
hazardous constituents, establish concentration limits, set the 
compliance period, and may adjust the point of compliance if needed to 
accord with developed data and site information as to the flow of 
groundwater or contaminants, when the detection monitoring established 
under Criterion 7A indicates leakage of hazardous constituents from the 
disposal area.
    5B(2)--A constituent becomes a hazardous constituent subject to 
paragraph 5B(5) only when the constituent meets all three of the 
following tests:
    (a) The constituent is reasonably expected to be in or derived from 
the byproduct material in the disposal area;
    (b) The constituent has been detected in the groundwater in the 
uppermost aquifer; and
    (c) The constituent is listed in Criterion 13 of this appendix.
    5B(3)--Even when constituents meet all three tests in paragraph 
5B(2) of this criterion, the Commission may exclude a detected 
constituent from the set of hazardous constituents on a site specific 
basis if it finds that the constituent is not capable of posing a 
substantial present or potential hazard to human health or the 
environment. In deciding whether to exclude constituents, the Commission 
will consider the following:
    (a) Potential adverse effects on groundwater quality, considering--
    (i) The physical and chemical characteristics of the waste in the 
licensed site, including its potential for migration;
    (ii) The hydrogeological characteristics of the facility and 
surrounding land;
    (iii) The quantity of groundwater and the direction of groundwater 
flow;
    (iv) The proximity and withdrawal rates of groundwater users;
    (v) The current and future uses of groundwater in the area;
    (vi) The existing quality of groundwater, including other sources of 
contamination and their cumulative impact on the groundwater quality;
    (vii) The potential for health risks caused by human exposure to 
waste constituents;
    (viii) The potential damage to wildlife, crops, vegetation, and 
physical structures caused by exposure to waste constituents;
    (ix) The persistence and permanence of the potential adverse 
effects.
    (b) Potential adverse effects on hydraulically-connected surface 
water quality, considering--
    (i) The volume and physical and chemical characteristics of the 
waste in the licensed site;
    (ii) The hydrogeological characteristics of the facility and 
surrounding land;
    (iii) The quantity and quality of groundwater, and the direction of 
groundwater flow;
    (iv) The patterns of rainfall in the region;
    (v) The proximity of the licensed site to surface waters;
    (vi) The current and future uses of surface waters in the area and 
any water quality standards established for those surface waters;

[[Page 839]]

    (vii) The existing quality of surface water, including other sources 
of contamination and the cumulative impact on surface-water quality;
    (viii) The potential for health risks caused by human exposure to 
waste constituents;
    (ix) The potential damage to wildlife, crops, vegetation, and 
physical structures caused by exposure to waste constituents; and
    (x) The persistence and permanence of the potential adverse effects.
    5B(4)--In making any determinations under paragraphs 5B(3) and 5B(6) 
of this criterion about the use of groundwater in the area around the 
facility, the Commission will consider any identification of underground 
sources of drinking water and exempted aquifers made by the 
Environmental Protection Agency.
    5B(5)--At the point of compliance, the concentration of a hazardous 
constituent must not exceed--
    (a) The Commission approved background concentration of that 
constituent in the groundwater;
    (b) The respective value given in the table in paragraph 5C if the 
constituent is listed in the table and if the background level of the 
constituent is below the value listed; or
    (c) An alternate concentration limit established by the Commission.
    5B(6)--Conceptually, background concentrations pose no incremental 
hazards and the drinking water limits in paragraph 5C state acceptable 
hazards but these two options may not be practically achievable at a 
specific site. Alternate concentration limits that present no 
significant hazard may be proposed by licensees for Commission 
consideration. Licensees must provide the basis for any proposed limits 
including consideration of practicable corrective actions, that limits 
are as low as reasonably achievable, and information on the factors the 
Commission must consider. The Commission will establish a site specific 
alternate concentration limit for a hazardous constituent as provided in 
paragraph 5B(5) of this criterion if it finds that the proposed limit is 
as low as reasonably achievable, after considering practicable 
corrective actions, and that the constituent will not pose a substantial 
present or potential hazard to human health or the environment as long 
as the alternate concentration limit is not exceeded. In making the 
present and potential hazard finding, the Commission will consider the 
following factors:
    (a) Potential adverse effects on groundwater quality, considering--
    (i) The physical and chemical characteristics of the waste in the 
licensed site including its potential for migration;
    (ii) The hydrogeological characteristics of the facility and 
surrounding land;
    (iii) The quantity of groundwater and the direction of groundwater 
flow;
    (iv) The proximity and withdrawal rates of groundwater = users;
    (v) The current and future uses of groundwater in the area;
    (vi) The existing quality of groundwater, including other sources of 
contamination and their cumulative impact on the groundwater = quality;
    (vii) The potential for health risks caused by human exposure to 
waste constituents;
    (viii) The potential damage to wildlife, crops, vegetation, and 
physical structures caused by exposure to waste constituents;
    (ix) The persistence and permanence of the potential adverse 
effects.
    (b) Potential adverse effects on hydraulically-connected surface 
water quality, considering--
    (i) The volume and physical and chemical characteristics of the 
waste in the licensed site;
    (ii) The hydrogeological characteristics of the facility and 
surrounding land;
    (iii) The quantity and quality of groundwater, and the direction of 
groundwater flow;
    (iv) The patterns of rainfall in the region;
    (v) The proximity of the licensed site to surface waters;
    (vi) The current and future uses of surface waters in the area and 
any water quality standards established for those surface waters;
    (vii) The existing quality of surface water including other sources 
of contamination and the cumulative impact on surface water quality;
    (viii) The potential for health risks caused by human exposure to 
waste constituents;
    (ix) The potential damage to wildlife, crops, vegetation, and 
physical structures caused by exposure to waste constituents; and
    (x) The persistence and permanence of the potential adverse effects.

              5C--Maximum Values for groundwater Protection
------------------------------------------------------------------------
                                                              Maximum
                 Constituent or property                   concentration
------------------------------------------------------------------------
Milligrams per liter:
  Arsenic................................................        0.05
  Barium.................................................        1.0
  Cadmium................................................        0.01
  Chromium...............................................        0.05
  Lead...................................................        0.05
  Mercury................................................        0.002
  Selenium...............................................        0.01
  Silver.................................................        0.05
  Endrin (1,2,3,4,10,10-hexachloro-1,7 -expoxy-1,4,4a,5,         0.0002
   6,7,8,9a-octahydro-1, 4-endo, endo-5,8-dimethano
   naphthalene)..........................................
  Lindane (1,2,3,4,5,6-hexachlorocyclohexane, gamma              0.004
   isomer)...............................................

[[Page 840]]

 
  Methoxychlor (1,1,1-Trichloro-2,2-bis (p-                      0.1
   methoxyphenylethane)..................................
  Toxaphene (C10 H10 C16, Technical chlorinated camphene,        0.005
   67-69 percent chlorine)...............................
  2,4-D (2,4-Dichlorophenoxyacetic acid).................        0.1
  2,4,5-TP Silvex (2,4,5-Trichlorophenoxypropionic acid).        0.01
Picocuries per liter:
  Combined radium-226 and radium-228.....................        5
  Gross alpha--particle activity (excluding radon and           15
   uranium when producing uranium byproduct material or
   radon and thorium when producing thorium byproduct
   material).............................................
------------------------------------------------------------------------

    5D--If the groundwater protection standards established under 
paragraph 5B(1) of this criterion are exceeded at a licensed site, a 
corrective action program must be put into operation as soon as is 
practicable, and in no event later than eighteen (18) months after the 
Commission finds that the standards have been exceeded. The licensee 
shall submit the proposed corrective action program and supporting 
rationale for Commission approval prior to putting the program into 
operation, unless otherwise directed by the Commission. The objective of 
the program is to return hazardous constituent concentration levels in 
groundwater to the concentration limits set as standards. The licensee's 
proposed program must address removing the hazardous constituents that 
have entered the groundwater at the point of compliance or treating them 
in place. The program must also address removing or treating in place 
any hazardous constituents that exceed concentration limits in 
groundwater between the point of compliance and the downgradient 
facility property boundary. The licensee shall continue corrective 
action measures to the extent necessary to achieve and maintain 
compliance with the groundwater protection standard. The Commission will 
determine when the licensee may terminate corrective action measures 
based on data from the groundwater monitoring program and other 
information that provide reasonable assurance that the groundwater 
protection standard will not be exceeded.
    5E--In developing and conducting groundwater protection programs, 
applicants and licensees shall also consider the following:
    (1) Installation of bottom liners (Where synthetic liners are used, 
a leakage detection system must be installed immediately below the liner 
to ensure major failures are detected if they occur. This is in addition 
to the groundwater monitoring program conducted as provided in Criterion 
7. Where clay liners are proposed or relatively thin, in-situ clay soils 
are to be relied upon for seepage control, tests must be conducted with 
representative tailings solutions and clay materials to confirm that no 
significant deterioration of permeability or stability properties will 
occur with continuous exposure of clay to tailings solutions. Tests must 
be run for a sufficient period of time to reveal any effects if they are 
going to occur (in some cases deterioration has been observed to occur 
rather rapidly after about nine months of exposure)).
    (2) Mill process designs which provide the maximum practicable 
recycle of solutions and conservation of water to reduce the net input 
of liquid to the tailings impoundment.
    (3) Dewatering of tailings by process devices and/or in-situ 
drainage systems (At new sites, tailings must be dewatered by a drainage 
system installed at the bottom of the impoundment to lower the phreatic 
surface and reduce the driving head of seepage, unless tests show 
tailings are not amenable to such a system. Where in-situ dewatering is 
to be conducted, the impoundment bottom must be graded to assure that 
the drains are at a low point. The drains must be protected by suitable 
filter materials to assure that drains remain free running. The drainage 
system must also be adequately sized to assure good drainage).
    (4) Neutralization to promote immobilization of hazardous 
constituents.
    5F--Where groundwater impacts are occurring at an existing site due 
to seepage, action must be taken to alleviate conditions that lead to 
excessive seepage impacts and restore groundwater quality. The specific 
seepage control and groundwater protection method, or combination of 
methods, to be used must be worked out on a site-specific basis. 
Technical specifications must be prepared to control installation of 
seepage control systems. A quality assurance, testing, and inspection 
program, which includes supervision by a qualified engineer or 
scientist, must be established to assure the specifications are met.
    5G--In support of a tailings disposal system proposal, the 
applicant/operator shall supply information concerning the following:
    (1) The chemical and radioactive characteristics of the waste 
solutions.
    (2) The characteristics of the underlying soil and geologic 
formations particularly as they will control transport of contaminants 
and solutions. This includes detailed information concerning extent, 
thickness, uniformity, shape, and orientation of underlying strata. 
Hydraulic gradients and conductivities of the various formations must be 
determined. This information must be gathered from borings and field 
survey methods taken within the proposed impoundment area and in 
surrounding areas where contaminants might migrate to groundwater. The 
information gathered on boreholes must

[[Page 841]]

include both geologic and geophysical logs in sufficient number and 
degree of sophistication to allow determining significant 
discontinuities, fractures, and channeled deposits of high hydraulic 
conductivity. If field survey methods are used, they should be in 
addition to and calibrated with borehole logging. Hydrologic parameters 
such as permeability may not be determined on the basis of laboratory 
analysis of samples alone; a sufficient amount of field testing (e.g., 
pump tests) must be conducted to assure actual field properties are 
adequately understood. Testing must be conducted to allow estimating 
chemi-sorption attenuation properties of underlying soil and rock.
    (3) Location, extent, quality, capacity and current uses of any 
groundwater at and near the site.
    5H--Steps must be taken during stockpiling of ore to minimize 
penetration of radionuclides into underlying soils; suitable methods 
include lining and/or compaction of ore storage areas.
    Criterion 6--(1) In disposing of waste byproduct material, licensees 
shall place an earthen cover (or approved alternative) over tailings or 
wastes at the end of milling operations and shall close the waste 
disposal area in accordance with a design \1\ which provides reasonable 
assurance of control of radiological hazards to (i) be effective for 
1,000 years, to the extent reasonably achievable, and, in any case, for 
at least 200 years, and (ii) limit releases of radon-222 from uranium 
byproduct materials, and radon-220 from thorium byproduct materials, to 
the atmosphere so as not to exceed an average \2\ release rate of 20 
picocuries per square meter per second (pCi/m\2\ s) to the extent 
practicable throughout the effective design life determined pursuant to 
(1)(i) of this Criterion. In computing required tailings cover 
thicknesses, moisture in soils in excess of amounts found normally in 
similar soils in similar circumstances may not be considered. Direct 
gamma exposure from the tailings or wastes should be reduced to 
background levels. The effects of any thin synthetic layer may not be 
taken into account in determining the calculated radon exhalation level. 
If non-soil materials are proposed as cover materials, it must be 
demonstrated that these materials will not crack or degrade by 
differential settlement, weathering, or other mechanism, over long-term 
intervals.
---------------------------------------------------------------------------

    \1\ In the case of thorium byproduct materials, the standard applies 
only to design. Monitoring for radon emissions from thorium byproduct 
materials after installation of an appropriately designed cover is not 
required.
    \2\ This average applies to the entire surface of each disposal area 
over a period of a least one year, but a period short compared to 100 
years. Radon will come from both byproduct materials and from covering 
materials. Radon emissions from covering materials should be estimated 
as part of developing a closure plan for each site. The standard, 
however, applies only to emissions from byproduct materials to the 
atmosphere.
---------------------------------------------------------------------------

    (2) As soon as reasonably achievable after emplacement of the final 
cover to limit releases of radon-222 from uranium byproduct material and 
prior to placement of erosion protection barriers or other features 
necessary for long-term control of the tailings, the licensee shall 
verify through appropriate testing and analysis that the design and 
construction of the final radon barrier is effective in limiting 
releases of radon-222 to a level not exceeding 20 pCi/m \2\s averaged 
over the entire pile or impoundment using the procedures described in 40 
CFR part 61, appendix B, Method 115, or another method of verification 
approved by the Commission as being at least as effective in 
demonstrating the effectiveness of the final radon barrier.
    (3) When phased emplacement of the final radon barrier is included 
in the applicable reclamation plan, the verification of radon-222 
release rates required in paragraph (2) of this criterion must be 
conducted for each portion of the pile or impoundment as the final radon 
barrier for that portion is emplaced.
    (4) Within ninety days of the completion of all testing and analysis 
relevant to the required verification in paragraphs (2) and (3) of this 
criterion, the uranium mill licensee shall report to the Commission the 
results detailing the actions taken to verify that levels of release of 
radon-222 do not exceed 20 pCi/m \2\s when averaged over the entire pile 
or impoundment. The licensee shall maintain records until termination of 
the license documenting the source of input parameters including the 
results of all measurements on which they are based, the calculations 
and/or analytical methods used to derive values for input parameters, 
and the procedure used to determine compliance. These records shall be 
kept in a form suitable for transfer to the custodial agency at the time 
of transfer of the site to DOE or a State for long-term care if 
requested.
    (5) Near surface cover materials (i.e., within the top three meters) 
may not include waste or rock that contains elevated levels of radium; 
soils used for near surface cover must be essentially the same, as far 
as radioactivity is concerned, as that of surrounding surface soils. 
This is to ensure that surface radon exhalation is not significantly 
above background because of the cover material itself.
    (6) The design requirements in this criterion for longevity and 
control of radon releases apply to any portion of a licensed and/or 
disposal site unless such portion contains a concentration of radium in 
land, averaged

[[Page 842]]

over areas of 100 square meters, which, as a result of byproduct 
material, does not exceed the background level by more than: (i) 5 
picocuries per gram (pCi/g) of radium-226, or, in the case of thorium 
byproduct material, radium-228, averaged over the first 15 centimeters 
(cm) below the surface, and (ii) 15 pCi/g of radium-226, or, in the case 
of thorium byproduct material, radium-228, averaged over 15-cm thick 
layers more than 15 cm below the surface.
    Byproduct material containing concentrations of radionuclides other 
than radium in soil, and surface activity on remaining structures, must 
not result in a total effective dose equivalent (TEDE) exceeding the 
dose from cleanup of radium contaminated soil to the above standard 
(benchmark dose), and must be at levels which are as low as is 
reasonably achievable. If more than one residual radionuclide is present 
in the same 100-square-meter area, the sum of the ratios for each 
radionuclide of concentration present to the concentration limit will 
not exceed ``1'' (unity). A calculation of the potential peak annual 
TEDE within 1000 years to the average member of the critical group that 
would result from applying the radium standard (not including radon) on 
the site must be submitted for approval. The use of decommissioning 
plans with benchmark doses which exceed 100 mrem/yr, before application 
of ALARA, requires the approval of the Commission after consideration of 
the recommendation of the NRC staff. This requirement for dose criteria 
does not apply to sites that have decommissioning plans for soil and 
structures approved before June 11, 1999.
    (7) The licensee shall also address the nonradiological hazards 
associated with the wastes in planning and implementing closure. The 
licensee shall ensure that disposal areas are closed in a manner that 
minimizes the need for further maintenance. To the extent necessary to 
prevent threats to human health and the environment, the licensee shall 
control, minimize, or eliminate post-closure escape of nonradiological 
hazardous constituents, leachate, contaminated rainwater, or waste 
decomposition products to the ground or surface waters or to the 
atmosphere.
    Criterion 6A--(1) For impoundments containing uranium byproduct 
materials, the final radon barrier must be completed as expeditiously as 
practicable considering technological feasibility after the pile or 
impoundment ceases operation in accordance with a written, Commission-
approved reclamation plan. (The term as expeditiously as practicable 
considering technological feasibility as specifically defined in the 
Introduction of this appendix includes factors beyond the control of the 
licensee.) Deadlines for completion of the final radon barrier and, if 
applicable, the following interim milestones must be established as a 
condition of the individual license: windblown tailings retrieval and 
placement on the pile and interim stabilization (including dewatering or 
the removal of freestanding liquids and recontouring). The placement of 
erosion protection barriers or other features necessary for long-term 
control of the tailings must also be completed in a timely manner in 
accordance with a written, Commission-approved reclamation plan.
    (2) The Commission may approve a licensee's request to extend the 
time for performance of milestones related to emplacement of the final 
radon barrier if, after providing an opportunity for public 
participation, the Commission finds that the licensee has adequately 
demonstrated in the manner required in paragraph (2) of Criterion 6 that 
releases of radon-222 do not exceed an average of 20 pCi/m\2\s. If the 
delay is approved on the basis that the radon releases do not exceed 20 
pCi/m\2\s, a verification of radon levels, as required by paragraph (2) 
of Criterion 6, must be made annually during the period of delay. In 
addition, once the Commission has established the date in the 
reclamation plan for the milestone for completion of the final radon 
barrier, the Commission may extend that date based on cost if, after 
providing an opportunity for public participation, the Commission finds 
that the licensee is making good faith efforts to emplace the final 
radon barrier, the delay is consistent with the definition of available 
technology, and the radon releases caused by the delay will not result 
in a significant incremental risk to the public health.
    (3) The Commission may authorize by license amendment, upon licensee 
request, a portion of the impoundment to accept uranium byproduct 
material or such materials that are similar in physical, chemical, and 
radiological characteristics to the uranium mill tailings and associated 
wastes already in the pile or impoundment, from other sources, during 
the closure process. No such authorization will be made if it results in 
a delay or impediment to emplacement of the final radon barrier over the 
remainder of the impoundment in a manner that will achieve levels of 
radon-222 releases not exceeding 20 pCi/m\2\s averaged over the entire 
impoundment. The verification required in paragraph (2) of Criterion 6 
may be completed with a portion of the impoundment being used for 
further disposal if the Commission makes a final finding that the 
impoundment will continue to achieve a level of radon-222 releases not 
exceeding 20 pCi/m\2\ s averaged over the entire impoundment. In this 
case, after the final radon barrier is complete except for the 
continuing disposal area, (a) only byproduct material will be authorized 
for disposal, (b) the disposal will be limited to the specified existing 
disposal area, and (c) this authorization will only be made after 
providing opportunity for public participation. Reclamation

[[Page 843]]

of the disposal area, as appropriate, must be completed in a timely 
manner after disposal operations cease in accordance with paragraph (1) 
of Criterion 6; however, these actions are not required to be complete 
as part of meeting the deadline for final radon barrier construction.
    Criterion 7--At least one full year prior to any major site 
construction, a preoperational monitoring program must be conducted to 
provide complete baseline data on a milling site and its environs. 
Throughout the construction and operating phases of the mill, an 
operational monitoring program must be conducted to measure or evaluate 
compliance with applicable standards and regulations; to evaluate 
performance of control systems and procedures; to evaluate environmental 
impacts of operation; and to detect potential long-term effects.
    7A--The licensee shall establish a detection monitoring program 
needed for the Commission to set the site-specific groundwater 
protection standards in paragraph 5B(1) of this appendix. For all 
monitoring under this paragraph the licensee or applicant will propose 
for Commission approval as license conditions which constituents are to 
be monitored on a site specific basis. A detection monitoring program 
has two purposes. The initial purpose of the program is to detect 
leakage of hazardous constituents from the disposal area so that the 
need to set groundwater protection standards is monitored. If leakage is 
detected, the second purpose of the program is to generate data and 
information needed for the Commission to establish the standards under 
Criterion 5B. The data and information must provide a sufficient basis 
to identify those hazardous constituents which require concentration 
limit standards and to enable the Commission to set the limits for those 
constituents and the compliance period. They may also need to provide 
the basis for adjustments to the point of compliance. For licenses in 
effect September 30, 1983, the detection monitoring programs must have 
been in place by October 1, 1984. For licenses issued after September 
30, 1983, the detection monitoring programs must be in place when 
specified by the Commission in orders or license conditions. Once 
groundwater protection standards have been established pursuant to 
paragraph 5B(1), the licensee shall establish and implement a compliance 
monitoring program. The purpose of the compliance monitoring program is 
to determine that the hazardous constituent concentrations in 
groundwater continue to comply with the standards set by the Commission. 
In conjunction with a corrective action program, the licensee shall 
establish and implement a corrective action monitoring program. The 
purpose of the corrective action monitoring program is to demonstrate 
the effectiveness of the corrective actions. Any monitoring program 
required by this paragraph may be based on existing monitoring programs 
to the extent the existing programs can meet the stated objective for 
the program.
    Criterion 8--Milling operations must be conducted so that all 
airborne effluent releases are reduced to levels as low as is reasonably 
achievable. The primary means of accomplishing this must be by means of 
emission controls. Institutional controls, such as extending the site 
boundary and exclusion area, may be employed to ensure that offsite 
exposure limits are met, but only after all practicable measures have 
been taken to control emissions at the source. Notwithstanding the 
existence of individual dose standards, strict control of emissions is 
necessary to assure that population exposures are reduced to the maximum 
extent reasonably achievable and to avoid site contamination. The 
greatest potential sources of offsite radiation exposure (aside from 
radon exposure) are dusting from dry surfaces of the tailings disposal 
area not covered by tailings solution and emissions from yellowcake 
drying and packaging operations. During operations and prior to closure, 
radiation doses from radon emissions from surface impoundments of 
uranium or thorium byproduct materials must be kept as low as is 
reasonably achievable.
    Checks must be made and logged hourly of all parameters (e.g., 
differential pressures and scrubber water flow rates) that determine the 
efficiency of yellowcake stack emission control equipment operation. The 
licensee shall retain each log as a record for three years after the 
last entry in the log is made. It must be determined whether or not 
conditions are within a range prescribed to ensure that the equipment is 
operating consistently near peak efficiency; corrective action must be 
taken when performance is outside of prescribed ranges. Effluent control 
devices must be operative at all times during drying and packaging 
operations and whenever air is exhausting from the yellowcake stack. 
Drying and packaging operations must terminate when controls are 
inoperative. When checks indicate the equipment is not operating within 
the range prescribed for peak efficiency, actions must be taken to 
restore parameters to the prescribed range. When this cannot be done 
without shutdown and repairs, drying and packaging operations must cease 
as soon as practicable. Operations may not be restarted after cessation 
due to off-normal performance until needed corrective actions have been 
identified and implemented. All these cessations, corrective actions, 
and restarts must be reported to the appropriate NRC regional office as 
indicated in Criterion 8A, in writing, within ten days of the subsequent 
restart.
    To control dusting from tailings, that portion not covered by 
standing liquids must be wetted or chemically stabilized to prevent or

[[Page 844]]

minimize blowing and dusting to the maximum extent reasonably 
achievable. This requirement may be relaxed if tailings are effectively 
sheltered from wind, such as may be the case where they are disposed of 
below grade and the tailings surface is not exposed to wind. 
Consideration must be given in planning tailings disposal programs to 
methods which would allow phased covering and reclamation of tailings 
impoundments because this will help in controlling particulate and radon 
emissions during operation. To control dusting from diffuse sources, 
such as tailings and ore pads where automatic controls do not apply, 
operators shall develop written operating procedures specifying the 
methods of control which will be utilized.
    Milling operations producing or involving thorium byproduct material 
must be conducted in such a manner as to provide reasonable assurance 
that the annual dose equivalent does not exceed 25 millirems to the 
whole body, 75 millirems to the thyroid, and 25 millirems to any other 
organ of any member of the public as a result of exposures to the 
planned discharge of radioactive materials, radon-220 and its daughters 
excepted, to the general environment.
    Uranium and thorium byproduct materials must be managed so as to 
conform to the applicable provisions of title 40 of the Code of Federal 
Regulations, part 440, ``Ore Mining and Dressing Point Source Category: 
Effluent Limitations Guidelines and New Source Performance Standards, 
subpart C, Uranium, Radium, and Vanadium Ores Subcategory,'' as codified 
on January 1, 1983.
    Criterion 8A--Daily inspections of tailings or waste retention 
systems must be conducted by a qualified engineer or scientist and 
documented. The licensee shall retain the documentation for each daily 
inspection as a record for three years after the documentation is made. 
The appropriate NRC regional office as indicated in appendix D to 10 CFR 
part 20 of this chapter, or the Director, Office of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001, must be immediately notified of any failure in a tailings 
or waste retention system that results in a release of tailings or waste 
into unrestricted areas, or of any unusual conditions (conditions not 
contemplated in the design of the retention system) that if not 
corrected could indicate the potential or lead to failure of the system 
and result in a release of tailings or waste into unrestricted areas.

                         II. Financial Criteria

    Criterion 9--(a) Financial surety arrangements must be established 
by each mill operator before the commencement of operations to assure 
that sufficient funds will be available to carry out the decontamination 
and decommissioning of the mill and site and for the reclamation of any 
tailings or waste disposal areas. The amount of funds to be ensured by 
such surety arrangements must be based on Commission-approved cost 
estimates in a Commission-approved plan, or a proposed revision to the 
plan submitted to the Commission for approval, if the proposed revision 
contains a higher cost estimate, for:
    (1) Decontamination and decommissioning of mill buildings and the 
milling site to levels which allow unrestricted use of these areas upon 
decommissioning, and
    (2) The reclamation of tailings and/or waste areas in accordance 
with technical criteria delineated in Section I of this appendix.
    (b) Each cost estimate must contain--
    (1) A detailed cost estimate for decontamination, decommissioning, 
and reclamation, in an amount reflecting:
    (i) The cost of an independent contractor to perform the 
decontamination, decommissioning and reclamation activities; and
    (ii) An adequate contingency factor;
    (2) An estimate of the amount of radioactive contamination in onsite 
subsurface material;
    (3) Identification of and justification for using the key 
assumptions contained in the DCE; and
    (4) A description of the method of assuring funds for 
decontamination, decommissioning, and reclamation.
    (c) The licensee shall submit this plan in conjunction with an 
environmental report that addresses the expected environmental impacts 
of the milling operation, decommissioning and tailings reclamation, and 
evaluates alternatives for mitigating these impacts. The plan must 
include a signed original of the financial instrument obtained to 
satisfy the surety arrangement requirements of this criterion (unless a 
previously submitted and approved financial instrument continues to 
cover the cost estimate for decommissioning). The surety arrangement 
must also cover the cost estimate and the payment of the charge for 
long-term surveillance and control required by Criterion 10 of this 
section.
    (d) To avoid unnecessary duplication and expense, the Commission may 
accept financial sureties that have been consolidated with financial or 
surety arrangements established to meet requirements of other Federal or 
state agencies and/or local governing bodies for decommissioning, 
decontamination, reclamation, and long-term site surveillance and 
control, provided such arrangements are considered adequate to satisfy 
these requirements and that the portion of the surety which covers the 
decommissioning and reclamation of the mill, mill tailings site and 
associated areas, and the long-term funding charge is clearly identified 
and committed for use in accomplishing these activities.

[[Page 845]]

    (e) The licensee's surety mechanism will be reviewed annually by the 
Commission to assure, that sufficient funds would be available for 
completion of the reclamation plan if the work had to be performed by an 
independent contractor.
    (f) The amount of surety liability should be adjusted to recognize 
any increases or decreases resulting from:
    (1) Inflation;
    (2) Changes in engineering plans;
    (3) Activities performed;
    (4) Spills, leakage or migration of radioactive material producing 
additional contamination in onsite subsurface material that must be 
remediated to meet applicable remediation criteria;
    (5) Waste inventory increasing above the amount previously 
estimated;
    (6) Waste disposal costs increasing above the amount previously 
estimated;
    (7) Facility modifications;
    (8) Changes in authorized possession limits;
    (9) Actual remediation costs that exceed the previous cost estimate;
    (10) Onsite disposal; and
    (11) Any other conditions affecting costs.
    (g) Regardless of whether reclamation is phased through the life of 
the operation or takes place at the end of operations, an appropriate 
portion of surety liability must be retained until final compliance with 
the reclamation plan is determined.
    (h) The appropriate portion of surety liability retained until final 
compliance with the reclamation plan is determined will be at least 
sufficient at all times to cover the costs of decommissioning and 
reclamation of the areas that are expected to be disturbed before the 
next license renewal. The term of the surety mechanism must be open 
ended, unless it can be demonstrated that another arrangement would 
provide an equivalent level of assurance. This assurance would be 
provided with a surety instrument which is written for a specified time 
(e.g., 5 years) and which must be automatically renewed unless the 
surety notifies the beneficiary (the Commission or the State regulatory 
agency) and the principal (the licensee) with reasonable time (e.g., 90 
days) before the renewal date of their intention not to renew. In such a 
situation the surety requirement still exists and the licensee would be 
required to submit an acceptable replacement surety within a brief time 
to allow at least 60 days for the regulatory agency to collect.
    (i) Proof of forfeiture must not be necessary to collect the surety. 
In the event that the licensee can not provide an acceptable replacement 
surety within the required time, the surety shall be automatically 
collected before its expiration. The surety instrument must provide for 
collection of the full face amount immediately on demand without 
reduction for any reason, except for trustee fees and expenses provided 
for in a trust agreement, and that the surety will not refuse to make 
full payment. The conditions described previously would have to be 
clearly stated on any surety instrument which is not open-ended, and 
must be agreed to by all parties. Financial surety arrangements 
generally acceptable to the Commission are:
    (1) Trust funds;
    (2) Surety bonds;
    (3) Irrevocable letters of credit; and
    (4) Combinations of the financial surety arrangements or other types 
of arrangements as may be approved by the Commission. If a trust is not 
used, then a standby trust must be set up to receive funds in the event 
the Commission or State regulatory agency exercises its right to collect 
the surety. The surety arrangement and the surety or trustee, as 
applicable, must be acceptable to the Commission. Self insurance, or any 
arrangement which essentially constitutes self insurance (e.g., a 
contract with a State or Federal agency), will not satisfy the surety 
requirement because this provides no additional assurance other than 
that which already exists through license requirements.
    Criterion 10--A minimum charge of $250,000 (1978 dollars) to cover 
the costs of long-term surveillance must be paid by each mill operator 
to the general treasury of the United States or to an appropriate State 
agency prior to the termination of a uranium or thorium mill license.
    If site surveillance or control requirements at a particular site 
are determined, on the basis of a site-specific evaluation, to be 
significantly greater than those specified in Criterion 12 (e.g., if 
fencing is determined to be necessary), variance in funding requirements 
may be specified by the Commission. In any case, the total charge to 
cover the costs of long-term surveillance must be such that, with an 
assumed 1 percent annual real interest rate, the collected funds will 
yield interest in an amount sufficient to cover the annual costs of site 
surveillance. The total charge will be adjusted annually prior to actual 
payment to recognize inflation. The inflation rate to be used is that 
indicated by the change in the Consumer Price Index published by the 
U.S. Department of Labor, Bureau of Labor Statistics.

               III. Site and Byproduct Material Ownership

    Criterion 11--A. These criteria relating to ownership of tailings 
and their disposal sites become effective on November 8, 1981, and apply 
to all licenses terminated, issued, or renewed after that date.
    B. Any uranium or thorium milling license or tailings license must 
contain such terms and conditions as the Commission determines necessary 
to assure that prior to termination of the license, the licensee will 
comply with ownership requirements of this criterion for sites used for 
tailings disposal.

[[Page 846]]

    C. Title to the byproduct material licensed under this part and 
land, including any interests therein (other than land owned by the 
United States or by a State) which is used for the disposal of any such 
byproduct material, or is essential to ensure the long term stability of 
such disposal site, must be transferred to the United States or the 
State in which such land is located, at the option of such State. In 
view of the fact that physical isolation must be the primary means of 
long-term control, and Government land ownership is a desirable 
supplementary measure, ownership of certain severable subsurface 
interests (for example, mineral rights) may be determined to be 
unnecessary to protect the public health and safety and the environment. 
In any case, however, the applicant/operator must demonstrate a serious 
effort to obtain such subsurface rights, and must, in the event that 
certain rights cannot be obtained, provide notification in local public 
land records of the fact that the land is being used for the disposal of 
radioactive material and is subject to either an NRC general or specific 
license prohibiting the disruption and disturbance of the tailings. In 
some rare cases, such as may occur with deep burial where no ongoing 
site surveillance will be required, surface land ownership transfer 
requirements may be waived. For licenses issued before November 8, 1981, 
the Commission may take into account the status of the ownership of such 
land, and interests therein, and the ability of a licensee to transfer 
title and custody thereof to the United States or a State.
    D. If the Commission subsequent to title transfer determines that 
use of the surface or subsurface estates, or both, of the land 
transferred to the United States or to a State will not endanger the 
public health, safety, welfare, or environment, the Commission may 
permit the use of the surface or subsurface estates, or both, of such 
land in a manner consistent with the provisions provided in these 
criteria. If the Commission permits such use of such land, it will 
provide the person who transferred such land with the right of first 
refusal with respect to such use of such land.
    E. Material and land transferred to the United States or a State in 
accordance with this Criterion must be transferred without cost to the 
United States or a State other than administrative and legal costs 
incurred in carrying out such transfer.
    F. The provisions of this part respecting transfer of title and 
custody to land and tailings and wastes do not apply in the case of 
lands held in trust by the United States for any Indian Tribe or lands 
owned by such Indian Tribe subject to a restriction against alienation 
imposed by the United States. In the case of such lands which are used 
for the disposal of byproduct material, as defined in this part, the 
licensee shall enter into arrangements with the Commission as may be 
appropriate to assure the long-term surveillance of such lands by the 
United States.

                     IV. Long-Term Site Surveillance

    Criterion 12--The final disposition of tailings, residual 
radioactive material, or wastes at milling sites should be such that 
ongoing active maintenance is not necessary to preserve isolation. As a 
minimum, annual site inspections must be conducted by the government 
agency responsible for long-term care of the disposal site to confirm 
its integrity and to determine the need, if any, for maintenance and/or 
monitoring. Results of the inspections for all the sites under the 
licensee's jurisdiction will be reported to the Commission annually 
within 90 days of the last site inspection in that calendar year. Any 
site where unusual damage or disruption is discovered during the 
inspection, however, will require a preliminary site inspection report 
to be submitted within 60 days. On the basis of a site specific 
evaluation, the Commission may require more frequent site inspections if 
necessary due to the features of a particular disposal site. In this 
case, a preliminary inspection report is required to be submitted within 
60 days following each inspection.

                        V. Hazardous Constituents

    Criterion 13--Secondary groundwater protection standards required by 
Criterion 5 of this appendix are concentration limits for individual 
hazardous constituents. The following list of constituents identifies 
the constituents for which standards must be set and complied with if 
the specific constituent is reasonably expected to be in or derived from 
the byproduct material and has been detected in groundwater. For 
purposes of this appendix, the property of gross alpha activity will be 
treated as if it is a hazardous constituent. Thus, when setting 
standards under paragraph 5B(5) of Criterion 5, the Commission will also 
set a limit for gross alpha activity. The Commission does not consider 
the following list imposed by 40 CFR part 192 to be exhaustive and may 
determine other constituents to be hazardous on a case-by-case basis, 
independent of those specified by the U.S. Environmental Protection 
Agency in part 192.

                         Hazardous Constituents

Acetonitrile (Ethanenitrile)
Acetophenone (Ethanone, 1-phenyl)
3-(alpha-Acetonylbenzyl)-4-hydroxycoumarin and salts (Warfarin)
2-Acetylaminofluorene (Acetamide, N-(9H-fluoren-2-yl)-)
Acetyl chloride (Ethanoyl chloride)
1-Acetyl-2-thiourea (Acetamide, N-(aminothioxomethyl)-)
Acrolein (2-Propenal)

[[Page 847]]

Acrylamide (2-Propenamide)
Acrylonitrile (2-Propenenitrile)
Aflatoxins
Aldrin (1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a,8b-hexahydro-endo, exo-
1,4:5,8-Dimethanonaphthalene)
Allyl alcohol (2-Propen-1-ol)
Aluminum phosphide
4-Aminobiphenyl ([1,1'-Biphenyl]-4-amine)
6-Amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methyl-
carbamate azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, (ester) 
(Mitomycin C) (Azirino[2'3':3,4]pyrrolo(1,2-a)indole-4,7-dione, 6-amino-
8-[((amino-cabonyl)oxy)methyl]-1,1a,2,8,8a,8b-hexa-hydro-8a methoxy-5-
methy-)
5-(Aminomethyl)-3-isoxazolol (3(2H)-Isoxazolone, 5-(aminomethyl)-) 4-
Aminopyridine (4-Pyridinamine)
Amitrole (1H-1,2,4-Triazol-3-amine)
Aniline (Benzenamine)
Antimony and compounds, N.O.S. \3\
---------------------------------------------------------------------------

    \3\ The abbreviation N.O.S. (not otherwise specified) signifies 
those members of the general class not specifically listed by name in 
this list.
---------------------------------------------------------------------------

Aramite (Sulfurous acid, 2-chloroethyl-, 2-[4-(1,1-dimethylethyl) 
phenoxy]-1-methylethyl ester)
Arsenic and compounds, N.O.S. \3\
Arsenic acid (Orthoarsenic acid)
Arsenic pentoxide (Arsenic (V) oxide)
Arsenic trioxide (Arsenic (III) oxide)
Auramine (Benzenamine, 4,4'-carbonimidoylbis[N,N-Dimethyl-, 
monohydrochloride)
Azaserine (L-Serine, diazoacetate (ester))
Barium and compounds, N.O.S. \3\
Barium cyanide
Benz[c]acridine (3,4-Benzacridine)
Benz[a]anthracene (1,2-Benzanthracene)
Benzene (Cyclohexatriene)
Benzenearsonic acid (Arsonic acid, phenyl-)
Benzene, dichloromethyl- (Benzal chloride)
Benzenethiol (Thiophenol)
Benzidine ([1,1'-Biphenyl]-4,4' diamine)
Benzo[b]fluoranthene (2,3-Benzofluoranthene)
Benzo[j]fluoranthene (7,8-Benzofluoranthene)
Benzo[a]pyrene (3,4-Benzopyrene)
p-Benzoquinone (1,4-Cyclohexadienedione)
Benzotrichloride (Benzene, trichloromethyl)
Benzyl chloride (Benzene, (chloromethyl)-)
Beryllium and compounds, N.O.S. \3\
Bis(2-chloroethoxy)methane (Ethane, 1,1'-[methylenebis(oxy)]bis[2-
chloro-])
Bis(2-chloroethyl) ether (Ethane, 1,1'-oxybis[2-chloro-])
N,N-Bis(2-chloroethyl)-2-naphthylamine (Chlornaphazine)
Bis(2-chloroisopropyl) ether (Propane, 2,2'-oxybis[2-chloro-])
Bis(chloromethyl) ether (Methane, oxybis[chloro-])
Bis(2-ethylhexyl) phthalate (1,2-Benzenedicarboxylic acid, bis(2-
ethylhexyl) ester)
Bromoacetone (2-Propanone, 1-bromo-)
Bromomethane (Methyl bromide)
4-Bromophenyl phenyl ether (Benzene, 1-bromo-4-phenoxy-)
Brucine (Strychnidin-10-one, 2,3-dimethoxy-)
2-Butanone peroxide (Methyl ethyl ketone, peroxide)
Butyl benzyl phthalate (1,2-Benzenedicarboxylic acid, butyl phenylmethyl 
ester)
2-sec-Butyl-4,6-dinitrophenol (DNBP) (Phenol, 2,4-dinitro-6-(1-
methylpropyl)-)
Cadmium and compounds, N.O.S. \3\
Calcium chromate (Chromic acid, calcium salt)
Calcium cyanide
Carbon disulfide (Carbon bisulfide)
Carbon oxyfluoride (Carbonyl fluoride)
Chloral (Acetaldehyde, trichloro-)
Chlorambucil (Butanoic acid, 4-[bis(2-chloroethyl)amino]benzene-)
Chlordane (alpha and gamma isomers) (4,7-Methanoindan, 1,2,4,5,6,7,8,8-
octachloro-3,4,7,7a-tetrahydro-) (alpha and gamma isomers)
Chlorinated benzenes, N.O.S. \3\
Chlorinated ethane, N.O.S. \3\
Chlorinated fluorocarbons, N.O.S. \3\
Chlorinated naphthalene, N.O.S. \3\
Chlorinated phenol, N.O.S. \3\
Chloroacetaldehyde (Acetaldehyde, chloro-)
Chloroalkyl ethers, N.O.S. \3\
p-Chloroaniline (Benzenamine, 4-chloro-)
Chlorobenzene (Benzene, chloro-)
Chlorobenzilate (Benzeneacetic acid, 4-chloro-alpha-(4-chlorophenyl)-
alpha-hydroxy-,ethyl ester)
p-Chloro-m-cresol (Phenol, 4-chloro-3-methyl)
1-Chloro-2,3-epoxypropane (Oxirane, 2-(chloromethyl)-)
2-Chloroethyl vinyl ether (Ethene, (2-chloroethoxy)-)
Chloroform (Methane, trichloro-)
Chloromethane (Methyl chloride)
Chloromethyl methyl ether (Methane, chloromethoxy-)
2-Chloronaphthalene (Naphthalene, betachloro-)
2-Chlorophenol (Phenol, o-chloro-)
1-(o-Chlorophenyl)thiourea (Thiourea, (2-chlorophenyl)-)
3-Chloropropionitrile (Propanenitrile, 3-chloro-)
Chromium and compounds, N.O.S. \3\
Chrysene (1,2-Benzphenanthrene)
Citrus red No. 2 (2-Naphthol, 1-[(2,5-dimethoxyphenyl)azo]-)
Coal tars
Copper cyanide
Creosote (Creosote, wood)
Cresols (Cresylic acid) (Phenol, methyl-)
Crotonaldehyde (2-Butenal)

[[Page 848]]

Cyanides (soluble salts and complexes), N.O.S. \3\
Cyanogen (Ethanedinitrile)
Cyanogen bromide (Bromine cyanide)
Cyanogen chloride (Chlorine cyanide)
Cycasin (beta-D-Glucopyranoside, (methyl-ONN-azoxy)methyl-)
2-Cyclohexyl-4,6-dinitrophenol (Phenol, 2-cyclohexyl-4,6-dinitro-)
Cyclophosphamide (2H-1,3,2,-Oxazaphosphorine, [bis(2-chloroethyl) 
amino]-tetrahydro-,2-oxide)
Daunomycin (5,12-Naphthacenedione, (8S-cis)-8-acetyl-10-[(3-amino-2,3,6-
trideoxy)-alpha-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-
trihydroxy-1-methoxy-)
DDD (Dichlorodiphenyldichloroethane) (Ethane, 1,1-dichloro-2,2-bis(p-
chlorophenyl)-)
DDE (Ethylene, 1,1-dichloro-2,2-bis(4-chlorophenyl)-)
DDT (Dichlorodiphenyltrichloroethane) (Ethane, 1,1,1-trichloro-2,2-bis 
(p-chlorophenyl)-)
Diallate (S-(2,3-dichloroallyl) diisopropylthiocarbamate)
Dibenz[a,h]acridine (1,2,5,6-Dibenzacridine)
Dibenz[a,j]acridine (1,2,7,8-Dibenzacridine)
Dibenz[a,h]anthracene (1,2,5,6-Dibenzanthracene)
7H-Dibenzo[c,g]carbazole (3,4,5,6-Dibenzcarbazole)
Dibenzo[a,e]pyrene (1,2,4,5-Dibenzpyrene)
Dibenzo[a,h]pyrene (1,2,5,6-Dibenzpyrene)
Dibenzo[a,i]pyrene (1,2,7,8-Dibenzpyrene)
1,2-Dibromo-3-chloropropane (Propane, 1,2-dibromo-3-chloro-)
1,2-Dibromoethane (Ethylene dibromide)
Dibromomethane (Methylene bromide)
Di-n-butyl phthalate (1,2-Benzenedicarboxylic acid, dibutyl ester)
o-Dichlorobenzene (Benzene, 1,2-dichloro-)
m-Dichlorobenzene (Benzene, 1,3-dichloro-)
p-Dichlorobenzene (Benzene, 1,4-dichlor-)
Dichlorobenzene, N.O.S. \3\ (Benzene, dichloro-, N.O.S. \3\)
3,3'-Dichlorobenzidine ([1,1'-Biphenyl]-4,4'-diamine, 3,3'-dichloro-)
1,4-Dichloro-2-butene (2-Butene, 1,4-dichloro-)
Dichlorodifluoromethane (Methane, dichlorodifluoro-)
1,1-Dichloroethane (Ethylidene dichloride)
1,2-Dichloroethane (Ethylene dichloride)
trans-1,2-Dichloroethene (1,2-Dichloroethylene)
Dichloroethylene, N.O.S. \3\ (Ethene, dichloro-, N.O.S. \3\)
1,1-Dichloroethylene (Ethene, 1,1-dichloro-)
Dichloromethane (Methylene chloride)
2,4-Dichlorophenol (Phenol, 2,4-dichloro-)
2,6-Dichlorophenol (Phenol, 2,6-dichloro-)
2,4-Dichlorophenoxyacetic acid (2,4-D), salts and esters (Acetic acid, 
2,4-dichlorophenoxy-, salts and esters)
Dichlorophenylarsine (Phenyl dichloroarsine)
Dichloropropane, N.O.S. \3\ (Propane, dichloro-, N.O.S. \3\)
1,2-Dichloropropane (Propylene dichloride)
Dichloropropanol, N.O.S. \3\ (Propanol, dichloro-, N.O.S. \3\)
Dichloropropene, N.O.S. \3\ (Propene, dichloro-, N.O.S. \3\)
1,3-Dichloropropene (1-Propene, 1,3-dichloro-)
Dieldin (1,2,3,4,10.10-hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octa-
hydro-endo, exo- 1,4:5,8-Dimethanonaphthalene)
1,2:3,4-Diepoxybutane (2,2'-Bioxirane)
Diethylarsine (Arsine, diethyl-)
N,N-Diethylhydrazine (Hydrazine, 1,2-diethyl)
O,O-Diethyl S-methyl ester of phosphorodithioic acid (Phosphorodithioic 
acid, O,O-diethyl S-methyl ester)
O,O-Diethylphosphoric acid, O-p-nitrophenyl ester (Phosphoric acid, 
diethyl p-nitrophenyl ester)
Diethyl phthalate (1,2-Benzenedicarboxylic acid, diethyl ester)
O,O-Diethyl O-2-pyrazinyl phosphorothioate (Phosphorothioic acid, O,O-
diethyl O-pyrazinyl ester)
Diethylstilbesterol (4,4'-Stilbenediol,alpha,alpha-diethyl, 
bis(dihydrogen phosphate, (E)-)
Dihydrosafrole (Benzene, 1,2-methylenedioxy-4-propyl-)
3,4-Dihydroxy-alpha-(methylamino)methyl benzyl alcohol (1,2-Benzenediol, 
4-[1-hydroxy-2-(methylamino)ethyl]-)
Dilsopropylfluorophosphate (DFP) (Phosphorofluoridic acid, bis(1-
methylethyl) ester)
Dimethoate (Phosphorodithioic acid, O,O-dimethyl S-[2-(methylamino)-2-
oxoethyl] ester)
3,3'-Dimethoxybenzidine ([1,1'-Biphenyl]- 4,4'-diamine, 3-3'-dimethoxy-)
p-Dimethylaminoazobenzene (Benzenamine, N,N-dimethyl-4-(phenylazo)-)
7,12-Dimethylbenz[a]anthracene (1,2-Benzanthracene, 7,12-dimethyl-)
3,3'-Dimethylbenzidine ([1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethyl-)
Dimethylcarbamoyl chloride (Carbamoyl chloride, dimethyl-)
1,1-Dimethylhydrazine (Hydrazine, 1,1-dimethyl-)
1,2-Dimethylhydrazine (Hydrazine, 1,2-dimethyl-)
3,3-Dimethyl-1-(methylthio)-2-butanone, O-[(methylamino) carbonyl] oxime 
(Thiofanox)
alpha,alpha-Dimethylphenethylamine (Ethanamine, 1,1-dimethyl-2-phenyl-)
2,4-Dimethylphenol (Phenol, 2,4-dimethyl-)
Dimethyl phthalate (1,2-Benzenedicarboxylic acid, dimethyl ester)
Dimethyl sulfate (Sulfuric acid, dimethyl ester)
Dinitrobenzene, N.O.S. \3\ (Benzene, dinitro-, N.O.S. \3\)

[[Page 849]]

4,6-Dinitro-o-cresol and salts (Phenol, 2,4-dinitro-6-methyl-, and 
salts)
2,4-Dinitrophenol (Phenol, 2,4-dinitro-)
2,4-Dinitrotoluene (Benzene, 1-methyl-2,4-dinitro-)
2,6-Dinitrotoluene (Benzene, 1-methyl-2,6-dinitro-)
Di-n-octyl phthalate (1,2-Benzenedicarboxylic acid, dioctyl ester)
1,4-Dioxane (1,4-Diethylene oxide)
Diphenylamine (Benzenamine, N-phenyl-)
1,2-Diphenylhydrazine (Hydrazine, 1,2-diphenyl-)
Di-n-propylnitrosamine (N-Nitroso-di-n-propylamine)
Disulfoton (O,O-diethyl S-[2-(ethylthio)ethyl] phosphorodithioate)
2,4-Dithiobiuret (Thioimidodicarbonic diamide)
Endosulfan (5-Norbornene, 2,3-dimethanol, 1,4,5,6,7,7-hexachloro-, 
cyclic sulfite)
Endrin and metabolites (1,2,3,4,10,10-hexachloro-6,7-epoxy-
1,4,4a,5,6,7,8,8a-octahydro-endo,endo-1,4:5,8-dimethanonaphthalene, and 
metabolites)
Ethyl carbamate (Urethan) (Carbamic acid, ethyl ester)
Ethyl cyanide (propanenitrile)
Ethylenebisdithiocarbamic acid, salts and esters (1,2-Ethanediyl-
biscarbamodithioic acid, salts and esters)
Ethyleneimine (Aziridine)
Ethylene oxide (Oxirane)
Ethylenethiourea (2-Imidazolidinethione)
Ethyl methacrylate (2-Propenoic acid, 2-methyl-, ethyl ester)
Ethyl methanesulfonate (Methanesulfonic acid, ethyl ester)
Fluoranthene (Benzo[j,k]fluorene)
Fluorine
2-Fluoroacetamide (Acetamide, 2-fluoro-)
Fluoroacetic acid, sodium salt (Acetic acid, fluoro-, sodium salt)
Formaldehyde (Methylene oxide)
Formic acid (Methanoic acid)
Glycidylaldehyde (1-Propanol-2,3-epoxy)
Halomethane, N.O.S. \3\
Heptachlor (4,7-Methano-1H-indene, 1,4,5,6,7,8,8-heptachloro-3a,4,7,7a-
tetrahydro-)
Heptachlor epoxide (alpha, beta, and gamma isomers) (4,7-Methano-1H-
indene, 1,4,5,6,7,8,8-heptachloro-2,3-epoxy-3a,4,7,7-tetrahydro-, alpha, 
beta, and gamma isomers)
Hexachlorobenzene (Benzene, hexachloro-)
Hexachlorobutadiene (1,3-Butadiene, 1,1,2,3,4,4-hexachloro-)
Hexachlorocyclohexane (all isomers) (Lindane and isomers)
Hexachlorocyclopentadiene (1,3-Cyclopentadiene, 1,2,3,4,5,5-hexachloro-)
Hexachloroethane (Ethane, 1,1,1,2,2,2-hexachloro-)
1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-endo,endo-
dimethanonaphthalene (Hexachlorohexa-hydro-endo,endo-
dimethanonaphthalene)
Hexachlorophene (2,2'-Methylenebis(3,4,6-trichlorophenol)
Hexachloropropene (1-Propene, 1,1,2,3,3,3-hexachloro-)
Hexaethyl tetraphosphate (Tetraphosphoric acid, hexaethyl ester)
Hydrazine (Diamine)
Hydrocyanic acid (Hydrogen cyanide)
Hydrofluoric acid (Hydrogen fluoride)
Hydrogen sulfide (Sulfur hydride)
Hydroxydimethylarsine oxide (Cacodylic acid)
Indeno (1,2,3-cd)pyrene (1,10-(1,2-phenylene)pyrene)
Iodomethane (Methyl iodide)
Iron dextran (Ferric dextran)
Isocyanic acid, methyl ester (Methyl isocyanate)
Isobutyl alcohol (1-Propanol, 2-methyl-)
Isosafrole (Benzene, 1,2-methylenedioxy-4-allyl-)
Kepone (Decachlorooctahydro-1,3,4-Methano-2H-cyclobuta[cd]pentalen-2-
one)
Lasiocarpine (2-Butenoic acid, 2-methyl-, 7-[(2,3-dihydroxy-2-(1-
methoxyethyl)-3-methyl-1-oxobutoxy)methyl]-2,3,5,7a- tetrahydro-1H-
pyrrolizin-1-yl ester)
Lead and compounds, N.O.S. \3\
Lead acetate (Acetic acid, lead salt)
Lead phosphate (Phosphoric acid, lead salt)
Lead subacetate (Lead, bis(acetato-0)tetrahydroxytri-)
Maleic anhydride (2,5-Furandione)
Maleic hydrazide (1,2-Dihydro-3,6-pyridazinedione)
Malononitrile (Propanedinitrile)
Melphalan (Alanine, 3-[p-bis(2-chloroethyl)amino]phenyl-,L-)
Mercury fulminate (Fulminic acid, mercury salt)
Mercury and compounds, N.O.S. \3\
Methacrylonitrile (2-Propenenitrile, 2-methyl-)
Methanethiol (Thiomethanol)
Methapyrilene (Pyridine. 2-[(2-dimethylamino)ethyl]-2-thenylamino-)
Metholmyl (Acetimidic acid, N-[(methylcarbamoyl)oxy]thio-, methyl ester)
Methoxychlor (Ethane, 1,1,1-trichloro-2,2'-bis(p-methoxyphenyl)-)
2-Methylaziridine (1,2-Propylenimine)
3-Methylcholanthrene (Benz[j]aceanthrylene, 1,2-dihydro-3-methyl-)
Methyl chlorocarbonate (Carbonochloridic acid, methyl ester)
4,4'-Methylenebis(2-chloroaniline) (Benzenamine, 4,4'-methylenebis- (2-
chloro-)
Methyl ethyl ketone (MEK) (2-Butanone)
Methyl hydrazine (Hydrazine, methyl-)
2-Methyllactonitrile (Propanenitrile, 2-hydroxy-2-methyl-)
Methyl methacrylate (2-Propenoic acid, 2-methyl-, methyl ester)

[[Page 850]]

Methyl methanesulfonate (Methanesulfonic acid, methyl ester)
2-Methyl-2-(methylthio)propionaldehyde-o-(methylcarbonyl) oxime 
(Propanal, 2-methyl-2-(methylthio)-, 0-[(methylamino)carbonyl]oxime)
N-Methyl-N'-nitro-N-nitrosoguanidine (Guanidine, N-nitroso-N-methyl-N'- 
nitro-)
Methyl parathion (0,0-dimethyl 0-(4-nitrophenyl) phosphorothioate)
Methylthiouracil (4-IH-Pyrimidinone, 2,3-dihydro-6-methyl-2-thioxo-)
Molybdenum and compounds, N.O.S. \3\
Mustard gas (Sulfide, bis(2-chloroethyl)-)
Naphthalene
1,4-Naphthoquinone (1,4-Naphthalenedione)
1-Naphthylamine (alpha-Naphthylamine)
2-Naphthylamine (beta-Naphthylamine)
1-Naphthyl-2-thiourea (Thiourea, 1-naphthalenyl-)
Nickel and compounds, N.O.S. \3\
Nickel carbonyl (Nickel tetracarbonyl)
Nickel cyanide (Nickel (II) cyanide)
Nicotine and salts (Pyridine, (S)-3-(1-methyl-2-pyrrolidinyl)-, and 
salts)
Nitric oxide (Nitrogen (II) oxide)
p-Nitroaniline (Benzenamine, 4-nitro-)
Nitrobenzine (Benzene, nitro-)
Nitrogen dioxide (Nitrogen (IV) oxide)
Nitrogen mustard and hydrochloride salt (Ethanamine, 2-chloro-, N-(2-
chloroethyl)- N-methyl-, and hydrochloride salt)
Nitrogen mustard N-Oxide and hydrochloride salt (Ethanamine, 2-chloro-, 
N-(2-chloroethyl)-N-methyl-, and hydrochloride salt)
Nitroglycerine (1,2,3-Propanetriol, trinitrate)
4-Nitrophenol (Phenol, 4-nitro-)
4-Nitroquinoline-1-oxide (Quinoline, 4-nitro-1-oxide-)
Nitrosamine, N.O.S. \3\
N-Nitrosodi-n-butylamine (1-Butanamine, N-butyl-N-nitroso-)
N-Nitrosodiethanolamine (Ethanol, 2,2'-(nitrosoimino)bis-)
N-Nitrosodiethylamine (Ethanamine, N-ethyl-N-nitroso-)
N-Nitrosodimethylamine (Dimethylnitrosamine)
N-Nitroso-N-ethylurea (Carbamide, N-ethyl-N-nitroso-)
N-Nitrosomethylethylamine (Ethanamine, N-methyl-N-nitroso-)
N-Nitroso-N-methylurea (Carbamide, N-methyl-N-nitroso-)
N-Nitroso-N-methylurethane (Carbamic acid, methylnitroso-, ethyl ester)
N-Nitrosomethylvinylamine (Ethenamine, N-methyl-N-nitroso-)
N-Nitrosomorpholine (Morpholine, N-nitroso-)
N-Nitrosonornicotine (Nornicotine, N-nitroso-)
N-Nitrosopiperidine (Pyridine, hexahydro-, N-nitroso-)
Nitrosopyrrolidine (Pyrrole, tetrahydro-, N-nitroso-)
N-Nitrososarcosine (Sarcosine, N-nitroso-)
5-Nitro-o-toluidine (Benzenamine, 2-methyl-5-nitro-)
Octamethylpyrophosphoramide (Diphosphoramide, octamethyl-)
Osmium tetroxide (Osmium (VIII) oxide)
7-Oxabicyclo[2.2.1]heptane-2,3-dicarboxylic acid (Endothal)
Paraldehyde (1,3,5-Trioxane, 2,4,6-trimethyl-)
Parathion (Phosphorothioic acid, O,O-diethyl O-(p-nitrophenyl)ester)
Pentachlorobenzene (Benzene, pentachloro-)
Pentachloroethane (Ethane, pentachloro-)
Pentachloronitrobenzene (PCNB) (Benzene, pentachloronitro-)
Pentachlorophenol (Phenol, pentachloro-)
Phenacetin (Acetamide, N-(4-ethoxyphenyl)-)
Phenol (Benzene, hydroxy-)
Phenylenediamine (Benzenediamine)
Phenylmercury acetate (Mercury, acetatophenyl-)
N-Phenylthiourea (Thiourea, phenyl-)
Phosgene (Carbonyl chloride)
Phosphine (Hydrogen phosphide)
Phosphorodithioic acid, O,O-diethyl S-[(ethylthio)methyl] ester 
(Phorate)
Phosphorothioic acid, O,O-dimethyl O-[p-((dimethylamino)sulfonyl)phenyl] 
ester (Famphur)
Phthalic acid esters, N.O.S. \3\ (Benzene, 1,2-dicarboxylic acid, 
esters, N.O.S. \3\)
Phthalic anhydride (1,2-Benzenedicarboxylic acid anhydride)
2-Picoline (Pyridine, 2-methyl-)
Polychlorinated biphenyl, N.O.S. \3\
Potassium cyanide
Potassium silver cyanide (Argentate(1-), dicyano-, potassium)
Pronamide (3,5-Dichloro-N-(1,1-dimethyl-2-propynyl)benzamide)
1,3-Propane sultone (1,2-Oxathiolane, 2,2-dioxide)
n-Propylamine (1-Propanamine)
Propylthiouracil (Undecamethylenediamine, N,N'-bis(2-chlorobenzyl-), 
dihydrochloride)
2-Propyn-1-ol (Propargyl alcohol)
Pyridine
Radium-226 and -228
Reserpine (Yohimban-16-carboxylic acid, 11,17-dimethoxy-18-[3,4,5- 
trimethoxybenzoyl)oxy]-, methyl ester)
Resorcinol (1,3-Benzenediol)
Saccharin and salts (1,2-Benzoisothiazolin-3-one, 1,1-dioxide, and 
salts)
Safrole (Benzene, 1,2-methylenedioxy-4-allyl-)
Selenious acid (Selenium dioxide)
Selenium and compounds, N.O.S. \3\
Selenium sulfide (Sulfur selenide)
Selenourea (Carbamimidoselenoic acid)
Silver and compounds, N.O.S. \3\
Silver cyanide
Sodium cyanide
Streptozotocin (D-Glucopyranose, 2-deoxy-2-(3-methyl-3-nitrosoureido)-)

[[Page 851]]

Strontium sulfide
Strychnine and salts (Strychnidin-10-one, and salts)
1,2,4,5-Tetrachlorobenzene (Benzene, 1,2,4,5-tetrachloro-)
2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) (Dibenzo-p-dioxin, 2,3,7,8-
tetrachloro-)
Tetrachloroethane, N.O.S. \3\ (Ethane, tetrachloro-, N.O.S. \3\)
1,1,1,2-Tetrachlorethane (Ethane, 1,1,1,2-tetrachloro-)
1,1,2,2-Tetrachlorethane (Ethane, 1,1,2,2-tetrachloro-)
Tetrachloroethane (Ethene, 1,1,2,2-tetrachloro-)
Tetrachloromethane (Carbon tetrachloride)
2,3,4,6,-Tetrachlorophenol (Phenol, 2,3,4,6-tetrachloro-)
Tetraethyldithiopyrophosphate (Dithiopyrophosphoric acid, tetraethyl-
ester)
Tetraethyl lead (Plumbane, tetraethyl-)
Tetraethylpyrophosphate (Pyrophosphoric acide, tetraethyl ester)
Tetranitromethane (Methane, tetranitro-)
Thallium and compounds, N.O.S. \3\
Thallic oxide (Thallium (III) oxide)
Thallium (I) acetate (Acetic acid, thallium (I) salt)
Thallium (I) carbonate (Carbonic acid, dithallium (I) salt)
Thallium (I) chloride
Thallium (I) nitrate (Nitric acid, thallium (I) salt)
Thallium selenite
Thallium (I) sulfate (Sulfuric acid, thallium (I) salt)
Thioacetamide (Ethanethioamide)
Thiosemicarbazide (Hydrazinecarbothioamide)
Thiourea (Carbamide thio-)
Thiuram (Bis(dimethylthiocarbamoyl) disulfide)
Thorium and compounds, N.O.S.,\3\ when producing thorium byproduct 
material
Toluene (Benzene, methyl-)
Toluenediamine (Diaminotoluene)
o-Toluidine hydrochloride (Benzenamine, 2-methyl-, hydrochloride)
Tolylene diisocyanate (Benzene, l,3-diisocyanatomethyl-)
Toxaphene (Camphene, octachloro-)
Tribromomethane (Bromoform)
1,2,4-Trichlorobenzene (Benzene, 1,2,4-trichloro-)
1,1,1-Trichloroethane (Methyl chloroform)
1,1,2-Trichloroethane (Ethane, 1,1,2-trichloro-)
Trichloroethene (Trichloroethylene)
Trichloromethanethiol (Methanethiol, trichloro-)
Trichloromonofluoromethane (Methane, trichlorofluoro-)
2,4,5-Trichlorophenol (Phenol, 2,4,5-trichloro-)
2,4,6-Trichlorophenol (Phenol, 2,4,6-trichloro-)
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T) (Acetic acid, 2,4,5-
trichlorophenoxy-)
2,4,5-Trichlorophenoxypropionic acid (2,4,5-TP) (Silvex) (Propionoic 
acid, 2-(2,4,5-trichlorophenoxy)-)
Trichloropropane, N.O.S. \3\ (Propane, trichloro-, N.O.S. \3\)
1,2,3-Trichloropropane (Propane, 1,2,3-trichloro-)
O,O,O-Triethyl phosphorothioate (Phosphorothioic acid, O,O,O-triethyl 
ester)
sym-Trinitrobenzene (Benzene, 1,3,5-trinitro-)
Tris(1-azridinyl) phosphine sulfide (Phosphine sulfide, tris(1-
aziridinyl-)
Tris(2,3-dibromopropyl) phosphate (1-Propanol, 2,3-dibromo-, phosphate)
Trypan blue (2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-dimethyl (1,1'-
biphenyl)- 4,4'-diyl)bis(azo)]bis(5-amino-4-hydroxy-, tetrasodium salt)
Uracil mustard (Uracil 5-[bis(2-chloroethyl)amino]-)
Uranium and compounds, N.O.S. \3\
Vanadic acid, ammonium salt (ammonium vanadate)
Vanadium pentoxide (Vanadium (V) oxide)
Vinyl chloride (Ethene, chloro-)
Zinc cyanide
Zinc phosphide

[50 FR 41862, Oct. 16, 1985, as amended at 52 FR 31611, Aug. 21, 1987; 
52 FR 43562, Nov. 13, 1987; 53 FR 19248, May 27, 1988; 55 FR 45600, Oct. 
30, 1990; 56 FR 23473, May 21, 1991; 58 FR 67661, Dec. 22, 1993; 59 FR 
28229, June 1, 1994; 64 FR 17510, Apr. 12, 1999; 77 FR 35570, June 17, 
2012; 81 FR 86909, Dec. 2, 2016]



PART 50_DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES
--Table of Contents



                           General Provisions

Sec.
50.1 Basis, purpose, and procedures applicable.
50.2 Definitions.
50.3 Interpretations.
50.4 Written communications.
50.5 Deliberate misconduct.
50.7 Employee protection.
50.8 Information collection requirements: OMB approval.
50.9 Completeness and accuracy of information.

                   Requirement of License, Exceptions

50.10 License required; limited work authorization.
50.11 Exceptions and exemptions from licensing requirements.
50.12 Specific exemptions.

[[Page 852]]

50.13 Attacks and destructive acts by enemies of the United States; and 
          defense activities.

               Classification and Description of Licenses

50.20 Two classes of licenses.
50.21 Class 104 licenses; for medical therapy and research and 
          development facilities.
50.22 Class 103 licenses; for commercial and industrial facilities.
50.23 Construction permits.

  Applications for Licenses, Certifications, and Regulatory Approvals; 
           Form; Contents; Ineligibility of Certain Applicants

50.30 Filing of application; oath or affirmation.
50.31 Combining applications.
50.32 Elimination of repetition.
50.33 Contents of applications; general information.
50.34 Contents of applications; technical information.
50.34a Design objectives for equipment to control releases of 
          radioactive material in effluents--nuclear power reactors.
50.35 Issuance of construction permits.
50.36 Technical specifications.
50.36a Technical specifications on effluents from nuclear power 
          reactors.
50.36b Environmental conditions.
50.37 Agreement limiting access to Classified Information.
50.38 Ineligibility of certain applicants.
50.39 Public inspection of applications.

    Standards for Licenses, Certifications, and Regulatory Approvals

50.40 Common standards.
50.41 Additional standards for class 104 licenses.
50.42 Additional standard for class 103 licenses.
50.43 Additional standards and provisions affecting class 103 licenses 
          and certifications for commercial power.
50.44 Combustible gas control for nuclear power reactors.
50.45 Standards for construction permits, operating licenses, and 
          combined licenses.
50.46 Acceptance criteria for emergency core cooling systems for light-
          water nuclear power reactors.
50.46a Acceptance criteria for reactor coolant system venting systems.
50.47 Emergency plans.
50.48 Fire protection.
50.49 Environmental qualification of electric equipment important to 
          safety for nuclear power plants.

   Issuance, Limitations, and Conditions of Licenses and Construction 
                                 Permits

50.50 Issuance of licenses and construction permits.
50.51 Continuation of license.
50.52 Combining licenses.
50.53 Jurisdictional limitations.
50.54 Conditions of licenses.
50.55 Conditions of construction permits, early site permits, combined 
          licenses, and manufacturing licenses.
50.55a Codes and standards.
50.56 Conversion of construction permit to license; or amendment of 
          license.
50.57 Issuance of operating license.
50.58 Hearings and report of the Advisory Committee on Reactor 
          Safeguards.
50.59 Changes, tests, and experiments.
50.60 Acceptance criteria for fracture prevention measures for 
          lightwater nuclear power reactors for normal operation.
50.61 Fracture toughness requirements for protection against pressurized 
          thermal shock events.
50.61a Alternate fracture toughness requirements for protection against 
          pressurized thermal shock events.
50.62 Requirements for reduction of risk from anticipated transients 
          without scram (ATWS) events for light-water-cooled nuclear 
          power plants.
50.63 Loss of all alternating current power.
50.64 Limitations on the use of highly enriched uranium (HEU) in 
          domestic non-power reactors.
50.65 Requirements for monitoring the effectiveness of maintenance at 
          nuclear power plants.
50.66 Requirements for thermal annealing of the reactor pressure vessel.
50.67 Accident source term.
50.68 Criticality accident requirements.
50.69 Risk-informed categorization and treatment of structures, systems 
          and components for nuclear power reactors.

              Inspections, Records, Reports, Notifications

50.70 Inspections.
50.71 Maintenance of records, making of reports.
50.72 Immediate notification requirements for operating nuclear power 
          reactors.
50.73 Licensee event report system.
50.74 Notification of change in operator or senior operator status.
50.75 Reporting and recordkeeping for decommissioning planning.
50.76 Licensee's change of status; financial qualifications.

                      US/IAEA Safeguards Agreement

50.78 Facility information and verification.

[[Page 853]]

     Transfers of Licenses--Creditors' Rights--Surrender of Licenses

50.80 Transfer of licenses.
50.81 Creditor regulations.
50.82 Termination of license.
50.83 Release of part of a power reactor facility or site for 
          unrestricted use.

    Amendment of License or Construction Permit at Request of Holder

50.90 Application for amendment of license, construction permit, or 
          early site permit.
50.91 Notice for public comment; State consultation.
50.92 Issuance of amendment.

    Revocation, Suspension, Modification, Amendment of Licenses and 
      Construction Permits, Emergency Operations by the Commission

50.100 Revocation, suspension, modification of licenses, permits, and 
          approvals for cause.
50.101 Retaking possession of special nuclear material.
50.102 Commission order for operation after revocation.
50.103 Suspension and operation in war or national emergency.

                               Backfitting

50.109 Backfitting.

                               Enforcement

50.110 Violations.
50.111 Criminal penalties.

   Additional Standards for Licenses, Certifications, and Regulatory 
                                Approvals

50.120 Training and qualification of nuclear power plant personnel.
50.150 Aircraft impact assessment.

Appendix A to Part 50--General Design Criteria for Nuclear Power Plants
Appendix B to Part 50--Quality Assurance Criteria for Nuclear Power 
          Plants and Fuel Reprocessing Plants
Appendix C to Part 50--A Guide for the Financial Data and Related 
          Information Required To Establish Financial Qualifications for 
          Construction Permits and Combined Licenses
Appendix D to Part 50 [Reserved]
Appendix E to Part 50--Emergency Planning and Preparedness for 
          Production and Utilization Facilities
Appendix F to Part 50--Policy Relating to the Siting of Fuel 
          Reprocessing Plants and Related Waste Management Facilities
Appendix G to Part 50--Fracture Toughness Requirements
Appendix H to Part 50--Reactor Vessel Material Surveillance Program 
          Requirements
Appendix I to Part 50--Numerical Guides for Design Objectives and 
          Limiting Conditions for Operation To Meet the Criterion ``As 
          Low as is Reasonably Achievable'' for Radioactive Material in 
          Light-Water-Cooled Nuclear Power Reactor Effluents
Appendix J to Part 50--Primary Reactor Containment Leakage Testing for 
          Water-Cooled Power Reactors
Appendix K to Part 50--ECCS Evaluation Models
Appendix L to Part 50 [Reserved]
Appendix M to Part 50 [Reserved]
Appendix N to Part 50--Standardization of Nuclear Power Plant Designs: 
          Permits To Construct and Licenses To Operate Nuclear Power 
          Reactors of Identical Design at Multiple Sites
Appendix O to Part 50 [Reserved]
Appendix P to Part 50 [Reserved]
Appendix Q to Part 50--Pre-application Early Review of Site Suitability 
          Issues
Appendix R to Part 50--Fire Protection Program for Nuclear Power 
          Facilities Operating Prior to January 1, 1979
Appendix S to Part 50--Earthquake Engineering Criteria for Nuclear Power 
          Plants

    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; Sec. 109, Pub. L. 96-295, 94 Stat. 
783.

    Source: 21 FR 355, Jan. 19, 1956, unless otherwise noted.

                           General Provisions



Sec.50.1  Basis, purpose, and procedures applicable.

    The regulations in this part are promulgated by the Nuclear 
Regulatory Commission pursuant to the Atomic Energy Act of 1954, as 
amended (68 Stat. 919), and Title II of the Energy Reorganization Act of 
1974 (88 Stat. 1242), to provide for the licensing of production and 
utilization facilities. This part also gives notice to all persons who 
knowingly provide to any licensee, applicant, contractor, or 
subcontractor, components, equipment,

[[Page 854]]

materials, or other goods or services, that relate to a licensee's or 
applicant's activities subject to this part, that they may be 
individually subject to NRC enforcement action for violation of Sec.
50.5.

[63 FR 1897, Jan. 13, 1998]



Sec.50.2  Definitions.

    As used in this part,
    Act means the Atomic Energy Act of 1954 (68 Stat. 919) including any 
amendments thereto.
    Alternate ac source means an alternating current (ac) power source 
that is available to and located at or nearby a nuclear power plant and 
meets the following requirements:
    (1) Is connectable to but not normally connected to the offsite or 
onsite emergency ac power systems;
    (2) Has minimum potential for common mode failure with offsite power 
or the onsite emergency ac power sources;
    (3) Is available in a timely manner after the onset of station 
blackout; and
    (4) Has sufficient capacity and reliability for operation of all 
systems required for coping with station blackout and for the time 
required to bring and maintain the plant in safe shutdown (non-design 
basis accident).
    Applicant means a person or an entity applying for a license, 
permit, or other form of Commission permission or approval under this 
part or part 52 of this chapter.
    Atomic energy means all forms of energy released in the course of 
nuclear fission or nuclear transformation.
    Atomic weapon means any device utilizing atomic energy, exclusive of 
the means for transporting or propelling the device (where such means is 
a separable and divisible part of the device), the prinicipal purpose of 
which is for use as, or for development of, a weapon, a weapon 
prototype, or a weapon test device.
    Basic component means, for the purposes of Sec.50.55(e) of this 
chapter:
    (1) When applied to nuclear power reactors, any plant structure, 
system, component, or part thereof 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.
    (2) When applied to other types of facilities or portions of such 
facilities for which construction permits are issued under Sec.50.23, 
a component, structure, system or part thereof that is directly procured 
by the construction permit holder for the facility subject to the 
regulations of this part and in which a defect or failure to comply with 
any applicable regulation in this chapter, order, or license issued by 
the Commission could create a substantial safety hazard.
    (3) In all cases, basic component includes safety related design, 
analysis, inspection, testing, fabrication, replacement parts, or 
consulting services that are associated with the component hardware, 
whether these services are performed by the component supplier or other 
supplier.
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 8, 
2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (3) Any discrete source of naturally occurring radioactive material, 
other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, the Secretary of Energy, the Secretary 
of Homeland Security, and the head of

[[Page 855]]

any other appropriate Federal agency, determines would pose a threat 
similar to the threat posed by a discrete source of radium-226 to the 
public health and safety or the common defense and security; and
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research activity.
    Certified fuel handler means, for a nuclear power reactor facility, 
a non-licensed operator who has qualified in accordance with a fuel 
handler training program approved by the Commission.
    Commission means the Nuclear Regulatory Commission or its duly 
authorized representatives.
    Committed dose equivalent means the dose equivalent to organs or 
tissues of reference that will be received from an intake of radioactive 
material by an individual during the 50-year period following the 
intake.
    Committed effective dose equivalent is the sum of the products of 
the weighting factors applicable to each of the body organs or tissues 
that are irradiated and the committed dose equivalent to these organs or 
tissues.
    Common defense and security means the common defense and security of 
the United States.
    Construction or constructing means, for the purposes of Sec.
50.55(e), the analysis, design, manufacture, fabrication, quality 
assurance, placement, erection, installation, modification, inspection, 
or testing of a facility or activity which is subject to the regulations 
in this part and consulting services related to the facility or activity 
that are safety related.
    Controls when used with respect to nuclear reactors means apparatus 
and mechanisms, the manipulation of which directly affects the 
reactivity or power level of the reactor.
    Controls when used with respect to any other facility means 
apparatus and mechanisms, the manipulation of which could affect the 
chemical, physical, metallurgical, or nuclear process of the facility in 
such a manner as to affect the protection of health and safety against 
radiation.
    Cost of service regulation means the traditional system of rate 
regulation, or similar regulation, including ``price cap'' or 
``incentive'' regulation, in which a rate regulatory authority generally 
allows an electric utility to charge its customers the reasonable and 
prudent costs of providing electricity services, including capital, 
operations, maintenance, fuel, decommissioning, and other costs required 
to provide such services.
    Decommission means to remove a facility or site safely from service 
and reduce residual radioactivity to a level that permits--
    (1) Release of the property for unrestricted use and termination of 
the license; or
    (2) Release of the property under restricted conditions and 
termination of the license.
    Deep-dose equivalent, which applies to external whole-body exposure, 
is the dose equivalent at a tissue depth of 1 cm (1000mg/cm\2\).
    Defect means, for the purposes of Sec.50.55(e) of this chapter:
    (1) A deviation in a basic component delivered to a purchaser for 
use in a facility or activity subject to a construction permit under 
this part, if on the basis of an evaluation, the deviation could create 
a substantial safety hazard; or
    (2) The installation, use, or operation of a basic component 
containing, a defect as defined in paragraph (1) of this definition; or
    (3) A deviation in a portion of a facility subject to the 
construction permit of this part provided the deviation could, on the 
basis of an evaluation, create a substantial safety hazard.
    Department and Department of Energy means the Department of Energy 
established by the Department of Energy Organization Act (Pub. L. 95-91, 
91 Stat. 565, 42 U.S.C. 7101 et seq.), to the extent that the 
department, or its duly authorized representatives, exercises functions 
formerly vested in the Atomic Energy Commission, its Chairman, members, 
officers and components and transferred to the U.S. Energy Research and 
Development Administration and to the Administrator thereof pursuant to 
sections 104 (b), (c) and (d) of the Energy Reorganization Act of 1974 
(Pub. L. 93-438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and 
retransferred to the

[[Page 856]]

Secretary of Energy pursuant to section 301(a) of the Department of 
Energy Organization Act (Pub. L. 95-91, 91 Stat. 565 at 577-578, 42 
U.S.C. 7151).
    Design bases means that information which identifies the specific 
functions to be performed by a structure, system, or component of a 
facility, and the specific values or ranges of values chosen for 
controlling parameters as reference bounds for design. These values may 
be (1) restraints derived from generally accepted ``state of the art'' 
practices for achieving functional goals, or (2) requirements derived 
from analysis (based on calculation and/or experiments) of the effects 
of a postulated accident for which a structure, system, or component 
must meet its functional goals.
    Deviation means, for the purposes of Sec.50.55(e) of this chapter, 
a departure from the technical or quality assurance requirements defined 
in procurement documents, safety analysis report, construction permit, 
or other documents provided for basic components installed in a facility 
subject to the regulations of this part.
    Director means, for the purposes of Sec.50.55(e) of this chapter, 
an individual, appointed or elected according to law, who is authorized 
to manage and direct the affairs of a corporation, partnership or other 
entity.
    Discovery means, for the purposes of Sec.50.55(e) of this chapter, 
the completion of the documentation first identifying the existence of a 
deviation or failure to comply potentially associated with a substantial 
safety hazard within the evaluation procedures discussed in Sec.
50.55(e)(1).
    Electric utility means any entity that generates or distributes 
electricity and which recovers the cost of this electricity, either 
directly or indirectly, through rates established by the entity itself 
or by a separate regulatory authority. Investor-owned utilities, 
including generation or distribution subsidiaries, public utility 
districts, municipalities, rural electric cooperatives, and State and 
Federal agencies, including associations of any of the foregoing, are 
included within the meaning of ``electric utility.''
    Evaluation means, for the purposes of Sec.50.55(e) of this 
chapter, the process of determining whether a particular deviation could 
create a substantial safety hazard or determining whether a failure to 
comply is associated with a substantial safety hazard.
    Exclusion area means that area surrounding the reactor, in which the 
reactor licensee has the authority to determine all activities including 
exclusion or removal of personnel and property from the area. This area 
may be traversed by a highway, railroad, or waterway, provided these are 
not so close to the facility as to interfere with normal operations of 
the facility and provided appropriate and effective arrangements are 
made to control traffic on the highway, railroad, or waterway, in case 
of emergency, to protect the public health and safety. Residence within 
the exclusion area shall normally be prohibited. In any event, residents 
shall be subject to ready removal in case of necessity. Activities 
unrelated to operation of the reactor may be permitted in an exclusion 
area under appropriate limitations, provided that no significant hazards 
to the public health and safety will result.
    Federal Government funding for conversion means funds appropriated 
to the Department of Energy or to any other Federal Agency to pay 
directly to or to reimburse non-power reactor licensees for costs 
attendant to conversion.
    Federal licensee means any NRC licensee, the obligations of which 
are guaranteed by and supported by the full faith and credit of the 
United States Government.
    Fuel acceptable to the Commission means that the fuel replacing the 
existing HEU fuel in a specific non-power reactor (1) meets the 
operating requirements of the existing license or, through appropriate 
NRC safety review and approval, can be used in a manner which protects 
public health and safety and promotes the common defense and security; 
and (2) meets the Commission's policy of limiting, to the maximum extent 
possible, the use of HEU fuel in that reactor.
    Government agency means any executive department, commission, 
independent establishment, corporation, wholly or partly owned by the 
United States of America which is an instrumentality of the United 
States, or any

[[Page 857]]

board, bureau, division, service, office, officer, authority, 
administration, or other establishment in the executive branch of the 
Government.
    Highly enriched uranium (HEU) fuel means fuel in which the weight 
percent of U-235 in the uranium is 20% or greater. Target material, 
special instrumentation, or experimental devices using HEU are not 
included.
    Historical site assessment means the identification of potential, 
likely, or known sources of radioactive material and radioactive 
contamination based on existing or derived information for the purpose 
of classifying a facility or site, or parts thereof, as impacted or non-
impacted.
    Impacted areas mean the areas with some reasonable potential for 
residual radioactivity in excess of natural background or fallout 
levels.
    Incentive regulation means the system of rate regulation in which a 
rate regulatory authority establishes rates that an electric generator 
may charge its customers that are based on specified performance 
factors, in addition to cost-of-service factors.
    License means a license, including a construction permit or 
operating license under this part, an early site permit, combined 
license or manufacturing license under part 52 of this chapter, or a 
renewed license issued by the Commission under this part, part 52, or 
part 54 of this chapter.
    Licensee means a person who is authorized to conduct activities 
under a license issued by the Commission.
    Low enriched uranium (LEU) fuel means fuel in which the weight 
percent of U-235 in the uranium is less than 20%.
    Low population zone means the area immediately surrounding the 
exclusion area which contains residents, the total number and density of 
which are such that there is a reasonable probability that appropriate 
protective measures could be taken in their behalf in the event of a 
serious accident. These guides do not specify a permissible population 
density or total population within this zone because the situation may 
vary from case to case. Whether a specific number of people can, for 
example, be evacuated from a specific area, or instructed to take 
shelter, on a timely basis will depend on many factors such as location, 
number and size of highways, scope and extent of advance planning, and 
actual distribution of residents within the area.
    Major decommissioning activity means, for a nuclear power reactor 
facility, any activity that results in permanent removal of major 
radioactive components, permanently modifies the structure of the 
containment, or results in dismantling components for shipment 
containing greater than class C waste in accordance with Sec.61.55 of 
this chapter.
    Major radioactive components means, for a nuclear power reactor 
facility, the reactor vessel and internals, steam generators, 
pressurizers, large bore reactor coolant system piping, and other large 
components that are radioactive to a comparable degree.
    Non-bypassable charges mean those charges imposed over an 
established time period by a Government authority that affected persons 
or entities are required to pay to cover costs associated with the 
decommissioning of a nuclear power plant. Such charges include, but are 
not limited to, wire charges, stranded cost charges, transition charges, 
exit fees, other similar charges, or the securitized proceeds of a 
revenue stream.
    Non-impacted areas mean the areas with no reasonable potential for 
residual radioactivity in excess of natural background or fallout 
levels.
    Non-power reactor means a research or test reactor licensed under 
Sec. Sec.50.21(c) or 50.22 of this part for research and development.
    Notification means the telephonic communication to the NRC 
Operations Center or written transmittal of information to the NRC 
Document Control Desk.
    Nuclear reactor means an apparatus, other than an atomic weapon, 
designed or used to sustain nuclear fission in a self-supporting chain 
reaction.
    Permanent cessation of operation(s) means, for a nuclear power 
reactor facility, a certification by a licensee to the NRC that it has 
permanently

[[Page 858]]

ceased or will permanently cease reactor operation(s), or a final 
legally effective order to permanently cease operation(s) has come into 
effect.
    Permanent fuel removal means, for a nuclear power reactor facility, 
a certification by the licensee to the NRC that it has permanently 
removed all fuel assemblies from the reactor vessel.
    Person means (1) any individual, corporation, partnership, firm, 
association, trust, estate, public or private institution, group, 
government agency other than the Commission or the Department, except 
that the Department shall be considered a person to the extent that its 
facilities are subject to the licensing and related regulatory authority 
of the Commission pursuant to section 202 of the Energy Reorganization 
Act of 1974, any State or any political subdivision of, or any political 
entity within a State, any foreign government or nation or any political 
subdivision of any such government or nation, or other entity; and (2) 
any legal successor, representative, agent, or agency of the foregoing.
    Price-cap regulation means the system of rate regulation in which a 
rate regulatory authority establishes rates that an electric generator 
may charge its customers that are based on a specified maximum price of 
electricity.
    Procurement document means, for the purposes of Sec.50.55(e) of 
this chapter, a contract that defines the requirements which facilities 
or basic components must meet in order to be considered acceptable by 
the purchaser.
    Produce, when used in relation to special nuclear material, means 
(1) to manufacture, make, produce, or refine special nuclear material; 
(2) to separate special nuclear material from other substances in which 
such material may be contained; or (3) to make or to produce new special 
nuclear material.
    Production facility means:
    (1) Any nuclear reactor designed or used primarily for the formation 
of plutonium or uranium-233; or
    (2) Any facility designed or used for the separation of the isotopes 
of plutonium, except laboratory scale facilities designed or used for 
experimental or analytical purposes only; or
    (3) Any facility designed or used for the processing of irradiated 
materials containing special nuclear material, except (i) laboratory 
scale facilities designed or used for experimental or analytical 
purposes, (ii) facilities in which the only special nuclear materials 
contained in the irradiated material to be processed are uranium 
enriched in the isotope U-235 and plutonium produced by the irradiation, 
if the material processed contains not more than 10-6 grams 
of plutonium per gram of U-235 and has fission product activity not in 
excess of 0.25 millicuries of fission products per gram of U-235, and 
(iii) facilities in which processing is conducted pursuant to a license 
issued under parts 30 and 70 of this chapter, or equivalent regulations 
of an Agreement State, for the receipt, possession, use, and transfer of 
irradiated special nuclear material, which authorizes the processing of 
the irradiated material on a batch basis for the separation of selected 
fission products and limits the process batch to not more than 100 grams 
of uranium enriched in the isotope 235 and not more than 15 grams of any 
other special nuclear material.
    Prototype plant means a nuclear reactor that is used to test design 
features, such as the testing required under Sec.50.43(e). The 
prototype plant is similar to a first-of-a-kind or standard plant design 
in all features and size, but may include additional safety features to 
protect the public and the plant staff from the possible consequences of 
accidents during the testing period.
    Reactor coolant pressure boundary means all those pressure-
containing components of boiling and pressurized water-cooled nuclear 
power reactors, such as pressure vessels, piping, pumps, and valves, 
which are:
    (1) Part of the reactor coolant system, or
    (2) Connected to the reactor coolant system, up to and including any 
and all of the following:
    (i) The outermost containment isolation valve in system piping which 
penetrates primary reactor containment,
    (ii) The second of two valves normally closed during normal reactor 
operation in system piping which does not penetrate primary reactor 
containment,

[[Page 859]]

    (iii) The reactor coolant system safety and relief valves.

For nuclear power reactors of the direct cycle boiling water type, the 
reactor coolant system extends to and includes the outermost containment 
isolation valve in the main steam and feedwater piping.
    Research and development means (1) theoretical analysis, 
exploration, or experimentation; or (2) the extension of investigative 
findings and theories of a scientific or technical nature into practical 
application for experimental and demonstration purposes, including the 
experimental production and testing of models, devices, equipment, 
materials, and processes.
    Responsible officer means, for the purposes of Sec.50.55(e) of 
this chapter, the president, vice-president, or other individual in the 
organization of a corporation, partnership, or other entity who is 
vested with executive authority over activities subject to this part.
    Restricted Data means all data concerning (1) design, manufacture, 
or utilization of atomic weapons; (2) the production of special nuclear 
material; or (3) the use of special nuclear material in the production 
of energy, but shall not include data declassified or removed from the 
Restricted Data category pursuant to section 142 of the Act.
    Safe shutdown (non-design basis accident (non-DBA)) for station 
blackout means bringing the plant to those shutdown conditions specified 
in plant technical specifications as Hot Standby or Hot Shutdown, as 
appropriate (plants have the option of maintaining the RCS at normal 
operating temperatures or at reduced temperatures).
    Safety-related structures, systems and components means those 
structures, systems and components that are relied upon to remain 
functional during and following design basis events to assure:
    (1) The integrity of the reactor coolant pressure boundary
    (2) The capability to shut down the reactor and maintain it in a 
safe shutdown condition; or
    (3) The capability to prevent or mitigate the consequences of 
accidents which could result in potential offsite exposures comparable 
to the applicable guideline exposures set forth in Sec.50.34(a)(1) or 
Sec.100.11 of this chapter, as applicable.
    Source material means source material as defined in subsection 11z. 
of the Act and in the regulations contained in part 40 of this chapter.
    Source term refers to the magnitude and mix of the radionuclides 
released from the fuel, expressed as fractions of the fission product 
inventory in the fuel, as well as their physical and chemical form, and 
the timing of their release.
    Special nuclear material means (1) plutonium, uranium-233, uranium 
enriched in the isotope-233 or in the isotope-235, and any other 
material which the Commission, pursuant to the provisions of section 51 
of the act, determines to be special nuclear material, but does not 
include source material; or (2) any material artificially enriched by 
any of the foregoing, but does not include source material.
    Station blackout means the complete loss of alternating current (ac) 
electric power to the essential and nonessential switchgear buses in a 
nuclear power plant (i.e., loss of offsite electric power system 
concurrent with turbine trip and unavailability of the onsite emergency 
ac power system). Station blackout does not include the loss of 
available ac power to buses fed by station batteries through inverters 
or by alternate ac sources as defined in this section, nor does it 
assume a concurrent single failure or design basis accident. At single 
unit sites, any emergency ac power source(s) in excess of the number 
required to meet minimum redundancy requirements (i.e., single failure) 
for safe shutdown (non-DBA) is assumed to be available and may be 
designated as an alternate power source(s) provided the applicable 
requirements are met. At multi-unit sites, where the combination of 
emergency ac power sources exceeds the minimum redundancy requirements 
for safe shutdown (non-DBA) of all units, the remaining emergency ac 
power sources may be used as alternate ac power sources provided they 
meet the applicable requirements. If these criteria are not met, station 
blackout must be assumed on all the units.

[[Page 860]]

    Substantial safety hazard means, for the purposes of Sec.50.55(e) 
of this chapter, 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 authorized by the construction 
permit issued under this part.
    Testing facility means a nuclear reactor which is of a type 
described in Sec.50.21(c) of this part and for which an application 
has been filed for a license authorizing operation at:
    (1) A thermal power level in excess of 10 megawatts; or
    (2) A thermal power level in excess of 1 megawatt, if the reactor is 
to contain:
    (i) A circulating loop through the core in which the applicant 
proposes to conduct fuel experiments; or
    (ii) A liquid fuel loading; or
    (iii) An experimental facility in the core in excess of 16 square 
inches in cross-section.
    Total Effective Dose Equivalent (TEDE) means the sum of the 
effective dose equivalent (for external exposures) and the committed 
effective dose equivalent (for internal exposures).
    Unique purpose means a project, program, or commercial activity 
which cannot reasonably be accomplished without the use of HEU fuel, and 
may include: (1) A specific experiment, program, or commercial activity 
(typically long-term) that significantly serves the U.S. national 
interest and cannot be accomplished without the use of HEU fuel; (2) 
Reactor physics or reactor development based explicitly on the use of 
HEU fuel; (3) Research projects based on neutron flux levels or spectra 
attainable only with HEU fuel; or (4) A reactor core of special design 
that could not perform its intended function without using HEU fuel.
    United States, when used in a geographical sense, includes Puerto 
Rico and all territories and possessions of the United States.
    Utilization facility means:
    (1) Any nuclear reactor other than one designed or used primarily 
for the formation of plutonium or U-233; or
    (2) An accelerator-driven subcritical operating assembly used for 
the irradiation of materials containing special nuclear material and 
described in the application assigned docket number 50-608.
    Note: Pursuant to subsections 11v. and 11cc., respectively, of the 
Act, the Commission may from time to time add to, or otherwise alter, 
the foregoing definitions of production and utilization facility. It may 
also include as a facility an important component part especially 
designed for a facility, but has not at this time included any component 
parts in the definitions.

[21 FR 355, Jan. 19, 1956]

    Editorial Note: For Federal Register citations affecting Sec.50.2, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfoo.gov.



Sec.50.3  Interpretations.

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



Sec.50.4  Written communications.

    (a) General requirements. All correspondence, reports, applications, 
and other written communications from the applicant or licensee to the 
Nuclear Regulatory Commission concerning the regulations in this part or 
individual license conditions must be sent either by mail addressed: 
ATTN: Document Control Desk, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; by hand delivery to the NRC's offices at 
11555 Rockville Pike, Rockville, Maryland, between the hours of 8:15 
a.m. and 4 p.m. eastern time; or, where practicable, by electronic 
submission, for example, via Electronic Information Exchange, e-mail, or 
CD-ROM. Electronic submissions must be made in a manner that enables the 
NRC to receive, read, authenticate, distribute, and archive the 
submission, and process and retrieve it a single page at a time. 
Detailed guidance on making electronic submissions can be obtained by 
visiting the NRC's Web site at http://www.nrc.gov/site-help/e-
submittals.html; by e-mail to [email protected]; or by writing

[[Page 861]]

the Office of the Chief Information Officer, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001. The guidance discusses, among 
other topics, the formats the NRC can accept, the use of electronic 
signatures, and the treatment of nonpublic information. If the 
communication is on paper, the signed original must be sent. If a 
submission due date falls on a Saturday, Sunday, or Federal holiday, the 
next Federal working day becomes the official due date.
    (b) Distribution requirements. Copies of all correspondence, 
reports, and other written communications concerning the regulations in 
this part or individual license conditions must be submitted to the 
persons listed below (addresses for the NRC Regional Offices are listed 
in appendix D to part 20 of this chapter).
    (1) Applications for amendment of permits and licenses; reports; and 
other communications. All written communications (including responses 
to: generic letters, bulletins, information notices, regulatory 
information summaries, inspection reports, and miscellaneous requests 
for additional information) that are required of holders of operating 
licenses or construction permits issued pursuant to this part, must be 
submitted as follows, except as otherwise specified in paragraphs (b)(2) 
through (b)(7) of this section: to the NRC's Document Control Desk (if 
on paper, the signed original), with a copy to the appropriate Regional 
Office, and a copy to the appropriate NRC Resident Inspector, if one has 
been assigned to the site of the facility.
    (2) Applications for permits and licenses, and amendments to 
applications. Applications for construction permits, applications for 
operating licenses and amendments to either type of application must be 
submitted as follows, except as otherwise specified in paragraphs (b)(3) 
through (b)(7) in this section.
    (i) Applications for licenses for facilities described in Sec.
50.21 (a) and (c) and amendments to these applications must be sent to 
the NRC's Document Control Desk, with a copy to the appropriate Regional 
Office. If the application or amendment is on paper, the submission to 
the Document Control Desk must be the signed original.
    (ii) Applications for permits and licenses for facilities described 
in Sec.50.21(b) or Sec.50.22, and amendments to these applications 
must be sent to the NRC's Document Control Desk, with a copy to the 
appropriate Regional Office, and a copy to the appropriate NRC Resident 
Inspector, if one has been assigned to the site of the facility. If the 
application or amendment is on paper, the submission to the Document 
Control Desk must be the signed original.
    (3) Acceptance review application. Written communications required 
for an application for determination of suitability for docketing under 
Sec.50.30(a)(6) must be submitted to the NRC's Document Control Desk, 
with a copy to the appropriate Regional Office. If the communication is 
on paper, the submission to the Document Control Desk must be the signed 
original.
    (4) Security plan and related submissions. Written communications, 
as defined in paragraphs (b)(4)(i) through (iv) of this section, must be 
submitted to the NRC's Document Control Desk, with a copy to the 
appropriate Regional Office. If the communication is on paper, the 
submission to the Document Control Desk must be the signed original.
    (i) Physical security plan under Sec.50.34;
    (ii) Safeguards contingency plan under Sec.50.34;
    (iii) Change to security plan, guard training and qualification 
plan, or safeguards contingency plan made without prior Commission 
approval under Sec.50.54(p);
    (iv) Application for amendment of physical security plan, guard 
training and qualification plan, or safeguards contingency plan under 
Sec.50.90.
    (5) Emergency plan and related submissions. Written communications 
as defined in paragraphs (b)(5)(i) through (iii) of this section must be 
submitted to the NRC's Document Control Desk, with a copy to the 
appropriate Regional Office, and a copy to the appropriate NRC Resident 
Inspector if one has been assigned to the site of the facility. If the 
communication is on paper, the submission to the Document

[[Page 862]]

Control Desk must be the signed original.
    (i) Emergency plan under Sec.50.34;
    (ii) Change to an emergency plan under Sec.50.54(q);
    (iii) Emergency implementing procedures under appendix E.V of this 
part.
    (6) Updated FSAR. An updated Final Safety Analysis Report (FSAR) or 
replacement pages, under Sec.50.71(e) must be submitted to the NRC's 
Document Control Desk, with a copy to the appropriate Regional Office, 
and a copy to the appropriate NRC Resident Inspector if one has been 
assigned to the site of the facility. Paper copy submissions may be made 
using replacement pages; however, if a licensee chooses to use 
electronic submission, all subsequent updates or submissions must be 
performed electronically on a total replacement basis. If the 
communication is on paper, the submission to the Document Control Desk 
must be the signed original. If the communications are submitted 
electronically, see Guidance for Electronic Submissions to the 
Commission.
    (7) Quality assurance related submissions. (i) A change to the 
Safety Analysis Report quality assurance program description under Sec.
50.54(a)(3) or Sec.50.55(f)(3), or a change to a licensee's NRC-
accepted quality assurance topical report under Sec.50.54(a)(3) or 
Sec.50.55(f)(3), must be submitted to the NRC's Document Control Desk, 
with a copy to the appropriate Regional Office, and a copy to the 
appropriate NRC Resident Inspector if one has been assigned to the site 
of the facility. If the communication is on paper, the submission to the 
Document Control Desk must be the signed original.
    (ii) A change to an NRC-accepted quality assurance topical report 
from nonlicensees (i.e., architect/engineers, NSSS suppliers, fuel 
suppliers, constructors, etc.) must be submitted to the NRC's Document 
Control Desk. If the communication is on paper, the signed original must 
be sent.
    (8) Certification of permanent cessation of operations. The 
licensee's certification of permanent cessation of operations, under 
Sec.50.82(a)(1), must state the date on which operations have ceased 
or will cease, and must be submitted to the NRC's Document Control Desk. 
This submission must be under oath or affirmation.
    (9) Certification of permanent fuel removal. The licensee's 
certification of permanent fuel removal, under Sec.50.82(a)(1), must 
state the date on which the fuel was removed from the reactor vessel and 
the disposition of the fuel, and must be submitted to the NRC's Document 
Control Desk. This submission must be under oath or affirmation.
    (c) Form of communications. All paper copies submitted to meet the 
requirements set forth in paragraph (b) of this section must be 
typewritten, printed or otherwise reproduced in permanent form on 
unglazed paper. Exceptions to these requirements imposed on paper 
submissions may be granted for the submission of micrographic, 
photographic, or similar forms.
    (d) Regulation governing submission. Licensees and applicants 
submitting correspondence, reports, and other written communications 
under the regulations of this part are requested but not required to 
cite whenever practical, in the upper right corner of the first page of 
the submission, the specific regulation or other basis requiring 
submission.
    (e) Conflicting requirements. The communications requirements 
contained in this section and Sec. Sec.50.12, 50.30, 50.36, 50.36a. 
50.44, 50.49, 50.54, 50.55, 50.55a, 50.59, 50.62, 50.71, 50.73, 50.82, 
50.90, and 50.91 supersede and replace all existing requirements in any 
license conditions or technical specifications in effect on January 5, 
1987. Exceptions to these requirements must be approved by the Office of 
the Chief Information Officer, Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-7233, e-mail 
[email protected].

[68 FR 58808, Oct. 10, 2003, as amended at 74 FR 62682, Dec. 1, 2009; 80 
FR 74979, Dec. 1, 2015]



Sec.50.5  Deliberate misconduct.

    (a) Any licensee, applicant for a license, employee of a licensee or 
applicant; or any contractor (including a supplier or consultant), 
subcontractor, employee of a contractor or subcontractor of any licensee 
or applicant for a license, who knowingly provides to

[[Page 863]]

any licensee, applicant, contractor, or subcontractor, any components, 
equipment, materials, or other goods or services that relate to a 
licensee's or applicant's activities in this part, may not:
    (1) Engage in deliberate misconduct that causes or would have 
caused, if not detected, a licensee or applicant to be in violation of 
any rule, regulation, or order; or any term, condition, or limitation of 
any license issued by the Commission; or
    (2) Deliberately submit to the NRC, a licensee, an applicant, or a 
licensee's or applicant's contractor or subcontractor, information that 
the person submitting the information knows to be incomplete or 
inaccurate in some respect material to the NRC.
    (b) A person who violates paragraph (a)(1) or (a)(2) of this section 
may be subject to enforcement action in accordance with the procedures 
in 10 CFR part 2, subpart B.
    (c) For the purposes of paragraph (a)(1) of this section, deliberate 
misconduct by a person means an intentional act or omission that the 
person knows:
    (1) Would cause a licensee or applicant to be in violation of any 
rule, regulation, or order; or any term, condition, or limitation, of 
any license issued by the Commission; or
    (2) Constitutes a violation of a requirement, procedure, 
instruction, contract, purchase order, or policy of a licensee, 
applicant, contractor, or subcontractor.

[63 FR 1897, Jan. 13, 1998]



Sec.50.7  Employee protection.

    (a) Discrimination by a Commission licensee, an applicant for a 
Commission license, or a contractor or subcontractor of a Commission 
licensee or applicant against an employee for engaging in certain 
protected activities is prohibited. Discrimination includes discharge 
and other actions that relate to compensation, terms, conditions, or 
privileges of employment. The protected activities are established in 
section 211 of the Energy Reorganization Act of 1974, as amended, and in 
general are related to the administration or enforcement of a 
requirement imposed under the Atomic Energy Act or the Energy 
Reorganization Act.
    (1) The protected activities include but are not limited to:
    (i) Providing the Commission or his or her employer information 
about alleged violations of either of the statutes named in paragraph 
(a) introductory text of this section or possible violations of 
requirements imposed under either of those statutes;
    (ii) Refusing to engage in any practice made unlawful under either 
of the statutes named in paragraph (a) introductory text or under these 
requirements if the employee has identified the alleged illegality to 
the employer;
    (iii) Requesting the Commission to institute action against his or 
her employer for the administration or enforcement of these 
requirements;
    (iv) Testifying in any Commission proceeding, or before Congress, or 
at any Federal or State proceeding regarding any provision (or proposed 
provision) of either of the statutes named in paragraph (a) introductory 
text.
    (v) Assisting or participating in, or is about to assist or 
participate in, these activities.
    (2) These activities are protected even if no formal proceeding is 
actually initiated as a result of the employee assistance or 
participation.
    (3) This section has no application to any employee alleging 
discrimination prohibited by this section who, acting without direction 
from his or her employer (or the employer's agent), deliberately causes 
a violation of any requirement of the Energy Reorganization Act of 1974, 
as amended, or the Atomic Energy Act of 1954, as amended.
    (b) Any employee who believes that he or she has been discharged or 
otherwise discriminated against by any person for engaging in protected 
activities specified in paragraph (a)(1) of this section may seek a 
remedy for the discharge or discrimination through an administrative 
proceeding in the Department of Labor. The administrative proceeding 
must be initiated within 180 days after an alleged violation occurs. The 
employee may do this by filing a complaint alleging the violation with 
the Department of Labor, Employment Standards Administration, Wage and

[[Page 864]]

Hour Division. The Department of Labor may order reinstatement, back 
pay, and compensatory damages.
    (c) A violation of paragraph (a), (e), or (f) of this section by a 
Commission licensee, an applicant for a Commission license, or a 
contractor or subcontractor of a Commission licensee or applicant may be 
grounds for--
    (1) Denial, revocation, or suspension of the license.
    (2) Imposition of a civil penalty on the licensee, applicant, or a 
contractor or subcontractor of the licensee or applicant.
    (3) Other enforcement action.
    (d) Actions taken by an employer, or others, which adversely affect 
an employee may be predicated upon nondiscriminatory grounds. The 
prohibition applies when the adverse action occurs because the employee 
has engaged in protected activities. An employee's engagement in 
protected activities does not automatically render him or her immune 
from discharge or discipline for legitimate reasons or from adverse 
action dictated by nonprohibited considerations.
    (e)(1) Each licensee and each applicant for a license shall 
prominently post the revision of NRC Form 3, ``Notice to Employees,'' 
referenced in 10 CFR 19.11(e)(1). This form must be posted at locations 
sufficient to permit employees protected by this section to observe a 
copy on the way to or from their place of work. Premises must be posted 
not later than 30 days after an application is docketed and remain 
posted while the application is pending before the Commission, during 
the term of the license, and for 30 days following license termination.
    (2) Copies of NRC Form 3 may be obtained by writing to the Regional 
Administrator of the appropriate U.S. Nuclear Regulatory Commission 
Regional Office listed in appendix D to part 20 of this chapter, via 
email to [email protected], or by visiting the NRC's online library 
at http://www.nrc.gov/reading-rm/doc-collections/forms/.
    (f) No agreement affecting the compensation, terms, conditions, or 
privileges of employment, including an agreement to settle a complaint 
filed by an employee with the Department of Labor pursuant to section 
211 of the Energy Reorganization Act of 1974, as amended, may contain 
any provision which would prohibit, restrict, or otherwise discourage an 
employee from participating in protected activity as defined in 
paragraph (a)(1) of this section including, but not limited to, 
providing information to the NRC or to his or her employer on potential 
violations or other matters within NRC's regulatory responsibilities.

[58 FR 52410, Oct. 8, 1993, as amended at 60 FR 24551, May 9, 1995; 61 
FR 6765, Feb. 22, 1996; 68 FR 58809, Oct. 10, 2003; 72 FR 63974, Nov. 
14, 2007; 73 FR 30458, May 28, 2008; 79 FR 66603, Nov. 10, 2014; 83 FR 
58465, Nov. 20, 2018]



Sec.50.8  Information collection requirements: OMB approval.

    (a) The Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. OMB 
has approved the information collection requirements contained in this 
part under control number 3150-0011.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.50.12, 50.30, 50.33, 50.34, 50.34a, 
50.35, 50.36, 50.36a, 50.36b, 50.44, 50.46, 50.47, 50.48, 50.49, 50.54, 
50.55, 50.55a, 50.59, 50.60, 50.61, 50.61a, 50.62, 50.63, 50.64, 50.65, 
50.66, 50.68, 50.69, 50.70, 50.71, 50.72, 50.74, 50.75, 50.80, 50.82, 
50.90, 50.91, 50.120, 50.150, and appendices A, B, E, G, H, I, J, K, M, 
N,O, Q, R, and S to this part.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection requirements 
and the control numbers under which they are approved are as follows:
    (1) In Sec.50.73, NRC Form 366 is approved under control number 
3150-0104.
    (2) In Sec.50.78, Form N-71 and associated forms are approved 
under control number 3150-0056.

[[Page 865]]

    (3) In Sec.50.78, DOC/NRC Forms AP-1, AP-A, and associated forms 
are approved under control numbers 0694-0135.

[49 FR 19627, May 9, 1984, as amended at 58 FR 68731, Dec. 29, 1993; 60 
FR 65468, Dec. 19, 1995; 61 FR 65172, Dec. 11, 1996; 62 FR 52187, Oct. 
6, 1997; 67 FR 67099, Nov. 4, 2002; 68 FR 19727, Apr. 22, 2003; 69 FR 
68046, Nov. 22, 2004; 70 FR 61887, Oct. 27, 2005; 73 FR 78605, Dec. 23, 
2008; 74 FR 28145, June 12, 2009; 75 FR 22, Jan. 4, 2010; 77 FR 39907, 
July 6, 2012; 83 FR 58465, Nov. 20, 2018]



Sec.50.9  Completeness and accuracy of information.

    (a) Information provided to the Commission by an applicant for a 
license or by a licensee or information required by statute or by the 
Commission's regulations, orders, or license conditions to be maintained 
by the applicant or the licensee shall be complete and accurate in all 
material respects.
    (b) Each applicant or licensee shall notify the Commission of 
information identified by the applicant or licensee as having for the 
regulated activity a significant implication for public health and 
safety or common defense and security. An applicant or licensee violates 
this paragraph only if the applicant or licensee fails to notify the 
Commission of information that the applicant or licensee has identified 
as having a significant implication for public health and safety or 
common defense and security. Notification shall be provided to the 
Administrator of the appropriate Regional Office within two working days 
of identifying the information. This requirement is not applicable to 
information which is already required to be provided to the Commission 
by other reporting or updating requirements.

[52 FR 49372, Dec. 31, 1987]

                   Requirement of License, Exceptions



Sec.50.10  License required; limited work authorization.

    (a) Definitions. As used in this section, construction means the 
activities in paragraph (a)(1) of this section, and does not mean the 
activities in paragraph (a)(2) of this section.
    (1) Activities constituting construction are the driving of piles, 
subsurface preparation, placement of backfill, concrete, or permanent 
retaining walls within an excavation, installation of foundations, or 
in-place assembly, erection, fabrication, or testing, which are for:
    (i) Safety-related structures, systems, or components (SSCs) of a 
facility, as defined in 10 CFR 50.2;
    (ii) SSCs relied upon to mitigate accidents or transients or used in 
plant emergency operating procedures;
    (iii) SSCs whose failure could prevent safety-related SSCs from 
fulfilling their safety-related function;
    (iv) SSCs whose failure could cause a reactor scram or actuation of 
a safety-related system;
    (v) SSCs necessary to comply with 10 CFR part 73;
    (vi) SSCs necessary to comply with 10 CFR 50.48 and criterion 3 of 
10 CFR part 50, appendix A; and
    (vii) Onsite emergency facilities, that is, technical support and 
operations support centers, necessary to comply with 10 CFR 50.47 and 10 
CFR part 50, appendix E.
    (2) Construction does not include:
    (i) Changes for temporary use of the land for public recreational 
purposes;
    (ii) Site exploration, including necessary borings to determine 
foundation conditions or other preconstruction monitoring to establish 
background information related to the suitability of the site, the 
environmental impacts of construction or operation, or the protection of 
environmental values;
    (iii) Preparation of a site for construction of a facility, 
including clearing of the site, grading, installation of drainage, 
erosion and other environmental mitigation measures, and construction of 
temporary roads and borrow areas;
    (iv) Erection of fences and other access control measures;
    (v) Excavation;
    (vi) Erection of support buildings (such as, construction equipment 
storage sheds, warehouse and shop facilities, utilities, concrete mixing 
plants, docking and unloading facilities, and office buildings) for use 
in connection with the construction of the facility;

[[Page 866]]

    (vii) Building of service facilities, such as paved roads, parking 
lots, railroad spurs, exterior utility and lighting systems, potable 
water systems, sanitary sewerage treatment facilities, and transmission 
lines;
    (viii) Procurement or fabrication of components or portions of the 
proposed facility occurring at other than the final, in-place location 
at the facility;
    (ix) Manufacture of a nuclear power reactor under a manufacturing 
license under subpart F of part 52 of this chapter to be installed at 
the proposed site and to be part of the proposed facility; or
    (x) With respect to production or utilization facilities, other than 
testing facilities and nuclear power plants, required to be licensed 
under Section 104.a or Section 104.c of the Act, the erection of 
buildings which will be used for activities other than operation of a 
facility and which may also be used to house a facility (e.g., the 
construction of a college laboratory building with space for 
installation of a training reactor).
    (b) Requirement for license. Except as provided in Sec.50.11 of 
this chapter, no person within the United States shall transfer or 
receive in interstate commerce, manufacture, produce, transfer, acquire, 
possess, or use any production or utilization facility except as 
authorized by a license issued by the Commission.
    (c) Requirement for construction permit, early site permit 
authorizing limited work authorization activities, combined license, or 
limited work authorization. No person may begin the construction of a 
production or utilization facility on a site on which the facility is to 
be operated until that person has been issued either a construction 
permit under this part, a combined license under part 52 of this 
chapter, an early site permit authorizing the activities under paragraph 
(d) of this section, or a limited work authorization under paragraph (d) 
of this section.
    (d) Request for limited work authorization. (1) Any person to whom 
the Commission may otherwise issue either a license or permit under 
Sections 103, 104.b, or 185 of the Act for a facility of the type 
specified in Sec. Sec.50.21(b)(2), (b)(3), or 50.22 of this chapter, 
or a testing facility, may request a limited work authorization allowing 
that person to perform the driving of piles, subsurface preparation, 
placement of backfill, concrete, or permanent retaining walls within an 
excavation, installation of the foundation, including placement of 
concrete, any of which are for an SSC of the facility for which either a 
construction permit or combined license is otherwise required under 
paragraph (c) of this section.
    (2) An application for a limited work authorization may be submitted 
as part of a complete application for a construction permit or combined 
license in accordance with 10 CFR 2.101(a)(1) through (a)(5), or as a 
partial application in accordance with 10 CFR 2.101(a)(9). An 
application for a limited work authorization must be submitted by an 
applicant for or holder of an early site permit as a complete 
application in accordance with 10 CFR 2.101(a)(1) through (a)(4).
    (3) The application must include:
    (i) A safety analysis report required by 10 CFR 50.34, 10 CFR 52.17 
or 10 CFR 52.79 of this chapter, as applicable, a description of the 
activities requested to be performed, and the design and construction 
information otherwise required by the Commission's rules and regulations 
to be submitted for a construction permit or combined license, but 
limited to those portions of the facility that are within the scope of 
the limited work authorization. The safety analysis report must 
demonstrate that activities conducted under the limited work 
authorization will be conducted in compliance with the technically-
relevant Commission requirements in 10 CFR Chapter I applicable to the 
design of those portions of the facility within the scope of the limited 
work authorization;
    (ii) An environmental report in accordance with Sec.51.49 of this 
chapter; and
    (iii) A plan for redress of activities performed under the limited 
work authorization, should limited work activities be terminated by the 
holder or the limited work authorization be revoked by the NRC, or upon 
effectiveness of the Commission's final decision denying the associated 
construction

[[Page 867]]

permit or combined license application, as applicable.
    (e) Issuance of limited work authorization. (1) The Director of New 
Reactors or the Director of Nuclear Reactor Regulation may issue a 
limited work authorization only after:
    (i) The NRC staff issues the final environmental impact statement 
for the limited work authorization in accordance with subpart A of part 
51 of this chapter;
    (ii) The presiding officer makes the finding in Sec.51.105(c) or 
Sec.51.107(d) of this chapter, as applicable;
    (iii) The Director determines that the applicable standards and 
requirements of the Act, and the Commission's regulations applicable to 
the activities to be conducted under the limited work authorization, 
have been met. The applicant is technically qualified to engage in the 
activities authorized. Issuance of the limited work authorization will 
provide reasonable assurance of adequate protection to public health and 
safety and will not be inimical to the common defense and security; and
    (iv) The presiding officer finds that there are no unresolved safety 
issues relating to the activities to be conducted under the limited work 
authorization that would constitute good cause for withholding the 
authorization.
    (2) Each limited work authorization will specify the activities that 
the holder is authorized to perform.
    (f) Effect of limited work authorization. Any activities undertaken 
under a limited work authorization are entirely at the risk of the 
applicant and, except as to the matters determined under paragraph 
(e)(1) of this section, the issuance of the limited work authorization 
has no bearing on the issuance of a construction permit or combined 
license with respect to the requirements of the Act, and rules, 
regulations, or orders issued under the Act. The environmental impact 
statement for a construction permit or combined license application for 
which a limited work authorization was previously issued will not 
address, and the presiding officer will not consider, the sunk costs of 
the holder of limited work authorization in determining the proposed 
action (i.e., issuance of the construction permit or combined license).
    (g) Implementation of redress plan. If construction is terminated by 
the holder, the underlying application is withdrawn by the applicant or 
denied by the NRC, or the limited work authorization is revoked by the 
NRC, then the holder must begin implementation of the redress plan in a 
reasonable time. The holder must also complete the redress of the site 
no later than 18 months after termination of construction, revocation of 
the limited work authorization, or upon effectiveness of the 
Commission's final decision denying the associated construction permit 
application or the underlying combined license application, as 
applicable.

[72 FR 57441, Oct. 9, 2007]



Sec.50.11  Exceptions and exemptions from licensing requirements.

    Nothing in this part shall be deemed to require a license for:
    (a) The manufacture, production, or acquisition by the Department of 
Defense of any utilization facility authorized pursuant to section 91 of 
the Act, or the use of such facility by the Department of Defense or by 
a person under contract with and for the account of the Department of 
Defense;
    (b) Except to the extent that Administration facilities of the types 
subject to licensing pursuant to section 202 of the Energy 
Reorganization Act of 1974 are involved;
    (1)(i) The processing, fabrication or refining of special nuclear 
material or the separation of special nuclear material, or the 
separation of special nuclear material from other substances by a prime 
contractor of the Department under a prime contract for:
    (A) The performance of work for the Department at a United States 
government-owned or controlled site;
    (B) Research in, or development, manufacture, storage, testing or 
transportation of, atomic weapons or components thereof; or
    (C) The use or operation of a production or utilization facility in 
a United States owned vehicle or vessel; or
    (ii) By a prime contractor or subcontractor of the Commission or the 
Department under a prime contract or

[[Page 868]]

subcontract when the Commission determines that the exemption of the 
prime contractor or subcontractor is authorized by law; and that, under 
the terms of the contract or subcontract, there is adequate assurance 
that the work thereunder can be accomplished without undue risk to the 
public health and safety;
    (2)(i) The construction or operation of a production or utilization 
facility for the Department at a United States government-owned or 
controlled site, including the transportation of the production or 
utilization facility to or from such site and the performance of 
contract services during temporary interruptions of such transportation; 
or the construction or operation of a production or utilization facility 
for the Department in the performance of research in, or development, 
manufacture, storage, testing, or transportation of, atomic weapons or 
components thereof; or the use or operation of a production or 
utilization facility for the Department in a United States government-
owned vehicle or vessel: Provided, That such activities are conducted by 
a prime contractor of the Department under a prime contract with the 
Department.
    (ii) The construction or operation of a production or utilization 
facility by a prime contractor or subcontractor of the Commission or the 
Department under his prime contract or subcontract when the Commission 
determines that the exemption of the prime contractor or subcontractor 
is authorized by law; and that, under the terms of the contract or 
subcontract, there is adequate assurance that the work thereunder can be 
accomplished without undue risk to the public health and safety.
    (c) The transportation or possession of any production or 
utilization facility by a common or contract carrier or warehousemen in 
the regular course of carriage for another or storage incident thereto.

[40 FR 8788, Mar. 3, 1975, as amended at 65 FR 54950, Sept. 12, 2000]



Sec.50.12  Specific exemptions.

    (a) The Commission may, upon application by any interested person or 
upon its own initiative, grant exemptions from the requirements of the 
regulations of this part, which are--
    (1) Authorized by law, will not present an undue risk to the public 
health and safety, and are consistent with the common defense and 
security.
    (2) The Commission will not consider granting an exemption unless 
special circumstances are present. Special circumstances are present 
whenever--
    (i) Application of the regulation in the particular circumstances 
conflicts with other rules or requirements of the Commission; or
    (ii) Application of the regulation in the particular circumstances 
would not serve the underlying purpose of the rule or is not necessary 
to achieve the underlying purpose of the rule; or
    (iii) Compliance would result in undue hardship or other costs that 
are significantly in excess of those contemplated when the regulation 
was adopted, or that are significantly in excess of those incurred by 
others similarly situated; or
    (iv) The exemption would result in benefit to the public health and 
safety that compensates for any decrease in safety that may result from 
the grant of the exemption; or
    (v) The exemption would provide only temporary relief from the 
applicable regulation and the licensee or applicant has made good faith 
efforts to comply with the regulation; or
    (vi) There is present any other material circumstance not considered 
when the regulation was adopted for which it would be in the public 
interest to grant an exemption. If such condition is relied on 
exclusively for satisfying paragraph (a)(2) of this section, the 
exemption may not be granted until the Executive Director for Operations 
has consulted with the Commission.
    (b) Any person may request an exemption permitting the conduct of 
activities prior to the issuance of a construction permit prohibited by 
Sec.50.10. The Commission may grant such an exemption upon considering 
and balancing the following factors:
    (1) Whether conduct of the proposed activities will give rise to a 
significant adverse impact on the environment and the nature and extent 
of such impact, if any;

[[Page 869]]

    (2) Whether redress of any adverse environment impact from conduct 
of the proposed activities can reasonably be effected should such 
redress be necessary;
    (3) Whether conduct of the proposed activities would foreclose 
subsequent adoption of alternatives; and
    (4) The effect of delay in conducting such activities on the public 
interest, including the power needs to be used by the proposed facility, 
the availability of alternative sources, if any, to meet those needs on 
a timely basis and delay costs to the applicant and to consumers.

Issuance of such an exemption shall not be deemed to constitute a 
commitment to issue a construction permit. During the period of any 
exemption granted pursuant to this paragraph (b), any activities 
conducted shall be carried out in such a manner as will minimize or 
reduce their environmental impact.

[37 FR 5748, Mar. 21, 1972, as amended at 40 FR 8789, Mar. 3, 1975; 50 
FR 50777, Dec. 12, 1985]



Sec.50.13  Attacks and destructive acts by enemies of the
United States; and defense activities.

    An applicant for a license to construct and operate a production or 
utilization facility, or for an amendment to such license, is not 
required to provide for design features or other measures for the 
specific purpose of protection against the effects of (a) attacks and 
destructive acts, including sabotage, directed against the facility by 
an enemy of the United States, whether a foreign government or other 
person, or (b) use or deployment of weapons incident to U.S. defense 
activities.

[32 FR 13445, Sept. 26, 1967]

               Classification and Description of Licenses



Sec.50.20  Two classes of licenses.

    Licenses will be issued to named persons applying to the 
    Commission therefor, and will be either class 104 or class 103.




Sec.50.21  Class 104 licenses; for medical therapy and research and
development facilities.

    A class 104 license will be issued, to an applicant who qualifies, 
for any one or more of the following: to transfer or receive in 
interstate commerce, manufacture, produce, transfer, acquire, possess, 
or use.
    (a) A utilization facility for use in medical therapy; or
    (b)(1) A production or utilization facility the construction or 
operation of which was licensed pursuant to subsection 104b of the Act 
prior to December 19, 1970;
    (2) A production or utilization facility for industrial or 
commercial purposes constructed or operated under an arrangement with 
the Administration entered into under the Cooperative Power Reactor 
Demonstration Program, except as otherwise specifically required by 
applicable law; and
    (3) A production or utilization facility for industrial or 
commercial purposes, when specifically authorized by law.
    (c) A production or utilization facility, which is useful in the 
conduct of research and development activities of the types specified in 
section 31 of the Act, and which is not a facility of the type specified 
in paragraph (b) of this section or in Sec.50.22.

[21 FR 355, Jan. 19, 1956, as amended at 31 FR 15145, Dec. 2, 1966; 35 
FR 19659, Dec. 29, 1970; 38 FR 11446, May 8, 1973; 43 FR 6924, Feb. 17, 
1978]



Sec.50.22  Class 103 licenses; for commercial and industrial 
facilities.

    A class 103 license will be issued, to an applicant who qualifies, 
for any one or more of the following: To transfer or receive in 
interstate commerce, manufacture, produce, transfer, acquire, possess, 
or use a production or utilization facility for industrial or commercial 
purposes; Provided, however, That in the case of a production or 
utilization facility which is useful in the conduct of research and 
development activities of the types specified in section 31 of the Act, 
such facility is deemed to be for industrial or commercial purposes if 
the facility is to be used so that more than 50 percent of the annual 
cost of owning and operating the facility is

[[Page 870]]

devoted to the production of materials, products, or energy for sale or 
commercial distribution, or to the sale of services, other than research 
and development or education or training.

[38 FR 11446, May 8, 1973, as amended at 43 FR 6924, Feb. 17, 1978]



Sec.50.23  Construction permits.

    A construction permit for the construction of a production or 
utilization facility will be issued before the issuance of a license if 
the application is otherwise acceptable, and will be converted upon 
completion of the facility and Commission action, into a license as 
provided in Sec.50.56. However, if a combined license for a nuclear 
power reactor is issued under part 52 of this chapter, the construction 
permit and operating license are deemed to be combined in a single 
license. A construction permit for the alteration of a production or 
utilization facility will be issued before the issuance of an amendment 
of a license, if the application for amendment is otherwise acceptable, 
as provided in Sec.50.92.

[72 FR 49490, Aug. 28, 2007, as amended at 81 FR 86909, Dec. 2, 2016]

  Applications for Licenses, Certifications, and Regulatory Approvals; 
           Form; Contents; Ineligibility of Certain Applicants



Sec.50.30  Filing of application; oath or affirmation.

    (a) Serving of applications. (1) Each filing of an application for a 
standard design approval or license to construct and/or operate, or 
manufacture, a production or utilization facility (including an early 
site permit, combined license, and manufacturing license under part 52 
of this chapter), and any amendments to the applications, must be 
submitted to the U.S. Nuclear Regulatory Commission in accordance with 
Sec.50.4 or Sec.52.3 of this chapter, as applicable.
    (2) The applicant shall maintain the capability to generate 
additional copies of the general information and the safety analysis 
report, or part thereof or amendment thereto, for subsequent 
distribution in accordance with the written instructions of the 
Director, Office of Nuclear Reactor Regulation, Director, Office of New 
Reactors, or Director, Office of Nuclear Material Safety and Safeguards, 
as appropriate.
    (3) Each applicant for a construction permit under this part, or an 
early site permit, combined license, or manufacturing license under part 
52 of this chapter, shall, upon notification by the Atomic Safety and 
Licensing Board appointed to conduct the public hearing required by the 
Atomic Energy Act, update the application and serve the updated copies 
of the application or parts of it, eliminating all superseded 
information, together with an index of the updated application, as 
directed by the Atomic Safety and Licensing Board. Any subsequent 
amendment to the application must be served on those served copies of 
the application and must be submitted to the U.S. Nuclear Regulatory 
Commission as specified in Sec.50.4 or Sec.52.3 of this chapter, as 
applicable.
    (4) The applicant must make a copy of the updated application 
available at the public hearing for the use of any other parties to the 
proceeding, and shall certify that the updated copies of the application 
contain the current contents of the application submitted in accordance 
with the requirements of this part.
    (5) At the time of filing an application, the Commission will make 
available at the NRC Web site, http://www.nrc.gov, a copy of the 
application, subsequent amendments, and other records pertinent to the 
matter which is the subject of the application for public inspection and 
copying.
    (6) The serving of copies required by this section must not occur 
until the application has been docketed under Sec.2.101(a) of this 
chapter. Copies must be submitted to the Commission, as specified in 
Sec.50.4 or Sec.52.3 of this chapter, as applicable, to enable the 
Director, Office of New Reactors, or the Director, Office of Nuclear 
Reactor Regulation, or the Director, Office of Nuclear Material Safety 
and Safeguards, as appropriate, to determine whether the application is 
sufficiently complete to permit docketing.
    (b) Oath or affirmation. Each application for a standard design 
approval or license, including, whenever appropriate, a construction 
permit or early

[[Page 871]]

site permit, or amendment of it, and each amendment of each application 
must be executed in a signed original by the applicant or duly 
authorized officer thereof under oath or affirmation.
    (c) [Reserved]
    (d) Application for operating licenses. The holder of a construction 
permit for a production or utilization facility shall, at the time of 
submission of the final safety analysis report, file an application for 
an operating license or an amendment to an application for a license to 
construct and operate a production or utilization facility for the 
issuance of an operating license, as appropriate. The application or 
amendment shall state the name of the applicant, the name, location and 
power level, if any, of the facility and the time when the facility is 
expected to be ready for operation, and may incorporate by reference any 
pertinent information submitted in accordance with Sec.50.33 with the 
application for a construction permit.
    (e) Filing Fees. Each application for a standard design approval or 
production or utilization facility license, including, whenever 
appropriate, a construction permit or early site permit, other than a 
license exempted from part 170 of this chapter, shall be accompanied by 
the fee prescribed in part 170 of this chapter. No fee will be required 
to accompany an application for renewal, amendment, or termination of a 
construction permit, operating license, combined license, or 
manufacturing license, except as provided in Sec.170.21 of this 
chapter.
    (f) Environmental report. An application for a construction permit, 
operating license, early site permit, combined license, or manufacturing 
license for a nuclear power reactor, testing facility, fuel reprocessing 
plant, or other production or utilization facility whose construction or 
operation may be determined by the Commission to have a significant 
impact in the environment, shall be accompanied by an Environmental 
Report required under subpart A of part 51 of this chapter.

[23 FR 3115, May 10, 1958, as amended at 33 FR 10924, Aug. 1, 1968; 34 
FR 6307, Apr. 3, 1969; 35 FR 19660, Dec. 29, 1970; 37 FR 5749, Mar. 21, 
1972; 51 FR 40307, Nov. 6, 1986; 64 FR 48951, Sept. 9, 1999; 68 FR 
58809, Oct. 10, 2003; 72 FR 49490, Aug. 28, 2007; 73 FR 5721, Jan. 31, 
2008]



Sec.50.31  Combining applications.

    An applicant may combine in one his several applications for 
different kinds of licenses under the regulations in this chapter.



Sec.50.32  Elimination of repetition.

    In his application, the applicant may incorporate by reference 
information contained in previous applications, statements or reports 
filed with the Commission: Provided, That such references are clear and 
specific.



Sec.50.33  Contents of applications; general information.

    Each application shall state:
    (a) Name of applicant;
    (b) Address of applicant;
    (c) Description of business or occupation of applicant;
    (d)(1) If applicant is an individual, state citizenship.
    (2) If applicant is a partnership, state name, citizenship and 
address of each partner and the principal location where the partnership 
does business.
    (3) If applicant is a corporation or an unincorporated association, 
state:
    (i) The state where it is incorporated or organized and the 
principal location where it does business;
    (ii) The names, addresses and citizenship of its directors and of 
its principal officers;
    (iii) Whether it is owned, controlled, or dominated by an alien, a 
foreign corporation, or foreign government, and if so, give details.
    (4) If the applicant is acting as agent or representative of another 
person in filing the application, identify the principal and furnish 
information required under this paragraph with respect to such 
principal.
    (e) The class of license applied for, the use to which the facility 
will be put, the period of time for which the license is sought, and a 
list of other licenses, except operator's licenses,

[[Page 872]]

issued or applied for in connection with the proposed facility.
    (f) Except for an electric utility applicant for a license to 
operate a utilization facility of the type described in Sec.50.21(b) 
or Sec.50.22, information sufficient to demonstrate to the Commission 
the financial qualification of the applicant to carry out, in accordance 
with regulations in this chapter, the activities for which the permit or 
license is sought. As applicable, the following should be provided:
    (1) If the application is for a construction permit, the applicant 
shall submit information that demonstrates that the applicant possesses 
or has reasonable assurance of obtaining the funds necessary to cover 
estimated construction costs and related fuel cycle costs. The applicant 
shall submit estimates of the total construction costs of the facility 
and related fuel cycle costs, and shall indicate the source(s) of funds 
to cover these costs.
    (2) If the application is for an operating license, the applicant 
shall submit information that demonstrates the applicant possesses or 
has reasonable assurance of obtaining the funds necessary to cover 
estimated operation costs for the period of the license. The applicant 
shall submit estimates for total annual operating costs for each of the 
first five years of operation of the facility. The applicant shall also 
indicate the source(s) of funds to cover these costs. An applicant 
seeking to renew or extend the term of an operating license for a power 
reactor need not submit the financial information that is required in an 
application for an initial license. Applicants to renew or extend the 
term of an operating license for a nonpower reactor shall include the 
financial information that is required in an application for an initial 
license.
    (3) If the application is for a combined license under subpart C of 
part 52 of this chapter, the applicant shall submit the information 
described in paragraphs (f)(1) and (f)(2) of this section.
    (4) Each application for a construction permit, operating license, 
or combined license submitted by a newly-formed entity organized for the 
primary purpose of constructing and/or operating a facility must also 
include information showing:
    (i) The legal and financial relationships it has or proposes to have 
with its stockholders or owners;
    (ii) The stockholders' or owners' financial ability to meet any 
contractual obligation to the entity which they have incurred or 
proposed to incur; and
    (iii) Any other information considered necessary by the Commission 
to enable it to determine the applicant's financial qualification.
    (5) The Commission may request an established entity or newly-formed 
entity to submit additional or more detailed information respecting its 
financial arrangements and status of funds if the Commission considers 
this information appropriate. This may include information regarding a 
licensee's ability to continue the conduct of the activities authorized 
by the license and to decommission the facility.
    (g) If the application is for an operating license or combined 
license for a nuclear power reactor, or if the application is for an 
early site permit and contains plans for coping with emergencies under 
Sec.52.17(b)(2)(ii) of this chapter, the applicant shall submit 
radiological emergency response plans of State and local governmental 
entities in the United States that are wholly or partially within the 
plume exposure pathway emergency planning zone (EPZ), \4\ as well as the 
plans of State governments wholly or partially within the ingestion 
pathway EPZ. \5\ If the application is for an early site permit that, 
under 10 CFR 52.17(b)(2)(i), proposes major features of the emergency 
plans describing the EPZs, then the descriptions of the EPZs must meet 
the requirements of this paragraph. Generally, the plume exposure 
pathway

[[Page 873]]

EPZ for nuclear power reactors shall consist of an area about 10 miles 
(16 km) in radius and the ingestion pathway EPZ shall consist of an area 
about 50 miles (80 km) in radius. The exact size and configuration of 
the EPZs surrounding a particular nuclear power reactor shall be 
determined in relation to the local emergency response needs and 
capabilities as they are affected by such conditions as demography, 
topography, land characteristics, access routes, and jurisdictional 
boundaries. The size of the EPZs also may be determined on a case-by-
case basis for gas-cooled reactors and for reactors with an authorized 
power level less than 250 MW thermal. The plans for the ingestion 
pathway shall focus on such actions as are appropriate to protect the 
food ingestion pathway.
---------------------------------------------------------------------------

    \4\ Emergency planning zones (EPZs) are discussed in NUREG-0396, EPA 
520/1-78-016, ``Planning Basis for the Development of State and Local 
Government Radiological Emergency Response Plans in Support of Light-
Water Nuclear Power Plants,'' December 1978.
    \5\ If the State and local emergency response plans have been 
previously provided to the NRC for inclusion in the facility docket, the 
applicant need only provide the appropriate reference to meet this 
requirement.
---------------------------------------------------------------------------

    (h) If the applicant, other than an applicant for a combined 
license, proposes to construct or alter a production or utilization 
facility, the application shall state the earliest and latest dates for 
completion of the construction or alteration.
    (i) If the proposed activity is the generation and distribution of 
electric energy under a class 103 license, a list of the names and 
addresses of such regulatory agencies as may have jurisdiction over the 
rates and services incident to the proposed activity, and a list of 
trade and news publications which circulate in the area where the 
proposed activity will be conducted and which are considered appropriate 
to give reasonable notice of the application to those municipalities, 
private utilities, public bodies, and cooperatives, which might have a 
potential interest in the facility.
    (j) If the application contains Restricted Data or other defense 
information, it shall be prepared in such manner that all Restricted 
Data and other defense information are separated from the unclassified 
information.
    (k)(1) For an application for an operating license or combined 
license for a production or utilization facility, information in the 
form of a report, as described in Sec.50.75, indicating how reasonable 
assurance will be provided that funds will be available to decommission 
the facility.
    (2) On or before July 26, 1990, each holder of an operating license 
for a production or utilization facility in effect on July 27, 1990, 
shall submit information in the form of a report as described in Sec.
50.75 of this part, indicating how reasonable assurance will be provided 
that funds will be available to decommission the facility.

[21 FR 355, Jan. 19, 1956, as amended at 35 FR 19660, Dec. 29, 1970; 38 
FR 3956, Feb. 9, 1973; 45 FR 55408, Aug. 19, 1980; 49 FR 35752, Sept. 
12, 1984; 53 FR 24049, June 27, 1988; 69 FR 4448, Jan. 30, 2004; 72 FR 
49490, Aug. 28, 2007]



Sec.50.34  Contents of applications; technical information.

    (a) Preliminary safety analysis report. Each application for a 
construction permit shall include a preliminary safety analysis report. 
The minimum information \5\ to be included shall consist of the 
following:
---------------------------------------------------------------------------

    \5\ The applicant may provide information required by this paragraph 
in the form of a discussion, with specific references, of similarities 
to and differences from, facilities of similar design for which 
applications have previously been filed with the Commission.
---------------------------------------------------------------------------

    (1) Stationary power reactor applicants for a construction permit 
who apply on or after January 10, 1997, shall comply with paragraph 
(a)(1)(ii) of this section. All other applicants for a construction 
permit shall comply with paragraph (a)(1)(i) of this section.
    (i) A description and safety assessment of the site on which the 
facility is to be located, with appropriate attention to features 
affecting facility design. Special attention should be directed to the 
site evaluation factors identified in part 100 of this chapter. The 
assessment must contain an analysis and evaluation of the major 
structures, systems and components of the facility which bear 
significantly on the acceptability of the site under the site evaluation 
factors identified in part 100 of this chapter, assuming that the 
facility will be operated at the ultimate power level which is 
contemplated by the applicant. With respect to operation at the 
projected initial power level, the applicant is required to submit 
information prescribed in paragraphs (a)(2) through (a)(8) of this 
section, as well as the information required by this paragraph, in 
support of

[[Page 874]]

the application for a construction permit, or a design approval.
    (ii) A description and safety assessment of the site and a safety 
assessment of the facility. It is expected that reactors will reflect 
through their design, construction and operation an extremely low 
probability for accidents that could result in the release of 
significant quantities of radioactive fission products. The following 
power reactor design characteristics and proposed operation will be 
taken into consideration by the Commission:
    (A) Intended use of the reactor including the proposed maximum power 
level and the nature and inventory of contained radioactive materials;
    (B) The extent to which generally accepted engineering standards are 
applied to the design of the reactor;
    (C) The extent to which the reactor incorporates unique, unusual or 
enhanced safety features having a significant bearing on the probability 
or consequences of accidental release of radioactive materials;
    (D) The safety features that are to be engineered into the facility 
and those barriers that must be breached as a result of an accident 
before a release of radioactive material to the environment can occur. 
Special attention must be directed to plant design features intended to 
mitigate the radiological consequences of accidents. In performing this 
assessment, an applicant shall assume a fission product release \6\ from 
the core into the containment assuming that the facility is operated at 
the ultimate power level contemplated. The applicant shall perform an 
evaluation and analysis of the postulated fission product release, using 
the expected demonstrable containment leak rate and any fission product 
cleanup systems intended to mitigate the consequences of the accidents, 
together with applicable site characteristics, including site 
meteorology, to evaluate the offsite radiological consequences. Site 
characteristics must comply with part 100 of this chapter. The 
evaluation must determine that:
---------------------------------------------------------------------------

    \6\ The fission product release assumed for this evaluation should 
be based upon a major accident, hypothesized for purposes of site 
analysis or postulated from considerations of possible accidental 
events. Such accidents have generally been assumed to result in 
substantial meltdown of the core with subsequent release into the 
containment of appreciable quantities of fission products.
---------------------------------------------------------------------------

    (1) An individual located at any point on the boundary of the 
exclusion area for any 2 hour period following the onset of the 
postulated fission product release, would not receive a radiation dose 
in excess of 25 rem \7\ total effective dose equivalent (TEDE).
---------------------------------------------------------------------------

    \7\ A whole body dose of 25 rem has been stated to correspond 
numerically to the once in a lifetime accidental or emergency dose for 
radiation workers which, according to NCRP recommendations at the time 
could be disregarded in the determination of their radiation exposure 
status (see NBS Handbook 69 dated June 5, 1959). However, its use is not 
intended to imply that this number constitutes an acceptable limit for 
an emergency dose to the public under accident conditions. Rather, this 
dose value has been set forth in this section as a reference value, 
which can be used in the evaluation of plant design features with 
respect to postulated reactor accidents, in order to assure that such 
designs provide assurance of low risk of public exposure to radiation, 
in the event of such accidents.
---------------------------------------------------------------------------

    (2) An individual located at any point on the outer boundary of the 
low population zone, who is exposed to the radioactive cloud resulting 
from the postulated fission product release (during the entire period of 
its passage) would not receive a radiation dose in excess of 25 rem 
total effective dose equivalent (TEDE);
    (E) With respect to operation at the projected initial power level, 
the applicant is required to submit information prescribed in paragraphs 
(a)(2) through (a)(8) of this section, as well as the information 
required by paragraph (a)(1)(i) of this section, in support of the 
application for a construction permit.
    (2) A summary description and discussion of the facility, with 
special attention to design and operating characteristics, unusual or 
novel design features, and principal safety considerations.
    (3) The preliminary design of the facility including:

[[Page 875]]

    (i) The principal design criteria for the facility. \8\ Appendix A, 
General Design Criteria for Nuclear Power Plants, establishes minimum 
requirements for the principal design criteria for water-cooled nuclear 
power plants similar in design and location to plants for which 
construction permits have previously been issued by the Commission and 
provides guidance to applicants for construction permits in establishing 
principal design criteria for other types of nuclear power units;
---------------------------------------------------------------------------

    \8\ General design criteria for chemical processing facilities are 
being developed.
    \9\ [Reserved]
---------------------------------------------------------------------------

    (ii) The design bases and the relation of the design bases to the 
principal design criteria;
    (iii) Information relative to materials of construction, general 
arrangement, and approximate dimensions, sufficient to provide 
reasonable assurance that the final design will conform to the design 
bases with adequate margin for safety.
    (4) A preliminary analysis and evaluation of the design and 
performance of structures, systems, and components of the facility with 
the objective of assessing the risk to public health and safety 
resulting from operation of the facility and including determination of 
the margins of safety during normal operations and transient conditions 
anticipated during the life of the facility, and the adequacy of 
structures, systems, and components provided for the prevention of 
accidents and the mitigation of the consequences of accidents. Analysis 
and evaluation of ECCS cooling performance and the need for high point 
vents following postulated loss-of-coolant accidents must be performed 
in accordance with the requirements of Sec.50.46 and Sec.50.46a of 
this part for facilities for which construction permits may be issued 
after December 28, 1974.
    (5) An identification and justification for the selection of those 
variables, conditions, or other items which are determined as the result 
of preliminary safety analysis and evaluation to be probable subjects of 
technical specifications for the facility, with special attention given 
to those items which may significantly influence the final design: 
Provided, however, That this requirement is not applicable to an 
application for a construction permit filed prior to January 16, 1969.
    (6) A preliminary plan for the applicant's organization, training of 
personnel, and conduct of operations.
    (7) 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. Appendix B, ``Quality Assurance 
Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,'' sets 
forth the requirements for quality assurance programs for nuclear power 
plants and fuel reprocessing plants. The description of the quality 
assurance program for a nuclear power plant or a fuel reprocessing plant 
shall include a discussion of how the applicable requirements of 
appendix B will be satisfied.
    (8) An identification of those structures, systems, or components of 
the facility, if any, which require research and development to confirm 
the adequacy of their design; and identification and description of the 
research and development program which will be conducted to resolve any 
safety questions associated with such structures, systems or components; 
and a schedule of the research and development program showing that such 
safety questions will be resolved at or before the latest date stated in 
the application for completion of construction of the facility.
    (9) The technical qualifications of the applicant to engage in the 
proposed activities in accordance with the regulations in this chapter.
    (10) A discussion of the applicant's preliminary plans for coping 
with emergencies. Appendix E sets forth items which shall be included in 
these plans.
    (11) On or after February 5, 1979, applicants who apply for 
construction permits for nuclear power plants to be built on multiunit 
sites shall identify potential hazards to the structures, systems and 
components important to safety of operating nuclear facilities from 
construction activities. A discussion shall also be included of any 
managerial and administrative controls that will be used during 
construction

[[Page 876]]

to assure the safety of the operating unit.
    (12) On or after January 10, 1997, stationary power reactor 
applicants who apply for a construction permit, as partial conformance 
to General Design Criterion 2 of appendix A to this part, shall comply 
with the earthquake engineering criteria in appendix S to this part.
    (13) On or after July 13, 2009, stationary power reactor applicants 
who apply for a construction permit shall submit the information 
required by 10 CFR 50.150(b) as a part of their preliminary safety 
analysis report.
    (b) Final safety analysis report. Each application for an operating 
license shall include a final safety analysis report. The final safety 
analysis report shall include information that describes the facility, 
presents the design bases and the limits on its operation, and presents 
a safety analysis of the structures, systems, and components and of the 
facility as a whole, and shall include the following:
    (1) All current information, such as the results of environmental 
and meteorological monitoring programs, which has been developed since 
issuance of the construction permit, relating to site evaluation factors 
identified in part 100 of this chapter.
    (2) A description and analysis of the structures, systems, and 
components of the facility, with emphasis upon performance requirements, 
the bases, with technical justification therefor, upon which such 
requirements have been established, and the evaluations required to show 
that safety functions will be accomplished. The description shall be 
sufficient to permit understanding of the system designs and their 
relationship to safety evaluations.
    (i) For nuclear reactors, such items as the reactor core, reactor 
coolant system, instrumentation and control systems, electrical systems, 
containment system, other engineered safety features, auxiliary and 
emergency systems, power conversion systems, radioactive waste handling 
systems, and fuel handling systems shall be discussed insofar as they 
are pertinent.
    (ii) For facilities other than nuclear reactors, such items as the 
chemical, physical, metallurgical, or nuclear process to be performed, 
instrumentation and control systems, ventilation and filter systems, 
electrical systems, auxiliary and emergency systems, and radioactive 
waste handling systems shall be discussed insofar as they are pertinent.
    (3) The kinds and quantities of radioactive materials expected to be 
produced in the operation and the means for controlling and limiting 
radioactive effluents and radiation exposures within the limits set 
forth in part 20 of this chapter.
    (4) A final analysis and evaluation of the design and performance of 
structures, systems, and components with the objective stated in 
paragraph (a)(4) of this section and taking into account any pertinent 
information developed since the submittal of the preliminary safety 
analysis report. Analysis and evaluation of ECCS cooling performance 
following postulated loss-of-coolant accidents shall be performed in 
accordance with the requirements of Sec.50.46 for facilities for which 
a license to operate may be issued after December 28, 1974.
    (5) A description and evaluation of the results of the applicant's 
programs, including research and development, if any, to demonstrate 
that any safety questions identified at the construction permit stage 
have been resolved.
    (6) The following information concerning facility operation:
    (i) The applicant's organizational structure, allocations or 
responsibilities and authorities, and personnel qualifications 
requirements.
    (ii) Managerial and administrative controls to be used to assure 
safe operation. Appendix B, ``Quality Assurance Criteria for Nuclear 
Power Plants and Fuel Reprocessing Plants,'' sets forth the requirements 
for such controls for nuclear power plants and fuel reprocessing plants. 
The information on the controls to be used for a nuclear power plant or 
a fuel reprocessing plant shall include a discussion of how the 
applicable requirements of appendix B will be satisfied.
    (iii) Plans for preoperational testing and initial operations.

[[Page 877]]

    (iv) Plans for conduct of normal operations, including maintenance, 
surveillance, and periodic testing of structures, systems, and 
components.
    (v) Plans for coping with emergencies, which shall include the items 
specified in appendix E.
    (vi) Proposed technical specifications prepared in accordance with 
the requirements of Sec.50.36.
    (vii) On or after February 5, 1979, applicants who apply for 
operating licenses for nuclear power plants to be operated on multiunit 
sites shall include an evaluation of the potential hazards to the 
structures, systems, and components important to safety of operating 
units resulting from construction activities, as well as a description 
of the managerial and administrative controls to be used to provide 
assurance that the limiting conditions for operation are not exceeded as 
a result of construction activities at the multiunit sites.
    (7) The technical qualifications of the applicant to engage in the 
proposed activities in accordance with the regulations in this chapter.
    (8) A description and plans for implementation of an operator 
requalification program. The operator requalification program must as a 
minimum, meet the requirements for those programs contained in Sec.
55.59 of part 55 of this chapter.
    (9) A description of protection provided against pressurized thermal 
shock events, including projected values of the reference temperature 
for reactor vessel beltline materials as defined in Sec.50.61 (b)(1) 
and (b)(2).
    (10) On or after January 10, 1997, stationary power reactor 
applicants who apply for an operating license, as partial conformance to 
General Design Criterion 2 of appendix A to this part, shall comply with 
the earthquake engineering criteria of appendix S to this part. However, 
for those operating license applicants and holders whose construction 
permit was issued before January 10, 1997, the earthquake engineering 
criteria in Section VI of appendix A to part 100 of this chapter 
continues to apply.
    (11) On or after January 10, 1997, stationary power reactor 
applicants who apply for an operating license, shall provide a 
description and safety assessment of the site and of the facility as in 
Sec.50.34(a)(1)(ii). However, for either an operating license 
applicant or holder whose construction permit was issued before January 
10, 1997, the reactor site criteria in part 100 of this chapter and the 
seismic and geologic siting criteria in appendix A to part 100 of this 
chapter continues to apply.
    (12) On or after July 13, 2009, stationary power reactor applicants 
who apply for an operating license which is subject to 10 CFR 50.150(a) 
shall submit the information required by 10 CFR 50.150(b) as a part of 
their final safety analysis report.
    (c) Physical security plan. (1) Each applicant for an operating 
license for a production or utilization facility that will be subject to 
Sec. Sec.73.50 and 73.60 of this chapter must include a physical 
security plan.
    (2) Each applicant for an operating license for a utilization 
facility that will be subject to the requirements of Sec.73.55 of this 
chapter must include a physical security plan, a training and 
qualification plan in accordance with the criteria set forth in appendix 
B to part 73 of this chapter, and a cyber security plan in accordance 
with the criteria set forth in Sec.73.54 of this chapter.
    (3) The physical security plan must describe how the applicant will 
meet the requirements of part 73 of this chapter (and part 11 of this 
chapter, if applicable, including the identification and description of 
jobs as required by Sec.11.11(a) of this chapter, at the proposed 
facility). Security plans must list tests, inspections, audits, and 
other means to be used to demonstrate compliance with the requirements 
of 10 CFR parts 11 and 73, if applicable.
    (d) Safeguards contingency plan. (1) Each application for a license 
to operate a production or utilization facility that will be subject to 
Sec. Sec.73.50 and 73.60 of this chapter must include a licensee 
safeguards contingency plan in accordance with the criteria set forth in 
section I of appendix C to part 73 of this chapter. The ``implementation 
procedures'' required per section I of appendix C to part 73 of this 
chapter do not have to be submitted to the Commission for approval.

[[Page 878]]

    (2) Each application for a license to operate a utilization facility 
that will be subject to Sec.73.55 of this chapter must include a 
licensee safeguards contingency plan in accordance with the criteria set 
forth in section II of appendix C to part 73 of this chapter. The 
``implementing procedures'' required in section II of appendix C to part 
73 of this chapter do not have to be submitted to the Commission for 
approval.
    (e) Protection against unauthorized disclosure. Each applicant for 
an operating license for a production or utilization facility, who 
prepares a physical security plan, a safeguards contingency plan, a 
training and qualification plan, or a cyber security plan, shall protect 
the plans and other related Safeguards Information against unauthorized 
disclosure in accordance with the requirements of Sec.73.21 of this 
chapter.
    (f) Additional TMI-related requirements. In addition to the 
requirements of paragraph (a) of this section, each applicant for a 
light-water-reactor construction permit or manufacturing license whose 
application was pending as of February 16, 1982, shall meet the 
requirements in paragraphs (f)(1) through (3) of this section. This 
regulation applies to the pending applications by Duke Power Company 
(Perkins Nuclear Station, Units 1, 2, and 3), Houston Lighting & Power 
Company (Allens Creek Nuclear Generating Station, Unit 1), Portland 
General Electric Company (Pebble Springs Nuclear Plant, Units 1 and 2), 
Public Service Company of Oklahoma (Black Fox Station, Units 1 and 2), 
Puget Sound Power & Light Company (Skagit/Hanford Nuclear Power Project, 
Units 1 and 2), and Offshore Power Systems (License to Manufacture 
Floating Nuclear Plants). The number of units that will be specified in 
the manufacturing license above, if issued, will be that number whose 
start of manufacture, as defined in the license application, can 
practically begin within a 10-year period commencing on the date of 
issuance of the manufacturing license, but in no event will that number 
be in excess of ten. The manufacturing license will require the plant 
design to be updated no later than 5 years after its approval. 
Paragraphs (f)(1)(xii), (2)(ix), and (3)(v) of this section, pertaining 
to hydrogen control measures, must be met by all applicants covered by 
this regulation. However, the Commission may decide to impose additional 
requirements and the issue of whether compliance with these provisions, 
together with 10 CFR 50.44 and criterion 50 of appendix A to 10 CFR part 
50, is sufficient for issuance of that manufacturing license which may 
be considered in the manufacturing license proceeding. In addition, each 
applicant for a design certification, design approval, combined license, 
or manufacturing license under part 52 of this chapter shall demonstrate 
compliance with the technically relevant portions of the requirements in 
paragraphs (f)(1) through (3) of this section, except for paragraphs 
(f)(1)(xii), (f)(2)(ix), and (f)(3)(v).
    (1) To satisfy the following requirements, the application shall 
provide sufficient information to describe the nature of the studies, 
how they are to be conducted, estimated submittal dates, and a program 
to ensure that the results of these studies are factored into the final 
design of the facility. For licensees identified in the introduction to 
paragraph (f) of this section, all studies must be completed no later 
than 2 years following the issuance of the construction permit or 
manufacturing license. \10\ For all other applicants, the studies must 
be submitted as part of the final safety analysis report.
---------------------------------------------------------------------------

    \10\ Alphanumeric designations correspond to the related action plan 
items in NUREG 0718 and NUREG-0660, ``NRC Action Plan Developed as a 
Result of the TMI-2 Accident.'' They are provided herein for information 
only.
---------------------------------------------------------------------------

    (i) Perform a plant/site specific probabilistic risk assessment, the 
aim of which is to seek such improvements in the reliability of core and 
containment heat removal systems as are significant and practical and do 
not impact excessively on the plant. (II.B.8)
    (ii) Perform an evaluation of the proposed auxiliary feedwater 
system (AFWS), to include (applicable to PWR's only) (II.E.1.1):
    (A) A simplified AFWS reliability analysis using event-tree and 
fault-tree logic techniques.
    (B) A design review of AFWS.

[[Page 879]]

    (C) An evaluation of AFWS flow design bases and criteria.
    (iii) Perform an evaluation of the potential for and impact of 
reactor coolant pump seal damage following small-break LOCA with loss of 
offsite power. If damage cannot be precluded, provide an analysis of the 
limiting small-break loss-of-coolant accident with subsequent reactor 
coolant pump seal damage. (II.K.2.16 and II.K.3.25)
    (iv) Perform an analysis of the probability of a small-break loss-
of-coolant accident (LOCA) caused by a stuck-open power-operated relief 
valve (PORV). If this probability is a significant contributor to the 
probability of small-break LOCA's from all causes, provide a description 
and evaluation of the effect on small-break LOCA probability of an 
automatic PORV isolation system that would operate when the reactor 
coolant system pressure falls after the PORV has opened. (Applicable to 
PWR's only). (II.K.3.2)
    (v) Perform an evaluation of the safety effectiveness of providing 
for separation of high pressure coolant injection (HPCI) and reactor 
core isolation cooling (RCIC) system initiation levels so that the RCIC 
system initiates at a higher water level than the HPCI system, and of 
providing that both systems restart on low water level. (For plants with 
high pressure core spray systems in lieu of high pressure coolant 
injection systems, substitute the words, ``high pressure core spray'' 
for ``high pressure coolant injection'' and ``HPCS'' for ``HPCI'') 
(Applicable to BWR's only). (II.K.3.13)
    (vi) Perform a study to identify practicable system modifications 
that would reduce challenges and failures of relief valves, without 
compromising the performance of the valves or other systems. (Applicable 
to BWR's only). (II.K.3.16)
    (vii) Perform a feasibility and risk assessment study to determine 
the optimum automatic depressurization system (ADS) design modifications 
that would eliminate the need for manual activation to ensure adequate 
core cooling. (Applicable to BWR's only). (II.K.3.18)
    (viii) Perform a study of the effect on all core-cooling modes under 
accident conditions of designing the core spray and low pressure coolant 
injection systems to ensure that the systems will automatically restart 
on loss of water level, after having been manually stopped, if an 
initiation signal is still present. (Applicable to BWR's only). 
(II.K.3.21)
    (ix) Perform a study to determine the need for additional space 
cooling to ensure reliable long-term operation of the reactor core 
isolation cooling (RCIC) and high-pressure coolant injection (HPCI) 
systems, following a complete loss of offsite power to the plant for at 
least two (2) hours. (For plants with high pressure core spray systems 
in lieu of high pressure coolant injection systems, substitute the 
words, ``high pressure core spray'' for ``high pressure coolant 
injection'' and ``HPCS'' for ``HPCI'') (Applicable to BWR's only). 
(II.K.3.24)
    (x) Perform a study to ensure that the Automatic Depressurization 
System, valves, accumulators, and associated equipment and 
instrumentation will be capable of performing their intended functions 
during and following an accident situation, taking no credit for non-
safety related equipment or instrumentation, and accounting for normal 
expected air (or nitrogen) leakage through valves. (Applicable to BWR's 
only). (II.K.3.28)
    (xi) Provide an evaluation of depressurization methods, other than 
by full actuation of the automatic depressurization system, that would 
reduce the possibility of exceeding vessel integrity limits during rapid 
cooldown. (Applicable to BWR's only) (II.K.3.45)
    (xii) Perform an evaluation of alternative hydrogen control systems 
that would satisfy the requirements of paragraph (f)(2)(ix) of this 
section. As a minimum include consideration of a hydrogen ignition and 
post-accident inerting system. The evaluation shall include:
    (A) A comparison of costs and benefits of the alternative systems 
considered.
    (B) For the selected system, analyses and test data to verify 
compliance with the requirements of (f)(2)(ix) of this section.
    (C) For the selected system, preliminary design descriptions of 
equipment, function, and layout.

[[Page 880]]

    (2) To satisfy the following requirements, the application shall 
provide sufficient information to demonstrate that the required actions 
will be satisfactorily completed by the operating license stage. This 
information is of the type customarily required to satisfy 10 CFR 
50.35(a)(2) or to address unresolved generic safety issues.
    (i) Provide simulator capability that correctly models the control 
room and includes the capability to simulate small-break LOCA's. 
(Applicable to construction permit applicants only) (I.A.4.2.)
    (ii) Establish a program, to begin during construction and follow 
into operation, for integrating and expanding current efforts to improve 
plant procedures. The scope of the program shall include emergency 
procedures, reliability analyses, human factors engineering, crisis 
management, operator training, and coordination with INPO and other 
industry efforts. (Applicable to construction permit applicants only) 
(I.C.9)
    (iii) Provide, for Commission review, a control room design that 
reflects state-of-the-art human factor principles prior to committing to 
fabrication or revision of fabricated control room panels and layouts. 
(I.D.1)
    (iv) Provide a plant safety parameter display console that will 
display to operators a minimum set of parameters defining the safety 
status of the plant, capable of displaying a full range of important 
plant parameters and data trends on demand, and capable of indicating 
when process limits are being approached or exceeded. (I.D.2)
    (v) Provide for automatic indication of the bypassed and operable 
status of safety systems. (I.D.3)
    (vi) Provide the capability of high point venting of noncondensible 
gases from the reactor coolant system, and other systems that may be 
required to maintain adequate core cooling. Systems to achieve this 
capability shall be capable of being operated from the control room and 
their operation shall not lead to an unacceptable increase in the 
probability of loss-of-coolant accident or an unacceptable challenge to 
containment integrity. (II.B.1)
    (vii) Perform radiation and shielding design reviews of spaces 
around systems that may, as a result of an accident, contain accident 
source term \11\ radioactive materials, and design as necessary to 
permit adequate access to important areas and to protect safety 
equipment from the radiation environment. (II.B.2)
---------------------------------------------------------------------------

    \11\ The fission product release assumed for these calculations 
should be based upon a major accident, hypothesized for purposes of site 
analysis or postulated from considerations of possible accidental 
events, that would result in potential hazards not exceeded by those 
from any accident considered credible. Such accidents have generally 
been assumed to result in substantial meltdown of the core with 
subsequent release of appreciable quantities of fission products.
---------------------------------------------------------------------------

    (viii) Provide a capability to promptly obtain and analyze samples 
from the reactor coolant system and containment that may contain 
accident source term \11\ radioactive materials without radiation 
exposures to any individual exceeding 5 rems to the whole body or 50 
rems to the extremities. Materials to be analyzed and quantified include 
certain radionuclides that are indicators of the degree of core damage 
(e.g., noble gases, radioiodines and cesiums, and nonvolatile isotopes), 
hydrogen in the containment atmosphere, dissolved gases, chloride, and 
boron concentrations. (II.B.3)
    (ix) Provide a system for hydrogen control that can safely 
accommodate hydrogen generated by the equivalent of a 100% fuel-clad 
metal water reaction. Preliminary design information on the tentatively 
preferred system option of those being evaluated in paragraph 
(f)(1)(xii) of this section is sufficient at the construction permit 
stage. The hydrogen control system and associated systems shall provide, 
with reasonable assurance, that: (II.B.8)
    (A) Uniformly distributed hydrogen concentrations in the containment 
do not exceed 10% during and following an accident that releases an 
equivalent amount of hydrogen as would be generated from a 100% fuel 
clad metal-water reaction, or that the post-accident atmosphere will not 
support hydrogen combustion.
    (B) Combustible concentrations of hydrogen will not collect in areas 
where unintended combustion or detonation could cause loss of 
containment

[[Page 881]]

integrity or loss of appropriate mitigating features.
    (C) Equipment necessary for achieving and maintaining safe shutdown 
of the plant and maintaining containment integrity will perform its 
safety function during and after being exposed to the environmental 
conditions attendant with the release of hydrogen generated by the 
equivalent of a 100% fuel-clad metal water reaction including the 
environmental conditions created by activation of the hydrogen control 
system.
    (D) If the method chosen for hydrogen control is a post-accident 
inerting system, inadvertent actuation of the system can be safely 
accommodated during plant operation.
    (x) Provide a test program and associated model development and 
conduct tests to qualify reactor coolant system relief and safety valves 
and, for PWR's, PORV block valves, for all fluid conditions expected 
under operating conditions, transients and accidents. Consideration of 
anticipated transients without scram (ATWS) conditions shall be included 
in the test program. Actual testing under ATWS conditions need not be 
carried out until subsequent phases of the test program are developed. 
(II.D.1)
    (xi) Provide direct indication of relief and safety valve position 
(open or closed) in the control room. (II.D.3)
    (xii) Provide automatic and manual auxiliary feedwater (AFW) system 
initiation, and provide auxiliary feedwater system flow indication in 
the control room. (Applicable to PWR's only) (II.E.1.2)
    (xiii) Provide pressurizer heater power supply and associated motive 
and control power interfaces sufficient to establish and maintain 
natural circulation in hot standby conditions with only onsite power 
available. (Applicable to PWR's only) (II.E.3.1)
    (xiv) Provide containment isolation systems that: (II.E.4.2)
    (A) Ensure all non-essential systems are isolated automatically by 
the containment isolation system,
    (B) For each non-essential penetration (except instrument lines) 
have two isolation barriers in series,
    (C) Do not result in reopening of the containment isolation valves 
on resetting of the isolation signal,
    (D) Utilize a containment set point pressure for initiating 
containment isolation as low as is compatible with normal operation,
    (E) Include automatic closing on a high radiation signal for all 
systems that provide a path to the environs.
    (xv) Provide a capability for containment purging/venting designed 
to minimize the purging time consistent with ALARA principles for 
occupational exposure. Provide and demonstrate high assurance that the 
purge system will reliably isolate under accident conditions. (II.E.4.4)
    (xvi) Establish a design criterion for the allowable number of 
actuation cycles of the emergency core cooling system and reactor 
protection system consistent with the expected occurrence rates of 
severe overcooling events (considering both anticipated transients and 
accidents). (Applicable to B&W designs only). (II.E.5.1)
    (xvii) Provide instrumentation to measure, record and readout in the 
control room: (A) containment pressure, (B) containment water level, (C) 
containment hydrogen concentration, (D) containment radiation intensity 
(high level), and (E) noble gas effluents at all potential, accident 
release points. Provide for continuous sampling of radioactive iodines 
and particulates in gaseous effluents from all potential accident 
release points, and for onsite capability to analyze and measure these 
samples. (II.F.1)
    (xviii) Provide instruments that provide in the control room an 
unambiguous indication of inadequate core cooling, such as primary 
coolant saturation meters in PWR's, and a suitable combination of 
signals from indicators of coolant level in the reactor vessel and in-
core thermocouples in PWR's and BWR's. (II.F.2)
    (xix) Provide instrumentation adequate for monitoring plant 
conditions following an accident that includes core damage. (II.F.3)
    (xx) Provide power supplies for pressurizer relief valves, block 
valves, and level indicators such that: (A) Level indicators are powered 
from vital buses;

[[Page 882]]

(B) motive and control power connections to the emergency power sources 
are through devices qualified in accordance with requirements applicable 
to systems important to safety and (C) electric power is provided from 
emergency power sources. (Applicable to PWR's only). (II.G.1)
    (xxi) Design auxiliary heat removal systems such that necessary 
automatic and manual actions can be taken to ensure proper functioning 
when the main feedwater system is not operable. (Applicable to BWR's 
only). (II.K.1.22)
    (xxii) Perform a failure modes and effects analysis of the 
integrated control system (ICS) to include consideration of failures and 
effects of input and output signals to the ICS. (Applicable to B&W-
designed plants only). (II.K.2.9)
    (xxiii) Provide, as part of the reactor protection system, an 
anticipatory reactor trip that would be actuated on loss of main 
feedwater and on turbine trip. (Applicable to B&W-designed plants only). 
(II.K.2.10)
    (xxiv) Provide the capability to record reactor vessel water level 
in one location on recorders that meet normal post-accident recording 
requirements. (Applicable to BWR's only). (II.K.3.23)
    (xxv) Provide an onsite Technical Support Center, an onsite 
Operational Support Center, and, for construction permit applications 
only, a nearsite Emergency Operations Facility. (III.A.1.2).
    (xxvi) Provide for leakage control and detection in the design of 
systems outside containment that contain (or might contain) accident 
source term \11\ radioactive materials following an accident. Applicants 
shall submit a leakage control program, including an initial test 
program, a schedule for re-testing these systems, and the actions to be 
taken for minimizing leakage from such systems. The goal is to minimize 
potential exposures to workers and public, and to provide reasonable 
assurance that excessive leakage will not prevent the use of systems 
needed in an emergency. (III.D.1.1)
    (xxvii) Provide for monitoring of inplant radiation and airborne 
radioactivity as appropriate for a broad range of routine and accident 
conditions. (III.D.3.3)
    (xxviii) Evaluate potential pathways for radioactivity and radiation 
that may lead to control room habitability problems under accident 
conditions resulting in an accident source term \11\ release, and make 
necessary design provisions to preclude such problems. (III.D.3.4)
    (3) To satisfy the following requirements, the application shall 
provide sufficient information to demonstrate that the requirement has 
been met. This information is of the type customarily required to 
satisfy paragraph (a)(1) of this section or to address the applicant's 
technical qualifications and management structure and competence.
    (i) Provide administrative procedures for evaluating operating, 
design and construction experience and for ensuring that applicable 
important industry experiences will be provided in a timely manner to 
those designing and constructing the plant. (I.C.5)
    (ii) Ensure that the quality assurance (QA) list required by 
Criterion II, app. B, 10 CFR part 50 includes all structures, systems, 
and components important to safety. (I.F.1)
    (iii) Establish a quality assurance (QA) program based on 
consideration of: (A) Ensuring independence of the organization 
performing checking functions from the organization responsible for 
performing the functions; (B) performing quality assurance/quality 
control functions at construction sites to the maximum feasible extent; 
(C) including QA personnel in the documented review of and concurrence 
in quality related procedures associated with design, construction and 
installation; (D) establishing criteria for determining QA programmatic 
requirements; (E) establishing qualification requirements for QA and QC 
personnel; (F) sizing the QA staff commensurate with its duties and 
responsibilities; (G) establishing procedures for maintenance of ``as-
built'' documentation; and (H) providing a QA role in design and 
analysis activities. (I.F.2)
    (iv) Provide one or more dedicated containment penetrations, 
equivalent

[[Page 883]]

in size to a single 3-foot diameter opening, in order not to preclude 
future installation of systems to prevent containment failure, such as a 
filtered vented containment system. (II.B.8)
    (v) Provide preliminary design information at a level of detail 
consistent with that normally required at the construction permit stage 
of review sufficient to demonstrate that: (II.B.8)
    (A)(1) Containment integrity will be maintained (i.e., for steel 
containments by meeting the requirements of the ASME Boiler and Pressure 
Vessel Code, Section III, Division 1, subarticle NE-3220, Service Level 
C Limits, except that evaluation of instability is not required, 
considering pressure and dead load alone. For concrete containments by 
meeting the requirements of the ASME Boiler Pressure Vessel Code, 
Section III, Division 2 subarticle CC-3720, Factored Load Category, 
considering pressure and dead load alone) during an accident that 
releases hydrogen generated from 100% fuel clad metal-water reaction 
accompanied by either hydrogen burning or the added pressure from post-
accident inerting assuming carbon dioxide is the inerting agent. As a 
minimum, the specific code requirements set forth above appropriate for 
each type of containment will be met for a combination of dead load and 
an internal pressure of 45 psig. Modest deviations from these criteria 
will be considered by the staff, if good cause is shown by an applicant. 
Systems necessary to ensure containment integrity shall also be 
demonstrated to perform their function under these conditions.
    (2) Subarticle NE-3220, Division 1, and subarticle CC-3720, Division 
2, of section III of the July 1, 1980 ASME Boiler and Pressure Vessel 
Code, which are referenced in paragraphs (f)(3)(v)(A)(1) and 
(f)(3)(v)(B)(1) of this section, were approved for incorporation by 
reference by the Director of the Office of the Federal Register. A 
notice of any changes made to the material incorporated by reference 
will be published in the Federal Register. Copies of the ASME Boiler and 
Pressure Vessel Code may be purchased from the American Society of 
Mechanical Engineers, United Engineering Center, 345 East 47th St., New 
York, NY 10017. It is also available for inspection at the NRC Library, 
11545 Rockville Pike, Rockville, Maryland 20852-2738.
    (B)(1) Containment structure loadings produced by an inadvertent 
full actuation of a post-accident inerting hydrogen control system 
(assuming carbon dioxide), but not including seismic or design basis 
accident loadings will not produce stresses in steel containments in 
excess of the limits set forth in the ASME Boiler and Pressure Vessel 
Code, Section III, Division 1, subarticle NE-3220, Service Level A 
Limits, except that evaluation of instability is not required (for 
concrete containments the loadings specified above will not produce 
strains in the containment liner in excess of the limits set forth in 
the ASME Boiler and Pressure Vessel Code, Section III, Division 2, 
subarticle CC-3720, Service Load Category, (2) The containment has the 
capability to safely withstand pressure tests at 1.10 and 1.15 times 
(for steel and concrete containments, respectively) the pressure 
calculated to result from carbon dioxide inerting.
    (vi) For plant designs with external hydrogen recombiners, provide 
redundant dedicated containment penetrations so that, assuming a single 
failure, the recombiner systems can be connected to the containment 
atmosphere. (II.E.4.1)
    (vii) Provide a description of the management plan for design and 
construction activities, to include: (A) The organizational and 
management structure singularly responsible for direction of design and 
construction of the proposed plant; (B) technical resources director by 
the applicant; (C) details of the interaction of design and construction 
within the applicant's organization and the manner by which the 
applicant will ensure close integration of the architect engineer and 
the nuclear steam supply vendor; (D) proposed procedures for handling 
the transition to operation; (E) the degree of top level management 
oversight and technical control to be exercised by the applicant during 
design and construction, including the preparation and implementation of 
procedures necessary to guide the effort. (II.J.3.1)
    (g) Combustible gas control. All applicants for a reactor 
construction permit

[[Page 884]]

or operating license whose application is submitted after October 16, 
2003, shall include the analyses, and the descriptions of the equipment 
and systems required by Sec.50.44 as a part of their application.
    (h) Conformance with the Standard Review Plan (SRP). (1)(i) 
Applications for light water cooled nuclear power plant operating 
licenses docketed after May 17, 1982 shall include an evaluation of the 
facility against the Standard Review Plan (SRP) in effect on May 17, 
1982 or the SRP revision in effect six months prior to the docket date 
of the application, whichever is later.
    (ii) Applications for light-water-cooled nuclear power plant 
construction permits docketed after May 17, 1982, shall include an 
evaluation of the facility against the SRP in effect on May 17, 1982, or 
the SRP revision in effect six months before the docket date of the 
application, whichever is later.
    (2) The evaluation required by this section shall include an 
identification and description of all differences in design features, 
analytical techniques, and procedural measures proposed for a facility 
and those corresponding features, techniques, and measures given in the 
SRP acceptance criteria. Where such a difference exists, the evaluation 
shall discuss how the alternative proposed provides an acceptable method 
of complying with those rules or regulations of Commission, or portions 
thereof, that underlie the corresponding SRP acceptance criteria.
    (3) The SRP was issued to establish criteria that the NRC staff 
intends to use in evaluating whether an applicant/licensee meets the 
Commission's regulations. The SRP is not a substitute for the 
regulations, and compliance is not a requirement. Applicants shall 
identify differences from the SRP acceptance criteria and evaluate how 
the proposed alternatives to the SRP criteria provide an acceptable 
method of complying with the Commission's regulations.
    (i) A description and plans for implementation of the guidance and 
strategies intended to maintain or restore core cooling, containment, 
and spent fuel pool cooling capabilities under the circumstances 
associated with the loss of large areas of the plant due to explosions 
or fire as required by Sec.50.54(hh)(2) of this chapter.

[33 FR 18612, Dec. 17, 1968, as amended at 81 FR 86909, Dec. 2, 2016]

    Editorial Note: For Federal Register citations affecting Sec.
50.34, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfoo.gov.



Sec.50.34a  Design objectives for equipment to control releases 
of radioactive material in effluents--nuclear power reactors.

    (a) An application for a construction permit shall include a 
description of the preliminary design of equipment to be installed to 
maintain control over radioactive materials in gaseous and liquid 
effluents produced during normal reactor operations, including expected 
operational occurrences. In the case of an application filed on or after 
January 2, 1971, the application shall also identify the design 
objectives, and the means to be employed, for keeping levels of 
radioactive material in effluents to unrestricted areas as low as is 
reasonably achievable. The term ``as low as is reasonably achievable'' 
as used in this part means as low as is reasonably achievable taking 
into account the state of technology, and the economics of improvements 
in relation to benefits to the public health and safety and other 
societal and socioeconomic considerations, and in relation to the use of 
atomic energy in the public interest. The guides set out in appendix I 
to this part provide numerical guidance on design objectives for light-
water-cooled nuclear power reactors to meet the requirements that 
radioactive material in effluents released to unrestricted areas be kept 
as low as is reasonably achievable. These numerical guides for design 
objectives and limiting conditions for operation are not to be construed 
as radiation protection standards.
    (b) Each application for a construction permit shall include:
    (1) A description of the preliminary design of equipment to be 
installed under paragraph (a) of this section;
    (2) An estimate of:
    (i) The quantity of each of the principal radionuclides expected to 
be released annually to unrestricted areas

[[Page 885]]

in liquid effluents produced during normal reactor operations; and
    (ii) The quantity of each of the principal radionuclides of the 
gases, halides, and particulates expected to be released annually to 
unrestricted areas in gaseous effluents produced during normal reactor 
operations.
    (3) A general description of the provisions for packaging, storage, 
and shipment offsite of solid waste containing radioactive materials 
resulting from treatment of gaseous and liquid effluents and from other 
sources.
    (c) Each application for an operating license shall include:
    (1) A description of the equipment and procedures for the control of 
gaseous and liquid effluents and for the maintenance and use of 
equipment installed in radioactive waste systems, under paragraph (a) of 
this section; and
    (2) A revised estimate of the information required in paragraph 
(b)(2) of this section if the expected releases and exposures differ 
significantly from the estimates submitted in the application for a 
construction permit.
    (d) Each application for a combined license under part 52 of this 
chapter shall include:
    (1) A description of the equipment and procedures for the control of 
gaseous and liquid effluents and for the maintenance and use of 
equipment installed in radioactive waste systems, under paragraph (a) of 
this section; and
    (2) The information required in paragraph (b)(2) of this section.
    (e) Each application for a design approval, a design certification, 
or a manufacturing license under part 52 of this chapter shall include:
    (1) A description of the equipment for the control of gaseous and 
liquid effluents and for the maintenance and use of equipment installed 
in radioactive waste systems, under paragraph (a) of this section; and
    (2) The information required in paragraph (b)(2) of this section.

[72 FR 49492, Aug. 28, 2007]



Sec.50.35  Issuance of construction permits. \1\
---------------------------------------------------------------------------

    \1\ The Commission may issue a provisional construction permit 
pursuant to the regulations in this part in effect on March 30, 1970, 
for any facility for which a notice of hearing on an application for a 
provisional construction permit has been published on or before that 
date.
---------------------------------------------------------------------------

    (a) When an applicant has not supplied initially all of the 
technical information required to complete the application and support 
the issuance of a construction permit which approves all proposed design 
features, the Commission may issue a construction permit if the 
Commission finds that (1) the applicant has described the proposed 
design of the facility, including, but not limited to, the principal 
architectural and engineering criteria for the design, and has 
identified the major features or components incorporated therein for the 
protection of the health and safety of the public; (2) such further 
technical or design information as may be required to complete the 
safety analysis, and which can reasonably be left for later 
consideration, will be supplied in the final safety analysis report; (3) 
safety features or components, if any, which require research and 
development have been described by the applicant and the applicant has 
identified, and there will be conducted, a research and development 
program reasonably designed to resolve any safety questions associated 
with such features or components; and that (4) on the basis of the 
foregoing, there is reasonable assurance that, (i) such safety questions 
will be satisfactorily resolved at or before the latest date stated in 
the application for completion of construction of the proposed facility, 
and (ii) taking into consideration the site criteria contained in part 
100 of this chapter, the proposed facility can be constructed and 
operated at the proposed location without undue risk to the health and 
safety of the public.
    Note: When an applicant has supplied initially all of the technical 
information required to complete the application, including the final 
design of the facility, the findings required above will be 
appropriately modified to reflect that fact.

[[Page 886]]

    (b) A construction permit will constitute an authorization to the 
applicant to proceed with construction but will not constitute 
Commission approval of the safety of any design feature or specification 
unless the applicant specifically requests such approval and such 
approval is incorporated in the permit. The applicant, at his option, 
may request such approvals in the construction permit or, from time to 
time, by amendment of his construction permit. The Commission may, in 
its discretion, incorporate in any construction permit provisions 
requiring the applicant to furnish periodic reports of the progress and 
results of research and development programs designed to resolve safety 
questions.
    (c) Any construction permit will be subject to the limitation that a 
license authorizing operation of the facility will not be issued by the 
Commission until (1) the applicant has submitted to the Commission, by 
amendment to the application, the complete final safety analysis report, 
portions of which may be submitted and evaluated from time to time, and 
(2) the Commission has found that the final design provides reasonable 
assurance that the health and safety of the public will not be 
endangered by operation of the facility in accordance with the 
requirements of the license and the regulations in this chapter.

[27 FR 12915, Dec. 29, 1962, as amended at 31 FR 12780, Sept. 30, 1966; 
35 FR 5318, Mar. 31, 1970; 35 FR 6644, Apr. 25, 1970; 35 FR 11461, July 
7, 1970]



Sec.50.36  Technical specifications.

    (a)(1) Each applicant for a license authorizing operation of a 
production or utilization facility shall include in his application 
proposed technical specifications in accordance with the requirements of 
this section. A summary statement of the bases or reasons for such 
specifications, other than those covering administrative controls, shall 
also be included in the application, but shall not become part of the 
technical specifications.
    (a)(2) Each applicant for a design certification or manufacturing 
license under part 52 of this chapter shall include in its application 
proposed generic technical specifications in accordance with the 
requirements of this section for the portion of the plant that is within 
the scope of the design certification or manufacturing license 
application.
    (b) Each license authorizing operation of a production or 
utilization facility of a type described in Sec.50.21 or Sec.50.22 
will include technical specifications. The technical specifications will 
be derived from the analyses and evaluation included in the safety 
analysis report, and amendments thereto, submitted pursuant to Sec.
50.34. The Commission may include such additional technical 
specifications as the Commission finds appropriate.
    (c) Technical specifications will include items in the following 
categories:
    (1) Safety limits, limiting safety system settings, and limiting 
control settings. (i)(A) Safety limits for nuclear reactors are limits 
upon important process variables that are found to be necessary to 
reasonably protect the integrity of certain of the physical barriers 
that guard against the uncontrolled release of radioactivity. If any 
safety limit is exceeded, the reactor must be shut down. The licensee 
shall notify the Commission, review the matter, and record the results 
of the review, including the cause of the condition and the basis for 
corrective action taken to preclude recurrence. Operation must not be 
resumed until authorized by the Commission. The licensee shall retain 
the record of the results of each review until the Commission terminates 
the license for the reactor, except for nuclear power reactors licensed 
under Sec.50.21(b) or Sec.50.22 of this part. For these reactors, 
the licensee shall notify the Commission as required by Sec.50.72 and 
submit a Licensee Event Report to the Commission as required by Sec.
50.73. Licensees in these cases shall retain the records of the review 
for a period of three years following issuance of a Licensee Event 
Report.
    (B) Safety limits for fuel reprocessing plants are those bounds 
within which the process variables must be maintained for adequate 
control of the operation and that must not be exceeded in order to 
protect the integrity of the physical system that is designed to guard 
against the uncontrolled release or radioactivity. If any safety limit 
for

[[Page 887]]

a fuel reprocessing plant is exceeded, corrective action must be taken 
as stated in the technical specification or the affected part of the 
process, or the entire process if required, must be shut down, unless 
this action would further reduce the margin of safety. The licensee 
shall notify the Commission, review the matter, and record the results 
of the review, including the cause of the condition and the basis for 
corrective action taken to preclude recurrence. If a portion of the 
process or the entire process has been shutdown, operation must not be 
resumed until authorized by the Commission. The licensee shall retain 
the record of the results of each review until the Commission terminates 
the license for the plant.
    (ii)(A) Limiting safety system settings for nuclear reactors are 
settings for automatic protective devices related to those variables 
having significant safety functions. Where a limiting safety system 
setting is specified for a variable on which a safety limit has been 
placed, the setting must be so chosen that automatic protective action 
will correct the abnormal situation before a safety limit is exceeded. 
If, during operation, it is determined that the automatic safety system 
does not function as required, the licensee shall take appropriate 
action, which may include shutting down the reactor. The licensee shall 
notify the Commission, review the matter, and record the results of the 
review, including the cause of the condition and the basis for 
corrective action taken to preclude recurrence. The licensee shall 
retain the record of the results of each review until the Commission 
terminates the license for the reactor except for nuclear power reactors 
licensed under Sec.50.21(b) or Sec.50.22 of this part. For these 
reactors, the licensee shall notify the Commission as required by Sec.
50.72 and submit a Licensee Event Report to the Commission as required 
by Sec.50.73. Licensees in these cases shall retain the records of the 
review for a period of three years following issuance of a Licensee 
Event Report.
    (B) Limiting control settings for fuel reprocessing plants are 
settings for automatic alarm or protective devices related to those 
variables having significant safety functions. Where a limiting control 
setting is specified for a variable on which a safety limit has been 
placed, the setting must be so chosen that protective action, either 
automatic or manual, will correct the abnormal situation before a safety 
limit is exceeded. If, during operation, the automatic alarm or 
protective devices do not function as required, the licensee shall take 
appropriate action to maintain the variables within the limiting 
control-setting values and to repair promptly the automatic devices or 
to shut down the affected part of the process and, if required, to shut 
down the entire process for repair of automatic devices. The licensee 
shall notify the Commission, review the matter, and record the results 
of the review, including the cause of the condition and the basis for 
corrective action taken to preclude recurrence. The licensee shall 
retain the record of the results of each review until the Commission 
terminates the license for the plant.
    (2) Limiting conditions for operation. (i) Limiting conditions for 
operation are the lowest functional capability or performance levels of 
equipment required for safe operation of the facility. When a limiting 
condition for operation of a nuclear reactor is not met, the licensee 
shall shut down the reactor or follow any remedial action permitted by 
the technical specifications until the condition can be met. When a 
limiting condition for operation of any process step in the system of a 
fuel reprocessing plant is not met, the licensee shall shut down that 
part of the operation or follow any remedial action permitted by the 
technical specifications until the condition can be met. In the case of 
a nuclear reactor not licensed under Sec.50.21(b) or Sec.50.22 of 
this part or fuel reprocessing plant, the licensee shall notify the 
Commission, review the matter, and record the results of the review, 
including the cause of the condition and the basis for corrective action 
taken to preclude recurrence. The licensee shall retain the record of 
the results of each review until the Commission terminates the license 
for the nuclear reactor or the fuel reprocessing plant. In the case of 
nuclear power reactors licensed under Sec.50.21(b) or Sec.50.22,

[[Page 888]]

the licensee shall notify the Commission if required by Sec.50.72 and 
shall submit a Licensee Event Report to the Commission as required by 
Sec.50.73. In this case, licensees shall retain records associated 
with preparation of a Licensee Event Report for a period of three years 
following issuance of the report. For events which do not require a 
Licensee Event Report, the licensee shall retain each record as required 
by the technical specifications.
    (ii) A technical specification limiting condition for operation of a 
nuclear reactor must be established for each item meeting one or more of 
the following criteria:
    (A) Criterion 1. Installed instrumentation that is used to detect, 
and indicate in the control room, a significant abnormal degradation of 
the reactor coolant pressure boundary.
    (B) Criterion 2. A process variable, design feature, or operating 
restriction that is an initial condition of a design basis accident or 
transient analysis that either assumes the failure of or presents a 
challenge to the integrity of a fission product barrier.
    (C) Criterion 3. A structure, system, or component that is part of 
the primary success path and which functions or actuates to mitigate a 
design basis accident or transient that either assumes the failure of or 
presents a challenge to the integrity of a fission product barrier.
    (D) Criterion 4. A structure, system, or component which operating 
experience or probabilistic risk assessment has shown to be significant 
to public health and safety.
    (iii) A licensee is not required to propose to modify technical 
specifications that are included in any license issued before August 18, 
1995, to satisfy the criteria in paragraph (c)(2)(ii) of this section.
    (3) Surveillance requirements. Surveillance requirements are 
requirements relating to test, calibration, or inspection to assure that 
the necessary quality of systems and components is maintained, that 
facility operation will be within safety limits, and that the limiting 
conditions for operation will be met.
    (4) Design features. Design features to be included are those 
features of the facility such as materials of construction and geometric 
arrangements, which, if altered or modified, would have a significant 
effect on safety and are not covered in categories described in 
paragraphs (c) (1), (2), and (3) of this section.
    (5) Administrative controls. Administrative controls are the 
provisions relating to organization and management, procedures, 
recordkeeping, review and audit, and reporting necessary to assure 
operation of the facility in a safe manner. Each licensee shall submit 
any reports to the Commission pursuant to approved technical 
specifications as specified in Sec.50.4.
    (6) Decommissioning. This paragraph applies only to nuclear power 
reactor facilities that have submitted the certifications required by 
Sec.50.82(a)(1) and to non-power reactor facilities which are not 
authorized to operate. Technical specifications involving safety limits, 
limiting safety system settings, and limiting control system settings; 
limiting conditions for operation; surveillance requirements; design 
features; and administrative controls will be developed on a case-by-
case basis.
    (7) Initial notification. Reports made to the Commission by 
licensees in response to the requirements of this section must be made 
as follows:
    (i) Licensees that have an installed Emergency Notification System 
shall make the initial notification to the NRC Operations Center in 
accordance with Sec.50.72 of this part.
    (ii) All other licensees shall make the initial notification by 
telephone to the Administrator of the appropriate NRC Regional Office 
listed in appendix D, part 20, of this chapter.
    (8) Written Reports. Licensees for nuclear power reactors licensed 
under Sec.50.21(b) and Sec.50.22 of this part shall submit written 
reports to the Commission in accordance with Sec.50.73 of this part 
for events described in paragraphs (c)(1) and (c)(2) of this section. 
For all licensees, the Commission may require Special Reports as 
appropriate.
    (d)(1) This section shall not be deemed to modify the technical 
specifications included in any license issued prior to January 16, 1969. 
A license in which technical specifications have not

[[Page 889]]

been designated shall be deemed to include the entire safety analysis 
report as technical specifications.
    (2) An applicant for a license authorizing operation of a production 
or utilization facility to whom a construction permit has been issued 
prior to January 16, 1969, may submit technical specifications in 
accordance with this section, or in accordance with the requirements of 
this part in effect prior to January 16, 1969.
    (3) At the initiative of the Commission or the licensee, any license 
may be amended to include technical specifications of the scope and 
content which would be required if a new license were being issued.
    (e) The provisions of this section apply to each nuclear reactor 
licensee whose authority to operate the reactor has been removed by 
license amendment, order, or regulation.

[33 FR 18612, Dec. 17, 1968, as amended at 48 FR 33860, July 26, 1983; 
51 FR 40308, Nov. 6, 1986; 53 FR 19249, May 27, 1988; 60 FR 36959, July 
19, 1995; 61 FR 39299, July 29, 1996; 72 FR 49493, Aug. 28, 2007; 73 FR 
54932, Sept. 24, 2008]



Sec.50.36a  Technical specifications on effluents from nuclear power
reactors.

    (a) To keep releases of radioactive materials to unrestricted areas 
during normal conditions, including expected occurrences, as low as is 
reasonably achievable, each licensee of a nuclear power reactor and each 
applicant for a design certification or a manufacturing license will 
include technical specifications that, in addition to requiring 
compliance with applicable provisions of Sec.20.1301 of this chapter, 
require that:
    (1) Operating procedures developed pursuant to Sec.50.34a(c) for 
the control of effluents be established and followed and that the 
radioactive waste system, pursuant to Sec.50.34a, be maintained and 
used. The licensee shall retain the operating procedures in effect as a 
record until the Commission terminates the license and shall retain each 
superseded revision of the procedures for 3 years from the date it was 
superseded.
    (2) Each holder of an operating license, and each holder of a 
combined license after the Commission has made the finding under Sec.
52.103(g) of this chapter, shall submit a report to the Commission 
annually that specifies the quantity of each of the principal 
radionuclides released to unrestricted areas in liquid and in gaseous 
effluents during the previous 12 months, including any other information 
as may be required by the Commission to estimate maximum potential 
annual radiation doses to the public resulting from effluent releases. 
The report must be submitted as specified in Sec.50.4, and the time 
between submission of the reports must be no longer than 12 months. If 
quantities of radioactive materials released during the reporting period 
are significantly above design objectives, the report must cover this 
specifically. On the basis of these reports and any additional 
information the Commission may obtain from the licensee or others, the 
Commission may require the licensee to take action as the Commission 
deems appropriate.
    (b) In establishing and implementing the operating procedures 
described in paragraph (a) of this section, the licensee shall be guided 
by the following considerations: Experience with the design, 
construction, and operation of nuclear power reactors indicates that 
compliance with the technical specifications described in this section 
will keep average annual releases of radioactive material in effluents 
and their resultant committed effective dose equivalents at small 
percentages of the dose limits specified in Sec.20.1301 and in the 
license. At the same time, the licensee is permitted the flexibility of 
operation, compatible with considerations of health and safety, to 
assure that the public is provided a dependable source of power even 
under unusual conditions which may temporarily result in releases higher 
than such small percentages, but still within the limits specified in 
Sec.20.1301 of this chapter and in the license. It is expected that in 
using this flexibility under unusual conditions, the licensee will exert 
its best efforts to keep levels of radioactive material in effluents as 
low as is reasonably achievable. The guides set out in appendix I, 
provide numerical guidance on limiting conditions for operation for 
light-water cooled nuclear power reactors to meet

[[Page 890]]

the requirement that radioactive materials in effluents released to 
unrestricted areas be kept as low as is reasonably achievable.

[61 FR 39299, July 29, 1996, as amended at 72 FR 49493, Aug. 28, 2007]



Sec.50.36b  Environmental conditions.

    (a) Each construction permit under this part, each early site permit 
under part 52 of this chapter, and each combined license under part 52 
of this chapter may include conditions to protect the environment during 
construction. These conditions are to be set out in an attachment to the 
permit or license, which is incorporated in and made a part of the 
permit or license. These conditions will be derived from information 
contained in the environmental report submitted pursuant to Sec.51.50 
of this chapter as analyzed and evaluated in the NRC record of decision, 
and will identify the obligations of the licensee in the environmental 
area, including, as appropriate, requirements for reporting and keeping 
records of environmental data, and any conditions and monitoring 
requirement for the protection of the nonaquatic environment.
    (b) Each license authorizing operation of a production or 
utilization facility, including a combined license under part 52 of this 
chapter, and each license for a nuclear power reactor facility for which 
the certification of permanent cessation of operations required under 
Sec.50.82(a)(1) or Sec.52.110(a) of this chapter has been submitted, 
which is of a type described in Sec.50.21(b)(2) or (3) or Sec.50.22 
or is a testing facility, may include conditions to protect the 
environment during operation and decommissioning. These conditions are 
to be set out in an attachment to the license which is incorporated in 
and made a part of the license. These conditions will be derived from 
information contained in the environmental report or the supplement to 
the environmental report submitted pursuant to Sec. Sec.51.50 and 
51.53 of this chapter as analyzed and evaluated in the NRC record of 
decision, and will identify the obligations of the licensee in the 
environmental area, including, as appropriate, requirements for 
reporting and keeping records of environmental data, and any conditions 
and monitoring requirement for the protection of the nonaquatic 
environment.

[72 FR 49493, Aug. 28, 2007]



Sec.50.37  Agreement limiting access to Classified Information.

    As part of its application and in any event before the receipt of 
Restricted Data or classified National Security Information or the 
issuance of a license, construction permit, early site permit, or 
standard design approval, or before the Commission has adopted a final 
standard design certification rule under part 52 of this chapter, the 
applicant shall agree in writing that it will not permit any individual 
to have access to any facility to possess Restricted Data or classified 
National Security Information until the individual and/or facility has 
been approved for access under the provisions of 10 CFR parts 25 and/or 
95. The agreement of the applicant becomes part of the license, or 
construction permit, or standard design approval.

[72 FR 49493, Aug. 28, 2007]



Sec.50.38  Ineligibility of certain applicants.

    Any person who is a citizen, national, or agent of a foreign 
country, or any corporation, or other entity which the Commission knows 
or has reason to believe is owned, controlled, or dominated by an alien, 
a foreign corporation, or a foreign government, shall be ineligible to 
apply for and obtain a license.

[21 FR 355, Jan. 16, 1956, as amended at 43 FR 6924, Feb. 17, 1978]



Sec.50.39  Public inspection of applications.

    Applications and documents submitted to the Commission in connection 
with applications may be made available for public inspection in 
accordance with the provisions of the regulations contained in part 2 of 
this chapter.

[[Page 891]]

    Standards for Licenses, Certifications, and Regulatory Approvals



Sec.50.40  Common standards.

    In determining that a construction permit or operating license in 
this part, or early site permit, combined license, or manufacturing 
license in part 52 of this chapter will be issued to an applicant, the 
Commission will be guided by the following considerations:
    (a) Except for an early site permit or manufacturing license, the 
processes to be performed, the operating procedures, the facility and 
equipment, the use of the facility, and other technical specifications, 
or the proposals, in regard to any of the foregoing collectively provide 
reasonable assurance that the applicant will comply with the regulations 
in this chapter, including the regulations in part 20 of this chapter, 
and that the health and safety of the public will not be endangered.
    (b) The applicant for a construction permit, operating license, 
combined license, or manufacturing license is technically and 
financially qualified to engage in the proposed activities in accordance 
with the regulations in this chapter. However, no consideration of 
financial qualification is necessary for an electric utility applicant 
for an operating license for a utilization facility of the type 
described in Sec.50.21(b) or Sec.50.22 or for an applicant for a 
manufacturing license.
    (c) The issuance of a construction permit, operating license, early 
site permit, combined license, or manufacturing license to the applicant 
will not, in the opinion of the Commission, be inimical to the common 
defense and security or to the health and safety of the public.
    (d) Any applicable requirements of subpart A of 10 CFR part 51 have 
been satisfied.

[72 FR 49493, Aug. 28, 2007]



Sec.50.41  Additional standards for class 104 licenses.

    In determining that a class 104 license will be issued to an 
applicant, the Commission will, in addition to applying the standards 
set forth in Sec.50.40 be guided by the following considerations:
    (a) The Commission will permit the widest amount of effective 
medical therapy possible with the amount of special nuclear material 
available for such purposes.
    (b) The Commission will permit the conduct of widespread and diverse 
research and development.
    (c) [Reserved]

[21 FR 355, Jan. 19, 1956, as amended at 35 FR 19660, Dec. 29, 1970; 73 
FR 44620, July 31, 2008]



Sec.50.42  Additional standard for class 103 licenses.

    In determining whether a class 103 license will be issued to an 
applicant, the Commission will, in addition to applying the standards 
set forth in Sec.50.40, consider whether the proposed activities will 
serve a useful purpose proportionate to the quantities of special 
nuclear material or source material to be utilized.

[73 FR 44620, July 31, 2008]



Sec.50.43  Additional standards and provisions affecting class 103
licenses and certifications for commercial power.

    In addition to applying the standards set forth in Sec. Sec.50.40 
and 50.42, paragraphs (a) through (e) of this section apply in the case 
of a class 103 license for a facility for the generation of commercial 
power. For a design certification under part 52 of this chapter, only 
paragraph (e) of this section applies.
    (a) The NRC will:
    (1) Give notice in writing of each application to the regulatory 
agency or State as may have jurisdiction over the rates and services 
incident to the proposed activity;
    (2) Publish notice of the application in trade or news publications 
as it deems appropriate to give reasonable notice to municipalities, 
private utilities, public bodies, and cooperatives which might have a 
potential interest in the utilization or production facility; and
    (3) Publish notice of the application once each week for 4 
consecutive weeks in the Federal Register. No license will be issued by 
the NRC prior to the giving of these notices and until 4 weeks after the 
last notice is published in the Federal Register.

[[Page 892]]

    (b) If there are conflicting applications for a limited opportunity 
for such license, the Commission will give preferred consideration in 
the following order: First, to applications submitted by public or 
cooperative bodies for facilities to be located in high cost power areas 
in the United States; second, to applications submitted by others for 
facilities to be located in such areas; third, to applications submitted 
by public or cooperative bodies for facilities to be located in other 
than high cost power areas; and, fourth, to all other applicants.
    (c) The licensee who transmits electric energy in interstate 
commerce, or sells it at wholesale in interstate commerce, shall be 
subject to the regulatory provisions of the Federal Power Act.
    (d) Nothing shall preclude any government agency, now or hereafter 
authorized by law to engage in the production, marketing, or 
distribution of electric energy, if otherwise qualified, from obtaining 
a construction permit or operating license under this part, or a 
combined license under part 52 of this chapter for a utilization 
facility for the primary purpose of producing electric energy for 
disposition for ultimate public consumption.
    (e) Applications for a design certification, combined license, 
manufacturing license, operating license or standard design approval 
that propose nuclear reactor designs which differ significantly from 
light-water reactor designs that were licensed before 1997. Or use 
simplified, inherent, passive, or other innovative means to accomplish 
their safety functions will be approved only if:
    (1)(i) The performance of each safety feature of the design has been 
demonstrated through either analysis, appropriate test programs, 
experience, or a combination thereof;
    (ii) Interdependent effects among the safety features of the design 
are acceptable, as demonstrated by analysis, appropriate test programs, 
experience, or a combination thereof; and
    (iii) Sufficient data exist on the safety features of the design to 
assess the analytical tools used for safety analyses over a sufficient 
range of normal operating conditions, transient conditions, and 
specified accident sequences, including equilibrium core conditions; or
    (2) There has been acceptable testing of a prototype plant over a 
sufficient range of normal operating conditions, transient conditions, 
and specified accident sequences, including equilibrium core conditions. 
If a prototype plant is used to comply with the testing requirements, 
then the NRC may impose additional requirements on siting, safety 
features, or operational conditions for the prototype plant to protect 
the public and the plant staff from the possible consequences of 
accidents during the testing period.

[21 FR 355, Jan. 19, 1956, as amended at 35 FR 19660, Dec. 29, 1970; 63 
FR 50480, Sept. 22, 1998; 72 FR 49494, Aug. 28, 2007; 82 FR 52825, Nov. 
15, 2017]



Sec.50.44  Combustible gas control for nuclear power reactors.

    (a) Definitions--(1) Inerted atmosphere means a containment 
atmosphere with less than 4 percent oxygen by volume.
    (2) Mixed atmosphere means that the concentration of combustible 
gases in any part of the containment is below a level that supports 
combustion or detonation that could cause loss of containment integrity.
    (b) Requirements for currently-licensed reactors. Each boiling or 
pressurized water nuclear power reactor with an operating license on 
October 16, 2003, except for those facilities for which the 
certifications required under Sec.50.82(a)(1) have been submitted, 
must comply with the following requirements, as applicable:
    (1) Mixed atmosphere. All containments must have a capability for 
ensuring a mixed atmosphere.
    (2) Combustible gas control. (i) All boiling water reactors with 
Mark I or Mark II type containments must have an inerted atmosphere.
    (ii) All boiling water reactors with Mark III type containments and 
all pressurized water reactors with ice condenser containments must have 
the capability for controlling combustible gas generated from a metal-
water reaction involving 75 percent of the fuel cladding surrounding the 
active fuel region (excluding the cladding surrounding the plenum 
volume) so that

[[Page 893]]

there is no loss of containment structural integrity.
    (3) Equipment survivability. All boiling water reactors with Mark 
III containments and all pressurized water reactors with ice condenser 
containments that do not rely upon an inerted atmosphere inside 
containment to control combustible gases must be able to establish and 
maintain safe shutdown and containment structural integrity with systems 
and components capable of performing their functions during and after 
exposure to the environmental conditions created by the burning of 
hydrogen. Environmental conditions caused by local detonations of 
hydrogen must also be included, unless such detonations can be shown 
unlikely to occur. The amount of hydrogen to be considered must be 
equivalent to that generated from a metal-water reaction involving 75 
percent of the fuel cladding surrounding the active fuel region 
(excluding the cladding surrounding the plenum volume).
    (4) Monitoring. (i) Equipment must be provided for monitoring oxygen 
in containments that use an inerted atmosphere for combustible gas 
control. Equipment for monitoring oxygen must be functional, reliable, 
and capable of continuously measuring the concentration of oxygen in the 
containment atmosphere following a significant beyond design-basis 
accident for combustible gas control and accident management, including 
emergency planning.
    (ii) Equipment must be provided for monitoring hydrogen in the 
containment. Equipment for monitoring hydrogen must be functional, 
reliable, and capable of continuously measuring the concentration of 
hydrogen in the containment atmosphere following a significant beyond 
design-basis accident for accident management, including emergency 
planning.
    (5) Analyses. Each holder of an operating license for a boiling 
water reactor with a Mark III type of containment or for a pressurized 
water reactor with an ice condenser type of containment, shall perform 
an analysis that:
    (i) Provides an evaluation of the consequences of large amounts of 
hydrogen generated after the start of an accident (hydrogen resulting 
from the metal-water reaction of up to and including 75 percent of the 
fuel cladding surrounding the active fuel region, excluding the cladding 
surrounding the plenum volume) and include consideration of hydrogen 
control measures as appropriate;
    (ii) Includes the period of recovery from the degraded condition;
    (iii) Uses accident scenarios that are accepted by the NRC staff. 
These scenarios must be accompanied by sufficient supporting 
justification to show that they describe the behavior of the reactor 
system during and following an accident resulting in a degraded core.
    (iv) Supports the design of the hydrogen control system selected to 
meet the requirements of this section; and,
    (v) Demonstrates, for those reactors that do not rely upon an 
inerted atmosphere to comply with paragraph (b)(2)(ii) of this section, 
that:
    (A) Containment structural integrity is maintained. Containment 
structural integrity must be demonstrated by use of an analytical 
technique that is accepted by the NRC staff in accordance with Sec.
50.90. This demonstration must include sufficient supporting 
justification to show that the technique describes the containment 
response to the structural loads involved. This method could include the 
use of actual material properties with suitable margins to account for 
uncertainties in modeling, in material properties, in construction 
tolerances, and so on; and
    (B) Systems and components necessary to establish and maintain safe 
shutdown and to maintain containment integrity will be capable of 
performing their functions during and after exposure to the 
environmental conditions created by the burning of hydrogen, including 
local detonations, unless such detonations can be shown unlikely to 
occur.
    (c) Requirements for future water-cooled reactor applicants and 
licensees. \2\ The requirements in this paragraph

[[Page 894]]

apply to all water-cooled reactor construction permits or operating 
licenses under this part, and to all water-cooled reactor design 
approvals, design certifications, combined licenses or manufacturing 
licenses under part 52 of this chapter, any of which are issued after 
October 16, 2003.
---------------------------------------------------------------------------

    \2\ The requirements of this paragraph apply only to water-cooled 
reactor designs with characteristics (e.g., type and quantity of 
cladding materials) such that the potential for production of 
combustible gases is comparable to light water reactor designs licensed 
as of October 16, 2003.
---------------------------------------------------------------------------

    (1) Mixed atmosphere. All containments must have a capability for 
ensuring a mixed atmosphere during design-basis and significant beyond 
design-basis accidents.
    (2) Combustible gas control. All containments must have an inerted 
atmosphere, or must limit hydrogen concentrations in containment during 
and following an accident that releases an equivalent amount of hydrogen 
as would be generated from a 100 percent fuel clad-coolant reaction, 
uniformly distributed, to less than 10 percent (by volume) and maintain 
containment structural integrity and appropriate accident mitigating 
features.
    (3) Equipment Survivability. Containments that do not rely upon an 
inerted atmosphere to control combustible gases must be able to 
establish and maintain safe shutdown and containment structural 
integrity with systems and components capable of performing their 
functions during and after exposure to the environmental conditions 
created by the burning of hydrogen. Environmental conditions caused by 
local detonations of hydrogen must also be included, unless such 
detonations can be shown unlikely to occur. The amount of hydrogen to be 
considered must be equivalent to that generated from a fuel clad-coolant 
reaction involving 100 percent of the fuel cladding surrounding the 
active fuel region.
    (4) Monitoring. (i) Equipment must be provided for monitoring oxygen 
in containments that use an inerted atmosphere for combustible gas 
control. Equipment for monitoring oxygen must be functional, reliable, 
and capable of continuously measuring the concentration of oxygen in the 
containment atmosphere following a significant beyond design-basis 
accident for combustible gas control and accident management, including 
emergency planning.
    (ii) Equipment must be provided for monitoring hydrogen in the 
containment. Equipment for monitoring hydrogen must be functional, 
reliable, and capable of continuously measuring the concentration of 
hydrogen in the containment atmosphere following a significant beyond 
design-basis accident for accident management, including emergency 
planning.
    (5) Structural analysis. An applicant must perform an analysis that 
demonstrates containment structural integrity. This demonstration must 
use an analytical technique that is accepted by the NRC and include 
sufficient supporting justification to show that the technique describes 
the containment response to the structural loads involved. The analysis 
must address an accident that releases hydrogen generated from 100 
percent fuel clad-coolant reaction accompanied by hydrogen burning. 
Systems necessary to ensure containment integrity must also be 
demonstrated to perform their function under these conditions.
    (d) Requirements for future non water-cooled reactor applicants and 
licensees and certain water-cooled reactor applicants and licensees. The 
requirements in this paragraph apply to all construction permits and 
operating licenses under this part, and to all design approvals, design 
certifications, combined licenses, or manufacturing licenses under part 
52 of this chapter, for non water-cooled reactors and water-cooled 
reactors that do not fall within the description in paragraph (c), 
footnote 1 of this section, any of which are issued after October 16, 
2003. Applications subject to this paragraph must include:
    (1) Information addressing whether accidents involving combustible 
gases are technically relevant for their design, and
    (2) If accidents involving combustible gases are found to be 
technically relevant, information (including a design-specific 
probabilistic risk assessment) demonstrating that the safety impacts of 
combustible gases during design-basis and significant beyond design-
basis accidents have been addressed to ensure adequate protection of 
public

[[Page 895]]

health and safety and common defense and security.

[68 FR 54141, Sept. 16, 2003]



Sec.50.45  Standards for construction permits, operating licenses,
and combined licenses.

    (a) An applicant for an operating license or an amendment of an 
operating license who proposes to construct or alter a production or 
utilization facility will be initially granted a construction permit if 
the application is in conformity with and acceptable under the criteria 
of Sec. Sec.50.31 through 50.38, and the standards of Sec. Sec.50.40 
through 50.43, as applicable.
    (b) A holder of a combined license who proposes, after the 
Commission makes the finding under Sec.52.103(g) of this chapter, to 
alter the licensed facility will be initially granted a construction 
permit if the application is in conformity with and acceptable under the 
criteria of Sec. Sec.50.30 through 50.33, Sec.50.34(f), Sec. Sec.
50.34a through 50.38, the standards of Sec. Sec.50.40 through 50.43, 
as applicable, and Sec. Sec.52.79 and 52.80 of this chapter.

[72 FR 49494, Aug. 28, 2007]



Sec.50.46  Acceptance criteria for emergency core cooling systems
for light-water nuclear power reactors.

    (a)(1)(i) Each boiling or pressurized light-water nuclear power 
reactor fueled with uranium oxide pellets within cylindrical zircaloy or 
ZIRLO cladding must be provided with an emergency core cooling system 
(ECCS) that must be designed so that its calculated cooling performance 
following postulated loss-of-coolant accidents conforms to the criteria 
set forth in paragraph (b) of this section. ECCS cooling performance 
must be calculated in accordance with an acceptable evaluation model and 
must be calculated for a number of postulated loss-of-coolant accidents 
of different sizes, locations, and other properties sufficient to 
provide assurance that the most severe postulated loss-of-coolant 
accidents are calculated. Except as provided in paragraph (a)(1)(ii) of 
this section, the evaluation model must include sufficient supporting 
justification to show that the analytical technique realistically 
describes the behavior of the reactor system during a loss-of-coolant 
accident. Comparisons to applicable experimental data must be made and 
uncertainties in the analysis method and inputs must be identified and 
assessed so that the uncertainty in the calculated results can be 
estimated. This uncertainty must be accounted for, so that, when the 
calculated ECCS cooling performance is compared to the criteria set 
forth in paragraph (b) of this section, there is a high level of 
probability that the criteria would not be exceeded. Appendix K, Part II 
Required Documentation, sets forth the documentation requirements for 
each evaluation model. This section does not apply to a nuclear power 
reactor facility for which the certifications required under Sec.
50.82(a)(1) have been submitted.
    (ii) Alternatively, an ECCS evaluation model may be developed in 
conformance with the required and acceptable features of appendix K ECCS 
Evaluation Models.
    (2) The Director of Nuclear Reactor Regulation may impose 
restrictions on reactor operation if it is found that the evaluations of 
ECCS cooling performance submitted are not consistent with paragraphs 
(a)(1) (i) and (ii) of this section.
    (3)(i) Each applicant for or holder of an operating license or 
construction permit issued under this part, applicant for a standard 
design certification under part 52 of this chapter (including an 
applicant after the Commission has adopted a final design certification 
regulation), or an applicant for or holder of a standard design 
approval, a combined license or a manufacturing license issued under 
part 52 of this chapter, shall estimate the effect of any change to or 
error in an acceptable evaluation model or in the application of such a 
model to determine if the change or error is significant. For this 
purpose, a significant change or error is one which results in a 
calculated peak fuel cladding temperature different by more than 50 
[deg]F from the temperature calculated for the limiting transient using 
the last acceptable model, or is a cumulation of changes and errors such 
that the sum

[[Page 896]]

of the absolute magnitudes of the respective temperature changes is 
greater than 50 [deg]F.
    (ii) For each change to or error discovered in an acceptable 
evaluation model or in the application of such a model that affects the 
temperature calculation, the applicant or holder of a construction 
permit, operating license, combined license, or manufacturing license 
shall report the nature of the change or error and its estimated effect 
on the limiting ECCS analysis to the Commission at least annually as 
specified in Sec.50.4 or Sec.52.3 of this chapter, as applicable. If 
the change or error is significant, the applicant or licensee shall 
provide this report within 30 days and include with the report a 
proposed schedule for providing a reanalysis or taking other action as 
may be needed to show compliance with Sec.50.46 requirements. This 
schedule may be developed using an integrated scheduling system 
previously approved for the facility by the NRC. For those facilities 
not using an NRC approved integrated scheduling system, a schedule will 
be established by the NRC staff within 60 days of receipt of the 
proposed schedule. Any change or error correction that results in a 
calculated ECCS performance that does not conform to the criteria set 
forth in paragraph (b) of this section is a reportable event as 
described in Sec. Sec.50.55(e), 50.72, and 50.73. The affected 
applicant or licensee shall propose immediate steps to demonstrate 
compliance or bring plant design or operation into compliance with Sec.
50.46 requirements.
    (iii) For each change to or error discovered in an acceptable 
evaluation model or in the application of such a model that affects the 
temperature calculation, the applicant or holder of a standard design 
approval or the applicant for a standard design certification (including 
an applicant after the Commission has adopted a final design 
certification rule) shall report the nature of the change or error and 
its estimated effect on the limiting ECCS analysis to the Commission and 
to any applicant or licensee referencing the design approval or design 
certification at least annually as specified in Sec.52.3 of this 
chapter. If the change or error is significant, the applicant or holder 
of the design approval or the applicant for the design certification 
shall provide this report within 30 days and include with the report a 
proposed schedule for providing a reanalysis or taking other action as 
may be needed to show compliance with Sec.50.46 requirements. The 
affected applicant or holder shall propose immediate steps to 
demonstrate compliance or bring plant design into compliance with Sec.
50.46 requirements.
    (b)(1) Peak cladding temperature. The calculated maximum fuel 
element cladding temperature shall not exceed 2200 [deg]F.
    (2) Maximum cladding oxidation. The calculated total oxidation of 
the cladding shall nowhere exceed 0.17 times the total cladding 
thickness before oxidation. As used in this subparagraph total oxidation 
means the total thickness of cladding metal that would be locally 
converted to oxide if all the oxygen absorbed by and reacted with the 
cladding locally were converted to stoichiometric zirconium dioxide. If 
cladding rupture is calculated to occur, the inside surfaces of the 
cladding shall be included in the oxidation, beginning at the calculated 
time of rupture. Cladding thickness before oxidation means the radial 
distance from inside to outside the cladding, after any calculated 
rupture or swelling has occurred but before significant oxidation. Where 
the calculated conditions of transient pressure and temperature lead to 
a prediction of cladding swelling, with or without cladding rupture, the 
unoxidized cladding thickness shall be defined as the cladding cross-
sectional area, taken at a horizontal plane at the elevation of the 
rupture, if it occurs, or at the elevation of the highest cladding 
temperature if no rupture is calculated to occur, divided by the average 
circumference at that elevation. For ruptured cladding the circumference 
does not include the rupture opening.
    (3) Maximum hydrogen generation. The calculated total amount of 
hydrogen generated from the chemical reaction of the cladding with water 
or steam shall not exceed 0.01 times the hypothetical amount that would 
be generated if all of the metal in the cladding cylinders surrounding 
the fuel, excluding the cladding surrounding the plenum volume, were to 
react.

[[Page 897]]

    (4) Coolable geometry. Calculated changes in core geometry shall be 
such that the core remains amenable to cooling.
    (5) Long-term cooling. After any calculated successful initial 
operation of the ECCS, the calculated core temperature shall be 
maintained at an acceptably low value and decay heat shall be removed 
for the extended period of time required by the long-lived radioactivity 
remaining in the core.
    (c) As used in this section:
    (1) Loss-of-coolant accidents (LOCA's) are hypothetical accidents 
that would result from the loss of reactor coolant, at a rate in excess 
of the capability of the reactor coolant makeup system, from breaks in 
pipes in the reactor coolant pressure boundary up to and including a 
break equivalent in size to the double-ended rupture of the largest pipe 
in the reactor coolant system.
    (2) An evaluation model is the calculational framework for 
evaluating the behavior of the reactor system during a postulated loss-
of-coolant accident (LOCA). It includes one or more computer programs 
and all other information necessary for application of the calculational 
framework to a specific LOCA, such as mathematical models used, 
assumptions included in the programs, procedure for treating the program 
input and output information, specification of those portions of 
analysis not included in computer programs, values of parameters, and 
all other information necessary to specify the calculational procedure.
    (d) The requirements of this section are in addition to any other 
requirements applicable to ECCS set forth in this part. The criteria set 
forth in paragraph (b), with cooling performance calculated in 
accordance with an acceptable evaluation model, are in implementation of 
the general requirements with respect to ECCS cooling performance design 
set forth in this part, including in particular Criterion 35 of appendix 
A.

[39 FR 1002, Jan. 4, 1974, as amended at 53 FR 36004, Sept. 16, 1988; 57 
FR 39358, Aug. 31, 1992; 61 FR 39299, July 29, 1996; 62 FR 59276, Nov. 
3, 1997; 72 FR 49494, Aug. 28, 2007]



Sec.50.46a  Acceptance criteria for reactor coolant system venting
systems.

    Each nuclear power reactor must be provided with high point vents 
for the reactor coolant system, for the reactor vessel head, and for 
other systems required to maintain adequate core cooling if the 
accumulation of noncondensible gases would cause the loss of function of 
these systems. High point vents are not required for the tubes in U-tube 
steam generators. Acceptable venting systems must meet the following 
criteria:
    (a) The high point vents must be remotely operated from the control 
room.
    (b) The design of the vents and associated controls, instruments and 
power sources must conform to appendix A and appendix B of this part.
    (c) The vent system must be designed to ensure that:
    (1) The vents will perform their safety functions; and
    (2) There would not be inadvertent or irreversible actuation of a 
vent.

[68 FR 54142, Sept. 16, 2003]



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 
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 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 10 CFR 52.17(b)(2)(ii), no early site permit will be issued unless 
a finding is made by

[[Page 898]]

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 10 CFR 52.17(b)(2)(i), 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 10 CFR 50.47 and 10 CFR part 50, appendix E, within the 
scope of emergency preparedness matters addressed in the major features.
    (2) The NRC will base its finding on a review of the Federal 
Emergency Management Agency (FEMA) findings and determinations as to 
whether State and local emergency plans are adequate and whether there 
is reasonable assurance that they can be implemented, and on the NRC 
assessment as to whether the applicant's onsite emergency plans are 
adequate and whether there is reasonable assurance that they can be 
implemented. A FEMA finding will primarily be based on a review of the 
plans. Any other information already available to FEMA may be considered 
in assessing whether there is reasonable assurance that the plans can be 
implemented. In any NRC licensing proceeding, a FEMA finding will 
constitute a rebuttable presumption on questions of adequacy and 
implementation capability.
    (b) The onsite and, except as provided in paragraph (d) of this 
section, offsite emergency response plans for nuclear power reactors 
must meet the following standards:
    (1) Primary responsibilities for emergency response by the nuclear 
facility licensee and by State and local organizations within the 
Emergency Planning Zones have been assigned, the emergency 
responsibilities of the various supporting organizations have been 
specifically established, and each principal response organization has 
staff to respond and to augment its initial response on a continuous 
basis.
    (2) On-shift facility licensee responsibilities for emergency 
response are unambiguously defined, adequate staffing to provide initial 
facility accident response in key functional areas is maintained at all 
times, timely augmentation of response capabilities is available and the 
interfaces among various onsite response activities and offsite support 
and response activities are specified.
    (3) Arrangements for requesting and effectively using assistance 
resources have been made, arrangements to accommodate State and local 
staff at the licensee's Emergency Operations Facility have been made, 
and other organizations capable of augmenting the planned response have 
been identified.
    (4) A standard emergency classification and action level scheme, the 
bases of which include facility system and effluent parameters, is in 
use by the nuclear facility licensee, and State and local response plans 
call for reliance on information provided by facility licensees for 
determinations of minimum initial offsite response measures.
    (5) Procedures have been established for notification, by the 
licensee, of State and local response organizations and for notification 
of emergency personnel by all organizations; the content of initial and 
followup messages to response organizations and the public has been 
established; and means to provide early notification and clear 
instruction to the populace within the plume exposure pathway Emergency 
Planning Zone have been established.
    (6) Provisions exist for prompt communications among principal 
response organizations to emergency personnel and to the public.
    (7) Information is made available to the public on a periodic basis 
on how they will be notified and what their initial actions should be in 
an emergency (e.g., listening to a local broadcast station and remaining 
indoors), the principal points of contact with the news media for 
dissemination of information during an emergency (including the physical 
location or locations) are established in advance, and procedures for 
coordinated dissemination of information to the public are established.
    (8) Adequate emergency facilities and equipment to support the 
emergency response are provided and maintained.

[[Page 899]]

    (9) Adequate methods, systems, and equipment for assessing and 
monitoring actual or potential offsite consequences of a radiological 
emergency condition are in use.
    (10) A range of protective actions has been developed for the plume 
exposure pathway EPZ for emergency workers and the public. In developing 
this range of actions, consideration has been given to evacuation, 
sheltering, and, as a supplement to these, the prophylactic use of 
potassium iodide (KI), as appropriate. Evacuation time estimates have 
been developed by applicants and licensees. Licensees shall update the 
evacuation time estimates on a periodic basis. Guidelines for the choice 
of protective actions during an emergency, consistent with Federal 
guidance, are developed and in place, and protective actions for the 
ingestion exposure pathway EPZ appropriate to the locale have been 
developed.
    (11) Means for controlling radiological exposures, in an emergency, 
are established for emergency workers. The means for controlling 
radiological exposures shall include exposure guidelines consistent with 
EPA Emergency Worker and Lifesaving Activity Protective Action Guides.
    (12) Arrangements are made for medical services for contaminated 
injured individuals.
    (13) General plans for recovery and reentry are developed.
    (14) Periodic exercises are (will be) conducted to evaluate major 
portions of emergency response capabilities, periodic drills are (will 
be) conducted to develop and maintain key skills, and deficiencies 
identified as a result of exercises or drills are (will be) corrected.
    (15) Radiological emergency response training is provided to those 
who may be called on to assist in an emergency.
    (16) Responsibilities for plan development and review and for 
distribution of emergency plans are established, and planners are 
properly trained.
    (c)(1) Failure to meet the applicable standards set forth in 
paragraph (b) of this section may result in the Commission declining to 
issue an operating license; however, the applicant will have an 
opportunity to demonstrate to the satisfaction of the Commission that 
deficiencies in the plans are not significant for the plant in question, 
that adequate interim compensating actions have been or will be taken 
promptly, or that there are other compelling reasons to permit plant 
operations. Where an applicant for an operating license asserts that its 
inability to demonstrate compliance with the requirements of paragraph 
(b) of this section results wholly or substantially from the decision of 
state and/or local governments not to participate further in emergency 
planning, an operating license may be issued if the applicant 
demonstrates to the Commission's satisfaction that:
    (i) The applicant's inability to comply with the requirements of 
paragraph (b) of this section is wholly or substantially the result of 
the non-participation of state and/or local governments.
    (ii) The applicant has made a sustained, good faith effort to secure 
and retain the participation of the pertinent state and/or local 
governmental authorities, including the furnishing of copies of its 
emergency plan.
    (iii) The applicant's emergency plan provides reasonable assurance 
that public health and safety is not endangered by operation of the 
facility concerned. To make that finding, the applicant must demonstrate 
that, as outlined below, adequate protective measures can and will be 
taken in the event of an emergency. A utility plan will be evaluated 
against the same planning standards applicable to a state or local plan, 
as listed in paragraph (b) of this section, with due allowance made both 
for--
    (A) Those elements for which state and/or local non-participation 
makes compliance infeasible and
    (B) The utility's measures designed to compensate for any 
deficiencies resulting from state and/or local non-participation.

In making its determination on the adequacy of a utility plan, the NRC 
will recognize the reality that in an actual emergency, state and local 
government officials will exercise their best efforts to protect the 
health and safety of the public. The NRC will determine the adequacy of 
that expected response, in combination with the utility's compensating 
measures, on a

[[Page 900]]

case-by-case basis, subject to the following guidance. In addressing the 
circumstance where applicant's inability to comply with the requirements 
of paragraph (b) of this section is wholly or substantially the result 
of non-participation of state and/or local governments, it may be 
presumed that in the event of an actual radiological emergency state and 
local officials would generally follow the utility plan. However, this 
presumption may be rebutted by, for example, a good faith and timely 
proffer of an adequate and feasible state and/or local radiological 
emergency plan that would in fact be relied upon in a radiological 
emergency.
    (2) Generally, the plume exposure pathway EPZ for nuclear power 
plants shall consist of an area about 10 miles (16 km) in radius and the 
ingestion pathway EPZ shall consist of an area about 50 miles (80 km) in 
radius. The exact size and configuration of the EPZs surrounding a 
particular nuclear power reactor shall be determined in relation to 
local emergency response needs and capabilities as they are affected by 
such conditions as demography, topography, land characteristics, access 
routes, and jurisdictional boundaries. The size of the EPZs also may be 
determined on a case-by-case basis for gas-cooled nuclear reactors and 
for reactors with an authorized power level less than 250 MW thermal. 
The plans for the ingestion pathway shall focus on such actions as are 
appropriate to protect the food ingestion pathway.
    (d) Notwithstanding the requirements of paragraphs (a) and (b) of 
this section, and except as specified by this paragraph, no NRC or FEMA 
review, findings, or determinations concerning the state of offsite 
emergency preparedness or the adequacy of and capability to implement 
State and local or utility offsite emergency plans are required prior to 
issuance of an operating license authorizing only fuel loading or low 
power testing and training (up to 5 percent of the rated thermal power). 
Insofar as emergency planning and preparedness requirements are 
concerned, a license authorizing fuel loading and/or low power testing 
and training may be issued after a finding is made by the NRC 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 paragraph (b) of this section and appendix E. 
Review of applicant's emergency plans will include the following 
standards with offsite aspects:
    (1) Arrangements for requesting and effectively using offsite 
assistance on site have been made, arrangements to accommodate State and 
local staff at the licensee's Emergency Operations Facility have been 
made, and other organizations capable of augmenting the planned onsite 
response have been identified.
    (2) Procedures have been established for licensee communications 
with State and local response organizations, including initial 
notification of the declaration of emergency and periodic provision of 
plant and response status reports.
    (3) Provisions exist for prompt communications among principal 
response organizations to offsite emergency personnel who would be 
responding onsite.
    (4) Adequate emergency facilities and equipment to support the 
emergency response onsite are provided and maintained.
    (5) Adequate methods, systems, and equipment for assessing and 
monitoring actual or potential offsite consequences of a radiological 
emergency condition are in use onsite.
    (6) Arrangements are made for medical services for contaminated and 
injured onsite individuals.
    (7) Radiological emergency response training has been made available 
to those offsite who may be called to assist in an emergency onsite.
    (e) Notwithstanding the requirements of paragraph (b) of this 
section and the provisions of Sec.52.103 of this chapter, a holder of 
a combined license under part 52 of this chapter may not load fuel or 
operate except as provided

[[Page 901]]

in accordance with appendix E to part 50 and Sec.50.54(gg).

[45 FR 55409, Aug. 8, 1980, as amended at 47 FR 30235, July 13, 1982; 47 
FR 40537, Sept. 15, 1982; 49 FR 27736, July 6, 1984; 50 FR 19324, May 8, 
1985; 52 FR 42085, Nov. 3, 1987; 53 FR 36959, Sept. 23, 1988; 56 FR 
64976, Dec. 13, 1991; 61 FR 30132, June 14, 1996; 66 FR 5440, Jan. 19, 
2001; 72 FR 49495, Aug. 28, 2007; 76 FR 72595, Nov. 23, 2011; 78 FR 
34248, June 7, 2013]



Sec.50.48  Fire protection.

    (a)(1) Each holder of an operating license issued under this part or 
a combined license issued under part 52 of this chapter must have a fire 
protection plan that satisfies Criterion 3 of appendix A to this part. 
This fire protection plan must:
    (i) Describe the overall fire protection program for the facility;
    (ii) Identify the various positions within the licensee's 
organization that are responsible for the program;
    (iii) State the authorities that are delegated to each of these 
positions to implement those responsibilities; and
    (iv) Outline the plans for fire protection, fire detection and 
suppression capability, and limitation of fire damage.
    (2) The plan must also describe specific features necessary to 
implement the program described in paragraph (a)(1) of this section such 
as--
    (i) Administrative controls and personnel requirements for fire 
prevention and manual fire suppression activities;
    (ii) Automatic and manually operated fire detection and suppression 
systems; and
    (iii) The means to limit fire damage to structures, systems, or 
components important to safety so that the capability to shut down the 
plant safely is ensured.
    (3) The licensee shall retain the fire protection plan and each 
change to the plan as a record until the Commission terminates the 
reactor license. The licensee shall retain each superseded revision of 
the procedures for 3 years from the date it was superseded.
    (4) Each applicant for a design approval, design certification, or 
manufacturing license under part 52 of this chapter must have a 
description and analysis of the fire protection design features for the 
standard plant necessary to demonstrate compliance with Criterion 3 of 
appendix A to this part.
    (b) Appendix R to this part establishes fire protection features 
required to satisfy Criterion 3 of appendix A to this part with respect 
to certain generic issues for nuclear power plants licensed to operate 
before January 1, 1979.
    (1) Except for the requirements of Sections III.G, III.J, and III.O, 
the provisions of Appendix R to this part do not apply to nuclear power 
plants licensed to operate before January 1, 1979, to the extent that--
    (i) Fire protection features proposed or implemented by the licensee 
have been accepted by the NRC staff as satisfying the provisions of 
Appendix A to Branch Technical Position (BTP) APCSB 9.5-1 reflected in 
NRC fire protection safety evaluation reports issued before the 
effective date of February 19, 1981; or
    (ii) Fire protection features were accepted by the NRC staff in 
comprehensive fire protection safety evaluation reports issued before 
Appendix A to Branch Technical Position (BTP) APCSB 9.5-1 was published 
in August 1976.
    (2) With respect to all other fire protection features covered by 
Appendix R, all nuclear power plants licensed to operate before January 
1, 1979, must satisfy the applicable requirements of Appendix R to this 
part, including specifically the requirements of Sections III.G, III.J, 
and III.O.
    (c) National Fire Protection Association Standard NFPA 805--(1) 
Approval of incorporation by reference. National Fire Protection 
Association (NFPA) Standard 805, ``Performance-Based Standard for Fire 
Protection for Light Water Reactor Electric Generating Plants, 2001 
Edition'' (NFPA 805), which is referenced in this section, was approved 
for incorporation by reference by the Director of the Federal Register 
pursuant to 5 U.S.C. 552(a) and 1 CFR part 51. Copies of NFPA 805 may be 
purchased from the NFPA Customer Service Department, 1 Batterymarch 
Park, P.O. Box 9101, Quincy, MA 02269-9101 and in PDF format through the 
NFPA Online Catalog (www.nfpa.org) or by calling 1-800-344-3555 or (617) 
770-3000. Copies are also available for inspection at the NRC Library, 
Two White Flint North,

[[Page 902]]

11545 Rockville Pike, Rockville, Maryland 20852-2738, and at the NRC 
Public Document Room, Building One White Flint North, Room O1-F15, 11555 
Rockville Pike, Rockville, Maryland 20852-2738. Copies are also 
available at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call (202) 
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (2) Exceptions, modifications, and supplementation of NFPA 805. As 
used in this section, references to NFPA 805 are to the 2001 Edition, 
with the following exceptions, modifications, and supplementation:
    (i) Life Safety Goal, Objectives, and Criteria. The Life Safety 
Goal, Objectives, and Criteria of Chapter 1 are not endorsed.
    (ii) Plant Damage/Business Interruption Goal, Objectives, and 
Criteria. The Plant Damage/Business Interruption Goal, Objectives, and 
Criteria of Chapter 1 are not endorsed.
    (iii) Use of feed-and-bleed. In demonstrating compliance with the 
performance criteria of Sections 1.5.1(b) and (c), a high-pressure 
charging/injection pump coupled with the pressurizer power-operated 
relief valves (PORVs) as the sole fire-protected safe shutdown path for 
maintaining reactor coolant inventory, pressure control, and decay heat 
removal capability (i.e., feed-and-bleed) for pressurized-water reactors 
(PWRs) is not permitted.
    (iv) Uncertainty analysis. An uncertainty analysis performed in 
accordance with
    Section 2.7.3.5 is not required to support deterministic approach 
calculations.
    (v) Existing cables. In lieu of installing cables meeting flame 
propagation tests as required by Section 3.3.5.3, a flame-retardant 
coating may be applied to the electric cables, or an automatic fixed 
fire suppression system may be installed to provide an equivalent level 
of protection. In addition, the italicized exception to Section 3.3.5.3 
is not endorsed.
    (vi) Water supply and distribution. The italicized exception to 
Section 3.6.4 is not endorsed. Licensees who wish to use the exception 
to Section 3.6.4 must submit a request for a license amendment in 
accordance with paragraph (c)(2)(vii) of this section.
    (vii) Performance-based methods. Notwithstanding the prohibition in 
Section 3.1 against the use of performance-based methods, the fire 
protection program elements and minimum design requirements of Chapter 3 
may be subject to the performance-based methods permitted elsewhere in 
the standard. Licensees who wish to use performance-based methods for 
these fire protection program elements and minimum design requirements 
shall submit a request in the form of an application for license 
amendment under Sec.50.90. The Director of the Office of Nuclear 
Reactor Regulation, or a designee of the Director, may approve the 
application if the Director or designee determines that the performance-
based approach;
    (A) Satisfies the performance goals, performance objectives, and 
performance criteria specified in NFPA 805 related to nuclear safety and 
radiological release;
    (B) Maintains safety margins; and
    (C) Maintains fire protection defense-in-depth (fire prevention, 
fire detection, fire suppression, mitigation, and post-fire safe 
shutdown capability).
    (3) Compliance with NFPA 805. (i) A licensee may maintain a fire 
protection program that complies with NFPA 805 as an alternative to 
complying with paragraph (b) of this section for plants licensed to 
operate before January 1, 1979, or the fire protection license 
conditions for plants licensed to operate after January 1, 1979. The 
licensee shall submit a request to comply with NFPA 805 in the form of 
an application for license amendment under Sec.50.90. The application 
must identify any orders and license conditions that must be revised or 
superseded, and contain any necessary revisions to the plant's technical 
specifications and the bases thereof. The Director of the Office of 
Nuclear Reactor Regulation, or a designee of the Director, may approve 
the application if the Director or designee determines that the licensee 
has identified orders, license conditions, and the technical 
specifications that must be revised or superseded, and that any

[[Page 903]]

necessary revisions are adequate. Any approval by the Director or the 
designee must be in the form of a license amendment approving the use of 
NFPA 805 together with any necessary revisions to the technical 
specifications.
    (ii) The licensee shall complete its implementation of the 
methodology in Chapter 2 of NFPA 805 (including all required evaluations 
and analyses) and, upon completion, modify the fire protection plan 
required by paragraph (a) of this section to reflect the licensee's 
decision to comply with NFPA 805, before changing its fire protection 
program or nuclear power plant as permitted by NFPA 805.
    (4) Risk-informed or performance-based alternatives to compliance 
with NFPA 805. A licensee may submit a request to use risk-informed or 
performance-based alternatives to compliance with NFPA 805. The request 
must be in the form of an application for license amendment under Sec.
50.90 of this chapter. The Director of the Office of Nuclear Reactor 
Regulation, or designee of the Director, may approve the application if 
the Director or designee determines that the proposed alternatives:
    (i) Satisfy the performance goals, performance objectives, and 
performance criteria specified in NFPA 805 related to nuclear safety and 
radiological release;
    (ii) Maintain safety margins; and
    (iii) Maintain fire protection defense-in-depth (fire prevention, 
fire detection, fire suppression, mitigation, and post-fire safe 
shutdown capability).
    (d)-(e) [Reserved]
    (f) Licensees that have submitted the certifications required under 
Sec.50.82(a)(1) shall maintain a fire protection program to address 
the potential for fires that could cause the release or spread of 
radioactive materials (i.e., that could result in a radiological 
hazard). A fire protection program that complies with NFPA 805 shall be 
deemed to be acceptable for complying with the requirements of this 
paragraph.
    (1) The objectives of the fire protection program are to--
    (i) Reasonably prevent these fires from occurring;
    (ii) Rapidly detect, control, and extinguish those fires that do 
occur and that could result in a radiological hazard; and
    (iii) Ensure that the risk of fire-induced radiological hazards to 
the public, environment and plant personnel is minimized.
    (2) The licensee shall assess the fire protection program on a 
regular basis. The licensee shall revise the plan as appropriate 
throughout the various stages of facility decommissioning.
    (3) The licensee may make changes to the fire protection program 
without NRC approval if these changes do not reduce the effectiveness of 
fire protection for facilities, systems, and equipment that could result 
in a radiological hazard, taking into account the decommissioning plant 
conditions and activities.

[65 FR 38190, June 20, 2000, as amended at 69 FR 33550, June 16, 2004; 
72 FR 49495, Aug. 28, 2007]



Sec.50.49  Environmental qualification of electric equipment 
important to safety for nuclear power plants.

    (a) Each holder of or an applicant for an operating license issued 
under this part, or a combined license or manufacturing license issued 
under part 52 of this chapter, other than a nuclear power plant for 
which the certifications required under Sec.50.82(a)(1) or Sec.
52.110(a)(1) of this chapter have been submitted, shall establish a 
program for qualifying the electric equipment defined in paragraph (b) 
of this section. For a manufacturing license, only electric equipment 
defined in paragraph (b) which is within the scope of the manufactured 
reactor must be included in the program.
    (b) Electric equipment important to safety covered by this section 
is:
    (1) Safety-related electric equipment. \3\
---------------------------------------------------------------------------

    \3\ Safety-related electric equipment is referred to as ``Class 1E'' 
equipment in IEEE 323-1974. Copies of this standard may be obtained from 
the Institute of Electrical and Electronics Engineers, Inc., 345 East 
47th Street, New York, NY 10017.
---------------------------------------------------------------------------

    (i) This equipment is that relied upon to remain functional during 
and following design basis events to ensure--
    (A) The integrity of the reactor coolant pressure boundary;

[[Page 904]]

    (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 that could result in potential offsite exposures comparable to 
the guidelines in Sec.50.34(a)(1), Sec.50.67(b)(2), or Sec.100.11 
of this chapter, as applicable.
    (ii) Design basis events are defined as conditions of normal 
operation, including anticipated operational occurrences, design basis 
accidents, external events, and natural phenomena for which the plant 
must be designed to ensure functions (b)(1)(i) (A) through (C) of this 
section.
    (2) Nonsafety-related electric equipment whose failure under 
postulated environmental conditions could prevent satisfactory 
accomplishment of safety functions specified in subparagraphs 
(b)(1)(i)(A) through (C) of this section by the safety-related 
equipment.
    (3) Certain post-accident monitoring equipment. \4\
---------------------------------------------------------------------------

    \4\ Specific guidance concerning the types of variables to be 
monitored is provided in Revision 2 of Regulatory Guide 1.97, 
``Instrumentation for Light-Water-Cooled Nuclear Power Plants to Assess 
Plant and Environs Conditions During and Following an Accident.'' Copies 
of the Regulatory Guide may be purchased through the U.S. Government 
Publishing Office by calling 202-512-1800 or by writing to the U.S. 
Government Publishing Office, P.O. Box 37082, Washington, DC 20013-7082.
---------------------------------------------------------------------------

    (c) Requirements for (1) dynamic and seismic qualification of 
electric equipment important to safety, (2) protection of electric 
equipment important to safety against other natural phenomena and 
external events, and (3) environmental qualification of electric 
equipment important to safety located in a mild environment are not 
included within the scope of this section. A mild environment is an 
environment that would at no time be significantly more severe than the 
environment that would occur during normal plant operation, including 
anticipated operational occurrences.
    (d) The applicant or licensee shall prepare a list of electric 
equipment important to safety covered by this section. In addition, the 
applicant or licensee shall include the information in paragraphs 
(d)(1), (2), and (3) of this section for this electric equipment 
important to safety in a qualification file. The applicant or licensee 
shall keep the list and information in the file current and retain the 
file in auditable form for the entire period during which the covered 
item is installed in the nuclear power plant or is stored for future use 
to permit verification that each item of electric equipment is important 
to safely meet the requirements of paragraph (j) of this section.
    (1) The performance specifications under conditions existing during 
and following design basis accidents.
    (2) The voltage, frequency, load, and other electrical 
characteristics for which the performance specified in accordance with 
paragraph (d)(1) of this section can be ensured.
    (3) The environmental conditions, including temperature, pressure, 
humidity, radiation, chemicals, and submergence at the location where 
the equipment must perform as specified in accordance with paragraphs 
(d) (1) and (2) of this section.
    (e) The electric equipment qualification program must include and be 
based on the following:
    (1) Temperature and pressure. The time-dependent temperature and 
pressure at the location of the electric equipment important to safety 
must be established for the most severe design basis accident during or 
following which this equipment is required to remain functional.
    (2) Humidity. Humidity during design basis accidents must be 
considered.
    (3) Chemical effects. The composition of chemicals used must be at 
least as severe as that resulting from the most limiting mode of plant 
operation (e.g., containment spray, emergency core cooling, or 
recirculation from containment sump). If the composition of the chemical 
spray can be affected by equipment malfunctions, the most severe 
chemical spray environment that results from a single failure in the 
spray system must be assumed.
    (4) Radiation. The radiation environment must be based on the type 
of radiation, the total dose expected during normal operation over the 
installed life

[[Page 905]]

of the equipment, and the radiation environment associated with the most 
severe design basis accident during or following which the equipment is 
required to remain functional, including the radiation resulting from 
recirculating fluids for equipment located near the recirculating lines 
and including dose-rate effects.
    (5) Aging. Equipment qualified by test must be preconditioned by 
natural or artificial (accelerated) aging to its end-of-installed life 
condition. Consideration must be given to all significant types of 
degradation which can have an effect on the functional capability of the 
equipment. If preconditioning to an end-of-installed life condition is 
not practicable, the equipment may be preconditioned to a shorter 
designated life. The equipment must be replaced or refurbished at the 
end of this designated life unless ongoing qualification demonstrates 
that the item has additional life.
    (6) Submergence (if subject to being submerged).
    (7) Synergistic effects. Synergistic effects must be considered when 
these effects are believed to have a significant effect on equipment 
performance.
    (8) Margins. Margins must be applied to account for unquantified 
uncertainty, such as the effects of production variations and 
inaccuracies in test instruments. These margins are in addition to any 
conservatisms applied during the derivation of local environmental 
conditions of the equipment unless these conservatisms can be quantified 
and shown to contain appropriate margins.
    (f) Each item of electric equipment important to safety must be 
qualified by one of the following methods:
    (1) Testing an identical item of equipment under identical 
conditions or under similar conditions with a supporting analysis to 
show that the equipment to be qualified is acceptable.
    (2) Testing a similar item of equipment with a supporting analysis 
to show that the equipment to be qualified is acceptable.
    (3) Experience with identical or similar equipment under similar 
conditions with a supporting analysis to show that the equipment to be 
qualified is acceptable.
    (4) Analysis in combination with partial type test data that 
supports the analytical assumptions and conclusions.
    (g) Each holder of an operating license issued prior to February 22, 
1983, shall, by May 20, 1983, identify the electric equipment important 
to safety within the scope of this section already qualified and submit 
a schedule for either the qualification to the provisions of this 
section or for the replacement of the remaining electric equipment 
important to safety within the scope of this section. This schedule must 
establish a goal of final environmental qualification of the electric 
equipment within the scope of this section by the end of the second 
refueling outage after March 31, 1982 or by March 31, 1985, whichever is 
earlier. The Director of the Office of Nuclear Reactor Regulation may 
grant requests for extensions of this deadline to a date no later than 
November 30, 1985, for specific pieces of equipment if these requests 
are filed on a timely basis and demonstrate good cause for the 
extension, such as procurement lead time, test complications, and 
installation problems. In exceptional cases, the Commission itself may 
consider and grant extensions beyond November 30, 1985, for completion 
of environmental qualification.

The schedule in this paragraph supersedes the June 30, 1982, deadline, 
or any other previously imposed date, for environmental qualification of 
electric equipment contained in certain nuclear power operating 
licenses.
    (h) Each license shall notify the Commission as specified in Sec.
50.4 of any significant equipment qualification problem that may require 
extension of the completion date provided in accordance with paragraph 
(g) of this section within 60 days of its discovery.
    (i) Applicants for operating licenses granted after February 22, 
1983, but prior to November 30, 1985, shall perform an analysis to 
ensure that the plant can be safely operated pending completion of 
equipment qualification required by this section. This analysis must be 
submitted, as specified in Sec.50.4, for consideration prior to the 
granting of an operating license and

[[Page 906]]

must include, where appropriate, consideration of:
    (1) Accomplishing the safety function by some designated alternative 
equipment if the principal equipment has not been demonstrated to be 
fully qualified.
    (2) The validity of partial test data in support of the original 
qualification.
    (3) Limited use of administrative controls over equipment that has 
not been demonstrated to be fully qualified.
    (4) Completion of the safety function prior to exposure to the 
accident environment resulting from a design basis event and ensuring 
that the subsequent failure of the equipment does not degrade any safety 
function or mislead the operator.
    (5) No significant degradation of any safety function or misleading 
information to the operator as a result of failure of equipment under 
the accident environment resulting from a design basis event.
    (j) A record of the qualification, including documentation in 
paragraph (d) of this section, must be maintained in an auditable form 
for the entire period during which the covered item is installed in the 
nuclear power plant or is stored for future use to permit verification 
that each item of electric equipment important to safety covered by this 
section:
    (1) Is qualified for its application; and
    (2) Meets its specified performance requirements when it is 
subjected to the conditions predicted to be present when it must perform 
its safety function up to the end of its qualified life.
    (k) Applicants for and holders of operating licenses are not 
required to requalify electric equipment important to safety in 
accordance with the provisions of this section if the Commission has 
previously required qualification of that equipment in accordance with 
``Guidelines for Evaluating Environmental Qualification of Class 1E 
Electrical Equipment in Operating Reactors,'' November 1979 (DOR 
Guidelines), or NUREG-0588 (For Comment version), ``Interim Staff 
Position on Environmental Qualification of Safety-Related Electrical 
Equipment.''
    (l) Replacement equipment must be qualified in accordance with the 
provisions of this section unless there are sound reasons to the 
contrary.

[48 FR 2733, Jan. 21, 1983, as amended at 49 FR 45576, Nov. 19, 1984; 51 
FR 40308, Nov. 6, 1986; 51 FR 43709, Dec. 3, 1986; 52 FR 31611, Aug. 21, 
1987; 53 FR 19250, May 27, 1988; 61 FR 39300, July 29, 1996; 61 FR 
65173, Dec. 11, 1996; 62 FR 47271, Sept. 8, 1997; 64 FR 72001, Dec. 23, 
1999; 66 FR 64738, Dec. 14, 2001; 72 FR 49495, Aug. 28, 2007; 80 FR 
45843, Aug. 3, 2015]

   Issuance, Limitations, and Conditions of Licenses and Construction 
                                 Permits



Sec.50.50  Issuance of licenses and construction permits.

    Upon determination that an application for a license meets the 
standards and requirements of the act and regulations, and that 
notifications, if any, to other agencies or bodies have been duly made, 
the Commission will issue a license, or if appropriate a construction 
permit, in such form and containing such conditions and limitations 
including technical specifications, as it deems appropriate and 
necessary.



Sec.50.51  Continuation of license.

    (a) Each license will be issued for a fixed period of time to be 
specified in the license but in no case to exceed 40 years from date of 
issuance. Where the operation of a facility is involved, the Commission 
will issue the license for the term requested by the applicant or for 
the estimated useful life of the facility if the Commission determines 
that the estimated useful life is less than the term requested. Where 
construction of a facility is involved, the Commission may specify in 
the construction permit the period for which the license will be issued 
if approved pursuant to Sec.50.56. Licenses may be renewed by the 
Commission upon the expiration of the period. Renewal of operating 
licenses for nuclear power plants is governed by 10 CFR part 54. 
Application for termination of license is to be made pursuant to Sec.
50.82.
    (b) Each license for a facility that has permanently ceased 
operations, continues in effect beyond the expiration date to authorize 
ownership and possession of the production or utilization facility, 
until the Commission notifies the licensee in writing that the

[[Page 907]]

license is terminated. During such period of continued effectiveness the 
licensee shall--
    (1) Take actions necessary to decommission and decontaminate the 
facility and continue to maintain the facility, including, where 
applicable, the storage, control and maintenance of the spent fuel, in a 
safe condition, and
    (2) Conduct activities in accordance with all other restrictions 
applicable to the facility in accordance with the NRC regulations and 
the provisions of the specific 10 CFR part 50 license for the facility.

[56 FR 64976, Dec. 13, 1991, as amended at 61 FR 39300, July 29, 1996]



Sec.50.52  Combining licenses.

    The Commission may combine in a single license the activities of an 
applicant which would otherwise be licensed severally.



Sec.50.53  Jurisdictional limitations.

    No license under this part shall be deemed to have been issued for 
activities which are not under or within the jurisdiction of the United 
States.

[21 FR 355, Jan. 19, 1956, as amended at 43 FR 6924, Feb. 17, 1978]



Sec.50.54  Conditions of licenses.

    The following paragraphs of this section, with the exception of 
paragraphs (r) and (gg), and the applicable requirements of 10 CFR 
50.55a, are conditions in every nuclear power reactor operating license 
issued under this part. The following paragraphs with the exception of 
paragraph (r), (s), and (u) of this section are conditions in every 
combined license issued under part 52 of this chapter, provided, 
however, that paragraphs (i) introductory text, (i)(1), (j), (k), (l), 
(m), (n), (w), (x), (y), (z), and (hh) of this section are only 
applicable after the Commission makes the finding under Sec.52.103(g) 
of this chapter.
    (a)(1) Each nuclear power plant or fuel reprocessing plant licensee 
subject to the quality assurance criteria in appendix B of this part 
shall implement, under Sec.50.34(b)(6)(ii) or Sec.52.79 of this 
chapter, the quality assurance program described or referenced in the 
safety analysis report, including changes to that report. However, a 
holder of a combined license under part 52 of this chapter shall 
implement the quality assurance program described or referenced in the 
safety analysis report applicable to operation 30 days prior to the 
scheduled date for the initial loading of fuel.
    (2) Each licensee described in paragraph (a)(1) of this section 
shall, by June 10, 1983, submit to the appropriate NRC Regional Office 
shown in appendix D of part 20 of this chapter the current description 
of the quality assurance program it is implementing for inclusion in the 
Safety Analysis Report, unless there are no changes to the description 
previously accepted by NRC. This submittal must identify changes made to 
the quality assurance program description since the description was 
submitted to NRC. (Should a licensee need additional time beyond June 
10, 1983 to submit its current quality assurance program description to 
NRC, it shall notify the appropriate NRC Regional Office in writing, 
explain why additional time is needed, and provide a schedule for NRC 
approval showing when its current quality assurance program description 
will be submitted.)
    (3) Each licensee described in paragraph (a)(1) of this section may 
make a change to a previously accepted quality assurance program 
description included or referenced in the Safety Analysis Report without 
prior NRC approval, provided the change does not reduce the commitments 
in the program description as accepted by the NRC. Changes to the 
quality assurance program description that do not reduce the commitments 
must be submitted to the NRC in accordance with the requirements of 
Sec.50.71(e). In addition to quality assurance program changes 
involving administrative improvements and clarifications, spelling 
corrections, punctuation, or editorial items, the following changes are 
not considered to be reductions in commitment:
    (i) The use of a QA standard approved by the NRC which is more 
recent than the QA standard in the licensee's current QA program at the 
time of the change;
    (ii) The use of a quality assurance alternative or exception 
approved by an NRC safety evaluation, provided that

[[Page 908]]

the bases of the NRC approval are applicable to the licensee's facility;
    (iii) The use of generic organizational position titles that clearly 
denote the position function, supplemented as necessary by descriptive 
text, rather than specific titles;
    (iv) The use of generic organizational charts to indicate functional 
relationships, authorities, and responsibilities, or, alternately, the 
use of descriptive text;
    (v) The elimination of quality assurance program information that 
duplicates language in quality assurance regulatory guides and quality 
assurance standards to which the licensee is committed; and
    (vi) Organizational revisions that ensure that persons and 
organizations performing quality assurance functions continue to have 
the requisite authority and organizational freedom, including sufficient 
independence from cost and schedule when opposed to safety 
considerations.
    (4) Changes to the quality assurance program description that do 
reduce the commitments must be submitted to the NRC and receive NRC 
approval prior to implementation, as follows:
    (i) Changes made to the quality assurance program description as 
presented in the Safety Analysis Report or in a topical report must be 
submitted as specified in Sec.50.4.
    (ii) The submittal of a change to the Safety Analysis Report quality 
assurance program description must include all pages affected by that 
change and must be accompanied by a forwarding letter identifying the 
change, the reason for the change, and the basis for concluding that the 
revised program incorporating the change continues to satisfy the 
criteria of appendix B of this part and the Safety Analysis Report 
quality assurance program description commitments previously accepted by 
the NRC (the letter need not provide the basis for changes that correct 
spelling, punctuation, or editorial items).
    (iii) A copy of the forwarding letter identifying the change must be 
maintained as a facility record for three years.
    (iv) Changes to the quality assurance program description included 
or referenced in the Safety Analysis Report shall be regarded as 
accepted by the Commission upon receipt of a letter to this effect from 
the appropriate reviewing office of the Commission or 60 days after 
submittal to the Commission, whichever occurs first.
    (b) No right to the special nuclear material shall be conferred by 
the license except as may be defined by the license.
    (c) Neither the license, nor any right thereunder, nor any right to 
utilize or produce special nuclear material shall be transferred, 
assigned, or disposed of in any manner, either voluntarily or 
involuntarily, directly or indirectly, through transfer of control of 
the license to any person, unless the Commission shall, after securing 
full information, find that the transfer is in accordance with the 
provisions of the act and give its consent in writing.
    (d) The license shall be subject to suspension and to the rights of 
recapture of the material or control of the facility reserved to the 
Commission under section 108 of the act in a state of war or national 
emergency declared by Congress.
    (e) The license shall be subject to revocation, suspension, 
modification, or amendment for cause as provided in the act and 
regulations, in accordance with the procedures provided by the act and 
regulations.
    (f) The licensee shall at any time before expiration of the license, 
upon request of the Commission, submit, as specified in Sec.50.4, 
written statements, signed under oath or affirmation, to enable the 
Commission to determine whether or not the license should be modified, 
suspended, or revoked. Except for information sought to verify licensee 
compliance with the current licensing basis for that facility, the NRC 
must prepare the reason or reasons for each information request prior to 
issuance to ensure that the burden to be imposed on respondents is 
justified in view of the potential safety significance of the issue to 
be addressed in the requested information. Each such justification 
provided for an evaluation performed by the NRC staff must be approved 
by the Executive Director for Operations or his or her designee prior to 
issuance of the request.

[[Page 909]]

    (g) The issuance or existence of the license shall not be deemed to 
waive, or relieve the licensee from compliance with, the antitrust laws, 
as specified in subsection 105a of the Act. In the event that the 
licensee should be found by a court of competent jurisdiction to have 
violated any provision of such antitrust laws in the conduct of the 
licensed activity, the Commission may suspend or revoke the license or 
take such other action with respect to it as shall be deemed necessary.
    (h) The license shall be subject to the provisions of the Act now or 
hereafter in effect and to all rules, regulations, and orders of the 
Commission. The terms and conditions of the license shall be subject to 
amendment, revision, or modification, by reason of amendments of the Act 
or by reason of rules, regulations, and orders issued in accordance with 
the terms of the act.
    (i) Except as provided in Sec.55.13 of this chapter, the licensee 
may not permit the manipulation of the controls of any facility by 
anyone who is not a licensed operator or senior operator as provided in 
part 55 of this chapter.
    (i-1) Within 3 months after either the issuance of an operating 
license or the date that the Commission makes the finding under Sec.
52.103(g) of this chapter for a combined license, as applicable, the 
licensee shall have in effect an operator requalification program. The 
operator requalification program must, as a minimum, meet the 
requirements of Sec.55.59(c) of this chapter. Notwithstanding the 
provisions of Sec.50.59, the licensee may not, except as specifically 
authorized by the Commission decrease the scope of an approved operator 
requalification program.
    (j) Apparatus and mechanisms other than controls, the operation of 
which may affect the reactivity or power level of a reactor shall be 
manipulated only with the knowledge and consent of an operator or senior 
operator licensed pursuant to part 55 of this chapter present at the 
controls.
    (k) An operator or senior operator licensed pursuant to part 55 of 
this chapter shall be present at the controls at all times during the 
operation of the facility.
    (l) The licensee shall designate individuals to be responsible for 
directing the licensed activities of licensed operators. These 
individuals shall be licensed as senior operators pursuant to part 55 of 
this chapter.
    (m)(1) A senior operator licensed pursuant to part 55 of this 
chapter shall be present at the facility or readily available on call at 
all times during its operation, and shall be present at the facility 
during initial start-up and approach to power, recovery from an 
unplanned or unscheduled shut-down or significant reduction in power, 
and refueling, or as otherwise prescribed in the facility license.
    (2) Notwithstanding any other provisions of this section, by January 
1, 1984, licensees of nuclear power units shall meet the following 
requirements:
    (i) Each licensee shall meet the minimum licensed operator staffing 
requirements in the following table:

Minimum Requirements \1\ Per Shift for On-Site Staffing of Nuclear Power Units by Operators and Senior Operators
                                          Licensed Under 10 CFR Part 55
----------------------------------------------------------------------------------------------------------------
                                                                One unit       Two units          Three units
                                                               -------------------------------------------------
    Number of nuclear power units              Position            One       One       Two       Two      Three
            operating \2\                                        control   control   control   control   control
                                                                  room      room      rooms     rooms     rooms
----------------------------------------------------------------------------------------------------------------
None.................................  Senior Operator........         1         1         1         1         1
                                       Operator...............         1         2         2         3         3
One..................................  Senior Operator........         2         2         2         2         2
                                       Operator...............         2         3         3         4         4
Two..................................  Senior Operator........  ........         2         3     \3\ 3         3
                                       Operator...............  ........         3         4     \3\ 5         5
Three................................  Senior Operator........  ........  ........  ........         3         4
                                       Operator...............  ........  ........  ........         5         6
----------------------------------------------------------------------------------------------------------------
\1\ Temporary deviations from the numbers required by this table shall be in accordance with criteria
  established in the unit's technical specifications.
\2\ For the purpose of this table, a nuclear power unit is considered to be operating when it is in a mode other
  than cold shutdown or refueling as defined by the unit's technical specifications.
\3\ The number of required licensed personnel when the operating nuclear power units are controlled from a
  common control room are two senior operators and four operators.


[[Page 910]]

    (ii) Each licensee shall have at its site a person holding a senior 
operator license for all fueled units at the site who is assigned 
responsibility for overall plant operation at all times there is fuel in 
any unit. If a single senior operator does not hold a senior operator 
license on all fueled units at the site, then the licensee must have at 
the site two or more senior operators, who in combination are licensed 
as senior operators on all fueled units.
    (iii) When a nuclear power unit is in an operational mode other than 
cold shutdown or refueling, as defined by the unit's technical 
specifications, each licensee shall have a person holding a senior 
operator license for the nuclear power unit in the control room at all 
times. In addition to this senior operator, for each fueled nuclear 
power unit, a licensed operator or senior operator shall be present at 
the controls at all times.
    (iv) Each licensee shall have present, during alteration of the core 
of a nuclear power unit (including fuel loading or transfer), a person 
holding a senior operator license or a senior operator license limited 
to fuel handling to directly supervise the activity and, during this 
time, the licensee shall not assign other duties to this person.
    (3) Licensees who cannot meet the January 1, 1984 deadline must 
submit by October 1, 1983 a request for an extension to the Director of 
the Office of Nuclear Regulation and demonstrate good cause for the 
request.
    (n) The licensee shall not, except as authorized pursuant to a 
construction permit, make any alteration in the facility constituting a 
change from the technical specifications previously incorporated in a 
license or construction permit pursuant to Sec.50.36 of this part.
    (o) Primary reactor containments for water cooled power reactors, 
other than facilities for which the certifications required under 
Sec. Sec.50.82(a)(1) or 52.110(a)(1) of this chapter have been 
submitted, shall be subject to the requirements set forth in appendix J 
to this part.
    (p)(1) The licensee shall prepare and maintain safeguards 
contingency plan procedures in accordance with appendix C of part 73 of 
this chapter for affecting the actions and decisions contained in the 
Responsibility Matrix of the safeguards contingency plan. The licensee 
may not make a change which would decrease the effectiveness of a 
physical security plan, or guard training and qualification plan, or 
cyber security plan prepared under Sec.50.34(c) or Sec.52.79(a), or 
part 73 of this chapter, or of the first four categories of information 
(Background, Generic Planning Base, Licensee Planning Base, 
Responsibility Matrix) contained in a licensee safeguards contingency 
plan prepared under Sec.50.34(d) or Sec.52.79(a), or part 73 of this 
chapter, as applicable, without prior approval of the Commission. A 
licensee desiring to make such a change shall submit an application for 
amendment to the licensee's license under Sec.50.90.
    (2) The licensee may make changes to the plans referenced in 
paragraph (p)(1) of this section, without prior Commission approval if 
the changes do not decrease the safeguards effectiveness of the plan. 
The licensee shall maintain records of changes to the plans made without 
prior Commission approval for a period of 3 years from the date of the 
change, and shall submit, as specified in Sec.50.4 or Sec.52.3 of 
this chapter, a report containing a description of each change within 2 
months after the change is made. Prior to the safeguards contingency 
plan being put into effect, the licensee shall have:
    (i) All safeguards capabilities specified in the safeguards 
contingency plan available and functional;
    (ii) Detailed procedures developed according to appendix C to part 
73 of this chapter available at the licensee's site; and
    (iii) All appropriate personnel trained to respond to safeguards 
incidents as outlined in the plan and specified in the detailed 
procedures.
    (3) The licensee shall provide for the development, revision, 
implementation, and maintenance of its safeguards contingency plan. The 
licensee shall ensure that all program elements are reviewed by 
individuals independent of both security program management and 
personnel who have direct responsibility for implementation of the 
security program either:
    (i) At intervals not to exceed 12 months; or

[[Page 911]]

    (ii) As necessary, based on an assessment by the licensee against 
performance indicators, and as soon as reasonably practicable after a 
change occurs in personnel, procedures, equipment, or facilities that 
potentially could adversely affect security, but no longer than 12 
months after the change. In any case, all elements of the safeguards 
contingency plan must be reviewed at least once every 24 months.
    (4) The review must include a review and audit of safeguards 
contingency procedures and practices, an audit of the security system 
testing and maintenance program, and a test of the safeguards systems 
along with commitments established for response by local law enforcement 
authorities. The results of the review and audit, along with 
recommendations for improvements, must be documented, reported to the 
licensee's corporate and plant management, and kept available at the 
plant for inspection for a period of 3 years.
    (q) Emergency plans--(1) Definitions for the purpose of this 
section:
    (i) Change means an action that results in modification or addition 
to, or removal from, the licensee's emergency plan. All such changes are 
subject to the provisions of this section except where the applicable 
regulations establish specific criteria for accomplishing a particular 
change.
    (ii) Emergency plan means the document(s), prepared and maintained 
by the licensee, that identify and describe the licensee's methods for 
maintaining emergency preparedness and responding to emergencies. An 
emergency plan includes the plan as originally approved by the NRC and 
all subsequent changes made by the licensee with, and without, prior NRC 
review and approval under paragraph (q) of this section.
    (iii) Emergency planning function means a capability or resource 
necessary to prepare for and respond to a radiological emergency, as set 
forth in the elements of section IV. of appendix E to this part and, for 
nuclear power reactor licensees, the planning standards of Sec.
50.47(b).
    (iv) Reduction in effectiveness means a change in an emergency plan 
that results in reducing the licensee's capability to perform an 
emergency planning function in the event of a radiological emergency.
    (2) A holder of a license under this part, or a combined license 
under part 52 of this chapter after the Commission makes the finding 
under Sec.52.103(g) of this chapter, shall follow and maintain the 
effectiveness of an emergency plan that meets the requirements in 
appendix E to this part and, for nuclear power reactor licensees, the 
planning standards of Sec.50.47(b).
    (3) The licensee may make changes to its emergency plan without NRC 
approval only if the licensee performs and retains an analysis 
demonstrating that the changes do not reduce the effectiveness of the 
plan and the plan, as changed, continues to meet the requirements in 
appendix E to this part and, for nuclear power reactor licensees, the 
planning standards of Sec.50.47(b).
    (4) The changes to a licensee's emergency plan that reduce the 
effectiveness of the plan as defined in paragraph (q)(1)(iv) of this 
section may not be implemented without prior approval by the NRC. A 
licensee desiring to make such a change after February 21, 2012 shall 
submit an application for an amendment to its license. In addition to 
the filing requirements of Sec. Sec.50.90 and 50.91, the request must 
include all emergency plan pages affected by that change and must be 
accompanied by a forwarding letter identifying the change, the reason 
for the change, and the basis for concluding that the licensee's 
emergency plan, as revised, will continue to meet the requirements in 
appendix E to this part and, for nuclear power reactor licensees, the 
planning standards of Sec.50.47(b).
    (5) The licensee shall retain a record of each change to the 
emergency plan made without prior NRC approval for a period of three 
years from the date of the change and shall submit, as specified in 
Sec.50.4, a report of each such change made after February 21, 2012, 
including a summary of its analysis, within 30 days after the change is 
put in effect.
    (6) The nuclear power reactor licensee shall retain the emergency 
plan and each change for which prior NRC approval was obtained pursuant 
to paragraph (q)(4) of this section as a

[[Page 912]]

record until the Commission terminates the license for the nuclear power 
reactor.
    (r) [Reserved]
    (s)(1) [Reserved]
    (2)(i) [Reserved]
    (ii) If after April 1, 1981, the NRC finds that the state of 
emergency preparedness does not provide reasonable assurance that 
adequate protective measures can and will be taken in the event of a 
radiological emergency (including findings based on requirements of 
appendix E, section IV.D.3) and if the deficiencies (including 
deficiencies based on requirements of appendix E, section IV.D.3) are 
not corrected within four months of that finding, the Commission will 
determine whether the reactor shall be shut down until such deficiencies 
are remedied or whether other enforcement action is appropriate. In 
determining whether a shutdown or other enforcement action is 
appropriate, the Commission shall take into account, among other 
factors, whether the licensee can demonstrate to the Commission's 
satisfaction that the deficiencies in the plan are not significant for 
the plant in question, or that adequate interim compensating actions 
have been or will be taken promptly, or that there are other compelling 
reasons for continued operation.
    (3) The NRC will base its finding on a review of the FEMA findings 
and determinations as to whether State and local emergency plans are 
adequate and capable of being implemented, and on the NRC assessment as 
to whether the licensee's emergency plans are adequate and capable of 
being implemented. Nothing in this paragraph shall be construed as 
limiting the authority of the Commission to take action under any other 
regulation or authority of the Commission or at any time other than that 
specified in this paragraph.
    (t)(1) The licensee shall provide for the development, revision, 
implementation, and maintenance of its emergency preparedness program. 
The licensee shall ensure that all program elements are reviewed by 
persons who have no direct responsibility for the implementation of the 
emergency preparedness program either:
    (i) At intervals not to exceed 12 months or,
    (ii) As necessary, based on an assessment by the licensee against 
performance indicators, and as soon as reasonably practicable after a 
change occurs in personnel, procedures, equipment, or facilities that 
potentially could adversely affect emergency preparedness, but no longer 
than 12 months after the change. In any case, all elements of the 
emergency preparedness program must be reviewed at least once every 24 
months.
    (2) The review must include an evaluation for adequacy of interfaces 
with State and local governments and of licensee drills, exercises, 
capabilities, and procedures. The results of the review, along with 
recommendations for improvements, must be documented, reported to the 
licensee's corporate and plant management, and retained for a period of 
5 years. The part of the review involving the evaluation for adequacy of 
interface with State and local governments must be available to the 
appropriate State and local governments.
    (u) [Reserved]
    (v) Each licensee subject to the requirements of Part 73 of this 
chapter shall ensure that Safeguards Information is protected against 
unauthorized disclosure in accordance with the requirements in Sec.
73.21 and the requirements in Sec.73.22 or Sec.73.23 of this 
chapter, as applicable.
    (w) Each power reactor licensee under this part for a production or 
utilization facility of the type described in Sec.50.21(b) or Sec.
50.22 shall take reasonable steps to obtain insurance available at 
reasonable costs and on reasonable terms from private sources or to 
demonstrate to the satisfaction of the NRC that it possesses an 
equivalent amount of protection covering the licensee's obligation, in 
the event of an accident at the licensee's reactor, to stabilize and 
decontaminate the reactor and the reactor station site at which the 
reactor experiencing the accident is located, provided that:
    (1) The insurance required by paragraph (w) of this section must 
have a minimum coverage limit for each reactor station site of either 
$1.06 billion or

[[Page 913]]

whatever amount of insurance is generally available from private 
sources, whichever is less. The required insurance must clearly state 
that, as and to the extent provided in paragraph (w)(4) of this section, 
any proceeds must be payable first for stabilization of the reactor and 
next for decontamination of the reactor and the reactor station site. If 
a licensee's coverage falls below the required minimum, the licensee 
shall within 60 days take all reasonable steps to restore its coverage 
to the required minimum. The required insurance may, at the option of 
the licensee, be included within policies that also provide coverage for 
other risks, including, but not limited to, the risk of direct physical 
damage.
    (2)(i) With respect to policies issued or annually renewed on or 
after April 2, 1991, the proceeds of such required insurance must be 
dedicated, as and to the extent provided in this paragraph, to 
reimbursement or payment on behalf of the insured of reasonable expenses 
incurred or estimated to be incurred by the licensee in taking action to 
fulfill the licensee's obligation, in the event of an accident at the 
licensee's reactor, to ensure that the reactor is in, or is returned to, 
and maintained in, a safe and stable condition and that radioactive 
contamination is removed or controlled such that personnel exposures are 
consistent with the occupational exposure limits in 10 CFR part 20. 
These actions must be consistent with any other obligation the licensee 
may have under this chapter and must be subject to paragraph (w)(4) of 
this section. As used in this section, an ``accident'' means an event 
that involves the release of radioactive material from its intended 
place of confinement within the reactor or on the reactor station site 
such that there is a present danger of release off site in amounts that 
would pose a threat to the public health and safety.
    (ii) The stabilization and decontamination requirements set forth in 
paragraph (w)(4) of this section must apply uniformly to all insurance 
policies required under paragraph (w) of this section.
    (3) The licensee shall report to the NRC on April 1 of each year the 
current levels of this insurance or financial security it maintains and 
the sources of this insurance or financial security.
    (4)(i) In the event of an accident at the licensee's reactor, 
whenever the estimated costs of stabilizing the licensed reactor and of 
decontaminating the reactor and the reactor station site exceed $100 
million, the proceeds of the insurance required by paragraph (w) of this 
section must be dedicated to and used, first, to ensure that the 
licensed reactor is in, or is returned to, and can be maintained in, a 
safe and stable condition so as to prevent any significant risk to the 
public health and safety and, second, to decontaminate the reactor and 
the reactor station site in accordance with the licensee's cleanup plan 
as approved by order of the Director of the Office of Nuclear Reactor 
Regulation. This priority on insurance proceeds must remain in effect 
for 60 days or, upon order of the Director, for such longer periods, in 
increments not to exceed 60 days except as provided for activities under 
the cleanup plan required in paragraphs (w)(4)(iii) and (w)(4)(iv) of 
this section, as the Director may find necessary to protect the public 
health and safety. Actions needed to bring the reactor to and maintain 
the reactor in a safe and stable condition may include one or more of 
the following, as appropriate:
    (A) Shutdown of the reactor;
    (B) Establishment and maintenance of long-term cooling with stable 
decay heat removal;
    (C) Maintenance of sub-criticality;
    (D) Control of radioactive releases; and
    (E) Securing of structures, systems, or components to minimize 
radiation exposure to onsite personnel or to the offsite public or to 
facilitate later decontamination or both.
    (ii) The licensee shall inform the Director of the Office of Nuclear 
Reactor Regulation in writing when the reactor is and can be maintained 
in a safe and stable condition so as to prevent any significant risk to 
the public health and safety. Within 30 days after the licensee informs 
the Director that the reactor is in this condition, or at such earlier 
time as the licensee may elect

[[Page 914]]

or the Director may for good cause direct, the licensee shall prepare 
and submit a cleanup plan for the Director's approval. The cleanup plan 
must identify and contain an estimate of the cost of each cleanup 
operation that will be required to decontaminate the reactor 
sufficiently to permit the licensee either to resume operation of the 
reactor or to apply to the Commission under Sec.50.82 for authority to 
decommission the reactor and to surrender the license voluntarily. 
Cleanup operations may include one or more of the following, as 
appropriate:
    (A) Processing any contaminated water generated by the accident and 
by decontamination operations to remove radioactive materials;
    (B) Decontamination of surfaces inside the auxiliary and fuel-
handling buildings and the reactor building to levels consistent with 
the Commission's occupational exposure limits in 10 CFR part 20, and 
decontamination or disposal of equipment;
    (C) Decontamination or removal and disposal of internal parts and 
damaged fuel from the reactor vessel; and
    (D) Cleanup of the reactor coolant system.
    (iii) Following review of the licensee's cleanup plan, the Director 
will order the licensee to complete all operations that the Director 
finds are necessary to decontaminate the reactor sufficiently to permit 
the licensee either to resume operation of the reactor or to apply to 
the Commission under Sec.50.82 for authority to decommission the 
reactor and to surrender the license voluntarily. The Director shall 
approve or disapprove, in whole or in part for stated reasons, the 
licensee's estimate of cleanup costs for such operations. Such order may 
not be effective for more than 1 year, at which time it may be renewed. 
Each subsequent renewal order, if imposed, may be effective for not more 
than 6 months.
    (iv) Of the balance of the proceeds of the required insurance not 
already expended to place the reactor in a safe and stable condition 
pursuant to paragraph (w)(2)(i) of this section, an amount sufficient to 
cover the expenses of completion of those decontamination operations 
that are the subject of the Director's order shall be dedicated to such 
use, provided that, upon certification to the Director of the amounts 
expended previously and from time to time for stabilization and 
decontamination and upon further certification to the Director as to the 
sufficiency of the dedicated amount remaining, policies of insurance may 
provide for payment to the licensee or other loss payees of amounts not 
so dedicated, and the licensee may proceed to use in parallel (and not 
in preference thereto) any insurance proceeds not so dedicated for other 
purposes.
    (x) A licensee may take reasonable action that departs from a 
license condition or a technical specification (contained in a license 
issued under this part) in an emergency when this action is immediately 
needed to protect the public health and safety and no action consistent 
with license conditions and technical specifications that can provide 
adequate or equivalent protection is immediately apparent.
    (y) Licensee action permitted by paragraph (x) of this section shall 
be approved, as a minimum, by a licensed senior operator, or, at a 
nuclear power reactor facility for which the certifications required 
under Sec.50.82(a)(1) have been submitted, by either a licensed senior 
operator or a certified fuel handler, prior to taking the action.
    (z) Each licensee with a utilization facility licensed pursuant to 
sections 103 or 104b. of the Act shall immediately notify the NRC 
Operations Center of the occurrence of any event specified in Sec.
50.72 of this part.
    (aa) The license shall be subject to all conditions deemed imposed 
as a matter of law by sections 401(a)(2) and 401(d) of the Federal Water 
Pollution Control Act, as amended (33 U.S.C.A. 1341 (a)(2) and (d).)
    (bb) For nuclear power reactors licensed by the NRC, the licensee 
shall, within 2 years following permanent cessation of operation of the 
reactor or 5 years before expiration of the reactor operating license, 
whichever occurs first, submit written notification to the Commission 
for its review and preliminary approval of the program by which the 
licensee intends to manage and provide funding for the management of all 
irradiated fuel at the reactor following permanent cessation of

[[Page 915]]

operation of the reactor until title to the irradiated fuel and 
possession of the fuel is transferred to the Secretary of Energy for its 
ultimate disposal in a repository. Licensees of nuclear power reactors 
that have permanently ceased operation by April 4, 1994 are required to 
submit such written notification by April 4, 1996. Final Commission 
review will be undertaken as part of any proceeding for continued 
licensing under part 50 or part 72 of this chapter. The licensee must 
demonstrate to NRC that the elected actions will be consistent with NRC 
requirements for licensed possession of irradiated nuclear fuel and that 
the actions will be implemented on a timely basis. Where implementation 
of such actions requires NRC authorizations, the licensee shall verify 
in the notification that submittals for such actions have been or will 
be made to NRC and shall identify them. A copy of the notification shall 
be retained by the licensee as a record until expiration of the reactor 
operating license. The licensee shall notify the NRC of any significant 
changes in the proposed waste management program as described in the 
initial notification.
    (cc)(1) Each licensee shall notify the appropriate NRC Regional 
Administrator, in writing, immediately following the filing of a 
voluntary or involuntary petition for bankruptcy under any chapter of 
title 11 (Bankruptcy) of the United States Code by or against:
    (i) The licensee;
    (ii) An entity (as that term is defined in 11 U.S.C. 101(14)) 
controlling the licensee or listing the license or licensee as property 
of the estate; or
    (iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of 
the licensee.
    (2) This notification must indicate:
    (i) The bankruptcy court in which the petition for bankruptcy was 
filed; and
    (ii) The date of the filing of the petition.
    (dd) A licensee may take reasonable action that departs from a 
license condition or a technical specification (contained in a license 
issued under this part) in a national security emergency:
    (1) When this action is immediately needed to implement national 
security objectives as designated by the national command authority 
through the Commission, and
    (2) No action consistent with license conditions and technical 
specifications that can meet national security objectives is immediately 
apparent.

A national security emergency is established by a law enacted by the 
Congress or by an order or directive issued by the President pursuant to 
statutes or the Constitution of the United States. The authority under 
this paragraph must be exercised in accordance with law, including 
section 57e of the Act, and is in addition to the authority granted 
under paragraph (x) of this section, which remains in effect unless 
otherwise directed by the Commission during a national security 
emergency.
    (ee)(1) Each license issued under this part authorizing the 
possession of byproduct and special nuclear material produced in the 
operation of the licensed reactor includes, whether stated in the 
license or not, the authorization to receive back that same material, in 
the same or altered form or combined with byproduct or special nuclear 
material produced in the operation of another reactor of the same 
licensee located at that site, from a licensee of the Commission or an 
Agreement State, or from a non-licensed entity authorized to possess the 
material.
    (2) The authorizations in this subsection are subject to the same 
limitations and requirements applicable to the original possession of 
the material.
    (3) This paragraph does not authorize the receipt of any material 
recovered from the reprocessing of irradiated fuel.
    (ff) For licensees of nuclear power plants that have implemented the 
earthquake engineering criteria in appendix S to this part, plant 
shutdown is required as provided in paragraph IV(a)(3) of appendix S to 
this part. Prior to resuming operations, the licensee shall demonstrate 
to the Commission that no functional damage has occurred to those 
features necessary for continued operation without undue risk to the 
health and safety of the public and the licensing basis is maintained.
    (gg)(1) Notwithstanding 10 CFR 52.103, if, following the conduct of 
the

[[Page 916]]

exercise required by paragraph IV.f.2.a of appendix E to part 50 of this 
chapter, FEMA identifies one or more deficiencies in the state of 
offsite emergency preparedness, the holder of a combined license under 
10 CFR part 52 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 Sec.50.47 
and appendix E to this part. Review of the applicant's emergency plans 
will include the following standards with offsite aspects:
    (i) Arrangements for requesting and effectively using offsite 
assistance onsite have been made, arrangements to accommodate State and 
local staff at the licensee's Emergency Operations Facility have been 
made, and other organizations capable of augmenting the planned onsite 
response have been identified.
    (ii) Procedures have been established for licensee communications 
with State and local response organizations, including initial 
notification of the declaration of emergency and periodic provision of 
plant and response status reports.
    (iii) Provisions exist for prompt communications among principal 
response organizations to offsite emergency personnel who would be 
responding onsite.
    (iv) Adequate emergency facilities and equipment to support the 
emergency response onsite are provided and maintained.
    (v) Adequate methods, systems, and equipment for assessing and 
monitoring actual or potential offsite consequences of a radiological 
emergency condition are in use onsite.
    (vi) Arrangements are made for medical services for contaminated and 
injured onsite individuals.
    (vii) Radiological emergency response training has been made 
available to those offsite who may be called to assist in an emergency 
onsite.
    (2) The condition in this paragraph, regarding operation at up to 5 
percent power, ceases to apply 30 days after FEMA informs the NRC that 
the offsite deficiencies have been corrected, unless the NRC notifies 
the combined license holder before the expiration of the 30-day period 
that the Commission finds under paragraphs (s)(2) and (3) of this 
section that the state of emergency preparedness does not provide 
reasonable assurance that adequate protective measures can and will be 
taken in the event of a radiological emergency.
    (hh) (1) Each licensee shall develop, implement and maintain 
procedures that describe how the licensee will address the following 
areas if the licensee is notified of a potential aircraft threat:
    (i) Verification of the authenticity of threat notifications;
    (ii) Maintenance of continuous communication with threat 
notification sources;
    (iii) Contacting all onsite personnel and applicable offsite 
response organizations;
    (iv) Onsite actions necessary to enhance the capability of the 
facility to mitigate the consequences of an aircraft impact;
    (v) Measures to reduce visual discrimination of the site relative to 
its surroundings or individual buildings within the protected area;
    (vi) Dispersal of equipment and personnel, as well as rapid entry 
into site protected areas for essential onsite personnel and offsite 
responders who are necessary to mitigate the event; and
    (vii) Recall of site personnel.
    (2) Each licensee shall develop and implement guidance and 
strategies intended to maintain or restore core cooling, containment, 
and spent fuel pool cooling capabilities under the circumstances 
associated with loss of large areas of the plant due to explosions or 
fire, to include strategies in the following areas:
    (i) Fire fighting;
    (ii) Operations to mitigate fuel damage; and
    (iii) Actions to minimize radiological release.
    (3) This section does not apply to a nuclear power plant for which 
the certifications required under Sec.50.82(a) or Sec.52.110(a)(1) 
of this chapter have been submitted.
    (ii) [Reserved]

[[Page 917]]

    (jj) Structures, systems, and components subject to the codes and 
standards in 10 CFR 50.55a must be designed, fabricated, erected, 
constructed, tested, and inspected to quality standards commensurate 
with the importance of the safety function to be performed.

[21 FR 355, Jan. 19, 1956]

    Editorial Note: For Federal Register citations affecting Sec.
50.54, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfoo.gov.



Sec.50.55  Conditions of construction permits, early site permits,
combined licenses, and manufacturing licenses.

    Each construction permit for a utilization facility is subject to 
the following terms and conditions and the applicable requirements of 
Sec.50.55a; each construction permit for a production facility is 
subject to the following terms and conditions with the exception of 
paragraph (i); each early site permit is subject to the terms and 
conditions in paragraph (f) of this section; each manufacturing license 
is subject to the terms and conditions in paragraphs (e), (f), and (i) 
of this section and the applicable requirements of Sec.50.55a; and 
each combined license is subject to the terms and conditions in 
paragraphs (e), (f), and (i) of this section and the applicable 
requirements of Sec.50.55a until the date that the Commission makes 
the finding under Sec.52.103(g) of this chapter:
    (a) The construction permit shall state the earliest and latest 
dates for completion of the construction or modification.
    (b) If the proposed construction or modification of the facility is 
not completed by the latest completion date, the construction permit 
shall expire and all rights are forfeited. However, upon good cause 
shown, the Commission will extend the completion date for a reasonable 
period of time. The Commission will recognize, among other things, 
developmental problems attributable to the experimental nature of the 
facility or fire, flood, explosion, strike, sabotage, domestic violence, 
enemy action, an act of the elements, and other acts beyond the control 
of the permit holder, as a basis for extending the completion date.
    (c) Except as modified by this section and Sec.50.55a, the 
construction permit shall be subject to the same conditions to which a 
license is subject.
    (d) At or about the time of completion of the construction or 
modification of the facility, the applicant will file any additional 
information needed to bring the original application for license up to 
date, and will file an application for an operating license or an 
amendment to an application for a license to construct and operate the 
facility for the issuance of an operating license, as appropriate, as 
specified in Sec.50.30(d) of this part.
    (e)(1) Definitions. For purposes of this paragraph, the definitions 
in Sec.21.3 of this chapter apply.
    (2) Posting requirements. (i) Each individual, partnership, 
corporation, dedicating entity, or other entity subject to the 
regulations in this part shall post current copies of the regulations in 
this part; Section 206 of the Energy Reorganization Act of 1974 (ERA); 
and procedures adopted under the regulations in this part. These 
documents must be posted in a conspicuous position on any premises 
within the United States where the activities subject to this part are 
conducted.
    (ii) If posting of the regulations in this part or the procedures 
adopted under the regulations in this part is not practicable, the 
licensee or firm subject to the regulations in this part may, in 
addition to posting Section 206 of the ERA, post a notice which 
describes the regulations/procedures, including the name of the 
individual to whom reports may be made, and states where the regulation, 
procedures, and reports may be examined.
    (3) Procedures. Each individual, corporation, partnership, or other 
entity holding a facility construction permit subject to this part, 
combined license (until the Commission makes the finding under 10 CFR 
52.103(g)), and manufacturing license under 10 CFR part 52 must adopt 
appropriate procedures to--
    (i) Evaluate deviations and failures to comply to identify defects 
and failures to comply associated with substantial safety hazards as 
soon as practicable, and, except as provided in

[[Page 918]]

paragraph (e)(3)(ii) of this section, in all cases within 60 days of 
discovery, to identify a reportable defect or failure to comply that 
could create a substantial safety hazard, were it to remain uncorrected.
    (ii) Ensure that if an evaluation of an identified deviation or 
failure to comply potentially associated with a substantial safety 
hazard cannot be completed within 60 days from discovery of the 
deviation or failure to comply, an interim report is prepared and 
submitted to the Commission through a director or responsible officer or 
designated person as discussed in paragraph (e)(4)(v) of this section. 
The interim report should describe the deviation or failure to comply 
that is being evaluated and should also state when the evaluation will 
be completed. This interim report must be submitted in writing within 60 
days of discovery of the deviation or failure to comply.
    (iii) Ensure that a director or responsible officer of the holder of 
a facility construction permit subject to this part, combined license 
(until the Commission makes the finding under 10 CFR 52.103(g)), and 
manufacturing license under 10 CFR part 52 is informed as soon as 
practicable, and, in all cases, within the 5 working days after 
completion of the evaluation described in paragraph (e)(3)(i) or 
(e)(3)(ii) of this section, if the construction or manufacture of a 
facility or activity, or a basic component supplied for such facility or 
activity--
    (A) Fails to comply with the AEA, as amended, or any applicable 
regulation, order, or license of the Commission, relating to a 
substantial safety hazard;
    (B) Contains a defect; or
    (C) Undergoes any significant breakdown in any portion of the 
quality assurance program conducted under the requirements of appendix B 
to 10 CFR part 50 which could have produced a defect in a basic 
component. These breakdowns in the quality assurance program are 
reportable whether or not the breakdown actually resulted in a defect in 
a design approved and released for construction, installation, or 
manufacture.
    (4) Notification. (i) The holder of a facility construction permit 
subject to this part, combined license (until the Commission makes the 
finding under 10 CFR 52.103(g)), and manufacturing license who obtains 
information reasonably indicating that the facility fails to comply with 
the AEA, as amended, or any applicable regulation, order, or license of 
the Commission relating to a substantial safety hazard must notify the 
Commission of the failure to comply through a director or responsible 
officer or designated person as discussed in paragraph (e)(4)(v) of this 
section.
    (ii) The holder of a facility construction permit subject to this 
part, combined license, or manufacturing license, who obtains 
information reasonably indicating the existence of any defect found in 
the construction or manufacture, or any defect found in the final design 
of a facility as approved and released for construction or manufacture, 
must notify the Commission of the defect through a director or 
responsible officer or designated person as discussed in paragraph 
(e)(4)(v) of this section.
    (iii) The holder of a facility construction permit subject to this 
part, combined license, or manufacturing license, who obtains 
information reasonably indicating that the quality assurance program has 
undergone any significant breakdown discussed in paragraph 
(e)(3)(iii)(C) of this section must notify the Commission of the 
breakdown in the quality assurance program through a director or 
responsible officer or designated person as discussed in paragraph 
(e)(4)(v) of this section.
    (iv) A dedicating entity is responsible for identifying and 
evaluating deviations and reporting defects and failures to comply 
associated with substantial safety hazards for dedicated items; and 
maintaining auditable records for the dedication process.
    (v) The notification requirements of this paragraph apply to all 
defects and failures to comply associated with a substantial safety 
hazard regardless of whether extensive evaluation, redesign, or repair 
is required to conform to the criteria and bases stated in the safety 
analysis report, construction permit, combined license, or manufacturing 
license. Evaluation of potential defects and failures to comply and 
reporting of defects and failures to comply under

[[Page 919]]

this section satisfies the construction permit holder's, combined 
license holder's, and manufacturing license holder's evaluation and 
notification obligations under part 21 of this chapter, and satisfies 
the responsibility of individual directors or responsible officers of 
holders of construction permits issued under Sec.50.23, holders of 
combined licenses (until the Commission makes the finding under Sec.
52.103 of this chapter), and holders of manufacturing licenses to report 
defects, and failures to comply associated with substantial safety 
hazards under Section 206 of the ERA. The director or responsible 
officer may authorize an individual to provide the notification required 
by this section, provided that this must not relieve the director or 
responsible officer of his or her responsibility under this section.
    (5) Notification--timing and where sent. The notification required 
by paragraph (e)(4) of this section must consist of--
    (i) Initial notification by facsimile, which is the preferred method 
of notification, to the NRC Operations Center at (301) 816-5151 or by 
telephone at (301) 816-5100 within 2 days following receipt of 
information by the director or responsible corporate officer under 
paragraph (e)(3)(iii) of this section, on the identification of a defect 
or a failure to comply. Verification that the facsimile has been 
received should be made by calling the NRC Operations Center. This 
paragraph does not apply to interim reports described in paragraph 
(e)(3)(ii) of this section.
    (ii) Written notification submitted to the Document Control Desk, 
U.S. Nuclear Regulatory Commission, by an appropriate method listed in 
Sec.50.4, with a copy to the appropriate Regional Administrator at the 
address specified in appendix D to part 20 of this chapter and a copy to 
the appropriate NRC resident inspector within 30 days following receipt 
of information by the director or responsible corporate officer under 
paragraph (e)(3)(iii) of this section, on the identification of a defect 
or failure to comply.
    (6) Content of notification. The written notification required by 
paragraph (e)(5)(ii) of this section must clearly indicate that the 
written notification is being submitted under Sec.50.55(e) and include 
the following information, to the extent known.
    (i) Name and address of the individual or individuals informing the 
Commission.
    (ii) Identification of the facility, the activity, or the basic 
component supplied for the facility or the activity within the United 
States which contains a defect or fails to comply.
    (iii) Identification of the firm constructing or manufacturing the 
facility or supplying the basic component which fails to comply or 
contains a defect.
    (iv) Nature of the defect or failure to comply and the safety hazard 
which is created or could be created by the defect or failure to comply.
    (v) The date on which the information of a defect or failure to 
comply was obtained.
    (vi) In the case of a basic component which contains a defect or 
fails to comply, the number and location of all the basic components in 
use at the facility subject to the regulations in this part.
    (vii) In the case of a completed reactor manufactured under part 52 
of this chapter, the entities to which the reactor was supplied.
    (viii) The corrective action which has been, is being, or will be 
taken; the name of the individual or organization responsible for the 
action; and the length of time that has been or will be taken to 
complete the action.
    (ix) Any advice related to the defect or failure to comply about the 
facility, activity, or basic component that has been, is being, or will 
be given to other entities.
    (7) Procurement documents. Each individual, corporation, 
partnership, dedicating entity, or other entity subject to the 
regulations in this part shall ensure that each procurement document for 
a facility, or a basic component specifies or is issued by the entity 
subject to the regulations, when applicable, that the provisions of 10 
CFR part 21 or 10 CFR 50.55(e) applies, as applicable.
    (8) Coordination with 10 CFR part 21. The requirements of Sec.
50.55(e) are satisfied when the defect or failure to comply associated 
with a substantial safety hazard has been previously reported under part 
21 of this chapter, under

[[Page 920]]

Sec.73.71 of this chapter, or under Sec. Sec.50.55(e) or 50.73. For 
holders of construction permits issued before October 29, 1991, 
evaluation, reporting and recordkeeping requirements of Sec.50.55(e) 
may be met by complying with the comparable requirements of part 21 of 
this chapter.
    (9) Records retention. The holder of a construction permit, combined 
license, and manufacturing license must prepare and maintain records 
necessary to accomplish the purposes of this section, specifically--
    (i) Retain procurement documents, which define the requirements that 
facilities or basic components must meet in order to be considered 
acceptable, for the lifetime of the facility or basic component.
    (ii) Retain records of evaluations of all deviations and failures to 
comply under paragraph (e)(3)(i) of this section for the longest of:
    (A) Ten (10) years from the date of the evaluation;
    (B) Five (5) years from the date that an early site permit is 
referenced in an application for a combined license; or
    (C) Five (5) years from the date of delivery of a manufactured 
reactor.
    (iii) Retain records of all interim reports to the Commission made 
under paragraph (e)(3)(ii) of this section, or notifications to the 
Commission made under paragraph (e)(4) of this section for the minimum 
time periods stated in paragraph (e)(9)(ii) of this section;
    (iv) Suppliers of basic components must retain records of:
    (A) All notifications sent to affected licensees or purchasers under 
paragraph (e)(4)(iv) of this section for a minimum of ten (10) years 
following the date of the notification;
    (B) The facilities or other purchasers to whom basic components or 
associated services were supplied for a minimum of fifteen (15) years 
from the delivery of the basic component or associated services.
    (v) Maintaining records in accordance with this section satisfies 
the recordkeeping obligations under part 21 of this chapter of the 
entities, including directors or responsible officers thereof, subject 
to this section.
    (f)(1) Each nuclear power plant or fuel reprocessing plant 
construction permit holder subject to the quality assurance criteria in 
appendix B of this part shall implement, pursuant to Sec.50.34(a)(7) 
of this part, the quality assurance program described or referenced in 
the Safety Analysis Report, including changes to that report.
    (2) Each construction permit holder described in paragraph (f)(1) of 
this section shall, by June 10, 1983, submit to the appropriate NRC 
Regional Office shown in appendix D of part 20 of this chapter the 
current description of the quality assurance program it is implementing 
for inclusion in the Safety Analysis Report, unless there are no changes 
to the description previously accepted by NRC. This submittal must 
identify changes made to the quality assurance program description since 
the description was submitted to NRC. (Should a permit holder need 
additional time beyond June 10, 1983 to submit its current quality 
assurance program description to NRC, it shall notify the appropriate 
NRC Regional Office in writing, explain why additional time is needed, 
and provide a schedule for NRC approval showing when its current quality 
assurance program description will be submitted.)
    (3) After March 11, 1983, each construction permit holder described 
in paragraph (f)(1) of this section may make a change to a previously 
accepted quality assurance program description included or referenced in 
the Safety Analysis Report, provided the change does not reduce the 
commitments in the program description previously accepted by the NRC. 
Changes to the quality assurance program description that do not reduce 
the commitments must be submitted to NRC within 90 days. Changes to the 
quality assurance program description that do reduce the commitments 
must be submitted to NRC and receive NRC approval before implementation, 
as follows:
    (i) Changes to the Safety Analysis Report must be submitted for 
review as specified in Sec.50.4. Changes made to NRC-accepted quality 
assurance topical report descriptions must be submitted as specified in 
Sec.50.4.
    (ii) The submittal of a change to the Safety Analysis Report quality 
assurance program description must include

[[Page 921]]

all pages affected by that change and must be accompanied by a 
forwarding letter identifying the change, the reason for the change, and 
the basis for concluding that the revised program incorporating the 
change continues to satisfy the criteria of appendix B of this part and 
the Safety Analysis Report quality assurance program description 
commitments previously accepted by the NRC (the letter need not provide 
the basis for changes that correct spelling, punctuation, or editorial 
items).
    (iii) A copy of the forwarding letter identifying the changes must 
be maintained as a facility record for three years.
    (iv) Changes to the quality assurance program description included 
or referenced in the Safety Analysis Report shall be regarded as 
accepted by the Commission upon receipt of a letter to this effect from 
the appropriate reviewing office of the Commission or 60 days after 
submittal to the Commission, whichever occurs first.
    (4) Each holder of an early site permit or a manufacturing license 
under part 52 of this chapter shall implement the quality assurance 
program described or referenced in the safety analysis report, including 
changes to that report. Each holder of a combined license shall 
implement the quality assurance program for design and construction 
described or referenced in the safety analysis report, including changes 
to that report, provided, however, that the holder of a combined license 
is not subject to the terms and conditions in this paragraph after the 
Commission makes the finding under Sec.52.103(g) of this chapter.
    (i) Each holder described in paragraph (f)(4) of this section may 
make a change to a previously accepted quality assurance program 
description included or referenced in the safety analysis report, if the 
change does not reduce the commitments in the program description 
previously accepted by the NRC. Changes to the quality assurance program 
description that do not reduce the commitments must be submitted to NRC 
within 90 days. Changes to the quality assurance program description 
that reduce the commitments must be submitted to NRC and receive NRC 
approval before implementation, as follows:
    (A) Changes to the safety analysis report must be submitted for 
review as specified in Sec.50.4. Changes made to NRC-accepted quality 
assurance topical report descriptions must be submitted as specified in 
Sec.50.4.
    (B) The submittal of a change to the safety analysis report quality 
assurance program description must include all pages affected by that 
change and must be accompanied by a forwarding letter identifying the 
change, the reason for the change, and the basis for concluding that the 
revised program incorporating the change continues to satisfy the 
criteria of appendix B of this part and the safety analysis report 
quality assurance program description commitments previously accepted by 
the NRC (the letter need not provide the basis for changes that correct 
spelling, punctuation, or editorial items).
    (C) A copy of the forwarding letter identifying the changes must be 
maintained as a facility record for three (3) years.
    (D) Changes to the quality assurance program description included or 
referenced in the safety analysis report shall be regarded as accepted 
by the Commission upon receipt of a letter to this effect from the 
appropriate reviewing office of the Commission or 60 days after 
submittal to the Commission, whichever occurs first.
    (ii) [Reserved]
    (g)-(h) [Reserved]
    (i) Structures, systems, and components subject to the codes and 
standards in 10 CFR 50.55a must be designed, fabricated, erected, 
constructed, tested, and inspected to quality standards commensurate 
with the importance of the safety function to be performed.

[21 FR 355, Jan. 19, 1956, as amended at 32 FR 4055, Mar. 15, 1967; 35 
FR 11461, July 17, 1970; 35 FR 19661, Dec. 29, 1970; 36 FR 11424, June 
12, 1971; 37 FR 6460, Mar. 30, 1972; 38 FR 1272, Jan. 11, 1973; 41 FR 
16446, Apr. 19, 1976; 42 FR 43385, Aug. 29, 1977; 48 FR 1029, Jan. 10, 
1983; 51 FR 40309, Nov. 6, 1986; 56 FR 36091, July 31, 1991; 59 FR 
14087, Mar. 25, 1994; 68 FR 58809, Oct. 10, 2003; 72 FR 49497, Aug. 28, 
2007; 78 FR 34248, June 7, 2013; 79 FR 65798, Nov. 5, 2014]



Sec.50.55a  Codes and standards.

    (a) Documents approved for incorporation by reference. The standards 
listed

[[Page 922]]

in this paragraph (a) have been approved for incorporation by reference 
by the Director of the Federal Register pursuant to 5 U.S.C. 552(a) and 
1 CFR part 51. The standards are available for inspection, by 
appointment, at the NRC Technical Library, which is located at Two White 
Flint North, 11545 Rockville Pike, Rockville, Maryland 20852; telephone: 
301-415-7000; email: [email protected]; or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030 or go to http:/
/www.archives.gov/federal-register/cfr/ibr-locations.html.
    (1) American Society of Mechanical Engineers (ASME), Three Park 
Avenue, New York, NY 10016; telephone:

1-800-843-2763; http://www.asme.org/Codes/.
    (i) ASME Boiler and Pressure Vessel Code, Section III. The editions 
and addenda for Section III of the ASME Boiler and Pressure Vessel Code 
(excluding Nonmandatory Appendices) (referred to herein as ASME BPV 
Code) are listed in this paragraph (a)(1)(i), but limited by those 
provisions identified in paragraph (b)(1) of this section.
    (A) ``Rules for Construction of Nuclear Vessels:''
    (1) 1963 Edition,
    (2) Summer 1964 Addenda,
    (3) Winter 1964 Addenda,
    (4) 1965 Edition,
    (5) 1965 Summer Addenda,
    (6) 1965 Winter Addenda,
    (7) 1966 Summer Addenda,
    (8) 1966 Winter Addenda,
    (9) 1967 Summer Addenda,
    (10) 1967 Winter Addenda,
    (11) 1968 Edition,
    (12) 1968 Summer Addenda,
    (13)1968 Winter Addenda,
    (14) 1969 Summer Addenda,
    (15) 1969 Winter Addenda,
    (16) 1970 Summer Addenda, and
    (17) 1970 Winter Addenda.
    (B) ``Rules for Construction of Nuclear Power Plant Components:''
    (1) 1971 Edition,
    (2) 1971 Summer Addenda,
    (3) 1971 Winter Addenda,
    (4) 1972 Summer Addenda,
    (5) 1972 Winter Addenda,
    (6) 1973 Summer Addenda, and
    (7) 1973 Winter Addenda.
    (C) ``Division 1 Rules for Construction of Nuclear Power Plant 
Components:''
    (1) 1974 Edition,
    (2) 1974 Summer Addenda,
    (3) 1974 Winter Addenda,
    (4) 1975 Summer Addenda,
    (5) 1975 Winter Addenda,
    (6) 1976 Summer Addenda, and
    (7) 1976 Winter Addenda;
    (D) ``Rules for Construction of Nuclear Power Plant Components--
Division 1'';
    (1) 1977 Edition,
    (2) 1977 Summer Addenda,
    (3) 1977 Winter Addenda,
    (4) 1978 Summer Addenda,
    (5) 1978 Winter Addenda,
    (6) 1979 Summer Addenda,
    (7) 1979 Winter Addenda,
    (8) 1980 Edition,
    (9) 1980 Summer Addenda,
    (10) 1980 Winter Addenda,
    (11) 1981 Summer Addenda,
    (12) 1981 Winter Addenda,
    (13) 1982 Summer Addenda,
    (14) 1982 Winter Addenda,
    (15) 1983 Edition,
    (16) 1983 Summer Addenda,
    (17) 1983 Winter Addenda,
    (18) 1984 Summer Addenda,
    (19) 1984 Winter Addenda,
    (20) 1985 Summer Addenda,
    (21) 1985 Winter Addenda,
    (22) 1986 Edition,
    (23) 1986 Addenda,
    (24) 1987 Addenda,
    (25) 1988 Addenda,
    (26) 1989 Edition,
    (27) 1989 Addenda,
    (28) 1990 Addenda,
    (29) 1991 Addenda,
    (30) 1992 Edition,
    (31) 1992 Addenda,
    (32) 1993 Addenda,
    (33) 1994 Addenda,
    (34) 1995 Edition,
    (35) 1995 Addenda,
    (36) 1996 Addenda, and
    (37) 1997 Addenda.
    (E) ``Rules for Construction of Nuclear Facility Components--
Division 1:''
    (1) 1998 Edition,
    (2) 1998 Addenda,
    (3) 1999 Addenda,
    (4) 2000 Addenda,
    (5) 2001 Edition,
    (6) 2001 Addenda,

[[Page 923]]

    (7) 2002 Addenda,
    (8) 2003 Addenda,
    (9) 2004 Edition,
    (10) 2005 Addenda,
    (11) 2006 Addenda,
    (12) 2007 Edition,
    (13) 2008 Addenda,
    (14) 2009b Addenda (including Subsection NCA; and Division 1 
subsections NB through NH and Appendices),
    (15) 2010 Edition (including Subsection NCA; and Division 1 
subsections NB through NH and Appendices),
    (16) 2011a Addenda (including Subsection NCA; and Division 1 
subsections NB through NH and Appendices), and
    (17) 2013 Edition (including Subsection NCA; and Division 1 
subsections NB through NH and Appendices).
    (ii) ASME Boiler and Pressure Vessel Code, Section XI. The editions 
and addenda for Section XI of the ASME BPV Code are listed in this 
paragraph (a)(1)(ii), but limited by those provisions identified in 
paragraph (b)(2) of this section.
    (A) ``Rules for Inservice Inspection of Nuclear Reactor Coolant 
Systems:''
    (1) 1970 Edition,
    (2) 1971 Edition,
    (3) 1971 Summer Addenda,
    (4) 1971 Winter Addenda,
    (5) 1972 Summer Addenda,
    (6) 1972 Winter Addenda,
    (7) 1973 Summer Addenda, and
    (8) 1973 Winter Addenda.
    (B) ``Rules for Inservice Inspection of Nuclear Power Plant 
Components:''
    (1) 1974 Edition,
    (2) 1974 Summer Addenda,
    (3) 1974 Winter Addenda, and
    (4) 1975 Summer Addenda.
    (5) 1975 Winter Addenda,
    (6) 1976 Summer Addenda, and
    (7) 1976 Winter Addenda.
    (C) ``Rules for Inservice Inspection of Nuclear Power Plant 
Components--Division 1:''
    (1) 1977 Edition,
    (2) 1977 Summer Addenda,
    (3) 1977 Winter Addenda,
    (4) 1978 Summer Addenda,
    (5) 1978 Winter Addenda,
    (6) 1979 Summer Addenda,
    (7) 1979 Winter Addenda,
    (8) 1980 Edition,
    (9) 1980 Winter Addenda,
    (10) 1981 Summer Addenda,
    (11) 1981 Winter Addenda,
    (12) 1982 Summer Addenda,
    (13) 1982 Winter Addenda,
    (14) 1983 Edition,
    (15) 1983 Summer Addenda,
    (16) 1983 Winter Addenda,
    (17) 1984 Summer Addenda,
    (18) 1984 Winter Addenda,
    (19) 1985 Summer Addenda,
    (20) 1985 Winter Addenda,
    (21) 1986 Edition,
    (22) 1986 Addenda,
    (23) 1987 Addenda,
    (24) 1988 Addenda,
    (25) 1989 Edition,
    (26) 1989 Addenda,
    (27) 1990 Addenda,
    (28) 1991 Addenda,
    (29) 1992 Edition,
    (30) 1992 Addenda,
    (31) 1993 Addenda,
    (32) 1994 Addenda,
    (33) 1995 Edition,
    (34) 1995 Addenda,
    (35) 1996 Addenda,
    (36) 1997 Addenda,
    (37) 1998 Edition,
    (38) 1998 Addenda,
    (39) 1999 Addenda,
    (40) 2000 Addenda,
    (41) 2001 Edition,
    (42) 2001 Addenda,
    (43) 2002 Addenda,
    (44) 2003 Addenda,
    (45) 2004 Edition,
    (46) 2005 Addenda,
    (47) 2006 Addenda,
    (48) 2007 Edition,
    (49) 2008 Addenda,
    (50) 2009b Addenda,
    (51) 2010 Edition,
    (52) 2011a Addenda (Excluding Article IWB-2000: IWB-2500 
``Examination and Inspection: Examination and Pressure Test 
Requirements,'' Table IWB-2500-1 ``Examination Categories,'' Item 
numbers B5.11 and B5.71), and
    (53) 2013 Edition (Excluding Article IWB-2000: IWB-2500 
``Examination and Inspection: Examination and Pressure Test 
Requirements,'' Table IWB-2500-1 (B-F) ``Examination Category B-F, 
Pressure Retaining Dissimilar Metal Welds in Vessel Nozzles,'' Item 
numbers B5.11 and B5.71; Article IWB-3000 ``Acceptance Standards,'' IWB-
3100

[[Page 924]]

``Evaluation of Examination Results,'' IWB-3110 ``Preservice Volumetric 
and Surface Examinations,'' IWB-3112 ``Acceptance,'' paragraph (a)(3); 
and Article IWC-3000 ``Acceptance Standards,'' IWC-3100 ``Evaluation of 
Examination Results,'' IWC-3110 ``Preservice Volumetric and Surface 
Examinations,'' IWC-3112 ``Acceptance,'' paragraph (a)(3)).
    (iii) ASME Code Cases: Nuclear Components--(A) ASME BPV Code Case N-
513-3 Mandatory Appendix I. ASME BPV Code Case N-513-3, ``Evaluation 
Criteria for Temporary Acceptance of Flaws in Moderate Energy Class 2 or 
3 Piping Section XI, Division 1,'' Mandatory Appendix I, ``Relations for 
Fm, Fb, and F for Through-Wall Flaws'' (Approval Date: January 26, 
2009). ASME BPV Code Case N-513-3 Mandatory Appendix I is referenced in 
paragraph (b)(2)(xxxiv)(B) of this section.
    (B) ASME BPV Code Case N-722-1. ASME BPV Code Case N-722-1, 
``Additional Examinations for PWR Pressure Retaining Welds in Class 1 
Components Fabricated with Alloy 600/82/182 Materials, Section XI, 
Division 1'' (Approval Date: January 26, 2009), with the conditions in 
paragraph (g)(6)(ii)(E) of this section.
    (C) ASME BPV Code Case N-729-4. ASME BPV Code Case N-729-4, 
``Alternative Examination Requirements for PWR Reactor Vessel Upper 
Heads With Nozzles Having Pressure-Retaining Partial-Penetration Welds 
Section XI, Division 1'' (Approval Date: June 22, 2012), with the 
conditions in paragraph (g)(6)(ii)(D) of this section.
    (D) ASME BPV Code Case N-770-2. ASME BPV Code Case N-770-2, 
``Alternative Examination Requirements and Acceptance Standards for 
Class 1 PWR Piping and Vessel Nozzle Butt Welds Fabricated with UNS 
N06082 or UNS W86182 Weld Filler Material With or Without Application of 
Listed Mitigation Activities Section XI, Division 1'' (Approval Date: 
June 9, 2011), with the conditions in paragraph (g)(6)(ii)(F) of this 
section.
    (E) ASME BPV Code Case N-824. ASME BPV Code Case N-824, ``Ultrasonic 
Examination of Cast Austenitic Piping Welds From the Outside Surface 
Section XI, Division 1'' (Approval Date: October 16, 2012), with the 
conditions in paragraphs (b)(2)(xxxvii)(A) through (D) of this section.
    (F) ASME BPV Code Case N-852. ASME BPV Code Case N-852, 
``Application of the ASME NPT Stamp, Section III, Division 1; Section 
III, Division 2; Section III, Division 3; Section III, Division 5'' 
(Approval Date: February 9, 2015). ASME BPV Code Case N-852 is 
referenced in paragraph (b)(1)(ix) of this section.
    (G) ASME OM Code Case OMN-20. ASME OM Code Case OMN-20, ``Inservice 
Test Frequency,'' in the 2012 Edition of the ASME OM Code. OMN-20 is 
referenced in paragraph (b)(3)(x) of this section.
    (iv) ASME Operation and Maintenance Code. The editions and addenda 
for the ASME Operation and Maintenance of Nuclear Power Plants (various 
edition titles referred to herein as ASME OM Code) are listed in this 
paragraph (a)(1)(iv), but limited by those provisions identified in 
paragraph (b)(3) of this section.
    (A) ``Code for Operation and Maintenance of Nuclear Power Plants:''
    (1) 1995 Edition,
    (2) 1996 Addenda,
    (3) 1997 Addenda,
    (4) 1998 Edition,
    (5) 1999 Addenda,
    (6) 2000 Addenda,
    (7) 2001 Edition,
    (8) 2002 Addenda,
    (9) 2003 Addenda,
    (10) 2004 Edition,
    (11) 2005 Addenda, and
    (12) 2006 Addenda.
    (B) ``Operation and Maintenance of Nuclear Power Plants, Division 1: 
Section IST Rules for Inservice Testing of Light-Water Reactor Power 
Plants:''
    (1) 2009 Edition; and
    (2) 2011 Addenda.
    (C) ``Operation and Maintenance of Nuclear Power Plants, Division 1: 
OM Code: Section IST:''
    (1) 2012 Edition.
    (2) [Reserved]
    (v) ASME Quality Assurance Requirements. (A) ASME NQA-1, ``Quality 
Assurance Program Requirements for Nuclear Facilities:''
    (1) NQA-1--1983 Edition;
    (2) NQA-1a--1983 Addenda;
    (3) NQA-1b--1984 Addenda;
    (4) NQA-1c--1985 Addenda;

[[Page 925]]

    (5) NQA-1--1986 Edition;
    (6) NQA-1a--1986 Addenda;
    (7) NQA-1b--1987 Addenda;
    (8) NQA-1c--1988 Addenda;
    (9) NQA-1--1989 Edition;
    (10) NQA-1a--1989 Addenda;
    (11) NQA-1b--1991 Addenda; and
    (12) NQA-1c--1992 Addenda.
    (B) ASME NQA-1, ``Quality Assurance Requirements for Nuclear 
Facility Applications:''
    (1) NQA-1--1994 Edition;
    (2) NQA-1--2008 Edition; and
    (3) NQA-1a--2009 Addenda.
    (2) Institute of Electrical and Electronics Engineers (IEEE) Service 
Center, 445 Hoes Lane, Piscataway, NJ 08855; telephone: 1-800-678-4333; 
http://ieeexplore.ieee.org.
    (i) IEEE standard 279-1968. (IEEE Std 279-1968), ``Proposed IEEE 
Criteria for Nuclear Power Plant Protection Systems'' (Approval Date: 
August 30, 1968), referenced in paragraph (h)(2) of this section. 
(Copies of this document may be purchased from IHS Global, 15 Inverness 
Way East, Englewood, CO 80112; https://global.ihs.com.)
    (ii) IEEE standard 279-1971. (IEEE Std 279-1971), ``Criteria for 
Protection Systems for Nuclear Power Generating Stations'' (Approval 
Date: June 3, 1971), referenced in paragraph (h)(2) of this section.
    (iii) IEEE standard 603-1991. (IEEE Std 603-1991), ``Standard 
Criteria for Safety Systems for Nuclear Power Generating Stations'' 
(Approval Date: June 27, 1991), referenced in paragraphs (h)(2) and 
(h)(3) of this section. All other standards that are referenced in IEEE 
Std 603-1991 are not approved for incorporation by reference.
    (iv) IEEE standard 603-1991, correction sheet. (IEEE Std 603-1991 
correction sheet), ``Standard Criteria for Safety Systems for Nuclear 
Power Generating Stations, Correction Sheet, Issued January 30, 1995,'' 
referenced in paragraphs (h)(2) and (h)(3) of this section. (This 
correction sheet is available from IEEE at http://standards.ieee.org/
findstds/errata/).
    (3) U.S. Nuclear Regulatory Commission (NRC) Public Document Room, 
11555 Rockville Pike, Rockville, Maryland 20852; telephone: 1-800-397-
4209; email: [email protected]; http://www.nrc.gov/reading-rm/doc-
collections/reg-guides/.
    (i) NRC Regulatory Guide 1.84, Revision 37. NRC Regulatory Guide 
1.84, Revision 37, ``Design, Fabrication, and Materials Code Case 
Acceptability, ASME Section III,'' dated March 2017, with the 
requirements in paragraph (b)(4) of this section.
    (ii) NRC Regulatory Guide 1.147, Revision 18. NRC Regulatory Guide 
1.147, Revision 18, ``Inservice Inspection Code Case Acceptability, ASME 
Section XI, Division 1,'' dated March 2017, which lists ASME Code Cases 
that the NRC has approved in accordance with the requirements in 
paragraph (b)(5) of this section.
    (iii) NRC Regulatory Guide 1.192, Revision 2. NRC Regulatory Guide 
1.192, Revision 2, ``Operation and Maintenance Code Case Acceptability, 
ASME OM Code,'' dated March 2017, which lists ASME Code Cases that the 
NRC has approved in accordance with the requirements in paragraph (b)(6) 
of this section.
    (b) Use and conditions on the use of standards. Systems and 
components of boiling and pressurized water-cooled nuclear power 
reactors must meet the requirements of the ASME BPV Code and the ASME OM 
Code as specified in this paragraph (b). Each combined license for a 
utilization facility is subject to the following conditions.
    (1) Conditions on ASME BPV Code Section III. Each manufacturing 
license, standard design approval, and design certification under 10 CFR 
part 52 is subject to the following conditions. As used in this section, 
references to Section III refer to Section III of the ASME BPV Code and 
include the 1963 Edition through 1973 Winter Addenda and the 1974 
Edition (Division 1) through the 2013 Edition (Division 1), subject to 
the following conditions:
    (i) Section III condition: Section III materials. When applying the 
1992 Edition of Section III, applicants or licensees must apply the 1992 
Edition with the 1992 Addenda of Section II of the ASME Boiler and 
Pressure Vessel Code.
    (ii) Section III condition: Weld leg dimensions. When applying the 
1989 Addenda through the latest edition and addenda incorporated by 
reference in

[[Page 926]]

paragraph (a)(1) of this section, applicants and licensees may not apply 
the Section III provisions identified in Table I of this section for 
welds with leg size less than 1.09 tn:

                   Table I--Prohibited Code Provisions
------------------------------------------------------------------------
         Editions and addenda                    Code provision
------------------------------------------------------------------------
1989 Addenda through 2013 Edition.....  Subparagraph NB-3683.4(c)(1);
                                         Subparagraph NB-3683.4(c)(2).
1989 Addenda through 2003 Addenda.....  Note 11 to Figure NC-3673.2(b)-
                                         1; Note 11 to Figure ND-
                                         3673.2(b)-1.
2004 Edition through 2010 Edition.....  Note 13 to Figure NC-3673.2(b)-
                                         1; Note 13 to Figure ND-
                                         3673.2(b)-1.
2011 Addenda through 2013 Edition.....  Note 11 to Table NC-3673.2(b)-1;
                                         Note 11 to Table ND-3673.2(b)-
                                         1.
------------------------------------------------------------------------

    (iii) Section III condition: Seismic design of piping. Applicants or 
licensees may use Subarticles NB-3200, NB-3600, NC-3600, and ND-3600 for 
seismic design of piping, up to and including the 1993 Addenda, subject 
to the condition specified in paragraph (b)(1)(ii) of this section. 
Applicants or licensees may not use these subarticles for seismic design 
of piping in the 1994 Addenda through the 2005 Addenda incorporated by 
reference in paragraph (a)(1) of this section, except that Subarticle 
NB-3200 in the 2004 Edition through the 2008 Addenda may be used by 
applicants and licensees, subject to the condition in paragraph 
(b)(1)(iii)(A) of this section. Applicants or licensees may use 
Subarticles NB-3600, NC-3600, and ND-3600 for the seismic design of 
piping in the 2006 Addenda through the 2008 Addenda, subject to the 
conditions of this paragraph corresponding to those subarticles.
    (A) Seismic design of piping: First provision. When applying Note 
(1) of Figure NB-3222-1 for Level B service limits, the calculation of 
Pb stresses must include reversing dynamic loads (including 
inertia earthquake effects) if evaluation of these loads is required by 
NB-3223(b).
    (B) Seismic design of piping: Second provision. For Class 1 piping, 
the material and Do/t requirements of NB-3656(b) must be met 
for all Service Limits when the Service Limits include reversing dynamic 
loads, and the alternative rules for reversing dynamic loads are used.
    (iv) Section III condition: Quality assurance. When applying 
editions and addenda later than the 1989 Edition of Section III, the 
requirements of NQA-1, ``Quality Assurance Requirements for Nuclear 
Facility Applications,'' 1994 Edition, 2008 Edition, and the 2009-1a 
Addenda specified in either NCA-4000 or NCA-7000 of that edition and 
addenda of Section III may be used by an applicant or licensee, provided 
that the administrative, quality, and technical provisions contained in 
that edition and addenda of Section III are used in conjunction with the 
applicant's or licensee's appendix B to this part quality assurance 
program; and that the applicant's or licensee's Section III activities 
comply with those commitments contained in the applicant's or licensee's 
quality assurance program description. Where NQA-1 and Section III do 
not address the commitments contained in the applicant's or licensee's 
appendix B quality assurance program description, those licensee 
commitments must be applied to Section III activities.
    (v) Section III condition: Independence of inspection. Applicants or 
licensees may not apply NCA-4134.10(a) of Section III, 1995 Edition 
through the latest edition and addenda incorporated by reference in 
paragraph (a)(1) of this section.
    (vi) Section III condition: Subsection NH. The provisions in 
Subsection NH, ``Class 1 Components in Elevated Temperature Service,'' 
1995 Addenda through the latest edition and addenda incorporated by 
reference in paragraph (a)(1) of this section, may only be used for the 
design and construction of Type 316 stainless steel pressurizer heater 
sleeves where service conditions do not cause the components to reach 
temperatures exceeding 900 [deg]F.

[[Page 927]]

    (vii) Section III condition: Capacity certification and 
demonstration of function of incompressible-fluid pressure-relief 
valves. When applying the 2006 Addenda through the 2013 Edition, 
applicants and licensees may use paragraph NB-7742, except that 
paragraph NB-7742(a)(2) may not be used. For a valve design of a single 
size to be certified over a range of set pressures, the demonstration of 
function tests under paragraph NB-7742 must be conducted as prescribed 
in NB-7732.2 on two valves covering the minimum set pressure for the 
design and the maximum set pressure that can be accommodated at the 
demonstration facility selected for the test.
    (viii) Section III condition: Use of ASME certification marks. When 
applying editions and addenda earlier than the 2011 Addenda to the 2010 
Edition, licensees may use either the ASME BPV Code Symbol Stamps or the 
ASME Certification Marks with the appropriate certification designators 
and class designators as specified in the 2013 Edition through the 
latest edition and addenda incorporated by reference in paragraph (a)(1) 
of this section.
    (ix) Section III Condition: NPT Code Symbol Stamps. Licensees may 
use the NPT Code Symbol Stamp with the letters arranged horizontally as 
specified in ASME BPV Code Case N-852 for the service life of a 
component that had the NPT Code Symbol Stamp applied during the time 
period from January 1, 2005, through December 31, 2015.
    (2) Conditions on ASME BPV Code, Section XI. As used in this 
section, references to Section XI refer to Section XI, Division 1, of 
the ASME BPV Code, and include the 1970 Edition through the 1976 Winter 
Addenda and the 1977 Edition through the 2013 Edition, subject to the 
following conditions:
    (i) [Reserved]
    (ii) Section XI condition: Pressure-retaining welds in ASME Code 
Class 1 piping (applies to Table IWB-2500 and IWB-2500-1 and Category B-
J). If the facility's application for a construction permit was docketed 
prior to July 1, 1978, the extent of examination for Code Class 1 pipe 
welds may be determined by the requirements of Table IWB-2500 and Table 
IWB-2600 Category B-J of Section XI of the ASME BPV Code in the 1974 
Edition and Addenda through the Summer 1975 Addenda or other 
requirements the NRC may adopt.
    (iii)-(v) [Reserved]
    (vi) Section XI condition: Effective edition and addenda of 
Subsection IWE and Subsection IWL. Licensees that implemented the 
expedited examination of containment, in accordance with Subsection IWE 
and Subsection IWL, during the period from September 9, 1996, to 
September 9, 2001, may use either the 1992 Edition with the 1992 Addenda 
or the 1995 Edition with the 1996 Addenda of Subsection IWE and 
Subsection IWL, as conditioned by the requirements in paragraphs 
(b)(2)(viii) and (ix) of this section, when implementing the initial 
120-month inspection interval for the containment inservice inspection 
requirements of this section. Successive 120-month interval updates must 
be implemented in accordance with paragraph (g)(4)(ii) of this section.
    (vii) Section XI condition: Section XI references to OM Part 4, OM 
Part 6, and OM Part 10 (Table IWA-1600-1). When using Table IWA-1600-1, 
``Referenced Standards and Specifications,'' in the Section XI, Division 
1, 1987 Addenda, 1988 Addenda, or 1989 Edition, the specified ``Revision 
Date or Indicator'' for ASME/ANSI OM part 4, ASME/ANSI part 6, and ASME/
ANSI part 10 must be the OMa-1988 Addenda to the OM-1987 Edition. These 
requirements have been incorporated into the OM Code, which is 
incorporated by reference in paragraph (a)(1)(iv) of this section.
    (viii) Section XI condition: Concrete containment examinations. 
Applicants or licensees applying Subsection IWL, 1992 Edition with the 
1992 Addenda, must apply paragraphs (b)(2)(viii)(A) through (E) of this 
section. Applicants or licensees applying Subsection IWL, 1995 Edition 
with the 1996 Addenda, must apply paragraphs (b)(2)(viii)(A), 
(b)(2)(viii)(D)(3), and (b)(2)(viii)(E) of this section. Applicants or 
licensees applying Subsection IWL, 1998 Edition through the 2000 
Addenda, must apply paragraphs (b)(2)(viii)(E) and (F) of this section. 
Applicants or licensees applying Subsection IWL, 2001 Edition through 
the 2004 Edition, up to and including the 2006 Addenda, must apply 
paragraphs (b)(2)(viii)(E) through (G) of

[[Page 928]]

this section. Applicants or licensees applying Subsection IWL, 2007 
Edition up to and including the 2008 Addenda must apply paragraph 
(b)(2)(viii)(E) of this section. Applicants or licensees applying 
Subsection IWL, 2007 Edition with the 2009 Addenda through the latest 
edition and addenda incorporated by reference in paragraph (a)(1)(ii) of 
this section, must apply paragraphs (b)(2)(viii)(H) and (I) of this 
section.
    (A) Concrete containment examinations: First provision. Grease caps 
that are accessible must be visually examined to detect grease leakage 
or grease cap deformations. Grease caps must be removed for this 
examination when there is evidence of grease cap deformation that 
indicates deterioration of anchorage hardware.
    (B) Concrete containment examinations: Second provision. When 
evaluation of consecutive surveillances of pre-stressing forces for the 
same tendon or tendons in a group indicates a trend of pre-stress loss 
such that the tendon force(s) would be less than the minimum design pre-
stress requirements before the next inspection interval, an evaluation 
must be performed and reported in the Engineering Evaluation Report as 
prescribed in IWL-3300.
    (C) Concrete containment examinations: Third provision. When the 
elongation corresponding to a specific load (adjusted for effective 
wires or strands) during re-tensioning of tendons differs by more than 
10 percent from that recorded during the last measurement, an evaluation 
must be performed to determine whether the difference is related to wire 
failures or slip of wires in anchorage. A difference of more than 10 
percent must be identified in the ISI Summary Report required by IWA-
6000.
    (D) Concrete containment examinations: Fourth provision. The 
applicant or licensee must report the following conditions, if they 
occur, in the ISI Summary Report required by IWA-6000:
    (1) The sampled sheathing filler grease contains chemically combined 
water exceeding 10 percent by weight or the presence of free water;
    (2) The absolute difference between the amount removed and the 
amount replaced exceeds 10 percent of the tendon net duct volume; and
    (3) Grease leakage is detected during general visual examination of 
the containment surface.
    (E) Concrete containment examinations: Fifth provision. For Class CC 
applications, the applicant or licensee must evaluate the acceptability 
of inaccessible areas when conditions exist in accessible areas that 
could indicate the presence of or the result in degradation to such 
inaccessible areas. For each inaccessible area identified, the applicant 
or licensee must provide the following in the ISI Summary Report 
required by IWA-6000:
    (1) A description of the type and estimated extent of degradation, 
and the conditions that led to the degradation;
    (2) An evaluation of each area, and the result of the evaluation; 
and
    (3) A description of necessary corrective actions.
    (F) Concrete containment examinations: Sixth provision. Personnel 
that examine containment concrete surfaces and tendon hardware, wires, 
or strands must meet the qualification provisions in IWA-2300. The 
``owner-defined'' personnel qualification provisions in IWL-2310(d) are 
not approved for use.
    (G) Concrete containment examinations: Seventh provision. Corrosion 
protection material must be restored following concrete containment 
post-tensioning system repair and replacement activities in accordance 
with the quality assurance program requirements specified in IWA-1400.
    (H) Concrete containment examinations: Eighth provision. For each 
inaccessible area of concrete identified for evaluation under IWL-
2512(a), or identified as susceptible to deterioration under IWL-
2512(b), the licensee must provide the applicable information specified 
in paragraphs (b)(2)(viii)(E)(1), (2), and (3) of this section in the 
ISI Summary Report required by IWA-6000.
    (I) Concrete containment examinations: Ninth provision. During the 
period of extended operation of a renewed license under part 54 of this 
chapter, the licensee must perform the technical evaluation under IWL-
2512(b) of inaccessible below-grade concrete surfaces exposed to 
foundation soil, backfill, or groundwater at periodic intervals not to 
exceed 5 years. In addition, the licensee must examine representative

[[Page 929]]

samples of the exposed portions of the below-grade concrete, when such 
below-grade concrete is excavated for any reason.
    (ix) Section XI condition: Metal containment examinations. 
Applicants or licensees applying Subsection IWE, 1992 Edition with the 
1992 Addenda, or the 1995 Edition with the 1996 Addenda, must satisfy 
the requirements of paragraphs (b)(2)(ix)(A) through (E) of this 
section. Applicants or licensees applying Subsection IWE, 1998 Edition 
through the 2001 Edition with the 2003 Addenda, must satisfy the 
requirements of paragraphs (b)(2)(ix)(A) and (B) and (F) through (I) of 
this section. Applicants or licensees applying Subsection IWE, 2004 
Edition, up to and including the 2005 Addenda, must satisfy the 
requirements of paragraphs (b)(2)(ix)(A) and (B) and (F) through (H) of 
this section. Applicants or licensees applying Subsection IWE, 2004 
Edition with the 2006 Addenda, must satisfy the requirements of 
paragraphs (b)(2)(ix)(A)(2) and (b)(2)(ix)(B) of this section. 
Applicants or licensees applying Subsection IWE, 2007 Edition through 
the latest edition and addenda incorporated by reference in paragraph 
(a)(1)(ii) of this section, must satisfy the requirements of paragraphs 
(b)(2)(ix)(A)(2) and (b)(2)(ix)(B) and (J) of this section.
    (A) Metal containment examinations: First provision. For Class MC 
applications, the following apply to inaccessible areas.
    (1) The applicant or licensee must evaluate the acceptability of 
inaccessible areas when conditions exist in accessible areas that could 
indicate the presence of or could result in degradation to such 
inaccessible areas.
    (2) For each inaccessible area identified for evaluation, the 
applicant or licensee must provide the following in the ISI Summary 
Report as required by IWA-6000:
    (i) A description of the type and estimated extent of degradation, 
and the conditions that led to the degradation;
    (ii) An evaluation of each area, and the result of the evaluation; 
and
    (iii) A description of necessary corrective actions.
    (B) Metal containment examinations: Second provision. When 
performing remotely the visual examinations required by Subsection IWE, 
the maximum direct examination distance specified in Table IWA-2210-1 
(1992 Edition through 2004 Edition) or Table IWA-2211-1 (2005 Addenda 
through the latest edition and addenda incorporated by reference in 
paragraph (a)(1) of this section) may be extended and the minimum 
illumination requirements specified may be decreased provided that the 
conditions or indications for which the visual examination is performed 
can be detected at the chosen distance and illumination.
    (C) Metal containment examinations: Third provision. The 
examinations specified in Examination Category E-B, Pressure Retaining 
Welds, and Examination Category E-F, Pressure Retaining Dissimilar Metal 
Welds, are optional.
    (D) Metal containment examinations: Fourth provision. This paragraph 
(b)(2)(ix)(D) may be used as an alternative to the requirements of IWE-
2430. If the examinations reveal flaws or areas of degradation exceeding 
the acceptance standards of Table IWE-3410-1, an evaluation must be 
performed to determine whether additional component examinations are 
required. For each flaw or area of degradation identified that exceeds 
acceptance standards, the applicant or licensee must provide the 
following in the ISI Summary Report required by IWA-6000:
    (1) A description of each flaw or area, including the extent of 
degradation, and the conditions that led to the degradation;
    (2) The acceptability of each flaw or area and the need for 
additional examinations to verify that similar degradation does not 
exist in similar components;
    (3) A description of necessary corrective actions; and
    (4) The number and type of additional examinations to ensure 
detection of similar degradation in similar components.
    (E) Metal containment examinations: Fifth provision. A general 
visual examination as required by Subsection IWE must be performed once 
each period.

[[Page 930]]

    (F) Metal containment examinations: Sixth provision. VT-1 and VT-3 
examinations must be conducted in accordance with IWA-2200. Personnel 
conducting examinations in accordance with the VT-1 or VT-3 examination 
method must be qualified in accordance with IWA-2300. The ``owner-
defined'' personnel qualification provisions in IWE-2330(a) for 
personnel that conduct VT-1 and VT-3 examinations are not approved for 
use.
    (G) Metal containment examinations: Seventh provision. The VT-3 
examination method must be used to conduct the examinations in Items 
E1.12 and E1.20 of Table IWE-2500-1, and the VT-1 examination method 
must be used to conduct the examination in Item E4.11 of Table IWE-2500-
1. An examination of the pressure-retaining bolted connections in Item 
E1.11 of Table IWE-2500-1 using the VT-3 examination method must be 
conducted once each interval. The ``owner-defined'' visual examination 
provisions in IWE-2310(a) are not approved for use for VT-1 and VT-3 
examinations.
    (H) Metal containment examinations: Eighth provision. Containment 
bolted connections that are disassembled during the scheduled 
performance of the examinations in Item E1.11 of Table IWE-2500-1 must 
be examined using the VT-3 examination method. Flaws or degradation 
identified during the performance of a VT-3 examination must be examined 
in accordance with the VT-1 examination method. The criteria in the 
material specification or IWB-3517.1 must be used to evaluate 
containment bolting flaws or degradation. As an alternative to 
performing VT-3 examinations of containment bolted connections that are 
disassembled during the scheduled performance of Item E1.11, VT-3 
examinations of containment bolted connections may be conducted whenever 
containment bolted connections are disassembled for any reason.
    (I) Metal containment examinations: Ninth provision. The ultrasonic 
examination acceptance standard specified in IWE-3511.3 for Class MC 
pressure-retaining components must also be applied to metallic liners of 
Class CC pressure-retaining components.
    (J) Metal containment examinations: Tenth provision. In general, a 
repair/replacement activity such as replacing a large containment 
penetration, cutting a large construction opening in the containment 
pressure boundary to replace steam generators, reactor vessel heads, 
pressurizers, or other major equipment; or other similar modification is 
considered a major containment modification. When applying IWE-5000 to 
Class MC pressure-retaining components, any major containment 
modification or repair/replacement must be followed by a Type A test to 
provide assurance of both containment structural integrity and leak-
tight integrity prior to returning to service, in accordance with 10 CFR 
part 50, Appendix J, Option A or Option B on which the applicant's or 
licensee's Containment Leak-Rate Testing Program is based. When applying 
IWE-5000, if a Type A, B, or C Test is performed, the test pressure and 
acceptance standard for the test must be in accordance with 10 CFR part 
50, Appendix J.
    (x) Section XI condition: Quality assurance. When applying the 
editions and addenda later than the 1989 Edition of ASME BPV Code, 
Section XI, the edition and addenda of NQA-1, ``Quality Assurance 
Requirements for Nuclear Facility Applications,'' 1994 Edition, the 2008 
Edition, and the 2009-1a Addenda specified in either IWA-1400 or Table 
IWA 1600-1 of that edition and addenda of Section XI, may be used by a 
licensee provided that the licensee uses its appendix B to this part 
quality assurance program in conjunction with Section XI requirements 
and the commitments contained in the licensee's quality assurance 
program description. Where NQA-1 and Section XI do not address the 
commitments contained in the licensee's appendix B quality assurance 
program description, those licensee commitments must be applied to 
Section XI activities.
    (xi) [Reserved]
    (xii) Section XI condition: Underwater welding. The provisions in 
IWA-4660, ``Underwater Welding,'' of Section XI, 1997 Addenda through 
the latest edition and addenda incorporated by reference in paragraph 
(a)(1)(ii) of this section, are approved for use on irradiated material 
with the following conditions:

[[Page 931]]

    (A) Underwater welding: First provision. Licensees must obtain NRC 
approval in accordance with paragraph (z) of this section regarding the 
welding technique to be used prior to performing welding on ferritic 
material exposed to fast neutron fluence greater than 1 x 10\17\ n/cm\2\ 
(E  1 MeV).
    (B) Underwater welding: Second provision. Licensees must obtain NRC 
approval in accordance with paragraph (z) of this section regarding the 
welding technique to be used prior to performing welding on austenitic 
material other than P-No. 8 material exposed to thermal neutron fluence 
greater than 1 x 10\17\ n/cm\2\ (E < 0.5 eV). Licensees must obtain NRC 
approval in accordance with paragraph (z) regarding the welding 
technique to be used prior to performing welding on P-No. 8 austenitic 
material exposed to thermal neutron fluence greater than 1 x 10\17\ n/
cm\2\ (E < 0.5 eV) and measured or calculated helium concentration of 
the material greater than 0.1 atomic parts per million.
    (xiii) [Reserved]
    (xiv) Section XI condition: Appendix VIII personnel qualification. 
All personnel qualified for performing ultrasonic examinations in 
accordance with Appendix VIII must receive 8 hours of annual hands-on 
training on specimens that contain cracks. Licensees applying the 1999 
Addenda through the latest edition and addenda incorporated by reference 
in paragraph (a)(1)(ii) of this section may use the annual practice 
requirements in VII-4240 of Appendix VII of Section XI in place of the 8 
hours of annual hands-on training provided that the supplemental 
practice is performed on material or welds that contain cracks, or by 
analyzing prerecorded data from material or welds that contain cracks. 
In either case, training must be completed no earlier than 6 months 
prior to performing ultrasonic examinations at a licensee's facility.
    (xv) Section XI condition: Appendix VIII specimen set and 
qualification requirements. Licensees using Appendix VIII in the 1995 
Edition through the 2001 Edition of the ASME Boiler and Pressure Vessel 
Code may elect to comply with all of the provisions in paragraphs 
(b)(2)(xv)(A) through (M) of this section, except for paragraph 
(b)(2)(xv)(F) of this section, which may be used at the licensee's 
option. Licensees using editions and addenda after 2001 Edition through 
the 2006 Addenda must use the 2001 Edition of Appendix VIII and may 
elect to comply with all of the provisions in paragraphs (b)(2)(xv)(A) 
through (M) of this section, except for paragraph (b)(2)(xv)(F) of this 
section, which may be used at the licensee's option.
    (A) Specimen set and qualification: First provision. When applying 
Supplements 2, 3, and 10 to Appendix VIII, the following examination 
coverage criteria requirements must be used:
    (1) Piping must be examined in two axial directions, and when 
examination in the circumferential direction is required, the 
circumferential examination must be performed in two directions, 
provided access is available. Dissimilar metal welds must be examined 
axially and circumferentially.
    (2) Where examination from both sides is not possible, full coverage 
credit may be claimed from a single side for ferritic welds. Where 
examination from both sides is not possible on austenitic welds or 
dissimilar metal welds, full coverage credit from a single side may be 
claimed only after completing a successful single-sided Appendix VIII 
demonstration using flaws on the opposite side of the weld. Dissimilar 
metal weld qualifications must be demonstrated from the austenitic side 
of the weld, and the qualification may be expanded for austenitic welds 
with no austenitic sides using a separate add-on performance 
demonstration. Dissimilar metal welds may be examined from either side 
of the weld.
    (B) Specimen set and qualification: Second provision. The following 
conditions must be used in addition to the requirements of Supplement 4 
to Appendix VIII:
    (1) Paragraph 3.1, Detection acceptance criteria--Personnel are 
qualified for detection if the results of the performance demonstration 
satisfy the detection requirements of ASME Section XI, Appendix VIII, 
Table VIII-S4-1, and no flaw greater than 0.25 inch through-wall 
dimension is missed.
    (2) Paragraph 1.1(c), Detection test matrix--Flaws smaller than the 
50 percent of allowable flaw size, as defined

[[Page 932]]

in IWB-3500, need not be included as detection flaws. For procedures 
applied from the inside surface, use the minimum thickness specified in 
the scope of the procedure to calculate a/t. For procedures applied from 
the outside surface, the actual thickness of the test specimen is to be 
used to calculate a/t.
    (C) Specimen set and qualification: Third provision. When applying 
Supplement 4 to Appendix VIII, the following conditions must be used:
    (1) A depth sizing requirement of 0.15 inch RMS must be used in lieu 
of the requirements in Subparagraphs 3.2(a) and 3.2(c), and a length 
sizing requirement of 0.75 inch RMS must be used in lieu of the 
requirement in Subparagraph 3.2(b).
    (2) In lieu of the location acceptance criteria requirements of 
Subparagraph 2.1(b), a flaw will be considered detected when reported 
within 1.0 inch or 10 percent of the metal path to the flaw, whichever 
is greater, of its true location in the X and Y directions.
    (3) In lieu of the flaw type requirements of Subparagraph 1.1(e)(1), 
a minimum of 70 percent of the flaws in the detection and sizing tests 
must be cracks. Notches, if used, must be limited by the following:
    (i) Notches must be limited to the case where examinations are 
performed from the clad surface.
    (ii) Notches must be semielliptical with a tip width of less than or 
equal to 0.010 inches.
    (iii) Notches must be perpendicular to the surface within 2 degrees.
    (4) In lieu of the detection test matrix requirements in paragraphs 
1.1(e)(2) and 1.1(e)(3), personnel demonstration test sets must contain 
a representative distribution of flaw orientations, sizes, and 
locations.
    (D) Specimen set and qualification: Fourth provision. The following 
conditions must be used in addition to the requirements of Supplement 6 
to Appendix VIII:
    (1) Paragraph 3.1, Detection Acceptance Criteria--Personnel are 
qualified for detection if:
    (i) No surface connected flaw greater than 0.25 inch through-wall 
has been missed.
    (ii) No embedded flaw greater than 0.50 inch through-wall has been 
missed.
    (2) Paragraph 3.1, Detection Acceptance Criteria--For procedure 
qualification, all flaws within the scope of the procedure are detected.
    (3) Paragraph 1.1(b) for detection and sizing test flaws and 
locations--Flaws smaller than the 50 percent of allowable flaw size, as 
defined in IWB-3500, need not be included as detection flaws. Flaws that 
are less than the allowable flaw size, as defined in IWB-3500, may be 
used as detection and sizing flaws.
    (4) Notches are not permitted.
    (E) Specimen set and qualification: Fifth provision. When applying 
Supplement 6 to Appendix VIII, the following conditions must be used:
    (1) A depth sizing requirement of 0.25 inch RMS must be used in lieu 
of the requirements of subparagraphs 3.2(a), 3.2(c)(2), and 3.2(c)(3).
    (2) In lieu of the location acceptance criteria requirements in 
Subparagraph 2.1(b), a flaw will be considered detected when reported 
within 1.0 inch or 10 percent of the metal path to the flaw, whichever 
is greater, of its true location in the X and Y directions.
    (3) In lieu of the length sizing criteria requirements of 
Subparagraph 3.2(b), a length sizing acceptance criteria of 0.75 inch 
RMS must be used.
    (4) In lieu of the detection specimen requirements in Subparagraph 
1.1(e)(1), a minimum of 55 percent of the flaws must be cracks. The 
remaining flaws may be cracks or fabrication type flaws, such as slag 
and lack of fusion. The use of notches is not allowed.
    (5) In lieu of paragraphs 1.1(e)(2) and 1.1(e)(3) detection test 
matrix, personnel demonstration test sets must contain a representative 
distribution of flaw orientations, sizes, and locations.
    (F) Specimen set and qualification: Sixth provision. The following 
conditions may be used for personnel qualification for combined 
Supplement 4 to Appendix VIII and Supplement 6 to Appendix VIII 
qualification. Licensees choosing to apply this combined qualification 
must apply all of the provisions of Supplements 4 and 6 including the 
following conditions:
    (1) For detection and sizing, the total number of flaws must be at 
least 10. A

[[Page 933]]

minimum of 5 flaws must be from Supplement 4, and a minimum of 50 
percent of the flaws must be from Supplement 6. At least 50 percent of 
the flaws in any sizing must be cracks. Notches are not acceptable for 
Supplement 6.
    (2) Examination personnel are qualified for detection and length 
sizing when the results of any combined performance demonstration 
satisfy the acceptance criteria of Supplement 4 to Appendix VIII.
    (3) Examination personnel are qualified for depth sizing when 
Supplement 4 to Appendix VIII and Supplement 6 to Appendix VIII flaws 
are sized within the respective acceptance criteria of those 
supplements.
    (G) Specimen set and qualification: Seventh provision. When applying 
Supplement 4 to Appendix VIII, Supplement 6 to Appendix VIII, or 
combined Supplement 4 and Supplement 6 qualification, the following 
additional conditions must be used, and examination coverage must 
include:
    (1) The clad-to-base-metal-interface, including a minimum of 15 
percent T (measured from the clad-to-base-metal-interface), must be 
examined from four orthogonal directions using procedures and personnel 
qualified in accordance with Supplement 4 to Appendix VIII.
    (2) If the clad-to-base-metal-interface procedure demonstrates 
detectability of flaws with a tilt angle relative to the weld centerline 
of at least 45 degrees, the remainder of the examination volume is 
considered fully examined if coverage is obtained in one parallel and 
one perpendicular direction. This must be accomplished using a procedure 
and personnel qualified for single-side examination in accordance with 
Supplement 6. Subsequent examinations of this volume may be performed 
using examination techniques qualified for a tilt angle of at least 10 
degrees.
    (3) The examination volume not addressed by paragraph 
(b)(2)(xv)(G)(1) of this section is considered fully examined if 
coverage is obtained in one parallel and one perpendicular direction, 
using a procedure and personnel qualified for single sided examination 
when the conditions in paragraph (b)(2)(xv)(G)(2) are met.
    (H) Specimen set and qualification: Eighth provision. When applying 
Supplement 5 to Appendix VIII, at least 50 percent of the flaws in the 
demonstration test set must be cracks and the maximum misorientation 
must be demonstrated with cracks. Flaws in nozzles with bore diameters 
equal to or less than 4 inches may be notches.
    (I) Specimen set and qualification: Ninth provision. When applying 
Supplement 5, Paragraph (a), to Appendix VIII, the number of false calls 
allowed must be D/10, with a maximum of 3, where D is the diameter of 
the nozzle.
    (J) [Reserved]
    (K) Specimen set and qualification: Eleventh provision. When 
performing nozzle-to-vessel weld examinations, the following conditions 
must be used when the requirements contained in Supplement 7 to Appendix 
VIII are applied for nozzle-to-vessel welds in conjunction with 
Supplement 4 to Appendix VIII, Supplement 6 to Appendix VIII, or 
combined Supplement 4 and Supplement 6 qualification.
    (1) For examination of nozzle-to-vessel welds conducted from the 
bore, the following conditions are required to qualify the procedures, 
equipment, and personnel:
    (i) For detection, a minimum of four flaws in one or more full-scale 
nozzle mock-ups must be added to the test set. The specimens must comply 
with Supplement 6, paragraph 1.1, to Appendix VIII, except for flaw 
locations specified in Table VIII S6-1. Flaws may be notches, 
fabrication flaws, or cracks. Seventy-five (75) percent of the flaws 
must be cracks or fabrication flaws. Flaw locations and orientations 
must be selected from the choices shown in paragraph (b)(2)(xv)(K)(4) of 
this section, Table VIII-S7-1--Modified, with the exception that flaws 
in the outer eighty-five (85) percent of the weld need not be 
perpendicular to the weld. There may be no more than two flaws from each 
category, and at least one subsurface flaw must be included.
    (ii) For length sizing, a minimum of four flaws as in paragraph 
(b)(2)(xv)(K)(1)(i) of this section must be included in the test set. 
The length

[[Page 934]]

sizing results must be added to the results of combined Supplement 4 to 
Appendix VIII and Supplement 6 to Appendix VIII. The combined results 
must meet the acceptance standards contained in paragraph 
(b)(2)(xv)(E)(3) of this section.
    (iii) For depth sizing, a minimum of four flaws as in paragraph 
(b)(2)(xv)(K)(1)(i) of this section must be included in the test set. 
Their depths must be distributed over the ranges of Supplement 4, 
Paragraph 1.1, to Appendix VIII, for the inner 15 percent of the wall 
thickness and Supplement 6, Paragraph 1.1, to Appendix VIII, for the 
remainder of the wall thickness. The depth sizing results must be 
combined with the sizing results from Supplement 4 to Appendix VIII for 
the inner 15 percent and to Supplement 6 to Appendix VIII for the 
remainder of the wall thickness. The combined results must meet the 
depth sizing acceptance criteria contained in paragraphs 
(b)(2)(xv)(C)(1), (b)(2)(xv)(E)(1), and (b)(2)(xv)(F)(3) of this 
section.
    (2) For examination of reactor pressure vessel nozzle-to-vessel 
welds conducted from the inside of the vessel, the following conditions 
are required:
    (i) The clad-to-base-metal-interface and the adjacent examination 
volume to a minimum depth of 15 percent T (measured from the clad-to-
base-metal-interface) must be examined from four orthogonal directions 
using a procedure and personnel qualified in accordance with Supplement 
4 to Appendix VIII as conditioned by paragraphs (b)(2)(xv)(B) and (C) of 
this section.
    (ii) When the examination volume defined in paragraph 
(b)(2)(xv)(K)(2)(i) of this section cannot be effectively examined in 
all four directions, the examination must be augmented by examination 
from the nozzle bore using a procedure and personnel qualified in 
accordance with paragraph (b)(2)(xv)(K)(1) of this section.
    (iii) The remainder of the examination volume not covered by 
paragraph (b)(2)(xv)(K)(2)(ii) of this section or a combination of 
paragraphs (b)(2)(xv)(K)(2)(i) and (ii) of this section, must be 
examined from the nozzle bore using a procedure and personnel qualified 
in accordance with paragraph (b)(2)(xv)(K)(1) of this section, or from 
the vessel shell using a procedure and personnel qualified for single 
sided examination in accordance with Supplement 6 to Appendix VIII, as 
conditioned by paragraphs (b)(2)(xv)(D) through (G) of this section.
    (3) For examination of reactor pressure vessel nozzle-to-shell welds 
conducted from the outside of the vessel, the following conditions are 
required:
    (i) The clad-to-base-metal-interface and the adjacent metal to a 
depth of 15 percent T (measured from the clad-to-base-metal-interface) 
must be examined from one radial and two opposing circumferential 
directions using a procedure and personnel qualified in accordance with 
Supplement 4 to Appendix VIII, as conditioned by paragraphs 
(b)(2)(xv)(B) and (C) of this section, for examinations performed in the 
radial direction, and Supplement 5 to Appendix VIII, as conditioned by 
paragraph (b)(2)(xv)(J) of this section, for examinations performed in 
the circumferential direction.
    (ii) The examination volume not addressed by paragraph 
(b)(2)(xv)(K)(3)(i) of this section must be examined in a minimum of one 
radial direction using a procedure and personnel qualified for single 
sided examination in accordance with Supplement 6 to Appendix VIII, as 
conditioned by paragraphs (b)(2)(xv)(D) through (G) of this section.
    (4) Table VIII-S7-1, ``Flaw Locations and Orientations,'' Supplement 
7 to Appendix VIII, is conditioned as follows:

                                           Table VIII--S7-1--Modified
                                        [Flaw locations and orientations]
----------------------------------------------------------------------------------------------------------------
                                                                  Parallel to weld        Perpendicular to weld
----------------------------------------------------------------------------------------------------------------
Inner 15 percent............................................                        X                         X
Outside Diameter Surface....................................                        X
Subsurface..................................................                        X   ........................
----------------------------------------------------------------------------------------------------------------


[[Page 935]]

    (L) Specimen set and qualification: Twelfth provision. As a 
condition to the requirements of Supplement 8, Subparagraph 1.1(c), to 
Appendix VIII, notches may be located within one diameter of each end of 
the bolt or stud.
    (M) Specimen set and qualification: Thirteenth provision. When 
implementing Supplement 12 to Appendix VIII, only the provisions related 
to the coordinated implementation of Supplement 3 to Supplement 2 
performance demonstrations are to be applied.
    (xvi) Section XI condition: Appendix VIII single side ferritic 
vessel and piping and stainless steel piping examinations. When applying 
editions and addenda prior to the 2007 Edition of Section XI, the 
following conditions apply.
    (A) Ferritic and stainless steel piping examinations: First 
provision. Examinations performed from one side of a ferritic vessel 
weld must be conducted with equipment, procedures, and personnel that 
have demonstrated proficiency with single side examinations. To 
demonstrate equivalency to two sided examinations, the demonstration 
must be performed to the requirements of Appendix VIII, as conditioned 
by this paragraph and paragraphs (b)(2)(xv)(B) through (G) of this 
section, on specimens containing flaws with non-optimum sound energy 
reflecting characteristics or flaws similar to those in the vessel being 
examined.
    (B) Ferritic and stainless steel piping examinations: Second 
provision. Examinations performed from one side of a ferritic or 
stainless steel pipe weld must be conducted with equipment, procedures, 
and personnel that have demonstrated proficiency with single side 
examinations. To demonstrate equivalency to two sided examinations, the 
demonstration must be performed to the requirements of Appendix VIII, as 
conditioned by this paragraph and paragraph (b)(2)(xv)(A) of this 
section.
    (xvii) Section XI condition: Reconciliation of quality requirements. 
When purchasing replacement items, in addition to the reconciliation 
provisions of IWA-4200, 1995 Addenda through 1998 Edition, the 
replacement items must be purchased, to the extent necessary, in 
accordance with the licensee's quality assurance program description 
required by 10 CFR 50.34(b)(6)(ii).
    (xviii) Section XI condition: NDE personnel certification. (A) NDE 
personnel certification: First provision. Level I and II nondestructive 
examination personnel must be recertified on a 3-year interval in lieu 
of the 5-year interval specified in the 1997 Addenda and 1998 Edition of 
IWA-2314, and IWA-2314(a) and IWA-2314(b) of the 1999 Addenda through 
the latest edition and addenda incorporated by reference in paragraph 
(a)(1)(ii) of this section.
    (B) NDE personnel certification: Second provision. When applying 
editions and addenda prior to the 2007 Edition of Section XI, paragraph 
IWA-2316 may only be used to qualify personnel that observe leakage 
during system leakage and hydrostatic tests conducted in accordance with 
IWA 5211(a) and (b).
    (C) NDE personnel certification: Third provision. When applying 
editions and addenda prior to the 2005 Addenda of Section XI, licensee's 
qualifying visual examination personnel for VT-3 visual examination 
under paragraph IWA-2317 of Section XI must demonstrate the proficiency 
of the training by administering an initial qualification examination 
and administering subsequent examinations on a 3-year interval.
    (D) NDE personnel certification: Fourth provision. The use of 
Appendix VII, Table VII-4110-1 and Appendix VIII, Subarticle VIII-2200 
of the 2011 Addenda and 2013 Edition of Section XI of the ASME BPV Code 
is prohibited. When using ASME BPV Code, Section XI editions and addenda 
later than the 2010 Edition, licensees and applicants must use the 
prerequisites for ultrasonic examination personnel certifications in 
Appendix VII, Table VII-4110-1 and Appendix VIII, Subarticle VIII-2200 
in the 2010 Edition.
    (xix) Section XI condition: Substitution of alternative methods. The 
provisions for substituting alternative examination methods, a 
combination of methods, or newly developed techniques in the 1997 
Addenda of IWA-2240 must be applied when using the 1998 Edition through 
the 2004 Edition of Section XI of the ASME BPV Code. The provisions in 
IWA-4520(c), 1997 Addenda through

[[Page 936]]

the 2004 Edition, allowing the substitution of alternative methods, a 
combination of methods, or newly developed techniques for the methods 
specified in the Construction Code, are not approved for use. The 
provisions in IWA-4520(b)(2) and IWA-4521 of the 2008 Addenda through 
the latest edition and addenda incorporated by reference in paragraph 
(a)(1)(ii) of this section, allowing the substitution of ultrasonic 
examination for radiographic examination specified in the Construction 
Code, are not approved for use.
    (xx) Section XI condition: System leakage tests--(A) System leakage 
tests: First provision. When performing system leakage tests in 
accordance with IWA-5213(a), 1997 through 2002 Addenda, the licensee 
must maintain a 10-minute hold time after test pressure has been reached 
for Class 2 and Class 3 components that are not in use during normal 
operating conditions. No hold time is required for the remaining Class 2 
and Class 3 components provided that the system has been in operation 
for at least 4 hours for insulated components or 10 minutes for 
uninsulated components.
    (B) System leakage tests: Second provision. The NDE provision in 
IWA-4540(a)(2) of the 2002 Addenda of Section XI must be applied when 
performing system leakage tests after repair and replacement activities 
performed by welding or brazing on a pressure retaining boundary using 
the 2003 Addenda through the latest edition and addenda incorporated by 
reference in paragraph (a)(1)(ii) of this section.
    (xxi) Section XI condition: Table IWB-2500-1 examination 
requirements. (A) Table IWB-2500-1 examination requirements: First 
provision. The provisions of Table IWB 2500-1, Examination Category B-D, 
Full Penetration Welded Nozzles in Vessels, Items B3.40 and B3.60 
(Inspection Program A) and Items B3.120 and B3.140 (Inspection Program 
B) of the 1998 Edition must be applied when using the 1999 Addenda 
through the latest edition and addenda incorporated by reference in 
paragraph (a)(1)(ii) of this section. A visual examination with 
magnification that has a resolution sensitivity to resolve 0.044 inch 
(1.1 mm) lower case characters without an ascender or descender (e.g., 
a, e, n, v), utilizing the allowable flaw length criteria in Table IWB-
3512-1, 1997 Addenda through the latest edition and addenda incorporated 
by reference in paragraph (a)(1)(ii) of this section, with a limiting 
assumption on the flaw aspect ratio (i.e., a/l = 0.5), may be performed 
instead of an ultrasonic examination.
    (B) [Reserved]
    (xxii) Section XI condition: Surface examination. The use of the 
provision in IWA-2220, ``Surface Examination,'' of Section XI, 2001 
Edition through the latest edition and addenda incorporated by reference 
in paragraph (a)(1)(ii) of this section, that allows use of an 
ultrasonic examination method is prohibited.
    (xxiii) Section XI condition: Evaluation of thermally cut surfaces. 
The use of the provisions for eliminating mechanical processing of 
thermally cut surfaces in IWA-4461.4.2 of Section XI, 2001 Edition 
through the 2009 Addenda, is prohibited.
    (xxiv) Section XI condition: Incorporation of the performance 
demonstration initiative and addition of ultrasonic examination 
criteria. The use of Appendix VIII and the supplements to Appendix VIII 
and Article I-3000 of Section XI of the ASME BPV Code, 2002 Addenda 
through the 2006 Addenda, is prohibited.
    (xxv) Section XI condition: Mitigation of defects by modification. 
The use of the provisions in IWA-4340, ``Mitigation of Defects by 
Modification,'' Section XI, 2001 Edition through the latest edition and 
addenda incorporated by reference in paragraph (a)(1)(ii) of this 
section are prohibited.
    (xxvi) Section XI condition: Pressure testing Class 1, 2 and 3 
mechanical joints. The repair and replacement activity provisions in 
IWA-4540(c) of the 1998 Edition of Section XI for pressure testing Class 
1, 2, and 3 mechanical joints must be applied when using the 2001 
Edition through the latest edition and addenda incorporated by reference 
in paragraph (a)(1)(ii) of this section.
    (xxvii) Section XI condition: Removal of insulation. When performing 
visual examination in accordance with IWA-5242 of Section XI of the ASME 
BPV Code, 2003 Addenda through the 2006

[[Page 937]]

Addenda, or IWA-5241 of the 2007 Edition through the latest edition and 
addenda incorporated by reference in paragraph (a)(1)(ii) of this 
section, insulation must be removed from 17-4 PH or 410 stainless steel 
studs or bolts aged at a temperature below 1100 [deg]F or having a 
Rockwell Method C hardness value above 30, and from A-286 stainless 
steel studs or bolts preloaded to 100,000 pounds per square inch or 
higher.
    (xxviii) Section XI condition: Analysis of flaws. Licensees using 
ASME BPV Code, Section XI, Appendix A, must use the following conditions 
when implementing Equation (2) in A-4300(b)(1):

    For R < 0, [Delta]KI depends on the crack depth (a), and 
the flow stress ([sigma]f). The flow stress is defined by 
[sigma]f = 1/2([sigma]ys + [sigma]ult), 
where [sigma]ys is the yield strength and 
[sigma]ult is the ultimate tensilestrength in units ksi (MPa) 
and (a) is in units in. (mm). For -2 <= R <= 0 and Kmax- 
Kmin <= 0.8 x 1.12 [sigma]f[radic]([pi]a), S = 1 
and [Delta]KI = Kmax. For R < -2 and 
Kmax- Kmin <= 0.8 x 1.12 
[sigma]f[radic]([pi]a), S = 1 and [Delta]KI = (1 - 
R) Kmax/3. For R < 0 and Kmax - Kmin 
 0.8 x 1.12[sigma]f[radic]([pi]a), S = 1 and 
[Delta]KI = Kmax-Kmin.

    (xxix) Section XI condition: Nonmandatory Appendix R. Nonmandatory 
Appendix R, ``Risk-Informed Inspection Requirements for Piping,'' of 
Section XI, 2005 Addenda through the latest edition and addenda 
incorporated by reference in paragraph (a)(1)(ii) of this section, may 
not be implemented without prior NRC authorization of the proposed 
alternative in accordance with paragraph (z) of this section.
    (xxx) [Reserved]
    (xxxi) Section XI condition: Mechanical clamping devices. When 
installing a mechanical clamping device on an ASME BPV Code class piping 
system, Appendix W of Section XI shall be treated as a mandatory 
appendix and all of the provisions of Appendix W shall be met for the 
mechanical clamping device being installed. Additionally, use of IWA-
4131.1(c) of the 2010 Edition of Section XI and IWA-4131.1(d) of the 
2011 Addenda of the 2010 Edition and later versions of Section XI is 
prohibited on small item Class 1 piping and portions of a piping system 
that form the containment boundary.
    (xxxii) Section XI condition: Summary report submittal. When using 
ASME BPV Code, Section XI, 2010 Edition through the latest edition and 
addenda incorporated by reference in paragraph (a)(1)(ii) of this 
section, Summary Reports described in IWA-6000 must be submitted to the 
NRC as described in IWA-6240(a) and IWA-6240(b). Preservice inspection 
summary reports shall be submitted prior to the date of placement of the 
unit into commercial service and inservice inspection summary reports 
shall be submitted within 90 calendar days of the completion of each 
refueling outage.
    (xxxiii) Section XI condition: Risk-Informed allowable pressure. The 
use of Paragraph G-2216 in Appendix G in the 2011 Addenda and later 
editions and addenda of the ASME BPV Code, Section XI is prohibited.
    (xxxiv) Section XI condition: Nonmandatory Appendix U. When using 
Nonmandatory Appendix U of the 2013 Edition of the ASME BPV Code, 
Section XI the following conditions apply:
    (A) The repair or replacement activities temporarily deferred under 
the provisions of Nonmandatory Appendix U must be performed during the 
next scheduled refueling outage.
    (B) In lieu of the appendix referenced in paragraph U-S1-4.2.1(c) of 
Appendix U the mandatory appendix in ASME BPV Code Case N-513-3 must be 
used.
    (xxxv) Section XI condition: Use of RTT0 in the KIa and KIc 
equations. When using the 2013 Edition of the ASME BPV Code, Section XI, 
Appendix A, paragraph A-4200, if T0 is available, then 
RTT0 may be used in place of RTNDT for 
applications using the KIc equation and the associated 
KIc curve, but not for applications using the KIa 
equation and the associated KIa curve.
    (xxxvi) Section XI condition: Fracture toughness of irradiated 
materials. When using the 2013 Edition of the ASME BPV Code, Section XI, 
Appendix A paragraph A-4400, the licensee shall obtain NRC approval 
under paragraph (z) of this section before using irradiated 
T0 and the associated RTT0 in establishing 
fracture toughness of irradiated materials.
    (xxxvii) Section XI condition: ASME BPV Code Case N-824. Licensees 
may use the provisions of ASME BPV Code Case N-824, ``Ultrasonic 
Examination of Cast Austenitic Piping Welds From

[[Page 938]]

the Outside Surface Section XI, Division 1,'' subject to the following 
conditions.
    (A) Ultrasonic examinations must be spatially encoded.
    (B) Instead of Paragraph 1(c)(1)(-a), licensees shall use dual, 
transmit-receive, refracted longitudinal wave, multi-element phased 
array search units.
    (C) Instead of Paragraph 1(c)(1)(-c)(-2), licensees shall use a 
phased array search unit with a center frequency of 500 kHz with a 
tolerance of  20 percent.
    (D) Instead of Paragraph 1(c)(1)(-d), the phased array search unit 
must produce angles including, but not limited to, 30 to 55 degrees with 
a maximum increment of 5 degrees.
    (3) Conditions on ASME OM Code. As used in this section, references 
to the ASME OM Code are to the ASME OM Code, Subsections ISTA, ISTB, 
ISTC, ISTD, ISTE, and ISTF; Mandatory Appendices I, II, III, and V; and 
Nonmandatory Appendices A through H and J through M, in the 1995 Edition 
through the 2012 Edition, as specified in paragraph (a)(1)(iv) of this 
section. Mandatory appendices must be used if required by the OM Code; 
nonmandatory appendices are approved for use by the NRC but need not be 
used. The following conditions are applicable when implementing the ASME 
OM Code:
    (i) OM condition: Quality assurance. When applying editions and 
addenda of the ASME OM Code, the requirements of ASME Standard NQA-1, 
``Quality Assurance Requirements for Nuclear Facility Applications,'' 
1994 Edition, 2008 Edition, and 2009-1a Addenda, are acceptable as 
permitted by either ISTA 1.4 of the 1995 Edition through 1997 Addenda or 
ISTA-1500 of the 1998 Edition through the latest edition and addenda of 
the ASME OM Code incorporated by reference in paragraph (a)(1)(iv) of 
this section, provided the licensee uses its appendix B to this part 
quality assurance program in conjunction with the ASME OM Code 
requirements and the commitments contained in the licensee's quality 
assurance program description. Where NQA-1 and the ASME OM Code do not 
address the commitments contained in the licensee's appendix B quality 
assurance program description, the commitments must be applied to ASME 
OM Code activities.
    (ii) OM condition: Motor-Operated Valve (MOV) testing. Licensees 
must comply with the provisions for testing MOVs in ASME OM Code, ISTC 
4.2, 1995 Edition with the 1996 and 1997 Addenda, or ISTC-3500, 1998 
Edition through the latest edition and addenda incorporated by reference 
in paragraph (a)(1)(iv) of this section, and must establish a program to 
ensure that MOVs continue to be capable of performing their design basis 
safety functions. Licensees implementing ASME OM Code, Mandatory 
Appendix III, ``Preservice and Inservice Testing of Active Electric 
Motor Operated Valve Assemblies in Light-Water Reactor Power Plants,'' 
of the 2009 Edition, 2011 Addenda, and 2012 Edition shall comply with 
the following conditions:
    (A) MOV diagnostic test interval. Licensees shall evaluate the 
adequacy of the diagnostic test intervals established for MOVs within 
the scope of ASME OM Code, Appendix III, not later than 5 years or three 
refueling outages (whichever is longer) from initial implementation of 
ASME OM Code, Appendix III.
    (B) MOV testing impact on risk. Licensees shall ensure that the 
potential increase in core damage frequency and large early release 
frequency associated with the extension is acceptably small when 
extending exercise test intervals for high risk MOVs beyond a quarterly 
frequency.
    (C) MOV risk categorization. When applying Appendix III to the ASME 
OM Code, licensees shall categorize MOVs according to their safety 
significance using the methodology described in ASME OM Code Case OMN-3, 
``Requirements for Safety Significance Categorization of Components 
Using Risk Insights for Inservice Testing of LWR Power Plants,'' subject 
to the conditions applicable to OMN-3 which are set forth in Regulatory 
Guide 1.192, or using an MOV risk ranking methodology accepted by the 
NRC on a plant-specific or industry-wide basis in accordance with the 
conditions in the applicable safety evaluation.
    (D) MOV stroke time. When applying Paragraph III-3600, ``MOV 
Exercising Requirements,'' of Appendix III to the

[[Page 939]]

ASME OM Code, licensees shall verify that the stroke time of MOVs 
specified in plant technical specifications satisfies the assumptions in 
the plant's safety analyses.
    (iii) OM condition: New reactors. In addition to complying with the 
provisions in the ASME OM Code with the conditions specified in 
paragraph (b)(3) of this section, holders of operating licenses for 
nuclear power reactors that received construction permits under this 
part on or after the date 12 months after August 17, 2017, and holders 
of combined licenses issued under 10 CFR part 52, whose initial fuel 
loading occurs on or after the date 12 months after August 17, 2017, 
shall also comply with the following conditions, as applicable:
    (A) Power-operated valves. Licensees shall periodically verify the 
capability of power-operated valves to perform their design-basis safety 
functions.
    (B) Check valves. Licensees must perform bi-directional testing of 
check valves within the IST program where practicable.
    (C) Flow-induced vibration. Licensees shall monitor flow-induced 
vibration from hydrodynamic loads and acoustic resonance during 
preservice testing or inservice testing to identify potential adverse 
flow effects on components within the scope of the IST program.
    (D) High risk non-safety systems. Licensees shall assess the 
operational readiness of pumps, valves, and dynamic restraints within 
the scope of the Regulatory Treatment of Non-Safety Systems for 
applicable reactor designs.
    (iv) OM condition: Check valves (Appendix II). Licensees applying 
Appendix II, ``Check Valve Condition Monitoring Program,'' of the ASME 
OM Code, 1995 Edition with the 1996 and 1997 Addenda, shall satisfy the 
requirements of paragraphs (b)(3)(iv)(A) through (C) of this section. 
Licensees applying Appendix II, 1998 Edition through the 2002 Addenda, 
shall satisfy the requirements of paragraphs (b)(3)(iv)(A), (B), and (D) 
of this section. Appendix II of the ASME OM Code, 2003 Addenda through 
the 2012 Edition, is acceptable for use with the following requirements. 
Trending and evaluation shall support the determination that the valve 
or group of valves is capable of performing its intended function(s) 
over the entire interval. At least one of the Appendix II condition 
monitoring activities for a valve group shall be performed on each valve 
of the group at approximate equal intervals not to exceed the maximum 
interval shown in the following table:

  Table II--Maximum Intervals for Use When Applying Interval Extensions
------------------------------------------------------------------------
                                                              Maximum
                                                             interval
                             Maximum interval between         between
       Group size         activities of member valves in   activities of
                                the groups (years)         each valve in
                                                             the group
                                                              (years)
------------------------------------------------------------------------
=4...........  4.5...........................              16
3.......................  4.5...........................              12
2.......................  6.............................              12
1.......................  Not applicable................              10
------------------------------------------------------------------------

    (A) Check valves: First provision. Valve opening and closing 
functions must be demonstrated when flow testing or examination methods 
(nonintrusive, or disassembly and inspection) are used;
    (B) Check valves: Second provision. The initial interval for tests 
and associated examinations may not exceed two fuel cycles or 3 years, 
whichever is longer; any extension of this interval may not exceed one 
fuel cycle per extension with the maximum interval not to exceed 10 
years. Trending and evaluation of existing data must be used to reduce 
or extend the time interval between tests.
    (C) Check valves: Third provision. If the Appendix II condition 
monitoring program is discontinued, then the requirements of ISTC 4.5.1 
through 4.5.4 must be implemented.
    (D) Check valves: Fourth provision. The applicable provisions of 
subsection ISTC must be implemented if the Appendix II condition 
monitoring program is discontinued.
    (v) OM condition: Snubbers ISTD. Article IWF-5000, ``Inservice 
Inspection Requirements for Snubbers,'' of the ASME BPV Code, Section 
XI, must be used when performing inservice inspection examinations and 
tests of snubbers at nuclear power plants, except as conditioned in 
paragraphs (b)(3)(v)(A) and (B) of this section.
    (A) Snubbers: First provision. Licensees may use Subsection ISTD,

[[Page 940]]

``Preservice and Inservice Examination and Testing of Dynamic Restraints 
(Snubbers) in Light-Water Reactor Power Plants,'' ASME OM Code, 1995 
Edition through the latest edition and addenda incorporated by reference 
in paragraph (a)(1)(iv) of this section, in place of the requirements 
for snubbers in the editions and addenda up to the 2005 Addenda of the 
ASME BPV Code, Section XI, IWF-5200(a) and (b) and IWF-5300(a) and (b), 
by making appropriate changes to their technical specifications or 
licensee-controlled documents. Preservice and inservice examinations 
must be performed using the VT-3 visual examination method described in 
IWA-2213.
    (B) Snubbers: Second provision. Licensees must comply with the 
provisions for examining and testing snubbers in Subsection ISTD of the 
ASME OM Code and make appropriate changes to their technical 
specifications or licensee-controlled documents when using the 2006 
Addenda and later editions and addenda of Section XI of the ASME BPV 
Code.
    (vi) OM condition: Exercise interval for manual valves. Manual 
valves must be exercised on a 2-year interval rather than the 5-year 
interval specified in paragraph ISTC-3540 of the 1999 through the 2005 
Addenda of the ASME OM Code, provided that adverse conditions do not 
require more frequent testing.
    (vii) OM condition: Subsection ISTB. Subsection ISTB, 2011 Addenda, 
is prohibited for use.
    (viii) OM condition: Subsection ISTE. Licensees may not implement 
the risk-informed approach for inservice testing (IST) of pumps and 
valves specified in Subsection ISTE, ``Risk-Informed Inservice Testing 
of Components in Light-Water Reactor Nuclear Power Plants,'' in the ASME 
OM Code, 2009 Edition, 2011 Addenda, or 2012 Edition, without first 
obtaining NRC authorization to use Subsection ISTE as an alternative to 
the applicable IST requirements in the ASME OM Code, pursuant to 
paragraph (z) of this section.
    (ix) OM condition: Subsection ISTF. Licensees applying Subsection 
ISTF, 2012 Edition, shall satisfy the requirements of Mandatory Appendix 
V, ``Pump Periodic Verification Test Program,'' of the ASME OM Code, 
2012 Edition. Subsection ISTF, 2011 Addenda, is prohibited for use.
    (x) OM condition: ASME OM Code Case OMN-20. Licensees may implement 
ASME OM Code Case OMN-20, ``Inservice Test Frequency,'' which is 
incorporated by reference in paragraph (a)(1)(iii)(G) of this section, 
for editions and addenda of the ASME OM Code listed in paragraph 
(a)(1)(iv) of this section.
    (xi) OM condition: Valve Position Indication. When implementing ASME 
OM Code, 2012 Edition, Subsection ISTC-3700, ``Position Verification 
Testing,'' licensees shall verify that valve operation is accurately 
indicated by supplementing valve position indicating lights with other 
indications, such as flow meters or other suitable instrumentation, to 
provide assurance of proper obturator position.
    (4) Conditions on Design, Fabrication, and Materials Code Cases. 
Each manufacturing license, standard design approval, and design 
certification application under part 52 of this chapter is subject to 
the following conditions. Licensees may apply the ASME BPV Code Cases 
listed in NRC Regulatory Guide 1.84, as incorporated by reference in 
paragraph (a)(3)(i) of this section, without prior NRC approval, subject 
to the following conditions:
    (i) Design, Fabrication, and Materials Code Case condition: Applying 
Code Cases. When an applicant or licensee initially applies a listed 
Code Case, the applicant or licensee must apply the most recent version 
of that Code Case incorporated by reference in paragraph (a) of this 
section.
    (ii) Design, Fabrication, and Materials Code Case condition: 
Applying different revisions of Code Cases. If an applicant or licensee 
has previously applied a Code Case and a later version of the Code Case 
is incorporated by reference in paragraph (a) of this section, the 
applicant or licensee may continue to apply the previous version of the 
Code Case as authorized or may apply the later version of the Code Case, 
including any NRC-specified conditions placed on its use, until it 
updates its Code of Record for the component being constructed.

[[Page 941]]

    (iii) Design, Fabrication, and Materials Code Case condition: 
Applying annulled Code Cases. Application of an annulled Code Case is 
prohibited unless an applicant or licensee applied the listed Code Case 
prior to it being listed as annulled in Regulatory Guide 1.84. If an 
applicant or licensee has applied a listed Code Case that is later 
listed as annulled in Regulatory Guide 1.84, the applicant or licensee 
may continue to apply the Code Case until it updates its Code of Record 
for the component being constructed.
    (5) Conditions on inservice inspection Code Cases. Licensees may 
apply the ASME BPV Code Cases listed in NRC Regulatory Guide 1.147, as 
incorporated by reference in paragraph (a)(3)(ii) of this section, 
without prior NRC approval, subject to the following:
    (i) ISI Code Case condition: Applying Code Cases. When a licensee 
initially applies a listed Code Case, the licensee must apply the most 
recent version of that Code Case incorporated by reference in paragraph 
(a) of this section.
    (ii) ISI Code Case condition: Applying different revisions of Code 
Cases. If a licensee has previously applied a Code Case and a later 
version of the Code Case is incorporated by reference in paragraph (a) 
of this section, the licensee may continue to apply, to the end of the 
current 120-month interval, the previous version of the Code Case, as 
authorized, or may apply the later version of the Code Case, including 
any NRC-specified conditions placed on its use. Licensees who choose to 
continue use of the Code Case during subsequent 120-month ISI program 
intervals will be required to implement the latest version incorporated 
by reference into this section as listed in Tables 1 and 2 of NRC 
Regulatory Guide 1.147, as incorporated by reference in paragraph 
(a)(3)(ii) of this section.
    (iii) ISI Code Case condition: Applying annulled Code Cases. 
Application of an annulled Code Case is prohibited unless a licensee 
previously applied the listed Code Case prior to it being listed as 
annulled in NRC Regulatory Guide 1.147. If a licensee has applied a 
listed Code Case that is later listed as annulled in NRC Regulatory 
Guide 1.147, the licensee may continue to apply the Code Case to the end 
of the current 120-month interval.
    (6) Conditions on ASME OM Code Cases. Licensees may apply the ASME 
OM Code Cases listed in NRC Regulatory Guide 1.192, as incorporated by 
reference in paragraph (a)(3)(iii) of this section, without prior NRC 
approval, subject to the following:
    (i) OM Code Case condition: Applying Code Cases. When a licensee 
initially applies a listed Code Case, the licensee must apply the most 
recent version of that Code Case incorporated by reference in paragraph 
(a) of this section.
    (ii) OM Code Case condition: Applying different revisions of Code 
Cases. If a licensee has previously applied a Code Case and a later 
version of the Code Case is incorporated by reference in paragraph (a) 
of this section, the licensee may continue to apply, to the end of the 
current 120-month interval, the previous version of the Code Case, as 
authorized, or may apply the later version of the Code Case, including 
any NRC-specified conditions placed on its use. Licensees who choose to 
continue use of the Code Case during subsequent 120-month ISI program 
intervals will be required to implement the latest version incorporated 
by reference into this section as listed in Tables 1 and 2 of NRC 
Regulatory Guide 1.192, as incorporated by reference in paragraph 
(a)(3)(iii) of this section.
    (iii) OM Code Case condition: Applying annulled Code Cases. 
Application of an annulled Code Case is prohibited unless a licensee 
previously applied the listed Code Case prior to it being listed as 
annulled in NRC Regulatory Guide 1.192. If a licensee has applied a 
listed Code Case that is later listed as annulled in NRC Regulatory 
Guide 1.192, the licensee may continue to apply the Code Case to the end 
of the current 120-month interval.
    (c) Reactor coolant pressure boundary. Systems and components of 
boiling and pressurized water-cooled nuclear power reactors must meet 
the requirements of the ASME BPV Code as specified in this paragraph. 
Each manufacturing license, standard design approval, and design 
certification application under part 52 of this chapter and each 
combined license for a utilization facility is subject to the following 
conditions:

[[Page 942]]

    (1) Standards requirement for reactor coolant pressure boundary 
components. Components that are part of the reactor coolant pressure 
boundary must meet the requirements for Class 1 components in Section 
III \1 4\ of the ASME BPV Code, except as provided in paragraphs (c)(2) 
through (4) of this section.
    (2) Exceptions to reactor coolant pressure boundary standards 
requirement. Components that are connected to the reactor coolant system 
and are part of the reactor coolant pressure boundary as defined in 
Sec.50.2 need not meet the requirements of paragraph (c)(1) of this 
section, provided that:
    (i) Exceptions: Shutdown and cooling capability. In the event of 
postulated failure of the component during normal reactor operation, the 
reactor can be shut down and cooled down in an orderly manner, assuming 
makeup is provided by the reactor coolant makeup system; or
    (ii) Exceptions: Isolation capability. The component is or can be 
isolated from the reactor coolant system by two valves in series (both 
closed, both open, or one closed and the other open). Each open valve 
must be capable of automatic actuation and, assuming the other valve is 
open, its closure time must be such that, in the event of postulated 
failure of the component during normal reactor operation, each valve 
remains operable and the reactor can be shut down and cooled down in an 
orderly manner, assuming makeup is provided by the reactor coolant 
makeup system only.
    (3) Applicable Code and Code Cases and conditions on their use. The 
Code edition, addenda, and optional ASME Code Cases to be applied to 
components of the reactor coolant pressure boundary must be determined 
by the provisions of paragraph NCA-1140, Subsection NCA of Section III 
of the ASME BPV Code, subject to the following conditions:
    (i) Reactor coolant pressure boundary condition: Code edition and 
addenda. The edition and addenda applied to a component must be those 
that are incorporated by reference in paragraph (a)(1)(i) of this 
section;
    (ii) Reactor coolant pressure boundary condition: Earliest edition 
and addenda for pressure vessel. The ASME Code provisions applied to the 
pressure vessel may be dated no earlier than the summer 1972 Addenda of 
the 1971 Edition;
    (iii) Reactor coolant pressure boundary condition: Earliest edition 
and addenda for piping, pumps, and valves. The ASME Code provisions 
applied to piping, pumps, and valves may be dated no earlier than the 
Winter 1972 Addenda of the 1971 Edition; and
    (iv) Reactor coolant pressure boundary condition: Use of Code Cases. 
The optional Code Cases applied to a component must be those listed in 
NRC Regulatory Guide 1.84 that is incorporated by reference in paragraph 
(a)(3)(i) of this section.
    (4) Standards requirement for components in older plants. For a 
nuclear power plant whose construction permit was issued prior to May 
14, 1984, the applicable Code edition and addenda for a component of the 
reactor coolant pressure boundary continue to be that Code edition and 
addenda that were required by Commission regulations for such a 
component at the time of issuance of the construction permit.
    (d) Quality Group B components. Systems and components of boiling 
and pressurized water-cooled nuclear power reactors must meet the 
requirements of the ASME BPV Code as specified in this paragraph. Each 
manufacturing license, standard design approval, and design 
certification application under part 52 of this chapter, and each 
combined license for a utilization facility is subject to the following 
conditions:
    (1) Standards requirement for Quality Group B components. For a 
nuclear power plant whose application for a construction permit under 
this part, or a combined license or manufacturing license under part 52 
of this chapter, docketed after May 14, 1984, or for an application for 
a standard design approval or a standard design certification docketed 
after May 14, 1984, components classified Quality Group B \7\ must meet 
the requirements for Class 2 Components in Section III of the ASME BPV 
Code.
    (2) Quality Group B: Applicable Code and Code Cases and conditions 
on their use. The Code edition, addenda, and optional ASME Code Cases to 
be applied to the systems and components identified in paragraph (d)(1) 
of this section

[[Page 943]]

must be determined by the rules of paragraph NCA-1140, Subsection NCA of 
Section III of the ASME BPV Code, subject to the following conditions:
    (i) Quality Group B condition: Code edition and addenda. The edition 
and addenda must be those that are incorporated by reference in 
paragraph (a)(1)(i) of this section;
    (ii) Quality Group B condition: Earliest edition and addenda for 
components. The ASME Code provisions applied to the systems and 
components may be dated no earlier than the 1980 Edition; and
    (iii) Quality Group B condition: Use of Code Cases. The optional 
Code Cases must be those listed in NRC Regulatory Guide 1.84 that is 
incorporated by reference in paragraph (a)(3)(i) of this section.
    (e) Quality Group C components. Systems and components of boiling 
and pressurized water-cooled nuclear power reactors must meet the 
requirements of the ASME BPV Code as specified in this paragraph. Each 
manufacturing license, standard design approval, and design 
certification application under part 52 of this chapter and each 
combined license for a utilization facility is subject to the following 
conditions.
    (1) Standards requirement for Quality Group C components. For a 
nuclear power plant whose application for a construction permit under 
this part, or a combined license or manufacturing license under part 52 
of this chapter, docketed after May 14, 1984, or for an application for 
a standard design approval or a standard design certification docketed 
after May 14, 1984, components classified Quality Group C \7\ must meet 
the requirements for Class 3 components in Section III of the ASME BPV 
Code.
    (2) Quality Group C applicable Code and Code Cases and conditions on 
their use. The Code edition, addenda, and optional ASME Code Cases to be 
applied to the systems and components identified in paragraph (e)(1) of 
this section must be determined by the rules of paragraph NCA-1140, 
subsection NCA of Section III of the ASME BPV Code, subject to the 
following conditions:
    (i) Quality Group C condition: Code edition and addenda. The edition 
and addenda must be those incorporated by reference in paragraph 
(a)(1)(i) of this section;
    (ii) Quality Group C condition: Earliest edition and addenda for 
components. The ASME Code provisions applied to the systems and 
components may be dated no earlier than the 1980 Edition; and
    (iii) Quality Group C condition: Use of Code Cases. The optional 
Code Cases must be those listed in NRC Regulatory Guide 1.84 that is 
incorporated by reference in paragraph (a)(3)(i) of this section.
    (f) Preservice and inservice testing requirements. Systems and 
components of boiling and pressurized water-cooled nuclear power 
reactors must meet the requirements for preservice and inservice testing 
(referred to in this paragraph (f) collectively as inservice testing) of 
the ASME BPV Code and ASME OM Code as specified in this paragraph (f). 
Each operating license for a boiling or pressurized water-cooled nuclear 
facility is subject to the following conditions. Each combined license 
for a boiling or pressurized water-cooled nuclear facility is subject to 
the following conditions, but the conditions in paragraphs (f)(4) 
through (6) of this section must be met only after the Commission makes 
the finding under Sec.52.103(g) of this chapter. Requirements for 
inservice inspection of Class 1, Class 2, Class 3, Class MC, and Class 
CC components (including their supports) are located in paragraph (g) of 
this section.
    (1) Inservice testing requirements for older plants (pre-1971 CPs). 
For a boiling or pressurized water-cooled nuclear power facility whose 
construction permit was issued prior to January 1, 1971, pumps and 
valves must meet the test requirements of paragraphs (f)(4) and (5) of 
this section to the extent practical. Pumps and valves that are part of 
the reactor coolant pressure boundary must meet the requirements 
applicable to components that are classified as ASME Code Class 1. Other 
pumps and valves that perform a function to shut down the reactor or 
maintain the reactor in a safe shutdown condition, mitigate the 
consequences of an accident, or provide overpressure protection for 
safety-related systems (in meeting the requirements of the 1986 Edition, 
or later, of the BPV or OM Code) must meet the test requirements

[[Page 944]]

applicable to components that are classified as ASME Code Class 2 or 
Class 3.
    (2) Design and accessibility requirements for performing inservice 
testing in plants with CPs issued between 1971 and 1974. For a boiling 
or pressurized water-cooled nuclear power facility whose construction 
permit was issued on or after January 1, 1971, but before July 1, 1974, 
pumps and valves that are classified as ASME BPV Code Class 1 and Class 
2 must be designed and provided with access to enable the performance of 
inservice tests for operational readiness set forth in editions and 
addenda of Section XI of the ASME BPV Code incorporated by reference in 
paragraph (a)(1)(ii) of this section (or the optional ASME Code Cases 
listed in NRC Regulatory Guide 1.147 or NRC Regulatory Guide 1.192, as 
incorporated by reference in paragraphs (a)(3)(ii) and (iii) of this 
section, respectively) in effect 6 months before the date of issuance of 
the construction permit. The pumps and valves may meet the inservice 
test requirements set forth in subsequent editions of this Code and 
addenda that are incorporated by reference in paragraph (a)(1)(ii) of 
this section (or the optional ASME Code Cases listed in NRC Regulatory 
Guide 1.147 or NRC Regulatory Guide 1.192, as incorporated by reference 
in paragraphs (a)(3)(ii) and (iii) of this section, respectively), 
subject to the applicable conditions listed therein.
    (3) Design and accessibility requirements for performing inservice 
testing in plants with CPs issued after 1974. For a boiling or 
pressurized water-cooled nuclear power facility whose construction 
permit under this part or design approval, design certification, 
combined license, or manufacturing license under part 52 of this chapter 
was issued on or after July 1, 1974:
    (i)-(ii) [Reserved]
    (iii) IST design and accessibility requirements: Class 1 pumps and 
valves. (A) Class 1 pumps and valves: First provision. In facilities 
whose construction permit was issued before November 22, 1999, pumps and 
valves that are classified as ASME BPV Code Class 1 must be designed and 
provided with access to enable the performance of inservice testing of 
the pumps and valves for assessing operational readiness set forth in 
the editions and addenda of Section XI of the ASME BPV Code incorporated 
by reference in paragraph (a)(1)(ii) of this section (or the optional 
ASME Code Cases listed in NRC Regulatory Guide 1.147 or NRC Regulatory 
Guide 1.192, as incorporated by reference in paragraphs (a)(3)(ii) and 
(iii) of this section, respectively) applied to the construction of the 
particular pump or valve or the summer 1973 Addenda, whichever is later.
    (B) Class 1 pumps and valves: Second provision. In facilities whose 
construction permit under this part, or design certification, design 
approval, combined license, or manufacturing license under part 52 of 
this chapter, issued on or after November 22, 1999, pumps and valves 
that are classified as ASME BPV Code Class 1 must be designed and 
provided with access to enable the performance of inservice testing of 
the pumps and valves for assessing operational readiness set forth in 
editions and addenda of the ASME OM Code (or the optional ASME OM Code 
Cases listed in NRC Regulatory Guide 1.192, as incorporated by reference 
in paragraph (a)(3)(iii) of this section), incorporated by reference in 
paragraph (a)(1)(iv) of this section at the time the construction 
permit, combined license, manufacturing license, design certification, 
or design approval is issued.
    (iv) IST design and accessibility requirements: Class 2 and 3 pumps 
and valves.(A) Class 2 and 3 pumps and valves: First provision. In 
facilities whose construction permit was issued before November 22, 
1999, pumps and valves that are classified as ASME BPV Code Class 2 and 
Class 3 must be designed and be provided with access to enable the 
performance of inservice testing of the pumps and valves for assessing 
operational readiness set forth in the editions and addenda of Section 
XI of the ASME BPV Code incorporated by reference in paragraph 
(a)(1)(ii) of this section (or the optional ASME BPV Code Cases listed 
in NRC Regulatory Guide 1.147, as incorporated by reference in paragraph 
(a)(3)(ii) of this section) applied to the construction of the 
particular pump or valve or the Summer 1973 Addenda, whichever is later.

[[Page 945]]

    (B) Class 2 and 3 pumps and valves: Second provision. In facilities 
whose construction permit under this part, or design certification, 
design approval, combined license, or manufacturing license under part 
52 of this chapter, issued on or after November 22, 1999, pumps and 
valves that are classified as ASME BPV Code Class 2 and 3 must be 
designed and provided with access to enable the performance of inservice 
testing of the pumps and valves for assessing operational readiness set 
forth in editions and addenda of the ASME OM Code (or the optional ASME 
OM Code Cases listed in NRC Regulatory Guide 1.192, as incorporated by 
reference in paragraph (a)(3)(iii) of this section), incorporated by 
reference in paragraph (a)(1)(iv) of this section at the time the 
construction permit, combined license, or design certification is 
issued.
    (v) IST design and accessibility requirements: Meeting later IST 
requirements. All pumps and valves may meet the test requirements set 
forth in subsequent editions of codes and addenda or portions thereof 
that are incorporated by reference in paragraph (a) of this section, 
subject to the conditions listed in paragraph (b) of this section.
    (4) Inservice testing standards requirement for operating plants. 
Throughout the service life of a boiling or pressurized water-cooled 
nuclear power facility, pumps and valves that are within the scope of 
the ASME OM Code must meet the inservice test requirements (except 
design and access provisions) set forth in the ASME OM Code and addenda 
that become effective subsequent to editions and addenda specified in 
paragraphs (f)(2) and (3) of this section and that are incorporated by 
reference in paragraph (a)(1)(iv) of this section, to the extent 
practical within the limitations of design, geometry, and materials of 
construction of the components. The inservice test requirements for 
pumps and valves that are within the scope of the ASME OM Code but are 
not classified as ASME BPV Code Class 1, Class 2, or Class 3 may be 
satisfied as an augmented IST program in accordance with paragraph 
(f)(6)(ii) of this section without requesting relief under paragraph 
(f)(5) of this section or alternatives under paragraph (z) of this 
section. This use of an augmented IST program may be acceptable provided 
the basis for deviations from the ASME OM Code, as incorporated by 
reference in this section, demonstrates an acceptable level of quality 
and safety, or that implementing the Code provisions would result in 
hardship or unusual difficulty without a compensating increase in the 
level of quality and safety, where documented and available for NRC 
review.
    (i) Applicable IST Code: Initial 120-month interval. Inservice tests 
to verify operational readiness of pumps and valves, whose function is 
required for safety, conducted during the initial 120-month interval 
must comply with the requirements in the latest edition and addenda of 
the ASME OM Code incorporated by reference in paragraph (a)(1)(iv) of 
this section on the date 12 months before the date of issuance of the 
operating license under this part, or 12 months before the date 
scheduled for initial loading of fuel under a combined license under 
part 52 of this chapter (or the optional ASME OM Code Cases listed in 
NRC Regulatory Guide 1.192, as incorporated by reference in paragraph 
(a)(3)(iii) of this section, subject to the conditions listed in 
paragraph (b) of this section).
    (ii) Applicable IST Code: Successive 120-month intervals. Inservice 
tests to verify operational readiness of pumps and valves, whose 
function is required for safety, conducted during successive 120-month 
intervals must comply with the requirements of the latest edition and 
addenda of the ASME OM Code incorporated by reference in paragraph 
(a)(1)(iv) of this section 12 months before the start of the 120-month 
interval (or the optional ASME Code Cases listed in NRC Regulatory Guide 
1.147 or NRC Regulatory Guide 1.192 as incorporated by reference in 
paragraphs (a)(3)(ii) and (iii) of this section, respectively), subject 
to the conditions listed in paragraph (b) of this section.
    (iii) [Reserved]
    (iv) Applicable IST Code: Use of later Code editions and addenda. 
Inservice tests of pumps and valves may meet the requirements set forth 
in subsequent editions and addenda that are incorporated by reference in 
paragraph (a)(1)(iv) of this section, subject to the

[[Page 946]]

conditions listed in paragraph (b) of this section, and subject to NRC 
approval. Portions of editions or addenda may be used, provided that all 
related requirements of the respective editions or addenda are met.
    (5) Requirements for updating IST programs--(i) IST program update: 
Applicable IST Code editions and addenda. The inservice test program for 
a boiling or pressurized water-cooled nuclear power facility must be 
revised by the licensee, as necessary, to meet the requirements of 
paragraph (f)(4) of this section.
    (ii) IST program update: Conflicting IST Code requirements with 
technical specifications. If a revised inservice test program for a 
facility conflicts with the technical specifications for the facility, 
the licensee must apply to the Commission for amendment of the technical 
specifications to conform the technical specifications to the revised 
program. The licensee must submit this application, as specified in 
Sec.50.4, at least 6 months before the start of the period during 
which the provisions become applicable, as determined by paragraph 
(f)(4) of this section.
    (iii) IST program update: Notification of impractical IST Code 
requirements. If the licensee has determined that conformance with 
certain Code requirements is impractical for its facility, the licensee 
must notify the Commission and submit, as specified in Sec.50.4, 
information to support the determination.
    (iv) IST program update: Schedule for completing impracticality 
determinations. Where a pump or valve test requirement by the Code or 
addenda is determined to be impractical by the licensee and is not 
included in the revised inservice test program (as permitted by 
paragraph (f)(4) of this section), the basis for this determination must 
be submitted for NRC review and approval not later than 12 months after 
the expiration of the initial 120-month interval of operation from the 
start of facility commercial operation and each subsequent 120-month 
interval of operation during which the test is determined to be 
impractical.
    (6) Actions by the Commission for evaluating impractical and 
augmented IST Code requirements--(i) Impractical IST requirements: 
Granting of relief. The Commission will evaluate determinations under 
paragraph (f)(5) of this section that code requirements are impractical. 
The Commission may grant relief and may impose such alternative 
requirements as it determines are authorized by law, will not endanger 
life or property or the common defense and security, and are otherwise 
in the public interest, giving due consideration to the burden upon the 
licensee that could result if the requirements were imposed on the 
facility.
    (ii) Augmented IST requirements. The Commission may require the 
licensee to follow an augmented inservice test program for pumps and 
valves for which the Commission deems that added assurance of 
operational readiness is necessary.
    (g) Preservice and inservice inspection requirements. Systems and 
components of boiling and pressurized water-cooled nuclear power 
reactors must meet the requirements of the ASME BPV Code as specified in 
this paragraph. Each operating license for a boiling or pressurized 
water-cooled nuclear facility is subject to the following conditions. 
Each combined license for a boiling or pressurized water-cooled nuclear 
facility is subject to the following conditions, but the conditions in 
paragraphs (g)(4) through (6) of this section must be met only after the 
Commission makes the finding under Sec.52.103(g) of this chapter. 
Requirements for inservice testing of Class 1, Class 2, and Class 3 
pumps and valves are located in paragraph (f) of this section.
    (1) Inservice inspection requirements for older plants (pre-1971 
CPs). For a boiling or pressurized water-cooled nuclear power facility 
whose construction permit was issued before January 1, 1971, components 
(including supports) must meet the requirements of paragraphs (g)(4) and 
(g)(5) of this section to the extent practical. Components that are part 
of the reactor coolant pressure boundary and their supports must meet 
the requirements applicable to components that are classified as ASME 
Code Class 1. Other safety-related pressure vessels, piping, pumps and 
valves, and their supports must meet the requirements applicable to 
components that

[[Page 947]]

are classified as ASME Code Class 2 or Class 3.
    (2) Accessibility requirements--(i) Accessibility requirements for 
plants with CPs issued between 1971 and 1974. For a boiling or 
pressurized water-cooled nuclear power facility whose construction 
permit was issued on or after January 1, 1971, but before July 1, 1974, 
components that are classified as ASME BPV Code Class 1 and Class 2 and 
supports for components that are classified as ASME BPV Code Class 1 and 
Class 2 must be designed and be provided with the access necessary to 
perform the required preservice and inservice examinations set forth in 
editions and addenda of Section III or Section XI of the ASME BPV Code 
incorporated by reference in paragraph (a)(1) of this section (or the 
optional ASME BPV Code Cases listed in NRC Regulatory Guide 1.147, as 
incorporated by reference in paragraph (a)(3)(ii) of this section) in 
effect 6 months before the date of issuance of the construction permit.
    (ii) Accessibility requirements for plants with CPs issued after 
1974. For a boiling or pressurized water-cooled nuclear power facility, 
whose construction permit under this part, or design certification, 
design approval, combined license, or manufacturing license under part 
52 of this chapter, was issued on or after July 1, 1974, components that 
are classified as ASME BPV Code Class 1, Class 2, and Class 3 and 
supports for components that are classified as ASME BPV Code Class 1, 
Class 2, and Class 3 must be designed and provided with the access 
necessary to perform the required preservice and inservice examinations 
set forth in editions and addenda of Section III or Section XI of the 
ASME BPV Code incorporated by reference in paragraph (a)(1) of this 
section (or the optional ASME BPV Code Cases listed in NRC Regulatory 
Guide 1.147, as incorporated by reference in paragraph (a)(3)(ii) of 
this section) applied to the construction of the particular component.
    (iii) Accessibility requirements: Meeting later Code requirements. 
All components (including supports) may meet the requirements set forth 
in subsequent editions of codes and addenda or portions thereof that are 
incorporated by reference in paragraph (a) of this section, subject to 
the conditions listed therein.
    (3) Preservice examination requirements--(i) Preservice examination 
requirements for plants with CPs issued between 1971 and 1974. For a 
boiling or pressurized water-cooled nuclear power facility whose 
construction permit was issued on or after January 1, 1971, but before 
July 1, 1974, components that are classified as ASME BPV Code Class 1 
and Class 2 and supports for components that are classified as ASME BPV 
Code Class 1 and Class 2 must meet the preservice examination 
requirements set forth in editions and addenda of Section III or Section 
XI of the ASME BPV Code incorporated by reference in paragraph (a)(1) of 
this section (or the optional ASME BPV Code Cases listed in NRC 
Regulatory Guide 1.147, as incorporated by reference in paragraph 
(a)(3)(ii) of this section) in effect 6 months before the date of 
issuance of the construction permit.
    (ii) Preservice examination requirements for plants with CPs issued 
after 1974. For a boiling or pressurized water-cooled nuclear power 
facility, whose construction permit under this part, or design 
certification, design approval, combined license, or manufacturing 
license under part 52 of this chapter, was issued on or after July 1, 
1974, components that are classified as ASME BPV Code Class 1, Class 2, 
and Class 3 and supports for components that are classified as ASME BPV 
Code Class 1, Class 2, and Class 3 must meet the preservice examination 
requirements set forth in the editions and addenda of Section III or 
Section XI of the ASME BPV Code incorporated by reference in paragraph 
(a)(1) of this section (or the optional ASME BPV Code Cases listed in 
NRC Regulatory Guide 1.147, as incorporated by reference in paragraph 
(a)(3)(ii) of this section) applied to the construction of the 
particular component.
    (iii)-(iv) [Reserved]
    (v) Preservice examination requirements: Meeting later Code 
requirements. All components (including supports) may meet the 
requirements set forth in subsequent editions of codes and addenda or 
portions thereof that are incorporated by reference in paragraph (a) of 
this section, subject to the conditions listed therein.

[[Page 948]]

    (4) Inservice inspection standards requirement for operating plants. 
Throughout the service life of a boiling or pressurized water-cooled 
nuclear power facility, components (including supports) that are 
classified as ASME Code Class 1, Class 2, and Class 3 must meet the 
requirements, except design and access provisions and preservice 
examination requirements, set forth in Section XI of editions and 
addenda of the ASME BPV Code (or ASME OM Code for snubber examination 
and testing) that become effective subsequent to editions specified in 
paragraphs (g)(2) and (3) of this section and that are incorporated by 
reference in paragraph (a)(1)(ii) or (iv) for snubber examination and 
testing of this section, to the extent practical within the limitations 
of design, geometry, and materials of construction of the components. 
Components that are classified as Class MC pressure retaining components 
and their integral attachments, and components that are classified as 
Class CC pressure retaining components and their integral attachments, 
must meet the requirements, except design and access provisions and 
preservice examination requirements, set forth in Section XI of the ASME 
BPV Code and addenda that are incorporated by reference in paragraph 
(a)(1)(ii) of this section, subject to the condition listed in paragraph 
(b)(2)(vi) of this section and the conditions listed in paragraphs 
(b)(2)(viii) and (ix) of this section, to the extent practical within 
the limitation of design, geometry, and materials of construction of the 
components.
    (i) Applicable ISI Code: Initial 120-month interval. Inservice 
examination of components and system pressure tests conducted during the 
initial 120-month inspection interval must comply with the requirements 
in the latest edition and addenda of the ASME Code incorporated by 
reference in paragraph (a) of this section on the date 12 months before 
the date of issuance of the operating license under this part, or 12 
months before the date scheduled for initial loading of fuel under a 
combined license under part 52 of this chapter (or the optional ASME 
Code Cases listed in NRC Regulatory Guide 1.147, when using ASME BPV 
Code, Section XI, or NRC Regulatory Guide 1.192, when using the ASME OM 
Code, as incorporated by reference in paragraphs (a)(3)(ii) and (iii) of 
this section, respectively), subject to the conditions listed in 
paragraph (b) of this section. Licensees may, at any time in their 120-
month ISI interval, elect to use the Appendix VIII in the latest edition 
and addenda of the ASME BPV Code incorporated by reference in paragraph 
(a) of this section, subject to any applicable conditions listed in 
paragraph (b) of this section. Licensees using this option must also use 
the same edition and addenda of Appendix I as Appendix VIII, including 
any applicable conditions listed in paragraph (b) of this section.
    (ii) Applicable ISI Code: Successive 120-month intervals. Inservice 
examination of components and system pressure tests conducted during 
successive 120-month inspection intervals must comply with the 
requirements of the latest edition and addenda of the ASME Code 
incorporated by reference in paragraph (a) of this section 12 months 
before the start of the 120-month inspection interval (or the optional 
ASME Code Cases listed in NRC Regulatory Guide 1.147, when using ASME 
BPV Code, Section XI, or NRC Regulatory Guide 1.192, when using the ASME 
OM Code, as incorporated by reference in paragraphs (a)(3)(ii) and (iii) 
of this section), subject to the conditions listed in paragraph (b) of 
this section. However, a licensee whose inservice inspection interval 
commences during the 12 through 18-month period after August 17, 2017, 
may delay the update of their Appendix VIII program by up to 18 months 
after August 17, 2017. Alternatively, licensees may, at any time in 
their 120-month ISI interval, elect to use the Appendix VIII in the 
latest edition and addenda of the ASME BPV Code incorporated by 
reference in paragraph (a) of this section, subject to any applicable 
conditions listed in paragraph (b) of this section. Licensees using this 
option must also use the same Edition and Addenda of Appendix I as 
Appendix VIII, including any applicable conditions listed in paragraph 
(b) of this section.
    (iii) Applicable ISI Code: Optional surface examination requirement. 
When applying editions and addenda prior to

[[Page 949]]

the 2003 Addenda of Section XI of the ASME BPV Code, licensees may, but 
are not required to, perform the surface examinations of high-pressure 
safety injection systems specified in Table IWB-2500-1, Examination 
Category B-J, Item Numbers B9.20, B9.21, and B9.22.
    (iv) Applicable ISI Code: Use of subsequent Code editions and 
addenda. Inservice examination of components and system pressure tests 
may meet the requirements set forth in subsequent editions and addenda 
that are incorporated by reference in paragraph (a) of this section, 
subject to the conditions listed in paragraph (b) of this section, and 
subject to Commission approval. Portions of editions or addenda may be 
used, provided that all related requirements of the respective editions 
or addenda are met.
    (v) Applicable ISI Code: Metal and concrete containments. For a 
boiling or pressurized water-cooled nuclear power facility whose 
construction permit under this part or combined license under part 52 of 
this chapter was issued after January 1, 1956, the following are 
required:
    (A) Metal and concrete containments: First provision. Metal 
containment pressure retaining components and their integral attachments 
must meet the inservice inspection, repair, and replacement requirements 
applicable to components that are classified as ASME Code Class MC;
    (B) Metal and concrete containments: Second provision. Metallic 
shell and penetration liners that are pressure retaining components and 
their integral attachments in concrete containments must meet the 
inservice inspection, repair, and replacement requirements applicable to 
components that are classified as ASME Code Class MC; and
    (C) Metal and concrete containments: Third provision. Concrete 
containment pressure retaining components and their integral 
attachments, and the post-tensioning systems of concrete containments, 
must meet the inservice inspections, repair, and replacement 
requirements applicable to components that are classified as ASME Code 
Class CC.
    (5) Requirements for updating ISI programs--(i) ISI program update: 
Applicable ISI Code editions and addenda. The inservice inspection 
program for a boiling or pressurized water-cooled nuclear power facility 
must be revised by the licensee, as necessary, to meet the requirements 
of paragraph (g)(4) of this section.
    (ii) ISI program update: Conflicting ISI Code requirements with 
technical specifications. If a revised inservice inspection program for 
a facility conflicts with the technical specifications for the facility, 
the licensee must apply to the Commission for amendment of the technical 
specifications to conform the technical specifications to the revised 
program. The licensee must submit this application, as specified in 
Sec.50.4, at least six months before the start of the period during 
which the provisions become applicable, as determined by paragraph 
(g)(4) of this section.
    (iii) ISI program update: Notification of impractical ISI Code 
requirements. If the licensee has determined that conformance with a 
Code requirement is impractical for its facility the licensee must 
notify the NRC and submit, as specified in Sec.50.4, information to 
support the determinations. Determinations of impracticality in 
accordance with this section must be based on the demonstrated 
limitations experienced when attempting to comply with the Code 
requirements during the inservice inspection interval for which the 
request is being submitted. Requests for relief made in accordance with 
this section must be submitted to the NRC no later than 12 months after 
the expiration of the initial or subsequent 120-month inspection 
interval for which relief is sought.
    (iv) ISI program update: Schedule for completing impracticality 
determinations. Where the licensee determines that an examination 
required by Code edition or addenda is impractical, the basis for this 
determination must be submitted for NRC review and approval not later 
than 12 months after the expiration of the initial or subsequent 120-
month inspection interval for which relief is sought.
    (6) Actions by the Commission for evaluating impractical and 
augmented ISI Code requirements--(i) Impractical ISI requirements: 
Granting of relief. The Commission will evaluate determinations

[[Page 950]]

under paragraph (g)(5) of this section that code requirements are 
impractical. The Commission may grant such relief and may impose such 
alternative requirements as it determines are authorized by law, will 
not endanger life or property or the common defense and security, and 
are otherwise in the public interest giving due consideration to the 
burden upon the licensee that could result if the requirements were 
imposed on the facility.
    (ii) Augmented ISI program. The Commission may require the licensee 
to follow an augmented inservice inspection program for systems and 
components for which the Commission deems that added assurance of 
structural reliability is necessary.
    (A) [Reserved]
    (B) Augmented ISI requirements: Submitting containment ISI programs. 
Licensees do not have to submit to the NRC for approval of their 
containment inservice inspection programs that were developed to satisfy 
the requirements of Subsection IWE and Subsection IWL with specified 
conditions. The program elements and the required documentation must be 
maintained on site for audit.
    (C) Augmented ISI requirements: Implementation of Appendix VIII to 
Section XI. (1) Appendix VIII and the supplements to Appendix VIII to 
Section XI, Division 1, 1995 Edition with the 1996 Addenda of the ASME 
BPV Code must be implemented in accordance with the following schedule: 
Appendix VIII and Supplements 1, 2, 3, and 8--May 22, 2000; Supplements 
4 and 6--November 22, 2000; Supplement 11--November 22, 2001; and 
Supplements 5, 7, and 10--November 22, 2002.
    (2) Licensees implementing the 1989 Edition and earlier editions and 
addenda of IWA-2232 of Section XI, Division 1, of the ASME BPV Code must 
implement the 1995 Edition with the 1996 Addenda of Appendix VIII and 
the supplements to Appendix VIII of Section XI, Division 1, of the ASME 
BPV Code.
    (D) Augmented ISI requirements: Reactor vessel head inspections--(1) 
Implementation. Holders of operating licenses or combined licenses for 
pressurized-water reactors as of or after August 17, 2017 shall 
implement the requirements of ASME BPV Code Case N-729-4 instead of ASME 
BPV Code Case N-729-1, subject to the conditions specified in paragraphs 
(g)(6)(ii)(D)(2) through (4) of this section, by the first refueling 
outage starting after August 17, 2017.
    (2) Appendix I use. Appendix I of ASME BPV Code Case N-729-4 shall 
not be implemented without prior NRC approval.
    (3) Bare metal visual frequency. Instead of Note 4 of ASME BPV Code 
Case N-729-4, the following shall be implemented. If effective 
degradation years (EDY) < 8 and if no flaws are found that are 
attributed to primary water stress corrosion cracking:
    (i) A bare metal visual examination is not required during refueling 
outages when a volumetric or surface examination is performed; and
    (ii) If a wetted surface examination has been performed of all of 
the partial penetration welds during the previous non-visual 
examination, the reexamination frequency may be extended to every third 
refueling outage or 5 calendar years, whichever is less, provided an 
IWA-2212 VT-2 visual examination of the head is performed under the 
insulation through multiple access points in outages that the VE is not 
completed. This IWA-2212 VT-2 visual examination may be performed with 
the reactor vessel depressurized.
    (4) Surface exam acceptance criteria. In addition to the 
requirements of Paragraph -3132.1(b) of ASME BPV Code Case N-729-4, a 
component whose surface examination detects rounded indications greater 
than allowed in Paragraph NB-5352 in size on the partial-penetration or 
associated fillet weld shall be classified as having an unacceptable 
indication and corrected in accordance with the provisions of paragraph-
3132.2 of ASME BPV Code Case N-729-4.
    (E) Augmented ISI requirements: Reactor coolant pressure boundary 
visual inspections \10\--(1) All licensees of pressurized water reactors 
must augment their inservice inspection program by implementing ASME 
Code Case N-722-1, subject to the conditions specified in paragraphs 
(g)(6)(ii)(E)(2) through (4) of this section. The inspection 
requirements of ASME Code Case N-722-1 do not apply to components with 
pressure

[[Page 951]]

retaining welds fabricated with Alloy 600/82/182 materials that have 
been mitigated by weld overlay or stress improvement.
    (2) If a visual examination determines that leakage is occurring 
from a specific item listed in Table 1 of ASME Code Case N-722-1 that is 
not exempted by the ASME Code, Section XI, IWB-1220(b)(1), additional 
actions must be performed to characterize the location, orientation, and 
length of a crack or cracks in Alloy 600 nozzle wrought material and 
location, orientation, and length of a crack or cracks in Alloy 82/182 
butt welds. Alternatively, licensees may replace the Alloy 600/82/182 
materials in all the components under the item number of the leaking 
component.
    (3) If the actions in paragraph (g)(6)(ii)(E)(2) of this section 
determine that a flaw is circumferentially oriented and potentially a 
result of primary water stress corrosion cracking, licensees must 
perform non-visual NDE inspections of components that fall under that 
ASME Code Case N-722-1 item number. The number of components inspected 
must equal or exceed the number of components found to be leaking under 
that item number. If circumferential cracking is identified in the 
sample, non-visual NDE must be performed in the remaining components 
under that item number.
    (4) If ultrasonic examinations of butt welds are used to meet the 
NDE requirements in paragraphs (g)(6)(ii)(E)(2) or (3) of this section, 
they must be performed using the appropriate supplement of Section XI, 
Appendix VIII, of the ASME BPV Code.
    (F) Augmented ISI requirements: Examination requirements for Class 1 
piping and nozzle dissimilar-metal butt welds--(1) Implementation. 
Holders of operating licenses or combined licenses for pressurized-water 
reactors as of or after August 17, 2017, shall implement the 
requirements of ASME BPV Code Case N-770-2 instead of ASME BPV Code Case 
N-770-1, subject to the conditions specified in paragraphs 
(g)(6)(ii)(F)(2) through (13) of this section, by the first refueling 
outage starting after August 17, 2017.
    (2) Categorization. Full structural weld overlays, authorized by the 
NRC staff in accordance with the alternatives approval process of this 
section, may be categorized as Inspection Items C-1 or F-1, as 
appropriate. Welds that have been mitigated by the Mechanical Stress 
Improvement Process (MSIP\TM\) may be categorized as Inspection Items D 
or E, as appropriate, provided the criteria in Appendix I of the code 
case have been met. For the purpose of determining ISI frequencies, all 
other butt welds that rely on Alloy 82/182 for structural integrity 
shall be categorized as Inspection Items A-1, A-2, or B until the NRC 
staff has reviewed the mitigation and authorized an alternative code 
case Inspection Item for the mitigated weld, or an alternative code case 
Inspection Item is used based on conformance with an ASME mitigation 
code case endorsed in NRC Regulatory Guide 1.147 with any applying 
conditions specified in NRC Regulatory Guide 1.147, as incorporated by 
reference in paragraph (a)(3)(ii) of this section. Paragraph -1100(e) of 
ASME BPV Code Case N-770-2 shall not be used to exempt welds that rely 
on Alloy 82/182 for structural integrity from any requirement of 
paragraph (g)(6)(ii)(F) of this section.
    (3) Baseline examinations. Baseline examinations for welds in Table 
1 of ASME BPV Code Case N-770-2, Inspection Items A-1, A-2, and B, if 
not previously performed or currently scheduled to be performed in an 
ongoing refueling outage as of August 17, 2017, in accordance with 
paragraph (g)(6)(ii)(F) of this section, shall be completed by the end 
of the next refueling outage. Previous examinations of these welds can 
be credited for baseline examinations only if they were performed within 
the re-inspection period for the weld item in Table 1 of ASME BPV Code 
Case N-770-2 and the examination of each weld meets the examination 
requirements of paragraphs -2500(a) or -2500(b) of ASME BPV Code Case N-
770-2 as conditioned in this section. Other previous examinations that 
do not meet these requirements can be used to meet the baseline 
examination requirement, provided NRC approval in accordance with 
paragraph (z)(1) or (2) of this section, is granted prior to the end of 
the next refueling outage.

[[Page 952]]

    (4) Examination coverage. When implementing Paragraph -2500(a) of 
ASME BPV Code Case N-770-2, essentially 100 percent of the required 
volumetric examination coverage shall be obtained, including greater 
than 90 percent of the volumetric examination coverage for 
circumferential flaws. Licensees are prohibited from using Paragraphs -
2500(c) and -2500(d) of ASME BPV Code Case N-770-2 to meet examination 
requirements.
    (5) Inlay/onlay inspection frequency. All hot-leg operating 
temperature welds in Inspection Items G, H, J, and K shall be inspected 
each inspection interval. A 25 percent sample of Inspection Items G, H, 
J, and K cold-leg operating temperature welds shall be inspected 
whenever the core barrel is removed (unless it has already been 
inspected within the past 10 years) or within 20 years, whichever is 
less.
    (6) Reporting requirements. For any mitigated weld whose volumetric 
examination detects growth of existing flaws in the required examination 
volume that exceed the previous IWB-3600 flaw evaluations or new flaws, 
a report summarizing the evaluation, along with inputs, methodologies, 
assumptions, and causes of the new flaw or flaw growth is to be provided 
to the NRC prior to the weld being placed in service other than modes 5 
or 6.
    (7) Defining ``t''. For Inspection Items G, H, J, and K, when 
applying the acceptance standards of ASME BPV Code, Section XI, IWB-
3514, for planar flaws contained within the inlay or onlay, the 
thickness ``t'' in IWB-3514 is the thickness of the inlay or onlay. For 
planar flaws in the balance of the dissimilar metal weld examination 
volume, the thickness ``t'' in IWB-3514 is the combined thickness of the 
inlay or onlay and the dissimilar metal weld.
    (8) Optimized weld overlay examination. Initial inservice 
examination of Inspection Item C-2 welds shall be performed between the 
third refueling outage and no later than 10 years after application of 
the overlay.
    (9) Deferral. Note (11)(b)(1) in ASME BPV Code Case N-770-2 shall 
not be used to defer the initial inservice examination of optimized weld 
overlays (i.e., Inspection Item C-2 of ASME BPV Code Case N-770-2).
    (10) Examination technique. Note 14(b) of Table 1 and Note (b) of 
Figure 5(a) of ASME BPV Code Case N-770-2 may only be implemented if the 
requirements of Note 14(a) of Table 1 of ASME BPV Code Case N-770-2 
cannot be met.
    (11) Cast stainless steel. Examination of ASME BPV Code Class 1 
piping and vessel nozzle butt welds involving cast stainless steel 
materials, shall be performed with Appendix VIII, Supplement 9 
qualifications, or qualifications similar to Appendix VIII, Supplement 2 
or 10 using cast stainless steel mockups no later than the next 
scheduled weld examination after January 1, 2022, in accordance with the 
requirements of Paragraph -2500(a).
    (12) Stress improvement inspection coverage. Under Paragraph I.5.1, 
for cast stainless steel items, the required examination volume shall be 
examined by Appendix VIII procedures to the maximum extent practical 
including 100 percent of the susceptible material volume.
    (13) Encoded ultrasonic examination. Ultrasonic examinations of non-
mitigated or cracked mitigated dissimilar metal butt welds in the 
reactor coolant pressure boundary must be performed in accordance with 
the requirements of Table 1 for Inspection Item A-1, A-2, B, E, F-2, J, 
and K for 100 percent of the required inspection volume using an encoded 
method.
    (h) Protection and safety systems. Protection systems of nuclear 
power reactors of all types must meet the requirements specified in this 
paragraph. Each combined license for a utilization facility is subject 
to the following conditions.
    (1) [Reserved]
    (2) Protection systems. For nuclear power plants with construction 
permits issued after January 1, 1971, but before May 13, 1999, 
protection systems must meet the requirements in IEEE Std 279-1968, 
``Proposed IEEE Criteria for Nuclear Power Plant Protection Systems,'' 
or the requirements in IEEE Std 279-1971, ``Criteria for Protection 
Systems for Nuclear Power Generating Stations,'' or the requirements in 
IEEE Std 603-1991, ``Criteria for Safety Systems for Nuclear Power 
Generating Stations,'' and the correction sheet dated January 30, 1995. 
For nuclear

[[Page 953]]

power plants with construction permits issued before January 1, 1971, 
protection systems must be consistent with their licensing basis or may 
meet the requirements of IEEE Std. 603-1991 and the correction sheet 
dated January 30, 1995.
    (3) Safety systems. Applications filed on or after May 13, 1999, for 
construction permits and operating licenses under this part, and for 
design approvals, design certifications, and combined licenses under 
part 52 of this chapter, must meet the requirements for safety systems 
in IEEE Std. 603-1991 and the correction sheet dated January 30, 1995.
    (i)-(y) [Reserved]
    (z) Alternatives to codes and standards requirements. Alternatives 
to the requirements of paragraphs (b) through (h) of this section or 
portions thereof may be used when authorized by the Director, Office of 
Nuclear Reactor Regulation, or Director, Office of New Reactors, as 
appropriate. A proposed alternative must be submitted and authorized 
prior to implementation. The applicant or licensee must demonstrate 
that:
    (1) Acceptable level of quality and safety. The proposed alternative 
would provide an acceptable level of quality and safety; or
    (2) Hardship without a compensating increase in quality and safety. 
Compliance with the specified requirements of this section would result 
in hardship or unusual difficulty without a compensating increase in the 
level of quality and safety. Footnotes to Sec.50.55a:

    \1\ USAS and ASME Code addenda issued prior to the winter 1977 
Addenda are considered to be ``in effect'' or ``effective'' 6 months 
after their date of issuance and after they are incorporated by 
reference in paragraph (a) of this section. Addenda to the ASME Code 
issued after the summer 1977 Addenda are considered to be ``in effect'' 
or ``effective'' after the date of publication of the addenda and after 
they are incorporated by reference in paragraph (a) of this section.
    2-3 [Reserved].
    \4\ For ASME Code editions and addenda issued prior to the winter 
1977 Addenda, the Code edition and addenda applicable to the component 
is governed by the order or contract date for the component, not the 
contract date for the nuclear energy system. For the winter 1977 Addenda 
and subsequent editions and addenda the method for determining the 
applicable Code editions and addenda is contained in Paragraph NCA 1140 
of Section III of the ASME Code.
    5-6 [Reserved].
    \7\ Guidance for quality group classifications of components that 
are to be included in the safety analysis reports pursuant to Sec.
50.34(a) and Sec.50.34(b) may be found in Regulatory Guide 1.26, 
``Quality Group Classifications and Standards for Water-, Steam-, and 
Radiological-Waste-Containing Components of Nuclear Power Plants,'' and 
in Section 3.2.2 of NUREG-0800, ``Standard Review Plan for Review of 
Safety Analysis Reports for Nuclear Power Plants.''
    8-9 [Reserved].
    \10\ For inspections to be conducted once per interval, the 
inspections must be performed in accordance with the schedule in Section 
XI, paragraph IWB-2400, except for plants with inservice inspection 
programs based on a Section XI edition or addenda prior to the 1994 
Addenda. For plants with inservice inspection programs based on a 
Section XI edition or addenda prior to the 1994 Addenda, the inspection 
must be performed in accordance with the schedule in Section XI, 
paragraph IWB-2400, of the 1994 Addenda.

[79 FR 65798, Nov. 5, 2014, as amended at 79 FR 66603, Nov. 10, 2014; 79 
FR 73462, Dec. 11, 2014; 82 FR 52825, Dec. 15, 2017; 83 FR 2354, Jan. 
17, 2018; 83 FR 2526, Jan. 18, 2018]



Sec.50.56  Conversion of construction permit to license; or amendment
of license.

    Upon completion of the construction or alteration of a facility, in 
compliance with the terms and conditions of the construction permit and 
subject to any necessary testing of the facility for health or safety 
purposes, the Commission will, in the absence of good cause shown to the 
contrary, issue a license of the class for which the construction permit 
was issued or an appropriate amendment of the license, as the case may 
be.

[21 FR 355, Jan. 19, 1956, as amended at 35 FR 11461, July 17, 1970; 75 
FR 73944, Nov. 30, 2010]



Sec.50.57  Issuance of operating license. \1\
---------------------------------------------------------------------------

    \1\ The Commission may issue a provisional operating license 
pursuant to the regulations in this part in effect on March 30, 1970, 
for any facility for which a notice of hearing on an application for a 
provisional operating license or a notice of proposed issuance of a 
provisional operating license has been published on or before that date.
---------------------------------------------------------------------------

    (a)Pursuant to Sec.50.56, an operating license may be issued by 
the Commission, up to the full term authorized by Sec.50.51, upon 
finding that:

[[Page 954]]

    (1) Construction of the facility has been substantially completed, 
in conformity with the construction permit and the application as 
amended, the provisions of the Act, and the rules and regulations of the 
Commission; and
    (2) The facility will operate in conformity with the application as 
amended, the provisions of the Act, and the rules and regulations of the 
Commission; and
    (3) There is reasonable assurance (i) that the activities authorized 
by the operating license can be conducted without endangering the health 
and safety of the public, and (ii) that such activities will be 
conducted in compliance with the regulations in this chapter; and
    (4) The applicant is technically and financially qualified to engage 
in the activities authorized by the operating license in accordance with 
the regulations in this chapter. However, no finding of financial 
qualification is necessary for an electric utility applicant for an 
operating license for a utilization facility of the type described in 
Sec.50.21(b) or Sec.50.22.
    (5) The applicable provisions of part 140 of this chapter have been 
satisfied; and
    (6) The issuance of the license will not be inimical to the common 
defense and security or to the health and safety of the public.
    (b) Each operating license will include appropriate provisions with 
respect to any uncompleted items of construction and such limitations or 
conditions as are required to assure that operation during the period of 
the completion of such items will not endanger public health and safety.
    (c) An applicant may, in a case where a hearing is held in 
connection with a pending proceeding under this section make a motion in 
writing, under this paragraph (c), for an operating license authorizing 
low-power testing (operation at not more than 1 percent of full power 
for the purpose of testing the facility), and further operations short 
of full power operation. Action on such a motion by the presiding 
officer shall be taken with due regard to the rights of the parties to 
the proceedings, including the right of any party to be heard to the 
extent that his contentions are relevant to the activity to be 
authorized. Before taking any action on such a motion that any party 
opposes, the presiding officer shall make findings on the matters 
specified in paragraph (a) of this section as to which there is a 
controversy, in the form of an initial decision with respect to the 
contested activity sought to be authorized. The Director of Nuclear 
Reactor Regulation will make findings on all other matters specified in 
paragraph (a) of this section. If no party opposes the motion, the 
presiding officer will issue an order in accordance with Sec.2.319(p) 
authorizing the Director of Nuclear Reactor Regulation to make 
appropriate findings on the matters specified in paragraph (a) of this 
section and to issue a license for the requested operation.

[35 FR 5318, Mar. 31, 1970, as amended at 35 FR 6644, Apr. 25, 1970; 37 
FR 11873, June 15, 1972; 37 FR 15142, July 28, 1972; 49 FR 35753, Sept. 
12, 1984; 51 FR 7765, Mar. 6, 1986; 69 FR 2275, Jan. 14, 2004]



Sec.50.58  Hearings and report of the Advisory Committee on Reactor
Safeguards.

    (a) Each application for a construction permit or an operating 
license for a facility which is of a type described in Sec.50.21(b) or 
Sec.50.22, or for a testing facility, shall be referred to the 
Advisory Committee on Reactor Safeguards for a review and report. An 
application for an amendment to such a construction permit or operating 
license may be referred to the Advisory Committee on Reactor Safeguards 
for review and report. Any report shall be made part of the record of 
the application and available to the public, except to the extent that 
security classification prevents disclosure.
    (b)(1) The Commission will hold a hearing after at least 30-days' 
notice and publication once in the Federal Register on each application 
for a construction permit for a production or utilization facility which 
is of a type described in Sec.50.21(b) or Sec.50.22, or for a 
testing facility.
    (2) When a construction permit has been issued for such a facility 
following the holding of a public hearing,

[[Page 955]]

and an application is made for an operating license or for an amendment 
to a construction permit or operating license, the Commission may hold a 
hearing after at least 30-days' notice and publication once in the 
Federal Register, or, in the absence of a request therefor by any person 
whose interest may be affected, may issue an operating license or an 
amendment to a construction permit or operating license without a 
hearing, upon 30-days' notice and publication once in the Federal 
Register of its intent to do so.
    (3) If the Commission finds, in an emergency situation, as defined 
in Sec.50.91, that no significant hazards consideration is presented 
by an application for an amendment to an operating license, it may 
dispense with public notice and comment and may issue the amendment. If 
the Commission finds that exigent circumstances exist, as described in 
Sec.50.91, it may reduce the period provided for public notice and 
comment.
    (4) Both in an emergency situation and in the case of exigent 
circumstances, the Commission will provide 30 days notice of opportunity 
for a hearing, though this notice may be published after issuance of the 
amendment if the Commission determines that no significant hazards 
consideration is involved.
    (5) The Commission will use the standards in Sec.50.92 to 
determine whether a significant hazards consideration is presented by an 
amendment to an operating license for a facility of the type described 
in Sec.50.21(b) or Sec.50.22, or which is a testing facility, and 
may make the amendment immediately effective, notwithstanding the 
pendency before it of a request for a hearing from any person, in 
advance of the holding and completion of any required hearing, where it 
has determined that no significant hazards consideration is involved.
    (6) No petition or other request for review of or hearing on the 
staff's significant hazards consideration determination will be 
entertained by the Commission. The staff's determination is final, 
subject only to the Commission's discretion, on its own initiative, to 
review the determination.

[27 FR 12186, Dec. 8, 1962, as amended at 35 FR 11461, July 17, 1970; 39 
FR 10555, Mar. 21, 1974; 51 FR 7765, Mar. 6, 1986]



Sec.50.59  Changes, tests, and experiments.

    (a) Definitions for the purposes of this section:
    (1) Change means a modification or addition to, or removal from, the 
facility or procedures that affects a design function, method of 
performing or controlling the function, or an evaluation that 
demonstrates that intended functions will be accomplished.
    (2) Departure from a method of evaluation described in the FSAR (as 
updated) used in establishing the design bases or in the safety analyses 
means:
    (i) Changing any of the elements of the method described in the FSAR 
(as updated) unless the results of the analysis are conservative or 
essentially the same; or
    (ii) Changing from a method described in the FSAR to another method 
unless that method has been approved by NRC for the intended 
application.
    (3) Facility as described in the final safety analysis report (as 
updated) means:
    (i) The structures, systems, and components (SSC) that are described 
in the final safety analysis report (FSAR) (as updated),
    (ii) The design and performance requirements for such SSCs described 
in the FSAR (as updated), and
    (iii) The evaluations or methods of evaluation included in the FSAR 
(as updated) for such SSCs which demonstrate that their intended 
function(s) will be accomplished.
    (4) Final Safety Analysis Report (as updated) means the Final Safety 
Analysis Report (or Final Hazards Summary Report) submitted in 
accordance with Sec.50.34, as amended and supplemented, and as updated 
per the requirements of Sec.50.71(e) or Sec.50.71(f), as applicable.
    (5) Procedures as described in the final safety analysis report (as 
updated) means those procedures that contain information described in 
the FSAR (as updated) such as how structures, systems,

[[Page 956]]

and components are operated and controlled (including assumed operator 
actions and response times).
    (6) Tests or experiments not described in the final safety analysis 
report (as updated) means any activity where any structure, system, or 
component is utilized or controlled in a manner which is either:
    (i) Outside the reference bounds of the design bases as described in 
the final safety analysis report (as updated) or
    (ii) Inconsistent with the analyses or descriptions in the final 
safety analysis report (as updated).
    (b) This section applies to each holder of an operating license 
issued under this part or a combined license issued under part 52 of 
this chapter, including the holder of a license authorizing operation of 
a nuclear power reactor that has submitted the certification of 
permanent cessation of operations required under Sec.50.82(a)(1) or 
Sec.50.110 or a reactor licensee whose license has been amended to 
allow possession of nuclear fuel but not operation of the facility.
    (c)(1) A licensee may make changes in the facility as described in 
the final safety analysis report (as updated), make changes in the 
procedures as described in the final safety analysis report (as 
updated), and conduct tests or experiments not described in the final 
safety analysis report (as updated) without obtaining a license 
amendment pursuant to Sec.50.90 only if:
    (i) A change to the technical specifications incorporated in the 
license is not required, and
    (ii) The change, test, or experiment does not meet any of the 
criteria in paragraph (c)(2) of this section.
    (2) A licensee shall obtain a license amendment pursuant to Sec.
50.90 prior to implementing a proposed change, test, or experiment if 
the change, test, or experiment would:
    (i) Result in more than a minimal increase in the frequency of 
occurrence of an accident previously evaluated in the final safety 
analysis report (as updated);
    (ii) Result in more than a minimal increase in the likelihood of 
occurrence of a malfunction of a structure, system, or component (SSC) 
important to safety previously evaluated in the final safety analysis 
report (as updated);
    (iii) Result in more than a minimal increase in the consequences of 
an accident previously evaluated in the final safety analysis report (as 
updated);
    (iv) Result in more than a minimal increase in the consequences of a 
malfunction of an SSC important to safety previously evaluated in the 
final safety analysis report (as updated);
    (v) Create a possibility for an accident of a different type than 
any previously evaluated in the final safety analysis report (as 
updated);
    (vi) Create a possibility for a malfunction of an SSC important to 
safety with a different result than any previously evaluated in the 
final safety analysis report (as updated);
    (vii) Result in a design basis limit for a fission product barrier 
as described in the FSAR (as updated) being exceeded or altered; or
    (viii) Result in a departure from a method of evaluation described 
in the FSAR (as updated) used in establishing the design bases or in the 
safety analyses.
    (3) In implementing this paragraph, the FSAR (as updated) is 
considered to include FSAR changes resulting from evaluations performed 
pursuant to this section and analyses performed pursuant to Sec.50.90 
since submittal of the last update of the final safety analysis report 
pursuant to Sec.50.71 of this part.
    (4) The provisions in this section do not apply to changes to the 
facility or procedures when the applicable regulations establish more 
specific criteria for accomplishing such changes.
    (d)(1) The licensee shall maintain records of changes in the 
facility, of changes in procedures, and of tests and experiments made 
pursuant to paragraph (c) of this section. These records must include a 
written evaluation which provides the bases for the determination that 
the change, test, or experiment does not require a license amendment 
pursuant to paragraph (c)(2) of this section.
    (2) The licensee shall submit, as specified in Sec.50.4 or Sec.
52.3 of this chapter, as applicable, a report containing a brief 
description of any changes, tests, and experiments, including a summary 
of the evaluation of each. A report must

[[Page 957]]

be submitted at intervals not to exceed 24 months. For combined 
licenses, the report must be submitted at intervals not to exceed 6 
months during the period from the date of application for a combined 
license to the date the Commission makes its findings under 10 CFR 
52.103(g).
    (3) The records of changes in the facility must be maintained until 
the termination of an operating license issued under this part, a 
combined license issued under part 52 of this chapter, or the 
termination of a license issued under 10 CFR part 54, whichever is 
later. Records of changes in procedures and records of tests and 
experiments must be maintained for a period of 5 years.

[64 FR 53613, Oct. 4, 1999, as amended at 66 FR 64738, Dec. 14, 2001; 72 
FR 49500, Aug. 28, 2007]



Sec.50.60  Acceptance criteria for fracture prevention measures for
lightwater nuclear power reactors for normal operation.

    (a) Except as provided in paragraph (b) of this section, all light-
water nuclear power reactors, other than reactor facilities for which 
the certifications required under Sec.50.82(a)(1) have been submitted, 
must meet the fracture toughness and material surveillance program 
requirements for the reactor coolant pressure boundary set forth in 
appendices G and H to this part.
    (b) Proposed alternatives to the described requirements in 
Appendices G and H of this part or portions thereof may be used when an 
exemption is granted by the Commission under Sec.50.12.

[48 FR 24009, May 27, 1983, as amended at 50 FR 50777, Dec. 12, 1985; 61 
FR 39300, July 29, 1996]



Sec.50.61  Fracture toughness requirements for protection against 
pressurized thermal shock events.

    (a) Definitions. For the purposes of this section:
    (1) ASME Code means the American Society of Mechanical Engineers 
Boiler and Pressure Vessel Code, Section III, Division I, ``Rules for 
the Construction of Nuclear Power Plant Components,'' edition and 
addenda and any limitations and modifications thereof as specified in 
Sec.50.55a.
    (2) Pressurized Thermal Shock Event means an event or transient in 
pressurized water reactors (PWRs) causing severe overcooling (thermal 
shock) concurrent with or followed by significant pressure in the 
reactor vessel.
    (3) Reactor Vessel Beltline means the region of the reactor vessel 
(shell material including welds, heat affected zones and plates or 
forgings) that directly surrounds the effective height of the active 
core and adjacent regions of the reactor vessel that are predicted to 
experience sufficient neutron radiation damage to be considered in the 
selection of the most limiting material with regard to radiation damage.
    (4) RTNDT means the reference temperature for a reactor vessel 
material, under any conditions. For the reactor vessel beltline 
materials, RTNDT must account for the effects of neutron 
radiation.
    (5) RTNDT(U) means the reference temperature for a reactor vessel 
material in the pre-service or unirradiated condition, evaluated 
according to the procedures in the ASME Code, Paragraph NB-2331 or other 
methods approved by the Director, Office of Nuclear Reactor Regulation 
or Director, Office of New Reactors, as appropriate.
    (6) EOL Fluence means the best-estimate neutron fluence projected 
for a specific vessel beltline material at the clad-base-metal interface 
on the inside surface of the vessel at the location where the material 
receives the highest fluence on the expiration date of the operating 
license.
    (7) RTPTS means the reference temperature, RTNDT, 
evaluated for the EOL Fluence for each of the vessel beltline materials, 
using the procedures of paragraph (c) of this section.
    (8) PTS Screening Criterion means the value of RTPTS for 
the vessel beltline material above which the plant cannot continue to 
operate without justification.
    (b) Requirements. (1) For each pressurized water nuclear power 
reactor for which an operating license has been issued under this part 
or a combined license issued under Part 52 of this chapter, other than a 
nuclear power reactor

[[Page 958]]

facility for which the certification required under Sec.50.82(a)(1) 
has been submitted, the licensee shall have projected values of 
RTPTS or RTMAX-X, accepted by the NRC, for each 
reactor vessel beltline material. For pressurized water nuclear power 
reactors for which a construction permit was issued under this part 
before February 3, 2010 and whose reactor vessel was designed and 
fabricated to the 1998 Edition or earlier of the ASME Code, the 
projected values must be in accordance with this section or Sec.
50.61a. For pressurized water nuclear power reactors for which a 
construction permit is issued under this part after February 3, 2010 and 
whose reactor vessel is designed and fabricated to an ASME Code after 
the 1998 Edition, or for which a combined license is issued under Part 
52, the projected values must be in accordance with this section. When 
determining compliance with this section, the assessment of 
RTPTS must use the calculation procedures described in 
paragraph (c)(1) and perform the evaluations described in paragraphs 
(c)(2) and (c)(3) of this section. The assessment must specify the bases 
for the projected value of RTPTS for each vessel beltline 
material, including the assumptions regarding core loading patterns, and 
must specify the copper and nickel contents and the fluence value used 
in the calculation for each beltline material. This assessment must be 
updated whenever there is a significant \2\ change in projected values 
of RTPTS, or upon request for a change in the expiration date 
for operation of the facility.
---------------------------------------------------------------------------

    \2\ Changes to RTPTS values are considered significant if 
either the previous value or the current value, or both values, exceed 
the screening criterion before the expiration of the operating license 
or the combined license under Part 52 of this chapter, including any 
renewed term, if applicable for the plant.
---------------------------------------------------------------------------

    (2) The pressurized thermal shock (PTS) screening criterion is 270 
[deg]F for plates, forgings, and axial weld materials, and 300 [deg]F 
for circumferential weld materials. For the purpose of comparison with 
this criterion, the value of RTPTS for the reactor vessel 
must be evaluated according to the procedures of paragraph (c) of this 
section, for each weld and plate, or forging, in the reactor vessel 
beltline. RTPTS must be determined for each vessel beltline 
material using the EOL fluence for that material.
    (3) For each pressurized water nuclear power reactor for which the 
value of RTPTS for any material in the beltline is projected 
to exceed the PTS screening criterion using the EOL fluence, the 
licensee shall implement those flux reduction programs that are 
reasonably practicable to avoid exceeding the PTS screening criterion 
set forth in paragraph (b)(2) of this section. The schedule for 
implementation of flux reduction measures may take into account the 
schedule for submittal and anticipated approval by the Director, Office 
of Nuclear Reactor Regulation, of detailed plant-specific analyses, 
submitted to demonstrate acceptable risk with RTPTS above the 
screening limit due to plant modifications, new information or new 
analysis techniques.
    (4) For each pressurized water nuclear power reactor for which the 
analysis required by paragraph (b)(3) of this section indicates that no 
reasonably practicable flux reduction program will prevent 
RTPTS from exceeding the PTS screening criterion using the 
EOL fluence, the licensee shall submit a safety analysis to determine 
what, if any, modifications to equipment, systems, and operation are 
necessary to prevent potential failure of the reactor vessel as a result 
of postulated PTS events if continued operation beyond the screening 
criterion is allowed. In the analysis, the licensee may determine the 
properties of the reactor vessel materials based on available 
information, research results, and plant surveillance data, and may use 
probabilistic fracture mechanics techniques. This analysis must be 
submitted at least three years before RTPTS is projected to 
exceed the PTS screening criterion.
    (5) After consideration of the licensee's analyses, including 
effects of proposed corrective actions, if any, submitted in accordance 
with paragraphs (b)(3) and (b)(4) of this section, the Director, Office 
of Nuclear Reactor Regulation, may, on a case-by-case basis, approve 
operation of the facility with RTPTS in excess of the PTS 
screening

[[Page 959]]

criterion. The Director, Office of Nuclear Reactor Regulation, will 
consider factors significantly affecting the potential for failure of 
the reactor vessel in reaching a decision.
    (6) If the Director, Office of Nuclear Reactor Regulation, 
concludes, pursuant to paragraph (b)(5) of this section, that operation 
of the facility with RTPTS in excess of the PTS screening 
criterion cannot be approved on the basis of the licensee's analyses 
submitted in accordance with paragraphs (b)(3) and (b)(4) of this 
section, the licensee shall request and receive approval by the 
Director, Office of Nuclear Reactor Regulation, prior to any operation 
beyond the criterion. The request must be based upon modifications to 
equipment, systems, and operation of the facility in addition to those 
previously proposed in the submitted analyses that would reduce the 
potential for failure of the reactor vessel due to PTS events, or upon 
further analyses based upon new information or improved methodology.
    (7) If the limiting RTPTS value of the plant is projected 
to exceed the screening criteria in paragraph (b)(2), or the criteria in 
paragraphs (b)(3) through (b)(6) of this section cannot be satisfied, 
the reactor vessel beltline may be given a thermal annealing treatment 
to recover the fracture toughness of the material, subject to the 
requirements of Sec.50.66. The reactor vessel may continue to be 
operated only for that service period within which the predicted 
fracture toughness of the vessel beltline materials satisfy the 
requirements of paragraphs (b)(2) through (b)(6) of this section, with 
RTPTS accounting for the effects of annealing and subsequent 
irradiation.
    (c) Calculation of RTPTS. RTPTS must be calculated for 
each vessel beltline material using a fluence value, f, which is the EOL 
fluence for the material. RTPTS must be evaluated using the 
same procedures used to calculate RTNDT, as indicated in 
paragraph (c)(1) of this section, and as provided in paragraphs (c)(2) 
and (c)(3) of this section.
    (1) Equation 1 must be used to calculate values of RTNDT 
for each weld and plate, or forging, in the reactor vessel beltline.

Equation 1: RTNDT = RTNDT(U) + M + 
[Delta]RTNDT

    (i) If a measured value of RTNDT(U) is not available, a 
generic mean value for the class \3\ of material may be used if there 
are sufficient test results to establish a mean and a standard deviation 
for the class.
---------------------------------------------------------------------------

    \3\ The class of material for estimating RTNDT(U) is 
generally determined for welds by the type of welding flux (Linde 80, or 
other), and for base metal by the material specification.
---------------------------------------------------------------------------

    (ii) For generic values of weld metal, the following generic mean 
values must be used unless justification for different values is 
provided: 0 [deg]F for welds made with Linde 80 flux, and -56 [deg]F for 
welds made with Linde 0091, 1092 and 124 and ARCOS B-5 weld fluxes.
    (iii) M means the margin to be added to account for uncertainties in 
the values of RTNDT(U), copper and nickel contents, fluence 
and the calculational procedures. M is evaluated from Equation 2.
[GRAPHIC] [TIFF OMITTED] TR19DE95.003

    (A) In Equation 2, [sigma]U is the standard deviation for 
RTNDT(U). If a measured value of RTNDT(U) is used, 
then [sigma]U is determined from the precision of the test 
method. If a measured value of RTNDT(U) is not available and 
a generic mean value for that class of materials is used, then 
[sigma]U is the standard deviation obtained from the set of 
data used to establish the mean. If a generic mean value given in 
paragraph (c)(1)(i)(B) of this section for welds is used, then 
[sigma]U is 17 [deg]F.
    (B) In Equation 2, [sigma][Delta] is the standard deviation for 
[Delta]RTNDT. The value of [sigma][Delta] to be used is 28 
[deg]F for welds and 17 [deg]F for base metal; the value of 
[sigma][Delta] need not exceed one-half of [Delta]RTNDT.
    (iv) [Delta]RTNDT is the mean value of the transition 
temperature shift, or change in RTNDT, due to irradiation, 
and must be calculated using Equation 3.

Equation 3: [Delta]RTNDT = (CF)f(0.28-0.10 log f)

    (A) CF ([deg]F) is the chemistry factor, which is a function of 
copper and nickel content. CF is given in table 1 for welds and in table 
2 for base metal

[[Page 960]]

(plates and forgings). Linear interpolation is permitted. In tables 1 
and 2, ``Wt - % copper'' and ``Wt - % nickel'' are the best-estimate 
values for the material, which will normally be the mean of the measured 
values for a plate or forging. For a weld, the best estimate values will 
normally be the mean of the measured values for a weld deposit made 
using the same weld wire heat number as the critical vessel weld. If 
these values are not available, the upper limiting values given in the 
material specifications to which the vessel material was fabricated may 
be used. If not available, conservative estimates (mean plus one 
standard deviation) based on generic data \4\ may be used if 
justification is provided. If none of these alternatives are available, 
0.35% copper and 1.0% nickel must be assumed.
---------------------------------------------------------------------------

    \4\ Data from reactor vessels fabricated to the same material 
specification in the same shop as the vessel in question and in the same 
time period is an example of ``generic data.''
---------------------------------------------------------------------------

    (B) f is the best estimate neutron fluence, in units of 10\19\ n/
cm\2\ (E greater than 1 MeV), at the clad-base-metal interface on the 
inside surface of the vessel at the location where the material in 
question receives the highest fluence for the period of service in 
question. As specified in this paragraph, the EOL fluence for the vessel 
beltline material is used in calculating KRTPTS.
    (v) Equation 4 must be used for determining RTPTS using 
equation 3 with EOL fluence values for determining 
[Delta]RTPTS.

Equation 4: RTPTS = RTNDT(U) + M + 
[Delta]RTPTS

    (2) To verify that RTNDT for each vessel beltline 
material is a bounding value for the specific reactor vessel, licensees 
shall consider plant-specific information that could affect the level of 
embrittlement. This information includes but is not limited to the 
reactor vessel operating temperature and any related surveillance 
program \5\ results.
---------------------------------------------------------------------------

    \5\ Surveillance program results means any data that demonstrates 
the embrittlement trends for the limiting beltline material, including 
but not limited to data from test reactors or from surveillance programs 
at other plants with or without surveillance program integrated per 10 
CFR part 50, appendix H.
---------------------------------------------------------------------------

    (i) Results from the plant-specific surveillance program must be 
integrated into the RTNDT estimate if the plant-specific 
surveillance data has been deemed credible as judged by the following 
criteria:
    (A) The materials in the surveillance capsules must be those which 
are the controlling materials with regard to radiation embrittlement.
    (B) Scatter in the plots of Charpy energy versus temperature for the 
irradiated and unirradiated conditions must be small enough to permit 
the determination of the 30-foot-pound temperature unambiguously.
    (C) Where there are two or more sets of surveillance data from one 
reactor, the scatter of [Delta]RTNDT values must be less than 
28 [deg]F for welds and 17 [deg]F for base metal. Even if the range in 
the capsule fluences is large (two or more orders of magnitude), the 
scatter may not exceed twice those values.
    (D) The irradiation temperature of the Charpy specimens in the 
capsule must equal the vessel wall temperature at the cladding/base 
metal interface within 25 [deg]F.
    (E) The surveillance data for the correlation monitor material in 
the capsule, if present, must fall within the scatter band of the data 
base for the material.
    (ii)(A) Surveillance data deemed credible according to the criteria 
of paragraph (c)(2)(i) of this section must be used to determine a 
material-specific value of CF for use in Equation 3. A material-specific 
value of CF is determined from Equation 5.

[[Page 961]]

[GRAPHIC] [TIFF OMITTED] TR19DE95.004

    (B) In Equation 5, ``n'' is the number of surveillance data points, 
``Ai'' is the measured value of [Delta]RTNDT and 
``fi'' is the fluence for each surveillance data point. If 
there is clear evidence that the copper and nickel content of the 
surveillance weld differs from the vessel weld, i.e., differs from the 
average for the weld wire heat number associated with the vessel weld 
and the surveillance weld, the measured values of 
[Delta]RTNDT must be adjusted for differences in copper and 
nickel content by multiplying them by the ratio of the chemistry factor 
for the vessel material to that for the surveillance weld.
    (iii) For cases in which the results from a credible plant-specific 
surveillance program are used, the value of [sigma][Delta] to be used is 
14 [deg]F for welds and 8.5 [deg]F for base metal; the value of 
[sigma][Delta] need not exceed one-half of [Delta]RTNDT.
    (iv) The use of results from the plant-specific surveillance program 
may result in an RTNDT that is higher or lower than those 
determined in paragraph (c)(1).
    (3) Any information that is believed to improve the accuracy of the 
RTPTS value significantly must be reported to the Director, 
Office of Nuclear Reactor Regulation or Director, Office of New 
Reactors, as appropriate. Any value of RTPTS that has been 
modified using the procedures of paragraph (c)(2) of this section is 
subject to the approval of the Director, Office of Nuclear Reactor 
Regulation or Director, Office of New Reactors, as appropriate, when 
used as provided in this section.

                                Table 1--Chemistry Factor for Weld Metals, [deg]F
----------------------------------------------------------------------------------------------------------------
                                                                                   Nickel, wt-%
                          Copper, wt-%                          ------------------------------------------------
                                                                   0     0.20   0.40   0.60   0.80   1.00   1.20
----------------------------------------------------------------------------------------------------------------
0..............................................................     20     20     20     20     20     20     20
0.01...........................................................     20     20     20     20     20     20     20
0.02...........................................................     21     26     27     27     27     27     27
0.03...........................................................     22     35     41     41     41     41     41
0.04...........................................................     24     43     54     54     54     54     54
0.05...........................................................     26     49     67     68     68     68     68
0.06...........................................................     29     52     77     82     82     82     82
0.07...........................................................     32     55     85     95     95     95     95
0.08...........................................................     36     58     90    106    108    108    108
0.09...........................................................     40     61     94    115    122    122    122
0.10...........................................................     44     65     97    122    133    135    135
0.11...........................................................     49     68    101    130    144    148    148
0.12...........................................................     52     72    103    135    153    161    161
0.13...........................................................     58     76    106    139    162    172    176
0.14...........................................................     61     79    109    142    168    182    188
0.15...........................................................     66     84    112    146    175    191    200
0.16...........................................................     70     88    115    149    178    199    211
0.17...........................................................     75     92    119    151    184    207    221
0.18...........................................................     79     95    122    154    187    214    230
0.19...........................................................     83    100    126    157    191    220    238
0.20...........................................................     88    104    129    160    194    223    245
0.21...........................................................     92    108    133    164    197    229    252
0.22...........................................................     97    112    137    167    200    232    257
0.23...........................................................    101    117    140    169    203    236    263
0.24...........................................................    105    121    144    173    206    239    268
0.25...........................................................    110    126    148    176    209    243    272
0.26...........................................................    113    130    151    180    212    246    276
0.27...........................................................    119    134    155    184    216    249    280
0.28...........................................................    122    138    160    187    218    251    284
0.29...........................................................    128    142    164    191    222    254    287
0.30...........................................................    131    146    167    194    225    257    290
0.31...........................................................    136    151    172    198    228    260    293
0.32...........................................................    140    155    175    202    231    263    296
0.33...........................................................    144    160    180    205    234    266    299
0.34...........................................................    149    164    184    209    238    269    302
0.35...........................................................    153    168    187    212    241    272    305
0.36...........................................................    158    172    191    216    245    275    308
0.37...........................................................    162    177    196    220    248    278    311
0.38...........................................................    166    182    200    223    250    281    314
0.39...........................................................    171    185    203    227    254    285    317
0.40...........................................................    175    189    207    231    257    288    320
----------------------------------------------------------------------------------------------------------------


                                Table 2--Chemistry Factor for Base Metals, [deg]F
----------------------------------------------------------------------------------------------------------------
                                                                                   Nickel, wt-%
                          Copper, wt-%                          ------------------------------------------------
                                                                   0     0.20   0.40   0.60   0.80   1.00   1.20
----------------------------------------------------------------------------------------------------------------
0..............................................................     20     20     20     20     20     20     20
0.01...........................................................     20     20     20     20     20     20     20
0.02...........................................................     20     20     20     20     20     20     20
0.03...........................................................     20     20     20     20     20     20     20
0.04...........................................................     22     26     26     26     26     26     26
0.05...........................................................     25     31     31     31     31     31     31
0.06...........................................................     28     37     37     37     37     37     37
0.07...........................................................     31     43     44     44     44     44     44
0.08...........................................................     34     48     51     51     51     51     51
0.09...........................................................     37     53     58     58     58     58     58
0.10...........................................................     41     58     65     65     67     67     67

[[Page 962]]

 
0.11...........................................................     45     62     72     74     77     77     77
0.12...........................................................     49     67     79     83     86     86     86
0.13...........................................................     53     71     85     91     96     96     96
0.14...........................................................     57     75     91    100    105    106    106
0.15...........................................................     61     80     99    110    115    117    117
0.16...........................................................     65     84    104    118    123    125    125
0.17...........................................................     69     88    110    127    132    135    135
0.18...........................................................     73     92    115    134    141    144    144
0.19...........................................................     78     97    120    142    150    154    154
0.20...........................................................     82    102    125    149    159    164    165
0.21...........................................................     86    107    129    155    167    172    174
0.22...........................................................     91    112    134    161    176    181    184
0.23...........................................................     95    117    138    167    184    190    194
0.24...........................................................    100    121    143    172    191    199    204
0.25...........................................................    104    126    148    176    199    208    214
0.26...........................................................    109    130    151    180    205    216    221
0.27...........................................................    114    134    155    184    211    225    230
0.28...........................................................    119    138    160    187    216    233    239
0.29...........................................................    124    142    164    191    221    241    248
0.30...........................................................    129    146    167    194    225    249    257
0.31...........................................................    134    151    172    198    228    255    266
0.32...........................................................    139    155    175    202    231    260    274
0.33...........................................................    144    160    180    205    234    264    282
0.34...........................................................    149    164    184    209    238    268    290
0.35...........................................................    153    168    187    212    241    272    298
0.36...........................................................    158    173    191    216    245    275    303
0.37...........................................................    162    177    196    220    248    278    308
0.38...........................................................    166    182    200    223    250    281    313
0.39...........................................................    171    185    203    227    254    285    317
0.40...........................................................    175    189    207    231    257    288    320
----------------------------------------------------------------------------------------------------------------


[60 FR 65468, Dec. 19, 1995, as amended at 61 FR 39300, July 29, 1996; 
72 FR 49500, Aug. 28, 2007; 73 FR 5722, Jan. 31, 2008; 75 FR 23, Jan. 4, 
2010]



Sec.50.61a  Alternate fracture toughness requirements for protection
against pressurized thermal shock events.

    (a) Definitions. Terms in this section have the same meaning as 
those presented in 10 CFR 50.61(a), with the exception of the term 
``ASME Code.''
    (1) ASME Code means the American Society of Mechanical Engineers 
Boiler and Pressure Vessel Code, Section III, Division I, ``Rules for 
the Construction of Nuclear Power Plant Components,'' and Section XI, 
Division I, ``Rules for Inservice Inspection of Nuclear Power Plant 
Components,'' edition and addenda and any limitations and modifications 
thereof as specified in Sec.50.55a.
    (2) RTMAX-AW means the material property which 
characterizes the reactor vessel's resistance to fracture initiating 
from flaws found along axial weld fusion lines. RTMAX-AW is 
determined under the provisions of paragraph (f) of this section and has 
units of [deg]F.
    (3) RTMAX-PL means the material property which 
characterizes the reactor vessel's resistance to fracture initiating 
from flaws found in plates in regions that are not associated with welds 
found in plates. RTMAX-PL is determined under the provisions 
of paragraph (f) of this section and has units of [deg]F.
    (4) RTMAX-FO means the material property which 
characterizes the reactor vessel's resistance to fracture initiating 
from flaws in forgings that are not associated with welds found in 
forgings. RTMAX-FO is determined under the provisions of 
paragraph (f) of this section and has units of [deg]F.
    (5) RTMAX-CW means the material property which 
characterizes the reactor vessel's resistance to fracture initiating 
from flaws found along the circumferential weld fusion lines. 
RTMAX-CW is determined under the provisions of paragraph (f) 
of this section and has units of [deg]F.
    (6) RTMAX-X means any or all of the material properties 
RTMAX-AW, RTMAX-PL, RTMAX-FO, 
RTMAX-CW, or sum of RTMAX-AW and 
RTMAX-PL, for a particular reactor vessel.
    (7) [phi]t means fast neutron fluence for neutrons with energies 
greater than 1.0 MeV. [phi]t is utilized under the provisions of 
paragraph (g) of this section and has units of n/cm\2\.
    (8) [phi] means average neutron flux for neutrons with energies 
greater than 1.0 MeV. [phi] is utilized under the provisions of 
paragraph (g) of this section and has units of n/cm\2\/sec.
    (9) [Delta]T30 means the shift in the Charpy V-notch 
transition temperature at the 30 ft-lb energy level produced by 
irradiation. The [Delta]T30 value is utilized under the 
provisions of paragraph (g) of this section and has units of [deg]F.
    (10) Surveillance data means any data that demonstrates the 
embrittlement trends for the beltline materials, including, but not 
limited to, surveillance programs at other plants with or without a 
surveillance program integrated under 10 CFR part 50, appendix H.
    (11) TC means cold leg temperature under normal full 
power operating conditions, as a time-weighted average from the start of 
full power operation

[[Page 963]]

through the end of licensed operation. TC has units of 
[deg]F.
    (12) CRP means the copper rich precipitate term in the embrittlement 
model from this section. The CRP term is defined in paragraph (g) of 
this section.
    (13) MD means the matrix damage term in the embrittlement model for 
this section. The MD term is defined in paragraph (g) of this section.
    (b) Applicability. The requirements of this section apply to each 
holder of an operating license for a pressurized water nuclear power 
reactor whose construction permit was issued before February 3, 2010 and 
whose reactor vessel was designed and fabricated to the ASME Boiler and 
Pressure Vessel Code, 1998 Edition or earlier. The requirements of this 
section may be implemented as an alternative to the requirements of 10 
CFR 50.61.
    (c) Request for approval. Before the implementation of this section, 
each licensee shall submit a request for approval in the form of an 
application for a license amendment in accordance with Sec.50.90 
together with the documentation required by paragraphs (c)(1), (c)(2), 
and (c)(3) of this section for review and approval by the Director of 
the Office of Nuclear Reactor Regulation (Director). The application 
must be submitted for review and approval by the Director at least three 
years before the limiting RTPTS value calculated under 10 CFR 
50.61 is projected to exceed the PTS screening criteria in 10 CFR 50.61 
for plants licensed under this part.
    (1) Each licensee shall have projected values of RTMAX-X 
for each reactor vessel beltline material for the EOL fluence of the 
material. The assessment of RTMAX-X values must use the 
calculation procedures given in paragraphs (f) and (g) of this section. 
The assessment must specify the bases for the projected value of 
RTMAX-X for each reactor vessel beltline material, including 
the assumptions regarding future plant operation (e.g., core loading 
patterns, projected capacity factors); the copper (Cu), phosphorus (P), 
manganese (Mn), and nickel (Ni) contents; the reactor cold leg 
temperature (TC); and the neutron flux and fluence values 
used in the calculation for each beltline material. Assessments 
performed under paragraphs (f)(6) and (f)(7) of this section, shall be 
submitted by the licensee to the Director in its license amendment 
application to utilize Sec.50.61a.
    (2) Each licensee shall perform an examination and an assessment of 
flaws in the reactor vessel beltline as required by paragraph (e) of 
this section. The licensee shall verify that the requirements of 
paragraphs (e), (e)(1), (e)(2), and (e)(3) of this section have been 
met. The licensee must submit to the Director, in its application to use 
Sec.50.61a, the adjustments made to the volumetric test data to 
account for NDE-related uncertainties as described in paragraph (e)(1) 
of this section, all information required by paragraph (e)(1)(iii) of 
this section, and, if applicable, analyses performed under paragraphs 
(e)(4), (e)(5) and (e)(6) of this section.
    (3) Each licensee shall compare the projected RTMAX-X 
values for plates, forgings, axial welds, and circumferential welds to 
the PTS screening criteria in Table 1 of this section, for the purpose 
of evaluating a reactor vessel's susceptibility to fracture due to a PTS 
event. If any of the projected RTMAX-X values are greater 
than the PTS screening criteria in Table 1 of this section, then the 
licensee may propose the compensatory actions or plant-specific analyses 
as required in paragraphs (d)(3) through (d)(7) of this section, as 
applicable, to justify operation beyond the PTS screening criteria in 
Table 1 of this section.
    (d) Subsequent requirements. Licensees who have been approved to use 
10 CFR 50.61a under the requirements of paragraph (c) of this section 
shall comply with the requirements of this paragraph.
    (1) Whenever there is a significant change in projected values of 
RTMAX-X, so that the previous value, the current value, or 
both values, exceed the screening criteria before the expiration of the 
plant operating license; or upon the licensee's request for a change in 
the expiration date for operation of the facility; a re-assessment of 
RTMAX-X values documented consistent with the requirements of 
paragraph (c)(1) and (c)(3) of this section must be submitted

[[Page 964]]

in the form of a license amendment for review and approval by the 
Director. If the surveillance data used to perform the re-assessment of 
RTMAX-X values meet the requirements of paragraph (f)(6)(v) 
of this section, the licensee shall submit the data and the results of 
the analysis of the data to the Director for review and approval within 
one year after the capsule is withdrawn from the vessel. If the 
surveillance data meet the requirements of paragraph (f)(6)(vi) of this 
section, the licensee shall submit the data, the results of the analysis 
of the data, and proposed [Delta]T30 and RTMAX-X 
values considering the surveillance data in the form of a license 
amendment to the Director for review and approval within two years after 
the capsule is withdrawn from the vessel. If the Director does not 
approve the assessment of RTMAX-X values, then the licensee 
shall perform the actions required in paragraphs (d)(3) through (d)(7) 
of this section, as necessary, before operation beyond the PTS screening 
criteria in Table 1 of this section.
    (2) The licensee shall verify that the requirements of paragraphs 
(e), (e)(1), (e)(2), and (e)(3) of this section have been met. The 
licensee must submit, within 120 days after completing a volumetric 
examination of reactor vessel beltline materials as required by ASME 
Code, Section XI, the adjustments made to the volumetric test data to 
account for NDE-related uncertainties as described in paragraph (e)(1) 
of this section and all information required by paragraph (e)(1)(iii) of 
this section in the form of a license amendment for review and approval 
by the Director. If a licensee is required to implement paragraphs 
(e)(4), (e)(5), and (e)(6) of this section, the information required in 
these paragraphs must be submitted in the form of a license amendment 
for review and approval by the Director within one year after completing 
a volumetric examination of reactor vessel materials as required by ASME 
Code, Section XI.
    (3) If the value of RTMAX-X is projected to exceed the 
PTS screening criteria, then the licensee shall implement those flux 
reduction programs that are reasonably practicable to avoid exceeding 
the PTS screening criteria. The schedule for implementation of flux 
reduction measures may take into account the schedule for review and 
anticipated approval by the Director of detailed plant-specific analyses 
which demonstrate acceptable risk with RTMAX-X values above 
the PTS screening criteria due to plant modifications, new information, 
or new analysis techniques.
    (4) If the analysis required by paragraph (d)(3) of this section 
indicates that no reasonably practicable flux reduction program will 
prevent the RTMAX-X value for one or more reactor vessel 
beltline materials from exceeding the PTS screening criteria, then the 
licensee shall perform a safety analysis to determine what, if any, 
modifications to equipment, systems, and operation are necessary to 
prevent the potential for an unacceptably high probability of failure of 
the reactor vessel as a result of postulated PTS events. In the 
analysis, the licensee may determine the properties of the reactor 
vessel materials based on available information, research results and 
plant surveillance data, and may use probabilistic fracture mechanics 
techniques. This analysis and the description of the modifications must 
be submitted to the Director in the form of a license amendment at least 
three years before RTMAX-X is projected to exceed the PTS 
screening criteria.
    (5) After consideration of the licensee's analyses, including 
effects of proposed corrective actions, if any, submitted under 
paragraphs (d)(3) and (d)(4) of this section, the Director may, on a 
case-by-case basis, approve operation of the facility with 
RTMAX-X values in excess of the PTS screening criteria. The 
Director will consider factors significantly affecting the potential for 
failure of the reactor vessel in reaching a decision. The Director shall 
impose the modifications to equipment, systems and operations described 
to meet paragraph (d)(4) of this section.
    (6) If the Director concludes, under paragraph (d)(5) of this 
section, that operation of the facility with RTMAX-X values 
in excess of the PTS screening criteria cannot be approved on the basis 
of the licensee's analyses submitted under paragraphs (d)(3) and

[[Page 965]]

(d)(4) of this section, then the licensee shall request a license 
amendment, and receive approval by the Director, before any operation 
beyond the PTS screening criteria. The request must be based on 
modifications to equipment, systems, and operation of the facility in 
addition to those previously proposed in the submitted analyses that 
would reduce the potential for failure of the reactor vessel due to PTS 
events, or on further analyses based on new information or improved 
methodology. The licensee must show that the proposed alternatives 
provide reasonable assurance of adequate protection of the public health 
and safety.
    (7) If the limiting RTMAX-X value of the facility is 
projected to exceed the PTS screening criteria and the requirements of 
paragraphs (d)(3) through (d)(6) of this section cannot be satisfied, 
the reactor vessel beltline may be given a thermal annealing treatment 
under the requirements of Sec.50.66 to recover the fracture toughness 
of the material. The reactor vessel may be used only for that service 
period within which the predicted fracture toughness of the reactor 
vessel beltline materials satisfy the requirements of paragraphs (d)(1) 
through (d)(6) of this section, with RTMAX-X values 
accounting for the effects of annealing and subsequent irradiation.
    (e) Examination and flaw assessment requirements. The volumetric 
examination results evaluated under paragraphs (e)(1), (e)(2), and 
(e)(3) of this section must be acquired using procedures, equipment and 
personnel that have been qualified under the ASME Code, Section XI, 
Appendix VIII, Supplement 4 and Supplement 6, as specified in 10 CFR 
50.55a(b)(2)(xv).
    (1) The licensee shall verify that the flaw density and size 
distributions within the volume described in ASME Code, Section XI,\1\ 
Figures IWB-2500-1 and IWB-2500-2 and limited to a depth from the clad-
to-base metal interface of 1-inch or 10 percent of the vessel thickness, 
whichever is greater, do not exceed the limits in Tables 2 and 3 of this 
section based on the test results from the volumetric examination. The 
values in Tables 2 and 3 represent actual flaw sizes. Test results from 
the volumetric examination may be adjusted to account for the effects of 
NDE-related uncertainties. The methodology to account for NDE-related 
uncertainties must be based on statistical data from the qualification 
tests and any other tests that measure the difference between the actual 
flaw size and the NDE detected flaw size. Licensees who adjust their 
test data to account for NDE-related uncertainties to verify conformance 
with the values in Tables 2 and 3 shall prepare and submit the 
methodology used to estimate the NDE uncertainty, the statistical data 
used to adjust the test data and an explanation of how the data was 
analyzed for review and approval by the Director in accordance with 
paragraphs (c)(2) and (d)(2) of this section. The verification of the 
flaw density and size distributions shall be performed line-by-line for 
Tables 2 and 3. If the flaw density and size distribution exceeds the 
limitations specified in Tables 2 and 3 of this section, the licensee 
shall perform the analyses required by paragraph (e)(4) of this section. 
If analyses are required in accordance with paragraph (e)(4) of this 
section, the licensee must address the effects on through-wall crack 
frequency (TWCF) in accordance with paragraph (e)(5) of this section and 
must prepare and submit a neutron fluence map in accordance with the 
requirements of paragraph (e)(6) of this section.
---------------------------------------------------------------------------

    \1\ For forgings susceptible to underclad cracking the determination 
of the flaw density for that forging from the licensee's inspection 
shall exclude those indications identified as underclad cracks.
---------------------------------------------------------------------------

    (i) The licensee shall determine the allowable number of weld flaws 
in the reactor vessel beltline by multiplying the values in Table 2 of 
this section by the total length of the reactor vessel beltline welds 
that were volumetrically inspected and dividing by 1000 inches of weld 
length.
    (ii) The licensee shall determine the allowable number of plate or 
forging flaws in their reactor vessel beltline by multiplying the values 
in Table 3 of this section by the total surface area of the reactor 
vessel beltline plates or forgings that were volumetrically inspected 
and dividing by 1000 square inches.

[[Page 966]]

    (iii) For each flaw detected in the inspection volume described in 
paragraph (e)(1) with a through-wall extent equal to or greater than 
0.075 inches, the licensee shall document the dimensions of the flaw, 
including through-wall extent and length, whether the flaw is axial or 
circumferential in orientation and its location within the reactor 
vessel, including its azimuthal and axial positions and its depth 
embedded from the clad-to-base metal interface.
    (2) The licensee shall identify, as part of the examination required 
by paragraph (c)(2) of this section and any subsequent ASME Code, 
Section XI ultrasonic examination of the beltline welds, any flaws 
within the inspection volume described in paragraph (e)(1) of this 
section that are equal to or greater than 0.075 inches in through-wall 
depth, axially-oriented, and located at the clad-to-base metal 
interface. The licensee shall verify that these flaws do not open to the 
vessel inside surface using surface or visual examination technique 
capable of detecting and characterizing service induced cracking of the 
reactor vessel cladding.
    (3) The licensee shall verify, as part of the examination required 
by paragraph (c)(2) of this section and any subsequent ASME Code, 
Section XI ultrasonic examination of the beltline welds, that all flaws 
between the clad-to-base metal interface and three-eights of the reactor 
vessel thickness from the interior surface are within the allowable 
values in ASME Code, Section XI, Table IWB-3510-1.
    (4) The licensee shall perform analyses to demonstrate that the 
reactor vessel will have a TWCF of less than 1 x 10-6 per 
reactor year if the ASME Code, Section XI volumetric examination 
required by paragraph (c)(2) or (d)(2) of this section indicates any of 
the following:
    (i) The flaw density and size in the inspection volume described in 
paragraph (e)(1) exceed the limits in Tables 2 or 3 of this section;
    (ii) There are axial flaws that penetrate through the clad into the 
low alloy steel reactor vessel shell, at a depth equal to or greater 
than 0.075 inches in through-wall extent from the clad-to-base metal 
interface; or
    (iii) Any flaws between the clad-to-base metal interface and three-
eighths \2\ of the vessel thickness exceed the size allowable in ASME 
Code, Section XI, Table IWB-3510-1.
---------------------------------------------------------------------------

    \2\ Because flaws greater than three-eights of the vessel wall 
thickness from the inside surface do not contribute to TWCF, flaws 
greater than three-eights of the vessel wall thickness from the inside 
surface need not be analyzed for their contribution to PTS.
---------------------------------------------------------------------------

    (5) The analyses required by paragraph (e)(4) of this section must 
address the effects on TWCF of the known sizes and locations of all 
flaws detected by the ASME Code, Section XI, Appendix VIII, Supplement 4 
and Supplement 6 ultrasonic examination out to three-eights of the 
vessel thickness from the inner surface, and may also take into account 
other reactor vessel-specific information, including fracture toughness 
information.
    (6) For all flaw assessments performed in accordance with paragraph 
(e)(4) of this section, the licensee shall prepare and submit a neutron 
fluence map, projected to the date of license expiration, for the 
reactor vessel beltline clad-to-base metal interface and indexed in a 
manner that allows the determination of the neutron fluence at the 
location of the detected flaws.
    (f) Calculation of RTMAX-X values. Each licensee shall 
calculate RTMAX-X values for each reactor vessel beltline 
material using [phi]t. The neutron flux ([phi][t]), must be calculated 
using a methodology that has been benchmarked to experimental 
measurements and with quantified uncertainties and possible biases.\3\
---------------------------------------------------------------------------

    \3\ Regulatory Guide 1.190 dated March 2001, establishes acceptable 
methods for determining neutron flux.
---------------------------------------------------------------------------

    (1) The values of RTMAX-AW, RTMAX-PL, 
RTMAX-FO, and RTMAX-CW must be determined using 
Equations 1 through 4 of this section. When calculating 
RTMAX-AW using Equation 1, RTMAX-AW is the maximum 
value of (RTNDT(U) + [Delta]T30) for the weld and 
for the adjoining plates. When calculating RTMAX-CW using 
Equation 4, RTMAX-CW is the maximum value of 
(RTNDT(U) + [Delta]T30) for the circumferential 
weld and for the adjoining plates or forgings.
    (2) The values of [Delta]T30 must be determined using 
Equations 5, 6 and 7 of this

[[Page 967]]

section, unless the conditions specified in paragraph (f)(6)(v) of this 
section are not met, for each axial weld, plate, forging, and 
circumferential weld. The [Delta]T30 value for each axial 
weld calculated as specified by Equation 1 of this section must be 
calculated for the maximum fluence ([phi]tAXIAL-WELD) 
occurring along a particular axial weld at the clad-to-base metal 
interface. The [Delta]T30 value for each plate calculated as 
specified by Equation 1 of this section must also be calculated using 
the same value of [phi]tAXIAL-WELD used for the axial weld. 
The [Delta]T30 values in Equation 1 shall be calculated for 
the weld itself and each adjoining plate. The [Delta]T30 
value for each plate or forging calculated as specified by Equations 2 
and 3 of this section must be calculated for the maximum fluence 
([phi]tMAX) occurring at the clad-to-base metal interface 
over the entire area of each plate or forging. In Equation 4, the 
fluence ([phi]tWELD-CIRC) value used for calculating the 
plate, forging, and circumferential weld [Delta]T30 value is 
the maximum fluence occurring for each material along the 
circumferential weld at the clad-to-base metal interface. The 
[Delta]T30 values in Equation 4 shall be calculated for the 
circumferential weld and for the adjoining plates or forgings. If the 
conditions specified in paragraph (f)(6)(v) of this section are not met, 
licensees must propose [Delta]T30 and RTMAX-X 
values in accordance with paragraph (f)(6)(vi) of this section.
    (3) The values of Cu, Mn, P, and Ni in Equations 6 and 7 of this 
section must represent the best estimate values for the material. For a 
plate or forging, the best estimate value is normally the mean of the 
measured values for that plate or forging. For a weld, the best estimate 
value is normally the mean of the measured values for a weld deposit 
made using the same weld wire heat number as the critical vessel weld. 
If these values are not available, either the upper limiting values 
given in the material specifications to which the vessel material was 
fabricated, or conservative estimates (i.e., mean plus one standard 
deviation) based on generic data \4\ as shown in Table 4 of this section 
for P and Mn, must be used.
---------------------------------------------------------------------------

    \4\ Data from reactor vessels fabricated to the same material 
specification in the same shop as the vessel in question and in the same 
time is an example of ``generic data.''
---------------------------------------------------------------------------

    (4) The values of RTNDT(U) must be evaluated according to 
the procedures in the ASME Code, Section III, paragraph NB-2331. If any 
other method is used for this evaluation, the licensee shall submit the 
proposed method for review and approval by the Director along with the 
calculation of RTMAX-X values required in paragraph (c)(1) of 
this section.
    (i) If a measured value of RTNDT(U) is not available, a 
generic mean value of RTNDT(U) for the class \5\ of material 
must be used if there are sufficient test results to establish a mean.
---------------------------------------------------------------------------

    \5\ The class of material for estimating RTNDT(U) must be 
determined by the type of welding flux (Linde 80, or other) for welds or 
by the material specification for base metal.
---------------------------------------------------------------------------

    (ii) The following generic mean values of RTNDT(U) must 
be used unless justification for different values is provided: 0 [deg]F 
for welds made with Linde 80 weld flux; and -56 [deg]F for welds made 
with Linde 0091, 1092, and 124 and ARCOS B-5 weld fluxes.
    (5) The value of TC in Equation 6 of this section must 
represent the time-weighted average of the reactor cold leg temperature 
under normal operating full power conditions from the beginning of full 
power operation through the end of licensed operation.
    (6) The licensee shall verify that an appropriate RTMAX-X 
value has been calculated for each reactor vessel beltline material by 
considering plant-specific information that could affect the use of the 
model (i.e., Equations 5, 6 and 7) of this section for the determination 
of a material's [Delta]T30 value.
    (i) The licensee shall evaluate the results from a plant-specific or 
integrated surveillance program if the surveillance data satisfy the 
criteria described in paragraphs (f)(6)(i)(A) and (f)(6)(i)(B) of this 
section:
    (A) The surveillance material must be a heat-specific match for one 
or more of the materials for which RTMAX-X is being 
calculated. The 30-foot-pound transition temperature must be determined 
as specified by the

[[Page 968]]

requirements of 10 CFR part 50, Appendix H.
    (B) If three or more surveillance data points measured at three or 
more different neutron fluences exist for a specific material, the 
licensee shall determine if the surveillance data show a significantly 
different trend than the embrittlement model predicts. This must be 
achieved by evaluating the surveillance data for consistency with the 
embrittlement model by following the procedures specified by paragraphs 
(f)(6)(ii), (f)(6)(iii), and (f)(6)(iv) of this section. If fewer than 
three surveillance data points exist for a specific material, then the 
embrittlement model must be used without performing the consistency 
check.
    (ii) The licensee shall estimate the mean deviation from the 
embrittlement model for the specific data set (i.e., a group of 
surveillance data points representative of a given material). The mean 
deviation from the embrittlement model for a given data set must be 
calculated using Equations 8 and 9 of this section. The mean deviation 
for the data set must be compared to the maximum heat-average residual 
given in Table 5 or derived using Equation 10 of this section. The 
maximum heat-average residual is based on the material group into which 
the surveillance material falls and the number of surveillance data 
points. For surveillance data sets with greater than 8 data points, the 
maximum credible heat-average residual must be calculated using Equation 
10 of this section. The value of [sigma] used in Equation 10 of this 
section must be obtained from Table 5 of this section.
    (iii) The licensee shall estimate the slope of the embrittlement 
model residuals (estimated using Equation 8) plotted as a function of 
the base 10 logarithm of neutron fluence for the specific data set. The 
licensee shall estimate the T-statistic for this slope 
(TSURV) using Equation 11 and compare this value to the 
maximum permissible T-statistic (TMAX) in Table 6. For 
surveillance data sets with greater than 15 data points, the 
TMAX value must be calculated using Student's T distribution 
with a significance level ([alpha]) of 1 percent for a one-tailed test.
    (iv) The licensee shall estimate the two largest positive deviations 
(i.e., outliers) from the embrittlement model for the specific data set 
using Equations 8 and 12. The licensee shall compare the largest 
normalized residual (r *) to the appropriate allowable value from the 
third column in Table 7 and the second largest normalized residual to 
the appropriate allowable value from the second column in Table 7.
    (v) The [Delta]T30 value must be determined using 
Equations 5, 6, and 7 of this section if all three of the following 
criteria are satisfied:
    (A) The mean deviation from the embrittlement model for the data set 
is equal to or less than the value in Table 5 or the value derived using 
Equation 10 of this section;
    (B) The T-statistic for the slope (TSURV) estimated using 
Equation 11 is equal to or less than the Maximum permissible T-statistic 
(TMAX) in Table 6; and
    (C) The largest normalized residual value is equal to or less than 
the appropriate allowable value from the third column in Table 7 and the 
second largest normalized residual value is equal to or less than the 
appropriate allowable value from the second column in Table 7. If any of 
these criteria is not satisfied, the licensee must propose 
[Delta]T30 and RTMAX-X values in accordance with 
paragraph (f)(6)(vi) of this section.
    (vi) If any of the criteria described in paragraph (f)(6)(v) of this 
section are not satisfied, the licensee shall review the data base for 
that heat in detail, including all parameters used in Equations 5, 6, 
and 7 of this section and the data used to determine the baseline Charpy 
V-notch curve for the material in an unirradiated condition. The 
licensee shall submit an evaluation of the surveillance data to the NRC 
and shall propose [Delta]T30 and RTMAX-X values, 
considering their plant-specific surveillance data, to be used for 
evaluation relative to the acceptance criteria of this rule. These 
evaluations must be submitted for review and approval by the Director in 
the form of a license amendment in accordance with the requirements of 
paragraphs (c)(1) and (d)(1) of this section.

[[Page 969]]

    (7) The licensee shall report any information that significantly 
influences the RTMAX-X value to the Director in accordance 
with the requirements of paragraphs (c)(1) and (d)(1) of this section.
    (g) Equations and variables used in this section.
    [GRAPHIC] [TIFF OMITTED] TR03FE10.000
    
    [GRAPHIC] [TIFF OMITTED] TR03FE10.001
    
    [GRAPHIC] [TIFF OMITTED] TR03FE10.002
    
    [GRAPHIC] [TIFF OMITTED] TR03FE10.003
    
    [GRAPHIC] [TIFF OMITTED] TR03FE10.004
    
    [GRAPHIC] [TIFF OMITTED] TR03FE10.005
    
    [GRAPHIC] [TIFF OMITTED] TR03FE10.006
    
Where:

P [wt-&%] = phosphorus content
Mn [wt-%] = manganese content
Ni [wt-%] = nickel content
Cu [wt-%] = copper content
A = 1.140 x 10-7 for forgings
A = 1.561 x 10-7 for plates
A = 1.417 x 10-7 for welds
B = 102.3 for forgings
B = 102.5 for plates in non-Combustion Engineering manufactured vessels
B = 135.2 for plates in Combustion Engineering vessels
B = 155.0 for welds

[phis]te = [phis]t for [phis] =4.39 x 10\10\ n/
cm\2\/sec
[phis]te = [phis]t x (4.39 x 10\10\/[phis])\0.2595\ for 
[phis] <4.39 x 10\10\ n/cm\2\/sec

Where:

[phis] [n/cm\2\/sec] = average neutron flux
t [sec] = time that the reactor has been in full power operation
[phis]t [n/cm\2\] = [phis] x t

f(Cue,P) = 0 for Cu <=0.072
f(Cue,P) = [Cue-0.072]\0.668\ for Cu 
0.072 and P <=0.008
f(Cue,P) = [Cue-0.072 + 1.359 x (P-0.008)]\0.668\ 
for Cu 0.072 and P 0.008

Where:

Cue = 0 for Cu <=0.072
Cue = MIN (Cu, maximum Cue) for Cu 
          0.072
maximum Cue = 0.243 for Linde 80 welds
maximum Cue = 0.301 for all other materials

g(Cue,Ni,[phis]te) = 0.5 + (0.5 x tanh 
{[log10([phis]te) + (1.1390 x Cue)-
(0.448 x Ni)-18.120]/0.629{time} 
Equation 8: Residual (r) = measured [Delta]T30-predicted 
[Delta]T30 (by Equations 5, 6 and 7)
[GRAPHIC] [TIFF OMITTED] TR03FE10.007

Equation 10: Maximum credible heat-average residual = 2.33[sigma]/n\0.5\

Where:

n = number of surveillance data points (sample size) in the specific 
          data set

[[Page 970]]

[sigma] = standard deviation of the residuals about the model for a 
          relevant material group given in Table 5.
          [GRAPHIC] [TIFF OMITTED] TR03FE10.008
          
Where:

m is the slope of a plot of all of the r values (estimated using 
          Equation 8) versus the base 10 logarithm of the neutron 
          fluence for each r value. The slope shall be estimated using 
          the method of least squares.
se(m) is the least squares estimate of the standard-error associated 
          with the estimated slope value m.
          [GRAPHIC] [TIFF OMITTED] TR03FE10.009
          
Where:

r is defined using Equation 8 and [sigma] is given in Table 5

                                         Table 1--PTS Screening Criteria
----------------------------------------------------------------------------------------------------------------
                                                            RTMAX	X limits [ [deg]F] for different vessel wall
                                                                         thicknesses \6\ (TWALL)
            Product form and RTMAX	X values             --------------------------------------------------------
                                                                              9.5 in. 0.072.....       26.4       35.5       30.8       27.5       25.1       23.2       21.7
Plates, for Cu 0.072....       21.2       28.5       24.7       22.1       20.2       18.7       17.5
Forgings, for Cu 0.072..       19.6       26.4       22.8       20.4       18.6       17.3       16.1
Weld, Plate or Forging, for Cu            18.6       25.0       21.7       19.4       17.7       16.4       15.3
 <=0.072...........................
----------------------------------------------------------------------------------------------------------------


 Table 6--TMAX Values for the Slope Deviation Test (Significance Level =
                                   1%)
------------------------------------------------------------------------
           Number of available data points (n)                 TMAX
------------------------------------------------------------------------
3.......................................................           31.82
4.......................................................            6.96
5.......................................................            4.54
6.......................................................            3.75
7.......................................................            3.36
8.......................................................            3.14
9.......................................................            3.00
10......................................................            2.90
11......................................................            2.82
12......................................................            2.76
13......................................................            2.72
14......................................................            2.68
15......................................................            2.65
------------------------------------------------------------------------


 Table 7--Threshold Values for the Outlier Deviation Test (Significance
                               Level = 1%)
------------------------------------------------------------------------
                                          Second largest      Largest
                                             allowable       allowable
   Number of available data points (n)      normalized      normalized
                                          residual value  residual value
                                               (r*)            (r*)
------------------------------------------------------------------------
3.......................................            1.55            2.71
4.......................................            1.73            2.81
5.......................................            1.84            2.88
6.......................................            1.93            2.93
7.......................................            2.00            2.98
8.......................................            2.05            3.02
9.......................................            2.11            3.06
10......................................            2.16            3.09
11......................................            2.19            3.12
12......................................            2.23            3.14

[[Page 972]]

 
13......................................            2.26            3.17
14......................................            2.29            3.19
15......................................            2.32            3.21
------------------------------------------------------------------------


[75 FR 23, Jan. 4, 2010, as amended at 75 FR 5495, Feb. 3, 2010; 75 FR 
10411, Mar. 8, 2010; 75 FR 72653, Nov. 26, 2010]



Sec.50.62  Requirements for reduction of risk from anticipated
transients without scram (ATWS) events for light-water-cooled nuclear
power plants.

    (a) Applicability. The requirements of this section apply to all 
commercial light-water-cooled nuclear power plants, other than nuclear 
power reactor facilities for which the certifications required under 
Sec.50.82(a)(1) have been submitted.
    (b) Definition. For purposes of this section, Anticipated Transient 
Without Scram (ATWS) means an anticipated operational occurrence as 
defined in appendix A of this part followed by the failure of the 
reactor trip portion of the protection system specified in General 
Design Criterion 20 of appendix A of this part.
    (c) Requirements. (1) Each pressurized water reactor must have 
equipment from sensor output to final actuation device, that is diverse 
from the reactor trip system, to automatically initiate the auxiliary 
(or emergency) feedwater system and initiate a turbine trip under 
conditions indicative of an ATWS. This equipment must be designed to 
perform its function in a reliable manner and be independent (from 
sensor output to the final actuation device) from the existing reactor 
trip system.
    (2) Each pressurized water reactor manufactured by Combustion 
Engineering or by Babcock and Wilcox must have a diverse scram system 
from the sensor output to interruption of power to the control rods. 
This scram system must be designed to perform its function in a reliable 
manner and be independent from the existing reactor trip system (from 
sensor output to interruption of power to the control rods).
    (3) Each boiling water reactor must have an alternate rod injection 
(ARI) system that is diverse (from the reactor trip system) from sensor 
output to the final actuation device. The ARI system must have redundant 
scram air header exhaust valves. The ARI must be designed to perform its 
function in a reliable manner and be independent (from the existing 
reactor trip system) from sensor output to the final actuation device.
    (4) Each boiling water reactor must have a standby liquid control 
system (SLCS) with the capability of injecting into the reactor pressure 
vessel a borated water solution at such a flow rate, level of boron 
concentration and boron-10 isotope enrichment, and accounting for 
reactor pressure vessel volume, that the resulting reactivity control is 
at least equivalent to that resulting from injection of 86 gallons per 
minute of 13 weight percent sodium pentaborate decahydrate solution at 
the natural boron-10 isotope abundance into a 251-inch inside diameter 
reactor pressure vessel for a given core design. The SLCS and its 
injection location must be designed to perform its function in a 
reliable manner. The SLCS initiation must be automatic and must be 
designed to perform its function in a reliable manner for plants granted 
a construction permit after July 26, 1984, and for plants granted a 
construction permit prior to July 26, 1984, that have already been 
designed and built to include this feature.
    (5) Each boiling water reactor must have equipment to trip the 
reactor coolant recirculating pumps automatically under conditions 
indicative of an

[[Page 973]]

ATWS. This equipment must be designed to perform its function in a 
reliable manner.
    (6) Information sufficient to demonstrate to the Commission the 
adequacy of items in paragraphs (c)(1) through (c)(5) of this section 
shall be submitted to the Commission as specified in Sec.50.4.
    (d) Implementation. For each light-water-cooled nuclear power plant 
operating license issued before September 27, 2007, by 180 days after 
the issuance of the QA guidance for non-safety related components, each 
licensee shall develop and submit to the Commission, as specified in 
Sec.50.4, a proposed schedule for meeting the requirements of 
paragraphs (c)(1) through (c)(5) of this section. Each shall include an 
explanation of the schedule along with a justification if the schedule 
calls for final implementation later than the second refueling outage 
after July 26, 1984, or the date of issuance of a license authorizing 
operation above 5 percent of full power. A final schedule shall then be 
mutually agreed upon by the Commission and licensee. For each light-
water-cooled nuclear power plant operating license application submitted 
after September 27, 2007, the applicant shall submit information in its 
final safety analysis report demonstrating how it will comply with 
paragraphs (c)(1) through (c)(5) of this section.

[49 FR 26044, June 26, 1984; 49 FR 27736, July 6, 1984, as amended at 51 
FR 40310, Nov. 6, 1986; 54 FR 13362, Apr. 3, 1989; 61 FR 39301, July 29, 
1996; 72 FR 49500, Aug. 28, 2007]



Sec.50.63  Loss of all alternating current power.

    (a) Requirements. (1) Each light-water-cooled nuclear power plant 
licensed to operate under this part, each light-water-cooled nuclear 
power plant licensed under subpart C of 10 CFR part 52 after the 
Commission makes the finding under Sec.52.103(g) of this chapter, and 
each design for a light-water-cooled nuclear power plant approved under 
a standard design approval, standard design certification, and 
manufacturing license under part 52 of this chapter must be able to 
withstand for a specified duration and recover from a station blackout 
as defined in Sec.50.2. The specified station blackout duration shall 
be based on the following factors:
    (i) The redundancy of the onsite emergency ac power sources;
    (ii) The reliability of the onsite emergency ac power sources;
    (iii) The expected frequency of loss of offsite power; and
    (iv) The probable time needed to restore offsite power.
    (2) The reactor core and associated coolant, control, and protection 
systems, including station batteries and any other necessary support 
systems, must provide sufficient capacity and capability to ensure that 
the core is cooled and appropriate containment integrity is maintained 
in the event of a station blackout for the specified duration. The 
capability for coping with a station blackout of specified duration 
shall be determined by an appropriate coping analysis. Licensees are 
expected to have the baseline assumptions, analyses, and related 
information used in their coping evaluations available for NRC review.
    (b) Limitation of scope. Paragraph (c) of this section does not 
apply to those plants licensed to operate prior to July 21, 1988, if the 
capability to withstand station blackout was specifically addressed in 
the operating license proceeding and was explicitly approved by the NRC.
    (c) Implementation--(1) Information Submittal. For each light-water-
cooled nuclear power plant licensed to operate on or before July 21, 
1988, the licensee shall submit the information defined below to the 
Director of the Office of Nuclear Reactor Regulation by April 17, 1989. 
For each light-water-cooled nuclear power plant licensed to operate 
after July 21, 1988, but before September 27, 2007, the licensee shall 
submit the information defined in this section to the Director of the 
Office of Nuclear Reactor Regulation, by 270 days after the date of 
license issuance. For each light-water-cooled nuclear power plant 
operating license application submitted after September 27, 2007, the 
applicant shall submit the information defined below in its final safety 
analysis report.
    (i) A proposed station blackout duration to be used in determining 
compliance with paragraph (a) of this section,

[[Page 974]]

including a justification for the selection based on the four factors 
identified in paragraph (a) of this section;
    (ii) A description of the procedures that will be implemented for 
station blackout events for the duration determined in paragraph 
(c)(1)(i) of this section and for recovery therefrom; and
    (iii) A list of modifications to equipment and associated 
procedures, if any, necessary to meet the requirements of paragraph (a) 
of this section, for the specified station blackout duration determined 
in paragraph (c)(1)(i) of this section, and a proposed schedule for 
implementing the stated modifications.
    (2) Alternate ac source: The alternate ac power source(s), as 
defined in Sec.50.2, will constitute acceptable capability to 
withstand station blackout provided an analysis is performed which 
demonstrates that the plant has this capability from onset of the 
station blackout until the alternate ac source(s) and required shutdown 
equipment are started and lined up to operate. The time required for 
startup and alignment of the alternate ac power source(s) and this 
equipment shall be demonstrated by test. Alternate ac source(s) serving 
a multiple unit site where onsite emergency ac sources are not shared 
between units must have, as a minimum, the capacity and capability for 
coping with a station blackout in any of the units. At sites where 
onsite emergency ac sources are shared between units, the alternate ac 
source(s) must have the capacity and capability as required to ensure 
that all units can be brought to and maintained in safe shutdown (non-
DBA) as defined in Sec.50.2. If the alternate ac source(s) meets the 
above requirements and can be demonstrated by test to be available to 
power the shutdown buses within 10 minutes of the onset of station 
blackout, then no coping analysis is required.
    (3) Regulatory Assessment: After consideration of the information 
submitted in accordance with paragraph (c)(1) of this section, the 
Director, Office of Nuclear Reactor Regulation, will notify the licensee 
of the Director's conclusions regarding the adequacy of the proposed 
specified station blackout duration, the proposed equipment 
modifications and procedures, and the proposed schedule for implementing 
the procedures and modifications for compliance with paragraph (a) this 
section.
    (4) Implementation Schedule: For each light-water-cooled nuclear 
power plant licensed to operate on or before June 21, 1988, the licensee 
shall, within 30 days of the notification provided in accordance with 
paragraph (c)(3) of this section, submit to the Director of the Office 
of Nuclear Reactor Regulation a schedule commitment for implementing any 
equipment and associated procedure modifications necessary to meet the 
requirements of paragraph (a) of this section. This submittal must 
include an explanation of the schedule and a justification if the 
schedule does not provide for completion of the modifications within two 
years of the notification provided in accordance with paragraph (c)(3) 
of this section. A final schedule for implementing modifications 
necessary to comply with the requirements of paragraph (a) of this 
section will be established by the NRC staff in consultation and 
coordination with the affected licensee.

[53 FR 23215, June 21, 1988, as amended at 63 FR 50480, Sept. 22, 1998; 
72 FR 49501, Aug. 28, 2007]



Sec.50.64  Limitations on the use of highly enriched uranium
(HEU) in domestic non-power reactors.

    (a) Applicability. The requirements of this section apply to all 
non-power reactors.
    (b) Requirements. (1) The Commission will not issue a construction 
permit after March 27, 1986 for a non-power reactor where the applicant 
proposes to use highly enriched uranium (HEU) fuel, unless the applicant 
demonstrates that the proposed reactor will have a unique purpose as 
defined in Sec.50.2.
    (2) Unless the Commission has determined, based on a request 
submitted in accordance with paragraph (c)(1) of this section, that the 
non-power reactor has a unique purpose, each licensee authorized to 
possess and use HEU fuel in connection with the reactor's operation 
shall:
    (i) Not initiate acquisition of additional HEU fuel, if low enriched 
uranium (LEU) fuel acceptable to the

[[Page 975]]

Commission for that reactor is available when it proposes that 
acquisition; and
    (ii) Replace all HEU fuel in its possession with available LEU fuel 
acceptable to the Commission for that reactor, in accordance with a 
schedule determined pursuant to paragraph (c)(2) of this section.
    (3) If not required by paragraphs (b) (1) and (2) of this section to 
use LEU fuel, the applicant or licensee must use HEU fuel of enrichment 
as close to 20% as is available and acceptable to the Commisson.
    (c) Implementation. (1) Any request by a licensee for a 
determination that a non-power reactor has a unique purpose as defined 
in Sec.50.2 should be submitted with supporting documentation to the 
Director of the Office of Nuclear Reactor Regulation, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555, by September 29, 1986.
    (2) (i) By March 27, 1987 and at 12-month intervals thereafter, each 
licensee of a non-power reactor authorized to possess and use HEU fuel 
shall develop and submit to the Director of the Office of Nuclear 
Reactor Regulation a written proposal for meeting the requirements of 
paragraph (b) (2) or (3) of this section. The licensee shall include in 
the proposal a certification that Federal Government funding for 
conversion is available through the Department of Energy (DOE) or other 
appropriate Federal Agency. The licensee shall also include in the 
proposal a schedule for conversion, based upon availability of 
replacement fuel acceptable to the Commisson for that reactor and upon 
consideration of other factors such as the availability of shipping 
casks, implementation of arrangements for the available financial 
support, and reactor usage.
    (ii) If Federal Government funding for conversion cannot be 
certified, the proposal's contents may be limited to a statement of this 
fact. If a statement of non-availability of Federal Government funding 
for conversion is submitted by a licensee, then it shall be required to 
resubmit a proposal for meeting the requirements of paragraph (b) (2) or 
(3) of this section at 12-month intervals.
    (iii) The proposal shall include, to the extent required to effect 
the conversion, all necessary changes in the license, facility, or 
procedures. Supporting safety analyses should be provided so as to meet 
the schedule established for conversion. As long as Federal Government 
funding for conversion is not available, the resubmittal may be a 
reiteration of the original proposal. The Director of the Office of 
Nuclear Reactor Regulation shall review the proposal and confirm the 
status of Federal Government funding for conversion and, if a schedule 
for conversion has been submitted by the licensee, will then determine a 
final schedule.
    (3) After review of the safety analysis required by paragraph 
(c)(2), the Director of the Office of Nuclear Reactor Regulation will 
issue an appropriate enforcement order directing both the conversion 
and, to the extent consistent with protection of the public health and 
safety, any necessary changes to the license, facility, or procedures.

[51 FR 6519, Feb. 25, 1986]



Sec.50.65  Requirements for monitoring the effectiveness of
maintenance at nuclear power plants.

    The requirements of this section are applicable during all 
conditions of plant operation, including normal shutdown operations.
    (a)(1) Each holder of an operating license for a nuclear power plant 
under this part and each holder of a combined license under part 52 of 
this chapter after the Commission makes the finding under Sec.
52.103(g) of this chapter, shall monitor the performance or condition of 
structures, systems, or components, against licensee-established goals, 
in a manner sufficient to provide reasonable assurance that these 
structures, systems, and components, as defined in paragraph (b) of this 
section, are capable of fulfilling their intended functions. These goals 
shall be established commensurate with safety and, where practical, take 
into account industry-wide operating experience. When the performance or 
condition of a structure, system, or component does not meet established 
goals, appropriate corrective action shall be taken. For a

[[Page 976]]

nuclear power plant for which the licensee has submitted the 
certifications specified in Sec.50.82(a)(1) or 52.110(a)(1) of this 
chapter, as applicable, this section shall only apply to the extent that 
the licensee shall monitor the performance or condition of all 
structures, systems, or components associated with the storage, control, 
and maintenance of spent fuel in a safe condition, in a manner 
sufficient to provide reasonable assurance that these structures, 
systems, and components are capable of fulfilling their intended 
functions.
    (2) Monitoring as specified in paragraph (a)(1) of this section is 
not required where it has been demonstrated that the performance or 
condition of a structure, system, or component is being effectively 
controlled through the performance of appropriate preventive 
maintenance, such that the structure, system, or component remains 
capable of performing its intended function.
    (3) Performance and condition monitoring activities and associated 
goals and preventive maintenance activities shall be evaluated at least 
every refueling cycle provided the interval between evaluations does not 
exceed 24 months. The evaluations shall take into account, where 
practical, industry-wide operating experience. Adjustments shall be made 
where necessary to ensure that the objective of preventing failures of 
structures, systems, and components through maintenance is appropriately 
balanced against the objective of minimizing unavailability of 
structures, systems, and components due to monitoring or preventive 
maintenance.
    (4) Before performing maintenance activities (including but not 
limited to surveillance, post-maintenance testing, and corrective and 
preventive maintenance), the licensee shall assess and manage the 
increase in risk that may result from the proposed maintenance 
activities. The scope of the assessment may be limited to structures, 
systems, and components that a risk-informed evaluation process has 
shown to be significant to public health and safety.
    (b) The scope of the monitoring program specified in paragraph 
(a)(1) of this section shall include safety related and nonsafety 
related structures, systems, and components, as follows:
    (1) Safety-related structures, systems and components that are 
relied upon 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), Sec.
50.67(b)(2), or Sec.100.11 of this chapter, as applicable.
    (2) Nonsafety related structures, systems, or components:
    (i) That are relied upon to mitigate accidents or transients or are 
used in plant emergency operating procedures (EOPs); or
    (ii) Whose failure could prevent safety-related structures, systems, 
and components from fulfilling their safety-related function; or
    (iii) Whose failure could cause a reactor scram or actuation of a 
safety-related system.
    (c) The requirements of this section shall be implemented by each 
licensee no later than July 10, 1996.

[56 FR 31324, July 10, 1991, as amended at 58 FR 33996, June 23, 1993; 
61 FR 39301, July 29, 1996; 61 FR 65173, Dec. 11, 1996; 62 FR 47271, 
Sept. 8, 1997; 62 FR 59276, Nov. 3, 1997; 64 FR 38557, July 19, 1999; 64 
FR 72001, Dec. 23, 1999; 72 FR 49501, Aug. 28, 2007]

    Effective Date Note: See 64 FR 38551, July 19, 1999, for 
effectiveness of Sec.50.65 (a)(3) and (a)(4).



Sec.50.66  Requirements for thermal annealing of the reactor
pressure vessel.

    (a) For those light water nuclear power reactors where neutron 
radiation has reduced the fracture toughness of the reactor vessel 
materials, a thermal annealing may be applied to the reactor vessel to 
recover the fracture toughness of the material. The use of a thermal 
annealing treatment is subject to the requirements in this section. A 
report describing the licensee's plan for conducting the thermal 
annealing must be submitted in accordance with Sec.50.4 at least three 
years prior to the date at which the limiting

[[Page 977]]

fracture toughness criteria in Sec.50.61 or appendix G to part 50 
would be exceeded. Within three years of the submittal of the Thermal 
Annealing Report and at least thirty days prior to the start of the 
thermal annealing, the NRC will review the Thermal Annealing Report and 
make available the results of its evaluation at the NRC Web site, http:/
/www.nrc.gov. The licensee may begin the thermal anneal after:
    (1) Submitting the Thermal Annealing Report required by paragraph 
(b) of this section;
    (2) The NRC makes available the results of its evaluation of the 
Thermal Annealing Report at the NRC Web site, http://www.nrc.gov; and
    (3) The requirements of paragraph (f)(1) of this section have been 
satisfied.
    (b) Thermal Annealing Report. The Thermal Annealing Report must 
include: a Thermal Annealing Operating Plan; a Requalification 
Inspection and Test Program; a Fracture Toughness Recovery and 
Reembrittlement Trend Assurance Program; and an Identification of 
Changes Requiring a License Amendment.
    (1) Thermal Annealing Operating Plan. The thermal annealing 
operating plan must include:
    (i) A detailed description of the pressure vessel and all structures 
and components that are expected to experience significant thermal or 
stress effects during the thermal annealing operation;
    (ii) An evaluation of the effects of mechanical and thermal stresses 
and temperatures on the vessel, containment, biological shield, attached 
piping and appurtenances, and adjacent equipment and components to 
demonstrate that operability of the reactor will not be detrimentally 
affected. This evaluation must include:
    (A) Detailed thermal and structural analyses to establish the time 
and temperature profile of the annealing operation. These analyses must 
include heatup and cooldown rates, and must demonstrate that localized 
temperatures, thermal stress gradients, and subsequent residual stresses 
will not result in unacceptable dimensional changes or distortions in 
the vessel, attached piping and appurtenances, and that the thermal 
annealing cycle will not result in unacceptable degradation of the 
fatigue life of these components.
    (B) The effects of localized high temperatures on degradation of the 
concrete adjacent to the vessel and changes in thermal and mechanical 
properties, if any, of the reactor vessel insulation, and on detrimental 
effects, if any, on containment and the biological shield. If the design 
temperature limitations for the adjacent concrete structure are to be 
exceeded during the thermal annealing operation, an acceptable maximum 
temperature for the concrete must be established for the annealing 
operation using appropriate test data.
    (iii) The methods, including heat source, instrumentation and 
procedures proposed for performing the thermal annealing. This shall 
include any special precautions necessary to minimize occupational 
exposure, in accordance with the As Low As Reasonably Achievable (ALARA) 
principle and the provisions of Sec.20.1206.
    (iv) The proposed thermal annealing operating parameters, including 
bounding conditions for temperatures and times, and heatup and cooldown 
schedules.
    (A) The thermal annealing time and temperature parameters selected 
must be based on projecting sufficient recovery of fracture toughness, 
using the procedures of paragraph (e) of this section, to satisfy the 
requirements of Sec.50.60 and Sec.50.61 for the proposed period of 
operation addressed in the application.
    (B) The time and temperature parameters evaluated as part of the 
thermal annealing operating plan, and supported by the evaluation 
results of paragraph (b)(1)(ii) of this section, represent the bounding 
times and temperatures for the thermal annealing operation. If these 
bounding conditions for times and temperatures are violated during the 
thermal annealing operation, then the annealing operation is considered 
not in accordance with the Thermal Annealing Operating Plan, as required 
by paragraph (c)(1) of this section, and the licensee must comply with 
paragraph (c)(2) of this section.

[[Page 978]]

    (2) Requalification Inspection and Test Program. The inspection and 
test program to requalify the annealed reactor vessel must include the 
detailed monitoring, inspections, and tests proposed to demonstrate that 
the limitations on temperatures, times and temperature profiles, and 
stresses evaluated for the proposed thermal annealing conditions of 
paragraph (b)(1)(iv) of this section have not been exceeded, and to 
determine the thermal annealing time and temperature to be used in 
quantifying the fracture toughness recovery. The requalification 
inspection and test program must demonstrate that the thermal annealing 
operation has not degraded the reactor vessel, attached piping or 
appurtenances, or the adjacent concrete structures to a degree that 
could affect the safe operation of the reactor.
    (3) Fracture Toughness Recovery and Reembrittlement Trend Assurance 
Program. The percent recovery of RTNDT and Charpy upper-shelf 
energy due to the thermal annealing treatment must be determined based 
on the time and temperature of the actual vessel thermal anneal. The 
recovery of RTNDT and Charpy upper-shelf energy provide the 
basis for establishing the post-anneal RTNDT and Charpy 
upper-shelf energy for each vessel material. Changes in the 
RTNDT and Charpy upper-shelf energy with subsequent plant 
operation must be determined using the post-anneal values of these 
parameters in conjunction with the projected reembrittlement trend 
determined in accordance with paragraph (b)(3)(ii) of this section. 
Recovery and reembrittlement evaluations shall include:
    (i) Recovery Evaluations. (A) The percent recovery of both 
RTNDT and Charpy upper-shelf energy must be determined by one 
of the procedures described in paragraph (e) of this section, using the 
proposed lower bound thermal annealing time and temperature conditions 
described in the operating plan.
    (B) If the percent recovery is determined from testing surveillance 
specimens or from testing materials removed from the reactor vessel, 
then it shall be demonstrated that the proposed thermal annealing 
parameters used in the test program are equal to or bounded by those 
used in the vessel annealing operation.
    (C) If generic computational methods are used, appropriate 
justification must be submitted as a part of the application.
    (ii) Reembrittlement Evaluations. (A) The projected post-anneal 
reembrittlement of RTNDT must be calculated using the 
procedures in Sec.50.61(c), or must be determined using the same basis 
as that used for the pre-anneal operating period. The projected change 
due to post-anneal reembrittlement for Charpy upper-shelf energy must be 
determined using the same basis as that used for the pre-anneal 
operating period.
    (B) The post-anneal reembrittlement trend of both RTNDT 
and Charpy upper-shelf energy must be estimated, and must be monitored 
using a surveillance program defined in the Thermal Annealing Report and 
which conforms to the intent of appendix H of this part, ``Reactor 
Vessel Material Surveillance Program Requirements.''
    (4) Identification of Changes Requiring a License Amendment. Any 
changes to the facility as described in the final safety analysis report 
(as updated) which requires a license amendment pursuant to Sec.
50.59(c)(2) of this part, and any changes to the Technical 
Specifications, which are necessary to either conduct the thermal 
annealing or to operate the nuclear power reactor following the 
annealing must be identified. The section shall demonstrate that the 
Commission's requirements continue to be complied with, and that there 
is reasonable assurance of adequate protection to the public health and 
safety following the changes.
    (c) Completion or Termination of Thermal Annealing. (1) If the 
thermal annealing was completed in accordance with the Thermal Annealing 
Operating Plan and the Requalification Inspection and Test Program, the 
licensee shall so confirm in writing to the Director, Office of Nuclear 
Reactor Regulation. The licensee may restart its reactor after the 
requirements of paragraph (f)(2) of this section have been met.
    (2) If the thermal annealing was completed but the annealing was not 
performed in accordance with the Thermal

[[Page 979]]

Annealing Operating Plan and the Requalification Inspection and Test 
Program, the licensee shall submit a summary of lack of compliance with 
the Thermal Annealing Operating Plan and the Requalification Inspection 
and Test Program and a justification for subsequent operation to the 
Director, Office of Nuclear Reactor Regulation. Any changes to the 
facility as described in the final safety analysis report (as updated) 
which are attributable to the noncompliances and which require a license 
amendment pursuant to Sec.50.59(c)(2) and any changes to the Technical 
Specifications shall also be identified.
    (i) If no changes requiring a license amendment pursuant to Sec.
50.59(c)(2) or changes to Technical Specifications are identified, the 
licensee may restart its reactor after the requirements of paragraph 
(f)(2) of this section have been met.
    (ii) If any changes requiring a license amendment pursuant to Sec.
50.59(c)(2) or changes to the Technical Specifications are identified, 
the licensee may not restart its reactor until approval is obtained from 
the Director, Office of Nuclear Reactor Regulation and the requirements 
of paragraph (f)(2) of this section have been met.
    (3) If the thermal annealing was terminated prior to completion, the 
licensee shall immediately notify the NRC of the premature termination 
of the thermal anneal.
    (i) If the partial annealing was otherwise performed in accordance 
with the Thermal Annealing Operating Plan and relevant portions of the 
Requalification Inspection and Test Program, and the licensee does not 
elect to take credit for any recovery, the licensee need not submit the 
Thermal Annealing Results Report required by paragraph (d) of this 
section but instead shall confirm in writing to the Director, Office of 
Nuclear Reactor Regulation that the partial annealing was otherwise 
performed in accordance with the Thermal Annealing Operating Plan and 
relevant portions of the Requalification Inspection and Test Program. 
The licensee may restart its reactor after the requirements of paragraph 
(f)(2) of this section have been met.
    (ii) If the partial annealing was otherwise performed in accordance 
with the Thermal Annealing Operating Plan and relevant portions of the 
Requalification Inspection and Test Program, and the licensee elects to 
take full or partial credit for the partial annealing, the licensee 
shall confirm in writing to the Director, Office of Nuclear Reactor 
Regulation that the partial annealing was otherwise performed in 
compliance with the Thermal Annealing Operating Plan and relevant 
portions of the Requalification Inspection and Test Program. The 
licensee may restart its reactor after the requirements of paragraph 
(f)(2) of this section have been met.
    (iii) If the partial annealing was not performed in accordance with 
the Thermal Annealing Operating Plan and the Requalification Inspection 
and Test Program, the licensee shall submit a summary of lack of 
compliance with the Thermal Annealing Operating Plan and the 
Requalification Inspection and Test Program and a justification for 
subsequent operation to the Director, Office of Nuclear Reactor 
Regulation. Any changes to the facility as described in the final safety 
analysis report (as updated) which are attributable to the 
noncompliances and which require a license amendment pursuant to Sec.
50.59(c)(2) and any changes to the technical specifications which are 
required as a result of the noncompliances, shall also be identified.
    (A) If no changes requiring a license amendment pursuant to Sec.
50.59(c)(2) or changes to Technical Specifications are identified, the 
licensee may restart its reactor after the requirements of paragraph 
(f)(2) of this section have been met.
    (B) If any changes requiring a license amendment pursuant to Sec.
50.59(c)(2) or changes to Technical Specifications are identified, the 
licensee may not restart its reactor until approval is obtained from the 
Director, Office of Nuclear Reactor Regulation and the requirements of 
paragraph (f)(2) of this section have been met.
    (d) Thermal Annealing Results Report. Every licensee that either 
completes a thermal annealing, or that terminates an annealing but 
elects to take full or

[[Page 980]]

partial credit for the annealing, shall provide the following 
information within three months of completing the thermal anneal, unless 
an extension is authorized by the Director, Office of Nuclear Reactor 
Regulation:
    (1) The time and temperature profiles of the actual thermal 
annealing;
    (2) The post-anneal RTNDT and Charpy upper-shelf energy 
values of the reactor vessel materials for use in subsequent reactor 
operation;
    (3) The projected post-anneal reembrittlement trends for both 
RTNDT and Charpy upper-shelf energy; and
    (4) The projected values of RTPTS and Charpy upper-shelf 
energy at the end of the proposed period of operation addressed in the 
Thermal Annealing Report.
    (e) Procedures for Determining the Recovery of Fracture Toughness. 
The procedures of this paragraph must be used to determine the percent 
recovery of [Delta]RTNDT, Rt, and percent recovery 
of Charpy upper-shelf energy, Ru. In all cases, Rt 
and Ru may not exceed 100.
    (1) For those reactors with surveillance programs which have 
developed credible surveillance data as defined in Sec.50.61, percent 
recovery due to thermal annealing (Rt and Ru) must 
be evaluated by testing surveillance specimens that have been withdrawn 
from the surveillance program and that have been annealed under the same 
time and temperature conditions as those given the beltline material.
    (2) Alternatively, the percent recovery due to thermal annealing 
(Rt and Ru) may be determined from the results of 
a verification test program employing materials removed from the 
beltline region of the reactor vessel \6\ and that have been annealed 
under the same time and temperature conditions as those given the 
beltline material.
---------------------------------------------------------------------------

    \6\ For those cases where materials are removed from the beltline of 
the pressure vessel, the stress limits of the applicable portions of the 
ASME Code Section III must be satisfied, including consideration of 
fatigue and corrosion, regardless of the Code of record for the vessel 
design.
---------------------------------------------------------------------------

    (3) Generic computational methods may be used to determine recovery 
if adequate justification is provided.
    (f) Public information and participation. (1) Upon receipt of a 
Thermal Annealing Report, and a minimum of 30 days before the licensee 
starts thermal annealing, the Commission shall:
    (i) Notify and solicit comments from local and State governments in 
the vicinity of the site where the thermal annealing will take place and 
any Indian Nation or other indigenous people that have treaty or 
statutory rights that could be affected by the thermal annealing,
    (ii) Publish a notice of a public meeting in the Federal Register 
and in a forum, such as local newspapers, which is readily accessible to 
individuals in the vicinity of the site, to solicit comments from the 
public, and
    (iii) Hold a public meeting on the licensee's Thermal Annealing 
Report.
    (2) Within 15 days after the NRC's receipt of the licensee 
submissions required by paragraphs (c)(1), (c)(2) and (c)(3)(i) through 
(iii) of this section, the NRC staff shall make available at the NRC Web 
site, http://www.nrc.gov, a summary of its inspection of the licensee's 
thermal annealing, and the Commission shall hold a public meeting:
    (i) For the licensee to explain to NRC and the public the results of 
the reactor pressure vessel annealing,
    (ii) for the NRC to discuss its inspection of the reactor vessel 
annealing, and
    (iii) for the NRC to receive public comments on the annealing.
    (3) Within 45 days of NRC's receipt of the licensee submissions 
required by paragraphs (c)(1), (c)(2) and (c)(3)(i) through (iii) of 
this section, the NRC staff shall complete full documentation of its 
inspection of the licensee's annealing process and make available this 
documentation at the NRC Web site, http://www.nrc.gov.

[60 FR 65472, Dec. 19, 1995, as amended at 64 FR 48952, Sept. 9, 1999; 
64 FR 53613, Oct. 4, 1999]

    Effective Date Note: See 64 FR 53582, Oct. 4, 1999, for 
effectiveness of Sec.50.66 (b) introductory text, paragraphs (b)(4), 
(c)(2), and (c)(3)(iii).

[[Page 981]]



Sec.50.67  Accident source term.

    (a) Applicability. The requirements of this section apply to all 
holders of operating licenses issued prior to January 10, 1997, and 
holders of renewed licenses under part 54 of this chapter whose initial 
operating license was issued prior to January 10, 1997, who seek to 
revise the current accident source term used in their design basis 
radiological analyses.
    (b) Requirements. (1) A licensee who seeks to revise its current 
accident source term in design basis radiological consequence analyses 
shall apply for a license amendment under Sec.50.90. The application 
shall contain an evaluation of the consequences of applicable design 
basis accidents \1\ previously analyzed in the safety analysis report.
---------------------------------------------------------------------------

    \1\ The fission product release assumed for these calculations 
should be based upon a major accident, hypothesized for purposes of 
design analyses or postulated from considerations of possible accidental 
events, that would result in potential hazards not exceeded by those 
from any accident considered credible. Such accidents have generally 
been assumed to result in substantial meltdown of the core with 
subsequent release of appreciable quantities of fission products.
---------------------------------------------------------------------------

    (2) The NRC may issue the amendment only if the applicant's analysis 
demonstrates with reasonable assurance that:
    (i) An individual located at any point on the boundary of the 
exclusion area for any 2-hour period following the onset of the 
postulated fission product release, would not receive a radiation dose 
in excess of 0.25 Sv (25 rem) \2\ total effective dose equivalent 
(TEDE).
---------------------------------------------------------------------------

    \2\ The use of 0.25 Sv (25 rem) TEDE is not intended to imply that 
this value constitutes an acceptable limit for emergency doses to the 
public under accident conditions. Rather, this 0.25 Sv (25 rem) TEDE 
value has been stated in this section as a reference value, which can be 
used in the evaluation of proposed design basis changes with respect to 
potential reactor accidents of exceedingly low probability of occurrence 
and low risk of public exposure to radiation.
---------------------------------------------------------------------------

    (ii) An individual located at any point on the outer boundary of the 
low population zone, who is exposed to the radioactive cloud resulting 
from the postulated fission product release (during the entire period of 
its passage), would not receive a radiation dose in excess of 0.25 Sv 
(25 rem) total effective dose equivalent (TEDE).
    (iii) Adequate radiation protection is provided to permit access to 
and occupancy of the control room under accident conditions without 
personnel receiving radiation exposures in excess of 0.05 Sv (5 rem) 
total effective dose equivalent (TEDE) for the duration of the accident.

[64 FR 72001, Dec. 23, 1999]



Sec.50.68  Criticality accident requirements.

    (a) Each holder of a construction permit or operating license for a 
nuclear power reactor issued under this part or a combined license for a 
nuclear power reactor issued under part 52 of this chapter, shall comply 
with either 10 CFR 70.24 of this chapter or the requirements in 
paragraph (b) of this section.
    (b) Each licensee shall comply with the following requirements in 
lieu of maintaining a monitoring system capable of detecting a 
criticality as described in 10 CFR 70.24:
    (1) Plant procedures shall prohibit the handling and storage at any 
one time of more fuel assemblies than have been determined to be safely 
subcritical under the most adverse moderation conditions feasible by 
unborated water.
    (2) The estimated ratio of neutron production to neutron absorption 
and leakage (k-effective) of the fresh fuel in the fresh fuel storage 
racks shall be calculated assuming the racks are loaded with fuel of the 
maximum fuel assembly reactivity and flooded with unborated water and 
must not exceed 0.95, at a 95 percent probability, 95 percent confidence 
level. This evaluation need not be performed if administrative controls 
and/or design features prevent such flooding or if fresh fuel storage 
racks are not used.
    (3) If optimum moderation of fresh fuel in the fresh fuel storage 
racks occurs when the racks are assumed to be loaded with fuel of the 
maximum fuel assembly reactivity and filled with low-density hydrogenous 
fluid, the k-effective corresponding to this optimum moderation must not 
exceed 0.98, at a 95 percent probability, 95 percent

[[Page 982]]

confidence level. This evaluation need not be performed if 
administrative controls and/or design features prevent such moderation 
or if fresh fuel storage racks are not used.
    (4) If no credit for soluble boron is taken, the k-effective of the 
spent fuel storage racks loaded with fuel of the maximum fuel assembly 
reactivity must not exceed 0.95, at a 95 percent probability, 95 percent 
confidence level, if flooded with unborated water. If credit is taken 
for soluble boron, the k-effective of the spent fuel storage racks 
loaded with fuel of the maximum fuel assembly reactivity must not exceed 
0.95, at a 95 percent probability, 95 percent confidence level, if 
flooded with borated water, and the k-effective must remain below 1.0 
(subcritical), at a 95 percent probability, 95 percent confidence level, 
if flooded with unborated water.
    (5) The quantity of SNM, other than nuclear fuel stored onsite, is 
less than the quantity necessary for a critical mass.
    (6) Radiation monitors are provided in storage and associated 
handling areas when fuel is present to detect excessive radiation levels 
and to initiate appropriate safety actions.
    (7) The maximum nominal U-235 enrichment of the fresh fuel 
assemblies is limited to five (5.0) percent by weight.
    (8) The FSAR is amended no later than the next update which Sec.
50.71(e) of this part requires, indicating that the licensee has chosen 
to comply with Sec.50.68(b).
    (c) While a spent fuel transportation package approved under Part 71 
of this chapter or spent fuel storage cask approved under Part 72 of 
this chapter is in the spent fuel pool:
    (1) The requirements in Sec.50.68(b) do not apply to the fuel 
located within that package or cask; and
    (2) The requirements in Part 71 or 72 of this chapter, as 
applicable, and the requirements of the Certificate of Compliance for 
that package or cask, apply to the fuel within that package or cask.

[63 FR 63130, Nov. 12, 1998, as amended at 71 FR 66652, Nov. 16, 2006]



Sec.50.69  Risk-informed categorization and treatment of structures,
systems and components for nuclear power reactors.

    (a) Definitions.
    Risk-Informed Safety Class (RISC)-1 structures, systems, and 
components (SSCs) means safety-related SSCs that perform safety 
significant functions.
    Risk-Informed Safety Class (RISC)-2 structures, systems and 
components (SSCs) means nonsafety-related SSCs that perform safety 
significant functions.
    Risk-Informed Safety Class (RISC)-3 structures, systems and 
components (SSCs) means safety-related SSCs that perform low safety 
significant functions.
    Risk-Informed Safety Class (RISC)-4 structures, systems and 
components (SSCs) means nonsafety-related SSCs that perform low safety 
significant functions.
    Safety significant function means a function whose degradation or 
loss could result in a significant adverse effect on defense-in-depth, 
safety margin, or risk.
    (b) Applicability and scope of risk-informed treatment of SSCs and 
submittal/approval process. (1) A holder of a license to operate a light 
water reactor (LWR) nuclear power plant under this part; a holder of a 
renewed LWR license under part 54 of this chapter; an applicant for a 
construction permit or operating license under this part; or an 
applicant for a design approval, a combined license, or manufacturing 
license under part 52 of this chapter; may voluntarily comply with the 
requirements in this section as an alternative to compliance with the 
following requirements for RISC-3 and RISC-4 SSCs:
    (i) 10 CFR part 21.
    (ii) The portion of 10 CFR 50.46a(b) that imposes requirements to 
conform to Appendix B to 10 CFR part 50.
    (iii) 10 CFR 50.49.
    (iv) 10 CFR 50.55(e).
    (v) The inservice testing requirements in 10 CFR 50.55a(f); the 
inservice inspection, and repair and replacement (with the exception of 
fracture toughness), requirements for ASME Class 2 and Class 3 SSCs in 
10 CFR 50.55a(g); and the electrical component quality

[[Page 983]]

and qualification requirements in Section 4.3 and 4.4 of IEEE 279, and 
Sections 5.3 and 5.4 of IEEE 603-1991, as incorporated by reference in 
10 CFR 50.55a(h).
    (vi) 10 CFR 50.65, except for paragraph (a)(4).
    (vii) 10 CFR 50.72.
    (viii) 10 CFR 50.73.
    (ix) Appendix B to 10 CFR part 50.
    (x) The Type B and Type C leakage testing requirements in both 
Options A and B of Appendix J to 10 CFR part 50, for penetrations and 
valves meeting the following criteria:
    (A) Containment penetrations that are either 1-inch nominal size or 
less, or continuously pressurized.
    (B) Containment isolation valves that meet one or more of the 
following criteria:
    (1) The valve is required to be open under accident conditions to 
prevent or mitigate core damage events;
    (2) The valve is normally closed and in a physically closed, water-
filled system;
    (3) The valve is in a physically closed system whose piping pressure 
rating exceeds the containment design pressure rating and is not 
connected to the reactor coolant pressure boundary; or
    (4) The valve is 1-inch nominal size or less.
    (xi) Appendix A to part 100, Sections VI(a)(1) and VI(a)(2), to the 
extent that these regulations require qualification testing and specific 
engineering methods to demonstrate that SSCs are designed to withstand 
the Safe Shutdown Earthquake and Operating Basis Earthquake.
    (2) A licensee voluntarily choosing to implement this section shall 
submit an application for license amendment under Sec.50.90 that 
contains the following information:
    (i) A description of the process for categorization of RISC-1, RISC-
2, RISC-3 and RISC-4 SSCs.
    (ii) A description of the measures taken to assure that the quality 
and level of detail of the systematic processes that evaluate the plant 
for internal and external events during normal operation, low power, and 
shutdown (including the plant-specific probabilistic risk assessment 
(PRA), margins-type approaches, or other systematic evaluation 
techniques used to evaluate severe accident vulnerabilities) are 
adequate for the categorization of SSCs.
    (iii) Results of the PRA review process conducted to meet Sec.
50.69(c)(1)(i).
    (iv) A description of, and basis for acceptability of, the 
evaluations to be conducted to satisfy Sec.50.69(c)(1)(iv). The 
evaluations must include the effects of common cause interaction 
susceptibility, and the potential impacts from known degradation 
mechanisms for both active and passive functions, and address internally 
and externally initiated events and plant operating modes (e.g., full 
power and shutdown conditions).
    (3) The Commission will approve a licensee's implementation of this 
section if it determines that the process for categorization of RISC-1, 
RISC-2, RISC-3, and RISC-4 SSCs satisfies the requirements of Sec.
50.69(c) by issuing a license amendment approving the licensee's use of 
this section.
    (4) An applicant choosing to implement this section shall include 
the information in Sec.50.69(b)(2) as part of application. The 
Commission will approve an applicant's implementation of this section if 
it determines that the process for categorization of RISC-1, RISC-2, 
RISC-3, and RISC-4 SSCs satisfies the requirements of Sec.50.69(c).
    (c) SSC Categorization Process. (1) SSCs must be categorized as 
RISC-1, RISC-2, RISC-3, or RISC-4 SSCs using a categorization process 
that determines if an SSC performs one or more safety significant 
functions and identifies those functions. The process must:
    (i) Consider results and insights from the plant-specific PRA. This 
PRA must at a minimum model severe accident scenarios resulting from 
internal initiating events occurring at full power operation. The PRA 
must be of sufficient quality and level of detail to support the 
categorization process, and must be subjected to a peer review process 
assessed against a standard or set of acceptance criteria that is 
endorsed by the NRC.
    (ii) Determine SSC functional importance using an integrated, 
systematic process for addressing initiating events (internal and 
external), SSCs, and plant operating modes, including those

[[Page 984]]

not modeled in the plant-specific PRA. The functions to be identified 
and considered include design bases functions and functions credited for 
mitigation and prevention of severe accidents. All aspects of the 
integrated, systematic process used to characterize SSC importance must 
reasonably reflect the current plant configuration and operating 
practices, and applicable plant and industry operational experience.
    (iii) Maintain defense-in-depth.
    (iv) Include evaluations that provide reasonable confidence that for 
SSCs categorized as RISC-3, sufficient safety margins are maintained and 
that any potential increases in core damage frequency (CDF) and large 
early release frequency (LERF) resulting from changes in treatment 
permitted by implementation of Sec. Sec.50.69(b)(1) and (d)(2) are 
small.
    (v) Be performed for entire systems and structures, not for selected 
components within a system or structure.
    (2) The SSCs must be categorized by an Integrated Decision-Making 
Panel (IDP) staffed with expert, plant-knowledgeable members whose 
expertise includes, at a minimum, PRA, safety analysis, plant operation, 
design engineering, and system engineering.
    (d) Alternative treatment requirements--(1) RISC-1 and RISC 2 SSCs. 
The licensee or applicant shall ensure that RISC-1 and RISC-2 SSCs 
perform their functions consistent with the categorization process 
assumptions by evaluating treatment being applied to these SSCs to 
ensure that it supports the key assumptions in the categorization 
process that relate to their assumed performance.
    (2) RISC-3 SSCs. The licensee or applicant shall ensure, with 
reasonable confidence, that RISC-3 SSCs remain capable of performing 
their safety-related functions under design basis conditions, including 
seismic conditions and environmental conditions and effects throughout 
their service life. The treatment of RISC-3 SSCs must be consistent with 
the categorization process. Inspection and testing, and corrective 
action shall be provided for RISC-3 SSCs.
    (i) Inspection and testing. Periodic inspection and testing 
activities must be conducted to determine that RISC-3 SSCs will remain 
capable of performing their safety-related functions under design basis 
conditions; and
    (ii) Corrective action. Conditions that would prevent a RISC-3 SSC 
from performing its safety-related functions under design basis 
conditions must be corrected in a timely manner. For significant 
conditions adverse to quality, measures must be taken to provide 
reasonable confidence that the cause of the condition is determined and 
corrective action taken to preclude repetition.
    (e) Feedback and process adjustment--(1) RISC-1, RISC-2, RISC-3 and 
RISC-4 SSCs. The licensee shall review changes to the plant, operational 
practices, applicable plant and industry operational experience, and, as 
appropriate, update the PRA and SSC categorization and treatment 
processes. The licensee shall perform this review in a timely manner but 
no longer than once every two refueling outages.
    (2) RISC-1 and RISC-2 SSCs. The licensee shall monitor the 
performance of RISC-1 and RISC-2 SSCs. The licensee shall make 
adjustments as necessary to either the categorization or treatment 
processes so that the categorization process and results are maintained 
valid.
    (3) RISC-3 SSCs. The licensee shall consider data collected in Sec.
50.69(d)(2)(i) for RISC-3 SSCs to determine if there are any adverse 
changes in performance such that the SSC unreliability values approach 
or exceed the values used in the evaluations conducted to satisfy Sec.
50.69(c)(1)(iv). The licensee shall make adjustments as necessary to the 
categorization or treatment processes so that the categorization process 
and results are maintained valid.
    (f) Program documentation, change control and records. (1) The 
licensee or applicant shall document the basis for its categorization of 
any SSC under paragraph (c) of this section before removing any 
requirements under Sec.50.69(b)(1) for those SSCs.
    (2) Following implementation of this section, licensees and 
applicants shall update their final safety analysis report (FSAR) to 
reflect which systems have been categorized, in accordance with Sec.
50.71(e).

[[Page 985]]

    (3) When a licensee first implements this section for a SSC, changes 
to the FSAR for the implementation of the changes in accordance with 
Sec.50.69(d) need not include a supporting Sec.50.59 evaluation of 
the changes directly related to implementation. Thereafter, changes to 
the programs and procedures for implementation of Sec.50.69(d), as 
described in the FSAR, may be made if the requirements of this section 
and Sec.50.59 continue to be met.
    (4) When a licensee first implements this section for a SSC, changes 
to the quality assurance plan for the implementation of the changes in 
accordance with Sec.50.69(d) need not include a supporting Sec.
50.54(a) review of the changes directly related to implementation. 
Thereafter, changes to the programs and procedures for implementation of 
Sec.50.69(d), as described in the quality assurance plan may be made 
if the requirements of this section and Sec.50.54(a) continue to be 
met.
    (g) Reporting. The licensee shall submit a licensee event report 
under Sec.50.73(b) for any event or condition that prevented, or would 
have prevented, a RISC-1 or RISC-2 SSC from performing a safety 
significant function.

[69 FR 68047, Nov. 22, 2004]

              Inspections, Records, Reports, Notifications



Sec.50.70  Inspections.

    (a) Each applicant for or holder of a license, including a 
construction permit or an early site permit, shall permit inspection, by 
duly authorized representatives of the Commission, of his records, 
premises, activities, and of licensed materials in possession or use, 
related to the license or construction permit or early site permit as 
may be necessary to effectuate the purposes of the Act, as amended, 
including Section 105 of the Act, and the Energy Reorganization Act of 
1974, as amended.
    (b)(1) Each licensee and each holder of a construction permit shall, 
upon request by the Director, Office of Nuclear Reactor Regulation or 
Director, Office of New Reactors, as appropriate, provide rent-free 
office space for the exclusive use of the Commission inspection 
personnel. Heat, air conditioning, light, electrical outlets, and 
janitorial services shall be furnished by each licensee and each holder 
of a construction permit. The office shall be convenient to and have 
full access to the facility and shall provide the inspector both visual 
and acoustic privacy.
    (2) For a site with a single power reactor or fuel facility licensed 
under part 50 or part 52 of this chapter, or a facility issued a 
manufacturing license under part 52, the space provided shall be 
adequate to accommodate a full-time inspector, a part-time secretary and 
transient NRC personnel and will be generally commensurate with other 
office facilities at the site. A space of 250 square feet either within 
the site's office complex or in an office trailer or other onsite space 
is suggested as a guide. For sites containing multiple power reactor 
units or fuel facilities, additional space may be requested to 
accommodate additional full-time inspector(s). The office space that is 
provided shall be subject to the approval of the Director, Office of New 
Reactors, or the Director, Office of Nuclear Reactor Regulation. All 
furniture, supplies and communication equipment will be furnished by the 
Commission.
    (3) The licensee or construction permit holder shall afford any NRC 
resident inspector assigned to that site, or other NRC inspectors 
identified by the Regional Administrator as likely to inspect the 
facility, immediate unfettered access, equivalent to access provided 
regular plant employees, following proper identification and compliance 
with applicable access control measures for security, radiological 
protection and personal safety.
    (4) The licensee or construction permit holder (nuclear power 
reactor only) shall ensure that the arrival and presence of an NRC 
inspector, who has been properly authorized facility access as described 
in paragraph (b)(3) of this section, is not announced or otherwise 
communicated by its employees or contractors to other persons at the 
facility unless specifically requested by the NRC inspector.

[21 FR 355, Jan. 19, 1956; 44 FR 47919, Aug. 16, 1979, as amended at 52 
FR 31612, Aug. 21, 1987; 53 FR 42942, Oct. 25, 1988; 72 FR 49501, Aug. 
28, 2007; 73 FR 5722, Jan. 31, 2008; 75 FR 73944, Nov. 30, 2010]

[[Page 986]]



Sec.50.71  Maintenance of records, making of reports.

    (a) Each licensee, including each holder of a construction permit or 
early site permit, shall maintain all records and make all reports, in 
connection with the activity, as may be required by the conditions of 
the license or permit or by the regulations, and orders of the 
Commission in effectuating the purposes of the Act, including Section 
105 of the Act, and the Energy Reorganization Act of 1974, as amended. 
Reports must be submitted in accordance with Sec.50.4 or 10 CFR 52.3, 
as applicable.
    (b) With respect to any production or utilization facility of a type 
described in Sec.50.21(b) or 50.22, or a testing facility, each 
licensee and each holder of a construction permit shall submit its 
annual financial report, including the certified financial statements, 
to the Commission, as specified in Sec.50.4, upon issuance of the 
report. However, licensees and holders of a construction permit who 
submit a Form 10-Q with the Securities and Exchange Commission or a Form 
1 with the Federal Energy Regulatory Commission, need not submit the 
annual financial report or the certified financial statement under this 
paragraph.
    (c) Records that are required by the regulations in this part or 
part 52 of this chapter, by license condition, or by technical 
specifications must be retained for the period specified by the 
appropriate regulation, license condition, or technical specification. 
If a retention period is not otherwise specified, these records must be 
retained until the Commission terminates the facility license or, in the 
case of an early site permit, until the permit expires.
    (d)(1) Records which must be maintained under this part or part 52 
of this chapter may be the original or a reproduced copy or microform if 
the reproduced copy or microform is duly authenticated by authorized 
personnel and the microform is capable of producing a clear and legible 
copy after storage for the period specified by Commission regulations. 
The record may also be stored in electronic media with the capability of 
producing legible, accurate, and complete records during the required 
retention period. Records such as letters, drawings, and specifications, 
must include all pertinent information such as stamps, initials, and 
signatures. The licensee shall maintain adequate safeguards against 
tampering with, and loss of records.
    (2) If there is a conflict between the Commission's regulations in 
this part, license condition, or technical specification, or other 
written Commission approval or authorization pertaining to the retention 
period for the same type of record, the retention period specified in 
the regulations in this part for such records shall apply unless the 
Commission, pursuant to Sec.50.12 of this part, has granted a specific 
exemption from the record retention requirements specified in the 
regulations in this part.
    (e) Each person licensed to operate a nuclear power reactor under 
the provisions of Sec.50.21 or Sec.50.22, and each applicant for a 
combined license under part 52 of this chapter, shall update 
periodically, as provided in paragraphs (e) (3) and (4) of this section, 
the final safety analysis report (FSAR) originally submitted as part of 
the application for the license, to assure that the information included 
in the report contains the latest information developed. This submittal 
shall contain all the changes necessary to reflect information and 
analyses submitted to the Commission by the applicant or licensee or 
prepared by the applicant or licensee pursuant to Commission requirement 
since the submittal of the original FSAR, or as appropriate, the last 
update to the FSAR under this section. The submittal shall include the 
effects \1\ of all changes made in the facility or procedures as 
described in the FSAR; all safety analyses and evaluations performed by 
the applicant or licensee either in support of approved license 
amendments or in support of conclusions that changes did not require a 
license amendment in accordance with Sec.50.59(c)(2) or, in the case 
of a license that references a certified design, in

[[Page 987]]

accordance with Sec.52.98(c) of this chapter; and all analyses of new 
safety issues performed by or on behalf of the applicant or licensee at 
Commission request. The updated information shall be appropriately 
located within the update to the FSAR.
---------------------------------------------------------------------------

    \1\ Effects of changes includes appropriate revisions of 
descriptions in the FSAR such that the FSAR (as updated) is complete and 
accurate.
---------------------------------------------------------------------------

    (1) The licensee shall submit revisions containing updated 
information to the Commission, as specified in Sec.50.4, on a 
replacement-page basis that is accompanied by a list which identifies 
the current pages of the FSAR following page replacement.
    (2) The submittal shall include (i) a certification by a duly 
authorized officer of the licensee that either the information 
accurately presents changes made since the previous submittal, necessary 
to reflect information and analyses submitted to the Commission or 
prepared pursuant to Commission requirement, or that no such changes 
were made; and (ii) an identification of changes made under the 
provisions of Sec.50.59 but not previously submitted to the 
Commission.
    (3)(i) A revision of the original FSAR containing those original 
pages that are still applicable plus new replacement pages shall be 
filed within 24 months of either July 22, 1980, or the date of issuance 
of the operating license, whichever is later, and shall bring the FSAR 
up to date as of a maximum of 6 months prior to the date of filing the 
revision.
    (ii) Not less than 15 days before Sec.50.71(e) becomes effective, 
the Director of the Office of Nuclear Reactor Regulation shall notify by 
letter the licensees of those nuclear power plants initially subject to 
the NRC's systematic evaluation program that they need not comply with 
the provisions of this section while the program is being conducted at 
their plant. The Director of the Office of Nuclear Reactor Regulation 
will notify by letter the licensee of each nuclear power plant being 
evaluated when the systematic evaluation program has been completed. 
Within 24 months after receipt of this notification, the licensee shall 
file a complete FSAR which is up to date as of a maximum of 6 months 
prior to the date of filing the revision.
    (iii) During the period from the docketing of an application for a 
combined license under subpart C of part 52 of this chapter until the 
Commission makes the finding under Sec.52.103(g) of this chapter, the 
update to the FSAR must be submitted annually.
    (4) Subsequent revisions must be filed annually or 6 months after 
each refueling outage provided the interval between successive updates 
does not exceed 24 months. The revisions must reflect all changes up to 
a maximum of 6 months prior to the date of filling. For nuclear power 
reactor facilities that have submitted the certifications required by 
Sec.50.82(a)(1), subsequent revisions must be filed every 24 months.
    (5) Each replacement page shall include both a change indicator for 
the area changed, e.g., a bold line vertically drawn in the margin 
adjacent to the portion actually changed, and a page change 
identification (date of change or change number or both).
    (6) The updated FSAR shall be retained by the licensee until the 
Commission terminates their license.
    (f) Each person licensed to manufacture a nuclear power reactor 
under subpart F of 10 CFR part 52 shall update the FSAR originally 
submitted as part of the application to reflect any modification to the 
design that is approved by the Commission under Sec.52.171 of this 
chapter, and any new analyses of the design performed by or on behalf of 
the licensee at the NRC's request. This submittal shall contain all the 
changes necessary to reflect information and analyses submitted to the 
Commission by the licensee or prepared by the licensee with respect to 
the modification approved under Sec.52.171 of this chapter or the 
analyses requested by the Commission under Sec.52.171 of this chapter. 
The updated information shall be appropriately located within the update 
to the FSAR.
    (g) The provisions of this section apply to nuclear power reactor 
licensees that have submitted the certification of permanent cessation 
of operations required under Sec. Sec.50.82(a)(1)(i) or 52.110(a)(1) 
of this chapter. The provisions of paragraphs (a), (c), and (d) of this 
section also apply to non-power reactor licensees that are no longer 
authorized to operate.
    (h)(1) No later than the scheduled date for initial loading of fuel, 
each

[[Page 988]]

holder of a combined license under subpart C of 10 CFR part 52 shall 
develop a level 1 and a level 2 probabilistic risk assessment (PRA). The 
PRA must cover those initiating events and modes for which NRC-endorsed 
consensus standards on PRA exist one year prior to the scheduled date 
for initial loading of fuel.
    (2) Each holder of a combined license shall maintain and upgrade the 
PRA required by paragraph (h)(1) of this section. The upgraded PRA must 
cover initiating events and modes of operation contained in NRC-endorsed 
consensus standards on PRA in effect one year prior to each required 
upgrade. The PRA must be upgraded every four years until the permanent 
cessation of operations under Sec.52.110(a) of this chapter.
    (3) Each holder of a combined license shall, no later than the date 
on which the licensee submits an application for a renewed license, 
upgrade the PRA required by paragraph (h)(1) of this section to cover 
all modes and all initiating events.

[33 FR 9704, July 4, 1968, as amended at 41 FR 18303, May 3, 1976; 45 FR 
30615, May 9, 1980; 51 FR 40310, Nov. 6, 1986; 53 FR 19250, May 27, 
1988; 57 FR 39358, Aug. 31, 1992; 61 FR 39301, July 29, 1996; 64 FR 
53614, Oct. 4, 1999; 71 FR 29246, May 22, 2006; 72 FR 49501, Aug. 28, 
2007]

    Effective Date Note: See 64 FR 53582, Oct. 4, 1999, for 
effectiveness of Sec.50.71(e) introductory text.



Sec.50.72  Immediate notification requirements for operating nuclear
power reactors.

    (a) General requirements.\1\ (1) Each nuclear power reactor licensee 
licensed under Sec. Sec.50.21(b) or 50.22 holding an operating license 
under this part or a combined license under part 52 of this chapter 
after the Commission makes the finding under Sec.52.103(g), shall 
notify the NRC Operations Center via the Emergency Notification System 
of:
---------------------------------------------------------------------------

    \1\ Other requirements for immediate notification of the NRC by 
licensed operating nuclear power reactors are contained elsewhere in 
this chapter, in particular Sec. Sec.20.1906, 20.2202, 50.36, 72.216, 
and 73.71.
---------------------------------------------------------------------------

    (i) The declaration of any of the Emergency Classes specified in the 
licensee's approved Emergency Plan; \2\ or
---------------------------------------------------------------------------

    \2\ These Emergency Classes are addressed in Appendix E of this 
part.
---------------------------------------------------------------------------

    (ii) Those non-emergency events specified in paragraph (b) of this 
section that occurred within three years of the date of discovery.
    (2) If the Emergency Notification System is inoperative, the 
licensee shall make the required notifications via commercial telephone 
service, other dedicated telephone system, or any other method which 
will ensure that a report is made as soon as practical to the NRC 
Operations Center. \3\
---------------------------------------------------------------------------

    \3\ Commercial telephone number of the NRC Operations Center is 
(301) 816-5100.
---------------------------------------------------------------------------

    (3) The licensee shall notify the NRC immediately after notification 
of the appropriate State or local agencies and not later than one hour 
after the time the licensee declares one of the Emergency Classes.
    (4) The licensee shall activate the Emergency Response Data System 
(ERDS) \4\ as soon as possible but not later than one hour after 
declaring an Emergency Class of alert, site area emergency, or general 
emergency. The ERDS may also be activated by the licensee during 
emergency drills or exercises if the licensee's computer system has the 
capability to transmit the exercise data.
---------------------------------------------------------------------------

    \4\ Requirements for ERDS are addressed in Appendix E, Section VI.
---------------------------------------------------------------------------

    (5) When making a report under paragraph (a)(1) of this section, the 
licensee shall identify:
    (i) The Emergency Class declared; or
    (ii) Paragraph (b)(1), ``One-hour reports,'' paragraph (b)(2), 
``Four-hour reports,'' or paragraph (b)(3), ``Eight-hour reports,'' as 
the paragraph of this section requiring notification of the non-
emergency event.
    (b) Non-emergency events--(1) One-hour reports. If not reported as a 
declaration of an Emergency Class under paragraph (a) of this section, 
the licensee shall notify the NRC as soon as practical and in all cases 
within one hour of the occurrence of any deviation from the plant's 
Technical Specifications authorized pursuant to Sec.50.54(x) of this 
part.

[[Page 989]]

    (2) Four-hour reports. If not reported under paragraphs (a) or 
(b)(1) of this section, the licensee shall notify the NRC as soon as 
practical and in all cases, within four hours of the occurrence of any 
of the following:
    (i) The initiation of any nuclear plant shutdown required by the 
plant's Technical Specifications.
    (ii)-(iii) [Reserved]
    (iv)(A) Any event that results or should have resulted in emergency 
core cooling system (ECCS) discharge into the reactor coolant system as 
a result of a valid signal except when the actuation results from and is 
part of a pre-planned sequence during testing or reactor operation.
    (B) Any event or condition that results in actuation of the reactor 
protection system (RPS) when the reactor is critical except when the 
actuation results from and is part of a pre-planned sequence during 
testing or reactor operation.
    (v)-(x) [Reserved]
    (xi) Any event or situation, related to the health and safety of the 
public or onsite personnel, or protection of the environment, for which 
a news release is planned or notification to other government agencies 
has been or will be made. Such an event may include an onsite fatality 
or inadvertent release of radioactively contaminated materials.
    (3) Eight-hour reports. If not reported under paragraphs (a), (b)(1) 
or (b)(2) of this section, the licensee shall notify the NRC as soon as 
practical and in all cases within eight hours of the occurrence of any 
of the following:
    (i) [Reserved]
    (ii) Any event or condition that results in:
    (A) The condition of the nuclear power plant, including its 
principal safety barriers, being seriously degraded; or
    (B) The nuclear power plant being in an unanalyzed condition that 
significantly degrades plant safety.
    (iii) [Reserved]
    (iv)(A) Any event or condition that results in valid actuation of 
any of the systems listed in paragraph (b)(3)(iv)(B) of this section, 
except when the actuation results from and is part of a pre-planned 
sequence during testing or reactor operation.
    (B) The systems to which the requirements of paragraph (b)(3)(iv)(A) 
of this section apply are:
    (1) Reactor protection system (RPS) including: Reactor scram and 
reactor trip. \5\
---------------------------------------------------------------------------

    \5\ Actuation of the RPS when the reactor is critical is reportable 
under paragraph (b)(2)(iv)(B) of this section.
---------------------------------------------------------------------------

    (2) General containment isolation signals affecting containment 
isolation valves in more than one system or multiple main steam 
isolation valves (MSIVs).
    (3) Emergency core cooling systems (ECCS) for pressurized water 
reactors (PWRs) including: High-head, intermediate-head, and low-head 
injection systems and the low pressure injection function of residual 
(decay) heat removal systems.
    (4) ECCS for boiling water reactors (BWRs) including: High-pressure 
and low-pressure core spray systems; high-pressure coolant injection 
system; low pressure injection function of the residual heat removal 
system.
    (5) BWR reactor core isolation cooling system; isolation condenser 
system; and feedwater coolant injection system.
    (6) PWR auxiliary or emergency feedwater system.
    (7) Containment heat removal and depressurization systems, including 
containment spray and fan cooler systems.
    (8) Emergency ac electrical power systems, including: Emergency 
diesel generators (EDGs); hydroelectric facilities used in lieu of EDGs 
at the Oconee Station; and BWR dedicated Division 3 EDGs.
    (v) Any event or condition that at the time of discovery could have 
prevented the fulfillment of the safety function of structures or 
systems that are needed to:
    (A) Shut down the reactor and maintain it in a safe shutdown 
condition;
    (B) Remove residual heat;
    (C) Control the release of radioactive material; or
    (D) Mitigate the consequences of an accident.
    (vi) Events covered in paragraph (b)(3)(v) of this section may 
include one

[[Page 990]]

or more procedural errors, equipment failures, and/or discovery of 
design, analysis, fabrication, construction, and/or procedural 
inadequacies. However, individual component failures need not be 
reported pursuant to paragraph (b)(3)(v) of this section if redundant 
equipment in the same system was operable and available to perform the 
required safety function.
    (vii)-(xi) [Reserved]
    (xii) Any event requiring the transport of a radioactively 
contaminated person to an offsite medical facility for treatment.
    (xiii) Any event that results in a major loss of emergency 
assessment capability, offsite response capability, or offsite 
communications capability (e.g., significant portion of control room 
indication, Emergency Notification System, or offsite notification 
system).
    (c) Followup notification. With respect to the telephone 
notifications made under paragraphs (a) and (b) of this section, in 
addition to making the required initial notification, each licensee, 
shall during the course of the event:
    (1) Immediately report (i) any further degradation in the level of 
safety of the plant or other worsening plant conditions, including those 
that require the declaration of any of the Emergency Classes, if such a 
declaration has not been previously made, or (ii) any change from one 
Emergency Class to another, or (iii) a termination of the Emergency 
Class.
    (2) Immediately report (i) the results of ensuing evaluations or 
assessments of plant conditions, (ii) the effectiveness of response or 
protective measures taken, and (iii) information related to plant 
behavior that is not understood.
    (3) Maintain an open, continuous communication channel with the NRC 
Operations Center upon request by the NRC.

[48 FR 39046, Aug. 29, 1983; 48 FR 40882, Sept. 12, 1983; 55 FR 29194, 
July 18, 1990, as amended at 56 FR 944, Jan. 10, 1991; 56 FR 23473, May 
21, 1991; 56 FR 40184, Aug. 13, 1991; 57 FR 41381, Sept. 10, 1992; 58 FR 
67661, Dec. 22, 1993; 59 FR 14087, Mar. 25, 1994; 65 FR 63786, Oct. 25, 
2000; 72 FR 49502, Aug. 28, 2007]



Sec.50.73  Licensee event report system.

    (a) Reportable events. (1) The holder of an operating license under 
this part or a combined license under part 52 of this chapter (after the 
Commission has made the finding under Sec.52.103(g) of this chapter) 
for a nuclear power plant (licensee) shall submit a Licensee Event 
Report (LER) for any event of the type described in this paragraph 
within 60 days after the discovery of the event. In the case of an 
invalid actuation reported under Sec.50.73(a)(2)(iv), other than 
actuation of the reactor protection system (RPS) when the reactor is 
critical, the licensee may, at its option, provide a telephone 
notification to the NRC Operations Center within 60 days after discovery 
of the event instead of submitting a written LER. Unless otherwise 
specified in this section, the licensee shall report an event if it 
occurred within 3 years of the date of discovery regardless of the plant 
mode or power level, and regardless of the significance of the 
structure, system, or component that initiated the event.
    (2) The licensee shall report:
    (i)(A) The completion of any nuclear plant shutdown required by the 
plant's Technical Specifications.
    (B) Any operation or condition which was prohibited by the plant's 
Technical Specifications except when:
    (1) The Technical Specification is administrative in nature;
    (2) The event consisted solely of a case of a late surveillance test 
where the oversight was corrected, the test was performed, and the 
equipment was found to be capable of performing its specified safety 
functions; or
    (3) The Technical Specification was revised prior to discovery of 
the event such that the operation or condition was no longer prohibited 
at the time of discovery of the event.
    (C) Any deviation from the plant's Technical Specifications 
authorized pursuant to Sec.50.54(x) of this part.
    (ii) Any event or condition that resulted in:
    (A) The condition of the nuclear power plant, including its 
principal safety barriers, being seriously degraded; or

[[Page 991]]

    (B) The nuclear power plant being in an unanalyzed condition that 
significantly degraded plant safety.
    (iii) Any natural phenomenon or other external condition that posed 
an actual threat to the safety of the nuclear power plant or 
significantly hampered site personnel in the performance of duties 
necessary for the safe operation of the nuclear power plant.
    (iv)(A) Any event or condition that resulted in manual or automatic 
actuation of any of the systems listed in paragraph (a)(2)(iv)(B) of 
this section, except when:
    (1) The actuation resulted from and was part of a pre-planned 
sequence during testing or reactor operation; or
    (2) The actuation was invalid and;
    (i) Occurred while the system was properly removed from service; or
    (ii) Occurred after the safety function had been already completed.
    (B) The systems to which the requirements of paragraph (a)(2)(iv)(A) 
of this section apply are:
    (1) Reactor protection system (RPS) including: reactor scram or 
reactor trip.
    (2) General containment isolation signals affecting containment 
isolation valves in more than one system or multiple main steam 
isolation valves (MSIVs).
    (3) Emergency core cooling systems (ECCS) for pressurized water 
reactors (PWRs) including: high-head, intermediate-head, and low-head 
injection systems and the low pressure injection function of residual 
(decay) heat removal systems.
    (4) ECCS for boiling water reactors (BWRs) including: high-pressure 
and low-pressure core spray systems; high-pressure coolant injection 
system; low pressure injection function of the residual heat removal 
system.
    (5) BWR reactor core isolation cooling system; isolation condenser 
system; and feedwater coolant injection system.
    (6) PWR auxiliary or emergency feedwater system.
    (7) Containment heat removal and depressurization systems, including 
containment spray and fan cooler systems.
    (8) Emergency ac electrical power systems, including: emergency 
diesel generators (EDGs); hydroelectric facilities used in lieu of EDGs 
at the Oconee Station; and BWR dedicated Division 3 EDGs.
    (9) Emergency service water systems that do not normally run and 
that serve as ultimate heat sinks.
    (v) Any event or condition that could have prevented the fulfillment 
of the safety function of structures or systems that are needed to:
    (A) Shut down the reactor and maintain it in a safe shutdown 
condition;
    (B) Remove residual heat;
    (C) Control the release of radioactive material; or
    (D) Mitigate the consequences of an accident.
    (vi) Events covered in paragraph (a)(2)(v) of this section may 
include one or more procedural errors, equipment failures, and/or 
discovery of design, analysis, fabrication, construction, and/or 
procedural inadequacies. However, individual component failures need not 
be reported pursuant to paragraph (a)(2)(v) of this section if redundant 
equipment in the same system was operable and available to perform the 
required safety function.
    (vii) Any event where a single cause or condition caused at least 
one independent train or channel to become inoperable in multiple 
systems or two independent trains or channels to become inoperable in a 
single system designed to:
    (A) Shut down the reactor and maintain it in a safe shutdown 
condition;
    (B) Remove residual heat;
    (C) Control the release of radioactive material; or
    (D) Mitigate the consequences of an accident.
    (viii)(A) Any airborne radioactive release that, when averaged over 
a time period of 1 hour, resulted in airborne radionuclide 
concentrations in an unrestricted area that exceeded 20 times the 
applicable concentration limits specified in appendix B to part 20, 
table 2, column 1.
    (B) Any liquid effluent release that, when averaged over a time 
period of 1 hour, exceeds 20 times the applicable concentrations 
specified in appendix B to part 20, table 2, column 2, at the point of 
entry into the receiving waters

[[Page 992]]

(i.e., unrestricted area) for all radionuclides except tritium and 
dissolved noble gases.
    (ix)(A) Any event or condition that as a result of a single cause 
could have prevented the fulfillment of a safety function for two or 
more trains or channels in different systems that are needed to:
    (1) Shut down the reactor and maintain it in a safe shutdown 
condition;
    (2) Remove residual heat;
    (3) Control the release of radioactive material; or
    (4) Mitigate the consequences of an accident.
    (B) Events covered in paragraph (a)(2)(ix)(A) of this section may 
include cases of procedural error, equipment failure, and/or discovery 
of a design, analysis, fabrication, construction, and/or procedural 
inadequacy. However, licensees are not required to report an event 
pursuant to paragraph (a)(2)(ix)(A) of this section if the event results 
from:
    (1) A shared dependency among trains or channels that is a natural 
or expected consequence of the approved plant design; or
    (2) Normal and expected wear or degradation.
    (x) Any event that posed an actual threat to the safety of the 
nuclear power plant or significantly hampered site personnel in the 
performance of duties necessary for the safe operation of the nuclear 
power plant including fires, toxic gas releases, or radioactive 
releases.
    (b) Contents. The Licensee Event Report shall contain:
    (1) A brief abstract describing the major occurrences during the 
event, including all component or system failures that contributed to 
the event and significant corrective action taken or planned to prevent 
recurrence.
    (2)(i) A clear, specific, narrative description of what occurred so 
that knowledgeable readers conversant with the design of commercial 
nuclear power plants, but not familiar with the details of a particular 
plant, can understand the complete event.
    (ii) The narrative description must include the following specific 
information as appropriate for the particular event:
    (A) Plant operating conditions before the event.
    (B) Status of structures, components, or systems that were 
inoperable at the start of the event and that contributed to the event.
    (C) Dates and approximate times of occurrences.
    (D) The cause of each component or system failure or personnel 
error, if known.
    (E) The failure mode, mechanism, and effect of each failed 
component, if known.
    (F) The Energy Industry Identification System component function 
identifier and system name of each component or system referred to in 
the LER.
    (1) The Energy Industry Identification System is defined in: IEEE 
Std 803-1983 (May 16, 1983) Recommended Practice for Unique 
Identification in Power Plants and Related Facilities--Principles and 
Definitions.
    (2) IEEE Std 803-1983 has been approved for incorporation by 
reference by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51.
    (3) A notice of any changes made to the material incorporated by 
reference will be published in the Federal Register. Copies may be 
obtained from the Institute of Electrical and Electronics Engineers, 445 
Hoes Lane, P.O. Box 1331, Piscataway, NJ 08855-1331. IEEE Std 803-1983 
is available for inspection at the NRC's Technical Library, which is 
located in the Two White Flint North Building, 11545 Rockville Pike, 
Rockville, Maryland 20852-2738; or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (G) For failures of components with multiple functions, include a 
list of systems or secondary functions that were also affected.
    (H) For failure that rendered a train of a safety system inoperable, 
an estimate of the elapsed time from the discovery of the failure until 
the train was returned to service.

[[Page 993]]

    (I) The method of discovery of each component or system failure or 
procedural error.
    (J) For each human performance related root cause, the licensee 
shall discuss the cause(s) and circumstances.
    (K) Automatically and manually initiated safety system responses.
    (L) The manufacturer and model number (or other identification) of 
each component that failed during the event.
    (3) An assessment of the safety consequences and implications of the 
event. This assessment must include:
    (i) The availability of systems or components that could have 
performed the same function as the components and systems that failed 
during the event, and
    (ii) For events that occurred when the reactor was shutdown, the 
availability of systems or components that are needed to shutdown the 
reactor and maintain safe shutdown conditions, remove residual heat, 
control the release of radioactive material, or mitigate the 
consequences of an accident.
    (4) A description of any corrective actions planned as a result of 
the event, including those to reduce the probability of similar events 
occurring in the future.
    (5) Reference to any previous similar events at the same plant that 
are known to the licensee.
    (6) The name and telephone number of a person within the licensee's 
organization who is knowledgeable about the event and can provide 
additional information concerning the event and the plant's 
characteristics.
    (c) Supplemental information. The Commission may require the 
licensee to submit specific additional information beyond that required 
by paragraph (b) of this section if the Commission finds that 
supplemental material is necessary for complete understanding of an 
unusually complex or significant event. These requests for supplemental 
information will be made in writing and the licensee shall submit, as 
specified in Sec.50.4, the requested information as a supplement to 
the initial LER.
    (d) Submission of reports. Licensee Event Reports must be prepared 
on Form NRC 366 and submitted to the U.S. Nuclear Regulatory Commission, 
as specified in Sec.50.4.
    (e) Report legibility. The reports and copies that licensees are 
required to submit to the Commission under the provisions of this 
section must be of sufficient quality to permit legible reproduction and 
micrographic processing.
    (f) [Reserved]
    (g) Reportable occurrences. The requirements contained in this 
section replace all existing requirements for licensees to report 
``Reportable Occurrences'' as defined in individual plant Technical 
Specifications.

[48 FR 33858, July 26, 1983, as amended at 49 FR 47824, Dec. 7, 1984; 51 
FR 40310, Nov. 6, 1986; 56 FR 23473, May 21, 1991; 56 FR 61352, Dec. 3, 
1991; 57 FR 41381, Sept. 10, 1992; 58 FR 67661, Dec. 22, 1993; 59 FR 
50689, Oct. 5, 1994; 63 FR 50480, Sept. 22, 1998; 65 FR 63787, Oct. 25, 
2000; 69 FR 18803, Apr. 9, 2004; 72 FR 49502, Aug. 28, 2007]



Sec.50.74  Notification of change in operator or senior operator 
status.

    Each licensee shall notify the appropriate Regional Administrator as 
listed in appendix D to part 20 of this chapter within 30 days of the 
following in regard to a licensed operator or senior operator:
    (a) Permanent reassignment from the position for which the licensee 
has certified the need for a licensed operator or senior operator under 
Sec.55.31(a)(3) of this chapter;
    (b) Termination of any operator or senior operator;
    (c) Permanent disability or illness as described in Sec.55.25 of 
this chapter.

[52 FR 9469, Mar. 25, 1987, as amended at 60 FR 13616, Mar. 14, 1995; 68 
FR 58809, Oct. 10, 2003]



Sec.50.75  Reporting and recordkeeping for decommissioning planning.

    (a) This section establishes requirements for indicating to NRC how 
a licensee will provide reasonable assurance that funds will be 
available for the decommissioning process. For power reactor licensees 
(except a holder of a manufacturing license under part 52 of this 
chapter), reasonable assurance consists of a series of steps as provided 
in paragraphs (b), (c), (e), and

[[Page 994]]

(f) of this section. Funding for the decommissioning of power reactors 
may also be subject to the regulation of Federal or State Government 
agencies (e.g., Federal Energy Regulatory Commission (FERC) and State 
Public Utility Commissions) that have jurisdiction over rate regulation. 
The requirements of this section, in particular paragraph (c) of this 
section, are in addition to, and not substitution for, other 
requirements, and are not intended to be used by themselves or by other 
agencies to establish rates.
    (b) Each power reactor applicant for or holder of an operating 
license, and each applicant for a combined license under subpart C of 10 
CFR part 52 for a production or utilization facility of the type and 
power level specified in paragraph (c) of this section shall submit a 
decommissioning report, as required by Sec.50.33(k).
    (1) For an applicant for or holder of an operating license under 
part 50, the report must contain a certification that financial 
assurance for decommissioning will be (for a license applicant), or has 
been (for a license holder), provided in an amount which may be more, 
but not less, than the amount stated in the table in paragraph (c)(1) of 
this section adjusted using a rate at least equal to that stated in 
paragraph (c)(2) of this section. For an applicant for a combined 
license under subpart C of 10 CFR part 52, the report must contain a 
certification that financial assurance for decommissioning will be 
provided no later than 30 days after the Commission publishes notice in 
the Federal Register under Sec.52.103(a) in an amount which may be 
more, but not less, than the amount stated in the table in paragraph 
(c)(1) of this section, adjusted using a rate at least equal to that 
stated in paragraph (c)(2) of this section.
    (2) The amount to be provided must be adjusted annually using a rate 
at least equal to that stated in paragraph (c)(2) of this section.
    (3) The amount must be covered by one or more of the methods 
described in paragraph (e) of this section as acceptable to the NRC.
    (4) The amount stated in the applicant's or licensee's certification 
may be based on a cost estimate for decommissioning the facility. As 
part of the certification, a copy of the financial instrument obtained 
to satisfy the requirements of paragraph (e) of this section must be 
submitted to NRC; provided, however, that an applicant for or holder of 
a combined license need not obtain such financial instrument or submit a 
copy to the Commission except as provided in paragraph (e)(3) of this 
section.
    (c) Table of minimum amounts (January 1986 dollars) required to 
demonstrate reasonable assurance of funds for decommissioning by reactor 
type and power level, P (in MWt); adjustment factor. \1\
---------------------------------------------------------------------------

    \1\ Amounts are based on activities related to the definition of 
``Decommission'' in Sec.50.2 of this part and do not include the cost 
of removal and disposal of spent fuel or of nonradioactive structures 
and materials beyond that necessary to terminate the license.

 
                                                            Millions
 
(1)(i) For a PWR:
  greater than or equal to 3400 MWt...................              $105
  between 1200 MWt and 3400 MWt (For a PWR of less       $(75 + 0.0088P)
   than 1200 MWt, use P = 1200 MWt)...................
(ii) For a BWR:
  greater than or equal to 3400 MWt...................              $135
  between 1200 MWt and 3400 MWt (For a BWR of less       $(104 + 0.009P)
   than 1200 MWt, use P = 1200 MWt)...................
 

    (2) An adjustment factor at least equal to 0.65 L + 0.13 E + 0.22 B 
is to be used where L and E are escalation factors for labor and energy, 
respectively, and are to be taken from regional data of U.S. Department 
of Labor Bureau of Labor Statistics and B is an escalation factor for 
waste burial and is to be taken from NRC report NUREG-1307, ``Report on 
Waste Burial Charges.''
    (d)(1) Each non-power reactor applicant for or holder of an 
operating license for a production or utilization facility shall submit 
a decommissioning report as required by Sec.50.33(k) of this part.
    (2) The report must:

[[Page 995]]

    (i) Contain a cost estimate for decommissioning the facility;
    (ii) Indicate which method or methods described in paragraph (e) of 
this section as acceptable to the NRC will be used to provide funds for 
decommissioning; and
    (iii) Provide a description of the means of adjusting the cost 
estimate and associated funding level periodically over the life of the 
facility.
    (e)(1) Financial assurance is to be provided by the following 
methods.
    (i) Prepayment. Prepayment is the deposit made preceding the start 
of operation or the transfer of a license under Sec.50.80 into an 
account segregated from licensee assets and outside the administrative 
control of the licensee and its subsidiaries or affiliates of cash or 
liquid assets such that the amount of funds would be sufficient to pay 
decommissioning costs at the time permanent termination of operations is 
expected. Prepayment may be in the form of a trust, escrow account, or 
Government fund with payment by, certificate of deposit, deposit of 
government or other securities or other method acceptable to the NRC. 
This trust, escrow account, Government fund, or other type of agreement 
shall be established in writing and maintained at all times in the 
United States with an entity that is an appropriate State or Federal 
government agency, or an entity whose operations in which the prepayment 
deposit is managed are regulated and examined by a Federal or State 
agency. A licensee that has prepaid funds based on a site-specific 
estimate under Sec.50.75(b)(1) of this section may take credit for 
projected earnings on the prepaid decommissioning trust funds, using up 
to a 2 percent annual real rate of return from the time of future funds' 
collection through the projected decommissioning period, provided that 
the site-specific estimate is based on a period of safe storage that is 
specifically described in the estimate. This includes the periods of 
safe storage, final dismantlement, and license termination. A licensee 
that has prepaid funds based on the formulas in Sec.50.75(c) of this 
section may take credit for projected earnings on the prepaid 
decommissioning funds using up to a 2 percent annual real rate of return 
up to the time of permanent termination of operations. A licensee may 
use a credit of greater than 2 percent if the licensee's rate-setting 
authority has specifically authorized a higher rate. However, licensees 
certifying only to the formula amounts (i.e., not a site-specific 
estimate) can take a pro-rata credit during the immediate dismantlement 
period (i.e., recognizing both cash expenditures and earnings the first 
7 years after shutdown). Actual earnings on existing funds may be used 
to calculate future fund needs.
    (ii) External sinking fund. An external sinking fund is a fund 
established and maintained by setting funds aside periodically in an 
account segregated from licensee assets and outside the administrative 
control of the licensee and its subsidiaries or affiliates in which the 
total amount of funds would be sufficient to pay decommissioning costs 
at the time permanent termination of operations is expected. An external 
sinking fund may be in the form of a trust, escrow account, or 
Government fund, with payment by certificate of deposit, deposit of 
Government or other securities, or other method acceptable to the NRC. 
This trust, escrow account, Government fund, or other type of agreement 
shall be established in writing and maintained at all times in the 
United States with an entity that is an appropriate State or Federal 
government agency, or an entity whose operations in which the external 
linking fund is managed are regulated and examined by a Federal or State 
agency. A licensee that has collected funds based on a site-specific 
estimate under Sec.50.75(b)(1) of this section may take credit for 
projected earnings on the external sinking funds using up to a 2 percent 
annual real rate of return from the time of future funds' collection 
through the decommissioning period, provided that the site-specific 
estimate is based on a period of safe storage that is specifically 
described in the estimate. This includes the periods of safe storage, 
final dismantlement, and license termination. A licensee that has 
collected funds based on the formulas in Sec.50.75(c) of this section 
may take credit for collected earnings on the decommissioning funds 
using up to a 2 percent annual real rate of return up to

[[Page 996]]

the time of permanent termination of operations. A licensee may use a 
credit of greater than 2 percent if the licensee's rate-setting 
authority has specifically authorized a higher rate. However, licensees 
certifying only to the formula amounts (i.e., not a site-specific 
estimate) can take a pro-rata credit during the dismantlement period 
(i.e., recognizing both cash expenditures and earnings the first 7 years 
after shutdown). Actual earnings on existing funds may be used to 
calculate future fund needs. A licensee, whose rates for decommissioning 
costs cover only a portion of these costs, may make use of this method 
only for the portion of these costs that are collected in one of the 
manners described in this paragraph, (e)(1)(ii). This method may be used 
as the exclusive mechanism relied upon for providing financial assurance 
for decommissioning in the following circumstances:
    (A) By a licensee that recovers, either directly or indirectly, the 
estimated total cost of decommissioning through rates established by 
``cost of service'' or similar ratemaking regulation. Public utility 
districts, municipalities, rural electric cooperatives, and State and 
Federal agencies, including associations of any of the foregoing, that 
establish their own rates and are able to recover their cost of service 
allocable to decommissioning, are assumed to meet this condition.
    (B) By a licensee whose source of revenues for its external sinking 
fund is a ``non-bypassable charge,'' the total amount of which will 
provide funds estimated to be needed for decommissioning pursuant to 
Sec. Sec.50.75(c), 50.75(f), or 50.82 of this part.
    (iii) A surety method, insurance, or other guarantee method:
    (A) These methods guarantee that decommissioning costs will be paid. 
A surety method may be in the form of a surety bond, or letter of 
credit. Any surety method or insurance used to provide financial 
assurance for decommissioning must contain the following conditions:
    (1) The surety method or insurance must be open-ended, or, if 
written for a specified term, such as 5 years, must be renewed 
automatically, unless 90 days or more prior to the renewal day the 
issuer notifies the NRC, the beneficiary, and the licensee of its 
intention not to renew. The surety or insurance must also provide that 
the full face amount be paid to the beneficiary automatically prior to 
the expiration without proof of forfeiture if the licensee fails to 
provide a replacement acceptable to the NRC within 30 days after receipt 
of notification of cancellation.
    (2) The surety or insurance must be payable to a trust established 
for decommissioning costs. The trustee and trust must be acceptable to 
the NRC. An acceptable trustee includes an appropriate State or Federal 
government agency or an entity that has the authority to act as a 
trustee and whose trust operations are regulated and examined by a 
Federal or State agency.
    (B) A parent company guarantee of funds for decommissioning costs 
based on a financial test may be used if the guarantee and test are as 
contained in appendix A to 10 CFR part 30.
    (C) For commercial companies that issue bonds, a guarantee of funds 
by the applicant or licensee for decommissioning costs based on a 
financial test may be used if the guarantee and test are as contained in 
appendix C to 10 CFR part 30. For commercial companies that do not issue 
bonds, a guarantee of funds by the applicant or licensee for 
decommissioning costs may be used if the guarantee and test are as 
contained in appendix D to 10 CFR part 30. For non-profit entities, such 
as colleges, universities, and non-profit hospitals, a guarantee of 
funds by the applicant or licensee may be used if the guarantee and test 
are as contained in appendix E to 10 CFR part 30. A guarantee by the 
applicant or licensee may not be used in any situation in which the 
applicant or licensee has a parent company holding majority control of 
voting stock of the company.
    (iv) For a power reactor licensee that is a Federal licensee, or for 
a non-power reactor licensee that is a Federal, State, or local 
government licensee, a statement of intent containing a cost estimate 
for decommissioning, and indicating that funds for decommissioning will 
be obtained when necessary.

[[Page 997]]

    (v) Contractual obligation(s) on the part of a licensee's 
customer(s), the total amount of which over the duration of the 
contract(s) will provide the licensee's total share of uncollected funds 
estimated to be needed for decommissioning pursuant to Sec. Sec.
50.75(c), 50.75(f), or Sec.50.82. To be acceptable to the NRC as a 
method of decommissioning funding assurance, the terms of the 
contract(s) shall include provisions that the electricity buyer(s) will 
pay for the decommissioning obligations specified in the contract(s), 
notwithstanding the operational status either of the licensed power 
reactor to which the contract(s) pertains or force majeure provisions. 
All proceeds from the contract(s) for decommissioning funding will be 
deposited to the external sinking fund. The NRC reserves the right to 
evaluate the terms of any contract(s) and the financial qualifications 
of the contracting entity or entities offered as assurance for 
decommissioning funding.
    (vi) Any other mechanism, or combination of mechanisms, that 
provides, as determined by the NRC upon its evaluation of the specific 
circumstances of each licensee submittal, assurance of decommissioning 
funding equivalent to that provided by the mechanisms specified in 
paragraphs (e)(1)(i) through (v) of this section. Licensees who do not 
have sources of funding described in paragraph (e)(1)(ii) of this 
section may use an external sinking fund in combination with a guarantee 
mechanism, as specified in paragraph (e)(1)(iii) of this section, 
provided that the total amount of funds estimated to be necessary for 
decommissioning is assured.
    (2) The NRC reserves the right to take the following steps in order 
to ensure a licensee's adequate accumulation of decommissioning funds: 
review, as needed, the rate of accumulation of decommissioning funds; 
and, either independently or in cooperation with the FERC and the 
licensee's State PUC, take additional actions as appropriate on a case-
by-case basis, including modification of a licensee's schedule for the 
accumulation of decommissioning funds.
    (3) Each holder of a combined license under subpart C of 10 CFR part 
52 shall, 2 years before and 1 year before the scheduled date for 
initial loading of fuel, consistent with the schedule required by Sec.
52.99(a), submit a report to the NRC containing a certification updating 
the information described under paragraph (b)(1) of this section, 
including a copy of the financial instrument to be used. No later than 
30 days after the Commission publishes notice in the Federal Register 
under 10 CFR 52.103(a), the licensee shall submit a report containing a 
certification that financial assurance for decommissioning is being 
provided in an amount specified in the licensee's most recent updated 
certification, including a copy of the financial instrument obtained to 
satisfy the requirements of paragraph (e) of this section.
    (f)(1) Each power reactor licensee shall report, on a calendar-year 
basis, to the NRC by March 31, 1999, and at least once every 2 years 
thereafter on the status of its decommissioning funding for each reactor 
or part of a reactor that it owns. However, each holder of a combined 
license under part 52 of this chapter need not begin reporting until the 
date that the Commission has made the finding under Sec.52.103(g) of 
this chapter. The information in this report must include, at a minimum, 
the amount of decommissioning funds estimated to be required pursuant to 
10 CFR 50.75(b) and (c); the amount of decommissioning funds accumulated 
to the end of the calendar year preceding the date of the report; a 
schedule of the annual amounts remaining to be collected; the 
assumptions used regarding rates of escalation in decommissioning costs, 
rates of earnings on decommissioning funds, and rates of other factors 
used in funding projections; any contracts upon which the licensee is 
relying pursuant to paragraph (e)(1)(v) of this section; any 
modifications occurring to a licensee's current method of providing 
financial assurance since the last submitted report; and any material 
changes to trust agreements. If any of the preceding items is not 
applicable, the licensee should so state in its report. Any licensee for 
a plant that is within 5 years of the projected end of its operation, or 
where conditions have changed such that it will close within 5 years 
(before the end of its licensed

[[Page 998]]

life), or that has already closed (before the end of its licensed life), 
or that is involved in a merger or an acquisition shall submit this 
report annually.
    (2) Each power reactor licensee shall report, on a calendar-year 
basis, to the NRC by March 31, 1999, and at least once every 2 years 
thereafter on the status of its decommissioning funding for each reactor 
or part of a reactor that it owns. The information in this report must 
include, at a minimum, the amount of decommissioning funds estimated to 
be required pursuant to 10 CFR 50.75(b) and (c); the amount of 
decommissioning funds accumulated to the end of the calendar year 
preceding the date of the report; a schedule of the annual amounts 
remaining to be collected; the assumptions used regarding rates of 
escalation in decommissioning costs, rates of earnings on 
decommissioning funds, and rates of other factors used in funding 
projections; any contracts upon which the licensee is relying pursuant 
to paragraph (e)(1)(v) of this section; any modifications occurring to a 
licensee's current method of providing financial assurance since the 
last submitted report; and any material changes to trust agreements. If 
any of the preceding items is not applicable, the licensee should so 
state in its report. Any licensee for a plant that is within 5 years of 
the projected end of its operation, or where conditions have changed 
such that it will close within 5 years (before the end of its licensed 
life), or that has already closed (before the end of its licensed life), 
or that is involved in a merger or an acquisition shall submit this 
report annually.
    (3) Each power reactor licensee shall at or about 5 years prior to 
the projected end of operations submit a preliminary decommissioning 
cost estimate which includes an up-to-date assessment of the major 
factors that could affect the cost to decommission.
    (4) Each non-power reactor licensee shall at or about 2 years prior 
to the projected end of operations submit a preliminary decommissioning 
plan containing a cost estimate for decommissioning and an up-to-date 
assessment of the major factors that could affect planning for 
decommissioning. Factors to be considered in submitting this preliminary 
plan information include--
    (i) The decommissioning alternative anticipated to be used. The 
requirements of Sec.50.82(b)(4)(i) must be considered at this time;
    (ii) Major technical actions necessary to carry out decommissioning 
safely;
    (iii) The current situation with regard to disposal of high-level 
and low-level radioactive waste;
    (iv) Residual radioactivity criteria;
    (v) Other site specific factors which could affect decommissioning 
planning and cost.
    (5) If necessary, the cost estimate, for power and non-power 
reactors, shall also include plans for adjusting levels of funds assured 
for decommissioning to demonstrate that a reasonable level of assurance 
will be provided that funds will be available when needed to cover the 
cost of decommissioning.
    (g) Each licensee shall keep records of information important to the 
safe and effective decommissioning of the facility in an identified 
location until the license is terminated by the Commission. If records 
of relevant information are kept for other purposes, reference to these 
records and their locations may be used. Information the Commission 
considers important to decommissioning consists of--
    (1) Records of spills or other unusual occurrences involving the 
spread of contamination in and around the facility, equipment, or site. 
These records may be limited to instances when significant contamination 
remains after any cleanup procedures or when there is reasonable 
likelihood that contaminants may have spread to inaccessible areas as in 
the case of possible seepage into porous materials such as concrete. 
These records must include any known information on identification of 
involved nuclides, quantities, forms, and concentrations.
    (2) As-built drawings and modifications of structures and equipment 
in restricted areas where radioactive materials are used and/or stored 
and of locations of possible inaccessible contamination such as buried 
pipes which may be subject to contamination. If required drawings are 
referenced, each relevant document need not be indexed

[[Page 999]]

individually. If drawings are not available, the licensee shall 
substitute appropriate records of available information concerning these 
areas and locations.
    (3) Records of the cost estimate performed for the decommissioning 
funding plan or of the amount certified for decommissioning, and records 
of the funding method used for assuring funds if either a funding plan 
or certification is used.
    (4) Records of:
    (i) The licensed site area, as originally licensed, which must 
include a site map and any acquisition or use of property outside the 
originally licensed site area for the purpose of receiving, possessing, 
or using licensed materials;
    (ii) The licensed activities carried out on the acquired or used 
property; and
    (iii) The release and final disposition of any property recorded in 
paragraph (g)(4)(i) of this section, the historical site assessment 
performed for the release, radiation surveys performed to support 
release of the property, submittals to the NRC made in accordance with 
Sec.50.83, and the methods employed to ensure that the property met 
the radiological criteria of 10 CFR Part 20, Subpart E, at the time the 
property was released.
    (h)(1) Licensees that are not ``electric utilities'' as defined in 
Sec.50.2 that use prepayment or an external sinking fund to provide 
financial assurance shall provide in the terms of the arrangements 
governing the trust, escrow account, or Government fund, used to 
segregate and manage the funds that--
    (i) The trustee, manager, investment advisor, or other person 
directing investment of the funds:
    (A) Is prohibited from investing the funds in securities or other 
obligations of the licensee or any other owner or operator of any 
nuclear power reactor or their affiliates, subsidiaries, successors or 
assigns, or in a mutual fund in which at least 50 percent of the fund is 
invested in the securities of a licensee or parent company whose 
subsidiary is an owner or operator of a foreign or domestic nuclear 
power plant. However, the funds may be invested in securities tied to 
market indices or other non-nuclear sector collective, commingled, or 
mutual funds, provided that this subsection shall not operate in such a 
way as to require the sale or transfer either in whole or in part, or 
other disposition of any such prohibited investment that was made before 
the publication date of this rule, and provided further that no more 
than 10 percent of trust assets may be indirectly invested in securities 
of any entity owning or operating one or more nuclear power plants.
    (B) Is obligated at all times to adhere to a standard of care set 
forth in the trust, which either shall be the standard of care, whether 
in investing or otherwise, required by State or Federal law or one or 
more State or Federal regulatory agencies with jurisdiction over the 
trust funds, or, in the absence of any such standard of care, whether in 
investing or otherwise, that a prudent investor would use in the same 
circumstances. The term ``prudent investor,'' shall have the same 
meaning as set forth in the Federal Energy Regulatory Commission's 
``Regulations Governing Nuclear Plant Decommissioning Trust Funds'' at 
18 CFR 35.32(a)(3), or any successor regulation.
    (ii) The licensee, its affiliates, and its subsidiaries are 
prohibited from being engaged as investment manager for the funds or 
from giving day-to-day management direction of the funds' investments or 
direction on individual investments by the funds, except in the case of 
passive fund management of trust funds where management is limited to 
investments tracking market indices.
    (iii) The trust, escrow account, Government fund, or other account 
used to segregate and manage the funds may not be amended in any 
material respect without written notification to the Director, Office of 
Nuclear Reactor Regulation, Director, Office of New Reactors, or 
Director, Office of Nuclear Material Safety and Safeguards, as 
applicable, at least 30 working days before the proposed effective date 
of the amendment. The licensee shall provide the text of the proposed 
amendment and a statement of the reason for the proposed amendment. The 
trust, escrow account, Government fund, or other account may not be 
amended if

[[Page 1000]]

the person responsible for managing the trust, escrow account, 
Government fund, or other account receives written notice of objection 
from the Director, Office of Nuclear Reactor Regulation, Director, 
Office of New Reactors, or Director, Office of Nuclear Material Safety 
and Safeguards, as applicable, within the notice period; and
    (iv) Except for withdrawals being made under Sec.50.82(a)(8) or 
for payments of ordinary administrative costs (including taxes) and 
other incidental expenses of the fund (including legal, accounting, 
actuarial, and trustee expenses) in connection with the operation of the 
fund, no disbursement or payment may be made from the trust, escrow 
account, Government fund, or other account used to segregate and manage 
the funds until written notice of the intention to make a disbursement 
or payment has been given to the Director, Office of Nuclear Reactor 
Regulation, Director, Office of New Reactors, or Director, Office of 
Nuclear Material Safety and Safeguards, as applicable, at least 30 
working days before the date of the intended disbursement or payment. 
The disbursement or payment from the trust, escrow account, Government 
fund or other account may be made following the 30-working day notice 
period if the person responsible for managing the trust, escrow account, 
Government fund, or other account does not receive written notice of 
objection from the Director, Office of Nuclear Reactor Regulation, 
Director, Office of New Reactors, or Director, Office of Nuclear 
Material Safety and Safeguards, as applicable, within the notice period. 
Disbursements or payments from the trust, escrow account, Government 
fund, or other account used to segregate and manage the funds, other 
than for payment of ordinary administrative costs (including taxes) and 
other incidental expenses of the fund (including legal, accounting, 
actuarial, and trustee expenses) in connection with the operation of the 
fund, are restricted to decommissioning expenses or transfer to another 
financial assurance method acceptable under paragraph (e) of this 
section until final decommissioning has been completed. After 
decommissioning has begun and withdrawals from the decommissioning fund 
are made under Sec.50.82(a)(8), no further notification need be made 
to the NRC.
    (2) Licensees that are ``electric utilities'' under Sec.50.2 that 
use prepayment or an external sinking fund to provide financial 
assurance shall include a provision in the terms of the trust, escrow 
account, Government fund, or other account used to segregate and manage 
funds that except for withdrawals being made under Sec.50.82(a)(8) or 
for payments of ordinary administrative costs (including taxes) and 
other incidental expenses of the fund (including legal, accounting, 
actuarial, and trustee expenses) in connection with the operation of the 
fund, no disbursement or payment may be made from the trust, escrow 
account, Government fund, or other account used to segregate and manage 
the funds until written notice of the intention to make a disbursement 
or payment has been given the Director, Office of Nuclear Reactor 
Regulation, Director, Office of New Reactors, or Director, Office of 
Nuclear Material Safety and Safeguards, as applicable, at least 30 
working days before the date of the intended disbursement or payment. 
The disbursement or payment from the trust, escrow account, Government 
fund or other account may be made following the 30-working day notice 
period if the person responsible for managing the trust, escrow account, 
Government fund, or other account does not receive written notice of 
objection from the Director, Office of Nuclear Reactor Regulation, 
Director, Office of New Reactors, or Director, Office of Nuclear 
Material Safety and Safeguards, as applicable, within the notice period. 
Disbursements or payments from the trust, escrow account, Government 
fund, or other account used to segregate and manage the funds, other 
than for payment of ordinary administrative costs (including taxes) and 
other incidental expenses of the fund (including legal, accounting, 
actuarial, and trustee expenses) in connection with the operation of the 
fund, are restricted to decommissioning expenses or transfer to another 
financial assurance method acceptable under paragraph (e) of this 
section until final decommissioning

[[Page 1001]]

has been completed. After decommissioning has begun and withdrawals from 
the decommissioning fund are made under Sec.50.82(a)(8), no further 
notification need be made to the NRC.
    (3) A licensee that is not an ``electric utility'' under Sec.50.2 
and using a surety method, insurance, or other guarantee method to 
provide financial assurance shall provide that the trust established for 
decommissioning costs to which the surety or insurance is payable 
contains in its terms the requirements in paragraphs (h)(1)(i), (ii), 
(iii), and (iv) of this section.
    (4) Unless otherwise determined by the Commission with regard to a 
specific application, the Commission has determined that any amendment 
to the license of a utilization facility that does no more than delete 
specific license conditions relating to the terms and conditions of 
decommissioning trust agreements involves ``no significant hazards 
consideration.''
    (5) The provisions of paragraphs (h)(1) through (h)(3) of this 
section do not apply to any licensee that as of December 24, 2003, has 
existing license conditions relating to decommissioning trust 
agreements, so long as the licensee does not elect to amend those 
license conditions. If a licensee with existing license conditions 
relating to decommissioning trust agreements elects to amend those 
conditions, the license amendment shall be in accordance with the 
provisions of paragraph (h) of this section.

[53 FR 24049, June 27, 1988, as amended at 58 FR 68731, Dec. 29, 1993; 
59 FR 1618, Jan. 12, 1994; 61 FR 39301, July 29, 1996; 63 FR 50480, 
Sept. 22, 1998; 63 FR 57236, Oct. 27, 1998; 68 FR 19727, Apr. 22, 2003; 
67 FR 78350, Dec. 24, 2002; 68 FR 12571, Mar. 17, 2003; 68 FR 65388, 
Nov. 20, 2003; 72 FR 49502, Aug. 28, 2007; 73 FR 5722, Jan. 31, 2008; 77 
FR 35571, June 17, 2012; 83 FR 30288, June 28, 2018]



Sec.50.76  Licensee's change of status; financial qualifications.

    An electric utility licensee holding an operating license (including 
a renewed license) for a nuclear power reactor, no later than seventy-
five (75) days prior to ceasing to be an electric utility in any manner 
not involving a license transfer under Sec.50.80, shall provide the 
NRC with the financial qualifications information that would be required 
for obtaining an initial operating license as specified in Sec.
50.33(f)(2). The financial qualifications information must address the 
first full five years of operation after the date the licensee ceases to 
be an electric utility.

[69 FR 4448, Jan. 30, 2004]

                      US/IAEA Safeguards Agreement



Sec.50.78  Facility information and verification.

    (a) In response to a written request by the Commission, each 
applicant for a construction permit or license and each recipient of a 
construction permit or a license shall submit facility information, as 
described in Sec.75.10 of this chapter, on Form N-71, and associated 
forms and site information on DOC/NRC Form AP-A and associated forms;
    (b) As required by the Additional Protocol, shall submit location 
information described in Sec.75.11 of this chapter on DOC/NRC Form AP-
1 and associated forms; and
    (c) Shall permit verification thereof by the International Atomic 
Energy Agency (IAEA) and take other action as necessary to implement the 
US/IAEA Safeguards Agreement, as described in part 75 of this chapter.

[73 FR 78605, Dec. 23, 2008]

     Transfers of Licenses--Creditors' Rights--Surrender of Licenses



Sec.50.80  Transfer of licenses.

    (a) No license for a production or utilization facility (including, 
but not limited to, permits under this part and part 52 of this chapter, 
and licenses under parts 50 and 52 of this chapter), or any right 
thereunder, shall be transferred, assigned, or in any manner disposed 
of, either voluntarily or involuntarily, directly or indirectly, through 
transfer of control of the license to any person, unless the Commission 
gives its consent in writing.
    (b)(1) An application for transfer of a license shall include:
    (i) For a construction permit or operating license under this part, 
as much of the information described in Sec. Sec.50.33 and 50.34 of 
this part with respect to the identity and technical and financial 
qualifications of the proposed transferee as would be required by

[[Page 1002]]

those sections if the application were for an initial license. The 
Commission may require additional information such as data respecting 
proposed safeguards against hazards from radioactive materials and the 
applicant's qualifications to protect against such hazards.
    (ii) For an early site permit under part 52 of this chapter, as much 
of the information described in Sec. Sec.52.16 and 52.17 of this 
chapter with respect to the identity and technical qualifications of the 
proposed transferee as would be required by those sections if the 
application were for an initial license.
    (iii) For a combined license under part 52 of this chapter, as much 
of the information described in Sec. Sec.52.77 and 52.79 of this 
chapter with respect to the identity and technical and financial 
qualifications of the proposed transferee as would be required by those 
sections if the application were for an initial license. The Commission 
may require additional information such as data respecting proposed 
safeguards against hazards from radioactive materials and the 
applicant's qualifications to protect against such hazards.
    (iv) For a manufacturing license under part 52 of this chapter, as 
much of the information described in Sec. Sec.52.156 and 52.157 of 
this chapter with respect to the identity and technical qualifications 
of the proposed transferee as would be required by those sections if the 
application were for an initial license.
    (2) The application shall include also a statement of the purposes 
for which the transfer of the license is requested, the nature of the 
transaction necessitating or making desirable the transfer of the 
license, and an agreement to limit access to Restricted Data pursuant to 
Sec.50.37. The Commission may require any person who submits an 
application for license pursuant to the provisions of this section to 
file a written consent from the existing licensee or a certified copy of 
an order or judgment of a court of competent jurisdiction attesting to 
the person's right (subject to the licensing requirements of the Act and 
these regulations) to possession of the facility or site involved.
    (c) After appropriate notice to interested persons, including the 
existing licensee, and observance of such procedures as may be required 
by the Act or regulations or orders of the Commission, the Commission 
will approve an application for the transfer of a license, if the 
Commission determines:
    (1) That the proposed transferee is qualified to be the holder of 
the license; and
    (2) That transfer of the license is otherwise consistent with 
applicable provisions of law, regulations, and orders issued by the 
Commission pursuant thereto.

[26 FR 9546, Oct. 10, 1961, as amended at 35 FR 19661, Dec. 29, 1970; 38 
FR 3956, Feb. 9, 1973; 65 FR 44660, July 19, 2000; 70 FR 61888, Oct. 27, 
2005; 72 FR 49503, Aug. 28, 2007]



Sec.50.81  Creditor regulations.

    (a) Pursuant to section 184 of the Act, the Commission consents, 
without individual application, to the creation of any mortgage, pledge, 
or other lien upon any production or utilization facility not owned by 
the United States which is the subject of a license or upon any 
leasehold or other interest in such facility: Provided:
    (1) That the rights of any creditor so secured may be exercised only 
in compliance with and subject to the same requirements and restrictions 
as would apply to the licensee pursuant to the provisions of the 
license, the Atomic Energy Act of 1954, as amended, and regulations 
issued by the Commission pursuant to said Act; and
    (2) That no creditor so secured may take possession of the facility 
pursuant to the provisions of this section prior to either the issuance 
of a license from the Commission authorizing such possession or the 
transfer of the license.
    (b) Any creditor so secured may apply for transfer of the license 
covering such facility by filing an application for transfer of the 
license pursuant to Sec.50.80(b). The Commission will act upon such 
application pursuant to Sec.50.80 (c).
    (c) Nothing contained in this regulation shall be deemed to affect 
the means of acquiring, or the priority of, any tax lien or other lien 
provided by law.
    (d) As used in this section:
    (1) License includes any license under this chapter, any 
construction permit

[[Page 1003]]

under this part, and any early site permit under part 52 of this 
chapter, which may be issued by the Commission with regard to a 
facility;
    (2) ``Creditor'' includes, without implied limitation, the trustee 
under any mortgage, pledge or lien on a facility made to secure any 
creditor, any trustee or receiver of the facility appointed by a court 
of competent jurisdiction in any action brought for the benefit of any 
creditor secured by such mortgage, pledge or lien, any purchaser of such 
facility at the sale thereof upon foreclosure of such mortgage, pledge, 
or lien or upon exercise of any power of sale contained therein, or any 
assignee of any such purchaser.
    (3) Facility includes but is not limited to, a site which is the 
subject of an early site permit under subpart A of part 52 of this 
chapter, and a reactor manufactured under a manufacturing license under 
subpart F of part 52 of this chapter.

[26 FR 9546, Oct. 10, 1961, as amended at 32 FR 2562, Feb. 7, 1967; 72 
FR 49504, Aug. 28, 2007]



Sec.50.82  Termination of license.

    For power reactor licensees who, before the effective date of this 
rule, either submitted a decommissioning plan for approval or possess an 
approved decommissioning plan, the plan is considered to be the PSDAR 
submittal required under paragraph (a)(4) of this section and the 
provisions of this section apply accordingly. For power reactor 
licensees whose decommissioning plan approval activities have been 
relegated to notice of opportunity for a hearing under subpart G of 10 
CFR part 2, the public meeting convened and 90-day delay of major 
decommissioning activities required in paragraphs (a)(4)(ii) and (a)(5) 
of this section shall not apply, and any orders arising from proceedings 
under subpart G of 10 CFR part 2 shall continue and remain in effect 
absent any orders from the Commission.
    (a) For power reactor licensees--
    (1)(i) When a licensee has determined to permanently cease 
operations the licensee shall, within 30 days, submit a written 
certification to the NRC, consistent with the requirements of Sec.
50.4(b)(8);
    (ii) Once fuel has been permanently removed from the reactor vessel, 
the licensee shall submit a written certification to the NRC that meets 
the requirements of Sec.50.4(b)(9) and;
    (iii) For licensees whose licenses have been permanently modified to 
allow possession but not operation of the facility, before the effective 
date of this rule, the certifications required in paragraphs (a)(1) (i)-
(ii) of this section shall be deemed to have been submitted.
    (2) Upon docketing of the certifications for permanent cessation of 
operations and permanent removal of fuel from the reactor vessel, or 
when a final legally effective order to permanently cease operations has 
come into effect, the 10 CFR part 50 license no longer authorizes 
operation of the reactor or emplacement or retention of fuel into the 
reactor vessel.
    (3) Decommissioning will be completed within 60 years of permanent 
cessation of operations. Completion of decommissioning beyond 60 years 
will be approved by the Commission only when necessary to protect public 
health and safety. Factors that will be considered by the Commission in 
evaluating an alternative that provides for completion of 
decommissioning beyond 60 years of permanent cessation of operations 
include unavailability of waste disposal capacity and other site-
specific factors affecting the licensee's capability to carry out 
decommissioning, including presence of other nuclear facilities at the 
site.
    (4)(i) Prior to or within 2 years following permanent cessation of 
operations, the licensee shall submit a post-shutdown decommissioning 
activities report (PSDAR) to the NRC, and a copy to the affected 
State(s). The PSDAR must contain a description of the planned 
decommissioning activities along with a schedule for their 
accomplishment, a discussion that provides the reasons for concluding 
that the environmental impacts associated with site-specific 
decommissioning activities will be bounded by appropriate previously 
issued environmental impact statements, and a site-specific DCE, 
including the projected cost of managing irradiated fuel.

[[Page 1004]]

    (ii) The NRC shall notice receipt of the PSDAR and make the PSDAR 
available for public comment. The NRC shall also schedule a public 
meeting in the vicinity of the licensee's facility upon receipt of the 
PSDAR. The NRC shall publish a notice in the Federal Register and in a 
forum, such as local newspapers, that is readily accessible to 
individuals in the vicinity of the site, announcing the date, time and 
location of the meeting, along with a brief description of the purpose 
of the meeting.
    (5) Licensees shall not perform any major decommissioning 
activities, as defined in Sec.50.2, until 90 days after the NRC has 
received the licensee's PSDAR submittal and until certifications of 
permanent cessation of operations and permanent removal of fuel from the 
reactor vessel, as required under Sec.50.82(a)(1), have been 
submitted.
    (6) Licensees shall not perform any decommissioning activities, as 
defined in Sec.50.2, that--
    (i) Foreclose release of the site for possible unrestricted use;
    (ii) Result in significant environmental impacts not previously 
reviewed; or
    (iii) Result in there no longer being reasonable assurance that 
adequate funds will be available for decommissioning.
    (7) In taking actions permitted under Sec.50.59 following 
submittal of the PSDAR, the licensee shall notify the NRC, in writing 
and send a copy to the affected State(s), before performing any 
decommissioning activity inconsistent with, or making any significant 
schedule change from, those actions and schedules described in the 
PSDAR, including changes that significantly increase the decommissioning 
cost.
    (8)(i) Decommissioning trust funds may be used by licensees if--
    (A) The withdrawals are for expenses for legitimate decommissioning 
activities consistent with the definition of decommissioning in Sec.
50.2;
    (B) The expenditure would not reduce the value of the 
decommissioning trust below an amount necessary to place and maintain 
the reactor in a safe storage condition if unforeseen conditions or 
expenses arise and;
    (C) The withdrawals would not inhibit the ability of the licensee to 
complete funding of any shortfalls in the decommissioning trust needed 
to ensure the availability of funds to ultimately release the site and 
terminate the license.
    (ii) Initially, 3 percent of the generic amount specified in Sec.
50.75 may be used for decommissioning planning. For licensees that have 
submitted the certifications required under Sec.50.82(a)(1) and 
commencing 90 days after the NRC has received the PSDAR, an additional 
20 percent may be used. A site-specific decommissioning cost estimate 
must be submitted to the NRC prior to the licensee using any funding in 
excess of these amounts.
    (iii) Within 2 years following permanent cessation of operations, if 
not already submitted, the licensee shall submit a site-specific 
decommissioning cost estimate.
    (iv) For decommissioning activities that delay completion of 
decommissioning by including a period of storage or surveillance, the 
licensee shall provide a means of adjusting cost estimates and 
associated funding levels over the storage or surveillance period.
    (v) After submitting its site-specific DCE required by paragraph 
(a)(4)(i) of this section, and until the licensee has completed its 
final radiation survey and demonstrated that residual radioactivity has 
been reduced to a level that permits termination of its license, the 
licensee must annually submit to the NRC, by March 31, a financial 
assurance status report. The report must include the following 
information, current through the end of the previous calendar year:
    (A) The amount spent on decommissioning, both cumulative and over 
the previous calendar year, the remaining balance of any decommissioning 
funds, and the amount provided by other financial assurance methods 
being relied upon;
    (B) An estimate of the costs to complete decommissioning, reflecting 
any difference between actual and estimated costs for work performed 
during the year, and the decommissioning criteria upon which the 
estimate is based;
    (C) Any modifications occurring to a licensee's current method of 
providing

[[Page 1005]]

financial assurance since the last submitted report; and
    (D) Any material changes to trust agreements or financial assurance 
contracts.
    (vi) If the sum of the balance of any remaining decommissioning 
funds, plus earnings on such funds calculated at not greater than a 2 
percent real rate of return, together with the amount provided by other 
financial assurance methods being relied upon, does not cover the 
estimated cost to complete the decommissioning, the financial assurance 
status report must include additional financial assurance to cover the 
estimated cost of completion.
    (vii) After submitting its site-specific DCE required by paragraph 
(a)(4)(i) of this section, the licensee must annually submit to the NRC, 
by March 31, a report on the status of its funding for managing 
irradiated fuel. The report must include the following information, 
current through the end of the previous calendar year:
    (A) The amount of funds accumulated to cover the cost of managing 
the irradiated fuel;
    (B) The projected cost of managing irradiated fuel until title to 
the fuel and possession of the fuel is transferred to the Secretary of 
Energy; and
    (C) If the funds accumulated do not cover the projected cost, a plan 
to obtain additional funds to cover the cost.
    (9) All power reactor licensees must submit an application for 
termination of license. The application for termination of license must 
be accompanied or preceded by a license termination plan to be submitted 
for NRC approval.
    (i) The license termination plan must be a supplement to the FSAR or 
equivalent and must be submitted at least 2 years before termination of 
the license date.
    (ii) The license termination plan must include--
    (A) A site characterization;
    (B) Identification of remaining dismantlement activities;
    (C) Plans for site remediation;
    (D) Detailed plans for the final radiation survey;
    (E) A description of the end use of the site, if restricted;
    (F) An updated site-specific estimate of remaining decommissioning 
costs; and
    (G) A supplement to the environmental report, pursuant to Sec.
51.53, describing any new information or significant environmental 
change associated with the licensee's proposed termination activities.
    (H) Identification of parts, if any, of the facility or site that 
were released for use before approval of the license termination plan.
    (iii) The NRC shall notice receipt of the license termination plan 
and make the license termination plan available for public comment. The 
NRC shall also schedule a public meeting in the vicinity of the 
licensee's facility upon receipt of the license termination plan. The 
NRC shall publish a notice in the Federal Register and in a forum, such 
as local newspapers, which is readily accessible to individuals in the 
vicinity of the site, announcing the date, time and location of the 
meeting, along with a brief description of the purpose of the meeting.
    (10) If the license termination plan demonstrates that the remainder 
of decommissioning activities will be performed in accordance with the 
regulations in this chapter, will not be inimical to the common defense 
and security or to the health and safety of the public, and will not 
have a significant effect on the quality of the environment and after 
notice to interested persons, the Commission shall approve the plan, by 
license amendment, subject to such conditions and limitations as it 
deems appropriate and necessary and authorize implementation of the 
license termination plan.
    (11) The Commission shall terminate the license if it determines 
that--
    (i) The remaining dismantlement has been performed in accordance 
with the approved license termination plan, and
    (ii) The final radiation survey and associated documentation, 
including an assessment of dose contributions associated with parts 
released for use before approval of the license termination plan, 
demonstrate that the facility and site have met the criteria for 
decommissioning in 10 CFR part 20, subpart E.
    (b) For non-power reactor licensees--

[[Page 1006]]

    (1) A licensee that permanently ceases operations must make 
application for license termination within 2 years following permanent 
cessation of operations, and in no case later than 1 year prior to 
expiration of the operating license. Each application for termination of 
a license must be accompanied or preceded by a proposed decommissioning 
plan. The contents of the decommissioning plan are specified in 
paragraph (b)(4) of this section.
    (2) For decommissioning plans in which the major dismantlement 
activities are delayed by first placing the facility in storage, 
planning for these delayed activities may be less detailed. Updated 
detailed plans must be submitted and approved prior to the start of 
these activities.
    (3) For decommissioning plans that delay completion of 
decommissioning by including a period of storage or surveillance, the 
licensee shall provide that--
    (i) Funds needed to complete decommissioning be placed into an 
account segregated from the licensee's assets and outside the licensee's 
administrative control during the storage or surveillance period, or a 
surety method or fund statement of intent be maintained in accordance 
with the criteria of Sec.50.75(e); and
    (ii) Means be included for adjusting cost estimates and associated 
funding levels over the storage or surveillance period.
    (4) The proposed decommissioning plan must include--
    (i) The choice of the alternative for decommissioning with a 
description of activities involved. An alternative is acceptable if it 
provides for completion of decommissioning without significant delay. 
Consideration will be given to an alternative which provides for delayed 
completion of decommissioning only when necessary to protect the public 
health and safety. Factors to be considered in evaluating an alternative 
which provides for delayed completion of decommissioning include 
unavailability of waste disposal capacity and other site-specific 
factors affecting the licensee's capability to carry out 
decommissioning, including the presence of other nuclear facilities at 
the site.
    (ii) A description of the controls and limits on procedures and 
equipment to protect occupational and public health and safety;
    (iii) A description of the planned final radiation survey;
    (iv) An updated cost estimate for the chosen alternative for 
decommissioning, comparison of that estimate with present funds set 
aside for decommissioning, and plan for assuring the availability of 
adequate funds for completion of decommissioning; and
    (v) A description of technical specifications, quality assurance 
provisions and physical security plan provisions in place during 
decommissioning.
    (5) If the decommissioning plan demonstrates that the 
decommissioning will be performed in accordance with the regulations in 
this chapter and will not be inimical to the common defense and security 
or to the health and safety of the public, and after notice to 
interested persons, the Commission will approve, by amendment, the plan 
subject to such conditions and limitations as it deems appropriate and 
necessary. The approved decommissioning plan will be a supplement to the 
Safety Analysis report or equivalent.
    (6) The Commission will terminate the license if it determines 
that--
    (i) The decommissioning has been performed in accordance with the 
approved decommissioning plan, and
    (ii) The terminal radiation survey and associated documentation 
demonstrate that the facility and site are suitable for release in 
accordance with the criteria for decommissioning in 10 CFR part 20, 
subpart E.
    (c) For a facility that has permanently ceased operation before the 
expiration of its license, the collection period for any shortfall of 
funds will be determined, upon application by the licensee, on a case-
by-case basis taking into account the specific financial situation of 
each licensee.

[61 FR 39301, July 29, 1996, as amended at 62 FR 39091, July 21, 1997; 
68 FR 19727, Apr. 22, 2003; 76 FR 35571, June 17, 2011; 79 FR 66603, 
Nov. 10, 2014]

[[Page 1007]]



Sec.50.83  Release of part of a power reactor facility or site for
unrestricted use.

    (a) Prior written NRC approval is required to release part of a 
facility or site for unrestricted use at any time before receiving 
approval of a license termination plan. Section 50.75 specifies 
recordkeeping requirements associated with partial release. Nuclear 
power reactor licensees seeking NRC approval shall--
    (1) Evaluate the effect of releasing the property to ensure that--
    (i) The dose to individual members of the public does not exceed the 
limits and standards of 10 CFR Part 20, Subpart D;
    (ii) There is no reduction in the effectiveness of emergency 
planning or physical security;
    (iii) Effluent releases remain within license conditions;
    (iv) The environmental monitoring program and offsite dose 
calculation manual are revised to account for the changes;
    (v) The siting criteria of 10 CFR Part 100 continue to be met; and
    (vi) All other applicable statutory and regulatory requirements 
continue to be met.
    (2) Perform a historical site assessment of the part of the facility 
or site to be released; and
    (3) Perform surveys adequate to demonstrate compliance with the 
radiological criteria for unrestricted use specified in 10 CFR 20.1402 
for impacted areas.
    (b) For release of non-impacted areas, the licensee may submit a 
written request for NRC approval of the release if a license amendment 
is not otherwise required. The request submittal must include--
    (1) The results of the evaluations performed in accordance with 
paragraphs (a)(1) and (a)(2) of this section;
    (2) A description of the part of the facility or site to be 
released;
    (3) The schedule for release of the property;
    (4) The results of the evaluations performed in accordance with 
Sec.50.59; and
    (5) A discussion that provides the reasons for concluding that the 
environmental impacts associated with the licensee's proposed release of 
the property will be bounded by appropriate previously issued 
environmental impact statements.
    (c) After receiving an approval request from the licensee for the 
release of a non-impacted area, the NRC shall--
    (1) Determine whether the licensee has adequately evaluated the 
effect of releasing the property as required by paragraph (a)(1) of this 
section;
    (2) Determine whether the licensee's classification of any release 
areas as non-impacted is adequately justified; and
    (3) Upon determining that the licensee's submittal is adequate, 
inform the licensee in writing that the release is approved.
    (d) For release of impacted areas, the licensee shall submit an 
application for amendment of its license for the release of the 
property. The application must include--
    (1) The information specified in paragraphs (b)(1) through (b)(3) of 
this section;
    (2) The methods used for and results obtained from the radiation 
surveys required to demonstrate compliance with the radiological 
criteria for unrestricted use specified in 10 CFR 20.1402; and
    (3) A supplement to the environmental report, under Sec.51.53, 
describing any new information or significant environmental change 
associated with the licensee's proposed release of the property.
    (e) After receiving a license amendment application from the 
licensee for the release of an impacted area, the NRC shall--
    (1) Determine whether the licensee has adequately evaluated the 
effect of releasing the property as required by paragraph (a)(1) of this 
section;
    (2) Determine whether the licensee's classification of any release 
areas as non-impacted is adequately justified;
    (3) Determine whether the licensee's radiation survey for an 
impacted area is adequate; and
    (4) Upon determining that the licensee's submittal is adequate, 
approve the licensee's amendment application.
    (f) The NRC shall notice receipt of the release approval request or 
license amendment application and make the

[[Page 1008]]

approval request or license amendment application available for public 
comment. Before acting on an approval request or license amendment 
application submitted in accordance with this section, the NRC shall 
conduct a public meeting in the vicinity of the licensee's facility for 
the purpose of obtaining public comments on the proposed release of part 
of the facility or site. The NRC shall publish a document in the Federal 
Register and in a forum, such as local newspapers, which is readily 
accessible to individuals in the vicinity of the site, announcing the 
date, time, and location of the meeting, along with a brief description 
of the purpose of the meeting.

[68 FR 19727, Apr. 22, 2003]

    Amendment of License or Construction Permit at Request of Holder



Sec.50.90  Application for amendment of license, construction
permit, or early site permit.

    Whenever a holder of a license, including a construction permit and 
operating license under this part, and an early site permit, combined 
license, and manufacturing license under part 52 of this chapter, 
desires to amend the license or permit, application for an amendment 
must be filed with the Commission, as specified in Sec. Sec.50.4 or 
52.3 of this chapter, as applicable, fully describing the changes 
desired, and following as far as applicable, the form prescribed for 
original applications.

[72 FR 49504, Aug. 28, 2007]



Sec.50.91  Notice for public comment; State consultation.

    The Commission will use the following procedures for an application 
requesting an amendment to an operating license under this part or a 
combined license under part 52 of this chapter for a facility licensed 
under Sec. Sec.50.21(b) or 50.22, or for a testing facility, except 
for amendments subject to hearings governed by 10 CFR part 2, subpart L. 
For amendments subject to 10 CFR part 2, subpart L, the following 
procedures will apply only to the extent specifically referenced in 
Sec.2.309(b) of this chapter, except that notice of opportunity for 
hearing must be published in the Federal Register at least 30 days 
before the requested amendment is issued by the Commission:
    (a) Notice for public comment. (1) At the time a licensee requests 
an amendment, it must provide to the Commission, in accordance with the 
distribution requirements specified in Sec.50.4, its analysis about 
the issue of no significant hazards consideration using the standards in 
Sec.50.92.
    (2)(i) The Commission may publish in the Federal Register under 
Sec.2.105 an individual notice of proposed action for an amendment for 
which it makes a proposed determination that no significant hazards 
consideration is involved, or, at least once every 30 days, publish a 
periodic Federal Register notice of proposed actions which identifies 
each amendment issued and each amendment proposed to be issued since the 
last such periodic notice, or it may publish both such notices.
    (ii) For each amendment proposed to be issued, the notice will (A) 
contain the staff's proposed determination, under the standards in Sec.
50.92, (B) provide a brief description of the amendment and of the 
facility involved, (C) solicit public comments on the proposed 
determination, and (D) provide for a 30-day comment period.
    (iii) The comment period will begin on the day after the date of the 
publication of the first notice, and, normally, the amendment will not 
be granted until after this comment period expires.
    (3) The Commission may inform the public about the final disposition 
of an amendment request for which it has made a proposed determination 
of no significant hazards consideration either by issuing an individual 
notice of issuance under Sec.2.106 of this chapter or by publishing 
such a notice in its periodic system of Federal Register notices. In 
either event, it will not make and will not publish a final 
determination on no significant hazards consideration, unless it 
receives a request for a hearing on that amendment request.
    (4) Where the Commission makes a final determination that no 
significant hazards consideration is involved and that the amendment 
should be issued, the amendment will be effective on

[[Page 1009]]

issuance, even if adverse public comments have been received and even if 
an interested person meeting the provisions for intervention called for 
in Sec.2.309 of this chapter has filed a request for a hearing. The 
Commission need hold any required hearing only after it issues an 
amendment, unless it determines that a significant hazards consideration 
is involved, in which case the Commission will provide an opportunity 
for a prior hearing.
    (5) Where the Commission finds that an emergency situation exists, 
in that failure to act in a timely way would result in derating or 
shutdown of a nuclear power plant, or in prevention of either resumption 
of operation or of increase in power output up to the plant's licensed 
power level, it may issue a license amendment involving no significant 
hazards consideration without prior notice and opportunity for a hearing 
or for public comment. In such a situation, the Commission will not 
publish a notice of proposed determination on no significant hazards 
consideration, but will publish a notice of issuance under Sec.2.106 
of this chapter, providing for opportunity for a hearing and for public 
comment after issuance. The Commission expects its licensees to apply 
for license amendments in timely fashion. It will decline to dispense 
with notice and comment on the determination of no significant hazards 
consideration if it determines that the licensee has abused the 
emergency provision by failing to make timely application for the 
amendment and thus itself creating the emergency. Whenever an emergency 
situation exists, a licensee requesting an amendment must explain why 
this emergency situation occurred and why it could not avoid this 
situation, and the Commission will assess the licensee's reasons for 
failing to file an application sufficiently in advance of that event.
    (6) Where the Commission finds that exigent circumstances exist, in 
that a licensee and the Commission must act quickly and that time does 
not permit the Commission to publish a Federal Register notice allowing 
30 days for prior public comment, and it also determines that the 
amendment involves no significant hazards considerations, it:
    (i)(A) Will either issue a Federal Register notice providing notice 
of an opportunity for hearing and allowing at least two weeks from the 
date of the notice for prior public comment; or
    (B) Will use local media to provide reasonable notice to the public 
in the area surrounding a licensee's facility of the licensee's 
amendment and of its proposed determination as described in paragraph 
(a)(2) of this section, consulting with the licensee on the proposed 
media release and on the geographical area of its coverage;
    (ii) Will provide for a reasonable opportunity for the public to 
comment, using its best efforts to make available to the public whatever 
means of communication it can for the public to respond quickly, and, in 
the case of telephone comments, have these comments recorded or 
transcribed, as necessary and appropriate;
    (iii) When it has issued a local media release, may inform the 
licensee of the public's comments, as necessary and appropriate;
    (iv) Will publish a notice of issuance under Sec.2.106;
    (v) Will provide a hearing after issuance, if one has been requested 
by a person who satisfies the provisions for intervention specified in 
Sec.2.309 of this chapter;
    (vi) Will require the licensee to explain the exigency and why the 
licensee cannot avoid it, and use its normal public notice and comment 
procedures in paragraph (a)(2) of this section if it determines that the 
licensee has failed to use its best efforts to make a timely application 
for the amendment in order to create the exigency and to take advantage 
of this procedure.
    (7) Where the Commission finds that significant hazards 
considerations are involved, it will issue a Federal Register notice 
providing an opportunity for a prior hearing even in an emergency 
situation, unless it finds an imminent danger to the health or safety of 
the public, in which case it will issue an appropriate order or rule 
under 10 CFR part 2.
    (b) State consultation. (1) At the time a licensee requests an 
amendment, it

[[Page 1010]]

must notify the State in which its facility is located of its request by 
providing that State with a copy of its application and its reasoned 
analysis about no significant hazards considerations and indicate on the 
application that it has done so. (The Commission will make available to 
the licensee the name of the appropriate State official designated to 
receive such amendments.)
    (2) The Commission will advise the State of its proposed 
determination about no significant hazards consideration normally by 
sending it a copy of the Federal Register notice.
    (3) The Commission will make available to the State official 
designated to consult with it about its proposed determination the names 
of the Project Manager or other NRC personnel it designated to consult 
with the State. The Commission will consider any comments of that State 
official. If it does not hear from the State in a timely manner, it will 
consider that the State has no interest in its determination; 
nonetheless, to ensure that the State is aware of the application, 
before it issues the amendment, it will make a good faith effort to 
telephone that official. (Inability to consult with a responsible State 
official following good faith attempts will not prevent the Commission 
from making effective a license amendment involving no significant 
hazards consideration.)
    (4) The Commission will make a good faith attempt to consult with 
the State before it issues a license amendment involving no significant 
hazards consideration. If, however, it does not have time to use its 
normal consultation procedures because of an emergency situation, it 
will attempt to telephone the appropriate State official. (Inability to 
consult with a responsible State official following good faith attempts 
will not prevent the Commission from making effective a license 
amendment involving no significant hazards consideration, if the 
Commission deems it necessary in an emergency situation.)
    (5) After the Commission issues the requested amendment, it will 
send a copy of its determination to the State.
    (c) Caveats about State consultation. (1) The State consultation 
procedures in paragraph (b) of this section do not give the State a 
right:
    (i) To veto the Commission's proposed or final determination;
    (ii) To a hearing on the determination before the amendment becomes 
effective; or
    (iii) To insist upon a postponement of the determination or upon 
issuance of the amendment.
    (2) These procedures do not alter present provisions of law that 
reserve to the Commission exclusive responsibility for setting and 
enforcing radiological health and safety requirements for nuclear power 
plants.

[51 FR 7765, Mar. 6, 1986, as amended at 51 FR 40310, Nov. 6, 1986; 61 
FR 39303, July 29, 1996; 69 FR 2276, Jan. 14, 2004; 72 FR 49504, Aug. 
28, 2007]



Sec.50.92  Issuance of amendment.

    (a) In determining whether an amendment to a license, construction 
permit, or early site permit will be issued to the applicant, the 
Commission will be guided by the considerations which govern the 
issuance of initial licenses, construction permits, or early site 
permits to the extent applicable and appropriate. If the application 
involves the material alteration of a licensed facility, a construction 
permit will be issued before the issuance of the amendment to the 
license, provided however, that if the application involves a material 
alteration to a nuclear power reactor manufactured under part 52 of this 
chapter before its installation at a site, or a combined license before 
the date that the Commission makes the finding under Sec.52.103(g) of 
this chapter, no application for a construction permit is required. If 
the amendment involves a significant hazards consideration, the 
Commission will give notice of its proposed action:
    (1) Under Sec.2.105 of this chapter before acting thereon; and
    (2) As soon as practicable after the application has been docketed.
    (b) The Commission will be particularly sensitive to a license 
amendment request that involves irreversible consequences (such as one 
that permits a significant increase in the amount of effluents or 
radiation emitted by a nuclear power plant).

[[Page 1011]]

    (c) The Commission may make a final determination, under the 
procedures in Sec.50.91, that a proposed amendment to an operating 
license or a combined license for a facility or reactor licensed under 
Sec. Sec.50.21(b) or 50.22, or for a testing facility involves no 
significant hazards consideration, if operation of the facility in 
accordance with the proposed amendment would not:
    (1) Involve a significant increase in the probability or 
consequences of an accident previously evaluated; or
    (2) Create the possibility of a new or different kind of accident 
from any accident previously evaluated; or
    (3) Involve a significant reduction in a margin of safety.

[51 FR 7767, Mar. 6, 1986, as amended at 72 FR 49504, Aug. 28, 2007]

    Revocation, Suspension, Modification, Amendment of Licenses and 
      Construction Permits, Emergency Operations by the Commission



Sec.50.100  Revocation, suspension, modification of licenses, permits,
and approvals for cause.

    A license, permit, or standard design approval under parts 50 or 52 
of this chapter may be revoked, suspended, or modified, in whole or in 
part, for any material false statement in the application or in the 
supplemental or other statement of fact required of the applicant; or 
because of conditions revealed by the application or statement of fact 
of any report, record, inspection, or other means which would warrant 
the Commission to refuse to grant a license, permit, or approval on an 
original application (other than those relating to Sec. Sec.50.51, 
50.42(a), and 50.43(b)); or for failure to manufacture a reactor, or 
construct or operate a facility in accordance with the terms of the 
permit or license, provided, however, that failure to make timely 
completion of the proposed construction or alteration of a facility 
under a construction permit under part 50 of this chapter or a combined 
license under part 52 of this chapter shall be governed by the 
provisions of Sec.50.55(b); or for violation of, or failure to 
observe, any of the terms and provisions of the act, regulations, 
license, permit, approval, or order of the Commission.

[72 FR 49504, Aug. 28, 2007]



Sec.50.101  Retaking possession of special nuclear material.

    Upon revocation of a license, the Commission may immediately cause 
the retaking of possession of all special nuclear material held by the 
licensee.

[21 FR 355, Jan. 19, 1956, as amended at 40 FR 8790, Mar. 3, 1975]



Sec.50.102  Commission order for operation after revocation.

    Whenever the Commission finds that the public convenience and 
necessity, or the Department finds that the production program of the 
Department requires continued operation of a production or utilization 
facility, the license for which has been revoked, the Commission may, 
after consultation with the appropriate federal or state regulatory 
agency having jurisdiction, order that possession be taken of such 
facility and that it be operated for a period of time as, in the 
judgment of the Commission, the public convenience and necessity or the 
production program of the Department may require, or until a license for 
operation of the facility shall become effective. Just compensation 
shall be paid for the use of the facility.

[40 FR 8790, Mar. 3, 1975]



Sec.50.103  Suspension and operation in war or national 
emergency.

    (a) Whenever Congress declares that a state of war or national 
emergency exists, the Commission, if it finds it necessary to the common 
defense and security, may,
    (1) Suspend any license it has issued.
    (2) Cause the recapture of special nuclear material.
    (3) Order the operation of any licensed facility.
    (4) Order entry into any plant or facility in order to recapture 
special nuclear material or to operate the facility.
    (b) Just compensation shall be paid for any damages caused by 
recapture of

[[Page 1012]]

special nuclear material or by operation of any facility, pursuant to 
this section.

[21 FR 355, Jan. 19, 1956, as amended at 35 FR 11416, July 17, 1970; 40 
FR 8790, Mar. 3, 1975]

                               Backfitting



Sec.50.109  Backfitting.

    (a)(1) Backfitting is defined as the modification of or addition to 
systems, structures, components, or design of a facility; or the design 
approval or manufacturing license for a facility; or the procedures or 
organization required to design, construct or operate a facility; any of 
which may result from a new or amended provision in the Commission's 
regulations or the imposition of a regulatory staff position 
interpreting the Commission's regulations that is either new or 
different from a previously applicable staff position after:
    (i) The date of issuance of the construction permit for the facility 
for facilities having construction permits issued after October 21, 
1985;
    (ii) Six (6) months before the date of docketing of the operating 
license application for the facility for facilities having construction 
permits issued before October 21, 1985;
    (iii) The date of issuance of the operating license for the facility 
for facilities having operating licenses;
    (iv) The date of issuance of the design approval under subpart E of 
part 52 of this chapter;
    (v) The date of issuance of a manufacturing license under subpart F 
of part 52 of this chapter;
    (vi) The date of issuance of the first construction permit issued 
for a duplicate design under appendix N of this part; or
    (vii) The date of issuance of a combined license under subpart C of 
part 52 of this chapter, provided that if the combined license 
references an early site permit, the provisions in Sec.52.39 of this 
chapter apply with respect to the site characteristics, design 
parameters, and terms and conditions specified in the early site permit. 
If the combined license references a standard design certification rule 
under subpart B of 10 CFR part 52, the provisions in Sec.52.63 of this 
chapter apply with respect to the design matters resolved in the 
standard design certification rule, provided however, that if any 
specific backfitting limitations are included in a referenced design 
certification rule, those limitations shall govern. If the combined 
license references a standard design approval under subpart E of 10 CFR 
part 52, the provisions in Sec.52.145 of this chapter apply with 
respect to the design matters resolved in the standard design approval. 
If the combined license uses a reactor manufactured under a 
manufacturing license under subpart F of 10 CFR part 52, the provisions 
of Sec.52.171 of this chapter apply with respect to matters resolved 
in the manufacturing license proceeding.
    (2) Except as provided in paragraph (a)(4) of this section, the 
Commission shall require a systematic and documented analysis pursuant 
to paragraph (c) of this section for backfits which it seeks to impose.
    (3) Except as provided in paragraph (a)(4) of this section, the 
Commission shall require the backfitting of a facility only when it 
determines, based on the analysis described in paragraph (c) of this 
section, that there is a substantial increase in the overall protection 
of the public health and safety or the common defense and security to be 
derived from the backfit and that the direct and indirect costs of 
implementation for that facility are justified in view of this increased 
protection.
    (4) The provisions of paragraphs (a)(2) and (a)(3) of this section 
are inapplicable and, therefore, backfit analysis is not required and 
the standards in paragraph (a)(3) of this section do not apply where the 
Commission or staff, as appropriate, finds and declares, with 
appropriated documented evaluation for its finding, either:
    (i) That a modification is necessary to bring a facility into 
compliance with a license or the rules or orders of the Commission, or 
into conformance with written commitments by the licensee; or
    (ii) That regulatory action is necessary to ensure that the facility 
provides adequate protection to the health and safety of the public and 
is in accord with the common defense and security; or
    (iii) That the regulatory action involves defining or redefining 
what level

[[Page 1013]]

of protection to the public health and safety or common defense and 
security should be regarded as adequate.
    (5) The Commission shall always require the backfitting of a 
facility if it determines that such regulatory action is necessary to 
ensure that the facility provides adequate protection to the health and 
safety of the public and is in accord with the common defense and 
security.
    (6) The documented evaluation required by paragraph (a)(4) of this 
section shall include a statement of the objectives of and reasons for 
the modification and the basis for invoking the exception. If 
immediately effective regulatory action is required, then the documented 
evaluation may follow rather than precede the regulatory action.
    (7) If there are two or more ways to achieve compliance with a 
license or the rules or orders of the Commission, or with written 
licensee commitments, or there are two or more ways to reach a level of 
protection which is adequate, then ordinarily the applicant or licensee 
is free to choose the way which best suits its purposes. However, should 
it be necessary or appropriate for the Commission to prescribe a 
specific way to comply with its requirements or to achieve adequate 
protection, then cost may be a factor in selecting the way, provided 
that the objective of compliance or adequate protection is met.
    (b) Paragraph (a)(3) of this section shall not apply to backfits 
imposed prior to October 21, 1985.
    (c) In reaching the determination required by paragraph (a)(3) of 
this section, the Commission will consider how the backfit should be 
scheduled in light of other ongoing regulatory activities at the 
facility and, in addition, will consider information available 
concerning any of the following factors as may be appropriate and any 
other information relevant and material to the proposed backfit:
    (1) Statement of the specific objectives that the proposed backfit 
is designed to achieve;
    (2) General description of the activity that would be required by 
the licensee or applicant in order to complete the backfit;
    (3) Potential change in the risk to the public from the accidental 
off-site release of radioactive material;
    (4) Potential impact on radiological exposure of facility employees;
    (5) Installation and continuing costs associated with the backfit, 
including the cost of facility downtime or the cost of construction 
delay;
    (6) The potential safety impact of changes in plant or operational 
complexity, including the relationship to proposed and existing 
regulatory requirements;
    (7) The estimated resource burden on the NRC associated with the 
proposed backfit and the availability of such resources;
    (8) The potential impact of differences in facility type, design or 
age on the relevancy and practicality of the proposed backfit;
    (9) Whether the proposed backfit is interim or final and, if 
interim, the justification for imposing the proposed backfit on an 
interim basis.
    (d) No licensing action will be withheld during the pendency of 
backfit analyses required by the Commission's rules.
    (e) The Executive Director for Operations shall be responsible for 
implementation of this section, and all analyses required by this 
section shall be approved by the Executive Director for Operations or 
his designee.

[53 FR 20610, June 6, 1988, as amended at 54 FR 15398, Apr. 18, 1989; 72 
FR 49504, Aug. 28, 2007]

                               Enforcement



Sec.50.110  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under Section 234 of the Atomic Energy Act:
    (1) For violations of--

[[Page 1014]]

    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55075, Nov. 24, 1992]



Sec.50.111  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of section 223, 
all the regulations in part 50 are issued under one or more of sections 
161b, 161i, or 161o, except for the sections listed in paragraph (b) of 
this section.
    (b) The regulations in 10 CFR part 50 that are not issued under 
sections 161b, 161i, or 161o for the purposes of section 223 are as 
follows: Sec. Sec.50.1, 50.2, 50.3, 50.4, 50.8, 50.11, 50.12, 50.13, 
50.20, 50.21, 50.22, 50.23, 50.30, 50.31, 50.32, 50.33, 50.34a, 50.35, 
50.36b, 50.37, 50.38, 50.39, 50.40, 50.41, 50.42, 50.43, 50.45, 50.50, 
50.51, 50.52, 50.53, 50.56, 50.57, 50.58, 50.81, 50.90, 50.91, 50.92, 
50.100, 50.101, 50.102, 50.103, 50.109, 50.110, 50.111.

[57 FR 55075, Nov. 24, 1992, as amended at 61 FR 39303, July 29, 1996]

   Additional Standards for Licenses, Certifications, and Regulatory 
                                Approvals



Sec.50.120  Training and qualification of nuclear power plant 
personnel.

    (a) Applicability. The requirements of this section apply to each 
applicant for and each holder of an operating license issued under this 
part and each holder of a combined license issued under part 52 of this 
chapter for a nuclear power plant of the type specified in Sec.
50.21(b) or Sec.50.22.
    (b) Requirements. (1)(i) Each nuclear power plant operating license 
applicant, by 18 months prior to fuel load, and each holder of an 
operating license shall establish, implement, and maintain a training 
program that meets the requirements of paragraphs (b)(2) and (b)(3) of 
this section.
    (ii) Each holder of a combined license shall establish, implement, 
and maintain the training program that meets the requirements of 
paragraphs (b)(2) and (b)(3) of this section, as described in the final 
safety analysis report no later than 18 months before the scheduled date 
for initial loading of fuel.
    (2) The training program must be derived from a systems approach to 
training as defined in 10 CFR 55.4, and must provide for the training 
and qualification of the following categories of nuclear power plant 
personnel:
    (i) Non-licensed operator.
    (ii) Shift supervisor.
    (iii) Shift technical advisor.
    (iv) Instrument and control technician.
    (v) Electrical maintenance personnel.
    (vi) Mechanical maintenance personnel.
    (vii) Radiological protection technician.
    (viii) Chemistry technician.
    (ix) Engineering support personnel.
    (3) The training program must incorporate the instructional 
requirements necessary to provide qualified personnel to operate and 
maintain the facility in a safe manner in all modes of operation. The 
training program must be developed to be in compliance with the facility 
license, including all technical specifications and applicable 
regulations. The training program must be periodically evaluated and 
revised as appropriate to reflect industry experience as well as changes 
to the facility, procedures, regulations, and quality assurance 
requirements. The training program must be periodically reviewed by 
licensee management for effectiveness. Sufficient records must be 
maintained by the licensee to maintain program integrity and kept 
available for NRC inspection to verify the adequacy of the program.

[72 FR 49505, Aug. 28, 2007]

[[Page 1015]]



Sec.50.150  Aircraft impact assessment.

    (a) Assessment requirements. (1) Assessment. Each applicant listed 
in paragraph (a)(3) shall perform a design-specific assessment of the 
effects on the facility of the impact of a large, commercial aircraft. 
Using realistic analyses, the applicant shall identify and incorporate 
into the design those design features and functional capabilities to 
show that, with reduced use of operator actions:
    (i) The reactor core remains cooled, or the containment remains 
intact; and
    (ii) spent fuel cooling or spent fuel pool integrity is maintained.
    (2) Aircraft impact characteristics. \1\ The assessment must be 
based on the beyond-design-basis impact of a large, commercial aircraft 
used for long distance flights in the United States, with aviation fuel 
loading typically used in such flights, and an impact speed and angle of 
impact considering the ability of both experienced and inexperienced 
pilots to control large, commercial aircraft at the low altitude 
representative of a nuclear power plant's low profile.
---------------------------------------------------------------------------

    \1\ Changes to the detailed parameters on aircraft impact 
characteristics set forth in guidance shall be approved by the 
Commission.
---------------------------------------------------------------------------

    (3) Applicability. The requirements of paragraphs (a)(1) and (a)(2) 
of this section apply to applicants for:
    (i) Construction permits for nuclear power reactors issued under 
this part after July 13, 2009;
    (ii) Operating licenses for nuclear power reactors issued under this 
part for which a construction permit was issued after July 13, 2009;
    (iii)(A) Standard design certifications issued under part 52 of this 
chapter after July 13, 2009;
    (B) Renewal of standard design certifications in effect on July 13, 
2009 which have not been amended to comply with the requirements of this 
section by the time of application for renewal;
    (iv) Standard design approvals issued under part 52 of this chapter 
after July 13, 2009;
    (v) Combined licenses issued under part 52 of this chapter that:
    (A) Do not reference a standard design certification, standard 
design approval, or manufactured reactor; or
    (B) Reference a standard design certification issued before July 13, 
2009 which has not been amended to address the requirements of this 
section; and
    (vi) Manufacturing licenses issued under part 52 of this chapter 
that:
    (A) Do not reference a standard design certification or standard 
design approval; or
    (B) Reference a standard design certification issued before July 13, 
2009 which has not been amended to address the requirements of this 
section.
    (b) Content of application. For applicants identified in paragraph 
(a)(3) of this section, the preliminary or final safety analysis report, 
as applicable, must include a description of:
    (1) The design features and functional capabilities identified in 
paragraph (a)(1) of this section; and
    (2) How the design features and functional capabilities identified 
in paragraph (a)(1) of this section meet the assessment requirements in 
paragraph (a)(1) of this section.
    (c) Control of changes. (1) For construction permits which are 
subject to paragraph (a) of this section, if the permit holder changes 
the information required by 10 CFR 50.34(a)(13) to be included in the 
preliminary safety analysis report, then the permit holder shall 
consider the effect of the changed feature or capability on the original 
assessment required by 10 CFR 50.150(a) and amend the information 
required by 10 CFR 50.34(a)(13) to be included in the preliminary safety 
analysis report to describe how the modified design features and 
functional capabilities continue to meet the assessment requirements in 
paragraph (a)(1) of this section.
    (2) For operating licenses which are subject to paragraph (a) of 
this section, if the licensee changes the information required by 10 CFR 
50.34(b)(12) to be included in the final safety analysis report, then 
the licensee shall consider the effect of the changed feature or 
capability on the original assessment required by 10 CFR 50.150(a) and 
amend the information required by 10 CFR 50.34(b)(12) to be included in 
the final safety analysis report to describe how

[[Page 1016]]

the modified design features and functional capabilities continue to 
meet the assessment requirements in paragraph (a)(1) of this section.
    (3) For standard design certifications which are subject to 
paragraph (a) of this section, generic changes to the information 
required by 10 CFR 52.47(a)(28) to be included in the final safety 
analysis report are governed by the applicable requirements of 10 CFR 
52.63.
    (4)(i) For combined licenses which are subject to paragraph (a) of 
this section, if the licensee changes the information required by 10 CFR 
52.79(a)(47) to be included in the final safety analysis report, then 
the licensee shall consider the effect of the changed feature or 
capability on the original assessment required by 10 CFR 50.150(a) and 
amend the information required by 10 CFR 52.79(a)(47) to be included in 
the final safety analysis report to describe how the modified design 
features and functional capabilities continue to meet the assessment 
requirements in paragraph (a)(1) of this section.
    (ii) For combined licenses which are not subject to paragraph (a) of 
this section but reference a standard design certification which is 
subject to paragraph (a) of this section, proposed departures from the 
information required by 10 CFR 52.47(a)(28) to be included in the final 
safety analysis report for the referenced standard design certification 
are governed by the change control requirements in the applicable design 
certification rule.
    (iii) For combined licenses which are not subject to paragraph (a) 
of this section but reference a manufactured reactor which is subject to 
paragraph (a) of this section, proposed departures from the information 
required by 10 CFR 52.157(f)(32) to be included in the final safety 
analysis report for the manufacturing license are governed by the 
applicable requirements in 10 CFR 52.171(b)(2).
    (5)(i) For manufacturing licenses which are subject to paragraph (a) 
of this section, generic changes to the information required by 10 CFR 
52.157(f)(32) to be included in the final safety analysis report are 
governed by the applicable requirements of 10 CFR 52.171.
    (ii) For manufacturing licenses which are not subject to paragraph 
(a) of this section but reference a standard design certification which 
is subject to paragraph (a) of this section, proposed departures from 
the information required by 10 CFR 52.47(a)(28) to be included in the 
final safety analysis report for the referenced standard design 
certification are governed by the change control requirements in the 
applicable design certification rule.

[74 FR 28146, June 12, 2009]



 Sec. Appendix A to Part 50--General Design Criteria for Nuclear Power 
                                 Plants

                            Table of Contents

                              introduction

                               definitions

Nuclear Power Unit.
Loss of Coolant Accidents.
Single Failure.
Anticipated Operational Occurrences.

                                criteria
------------------------------------------------------------------------
                                                                 Number
------------------------------------------------------------------------
I. Overall Requirements:
  Quality Standards and Records..............................          1
  Design Bases for Protection Against Natural Phenomena......          2
  Fire Protection............................................          3
  Environmental and Dynamic Effects Design Bases.............          4
  Sharing of Structures, Systems, and Components.............          5
 
II. Protection by Multiple Fission Product Barriers:
  Reactor Design.............................................         10
  Reactor Inherent Protection................................         11
  Suppression of Reactor Power Oscillations..................         12
  Instrumentation and Control................................         13
  Reactor Coolant Pressure Boundary..........................         14
  Reactor Coolant System Design..............................         15
  Containment Design.........................................         16
  Electric Power Systems.....................................         17
  Inspection and Testing of Electric Power Systems...........         18
  Control Room...............................................         19
 
III. Protection and Reactivity Control Systems:
  Protection System Functions................................         20
  Protection System Reliability and Testability..............         21
  Protection System Independence.............................         22
  Protection System Failure Modes............................         23
  Separation of Protection and Control Systems...............         24
  Protection System Requirements for Reactivity Control               25
   Malfunctions..............................................
  Reactivity Control System Redundancy and Capability........         26
  Combined Reactivity Control Systems Capability.............         27
  Reactivity Limits..........................................         28

[[Page 1017]]

 
  Protection Against Anticipated Operational Occurrences.....         29
 
IV. Fluid Systems:
  Quality of Reactor Coolant Pressure Boundary...............         30
  Fracture Prevention of Reactor Coolant Pressure Boundary...         31
  Inspection of Reactor Coolant Pressure Boundary............         32
  Reactor Coolant Makeup.....................................         33
  Residual Heat Removal......................................         34
  Emergency Core Cooling.....................................         35
  Inspection of Emergency Core Cooling System................         36
  Testing of Emergency Core Cooling System...................         37
  Containment Heat Removal...................................         38
  Inspection of Containment Heat Removal System..............         39
  Testing of Containment Heat Removal System.................         40
  Containment Atmosphere Cleanup.............................         41
  Inspection of Containment Atmosphere Cleanup Systems.......         42
  Testing of Containment Atmosphere Cleanup Systems..........         43
  Cooling Water..............................................         44
  Inspection of Cooling Water System.........................         45
  Testing of Cooling Water System............................         46
 
V. Reactor Containment:
  Containment Design Basis...................................         50
  Fracture Prevention of Containment Pressure Boundary.......         51
  Capability for Containment Leakage Rate Testing............         52
  Provisions for Containment Testing and Inspection..........         53
  Systems Penetrating Containment............................         54
  Reactor Coolant Pressure Boundary Penetrating Containment..         55
  Primary Containment Isolation..............................         56
  Closed Systems Isolation Valves............................         57
 
VI. Fuel and Radioactivity Control:
  Control of Releases of Radioactive Materials to the                 60
   Environment...............................................
  Fuel Storage and Handling and Radioactivity Control........         61
  Prevention of Criticality in Fuel Storage and Handling.....         62
  Monitoring Fuel and Waste Storage..........................         63
  Monitoring Radioactivity Releases..........................         64
------------------------------------------------------------------------

                              introduction

    Under the provisions of Sec.50.34, an application for a 
construction permit must include the principal design criteria for a 
proposed facility. Under the provisions of 10 CFR 52.47, 52.79, 52.137, 
and 52.157, an application for a design certification, combined license, 
design approval, or manufacturing license, respectively, must include 
the principal design criteria for a proposed facility. The principal 
design criteria establish the necessary design, fabrication, 
construction, testing, and performance requirements for structures, 
systems, and components important to safety; that is, structures, 
systems, and components that provide reasonable assurance that the 
facility can be operated without undue risk to the health and safety of 
the public.
    These General Design Criteria establish minimum requirements for the 
principal design criteria for water-cooled nuclear power plants similar 
in design and location to plants for which construction permits have 
been issued by the Commission. The General Design Criteria are also 
considered to be generally applicable to other types of nuclear power 
units and are intended to provide guidance in establishing the principal 
design criteria for such other units.
    The development of these General Design Criteria is not yet 
complete. For example, some of the definitions need further 
amplification. Also, some of the specific design requirements for 
structures, systems, and components important to safety have not as yet 
been suitably defined. Their omission does not relieve any applicant 
from considering these matters in the design of a specific facility and 
satisfying the necessary safety requirements. These matters include:
    (1) Consideration of the need to design against single failures of 
passive components in fluid systems important to safety. (See Definition 
of Single Failure.)
    (2) Consideration of redundancy and diversity requirements for fluid 
systems important to safety. A ``system'' could consist of a number of 
subsystems each of which is separately capable of performing the 
specified system safety function. The minimum acceptable redundancy and 
diversity of subsystems and components within a subsystem, and the 
required interconnection and independence of the subsystems have not yet 
been developed or defined. (See Criteria 34, 35, 38, 41, and 44.)
    (3) Consideration of the type, size, and orientation of possible 
breaks in components of the reactor coolant pressure boundary in 
determining design requirements to suitably protect against postulated 
loss-of-coolant accidents. (See Definition of Loss of Coolant 
Accidents.)
    (4) Consideration of the possibility of systematic, nonrandom, 
concurrent failures of redundant elements in the design of protection 
systems and reactivity control systems. (See Criteria 22, 24, 26, and 
29.)
    It is expected that the criteria will be augmented and changed from 
time to time as important new requirements for these and other features 
are developed.
    There will be some water-cooled nuclear power plants for which the 
General Design Criteria are not sufficient and for which additional 
criteria must be identified and satisfied in the interest of public 
safety. In particular, it is expected that additional or different 
criteria will be needed to take into account unusual sites and 
environmental conditions, and for water-cooled nuclear power units of 
advanced design. Also, there may be

[[Page 1018]]

water-cooled nuclear power units for which fulfillment of some of the 
General Design Criteria may not be necessary or appropriate. For plants 
such as these, departures from the General Design Criteria must be 
identified and justified.

                      definitions and explanations

    Nuclear power unit. A nuclear power unit means a nuclear power 
reactor and associated equipment necessary for electric power generation 
and includes those structures, systems, and components required to 
provide reasonable assurance the facility can be operated without undue 
risk to the health and safety of the public.
    Loss of coolant accidents. Loss of coolant accidents mean those 
postulated accidents that result from the loss of reactor coolant at a 
rate in excess of the capability of the reactor coolant makeup system 
from breaks in the reactor coolant pressure boundary, up to and 
including a break equivalent in size to the double-ended rupture of the 
largest pipe of the reactor coolant system. \1\
---------------------------------------------------------------------------

    \1\ Further details relating to the type, size, and orientation of 
postulated breaks in specific components of the reactor coolant pressure 
boundary are under development.
---------------------------------------------------------------------------

    Single failure. A single failure means an occurrence which results 
in the loss of capability of a component to perform its intended safety 
functions. Multiple failures resulting from a single occurrence are 
considered to be a single failure. Fluid and electric systems are 
considered to be designed against an assumed single failure if neither 
(1) a single failure of any active component (assuming passive 
components function properly) nor (2) a single failure of a passive 
component (assuming active components function properly), results in a 
loss of the capability of the system to perform its safety functions. 
\2\
---------------------------------------------------------------------------

    \2\ Single failures of passive components in electric systems should 
be assumed in designing against a single failure. The conditions under 
which a single failure of a passive component in a fluid system should 
be considered in designing the system against a single failure are under 
development.
---------------------------------------------------------------------------

    Anticipated operational occurrences. Anticipated operational 
occurrences mean those conditions of normal operation which are expected 
to occur one or more times during the life of the nuclear power unit and 
include but are not limited to loss of power to all recirculation pumps, 
tripping of the turbine generator set, isolation of the main condenser, 
and loss of all offsite power.

                                criteria

                         I. Overall Requirements

    Criterion 1--Quality standards and records. Structures, systems, and 
components important to safety shall be designed, fabricated, erected, 
and tested to quality standards commensurate with the importance of the 
safety functions to be performed. Where generally recognized codes and 
standards are used, they shall be identified and evaluated to determine 
their applicability, adequacy, and sufficiency and shall be supplemented 
or modified as necessary to assure a quality product in keeping with the 
required safety function. A quality assurance program shall be 
established and implemented in order to provide adequate assurance that 
these structures, systems, and components will satisfactorily perform 
their safety functions. Appropriate records of the design, fabrication, 
erection, and testing of structures, systems, and components important 
to safety shall be maintained by or under the control of the nuclear 
power unit licensee throughout the life of the unit.
    Criterion 2--Design bases for protection against natural phenomena. 
Structures, systems, and components important to safety shall be 
designed to withstand the effects of natural phenomena such as 
earthquakes, tornadoes, hurricanes, floods, tsunami, and seiches without 
loss of capability to perform their safety functions. The design bases 
for these structures, systems, and components shall reflect: (1) 
Appropriate consideration of the most severe of the natural phenomena 
that have been historically reported for the site and surrounding area, 
with sufficient margin for the limited accuracy, quantity, and period of 
time in which the historical data have been accumulated, (2) appropriate 
combinations of the effects of normal and accident conditions with the 
effects of the natural phenomena and (3) the importance of the safety 
functions to be performed.
    Criterion 3--Fire protection. Structures, systems, and components 
important to safety shall be designed and located to minimize, 
consistent with other safety requirements, the probability and effect of 
fires and explosions. Noncombustible and heat resistant materials shall 
be used wherever practical throughout the unit, particularly in 
locations such as the containment and control room. Fire detection and 
fighting systems of appropriate capacity and capability shall be 
provided and designed to minimize the adverse effects of fires on 
structures, systems, and components important to safety. Firefighting 
systems shall be designed to assure that their rupture or inadvertent 
operation does not significantly impair the safety capability of these 
structures, systems, and components.
    Criterion 4--Environmental and dynamic effects design bases. 
Structures, systems, and components important to safety shall be 
designed to accommodate the effects of and to be compatible with the 
environmental conditions associated with normal operation,

[[Page 1019]]

maintenance, testing, and postulated accidents, including loss-of-
coolant accidents. These structures, systems, and components shall be 
appropriately protected against dynamic effects, including the effects 
of missiles, pipe whipping, and discharging fluids, that may result from 
equipment failures and from events and conditions outside the nuclear 
power unit. However, dynamic effects associated with postulated pipe 
ruptures in nuclear power units may be excluded from the design basis 
when analyses reviewed and approved by the Commission demonstrate that 
the probability of fluid system piping rupture is extremely low under 
conditions consistent with the design basis for the piping.
    Criterion 5--Sharing of structures, systems, and components. 
Structures, systems, and components important to safety shall not be 
shared among nuclear power units unless it can be shown that such 
sharing will not significantly impair their ability to perform their 
safety functions, including, in the event of an accident in one unit, an 
orderly shutdown and cooldown of the remaining units.

           II. Protection by Multiple Fission Product Barriers

    Criterion 10--Reactor design. The reactor core and associated 
coolant, control, and protection systems shall be designed with 
appropriate margin to assure that specified acceptable fuel design 
limits are not exceeded during any condition of normal operation, 
including the effects of anticipated operational occurrences.
    Criterion 11--Reactor inherent protection. The reactor core and 
associated coolant systems shall be designed so that in the power 
operating range the net effect of the prompt inherent nuclear feedback 
characteristics tends to compensate for a rapid increase in reactivity.
    Criterion 12--Suppression of reactor power oscillations. The reactor 
core and associated coolant, control, and protection systems shall be 
designed to assure that power oscillations which can result in 
conditions exceeding specified acceptable fuel design limits are not 
possible or can be reliably and readily detected and suppressed.
    Criterion 13--Instrumentation and control. Instrumentation shall be 
provided to monitor variables and systems over their anticipated ranges 
for normal operation, for anticipated operational occurrences, and for 
accident conditions as appropriate to assure adequate safety, including 
those variables and systems that can affect the fission process, the 
integrity of the reactor core, the reactor coolant pressure boundary, 
and the containment and its associated systems. Appropriate controls 
shall be provided to maintain these variables and systems within 
prescribed operating ranges.
    Criterion 14--Reactor coolant pressure boundary. The reactor coolant 
pressure boundary shall be designed, fabricated, erected, and tested so 
as to have an extremely low probability of abnormal leakage, of rapidly 
propagating failure, and of gross rupture.
    Criterion 15--Reactor coolant system design. The reactor coolant 
system and associated auxiliary, control, and protection systems shall 
be designed with sufficient margin to assure that the design conditions 
of the reactor coolant pressure boundary are not exceeded during any 
condition of normal operation, including anticipated operational 
occurrences.
    Criterion 16--Containment design. Reactor containment and associated 
systems shall be provided to establish an essentially leak-tight barrier 
against the uncontrolled release of radioactivity to the environment and 
to assure that the containment design conditions important to safety are 
not exceeded for as long as postulated accident conditions require.
    Criterion 17--Electric power systems. An onsite electric power 
system and an offsite electric power system shall be provided to permit 
functioning of structures, systems, and components important to safety. 
The safety function for each system (assuming the other system is not 
functioning) shall be to provide sufficient capacity and capability to 
assure that (1) specified acceptable fuel design limits and design 
conditions of the reactor coolant pressure boundary are not exceeded as 
a result of anticipated operational occurrences and (2) the core is 
cooled and containment integrity and other vital functions are 
maintained in the event of postulated accidents.
    The onsite electric power supplies, including the batteries, and the 
onsite electric distribution system, shall have sufficient independence, 
redundancy, and testability to perform their safety functions assuming a 
single failure.
    Electric power from the transmission network to the onsite electric 
distribution system shall be supplied by two physically independent 
circuits (not necessarily on separate rights of way) designed and 
located so as to minimize to the extent practical the likelihood of 
their simultaneous failure under operating and postulated accident and 
environmental conditions. A switchyard common to both circuits is 
acceptable. Each of these circuits shall be designed to be available in 
sufficient time following a loss of all onsite alternating current power 
supplies and the other offsite electric power circuit, to assure that 
specified acceptable fuel design limits and design conditions of the 
reactor coolant pressure boundary are not exceeded. One of these 
circuits shall be designed to be available within a few seconds 
following a loss-of-coolant accident to assure that core cooling,

[[Page 1020]]

containment integrity, and other vital safety functions are maintained.
    Provisions shall be included to minimize the probability of losing 
electric power from any of the remaining supplies as a result of, or 
coincident with, the loss of power generated by the nuclear power unit, 
the loss of power from the transmission network, or the loss of power 
from the onsite electric power supplies.
    Criterion 18--Inspection and testing of electric power systems. 
Electric power systems important to safety shall be designed to permit 
appropriate periodic inspection and testing of important areas and 
features, such as wiring, insulation, connections, and switchboards, to 
assess the continuity of the systems and the condition of their 
components. The systems shall be designed with a capability to test 
periodically (1) the operability and functional performance of the 
components of the systems, such as onsite power sources, relays, 
switches, and buses, and (2) the operability of the systems as a whole 
and, under conditions as close to design as practical, the full 
operation sequence that brings the systems into operation, including 
operation of applicable portions of the protection system, and the 
transfer of power among the nuclear power unit, the offsite power 
system, and the onsite power system.
    Criterion 19--Control room. A control room shall be provided from 
which actions can be taken to operate the nuclear power unit safely 
under normal conditions and to maintain it in a safe condition under 
accident conditions, including loss-of-coolant accidents. Adequate 
radiation protection shall be provided to permit access and occupancy of 
the control room under accident conditions without personnel receiving 
radiation exposures in excess of 5 rem whole body, or its equivalent to 
any part of the body, for the duration of the accident. Equipment at 
appropriate locations outside the control room shall be provided (1) 
with a design capability for prompt hot shutdown of the reactor, 
including necessary instrumentation and controls to maintain the unit in 
a safe condition during hot shutdown, and (2) with a potential 
capability for subsequent cold shutdown of the reactor through the use 
of suitable procedures.
    Applicants for and holders of construction permits and operating 
licenses under this part who apply on or after January 10, 1997, 
applicants for design approvals or certifications under part 52 of this 
chapter who apply on or after January 10, 1997, applicants for and 
holders of combined licenses or manufacturing licenses under part 52 of 
this chapter who do not reference a standard design approval or 
certification, or holders of operating licenses using an alternative 
source term under Sec.50.67, shall meet the requirements of this 
criterion, except that with regard to control room access and occupancy, 
adequate radiation protection shall be provided to ensure that radiation 
exposures shall not exceed 0.05 Sv (5 rem) total effective dose 
equivalent (TEDE) as defined in Sec.50.2 for the duration of the 
accident.

             III. Protection and Reactivity Control Systems

    Criterion 20--Protection system functions. The protection system 
shall be designed (1) to initiate automatically the operation of 
appropriate systems including the reactivity control systems, to assure 
that specified acceptable fuel design limits are not exceeded as a 
result of anticipated operational occurrences and (2) to sense accident 
conditions and to initiate the operation of systems and components 
important to safety.
    Criterion 21--Protection system reliability and testability. The 
protection system shall be designed for high functional reliability and 
inservice testability commensurate with the safety functions to be 
performed. Redundancy and independence designed into the protection 
system shall be sufficient to assure that (1) no single failure results 
in loss of the protection function and (2) removal from service of any 
component or channel does not result in loss of the required minimum 
redundancy unless the acceptable reliability of operation of the 
protection system can be otherwise demonstrated. The protection system 
shall be designed to permit periodic testing of its functioning when the 
reactor is in operation, including a capability to test channels 
independently to determine failures and losses of redundancy that may 
have occurred.
    Criterion 22--Protection system independence. The protection system 
shall be designed to assure that the effects of natural phenomena, and 
of normal operating, maintenance, testing, and postulated accident 
conditions on redundant channels do not result in loss of the protection 
function, or shall be demonstrated to be acceptable on some other 
defined basis. Design techniques, such as functional diversity or 
diversity in component design and principles of operation, shall be used 
to the extent practical to prevent loss of the protection function.
    Criterion 23--Protection system failure modes. The protection system 
shall be designed to fail into a safe state or into a state demonstrated 
to be acceptable on some other defined basis if conditions such as 
disconnection of the system, loss of energy (e.g., electric power, 
instrument air), or postulated adverse environments (e.g., extreme heat 
or cold, fire, pressure, steam, water, and radiation) are experienced.
    Criterion 24--Separation of protection and control systems. The 
protection system shall be separated from control systems to the extent 
that failure of any single control system component or channel, or 
failure or removal from service of any single protection

[[Page 1021]]

system component or channel which is common to the control and 
protection systems leaves intact a system satisfying all reliability, 
redundancy, and independence requirements of the protection system. 
Interconnection of the protection and control systems shall be limited 
so as to assure that safety is not significantly impaired.
    Criterion 25--Protection system requirements for reactivity control 
malfunctions. The protection system shall be designed to assure that 
specified acceptable fuel design limits are not exceeded for any single 
malfunction of the reactivity control systems, such as accidental 
withdrawal (not ejection or dropout) of control rods.
    Criterion 26--Reactivity control system redundancy and capability. 
Two independent reactivity control systems of different design 
principles shall be provided. One of the systems shall use control rods, 
preferably including a positive means for inserting the rods, and shall 
be capable of reliably controlling reactivity changes to assure that 
under conditions of normal operation, including anticipated operational 
occurrences, and with appropriate margin for malfunctions such as stuck 
rods, specified acceptable fuel design limits are not exceeded. The 
second reactivity control system shall be capable of reliably 
controlling the rate of reactivity changes resulting from planned, 
normal power changes (including xenon burnout) to assure acceptable fuel 
design limits are not exceeded. One of the systems shall be capable of 
holding the reactor core subcritical under cold conditions.
    Criterion 27--Combined reactivity control systems capability. The 
reactivity control systems shall be designed to have a combined 
capability, in conjunction with poison addition by the emergency core 
cooling system, of reliably controlling reactivity changes to assure 
that under postulated accident conditions and with appropriate margin 
for stuck rods the capability to cool the core is maintained.
    Criterion 28--Reactivity limits. The reactivity control systems 
shall be designed with appropriate limits on the potential amount and 
rate of reactivity increase to assure that the effects of postulated 
reactivity accidents can neither (1) result in damage to the reactor 
coolant pressure boundary greater than limited local yielding nor (2) 
sufficiently disturb the core, its support structures or other reactor 
pressure vessel internals to impair significantly the capability to cool 
the core. These postulated reactivity accidents shall include 
consideration of rod ejection (unless prevented by positive means), rod 
dropout, steam line rupture, changes in reactor coolant temperature and 
pressure, and cold water addition.
    Criterion 29--Protection against anticipated operational 
occurrences. The protection and reactivity control systems shall be 
designed to assure an extremely high probability of accomplishing their 
safety functions in the event of anticipated operational occurrences.

                            IV. Fluid Systems

    Criterion 30--Quality of reactor coolant pressure boundary. 
Components which are part of the reactor coolant pressure boundary shall 
be designed, fabricated, erected, and tested to the highest quality 
standards practical. Means shall be provided for detecting and, to the 
extent practical, identifying the location of the source of reactor 
coolant leakage.
    Criterion 31--Fracture prevention of reactor coolant pressure 
boundary. The reactor coolant pressure boundary shall be designed with 
sufficient margin to assure that when stressed under operating, 
maintenance, testing, and postulated accident conditions (1) the 
boundary behaves in a nonbrittle manner and (2) the probability of 
rapidly propagating fracture is minimized. The design shall reflect 
consideration of service temperatures and other conditions of the 
boundary material under operating, maintenance, testing, and postulated 
accident conditions and the uncertainties in determining (1) material 
properties, (2) the effects of irradiation on material properties, (3) 
residual, steady state and transient stresses, and (4) size of flaws.
    Criterion 32--Inspection of reactor coolant pressure boundary. 
Components which are part of the reactor coolant pressure boundary shall 
be designed to permit (1) periodic inspection and testing of important 
areas and features to assess their structural and leaktight integrity, 
and (2) an appropriate material surveillance program for the reactor 
pressure vessel.
    Criterion 33--Reactor coolant makeup. A system to supply reactor 
coolant makeup for protection against small breaks in the reactor 
coolant pressure boundary shall be provided. The system safety function 
shall be to assure that specified acceptable fuel design limits are not 
exceeded as a result of reactor coolant loss due to leakage from the 
reactor coolant pressure boundary and rupture of small piping or other 
small components which are part of the boundary. The system shall be 
designed to assure that for onsite electric power system operation 
(assuming offsite power is not available) and for offsite electric power 
system operation (assuming onsite power is not available) the system 
safety function can be accomplished using the piping, pumps, and valves 
used to maintain coolant inventory during normal reactor operation.
    Criterion 34--Residual heat removal. A system to remove residual 
heat shall be provided. The system safety function shall be to transfer 
fission product decay heat and other residual heat from the reactor core 
at a rate such that specified acceptable fuel design

[[Page 1022]]

limits and the design conditions of the reactor coolant pressure 
boundary are not exceeded.
    Suitable redundancy in components and features, and suitable 
interconnections, leak detection, and isolation capabilities shall be 
provided to assure that for onsite electric power system operation 
(assuming offsite power is not available) and for offsite electric power 
system operation (assuming onsite power is not available) the system 
safety function can be accomplished, assuming a single failure.
    Criterion 35--Emergency core cooling. A system to provide abundant 
emergency core cooling shall be provided. The system safety function 
shall be to transfer heat from the reactor core following any loss of 
reactor coolant at a rate such that (1) fuel and clad damage that could 
interfere with continued effective core cooling is prevented and (2) 
clad metal-water reaction is limited to negligible amounts.
    Suitable redundancy in components and features, and suitable 
interconnections, leak detection, isolation, and containment 
capabilities shall be provided to assure that for onsite electric power 
system operation (assuming offsite power is not available) and for 
offsite electric power system operation (assuming onsite power is not 
available) the system safety function can be accomplished, assuming a 
single failure.
    Criterion 36--Inspection of emergency core cooling system. The 
emergency core cooling system shall be designed to permit appropriate 
periodic inspection of important components, such as spray rings in the 
reactor pressure vessel, water injection nozzles, and piping, to assure 
the integrity and capability of the system.
    Criterion 37--Testing of emergency core cooling system. The 
emergency core cooling system shall be designed to permit appropriate 
periodic pressure and functional testing to assure (1) the structural 
and leaktight integrity of its components, (2) the operability and 
performance of the active components of the system, and (3) the 
operability of the system as a whole and, under conditions as close to 
design as practical, the performance of the full operational sequence 
that brings the system into operation, including operation of applicable 
portions of the protection system, the transfer between normal and 
emergency power sources, and the operation of the associated cooling 
water system.
    Criterion 38--Containment heat removal. A system to remove heat from 
the reactor containment shall be provided. The system safety function 
shall be to reduce rapidly, consistent with the functioning of other 
associated systems, the containment pressure and temperature following 
any loss-of-coolant accident and maintain them at acceptably low levels.
    Suitable redundancy in components and features, and suitable 
interconnections, leak detection, isolation, and containment 
capabilities shall be provided to assure that for onsite electric power 
system operation (assuming offsite power is not available) and for 
offsite electric power system operation (assuming onsite power is not 
available) the system safety function can be accomplished, assuming a 
single failure.
    Criterion 39--Inspection of containment heat removal system. The 
containment heat removal system shall be designed to permit appropriate 
periodic inspection of important components, such as the torus, sumps, 
spray nozzles, and piping to assure the integrity and capability of the 
system.
    Criterion 40--Testing of containment heat removal system. The 
containment heat removal system shall be designed to permit appropriate 
periodic pressure and functional testing to assure (1) the structural 
and leaktight integrity of its components, (2) the operability and 
performance of the active components of the system, and (3) the 
operability of the system as a whole, and under conditions as close to 
the design as practical the performance of the full operational sequence 
that brings the system into operation, including operation of applicable 
portions of the protection system, the transfer between normal and 
emergency power sources, and the operation of the associated cooling 
water system.
    Criterion 41--Containment atmosphere cleanup. Systems to control 
fission products, hydrogen, oxygen, and other substances which may be 
released into the reactor containment shall be provided as necessary to 
reduce, consistent with the functioning of other associated systems, the 
concentration and quality of fission products released to the 
environment following postulated accidents, and to control the 
concentration of hydrogen or oxygen and other substances in the 
containment atmosphere following postulated accidents to assure that 
containment integrity is maintained.
    Each system shall have suitable redundancy in components and 
features, and suitable interconnections, leak detection, isolation, and 
containment capabilities to assure that for onsite electric power system 
operation (assuming offsite power is not available) and for offsite 
electric power system operation (assuming onsite power is not available) 
its safety function can be accomplished, assuming a single failure.
    Criterion 42--Inspection of containment atmosphere cleanup systems. 
The containment atmosphere cleanup systems shall be designed to permit 
appropriate periodic inspection of important components, such as filter 
frames, ducts, and piping to assure the integrity and capability of the 
systems.

[[Page 1023]]

    Criterion 43--Testing of containment atmosphere cleanup systems. The 
containment atmosphere cleanup systems shall be designed to permit 
appropriate periodic pressure and functional testing to assure (1) the 
structural and leaktight integrity of its components, (2) the 
operability and performance of the active components of the systems such 
as fans, filters, dampers, pumps, and valves and (3) the operability of 
the systems as a whole and, under conditions as close to design as 
practical, the performance of the full operational sequence that brings 
the systems into operation, including operation of applicable portions 
of the protection system, the transfer between normal and emergency 
power sources, and the operation of associated systems.
    Criterion 44--Cooling water. A system to transfer heat from 
structures, systems, and components important to safety, to an ultimate 
heat sink shall be provided. The system safety function shall be to 
transfer the combined heat load of these structures, systems, and 
components under normal operating and accident conditions.
    Suitable redundancy in components and features, and suitable 
interconnections, leak detection, and isolation capabilities shall be 
provided to assure that for onsite electric power system operation 
(assuming offsite power is not available) and for offsite electric power 
system operation (assuming onsite power is not available) the system 
safety function can be accomplished, assuming a single failure.
    Criterion 45--Inspection of cooling water system. The cooling water 
system shall be designed to permit appropriate periodic inspection of 
important components, such as heat exchangers and piping, to assure the 
integrity and capability of the system.
    Criterion 46--Testing of cooling water system. The cooling water 
system shall be designed to permit appropriate periodic pressure and 
functional testing to assure (1) the structural and leaktight integrity 
of its components, (2) the operability and the performance of the active 
components of the system, and (3) the operability of the system as a 
whole and, under conditions as close to design as practical, the 
performance of the full operational sequence that brings the system into 
operation for reactor shutdown and for loss-of-coolant accidents, 
including operation of applicable portions of the protection system and 
the transfer between normal and emergency power sources.

                         V. Reactor Containment

    Criterion 50--Containment design basis. The reactor containment 
structure, including access openings, penetrations, and the containment 
heat removal system shall be designed so that the containment structure 
and its internal compartments can accommodate, without exceeding the 
design leakage rate and with sufficient margin, the calculated pressure 
and temperature conditions resulting from any loss-of-coolant accident. 
This margin shall reflect consideration of (1) the effects of potential 
energy sources which have not been included in the determination of the 
peak conditions, such as energy in steam generators and as required by 
Sec.50.44 energy from metal-water and other chemical reactions that 
may result from degradation but not total failure of emergency core 
cooling functioning, (2) the limited experience and experimental data 
available for defining accident phenomena and containment responses, and 
(3) the conservatism of the calculational model and input parameters.
    Criterion 51--Fracture prevention of containment pressure boundary. 
The reactor containment boundary shall be designed with sufficient 
margin to assure that under operating, maintenance, testing, and 
postulated accident conditions (1) its ferritic materials behave in a 
nonbrittle manner and (2) the probability of rapidly propagating 
fracture is minimized. The design shall reflect consideration of service 
temperatures and other conditions of the containment boundary material 
during operation, maintenance, testing, and postulated accident 
conditions, and the uncertainties in determining (1) material 
properties, (2) residual, steady state, and transient stresses, and (3) 
size of flaws.
    Criterion 52--Capability for containment leakage rate testing. The 
reactor containment and other equipment which may be subjected to 
containment test conditions shall be designed so that periodic 
integrated leakage rate testing can be conducted at containment design 
pressure.
    Criterion 53--Provisions for containment testing and inspection. The 
reactor containment shall be designed to permit (1) appropriate periodic 
inspection of all important areas, such as penetrations, (2) an 
appropriate surveillance program, and (3) periodic testing at 
containment design pressure of the leaktightness of penetrations which 
have resilient seals and expansion bellows.
    Criterion 54--Piping systems penetrating containment. Piping systems 
penetrating primary reactor containment shall be provided with leak 
detection, isolation, and containment capabilities having redundancy, 
reliability, and performance capabilities which reflect the importance 
to safety of isolating these piping systems. Such piping systems shall 
be designed with a capability to test periodically the operability of 
the isolation valves and associated apparatus and to determine if valve 
leakage is within acceptable limits.
    Criterion 55--Reactor coolant pressure boundary penetrating 
containment. Each line that is part of the reactor coolant pressure 
boundary and that penetrates primary reactor containment shall be 
provided with containment isolation valves as follows, unless it can be

[[Page 1024]]

demonstrated that the containment isolation provisions for a specific 
class of lines, such as instrument lines, are acceptable on some other 
defined basis:
    (1) One locked closed isolation valve inside and one locked closed 
isolation valve outside containment; or
    (2) One automatic isolation valve inside and one locked closed 
isolation valve outside containment; or
    (3) One locked closed isolation valve inside and one automatic 
isolation valve outside containment. A simple check valve may not be 
used as the automatic isolation valve outside containment; or
    (4) One automatic isolation valve inside and one automatic isolation 
valve outside containment. A simple check valve may not be used as the 
automatic isolation valve outside containment.

Isolation valves outside containment shall be located as close to 
containment as practical and upon loss of actuating power, automatic 
isolation valves shall be designed to take the position that provides 
greater safety.
    Other appropriate requirements to minimize the probability or 
consequences of an accidental rupture of these lines or of lines 
connected to them shall be provided as necessary to assure adequate 
safety. Determination of the appropriateness of these requirements, such 
as higher quality in design, fabrication, and testing, additional 
provisions for inservice inspection, protection against more severe 
natural phenomena, and additional isolation valves and containment, 
shall include consideration of the population density, use 
characteristics, and physical characteristics of the site environs.
    Criterion 56--Primary containment isolation. Each line that connects 
directly to the containment atmosphere and penetrates primary reactor 
containment shall be provided with containment isolation valves as 
follows, unless it can be demonstrated that the containment isolation 
provisions for a specific class of lines, such as instrument lines, are 
acceptable on some other defined basis:
    (1) One locked closed isolation valve inside and one locked closed 
isolation valve outside containment; or
    (2) One automatic isolation valve inside and one locked closed 
isolation valve outside containment; or
    (3) One locked closed isolation valve inside and one automatic 
isolation valve outside containment. A simple check valve may not be 
used as the automatic isolation valve outside containment; or
    (4) One automatic isolation valve inside and one automatic isolation 
valve outside containment. A simple check valve may not be used as the 
automatic isolation valve outside containment.

Isolation valves outside containment shall be located as close to the 
containment as practical and upon loss of actuating power, automatic 
isolation valves shall be designed to take the position that provides 
greater safety.
    Criterion 57--Closed system isolation valves. Each line that 
penetrates primary reactor containment and is neither part of the 
reactor coolant pressure boundary nor connected directly to the 
containment atmosphere shall have at least one containment isolation 
valve which shall be either automatic, or locked closed, or capable of 
remote manual operation. This valve shall be outside containment and 
located as close to the containment as practical. A simple check valve 
may not be used as the automatic isolation valve.

                   VI. Fuel and Radioactivity Control

    Criterion 60--Control of releases of radioactive materials to the 
environment. The nuclear power unit design shall include means to 
control suitably the release of radioactive materials in gaseous and 
liquid effluents and to handle radioactive solid wastes produced during 
normal reactor operation, including anticipated operational occurrences. 
Sufficient holdup capacity shall be provided for retention of gaseous 
and liquid effluents containing radioactive materials, particularly 
where unfavorable site environmental conditions can be expected to 
impose unusual operational limitations upon the release of such 
effluents to the environment.
    Criterion 61--Fuel storage and handling and radioactivity control. 
The fuel storage and handling, radioactive waste, and other systems 
which may contain radioactivity shall be designed to assure adequate 
safety under normal and postulated accident conditions. These systems 
shall be designed (1) with a capability to permit appropriate periodic 
inspection and testing of components important to safety, (2) with 
suitable shielding for radiation protection, (3) with appropriate 
containment, confinement, and filtering systems, (4) with a residual 
heat removal capability having reliability and testability that reflects 
the importance to safety of decay heat and other residual heat removal, 
and (5) to prevent significant reduction in fuel storage coolant 
inventory under accident conditions.
    Criterion 62--Prevention of criticality in fuel storage and 
handling. Criticality in the fuel storage and handling system shall be 
prevented by physical systems or processes, preferably by use of 
geometrically safe configurations.
    Criterion 63--Monitoring fuel and waste storage. Appropriate systems 
shall be provided in fuel storage and radioactive waste systems and 
associated handling areas (1) to detect conditions that may result in 
loss of residual

[[Page 1025]]

heat removal capability and excessive radiation levels and (2) to 
initiate appropriate safety actions.
    Criterion 64--Monitoring radioactivity releases. Means shall be 
provided for monitoring the reactor containment atmosphere, spaces 
containing components for recirculation of loss-of-coolant accident 
fluids, effluent discharge paths, and the plant environs for 
radioactivity that may be released from normal operations, including 
anticipated operational occurrences, and from postulated accidents.

[36 FR 3256, Feb. 20, 1971, as amended at 36 FR 12733, July 7, 1971; 41 
FR 6258, Feb. 12, 1976; 43 FR 50163, Oct. 27, 1978; 51 FR 12505, Apr. 
11, 1986; 52 FR 41294, Oct. 27, 1987; 64 FR 72002, Dec. 23, 1999; 72 FR 
49505, Aug. 28, 2007]



Sec. 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 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 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 under part 52 of this chapter is 
required by the provisions of Sec.52.79 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 under part 
52 of this chapter is required by the provisions of Sec.52.17 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 or design 
certification under part 52 of this chapter is required by the 
provisions of 10 CFR 52.137 and 52.47, respectively, 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 under part 
52 of this chapter is required by the provisions of 10 CFR 52.157 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.
    As used in this appendix, ``quality assurance'' comprises all those 
planned and systematic actions necessary to provide adequate confidence 
that a structure, system, or component will perform satisfactorily in 
service. Quality assurance includes quality control, which comprises 
those quality assurance actions related to the physical characteristics 
of a material, structure, component, or system which provide a means to 
control the quality of the material, structure, component, or system to 
predetermined requirements.

                             I. Organization

    The applicant \1\ shall be responsible for the establishment and 
execution of the quality assurance program. The applicant may delegate 
to others, such as contractors, agents, or consultants, the work of 
establishing and executing the quality assurance program, or any part 
thereof, but shall retain responsibility for the quality assurance 
program. The authority and duties of persons and organizations 
performing activities affecting the safety-related functions of 
structures,

[[Page 1026]]

systems, and components shall be clearly established and delineated in 
writing. These activities include both the performing functions of 
attaining quality objectives and the quality assurance functions. The 
quality assurance functions are those of (1) assuring that an 
appropriate quality assurance program is established and effectively 
executed; and (2) verifying, such as by checking, auditing, and 
inspecting, that activities affecting the safety-related functions have 
been correctly performed. The persons and organizations performing 
quality assurance functions shall have sufficient authority and 
organizational freedom to identify quality problems; to initiate, 
recommend, or provide solutions; and to verify implementation of 
solutions. There persons and organizations performing quality assurance 
functions shall report to a management level so that the required 
authority and organizational freedom, including sufficient independence 
from cost and schedule when opposed to safety considerations, are 
provided. Because of the many variables involved, such as the number of 
personnel, the type of activity being performed, and the location or 
locations where activities are performed, the organizational structure 
for executing the quality assurance program may take various forms, 
provided that the persons and organizations assigned the quality 
assurance functions have the required authority and organizational 
freedom. Irrespective of the organizational structure, the individual(s) 
assigned the responsibility for assuring effective execution of any 
portion of the quality assurance program at any location where 
activities subject to this appendix are being performed, shall have 
direct access to the levels of management necessary to perform this 
function.
---------------------------------------------------------------------------

    \1\ While the term ``applicant'' is used in these criteria, the 
requirements are, of course, applicable after such a person has received 
a license to construct and operate a nuclear power plant or a fuel 
reprocessing plant or has received an early site permit, design 
approval, design certification, or manufacturing license, as applicable. 
These criteria will also be used for guidance in evaluating the adequacy 
of quality assurance programs in use by holders of construction permits, 
operating licenses, early site permits, design approvals, combined 
licenses, and manufacturing licenses.
---------------------------------------------------------------------------

                      II. Quality Assurance Program

    The applicant shall establish at the earliest practicable time, 
consistent with the schedule for accomplishing the activities, a quality 
assurance program which complies with the requirements of this appendix. 
This program shall be documented by written policies, procedures, or 
instructions and shall be carried out throughout plant life in 
accordance with those policies, procedures, or instructions. The 
applicant shall identify the structures, systems, and components to be 
covered by the quality assurance program and the major organizations 
participating in the program, together with the designated functions of 
these organizations. The quality assurance program shall provide control 
over activities affecting the quality of the identified structures, 
systems, and components, to an extent consistent with their importance 
to safety. Activities affecting quality shall be accomplished under 
suitably controlled conditions. Controlled conditions include the use of 
appropriate equipment; suitable environmental conditions for 
accomplishing the activity, such as adequate cleanness; and assurance 
that all prerequisites for the given activity have been satisfied. The 
program shall take into account the need for special controls, 
processes, test equipment, tools, and skills to attain the required 
quality, and the need for verification of quality by inspection and 
test. The program shall provide for indoctrination and training of 
personnel performing activities affecting quality as necessary to assure 
that suitable proficiency is achieved and maintained. The applicant 
shall regularly review the status and adequacy of the quality assurance 
program. Management of other organizations participating in the quality 
assurance program shall regularly review the status and adequacy of that 
part of the quality assurance program which they are executing.

                           III. Design Control

    Measures shall be established to assure that applicable regulatory 
requirements and the design basis, as defined in Sec.50.2 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.
    Measures shall be established for the identification and control of 
design interfaces and for coordination among participating design 
organizations. These measures shall include the establishment of 
procedures among participating design organizations for the review, 
approval, release, distribution, and revision of documents involving 
design interfaces.
    The design control measures shall provide for verifying or checking 
the adequacy of design, such as by the performance of design reviews, by 
the use of alternate or simplified calculational methods, or by the 
performance of a suitable testing program. The verifying or checking 
process shall be performed by individuals or groups other than those who 
performed the original design, but who may be from the same 
organization. Where a test program is used to verify the adequacy of a 
specific design feature in lieu of other verifying or checking 
processes, it shall include suitable qualifications testing of a 
prototype unit under the most adverse design conditions. Design control 
measures

[[Page 1027]]

shall be applied to items such as the following: reactor physics, 
stress, thermal, hydraulic, and accident analyses; compatibility of 
materials; accessibility for inservice inspection, maintenance, and 
repair; and delineation of acceptance criteria for inspections and 
tests.
    Design changes, including field changes, shall be subject to design 
control measures commensurate with those applied to the original design 
and be approved by the organization that performed the original design 
unless the applicant designates another responsible organization.

                    IV. Procurement Document Control

    Measures shall be established to assure that applicable regulatory 
requirements, design bases, and other requirements which are necessary 
to assure adequate quality are suitably included or referenced in the 
documents for procurement of material, equipment, and services, whether 
purchased by the applicant or by its contractors or subcontractors. To 
the extent necessary, procurement documents shall require contractors or 
subcontractors to provide a quality assurance program consistent with 
the pertinent provisions of this appendix.

                V. Instructions, Procedures, and Drawings

    Activities affecting quality shall be prescribed by documented 
instructions, procedures, or drawings, of a type appropriate to the 
circumstances and shall be accomplished in accordance with these 
instructions, procedures, or drawings. Instructions, procedures, or 
drawings shall include appropriate quantitative or qualitative 
acceptance criteria for determining that important activities have been 
satisfactorily accomplished.

                          VI. Document Control

    Measures shall be established to control the issuance of documents, 
such as instructions, procedures, and drawings, including changes 
thereto, which prescribe all activities affecting quality. These 
measures shall assure that documents, including changes, are reviewed 
for adequacy and approved for release by authorized personnel and are 
distributed to and used at the location where the prescribed activity is 
performed. Changes to documents shall be reviewed and approved by the 
same organizations that performed the original review and approval 
unless the applicant designates another responsible organization.

       VII. Control of Purchased Material, Equipment, and Services

    Measures shall be established to assure that purchased material, 
equipment, and services, whether purchased directly or through 
contractors and subcontractors, conform to the procurement documents. 
These measures shall include provisions, as appropriate, for source 
evaluation and selection, objective evidence of quality furnished by the 
contractor or subcontractor, inspection at the contractor or 
subcontractor source, and examination of products upon delivery. 
Documentary evidence that material and equipment conform to the 
procurement requirements shall be available at the nuclear power plant 
or fuel reprocessing plant site prior to installation or use of such 
material and equipment. This documentary evidence shall be retained at 
the nuclear power plant or fuel reprocessing plant site and shall be 
sufficient to identify the specific requirements, such as codes, 
standards, or specifications, met by the purchased material and 
equipment. The effectiveness of the control of quality by contractors 
and subcontractors shall be assessed by the applicant or designee at 
intervals consistent with the importance, complexity, and quantity of 
the product or services.

  VIII. Identification and Control of Materials, Parts, and Components

    Measures shall be established for the identification and control of 
materials, parts, and components, including partially fabricated 
assemblies. These measures shall assure that identification of the item 
is maintained by heat number, part number, serial number, or other 
appropriate means, either on the item or on records traceable to the 
item, as required throughout fabrication, erection, installation, and 
use of the item. These identification and control measures shall be 
designed to prevent the use of incorrect or defective material, parts, 
and components.

                    IX. Control of Special Processes

    Measures shall be established to assure that special processes, 
including welding, heat treating, and nondestructive testing, are 
controlled and accomplished by qualified personnel using qualified 
procedures in accordance with applicable codes, standards, 
specifications, criteria, and other special requirements.

                              X. Inspection

    A program for inspection of activities affecting quality shall be 
established and executed by or for the organization performing the 
activity to verify conformance with the documented instructions, 
procedures, and drawings for accomplishing the activity. Such inspection 
shall be performed by individuals other than those who performed the 
activity being inspected. Examinations, measurements, or tests of 
material or products processed shall be performed for each work 
operation where necessary to assure quality. If inspection of processed 
material or products is impossible or disadvantageous,

[[Page 1028]]

indirect control by monitoring processing methods, equipment, and 
personnel shall be provided. Both inspection and process monitoring 
shall be provided when control is inadequate without both. If mandatory 
inspection hold points, which require witnessing or inspecting by the 
applicant's designated representative and beyond which work shall not 
proceed without the consent of its designated representative are 
required, the specific hold points shall be indicated in appropriate 
documents.

                            XI. Test Control

    A test program shall be established to assure that all testing 
required to demonstrate that structures, systems, and components will 
perform satisfactorily in service is identified and performed in 
accordance with written test procedures which incorporate the 
requirements and acceptance limits contained in applicable design 
documents. The test program shall include, as appropriate, proof tests 
prior to installation, preoperational tests, and operational tests 
during nuclear power plant or fuel reprocessing plant operation, of 
structures, systems, and components. Test procedures shall include 
provisions for assuring that all prerequisites for the given test have 
been met, that adequate test instrumentation is available and used, and 
that the test is performed under suitable environmental conditions. Test 
results shall be documented and evaluated to assure that test 
requirements have been satisfied.

              XII. Control of Measuring and Test Equipment

    Measures shall be established to assure that tools, gages, 
instruments, and other measuring and testing devices used in activities 
affecting quality are properly controlled, calibrated, and adjusted at 
specified periods to maintain accuracy within necessary limits.

                  XIII. Handling, Storage and Shipping

    Measures shall be established to control the handling, storage, 
shipping, cleaning and preservation of material and equipment in 
accordance with work and inspection instructions to prevent damage or 
deterioration. When necessary for particular products, special 
protective environments, such as inert gas atmosphere, specific moisture 
content levels, and temperature levels, shall be specified and provided.

               XIV. Inspection, Test, and Operating Status

    Measures shall be established to indicate, by the use of markings 
such as stamps, tags, labels, routing cards, or other suitable means, 
the status of inspections and tests performed upon individual items of 
the nuclear power plant or fuel reprocessing plant. These measures shall 
provide for the identification of items which have satisfactorily passed 
required inspections and tests, where necessary to preclude inadvertent 
bypassing of such inspections and tests. Measures shall also be 
established for indicating the operating status of structures, systems, 
and components of the nuclear power plant or fuel reprocessing plant, 
such as by tagging valves and switches, to prevent inadvertent 
operation.

            XV. Nonconforming Materials, Parts, or Components

    Measures shall be established to control materials, parts, or 
components which do not conform to requirements in order to prevent 
their inadvertent use or installation. These measures shall include, as 
appropriate, procedures for identification, documentation, segregation, 
disposition, and notification to affected organizations. Nonconforming 
items shall be reviewed and accepted, rejected, repaired or reworked in 
accordance with documented procedures.

                         XVI. Corrective Action

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

                     XVII. Quality Assurance Records

    Sufficient records shall be maintained to furnish evidence of 
activities affecting quality. The records shall include at least the 
following: Operating logs and the results of reviews, inspections, 
tests, audits, monitoring of work performance, and materials analyses. 
The records shall also include closely-related data such as 
qualifications of personnel, procedures, and equipment. Inspection and 
test records shall, as a minimum, identify the inspector or data 
recorder, the type of observation, the results, the acceptability, and 
the action taken in connection with any deficiencies noted. Records 
shall be identifiable and retrievable. Consistent with applicable 
regulatory requirements, the applicant shall establish requirements 
concerning record retention, such as duration, location, and assigned 
responsibility.

[[Page 1029]]

                              XVIII. Audits

    A comprehensive system of planned and periodic audits shall be 
carried out to verify compliance with all aspects of the quality 
assurance program and to determine the effectiveness of the program. The 
audits shall be performed in accordance with the written procedures or 
check lists by appropriately trained personnel not having direct 
responsibilities in the areas being audited. Audit results shall be 
documented and reviewed by management having responsibility in the area 
audited. Followup action, including reaudit of deficient areas, shall be 
taken where indicated.

[35 FR 10499, June 27, 1970, as amended at 36 FR 18301, Sept. 11, 1971; 
40 FR 3210, Jan. 20, 1975; 72 FR 49505, Aug. 28, 2007]



 Sec. Appendix C to Part 50--A Guide for the Financial Data and Related 
     Information Required To Establish Financial Qualifications for 
               Construction Permits and Combined Licenses

                           General Information

    This appendix is intended to appraise applicants for construction 
permits and combined licenses for production or utilization facilities 
of the types described in Sec.50.21(b) or Sec.50.22, or testing 
facilities, of the general kinds of financial data and other related 
information that will demonstrate the financial qualification of the 
applicant to carry out the activities for which the permit or license is 
sought. The kind and depth of information described in this guide is not 
intended to be a rigid and absolute requirement. In some instances, 
additional pertinent material may be needed. In any case, the applicant 
should include information other than that specified, if the information 
is pertinent to establishing the applicant's financial ability to carry 
out the activities for which the permit or license is sought.
    It is important to observe also that both Sec.50.33(f) and this 
appendix distinguish between applicants which are established 
organizations and those which are newly-formed entities organized 
primarily for the purpose of engaging in the activity for which the 
permit is sought. Those in the former category will normally have a 
history of operating experience and be able to submit financial 
statements reflecting the financial results of past operations. With 
respect, however, to the applicant which is a newly formed company 
established primarily for the purpose of carrying out the licensed 
activity, with little or no prior operating history, somewhat more 
detailed data and supporting documentation will generally be necessary. 
For this reason, the appendix describes separately the scope of 
information to be included in applications by each of these two classes 
of applicants.
    In determining an applicant's financial qualification, the 
Commission will require the minimum amount of information necessary for 
that purpose. No special forms are prescribed for submitting the 
information. In many cases, the financial information usually contained 
in current annual financial reports, including summary data of prior 
years, will be sufficient for the Commission's needs. The Commission 
reserves the right, however, to require additional financial information 
at the construction permit stage, particularly in cases in which the 
proposed power generating facility will be commonly owned by two or more 
existing companies or in which financing depends upon long-term 
arrangements for sharing of the power from the facility by two or more 
electrical generating companies.
    Applicants are encouraged to consult with the Commission with 
respect to any questions they may have relating to the requirements of 
the Commission's regulations or the information set forth in this 
appendix.

            I. Applicants Which Are Established Organizations

      A. Applications for Construction Permits or Combined Licenses

    1. Estimate of construction costs. For electric utilities, each 
applicant's estimate of the total cost of the proposed facility should 
be broken down as follows and be accompanied by a statement describing 
the bases from which the estimate is derived:

(a) Total nuclear production plant costs.....................  $........
                                                                      ..
(b) Transmission, distribution, and general plant costs......  $........
                                                                      ..
(c) Nuclear fuel inventory cost for first core \1\...........  $........
                                                                      ..
                                                              ----------
    Total estimated cost.....................................  $........
                                                                      ..
 
\1\ Section 2.790 of 10 CFR part 2 and Sec. 9.5 of 10 CFR part 9
  indicate the circumstances under which information submitted by
  applicants may be withheld from public disclosure.

If the fuel is to be acquired by lease or other arrangement than 
purchase, the application should so state. The items to be included in 
these categories should be the same as those defined in the applicable 
electric plant and nuclear fuel inventory accounts prescribed by the 
Federal Energy Regulatory Commission or an explanation given as to any 
departure therefrom.
    Since the composition of construction cost estimates for production 
and utilization facilities other than nuclear power reactors will vary 
according to the type of facility, no particular format is suggested for 
submitting such estimates. The estimate should, however, be itemized by 
categories of cost in sufficient detail to permit an evaluation of its 
reasonableness.
    2. Source of construction funds. The application should include a 
brief statement of the

[[Page 1030]]

applicant's general financial plan for financing the cost of the 
facility, identifying the source or sources upon which the applicant 
relies for the necessary construction funds, e.g., internal sources such 
as undistributed earnings and depreciation accruals, or external sources 
such as borrowings.
    3. Applicant's financial statements. The application should also 
include the applicant's latest published annual financial report, 
together with any current interim financial statements that are 
pertinent. If an annual financial report is not published, the balance 
sheet and operating statement covering the latest complete accounting 
year together with all pertinent notes thereto and certification by a 
public accountant should be furnished.

             II. Applicants Which Are Newly Formed Entities

      A. Applications for Construction Permits or Combined Licenses

    1. Estimate of construction costs. The information that will 
normally be required of applicants which are newly formed entities will 
not differ in scope from that required of established organizations. 
Accordingly, applicants should submit estimates as described above for 
established organizations.
    2. Source of construction funds. The application should specifically 
identify the source or sources upon which the applicant relies for the 
funds necessary to pay the cost of constructing the facility, and the 
amount to be obtained from each. With respect to each source, the 
application should describe in detail the applicant's legal and 
financial relationships with its stockholders, corporate affiliates, or 
others (such as financial institutions) upon which the applicant is 
relying for financial assistance. If the sources of funds relied upon 
include parent companies or other corporate affiliates, information to 
support the financial capability of each such company or affiliate to 
meet its commitments to the applicant should be set forth in the 
application. This information should be of the same kind and scope as 
would be required if the parent companies or affiliates were in fact the 
applicant. Ordinarily, it will be necessary that copies of agreements or 
contracts among the companies be submitted.

As noted earlier in this appendix, an applicant which is a newly formed 
entity will normally not be in a position to submit the usual types of 
balance sheets and income statements reflecting the results of prior 
operations. The applicant should, however, include in its application a 
statement of its assets, liabilities, and capital structure as of the 
date of the application.

                     III. Annual Financial Statement

    Each holder of a construction permit for a production or utilization 
facility of a type described in Sec.50.21(b) or Sec.50.22 or a 
testing facility, and each holder of a combined license issued under 
part 52 of this chapter, is required by Sec.50.71(b) to file its 
annual financial report with the Commission at the time of issuance. 
This requirement does not apply to licensees or holders of construction 
permits for medical and research reactors.

                       IV. Additional Information

    The Commission may, from time to time, request the applicant, 
whether an established organization or newly formed entity, to submit 
additional or more detailed information respecting its financial 
arrangements and status of funds if such information is deemed necessary 
to enable the Commission to determine an applicant's financial 
qualifications for the license.

[49 FR 35753, Sept. 12, 1984, as amended at 50 FR 18853, May 3, 1985; 72 
FR 49506, Aug. 28, 2007; 81 FR 86909, Dec. 2, 2016]



                  Sec. Appendix D to Part 50 [Reserved]



  Sec. Appendix E to Part 50--Emergency Planning and Preparedness for 
                  Production and Utilization Facilities

                            Table of Contents

I. Introduction
II. The Preliminary Safety Analysis Report
III. The Final Safety Analysis Report
IV. Content of Emergency Plans
V. Implementing Procedures
VI. Emergency Response Data System

                             I. Introduction

    1. Each applicant for a construction permit is required by Sec.
50.34(a) to include in the preliminary safety analysis report a 
discussion of preliminary plans for coping with emergencies. Each 
applicant for an operating license is required by Sec.50.34(b) to 
include in the final safety analysis report plans for coping with 
emergencies. Each applicant for a combined license under subpart C of 
part 52 of this chapter is required by Sec.52.79 of this chapter to 
include in the application plans for coping with emergencies. Each 
applicant for an early site permit under subpart A of part 52 of this 
chapter may submit plans for coping with emergencies under Sec.52.17 
of this chapter.
    2. This appendix establishes minimum requirements for emergency 
plans for use in attaining an acceptable state of emergency 
preparedness. These plans shall be described generally in the 
preliminary safety analysis

[[Page 1031]]

report for a construction permit and submitted as part of the final 
safety analysis report for an operating license. These plans, or major 
features thereof, may be submitted as part of the site safety analysis 
report for an early site permit.
    3. The potential radiological hazards to the public associated with 
the operation of research and test reactors and fuel facilities licensed 
under 10 CFR parts 50 and 70 involve considerations different than those 
associated with nuclear power reactors. Consequently, the size of 
Emergency Planning Zones\1\ (EPZs) for facilities other than power 
reactors and the degree to which compliance with the requirements of 
this section and sections II, III, IV, and V of this appendix as 
necessary will be determined on a case-by-case basis.\2\
---------------------------------------------------------------------------

    \1\ EPZs for power reactors are discussed in NUREG-0396; EPA 520/1-
78-016, ``Planning Basis for the Development of State and Local 
Government Radiological Emergency Response Plans in Support of Light 
Water Nuclear Power Plants,'' December 1978. The size of the EPZs for a 
nuclear power plant shall be determined in relation to local emergency 
response needs and capabilities as they are affected by such conditions 
as demography, topography, land characteristics, access routes, and 
jurisdictional boundaries. The size of the EPZs also may be determined 
on a case-by-case basis for gas-cooled nuclear reactors and for reactors 
with an authorized power level less than 250 MW thermal. Generally, the 
plume exposure pathway EPZ for nuclear power plants with an authorized 
power level greater than 250 MW thermal shall consist of an area about 
10 miles (16 km) in radius and the ingestion pathway EPZ shall consist 
of an area about 50 miles (80 km) in radius.
    \2\ Regulatory Guide 2.6 will be used as guidance for the 
acceptability of research and test reactor emergency response plans.
---------------------------------------------------------------------------

    4. Notwithstanding the above paragraphs, in the case of an operating 
license authorizing only fuel loading and/or low power operations up to 
5 percent of rated power, no NRC or FEMA review, findings, or 
determinations concerning the state of offsite emergency preparedness or 
the adequacy of and the capability to implement State and local offsite 
emergency plans, as defined in this Appendix, are required prior to the 
issuance of such a license.
    5. Each applicant for a combined license or early site permit under 
part 52 of this chapter whose application is docketed before December 
23, 2011 may defer compliance with any change to emergency preparedness 
regulations under the final rule issued November 23, 2011. If that 
applicant chooses to defer compliance, it shall subsequently request to 
amend the combined license or early site permit to comply with those 
changes no later than December 31, 2013. An applicant that does not 
receive a combined license or early site permit before December 31, 
2013, shall revise its combined license or early site permit application 
to comply with those changes no later than December 31, 2013. 
Notwithstanding any Commission finding under 10 CFR 52.103(g) regarding 
the combined license holder's facility, the combined license holder may 
not operate the facility until the NRC has approved the license 
amendment demonstrating compliance with the final rule.
    6. The Tennessee Valley Authority Watts Bar Nuclear Plant, Unit 2, 
holding a construction permit under the provisions of part 50 of this 
chapter, shall meet the requirements of the final rule issued November 
23, 2011 as applicable to operating nuclear power reactor licensees.

               II. The Preliminary Safety Analysis Report

    The Preliminary Safety Analysis Report shall contain sufficient 
information to ensure the compatibility of proposed emergency plans for 
both onsite areas and the EPZs, with facility design features, site 
layout, and site location with respect to such considerations as access 
routes, surrounding population distributions, land use, and local 
jurisdictional boundaries for the EPZs in the case of nuclear power 
reactors as well as the means by which the standards of Sec.50.47(b) 
will be met.
    As a minimum, the following items shall be described:
    A. Onsite and offsite organizations for coping with emergencies and 
the means for notification, in the event of an emergency, of persons 
assigned to the emergency organizations.
    B. Contacts and arrangements made and documented with local, State, 
and Federal governmental agencies with responsibility for coping with 
emergencies, including identification of the principal agencies.
    C. Protective measures to be taken within the site boundary and 
within each EPZ to protect health and safety in the event of an 
accident; procedures by which these measures are to be carried out 
(e.g., in the case of an evacuation, who authorizes the evacuation, how 
the public is to be notified and instructed, how the evacuation is to be 
carried out); and the expected response of offsite agencies in the event 
of an emergency.
    D. Features of the facility to be provided for onsite emergency 
first aid and decontamination and for emergency transportation of onsite 
individuals to offsite treatment facilities.
    E. Provisions to be made for emergency treatment at offsite 
facilities of individuals injured as a result of licensed activities.

[[Page 1032]]

    F. Provisions for a training program for employees of the licensee, 
including those who are assigned specific authority and responsibility 
in the event of an emergency, and for other persons who are not 
employees of the licensee but whose assistance may be needed in the 
event of a radiological emergency.
    G. A preliminary analysis that projects the time and means to be 
employed in the notification of State and local governments and the 
public in the event of an emergency. A nuclear power plant applicant 
shall perform a preliminary analysis of the time required to evacuate 
various sectors and distances within the plume exposure pathway EPZ for 
transient and permanent populations, noting major impediments to the 
evacuation or taking of protective actions.
    H. A preliminary analysis reflecting the need to include facilities, 
systems, and methods for identifying the degree of seriousness and 
potential scope of radiological consequences of emergency situations 
within and outside the site boundary, including capabilities for dose 
projection using real-time meteorological information and for dispatch 
of radiological monitoring teams within the EPZs; and a preliminary 
analysis reflecting the role of the onsite technical support center and 
the emergency operations facility in assessing information, recommending 
protective action, and disseminating information to the public.

   III. The Final Safety Analysis Report; Site Safety Analysis Report

    The final safety analysis report or the site safety analysis report 
for an early site permit that includes complete and integrated emergency 
plans under Sec.52.17(b)(2)(ii) of this chapter shall contain the 
plans for coping with emergencies. The plans shall be an expression of 
the overall concept of operation; they shall describe the essential 
elements of advance planning that have been considered and the 
provisions that have been made to cope with emergency situations. The 
plans shall incorporate information about the emergency response roles 
of supporting organizations and offsite agencies. That information shall 
be sufficient to provide assurance of coordination among the supporting 
groups and with the licensee. The site safety analysis report for an 
early site permit which proposes major features must address the 
relevant provisions of 10 CFR 50.47 and 10 CFR part 50, appendix E, 
within the scope of emergency preparedness matters addressed in the 
major features.
    The plans submitted must include a description of the elements set 
out in Section IV for the emergency planning zones (EPZs) to an extent 
sufficient to demonstrate that the plans provide reasonable assurance 
that adequate protective measures can and will be taken in the event of 
an emergency.

                     IV. Content of Emergency Plans

    1. The applicant's emergency plans shall contain, but not 
necessarily be limited to, information needed to demonstrate compliance 
with the elements set forth below, i.e., organization for coping with 
radiological emergencies, assessment actions, activation of emergency 
organization, notification procedures, emergency facilities and 
equipment, training, maintaining emergency preparedness, recovery, and 
onsite protective actions during hostile action. In addition, the 
emergency response plans submitted by an applicant for a nuclear power 
reactor operating license under this part, or for an early site permit 
(as applicable) or combined license under 10 CFR part 52, shall contain 
information needed to demonstrate compliance with the standards 
described in Sec.50.47(b), and they will be evaluated against those 
standards.
    2. This nuclear power reactor license applicant shall also provide 
an analysis of the time required to evacuate various sectors and 
distances within the plume exposure pathway EPZ for transient and 
permanent populations, using the most recent U.S. Census Bureau data as 
of the date the applicant submits its application to the NRC.
    3. Nuclear power reactor licensees shall use NRC approved evacuation 
time estimates (ETEs) and updates to the ETEs in the formulation of 
protective action recommendations and shall provide the ETEs and ETE 
updates to State and local governmental authorities for use in 
developing offsite protective action strategies.
    4. Within 365 days of the later of the date of the availability of 
the most recent decennial census data from the U.S. Census Bureau or 
December 23, 2011, nuclear power reactor licensees shall develop an ETE 
analysis using this decennial data and submit it under Sec.50.4 to the 
NRC. These licensees shall submit this ETE analysis to the NRC at least 
180 days before using it to form protective action recommendations and 
providing it to State and local governmental authorities for use in 
developing offsite protective action strategies.
    5. During the years between decennial censuses, nuclear power 
reactor licensees shall estimate EPZ permanent resident population 
changes once a year, but no later than 365 days from the date of the 
previous estimate, using the most recent U.S. Census Bureau annual 
resident population estimate and State/local government population data, 
if available. These licensees shall maintain these estimates so that 
they are available for NRC inspection during the period between 
decennial censuses and shall submit these estimates to the NRC with any 
updated ETE analysis.
    6. If at any time during the decennial period, the EPZ permanent 
resident population increases such that it causes the longest

[[Page 1033]]

ETE value for the 2-mile zone or 5-mile zone, including all affected 
Emergency Response Planning Areas, or for the entire 10-mile EPZ to 
increase by 25 percent or 30 minutes, whichever is less, from the 
nuclear power reactor licensee's currently NRC approved or updated ETE, 
the licensee shall update the ETE analysis to reflect the impact of that 
population increase. The licensee shall submit the updated ETE analysis 
to the NRC under Sec.50.4 no later than 365 days after the licensee's 
determination that the criteria for updating the ETE have been met and 
at least 180 days before using it to form protective action 
recommendations and providing it to State and local governmental 
authorities for use in developing offsite protective action strategies.
    7. After an applicant for a combined license under part 52 of this 
chapter receives its license, the licensee shall conduct at least one 
review of any changes in the population of its EPZ at least 365 days 
prior to its scheduled fuel load. The licensee shall estimate EPZ 
permanent resident population changes using the most recent U.S. Census 
Bureau annual resident population estimate and State/local government 
population data, if available. If the EPZ permanent resident population 
increases such that it causes the longest ETE value for the 2-mile zone 
or 5-mile zone, including all affected Emergency Response Planning 
Areas, or for the entire 10-mile EPZ, to increase by 25 percent or 30 
minutes, whichever is less, from the licensee's currently approved ETE, 
the licensee shall update the ETE analysis to reflect the impact of that 
population increase. The licensee shall submit the updated ETE analysis 
to the NRC for review under Sec.50.4 of this chapter no later than 365 
days before the licensee's scheduled fuel load.

                             A. Organization

    The organization for coping with radiological emergencies shall be 
described, including definition of authorities, responsibilities, and 
duties of individuals assigned to the licensee's emergency organization 
and the means for notification of such individuals in the event of an 
emergency. Specifically, the following shall be included:
    1. A description of the normal plant operating organization.
    2. A description of the onsite emergency response organization (ERO) 
with a detailed discussion of:
    a. Authorities, responsibilities, and duties of the individual(s) 
who will take charge during an emergency;
    b. Plant staff emergency assignments;
    c. Authorities, responsibilities, and duties of an onsite emergency 
coordinator who shall be in charge of the exchange of information with 
offsite authorities responsible for coordinating and implementing 
offsite emergency measures.
    3. A description, by position and function to be performed, of the 
licensee's headquarters personnel who will be sent to the plant site to 
augment the onsite emergency organization.
    4. Identification, by position and function to be performed, of 
persons within the licensee organization who will be responsible for 
making offsite dose projections, and a description of how these 
projections will be made and the results transmitted to State and local 
authorities, NRC, and other appropriate governmental entities.
    5. Identification, by position and function to be performed, of 
other employees of the licensee with special qualifications for coping 
with emergency conditions that may arise. Other persons with special 
qualifications, such as consultants, who are not employees of the 
licensee and who may be called upon for assistance for emergencies shall 
also be identified. The special qualifications of these persons shall be 
described.
    6. A description of the local offsite services to be provided in 
support of the licensee's emergency organization.
    7. By June 23, 2014, identification of, and a description of the 
assistance expected from, appropriate State, local, and Federal agencies 
with responsibilities for coping with emergencies, including hostile 
action at the site. For purposes of this appendix, ``hostile action'' is 
defined as an act directed toward a nuclear power plant or its personnel 
that includes the use of violent force to destroy equipment, take 
hostages, and/or intimidate the licensee to achieve an end. This 
includes attack by air, land, or water using guns, explosives, 
projectiles, vehicles, or other devices used to deliver destructive 
force.
    8. Identification of the State and/or local officials responsible 
for planning for, ordering, and controlling appropriate protective 
actions, including evacuations when necessary.
    9. By December 24, 2012, for nuclear power reactor licensees, a 
detailed analysis demonstrating that on-shift personnel assigned 
emergency plan implementation functions are not assigned 
responsibilities that would prevent the timely performance of their 
assigned functions as specified in the emergency plan.

                          B. Assessment Actions

    1. The means to be used for determining the magnitude of, and for 
continually assessing the impact of, the release of radioactive 
materials shall be described, including emergency action levels that are 
to be used as criteria for determining the need for notification and 
participation of local and State agencies, the Commission, and other 
Federal agencies, and the emergency action levels that are to be used 
for determining when and what type of protective measures should be 
considered within and outside the site

[[Page 1034]]

boundary to protect health and safety. The emergency action levels shall 
be based on in-plant conditions and instrumentation in addition to 
onsite and offsite monitoring. By June 20, 2012, for nuclear power 
reactor licensees, these action levels must include hostile action that 
may adversely affect the nuclear power plant. The initial emergency 
action levels shall be discussed and agreed on by the applicant or 
licensee and state and local governmental authorities, and approved by 
the NRC. Thereafter, emergency action levels shall be reviewed with the 
State and local governmental authorities on an annual basis.
    2. A licensee desiring to change its entire emergency action level 
scheme shall submit an application for an amendment to its license and 
receive NRC approval before implementing the change. Licensees shall 
follow the change process in Sec.50.54(q) for all other emergency 
action level changes.

                 C. Activation of Emergency Organization

    1. The entire spectrum of emergency conditions that involve the 
alerting or activating of progressively larger segments of the total 
emergency organization shall be described. The communication steps to be 
taken to alert or activate emergency personnel under each class of 
emergency shall be described. Emergency action levels (based not only on 
onsite and offsite radiation monitoring information but also on readings 
from a number of sensors that indicate a potential emergency, such as 
the pressure in containment and the response of the Emergency Core 
Cooling System) for notification of offsite agencies shall be described. 
The existence, but not the details, of a message authentication scheme 
shall be noted for such agencies. The emergency classes defined shall 
include: (1) Notification of unusual events, (2) alert, (3) site area 
emergency, and (4) general emergency. These classes are further 
discussed in NUREG-0654/FEMA-REP-1.
    2. By June 20, 2012, nuclear power reactor licensees shall establish 
and maintain the capability to assess, classify, and declare an 
emergency condition within 15 minutes after the availability of 
indications to plant operators that an emergency action level has been 
exceeded and shall promptly declare the emergency condition as soon as 
possible following identification of the appropriate emergency 
classification level. Licensees shall not construe these criteria as a 
grace period to attempt to restore plant conditions to avoid declaring 
an emergency action due to an emergency action level that has been 
exceeded. Licensees shall not construe these criteria as preventing 
implementation of response actions deemed by the licensee to be 
necessary to protect public health and safety provided that any delay in 
declaration does not deny the State and local authorities the 
opportunity to implement measures necessary to protect the public health 
and safety.

                       D. Notification Procedures

    1. Administrative and physical means for notifying local, State, and 
Federal officials and agencies and agreements reached with these 
officials and agencies for the prompt notification of the public and for 
public evacuation or other protective measures, should they become 
necessary, shall be described. This description shall include 
identification of the appropriate officials, by title and agency, of the 
State and local government agencies within the EPZs.
    2. Provisions shall be described for yearly dissemination to the 
public within the plume exposure pathway EPZ of basic emergency planning 
information, such as the methods and times required for public 
notification and the protective actions planned if an accident occurs, 
general information as to the nature and effects of radiation, and a 
listing of local broadcast stations that will be used for dissemination 
of information during an emergency. Signs or other measures shall also 
be used to disseminate to any transient population within the plume 
exposure pathway EPZ appropriate information that would be helpful if an 
accident occurs.
    3. A licensee shall have the capability to notify responsible State 
and local governmental agencies within 15 minutes after declaring an 
emergency. The licensee shall demonstrate that the appropriate 
governmental authorities have the capability to make a public alerting 
and notification decision promptly on being informed by the licensee of 
an emergency condition. Prior to initial operation greater than 5 
percent of rated thermal power of the first reactor at a site, each 
nuclear power reactor licensee shall demonstrate that administrative and 
physical means have been established for alerting and providing prompt 
instructions to the public within the plume exposure pathway EPZ. The 
design objective of the prompt public alert and notification system 
shall be to have the capability to essentially complete the initial 
alerting and initiate notification of the public within the plume 
exposure pathway EPZ within about 15 minutes. The use of this alerting 
and notification capability will range from immediate alerting and 
notification of the public (within 15 minutes of the time that State and 
local officials are notified that a situation exists requiring urgent 
action) to the more likely events where there is substantial time 
available for the appropriate governmental authorities to make a 
judgment whether or not to activate the public alert and notification 
system. The alerting and notification capability shall additionally 
include administrative and physical means for a backup

[[Page 1035]]

method of public alerting and notification capable of being used in the 
event the primary method of alerting and notification is unavailable 
during an emergency to alert or notify all or portions of the plume 
exposure pathway EPZ population. The backup method shall have the 
capability to alert and notify the public within the plume exposure 
pathway EPZ, but does not need to meet the 15-minute design objective 
for the primary prompt public alert and notification system. When there 
is a decision to activate the alert and notification system, the 
appropriate governmental authorities will determine whether to activate 
the entire alert and notification system simultaneously or in a 
graduated or staged manner. The responsibility for activating such a 
public alert and notification system shall remain with the appropriate 
governmental authorities.
    4. If FEMA has approved a nuclear power reactor site's alert and 
notification design report, including the backup alert and notification 
capability, as of December 23, 2011, then the backup alert and 
notification capability requirements in Section IV.D.3 must be 
implemented by December 24, 2012. If the alert and notification design 
report does not include a backup alert and notification capability or 
needs revision to ensure adequate backup alert and notification 
capability, then a revision of the alert and notification design report 
must be submitted to FEMA for review by June 24, 2013, and the FEMA-
approved backup alert and notification means must be implemented within 
365 days after FEMA approval. However, the total time period to 
implement a FEMA-approved backup alert and notification means must not 
exceed June 22, 2015.

                  E. Emergency Facilities and Equipment

    Adequate provisions shall be made and described for emergency 
facilities and equipment, including:
    1. Equipment at the site for personnel monitoring;
    2. Equipment for determining the magnitude of and for continuously 
assessing the impact of the release of radioactive materials to the 
environment;
    3. Facilities and supplies at the site for decontamination of onsite 
individuals;
    4. Facilities and medical supplies at the site for appropriate 
emergency first aid treatment;
    5. Arrangements for medical service providers qualified to handle 
radiological emergencies onsite;
    6. Arrangements for transportation of contaminated injured 
individuals from the site to specifically identified treatment 
facilities outside the site boundary;
    7. Arrangements for treatment of individuals injured in support of 
licensed activities on the site at treatment facilities outside the site 
boundary;
    8.a. (i) A licensee onsite technical support center and an emergency 
operations facility from which effective direction can be given and 
effective control can be exercised during an emergency;
    (ii) For nuclear power reactor licensees, a licensee onsite 
operational support center;
    b. For a nuclear power reactor licensee's emergency operations 
facility required by paragraph 8.a of this section, either a facility 
located between 10 miles and 25 miles of the nuclear power reactor 
site(s), or a primary facility located less than 10 miles from the 
nuclear power reactor site(s) and a backup facility located between 10 
miles and 25 miles of the nuclear power reactor site(s). An emergency 
operations facility may serve more than one nuclear power reactor site. 
A licensee desiring to locate an emergency operations facility more than 
25 miles from a nuclear power reactor site shall request prior 
Commission approval by submitting an application for an amendment to its 
license. For an emergency operations facility located more than 25 miles 
from a nuclear power reactor site, provisions must be made for locating 
NRC and offsite responders closer to the nuclear power reactor site so 
that NRC and offsite responders can interact face-to-face with emergency 
response personnel entering and leaving the nuclear power reactor site. 
Provisions for locating NRC and offsite responders closer to a nuclear 
power reactor site that is more than 25 miles from the emergency 
operations facility must include the following:
    (1) Space for members of an NRC site team and Federal, State, and 
local responders;
    (2) Additional space for conducting briefings with emergency 
response personnel;
    (3) Communication with other licensee and offsite emergency response 
facilities;
    (4) Access to plant data and radiological information; and
    (5) Access to copying equipment and office supplies;
    c. By June 20, 2012, for a nuclear power reactor licensee's 
emergency operations facility required by paragraph 8.a of this section, 
a facility having the following capabilities:
    (1) The capability for obtaining and displaying plant data and 
radiological information for each reactor at a nuclear power reactor 
site and for each nuclear power reactor site that the facility serves;
    (2) The capability to analyze plant technical information and 
provide technical briefings on event conditions and prognosis to 
licensee and offsite response organizations for each reactor at a 
nuclear power reactor site and for each nuclear power reactor site that 
the facility serves; and
    (3) The capability to support response to events occurring 
simultaneously at more than one nuclear power reactor site if the 
emergency operations facility serves more than one site; and

[[Page 1036]]

    d. For nuclear power reactor licensees, an alternative facility (or 
facilities) that would be accessible even if the site is under threat of 
or experiencing hostile action, to function as a staging area for 
augmentation of emergency response staff and collectively having the 
following characteristics: the capability for communication with the 
emergency operations facility, control room, and plant security; the 
capability to perform offsite notifications; and the capability for 
engineering assessment activities, including damage control team 
planning and preparation, for use when onsite emergency facilities 
cannot be safely accessed during hostile action. The requirements in 
this paragraph 8.d must be implemented no later than December 23, 2014, 
with the exception of the capability for staging emergency response 
organization personnel at the alternative facility (or facilities) and 
the capability for communications with the emergency operations 
facility, control room, and plant security, which must be implemented no 
later than June 20, 2012.
    e. A licensee shall not be subject to the requirements of paragraph 
8.b of this section for an existing emergency operations facility 
approved as of December 23, 2011;
    9. At least one onsite and one offsite communications system; each 
system shall have a backup power source. All communication plans shall 
have arrangements for emergencies, including titles and alternates for 
those in charge at both ends of the communication links and the primary 
and backup means of communication. Where consistent with the function of 
the governmental agency, these arrangements will include:
    a. Provision for communications with contiguous State/local 
governments within the plume exposure pathway EPZ. Such communications 
shall be tested monthly.
    b. Provision for communications with Federal emergency response 
organizations. Such communications systems shall be tested annually.
    c. Provision for communications among the nuclear power reactor 
control room, the onsite technical support center, and the emergency 
operations facility; and among the nuclear facility, the principal State 
and local emergency operations centers, and the field assessment teams. 
Such communications systems shall be tested annually.
    d. Provisions for communications by the licensee with NRC 
Headquarters and the appropriate NRC Regional Office Operations Center 
from the nuclear power reactor control room, the onsite technical 
support center, and the emergency operations facility. Such 
communications shall be tested monthly.

                               F. Training

    1. The program to provide for: (a) The training of employees and 
exercising, by periodic drills, of emergency plans to ensure that 
employees of the licensee are familiar with their specific emergency 
response duties, and (b) The participation in the training and drills by 
other persons whose assistance may be needed in the event of a 
radiological emergency shall be described. This shall include a 
description of specialized initial training and periodic retraining 
programs to be provided to each of the following categories of emergency 
personnel:
    i. Directors and/or coordinators of the plant emergency 
organization;
    ii. Personnel responsible for accident assessment, including control 
room shift personnel;
    iii. Radiological monitoring teams;
    iv. Fire control teams (fire brigades);
    v. Repair and damage control teams;
    vi. First aid and rescue teams;
    vii. Medical support personnel;
    viii. Licensee's headquarters support personnel;
    ix. Security personnel.
    In addition, a radiological orientation training program shall be 
made available to local services personnel; e.g., local emergency 
services/Civil Defense, local law enforcement personnel, local news 
media persons.
    2. The plan shall describe provisions for the conduct of emergency 
preparedness exercises as follows: Exercises shall test the adequacy of 
timing and content of implementing procedures and methods, test 
emergency equipment and communications networks, test the public alert 
and notification system, and ensure that emergency organization 
personnel are familiar with their duties.\3\
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    \3\ Use of site specific simulators or computers is acceptable for 
any exercise.
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    a. A full participation \4\ exercise which tests as much of the 
licensee, State, and local emergency plans as is reasonably achievable 
without mandatory public participation shall be conducted for each site 
at which a power reactor is located. Nuclear power reactor licensees 
shall submit exercise scenarios under Sec.50.4 at least 60 days before 
use in a full participation exercise required by this paragraph 2.a.
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    \4\ Full participation when used in conjunction with emergency 
preparedness exercises for a particular site means appropriate offsite 
local and State authorities and licensee personnel physically and 
actively take part in testing their integrated capability to adequately 
assess and respond to an accident at a commercial nuclear power plant. 
Full participation includes testing major observable portions of the 
onsite and offsite emergency plans and mobilization of State, local and 
licensee personnel and other resources in sufficient numbers to verify 
the capability to respond to the accident scenario.
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    (i) For an operating license issued under this part, this exercise 
must be conducted

[[Page 1037]]

within 2 years before the issuance of the first operating license for 
full power (one authorizing operation above 5 percent of rated thermal 
power) of the first reactor and shall include participation by each 
State and local government within the plume exposure pathway EPZ and 
each state within the ingestion exposure pathway EPZ. If the full 
participation exercise is conducted more than 1 year prior to issuance 
of an operating licensee for full power, an exercise which tests the 
licensee's onsite emergency plans must be conducted within one year 
before issuance of an operating license for full power. This exercise 
need not have State or local government participation.
    (ii) For a combined license issued under part 52 of this chapter, 
this exercise must be conducted within two years of the scheduled date 
for initial loading of fuel. If the first full participation exercise is 
conducted more than one year before the scheduled date for initial 
loading of fuel, an exercise which tests the licensee's onsite emergency 
plans must be conducted within one year before the scheduled date for 
initial loading of fuel. This exercise need not have State or local 
government participation. If FEMA identifies one or more deficiencies in 
the state of offsite emergency preparedness as the result of the first 
full participation exercise, or if the Commission finds that the state 
of emergency preparedness does not provide reasonable assurance that 
adequate protective measures can and will be taken in the event of a 
radiological emergency, the provisions of Sec.50.54(gg) apply.
    (iii) For a combined license issued under part 52 of this chapter, 
if the applicant currently has an operating reactor at the site, an 
exercise, either full or partial participation,\5\ shall be conducted 
for each subsequent reactor constructed on the site. This exercise may 
be incorporated in the exercise requirements of Sections IV.F.2.b. and 
c. in this appendix. If FEMA identifies one or more deficiencies in the 
state of offsite emergency preparedness as the result of this exercise 
for the new reactor, or if the Commission finds that the state of 
emergency preparedness does not provide reasonable assurance that 
adequate protective measures can and will be taken in the event of a 
radiological emergency, the provisions of Sec.50.54(gg) apply.
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    \5\ Partial participation when used in conjunction with emergency 
preparedness exercises for a particular site means appropriate offsite 
authorities shall actively take part in the exercise sufficient to test 
direction and control functions; i.e., (a) protective action decision 
making related to emergency action levels, and (b) communication 
capabilities among affected State and local authorities and the 
licensee.
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    b. Each licensee at each site shall conduct a subsequent exercise of 
its onsite emergency plan every 2 years. Nuclear power reactor licensees 
shall submit exercise scenarios under Sec.50.4 at least 60 days before 
use in an exercise required by this paragraph 2.b. The exercise may be 
included in the full participation biennial exercise required by 
paragraph 2.c. of this section. In addition, the licensee shall take 
actions necessary to ensure that adequate emergency response 
capabilities are maintained during the interval between biennial 
exercises by conducting drills, including at least one drill involving a 
combination of some of the principal functional areas of the licensee's 
onsite emergency response capabilities. The principal functional areas 
of emergency response include activities such as management and 
coordination of emergency response, accident assessment, event 
classification, notification of offsite authorities, assessment of the 
onsite and offsite impact of radiological releases, protective action 
recommendation development, protective action decision making, plant 
system repair and mitigative action implementation. During these drills, 
activation of all of the licensee's emergency response facilities 
(Technical Support Center (TSC), Operations Support Center (OSC), and 
the Emergency Operations Facility (EOF)) would not be necessary, 
licensees would have the opportunity to consider accident management 
strategies, supervised instruction would be permitted, operating staff 
in all participating facilities would have the opportunity to resolve 
problems (success paths) rather than have controllers intervene, and the 
drills may focus on the onsite exercise training objectives.
    c. Offsite plans for each site shall be exercised biennially with 
full participation by each offsite authority having a role under the 
radiological response plan. Where the offsite authority has a role under 
a radiological response plan for more than one site, it shall fully 
participate in one exercise every two years and shall, at least, 
partially participate in other offsite plan exercises in this period. If 
two different licensees each have licensed facilities located either on 
the same site or on adjacent, contiguous sites, and share most of the 
elements defining co-located licensees,\6\ then each licensee shall:
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    \6\ Co-located licensees are two different licensees whose licensed 
facilities are located either on the same site or on adjacent, 
contiguous sites, and that share most of the following emergency 
planning and siting elements:
    a. Plume exposure and ingestion emergency planning zones;
    b. Offsite governmental authorities;
    c. Offsite emergency response organizations;
    d. Public notification system; and/or
    e. Emergency facilities.

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[[Page 1038]]

    (1) Conduct an exercise biennially of its onsite emergency plan;
    (2) Participate quadrennially in an offsite biennial full or partial 
participation exercise;
    (3) Conduct emergency preparedness activities and interactions in 
the years between its participation in the offsite full or partial 
participation exercise with offsite authorities, to test and maintain 
interface among the affected State and local authorities and the 
licensee. Co-located licensees shall also participate in emergency 
preparedness activities and interaction with offsite authorities for the 
period between exercises;
    (4) Conduct a hostile action exercise of its onsite emergency plan 
in each exercise cycle; and
    (5) Participate in an offsite biennial full or partial participation 
hostile action exercise in alternating exercise cycles.
    d. Each State with responsibility for nuclear power reactor 
emergency preparedness should fully participate in the ingestion pathway 
portion of exercises at least once every exercise cycle. In States with 
more than one nuclear power reactor plume exposure pathway EPZ, the 
State should rotate this participation from site to site. Each State 
with responsibility for nuclear power reactor emergency preparedness 
should fully participate in a hostile action exercise at least once 
every cycle and should fully participate in one hostile action exercise 
by December 31, 2015. States with more than one nuclear power reactor 
plume exposure pathway EPZ should rotate this participation from site to 
site.
    e. Licensees shall enable any State or local government located 
within the plume exposure pathway EPZ to participate in the licensee's 
drills when requested by such State or local government.
    f. Remedial exercises will be required if the emergency plan is not 
satisfactorily tested during the biennial exercise, such that NRC, in 
consultation with FEMA, cannot (1) find reasonable assurance that 
adequate protective measures can and will be taken in the event of a 
radiological emergency or (2) determine that the Emergency Response 
Organization (ERO) has maintained key skills specific to emergency 
response. The extent of State and local participation in remedial 
exercises must be sufficient to show that appropriate corrective 
measures have been taken regarding the elements of the plan not properly 
tested in the previous exercises.
    g. All exercises, drills, and training that provide performance 
opportunities to develop, maintain, or demonstrate key skills must 
provide for formal critiques in order to identify weak or deficient 
areas that need correction. Any weaknesses or deficiencies that are 
identified in a critique of exercises, drills, or training must be 
corrected.
    h. The participation of State and local governments in an emergency 
exercise is not required to the extent that the applicant has identified 
those governments as refusing to participate further in emergency 
planning activities, pursuant to Sec.50.47(c)(1). In such cases, an 
exercise shall be held with the applicant or licensee and such 
governmental entities as elect to participate in the emergency planning 
process.
    i. Licensees shall use drill and exercise scenarios that provide 
reasonable assurance that anticipatory responses will not result from 
preconditioning of participants. Such scenarios for nuclear power 
reactor licensees must include a wide spectrum of radiological releases 
and events, including hostile action. Exercise and drill scenarios as 
appropriate must emphasize coordination among onsite and offsite 
response organizations.
    j. The exercises conducted under paragraph 2 of this section by 
nuclear power reactor licensees must provide the opportunity for the ERO 
to demonstrate proficiency in the key skills necessary to implement the 
principal functional areas of emergency response identified in paragraph 
2.b of this section. Each exercise must provide the opportunity for the 
ERO to demonstrate key skills specific to emergency response duties in 
the control room, TSC, OSC, EOF, and joint information center. 
Additionally, in each eight calendar year exercise cycle, nuclear power 
reactor licensees shall vary the content of scenarios during exercises 
conducted under paragraph 2 of this section to provide the opportunity 
for the ERO to demonstrate proficiency in the key skills necessary to 
respond to the following scenario elements: hostile action directed at 
the plant site, no radiological release or an unplanned minimal 
radiological release that does not require public protective actions, an 
initial classification of or rapid escalation to a Site Area Emergency 
or General Emergency, implementation of strategies, procedures, and 
guidance developed under Sec.50.54(hh)(2), and integration of offsite 
resources with onsite response. The licensee shall maintain a record of 
exercises conducted during each eight year exercise cycle that documents 
the content of scenarios used to comply with the requirements of this 
paragraph. Each licensee shall conduct a hostile action exercise for 
each of its sites no later than December 31, 2015. The first eight-year 
exercise cycle for a site will begin in the calendar year in which the 
first hostile action exercise is conducted. For a site licensed under 
Part 52, the first eight-year exercise cycle begins in the calendar year 
of the initial exercise required by Section IV.F.2.a.

[[Page 1039]]

                  G. Maintaining Emergency Preparedness

    Provisions to be employed to ensure that the emergency plan, its 
implementing procedures, and emergency equipment and supplies are 
maintained up to date shall be described.

                               H. Recovery

    Criteria to be used to determine when, following an accident, 
reentry of the facility would be appropriate or when operation could be 
resumed shall be described.

           I. Onsite Protective Actions During Hostile Action

    By June 20, 2012, for nuclear power reactor licensees, a range of 
protective actions to protect onsite personnel during hostile action 
must be developed to ensure the continued ability of the licensee to 
safely shut down the reactor and perform the functions of the licensee's 
emergency plan.

                       V. Implementing Procedures

    No less than 180 days before the scheduled issuance of an operating 
license for a nuclear power reactor or a license to possess nuclear 
material, or the scheduled date for initial loading of fuel for a 
combined license under part 52 of this chapter, the applicant's or 
licensee's detailed implementing procedures for its emergency plan shall 
be submitted to the Commission as specified in Sec.50.4.

                   VI. Emergency Response Data System

    1. The Emergency Response Data System (ERDS) is a direct near real-
time electronic data link between the licensee's onsite computer system 
and the NRC Operations Center that provides for the automated 
transmission of a limited data set of selected parameters. The ERDS 
supplements the existing voice transmission over the Emergency 
Notification System (ENS) by providing the NRC Operations Center with 
timely and accurate updates of a limited set of parameters from the 
licensee's installed onsite computer system in the event of an 
emergency. When selected plant data are not available on the licensee's 
onsite computer system, retrofitting of data points is not required. The 
licensee shall test the ERDS periodically to verify system availability 
and operability. The frequency of ERDS testing will be quarterly unless 
otherwise set by NRC based on demonstrated system performance.
    2. Except for Big Rock Point and all nuclear power facilities that 
are shut down permanently or indefinitely, onsite hardware shall be 
provided at each unit by the licensee to interface with the NRC 
receiving system. Software, which will be made available by the NRC, 
will assemble the data to be transmitted and transmit data from each 
unit via an output port on the appropriate data system. The hardware and 
software must have the following characteristics:
    a. Data points, if resident in the in-plant computer systems, must 
be transmitted for four selected types of plant conditions: Reactor core 
and coolant system conditions; reactor containment conditions; 
radioactivity release rates; and plant meteorological tower data. A 
separate data feed is required for each reactor unit. While it is 
recognized that ERDS is not a safety system, it is conceivable that a 
licensee's ERDS interface could communicate with a safety system. In 
this case, appropriate isolation devices would be required at these 
interfaces. \7\ The data points, identified in the following parameters 
will be transmitted:
---------------------------------------------------------------------------

    \7\ See 10 CFR 50.55a(h) Protection Systems.
---------------------------------------------------------------------------

    (i) For pressurized water reactors (PWRs), the selected plant 
parameters are: (1) Primary coolant system: pressure, temperatures (hot 
leg, cold leg, and core exit thermocouples), subcooling margin, 
pressurizer level, reactor coolant charging/makeup flow, reactor vessel 
level, reactor coolant flow, and reactor power; (2) Secondary coolant 
system: Steam generator levels and pressures, main feedwater flows, and 
auxiliary and emergency feedwater flows; (3) Safety injection: High- and 
low-pressure safety injection flows, safety injection flows 
(Westinghouse), and borated water storage tank level; (4) Containment: 
pressure, temperatures, hydrogen concentration, and sump levels; (5) 
Radiation monitoring system: Reactor coolant radioactivity, containment 
radiation level, condenser air removal radiation level, effluent 
radiation monitors, and process radiation monitor levels; and (6) 
Meteorological data: wind speed, wind direction, and atmospheric 
stability.
    (ii) For boiling water reactors (BWRs), the selected parameters are: 
(1) Reactor coolant system: Reactor pressure, reactor vessel level, 
feedwater flow, and reactor power; (2) Safety injection: Reactor core 
isolation cooling flow, high-pressure coolant injection/high-pressure 
core spray flow, core spray flow, low-pressure coolant injection flow, 
and condensate storage tank level; (3) Containment: drywell pressure, 
drywell temperatures, drywell sump levels, hydrogen and oxygen 
concentrations, suppression pool temperature, and suppression pool 
level; (4) Radiation monitoring system: Reactor coolant radioactivity 
level, primary containment radiation level, condenser off-gas radiation 
level, effluent radiation monitor, and process radiation levels; and (5) 
Meteorological data: Wind speed, wind direction, and atmospheric 
stability.
    b. The system must be capable of transmitting all available ERDS 
parameters at time intervals of not less than 15 seconds or more

[[Page 1040]]

than 60 seconds. Exceptions to this requirement will be considered on a 
case by case basis.
    c. All link control and data transmission must be established in a 
format compatible with the NRC receiving system \8\ as configured at the 
time of licensee implementation.
---------------------------------------------------------------------------

    \8\ Guidance is provided in NUREG-1394, Revision 1.
---------------------------------------------------------------------------

    3. Maintaining Emergency Response Data System:
    a. Any hardware and software changes that affect the transmitted 
data points identified in the ERDS Data Point Library \9\ (site specific 
data base residing on the ERDS computer) must be submitted to the NRC 
within 30 days after the changes are completed.
---------------------------------------------------------------------------

    \9\ See NUREG-1394, Revision 1, appendix C, Data Point Library.
---------------------------------------------------------------------------

    b. Hardware and software changes, with the exception of data point 
modifications, that could affect the transmission format and computer 
communication protocol to the ERDS must be provided to the NRC as soon 
as practicable and at least 30 days prior to the modification.
    c. In the event of a failure of the NRC supplied onsite modem, a 
replacement unit will be furnished by the NRC for licensee installation.
    4. Implementing the Emergency Response Data System Program:
    a. Each licensee shall develop and submit an ERDS implementation 
program plan to the NRC by October 28, 1991. To ensure compatibility 
with the guidance provided for the ERDS, the ERDS implementation program 
plan, \10\ must include, but not be limited to, information on the 
licensee's computer system configuration (i.e., hardware and software), 
interface, and procedures.
---------------------------------------------------------------------------

    \10\ See NUREG-1394, Revision 1, section 3.
---------------------------------------------------------------------------

    b. Licensees must comply with appendix E to part 50, section V.
    c. Licensees that have submitted the required information under the 
voluntary ERDS implementation program will not be required to resubmit 
this information. The licensee shall meet the implementation schedule of 
appendix E to part 50, section VI.4d.
    d. Each licensee shall complete implementation of the ERDS by 
February 13, 1993, or before initial escalation to full power, whichever 
comes later. Licensees with currently operational ERDS interfaces 
approved under the voluntary ERDS implementation program \11\ will not 
be required to submit another implementation plan and will be considered 
to have met the requirements for ERDS under appendix E to part 50, 
section VI.1 and 2 of this part.
---------------------------------------------------------------------------

    \11\ See NUREG-1394, Revision 1.

[45 FR 55410, Aug. 19, 1980; 46 FR 28839, May 29, 1981, as amended at 46 
FR 63032, Dec. 30, 1981; 47 FR 30236, July 13, 1982; 47 FR 57671, Dec. 
28, 1982; 49 FR 27736, July 6, 1984; 51 FR 40310, Nov. 6, 1986; 52 FR 
16829, May 6, 1987; 52 FR 42086, Nov. 3, 1987; 56 FR 40185, Aug. 13, 
1991; 59 FR 14090, Mar. 25, 1994; 61 FR 30132, June 14, 1996; 72 FR 
49506, Aug. 28, 2007; 73 FR 42674, July 23, 2008; 76 FR 72596, Nov. 23, 
---------------------------------------------------------------------------
2011; 78 FR 34248, June 7, 2013; 80 FR 74980, Dec. 1, 2015]

    Editorial Note: At 72 FR 49506, Aug. 28, 2007, Appendix E to part 50 
was amended by redesignating footnotes 6, 7, 8, 9, 10, 11 as 7, 8, 9, 
10, 11, 12; however, the amendment could not be incorporated due to 
inaccurate amendatory instruction.



   Sec. Appendix F to Part 50--Policy Relating to the Siting of Fuel 
       Reprocessing Plants and Related Waste Management Facilities

    1. Public health and safety considerations relating to licensed fuel 
reprocessing plants do not require that such facilities be located on 
land owned and controlled by the Federal Government. Such plants, 
including the facilities for the temporary storage of highlevel 
radioactive wastes, may be located on privately owned property.
    2. A fuel reprocessing plant's inventory of high-level liquid 
radioactive wastes will be limited to that produced in the prior 5 
years. (For the purpose of this statement of policy, ``high-level liquid 
radioactive wastes'' means those aqueous wastes resulting from the 
operation of the first cycle solvent extraction system, or equivalent, 
and the concentrated wastes from subsequent extraction cycles, or 
equivalent, in a facility for reprocessing irradiated reactor fuels.) 
High-level liquid radioactive wastes shall be converted to a dry solid 
as required to comply with this inventory limitation, and placed in a 
sealed container prior to transfer to a Federal repository in a shipping 
cask meeting the requirements of 10 CFR part 71. The dry solid shall be 
chemically, thermally, and radiolytically stable to the extent that the 
equilibrium pressure in the sealed container will not exceed the safe 
operating pressure for that container during the period from canning 
through a minimum of 90 days after receipt (transfer of physical 
custody) at the Federal repository. All of these high-level radioactive 
wastes shall be transferred to a Federal repository no later than 10 
years following separation of fission products from the irradiated fuel. 
Upon receipt, the Federal repository will assume permanent custody of 
these radioactive waste materials although industry will pay the Federal 
Government a

[[Page 1041]]

charge which together with interest on unexpended balances will be 
designed to defray all costs of disposal and perpetual surveillance. The 
Department of Energy will take title to the radioactive waste material 
upon transfer to a Federal repository. Before retirement of the 
reprocessing plant from operational status and before termination of 
licensing pursuant to Sec.50.82, transfer of all such wastes to a 
Federal repository shall be completed. Federal repositories, which will 
be limited in number, will be designated later by the Commission.
    3. Disposal of high-level radioactive fission product waste material 
will not be permitted on any land other than that owned and controlled 
by the Federal Government.
    4. A design objective for fuel reprocessing plants shall be to 
facilitate decontamination and removal of all significant radioactive 
wastes at the time the facility is permanently decommissioned. Criteria 
for the extent of decontamination to be required upon decommissioning 
and license termination will be developed in consultation with competent 
groups. Opportunity will be afforded for public comment before such 
criteria are made effective.
    5. Applicants proposing to operate fuel reprocessing plants, in 
submitting information concerning financial qualifications as required 
by Sec.50.33(f), shall include information enabling the Commission to 
determine whether the applicant is financially qualified, among other 
things, to provide for the removal and disposal of radioactive wastes, 
during operation and upon decommissioning of the facility, in accordance 
with the Commission's regulations, including the requirements set out in 
this appendix.
    6. With respect to fuel reprocessing plants already licensed, the 
licenses will be appropriately conditioned to carry out the purposes of 
the policy stated above with respect to high-level radioactive fission 
product wastes generated after installation of new equipment for interim 
storage of liquid wastes, or after installation of equipment required 
for solidification without interim liquid storage. In either case, such 
equipment shall be installed at the earliest practicable date, taking 
into account the time required for design, procurement and installation 
thereof. With respect to such plants, the application of the policy 
stated in this appendix to existing wastes and to wastes generated prior 
to the installation of such equipment, will be the subject of a further 
rulemaking proceeding.

[35 FR 17533, Nov. 14, 1970, as amended at 36 FR 5411, Mar. 23, 1971; 42 
FR 20139, Apr. 18, 1977; 45 FR 14201, Mar. 5, 1980; 70 FR 3599, Jan. 26, 
2005]



       Sec. Appendix G to Part 50--Fracture Toughness Requirements

I. Introduction and scope.
II. Definitions.
III. Fracture toughness tests.
IV. Fracture toughness requirements.

                        I. Introduction and Scope

    This appendix specifies fracture toughness requirements for ferritic 
materials of pressure-retaining components of the reactor coolant 
pressure boundary of light water nuclear power reactors to provide 
adequate margins of safety during any condition of normal operation, 
including anticipated operational occurrences and system hydrostatic 
tests, to which the pressure boundary may be subjected over its service 
lifetime.
    The ASME Code forms the basis for the requirements of this appendix. 
``ASME Code'' means the American Society of Mechanical Engineers Boiler 
and Pressure Vessel Code. If no section is specified, the reference is 
to Section III, Division 1, ``Rules for Construction of Nuclear Power 
Plant Components.'' ``Section XI'' means Section XI, Division 1, ``Rules 
for Inservice Inspection of Nuclear Power Plant Components.'' If no 
edition or addenda are specified, the ASME Code edition and addenda and 
any limitations and modifications thereof, which are specified in Sec.
50.55a, are applicable.
    The sections, editions and addenda of the ASME Boiler and Pressure 
Vessel Code specified in Sec.50.55a have been approved for 
incorporation by reference by the Director of the Federal Register. A 
notice of any changes made to the material incorporated by reference 
will be published in the Federal Register. Copies of the ASME Boiler and 
Pressure Vessel Code may be purchased from the American Society of 
Mechanical Engineers, United Engineering Center, 345 East 47th Street, 
New York, NY 10017, and are available for inspection at the NRC Library, 
11545 Rockville Pike, Two White Flint North, Rockville, MD 20852-2738.
    The requirements of this appendix apply to the following materials:
    A. Carbon and low-alloy ferritic steel plate, forgings, castings, 
and pipe with specified minimum yield strengths not over 50,000 psi (345 
MPa), and to those with specified minimum yield strengths greater than 
50,000 psi (345 MPa) but not over 90,000 psi (621 MPa) if qualified by 
using methods equivalent to those described in paragraph G-2110 of 
appendix G of section XI of the latest edition and addenda of the ASME 
Code incorporated by reference into Sec.50.55a(b)(2).
    B. Welds and weld heat-affected zones in the materials specified in 
paragraph I.A. of this appendix.
    C. Materials for bolting and other types of fasteners with specified 
minimum yield strengths not over 130,000 psi (896 MPa).

[[Page 1042]]

    Note: The adequacy of the fracture toughness of other ferritic 
materials not covered in this section must be demonstrated to the 
Director, Office of Nuclear Reactor Regulation or the Director, Office 
of New Reactors, as appropriate, on an individual case basis.

                             II. Definitions

    A. Ferritic material means carbon and low-alloy steels, higher alloy 
steels including all stainless alloys of the 4xx series, and maraging 
and precipitation hardening steels with a predominantly body-centered 
cubic crystal structure.
    B. System hydrostatic tests means all preoperational system leakage 
and hydrostatic pressure tests and all system leakage and hydrostatic 
pressure tests performed during the service life of the pressure 
boundary in compliance with the ASME Code, Section XI.
    C. Specified minimum yield strength means the minimum yield strength 
(in the unirradiated condition) of a material specified in the 
construction code under which the component is built under Sec.50.55a.
    D. RTNDT means the reference temperature of the material, for all 
conditions.
    (i) For the pre-service or unirradiated condition, RTNDT 
is evaluated according to the procedures in the ASME Code, Paragraph NB-
2331.
    (ii) For the reactor vessel beltline materials, RTNDT 
must account for the effects of neutron radiation.
    E. [Delta]RTNDT means the transition temperature shift, or change in 
RTNDT, due to neutron radiation effects, which is evaluated as the 
difference in the 30 ft-lb (41 J) index temperatures from the average 
Charpy curves measured before and after irradiation.
    F. Beltline or Beltline region of reactor vessel means the region of 
the reactor vessel (shell material including welds, heat affected zones, 
and plates or forgings) that directly surrounds the effective height of 
the active core and adjacent regions of the reactor vessel that are 
predicted to experience sufficient neutron radiation damage to be 
considered in the selection of the most limiting material with regard to 
radiation damage.

                      III. Fracture Toughness Tests

    A. To demonstrate compliance with the fracture toughness 
requirements of section IV of this appendix, ferritic materials must be 
tested in accordance with the ASME Code and, for the beltline materials, 
the test requirements of appendix H of this part. For a reactor vessel 
that was constructed to an ASME code earlier than the Summer 1972 
Addenda of the 1971 Edition (under Sec.50.55a), the fracture toughness 
data and data analysis must be supplemented in a manner approved by the 
Director, Office of Nuclear Reactor Regulation or Director, Office of 
New Reactors, as appropriate, to demonstrate equivalence with the 
fracture toughness requirements of this appendix.
    B. Test methods for supplemental fracture toughness tests described 
in paragraph IV.A.1.b of this appendix must be submitted to and approved 
by the Director, Office of Nuclear Reactor Regulation or Director, 
Office of New Reactors, as appropriate, prior to testing.
    C. All fracture toughness test programs conducted in accordance with 
paragraphs III.A and III.B must comply with ASME Code requirements for 
calibration of test equipment, qualification of test personnel, and 
retention of records of these functions and of the test data.

                   IV. Fracture Toughness Requirements

    A. The pressure-retaining components of the reactor coolant pressure 
boundary that are made of ferritic materials must meet the requirements 
of the ASME Code, supplemented by the additional requirements set forth 
below, for fracture toughness during system hydrostatic tests and any 
condition of normal operation, including anticipated operational 
occurrences. Reactor vessels may continue to be operated only for that 
service period within which the requirements of this section are 
satisfied. For the reactor vessel beltline materials, including welds, 
plates and forgings, the values of RTNDT and Charpy upper-
shelf energy must account for the effects of neutron radiation, 
including the results of the surveillance program of appendix H of this 
part. The effects of neutron radiation must consider the radiation 
conditions (i.e., the fluence) at the deepest point on the crack front 
of the flaw assumed in the analysis.

        1. Reactor Vessel Charpy Upper-Shelf Energy Requirements

    a. Reactor vessel beltline materials must have Charpy upper-shelf 
energy \1\ in the transverse direction for base material and along the 
weld for weld material according to the ASME Code, of no less than 75 
ft-lb (102 J) initially and must maintain Charpy upper-shelf energy 
throughout the life of the vessel of no less than 50 ft-lb (68 J), 
unless it is demonstrated in a manner approved by the Director, Office 
of Nuclear Reactor Regulation or Director, Office of New Reactors, as 
appropriate, that lower values of Charpy upper-shelf energy will provide 
margins of safety against fracture equivalent to those required by 
Appendix G of Section XI of the ASME Code. This analysis must use the 
latest edition and addenda of the ASME Code

[[Page 1043]]

incorporated by reference into Sec.50.55a(b)(2) at the time the 
analysis is submitted.
---------------------------------------------------------------------------

    \1\ Defined in ASTME 185-79 and -82 which are incorporated by 
reference in appendix H to part 50.
---------------------------------------------------------------------------

    b. Additional evidence of the fracture toughness of the beltline 
materials after exposure to neutron irradiation may be obtained from 
results of supplemental fracture toughness tests for use in the analysis 
specified in section IV.A.1.a.
    c. The analysis for satisfying the requirements of section IV.A.1 of 
this appendix must be submitted, as specified in Sec.50.4, for review 
and approval on an individual case basis at least three years prior to 
the date when the predicted Charpy upper-shelf energy will no longer 
satisfy the requirements of section IV.A.1 of this appendix, or on a 
schedule approved by the Director, Office of Nuclear Reactor Regulation 
or Director, Office of New Reactors, as appropriate.

   2. Pressure-Temperature Limits and Minimum Temperature Requirements

    a. Pressure-temperature limits and minimum temperature requirements 
for the reactor vessel are given in table 1, and are defined by the 
operating condition (i.e., hydrostatic pressure and leak tests, or 
normal operation including anticipated operational occurrences), the 
vessel pressure, whether or not fuel is in the vessel, and whether the 
core is critical. In table 1, the vessel pressure is defined as a 
percentage of the preservice system hydrostatic test pressure. The 
appropriate requirements on both the pressure-temperature limits and the 
minimum permissible temperature must be met for all conditions.
    b. The pressure-temperature limits identified as ``ASME Appendix G 
limits'' in table 1 require that the limits must be at least as 
conservative as limits obtained by following the methods of analysis and 
the margins of safety of Appendix G of Section XI of the ASME Code.
    c. The minimum temperature requirements given in table 1 pertain to 
the controlling material, which is either the material in the closure 
flange or the material in the beltline region with the highest reference 
temperature. As specified in table 1, the minimum temperature 
requirements and the controlling material depend on the operating 
condition (i.e., hydrostatic pressure and leak tests, or normal 
operation including anticipated operational occurrences), the vessel 
pressure, whether fuel is in the vessel, and whether the core is 
critical. The metal temperature of the controlling material, in the 
region of the controlling material which has the least favorable 
combination of stress and temperature must exceed the appropriate 
minimum temperature requirement for the condition and pressure of the 
vessel specified in table 1.
    d. Pressure tests and leak tests of the reactor vessel that are 
required by Section XI of the ASME Code must be completed before the 
core is critical.
    B. If the procedures of section IV.A. of this appendix do not 
indicate the existence of an equivalent safety margin, the reactor 
vessel beltline may be given a thermal annealing treatment to recover 
the fracture toughness of the material, subject to the requirements of 
Sec.50.66. The reactor vessel may continue to be operated only for 
that service period within which the predicted fracture toughness of the 
beltline region materials satisfies the requirements of section IV.A. of 
this appendix using the values of RTNDT and Charpy upper-
shelf energy that include the effects of annealing and subsequent 
irradiation.

                 Table 1--Pressure and Temperature Requirements for the Reactor Pressure Vessel
----------------------------------------------------------------------------------------------------------------
                                     Vessel
        Operating condition         pressure     Requirements for pressure-     Minimum temperature requirements
                                       \1\           temperature limits
----------------------------------------------------------------------------------------------------------------
1. Hydrostatic pressure and leak
 tests (core is not critical):
  1.a Fuel in the vessel..........    <=20%   ASME Appendix G Limits           (\2\)
  1.b Fuel in the vessel..........  
Sec. Appendix H to Part 50--Reactor Vessel Material Surveillance 
Program 
                              Requirements

I. Introduction
II. Definitions
III. Surveillance Program Criteria
IV. Report of Test Results

                             I. Introduction

    The purpose of the material surveillance program required by this 
appendix is to monitor changes in the fracture toughness properties of 
ferritic materials in the reactor vessel beltline region of light water 
nuclear power reactors which result from exposure of these materials to 
neutron irradiation and the thermal environment. Under the program, 
fracture toughness test data are obtained from material specimens 
exposed in surveillance capsules, which are withdrawn periodically from 
the reactor vessel. These data will be used as described in section IV 
of appendix G to part 50.
    ASTM E 185-73, ``Standard Recommended Practice for Surveillance 
Tests for Nuclear Reactor Vessels''; ASTM E 185-79, ``Standard Practice 
for Conducting Surveillance Tests for Light-Water Cooled Nuclear Power 
Reactor Vessels''; and ASTM E 185-82, ``Standard Practice for Conducting 
Surveillance Tests for Light-Water Cooled Nuclear Power Reactor 
Vessels''; which are referenced in the following paragraphs, have been 
approved for incorporation by reference by the Director of the Federal 
Register. Copies of ASTM E 185-73, -79, and -82, may be purchased from 
the American Society for Testing and Materials, 1916 Race Street, 
Philadelphia, PA 19103 and are available for inspection at the NRC 
Library, 11545 Rockville Pike, Two White Flint North, Rockville, MD 
20852-2738.

                             II. Definitions

    All terms used in this appendix have the same meaning as in appendix 
G.

                   III. Surveillance Program Criteria

    A. No material surveillance program is required for reactor vessels 
for which it can be conservatively demonstrated by analytical methods 
applied to experimental data and tests performed on comparable vessels, 
making appropriate allowances for all uncertainties in the measurements, 
that the peak neutron fluence at the end of the design life of the 
vessel will not exceed 10\17\ n/cm\2\ (E 1 MeV).
    B. Reactor vessels that do not meet the conditions of paragraph 
III.A of this appendix must have their beltline materials monitored by a 
surveillance program complying with ASTM E 185, as modified by this 
appendix.
    1. The design of the surveillance program and the withdrawal 
schedule must meet the requirements of the edition of ASTM E 185 that is 
current on the issue date of the ASME Code to which the reactor vessel 
was purchased. Later editions of ASTM E 185 may be used, but including 
only those editions through 1982. For each capsule withdrawal, the test 
procedures and reporting requirements must meet the requirements of ASTM 
E 185-82 to the extent practicable for the configuration of the 
specimens in the capsule.
    2. Surveillance specimen capsules must be located near the inside 
vessel wall in the beltline region so that the specimen irradiation 
history duplicates, to the extent practicable within the physical 
constraints of the system, the neutron spectrum, temperature history, 
and maximum neutron fluence experienced by the reactor vessel inner 
surface. If the capsule holders are attached to the vessel wall or to 
the vessel cladding, construction and inservice inspection of the 
attachments and attachment welds must be done according to the 
requirements for permanent structural attachments to reactor vessels 
given in Sections III and XI of the American Society of Mechanical 
Engineers Boiler and Pressure Vessel Code (ASME Code). The design and 
location of the capsule holders must permit insertion of replacement 
capsules. Accelerated irradiation capsules may be used in addition to 
the required number of surveillance capsules.
    3. A proposed withdrawal schedule must be submitted with a technical 
justification as specified in Sec.50.4. The proposed schedule must be 
approved prior to implementation.
    C. Requirements for an Integrated Surveillance Program.
    1. In an integrated surveillance program, the representative 
materials chosen for surveillance for a reactor are irradiated in one or 
more other reactors that have similar design and operating features. 
Integrated surveillance programs must be approved by the Director, 
Office of Nuclear Reactor Regulation or the Director, Office of New 
Reactors, as appropriate, on a case-by-case basis. Criteria for approval 
include the following:
    a. The reactor in which the materials will be irradiated and the 
reactor for which the materials are being irradiated must have 
sufficiently similar design and operating features to permit accurate 
comparisons of the predicted amount of radiation damage.

[[Page 1045]]

    b. Each reactor must have an adequate dosimetry program.
    c. There must be adequate arrangement for data sharing between 
plants.
    d. There must be a contingency plan to assure that the surveillance 
program for each reactor will not be jeopardized by operation at reduced 
power level or by an extended outage of another reactor from which data 
are expected.
    e. There must be substantial advantages to be gained, such as 
reduced power outages or reduced personnel exposure to radiation, as a 
direct result of not requiring surveillance capsules in all reactors in 
the set.
    2. No reduction in the requirements for number of materials to be 
irradiated, specimen types, or number of specimens per reactor is 
permitted.
    3. After (the effective date of this section), no reduction in the 
amount of testing is permitted unless previously authorized by the 
Director, Office of Nuclear Reactor Regulation or the Director, Office 
of New Reactors, as appropriate.

                       IV. Report of Test Results

    A. Each capsule withdrawal and the test results must be the subject 
of a summary technical report to be submitted, as specified in Sec.
50.4, within one year of the date of capsule withdrawal, unless an 
extension is granted by the Director, Office of Nuclear Reactor 
Regulation.
    B. The report must include the data required by ASTM E 185, as 
specified in paragraph III.B.1 of this appendix, and the results of all 
fracture toughness tests conducted on the beltline materials in the 
irradiated and unirradiated conditions.
    C. If a change in the Technical Specifications is required, either 
in the pressure-temperature limits or in the operating procedures 
required to meet the limits, the expected date for submittal of the 
revised Technical Specifications must be provided with the report.

[60 FR 65476, Dec. 19, 1995, as amended at 68 FR 75390, Dec. 31, 2003; 
73 FR 5723, Jan. 31, 2008]



 Sec. Appendix I to Part 50--Numerical Guides for Design Objectives and 
 Limiting Conditions for Operation To Meet the Criterion ``As Low as is 
 Reasonably Achievable'' for Radioactive Material in Light-Water-Cooled 
                     Nuclear Power Reactor Effluents

    SECTION I. Introduction. Section 50.34a provides that an application 
for a construction permit shall include a description of the preliminary 
design of equipment to be installed to maintain control over radioactive 
materials in gaseous and liquid effluents produced during normal 
conditions, including expected occurrences. In the case of an 
application filed on or after January 2, 1971, the application must also 
identify the design objectives, and the means to be employed, for 
keeping levels of radioactive material in effluents to unrestricted 
areas as low as practicable. Sections 52.47, 52.79, 52.137, and 52.157 
of this chapter provide that applications for design certification, 
combined license, design approval, or manufacturing license, 
respectively, shall include a description of the equipment and 
procedures for the control of gaseous and liquid effluents and for the 
maintenance and use of equipment installed in radioactive waste systems.
    Section 50.36a contains provisions designed to assure that releases 
of radioactive material from nuclear power reactors to unrestricted 
areas during normal conditions, including expected occurrences, are kept 
as low as practicable.
    SECTION II. Guides on design objectives for light-water-cooled 
nuclear power reactors licensed under 10 CFR part 50 or part 52 of this 
chapter. The guides on design objectives set forth in this section may 
be used by an applicant for a construction permit as guidance in meeting 
the requirements of Sec.50.34a(a), or by an applicant for a combined 
license under part 52 of this chapter as guidance in meeting the 
requirements of Sec.50.34a(d), or by an applicant for a design 
approval, a design certification, or a manufacturing license as guidance 
in meeting the requirements of Sec.50.34a(e). The applicant shall 
provide reasonable assurance that the following design objectives will 
be met.
    A. The calculated annual total quantity of all radioactive material 
above background \1\ to be released from each light-water-cooled nuclear 
power reactor to unrestricted areas will not result in an estimated 
annual dose or dose commitment from liquid effluents for any individual 
in an unrestricted area from all pathways of exposure in excess of 3 
millirems to the total body or 10 millirems to any organ.
---------------------------------------------------------------------------

    \1\ Here and elsewhere in this appendix background means radioactive 
materials in the environment and in the effluents from light-water-
cooled power reactors not generated in, or attributable to, the reactors 
of which specific account is required in determining design objectives.
---------------------------------------------------------------------------

    B.1. The calculated annual total quantity of all radioactive 
material above background to be released from each light-water-cooled 
nuclear power reactor to the atmosphere will not result in an estimated 
annual air dose from gaseous effluents at any location near ground level 
which could be occupied by individuals in unrestricted areas in excess 
of 10

[[Page 1046]]

millirads for gamma radiation or 20 millirads for beta radiation.
    2. Notwithstanding the guidance of paragraph B.1:
    (a) The Commission may specify, as guidance on design objectives, a 
lower quantity of radioactive material above background to be released 
to the atmosphere if it appears that the use of the design objectives in 
paragraph B.1 is likely to result in an estimated annual external dose 
from gaseous effluents to any individual in an unrestricted area in 
excess of 5 millirems to the total body; and
    (b) Design objectives based upon a higher quantity of radioactive 
material above background to be released to the atmosphere than the 
quantity specified in paragraph B.1 will be deemed to meet the 
requirements for keeping levels of radioactive material in gaseous 
effluents as low as is reasonably achievable if the applicant provides 
reasonable assurance that the proposed higher quantity will not result 
in an estimated annual external dose from gaseous effluents to any 
individual in unrestricted areas in excess of 5 millirems to the total 
body or 15 millirems to the skin.
    C. The calculated annual total quantity of all radioactive iodine 
and radioactive material in particulate form above background to be 
released from each light-water-cooled nuclear power reactor in effluents 
to the atmosphere will not result in an estimated annual dose or dose 
commitment from such radioactive iodine and radioactive material in 
particulate form for any individual in an unrestricted area from all 
pathways of exposure in excess of 15 millirems to any organ.
    D. In addition to the provisions of paragraphs A, B, and C above, 
the applicant shall include in the radwaste system all items of 
reasonably demonstrated technology that, when added to the system 
sequentially and in order of diminishing cost-benefit return, can for a 
favorable cost-benefit ratio effect reductions in dose to the population 
reasonably expected to be within 50 miles of the reactor. As an interim 
measure and until establishment and adoption of better values (or other 
appropriate criteria), the values $1000 per total body man-rem and $1000 
per man-thyroid-rem (or such lesser values as may be demonstrated to be 
suitable in a particular case) shall be used in this cost-benefit 
analysis. The requirements of this paragraph D need not be complied with 
by persons who have filed applications for construction permits which 
were docketed on or after January 2, 1971, and prior to June 4, 1976, if 
the radwaste systems and equipment described in the preliminary or final 
safety analysis report and amendments thereto satisfy the Guides on 
Design Objectives for Light-Water-Cooled Nuclear Power Reactors proposed 
in the Concluding Statement of Position of the Regulatory Staff in 
Docket-RM-50-2 dated February 20, 1974, pp. 25-30, reproduced in the 
annex to this appendix I.
    SECTION III. Implementation. A.1. Conformity with the guides on 
design objectives of Section II shall be demonstrated by calculational 
procedures based upon models and data such that the actual exposure of 
an individual through appropriate pathways is unlikely to be 
substantially underestimated, all uncertainties being considered 
together. Account shall be taken of the cumulative effect of all sources 
and pathways within the plant contributing to the particular type of 
effluent being considered. For determination of design objectives in 
accordance with the guides of Section II, the estimations of exposure 
shall be made with respect to such potential land and water usage and 
food pathways as could actually exist during the term of plant 
operation: Provided, That, if the requirements of paragraph B of Section 
III are fulfilled, the applicant shall be deemed to have complied with 
the requirements of paragraph C of Section II with respect to 
radioactive iodine if estimations of exposure are made on the basis of 
such food pathways and individual receptors as actually exist at the 
time the plant is licensed.
    2. The characteristics attributed to a hypothetical receptor for the 
purpose of estimating internal dose commitment shall take into account 
reasonable deviations of individual habits from the average. The 
applicant may take account of any real phenomenon or factors actually 
affecting the estimate of radiation exposure, including the 
characteristics of the plant, modes of discharge of radioactive 
materials, physical processes tending to attenuate the quantity of 
radioactive material to which an individual would be exposed, and the 
effects of averaging exposures over times during which determining 
factors may fluctuate.
    B. If the applicant determines design objectives with respect to 
radioactive iodine on the basis of existing conditions and if potential 
changes in land and water usage and food pathways could result in 
exposures in excess of the guideline values of paragraph C of Section 
II, the applicant shall provide reasonable assurance that a monitoring 
and surveillance program will be performed to determine:
    1. The quantities of radioactive iodine actually released to the 
atmosphere and deposited relative to those estimated in the 
determination of design objectives;
    2. Whether changes in land and water usage and food pathways which 
would result in individual exposures greater than originally estimated 
have occurred; and
    3. The content of radioactive iodine and foods involved in the 
changes, if and when they occur.
    SECTION IV. Guides on technical specifications for limiting 
conditions for operation for

[[Page 1047]]

light-water-cooled nuclear power reactors licensed under 10 CFR part 50 
or part 52 of this chapter. The guides on limiting conditions for 
operation for light-water-cooled nuclear power reactors set forth below 
may be used by an applicant for an operating license under this part or 
a design certification or combined license under part 52 of this 
chapter, or a licensee who has submitted a certification of permanent 
cessation of operations under Sec.50.82(a)(1) or Sec.52.110 of this 
chapter as guidance in developing technical specifications under Sec.
50.36a(a) to keep levels of radioactive materials in effluents to 
unrestricted areas as low as is reasonably achievable.
    Section 50.36a(b) provides that licensees shall be guided by certain 
considerations in establishing and implementing operating procedures 
specified in technical specifications that take into account the need 
for operating flexibility and at the same time assure that the licensee 
will exert his best effort to keep levels of radioactive material in 
effluents as low as is reasonably achievable. The guidance set forth 
below provides additional and more specific guidance to licensees in 
this respect.
    Through the use of the guides set forth in this section it is 
expected that the annual release of radioactive material in effluents 
from light-water-cooled nuclear power reactors can generally be 
maintained within the levels set forth as numerical guides for design 
objectives in Section II.
    At the same time, the licensee is permitted the flexibility of 
operations, compatible with considerations of health and safety, to 
assure that the public is provided a dependable source of power even 
under unusual conditions which may temporarily result in releases higher 
than numerical guides for design objectives but still within levels that 
assure that the average population exposure is equivalent to small 
fractions of doses from natural background radiation. It is expected 
that in using this operational flexibility under unusual conditions, the 
licensee will exert his best efforts to keep levels of radioactive 
material in effluents within the numerical guides for design objectives.
    A. If the quantity of radioactive material actually released in 
effluents to unrestricted areas from a light-water-cooled nuclear power 
reactor during any calendar quarter is such that the resulting radiation 
exposure, calculated on the same basis as the respective design 
objective exposure, would exceed one-half the design objective annual 
exposure derived pursuant to Sections II and III, the licensee shall: 
\2\
---------------------------------------------------------------------------

    \2\ Section 50.36a(a)(2) requires the licensee to submit certain 
reports to the Commission with regard to the quantities of the principal 
radionuclides released to unrestricted areas. It also provides that, on 
the basis of such reports and any additional information the Commission 
may obtain from the licensee and others, the Commission may from time to 
time require the license to take such action as the Commission deems 
appropriate.
---------------------------------------------------------------------------

    1. Make an investigation to identify the causes for such release 
rates;
    2. Define and initiate a program of corrective action; and
    3. Report these actions as specified in Sec.50.4, within 30 days 
from the end of the quarter during which the release occurred.
    B. The licensee shall establish an appropriate surveillance and 
monitoring program to:
    1. Provide data on quantities of radioactive material released in 
liquid and gaseous effluents to assure that the provisions of paragraph 
A of this section are met;
    2. Provide data on measurable levels of radiation and radioactive 
materials in the environment to evaluate the relationship between 
quantities of radioactive material released in effluents and resultant 
radiation doses to individuals from principal pathways of exposure; and
    3. Identify changes in the use of unrestricted areas (e.g., for 
agricultural purposes) to permit modifications in monitoring programs 
for evaluating doses to individuals from principal pathways of exposure.
    C. If the data developed in the surveillance and monitoring program 
described in paragraph B of Section III or from other monitoring 
programs show that the relationship between the quantities of 
radioactive material released in liquid and gaseous effluents and the 
dose to individuals in unrestricted areas is significantly different 
from that assumed in the calculations used to determine design 
objectives pursuant to Sections II and III, the Commission may modify 
the quantities in the technical specifications defining the limiting 
conditions in a license to operate a light-water-cooled nuclear power 
reactor or a license whose holder has submitted a certification of 
permanent cessation of operations under Sec.50.82(a)(1).
    SECTION V. Effective dates. A. The guides for limiting conditions 
for operation set forth in this appendix shall be applicable in any case 
in which an application was filed on or after January 2, 1971, for a 
construction permit for a light-water-cooled nuclear power reactor under 
this part, or a design certification, a combined license, or a 
manufacturing license for a light-water-cooled nuclear power reactor 
under part 52 of this chapter.
    B. For each light-water-cooled nuclear power reactor constructed 
pursuant to a permit for which application was filed prior to January 2, 
1971, the holder of the permit or

[[Page 1048]]

a license, authorizing operation of the reactor shall, within a period 
of twelve months from June 4, 1975, file with the Commission:
    1. Such information as is necessary to evaluate the means employed 
for keeping levels of radioactivity in effluents to unrestricted areas 
as low as is reasonably achievable, including all such information as is 
required by Sec.50.34a (b) and (c) not already contained in his 
application; and
    2. Plans and proposed technical specifications developed for the 
purpose of keeping releases of radioactive materials to unrestricted 
areas during normal reactor operations, including expected operational 
occurrences, as low as is reasonably achievable.

 Concluding Statement of Position of the Regulatory Staff (Docket-RM-50-
                                   2)

    guides on design objectives for light-water-cooled nuclear power 
                                reactors

    A. For radioactive material above background \1\ in liquid effluents 
to be released to unrestricted areas:
---------------------------------------------------------------------------

    \1\ ``Background,'' means the quantity of radioactive material in 
the effluent from light-water-cooled nuclear power reactors at a site 
that did not originate in the reactors.
---------------------------------------------------------------------------

    1. The calculated annual total quantity of all radioactive material 
from all light-water-cooled nuclear power reactors at a site should not 
result in an annual dose or dose commitment to the total body or to any 
organ of an individual in an unrestricted area from all pathways of 
exposure in excess of 5 millirems; and
    2. The calculated annual total quantity of radioactive material, 
except tritium and dissolved gases, should not exceed 5 curies for each 
light-water-cooled reactor at a site.
    3. Notwithstanding the guidance in paragraph A.2, for a particular 
site, if an applicant for a permit to construct a light-water-cooled 
nuclear power reactor has proposed baseline in-plant control measures 
\2\ to reduce the possible sources of radioactive material in liquid 
effluent releases and the calculated quantity exceeds the quantity set 
forth in paragraph A.2, the requirements for design objectives for 
radioactive material in liquid effluents may be deemed to have been met 
provided:
---------------------------------------------------------------------------

    \2\ Such measures may include treatment of clear liquid waste 
streams (normally tritiated, nonaerated, low conductivity equipment 
drains and pump seal leakoff), dirty liquid waste streams (normally 
nontritiated, aerated, high conductivity building sumps, floor and 
sample station drains), steam generator blowdown streams, chemical waste 
streams, low purity and high purity liquid streams (resin regenerate and 
laboratory wastes), as appropriate for the type of reactor.
---------------------------------------------------------------------------

    a. The applicant submits, as specified in Sec.50.4, an evaluation 
of the potential for effects from long-term buildup on the environment 
in the vicinity of the site of radioactive material, with a radioactive 
half-life greater than one year, to be released; and
    b. The provisions of paragraph A.1 are met.
    B. For radioactive material above background in gaseous effluents 
the annual total quantity of radioactive material to be released to the 
atmosphere by all light-water-cooled nuclear power reactors at a site:
    1. The calculated annual air dose due to gamma radiation at any 
location near ground level which could be occupied by individuals at or 
beyond the boundary of the site should not exceed 10 millirads; and
    2. The calculated annual air dose due to beta radiation at any 
location near ground level which could be occupied by individuals at or 
beyond the boundary of the site should not exceed 20 millirads.
    3. Notwithstanding the guidance in paragraphs B.1 and B.2, for a 
particular site:
    a. The Commission may specify, as guidance on design objectives, a 
lower quantity of radioactive material above background in gaseous 
effluents to be released to the atmosphere if it appears that the use of 
the design objectives described in paragraphs B.1 and B.2 is likely to 
result in an annual dose to an individual in an unrestricted area in 
excess of 5 millirems to the total body or 15 millirems to the skin; or
    b. Design objectives based on a higher quantity of radioactive 
material above background in gaseous effluents to be released to the 
atmosphere than the quantity specified in paragraphs B.1 and B.2 may be 
deemed to meet the requirements for keeping levels of radioactive 
material in gaseous effluents as low as practicable if the applicant 
provides reasonable assurance that the proposed higher quantity will not 
result in annual doses to an individual in an unrestricted area in 
excess of 5 millirems to the total body or 15 millirems to the skin.
    C. For radioactive iodine and radioactive material in particulate 
form above background released to the atmosphere:
    1. The calculated annual total quantity of all radioactive iodine 
and radioactive material in particulate form from all light-water-cooled 
nuclear power reactors at a site should not result in an annual dose or 
dose commitment to any organ of an individual in an unrestricted area 
from all pathways of exposure in excess of 15 millirems. In determining 
the dose or dose commitment the portion thereof due to intake of 
radioactive material via the food pathways may be evaluated at the 
locations where the food pathways actually exist; and
    2. The calculated annual total quantity of iodine-131 in gaseous 
effluents should not exceed 1 curie for each light-water-cooled nuclear 
power reactor at a site.

[[Page 1049]]

    3. Notwithstanding the guidance in paragraphs C.1 and C.2 for a 
particular site, if an applicant for a permit to construct a light-
water-cooled nuclear power reactor has proposed baseline in-plant 
control measures \3\ to reduce the possible sources of radioactive 
iodine releases, and the calculated annual quantities taking into 
account such control measures exceed the design objective quantities set 
forth in paragraphs C.1 and C.2, the requirements for design objectives 
for radioactive iodine and radioactive material in particulate form in 
gaseous effluents may be deemed to have been met provided the calculated 
annual total quantity of all radioactive iodine and radioactive material 
in particulate form that may be released in gaseous effluents does not 
exceed four times the quantity calculated pursuant to paragraph C.1.
---------------------------------------------------------------------------

    \3\ Such in-plant control measures may include treatment of steam 
generator blowdown tank exhaust, clean steam supplies for turbine gland 
seals, condenser vacuum systems, containment purging exhaust and 
ventilation exhaust systems and special design features to reduce 
contaminated steam and liquid leakage from valves and other sources such 
as sumps and tanks, as appropriate for the type of reactor.

[40 FR 19442, May 5, 1975, as amended at 40 FR 40818, Sept. 4, 1975; 40 
FR 58847, Dec. 19, 1975; 41 FR 16447, Apr. 19, 1976; 42 FR 20139, Apr. 
18, 1977; 51 FR 40311, Nov. 6, 1986; 61 FR 39303, July 29, 1996; 72 FR 
49507, Aug. 28, 2007]



Sec. Appendix J to Part 50--Primary Reactor Containment Leakage Testing 
                     for Water-Cooled Power Reactors

    This appendix includes two options, A and B, either of which can be 
chosen for meeting the requirements of this appendix.

                   Option A--Prescriptive Requirements

                            Table of Contents

    I. Introduction.
    II. Explanation of terms.
    III. Leakage test requirements.
    A. Type A test.
    B. Type B test.
    C. Type C test.
    D. Periodic retest schedule.
    IV. Special test requirements.
    A. Containment modifications.
    B. Multiple leakage-barrier containments.
    V. Inspection and reporting of tests.
    A. Containment inspection.
    B. Repordkeeping of test results.

                             I. Introduction

    One of the conditions of all operating licenses under this part and 
combined licenses under part 52 of this chapter for water-cooled power 
reactors as specified in Sec.50.54(o) is that primary reactor 
containments shall meet the containment leakage test requirements set 
forth in this appendix. These test requirements provide for 
preoperational and periodic verification by tests of the leak-tight 
integrity of the primary reactor containment, and systems and components 
which penetrate containment of water-cooled power reactors, and 
establish the acceptance criteria for these tests. The purposes of the 
tests are to assure that (a) leakage through the primary reactor 
containment and systems and components penetrating primary containment 
shall not exceed allowable leakage rate values as specified in the 
technical specifications or associated bases; and (b) periodic 
surveillance of reactor containment penetrations and isolation valves is 
performed so that proper maintenance and repairs are made during the 
service life of the containment, and systems and components penetrating 
primary containment. These test requirements may also be used for 
guidance in establishing appropriate containment leakage test 
requirements in technical specifications or associated bases for other 
types of nuclear power reactors.

                        II. Explanation of Terms

    A. ``Primary reactor containment'' means the structure or vessel 
that encloses the components of the reactor coolant pressure boundary, 
as defined in Sec.50.2, and serves as an essentially leak-tight 
barrier against the uncontrolled release of radioactivity to the 
environment.
    B. ``Containment isolation valve'' means any valve which is relied 
upon to perform a containment isolation function.
    C. ``Reactor containment leakage test program'' includes the 
performance of Type A, Type B, and Type C tests, described in II.F, 
II.G, and II.H, respectively.
    D. ``Leakage rate'' for test purposes is that leakage which occurs 
in a unit of time, stated as a percentage of weight of the original 
content of containment air at the leakage rate test pressure that 
escapes to the outside atmosphere during a 24-hour test period.
    E. ``Overall integrated leakage rate'' means that leakage rate which 
obtains from a summation of leakage through all potential leakage paths 
including containment welds, valves, fittings, and components which 
penetrate containment.
    F. ``Type A Tests'' means tests intended to measure the primary 
reactor containment overall integrated leakage rate (1) after the 
containment has been completed and is ready for operation, and (2) at 
periodic intervals thereafter.
    G. ``Type B Tests'' means tests intended to detect local leaks and 
to measure leakage across each pressure-containing or leakage-

[[Page 1050]]

limiting boundary for the following primary reactor containment 
penetrations:
    1. Containment penetrations whose design incorporates resilient 
seals, gaskets, or sealant componds, piping penetrations fitted with 
expansion bellows, and electrical penetrations fitted with flexible 
metal seal assemblies.
    2. Air lock door seals, including door operating mechanism 
penetrations which are part of the containment pressure boundary.
    3. Doors with resilient seals or gaskets except for seal-welded 
doors.
    4. Components other than those listed in II.G.1, II.G.2, or II.G.3 
which must meet the acceptance criteria in III.B.3.
    H. ``Type C Tests'' means tests intended to measure containment 
isolation valve leakage rates. The containment isolation valves included 
are those that:
    1. Provide a direct connection between the inside and outside 
atmospheres of the primary reactor containment under normal operation, 
such as purge and ventilation, vacuum relief, and instrument valves;
    2. Are required to close automatically upon receipt of a containment 
isolation signal in response to controls intended to effect containment 
isolation;
    3. Are required to operate intermittently under postaccident 
conditions; and
    4. Are in main steam and feedwater piping and other systems which 
penetrate containment of direct-cycle boiling water power reactors.
    I. Pa (p.s.i.g.) means the calculated peak containment internal 
pressure related to the design basis accident and specified either in 
the technical specification or associated bases.
    J. Pt (p.s.i.g.) means the containment vessel reduced test pressure 
selected to measure the integrated leakage rate during periodic Type A 
tests.
    K. La (percent/24 hours) means the maximum allowable leakage rate at 
pressure Pa as specified for preoperational tests in the technical 
specifications or associated bases, and as specified for periodic tests 
in the operating license or combined license, including the technical 
specifications in any referenced design certification or manufactured 
reactor used at the facility.
    L. Ld (percent/24 hours) means the design leakage rate at pressure, 
Pa, as specified in the technical specifications or associated bases.
    M. Lt (percent/24 hours) means the maximum allowable leakage rate at 
pressure Pt derived from the preoperational test data as specified in 
III.A.4.(a)(iii).
    N. Lam, Ltm (percent/24 hours) means the total measured containment 
leakage rates at pressure Pa and Pt, respectively, obtained from testing 
the containment with components and systems in the state as close as 
practical to that which would exist under design basis accident 
conditions (e.g., vented, drained, flooded or pressurized).
    O. ``Acceptance criteria'' means the standard against which test 
results are to be compared for establishing the functional acceptability 
of the containment as a leakage limiting boundary.

                    III. Leakage Testing Requirements

    A program consisting of a schedule for conducting Type A, B, and C 
tests shall be developed for leak testing the primary reactor 
containment and related systems and components penetrating primary 
containment pressure boundary.
    Upon completion of construction of the primary reactor containment, 
including installation of all portions of mechanical, fluid, electrical, 
and instrumentation systems penetrating the primary reactor containment 
pressure boundary, and prior to any reactor operating period, 
preoperational and periodic leakage rate tests, as applicable, shall be 
conducted in accordance with the following:
    A. Type A test--1. Pretest requirements. (a) Containment inspection 
in accordance with V. A. shall be performed as a prerequisite to the 
performance of Type A tests. During the period between the initiation of 
the containment inspection and the performance of the Type A test, no 
repairs or adjustments shall be made so that the containment can be 
tested in as close to the ``as is'' condition as practical. During the 
period between the completion of one Type A test and the initiation of 
the containment inspection for the subsequent Type A test, repairs or 
adjustments shall be made to components whose leakage exceeds that 
specified in the technical specification as soon as practical after 
identification. If during a Type A test, including the supplemental test 
specified in III.A.3.(b), potentially excessive leakage paths are 
identified which will interfere with satisfactory completion of the 
test, or which result in the Type A test not meeting the acceptance 
criteria III.A.4.(b) or III.A.5.(b), the Type A test shall be terminated 
and the leakage through such paths shall be measured using local leakage 
testing methods. Repairs and/or adjustments to equipment shall be made 
and Type A test performed. The corrective action taken and the change in 
leakage rate determined from the tests and overall integrated leakage 
determined from local leak and Type A tests shall be included in the 
summary report required by V.B.
    (b) Closure of containment isolation valves for the Type A test 
shall be accomplished by normal operation and without any preliminary 
exercising or adjustments (e.g., no tightening of valve after closure by 
valve motor). Repairs of maloperating or leaking valves shall be made as 
necessary. Information on any valve closure malfunction or

[[Page 1051]]

valve leakage that require corrective action before the test, shall be 
included in the summary report required by V.B.
    (c) The containment test conditions shall stabilize for a period of 
about 4 hours prior to the start of a leakage rate test.
    (d) Those portions of the fluid systems that are part of the reactor 
coolant pressure boundary and are open directly to the containment 
atmosphere under post-accident conditions and become an extension of the 
boundary of the containment shall be opened or vented to the containment 
atmosphere prior to and during the test. Portions of closed systems 
inside containment that penetrate containment and rupture as a result of 
a loss of coolant accident shall be vented to the containment 
atmosphere. All vented systems shall be drained of water or other fluids 
to the extent necessary to assure exposure of the system containment 
isolation valves to containment air test pressure and to assure they 
will be subjected to the post accident differential pressure. Systems 
that are required to maintain the plant in a safe condition during the 
test shall be operable in their normal mode, and need not be vented. 
Systems that are normally filled with water and operating under post-
accident conditions, such as the containment heat removal system, need 
not be vented. However, the containment isolation valves in the systems 
defined in III.A.1.(d) shall be tested in accordance with III.C. The 
measured leakage rate from these tests shall be included in the summary 
report required by V.B.
    2. Conduct of tests. Preoperational leakage rate tests at either 
reduced or at peak pressure, shall be conducted at the intervals 
specified in III.D.
    3. Test Methods. (a) All Type A tests shall be conducted in 
accordance with the provisions of the American National Standards N45.4-
1972, ``Leakage Rate Testing of Containment Structures for Nuclear 
Reactors,'' March 16, 1972. In addition to the Total time and Point-to-
Point methods described in that standard, the Mass Point Method, when 
used with a test duration of at least 24 hours, is an acceptable method 
to use to calculate leakage rates. A typical description of the Mass 
Point method can be found in the American National Standard ANSI/ANS 
56.8-1987, ``Containment System Leakage Testing Requirements,'' January 
20, 1987. Incorporation of ANSI N45.4-1972 by reference was approved by 
the Director of the Federal Register. Copies of this standard, as well 
as ANSI/ANS-56.8-1987, ``Containment System Leakage Testing 
Requirements'' (dated January 20, 1987) may be obtained from the 
American Nuclear Society, 555 North Kensington Avenue, La Grange Park, 
IL 60525. A copy of each of these standards is available for inspection 
at the NRC Library, 11545 Rockville Pike, Rockville, Maryland 20852-
2738.
    (b) The accuracy of any Type A test shall be verified by a 
supplemental test. An acceptable method is described in Appendix C of 
ANSI N45.4-1972. The supplemental test method selected shall be 
conducted for sufficient duration to establish accurately the change in 
leakage rate between the Type A and supplemental test. Results from this 
supplemental test are acceptable provided the difference between the 
supplemental test data and the Type A test data is within 0.25 La (or 
0.25 Lt). If results are not within 0.25 La (or 0.25 Lt), the reason 
shall be determined, corrective action taken, and a successful 
supplemental test performed.
    (c) Test leakage rates shall be calculated using absolute values 
corrected for instrument error.
    4. Preoperational leakage rate tests. (a) Test pressure--(1) Reduced 
pressure tests. (i) An initial test shall be performed at a pressure Pt, 
not less than 0.50 Pa to measure a leakage rate Ltm.
    (ii) A second test shall be performed at pressure Pa to measure a 
leakage rate Lam.
    (iii) The leakage characteristics yielded by measurements Ltm and 
Lam shall establish the maximum allowable test leakage rate Lt of not 
more than La (Ltm/Lam). In the event Ltm/Lam is greater than 0.7, Lt 
shall be specified as equal to La (Pt/Pa). \1\
---------------------------------------------------------------------------

    \1\ Such inservice inspections are required by Sec.50.55a.
---------------------------------------------------------------------------

    (2) Peak pressure tests. A test shall be performed at pressure Pa to 
measure the leakage rate Lam.
    (b) Acceptance criteria--(1) Reduced pressure tests. The leakage 
rate Ltm shall be less than 0.75 Lt.
    (2) Peak pressure tests. The leakage rate Lam shall be less than 
0.75 La and not greater than Ld.
    5. Periodic leakage rate tests--(a) Test pressure. (1) Reduced 
pressure tests shall be conducted at Pt;
    (2) Peak pressure tests shall be conducted at Pa.
    (b) Acceptance criteria--(1) Reduced pressure tests. The leakage 
rate Ltm shall be less than 0.75 Lt. If local leakage measurements are 
taken to effect repairs in order to meet the acceptance criteria, these 
measurements shall be taken at a test pressure Pt.
    (2) Peak pressure tests. The leakage rate Lam shall be less than 
0.75 La. If local leakage measurements are taken to effect repairs in 
order to meet the acceptance criteria, these measurements shall be taken 
at a test pressure Pa.
    6. Additional requirements. (a) If any periodic Type A test fails to 
meet the applicable acceptance criteria in III.A.5.(b), the test 
schedule applicable to subsequent Type A tests will be reviewed and 
approved by the Commission.

[[Page 1052]]

    (b) If two consecutive periodic Type A tests fail to meet the 
applicable acceptance criteria in III.A.5(b), notwithstanding the 
periodic retest schedule of III.D., a Type A test shall be performed at 
each plant shutdown for refueling or approximately every 18 months, 
whichever occurs first, until two consecutive Type A tests meet the 
acceptance criteria in III.A.5(b), after which time the retest schedule 
specified in III.D. may be resumed.
    B. Type B tests--1. Test methods. Acceptable means of performing 
preoperation and periodic Type B tests include:
    (a) Examination by halide leak-detection method (or by other 
equivalent test methods such as mass spectrometer) of a test chamber, 
pressurized with air, nitrogen, or pneumatic fluid specified in the 
technical specifications or associated bases and constructed as part of 
individual containment penetrations.
    (b) Measurement of the rate of pressure loss of the test chamber of 
the containment penetration pressurized with air, nitrogen, or pneumatic 
fluid specified in the technical specifications or associated bases.
    (c) Leakage surveillance by means of a permanently installed system 
with provisions for continuous or intermittent pressurization of 
individual or groups of containment penetrations and measurement of rate 
of pressure loss of air, nitrogen, or pneumatic fluid specified in the 
technical specification or associated bases through the leak paths.
    2. Test pressure. All preoperational and periodic Type B tests shall 
be performed by local pneumatic pressurization of the containment 
penetrations, either individually or in groups, at a pressure not less 
than Pa.
    3. Acceptance criteria. (See also Type C tests.) (a) The combined 
leakage rate of all penetrations and valves subject to Type B and C 
tests shall be less than 0.60 La, with the exception of the valves 
specified in III.C.3.
    (b) Leakage measurements obtained through component leakage 
surveillance systems (e.g., continuous pressurization of individual 
containment components) that maintains a pressure not less than Pa at 
individual test chambers of containment penetrations during normal 
reactor operation, are acceptable in lieu of Type B tests.
    C. Type C tests--1. Test method. Type C tests shall be performed by 
local pressurization. The pressure shall be applied in the same 
direction as that when the value would be required to perform its safety 
function, unless it can be determined that the results from the tests 
for a pressure applied in a different direction will provide equivalent 
or more conservative results. The test methods in III.B.1 may be 
substituted where appropriate. Each valve to be tested shall be closed 
by normal operation and without any preliminary exercising or 
adjustments (e.g., no tightening of valve after closure by valve motor).
    2. Test pressure. (a) Valves, unless pressurized with fluid (e.g., 
water, nitrogen) from a seal system, shall be pressurized with air or 
nitrogen at a pressure of Pa.
    (b) Valves, which are sealed with fluid from a seal system shall be 
pressurized with that fluid to a pressure not less than 1.10 Pa.
    3. Acceptance criterion. The combined leakage rate for all 
penetrations and valves subject to Type B and C tests shall be less than 
0.60 La. Leakage from containment isolation valves that are sealed with 
fluid from a seal system may be excluded when determining the combined 
leakage rate: Provided, That;
    (a) Such valves have been demonstrated to have fluid leakage rates 
that do not exceed those specified in the technical specifications or 
associated bases, and
    (b) The installed isolation valve seal-water system fluid inventory 
is sufficient to assure the sealing function for at least 30 days at a 
pressure of 1.10 Pa.
    D. Periodic retest schedule--1. Type A test. (a) After the 
preoperational leakage rate tests, a set of three Type A tests shall be 
performed, at approximately equal intervals during each 10-year service 
period. The third test of each set shall be conducted when the plant is 
shutdown for the 10-year plant inservice inspections. \2\
---------------------------------------------------------------------------

    \2\ Such inservice inspections are required by Sec.50.55a.
---------------------------------------------------------------------------

    (b) Permissible periods for testing. The performance of Type A tests 
shall be limited to periods when the plant facility is non-operational 
and secured in the shutdown condition under the administrative control 
and in accordance with the safety procedures defined in the license.
    2. Type B tests. (a) Type B tests, except tests for air locks, shall 
be performed during reactor shutdown for refueling, or other convenient 
intervals, but in no case at intervals greater than 2 years. If opened 
following a Type A or B test, containment penetrations subject to Type B 
testing shall be Type B tested prior to returning the reactor to an 
operating mode requiring containment integrity. For primary reactor 
containment penetrations employing a continuous leakage monitoring 
system, Type B tests, except for tests of air locks, may, 
notwithstanding the test schedule specified under III.D.1., be performed 
every other reactor shutdown for refueling but in no case at intervals 
greater than 3 years.
    (b)(i) Air locks shall be tested prior to initial fuel loading and 
at 6-month intervals thereafter at an internal pressure not less than 
Pa.
    (ii) Air locks opened during periods when containment integrity is 
not required by the plant's Technical Specifications shall be

[[Page 1053]]

tested at the end of such periods at not less than Pa.
    (iii) Air locks opened during periods when containment integrity is 
required by the plant's Technical Specifications shall be tested within 
3 days after being opened. For air lock doors opened more frequently 
than once every 3 days, the air lock shall be tested at least once every 
3 days during the period of frequent openings. For air lock doors having 
testable seals, testing the seals fulfills the 3-day test requirements. 
In the event that the testing for this 3-day interval cannot be at 
Pa, the test pressure shall be as stated in the Technical 
Specifications. Air lock door seal testing shall not be substituted for 
the 6-month test of the entire air lock at not less than Pa.
    (iv) The acceptance criteria for air lock testing shall be stated in 
the Technical Specifications.
    3. Type C tests. Type C tests shall be performed during each reactor 
shutdown for refueling but in no case at intervals greater than 2 years.

                    IV. Special Testing Requirements

    A. Containment modification. Any major modification, replacement of 
a component which is part of the primary reactor containment boundary, 
or resealing a seal-welded door, performed after the preoperational 
leakage rate test shall be followed by either a Type A, Type B, or Type 
C test, as applicable for the area affected by the modification. The 
measured leakage from this test shall be included in the summary report 
required by V.B. The acceptance criteria of III.A.5.(b), III.B.3., or 
III.C.3., as appropriate, shall be met. Minor modifications, 
replacements, or resealing of seal-welded doors, performed directly 
prior to the conduct of a scheduled Type A test do not require a 
separate test.
    B. Multiple leakage barrier or subatmospheric containments. The 
primary reactor containment barrier of a multiple barrier or 
subatmospheric containment shall be subjected to Type A tests to verify 
that its leakage rate meets the requirements of this appendix. Other 
structures of multiple barrier or subatmospheric containments (e.g., 
secondary containments for boiling water reactors and shield buildings 
for pressurized water reactors that enclose the entire primary reactor 
containment or portions thereof) shall be subject to individual tests in 
accordance with the procedures specified in the technical 
specifications, or associated bases.

                  V. Inspection and Reporting of Tests

    A. Containment inspection. A general inspection of the accessible 
interior and exterior surfaces of the containment structures and 
components shall be performed prior to any Type A test to uncover any 
evidence of structural deterioration which may affect either the 
containment structural integrity or leak-tightness. If there is evidence 
of structural deterioration, Type A tests shall not be performed until 
corrective action is taken in accordance with repair procedures, non 
destructive examinations, and tests as specified in the applicable code 
specified in Sec.50.55a at the commencement of repair work. Such 
structural deterioration and corrective actions taken shall be included 
in the summary report required by V.B.
    B. Recordkeeping of test results. 1. The preoperational and periodic 
tests must be documented in a readily available summary report that will 
be made available for inspection, upon request, at the nuclear power 
plant. The summary report shall include a schematic arrangement of the 
leakage rate measurement system, the instrumentation used, the 
supplemental test method, and the test program selected as applicable to 
the preoperational test, and all the subsequent periodic tests. The 
report shall contain an analysis and interpretation of the leakage rate 
test data for the Type A test results to the extent necessary to 
demonstrate the acceptability of the containment's leakage rate in 
meeting acceptance criteria.
    2. For each periodic test, leakage test results from Type A, B, and 
C tests shall be included in the summary report. The summary report 
shall contain an analysis and interpretation of the Type A test results 
and a summary analysis of periodic Type B and Type C tests that were 
performed since the last type A test. Leakage test results from type A, 
B, and C tests that failed to meet the acceptance criteria of 
III.A.5(b), III.B.3, and III.C.3, respectively, shall be included in a 
separate accompanying summary report that includes an analysis and 
interpretation of the test data, the least squares fit analysis of the 
test data, the instrumentation error analysis, and the structural 
conditions of the containment or components, if any, which contributed 
to the failure in meeting the acceptance criteria. Results and analyses 
of the supplemental verification test employed to demonstrate the 
validity of the leakage rate test measurements shall also be included.

                Option B--Performance-Based Requirements

                            Table of Contents

I. Introduction.
II. Definitions.
III. Performance-based leakage-test requirements.
    A. Type A test.
    B. Type B and C tests.
IV. Recordkeeping.
V. Application.

[[Page 1054]]

                             I. Introduction

    One of the conditions required of all operating licenses and 
combined licenses for light-water-cooled power reactors as specified in 
Sec.50.54(o) is that primary reactor containments meet the leakage-
rate test requirements in either Option A or B of this appendix. These 
test requirements ensure that (a) leakage through these containments or 
systems and components penetrating these containments does not exceed 
allowable leakage rates specified in the technical specifications; and 
(b) integrity of the containment structure is maintained during its 
service life. Option B of this appendix identifies the performance-based 
requirements and criteria for preoperational and subsequent periodic 
leakage-rate testing. \3\
---------------------------------------------------------------------------

    \3\ Specific guidance concerning a performance-based leakage-test 
program, acceptable leakage-rate test methods, procedures, and analyses 
that may be used to implement these requirements and criteria are 
provided in Regulatory Guide 1.163, ``Performance-Based Containment 
Leak-Test Program.''
---------------------------------------------------------------------------

                             II. Definitions

    Performance criteria means the performance standards against which 
test results are to be compared for establishing the acceptability of 
the containment system as a leakage-limiting boundary.
    Containment system means the principal barrier, after the reactor 
coolant pressure boundary, to prevent the release of quantities of 
radioactive material that would have a significant radiological effect 
on the health of the public.
    Overall integrated leakage rate means the total leakage rate through 
all tested leakage paths, including containment welds, valves, fittings, 
and components that penetrate the containment system.
    La (percent/24 hours) means the maximum allowable leakage rate at 
pressure Pa as specified in the Technical Specifications.
    Pa (p.s.i.g) means the calculated peak containment internal pressure 
related to the design basis loss-of-coolant accident as specified in the 
Technical Specifications.

            III. Performance-Based Leakage-Test Requirements

                             A. Type A Test

    Type A tests to measure the containment system overall integrated 
leakage rate must be conducted under conditions representing design 
basis loss-of-coolant accident containment peak pressure. A Type A test 
must be conducted (1) after the containment system has been completed 
and is ready for operation and (2) at a periodic interval based on the 
historical performance of the overall containment system as a barrier to 
fission product releases to reduce the risk from reactor accidents. A 
general visual inspection of the accessible interior and exterior 
surfaces of the containment system for structural deterioration which 
may affect the containment leak-tight integrity must be conducted prior 
to each test, and at a periodic interval between tests based on the 
performance of the containment system. The leakage rate must not exceed 
the allowable leakage rate (La) with margin, as specified in the 
Technical Specifications. The test results must be compared with 
previous results to examine the performance history of the overall 
containment system to limit leakage.

                          B. Type B and C Tests

    Type B pneumatic tests to detect and measure local leakage rates 
across pressure retaining, leakage-limiting boundaries, and Type C 
pneumatic tests to measure containment isolation valve leakage rates, 
must be conducted (1) prior to initial criticality, and (2) periodically 
thereafter at intervals based on the safety significance and historical 
performance of each boundary and isolation valve to ensure the integrity 
of the overall containment system as a barrier to fission product 
release to reduce the risk from reactor accidents. The performance-based 
testing program must contain a performance criterion for Type B and C 
tests, consideration of leakage-rate limits and factors that are 
indicative of or affect performance, when establishing test intervals, 
evaluations of performance of containment system components, and 
comparison to previous test results to examine the performance history 
of the overall containment system to limit leakage. The tests must 
demonstrate that the sum of the leakage rates at accident pressure of 
Type B tests, and pathway leakage rates from Type C tests, is less than 
the performance criterion (La) with margin, as specified in the 
Technical Specification.

                            IV. Recordkeeping

    The results of the preoperational and periodic Type A, B, and C 
tests must be documented to show that performance criteria for leakage 
have been met. The comparison to previous results of the performance of 
the overall containment system and of individual components within it 
must be documented to show that the test intervals established for the 
containment system and components within it are adequate. These records 
must be available for inspection at plant sites.
    If the test results exceed the performance criteria (La) as defined 
in the plant Technical Specifications, those exceedances must be 
assessed for Emergency Notification System reporting under Sec. Sec.
50.72 (b)(1)(ii) and

[[Page 1055]]

Sec.50.72 (b)(2)(i), and for a Licensee Event Report under Sec.50.73 
(a)(2)(ii).

                             V. Application

                            A. Applicability

    The requirements in either or both Option B, III.A for Type A tests, 
and Option B, III.B for Type B and C tests, may be adopted on a 
voluntary basis by an operating nuclear power reactor licensee as 
specified in Sec.50.54 in substitution of the requirements for those 
tests contained in Option A of this appendix. If the requirements for 
tests in Option B, III.A or Option B, III.B are implemented, the 
recordkeeping requirements in Option B, IV for these tests must be 
substituted for the reporting requirements of these tests contained in 
Option A of this appendix.

                            B. Implementation

    1. Specific exemptions to Option A of this appendix that have been 
formally approved by the AEC or NRC, according to 10 CFR 50.12, are 
still applicable to Option B of this appendix if necessary, unless 
specifically revoked by the NRC.
    2. A licensee or applicant for an operating license under this part 
or a combined license under part 52 of this chapter may adopt Option B, 
or parts thereof, as specified in Section V.A of this appendix, by 
submitting its implementation plan and request for revision to technical 
specifications (see paragraph B.3 of this section) to the Director, 
Office of Nuclear Reactor Regulation or Director, Office of New 
Reactors, as appropriate.
    3. The regulatory guide or other implementation document used by a 
licensee or applicant for an operating license under this part or a 
combined license under part 52 of this chapter to develop a performance-
based leakage-testing program must be included, by general reference, in 
the plant technical specifications. The submittal for technical 
specification revisions must contain justification, including supporting 
analyses, if the licensee chooses to deviate from methods approved by 
the Commission and endorsed in a regulatory guide.
    4. The detailed licensee programs for conducting testing under 
Option B must be available at the plant site for NRC inspection.

[38 FR 4386, Feb. 14, 1973; 38 FR 5997, Mar. 6, 1973, as amended at 41 
FR 16447, Apr. 19, 1976; 45 FR 62789, Sept. 22, 1980; 51 FR 40311, Nov. 
6, 1986; 53 FR 45891, Nov. 15, 1988; 57 FR 61786, Dec. 29, 1992; 59 FR 
50689, Oct. 5, 1994; 60 FR 13616, Mar. 14, 1995; 60 FR 49504, Sept. 26, 
1995; 72 FR 49508, Aug. 28, 2007; 73 FR 5723, Jan. 31, 2008]



           Sec. Appendix K to Part 50--ECCS Evaluation Models

    I. Required and Acceptable Features of Evaluation Models.
    II. Required Documentation.

      I. Required and Acceptable Features of the Evaluation Models

    A. Sources of heat during the LOCA. For the heat sources listed in 
paragraphs I.A.1 to 4 of this appendix it must be assumed that the 
reactor has been operating continuously at a power level at least 1.02 
times the licensed power level (to allow for instrumentation error), 
with the maximum peaking factor allowed by the technical specifications. 
An assumed power level lower than the level specified in this paragraph 
(but not less than the licensed power level) may be used provided the 
proposed alternative value has been demonstrated to account for 
uncertainties due to power level instrumentation error. A range of power 
distribution shapes and peaking factors representing power distributions 
that may occur over the core lifetime must be studied. The selected 
combination of power distribution shape and peaking factor should be the 
one that results in the most severe calculated consequences for the 
spectrum of postulated breaks and single failures that are analyzed.
    1. The Initial Stored Energy in the Fuel. The steady-state 
temperature distribution and stored energy in the fuel before the 
hypothetical accident shall be calculated for the burn-up that yields 
the highest calculated cladding temperature (or, optionally, the highest 
calculated stored energy.) To accomplish this, the thermal conductivity 
of the UO2 shall be evaluated as a function of burn-up and 
temperature, taking into consideration differences in initial density, 
and the thermal conductance of the gap between the UO2 and 
the cladding shall be evaluated as a function of the burn-up, taking 
into consideration fuel densification and expansion, the composition and 
pressure of the gases within the fuel rod, the initial cold gap 
dimension with its tolerances, and cladding creep.
    2. Fission Heat. Fission heat shall be calculated using reactivity 
and reactor kinetics. Shutdown reactivities resulting from temperatures 
and voids shall be given their minimum plausible values, including 
allowance for uncertainties, for the range of power distribution shapes 
and peaking factors indicated to be studied above. Rod trip and 
insertion may be assumed if they are calculated to occur.
    3. Decay of Actinides. The heat from the radioactive decay of 
actinides, including neptunium and plutonium generated during operation, 
as well as isotopes of uranium, shall be calculated in accordance with 
fuel cycle calculations and known radioactive properties. The actinide 
decay heat chosen shall

[[Page 1056]]

be that appropriate for the time in the fuel cycle that yields the 
highest calculated fuel temperature during the LOCA.
    4. Fission Product Decay. The heat generation rates from radioactive 
decay of fission products shall be assumed to be equal to 1.2 times the 
values for infinite operating time in the ANS Standard (Proposed 
American Nuclear Society Standards--``Decay Energy Release Rates 
Following Shutdown of Uranium-Fueled Thermal Reactors.'' Approved by 
Subcommittee ANS-5, ANS Standards Committee, October 1971). This 
standard has been approved for incorporation by reference by the 
Director of the Federal Register. A copy of the standard is available 
for inspection at the NRC Library, 11545 Rockville Pike, Rockville, 
Maryland 20852-2738. The fraction of the locally generated gamma energy 
that is deposited in the fuel (including the cladding) may be different 
from 1.0; the value used shall be justified by a suitable calculation.
    5. Metal--Water Reaction Rate. The rate of energy release, hydrogen 
generation, and cladding oxidation from the metal/water reaction shall 
be calculated using the Baker-Just equation (Baker, L., Just, L.C., 
``Studies of Metal Water Reactions at High Temperatures, III. 
Experimental and Theoretical Studies of the Zirconium-Water Reaction,'' 
ANL-6548, page 7, May 1962). This publication has been approved for 
incorporation by reference by the Director of the Federal Register. A 
copy of the publication is available for inspection at the NRC Library, 
11545 Rockville Pike, Two White Flint North, Rockville, Maryland 20852-
2738. The reaction shall be assumed not to be steam limited. For rods 
whose cladding is calculated to rupture during the LOCA, the inside of 
the cladding shall be assumed to react after the rupture. The 
calculation of the reaction rate on the inside of the cladding shall 
also follow the Baker-Just equation, starting at the time when the 
cladding is calculated to rupture, and extending around the cladding 
inner circumference and axially no less that 1.5 inches each way from 
the location of the rupture, with the reaction assumed not to be steam 
limited.
    6. Reactor Internals Heat Transfer. Heat transfer from piping, 
vessel walls, and non-fuel internal hardware shall be taken into 
account.
    7. Pressurized Water Reactor Primary-to-Secondary Heat Transfer. 
Heat transferred between primary and secondary systems through heat 
exchangers (steam generators) shall be taken into account. (Not 
applicable to Boiling Water Reactors.)

 B. Swelling and Rupture of the Cladding and Fuel Rod Thermal Parameters

    Each evaluation model shall include a provision for predicting 
cladding swelling and rupture from consideration of the axial 
temperature distribution of the cladding and from the difference in 
pressure between the inside and outside of the cladding, both as 
functions of time. To be acceptable the swelling and rupture 
calculations shall be based on applicable data in such a way that the 
degree of swelling and incidence of rupture are not underestimated. The 
degree of swelling and rupture shall be taken into account in 
calculations of gap conductance, cladding oxidation and embrittlement, 
and hydrogen generation.
    The calculations of fuel and cladding temperatures as a function of 
time shall use values for gap conductance and other thermal parameters 
as functions of temperature and other applicable time-dependent 
variables. The gap conductance shall be varied in accordance with 
changes in gap dimensions and any other applicable variables.

                          C. Blowdown Phenomena

    1. Break Characteristics and Flow. a. In analyses of hypothetical 
loss-of-coolant accidents, a spectrum of possible pipe breaks shall be 
considered. This spectrum shall include instantaneous double-ended 
breaks ranging in cross-sectional area up to and including that of the 
largest pipe in the primary coolant system. The analysis shall also 
include the effects of longitudinal splits in the largest pipes, with 
the split area equal to the cross-sectional area of the pipe.
    b. Discharge Model. For all times after the discharging fluid has 
been calculated to be two-phase in composition, the discharge rate shall 
be calculated by use of the Moody model (F.J. Moody, ``Maximum Flow Rate 
of a Single Component, Two-Phase Mixture,'' Journal of Heat Transfer, 
Trans American Society of Mechanical Engineers, 87, No. 1, February, 
1965). This publication has been approved for incorporation by reference 
by the Director of the Federal Register. A copy of this publication is 
available for inspection at the NRC Library, 11545 Rockville Pike, 
Rockville, Maryland 20852-2738. The calculation shall be conducted with 
at least three values of a discharge coefficient applied to the 
postulated break area, these values spanning the range from 0.6 to 1.0. 
If the results indicate that the maximum clad temperature for the 
hypothetical accident is to be found at an even lower value of the 
discharge coefficient, the range of discharge coefficients shall be 
extended until the maximum clad temperatures calculated by this 
variation has been achieved.
    c. End of Blowdown. (Applies Only to Pressurized Water Reactors.) 
For postulated cold leg breaks, all emergency cooling water injected 
into the inlet lines or the reactor vessel during the bypass period 
shall in the calculations be subtracted from the reactor vessel 
calculated inventory. This may be executed in the calculation during the 
bypass period, or as an alternative the amount of

[[Page 1057]]

emergency core cooling water calculated to be injected during the bypass 
period may be subtracted later in the calculation from the water 
remaining in the inlet lines, downcomer, and reactor vessel lower plenum 
after the bypass period. This bypassing shall end in the calculation at 
a time designated as the ``end of bypass,'' after which the expulsion or 
entrainment mechanisms responsible for the bypassing are calculated not 
to be effective. The end-of-bypass definition used in the calculation 
shall be justified by a suitable combination of analysis and 
experimental data. Acceptable methods for defining ``end of bypass'' 
include, but are not limited to, the following: (1) Prediction of the 
blowdown calculation of downward flow in the downcomer for the remainder 
of the blowdown period; (2) Prediction of a threshold for droplet 
entrainment in the upward velocity, using local fluid conditions and a 
conservative critical Weber number.
    d. Noding Near the Break and the ECCS Injection Points. The noding 
in the vicinity of and including the broken or split sections of pipe 
and the points of ECCS injection shall be chosen to permit a reliable 
analysis of the thermodynamic history in these regions during blowdown.
    2. Frictional Pressure Drops. The frictional losses in pipes and 
other components including the reactor core shall be calculated using 
models that include realistic variation of friction factor with Reynolds 
number, and realistic two-phase friction multipliers that have been 
adequately verified by comparison with experimental data, or models that 
prove at least equally conservative with respect to maximum clad 
temperature calculated during the hypothetical accident. The modified 
Baroczy correlation (Baroczy, C. J., ``A Systematic Correlation for Two-
Phase Pressure Drop,'' Chem. Enging. Prog. Symp. Series, No. 64, Vol. 
62, 1965) or a combination of the Thom correlation (Thom, J.R.S., 
``Prediction of Pressure Drop During Forced Circulation Boiling of 
Water,'' Int. J. of Heat & Mass Transfer, 7, 709-724, 1964) for 
pressures equal to or greater than 250 psia and the Martinelli-Nelson 
correlation (Martinelli, R. C. Nelson, D.B., ``Prediction of Pressure 
Drop During Forced Circulation Boiling of Water,'' Transactions of ASME, 
695-702, 1948) for pressures lower than 250 psia is acceptable as a 
basis for calculating realistic two-phase friction multipliers.
    3. Momentum Equation. The following effects shall be taken into 
account in the conservation of momentum equation: (1) temporal change of 
momentum, (2) momentum convection, (3) area change momentum flux, (4) 
momentum change due to compressibility, (5) pressure loss resulting from 
wall friction, (6) pressure loss resulting from area change, and (7) 
gravitational acceleration. Any omission of one or more of these terms 
under stated circumstances shall be justified by comparative analyses or 
by experimental data.
    4. Critical Heat Flux. a. Correlations developed from appropriate 
steady-state and transient-state experimental data are acceptable for 
use in predicting the critical heat flux (CHF) during LOCA transients. 
The computer programs in which these correlations are used shall contain 
suitable checks to assure that the physical parameters are within the 
range of parameters specified for use of the correlations by their 
respective authors.
    b. Steady-state CHF correlations acceptable for use in LOCA 
transients include, but are not limited to, the following:
    (1) W 3. L. S. Tong, ``Prediction of Departure from Nucleate Boiling 
for an Axially Non-uniform Heat Flux Distribution,'' Journal of Nuclear 
Energy, Vol. 21, 241-248, 1967.
    (2) B&W-2. J. S. Gellerstedt, R. A. Lee, W. J. Oberjohn, R. H. 
Wilson, L. J. Stanek, ``Correlation of Critical Heat Flux in a Bundle 
Cooled by Pressurized Water,'' Two-Phase Flow and Heat Transfer in Rod 
Bundles, ASME, New York, 1969.
    (3) Hench-Levy. J. M. Healzer, J. E. Hench, E. Janssen, S. Levy, 
``Design Basis for Critical Heat Flux Condition in Boiling Water 
Reactors,'' APED-5186, GE Company Private report, July 1966.
    (4) Macbeth. R. V. Macbeth, ``An Appraisal of Forced Convection 
Burnout Data,'' Proceedings of the Institute of Mechanical Engineers, 
1965-1966.
    (5) Barnett. P. G. Barnett, ``A Correlation of Burnout Data for 
Uniformly Heated Annuli and Its Uses for Predicting Burnout in Uniformly 
Heated Rod Bundles,'' AEEW-R 463, 1966.
    (6) Hughes. E. D. Hughes, ``A Correlation of Rod Bundle Critical 
Heat Flux for Water in the Pressure Range 150 to 725 psia,'' IN-1412, 
Idaho Nuclear Corporation, July 1970.
    c. Correlations of appropriate transient CHF data may be accepted 
for use in LOCA transient analyses if comparisons between the data and 
the correlations are provided to demonstrate that the correlations 
predict values of CHF which allow for uncertainty in the experimental 
data throughout the range of parameters for which the correlations are 
to be used. Where appropriate, the comparisons shall use statistical 
uncertainty analysis of the data to demonstrate the conservatism of the 
transient correlation.
    d. Transient CHF correlations acceptable for use in LOCA transients 
include, but are not limited to, the following:
    (1) GE transient CHF. B. C. Slifer, J. E. Hench, ``Loss-of-Coolant 
Accident and Emergency Core Cooling Models for General Electric Boiling 
Water Reactors,'' NEDO-10329, General Electric Company, Equation C-32, 
April 1971.
    e. After CHF is first predicted at an axial fuel rod location during 
blowdown, the calculation shall not use nucleate boiling heat

[[Page 1058]]

transfer correlations at that location subsequently during the blowdown 
even if the calculated local fluid and surface conditions would 
apparently justify the reestablishment of nucleate boiling. Heat 
transfer assumptions characteristic of return to nucleate boiling 
(rewetting) shall be permitted when justified by the calculated local 
fluid and surface conditions during the reflood portion of a LOCA.
    5. Post-CHF Heat Transfer Correlations. a. Correlations of heat 
transfer from the fuel cladding to the surrounding fluid in the post-CHF 
regimes of transition and film boiling shall be compared to applicable 
steady-state and transient-state data using statistical correlation and 
uncertainty analyses. Such comparison shall demonstrate that the 
correlations predict values of heat transfer co-efficient equal to or 
less than the mean value of the applicable experimental heat transfer 
data throughout the range of parameters for which the correlations are 
to be used. The comparisons shall quantify the relation of the 
correlations to the statistical uncertainty of the applicable data.
    b. The Groeneveld flow film boiling correlation (equation 5.7 of 
D.C. Groeneveld, ``An Investigation of Heat Transfer in the Liquid 
Deficient Regime,'' AECL-3281, revised December 1969) and the 
Westinghouse correlation of steady-state transition boiling 
(``Proprietary Redirect/Rebuttal Testimony of Westinghouse Electric 
Corporation,'' USNRC Docket RM-50-1, page 25-1, October 26, 1972) are 
acceptable for use in the post-CHF boiling regimes. In addition, the 
transition boiling correlation of McDonough, Milich, and King (J.B. 
McDonough, W. Milich, E.C. King, ``An Experimental Study of Partial Film 
Boiling Region with Water at Elevated Pressures in a Round Vertical 
Tube,'' Chemical Engineering Progress Symposium Series, Vol. 57, No. 32, 
pages 197-208, (1961) is suitable for use between nucleate and film 
boiling. Use of all these correlations is restricted as follows:
    (1) The Groeneveld correlation shall not be used in the region near 
its low-pressure singularity,
    (2) The first term (nucleate) of the Westinghouse correlation and 
the entire McDonough, Milich, and King correlation shall not be used 
during the blowdown after the temperature difference between the clad 
and the saturated fluid first exceeds 300 [deg]F,
    (3) Transition boiling heat transfer shall not be reapplied for the 
remainder of the LOCA blowdown, even if the clad superheat returns below 
300 [deg]F, except for the reflood portion of the LOCA when justified by 
the calculated local fluid and surface conditions.
    c. Evaluation models approved after October 17, 1988, which make use 
of the Dougall-Rohsenow flow film boiling correlation (R.S. Dougall and 
W.M. Rohsenow, ``Film Boiling on the Inside of Vertical Tubes with 
Upward Flow of Fluid at Low Qualities,'' MIT Report Number 9079 26, 
Cambridge, Massachusetts, September 1963) may not use this correlation 
under conditions where nonconservative predictions of heat transfer 
result. Evaluation models that make use of the Dougall-Rohsenow 
correlation and were approved prior to October 17, 1988, continue to be 
acceptable until a change is made to, or an error is corrected in, the 
evaluation model that results in a significant reduction in the overall 
conservatism in the evaluation model. At that time continued use of the 
Dougall-Rohsenow correlation under conditions where nonconservative 
predictions of heat transfer result will no longer be acceptable. For 
this purpose, a significant reduction in the overall conservatism in the 
evaluation model would be a reduction in the calculated peak fuel 
cladding temperature of at least 50 [deg]F from that which would have 
been calculated on October 17, 1988, due either to individual changes or 
error corrections or the net effect of an accumulation of changes or 
error corrections.
    6. Pump Modeling. The characteristics of rotating primary system 
pumps (axial flow, turbine, or centrifugal) shall be derived from a 
dynamic model that includes momentum transfer between the fluid and the 
rotating member, with variable pump speed as a function of time. The 
pump model resistance used for analysis should be justified. The pump 
model for the two-phase region shall be verified by applicable two-phase 
pump performance data. For BWR's after saturation is calculated at the 
pump suction, the pump head may be assumed to vary linearly with 
quality, going to zero for one percent quality at the pump suction, so 
long as the analysis shows that core flow stops before the quality at 
pump suction reaches one percent.
    7. Core Flow Distribution During Blowdown. (Applies only to 
pressurized water reactors.)
    a. The flow rate through the hot region of the core during blowdown 
shall be calculated as a function of time. For the purpose of these 
calculations the hot region chosen shall not be greater than the size of 
one fuel assembly. Calculations of average flow and flow in the hot 
region shall take into account cross flow between regions and any flow 
blockage calculated to occur during blowdown as a result of cladding 
swelling or rupture. The calculated flow shall be smoothed to eliminate 
any calculated rapid oscillations (period less than 0.1 seconds).
    b. A method shall be specified for determining the enthalpy to be 
used as input data to the hot channel heatup analysis from quantities 
calculated in the blowdown analysis, consistent with the flow 
distribution calculations.

[[Page 1059]]

          D. Post-Blowdown Phenomena; Heat Removal by the ECCS

    1. Single Failure Criterion. An analysis of possible failure modes 
of ECCS equipment and of their effects on ECCS performance must be made. 
In carrying out the accident evaluation the combination of ECCS 
subsystems assumed to be operative shall be those available after the 
most damaging single failure of ECCS equipment has taken place.
    2. Containment Pressure. The containment pressure used for 
evaluating cooling effectiveness during reflood and spray cooling shall 
not exceed a pressure calculated conservatively for this purpose. The 
calculation shall include the effects of operation of all installed 
pressure-reducing systems and processes.
    3. Calculation of Reflood Rate for Pressurized Water Reactors. The 
refilling of the reactor vessel and the time and rate of reflooding of 
the core shall be calculated by an acceptable model that takes into 
consideration the thermal and hydraulic characteristics of the core and 
of the reactor system. The primary system coolant pumps shall be assumed 
to have locked impellers if this assumption leads to the maximum 
calculated cladding temperature; otherwise the pump rotor shall be 
assumed to be running free. The ratio of the total fluid flow at the 
core exit plane to the total liquid flow at the core inlet plane 
(carryover fraction) shall be used to determine the core exit flow and 
shall be determined in accordance with applicable experimental data (for 
example, ``PWR FLECHT (Full Length Emergency Cooling Heat Transfer) 
Final Report,'' Westinghouse Report WCAP-7665, April 1971; ``PWR Full 
Length Emergency Cooling Heat Transfer (FLECHT) Group I Test Report,'' 
Westinghouse Report WCAP-7435, January 1970; ``PWR FLECHT (Full Length 
Emergency Cooling Heat Transfer) Group II Test Report,'' Westinghouse 
Report WCAP-7544, September 1970; ``PWR FLECHT Final Report 
Supplement,'' Westinghouse Report WCAP-7931, October 1972).
    The effects on reflooding rate of the compressed gas in the 
accumulator which is discharged following accumulator water discharge 
shall also be taken into account.
    4. Steam Interaction with Emergency Core Cooling Water in 
Pressurized Water Reactors. The thermal-hydraulic interaction between 
steam and all emergency core cooling water shall be taken into account 
in calculating the core reflooding rate. During refill and reflood, the 
calculated steam flow in unbroken reactor coolant pipes shall be taken 
to be zero during the time that accumulators are discharging water into 
those pipes unless experimental evidence is available regarding the 
realistic thermal-hydraulic interaction between the steam and the 
liquid. In this case, the experimental data may be used to support an 
alternate assumption.
    5. Refill and Reflood Heat Transfer for Pressurized Water Reactors. 
a. For reflood rates of one inch per second or higher, reflood heat 
transfer coefficients shall be based on applicable experimental data for 
unblocked cores including FLECHT results (``PWR FLECHT (Full Length 
Emergency Cooling Heat Transfer) Final Report,'' Westinghouse Report 
WCAP-7665, April 1971). The use of a correlation derived from FLECHT 
data shall be demonstrated to be conservative for the transient to which 
it is applied; presently available FLECHT heat transfer correlations 
(``PWR Full Length Emergency Cooling Heat Transfer (FLECHT) Group I Test 
Report,'' Westinghouse Report WCAP-7544, September 1970; ``PWR FLECHT 
Final Report Supplement,'' Westinghouse Report WCAP-7931, October 1972) 
are not acceptable. Westinghouse Report WCAP-7665 has been approved for 
incorporation by reference by the Director of the Federal Register. A 
copy of this report is available for inspection at the NRC Library, 
11545 Rockville Pike, Rockville, Maryland 20852-2738. New correlations 
or modifications to the FLECHT heat transfer correlations are acceptable 
only after they are demonstrated to be conservative, by comparison with 
FLECHT data, for a range of parameters consistent with the transient to 
which they are applied.
    b. During refill and during reflood when reflood rates are less than 
one inch per second, heat transfer calculations shall be based on the 
assumption that cooling is only by steam, and shall take into account 
any flow blockage calculated to occur as a result of cladding swelling 
or rupture as such blockage might affect both local steam flow and heat 
transfer.
    6. Convective Heat Transfer Coefficients for Boiling Water Reactor 
Fuel Rods Under Spray Cooling. Following the blowdown period, convective 
heat transfer shall be calculated using coefficients based on 
appropriate experimental data. For reactors with jet pumps and having 
fuel rods in a 7 x 7 fuel assembly array, the following convective 
coefficients are acceptable:
    a. During the period following lower plenum flashing but prior to 
the core spray reaching rated flow, a convective heat transfer 
coefficient of zero shall be applied to all fuel rods.
    b. During the period after core spray reaches rated flow but prior 
to reflooding, convective heat transfer coefficients of 3.0, 3.5, 1.5, 
and 1.5 Btu-hr -1-ft -2 [deg]F -1 shall 
be applied to the fuel rods in the outer corners, outer row, next to 
outer row, and to those remaining in the interior, respectively, of the 
assembly.
    c. After the two-phase reflooding fluid reaches the level under 
consideration, a convective heat transfer coefficient of 25 Btu-

[[Page 1060]]

hr -1-ft -2 [deg]F -1 shall be applied 
to all fuel rods.
    7. The Boiling Water Reactor Channel Box Under Spray Cooling. 
Following the blowdown period, heat transfer from, and wetting of, the 
channel box shall be based on appropriate experimental data. For 
reactors with jet pumps and fuel rods in a 7 x 7 fuel assembly array, 
the following heat transfer coefficients and wetting time correlation 
are acceptable.
    a. During the period after lower plenum flashing, but prior to core 
spray reaching rated flow, a convective coefficient of zero shall be 
applied to the fuel assembly channel box.
    b. During the period after core spray reaches rated flow, but prior 
to wetting of the channel, a convective heat transfer coefficient of 5 
Btu-hr -1-ft -2- [deg]F -1 shall be 
applied to both sides of the channel box.
    c. Wetting of the channel box shall be assumed to occur 60 seconds 
after the time determined using the correlation based on the Yamanouchi 
analysis (``Loss-of-Coolant Accident and Emergency Core Cooling Models 
for General Electric Boiling Water Reactors,'' General Electric Company 
Report NEDO-10329, April 1971). This report was approved for 
incorporation by reference by the Director of the Federal Register. A 
copy of the report is available for inspection at the NRC Library, 11545 
Rockville Pike, Rockville, Maryland 20852-2738.

                       II. Required Documentation

    1. a. A description of each evaluation model shall be furnished. The 
description shall be sufficiently complete to permit technical review of 
the analytical approach including the equations used, their 
approximations in difference form, the assumptions made, and the values 
of all parameters or the procedure for their selection, as for example, 
in accordance with a specified physical law or empirical correlation.
    b. A complete listing of each computer program, in the same form as 
used in the evaluation model, must be furnished to the Nuclear 
Regulatory Commission upon request.
    2. For each computer program, solution convergence shall be 
demonstrated by studies of system modeling or noding and calculational 
time steps.
    3. Appropriate sensitivity studies shall be performed for each 
evaluation model, to evaluate the effect on the calculated results of 
variations in noding, phenomena assumed in the calculation to 
predominate, including pump operation or locking, and values of 
parameters over their applicable ranges. For items to which results are 
shown to be sensitive, the choices made shall be justified.
    4. To the extent practicable, predictions of the evaluation model, 
or portions thereof, shall be compared with applicable experimental 
information.
    5. General Standards for Acceptability--Elements of evaluation 
models reviewed will include technical adequacy of the calculational 
methods, including: For models covered by Sec.50.46(a)(1)(ii), 
compliance with required features of section I of this appendix K; and, 
for models covered by Sec.50.46(a)(1)(i), assurance of a high level of 
probability that the performance criteria of Sec.50.46(b) would not be 
exceeded.

[39 FR 1003, Jan. 4, 1974, as amended at 51 FR 40311, Nov. 6, 1986; 53 
FR 36005, Sept. 16, 1988; 57 FR 61786, Dec. 29, 1992; 59 FR 50689, Oct. 
5, 1994; 60 FR 24552, May 9, 1995; 65 FR 34921, June 1, 2000]



                Sec. Appendixes L-M to Part 50 [Reserved]



   Sec. Appendix N to Part 50--Standardization of Nuclear Power Plant 
  Designs: Permits To Construct and Licenses To Operate Nuclear Power 
             Reactors of Identical Design at Multiple Sites

    Section 101 of the Atomic Energy Act of 1954, as amended, and Sec.
50.10 of this part require a Commission license to transfer or receive 
in interstate commerce, manufacture, produce, transfer, acquire, 
possess, use, import or export any production or utilization facility. 
The regulations in this part require the issuance of a construction 
permit by the Commission before commencement of construction of a 
production or utilization facility, except as provided in Sec.
50.10(e), and the issuance of an operating license before operation of 
the facility.
    The Commission's regulations in part 2 of this chapter specifically 
provide for the holding of hearings on particular issues separately from 
other issues involved in hearings in licensing proceedings (Sec.
2.761a, appendix A, section I(c)), and for the consolidation of 
adjudicatory proceedings and of the presentations of parties in 
adjudicatory proceedings such as licensing proceedings (Sec. Sec.
2.715a, 2.716).
    This appendix sets out the particular requirements and provisions 
applicable to situations in which applications are filed by one or more 
applicants for licenses to construct and operate nuclear power reactors 
of essentially the same design to be located at different sites. \1\
---------------------------------------------------------------------------

    \1\ If the design for the power reactor(s) proposed in a particular 
application is not identical to the others, that application may not be 
processed under this appendix and subpart D of part 2 of this chapter.
---------------------------------------------------------------------------

    1. Except as otherwise specified in this appendix or as the context 
otherwise indicates,

[[Page 1061]]

the provisions of this part applicable to construction permits and 
operating licenses, including the requirement in Sec.50.58 for review 
of the application by the Advisory Committee on Reactor Safeguards and 
the holding of public hearings, apply to construction permits and 
operating licenses subject to this appendix N.
    2. Applications for construction permits submitted pursuant to this 
appendix must include the information required by Sec. Sec.50.33, 
50.34(a) and 50.34a(a) and (b) and be submitted as specified in Sec.
50.4. The applicant shall also submit the information required by Sec.
51.50 of this chapter.
    3. Applications for operating licenses submitted pursuant to this 
appendix N shall include the information required by Sec. Sec.50.33, 
50.34(b) and (c), and 50.34a(c). The applicant shall also submit the 
information required by Sec.51.53 of this chapter. For the technical 
information required by Sec. Sec.50.34(b)(2) through (5) and 
50.34a(c), reference may be made to a single final safety analysis of 
the design.

[40 FR 2977, Jan. 17, 1975, as amended at 49 FR 9405, Mar. 12, 1984; 51 
FR 40311, Nov. 6, 1986; 70 FR 61888, Oct. 27, 2005]



                Sec. Appendixes O-P to Part 50 [Reserved]



    Sec. Appendix Q to Part 50--Pre-Application Early Review of Site 
                           Suitability Issues

    This appendix sets out procedures for the filing, Staff review, and 
referral to the Advisory Committee on Reactor Safeguards of requests for 
early review of one or more site suitability issues relating to the 
construction and operation of certain utilization facilities separately 
from and prior to the submittal of applications for construction permits 
for the facilities. The appendix also sets out procedures for the 
preparation and issuance of Staff Site Reports and for their 
incorporation by reference in applications for the construction and 
operation of certain utilization facilities. The utilization facilities 
are those which are subject to Sec.51.20(b) of this chapter and are of 
the type specified in Sec.50.21(b) (2) or (3) or Sec.50.22 or are 
testing facilities. This appendix does not apply to proceedings 
conducted pursuant to subpart F of part 2 of this chapter.
    1. Any person may submit information regarding one or more site 
suitability issues to the Commission's Staff for its review separately 
from and prior to an application for a construction permit for a 
facility. Such a submittal shall be accompanied by any fee required by 
part 170 of this chapter and shall consist of the portion of the 
information required of applicants for construction permits by 
Sec. Sec.50.33(a)-(c) and (e), and, insofar as it relates to the 
issue(s) of site suitability for which early review is sought, by 
Sec. Sec.50.34(a)(1) and 50.30(f), except that information with 
respect to operation of the facility at the projected initial power 
level need not be supplied.
    2. The submittal for early review of site suitability issue(s) must 
be made in the same manner and in the same number of copies as provided 
in Sec. Sec.50.4 and 50.30 for license applications. The submittal 
must include sufficient information concerning a range of postulated 
facility design and operation parameters to enable the Staff to perform 
the requested review of site suitability issues. The submittal must 
contain suggested conclusions on the issues of site suitability 
submitted for review and must be accompanied by a statement of the bases 
or the reasons for those conclusions. The submittal must also list, to 
the extent possible, any long-range objectives for ultimate development 
of the site, state whether any site selection process was used in 
preparing the submittal, describe any site selection process used, and 
explain what consideration, if any, was given to alternative sites.
    3. The Staff shall publish a notice of docketing of the submittal in 
the Federal Register, and shall send a copy of the notice of docketing 
to the Governor or other appropriate official of the State in which the 
site is located. This notice shall identify the location of the site, 
briefly describe the site suitability issue(s) under review, and invite 
comments from Federal, State, and local agencies and interested persons 
within 120 days of publication or such other time as may be specified, 
for consideration by the staff in connection with the initiation or 
outcome of the review and, if appropriate by the ACRS, in connection 
with the outcome of their review. The person requesting review shall 
serve a copy of the submittal on the Governor or other appropriate 
official of the State in which the site is located, and on the chief 
executive of the municipality in which the site is located or, if the 
site is not located in a municipality, on the chief executive of the 
county. The portion of the submittal containing information required of 
applicants for construction permits by Sec. Sec.50.33(a)-(c) and (e) 
and 50.34(a)(1) will be referred to the Advisory Committee on Reactor 
Safeguards (ACRS) for a review and report. There will be no referral to 
the ACRS unless early review of the site safety issues under Sec.
50.34(a)(1) is requested.
    4. Upon completion of review by the NRC staff and, if appropriate by 
the ACRS, of a submittal under this appendix, the NRC staff shall 
prepare a Staff Site Report which shall identify the location of the 
site, state the site suitability issues reviewed, explain the nature and 
scope of the review, state the conclusions of the staff regarding the 
issues reviewed and state the reasons for those conclusions. Upon 
issuance of an NRC Staff Site

[[Page 1062]]

Report, the NRC staff shall publish a notice of the availability of the 
report in the Federal Register and shall make the report available at 
the NRC Web site, http://www.nrc.gov. The NRC staff shall also send a 
copy of the report to the Governor or other appropriate official of the 
State in which the site is located, and to the chief executive of the 
municipality in which the site is located or, if the site is not located 
in a municipality, to the chief executive of the county.
    5. Any Staff Site Report prepared and issued in accordance with this 
appendix may be incorporated by reference, as appropriate, in 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 of this chapter or 
is a testing facility. The conclusions of the Staff Site Report will be 
reexamined by the staff where five years or more have elapsed between 
the issuance of the Staff Site Report and its incorporation by reference 
in a construction permit application.
    6. Issuance of a Staff Site Report shall not constitute a commitment 
to issue a permit or license, to permit on-site work under Sec.
50.10(e), or in any way affect the authority of the Commission, Atomic 
Safety and Licensing Appeal Panel, Atomic Safety and Licensing Board, 
and other presiding officers in any proceeding under subpart F and/or G 
of part 2 of this chapter.
    7. The staff will not conduct more than one review of site 
suitability issues with regard to a particular site prior to the full 
construction permit review required by subpart A of part 51 of this 
chapter. The staff may decline to prepare and issue a Staff Site Report 
in response to a submittal under this appendix where it appears that, 
(a) in cases where no review of the relative merits of the submitted 
site and alternative sites under subpart A of part 51 of this chapter is 
requested, there is a reasonable likelihood that further Staff review 
would identify one or more preferable alternative sites and the Staff 
review of one or more site suitability issues would lead to an 
irreversible and irretrievable commitment of resources prior to the 
submittal of the analysis of alternative sites in the Environmental 
Report that would prejudice the later review and decision on alternative 
sites under subpart F and/or G of part 2 and subpart A of part 51 of 
this chapter; or (b) in cases where, in the judgment of the Staff, early 
review of any site suitability issue or issues would not be in the 
public interest, considering (1) the degree of likelihood that any early 
findings on those issues would retain their validity in later reviews, 
(2) the objections, if any, of cognizant state or local government 
agencies to the conduct of an early review on those issues, and (3) the 
possible effect on the public interest of having an early, if not 
necessarily conclusive, resolution of those issues.

[42 FR 22887, May 5, 1977, as amended at 49 FR 9405, Mar. 12, 1984; 51 
FR 40311, Nov. 6, 1986; 53 FR 43420, Oct. 27, 1988; 64 FR 48952, Sept. 
9, 1999]



 Sec. Appendix R to Part 50--Fire Protection Program for Nuclear Power 
              Facilities Operating Prior to January 1, 1979

                        I. Introduction and Scope

    This appendix applies to licensed nuclear power electric generating 
stations that were operating prior to January 1, 1979, except to the 
extent set forth in Sec.50.48(b) of this part. With respect to certain 
generic issues for such facilities it sets forth fire protection 
features required to satisfy Criterion 3 of appendix A to this part.
    Criterion 3 of appendix A to this part specifies that ``Structures, 
systems, and components important to safety shall be designed and 
located to minimize, consistent with other safety requirements, the 
probability and effect of fires and explosions.''
    When considering the effects of fire, those systems associated with 
achieving and maintaining safe shutdown conditions assume major 
importance to safety because damage to them can lead to core damage 
resulting from loss of coolant through boiloff.
    The phrases ``important to safety,'' or ``safety-related,'' will be 
used throughout this appendix R as applying to all safety functions. The 
phrase ``safe shutdown'' will be used throughout this appendix as 
applying to both hot and cold shutdown functions.
    Because fire may affect safe shutdown systems and because the loss 
of function of systems used to mitigate the consequences of design basis 
accidents under postfire conditions does not per se impact public 
safety, the need to limit fire damage to systems required to achieve and 
maintain safe shutdown conditions is greater than the need to limit fire 
damage to those systems required to mitigate the consequences of design 
basis accidents. Three levels of fire damage limits are established 
according to the safety functions of the structure, system, or 
component:

------------------------------------------------------------------------
            Safety function                     Fire damage limits
------------------------------------------------------------------------
Hot Shutdown...........................  One train of equipment
                                          necessary to achieve hot
                                          shutdown from either the
                                          control room or emergency
                                          control station(s) must be
                                          maintained free of fire damage
                                          by a single fire, including an
                                          exposure fire. \1\

[[Page 1063]]

 
Cold Shutdown..........................  Both trains of equipment
                                          necessary to achieve cold
                                          shutdown may be damaged by a
                                          single fire, including an
                                          exposure fire, but damage must
                                          be limited so that at least
                                          one train can be repaired or
                                          made operable within 72 hours
                                          using onsite capability.
Design Basis Accidents.................  Both trains of equipment
                                          necessary for mitigation of
                                          consequences following design
                                          basis accidents may be damaged
                                          by a single exposure fire.
------------------------------------------------------------------------
\1\ Exposure Fire. An exposure fire is a fire in a given area that
  involves either in situ or transient combustibles and is external to
  any structures, systems, or components located in or adjacent to that
  same area. The effects of such fire (e.g., smoke, heat, or ignition)
  can adversely affect those structures, systems, or components
  important to safety. Thus, a fire involving one train of safe shutdown
  equipment may constitute an exposure fire for the redundant train
  located in the same area, and a fire involving combustibles other than
  either redundant train may constitute an exposure fire to both
  redundant trains located in the same area.

    The most stringent fire damage limit shall apply for those systems 
that fall into more than one category. Redundant systems used to 
mitigate the consequences of other design basis accidents but not 
necessary for safe shutdown may be lost to a single exposure fire. 
However, protection shall be provided so that a fire within only one 
such system will not damage the redundant system.

                        II. General Requirements

    A. Fire protection program. A fire protection program shall be 
established at each nuclear power plant. The program shall establish the 
fire protection policy for the protection of structures, systems, and 
components important to safety at each plant and the procedures, 
equipment, and personnel required to implement the program at the plant 
site.
    The fire protection program shall be under the direction of an 
individual who has been delegated authority commensurate with the 
responsibilities of the position and who has available staff personnel 
knowledgeable in both fire protection and nuclear safety.
    The fire protection program shall extend the concept of defense-in-
depth to fire protection in fire areas important to safety, with the 
following objectives:
     To prevent fires from starting;
     To detect rapidly, control, and extinguish 
promptly those fires that do occur;
     To provide protection for structures, systems, 
and components important to safety so that a fire that is not promptly 
extinguished by the fire suppression activities will not prevent the 
safe shutdown of the plant.
    B. Fire hazards analysis. A fire hazards analysis shall be performed 
by qualified fire protection and reactor systems engineers to (1) 
consider potential in situ and transient fire hazards; (2) determine the 
consequences of fire in any location in the plant on the ability to 
safely shut down the reactor or on the ability to minimize and control 
the release of radioactivity to the environment; and (3) specify 
measures for fire prevention, fire detection, fire suppression, and fire 
containment and alternative shutdown capability as required for each 
fire area containing structures, systems, and components important to 
safety in accordance with NRC guidelines and regulations.
    C. Fire prevention features. Fire protection features shall meet the 
following general requirements for all fire areas that contain or 
present a fire hazard to structures, systems, or components important to 
safety.
    1. In situ fire hazards shall be identified and suitable protection 
provided.
    2. Transient fire hazards associated with normal operation, 
maintenance, repair, or modification activities shall be identified and 
eliminated where possible. Those transient fire hazards that can not be 
eliminated shall be controlled and suitable protection provided.
    3. Fire detection systems, portable extinguishers, and standpipe and 
hose stations shall be installed.
    4. Fire barriers or automatic suppression systems or both shall be 
installed as necessary to protect redundant systems or components 
necessary for safe shutdown.
    5. A site fire brigade shall be established, trained, and equipped 
and shall be on site at all times.
    6. Fire detection and suppression systems shall be designed, 
installed, maintained, and tested by personnel properly qualified by 
experience and training in fire protection systems.
    7. Surveillance procedures shall be established to ensure that fire 
barriers are in place and that fire suppression systems and components 
are operable.
    D. Alternative or dedicated shutdown capability. In areas where the 
fire protection features cannot ensure safe shutdown capability in the 
event of a fire in that area, alternative or dedicated safe shutdown 
capability shall be provided.

                       III. Specific Requirements

    A. Water supplies for fire suppression systems. Two separate water 
supplies shall be provided to furnish necessary water volume and 
pressure to the fire main loop.
    Each supply shall consist of a storage tank, pump, piping, and 
appropriate isolation and control valves. Two separate redundant 
suctions in one or more intake structures from a large body of water 
(river, lake, etc.) will satisfy the requirement for two separated water 
storage tanks. These supplies shall be separated so that a failure of 
one supply will not result in a failure of the other supply.
    Each supply of the fire water distribution system shall be capable 
of providing for a period of 2 hours the maximum expected water demands 
as determined by the fire hazards

[[Page 1064]]

analysis for safety-related areas or other areas that present a fire 
exposure hazard to safety-related areas.
    When storage tanks are used for combined service-water/fire-water 
uses the minimum volume for fire uses shall be ensured by means of 
dedicated tanks or by some physical means such as a vertical standpipe 
for other water service. Administrative controls, including locks for 
tank outlet valves, are unacceptable as the only means to ensure minimum 
water volume.
    Other water systems used as one of the two fire water supplies shall 
be permanently connected to the fire main system and shall be capable of 
automatic alignment to the fire main system. Pumps, controls, and power 
supplies in these systems shall satisfy the requirements for the main 
fire pumps. The use of other water systems for fire protection shall not 
be incompatible with their functions required for safe plant shutdown. 
Failure of the other system shall not degrade the fire main system.
    B. Sectional isolation valves. Sectional isolation valves such as 
post indicator valves or key operated valves shall be installed in the 
fire main loop to permit isolation of portions of the fire main loop for 
maintenance or repair without interrupting the entire water supply.
    C. Hydrant isolation valves. Valves shall be installed to permit 
isolation of outside hydrants from the fire main for maintenance or 
repair without interrupting the water supply to automatic or manual fire 
suppression systems in any area containing or presenting a fire hazard 
to safety-related or safe shutdown equipment.
    D. Manual fire suppression. Standpipe and hose systems shall be 
installed so that at least one effective hose stream will be able to 
reach any location that contains or presents an exposure fire hazard to 
structures, systems, or components important to safety.
    Access to permit effective functioning of the fire brigade shall be 
provided to all areas that contain or present an exposure fire hazard to 
structures, systems, or components important to safety.
    Standpipe and hose stations shall be inside PWR containments and BWR 
containments that are not inerted. Standpipe and hose stations inside 
containment may be connected to a high quality water supply of 
sufficient quantity and pressure other than the fire main loop if plant-
specific features prevent extending the fire main supply inside 
containment. For BWR drywells, standpipe and hose stations shall be 
placed outside the dry well with adequate lengths of hose to reach any 
location inside the dry well with an effective hose stream.
    E. Hydrostatic hose tests. Fire hose shall be hydrostatically tested 
at a pressure of 150 psi or 50 psi above maximum fire main operating 
pressure, whichever is greater. Hose stored in outside hose houses shall 
be tested annually. Interior standpipe hose shall be tested every three 
years.
    F. Automatic fire detection. Automatic fire detection systems shall 
be installed in all areas of the plant that contain or present an 
exposure fire hazard to safe shutdown or safety-related systems or 
components. These fire detection systems shall be capable of operating 
with or without offsite power.
    G. Fire protection of safe shutdown capability. 1. Fire protection 
features shall be provided for structures, systems, and components 
important to safe shutdown. These features shall be capable of limiting 
fire damage so that:
    a. One train of systems necessary to achieve and maintain hot 
shutdown conditions from either the control room or emergency control 
station(s) is free of fire damage; and
    b. Systems necessary to achieve and maintain cold shutdown from 
either the control room or emergency control station(s) can be repaired 
within 72 hours.
    2. Except as provided for in paragraph G.3 of this section, where 
cables or equipment, including associated non-safety circuits that could 
prevent operation or cause maloperation due to hot shorts, open 
circuits, or shorts to ground, of redundant trains of systems necessary 
to achieve and maintain hot shutdown conditions are located within the 
same fire area outside of primary containment, one of the following 
means of ensuring that one of the redundant trains is free of fire 
damage shall be provided:
    a. Separation of cables and equipment and associated non-safety 
circuits of redundant trains by a fire barrier having a 3-hour rating. 
Structural steel forming a part of or supporting such fire barriers 
shall be protected to provide fire resistance equivalent to that 
required of the barrier;
    b. Separation of cables and equipment and associated non-safety 
circuits of redundant trains by a horizontal distance of more than 20 
feet with no intervening combustible or fire hazards. In addition, fire 
detectors and an automatic fire suppression system shall be installed in 
the fire area; or
    c. Enclosure of cable and equipment and associated non-safety 
circuits of one redundant train in a fire barrier having a 1-hour 
rating, In addition, fire detectors and an automatic fire suppression 
system shall be installed in the fire area;
    Inside noninerted containments one of the fire protection means 
specified above or one of the following fire protection means shall be 
provided:
    d. Separation of cables and equipment and associated non-safety 
circuits of redundant trains by a horizontal distance of more than 20 
feet with no intervening combustibles or fire hazards;

[[Page 1065]]

    e. Installation of fire detectors and an automatic fire suppression 
system in the fire area; or
    f. Separation of cables and equipment and associated non-safety 
circuits of redundant trains by a noncombustible radiant energy shield.
    3. Alternative or dedicated shutdown capability and its associated 
circuits, \1\ independent of cables, systems or components in the area, 
room, zone under consideration should be provided:
---------------------------------------------------------------------------

    \1\ Alternative shutdown capability is provided by rerouting, 
relocating, or modifying existing systems; dedicated shutdown capability 
is provided by installing new structures and systems for the function of 
post-fire shutdown.
---------------------------------------------------------------------------

    a. Where the protection of systems whose function is required for 
hot shutdown does not satisfy the requirement of paragraph G.2 of this 
section; or
    b. Where redundant trains of systems required for hot shutdown 
located in the same fire area may be subject to damage from fire 
suppression activities or from the rupture or inadvertent operation of 
fire suppression systems.
    In addition, fire detection and a fixed fire suppression system 
shall be installed in the area, room, or zone under consideration.
    H. Fire brigade. A site fire brigade trained and equipped for fire 
fighting shall be established to ensure adequate manual fire fighting 
capability for all areas of the plant containing structures, systems, or 
components important to safety. The fire brigade shall be at least five 
members on each shift. The brigade leader and at least two brigade 
members shall have sufficient training in or knowledge of plant safety-
related systems to understand the effects of fire and fire suppressants 
on safe shutdown capability. The qualification of fire brigade members 
shall include an annual physical examination to determine their ability 
to perform strenuous fire fighting activities. The shift supervisor 
shall not be a member of the fire brigade. The brigade leader shall be 
competent to assess the potential safety consequences of a fire and 
advise control room personnel. Such competence by the brigade leader may 
be evidenced by possession of an operator's license or equivalent 
knowledge of plant safety-related systems.
    The minimum equipment provided for the brigade shall consist of 
personal protective equipment such as turnout coats, boots, gloves, hard 
hats, emergency communications equipment, portable lights, portable 
ventilation equipment, and portable extinguishers. Self-contained 
breathing apparatus using full-face positive-pressure masks approved by 
NIOSH (National Institute for Occupational Safety and Health--approval 
formerly given by the U.S. Bureau of Mines) shall be provided for fire 
brigade, damage control, and control room personnel. At least 10 masks 
shall be available for fire brigade personnel. Control room personnel 
may be furnished breathing air by a manifold system piped from a storage 
reservoir if practical. Service or rated operating life shall be a 
minimum of one-half hour for the self-contained units.
    At least a 1-hour supply of breathing air in extra bottles shall be 
located on the plant site for each unit of self-contained breathing 
appratus. In addition, an onsite 6-hour supply of reserve air shall be 
provided and arranged to permit quick and complete replenishment of 
exhausted air supply bottles as they are returned. If compressors are 
used as a source of breathing air, only units approved for breathing air 
shall be used and the compressors shall be operable assuming a loss of 
offsite power. Special care must be taken to locate the compressor in 
areas free of dust and contaminants.
    I. Fire brigade training. The fire brigade training program shall 
ensure that the capability to fight potential fires is established and 
maintained. The program shall consist of an initial classroom 
instruction program followed by periodic classroom instruction, fire 
fighting practice, and fire drills:
    1. Instruction
    a. The initial classroom instruction shall include:
    (1) Indoctrination of the plant fire fighting plan with specific 
identification of each individual's responsibilities.
    (2) Identification of the type and location of fire hazards and 
associated types of fires that could occur in the plant.
    (3) The toxic and corrosive characteristics of expected products of 
combustion.
    (4) Identification of the location of fire fighting equipment for 
each fire area and familiarization with the layout of the plant, 
including access and egress routes to each area.
    (5) The proper use of available fire fighting equipment and the 
correct method of fighting each type of fire. The types of fires covered 
should include fires in energized electrical equipment, fires in cables 
and cable trays, hydrogen fires, fires involving flammable and 
combustible liquids or hazardous process chemicals, fires resulting from 
construction or modifications (welding), and record file fires.
    (6) The proper use of communication, lighting, ventilation, and 
emergency breathing equipment.
    (7) The proper method for fighting fires inside buildings and 
confined spaces.
    (8) The direction and coordination of the fire fighting activities 
(fire brigade leaders only).
    (9) Detailed review of fire fighting strategies and procedures.

[[Page 1066]]

    (10) Review of the latest plant modifications and corresponding 
changes in fire fighting plans.
    Note: Items (9) and (10) may be deleted from the training of no more 
than two of the non-operations personnel who may be assigned to the fire 
brigade.
    b. The instruction shall be provided by qualified individuals who 
are knowledgeable, experienced, and suitably trained in fighting the 
types of fires that could occur in the plant and in using the types of 
equipment available in the nuclear power plant.
    c. Instruction shall be provided to all fire brigade members and 
fire brigade leaders.
    d. Regular planned meetings shall be held at least every 3 months 
for all brigade members to review changes in the fire protection program 
and other subjects as necessary.
    e. Periodic refresher training sessions shall be held to repeat the 
classroom instruction program for all brigade members over a two-year 
period. These sessions may be concurrent with the regular planned 
meetings.
    2. Practice
    Practice sessions shall be held for each shift fire brigade on the 
proper method of fighting the various types of fires that could occur in 
a nuclear power plant. These sessions shall provide brigade members with 
experience in actual fire extinguishment and the use of emergency 
breathing apparatus under strenuous conditions encountered in fire 
fighting. These practice sessions shall be provided at least once per 
year for each fire brigade member.
    3. Drills
    a. Fire brigade drills shall be performed in the plant so that the 
fire brigade can practice as a team.
    b. Drills shall be performed at regular intervals not to exceed 3 
months for each shift fire brigade. Each fire brigade member should 
participate in each drill, but must participate in at least two drills 
per year.
    A sufficient number of these drills, but not less than one for each 
shift fire brigade per year, shall be unannounced to determine the fire 
fighting readiness of the plant fire brigade, brigade leader, and fire 
protection systems and equipment. Persons planning and authorizing an 
unannounced drill shall ensure that the responding shift fire brigade 
members are not aware that a drill is being planned until it is begun. 
Unannounced drills shall not be scheduled closer than four weeks.
    At least one drill per year shall be performed on a ``back shift'' 
for each shift fire brigade.
    c. The drills shall be preplanned to establish the training 
objectives of the drill and shall be critiqued to determine how well the 
training objectives have been met. Unannounced drills shall be planned 
and critiqued by members of the management staff responsible for plant 
safety and fire protection. Performance deficiencies of a fire brigade 
or of individual fire brigade members shall be remedied by scheduling 
additional training for the brigade or members. Unsatisfactory drill 
performance shall be followed by a repeat drill within 30 days.
    d. At 3-year intervals, a randomly selected unannounced drill must 
be critiqued by qualified individuals independent of the licensee's 
staff. A copy of the written report from these individuals must be 
available for NRC review and shall be retained as a record as specified 
in section III.I.4 of this appendix.
    e. Drills shall as a minimum include the following:
    (1) Assessment of fire alarm effectiveness, time required to notify 
and assemble fire brigade, and selection, placement and use of 
equipment, and fire fighting strategies.
    (2) Assessment of each brigade member's knowledge of his or her role 
in the fire fighting strategy for the area assumed to contain the fire. 
Assessment of the brigade member's conformance with established plant 
fire fighting procedures and use of fire fighting equipment, including 
self-contained emergency breathing apparatus, communication equipment, 
and ventilation equipment, to the extent practicable.
    (3) The simulated use of fire fighting equipment required to cope 
with the situation and type of fire selected for the drill. The area and 
type of fire chosen for the drill should differ from those used in the 
previous drill so that brigade members are trained in fighting fires in 
various plant areas. The situation selected should simulate the size and 
arrangement of a fire that could reasonably occur in the area selected, 
allowing for fire development due to the time required to respond, to 
obtain equipment, and organize for the fire, assuming loss of automatic 
suppression capability.
    (4) Assessment of brigade leader's direction of the fire fighting 
effort as to thoroughness, accuracy, and effectiveness.
    4. Records
    Individual records of training provided to each fire brigade member, 
including drill critiques, shall be maintained for at least 3 years to 
ensure that each member receives training in all parts of the training 
program. These records of training shall be available for NRC review. 
Retraining or broadened training for fire fighting within buildings 
shall be scheduled for all those brigade members whose performance 
records show deficiencies.
    J. Emergency lighting. Emergency lighting units with at least an 8-
hour battery power supply shall be provided in all areas needed for 
operation of safe shutdown equipment and in access and egress routes 
thereto.
    K. Administrative controls. Administrative controls shall be 
established to minimize fire

[[Page 1067]]

hazards in areas containing structures, systems, and components 
important to safety. These controls shall establish procedures to:
    1. Govern the handling and limitation of the use of ordinary 
combustible materials, combustible and flammable gases and liquids, high 
efficiency particulate air and charcoal filters, dry ion exchange 
resins, or other combustible supplies in safety-related areas.
    2. Prohibit the storage of combustibles in safety-related areas or 
establish designated storage areas with appropriate fire protection.
    3. Govern the handling of and limit transient fire loads such as 
combustible and flammable liquids, wood and plastic products, or other 
combustible materials in buildings containing safety-related systems or 
equipment during all phases of operating, and especially during 
maintenance, modification, or refueling operations.
    4. Designate the onsite staff member responsible for the inplant 
fire protection review of proposed work activities to identify potential 
transient fire hazards and specify required additional fire protection 
in the work activity procedure.
    5. Govern the use of ignition sources by use of a flame permit 
system to control welding, flame cutting, brazing, or soldering 
operations. A separate permit shall be issued for each area where work 
is to be done. If work continues over more than one shift, the permit 
shall be valid for not more than 24 hours when the plant is operating or 
for the duration of a particular job during plant shutdown.
    6. Control the removal from the area of all waste, debris, scrap, 
oil spills, or other combustibles resulting from the work activity 
immediately following completion of the activity, or at the end of each 
work shift, whichever comes first.
    7. Maintain the periodic housekeeping inspections to ensure 
continued compliance with these administrative controls.
    8. Control the use of specific combustibles in safety-related areas. 
All wood used in safety-related areas during maintenance, modification, 
or refueling operations (such as lay-down blocks or scaffolding) shall 
be treated with a flame retardant. Equipment or supplies (such as new 
fuel) shipped in untreated combustible packing containers may be 
unpacked in safety-related areas if required for valid operating 
reasons. However, all combustible materials shall be removed from the 
area immediately following the unpacking. Such transient combustible 
material, unless stored in approved containers, shall not be left 
unattended during lunch breaks, shift changes, or other similar periods. 
Loose combustible packing material such as wood or paper excelsior, or 
polyethylene sheeting shall be placed in metal containers with tight-
fitting self-closing metal covers.
    9. Control actions to be taken by an individual discovering a fire, 
for example, notification of control room, attempt to extinguish fire, 
and actuation of local fire suppression systems.
    10. Control actions to be taken by the control room operator to 
determine the need for brigade assistance upon report of a fire or 
receipt of alarm on control room annunciator panel, for example, 
announcing location of fire over PA system, sounding fire alarms, and 
notifying the shift supervisor and the fire brigade leader of the type, 
size, and location of the fire.
    11. Control actions to be taken by the fire brigade after 
notification by the control room operator of a fire, for example, 
assembling in a designated location, receiving directions from the fire 
brigade leader, and discharging specific fire fighting responsibilities 
including selection and transportation of fire fighting equipment to 
fire location, selection of protective equipment, operating instructions 
for use of fire suppression systems, and use of preplanned strategies 
for fighting fires in specific areas.
    12. Define the strategies for fighting fires in all safety-related 
areas and areas presenting a hazard to safety-related equipment. These 
strategies shall designate:
    a. Fire hazards in each area covered by the specific prefire plans.
    b. Fire extinguishants best suited for controlling the fires 
associated with the fire hazards in that area and the nearest location 
of these extinguishants.
    c. Most favorable direction from which to attack a fire in each area 
in view of the ventilation direction, access hallways, stairs, and doors 
that are most likely to be free of fire, and the best station or 
elevation for fighting the fire. All access and egress routes that 
involve locked doors should be specifically identified in the procedure 
with the appropriate precautions and methods for access specified.
    d. Plant systems that should be managed to reduce the damage 
potential during a local fire and the location of local and remote 
controls for such management (e.g., any hydraulic or electrical systems 
in the zone covered by the specific fire fighting procedure that could 
increase the hazards in the area because of overpressurization or 
electrical hazards).
    e. Vital heat-sensitive system components that need to be kept cool 
while fighting a local fire. Particularly hazardous combustibles that 
need cooling should be designated.
    f. Organization of fire fighting brigades and the assignment of 
special duties according to job title so that all fire fighting 
functions are covered by any complete shift personnel complement. These 
duties include command

[[Page 1068]]

control of the brigade, transporting fire suppression and support 
equipment to the fire scenes, applying the extinguishant to the fire, 
communication with the control room, and coordination with outside fire 
departments.
    g. Potential radiological and toxic hazards in fire zones.
    h. Ventilation system operation that ensures desired plant air 
distribution when the ventilation flow is modified for fire containment 
or smoke clearing operations.
    i. Operations requiring control room and shift engineer coordination 
or authorization.
    j. Instructions for plant operators and general plant personnel 
during fire.
    L. Alternative and dedicated shutdown capability. 1. Alternative or 
dedicated shutdown capability provided for a specific fire area shall be 
able to (a) achieve and maintain subcritical reactivity conditions in 
the reactor; (b) maintain reactor coolant inventory; (c) achieve and 
maintain hot standby \2\ conditions for a PWR (hot shutdown \2\ for a 
BWR); (d) achieve cold shutdown conditions within 72 hours; and (e) 
maintain cold shutdown conditions thereafter. During the postfire 
shutdown, the reactor coolant system process variables shall be 
maintained within those predicted for a loss of normal a.c. power, and 
the fission product boundary integrity shall not be affected; i.e., 
there shall be no fuel clad damage, rupture of any primary coolant 
boundary, of rupture of the containment boundary.
---------------------------------------------------------------------------

    \2\ As defined in the Standard Technical Specifications.
---------------------------------------------------------------------------

    2. The performance goals for the shutdown functions shall be:
    a. The reactivity control function shall be capable of achieving and 
maintaining cold shutdown reactivity conditions.
    b. The reactor coolant makeup function shall be capable of 
maintaining the reactor coolant level above the top of the core for BWRs 
and be within the level indication in the pressurizer for PWRs.
    c. The reactor heat removal function shall be capable of achieving 
and maintaining decay heat removal.
    d. The process monitoring function shall be capable of providing 
direct readings of the process variables necessary to perform and 
control the above functions.
    e. The supporting functions shall be capable of providing the 
process cooling, lubrication, etc., necessary to permit the operation of 
the equipment used for safe shutdown functions.
    3. The shutdown capability for specific fire areas may be unique for 
each such area, or it may be one unique combination of systems for all 
such areas. In either case, the alternative shutdown capability shall be 
independent of the specific fire area(s) and shall accommodate postfire 
conditions where offsite power is available and where offsite power is 
not available for 72 hours. Procedures shall be in effect to implement 
this capability.
    4. If the capability to achieve and maintain cold shutdown will not 
be available because of fire damage, the equipment and systems 
comprising the means to achieve and maintain the hot standby or hot 
shutdown condition shall be capable of maintaining such conditions until 
cold shutdown can be achieved. If such equipment and systems will not be 
capable of being powered by both onsite and offsite electric power 
systems because of fire damage, an independent onsite power system shall 
be provided. The number of operating shift personnel, exclusive of fire 
brigade members, required to operate such equipment and systems shall be 
on site at all times.
    5. Equipment and systems comprising the means to achieve and 
maintain cold shutdown conditions shall not be damaged by fire; or the 
fire damage to such equipment and systems shall be limited so that the 
systems can be made operable and cold shutdown can be achieved within 72 
hours. Materials for such repairs shall be readily available on site and 
procedures shall be in effect to implement such repairs. If such 
equipment and systems used prior to 72 hours after the fire will not be 
capable of being powered by both onsite and offsite electric power 
systems because of fire damage, an independent onsite power system shall 
be provided. Equipment and systems used after 72 hours may be powered by 
offsite power only.
    6. Shutdown systems installed to ensure postfire shutdown capability 
need not be designed to meet seismic Category I criteria, single failure 
criteria, or other design basis accident criteria, except where required 
for other reasons, e.g., because of interface with or impact on existing 
safety systems, or because of adverse valve actions due to fire damage.
    7. The safe shutdown equipment and systems for each fire area shall 
be known to be isolated from associated non-safety circuits in the fire 
area so that hot shorts, open circuits, or shorts to ground in the 
associated circuits will not prevent operation of the safe shutdown 
equipment. The separation and barriers between trays and conduits 
containing associated circuits of one safe shutdown division and trays 
and conduits containing associated circuits or safe shutdown cables from 
the redundant division, or the isolation of these associated circuits 
from the safe shutdown equipment, shall be such

[[Page 1069]]

that a postulated fire involving associated circuits will not prevent 
safe shutdown. \3\
---------------------------------------------------------------------------

    \3\ An acceptable method of complying with this alternative would be 
to meet Regulatory Guide 1.75 position 4 related to associated circuits 
and IEEE Std 384-1974 (Section 4.5) where trays from redundant safety 
divisions are so protected that postulated fires affect trays from only 
one safety division.
---------------------------------------------------------------------------

    M. Fire barrier cable penetration seal qualification. Penetration 
seal designs must be qualified by tests that are comparable to tests 
used to rate fire barriers. The acceptance criteria for the test must 
include the following:
    1. The cable fire barrier penetration seal has withstood the fire 
endurance test without passage of flame or ignition of cables on the 
unexposed side for a period of time equivalent to the fire resistance 
rating required of the barrier;
    2. The temperature levels recorded for the unexposed side are 
analyzed and demonstrate that the maximum temperature is sufficiently 
below the cable insulation ignition temperature; and
    3. The fire barrier penetration seal remains intact and does not 
allow projection of water beyond the unexposed surface during the hose 
stream test.
    N. Fire doors. Fire doors shall be self-closing or provided with 
closing mechanisms and shall be inspected semiannually to verify that 
automatic hold-open, release, and closing mechanisms and latches are 
operable.
    One of the following measures shall be provided to ensure they will 
protect the opening as required in case of fire:
    1. Fire doors shall be kept closed and electrically supervised at a 
continuously manned location;
    2. Fire doors shall be locked closed and inspected weekly to verify 
that the doors are in the closed position;
    3. Fire doors shall be provided with automatic hold-open and release 
mechanisms and inspected daily to verify that doorways are free of 
obstructions; or
    4. Fire doors shall be kept closed and inspected daily to verify 
that they are in the closed position.
    The fire brigade leader shall have ready access to keys for any 
locked fire doors.
    Areas protected by automatic total flooding gas suppression systems 
shall have electrically supervised self-closing fire doors or shall 
satisfy option 1 above.
    O. Oil collection system for reactor coolant pump. The reactor 
coolant pump shall be equipped with an oil collection system if the 
containment is not inerted during normal operation. The oil collection 
system shall be so designed, engineered, and installed that failure will 
not lead to fire during normal or design basis accident conditions and 
that there is reasonable assurance that the system will withstand the 
Safe Shutdown Earthquake. \4\
---------------------------------------------------------------------------

    \4\ See Regulatory Guide 1.29--``Seismic Design Classification'' 
paragraph C.2.
---------------------------------------------------------------------------

    Such collection systems shall be capable of collecting lube oil from 
all potential pressurized and unpressurized leakage sites in the reactor 
coolant pump lube oil systems. Leakage shall be collected and drained to 
a vented closed container that can hold the entire lube oil system 
inventory. A flame arrester is required in the vent if the flash point 
characteristics of the oil present the hazard of fire flashback. Leakage 
points to be protected shall include lift pump and piping, overflow 
lines, lube oil cooler, oil fill and drain lines and plugs, flanged 
connections on oil lines, and lube oil reservoirs where such features 
exist on the reactor coolant pumps. The drain line shall be large enough 
to accommodate the largest potential oil leak.

[45 FR 76611, Nov. 19, 1980; 46 FR 44735, Sept. 8, 1981, as amended at 
53 FR 19251, May 27, 1988; 65 FR 38191, June 20, 2000; 77 FR 39907, July 
6, 2012]



Sec. Appendix S to Part 50--Earthquake Engineering Criteria for 
                         Nuclear Power Plants

                           General Information

    This appendix applies to applicants for a construction permit or 
operating license under part 50, or a design certification, combined 
license, design approval, or manufacturing license under part 52 of this 
chapter, on or after January 10, 1997. However, for either an operating 
license applicant or holder whose construction permit was issued before 
January 10, 1997, the earthquake engineering criteria in Section VI of 
appendix A to 10 CFR part 100 continue to apply. Paragraphs IV.a.1.i, 
IV.a.1.ii, IV.4.b, and IV.4.c of this appendix apply to applicants for 
an early site permit under part 52.

                             I. Introduction

    (a) Each applicant for a construction permit, operating license, 
design certification, combined license, design approval, or 
manufacturing license is required by Sec. Sec.50.34(a)(12), 
50.34(b)(10), or 10 CFR 52.47, 52.79, 52.137, or 52.157, and General 
Design Criterion 2 of appendix A to this part, to design nuclear power 
plant structures, systems, and components important to safety to 
withstand the effects of natural phenomena, such as earthquakes, without 
loss of capability to perform their safety functions. Also, as specified 
in Sec.50.54(ff), nuclear power plants that have implemented the 
earthquake engineering criteria described herein must shut down if the

[[Page 1070]]

criteria in paragraph IV(a)(3) of this appendix are exceeded.
    (b) These criteria implement General Design Criterion 2 insofar as 
it requires structures, systems, and components important to safety to 
withstand the effects of earthquakes.

                                II. Scope

    The evaluations described in this appendix are within the scope of 
investigations permitted by Sec.50.10(c)(1).

                            III. Definitions

    As used in these criteria:
    Combined license means a combined construction permit and operating 
license with conditions for a nuclear power facility issued under 
subpart C of part 52 of this chapter.
    Design Approval means an NRC staff approval, issued under subpart E 
of part 52 of this chapter, of a final standard design for a nuclear 
power reactor of the type described in 10 CFR 50.22.
    Design Certification means a Commission approval, issued under 
subpart B of part 52 of this chapter, of a standard design for a nuclear 
power facility.
    Manufacturing license means a license, issued under subpart F of 
part 52 of this chapter, authorizing the manufacture of nuclear power 
reactors but not their installation into facilities located at the sites 
on which the facilities are to be operated.
    Operating basis earthquake ground motion (OBE) is the vibratory 
ground motion for which those features of the nuclear power plant 
necessary for continued operation without undue risk to the health and 
safety of the public will remain functional. The operating basis 
earthquake ground motion is only associated with plant shutdown and 
inspection unless specifically selected by the applicant as a design 
input.
    Response spectrum is a plot of the maximum responses (acceleration, 
velocity, or displacement) of idealized single-degree-of-freedom 
oscillators as a function of the natural frequencies of the oscillators 
for a given damping value. The response spectrum is calculated for a 
specified vibratory motion input at the oscillators' supports.
    Safe-shutdown earthquake ground motion (SSE) is the vibratory ground 
motion for which certain structures, systems, and components must be 
designed to remain functional.
    Structures, systems, and components required to withstand the 
effects of the safe-shutdown earthquake ground motion or surface 
deformation are those necessary to assure:
    (1) The integrity of the reactor coolant pressure boundary;
    (2) The capability to shut down the reactor and maintain it in a 
safe-shutdown condition; or
    (3) The capability to prevent or mitigate the consequences of 
accidents that could result in potential offsite exposures comparable to 
the guideline exposures of Sec.50.34(a)(1).
    Surface deformation is distortion of geologic strata at or near the 
ground surface by the processes of folding or faulting as a result of 
various earth forces. Tectonic surface deformation is associated with 
earthquake processes.

                  IV. Application to Engineering Design

    The following are pursuant to the seismic and geologic design basis 
requirements of Sec.100.23 of this chapter:
    (a) Vibratory Ground Motion. (1) Safe Shutdown Earthquake Ground 
Motion. (i) The Safe Shutdown Earthquake Ground Motion must be 
characterized by free-field ground motion response spectra at the free 
ground surface. In view of the limited data available on vibratory 
ground motions of strong earthquakes, it usually will be appropriate 
that the design response spectra be smoothed spectra. The horizontal 
component of the Safe Shutdown Earthquake Ground Motion in the free-
field at the foundation level of the structures must be an appropriate 
response spectrum with a peak ground acceleration of at least 0.1g.
    (ii) The nuclear power plant must be designed so that, if the Safe 
Shutdown Earthquake Ground Motion occurs, certain structures, systems, 
and components will remain functional and within applicable stress, 
strain, and deformation limits. In addition to seismic loads, applicable 
concurrent normal operating, functional, and accident-induced loads must 
be taken into account in the design of these safety-related structures, 
systems, and components. The design of the nuclear power plant must also 
take into account the possible effects of the Safe Shutdown Earthquake 
Ground Motion on the facility foundations by ground disruption, such as 
fissuring, lateral spreads, differential settlement, liquefaction, and 
landsliding, as required in Sec.100.23 of this chapter.
    (iii) The required safety functions of structures, systems, and 
components must be assured during and after the vibratory ground motion 
associated with the Safe Shutdown Earthquake Ground Motion through 
design, testing, or qualification methods.
    (iv) The evaluation must take into account soil-structure 
interaction effects and the expected duration of vibratory motion. It is 
permissible to design for strain limits in excess of yield strain in 
some of these safety-related structures, systems, and components during 
the Safe Shutdown Earthquake Ground Motion and under the postulated 
concurrent loads, provided the necessary safety functions are 
maintained.
    (2) Operating Basis Earthquake Ground Motion. (i) The Operating 
Basis Earthquake

[[Page 1071]]

Ground Motion must be characterized by response spectra. The value of 
the Operating Basis Earthquake Ground Motion must be set to one of the 
following choices:
    (A) One-third or less of the Safe Shutdown Earthquake Ground Motion 
design response spectra. The requirements associated with this Operating 
Basis Earthquake Ground Motion in Paragraph (a)(2)(i)(B)(I) can be 
satisfied without the applicant performing explicit response or design 
analyses, or
    (B) A value greater than one-third of the Safe Shutdown Earthquake 
Ground Motion design response spectra. Analysis and design must be 
performed to demonstrate that the requirements associated with this 
Operating Basis Earthquake Ground Motion in Paragraph (a)(2)(i)(B)(I) 
are satisfied. The design must take into account soil-structure 
interaction effects and the duration of vibratory ground motion.
    (I) When subjected to the effects of the Operating Basis Earthquake 
Ground Motion in combination with normal operating loads, all 
structures, systems, and components of the nuclear power plant necessary 
for continued operation without undue risk to the health and safety of 
the public must remain functional and within applicable stress, strain, 
and deformation limits.
    (3) Required Plant Shutdown. If vibratory ground motion exceeding 
that of the Operating Basis Earthquake Ground Motion or if significant 
plant damage occurs, the licensee must shut down the nuclear power 
plant. If systems, structures, or components necessary for the safe 
shutdown of the nuclear power plant are not available after the 
occurrence of the Operating Basis Earthquake Ground Motion, the licensee 
must consult with the Commission and must propose a plan for the timely, 
safe shutdown of the nuclear power plant. Prior to resuming operations, 
the licensee must demonstrate to the Commission that no functional 
damage has occurred to those features necessary for continued operation 
without undue risk to the health and safety of the public and the 
licensing basis is maintained.
    (4) Required Seismic Instrumentation. Suitable instrumentation must 
be provided so that the seismic response of nuclear power plant features 
important to safety can be evaluated promptly after an earthquake.
    (b) Surface Deformation. The potential for surface deformation must 
be taken into account in the design of the nuclear power plant by 
providing reasonable assurance that in the event of deformation, certain 
structures, systems, and components will remain functional. In addition 
to surface deformation induced loads, the design of safety features must 
take into account seismic loads and applicable concurrent functional and 
accident-induced loads. The design provisions for surface deformation 
must be based on its postulated occurrence in any direction and azimuth 
and under any part of the nuclear power plant, unless evidence indicates 
this assumption is not appropriate, and must take into account the 
estimated rate at which the surface deformation may occur.
    (c) Seismically Induced Floods and Water Waves and Other Design 
Conditions. Seismically induced floods and water waves from either 
locally or distantly generated seismic activity and other design 
conditions determined pursuant to Sec.100.23 of this chapter must be 
taken into account in the design of the nuclear power plant so as to 
prevent undue risk to the health and safety of the public.

[61 FR 65173, Dec. 11, 1996, as amended at 72 FR 49508, Aug. 28, 2007]

[[Page 1073]]



                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 1075]]



                    Table of CFR Titles and Chapters




                     (Revised as of January 1, 2019)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 1076]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600--3699)

[[Page 1077]]

    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  Overseas Private Investment Corporation (Parts 4300--
                4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)

[[Page 1078]]

     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Part 10101)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                Department of Agriculture (Parts 800--899)

[[Page 1079]]

        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  Local Television Loan Guarantee Board (Parts 2200--
                2299)
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

[[Page 1080]]

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Immigration and 
                Naturalization) (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                Department of Agriculture (Parts 200--299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  (Parts 500--599) [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)

[[Page 1081]]

       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, Department of 
                Commerce (Parts 1100--1199)

[[Page 1082]]

      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)

[[Page 1083]]

        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  Broadcasting Board of Governors (Parts 500--599)
       VII  Overseas Private Investment Corporation (Parts 700--
                799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)

[[Page 1084]]

        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

[[Page 1085]]

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        VI  Office of the Assistant Secretary, Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--699)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)
        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)

[[Page 1086]]

        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)

[[Page 1087]]

      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army, Department 
                of Defense (Parts 200--399)
        IV  Saint Lawrence Seaway Development Corporation, 
                Department of Transportation (Parts 400--499)

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)

[[Page 1088]]

        IV  Office of Career, Technical and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  (Parts 1100--1199) [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

[[Page 1089]]

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  [Reserved]
       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)

[[Page 1090]]

       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)

[[Page 1091]]

         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
        IX  Denali Commission (Parts 900--999)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Administration for Children and Families, Department 
                of Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

[[Page 1092]]

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management, Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

[[Page 1093]]

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)
        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 1095]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of January 1, 2019)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, IX, X, XI
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Grain Inspection, Packers and Stockyards        7, VIII; 9, II
       Administration
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Telephone Bank                            7, XVI
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force, Department of                          32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I

[[Page 1096]]

Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Army, Department of                               32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
Broadcasting Board of Governors                   22, V
  Federal Acquisition Regulation                  48, 19
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazardous Investigation       40, VI
     Board
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX
     for the District of Columbia
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce, Department of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense Contract Audit Agency                     32, I
Defense, Department of                            2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII

[[Page 1097]]

  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, 2

[[Page 1098]]

  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Housing Finance Board                     12, IX
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105

[[Page 1099]]

  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
   Secretary
[[Page 1100]]

Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Enforcement Bureau, Bureau of        30, II
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice, Department of                            2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 5, XLII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI
  Federal Acquisition Regulation                  48, 29
  Federal Contract Compliance Programs, Office    41, 60
     of
[[Page 1101]]

  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I, VII
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
Local Television Loan Guarantee Board             7, XX
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI

[[Page 1102]]

National Security Council and Office of Science   47, II
     and Technology Policy
National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resources Conservation Service            7, VI
Natural Resource Revenue, Office of               30, XII
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 5, IV; 45, 
                                                  VIII
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public Contracts, Department of Labor             41, 50
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of   30, II
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of          32, XXIV
Science and Technology Policy, Office of, and     47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II

[[Page 1103]]

Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State, Department of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury, Department of the                       2, X;5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVII

[[Page 1104]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2014 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.fdsys.gov. For changes to this volume of the CFR 
prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 1964-
1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. The 
``List of CFR Sections Affected 1986-2000'' is available at 
www.fdsys.gov.

                                  2014

10 CFR
                                                                   79 FR
                                                                    Page
Chapter I
Chapter I Regulatory review plan....................................9981
1.3 (a) revised....................................................75737
1.5 (a)(3) revised; (a)(4) removed.................................75737
1.18 Removed.......................................................75737
1.19 (b) and (c) removed; (d) redesignated as new (b)..............75737
1.32 (b) amended...................................................75737
1.38 Added.........................................................75737
1.41 Removed.......................................................75737
1.42 Revised.......................................................75737
2 Nomenclature changes.............................................75739
2.101 (a)(1) amended...............................................75739
2.103 (a) amended..................................................75739
2.106 (d) amended..................................................75739
2.340 (e)(2) and (k) amended.......................................75739
2.810 (e) revised..................................................66601
2.1023 (a) introductory text revised...............................66601
2.1210 (a) introductory text revised...............................66601
2.1406 (c) revised.................................................66602
15.20 (d) and (e) amended..........................................66602
15.33 (b)(1) amended...............................................66602
19.11 (e)(2) revised...............................................66602
20 Appendix D amended..............................................66602
26.135 (c) revised.................................................66602
26.159 (i) revised.................................................66602
26.717 (g) revised.................................................66603
30 Nomenclature change.............................................75739
30.4 Amended; eff. 1-28-15.........................................58671
30.7 (e)(3) revised................................................66603
30.32 (k) removed; eff. 1-28-15....................................58671
30.34 (l) removed; eff. 1-28-15....................................58671
31 Nomenclature change.............................................75739
32 Nomenclature change.............................................75739
34 Nomenclature change.............................................75739
35 Nomenclature change.............................................75739
37 Nomenclature change.............................................75739
37.7 Amended.......................................................75740
37.29 (a)(10) revised; eff. 1-28-15................................58671
37.43 (d)(1) revised; (d)(9) removed; eff. 1-28-15.................58671
37.77 (f) revised; eff. 1-28-15....................................58671
40 Nomenclature changes............................................75740
40.7 (e)(3) revised................................................66603
50 Authority citation revised...............................62334, 65798
    Technical correction...........................................65541
50.2 Amended.......................................................62335
50.7 (e)(2) revised................................................66603
50.54 Introductory text revised; (jj) added........................65798
50.55 Introductory text revised; (i) added.........................65798
50.55a Revised.....................................................65798
    (b)(2)(viii)(B), (C) and (ix)(J) amended.......................66603
    (a)(1)(ii)(B)(5), (6) and (7) added; (e)(1) amended............73462
50.82 (a)(4)(i) revised............................................66603

[[Page 1106]]

                                  2015

10 CFR
                                                                   80 FR
                                                                    Page
Chapter I
1 Authority citation revised.......................................54232
1.3 (c) amended.............................................45842, 74977
1.32 (b) amended...................................................74978
1.35 Heading and introductory text revised; (f) and (g) amended; 
        (h) through (l) added......................................74978
1.38 Removed.......................................................74978
1.42 (b)(3) amended................................................74978
2 Authority citation revised.......................................54232
    Nomenclature changes...........................................74978
2.202 (c)(2) revised...............................................63419
2.802 Revised......................................................60526
2.803 Revised......................................................60526
2.811 (e) revised..................................................60527
4 Authority citation revised.......................................54232
4.5 Amended........................................................74978
7 Authority citation revised.......................................54232
7.2 Amended........................................................74978
7.22 (b) amended...................................................74978
9 Authority citation revised.......................................54233
    Nomenclature change............................................74978
10 Authority citation revised......................................54233
11 Authority citation revised......................................54233
11.15 (a)(1) amended...............................................74978
12 Authority citation revised......................................54233
13 Authority citation revised......................................54233
14 Authority citation revised......................................54233
15 Authority citation revised......................................54233
15.3 Amended.......................................................74978
16 Authority citation revised......................................54233
19 Authority citation revised......................................54233
19.17 (a) amended..................................................74978
20 Authority citation revised......................................54233
    Authority citation correctly revised...........................58574
    Nomenclature change............................................74979
21 Authority citation revised......................................54233
21.5 Amended.......................................................74979
25 Authority citation revised......................................54233
25.9 Amended.......................................................74979
26 Authority citation revised......................................54233
26.11 Amended......................................................74979
30 Technical correction.............................................3865
    Authority citation revised.....................................54233
30.4 Regulation at 79 FR 58671 eff. date confirmed..................3865
30.6 (a)(3) amended................................................74979
30.32 Regulation at 79 FR 58671 eff. date confirmed.................3865
30.34 Regulation at 79 FR 58671 eff. date confirmed.................3865
31 Authority citation revised......................................54233
32 Actions on petitions............................................45413
    Authority citation revised.....................................54234
    Authority citation correctly revised...........................58574
32.1 (c)(1) amended................................................74979
33 Authority citation revised......................................54234
34 Authority citation revised......................................54234
35 Authority citation revised......................................54234
36 Authority citation revised......................................54234
37 Technical correction.............................................3865
    Authority citation revised.....................................54234
    Nomenclature change............................................74979
37.23 (b)(2) amended...............................................45843
37.29 Regulation at 79 FR 58671 eff. date confirmed.................3865
37.43 Regulation at 79 FR 58671 eff. date confirmed.................3865
37.77 Regulation at 79 FR 58671 eff. date confirmed.................3865
    (a)(1) amended.................................................74979
39 Authority citation revised......................................54234
40 Authority citation revised......................................54234
    Nomenclature change............................................74979
40.5 (a)(3) amended................................................74979
40.61 (a)(2) revised...............................................45843
50 Authority citation revised......................................54234
50.4 (a) and (e) amended...........................................74979
50.34 (f)(3)(v)(A)(1) and (B)(1) amended...........................74980
50.49 Footnote 4 revised...........................................45843
50.54 Introductory text amended....................................45843
50.55a (a)(2)(i), (ii), (iii) and (h)(2) revised; (a)(2)(iv) added
                                                                   45843
50 Appendix E amended..............................................74980

                                  2016

10 CFR
                                                                   81 FR
                                                                    Page
Chapter I
Policy statement...................................................47689
2 Authority citation revised.......................................43021
2.205 (j) revised; interim.........................................43021
2.305 (g)(1) amended...............................................86909
2.327 (d) revised..................................................47006
2.390 (a)(5) revised; eff. 1-30-17.................................96346
9.17 (a)(5) revised; (c) redesignated as (d); new (c) added; eff. 
        1-30-17....................................................96346
9.19 (b)(1) amended; eff. 1-30-17..................................96346
9.21 (c) introductory text and (5) revised; eff. 1-30-17...........96346
9.25 (c) revised; (f) amended; eff. 1-30-17........................96346
9.27 (a) and (b)(5) amended; (b)(6) and (7) added; eff. 1-30-17....96346
9.29 (a) amended; eff. 1-30-17.....................................96346
9.30 Added; eff. 1-30-17...........................................96346

[[Page 1107]]

9.39 (f) added; eff. 1-30-17.......................................96346
9.43 (d) amended; eff. 1-30-17.....................................96347
9.45 Revised; eff. 1-30-17.........................................96347
9.201 Revised......................................................41185
10 Nomenclature change.............................................86909
13 Authority citation revised......................................43021
13.3 (a)(1)(iv) and (b)(1)(ii) revised; interim....................43021
20 Policy statement..................................49863, 52974, 95410
26 Policy statement................................................49863
    Nomenclature change............................................86909
30 Nomenclature change.............................................86909
32 Policy statement................................................49863
37 Regulation at 78 FR 17007 request for comment...................13263
40 Policy statement................................................49863
    Nomenclature change............................................86909
50 Actions on petitions............................................29761
    Policy statement.................................49863, 88615, 95410
50.23 Amended......................................................86909
50.34 (a)(3)(i) amended............................................86909
50 Appendices C and J amended......................................86909

                                  2017

10 CFR
                                                                   82 FR
                                                                    Page
Chapter I
2.205 (j) revised...................................................8135
2.1200 Amended.....................................................52825
9 Amended..........................................................52825
13.3 (a)(1)(iv) and (b)(1)(ii) revised..............................8135
20 Policy statement................................................46666
40.35 (f) amended..................................................52825
50.43 (e) introductory text revised................................52825
50.55a (a) introductory text, (1)(i) introductory text, (E)(12), 
        (13), (ii) introductory text, (C)(48), (49), (iii)(A), 
        (B), (C), (1)(iv) introductory text, (b) introductory 
        text, (1) introductory text, ( ii), (iv), (vii), (2) 
        introductory text, (vi), (viii) introductory text, (ix) 
        introductory text, (D), (x), (xii), (xxi)(A), (xxiii), (3) 
        introductory text, (i), (ii), (iv) introductory text, (4) 
        introductory text, (5), (6), (f) heading, introductory 
        text, (2), (3)(iii)(A), (B), (iv)(A), (B), (4) 
        introductory text, (i), (ii), (g) heading and introductory 
        text, (2), (3) heading, (i), (ii), (v), (4)(i), (ii), 
        (6)(ii)(D)(1) through (4), and (F)(1) through (10) 
        revised; (a)(1)(i)(E)(14) through (17), (ii)(C)(50) 
        through (53), (iii)(D) through (G), (iv)(B), (C), (v), 
        (b)(1)(viii), (ix), (2)(viii)(H), (I),(xviii)(D), (xxx), 
        (xxxi) through (xxxvii), (3)(iii), (3)(vii) through (xi), 
        (g)(6)(ii)(F)(11), (12), (13) added; (g)(3) introductory 
        text, (6)(ii)(D)(5) and (6) removed........................32977
    (b)(2)(ix)(B) revised..........................................52825

                                  2018

10 CFR
                                                                   83 FR
                                                                    Page
Chapter I
Chapter I Notification.............................................29437
    Policy statement...............................................65283
1.34 (d) revised...................................................30287
1.42 (a) revised; (b)(26) through (31) redesignated as (b)(27) 
        through (32); new (b)(26) added............................30287
2.101 (a)(2) amended...............................................30287
2.205 (j) revised...................................................1517
2.802 (b) introductory text revised................................30287
9.37 (a) and (b) revised; eff. 3-4-19..............................65077
13.3 (a)(1)(iv) and (b)(1)(ii) revised..............................1517
26.5 Amended.......................................................58464
26.183 (a) amended.................................................58464
26.187 (a) amended.................................................58464
30 Policy statement................................................32759

[[Page 1108]]

30.7 (e)(1) amended................................................58465
30.34 (g) amended; eff. 1-14-19....................................33101
32 Policy statement................................................32759
32.72 (a)(4) introductory text and (b)(5)(i) revised; (d) 
        redesignated as (e); new (d) added; eff. 1-14-19...........33101
34.101 (c) amended.................................................30287
35 Policy statement................................................32759
35.2 Amended; eff. 1-14-19.........................................33102
35.8 (b) revised; eff. 1-14-19.....................................33102
35.12 (b)(1), (c)(1) introductory text, (ii), and (d) revised; 
        eff. 1-14-19...............................................33102
35.13 (b) revised; (d) through (g) redesignated as (e) through 
        (h); new (g) and new (h) revised; new (d) and (i) added; 
        eff. 1-14-19...............................................33102
35.14 (a) and (b) revised; eff. 1-14-19............................33103
35.15 (c) and (e) revised; eff. 1-14-19............................33103
35.24 (b) and (c) revised; eff. 1-14-19............................33103
35.40 (b)(6) and (c)(1) redesignated as (b)(7) and (c)(2); (c) 
        introductory text redesignated as new (c)(1); new (b)(6) 
        added; (b)(5) and new (b)(7) revised; eff. 1-14-19.........33103
35.41 (b)(3) and (4) revised; (b)(5) and (6) added; eff. 1-14-19 
                                                                   33104
35.50 Revised; eff. 1-14-19........................................33104
35.51 (a) introductory text, (2)(i), and (b)(2) revised; eff. 1-
        14-19......................................................33105
35.55 (a) introductory text and (b)(2) revised; eff. 1-14-19.......33105
35.57 (a) and (b) revised; eff. 1-14-19............................33105
35.65 Revised; eff. 1-14-19........................................33106
35.190 (a) introductory text and (c)(2) revised; eff. 1-14-19......33106
35.204 (b) revised; (e) added; eff. 1-14-19........................33107
35.290 (a) introductory text, (c)(1)(ii) introductory text, and 
        (2) revised; eff. 1-14-19..................................33107
35.300 Introductory text revised; eff. 1-14-19.....................33107
35.390 (a) introductory text, (b)(1)(ii)(G), and (2) revised; eff. 
        1-14-19....................................................33107
35.392 (a) and (c)(3) revised; eff. 1-14-19........................33108
35.394 (a) and (c)(3) revised; eff. 1-14-19........................33108
35.396 Revised; eff. 1-14-19.......................................33108
35.400 Revised; eff. 1-14-19.......................................33109
35.433 Revised; eff. 1-14-19.......................................33109
35.490 (a) introductory text, (b)(1)(ii) introductory text, and 
        (3) revised; eff. 1-14-19..................................33109
35.491 (b)(3) revised; eff. 1-14-19................................33109
35.500 Revised; eff. 1-14-19.......................................33110
35.590 Revised; eff. 1-14-19.......................................33110
35.600 Revised; eff. 1-14-19.......................................33110
35.610 (d) and (g) revised; eff. 1-14-19...........................33110
35.655 Heading and (a) revised; eff. 1-14-19.......................33110
35.690 (a) introductory text, (b)(1)(ii) introductory text, and 
        (3) revised; eff. 1-14-19..................................33110
35.2024 (c) added; eff. 1-14-19....................................33111
35.2310 Revised; eff. 1-14-19......................................33111
35.2655 Heading and (a) revised; eff. 1-14-19......................33111
35.3045 (a) revised; eff. 1-14-19..................................33111
35.3204 Added; eff. 1-14-19........................................33111
37.7 (a) revised...................................................58722
37.23 (b)(2) revised...............................................30287
37.43 (d)(2), (3) introductory text, (i), (5), (6), (7), and 
        (8)(ii) revised............................................30287
37.45 (b) introductory text amended................................30288
37.77 (a)(1) amended...............................................30288
    (c)(1) and section amended.....................................58723
37.81 (g) introductory text amended................................58723
40.7 (e)(1) amended................................................58465
40.23 (b)(1), (2)(ix), (c), and (d) amended........................58723
40.64 (c)(2) and (3) amended.......................................58723
40.66 (a), (b)(5), and (c) amended.................................58723

[[Page 1109]]

40.67 (a), (c), and (d) amended....................................58723
50.7 (e)(1) amended................................................58465
50.8 (b) amended...................................................58465
50.55a (a)(3)(i), (ii), and (iii) revised...........................2354
    (b)(2)(xviii)(D) and (3)(iv) introductory text revised..........2526
50.75 (e)(1)(v) amended............................................30288


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