[Title 10 CFR ]
[Code of Federal Regulations (annual edition) - January 1, 2006 Edition]
[From the U.S. Government Printing Office]



[[Page i]]



          10


          Parts 1 to 50

                         Revised as of January 1, 2006


          Energy
          
          


________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of January 1, 2006
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

[[Page ii]]

          U.S. GOVERNMENT OFFICIAL EDITION NOTICE

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                            Table of Contents



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

  Title 10:
          Chapter I--Nuclear Regulatory Commission                   3
  Finding Aids:
      Material Approved for Incorporation by Reference........     885
      Table of CFR Titles and Chapters........................     889
      Alphabetical List of Agencies Appearing in the CFR......     907
      List of CFR Sections Affected...........................     917

[[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, 2006), 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.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate 
volumes. For the period beginning January 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

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.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume 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, Washington DC 
20408, 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 Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    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.

[[Page vii]]


REPUBLICATION OF MATERIAL

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

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
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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, Washington, DC 20408 or e-mail 
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ELECTRONIC SERVICES

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CFR Sections Affected), The United States Government Manual, the Federal 
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mail, [email protected].
    The Office of the Federal Register also offers a free service on the 
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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 NARA site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

January 1, 2006.

[[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, and chapter XVII--Defense Nuclear Facilities Safety Board. 
The contents of these volumes represent all current regulations codified 
under this title of the CFR as of January 1, 2006.

    For this volume, Bonnie Fritts was Chief Editor. The Code of Federal 
Regulations publication program is under the direction of Frances D. 
McDonald, assisted by Alomha S. Morris.

[[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.
Part                                                                Page
1               Statement of organization and general 
                    information.............................           5
2               Rules of practice for domestic licensing 
                    proceedings and issuance of orders......          17
4               Nondiscrimination in Federally assisted 
                    programs or activities receiving Federal 
                    financial assistance from the Commission         143
5               Nondiscrimination on the basis of sex in 
                    education programs or activities 
                    receiving Federal financial assistance..         174
7               Advisory committees.........................         191
8               Interpretations.............................         203
9               Public records..............................         209
10              Criteria and procedures for determining 
                    eligibility for access to restricted 
                    data or national security information or 
                    an employment clearance.................         242
11              Criteria and procedures for determining 
                    eligibility for access to or control 
                    over special nuclear material...........         256
12              Implementation of the Equal Access to 
                    Justice Act in agency proceedings.......         264
13              Program fraud civil remedies................         270
14              Administrative claims under Federal Tort 
                    Claims Act..............................         286
15              Debt collection procedures..................         292
16              Salary offset procedures for collecting 
                    debts owed by Federal employees to the 
                    Federal government......................         307
19              Notices, instructions and reports to 
                    workers: inspection and investigations..         313
20              Standards for protection against radiation..         319
21              Reporting of defects and noncompliance......         421
25              Access authorization for licensee personnel.         429
26              Fitness for duty programs...................         438
30              Rules of general applicability to domestic 
                    licensing of byproduct material.........         463

[[Page 4]]

31              General domestic licenses for byproduct 
                    material................................         501
32              Specific domestic licenses to manufacture or 
                    transfer certain items containing 
                    byproduct material......................         510
33              Specific domestic licenses of broad scope 
                    for byproduct material..................         542
34              Licenses for industrial radiography and 
                    radiation safety requirements for 
                    industrial radiographic operations......         546
35              Medical use of byproduct material...........         564
36              Licenses and radiation safety requirements 
                    for irradiators.........................         616
39              Licenses and radiation safety requirements 
                    for well logging........................         630
40              Domestic licensing of source material.......         642
50              Domestic licensing of production and 
                    utilization facilities..................         696

[[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 Advisory Committee on Nuclear Waste.
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 Information Services.
1.36 Office of Investigations.
1.37 Office of Small Business and Civil Rights.
1.38 [Reserved]
1.39 Office of Human Resources.
1.40 [Reserved]
1.41 Office of State and Tribal Programs.

                             Program Offices

1.42 Office of Nuclear Material Safety and Safeguards.
1.43 Office of Nuclear Reactor Regulation.
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: Sec. 23, 161, 68 Stat. 925, 948, as amended (42 U.S.C. 
2033, 2201); sec. 29, Pub. L. 85-256, 71 Stat. 579, Pub. L. 95-209, 91 
Stat. 1483 (42 U.S.C. 2039); sec. 191, Pub. L. 87-615, 76 Stat. 409 (42 
U.S.C. 2241); secs. 201, 203, 204, 205, 209, 88 Stat. 1242, 1244, 1245, 
1246, 1248, as amended (42 U.S.C. 5841, 5843, 5844, 5845, 5849); 5 
U.S.C. 552, 553; Reorganization Plan No. 1 of 1980, 45 FR 40561, June 
16, 1980.

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



                         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. In addition, NRC Functional 
Organization Charts, NUREG-0325, contains detailed descriptions of the 
functional responsibilities of NRC's offices. It is revised annually and 
is available for public inspection at the NRC Web site, http://
www.nrc.gov, and/or at the NRC Public Document Room, or for purchase 
from the Superintendent of Documents, US Government Printing Office, 
P.O. Box 37082, Washington, DC 20013-7082; and from the National 
Technical Information Service, Springfield, VA 22161.
    (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 Information and Records Services Division, Office of Information 
Services. 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, 5285 Port Royal Road, Springfield, VA 
22161.

[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]



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 papers 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.
    (b) The addresses of the NRC Regional Offices are as follows:
    (1) Region 1, USNRC, 475 Allendale Road, King of Prussia, PA 19406-
1415.
    (2) Region II, USNRC, Sam Nunn Atlanta Federal Center, 61 Forsyth 
Street, SW., Suite 23 T85, Atlanta, GA 30303-8931.
    (3) Region III, USNRC, 2443 Warrenville Road, Suite 210, Lisle, IL 
60532-4351.
    (4) Region IV, USNRC, 611 Ryan Plaza Drive, Suite 400, Arlington, TX 
76011-4005.

[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]

[[Page 7]]



                         Subpart B_Headquarters



Sec. 1.11  The Commission.

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

[[Page 8]]

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]

                     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  Advisory Committee on Nuclear Waste.

    The Advisory Committee on Nuclear Waste (ACNW) provides advice to 
the Commission on all aspects of nuclear waste management, as 
appropriate, within the purview of NRC's regulatory responsibilities. 
The primary emphasis of the ACNW is disposal but will also include other 
aspects of nuclear waste management such as handling, processing, 
transportation, storage, and safeguarding of nuclear wastes including 
spent fuel, nuclear wastes mixed with other hazardous substances, and 
uranium mill tailings. In performing its work, the committee examines 
and reports on specific areas of concern referred to it by the 
Commission or designated representatives of the Commission, and 
undertakes studies and activities on its own initiative as appropriate 
to carry out its responsibilities. The committee interacts with 
representatives of NRC, other Federal agencies, state and local 
governments, Indian Tribes, and private organizations, as appropriate, 
to fulfill its responsibilities.

[54 FR 53314, Dec. 28, 1989]



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

[[Page 9]]

the NRC staff, as requested, on matters of policy regarding licensing of 
medical uses of radioisotopes.
    (b) The Advisory Committee for the Decontamination of Three Mile 
Island, Unit 2, was established by the NRC in October 1980. Its purpose 
is to obtain input and views from the residents of the Three Mile Island 
area and afford Pennsylvania government officials an opportunity to 
participate in the Commission's decisional process regarding cleanup for 
Three Mile Island, Unit 2.
    (c) The Nuclear Safety Research Review Committee (NSRRC) was 
established by the NRC in February 1988 for the purpose of reporting to 
the Commission through the Director of the Office of Nuclear Regulatory 
Research on important management matters in the direction of the 
Commission's nuclear safety research program. The committee activities 
cover all aspects of nuclear safety research including, but not limited 
to, accident management, plant aging, human factors and system 
reliability, earth science, waste disposal and seismic and structural 
engineering. In performing its activities, the committee evaluates and 
reports on the conformance of the nuclear safety research program to the 
NRC philosophy of nuclear regulatory research. The committee conducts 
specialized studies when requested by the Commission or Director of the 
Office of Nuclear Regulatory Research. The committee interacts with the 
Office of Research management staff and selected contractors in private 
industry, at national laboratories and universities.
    (d) 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]

                            Commission Staff



Sec. 1.23  Office of the General Counsel.

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

[[Page 10]]

    (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
    (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;

[[Page 11]]

    (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 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

[[Page 12]]

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 line offices; the Office of 
Nuclear Reactor Regulation, 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 Information Services, the Office of 
Investigations, the Office of Small Business and Civil Rights, the 
Office of Human Resources, the Office of State and Tribal Programs, 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]

                              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
    (d) 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, 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]



Sec. 1.35  Office of Information Services.

    The Office of Information Services--
    (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; and
    (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

[[Page 13]]

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.

[70 FR 69422, Nov. 16, 2005]



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 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 Human Resources.

    The Office of Human Resources--
    (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]



Sec. 1.40  [Reserved]



Sec. 1.41  Office of State and Tribal Programs.

    The Office of State and Tribal Programs--
    (a) Plans and directs NRC's program of cooperation and liaison with 
States,

[[Page 14]]

local governments, interstate and Indian Tribe organizations; and 
coordinates liaison with other Federal Agencies;
    (b) Participates in formulation of policies involving NRC/State 
cooperation and liaison;
    (c) Develops and directs administrative and contractual programs for 
coordinating and integrating Federal and State regulatory activities;
    (d) Maintains liaison between NRC and State, interstate, regional, 
Indian Tribe, and quasi-governmental organizations on regulatory 
matters;
    (e) Promotes NRC visibility and performs general liaison with other 
Federal Agencies, and keeps NRC management informed of significant 
developments at other Federal Agencies which affect the NRC;
    (f) Monitors nuclear-related State legislative activities;
    (g) Directs regulatory activities of State Liaison and State 
Agreement Officers located in Regional Offices;
    (h) Participates in policy matters on State Public Utility 
Commissions (PUCs);
    (i) Administers the State Agreements program in a partnership 
arrangement with the States;
    (j) Develops staff policy and procedures and implementation of the 
State Agreements program under the provisions of section 274b of the 
Atomic Energy Act, as amended;
    (k) Provides oversight of program of periodic routine 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;
    (l) 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;
    (m) Provides technical assistance to Agreement States;
    (n) Maintains an exchange of information with the States;
    (o) Conducts negotiations with States expressing an interest in 
seeking a section 274b Agreement;
    (p) Supports, consistent with Commission directives, State efforts 
to improve regulatory control for radiation safety over radioactive 
materials not covered by the Act; and
    (q) Serves as the NRC liaison to the Conference of Radiation Control 
Program Directors, Inc. (CRCPD) and coordinates NRC technical support of 
CRCPD committees.

[57 FR 1639, Jan. 15, 1992, as amended at 59 FR 5519, Feb. 7, 1994; 70 
FR 69422, Nov. 16, 2005]

                             Program Offices



Sec. 1.42  Office of Nuclear Material Safety and Safeguards.

    (a) The Office of Nuclear Material Safety and Safeguards is 
responsible for protecting the public health and safety, the common 
defense and security, and the environment by licensing, inspection, and 
environmental impact assessment for all nuclear facilities and 
activities, and for the import and export of special nuclear material.
    (b) The Office responsibilities include--
    (1) Development and promulgation of regulations;
    (2) Development and implementation of NRC policy for the regulation 
of activities involving safety, quality, approval, and inspection of the 
use and handling of nuclear and other radioactive materials, such as 
uranium activities;
    (3) Fuel fabrication and fuel development;
    (4) Medical, industrial, academic, and commercial uses of 
radioactive isotopes;
    (5) Safeguards activities;
    (6) Transportation of nuclear materials, including certification of 
transport containers;
    (7) Out-of-reactor spent fuel storage;
    (8) Safe management and disposal of low-level and high-level 
radioactive wastes;
    (9) Planning and direction of program for financial assurance of 
NMSS licensees; and
    (10) Management of the decommissioning of facilities and sites when 
their licensed functions are over.
    (c) Safeguards responsibilities include--
    (1) Development of overall agency policy;

[[Page 15]]

    (2) Monitoring and assessment of the threat environment, including 
liaison with intelligence agencies, as appropriate; and
    (3) Those licensing and review activities appropriate to deter and 
protect against threats of radiological sabotage and threats of theft or 
diversion of special nuclear material at fuel facilities and during 
transport.
    (d) The Office identifies and takes action to control safety and 
safeguards issues for activities under its responsibility, including 
consulting and coordinating with international, Federal, State, and 
local agencies, as appropriate.

[52 FR 31602, Aug. 21, 1987. Redesignated at 57 FR 1639, Jan. 15, 1992, 
as amended at 63 FR 69544, Dec. 17, 1998]



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 part 50;
    (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]



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 both currently licensed

[[Page 16]]

nuclear reactors and potential new nuclear reactors;
    (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 the DHS, the Federal Emergency Management Agency (FEMA) and other 
Federal agencies.

[70 FR 69422, Nov. 16, 2005]



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.

[[Page 17]]

    (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;
    (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_RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE 
OF ORDERS--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

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 design review 
          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; acceptance for filing.
2.305 Service of papers, methods, proof.
2.306 Computation of time.
2.307 Extension and reduction of time limits.
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.

[[Page 18]]

2.310 Selection of hearing procedures.
2.311 Interlocutory review of rulings on requests for hearings/petitions 
          to intervene and selection of hearing procedures.
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.
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 contested proceedings on applications for 
          facility operating licenses; immediate effectiveness of 
          initial decision directing issuance or amendment of 
          construction permit or operating license.
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 or Operate Nuclear Power Plants of 
                   Duplicate Design at Multiple Sites

2.400 Scope of subpart.
2.401 Notice of hearing on applications pursuant to appendix N of part 
          52 for construction permits.
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 part 52.
2.404 Hearings on applications for operating licenses pursuant to 
          appendix N of part 52.
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 pursuant to appendix M of part 52 
          for a license to manufacture nuclear power reactors.
2.502 Notice of hearing on application for a permit to construct a 
          nuclear power reactor manufactured pursuant to a Commission 
          license issued pursuant to appendix M of part 52 of this 
          chapter at the site at which the reactor is to be operated.
2.503 Finality of decision on separate issues.
2.504 Applicability of other sections.

Subpart F_Additional Procedures Applicable to Early Partial Decisions on 
 Site Suitability Issues in Connection With an Application for a Permit 
               To Construct Certain Utilization Facilities

2.600 Scope of subpart.
2.601 Applicability of other sections.
2.602 Filing fees.
2.603 Acceptance and docketing of application for early review of site 
          suitability issues.
2.604 Notice of hearing on application for early review of site 
          suitability issues.
2.605 Additional considerations.
2.606 Partial decisions on site suitability issues.

[[Page 19]]

                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 of rulemaking.
2.801 Initiation of rulemaking.
2.802 Petition for rulemaking.
2.803 Determination of petition.
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.

  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.

       Subpart L_Informal Hearing Procedures for NRC Adjudications

2.1200 Scope of subpart L.
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.

[[Page 20]]

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.
2.1211 Immediate effectiveness of initial decision directing issuance or 
          amendment of licenses under part 61 of this chapter.
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.
2.1304 Hearing procedures.
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: Secs. 161, 181, 68 Stat. 948, 953, as amended (42 U.S.C. 
2201, 2231); sec. 191, as amended, Pub. L. 87-615, 76 Stat. 409 (42 
U.S.C. 2241); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); 5 
U.S.C. 552; sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
    Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 68 
Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 U.S.C. 2073, 
2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub. L. 97-425, 96 
Stat. 2213, as amended (42 U.S.C. 10143(f)), sec. 102, Pub. L. 91-190, 
83 Stat. 853, as amended (42 U.S.C. 4332); sec. 301, 88 Stat. 1248 (42 
U.S.C. 5871).
    Sections 2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 
102, 103, 104, 183i, 189, 68 Stat. 936, 937, 938, 954, 955, as amended 
(42 U.S.C. 2132, 2133, 2134, 2135, 2233, 2239). Sections 2.105 also 
issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239).
    Sections 2.200-2.206 also issued under secs. 161b, I, o, 182, 186, 
234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended (42 U.S.C. 2201(b), 
(I), (o), 2236, 2282); sec. 206, 88 Stat 1246 (42 U.S.C. 5846). Section 
2.205(j) also issued under Pub. L. 101-410, 104 Stat. 90, as amended by 
section 3100(s), Pub. L. 104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 
note). Sections 2.600-2.606 also issued under sec. 102, Pub. L. 91-190, 
83 Stat. 853, as amended (42 U.S.C. 4332). Sections 2.700a, 2.719 also 
issued under 5 U.S.C. 554. Sections 2.754, 2.760, 2.770, 2.780 also 
issued under 5 U.S.C. 557. Section 2.764 also issued under secs. 135, 
141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). 
Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42 
U.S.C. 2133), and 5 U.S.C. 552. Sections 2.800 and 2.808 also issued 
under 5 U.S.C. 553. Section 2.809 also issued under 5 U.S.C. 553, and 
sec. 29, Pub. L. 85-256, 71 Stat. 579, as amended (42 U.S.C. 2039). 
Subpart K

[[Page 21]]

also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, 
Pub. L. 97-425, 96 Stat. 2230 (42 U.S.C. 10154).
    Subpart L also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239). 
Subpart M also issued under sec. 184 (42 U.S.C. 2234) and sec. 189, 68 
Stat. 955 (42 U.S.C. 2239). Appendix A also issued under sec. 6, Pub. L. 
91-560, 84 Stat. 1473 (42 U.S.C. 2135).

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



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 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; and
    (d) Public rulemaking.

[56 FR 40684, Aug. 15, 1991]



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.

[[Page 22]]

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 staff of the Commission and the applicant for a 
license concerning the issuance of the license or any of the terms or 
conditions thereof or (2) a proceeding in which a petition for leave to 
intervene in opposition to an application for a license 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).
    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.''
    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.
    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 a renewed license, or 
construction permit issued by the Commission.
    Licensee means a person who is authorized to conduct activities 
under a license, including a renewed license, or construction permit 
issued by the Commission.
    NRC personnel means:
    (1) NRC employees;
    (2) For the purpose of Sec. Sec. 2.336, 2.702, 2.709 and 2.1018 
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
    (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.

[[Page 23]]

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 rec ords 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.
    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.
    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 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.
    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 Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



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



Sec. 2.100  Scope of subpart.

    This subpart prescribes the procedures for issuance of a license, 
amendment of a license at the request of the licensee, and transfer and 
renewal of a license.

[69 FR 2234, Jan. 14, 2004]



Sec. 2.101  Filing of application.

    (a)(1) An application for a license, a license transfer, or an 
amendment to a license shall be filed with the Director of the Office of 
Nuclear Reactor Regulation or Director of the Office of Nuclear Material 
Safety and Safeguards,

[[Page 24]]

as prescribed by the applicable provisions of this chapter. A 
prospective applicant may confer informally with the NRC staff prior to 
the filing of 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 construction permit or operating 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://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 thirty (30) days. However, in 
selected construction permit applications, the Commission may decide to 
determine acceptability on the basis of the technical adequacy of the 
application as well as its completeness. In these cases, the Commission, 
pursuant to 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 sixty (60) days. For docketing and other requirements for 
applications pursuant to part 61 of this chapter, see paragraph (g) of 
this section.
    (3) If the Director of Nuclear Reactor Regulation or Director 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 of Nuclear Reactor Regulation or Director 
of Nuclear Material Safety and Safeguards, as appropriate, such 
additional copies as the regulations in part 50 and subpart A of part 51 
require;
    (ii) Serve a copy on the chief executive of the municipality in 
which the facility is to be located or, if the facility 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 the 
following information: 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 of Nuclear Reactor Regulation 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

[[Page 25]]

requirements of this chapter and written instructions furnished to the 
applicant by the Director of Nuclear Reactor Regulation or Director 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 of Nuclear Reactor Regulation or 
Director of Nuclear Material Safety and Safeguards, as appropriate, and 
distributed by the applicant shall be completely assembled 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 or operating 
license for a production or utilization facility will be formally 
docketed upon receipt by the Director of Nuclear Reactor Regulation or 
Director 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 of Nuclear Reactor Regulation or 
Director of Nuclear Material Safety and Safeguards, as appropriate. 
Within ten (10) days after docketing the applicant shall submit to the 
Director of Nuclear Reactor Regulation or Director 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 of Nuclear 
Reactor Regulation or Director 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 of Nuclear Reactor Regulation or 
Director 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 for a production or 
utilization facility which is subject to Sec. 51.20(b) of this chapter, 
and is of the type specified in Sec. 50.21(b)(2) or (3) or Sec. 50.22 
of this chapter or is a testing facility may submit the information 
required of applicants by part 50 of the chapter in two parts. One part 
shall be accompanied by the information required by Sec. 50.30(f) of 
this chapter, another part shall include any information required by 
Sec. 50.34(a) and, if applicable, Sec. 50.34a of this chapter. One 
part may precede or follow other parts by no longer than six (6) months. 
If it is determined that either of the parts as described above is 
incomplete and not acceptable for processing, the Director of Nuclear 
Reactor Regulation or Director 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 thirty (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) and 50.37 of 
this chapter. The Director of Nuclear Reactor Regulation or Director of 
Nuclear Material Safety and Safeguards, as appropriate, will accept for 
docketing an application for a construction permit for a production or 
utilization facility which is subject to Sec. 51.20(b) of this chapter, 
and is of the type specified in Sec. 50.21(b)(2) or (3) or Sec. 50.22 
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 of Nuclear Reactor 
Regulation or Director of Nuclear Material Safety and

[[Page 26]]

Safeguards, as appropriate, that it is complete.
    (a-1) Early consideration of site suitability issues. An applicant 
for a construction permit for a utilization facility which is subject to 
Sec. 51.20(b) of this chapter and is of the type specified in Sec. 
50.21(b)(2) or (3) or Sec. 50.22 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 on issues of site suitability within the purview of the applicable 
provisions of parts 50, 51 and 100 of this chapter. In such cases, the 
applicant for the construction permit may submit the information 
required of applicants by the provisions of this chapter in three parts:
    (1) 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: (i) 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, (ii) 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 (iii) 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).
    (2) 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.
    (3) 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.
    (4) 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 six months or follow by no more than six 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, who must comply with paragraph 
(g) 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 following information: 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 of Nuclear Material 
Safety and Safeguards an affidavit that service of the notice of 
availability of the application or environmental report has been 
completed

[[Page 27]]

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 of Nuclear Reactor Regulation or Director 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 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 (g) 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 cause to be published 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 of Nuclear Material Safety and Safeguards 
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 of Nuclear Material Safety and Safeguards of the required 
additional copies. The date of docketing shall be the date when the 
required copies are received by the Director of Nuclear Material Safety 
and Safeguards. Within ten (10) days after docketing, the applicant 
shall submit to the Director of Nuclear Material Safety and Safeguards a 
written statement that distribution of the additional copies to Federal, 
State, Indian Tribe, and

[[Page 28]]

local officials has been completed in accordance with requirements of 
this chapter and written instructions furnished to the applicant by the 
Director of Nuclear Material Safety and Safeguards. 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 of Nuclear Material 
Safety and Safeguards in the same manner as for the initial application 
and environmental impact statement.
    (8) The Director of Nuclear Material Safety and Safeguards 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 of Nuclear Material Safety and Safeguards 
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 of Nuclear Material Safety and Safeguards 
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 Tribe, and local officials in accordance with the requirements of 
this chapter

[[Page 29]]

and written instructions from the Director of Nuclear Material Safety 
and Safeguards; 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 
(g)(2)(i)(C) of this section to the executives or bodies.
    (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 such 
cases, the recipients will be responsible for inserting the revised 
pages. In complying with the requirements of paragraph (g) 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 of Nuclear Material Safety and Safeguards 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 of Nuclear Material Safety and Safeguards. 
Within ten (10) days after docketing, the applicant shall submit to the 
Director of Nuclear Material Safety and Safeguards 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 section and written instructions furnished to the 
applicant by the Director of Nuclear Material Safety and Safeguards.
    (4) Amendments to the application and environmental report shall be 
filed and distributed and a written statement shall be furnished to the 
Director of Nuclear Material Safety and Safeguards in the same manner as 
for the initial application and environmental report.
    (5) The Director of Nuclear Material Safety and Safeguards 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 (g)(3) of this section and, in a 
reasonable period thereafter, publish in the Federal Register a notice 
pursuant to Sec. 2.105 offering opportunity to request a hearing to the 
applicant and other affected persons.

[41 FR 15833, Apr. 15, 1976]

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



Sec. 2.102  Administrative review of application.

    (a) During review of an application by the staff, an applicant may 
be required to supply additional information. The staff may request any 
one party to the proceeding to confer with the staff informally. In the 
case of a docketed application for a construction permit or an operating 
license for a facility, the 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 of Nuclear Reactor Regulation or Director 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 of Nuclear Reactor Regulation or Director 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]

[[Page 30]]



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

    (a) If the Director of Nuclear Reactor Regulation or the Director 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 to 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 of Nuclear Reactor Regulation or 
the Director of Nuclear Material Safety and Safeguards, as appropriate, 
will inform the State, Tribal and local officials specified in Sec. 
2.104(e) 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 of Nuclear Reactor Regulation or Director 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]

                  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 as required by law at 
least fifteen (15) days, and in the case of an application concerning a 
construction permit for a facility of the type described in Sec. 
50.21(b) or Sec. 50.22 of this chapter or a testing facility, at least 
thirty (30) days, prior to the date set for hearing in the notice. \1\ 
In addition, in the case of an application for a construction permit for 
a facility of the type described in Sec. 50.22 of this chapter, or a 
testing facility, the notice (other than a notice pursuant to paragraph 
(d) of this section) shall be issued as soon as practicable after the 
application has been docketed: Provided, That if the Commission, 
pursuant to Sec. 2.101(a)(2), decides to determine the acceptability of 
the application on the basis of its technical adequacy as well as 
completeness, the notice shall be issued as soon as practicable after 
the application has been tendered. The notice will state:
---------------------------------------------------------------------------

    \1\ If the notice of hearing concerning an application for a 
construction permit for a facility of the type described in Sec. 
50.21(b) or Sec. 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 thirty 
(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 thirty (30) days notice.
---------------------------------------------------------------------------

    (1) The time, place, and nature of the hearing and/or prehearing 
conference, if any;
    (2) The authority under 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) In the case of an application for a construction permit for a 
facility on

[[Page 31]]

which the Act requires a hearing, the notice of hearing will, except as 
provided in paragraph (d) of this section and unless the Commission 
determines otherwise, state, in implementation of paragraph (a)(3) of 
this section:
    (1) That, if the proceeding is a contested proceeding, the presiding 
officer will consider the following issues: \2\
---------------------------------------------------------------------------

    \2\ Issues (i) to (iv) are the issues pursuant to the Atomic Energy 
Act of 1954, as amended. Issue (v) is the issue pursuant to the National 
Environmental Policy Act of 1969.
---------------------------------------------------------------------------

    (i) Whether in accordance with the provisions of Sec. 50.35(a) of 
this chapter:
    (a) 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;
    (b) 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;
    (c) 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
    (d) On the basis of the foregoing, there is reasonable assurance 
that (1) such safety questions will be satisfactorily resolved at or 
before the latest date stated in the application for completion of the 
proposed facility; and (2) 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;
    (ii) Whether the applicant is technically qualified to design and 
construct the proposed facility;
    (iii) Whether the applicant is financially qualified to design and 
construct the proposed facility;
    (iv) Whether the issuance of a permit for the construction of the 
facility will be inimical to the common defense and security or to the 
health and safety of the public;
    (v) If the application is for a construction permit for a nuclear 
power reactor, a testing facility, a fuel reprocessing plant, or other 
facility whose construction or operation has been determined by the 
Commission to have a significant impact on the environment, whether, in 
accordance with the requirements of subpart A of part 51 of this 
chapter, the construction permit should be issued as proposed.
    (2) That, if the proceeding is not a contested proceeding, the 
presiding officer will determine:
    (i) Without conducting a de novo evaluation of the application, 
whether the application and the record of the proceeding contain 
sufficient information, and the review of the application by the 
Commission's staff has been adequate to support affirmative findings on 
(b)(1) (i) through (iii) specified in this section and a negative 
finding on (b)(1)(iv) specified in this section proposed to be made and 
the issuance of the construction permit proposed by the Director of 
Nuclear Reactor Regulation or Director of Nuclear Material Safety and 
Safeguards, as appropriate, and
    (ii) If the application is for a construction permit for a nuclear 
power reactor, a testing facility, a fuel processing plant, a uranium 
enrichment facility, or other facility whose construction or operation 
has been determined by the Commission to have a significant impact on 
the environment, whether the review conducted by the Commission pursuant 
to the National Environmental Policy Act (NEPA) has been adequate.
    (3) That, regardless of whether the proceeding is contested or 
uncontested, the presiding officer will, in accordance with subpart A of 
part 51 of this chapter.
    (i) Determine whether the requirements of section 102(2) (A), (C) 
and (E) of the National Environmental Policy Act and subpart A of part 
51 of this chapter have been complied with in the proceeding;
    (ii) Independently consider the final balance among conflicting 
factors contained in the record of the proceeding

[[Page 32]]

with a view to determining the appropriate action to be taken; and
    (iii) Determine whether the construction permit should be issued, 
denied, or appropriately conditioned to protect environmental values.
    (c) In the case of an application for an operating license in which 
a hearing will be held, the notice of hearing will, except as provided 
in paragraph (d) of this section and unless the Commission determines 
otherwise, state, in implementation of paragraph (a)(3) of this section, 
that the presiding officer will consider any matters in controversy 
among the parties and may, where he or she determines that a serious 
safety, environmental, or common defense and security matter has not 
been raised by the parties, consider such other matter within the 
purview of:
    (1) Whether there is reasonable assurance that construction of the 
facility will be substantially completed on a timely basis, in 
conformity with the construction permit and the application as amended, 
the provisions of the Act, and the regulations in this chapter;
    (2) Whether the facility will operate in conformity with the 
application as amended, the provisions of the Act, and the regulations 
in this chapter;
    (3) Whether there is reasonable assurance: (i) That the activities 
to be 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;
    (4) Whether the applicant is technically and financially qualified 
to engage in the activities to be authorized by the operating license in 
accordance with the regulations in this chapter, except that the issue 
of financial qualification shall not be considered by the presiding 
officer in an operating license hearing if the applicant is an electric 
utility seeking a license to operate a utilization facility of the type 
described in Sec. 50.21(b) or Sec. 50.22;
    (5) Whether the applicable provisions of part 140 of this chapter 
have been satisfied;
    (6) Whether issuance of the license will be inimical to the common 
defense and security or to the health and safety of the public; and
    (7) If the application is for an operating license for a nuclear 
power reactor, a testing facility, or a fuel reprocessing plant, or 
other facility whose operation has been determined by the Commission to 
have a significant impact on the environment, whether, in accordance 
with the requirements of subpart A of part 51 of this chapter, the 
operating license should be issued as proposed.\3\
---------------------------------------------------------------------------

    \3\ Issues (1) to (6) are the issues pursuant to the Atomic Energy 
Act of 1954, as amended. Issue (7) is the issue pursuant to the National 
Environmental Policy Act of 1969.
---------------------------------------------------------------------------

    (d) In an application for a construction permit or an operating 
license for a facility on which a hearing is required by the Act or this 
chapter, the notice of hearing will, unless the Commission determines 
otherwise, state:
    (1) A time of the hearing which will be as soon as practicable after 
compliance with section 189a of the Act and this part;
    (2) The presiding officer for the hearing who shall be either an 
administrative law judge or an atomic safety and licensing board 
established by the Commission or by the Chief Administrative Judge of 
the Atomic Safety and Licensing Board Panel; and
    (3) That matters of radiological health and safety and common 
defense and security, and matters raised under the National 
Environmental Policy Act of 1969, will be considered at another hearing 
if otherwise required or ordered to be held, for which a notice will be 
published pursuant to paragraphs (a) and (b) of this section, unless 
otherwise authorized by the Commission.
    (e) The Secretary will give timely notice of the hearing to all 
parties and to other persons, if any, entitled by law to notice. The 
Secretary will transmit a notice of hearing on an application for a 
license for a production or utilization facility, 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 
HLW repository at a geologic repository operations area pursuant to

[[Page 33]]

parts 60 or 63 of this chapter, 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 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 so located or conducted within an Indian reservation). 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.

[27 FR 377, Jan. 13, 1962]

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



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, prior to acting thereon, cause to be published in the Federal 
Register 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 for a facility licensed 
under Sec. 50.21(b) or Sec. 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 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

[[Page 34]]

    (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.
    (b) The notice of proposed action 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.
    (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.
    (d) The notice of proposed action will provide that, within thirty 
(30) days from the date of publication of the notice in the Federal 
Register, or such lesser period authorized by law as the Commission may 
specify:
    (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 of Nuclear Reactor Regulation or the Director 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 on GPO Access.



Sec. 2.106  Notice of issuance.

    (a) The Director of Nuclear Reactor Regulation or Director of 
Nuclear Material Safety and Safeguards, as appropriate, will cause to be 
published in the Federal Register notice of, and will inform the State 
and local officials specified in Sec. 2.104(e) of the issuance of:
    (1) A license or an amendment of a license for which a notice of 
proposed action has been previously published; and
    (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.
    (b) The notice of issuance will set forth:
    (1) The nature of the license or amendment;
    (2) The manner in which copies of the safety analysis, if any, may 
be obtained and examined; and
    (3) A finding that the application for the license or amendment 
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

[[Page 35]]

State, local, and Tribal officials specified in Sec. 2.104(e) 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 Director 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(e) 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 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]



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 of Nuclear Reactor Regulation or Director 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]



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

    (a) The Director of Nuclear Reactor Regulation or Director 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 of Nuclear Reactor Regulation or Director 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 not notice 
of hearing has 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 of Nuclear Reactor Regulation or Director of 
Nuclear Material Safety and Safeguards, as appropriate, under paragraph 
(a) of this section.

[27 FR 377, Jan. 13, 1962, as amended at 39 FR 43195, Dec. 11, 1974; 69 
FR 2236, Jan. 14, 2004]



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, if, at least 30 days prior 
to 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.

[[Page 36]]

    (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 an 
operating license at least 5 years prior to the expiration of the 
existing license, the existing license will not be deemed to have 
expired until the application has been finally determined.

[56 FR 64975, Dec. 13, 1991]



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

    (a)(1) A submittal pursuant to appendix O 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 part 52 of this chapter, a submittal pursuant to appendix 
Q shall be subject to 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 staff of a submittal of a type 
described in paragraph (a)(1) of this section, the Director of Nuclear 
Reactor Regulation shall publish in the Federal Register a notice of 
receipt of the submittal, inviting comments from interested persons 
within 60 days of publication or such other time as may be specified, 
for consideration by the staff and ACRS in their review.
    (c) Upon completion of review by the NRC staff and the ACRS of a 
submittal of the type described in paragraph (a)(1) of this section, the 
Director of the Office of Nuclear Reactor Regulation shall publish in 
the Federal Register a determination as to whether or not the design is 
acceptable, subject to conditions as may be appropriate, and shall make 
available at the NRC Web site, http://www.nrc.gov, a report that 
analyzes the design.

[40 FR 2976, Jan. 17, 1975, as amended at 42 FR 22885, May 5, 1977; 54 
FR 15398, Apr. 18, 1989; 64 FR 48948, Sept. 9, 1999; 69 FR 2236, Jan. 
14, 2004]



Sec. 2.111  Prohibition of sex discrimination.

    No person shall on the ground of sex be excluded from participation 
in, be denied a license under, 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.

[40 FR 8777, Mar. 3, 1975]



     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 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

[[Page 37]]

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 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 may, in addition to demanding a 
hearing, at the time the answer is filed or sooner, move 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. The NRC staff 
shall respond within (5) days of the receipt of the motion. The motion 
must be decided by the presiding officer expeditiously. During the 
pendency of the motion 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. The presiding 
officer will uphold the immediate effectiveness of

[[Page 38]]

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. An order 
setting aside immediate effectiveness will be referred promptly to the 
Commission itself and will not be effective pending further order of the 
Commission.
    (ii) 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 and other 
affected parties.
    (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 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) 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.

[56 FR 40684, Aug. 15, 1991, as amended at 57 FR 20198, May 12, 1992]



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 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.

[[Page 39]]

    (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 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

[[Page 40]]

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 $130,000 for each violation. If any violation is a 
continuing one, each day of such violation shall constitute a separate 
violation for the purpose 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]



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/eie.html, by calling (301) 415-6030, by e-mail to 
[email protected]; or by writing the Office of Information Services, 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) 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

[[Page 41]]

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]



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 must be filed with the Commission in adjudications 
subject to this part either by:
    (1) First class mail addressed to: Office of the Secretary, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: 
Rulemakings and Adjudications Staff;
    (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;
    (3) E-mail addressed to the Office of the Secretary, U.S. Nuclear 
Regulatory Commission, [email protected];
    (4) By facsimile transmission addressed to the Office of the 
Secretary, U.S. Nuclear Regulatory Commission, Washington, DC, 
Attention: Rulemakings and Adjudications Staff, at (301) 415-1101; 
verification number is (301) 415-1966.
    (b) All documents offered for filing must be accompanied by proof of 
service on all parties to the proceeding or their attorneys of record as 
required by law or by rule or order of the Commission. For purposes of 
service of documents, the staff of the Commission is considered a party.
    (c) Filing by mail, electronic mail, or facsimile is considered 
complete as of the time of deposit in the mail or upon electronic mail 
or facsimile transmission.



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 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; acceptance for filing.

    (a) Each document filed in an adjudication subject to this part to 
which a docket number has been assigned must show the docket number and 
title of the proceeding.
    (b) Each document must be bound on the left side and typewritten, 
printed, or otherwise reproduced in permanent form on good unglazed 
paper of standard letterhead size. Each page 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

[[Page 42]]

apply to original documents or admissible copies offered as exhibits, or 
to specifically prepared exhibits.
    (c) The original of each document must be signed in ink by the party 
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, and the date of signature. The signature of 
a person signing in a representative capacity 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. If a document 
is not signed, or is signed with intent to defeat the purpose of this 
section, it may be stricken.
    (d) Except as otherwise required by this part or by order, a 
pleading or other document, other than correspondence, must be filed in 
an original and two conformed copies.
    (e) The first document filed by any person in a proceeding must 
designate the name and address of a person on whom service may be made. 
This document must also designate the electronic mail address and 
facsimile number, if any, of the person on whom service may be made.
    (f) A document filed by electronic mail or facsimile transmission 
need not comply with the formal requirements of paragraphs (b), (c), and 
(d) of this section if an original and two (2) copies otherwise 
complying with all of the requirements of this section are mailed within 
two (2) days thereafter to the Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, Attention: Rulemakings and 
Adjudications Staff.
    (g) Acceptance for filing. Any document that fails to conform to the 
requirements of this section may be refused acceptance for filing 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.



Sec. 2.305  Service of papers, methods, proof.

    (a) Service of papers by the Commission. Except for subpoenas, the 
Commission will serve all orders, decisions, notices, and other papers 
issued by it upon all parties.
    (b) Who may be served. Any paper required to be served upon a party 
must be served upon that person or upon the representative designated by 
the party or by law to receive service of papers. When a party has 
appeared by attorney, service must be made upon the attorney of record.
    (c) How service may be made. Service may be made by personal 
delivery or courier, by express mail or expedited delivery service, by 
first class, certified or registered mail, by e-mail or facsimile 
transmission, or as otherwise authorized by law. If service is made by 
e-mail or facsimile transmission, the original signed copy must be 
transmitted to the Secretary by personal delivery, courier, express mail 
or expedited delivery service, or first class, certified, or registered 
mail. In addition, if service is by e-mail, a paper copy must also be 
served by any other service method permitted under this paragraph. Where 
there are numerous parties to a proceeding, the Commission may make 
special provision regarding the service of papers. The presiding officer 
shall require service by the most expeditious means that is available to 
all parties in the proceeding, including express mail or expedited 
delivery service, and/or electronic or facsimile transmission, unless 
the presiding officer finds that this requirement would impose undue 
burden or expense on some or all of the parties.
    (d) Service on the Secretary. (1) All pleadings must be served on 
the Secretary of the Commission in the same or equivalent manner, i.e., 
personal delivery or courier, express mail or expedited delivery 
service, facsimile or electronic transmission, that they are served upon 
the adjudicatory tribunals and the parties to the proceedings, so that 
the Secretary will receive the pleading at approximately the same time 
that it is received by the tribunal to which the pleading is directed.

[[Page 43]]

    (2) When pleadings are personally delivered to tribunals while they 
are conducting proceedings outside the Washington, DC area, service on 
the Secretary may be accomplished by courier, express mail or expedited 
delivery service, or by electronic or facsimile transmission.
    (3) Service of pre-filed testimony and demonstrative evidence (e.g., 
maps and other physical exhibits) on the Secretary may be made by first 
class mail in all cases, unless the presiding officer directs otherwise.
    (4) The addresses for the Secretary are:
    (i) First class mail: Office of the Secretary, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings 
and Adjudications Staff.
    (ii) 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.
    (iii) E-mail addressed to the Secretary, U.S. Nuclear Regulatory 
Commission, [email protected]; and
    (iv) Facsimile transmission addressed to the Office of the 
Secretary, U.S. Nuclear Regulatory Commission, Washington, DC, 
Attention: Rulemakings and Adjudications Staff, at (301) 415-1101; 
verification number is (301) 415-1966.
    (e) When service is complete. Service upon a party is complete:
    (1) By personal delivery, on handing the paper to the individual, or 
leaving it at his 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 usual place of residence with 
some person of suitable age and discretion then residing there;
    (2) By mail, on deposit in the United States mail, properly stamped 
and addressed;
    (3) By electronic mail, on transmission thereof, and service of a 
copy by another method of service permitted in paragraph (c) of this 
section;
    (4) By facsimile transmission, on transmission thereof and receipt 
of electronic confirmation that one or more of the addressees for a 
party has successfully received the transmission. If the sender receives 
an electronic message that the facsimile transmission to an addressee 
was not deliverable or is otherwise informed that a transmission was 
unreadable, transmission to that person is not considered complete. In 
such an event, the sender shall reserve the document in accordance with 
paragraph (e)(1) through (e)(4) of this section; or
    (5) When service cannot be effected in a manner provided by 
paragraphs (e)(1) to (4) inclusive of this section, in any other manner 
authorized by law.
    (f) Service on the NRC staff. (1) Service shall be made upon the NRC 
staff of all papers and documents required to be filed with parties 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.
    (2) If the NRC staff decides not to participate as a party in a 
proceeding, it shall, in its notification to the presiding officer and 
parties of its determination not to participate, designate a person and 
address for service of papers and documents.



Sec. 2.306  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 has the right or is required to do some act within a prescribed 
period after the service of a notice or other paper upon him or her and 
the notice or paper is served upon by first class mail, five (5) days 
are added to the prescribed period. Two (2) days are added to the 
prescribed period when a document is served by express mail or expedited 
delivery service. No time is added when the notice or paper is served in

[[Page 44]]

person, by courier, electronic mail or facsimile transmission. The 
period allotted for the recipient's response commences upon confirmation 
of receipt under Sec. 2.305(e)(3) or (4), except that if a document is 
served in person, by courier, electronic transmission, or facsimile, and 
is received by a party after 5 p.m., in the recipient's time zone on the 
date of transmission, the recipient's response date is extended by one 
(1) business day.



Sec. 2.307  Extension and reduction of time limits.

    (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.



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 
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 or petition for leave to intervene and a 
specification of the contentions which the person seeks to have 
litigated in the hearing. 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 otherwise provided by the Commission, the request 
and/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/

[[Page 45]]

or petition, which may not, with the exception of a notice provided 
under Sec. 2.102(d)(3), be less than 60 days from the date of 
publication of the notice in the Federal Register;
    (ii) The time provided in Sec. 2.102(d)(3); or
    (iii) 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.
    (5) For orders issued under Sec. 2.202 the time period provided 
therein.
    (c) Nontimely filings. (1) Nontimely requests and/or petitions and 
contentions will not be entertained absent a determination by the 
Commission, the presiding officer or the Atomic Safety and Licensing 
Board designated to rule on the request and/or petition and contentions 
that the request and/or petition should be granted and/or the 
contentions should be admitted based upon a balancing of the following 
factors to the extent that they apply to the particular nontimely 
filing:
    (i) Good cause, if any, for the failure to file on time;
    (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;
    (iv) The possible effect of any order that may be entered in the 
proceeding on the requestor's/petitioner's interest;
    (v) The availability of other means whereby the requestor's/
petitioner's interest will be protected;
    (vi) The extent to which the requestor's/petitioner's interests will 
be represented by existing parties;
    (vii) The extent to which the requestor's/petitioner's participation 
will broaden the issues or delay the proceeding; and
    (viii) The extent to which the requestor's/petitioner's 
participation may reasonably be expected to assist in developing a sound 
record.
    (2) The requestor/petitioner shall address the factors in paragraphs 
(c)(1)(i) through (c)(1)(viii) of this section in its nontimely filing.
    (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) State, local governmental body, and affected, Federally-
recognized Indian Tribe. (i) A State, local governmental body (county, 
municipality or other subdivision), and any affected Federally-
recognized Indian Tribe that desires to participate as a party in the 
proceeding shall submit a request for hearing/petition to intervene. The 
request/petition must meet the requirements of this section (including 
the contention requirements in paragraph (f) of this section), except 
that a State, local governmental body or affected Federally-recognized 
Indian Tribe that wishes to be a party in a proceeding for a facility 
located within its boundaries need not address the standing requirements 
under this paragraph. The State, local governmental body, and affected 
Federally-recognized Indian Tribe shall, in its request/petition, each 
designate a single representative for the hearing.
    (ii) The Commission, the presiding officer or the Atomic Safety and 
Licensing Board designated to rule on requests for hearings or petitions 
for leave to intervene will admit as a party to a 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

[[Page 46]]

affected Federally-recognized Indian Tribe. In determining the request/
petition of a State, local governmental body, and any affected 
Federally-recognized Indian Tribe that wishes to be a party in a 
proceeding for a facility located within its boundaries, the Commission, 
the presiding officer or the Atomic Safety and Licensing Board 
designated to rule on requests for hearings or petitions for leave to 
intervene shall not require a further demonstration of standing.
    (iii) 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.
    (3) The Commission, the presiding officer, or the Atomic Safety and 
Licensing Board designated to rule on requests for hearing and/or 
petitions for leave to intervene will determine whether the petitioner 
has an interest affected by the proceeding considering the factors 
enumerated in Sec. 2.309(d)(1)-(2), among other things. 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--
    (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;
    (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;

[[Page 47]]

    (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; and
    (vi) 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.
    (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, the petitioner shall file contentions 
based on the applicant's environmental report. The petitioner may amend 
those contentions or file new contentions if there are data or 
conclusions in the NRC draft or final environmental impact statement, 
environmental assessment, or any supplements relating thereto, that 
differ significantly from the data or conclusions in the applicant's 
documents. Otherwise, contentions may be amended or new contentions 
filed after the initial filing only with leave of the presiding officer 
upon a showing that--
    (i) The information upon which the amended or new contention is 
based was not previously available;
    (ii) The information upon which the amended or new contention is 
based is materially different than information previously available; and
    (iii) The amended or new contention has been submitted in a timely 
fashion based on the availability of the subsequent information.
    (3) If two or more requestors/petitioners seek to co-sponsor a 
contention, the requestors/petitioners shall jointly designate a 
representative who 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 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) Answers to requests for hearing and petitions to intervene. 
Unless otherwise specified by the Commission, the presiding officer, or 
the Atomic Safety and Licensing Board designated to rule on requests for 
hearings or petitions for leave to intervene--
    (1) The applicant/licensee, the NRC staff, and any other party to a 
proceeding may file an answer to a request for a hearing, a petition to 
intervene and/or proffered contentions within twenty-five (25) days 
after service of the request for hearing, petition and/or contentions. 
Answers should address, at a minimum, the factors set forth in 
paragraphs (a) through (g) of this section insofar as these sections 
apply to the filing that is the subject of the answer.
    (2) The requestor/petitioner may file a reply to any answer withing 
seven (7) days after service of that answer.

[[Page 48]]

    (3) No other written answers or replies will be entertained.
    (i) Decision on request/petition. The presiding officer shall, 
within forty-five (45) days after the filing of answers and replies 
under paragraph (h) of this section, issue a decision on each request 
for hearing/petition to intervene, absent an extension from the 
Commission.



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.
    (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

[[Page 49]]

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) 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.



Sec. 2.311  Interlocutory review of rulings on requests for 
hearing/petitions to intervene and selection of hearing procedures.

    (a) An order of the presiding officer or of the Atomic Safety and 
Licensing Board on a request for hearing or a petition to intervene may 
be appealed to the Commission, only in accordance with the provisions of 
this section, within ten (10) 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 ten (10) days after service 
of the appeal. The supporting brief and any answer must conform to the 
requirements of Sec. 2.341(c)(2). No other appeals from rulings on 
requests for hearings are allowed.
    (b) An order denying a petition to intervene and/or request for 
hearing is appealable by the requestor/petitioner on the question as to 
whether the request and/or petition should have been granted.
    (c) An order granting a petition to intervene and/or request for 
hearing is appealable by a party other than the requestor/petitioner on 
the question as to whether the request/petition should have been wholly 
denied.
    (d) 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.



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.

[[Page 50]]

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 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

[[Page 51]]

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 ten (10) 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 
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.



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 
affected, Federally-recognized Indian Tribe, which has not been admitted 
as a party under Sec. 2.309, a reasonable opportunity to participate in 
a hearing. Each State, local governmental body, and affected Federally-
recognized Indian Tribe shall, in its request to participate in a 
hearing, each 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

[[Page 52]]

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 it 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 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.



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 of Nuclear Reactor Regulation or the Director 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

[[Page 53]]

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.



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 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) Certify questions to the Commission for its determination, 
either in the presiding officer's discretion, or on motion of a party 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) Take any other action consistent with the Act, this chapter, and 
5 U.S.C. 551-558.



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

[[Page 54]]

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 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

[[Page 55]]

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
    (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) Presentation and disposition. All motions must be addressed to 
the Commission or other designated presiding officer. A motion 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, prompt decision is necessary to 
prevent detriment to the public interest or unusual delay or expense, or 
if the presiding officer determines that the decision or ruling involves 
a novel issue that merits Commission review at the earliest opportunity, 
the presiding officer may refer the ruling promptly to the Commission. 
The presiding officer must notify the parties of the referral either by 
announcement on-the-record or by written notice if the hearing is not in 
session.
    (2) A party may petition the presiding officer to certify an issue 
to the Commission for early review. The presiding officer shall apply 
the alternative standards of Sec. 2.341(f) in ruling on the petition 
for certification. No

[[Page 56]]

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.



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 which relates to a contention not previously 
in controversy among the parties must also satisfy the requirements for 
nontimely contentions in Sec. 2.309(c).



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.
    (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

[[Page 57]]

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 of the official transcript 
may be made only in the manner provided by this paragraph. Corrections 
ordered or approved by the presiding officer must be included in the 
record as an appendix. When so incorporated, the Secretary shall make 
the necessary physical corrections in the official transcript so that it 
will incorporate the changes ordered. In making corrections, pages may 
not be substituted but, to the extent practicable, corrections must be 
made by running a line through the matter to be changed without 
obliteration and writing the matter as changed immediately above. If the 
correction consists of an insertion, it must be added by rider or 
interlineation as near as possible to the text which is intended to 
precede and follow it.



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 of reasonable 
limits on the time allowed for presenting direct and, where permitted, 
cross-examination evidence;
    (7) The disposition of pending motions;

[[Page 58]]

    (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 fair and expeditious resolution of the 
issues sought to be adjudicated by the parties in the proceeding.

[[Page 59]]

    (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 60]]

    (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 party 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 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 party 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 party 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 61]]

(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 party to an initial or renewal licensing proceeding may 
file a petition for rulemaking under Sec. 2.802.



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 subpart 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 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/or provide, to the 
extent available (but excluding those documents for which there is a 
claim of privilege or protected status):
    (1) The application and/or applicant/licensee requests associated 
with the application or proposed action that is the subject of the 
proceeding;
    (2) NRC correspondence with the applicant or licensee 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) supporting the NRC 
staff's review of the application or proposed action that is the subject 
of the proceeding;
    (4) Any NRC staff documents (except those documents for which there 
is a claim of privilege or protected status) representing the NRC 
staff's determination on the application or proposal that is the subject 
of the proceeding; 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 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

[[Page 62]]

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, and any 
information or documents that are subsequently developed or obtained 
must be disclosed within fourteen (14) days.
    (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) 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.



Sec. 2.337  Evidence at a hearing.

    (a) 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.
    (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

[[Page 63]]

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 of Nuclear Reactor Regulation or Director 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/controverted matter prepared in advance of the completion of 
the safety evaluation;
    (iii) Any NRC staff statement of position on the contention/
controverted matter provided to the presiding officer under Sec. 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 of Nuclear Reactor Regulation or Director of Nuclear 
Material Safety and Safeguards, as appropriate, or his or her designee 
if there is any, but only if there are contentions/controverted matters 
with respect to the adequacy of the environmental impact statement or 
environmental assessment.
    (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/controverted matter prepared in advance of the completion of 
the safety evaluation;
    (iii) Any NRC staff statement of position on the contention/
controverted 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 of Nuclear Reactor Regulation or Director of Nuclear 
Material Safety and Safeguards, as appropriate, or his or her designee 
if there is any, but only if there are contentions/controverted matters 
with respect to the adequacy of the environmental impact statement or 
environmental assessment.



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.

[[Page 64]]

    (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.
    (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

[[Page 65]]

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 or amendment of a construction permit or 
construction authorization, or the issuance of an operating license or 
provisional operating authorization.



Sec. 2.340  Initial decision in contested proceedings on applications 
for facility operating licenses; immediate effectiveness of initial 
decision directing issuance or amendment of construction permit or 
operating license.

    (a) Production or utilization facility operating license. In any 
initial decision in a contested proceeding on an application for an 
operating 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 to the proceeding and on 
matters which have been determined to be the issues in the proceeding by 
the Commission or the presiding officer. Matters not put into 
controversy by the parties will be examined and decided by the presiding 
officer only where he or she determines that a serious safety, 
environmental, or common defense and security matter exists, and the 
Commission approves such examination and decision upon referral of the 
question by the presiding officer. Depending on the resolution of those 
matters, the Director of Nuclear Reactor Regulation or Director of 
Nuclear Material Safety and Safeguards, as appropriate, after making the 
requisite findings, will issue, deny or appropriately condition the 
license.
    (b) Immediate effectiveness of certain decisions. Except as provided 
in paragraphs (d) through (g) of this section, or as otherwise ordered 
by the Commission in special circumstances, an initial decision 
directing the issuance or amendment of a construction permit, a 
construction authorization, an operating license or a license under 10 
CFR Part 72 to store spent fuel in an independent spent fuel storage 
installation (ISFSI) at a reactor site is effective immediately 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, subject to review thereof and further decision by the 
Commission upon petition for review filed by any party under Sec. 2.341 
or upon its own motion.
    (c) Issuance of license after initial decision. Except as provided 
in paragraphs (d) through (g) of this section, or as otherwise ordered 
by the Commission in special circumstances, the Director of Nuclear 
Reactor Regulation or Director of Nuclear Material Safety and 
Safeguards, as appropriate, notwithstanding the filing or granting of a 
petition for review, shall issue a construction permit, a construction 
authorization, an operating license, or a license under 10 CFR part 72 
to store spent fuel in an independent spent fuel storage installation at 
a reactor site, or amendments thereto, authorized by an initial 
decision, within ten (10) days from the date of issuance of the 
decision.

[[Page 66]]

    (d) Immediate effectiveness of initial decisions on a ISFSI and MRS. 
An initial decision directing the issuance of an initial license 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 
becomes effective only upon order of the Commission. The Director of 
Nuclear Material Safety and Safeguards may not issue an initial license 
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 
until expressly authorized to do so by the Commission.
    (e) [Reserved].
    (f) Nuclear power reactor construction permits--(1) Presiding 
officers. Presiding officers shall hear and decide all issues that come 
before them, indicating in their decisions the type of licensing action, 
if any, which their decision would authorize. The presiding officer's 
decisions concerning construction permits are not effective until the 
Commission actions outlined in paragraph (f)(2) of this section have 
taken place.
    (2) Commission. Within sixty (60) days of the service of any 
presiding officer decision that would otherwise authorize issuance of a 
construction permit, the Commission will seek to issue a decision on any 
stay motions that are timely filed. These motions must be filed as 
provided by Sec. 2.341. For the purpose of this paragraph, a stay 
motion is one that seeks to defer the effectiveness of a presiding 
officer decision beyond the period necessary for the Commission action 
described herein. If no stay papers are filed, the Commission will, 
within the same time period (or earlier if possible), analyze the record 
and construction permit decision below on its own motion and will seek 
to issue a decision on whether a stay is warranted. However, the 
Commission will not decide that a stay is warranted without giving the 
affected parties an opportunity to be heard. The initial decision will 
be considered stayed pending the Commission's decision. In deciding 
these stay questions, the Commission shall employ the procedures set out 
in Sec. 2.342.
    (g) Nuclear power reactor operating licenses--(1) Presiding 
officers. Presiding officers shall hear and decide all issues that come 
before them, indicating in their decisions the type of licensing action, 
if any, which their decision would authorize. A presiding officer's 
decision authorizing issuance of an operating license may not become 
effective if it authorizes operating at greater than five (5) percent of 
rated power until the Commission actions outlined in paragraph (g)(2) of 
this section have taken place. If a decision authorizes operation up to 
five (5) percent, the decision is effective and the Director shall issue 
the appropriate license in accordance with paragraph (c) of this 
section.
    (2) The Commission. (i) Reserving the power to step in at an earlier 
time, the Commission will, upon receipt of the presiding officer's 
decision authorizing issuance of an operating license, other than a 
decision authorizing only fuel loading and low power (up to five (5) 
percent of rated power) testing, review the matter on its own motion to 
determine whether to stay the effectiveness of the decision. An 
operating license decision will be stayed by the Commission, insofar as 
it authorizes other than fuel loading and low power testing, if it 
determines that it is in the public interest to do so, based on a 
consideration of the gravity of the substantive issue, the likelihood 
that it has been resolved incorrectly below, the degree to which correct 
resolution of the issue would be prejudiced by operation pending review, 
and other relevant public interest factors.
    (ii) For operating license decisions other than those authorizing 
only fuel loading and low power testing consistent with the target 
schedule set forth below, the parties may file brief comments with the 
Commission pointing out matters which, in their view, pertain to the 
immediate effectiveness issue. To be considered, these comments must be 
received within ten (10) days of the presiding officer's decision. 
However, the Commission may dispense with comments by so advising the 
parties. An extensive stay will not

[[Page 67]]

be issued without giving the affected parties an opportunity to be 
heard.
    (iii) The Commission intends to issue a stay decision within thirty 
(30) days of receipt of the presiding officer's decision. The presiding 
officer's initial decision will be considered stayed pending the 
Commission's decision insofar as it may authorize operations other than 
fuel loading and low power (up to five (5) percent of rated power) 
testing.
    (iv) In announcing a stay decision, the Commission may allow the 
proceeding to run its ordinary course or give instructions as to the 
future handling of the proceeding. Furthermore, the Commission may, in a 
particular case, determine that compliance with existing regulations and 
policies may no longer be sufficient to warrant approval of a license 
application and may alter those regulations and policies.
    (h) Lack of prejudice of Commission effectiveness decision. The 
Commission's effectiveness determination is entirely without prejudice 
to proceedings under Sec. Sec. 2.341 or 2.342.



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

    (a)(1) Except for requests for review or appeals of actions under 
Sec. 2.311 or in a proceeding on the high-level radioactive waste 
repository (which are governed by Sec. 2.1015), review of decisions and 
actions of a presiding officer are treated under this section.
    (2) Within forty (40) days after the date of a decision or action by 
a presiding officer, or within forty (40) 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 fifteen (15) days after service of a full or partial 
initial decision by a presiding officer, and within fifteen (15) 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.
    (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 ten (10) days 
after service of a petition for review, file an answer supporting or 
opposing Commission review. This answer may not be longer than twenty-
five (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 five (5) days of service of any answer. 
This reply brief may not be longer than five (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

[[Page 68]]

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 a petition for review is granted, the Commission will 
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.
    (2) Unless the Commission orders otherwise, any briefs on review may 
not exceed thirty (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 ten 
(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 question certified to the Commission 
under Sec. 2.319(l), or a ruling referred or issue certified to the 
Commission under Sec. 2.323(f), will be reviewed if the certification 
or referral raises significant and novel legal or policy issues, and 
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.



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

[[Page 69]]

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.



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 papers are submitted to the Commission 
itself, as opposed to the 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

[[Page 70]]

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. Sec. 2.311 and 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 minor procedural matters.



Sec. 2.347  Ex parte communications.

    In any proceeding under this subpart--
    (a) 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.
    (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), 2.204, 
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. Sec. 2.104(a), 2.105(e)(2), 2.202(c), 2.204, 2.205(e), or 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.

[[Page 71]]



Sec. 2.348  Separation of functions.

    (a) In any proceeding under this subpart, any NRC officer or 
employee engaged in the performance of any investigative or litigating 
function in that proceeding or in a factually related proceeding may not 
participate in or advise a Commission adjudicatory employee about the 
initial or final decision on any disputed issue in that proceeding, 
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 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), 2.204, 
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), 2.204, 2.205(e), or 2.312.
    (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.
    (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

[[Page 72]]

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.



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,\1\ 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, or order, 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\Such records and documents do not include handwritten notes and 
drafts.
---------------------------------------------------------------------------

    (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 which would 
not be available by law to a party other than an agency in litigation 
with the Commission;
    (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

[[Page 73]]

    (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 (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 top of the first page of the document and the top of each 
page containing such information must be marked 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 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 at the top 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. Such statement shall 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 paper. 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

[[Page 74]]

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.
    (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;

[[Page 75]]

    (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 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).



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

    Source: 40 FR 2976, Jan. 17, 1975, 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 
part 52 of this chapter, for licenses to construct and operate nuclear 
power reactors of essentially the same design to be located at different 
sites.

[40 FR 2976, Jan. 17, 1975, as amended at 54 FR 15398, Apr. 18, 1989]



Sec. 2.401  Notice of hearing on applications pursuant to appendix N 
of part 52 for construction permits.

    (a) In the case of applications pursuant to appendix N of part 52 of 
this chapter for construction permits for nuclear power reactors of the 
type described in Sec. 50.22 of this chapter, 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.

[40 FR 2976, Jan. 17, 1975, as amended at 54 FR 15398, Apr. 18, 1989]



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

    (a) In the case of applications under appendix N of part 52 of this 
chapter for construction permits for nuclear power reactors of a type 
described in Sec. 50.22 of this chapter, 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 Sec. 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

[[Page 76]]

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.

[40 FR 2976, Jan. 17, 1975, as amended at 43 FR 17801, Apr. 26, 1978; 54 
FR 15398, Apr. 18, 1989; 69 FR 2256, Jan. 14, 2004; 70 FR 61887, Oct. 
27, 2005]



Sec. 2.403  Notice of proposed action on applications for operating 
licenses pursuant to appendix N of part 52.

    In the case of applications pursuant to appendix N of part 52 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 
Director of Nuclear Reactor Regulation 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.

[40 FR 2976, Jan. 17, 1975, as amended at 54 FR 15398, Apr. 18, 1989]



Sec. 2.404  Hearings on applications for operating licenses pursuant 
to appendix N of part 52.

    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 52 
of this chapter with respect to a specific reactor(s) at a specific site 
and the Commission or an atomic safety and licensing board designated by 
the Commission or by the Chairman of the Atomic Safety and Licensing 
Board Panel has issued a notice of hearing or other appropriate order, 
the Commission or the atomic safety and licensing board 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.

[40 FR 2976, Jan. 17, 1975, as amended at 54 FR 15398, Apr. 18, 1989]



Sec. 2.405  Initial decisions in consolidated hearings.

    At the conclusion of any hearing held under this subpart, the 
presiding officer will render a partial initial decision that may be 
appealed under Sec. 2.341. No construction permit or full power 
operating license 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.

[69 FR 2256, Jan. 14, 2004]



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 appendix N of part 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.

[40 FR 2976, Jan. 17, 1975, as amended at 54 FR 15398, Apr. 18, 1989]



Sec. 2.407  Applicability of other sections.

    The provisions of subparts A and G relating to construction permits 
and operating licenses apply, respectively, to construction permits and 
operating licenses subject to this subpart, except as 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

[[Page 77]]

which involve the consideration in separate hearings of an application 
for a license to manufacture nuclear power reactors pursuant to appendix 
M of part 52 of this chapter, and applications for construction permits 
and operating licenses for nuclear power reactors which have been the 
subject of such an application for a license to manufacture such 
facilities (manufacturing license).

[40 FR 2976, Jan. 17, 1975, as amended at 54 FR 15398, Apr. 18, 1989]



Sec. 2.501  Notice of hearing on application pursuant to appendix M 
of part 52 for a license to manufacture nuclear power reactors.

    (a) In the case of an application pursuant to appendix M 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 thirty (30) days prior to 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 (30) day 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 issues stated in the notice of hearing pursuant to paragraph 
(a) of this section will not involve consideration of the particular 
sites at which any of the nuclear power reactors to be manufactured will 
be located and operated. Except as the Commission determines otherwise, 
the notice of hearing will state:
    (1) That, if the proceeding is a contested proceeding, the presiding 
officer will consider the following issues: \2\
---------------------------------------------------------------------------

    \2\ Issues (i) and (vi) are the issues pursuant to the Atomic Energy 
Act of 1954, as amended. Issue (vii) is the issue pursuant to the 
National Environmental Policy Act of 1969.
---------------------------------------------------------------------------

    (i) Whether the applicant has described the proposed design of, and 
the site parameters postulated for, the reactor(s), 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;
    (ii) Whether such further technical or design information as may be 
required to complete the design report and which can reasonably be left 
for later consideration, will be supplied in a supplement to the design 
report;
    (iii) Whether 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;
    (iv) Whether on the basis of the foregoing, there is reasonable 
assurance that (A) such safety questions will be satisfactorily resolved 
before any of the proposed nuclear power reactors are removed from the 
manufacturing site, and (B) taking into consideration the site criteria 
contained in part 100 of this chapter, the proposed reactor(s) can be 
constructed and operated at sites having characteristics that fall 
within the site parameters postulated for the design of the reactor(s) 
without undue risk to the health and safety of the public;
    (v) Whether the applicant is technically and financially qualified 
to design and manufacture the proposed reactor(s);
    (vi) Whether the issuance of a license for manufacture of the 
reactor(s) will be inimical to the common defense and security or to the 
health and safety of the public; and
    (vii) Whether, in accordance with the requirements of subpart A of 
part 51

[[Page 78]]

and appendix M of part 52 of this chapter, the license should be issued 
as proposed.
    (2) That, if the proceeding is not a contested proceeding, the 
presiding officer will determine (i) without conducting a de novo 
evaluation of the application, whether the application and the record of 
the proceeding contain sufficient information, and the review of the 
application by the Commission's staff has been adequate to support 
affirmative findings on paragraphs (b)(1) (i) through (v) of this 
section and a negative finding on paragraph (b)(1)(vi) of this section 
proposed to be made and the issuance of the license to manufacture 
proposed by the Director of Nuclear Reactor Regulation, and (ii) whether 
the review conducted by the Commission pursuant to the National 
Environmental Policy Act (NEPA) has been adequate.
    (3) That, regardless of whether the proceeding is contested or 
uncontested, the presiding officer will, in accordance with subpart A of 
part 51 and paragraph 3 of appendix M of part 52 of this chapter,
    (i) Determine whether the requirements of section 102(2) (A), (C) 
and (E) of the National Environmental Policy Act and subpart A of part 
51 of this chapter have been complied with in the proceeding;
    (ii) Independently consider the final balance among conflicting 
factors contained in the record of the proceeding with a view to 
determining the appropriate action to be taken; and
    (iii) Determine whether the manufacturing license should be issued, 
denied or appropriately conditioned to protect environmental values.
    (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]



Sec. 2.502  Notice of hearing on application for a permit to construct 
a nuclear power reactor manufactured pursuant to a Commission license 
issued pursuant to appendix M of part 52 of this chapter at the site 
at which the reactor is to be operated.

    The issues stated for consideration in the notice of hearing on an 
application for a permit to construct a nuclear power reactor(s) which 
is the subject of an application for a manufacturing license pursuant to 
appendix M of part 52 of this chapter, will be those stated in Sec. 
2.104(b) and, in addition, whether the site on which the facility is to 
be operated falls within the postulated site parameters specified in the 
relevant application for a manufacturing license.

[40 FR 2976, Jan. 17, 1975, as amended at 54 FR 15398, Apr. 18, 1989]



Sec. 2.503  Finality of decisions on separate issues.

    Notwithstanding any other provision of this chapter, no matter which 
has been resolved at an earlier stage of the licensing process which 
involves a manufacturing license, a permit to construct a reactor for 
which a manufacturing license is sought, a license to operate such a 
reactor, and any amendment to such permit or licenses shall be 
determined to be at issue in any subsequent state of the licensing 
process except on the basis of significant new information that 
substantially affects the conclusion(s) reached at the earlier stage or 
other good cause.



Sec. 2.504  Applicability of other sections.

    The provisions of subparts A and G relating to construction permits 
apply to manufacturing licenses subject to this subpart, with respect to 
matters of radiological health and safety, environmental protection, and 
the common defense and security, except that Sec. 2.104 (a) and (b) do 
not apply to manufacturing licenses. The provisions of subparts A and G 
relating to construction permits and operating licenses apply, 
respectively, to construction permits and operating licenses subject to 
this subpart, except as qualified by the provisions of this subpart.

[[Page 79]]



Subpart F_Additional Procedures Applicable to Early Partial Decisions on 
 Site Suitability Issues in Connection With an Application for a Permit 
               To Construct Certain Utilization Facilities

    Source: 42 FR 22885, May 5, 1977, 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.

[49 FR 9401, Mar. 12, 1984]



Sec. 2.601  Applicability of other sections.

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



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.

    (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 Nuclear Reactor Regulation 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 thirty (30) days.
    (b)(1) The Director of Nuclear Reactor Regulation will accept for 
docketing an application for a construction permit for a utilization 
facility which is subject to Sec. 51.20(b) of this chapter and is of 
the type specified in Sec. 50.21(b) (2) or (3) or Sec. 50.22 or 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 Nuclear Reactor Regulation that they 
are complete.
    (c) If part one of the application is docketed, the Director of 
Nuclear Reactor Regulation 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, and in the 
case of applications filed under section 103 of the Act, states that a 
person who wishes to have his views on the antitrust aspects of the 
application presented to the Attorney General for consideration shall 
submit

[[Page 80]]

such views in accordance with a subsequent notice that will be published 
in the Federal Register. In the case of a nuclear power reactor, such 
subsequent notice will be published following submission of the 
information required by Sec. 50.33a.

[42 FR 22885, May 5, 1977, as amended at 49 FR 9401, Mar. 12, 1984]



Sec. 2.604  Notice of hearing on application for early review of site 
suitability issues.

    (a) Where an applicant for a construction permit for a utilization 
facility subject to this subpart 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 
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 the 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.

[42 FR 22885, May 5, 1977, as amended by 69 FR 2256, Jan. 14, 2004]



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 sixty (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)

[[Page 81]]

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.

[42 FR 22885, May 5, 1977, as amended at 49 FR 9401, Mar. 12, 1984]



Sec. 2.606  Partial decisions on site suitability issues.

    (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 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 five 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 five year period 
during which a partial decision shall remain in effect for a reasonable 
period of time not to exceed one year.
---------------------------------------------------------------------------

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

[42 FR 22885, May 5, 1977, as amended at 49 FR 9401, Mar. 12, 1984; 69 
FR 2256, Jan. 14, 2004]



                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,

[[Page 82]]

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.
    (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

[[Page 83]]

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 or directed by the presiding 
officer, these disclosures must be made within forty-five (45) days 
after the issuance of a prehearing conference order following the 
initial prehearing conference specified in Sec. 2.329. A party shall 
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 the sufficiency of another party's disclosures, or 
because another party has not made its disclosures.
    (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

[[Page 84]]

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.
    (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) A party is under a duty to supplement at appropriate intervals 
its disclosures under paragraph (a) of this section within a reasonable 
time after a party learns that in some material respect the information 
disclosed is 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.
    (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.



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

[[Page 85]]

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 alter the limits in these rules 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:
    (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.

[[Page 86]]

    (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 any party or person provide or permit discovery.
    (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

[[Page 87]]

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 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

[[Page 88]]

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.



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.

[[Page 89]]

    (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 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

[[Page 90]]

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
    (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.
    (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

[[Page 91]]

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) In the case of requested documents and records (including 
Safeguards Information referred to in sections 147 and 181 of the Atomic 
Energy Act, as amended) exempt from disclosure under Sec. 2.390, but 
whose disclosure is found by the presiding officer to be necessary to a 
proper decision in the proceeding, any order to the Executive Director 
for Operations or a delegee of the Executive Director for Operations, to 
produce the document or records (or any other order issued ordering 
production of the document or records) may contain any protective terms 
and conditions (including affidavits of non-disclosure) as may be 
necessary and appropriate to limit the disclosure to parties in the 
proceeding, to interested States and other governmental entities 
participating under Sec. 2.315(c), and to their qualified witnesses and 
counsel. When Safeguards Information protected from disclosure under 
section 147 of the Atomic Energy Act, as amended, is received and 
possessed by a party other than the Commission staff, it must also be 
protected according to the requirements of Sec. 73.21 of this chapter. 
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. 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 an order pertaining to the disclosure of Safeguards 
Information protected from disclosure under section 147 of the Atomic 
Energy Act, as amended, may be subject to a civil penalty imposed under 
Sec. 2.205. For the purpose of imposing the criminal penalties 
contained in Section 223 of the Atomic Energy Act, as amended, any order 
issued pursuant to this paragraph with respect to Safeguards Information 
is considered to be an order issued under Section 161.b of the Atomic 
Energy Act.
    (g) A ruling by the presiding officer or the Commission for the 
production of a record or document will specify

[[Page 92]]

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.



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 twenty (20) days 
after the close of discovery. The moving party shall attach 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. Any other party may serve an answer supporting or opposing the 
motion, with or without affidavits, within twenty (20) days after 
service of the motion. The party shall attach 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 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 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 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.
    (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

[[Page 93]]

whether the motion is granted, or denied, and the bases therefore.



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 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

[[Page 94]]

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 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.

[[Page 95]]



                          Subpart H_Rulemaking



Sec. 2.800  Scope of rulemaking.

    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.

[35 FR 11459, July 17, 1970]



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.



Sec. 2.802  Petition for rulemaking.

    (a) Any interested person may petition the Commission to issue, 
amend or rescind any regulation. The petition should be addressed to the 
Secretary, Attention: Rulemakings and Adjudications Staff, and sent 
either by mail addressed to the 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; 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/eie.html, by calling (301) 415-6030, by e-mail to 
[email protected], or by writing the Office of Information Services, 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) A prospective petitioner may consult with the NRC before filing 
a petition for rulemaking by writing to the Chief, Rules and Directives 
Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. A 
prospective petitioner also may telephone the Rules and Directives 
Branch on (301) 415-7163, or toll free on (800) 368-5642, or send e-mail 
to [email protected].
    (1) In any consultation prior to the filing of a petition for 
rulemaking, the assistance that may be provided by the NRC staff is 
limited to--
    (i) Describing the procedure and process for filing and responding 
to a petition for rulemaking;
    (ii) Clarifying an existing NRC regulation and the basis for the 
regulation; and
    (iii) Assisting the prospective petitioner to clarify a potential 
petition so that the Commission is able to understand the nature of the 
issues of concern to the petitioner.
    (2) In any consultation prior to the filing 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 prospective petition 
for rulemaking.
    (c) Each petition filed under this section shall:
    (1) Set forth a general solution to the problem or the substance or 
text of any proposed regulation or amendment, or specify the regulation 
which is to be revoked or amended;
    (2) State clearly and concisely the petitioner's grounds for and 
interest in the action requested;
    (3) Include a statement in support of the petition which shall set 
forth the specific issues involved, the petitioner's views or arguments 
with respect to those issues, relevant technical, scientific or other 
data involved which is reasonably available to the petitioner, and such 
other pertinent information as the petitioner deems necessary to support 
the action sought. In support of its petition, petitioner should note 
any specific cases of which petitioner is aware where the current rule 
is unduly burdensome, deficient, or needs to be strengthened.
    (d) The petitioner may request the Commission to suspend all or any 
part of any licensing proceeding to which the petitioner is a party 
pending disposition of the petition for rulemaking.
    (e) If it is determined that the petition includes the information 
required by paragraph (c) of this section and is

[[Page 96]]

complete, the Director, Division of Administrative Services, Office of 
Administration, or designee, will assign a docket number to the 
petition, will cause the petition to be formally docketed, and will make 
a copy of the docketed petition available at the NRC Web site, http://
www.nrc.gov. Public comment may be requested by publication of a notice 
of the docketing of the petition in the Federal Register, or, in 
appropriate cases, may be invited for the first time upon publication in 
the Federal Register of a proposed rule developed in response to the 
petition. Publication will be limited by the requirements of Section 181 
of the Atomic Energy Act of 1954, as amended, and may be limited by 
order of the Commission.
    (f) If it is determined by the Executive Director for Operations 
that the petition does not include the information required by paragraph 
(c) of this section and is incomplete, the petitioner will be notified 
of that determination and the respects in which the petition is 
deficient and will be accorded an opportunity to submit additional data. 
Ordinarily this determination will be made within 30 days from the date 
of receipt of the petition by the Office of the Secretary of the 
Commission. If the petitioner does not submit additional data to correct 
the deficiency within 90 days from the date of notification to the 
petitioner that the petition is incomplete, the petition may be returned 
to the petitioner without prejudice to the right of the petitioner to 
file a new petition.
    (g) The Director, Division of Administrative Services, Office of 
Administration, will prepare on a semiannual basis a summary of 
petitions for rulemaking before the Commission, including the status of 
each petition. A copy of the report will be available for public 
inspection and copying at the NRC Web site, http://www.nrc.gov, and/or 
at the NRC Public Document Room.

[44 FR 61322, Oct. 25, 1979, as amended at 46 FR 35487, July 9, 1981; 52 
FR 31609, Aug. 21, 1987; 53 FR 52993, Dec. 30, 1988; 54 FR 53315, Dec. 
28, 1989; 56 FR 10360, Mar. 12, 1991; 59 FR 44895, Aug. 31, 1994; 59 FR 
60552, Nov. 25, 1994; 62 FR 27495, May 20, 1997; 63 FR 15742, Apr. 1, 
1998; 64 FR 48949, Sept. 9, 1999; 68 FR 58799, Oct. 10, 2003]



Sec. 2.803  Determination of petition.

    No hearing will be held on the petition unless the Commission deems 
it advisable. If the Commission determines that sufficient reason 
exists, it will publish a notice of proposed rulemaking. In any other 
case, it will deny the petition and will notify the petitioner with a 
simple statement of the grounds of denial.



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.
    (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,

[[Page 97]]

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 papers 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 are 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 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]



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

[[Page 98]]

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 $5 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 $5 
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 121.402(b)(2)). 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]



  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.



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

[[Page 99]]

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 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

[[Page 100]]

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 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.

[[Page 101]]

    (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.
    (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

[[Page 102]]

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 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

[[Page 103]]

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 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.

[[Page 104]]

    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 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

[[Page 105]]

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 of 
this chapter.
    (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, 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]



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

[[Page 106]]

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]



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]

[[Page 107]]



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 participants, interested governmental 
participants and parties in the proceeding, or to their qualified 
witnesses and counsel. 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 
governmental participant, or party, other than the Commission staff, it 
shall also be protected according to the requirements of Sec. 73.21 of 
this chapter. 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. In addition to 
any other sanction that may be imposed by the Pre-License Application 
Presiding Officer for violation of an order pertaining to the disclosure 
of Safeguards Information protected from disclosure under section 147 of 
the

[[Page 108]]

Atomic Energy Act of 1954, as amended, the entity in violation may be 
subject to a civil penalty imposed pursuant to Sec. 2.205. For the 
purpose of imposing the criminal penalties contained in section 223 of 
the Atomic Energy Act of 1954, as amended, any order issued pursuant to 
this paragraph with respect to Safeguards Information shall be deemed to 
be an order 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]



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 [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

[[Page 109]]

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 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).

[[Page 110]]

    (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 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

[[Page 111]]

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 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.

[[Page 112]]

    (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 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

[[Page 113]]

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);
    (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,

[[Page 114]]

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 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

[[Page 115]]

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.

[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. 2.1019  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

[[Page 116]]

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.
    (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.

[[Page 117]]

    (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 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

[[Page 118]]

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 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, and 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 geologic 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

[[Page 119]]

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 
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]

[[Page 120]]



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 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

[[Page 121]]

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 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

[[Page 122]]

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.
    (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

[[Page 123]]

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]



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_Informal 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(f)(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

[[Page 124]]

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.



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 own review of the 
application or matter which is the subject of the hearing and as 
authorized by law, the NRC staff is expected to issue its approval or 
denial of the application promptly, or take other appropriate action on 
the underlying regulatory matter for which a hearing was provided. When 
the NRC staff takes its action, it shall notify the presiding officer 
and the parties to the proceeding of its action. That notice must 
include the NRC staff's position on the matters in controversy before 
the presiding officer with respect to the staff action. 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;
    (2) 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;
    (3) 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
    (4) 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 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.



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

[[Page 125]]

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.
    (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 forty-five (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, and affidavits 
to support statements of fact. 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.



Sec. 2.1206  Informal hearings.

    Hearings under this subpart will be oral hearings as described in 
Sec. 2.1207,

[[Page 126]]

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 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.

[[Page 127]]



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.



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 thirty 
(30) days of the close of the hearing or at such other time as the 
presiding officer directs.



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 forty (40) 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;

[[Page 128]]

    (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:
    (1) As provided in any order issued in accordance with Sec. 2.1211 
that stays the effectiveness of an initial decision; or
    (2) 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.



Sec. 2.1211  Immediate effectiveness of initial decision directing 
issuance or amendment of licenses under part 61 of this chapter.

    An initial decision directing the issuance of a license under part 
61 of this chapter (relating to land disposal of radioactive waste or 
any amendments to such a license authorizing actions which may 
significantly affect the health and safety of the public) will become 
effective only upon order of the Commission. The Director of Nuclear 
Material Safety and Safeguards may not issue a license under part 61 of 
this chapter, or any amendment to such a license that may significantly 
affect the health and safety of the public until expressly authorized to 
do so by the Commission.



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.
    (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.

[[Page 129]]



   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 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.

[69 FR 2270, Jan. 14, 2004]



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:
    (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. 2.1304  Hearing procedures.

    The procedures in this subpart will constitute the exclusive basis 
for hearings on license transfer applications for all NRC specific 
licenses.



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.

[[Page 130]]



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
    (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

[[Page 131]]

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) If the NRC staff desires to participate as a party, the staff 
shall notify the Presiding Officer and the parties and shall thereupon 
be deemed to be a party with all the rights and responsibilities of a 
party.



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 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

[[Page 132]]

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 to 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]



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 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.

[[Page 133]]

    (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 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]

[[Page 134]]



           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 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.

[[Page 135]]



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 own review of the 
application or matter which is the subject of the hearing and as 
authorized by law, the NRC staff is expected to issue its approval or 
denial of the application promptly, or take other appropriate action on 
the matter which is the subject of the hearing. When the NRC staff takes 
its action, it shall notify the presiding officer and the parties to the 
proceeding of its action. 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 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.



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

[[Page 136]]

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 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 (20) 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.



Sec. 2.1407  Appeal and Commission review of initial decision.

    (a)(1) Within fifteen (15) 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.

[[Page 137]]

    (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 fifteen (15) days 
after service of the appeal, file an answer supporting or opposing the 
appeal. The answer may not be longer than twenty (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;
    (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.



                     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

[[Page 138]]

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;
    (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

[[Page 139]]

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.



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;

[[Page 140]]

    (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.

                     Appendix A to Part 2 [Reserved]

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 
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

[[Page 141]]

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.
 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:

[[Page 142]]

 
 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.
 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]

                     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.

------------------------------------------------------------------------
 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.

[[Page 143]]

 
 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.
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.

[[Page 144]]

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.

Subpart D [Reserved]

 Subpart E_Enforcement of Nondiscrimination on the Basis of Handicap 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: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 
274, 73 Stat. 688, as amended (42 U.S.C. 2021); sec. 201, 88 Stat. 1242, 
as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 
note).
    Subpart A also issued under secs. 602-605, Pub. L. 88-352, 78 Stat. 
252, 253 (42 U.S.C. 2000d-1-2000d-4); sec. 401, 88 Stat. 1254 (42 U.S.C. 
5891).
    Subpart B also issued under sec. 504, Pub. L. 93-112, 87 Stat. 394 
(29 U.S.C. 706); sec. 119, Pub. L. 95-602, 92 Stat. 2984 (29 U.S.C. 
794); sec. 122, Pub. L. 95-602, 92 Stat. 2984 (29 U.S.C. 706(6)).
    Subpart C also issued under Title III of Pub. L. 94-135, 89 Stat. 
728, as amended (42 U.S.C. 6101).
    Subpart E also issued under 29 U.S.C. 794.

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

                           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 handicapped 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]

[[Page 145]]



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 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.

[[Page 146]]

    (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 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/eie.html, by calling (301) 415-6030, by e-
mail to [email protected], or by writing the Office of Information Services, 
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]



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

[[Page 147]]

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 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

[[Page 148]]

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 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

[[Page 149]]

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 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]

[[Page 150]]



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 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

[[Page 151]]

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 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.

[[Page 152]]



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.



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.

[[Page 153]]

    (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 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.

[[Page 154]]

    (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 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

[[Page 155]]

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.
    (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

[[Page 156]]

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 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) Handicapped 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

[[Page 157]]

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 handicapped person means: (1) With respect to 
employment, a handicapped person who, with reasonable accommodation, can 
perform essential functions of the job in question and (2) with respect 
to services, a handicapped 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 handicapped person, shall, on the basis of 
handicap, 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 handicap:
    (i) Deny a qualified handicapped person the opportunity to 
participate in or benefit from the aid, benefit, or service;
    (ii) Afford a qualified handicapped 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 handicapped 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 
handicapped persons or to any class of handicapped persons than is 
provided to others unless such action is necessary to provide qualified 
handicapped persons with aid, benefits, or services that are as 
effective as those provided to others;
    (v) Aid or perpetuate discrimination against a qualified handicapped 
person by providing significant assistance to any agency, organization, 
or person that discriminates on the basis of handicap in providing any 
aid, benefit, or service to beneficiaries of the recipient's program or 
activity;
    (vi) Deny a qualified handicapped person the opportunity to 
participate as a member of planning or advisory boards; or
    (vii) Otherwise limit a qualified handicapped 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 handicapped 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 handicapped persons to 
discrimination on the basis of handicap, (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 
handicapped 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 
handicapped persons

[[Page 158]]

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 handicapped 
persons.
    (c) The exclusion of nonhandicapped persons from aid, benefits, or 
services limited by Federal statute or Executive Order to handicapped 
persons or the exclusion of a specific class of handicapped persons from 
aid, benefits, or services limited by Federal statute or Executive Order 
to a different class of handicapped 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 handicapped 
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 handicapped person shall, on the basis of handicap, 
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 handicap 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 
handicap.
    (c) The prohibition against discrimination in employment applies to 
the following activities:
    (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 handicapped 
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 handicapped 
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 handicapped 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

[[Page 159]]

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 handicapped 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 handicapped 
persons or any class of handicapped 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 handicapped 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 handicap 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 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 handicapped person or as to the nature of severity of a handicap. 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 handicapped: 
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 handicap; 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

[[Page 160]]

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 handicapped persons and 
regarding necessary accommodations;
    (2) First aid and safety personnel may be informed, where 
appropriate, if the condition associated with the handicap 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 handicapped person shall, because a recipient's 
facilities are inaccessible to or unusable by handicapped 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 handicapped 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 
handicapped 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 
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 handicapped 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 handicapped 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 handicapped 
persons, or organizations representing handicapped 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 
handicapped persons;
    (2) Describe in detail the methods that will be used to make the 
facilities accessible to and usable by handicapped 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.

[[Page 161]]

    (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, handicapped 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 
handicapped persons. Alterations to existing facilities shall, to the 
maximum extent feasible, be designed and constructed to be readily 
accessible to and usable by handicapped 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 handicaps.
    (3) This section does not require recipients to make building 
alterations 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 handicap 
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 handicap 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 handicapped 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 handicapped 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 handicapped persons.
    (e) Self-evaluation. (1) A recipient shall as soon as practicable:

[[Page 162]]

    (i) Evaluate, with the assistance of interested persons, including 
handicapped persons or organizations representing handicapped 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 
handicapped persons or organizations representing handicapped persons, 
any policies and practices that do not meet the requirements of this 
subpart; and
    (iii) Take, after consultation with interested persons, including 
handicapped persons or organizations representing handicapped 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 handicap in violation of section 504 and this subpart. The 
notification shall 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 
handicap.



 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.

[[Page 163]]



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 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,

[[Page 164]]

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.

                        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

[[Page 165]]

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, 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

[[Page 166]]

    (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]



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.

[[Page 167]]

    (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 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--

[[Page 168]]

    (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 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 Handicap 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 handicap 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,

[[Page 169]]

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.
    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.
    Handicapped 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, 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.
    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 handicapped person means--
    (1) With respect to preschool, elementary, or secondary education 
services provided by the agency, a handicapped 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 handicapped 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 handicapped 
person who meets the essential eligibility requirements for 
participation in, or receipt of benefits from, that program or activity; 
and
    (4) Qualified handicapped person is defined for purposes of 
employment in 29

[[Page 170]]

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 handicapped persons or organizations representing handicapped 
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.



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 handicapped person shall, on the basis of handicap, 
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 handicap--
    (i) Deny a qualified handicapped person the opportunity to 
participate in or benefit from the aid, benefit, or service;
    (ii) Afford a qualified handicapped 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 handicapped 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 
handicapped persons or to any class of handicapped persons than is 
provided to others unless such action is necessary to provide qualified 
handicapped persons with aid, benefits, or services that are as 
effective as those provided to others;
    (v) Deny a qualified handicapped person the opportunity to 
participate as a member of planning or advisory boards; or
    (vi) Otherwise limit a qualified handicapped 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 handicapped person the 
opportunity to participate in programs or

[[Page 171]]

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 handicapped persons to discrimination on the 
basis of handicap; or
    (ii) Defeat or substantially impair accomplishment of the objectives 
of a program or activity with respect to handicapped 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 handicapped 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 handicapped persons.
    (5) The agency, in the selection of procurement contractors, may not 
use criteria that subject qualified handicapped persons to 
discrimination on the basis of handicap.
    (6) The agency may not administer a licensing or certification 
program in a manner that subjects qualified handicapped persons to 
discrimination on the basis of handicap, nor may the agency establish 
requirements for the programs or activities of licensees or certified 
entities that subject qualified handicapped persons to discrimination on 
the basis of handicap. 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 nonhandicapped persons from the benefits of a 
program limited by Federal statute or Executive order to handicapped 
persons or the exclusion of a specific class of handicapped persons from 
a program limited by Federal statute or Executive order to a different 
class of handicapped 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 handicapped 
persons.



Sec. Sec. 4.531-4.539  [Reserved]



Sec. 4.540  Employment.

    No qualified handicapped person shall, on the basis of handicap, 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 
handicapped person shall, because the agency's facilities are 
inaccessible to or unusable by handicapped 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 handicapped persons. This paragraph does 
not--
    (1) Necessarily require the agency to make each of its existing 
facilities accessible to and usable by handicapped 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

[[Page 172]]

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 handicapped 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 handicapped 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 
handicapped persons in the most integrated setting appropriate.
    (2) Historic preservation programs. In meeting the requirements of 
Sec. 4.550(a) in historic preservation programs, the agency shall give 
priority to methods that provide physical access to handicapped 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 handicapped 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 handicapped 
persons or organizations representing handicapped 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 handicapped 
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.

[[Page 173]]



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 
handicapped 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 handicapped 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 
handicapped 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 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, 
handicapped 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 
handicap 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

[[Page 174]]

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 handicapped 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 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]

 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.

[[Page 175]]

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.
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.

[[Page 176]]

    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 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

[[Page 177]]

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 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

[[Page 178]]

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).



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.

[[Page 179]]



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 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.

[[Page 180]]



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 
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.

[[Page 181]]



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 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

[[Page 182]]

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 
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

[[Page 183]]

    (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 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

[[Page 184]]

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 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.

[[Page 185]]

    (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.
    (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

[[Page 186]]

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.
    (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

[[Page 187]]

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 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

[[Page 188]]

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.



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;

[[Page 189]]

    (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 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

[[Page 190]]

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 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

[[Page 191]]

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]

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, 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.


[[Page 192]]


    Authority: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 
201, 88 Stat. 1242, as amended (42 U.S.C. 5841); Pub. L. 92-463, 86 
Stat. 770 (5 U.S.C. App.).

    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 Commitee 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 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,

[[Page 193]]

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;
    (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

[[Page 194]]

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, 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]



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

[[Page 195]]

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;
    (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

[[Page 196]]

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]



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.

[[Page 197]]

    (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]



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

[[Page 198]]

    (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;
    (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.

[[Page 199]]

    (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:
    (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

[[Page 200]]

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).
    (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.

[[Page 201]]

    (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.
    (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.

[[Page 202]]

    (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).
    (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.)

[[Page 203]]



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 Information Services 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]



PART 8_INTERPRETATIONS--Table of Contents




Sec.
8.1 Interpretation of section 152 of the Atomic Energy Act of 1954; 
          opinion of the General Counsel.
8.2 Interpretation of Price-Anderson Act, section 170 of the Atomic 
          Energy Act of 1954.
8.3 [Reserved]
8.4 Interpretation by the General Counsel: AEC jurisdiction over nuclear 
          facilities and materials under the Atomic Energy Act.
8.5 Interpretation by the General Counsel of Sec. 73.55 of this 
          chapter; illumination and physical search requirements.

    Authority: Secs. 152, 161, 68 Stat. 944, 948, as amended; 42 U.S.C. 
2182, 2201.



Sec. 8.1  Interpretation of section 152 of the Atomic Energy Act of 
1954; opinion of the General Counsel.

    (a) Inquiries have been received as to the applicability of the 
provisions of section 152 of the Atomic Energy Act of 1954 (68 Stat. 
944) to inventions or discoveries made or conceived in the course of 
activities under licenses issued by the Atomic Energy Commission.
    (b) In my [General Counsel, U.S. Atomic Energy Commission] opinion a 
license issued by the Atomic Energy Commission is not a ``contract, 
subcontract, arrangement or other relationship with the Commission'' as 
those terms are used in section 152 of the act. Hence, the mere fact 
that an invention or discovery is made by a licensee in the course of 
activities authorized by a license would not give the Commission rights 
under section 152 with respect to such invention or discovery. On the 
other hand, if a licensee has entered into a ``contract, subcontract, 
arrangement or other relationship with the Commission,'' inventions or 
discoveries made or conceived by the licensee under the contract or 
other relationship would come within the purview of section 152.
    (c) As used in this section, ``license'' means a license issued 
pursuant to Chapter 6 (Special Nuclear Material), 7 (Source Material), 8 
(Byproduct Material) or 10 (Atomic Energy Licenses) of the Atomic Energy 
Act of 1954, or a construction permit issued pursuant to section 185 of 
the act.

[21 FR 1414, Mar. 3, 1956]



Sec. 8.2  Interpretation of Price-Anderson Act, section 170 of the Atomic 
Energy Act of 1954.

    (a) It is my opinion that an indemnity agreement entered into by the 
Atomic Energy Commission under the authority of the Atomic Energy Act of 
1954 (42 U.S.C. 2011, et seq.), hereafter cited as ``the Act,'' as 
amended by Pub. L. 85-256 (the ``Price-Anderson Act'') 42 U.S.C. 2210 
indemnifies persons indemnified against public liability for bodily 
injury, sickness, disease or death, or loss of or damage to property, or 
for loss of use of property caused outside the United States by a 
nuclear incident occurring within the United States.
    (b) Section 170 authorizes the Commission to indemnify against 
``public liability'' as defined in section 11(u) of the Act. \1\ 
Coverage under the Act

[[Page 204]]

therefore is predicated upon ``public liability,'' and requires (1) 
``legal liability'' for (2) a ``nuclear incident.'' Determination of the 
Act's coverage, therefore, necessitates a finding that these two 
elements are present.
---------------------------------------------------------------------------

    \1\ Sec. 11u. ``The term `public liability' means any legal 
liability arising out of or resulting from a nuclear incident, except 
claims under State or Federal Workmen's Compensation Acts of employees 
of persons indemnified who are employed at the site of and in connection 
with the activity where the nuclear incident occurs, and except for 
claims arising out of an act of war. `Public Liability' also includes 
damage to property of persons indemnified: Provided, That such property 
is covered under the terms of the financial protection required, except 
property which is located at the site of and used in connection with the 
activity where the nuclear incident occurs.''
---------------------------------------------------------------------------

    (c) In the case of damage outside of the United States caused by a 
nuclear facility based in the United States there would be a ``nuclear 
incident'' as defined in section 11(o) since there would be an 
``occurrence within the United States causing * * * damage.'' \2\ The 
``occurrence'' would be ``within the United States'' since 
``occurrence'' is intended by the Act to be ``that event at the site of 
the licensed activity * * * which may cause damage rather than the site 
where the damage may perhaps be caused.'' (S. Rep. 296, 85th Cong., 1st 
Sess., p. 16 1957) (hereafter cited as Report). In section 11(o) an 
``occurrence'' is that which causes damage. It would be, therefore, an 
event taking place at the site. This definition of ``occurrence'' is 
referred to in the Report at page 22 and is crucial to the Act's placing 
of venue under section 170(e). \3\ 027 In its definition of ``nuclear 
incident.'' The Act makes no limitation upon the place where the damage 
is received but states only that the ``occurrence'' must be within the 
United States.
---------------------------------------------------------------------------

    \2\ Sec. 11o. ``The term `nuclear incident' means any occurrence 
within the United States causing bodily injury, sickness, disease, or 
death, or loss of or damage to property, or for loss of use of property, 
arising out of or resulting from the radioactive, toxic, explosive, or 
other hazardous properties of source, special nuclear, or byproduct 
material: * * *''
    \3\ ``In order to provide a framework for establishing the 
limitation of liability, the Commission or any person indemnified is 
permitted to apply to the appropriate district court of the United 
States which has venue in bankruptcy matters over the site of the 
nuclear incident. Again it should be pointed out that the site is where 
the occurrence takes place which gives rise to the liability, not the 
place where the damage may be caused * * * '' Report. p. 22.
---------------------------------------------------------------------------

    (d) Similarly, the requirement of ``legal liability'' would be met. 
The words of the Act impose no limitation that the liability be one for 
damage caused in the United States but, on the contrary, are exceedingly 
broad permitting indemnification for ``any legal liability.'' In the 
most exhaustive study of the subject, it is stated that the phrase ``any 
legal liability'' indicates that liability for damage outside the United 
States is covered by the Act. Atomic Industrial Forum, Financial 
Protection Against Atomic Hazards 61 n. 355 (1957).
    (e) Thus the precise language of the Act provides coverage for 
damage ensuing both within and without the United States arising out of 
an occurrence within the United States. There would be no occasion for 
doubt were it not for a single statement contained in the Report of the 
Joint Committee on Atomic Energy on the Price-Anderson Act. The Report 
states, at p. 16 that ``[i]f there is anything from a nuclear incident 
at the licensed activity which causes injury abroad, or if there is any 
activity abroad which causes further injury in the United States the 
situation will require further investigation at that time.'' This 
sentence follows an explicit and lengthy statement that the 
``occurrence'' is an event at the site of the activity:

    * * * The occurrence which is the subject of this definition is that 
event at the site of the licensed activity, or activity for which the 
Commission has entered into a contract, which may cause damage, rather 
than the site where the damage may perhaps be caused. This site must be 
within the United States. The suggested exclusion of facilities under 
license for export was not accepted. This is because the definition of 
``nuclear incident'' limits the occurrence causing damage to one within 
the United States. It does not matter what license may be applicable if 
the occurrence is within the United States. If there is anything from a 
nuclear incident at the licensed activity which causes injury abroad or 
if there is any activity abroad which causes further injury in the 
United States the situation will require further investigation by the 
Congress at that time * * *


Read literally, the last sentence would seem inconsistent with the 
preceding

[[Page 205]]

statement. It is, however, possible to read the sentence as consistent 
with the preceding statement if it is taken as indicating a recognition 
by Congress of the fact that the statutory limitation of liability to 
$500,000,000 would probably not limit claims by foreign residents to 
that amount in foreign courts and that therefore the persons indemnified 
were not fully protected against bankrupting claims, one of the primary 
purposes of the bill. \4\
---------------------------------------------------------------------------

    \4\ Atomic Industrial Forum, Financial Protection Against Atomic 
Hazards, The International Aspects, p. 52 (1959).
---------------------------------------------------------------------------

    (f) The point in question received scant consideration during the 
hearings preceding adoption of the bill held by the Joint Committee on 
Atomic Energy. A summary of the study of the Atomic Industrial Forum, 
cited above, was introduced into the record of the hearing and included 
a conclusion that the provisions of the bill seemed to cover the 
situation. \5\ That conclusion would seem entitled to more than ordinary 
weight since the Forum study received the careful consideration of the 
Joint Committee. \6\ and the study referenced a statement from the 1956 
Report very similar to the confusing statement in the 1957 Report noted 
above. \7\
---------------------------------------------------------------------------

    \5\ Hearings before the Joint Committee on Atomic Energy, 
Governmental Indemnity and Reactor Safety, 85th Cong., 1st Sess., p. 181 
(1957) (hereinafter referred to as ``Hearings.'')
    \6\ Hearings, p. 168.
    \7\ Hearings, p. 182.
---------------------------------------------------------------------------

    (g) There was also a rather ambiguous colloquy in the hearings 
between Representative Cole and Mr. Charles Haugh in which 
Representative Cole indicated that the Joint Committee

``* * * will do pretty well if we successfully protect the American 
people and property owners in this country without worrying about those 
that live abroad.'' \8\
---------------------------------------------------------------------------

    \8\ Hearings, p. 97. It is significant to note that Mr. Haugh stated 
at that point the problem of the reactor operator who is concerned with 
any type of liability. He noted that the insurance contracts would cover 
``* * * the instance where * * * something happen[ed] out of the country 
and a suit is brought in the United States on that.''
---------------------------------------------------------------------------

    (h) Congress, in enacting the Price-Anderson Indemnity Act added to 
section 2 of the Atomic Energy Act of 1954, a new subsection which 
stated, inter alia:

    In order * * * to encourage the development of the atomic energy 
industry, * * * the United States may make funds available for a portion 
of the damages suffered by the public from nuclear incidents and may 
limit the liability of those persons liable for such losses.


This statutory purpose is frustrated if the atomic energy industry is 
not protected from bankrupting liabilities for damages caused abroad by 
an accident occurring in the United States. \9\ In the Report, the Joint 
Committee on Atomic Energy made explicit mention of the fact that the 
private insurance to be provided for reactor operators included

[[Page 206]]

coverage for damage in Canada and Mexico and, at another point, noted 
the Committee's hope that the insurance contract in its final form would 
cover the same scope as the bill. \10\
---------------------------------------------------------------------------

    \9\ The Atomic Industrial Forum study notes that ``[T]o be adequate, 
the governmental indemnity must cover industry's liability to residents 
of the countries who suffer as a result of an accident at an 
installation based in the United States.'' p. 61. This is certainly the 
case and one of the major Congressional purposes is frustrated should 
the Act be said to be unclear on this point. The principal reason for 
the conclusion that there is coverage reached in the Forum study is the 
fact that Price-Anderson provides indemnity for ``any legal liability.'' 
Arthur Murphy, Director of the study, in a recent article, has stated 
that the confusing sentence in the Report is `` * * * inconsistent with 
the flat coverage of any legal liability by the indemnity.'' Murphy, 
Liability for Atomic Accidents and Insurance, in Law and Administration 
in Nuclear Energy 75 (1959). In the testimony before the Joint Committee 
last year, Professor Samuel D. Estep, one of three authors of the 
comprehensive study of Atoms and the Law apparently relying upon the 
legislative history, stated that the problem of a reactor accident in 
the United States causing damage in a foreign country was unclear, 
presumably since he considered the phrase ``any legal liability'' 
directed at a different problem. Hearings before the Joint Committee on 
Atomic Energy, Indemnity and Reactor Safety, 86th Cong., 1st Sess., p. 
77 (1959); Stason Estep, and Pierce, Atoms and the Law, 577 (1959). 
Professor Estep stated that there ``surely ought to be'' coverage and 
suggested a clarifying amendment. His statement that the phrase ``any 
legal liability'' covers only the question of time restrictions for 
claims seems to me erroneous since the language used, ``any legal 
liability,'' seems intentionally broad. Additionally, should this very 
narrow reading be given to admittedly broad statutory language, the 
Congressional purpose would be frustrated.
    \10\ Report, p. 11.
---------------------------------------------------------------------------

    (i) It is my opinion that since the language of the Act draws no 
distinction between damage received in the United States and that 
received abroad, none can properly be drawn. To read the Act as imposing 
such a limitation in the absence of statutory direction and in the light 
of an avowed Congressional intention to encourage the development of the 
atomic energy industry would be unwarranted. The confusing sentence 
cited in the Report must, therefore, be read consistently with the 
language of the Act in the manner suggested above, i.e., as recognizing 
Congressional inability to limit foreign liability, or must be ignored 
as inconsistent with the broad coverage of the statutory language.

[25 FR 4075, May 7, 1960]



Sec. 8.3  [Reserved]



Sec. 8.4  Interpretation by the General Counsel: AEC jurisdiction over 
nuclear facilities and materials under the Atomic Energy Act.

    (a) By virtue of the Atomic Energy Act of 1954, as amended, \11\ the 
individual States may not, in the absence of an agreement with the 
Atomic Energy Commission, regulate the materials described in the Act 
from the standpoint of radiological health and safety. Even States which 
have entered into agreements with the AEC lack authority to regulate the 
facilities described in the Act, including nuclear power plants and the 
discharge of effluents from such facilities, from the standpoint of 
radiological health and safety.
---------------------------------------------------------------------------

    \11\ Pub. L. 83-703, 68 Stat. 919.
---------------------------------------------------------------------------

    (b) The Atomic Energy Act of 1954 sets out a pattern for licensing 
and regulation of certain nuclear materials and facilities on the basis 
of the common defense and security and radiological health and safety. 
The regulatory pattern requires, in general, that the construction and 
operation of production facilities (nuclear reactors used for production 
and separation of plutonium or uranium-233 or fuel reprocessing plants) 
and utilization facilities (nuclear reactors used for production of 
power, medical therapy, research, and testing) and the possession and 
use of byproduct material (radioisotopes), source material (thorium and 
uranium ores), and special nuclear material (enriched uranium and 
plutonium, used as fuel in nuclear reactors), be licensed and regulated 
by the Commission. \12\ In carrying out its statutory responsibilities 
for the protection of the public health and safety from radiation 
hazards and for the promotion of the common defense and security, the 
AEC has promulgated regulations which establish requirements for the 
issuance of licenses (Parts 30-36, 40, 50, 70, 71, and 100 of this 
chapter) and specify standards for radiation protection (part 20 of this 
chapter).
---------------------------------------------------------------------------

    \12\ The terms ``byproduct material,'' ``source material,'' and 
``special nuclear material'' are defined in the Atomic Energy Act, 
sections 11e, 11z, and 11aa, respectively. The terms ``production 
facility'' and ``utilization facility'' are defined in sections 11v and 
11cc of the Act, respectively.
---------------------------------------------------------------------------

    (c) The Atomic Energy Act of 1954 had the effect of preempting to 
the Federal Government the field of regulation of nuclear facilities and 
byproduct, source, and special nuclear material. Whatever doubts may 
have existed as to that preemption were settled by the passage of the 
Federal-State amendment to the Atomic Energy Act of 1954 in 1959. \13\
---------------------------------------------------------------------------

    \13\ Pub. L. 86-373, 73 Stat. 688.
---------------------------------------------------------------------------

    (d) Prior to 1954, all nuclear facilities and the special nuclear 
material produced by or used in them were owned by the AEC. \14\ This 
Federal monopoly of atomic energy activities was due in large part to 
the use of atomic energy materials and facilities in our national 
weapons program, and the large capital investment required for their 
development. The Atomic Energy Act of 1954 permitted private ownership 
of nuclear facilities for the first time, but only

[[Page 207]]

under a comprehensive, pervasive system of Federal regulation and 
licensing. That Act recognized no State responsibility or authority over 
such facilities and materials except the States' traditional regulatory 
authority over generation, sale, and transmission of electric power 
produced through the use of nuclear facilities. \15\ As interest grew in 
the private construction of facilities and the use of atomic energy 
materials, and the numbers of persons qualified in the field increased, 
questions arose as to the role State authorities should play with regard 
to the public health and safety aspects of such activities. Several 
bills were introduced with respect to Federal-State cooperation in 1956 
and 1957. \16\ An AEC proposed bill which would have authorized 
concurrent radiation safety standards to be enforced by the States was 
forwarded to the Joint Committee on Atomic Energy in 1957, but was never 
reported out. Finally, in 1959, legislation was enacted whose purpose 
was to promote an orderly regulatory pattern between the Federal and 
State governments with respect to regulation of byproduct, source, and 
special nuclear material, while avoiding dual regulation (see section 
274a). That legislation added section 274, the so-called Federal-State 
amendment, to the Atomic Energy Act.
---------------------------------------------------------------------------

    \14\ Atomic Energy Act of 1946, Pub. L. 79-585, 60 Stat. 755.
    \15\ Sec. 271, 42 U.S.C. 2018.
    \16\ S. 4298 and H.R. 8676, 84th Cong., second session; S. 53, 85th 
Cong., first session.
---------------------------------------------------------------------------

    (e) Section 274 (42 U.S.C. 2021) authorizes the Commission to enter 
into an agreement with the Governor of any State providing for the 
discontinuance of regulatory authority of the Commission with respect to 
byproduct materials, source materials, and special nuclear materials in 
quantities not sufficient to form a ``critical mass.'' However, section 
274c (42 U.S.C. 2021(c)) provides that the Commission shall retain 
authority and responsibility with respect to the regulation of:
    (1) The construction and operation of production or utilization 
facilities (note: this includes construction and operation of nuclear 
power plants);
    (2) The export and import of by-product, source or special nuclear 
material or production or utilization facilities;
    (3) The disposal into the ocean of waste byproduct, source or 
special nuclear materials; and
    (4) The disposal of such other byproduct, source or special nuclear 
material as the Commission determines should, because of the hazards or 
potential hazards thereof, not be so disposed of without a Commission 
license.
    (f) The amendment, in providing for the discontinuance of some of 
the AEC's regulatory authority over source, by-product and special 
nuclear material in States which entered into agreements with the AEC, 
made clear that there should be no ``dual regulation'' with respect to 
those materials for the purpose of protection of the public health and 
safety from radiation hazards.
    (g) Section 274b of the Atomic Energy Act (42 U.S.C. 2021(b)) states 
that:

    During the duration of such an agreement it is recognized that the 
State shall have authority to regulate the materials covered by the 
agreement for the protection of the public health and safety from 
radiation hazards.


Section 274k (42 U.S.C. 2021(k)) states:

    Nothing in this section shall be construed to affect the authority 
of any State or local agency to regulate activities for purposes other 
than protection against radiation hazards.

    (h) In its comments on the bill that was enacted as section 274, the 
Joint Committee on Atomic Energy commented that:

    It is not intended to leave any room for the exercise of dual or 
concurrent jurisdiction by States to control radiation hazards by 
regulating byproduct, source, or special nuclear materials. The intent 
is to have the material regulated and licensed either by the Commission, 
or by the State and local governments, but not by both. \17\
---------------------------------------------------------------------------

    \17\ 1959 U.S. Code Congressional and Administrative News, v. 2, p. 
2879.


---------------------------------------------------------------------------
In explaining section 274k, the Joint Committee said:

    As indicated elsewhere, the Commission has exclusive authority to 
regulate for protection against radiation hazards until such time as the 
State enters into an agreement with the Commission to assume such 
responsibility. \18\
---------------------------------------------------------------------------

    \18\ Id. at pp. 2882-3.


[[Page 208]]


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

    (i) It seems completely clear that the Congress, in enacting section 
274, intended to preempt to the Federal Government the total 
responsibility and authority for regulating, from the standpoint of 
radiological health and safety, the specified nuclear facilities and 
materials; that it stated that intent unequivocally; and that the 
enactment of section 274 effectively carried out the Congressional 
intent, subject to the arrangement for limited relinquishment of AEC's 
regulatory authority and assumption thereof by states in areas 
permitted, and subject to conditions imposed, by section 274. \19\
---------------------------------------------------------------------------

    \19\ As noted above, regulation of construction and operation of 
production or utilization facilities was one of the areas reserved to 
the AEC. It is clear from the legislative history of section 274 that 
control of ``operation'' of such facilities includes the regulation of 
the radiological effects of the discharge of affluents from the 
facilities. (Hearings before the Joint Committee on Atomic Energy on 
Federal-State Relationships in the Atomic Energy Field, 86th Cong., 
first session, 1959, p. 306.) AEC regulations implementing section 274 
recognize that intent by defining facility operation to include the 
discharge of radioactive effluents from the facility site (10 CFR 
150.15).
---------------------------------------------------------------------------

    (j) Thus, under the pattern of the Atomic Energy Act, as amended by 
section 274, States which have not entered into a section 274 agreement 
with the AEC are without authority to license or regulate, from the 
standpoint of radiological health and safety, byproduct, source, and 
special nuclear material or production and utilization facilities. Even 
those States which have entered into a section 274 agreement with the 
AEC (Agreement States) lack authority to license or regulate, from the 
standpoint of radiological health and safety, the construction and 
operation of production and utilization facilities (including nuclear 
power plants) and other activities reserved to the AEC by section 274c. 
(To the extent that Agreement States have authority to regulate 
byproduct, source, and special nuclear material, their section 274 
Agreements require them to use their best efforts to assure that their 
regulatory programs for protection against radiation hazards will 
continue to be compatible with the AEC's program for the regulation of 
byproduct, source and special nuclear material.)
    (k) The following judicial precedents and legal authorities support 
the foregoing conclusions: Northern California Ass'n, Etc. v. Public 
Utilities Commission, 37 Cal. Rep. 432, 390 P. 2d 200 (1964); Boswell v. 
City of Long Beach, CCH Atomic Energy Law Reports, par. 4045 (1960); 
Opinion of the Attorney General of Michigan (Oct. 31, 1962); Opinion of 
the Attorney General of South Dakota (July 23, 1964); New York State Bar 
Association, Committee on Atomic Energy, State Jurisdiction to Regulate 
Atomic Activities (July 12, 1963). No precedents or authorities to the 
contrary have come to our attention.

[34 FR 7273, May 3, 1969]



Sec. 8.5  Interpretation by the General Counsel of Sec. 73.55 of this 
chapter; illumination and physical search requirements.

    (a) A request has been received to interpret 10 CFR 73.55(c)(5) and 
73.55(d)(1).

10 CFR 73.55(c)(5) provides:

    Isolation zones and all exterior areas within the protected area 
shall be provided with illumination sufficient for the monitoring and 
observation requirements of paragraphs (c)(3), (c)(4), and (h)(4) of 
this section, but not less than 02. footcandle measured horizontally at 
ground level.

    (b) The requester contends that the regulation is satisfied if 0.2 
footcandle is provided only at the protected area boundary and the 
isolation zone. The language of the regulation is clearly to the 
contrary. It requires not less than 0.2 footcandle for ``all exterior 
areas within the protected area.'' This regulation helps effectuate the 
monitoring and observation requirements of 10 CFR 73.55. For example, 10 
CFR 73.55(c)(4) states that ``All exterior areas within the protected 
area shall be periodically checked to detect the presence of 
unauthorized persons, vehicles, or materials.'' In the absence of 
illumination, such checking could not be fully effective.
    (c) The requester also asks whether the illumination requirement 
extends to the tops and sides of buildings within the protected area. To 
effectuate the monitoring and observation requirements cited above, 
illumination must

[[Page 209]]

be maintained for the tops and sides of all accessible structures within 
the protected area. This interpretation is consistent with that given by 
the Commission's staff to affected licensees and applicants at a series 
of regional meetings held in March of 1977 and will be reflected in 
forthcoming revisions to NUREG 0220, Draft Interim Acceptance Criteria 
for a Physical Security Plan for Nuclear Power Plants (March 1977).
    (d) 10 CFR 73.55(d)(1) provides in pertinent part: The search 
function for detection of firearms, explosives, and incendiary devices 
shall be conducted either by a physical search or by use of equipment 
capable of detecting such devices.
    (e) The requester contends that until ``equipment capable of 
detecting such devices'' is in place, a licensee need not comply with 
the search requirement, but can utilize instead previous security 
programs. This contention is based on the first sentence of 10 CFR 73.55 
which provides in pertinent part that the requirements of paragraph (d) 
of that section shall be met by May 25, 1977, ``except for any 
requirement involving construction and installation of equipment not 
already in place expressed in (paragraph)(d)(1) * * * '' Under this 
sentence only those requirements of paragraph (d) which involve 
``construction and installation of equipment'' do not take effect on May 
25, 1977. Because a ``physical search'' does not require ``constuction 
and installation of equipment'', implementation of such searches is 
required on May 25, 1977. The regulation provides alternative: ``the 
search function * * * shall be conducted either by a physical search or 
by use of equipment * * *.'' Thus when appropriate equipment is in 
place, the search function need not involve a physical search.
    (f) The paragraphs above set forth interpretation of regulations; 
they do not apply those regulations to particular factual settings. For 
example, no effort is made to state what lighting system might be used 
for a given facility; all that is stated is that a system must provide 
not less than 0.2 footcandle for all exterior areas within the protected 
area. Similarly, no effort is made to define what is an adequate 
``physical search''; all that is stated is that, in the absence of 
appropriate equipment, such searches must begin on May 25, 1977.

[42 FR 33265, June 30, 1977]



PART 9_PUBLIC RECORDS--Table of Contents




Sec.
9.1 Scope and purpose.
9.3 Definitions.
9.5 Interpretations.
9.6 Communications.
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.
9.31 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.

                    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.

[[Page 210]]

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: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 
201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 
2750 (44 U.S.C. 3504 note).
    Subpart A also issued under 5 U.S.C. 552; 31 U.S.C. 9701; Pub. L. 
99-570.
    Subpart B is also issued under 5 U.S.C. 552a.
    Subpart C also issued under 5 U.S.C. 552b.



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

[[Page 211]]

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/
eie.html, by calling (301) 415-6030, by e-mail to [email protected], or by 
writing the Office of Information Services, 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]



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 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

[[Page 212]]

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.
    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--

[[Page 213]]

    (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;
    (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;
    (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

[[Page 214]]

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) 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.



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(a) 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.



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 and copying:

[[Page 215]]

    (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 records that have been released to a person under the 
FOIA 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 and a general index to those 
records; and
    (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 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]



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.

[[Page 216]]

    (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 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

[[Page 217]]

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. 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.
    (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(a). 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

[[Page 218]]

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 
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.

[[Page 219]]

    (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]



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 will also advise the requester of 
any 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's Electronic Reading Room 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 30 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.
    (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]



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

[[Page 220]]

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 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 30 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

[[Page 221]]

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. 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

[[Page 222]]

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 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]



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.



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, MD are as follows:

[[Page 223]]

    (i) Paper-to-paper reproduction is $0.15 per page for standard size 
(up to 11x14). Pages 11x17 
are $0.30 per page. Pages larger than 11x17, 
including engineering drawings, are $2.50 per square foot.
    (ii) Color drawings are $2.00 per 8\1/2\x11 
page. Pages larger than 8\1/2\x11 are $12.00 per 
square foot.
    (iii) Microfiche-to-paper reproduction is $0.15 per page. Aperture 
cards are $2.50 per square foot.
    (iv) 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 $0.15 per page.
    (B) Electronic Full Text (EFT) copying of ADAMS documents to CD-ROM 
is $10.00 for the first document on the CD-ROM and $5.00 for each 
additional document per accession number on the same CD-ROM.
    (C) CD-ROM-to-paper reproduction is $0.15 per page.
    (v) Priority rates (rush processing) are as follows:
    (A) The priority rate is offered for standard size paper-to-paper 
reproduction, microfiche-to-paper reproduction, electronic full text 
(EFT) copying of ADAMS documents to paper, and CD-ROM-to-paper 
production at $0.20 per page. The priority rate for standard size color 
prints is $2.50 per print. The priority rate for color drawings larger 
than 8\1/2\x11 is $15.00 per square foot.
    (B) The priority rate for aperture cards is $3.50 per square foot. 
The priority rate for electronic full text (EFT) to CD-ROM is $15.00 for 
the first document on the CD-ROM and $7.50 per each additional document 
on the same CD-ROM.
    (vi) Facsimile charges are $0.30 per page for local calls; $0.50 per 
page for U.S. long distance calls, and $1.00 per page for foreign long 
distance calls.
    (2) Self-service duplicating machines are available at the NRC 
Public Document Room for the use of the public. Paper to paper copy is 
$0.08 per page. Microfiche to paper is $0.10 per page on the reader 
printers.
    (3) 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.
    (4) 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.
    (5) 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\x14 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 and advised to contact the NRC Public

[[Page 224]]

Document Room to arrange to view the publication.

[63 FR 2876, Jan. 20, 1998, as amended at 64 FR 48951, Sept. 9, 1999; 66 
FR 22907, May 7, 2001; 67 FR 67098, Nov. 4, 2002; 70 FR 34308, June 14, 
2005]



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 7, 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-4, plus 16 percent fringe benefits.



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.



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]

[[Page 225]]



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 Information Services, 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.
    (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]



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

[[Page 226]]

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 30 calendar days from 
the date of the notice.

[63 FR 2876, Jan. 20, 1998, as amended at 70 FR 34308, June 14, 2005]



Sec. 9.45  Annual report to the Attorney General of the United States.

    (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 which shall include--
    (1) The number of determinations made by the NRC to deny requests 
for records made to the NRC under this part and the reasons for each 
determination;
    (2) The number of appeals made by persons under Sec. 9.29, the 
results of the appeals, and the reason for the action taken on each 
appeal that results in a denial of information;
    (3) A complete list of all statutes that the NRC relied upon to 
withhold information under subsection (b)(3) of 5 U.S.C. 552, a 
description of whether a court has upheld the decision of the NRC to 
withhold information under each such statute, and a concise description 
of the scope of any information withheld;
    (4) The number of requests for records pending before the NRC as of 
September 30 of the preceding year, and the median number of days that 
such requests had been pending before the agency as of that date;
    (5) The number of requests for records received by the NRC and the 
number of requests that the NRC processed;
    (6) The median number of days taken to process different types of 
requests;
    (7) The total amount of fees collected by the NRC for processing 
requests;
    (8) The number of full-time staff of the NRC devoted to processing 
requests under the FOIA and the total amount expended for processing 
these requests.
    (b) The NRC will make a copy of the most recent report available to 
the public at the NRC Web site, http://www.nrc.gov.

[63 FR 2876, Jan. 20, 1998; 63 FR 12988, Mar. 17, 1998, as amended at 64 
FR 48951, Sept. 9, 1999]



                    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 
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 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.

[[Page 227]]

    (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 
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, except that no verification of 
identity shall be required if the records requested are

[[Page 228]]

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 may establish his 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 may establish his 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 who cannot provide the necessary documentation of identity 
may provide a notarized statement, swearing or affirming to his identity 
and to the fact that he 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 
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 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 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 may be 
accompanied by another individual of his own choosing. Both the 
individual requesting access and the individual accompanying him 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.

[[Page 229]]

                 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 
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 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 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
    (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

[[Page 230]]

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 is eligible or to which he 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]



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

[[Page 231]]

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/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:

[[Page 232]]

    (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 
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

[[Page 233]]

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 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]

[[Page 234]]

            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;
    (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.

[[Page 235]]



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 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 own choosing when he reviews his 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.

                               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

[[Page 236]]

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 office specially designated in writing by 
him pursuant to this subsection to carry out his 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 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;

[[Page 237]]

    (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 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

[[Page 238]]

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 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

[[Page 239]]

(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 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

[[Page 240]]

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:
    (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.

    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

[[Page 241]]

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.

[55 FR 33648, Aug. 17, 1990]



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 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

[[Page 242]]

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 Information Services 
          and Administration and Chief Information Officer.
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: Secs. 145, 161, 68 Stat. 942, 948, as amended (42 U.S.C. 
2165, 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); E.O. 
10450, 3 CFR parts 1949--1953 COMP., p. 936, as amended; E.O. 10865, 3 
CFR 1959-1963 COMP., p. 398, as amended; 3 CFR Table 4.; E.O. 12968, 3 
CFR 1995 COMP., p.396.

    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.



                      Subpart A_General Provisions



Sec. 10.1  Purpose.

    (a) This part establishes the criteria, procedures, and methods for 
resolving questions concerning:
    (1) The eligibility of individuals who are employed by or applicants 
for employment with NRC contractors, agents, and licensees of the NRC, 
individuals who are NRC employees or applicants for NRC employment, and 
other persons designated by the Deputy Executive Director for 
Information Services and Administration and Chief Information Officer of 
the NRC, for access to Restricted Data pursuant to the Atomic Energy Act 
of 1954, as amended, and the Energy Reorganization Act of 1974, or for 
access to national security information; and
    (2) The eligibility of NRC employees, or the eligibility of 
applicants for employment with the NRC, for employment clearance.
    (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]



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) Licensees of the NRC and their employees (including consultants) 
and applicants for employment;

[[Page 243]]

    (c) NRC employees (including consultants) and applicants for 
employment; and
    (d) Any other person designated by the Deputy Executive Director for 
Information Services and Administration and Chief Information Officer of 
the Nuclear Regulatory Commission.

[47 FR 38676, Sept. 2, 1982, as amended at 64 FR 15641, Apr. 1, 1999]



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 
Information Services and Administration and Chief Information Officer, 
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.
    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 Information Services and Administration and Chief 
Information Officer 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 pursuant to Executive Order 12958 or any predecessor 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 Information Services and 
Administration and Chief Information Officer 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]

[[Page 244]]



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 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.

[[Page 245]]

    (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.
    (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]

[[Page 246]]



                          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 Information Services 
and Administration and Chief Information Officer 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 Operations, Deputy Executive 
Director for Information Services and Administration and Chief 
Information Officer 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

[[Page 247]]

the final action to the Deputy Executive Director for Information 
Services and Administration and Chief Information Officer 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 will be made by the Director, Division of 
Facilities and Security, through the Director, Office of Administration, 
to the Deputy Executive Director for Information Services and 
Administration and Chief Information Officer 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]

[[Page 248]]



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 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

[[Page 249]]

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 
Information Services and Administration and Chief Information Officer 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 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

[[Page 250]]

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 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

[[Page 251]]

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 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 Information 
Services and Administration and Chief Information Officer 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 the Deputy Executive Director 
for Information Services and Administration and Chief Information 
Officer.
    (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

[[Page 252]]

revoked, the Deputy Executive Director for Information Services and 
Administration and Chief Information Officer 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 Information 
Services and Administration and Chief Information Officer within five 
days after the receipt of the notice. The brief will be forwarded to the 
Deputy Executive Director for Information Services and Administration 
and Chief Information Officer, 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 Information Services 
and Administration and Chief Information Officer 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 Information Services and Administration and Chief Information 
Officer 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 Information 
Services and Administration and Chief Information Officer may at his or 
her discretion request a review of the record of the case by the NRC 
Personnel Security Review Panel. If this request is made, the Deputy 
Executive Director for Information Services and Administration and Chief 
Information Officer 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 Information Services and 
Administration and Chief Information Officer desires a review by the NRC 
Personnel Security Review Panel. The Deputy Executive Director for 
Information Services and Administration and Chief Information Officer 
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 
Information Services and Administration and Chief Information Officer 
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 
Information Services and Administration and Chief Information Officer 
that a review has been requested. The brief will be forwarded to the 
Deputy Executive Director for Information Services and Administration 
and Chief Information Officer 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 Information Services and 
Administration and Chief Information Officer 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

[[Page 253]]

forwarded to the Deputy Executive Director for Information Services and 
Administration 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 Information Services and Administration and Chief 
Information Officer 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 
Information Services and Administration and Chief Information Officer 
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 Information Services and Administration and Chief 
Information Officer, nor the Hearing Counsel requests a review, the 
final determination will be made by the Deputy Executive Director for 
Information Services and Administration and Chief Information Officer on 
the basis of the record with all findings and recommendations.

[64 FR 15643, Apr. 1, 1999]



Sec. 10.32  Recommendation of the NRC Personnel Security Review Panel.

    (a) The Deputy Executive Director for Information Services and 
Administration and Chief Information Officer 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 Information 
Services and Administration and Chief Information Officer 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.

[[Page 254]]

    (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 Information 
Services and Administration and Chief Information Officer, 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]



Sec. 10.33  Action by the Deputy Executive Director for Information 
Services and Administration and Chief Information Officer.

    (a) The Deputy Executive Director for Information Services and 
Administration and Chief Information Officer, 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 Information Services and Administration and Chief 
Information Officer 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 Information Services and 
Administration and Chief Information Officer 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 Information Services and Administration and Chief 
Information Officer 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 Information Services and Administration and Chief 
Information Officer 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 Information Services and Administration and Chief 
Information Officer, 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

[[Page 255]]

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 Information Services 
and Administration and Chief Information Officer or the Commission has 
made a determination 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 Information Services and Administration and Chief 
Information Officer 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 Information Services and Administration and Chief 
Information Officer 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 
Information Services and Administration and Chief Information Officer 
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.

[[Page 256]]



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]



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: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 
201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 
2750 (44 U.S.C. 3504 note).
    Section 11.15(e) also issued under sec. 501, 85 Stat. 290 (31 U.S.C. 
483a).

    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

[[Page 257]]

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.
    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]

[[Page 258]]

     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 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

[[Page 259]]

    (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 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/eie.html, by calling (301) 415-6030, by e-mail to 
[email protected], or by writing the Office of Information Services, 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

[[Page 260]]

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 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

[[Page 261]]

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-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)(1) The Office of Personnel Management (OPM) bills NRC for the 
cost of each background investigation conducted in support of an 
application for special nuclear material access authorization. The 
combined cost of the OPM investigation and NRC's application processing 
overhead are recovered from the licensee through a material access 
authorization fee calculated with reference to current OPM personnel 
investigation billing rates {OPM rate + [(OPM rate x 11.6%), rounded to 
the nearest dollar] = NRC access authorization fee{time} . Updated OPM 
billing rates are published periodically in a Federal Investigations 
Notice (FIN) issued by OPM's Investigations Service. Copies of the 
current OPM billing schedule can be obtained by phoning the NRC's 
Security Branch, Division of Facilities and Security, Office of 
Administration at 1-800-368-5642. 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 OPM's most recently 
published investigations billing schedule.
    (2) Each application for a special nuclear material access 
authorization, renewal, or change in level must be accompanied by the 
licensee's remittance, payable to the U.S. Nuclear Regulatory 
Commission. Applicants shall calculate the access authorization fee 
according to the stated formula {OPM rate + [(OPM rate x 11.6%), rounded 
to the nearest dollar] = NRC access authorization fee{time}  and with 
reference to the following table:

------------------------------------------------------------------------
                                                        Plus the NRC's
                                                        processing fee
                                                        (rounded to the
                                   Is the sum of the   nearest dollar),
 The NRC application fee for an       current OPM      which is equal to
access authorization of type * *     billing rate       the OPM billing
                *                   charged  for an    rate for the type
                                   investigation of    of investigation
                                      type * * *          referenced
                                                       multiplied by * *
                                                               *
------------------------------------------------------------------------
i. NRC-R \1\....................  NACLC--National                 11.6%
                                   Agency Check with
                                   Law and Credit
                                   (Standard
                                   Service, Code B).
ii. NRC-R \1\ (expedited          NACLC--National                 11.6%
 processing).                      Agency Check with
                                   Law and Credit
                                   (Expedite
                                   Handling, Code A).
iii. NRC-R based on                       No fee assessed for most
 certification of comparable                   applications.
 investigation \2\.
iv. NRC-R renewal \1\...........  NACLC--National                 11.6%
                                   Agency Check with
                                   Law and Credit
                                   (Standard
                                   Service, Code B).
v. NRC-U requiring single scope   SSBI--Single Scope              11.6%
 investigation.                    Background
                                   Investigation
                                   (120 Day Service,
                                   Code C).
vi. NRC-U requiring single scope  SSBI--Single Scope              11.6%
 investigation (expedited          Background
 processing).                      Investigation (35
                                   Day Service, Code
                                   A).
vii. NRC-U based on                       No fee assessed for most
 certification of comparable                   applications.
 investigation \2\.

[[Page 262]]

 
viii. NRC-U renewal \2\.........  LBI--Limited                    11.6%
                                   Background
                                   Investigation
                                   (120 Day 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 prior to 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 prior to the conduct of the investigation.

    (3) 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]



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]

  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

[[Page 263]]

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;
    (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

[[Page 264]]

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: Sec. 203(a)(1), Pub. L. 96-481, 94 Stat. 2325 (5 U.S.C. 
504(c)(1)); Pub. L. 99-80, 99 Stat. 183.

    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 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.

[[Page 265]]



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 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.

[[Page 266]]

    (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 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

[[Page 267]]

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 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

[[Page 268]]

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 
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

[[Page 269]]

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 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.

[[Page 270]]



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 2.786. 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 forty (40) 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 forty-day period provided in paragraph (a) 
of this section; or
    (2) If within the forty-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.



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 Form 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.
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.


[[Page 271]]


    Authority: Public Law 99-509, secs. 6101-6104, 100 Stat. 1874 (31 
U.S.C. 3801-3812). Sections 13.13 (a) and (b) also issued under section 
Pub. L. 101-410, 104 Stat. 890, as amended by section 31001(s), Pub. L. 
104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 note).

    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.
    Government means the United States Government.
    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

[[Page 272]]

or made shall likewise include the corresponding forms of such terms.
    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, the authority, or 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 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]



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 $6,000 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

[[Page 273]]

    (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 $6,000 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 by 61 FR 53555, Oct. 11, 1996; 
62 FR 59275, Nov. 3, 1997; 65 FR 59273, Oct. 4, 2000]



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--

[[Page 274]]

    (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.
    (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 under 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

[[Page 275]]

    (3) Written acknowledgment of receipt by the defendant or his or her 
representative.



Sec. 13.9  Answer.

    (a) The defendant may request a hearing by filing an answer with the 
reviewing official within 30 days of service of the complaint. Service 
of an answer shall be made by delivering a copy to the reviewing 
official or by placing a copy in the United States mail, postage prepaid 
and addressed to the reviewing official. An answer shall be deemed to be 
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 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]



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

[[Page 276]]

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
    (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.

[[Page 277]]

    (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.



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;

[[Page 278]]

    (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 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.

[[Page 279]]

    (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.



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;

[[Page 280]]

    (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  Form filing and service of papers.

    (a) Form. (1) Documents filed with the ALJ shall include an original 
and two copies.
    (2) Every pleading and paper filed in the proceeding shall contain a 
caption setting forth the title of the action, the case number assigned 
by the ALJ, and a designation of the paper (e.g., motion to quash 
subpoena).
    (3) Every pleading and paper shall be signed by, and shall contain 
the address and telephone number of the party or the person on whose 
behalf the paper was filed, or his or her representative.
    (4) Papers are considered filed when they are mailed. Date of 
mailing may be established by a certificate from the party or its 
representative or by proof that the document was sent by certified or 
registered mail.
    (b) Service. A party filing a document with the ALJ shall at the 
time of filing, serve a copy of such document on every other party. 
Service upon any party of any document other than those required to be 
served as prescribed in Sec. 13.8 shall be made by delivering a copy or 
by placing a copy of the document in the United States mail, postage 
prepaid and addressed, to the party's last known address. When a party 
is represented by a representative, service shall be made upon such 
representative in lieu of the actual party.
    (c) Proof of service. A certificate of the individual serving the 
document by personal delivery or by mail, setting forth the manner of 
service, shall be proof of service.



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, Sunday, or legal holiday observed by the Federal government, 
in which event it includes the next business day.
    (b) When the period of time allowed is less than seven days, 
intermediate Saturdays, Sundays, and legal holidays observed by the 
Federal government shall be excluded from the computation.
    (c) Where a document has been served or issued by placing it in the 
mail, an additional five days will be added to the time permitted for 
any response.



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

[[Page 281]]

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.



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;

[[Page 282]]

    (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.
    (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

[[Page 283]]

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, 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

[[Page 284]]

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 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

[[Page 285]]

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 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.

[[Page 286]]

    (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: Sec. 1, 80 Stat. 306 (28 U.S.C. 2672); sec. 2679, 62 
Stat. 984 as amended (28 U.S.C. 2679); sec. 161, 68 Stat. 948 as amended 
(42 U.S.C. 2201); 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.
    (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

[[Page 287]]

    (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 
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

[[Page 288]]

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.
    (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

[[Page 289]]

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 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

[[Page 290]]

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 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 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

[[Page 291]]

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 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.

[[Page 292]]



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: Secs. 161, 186, 68 Stat. 948, 955, as amended (42 U.S.C. 
2201, 2236); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 
1, Pub. L. 97-258, 96 Stat. 972 (31 U.S.C. 3713); sec. 5, Pub. L. 89-
508, 80 Stat. 308, as amended (31 U.S.C. 3716); Pub. L. 97-365, 96 Stat. 
1749 (31 U.S.C. 3719); Federal Claims Collection Standards, 31 CFR 
Chapter IX, parts 900-904; 31 U.S.C. Secs. 3701, 3716; 31 CFR Sec 285; 
26 U.S.C. Sec 6402(d); 31 U.S.C. Sec. 3720A; 26 U.S.C. Sec. 6402(c); 42 
U.S.C. Sec. 664; Pub. L. 104-134, as amended (31 U.S.C. 3713); 5 U.S.C. 
5514; Executive Order 12146 (3 CFR 1980 Comp. pp. 409-412); Executive 
Order 12988 (3 CFR, 1996 Comp., pp. 157-163); sec. 1704, 112 Stat. 2750 
(44 U.S.C. 3504 note).

    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--
    (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.

[[Page 293]]

    (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.
    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

[[Page 294]]

by visiting the NRC's Web site at http://www.nrc.gov/site-help/eie.html, 
by calling (301) 415-6030, by e-mail to [email protected], or by writing the 
Office of Information Services, 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]



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]



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

[[Page 295]]

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 180 
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 180 
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]



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:
    (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

[[Page 296]]

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.
    (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--

[[Page 297]]

    (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]



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

[[Page 298]]

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 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.

[[Page 299]]

    (b) Mandatory centralized offset. (1) The NRC is required to refer 
past due, legally enforceable, nontax debts that are over 180 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 180 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
    (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

[[Page 300]]

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 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.

[[Page 301]]

    (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]



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 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

[[Page 302]]

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.
    (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

[[Page 303]]

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.
    (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

[[Page 304]]

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 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

[[Page 305]]

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]



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]

[[Page 306]]



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 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]

[[Page 307]]



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.

    Authority: Secs. 161, 186, 68 Stat. 948, 955, as amended (42 U.S.C. 
2201, 2236); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 
1, Pub. L. 97-258, 96 Stat. 972 (31 U.S.C. 3713); sec 5, Pub. L. 89-508, 
80 Stat. 308, as amended (31 U.S.C. 3711, 3717, 3718); Pub. L. 97-365, 
96 Stat. 1749; Federal Claims Collection Standards, 31 CFR Chapter IX, 
Parts 900-904; 31 U.S.C. Secs. 3701, 3716; 31 CFR Sec 285; 26 U.S.C. Sec 
6402(d); 31 U.S.C. Sec. 3720A; 26 U.S.C. Sec. 6402(c); 42 U.S.C. Sec. 
664; Pub. L. 104-134, as amended (31 U.S.C. 3713); 5 U.S.C. 5514; 
Executive Order 12988 (3 CFR, 1996 Comp., pp. 157-163); 5 CFR 550.

    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

[[Page 308]]

    (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 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

[[Page 309]]

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;
    (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

[[Page 310]]

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.
    (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.

[[Page 311]]



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:
    (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.

[[Page 312]]

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.
    (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

[[Page 313]]

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 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: Secs. 53, 63, 81, 103, 104, 161, 186, 68 Stat. 930, 933, 
935, 936, 937, 948, 955, as amended, sec. 234, 83 Stat. 444, as amended, 
sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2111, 2133, 
2134, 2201, 2236, 2282, 2297f); sec. 201, 88 Stat. 1242, as amended (42 
U.S.C. 5841); Pub. L. 95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851); 
sec. 1704, 112 Stat. 2750 (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 to individuals participating in 
licensed activities and options available to these individuals in 
connection with Commission inspections of licensees to ascertain 
compliance with the provisions of the Atomic Energy Act of 1954, as 
amended, title II of the Energy Reorganization Act of 1974, and 
regulations, orders, and licenses thereunder regarding radiological 
working conditions. 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 pursuant to section 161c of the Atomic Energy Act of 
1954, as amended, on any matter within the Commission's jurisdiction.

[55 FR 247, Jan. 4, 1990]



Sec. 19.2  Scope.

    The regulations in this part apply to all persons who receive, 
possess, use, or transfer material licensed by the Nuclear Regulatory 
Commission pursuant to the regulations in parts 30 through 36, 39, 40, 
60, 61, 63, 70, or part 72 of this chapter, including persons licensed 
to operate a production or utilization facility under part 50 of this 
chapter, persons licensed to possess power reactor spent fuel in an 
independent spent fuel storage installation (ISFSI) pursuant to part 72 
of this chapter, and in accordance with 10 CFR 76.60 to persons required 
to obtain a certificate of compliance or an approved compliance plan 
under part 76 of this chapter. The regulations regarding interviews of 
individuals under subpoena apply to all investigations and inspections 
within the jurisdiction of the Nuclear Regulatory Commission other than 
those involving NRC employees or NRC contractors. The regulations in 
this part do not apply to subpoenas issued pursuant to 10 CFR 2.720.

[66 FR 55789, Nov. 2, 2001]



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,

[[Page 314]]

including licenses to operate a production or utilization facility 
pursuant to part 50 of this chapter.
    Licensee means the holder of such a license.
    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 by the 
Commission and controlled by a licensee, but does not include the 
licensee.

[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]



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 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 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) If posting of a document specified in paragraph (a) (1), (2) or 
(3) of this section is not practicable, the licensee may post a notice 
which describes the document and states where it may be examined.
    (c)(1) Each licensee and each applicant for a specific license 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.

[[Page 315]]

    (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, by calling (301) 415-5877, via e-mail to [email protected], or by 
visiting the NRC's Web site at http://www.nrc.gov and selecting forms 
from the index found on the home page.
    (d) Documents, notices, or forms posted pursuant to this section 
shall appear in a sufficient number of places to permit individuals 
engaged in licensed activities to observe them on the way to or from any 
particular licensed activity location to which the document applies, 
shall be conspicuous, and shall be replaced if defaced or altered.
    (e) Commission documents posted pursuant to paragraph (a)(4) of this 
section shall be posted within 2 working days after receipt of the 
documents from the Commission; the licensee's response, if any, shall be 
posted within 2 working days after dispatch by the licensee. Such 
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]



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.


[[Page 316]]


    (b) Each licensee shall advise each worker annually of the worker's 
dose as shown in records maintained by the licensee pursuant to the 
provisions of Sec. 20.2106 of 10 CFR part 20.
    (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:
    (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 pursuant to Sec. Sec. 20.2202, 
20.2203, 20.2204, or 20.2206 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 therein. This report must be transmitted at a 
time not 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]



Sec. 19.14  Presence of representatives of licensees and workers during 
inspections.

    (a) Each licensee shall afford to the Commission at all reasonable 
times opportunity to inspect materials, activities, facilities, 
premises, and records pursuant to the regulations in this chapter.
    (b) During an inspection, Commission inspectors may consult 
privately with workers as specified in Sec. 19.15. The licensee or 
licensee's representative may accompany Commission inspectors during 
other phrases 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 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 
licensed activities under control of the licensee and shall have 
received instructions as specified in Sec. 19.12.
    (e) Different representatives of licensees 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 and the workers' 
representative an individual who is not routinely engaged in licensed 
activities under control of the license, for example, a consultant to 
the licensee or to 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

[[Page 317]]

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 to enter that area.



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 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://

[[Page 318]]

www.nrc.gov/site-help/eie.html, by calling (301) 415-6030, by e-mail to 
[email protected], or by writing the Office of Information Services, 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]



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 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

[[Page 319]]

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 (or a holder of a 
certificate of compliance issued pursuant to part 76) or a contractor or 
subcontractor of a licensee (or a holder of a certificate of compliance 
issued pursuant to part 76) against an employee for engaging in 
protected activities under this part or parts 30, 40, 50, 60, 61, 63, 
70, 72, 76, or 150 of this chapter is prohibited.

[66 FR 55789, Nov. 2, 2001]



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 licensee 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 result in undue hazard to life or property.



Sec. 19.32  Discrimination prohibited.

    No person shall on the ground of sex be excluded from participation 
in, be denied the benefit of, or be subjected to discrimination under 
any program or activity licensed by the Nuclear Regulatory Commission. 
This provision will be enforced through agency provisions and rules 
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.

[68 FR 75389, Dec. 31, 2003]



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, 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.

[[Page 320]]

                   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.

                            Subpart L_Records

20.2101 General provisions.
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.

            Subpart N_Exemptions and Additional Requirements

20.2301 Applications for exemptions.

[[Page 321]]

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
Appendixes E-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: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 
930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 
2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 
2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as 
amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 
2750 (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, 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 voluntary participation 
in medical research programs.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002, as amended at 67 
FR 77652, Dec. 19, 2002]



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).
    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

[[Page 322]]

    (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 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 utilizing special nuclear material; and
    (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.
    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

[[Page 323]]

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.
    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).
    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

[[Page 324]]

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.
    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.

[[Page 325]]

    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.
    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.
    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.
    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.

[[Page 326]]

    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.
    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.

[[Page 327]]

    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 equivalent at a tissue depth of 0.007 
centimeter (7 mg/cm2).
    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 evalulation 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 deep-
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)).
    Week means 7 consecutive days starting on Sunday.
    Weighting factor wT, for an organ or tissue (T) is the 
proportion of the risk 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.

[[Page 328]]

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 
1.3x10\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]



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 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.

[[Page 329]]



   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).............  2.5x10 -8               2     980x10 \6\
                        1x10 -7                 2     980x10 \6\
                        1x10 -6                 2     810x10 \6\
                        1x10 -5                 2     810x10 \6\
                        1x10 -4                 2     840x10 \6\
                        1x10 -3                 2     980x10 \6\
                        1x10 -2                 2.5  1010x10 \6\
                        1x10 - 1                7.5   170x10 \6\
                        5x10 -1                11     39x10 \6\
                        1                      11     27x10 \6\
                        2.5                     9     29x10 \6\
                        5                       8     23x10 \6\
                        7                       7     24x10 \6\
                        10                      6.5   24x10 \6\
                        14                      7.5   17x10 \6\
                        20                      8     16x10 \6\
                        40                      7     14x10 \6\
                        60                      5.5   16x10 \6\
                        1x10 \2\                4     20x10 \6\
                        2x10 \2\                3.5   19x10 \6\
                        3x10 \2\                3.5   16x10 \6\
                        4x10 \2\                3.5   14x10 \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 = 3.7x10 \10\ disintegrations per second = 3.7x10 \10\ 
becquerels = 2.22x10 \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/eie.html, by calling (301) 415-6030, by e-mail to 
[email protected], or by writing the Office of Information Services, 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]



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 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

[[Page 330]]

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, 20.2301, 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.

[63 FR 50128, Sept. 21, 1998, as amended at 67 FR 67099, Nov. 4, 2002]



                 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 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

[[Page 331]]

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) 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]]



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:

[[Page 332]]

    (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 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

[[Page 333]]

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.
    (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.

[[Page 334]]

    (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 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

[[Page 335]]

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]



         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, 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, 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 to 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);

[[Page 336]]

    (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]



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 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 an account segregated from the licensee's 
assets and outside the licensee's administrative control as described in 
Sec. 30.35(f)(1) of this chapter;
    (2) Surety method, insurance, or other guarantee method as described 
in Sec. 30.35(f)(2) of this chapter;
    (3) 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
    (4) 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

[[Page 337]]

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 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.



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

[[Page 338]]

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.
    (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.



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.



Sec. 20.1406  Minimization of contamination.

    Applicants for licenses, other than renewals, 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.



                    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 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 radioactive material; and
    (iii) The potential radiological hazards.
    (b) 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.
    (c) 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

[[Page 339]]

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]



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--
    (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

[[Page 340]]

(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 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.

[[Page 341]]

    (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;
    (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.

[[Page 342]]

    (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 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 343]]

[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 344]]

    (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 345]]

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.

[56 FR 23401, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995]



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 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.

[[Page 346]]



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, or 
Sec. 20.2005.
    (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]



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.
    (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)

[[Page 347]]

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 
requirements specified in section III of appendix G to 10 CFR part 20.

[63 FR 50128, Sept. 21, 1998]



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.



                            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.

[[Page 348]]

    (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.
    (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 in a year, an 
occupational dose requiring monitoring pursuant to Sec. 20.1502 the 
licensee shall--
    (1) Determine the occupational radiation dose received during the 
current year; and
    (2) Attempt to obtain the records of cumulative occupational 
radiation dose.

[[Page 349]]

    (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 paragraph (a) 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 paragraph (a) of this section, on NRC Form 4, 
or other clear and legible record, including all of the information 
required by NRC Form 4 \4\. 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]



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

[[Page 350]]

    (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 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

[[Page 351]]

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
    (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), 40.64(c),

[[Page 352]]

50.72, 50.73, 70.52, 73.27(b), 73.67(e)(3)(vii), 73.67(g)(3)(iii), 
73.71, or Sec. 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]



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:
    (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

[[Page 353]]

    (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.
    (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 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. 50.73(b), 
(c), (d), (e), and (g) of this chapter and must also 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 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/eie.html, by 
calling (301) 415-6030, by e-mail to [email protected], or by writing the 
Office of Information Services, 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 14308a, Mar. 25, 2003; 68 FR 58801, Oct. 
10, 2003]

[[Page 354]]



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, pursuant to the provisions of 
Sec. Sec. 20.2203, 20.2204, or 20.2206, 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 a copy of the report submitted to the 
Commission to the individual. This report must be transmitted at a time 
no later than the transmittal to the Commission.

[60 FR 36043, July 13, 1995]



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 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]



            Subpart N_Exemptions and Additional Requirements

    Source: 56 FR 23408, May 21, 1991, unless otherwise noted.

[[Page 355]]



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, 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]

 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 d  Negative Pressure.....         (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:

[[Page 356]]

 
    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]

 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-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 
6x10-2 or 0.06, 6E+2 represents 6x10\2\ or 600, and 6E+0 
represents 6x10\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

[[Page 357]]

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 yearx60 minutes/hourx2x10\4\ ml per minute) = [ALI/
2.4x10\9\] [micro]Ci/ml, where 2x10\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 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

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methods. For those radionuclides for which the stochastic limit is 
governing, the occupational stochastic inhalation ALI was divided by 
2.4x10 \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 7.3x10\7\. 
The factor of 7.3x10\7\ (ml) includes the following components: the 
factors of 50 and 2 described above and a factor of 7.3x10\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 7.3x10\6\ (ml). The factor 
of 7.3x10\6\ (ml) is composed of a factor of 7.3x10\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
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
Osmium..................................  Os                          76
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

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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
Thalium.................................  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]

[[Page 411]]

  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

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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 413]]

 
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 414]]

 
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 415]]

 
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 (1.15x10\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 416]]

 
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, 475     (610) 337-5000           RidsRgn1Mail
 District of Columbia, Maine,           Allendale Road, King    (800) 432-1156.........   [email protected]
 Maryland, Massachusetts, New           of Prussia, PA 19406-   TDD: (301) 415-5575....
 Hampshire, New Jersey, New York,       1415.
 Pennsylvania, Rhode Island, and
 Vermont.
Region II: Alabama, Florida, Georgia,  USNRC, Region II, Sam    (404) 562-4400           RidsRgn2Mail
 Kentucky, Mississippi, North           Nunn Atlanta Federal    (800) 877-8510.........   [email protected]
 Carolina, Puerto Rico, South           Center, Suite 23T85,    TDD: (301) 415-5575....
 Carolina, Tennessee, Virginia,         61 Forsyth Street, SW,
 Virgin Islands, and West Virginia.     Atlanta, GA 30303-8931.
Region III: Illinois, Indiana, Iowa,   USNRC, Region III, 801   (630) 829-9500           RidsRgn3Mail
 Michigan, Minnesota, Missouri, Ohio    Warrenville Road,       (800) 522-3025.........   [email protected]
 and Wisconsin.                         Lisle, IL 60532-4351.   TDD: (301) 415-5575....
Region IV: Alaska, Arizona, Arkansas,  USNRC, Region IV, 611    (817) 860-8100           RidsRgn4Mail
 California, Colorado, Hawaii, Idaho,   Ryan Plaza Drive,       (800) 952-9677.........   [email protected]
 Kansas, Louisiana, Montana,            Suite 400, Arlington,   TDD: (301) 415-5575....
 Nebraska, Nevada, New Mexico, North    TX 76011-4005.
 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]

[[Page 417]]

                  Appendixes E-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

                               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 Information Services, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-5877, 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 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

[[Page 418]]

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, 
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;

[[Page 419]]

    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.

            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.

[[Page 420]]

                        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 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

[[Page 421]]

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 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]



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: Sec. 161, 68 Stat. 948, as amended, sec. 234, 83 Stat. 
444, as amended, sec. 1701, 106 Stat. 2951, 2953 (42 U.S.C. 2201, 2282, 
2297f); secs. 201, as amended, 206, 88 Stat. 1242, as amended, 1246 (42 
U.S.C. 5841, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
    Section 21.2 also issued under secs. 135, 141, Pub. L. 97-425, 96 
Stat. 2232, 2241 (42 U.S.C. 10155, 10161).

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

                           General Provisions



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

[[Page 422]]

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 each individual, partnership, corporation, or 
other entity licensed pursuant to the regulations in this chapter to 
possess, use, or transfer within the United States source material, 
byproduct material, special nuclear material, and/or spent fuel and 
high-level radioactive waste, or to construct, manufacture, possess, 
own, operate, or transfer within the United States, any production or 
utilization facility or independent spent fuel storage installation 
(ISFSI) or monitored retrievable storage installation (MRS); and to each 
director and responsible officer of such a licensee. The regulations in 
this part apply also to each individual, corporation, partnership, or 
other entity doing business within the United States, and each director 
and responsible officer of such organization, that constructs a 
production or utilization facility licensed for the manufacture, 
construction, or operation pursuant to part 50 of this chapter, an ISFSI 
for the storage of spent fuel licensed pursuant to part 72 of this 
chapter, an MRS for the storage of spent fuel or high-level radioactive 
waste pursuant to part 72 of this chapter, or a geologic repository for 
the disposal of high-level radioactive waste under part 60 or 63 of this 
chapter; or supplies basic components for a facility or activity 
licensed, other than for export, under parts 30, 40, 50, 60, 61, 63, 70, 
71, or part 72 of this chapter.
    (b) For persons licensed to construct a facility under a 
construction permit issued under Sec. 50.23 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 such licensees to 
report defects under section 206 of the Energy Reorganization Act of 
1974.
    (c) For persons licensed to operate a nuclear power plant under part 
50 of this chapter, evaluation of potential defects and appropriate 
reporting of defects under 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 such 
licensees to report defects under section 206 of the Energy 
Reorganization Act of 1974.
    (d) Nothing in these regulations should be deemed to preclude either 
an individual, a manufacturer, or a supplier of a commercial grade item 
(as defined in 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

[[Page 423]]

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]



Sec. 21.3  Definitions.

    As used in this part:
    Basic component. (1)(i) When applied to nuclear power plants 
licensed pursuant to 10 CFR part 50 of this chapter, basic component 
means a structure, system, or component, or part thereof that affects 
its safety function necessary to assure:
    (A) The integrity of the reactor coolant pressure boundary;
    (B) The capability to shut down the reactor and maintain it in a 
safe shutdown condition; or
    (C) The capability to prevent or mitigate the consequences of 
accidents which could result in potential offsite exposures comparable 
to those referred to in Sec. 50.34(a)(1), Sec. 50.67(b)(2), or Sec. 
100.11 of this chapter, as applicable.
    (ii) Basic components are items designed and manufactured under a 
quality assurance program complying with 10 CFR part 50, appendix B, or 
commercial grade items which have successfully completed the dedication 
process.
    (2) When applied to other facilities and when applied to other 
activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than 
nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, basic 
component means a structure, system, or component, or part thereof that 
affects their safety function, that is directly procured by the licensee 
of a facility or activity subject to the regulations in this part and in 
which a defect or failure to comply with any applicable regulation in 
this chapter, order, or license issued by the Commission could create a 
substantial safety hazard.
    (3) In all cases, basic component includes safety-related design, 
analysis, inspection, testing, fabrication, replacement of parts, or 
consulting services that are associated with the component hardware 
whether these 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

[[Page 424]]

be performed by the manufacturer of 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; or
    (2) The installation, use, or operation of a basic component 
containing a defect as defined in this section; or
    (3) A deviation in a portion of a facility subject to the 
construction permit or manufacturing licensing requirements of part 50 
of this chapter provided the deviation could, on the basis of an 
evaluation, create a substantial safety hazard and the portion of the 
facility containing the deviation has been offered to the purchaser for 
acceptance; or
    (4) A condition or circumstance involving a basic component that 
could contribute to the exceeding of a safety limit, as defined in the 
technical specifications of a license for operation issued pursuant to 
part 50 of this chapter.
    Deviation means a departure from the technical requirements included 
in a procurement document.
    Director means an individual, appointed or elected according to law, 
who is authorized to manage and direct the affairs of a corporation, 
partnership or other entity. In the case of an individual 
proprietorship, director means the individual.
    Discovery means the completion of the documentation first 
identifying the existence of a deviation or failure to comply 
potentially associated with a substantial safety hazard within the 
evaluation procedures discussed 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.
    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

[[Page 425]]

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, other than for export, pursuant to parts 30, 40, 50, 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]



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 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-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/eie.html, by calling (301) 415-6030, by e-mail to 
[email protected], or by writing the Office of Information Services, 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, 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.

[68 FR 58802, Oct. 10, 2003]



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]



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

[[Page 426]]

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 Sec. 21.21(a)(1) or Sec. 21.21(a)(2) if the construction 
or operation of a facility or activity, or a basic component supplied 
for such facility or activity--
    (i) 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 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--
    (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 construction or operation of a facility or an activity 
within the United States that is subject to the licensing requirements 
under parts 30,

[[Page 427]]

40, 50, 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 requirements under parts 
30, 40, 50, 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 all such components in use 
at, supplied for, or being supplied 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.
    (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.
    (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]

                          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,

[[Page 428]]

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.
    (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 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]

                               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 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 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]



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]

[[Page 429]]



PART 25_ACCESS AUTHORIZATION FOR LICENSEE PERSONNEL--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: Secs. 145, 161, 68 Stat. 942, 948, as amended (42 U.S.C. 
2165, 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 
1704, 112 Stat. 2750 (44 U.S.C. 3504 note); E.O. 10865, as amended, 3 
CFR 1959-1963 Comp., p. 398 (50 U.S.C. 401, note); E.O. 12829, 3 CFR, 
1993 Comp., p. 570; E.O. 12958, as amended, 3 CFR, 1995 Comp., p. 333, 
as amended by E.O. 13292, 3 CFR, 2004 Comp., p.196; E.O. 12968, 3 CFR, 
1995 Comp, p. 396.
    Appendix A also issued under 96 Stat. 1051 (31 U.S.C. 9701).

    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, 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 pursuant to E.O. 12958, as amended, or any predecessor 
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

[[Page 430]]

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 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]



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

[[Page 431]]

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-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/eie.html, by 
calling (301) 415-6030, by e-mail to [email protected], or by writing the 
Office of Information Services, 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]



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

[[Page 432]]

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 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:

[[Page 433]]

    (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)(1) The Office of Personnel Management (OPM) bills NRC for the 
cost of each background investigation conducted in support of an 
application for access authorization. The combined cost of the OPM 
investigation and NRC's application processing overhead are recovered 
from the licensee through an authorization fee calculated with reference 
to current OPM personnel investigation billing rates {OPM rate + [(OPM 
rate x 11.6%), rounded to the nearest dollar] = NRC access authorization 
fee{time} . Updated OPM billing rates are published periodically in a 
Federal Investigations Notice (FIN) issued by OPM's Investigations 
Service. Copies of the current OPM billing schedule can be obtained by 
phoning the NRC's Security Branch, Division of Facilities and Security, 
Office of Administration at 1-800-368-5642. 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 OPM's 
most recently published investigations billing schedule.
    (2) Applications for access authorization or access authorization 
renewal processing that are submitted to the NRC for processing must be 
accompanied by a check or money order, payable to the United States 
Nuclear Regulatory Commission, representing the current cost for the 
processing of each ``Q'' and ``L'' access authorization, or renewal 
request. Applicants shall calculate the access authorization fee 
according to the stated formula {OPM rate + [(OPM rate x 11.6%), rounded 
to the nearest dollar] = NRC access authorization fee{time}  and with 
reference to the table in Appendix A to this part.
    (3) Certain applications from individuals having current Federal 
access authorizations may be processed more expeditiously and at less 
cost, since 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]



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

[[Page 434]]

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.
    (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

[[Page 435]]

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 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

[[Page 436]]

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]



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]

                            Classified Visits



Sec. 25.35  Classified visits.

    (a) The number of classified visits must be held to a minimum. The 
licensee, certificate holder, or other facility shall determine that the 
visit is necessary and that the purpose of the visit cannot be achieved 
without access

[[Page 437]]

to, or disclosure of, classified information. All classified visits 
require advanced 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 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]

                               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 12958, as amended.

[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]



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 438]]

        Appendix A to Part 25--Fees for NRC Access Authorization

------------------------------------------------------------------------
                                                        Plus the NRC's
                                                        processing fee
                                                        (rounded to the
                                   Is the sum of the   nearest dollar),
 The NRC application fee for an       current OPM      which is equal to
access authorization of type * *     billing rate       the OPM billing
                *                   charged  for an    rate for the type
                                   investigation of    of investigation
                                      type * * *          referenced
                                                       multiplied by * *
                                                               *
------------------------------------------------------------------------
Initial ``L'' access              ANACI--Access                   11.6%
 authorization \1\.                National Agency
                                   Check with
                                   Inquiries
                                   (Standard
                                   Service, Code B).
Initial ``L'' access              ANACI--Access                   11.6%
 authorization \1\ (expedited      National Agency
 processing).                      Check with
                                   Inquiries
                                   (Expedite
                                   Handling, Code A).
Reinstatement of ``L'' access     ANACI--Access                   11.6%
 authorization \2\.                National Agency
                                   Check with
                                   Inquiries
                                   (Standard
                                   Service, Code B).
Extension or Transfer of ``L''    ANACI--Access                   11.6%
 access authorization \2\.         National Agency
                                   Check with
                                   Inquiries
                                   (Standard
                                   Service, Code B).
Renewal of ``L'' access           ANACI--Access                   11.6%
 authorization \1\.                National Agency
                                   Check with
                                   Inquiries
                                   (Standard
                                   Service, Code B).
Initial ``Q'' access              SSBI--Single Scope              11.6%
 authorization.                    Background
                                   Investigation
                                   (120 Day Service,
                                   Code C).
Initial ``Q'' access              SSBI--Single Scope              11.6%
 authorization (expedited          Background
 processing).                      Investigation (35
                                   Day Service, Code
                                   A).
Reinstatement of ``Q'' access     SSBI--Single Scope              11.6%
 authorization \2\.                Background
                                   Investigation
                                   (120 Day Service,
                                   Code C).
Reinstatement of ``Q'' access     SSBI--Single Scope              11.6%
 authorization \2\ (expedited      Background
 processing).                      Investigation (35
                                   Day Service, Code
                                   A).
Extension or Transfer of ``Q''    SSBI--Single Scope              11.6%
 \2\.                              Background
                                   Investigation
                                   (120 Day Service,
                                   Code C).
Extension or Transfer of ``Q''    SSBI--Single Scope              11.6%
 \2\ (expedited processing).       Background
                                   Investigation (35
                                   Day Service, Code
                                   A).
Renewal of ``Q'' access           LBI--Limited                    11.6%
 authorization \2\.                Background
                                   Investigation
                                   (120 Day 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 the investigation.
\2\ Full fee will only be charged if an investigation is required.


[68 FR 62512, Nov. 5, 2003; 68 FR 65765, Nov. 21, 2003]



PART 26_FITNESS FOR DUTY PROGRAMS--Table of Contents




                           General Provisions

Sec.
26.1 Purpose.
26.2 Scope.
26.3 Definitions.
26.4 Interpretations.
26.6 Exemptions.
26.8 Information collection requirements: OMB approval.

                     General Performance Objectives

26.10 General performance objectives.

                     Program Elements and Procedures

26.20 Written policy and procedures.
26.21 Policy communications and awareness training.
26.22 Training of supervisors and escorts.
26.23 Contractors and vendors.
26.24 Chemical and alcohol testing.
26.25 Employee assistance programs (EAP).
26.27 Management actions and sanctions to be imposed.
26.28 Appeals.
26.29 Protection of information.

                    Inspections, Records and Reports

26.70 Inspections.
26.71 Recordkeeping requirements.
26.73 Reporting requirements.

                                 Audits

26.80 Audits.

                               Enforcement

26.90 Violations.
26.91 Criminal penalties.

Appendix A to Part 26--Guidelines for Drug and Alcohol Testing Programs

    Authority: Secs. 53, 81, 103, 104, 107, 161, 68 Stat. 930, 935, 936, 
937, 948, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 
2073, 2111, 2112, 2133, 2134, 2137, 2201, 2297f); secs. 201, 202, 206, 
88 S at. 1242, 1244, 1246, as amended (42 U.S.C. 5841, 5842, 5846).

    Source: 54 FR 24494, June 7, 1989, unless otherwise noted.

[[Page 439]]

                           General Provisions



Sec. 26.1  Purpose.

    This part prescribes requirements and standards for the 
establishment and maintenance of certain aspects of fitness-for-duty 
programs and procedures by the licensed nuclear power industry, and by 
licensees authorized to possess, use, or transport formula quantities of 
strategic special nuclear material (SSNM).

[58 FR 31469, June 3, 1993]



Sec. 26.2  Scope.

    (a) The regulations in this part apply to licensees authorized to 
operate a nuclear power reactor, to possess or use formula quantities of 
SSNM, or to transport formula quantities of SSNM. Each licensee shall 
implement a fitness-for-duty program which complies with this part. The 
provisions of the fitness-for-duty program must apply to all persons 
granted unescorted access to nuclear power plant protected areas, to 
licensee, vendor, or contractor personnel required to physically report 
to a licensee's Technical Support Center (TSC) or Emergency Operations 
Facility (EOF) in accordance with licensee emergency plans and 
procedures, and to SSNM licensee and transporter personnel who:
    (1) Are granted unescorted access to Category IA Material;
    (2) Create or have access to procedures or records for safeguarding 
SSNM;
    (3) Make measurements of Category IA Material;
    (4) Transport or escort Category IA Material; or
    (5) Guard Category IA Material.
    (b) The regulations in this part do not apply to NRC employees, to 
law enforcement personnel, or offsite emergency fire and medical 
response personnel while responding onsite, or SSNM transporters who are 
subject to U.S. Department of Transportation drug or alcohol fitness 
programs that require random testing for drugs and alcohol. The 
regulations in this part also do not apply to spent fuel storage 
facility licensees or non-power reactor licensees who possess, use, or 
transport formula quantities of irradiated SSNM as these materials are 
exempt from the Category I physical protection requirements as set forth 
in 10 CFR 73.6.
    (c) Certain regulations in this part apply to licensees holding 
permits to construct a nuclear power plant. Each construction permit 
holder, with a plant under active construction, shall comply with 
Sec. Sec. 26.10, 26.20, 26.23, 26.70, and 26.73 of this part; shall 
implement a chemical testing program, including random tests; and shall 
make provisions for employee assistance programs, imposition of 
sanctions, appeals procedures, the protection of information, and 
recordkeeping.
    (d) The regulations in this part apply to the Corporation required 
to obtain a certificate of compliance or an approved compliance plan 
under part 76 of this chapter only if the Corporation elects to engage 
in activities involving formula quantities of strategic special nuclear 
material. When applicable, the requirements apply only to the 
Corporation and personnel carrying out the activities specified in Sec. 
26.2(a)(1) through (5).

[58 FR 31469, June 3, 1993, as amended at 59 FR 48959, Sept. 23, 1994]



Sec. 26.3  Definitions.

    Aliquot means a portion of a specimen used for testing.
    Category IA Material means strategic special nuclear material (SSNM) 
directly useable in the manufacture of a nuclear explosive device, 
except if:
    (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 cm in each of three dimensions) to preclude hiding the item on 
an individual;
    (2) The total weight of 5 formula kilograms of SSNM plus its matrix 
(at least 50 kilograms) cannot be carried inconspicuously by one person; 
or
    (3) The quantity of SSNM (less than 0.05 formula kilogram) in each 
container requires protracted diversions in order to accumulate 5 
formula kilograms.
    Commission means the Nuclear Regulatory Commission or its duly 
authorized representatives.
    Confirmatory test means a second analytical procedure to identify 
the presence of a specific drug or drug metabolite which is independent 
of the initial

[[Page 440]]

screening test and which uses a different technique and chemical 
principle from that of the initial screening test in order to ensure 
reliability and accuracy. For determining blood alcohol levels, a 
``confirmatory test'' means a second test using another breath alcohol 
analysis device. Further confirmation upon demand will be by gas 
chromatography analysis of blood.
    Confirmed positive test means the result of a confirmatory test that 
has established the presence of drugs, drug metabolites, or alcohol in a 
specimen at or above the cut-off level, and that has been deemed 
positive by the Medical Review Officer (MRO) after evaluation. A 
``confirmed positive test'' for alcohol can also be obtained as a result 
of a confirmation of blood alcohol levels with a second breath analysis 
without MRO evaluation.
    Contractor means any company or individual with which the licensee 
has contracted for work or service to be performed inside the protected 
area boundary, either by contract, purchase order, or verbal agreement.
    Cut-off level means the value set for designating a test result as 
positive.
    Follow-up testing means chemical testing at unannounced intervals, 
to ensure that an employee is maintaining abstinence from the abuse of 
drugs or alcohol.
    Illegal drugs means those drugs included in Schedules I through V of 
the Controlled Substances Act (CSA), but not when used pursuant to a 
valid prescription or when used as otherwise authorized by law.
    Initial or screening tests means an immunoassay screen for drugs or 
drug metabolites to eliminate ``negative'' urine specimens from further 
consideration or the first breathalyzer test for alcohol. Initial 
screening may be performed at the licensee's testing facility; a second 
screen and confirmation testing for drugs or drug metabolites must be 
conducted by a HHS-certified laboratory.
    Medical Review Officer means a licensed physician responsible for 
receiving laboratory results generated by an employer's drug testing 
program who has knowledge of substance abuse disorders and has 
appropriate medical training to interpret and evaluate an individual's 
positive test result together with his or her medical history and any 
other relevant biomedical information.
    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.
    Random test means a system of unannounced drug testing administered 
in a statistically random manner to a group so that all persons within 
that group have an equal probability of selection.
    Suitable inquiry means best-effort verification of employment 
history for the past five years, but in no case less than three years, 
obtained through contacts with previous employers to determine if a 
person was, in the past, tested positive for illegal drugs, subject to a 
plan for treating substance abuse, removed from, or made ineligible for 
activities within the scope of 10 CFR part 26, or denied unescorted 
access at any other nuclear power plant or other employment in 
accordance with a fitness-for-duty policy.
    Transporter means a general licensee pursuant to 10 CFR 70.20a, 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.
    Vendor means any company or individual, not under contract to a 
licensee, providing services in protected areas.

[54 FR 24494, June 7, 1989, as amended at 58 FR 31469, June 3, 1993]



Sec. 26.4  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. 26.6  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

[[Page 441]]

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. 26.8  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 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. 26.6, 26.20, 26.21, 26.22, 26.23, 26.24, 
26.25, 26.27, 26.28, 26.29, 26.70, 26.71, 26.73, 26.80, and appendix A 
to this part.

[54 FR 24494, June 7, 1989, as amended at 62 FR 52185, Oct. 6, 1997; 67 
FR 67099, Nov. 4, 2002]

                     General Performance Objectives



Sec. 26.10  General performance objectives.

    Fitness-for-duty programs must:
    (a) Provide reasonable assurance that nuclear power plant personnel, 
transporter personnel, and personnel of licensees authorized to possess 
or use formula quantities of SSNM, will perform their tasks in a 
reliable and trustworthy manner and 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;
    (b) Provide reasonable measures for the early detection of persons 
who are not fit to perform activities within the scope of this part; and
    (c) Have a goal of achieving a drug-free workplace and a workplace 
free of the effects of such substances.

[54 FR 24494, June 7, 1989, as amended at 58 FR 31469, June 3, 1993]

                     Program Elements and Procedures



Sec. 26.20  Written policy and procedures.

    Each licensee subject to this part shall establish and implement 
written policies and procedures designed to meet the general performance 
objectives and specific requirements of this part. Each licensee shall 
retain a copy of the current written policy and procedures as a record 
until the Commission terminates each license for which the policy and 
procedures were developed and, if any portion of the policies and 
procedures are superseded, retain the superseded material for three 
years after each change. As a minimum, written policies and procedures 
must address fitness for duty through the following:
    (a) An overall description of licensee policy on fitness for duty. 
The policy must address use of illegal drugs and abuse of legal drugs 
(e.g., alcohol, prescription and over-the-counter drugs). Written policy 
documents must be in sufficient detail to provide affected individuals 
with information on what is expected of them, and what consequences may 
result from lack of adherence to the policy. As a minimum, the written 
policy must prohibit the consumption of alcohol--
    (1) Within an abstinence period of at least 5 hours preceding any 
scheduled working tour, and
    (2) During the period of any working tour.

Licensee policy should also address other factors that could affect 
fitness for duty such as mental stress, fatigue and illness.
    (b) A description of programs which are available to personnel 
desiring assistance in dealing with drug, alcohol, or other problems 
that could adversely affect the performance of activities within the 
scope of this part.
    (c) Procedures to be utilized in testing for drugs and alcohol, 
including procedures for protecting the employee and the integrity of 
the specimen, and the quality controls used to ensure the test results 
are valid and attributable to the correct individual.
    (d) A description of immediate and follow-on actions which will be 
taken, and the procedures to be utilized, in those cases where 
employees, vendors,

[[Page 442]]

or contractors assigned to duties within the scope of this part are 
determined to have been involved in the use, sale, or possession of 
illegal drugs; or to have consumed alcohol during the mandatory pre-work 
abstinence period, while on duty, or to excess prior to reporting to 
duty as demonstrated with a test that can be used to determine blood 
alcohol concentration.
    (e) A procedure that will ensure that persons called in to perform 
an unscheduled working tour are fit to perform the task assigned. As a 
minimum, this procedure must--
    (1) Require a statement to be made by a called-in person as to 
whether he or she has consumed alcohol within the length of time stated 
in the pre-duty abstinence policy;
    (2) If alcohol has been consumed within this period, require a 
determination of fitness for duty by breath analysis or other means; and
    (3) Require the establishment of controls and conditions under which 
a person who has been called-in can perform work, if necessary, although 
alcohol has been consumed. Consumption of alcohol during the abstinence 
period shall not by itself preclude a licensee from using individuals 
needed to respond to an emergency.
    (f) The Commission may at any time review the licensee's written 
policy and procedures to assure that they meet the performance 
objectives of this part.



Sec. 26.21  Policy communications and awareness training.

    (a) Persons assigned to activities within the scope of this part 
shall be provided with appropriate training to ensure they understand--
    (1) Licensee policy and procedures, including the methods that will 
be used to implement the policy;
    (2) The personal and public health and safety hazards associated 
with abuse of drugs and misuse of alcohol;
    (3) The effect of prescription and over-the-counter drugs and 
dietary conditions on job performance and on chemical test results, and 
the role of the Medical Review Officer;
    (4) Employee assistance programs provided by the licensee; and
    (5) What is expected of them and what consequences may result from 
lack of adherence to the policy,
    (b) Initial training must be completed prior to assignment to 
activities within the scope of this part. Refresher training must be 
completed on a nominal 12 month frequency or more frequently where the 
need is indicated. A record of the training must be retained for a 
period of at least three years.



Sec. 26.22  Training of supervisors and escorts.

    (a) Managers and supervisors of activities within the scope of this 
part must be provided appropriate training to ensure they understand--
    (1) Their role and responsibilities in implementing the program;
    (2) The roles and responsibilities of others, such as the personnel, 
medical, and employee assistance program staffs;
    (3) Techniques for recognizing drugs and indications of the use, 
sale, or possession of drugs;
    (4) Behavioral observation techniques for detecting degradation in 
performance, impairment, or changes in employee behavior; and
    (5) Procedures for initiating appropriate corrective action, to 
include referral to the employee assistance program.
    (b) Persons assigned to escort duties shall be provided appropriate 
training in techniques for recognizing drugs and indications of the use, 
sale, or possession of drugs, techniques for recognizing aberrant 
behavior, and the procedures for reporting problems to supervisory or 
security personnel.
    (c) Initial training must be completed prior to assignment of duties 
within the scope of this part and within 3 months after initial 
supervisory assignment, as applicable. Refresher training must be 
completed on a nominal 12 month frequency, or more frequently where the 
need is indicated. A record of the training must be retained for a 
period of at least three years.



Sec. 26.23  Contractors and vendors.

    (a) All contractor and vendor personnel performing activities within 
the scope of this part for a licensee must be subject to either the 
licensee's program

[[Page 443]]

relating to fitness for duty, or to a program, formally reviewed and 
approved by the licensee, which meets the requirements of this part. 
Written agreements between licensees and contractors or vendors for 
activities within the scope of this part must be retained for the life 
of the contract and will clearly show that--
    (1) The contractor or vendor is responsible to the licensee for 
adhering to the licensee's fitness-for-duty policy, or maintaining and 
adhering to an effective fitness-for-duty program; which meets the 
standards of this part; and
    (2) Personnel having been denied access or removed from activities 
within the scope of this part at any nuclear power plant for violations 
of a fitness-for-duty policy will not be assigned to work within the 
scope of this part without the knowledge and consent of the licensee.
    (b) Each licensee subject to this part shall assure that contractors 
whose own fitness-for-duty programs are relied on by the licensee adhere 
to an effective program, which meets the requirements of this part, and 
shall conduct audits pursuant to Sec. 26.80 for this purpose.



Sec. 26.24  Chemical and alcohol testing.

    (a) To provide a means to deter and detect substance abuse, the 
licensee shall implement the following chemical testing programs for 
persons subject to this part:
    (1) Testing within 60 days prior to the initial granting of 
unescorted access to protected areas or assignment to activities within 
the scope of this part.
    (2) Unannounced drug and alcohol tests imposed in a statistically 
random and unpredictable manner so that all persons in the population 
subject to testing have an equal probability of being selected and 
tested. The tests must be administered so that a person completing a 
test is immediately eligible for another unannounced test. As a minimum, 
tests must be administered on a nominal weekly frequency and at various 
times during the day. Random testing must be conducted at an annual rate 
equal to at least 50 percent of the workforce.
    (3) Testing for-cause, i.e., as soon as possible following any 
observed behavior indicating possible substance abuse; after accidents 
involving a failure in individual performance resulting in personal 
injury, in a radiation exposure or release of radioactivity in excess of 
regulatory limits, or actual or potential substantial degradations of 
the level of safety of the plant if there is reasonable suspicion that 
the worker's behavior contributed to the event; or after receiving 
credible information that an individual is abusing drugs or alcohol.
    (4) Follow-up testing on an unannounced basis to verify continued 
abstention from the use of substances covered under this part.
    (b) Testing for drugs and alcohol, at a minimum, must conform to the 
``Guidelines for Drug and Alcohol Testing Programs,'' issued by the 
Nuclear Regulatory Commission and appearing in appendix A to this part, 
hereinafter referred to as the NRC Guidelines. Licensees, at their 
discretion, may implement programs with more stringent standards (e.g., 
lower cutoff levels, broader panel of drugs). All requirements in this 
part still apply to persons who fail a more stringent standard, but do 
not test positive under the NRC Guidelines. Management actions must be 
the same with the more stringent standards as if the individual had 
failed the NRC standards.
    (c) Licensees shall test for all substances described in paragraph 
2.1(a) of the NRC Guidelines. In addition, licensees may consult with 
local law enforcement authorities, hospitals, and drug counseling 
services to determine whether other substances with abuse potential are 
being used in the geographical locale of the facility and the local 
workforce. When appropriate, other substances so identified may be added 
to the panel of substances for testing. Appropriate cutoff limits must 
be established by the licensee for these substances.
    (d)(1) Licensees may conduct initial screening tests of an aliquot 
before forwarding selected specimens to a laboratory certified by the 
Department of Health and Human Services (HHS), provided the licensee's 
staff possesses the necessary training and skills for the

[[Page 444]]

tasks assigned, the staff's qualifications are documented, and adequate 
quality controls for the testing are implemented. Quality control 
procedures for initial screening tests by a licensee's testing facility 
must include the processing of blind performance test specimens and the 
submission to the HHS-certified laboratory of a sampling of specimens 
initially tested as negative. Except for the purposes discussed below, 
access to the results of preliminary tests must be limited to the 
licensee's testing staff, the Medical Review Officer (MRO), the Fitness-
for-Duty Program Manager, and the employee assistance program staff, 
when appropriate.
    (2) No individual may be removed or temporarily suspended from 
unescorted access or be subjected to other administrative action based 
solely on an unconfirmed positive result from any drug test, other than 
for marijuana (THC) or cocaine, unless other evidence indicates that the 
individual is impaired or might otherwise pose a safety hazard. With 
respect to onsite initial screening tests for marijuana (THC) and 
cocaine, licensee management may be informed and licensees may 
temporarily suspend individuals from unescorted access or from normal 
duties or take lesser administrative actions against the individual 
based on an unconfirmed presumptive positive result provided the 
licensee complies with the following conditions:
    (i) For the drug for which action will be taken, at least 85 percent 
of the specimens which were determined to be presumptively positive as a 
result of preliminary onsite screening tests during the last 6-month 
data reporting period submitted to the Commission under Sec. 26.71(d) 
were subsequently reported as positive by the HHS-certified laboratory 
as the result of a GC/MS confirmatory test.
    (ii) There is no loss of compensation or benefits to the tested 
person during the period of temporary administrative action.
    (iii) Immediately upon receipt of a negative report from the HHS-
certified laboratory, any matter which could link the individual to a 
temporary suspension is eliminated from the tested individual's 
personnel record or other records.
    (iv) No disclosure of the temporary removal or suspension of, or 
other administrative action against, an individual whose test is not 
subsequently confirmed as positive by the MRO may be made in response to 
a suitable inquiry conducted under the provisions of Sec. 26.27(a), a 
background investigation conducted under the provisions of Sec. 73.56, 
or to any other inquiry or investigation. For the purpose of assuring 
that no records have been retained, access to the system of files and 
records must be provided to licensee personnel conducting appeal 
reviews, inquiries into an allegation, or audits under the provisions of 
Sec. 26.80, or to an NRC inspector or other Federal officials. The 
tested individual must be provided a statement that the records in 
paragraph (d)(2)(iii) of this section have not been retained and must be 
informed in writing that the temporary removal or suspension or other 
administrative action that was taken will not be disclosed, and need not 
be disclosed by the individual, in response to requests for information 
concerning removals, suspensions, administrative actions or history of 
substance abuse.
    (e) The Medical Review Officer's review of the test results must be 
completed and licensee management notified within 10 days of the initial 
presumptive positive screening test.
    (f) All testing of specimens for urine drug testing, except onsite 
testing under paragraph (d) above, must be performed in a laboratory 
certified by the U.S. Department of Health and Human Services for that 
purpose consistent with its standards and procedures for certification. 
Except for suspect specimens submitted for special processing (Section 
2.7(d) of appendix A), all specimens sent to certified laboratories 
shall be subject to initial screening by the laboratory and all 
specimens screened as presumptively positive shall be subject to 
confirmation testing by the laboratory. Licensees shall submit blind 
performance test specimens to certified laboratories in accordance with 
the NRC Guidelines (appendix A).
    (g) Tests for alcohol must be administered by breath analysis using 
breath

[[Page 445]]

alcohol analyses devices meeting evidential standards described in 
section 2.7(O)(3) of appendix A. A breath alcohol content indicating a 
blood alcohol concentration of 0.04 percent or greater must be a 
positive test result. The confirmatory test for alcohol shall be done 
with another breath measurement instrument. Should the person demand 
further confirmation, the test must be a gas chromatography analysis of 
blood.

[54 FR 24494, June 7, 1989, as amended at 56 FR 41926, Aug. 26, 1991; 58 
FR 31469, June 3, 1993; 59 FR 507, Jan. 5, 1994]



Sec. 26.25  Employee assistance programs (EAP).

    Each licensee subject to this part shall maintain an employee 
assistance program to strengthen fitness-for-duty programs by offering 
assessment, short-term counseling, referral services, and treatment 
monitoring to employees with problems that could adversely affect the 
performance of activities within the scope of this part. Employee 
assistance programs should be designed to achieve early intervention and 
provide for confidential assistance. The employee assistance program 
staff shall inform licensee management when a determination has been 
made that any individual's condition constitutes a hazard to himself or 
herself or others (including those who have self-referred).



Sec. 26.27  Management actions and sanctions to be imposed.

    (a)(1) The licensee shall obtain a written statement from the 
individual as to whether activities within the scope of this part were 
ever denied the individual before the initial--
    (i) Granting of unescorted access to a nuclear power plant protected 
area;
    (ii) Granting of unescorted access by a formula quantity SSNM 
licensee to Category IA Material;
    (iii) Assignment to create or the initial granting of access to 
safeguards of procedures for SSNM;
    (iv) Assignment to measure Category IA Material;
    (v) Assignment to transport or escort Category IA Material;
    (vi) Assignment to guard Category IA Material; or
    (vii) Assignment to activities within the scope of this part to any 
person.
    (2) The licensee, as applicable, shall complete a suitable inquiry 
on a best-efforts basis to determine if that person was, in the past--
    (i) Tested positive for drugs or use of alcohol that resulted in on-
duty impairment;
    (ii) Subject to a plan for treating substance abuse (except for 
self-referral for treatment);
    (iii) Removed from activities within the scope of this part;
    (iv) Denied unescorted access at any other nuclear power plant;
    (v) Denied unescorted access to SSNM;
    (vi) Removed from responsibilities to create or have access to 
safeguards records or procedures for SSNM;
    (vii) Removed from responsibilities to measure SSNM;
    (viii) Removed from the responsibilities of transporting or 
escorting SSNM; or
    (ix) Removed from the responsibilities of guarding SSNM at any other 
facility in accordance with a fitness-for-duty policy.
    (3) If a record of the type described in paragraph (a)(2) of this 
section is established, the new assignment to activities within the 
scope of this part or granting of unescorted access must be based upon a 
management and medical determination of fitness for duty and the 
establishment of an appropriate follow-up testing program, provided the 
restrictions of paragraph (b) of this section are observed. To meet this 
requirement, the identity of persons denied unescorted access or removed 
under the provisions of this part and the circumstances for the denial 
or removal, including test results, will be made available in response 
to a licensee's, contractor's or vendor's inquiry supported by a signed 
release from the individual.
    (4) Failure to list reasons for removal or revocation of unescorted 
access is sufficient cause for denial of unescorted access. Temporary 
access provisions are not affected by this part if the prospective 
worker passes a chemical test conducted according to the requirements of 
Sec. 26.24(a)(1).

[[Page 446]]

    (b) Each licensee subject to this part shall, as a minimum, take the 
following actions. Nothing herein shall prohibit the licensee from 
taking more stringent action.
    (1) Impaired workers, or those whose fitness may be questionable, 
shall be removed from activities within the scope of this part, and may 
be returned only after determined to be fit to safely and competently 
perform activities within the scope of this part.
    (2) Lacking any other evidence to indicate the use, sale, or 
possession of illegal drugs onsite, a confirmed positive test result 
must be presumed to be an indication of offsite drug use. The first 
confirmed positive test must, as a minimum, result in immediate removal 
from activities within the scope of this part for at least 14 days and 
referral to the EAP for assessment and counseling during any suspension 
period. Plans for treatment, follow-up, and future employment must be 
developed, and any rehabilitation program deemed appropriate must be 
initiated during such suspension period. Satisfactory management and 
medical assurance of the individual's fitness to adequately perform 
activities within the scope of this part must be obtained before 
permitting the individual to be returned to these activities. Any 
subsequent confirmed positive test must result in, as applicable--
    (i) Removal from unescorted access to nuclear power plant protected 
areas;
    (ii) Removal from unescorted access to Category IA Material;
    (iii) Removal from responsibilities to create or have access to 
records or procedures for safeguarding SSNM;
    (iv) Removal from responsibilities to measure Category IA Material;
    (v) Removal from the responsibilities of transporting or escorting 
Category IA Material;
    (vi) Removal from the responsibilities of guarding Category IA 
Material at any other licensee facility; and
    (vii) Removal from activities within the scope of this part for a 
minimum of 3 years from the date of removal.
    (3) Any individual determined to have been involved in the sale, 
use, or possession of illegal drugs, while, as applicable, within a 
protected area of any nuclear power plant, within a facility that is 
licensed to possess or use SSNM, or within a transporter's facility or 
vehicle, must be removed from activities within the scope of this part. 
The individual may not--
    (i) Be granted unescorted access to nuclear power plant protected 
areas;
    (ii) Be granted unescorted access to Category IA Material;
    (iii) Be given responsibilities to create or have access to 
safeguards records or procedures for SSNM;
    (iv) Be given responsibilities to measure Category IA Material;
    (v) Be given responsibilities to transport or escort Category IA 
Material;
    (vi) Be given responsibilities to guard Category IA Material; or
    (vii) Be assigned to activities within the scope of this part for a 
minimum of 5 years from the date of removal.
    (4) Persons removed for periods of three years or more under the 
provisions of paragraphs (b) (2) and (3) of this section for the illegal 
sale, use or possession of drugs and who would have been removed under 
the current standards of a hiring licensee, may be granted unescorted 
access and assigned duties within the scope of this part by a licensee 
subject to this part only when the hiring licensee receives satisfactory 
medical assurance that the person has abstained from drugs for at least 
three years. Satisfactory management and medical assurance of the 
individual's fitness to adequately perform activities within the scope 
of this part must be obtained before permitting the individual to 
perform activities within the scope of this part. Any person granted 
unescorted access or whose access is reinstated under these provisions 
must be given unannounced follow-up tests at least once every month for 
four months and at least once every three months for the next two years 
and eight months after unescorted access is reinstated to verify 
continued abstinence from proscribed substances. Any confirmed use of 
drugs through this process or any other determination of subsequent 
involvement in the sale, use or possession of illegal substances must 
result in permanent denial of unescorted access.
    (5) Paragraphs (b) (2), (3), and (4) of this section do not apply to 
alcohol, valid prescriptions, or over-the-counter

[[Page 447]]

drugs. Licensee sanctions for confirmed misuse of alcohol, valid 
prescription, and over-the-counter drugs shall be sufficient to deter 
abuse of legally obtainable substances as a substitute for abuse of 
proscribed drugs.
    (c) Refusal to provide a specimen for testing and resignation prior 
to removal for violation of company fitness-for-duty policy concerning 
drugs must be recorded as removals for cause. These records must be 
retained for the purpose of meeting the requirements of Sec. 26.27(a).
    (d) If a licensee has a reasonable belief that an NRC employee may 
be under the influence of any substance, or otherwise unfit for duty, 
the licensee may not deny access but shall escort the individual. In any 
instance of this occurrence, the appropriate Regional Administrator must 
be notified immediately by telephone. During other than normal working 
hours, the NRC Operations Center must be notified.

[54 FR 24494, June 7, 1989, as amended at 58 FR 31470, June 3, 1993]



Sec. 26.28  Appeals.

    Each licensee subject to this part, and each contractor or vendor 
implementing a fitness-for-duty program under the provisions of Sec. 
26.23, shall establish a procedure for licensee and contractor or vendor 
employees to appeal a positive alcohol or drug determination. The 
procedure must provide notice and an opportunity to respond and may be 
an impartial internal management review. A licensee review procedure 
need not be provided to employees of contractors or vendors when the 
contractor or vendor is administering his own alcohol and drug testing.



Sec. 26.29  Protection of information.

    (a) Each licensee subject to this part, who collects personal 
information on an individual for the purpose of complying with this 
part, shall establish and maintain a system of files and procedures for 
the protection of the personal information. This system must be 
maintained until the Commission terminates each license for which the 
system was developed.
    (b) Licensees, contractors, and vendors shall not disclose the 
personal information collected and maintained to persons other than 
assigned Medical Review Officers, other licensees or their authorized 
representatives legitimately seeking the information as required by this 
part for unescorted access decisions and who have obtained a release 
from current or prospective employees or contractor personnel, NRC 
representatives, appropriate law enforcement officials under court 
order, the subject individual or his or her representative, or to those 
licensee representatives who have a need to have access to the 
information in performing assigned duties, including audits of 
licensee's, contractor's, and vendor's programs, to persons deciding 
matters on review or appeal, and to other persons pursuant to court 
order. This section does not authorize the licensee, contractor, or 
vendor to withhold evidence of criminal conduct from law enforcement 
officials.

                    Inspections, Records, and Reports



Sec. 26.70  Inspections.

    (a) Each licensee subject to this part shall permit duly authorized 
representatives of the Commission to inspect, copy, or take away copies 
of its records and inspect its premises, activities, and personnel as 
may be necessary to accomplish the purposes of this part.
    (b) Written agreements between licensees and their contractors and 
vendors must clearly show that the--
    (1) Licensee is responsible to the Commission for maintaining an 
effective fitness-for-duty program in accordance with this part; and
    (2) Duly authorized representatives of the Commission may inspect, 
copy, or take away copies of any licensee, contractor, or vendor's 
documents, records, and reports related to implementation of the 
licensee's, contractor's, or vendor's fitness-for-duty program under the 
scope of the contracted activities.



Sec. 26.71  Recordkeeping requirements.

    Each licensee subject to this part and each contractor and vendor 
implementing a licensee approved program under the provisions of Sec. 
26.23 shall--
    (a) Retain records of inquiries conducted in accordance with Sec. 
26.27(a),

[[Page 448]]

that result in the granting of unescorted access to protected areas, 
until five years following termination of such access authorizations;
    (b) Retain records of confirmed positive test results which are 
concurred in by the Medical Review Officer, and the related personnel 
actions for a period of at least five years;
    (c) Retain records of persons made ineligible for three years or 
longer for assignment to activities within the scope of this part under 
the provisions of Sec. 26.27(b) (2), (3), (4) or (c), until the 
Commission terminates each license under which the records were created; 
and
    (d) Collect and compile fitness-for-duty program performance data on 
a standard form and submit this data to the Commission within 60 days of 
the end of each 6-month reporting period (January-June and July-
December). The data for each site (corporate and other support staff 
locations may be separately consolidated) must include: random testing 
rate; drugs tested for and cut-off levels, including results of tests 
using lower cut-off levels and tests for other drugs; workforce 
populations tested; numbers of tests and results by population, and type 
of test (i.e., pre-access, random, for-cause, etc.); substances 
identified; summary of management actions; and a list of events 
reported. The data must be analyzed and appropriate actions taken to 
correct program weaknesses. The data and analysis must be retained for 
three years. Any licensee choosing to temporarily suspend individuals 
under the provisions of Sec. 26.24(d) must report test results by 
process stage (i.e., onsite screening, laboratory screening, 
confirmatory tests, and MRO determinations) and the number of temporary 
suspensions or other administrative actions taken against individuals 
based on onsite unconfirmed screening positives for marijuana (THC) and 
for cocaine.

[54 FR 24494, June 7, 1989, as amended at 57 FR 55444, Nov. 25, 1992]



Sec. 26.73  Reporting requirements.

    (a) Each licensee subject to this part shall inform the Commission 
of significant fitness-for-duty events including:
    (1) Sale, use, or possession of illegal drugs within the protected 
area and,
    (2) Any acts by any person licensed under 10 CFR part 55 to operate 
a power reactor or by any supervisory personnel assigned to perform 
duties within the scope of this part--
    (i) Involving the sale, use, or possession of a controlled 
substance,
    (ii) Resulting in confirmed positive tests on such persons,
    (iii) Involving use of alcohol within the protected area, or
    (iv) Resulting in a determination of unfitness for scheduled work 
due to the consumption of alcohol.
    (b) Notifications must be made to the NRC Operations Center by 
telephone within 24 hours of the discovery of the event by the licensee.
    (c) Fitness-for-duty events shall be reported under this section 
rather than reported under the provisions of Sec. 73.71.
    (d) By November 30, 1993 each licensee who is authorized to possess, 
use, or transport formula quantities of SSNM shall certify to the NRC 
that it has implemented a fitness-for-duty program that meets the 
requirements of 10 CFR part 26. The certification shall describe any 
licensee cut-off levels more stringent than those imposed by this part.

[54 FR 24494, June 7, 1989; 54 FR 47451, Nov. 14, 1989, as amended at 58 
FR 31470, June 3, 1993]

                                 Audits



Sec. 26.80  Audits.

    (a) Each licensee subject to this part shall audit the fitness-for-
duty program nominally every 12 months. In addition, audits must be 
conducted, nominally every 12 months, of those portions of fitness-for-
duty programs implemented by contractors and vendors. Licensees may 
accept audits of contractors and vendors conducted by other licensees 
and need not re-audit the same contractor or vendor for the same period 
of time. Each sharing utility shall maintain a copy of the audit report, 
to include findings, recommendations and corrective actions. Licensees 
retain responsibility for the effectiveness of contractor and vendor 
programs and the implementation of appropriate corrective action.

[[Page 449]]

    (b) Audits must focus on the effectiveness of the program and be 
conducted by individuals qualified in the subject(s) being audited, and 
independent of both fitness-for-duty program management and personnel 
directly responsible for implementation of the fitness-for-duty program.
    (c) The result of the audit, along with recommendations, if any, 
must be documented and reported to senior corporate and site management. 
The resolution of the audit findings and corrective actions must be 
documented. These documents must be retained for three years. NRC 
Guidelines require licensee audits of HHS-certified laboratories as 
described in appendix A.

                               Enforcement



Sec. 26.90  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; 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.

[54 FR 24494, June 7, 1989, as amended at 57 FR 55072, Nov. 24, 1992]



Sec. 26.91  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 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, 26.2, 26.3, 26.4, 26.6, 26.8, 26.90, and 26.91.

[57 FR 55072, Nov. 24, 1992]

 Appendix A to Part 26--Guidelines for Drug and Alcohol Testing Programs

                           Subpart A--General

1.1 Applicability
1.2 Definitions

            Subpart B--Scientific and Technical Requirements

2.1 The Substances
2.2 General Administration of Testing
2.3 Preventing Subversion of Testing
2.4 Specimen Collection Procedures
2.5 HHS-Certified Laboratory Personnel
2.6 Licensee Testing Facility Personnel
2.7 Laboratory and Testing Facility Analysis Procedures
2.8 Quality Assurance and Quality Control
2.9 Reporting and Review of Results

                     Subpart C--Employee Protection

3.1 Protection of Employee Records
3.2 Individual Access to Test and Laboratory Certification Results

  Subpart D--Certification of Laboratories Engaged in Chemical Testing

4.1 Use of DHHS-Certified Laboratories

                           Subpart A--General

                            1.1 Applicability

    (1) These guidelines apply to licensees authorized to operate 
nuclear power reactors and licensees who are authorized to possess, use, 
or transport formula quantities of strategic special nuclear material 
(SSNM).
    (2) Licensees may set more stringent cut-off levels than specified 
herein or test for substances other than specified herein and shall 
inform the Commission of such deviation within 60 days of implementing 
such change. Licensees may not deviate from the provisions of these 
guidelines without the written approval of the Commission.
    (3) Only laboratories which are HHS-certified are authorized to 
perform urine drug testing for NRC licensees, vendors, and licensee 
contractors.

                             1.2 Definitions

    For the purposes of this part, the following definitions apply:

[[Page 450]]

    ``Aliquot.'' A portion of a specimen used for testing.
    ``BAC.'' Blood alcohol concentration (BAC), which can be measured 
directly from blood or derived from a measure of the concentration of 
alcohol in a breath specimen, is a measure of the mass of alcohol in a 
volume of blood such that an individual with 100 mg of alcohol per 100 
ml of blood has a BAC of 0.10 percent.
    ``Commission.'' The U.S. Nuclear Regulatory Commission or its duly 
authorized representatives.
    ``Chain-of-custody.'' Procedures to account for the integrity of 
each specimen by tracking its handling and storage from the point of 
specimen collection to final disposition of the specimen.
    ``Collection site.'' A place designated by the licensee where 
individuals present themselves for the purpose of providing a specimen 
of their urine, breath, and/or blood to be analyzed for the presence of 
drugs or alcohol.
    ``Collection site person.'' A person who instructs and assists 
individuals at a collection site and who receives and makes an initial 
examination of the specimen(s) provided by those individuals. A 
collection site person shall have successfully completed training to 
carry out this function or shall be a licensed medical professional or 
technician who is provided instructions for collection under this part 
and certifies completion as required herein. In any case where: (a) a 
collection is observed or (b) collection is monitored by nonmedical 
personnel, the collection site person must be a person of the same 
gender as the donor.
    ``Confirmatory test.'' A second analytical procedure to identify the 
presence of a specific drug or drug metabolite which is independent of 
the initial screening test and which uses a different technique and 
chemical principle from that of the initial test in order to ensure 
reliability and accuracy. (At this time gas chromatography/mass 
spectrometry [GC/MS] is the only authorized confirmation method for 
cocaine, marijuana, opiates, amphetamines, phencyclidine). For 
determining blood alcohol levels, a ``confirmatory test'' means a second 
test using another breath alcohol analysis device. Further confirmation 
upon demand will be by gas chromatography analysis of blood.
    ``Confirmed positive test.'' The result of a confirmatory test that 
has established the presence of drugs, drug metabolites, or alcohol in a 
specimen at or above the cut-off level, and that has been deemed 
positive by the Medical Review Officer (MRO) after evaluation. A 
``confirmed positive test'' for alcohol can also be obtained as a result 
of a confirmation of blood alcohol levels with a second breath analysis 
without MRO evaluation.
    ``HHS-certified laboratory.'' A urine and blood testing laboratory 
that maintains certification to perform drug testing under the 
Department of Health and Human Services (HHS) ``Mandatory Guidelines for 
Federal Workplace Drug Testing Programs'' (53 FR 11970).
    ``Illegal drugs.'' Those drugs included in Schedules I through V of 
the Controlled Substances Act (CSA), but not when used pursuant to a 
valid prescription or when used as otherwise authorized by law.
    ``Initial or screening test.'' An immunoassay screen for drugs or 
drug metabolites to eliminate ``negative'' urine specimens from further 
consideration or the first breathalyzer test for alcohol.
    ``Licensee's testing facility.'' A drug testing facility operated by 
the licensee or one of its vendors or contractors to perform the initial 
testing of urine samples and to perform initial breath tests for 
alcohol. Such a testing facility is optional and not required to 
maintain HHS certification under this part.
    ``Medical Review Officer.'' A licensed physician responsible for 
receiving laboratory results generated by an employer's drug testing 
program who has knowledge of substance abuse disorders and has 
appropriate medical training to interpret and evaluate an individual's 
positive test result together with his or her medical history and any 
other relevant biomedical information.
    ``Permanent record book.'' A permanently bound book in which 
identifying data on each specimen collected at a collection site are 
permanently recorded in the sequence of collection.
    ``Reason to believe.'' Reason to believe that a particular 
individual may alter or substitute the urine specimen.
    ``Split sample.'' A portion of a urine specimen that may be stored 
by the licensee to be tested in the event of appeal.

            Subpart B--Scientific and Technical Requirements

                           2.1 The Substances

    (a) Licensees shall, as a minimum, test for marijuana, cocaine, 
opiates, amphetamines, phencyclidine, and alcohol for pre-access, for-
cause, random, and follow-up tests.
    (b) Licensees may test for any illegal drugs during a for-cause 
test, or analysis of any specimen suspected of being adulterated or 
diluted through hydration or other means.
    (c) Licensees shall establish rigorous testing procedures that are 
consistent with the intent of these guidelines for any other drugs not 
specified in these guidelines for which testing is authorized under 10 
CFR 26, so that the appropriateness of the use of these substances can 
be evaluated by the Medical Review Officer to ensure that individuals 
granted unescorted access are fit for maintaining access to and for 
performing duties in protected areas.

[[Page 451]]

    (d) Specimens collected under NRC regulations requiring compliance 
with this part may only be designated or approved for testing as 
described in this part and shall not be used to conduct any other 
analysis or test without the permission of the tested individual.
    (e) This section does not prohibit procedures reasonably incident to 
analysis of a specimen for controlled substances (e.g., determination of 
pH on tests for specific gravity, creatinine concentration, or presence 
of adulterants).

                  2.2 General Administration of Testing

    The licensee testing facilities and HHS-certified laboratories 
described in this part shall develop and maintain clear and well-
documented procedures for collection, shipment, and accession of urine 
and blood specimens under this part. Such procedures shall include, as a 
minimum, the following:
    (a) Use of a chain-of-custody form. The original shall accompany the 
specimen to the HHS-certified laboratory. A copy shall accompany any 
split sample. The form shall be a permanent record on which is retained 
identity data (or codes) on the employee and information on the specimen 
collection process and transfers of custody of the specimen.
    (b) Use of a tamperevident sealing system designed in a manner such 
that the specimen container top can be sealed against undetected 
opening, the container can be identified with a unique identifying 
number identical to that appearing on the chain-of-custody form, and 
space has been provided to initial the container affirming its identity. 
For purposes of clarity, this requirement assumes use of a system made 
up of one or more pre-printed labels and seals (or a unitary label/
seal), but use of other, equally effective technologies is authorized.
    (c) Use of a shipping container in which one or more specimens and 
associated paperwork may be transferred and which can be sealed and 
initialled to prevent undetected tampering.
    (d) Written procedures, instructions, and training shall be provided 
as follows:
    (1) Licensee collection site procedures and training of collection 
site personnel shall clearly emphasize that the collection site person 
is responsible for maintaining the integrity of the specimen collection 
and transfer process, carefully ensuring the modesty and privacy of the 
individual tested, and is to avoid any conduct or remarks that might be 
construed as accusatorial or otherwise offensive or inappropriate.
    (2) A non-medical collection site person shall receive training in 
compliance with this appendix and shall demonstrate proficiency in the 
application of this appendix prior to serving as a collection site 
person. A medical professional, technologist, or technician licensed or 
otherwise approved to practice in the jurisdiction in which collection 
occurs may serve as a collection site person if that person is provided 
the instructions described in 2.2(3) and performs collections in 
accordance with those instructions.
    (3) Collection site persons shall be provided with detailed, 
clearly-illustrated, written instructions on the collection of specimens 
in compliance with this part. Individuals subject to testing shall also 
be provided standard written instructions setting forth their 
responsibilities.
    (4) The option to provide a blood specimen for confirmatory analysis 
following a positive breath test shall be specified in the written 
instructions provided to individuals tested. The instructions shall also 
state that failure to request a confirmatory blood test indicates that 
the individual accepts the breath test results.

                  2.3 Preventing Subversion of Testing

    Licensees shall carefully select and monitor persons responsible for 
administering the testing program (e.g., collection site persons, 
laboratory technicians, specimen couriers, and those selecting and 
notifying personnel to be tested), based upon the highest standards for 
honesty and integrity, and shall implement measures to ensure that these 
standards are maintained. As a minimum, these measures shall ensure that 
the integrity of such persons is not compromised or subject to efforts 
to compromise due to personal relationships with any individuals subject 
to testing.
    As a minimum:
    (1) Supervisors, co-workers, and relatives of the individual being 
tested shall not perform any collection, assessment, or evaluation 
procedures.
    (2) Appropriate background checks and psychological evaluations 
shall be completed prior to assignment of any tasks associated with the 
administration of the program, and shall be conducted at least once 
every three years.
    (3) Persons responsible for administering the testing program shall 
be subjected to a behavioral observation program designed to assure that 
they continue to meet the highest standards for honesty and integrity.

                   2.4 Specimen Collection Procedures

    (a) ``Designation of Collection Site.'' Each drug testing program 
shall have one or more designated collection sites which have all 
necessary personnel, materials, equipment, facilities, and supervision 
to provide for the collection, security, temporary storage, and shipping 
or transportation of urine or blood specimens to a drug testing 
laboratory. A properly equipped mobile facility that meets the 
requirements of this part is an acceptable collection site.

[[Page 452]]

    (b) ``Collection Site Person.'' A collection site person shall have 
successfully completed training to carry out this function. In any case 
where the collection of urine is observed, the collection site person 
must be a person of the same gender as the donor. Persons drawing blood 
shall be qualified to perform that task.
    (c) ``Security.'' The purpose of this paragraph is to prevent 
unauthorized access which could compromise the integrity of the 
collection process or the specimen. Security procedures shall provide 
for the designated collection site to be secure. If a collection site 
facility cannot be dedicated solely to drug and alcohol testing, the 
portion of the facility used for testing shall be secured during that 
testing.
    (1) A facility normally used for other purposes, such as a public 
rest room or hospital examining room, may be secured by visual 
inspection to ensure other persons are not present, and that undetected 
access (e.g., through a rear door not in the view of the collection site 
person) is impossible. Security during collection may be maintained by 
effective restriction of access to collection materials and specimens. 
In the case of a public rest room, the facility must be posted against 
access during the entire collection procedure to avoid embarrassment to 
the individual or distraction of the collection site person.
    (2) If it is impractical to maintain continuous physical security of 
a collection site from the time the specimen is presented until the 
sealed container is transferred for shipment, the following minimum 
procedures shall apply: The specimen shall remain under the direct 
control of the collection site person from delivery to its being sealed 
in a mailer or secured for shipment. The mailer shall be immediately 
mailed, maintained in secure storage, or remain until mailed under the 
personal control of the collection site person. These minimum procedures 
shall apply to the mailing of specimens to licensee testing facilities 
from collection sites (except where co-located) as well as to the 
mailing of specimens to HHS-certified laboratories. As an option, 
licensees may ship several specimens via courier in a locked or sealed 
shipping container.
    (d) ``Chain-of-Custody.'' Licensee chain-of-custody forms shall be 
properly executed by authorized collection site personnel upon receipt 
of specimens. Handling and transportation of urine and blood specimens 
from one authorized individual or place to another shall always be 
accomplished through chain-of-custody procedures. Every effort shall be 
made to minimize the number of persons handling the specimens.
    (e) ``Access to Authorized Personnel Only.'' No unauthorized 
personnel shall be permitted in any part of the designated collection 
site where specimens are collected or stored. Only the collection site 
person may handle specimens prior to their securement in the mailing or 
shipping container or monitor or observe specimen collection (under the 
conditions specified in this part). In order to promote security of 
specimens, avoid distraction of the collection site person, and ensure 
against any confusion in the identification of specimens, a collection 
site person shall conduct only one collection procedure at any given 
time. For this purpose, a collection procedure is complete when the 
specimen container has been sealed and initialed, the chain-of-custody 
form has been executed, and the individual has departed the collection 
site.
    (f) ``Privacy.'' Procedures for collecting urine specimens shall 
allow individual privacy unless there is reason to believe that a 
particular individual may alter or substitute the specimen to be 
provided. For purposes of this appendix the following circumstances are 
the exclusive grounds constituting a reason to believe that the 
individual may alter or substitute a urine specimen:
    (1) The individual has presented a urine specimen that falls outside 
the normal temperature range, and the individual declines to provide a 
measurement of oral body temperature by sterile thermometer, as provided 
in paragraph (g)(14) of this appendix, or the oral temperature does not 
equal or exceed that of the specimen.
    (2) The last urine specimen provided by the individual (i.e., on a 
previous occasion) was determined by the laboratory to have a specific 
gravity of less than 1.003 or a creatinine concentration below .2 g/L.
    (3) The collection site person observes conduct clearly and 
unequivocally indicating an attempt to substitute or adulterate the 
sample (e.g., substitute urine in plain view, blue dye in specimen 
presented, etc.).
    (4) The individual has previously been determined to have used a 
substance inappropriately or without medical authorization and the 
particular test is being conducted as a part of a rehabilitation program 
or on return to service after evaluation and/or treatment for a 
confirmed positive test result.
    (g) ``Integrity and Identity of Specimens.'' Licensees shall take 
precautions to ensure that a urine specimen is not adulterated or 
diluted during the collection procedure, that a blood sample or breath 
exhalent tube cannot be substituted or tampered with, and that the 
information on the specimen container and in the record book can 
identify the individual from whom the specimen was collected. The 
following minimum precautions shall be taken to ensure that authentic 
specimens are obtained and correctly identified:
    (1) To deter the dilution of urine specimens at the collection site, 
toilet bluing agents shall be placed in toilet tanks wherever possible, 
so the reservoir of water in the toilet

[[Page 453]]

bowl always remains blue. There shall be no other source of water (e.g., 
no shower or sink) in the enclosure where urination occurs. If there is 
another source of water in the enclosure, it shall be effectively 
secured or monitored to ensure it is not used (undetected) as a source 
for diluting the specimen.
    (2) When an individual arrives at the collection site for a urine or 
breath test, the collection site person shall ensure that the individual 
is positively identified as the person selected for testing (e.g., 
through presentation of photo identification or identification by the 
employer's representative). If the individual's identity cannot be 
established, the collection site person shall not proceed with the 
collection.
    (3) If the individual fails to arrive for a urine or breath test at 
the assigned time, the collection site person shall contact the 
appropriate authority to obtain guidance on the action to be taken.
    (4) After the individual has been positively identified, the 
collection site person shall ask the individual to sign a consent-to-
testing form and to list all of the prescription medications and over-
the-counter preparations that he or she can remember using within the 
past 30 days.
    (5) The collection site person shall ask the individual to remove 
any unnecessary outer garments such as a coat or jacket that might 
conceal items or substances that could be used to tamper with or 
adulterate the individual's urine, breath, or blood specimen. The 
collection site person shall ensure that all personal belongings such as 
a purse or briefcase remain with the outer garments outside of the room 
in which the blood, breath, or urine sample is collected. The individual 
may retain his or her wallet.
    (6) The individual shall be instructed to wash and dry his or her 
hands prior to urination.
    (7) After washing hands prior to urination, the individual shall 
remain in the presence of the collection site person and shall not have 
access to any water fountain, faucet, soap dispenser, cleaning agent or 
any other materials which could be used to adulterate the urine 
specimen.
    (8) The individual may provide his/her urine specimen in the privacy 
of a stall or otherwise partitioned areas that allows for individual 
privacy.
    (9) The collection site person shall note any unusual behavior or 
appearance in the permanent record book and on the chain-of-custody 
form.
    (10) In the exceptional event that a designated collection site is 
inaccessible and there is an immediate requirement for urine specimen 
collection (e.g., an accident investigation), a public or on-site rest 
room may be used according to the following procedures. A collection 
site person of the same gender as the individual shall accompany the 
individual into the rest room which shall be made secure during the 
collection procedure. If possible, a toilet bluing agent shall be placed 
in the bowl and any accessible toilet tank. The collection site person 
shall remain in the rest room, but outside the stall, until the specimen 
is collected. If no bluing agent is available to deter specimen 
dilution, the collection site person shall instruct the individual not 
to flush the toilet until the specimen is delivered to the collection 
site person. After the collection site person has possession of the 
specimen, the individual will be instructed to flush the toilet and to 
participate with the collection site person in completing the chain-of-
custody procedures.
    (11) Upon receiving a urine specimen from the individual, the 
collection site person shall determine that it contains at least 60 
milliliters of urine. If there is less than 60 milliliters of urine in 
the container, additional urine shall be collected in a separate 
container to reach a total of 60 milliliters. (The temperature of the 
partial specimen in each separate container shall be measured in 
accordance with paragraph (f)(13) of this section, and the partial 
specimens shall be combined in one container.) The individual may be 
given a reasonable amount of liquid to drink for this purpose (e.g., a 
glass of water). If the individual fails for any reason to provide 60 
milliliters of urine, the collection site person shall contact the 
appropriate authority to obtain guidance on the action to be taken.
    (12) After the urine specimen has been provided and submitted to the 
collection site person, the individual shall be allowed to wash his or 
her hands.
    (13) Immediately after the urine specimen is collected, the 
collection site person 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 is critical and in no case 
shall exceed 4 minutes.
    (14) If the temperature of a urine specimen is outside the range of 
32.5[deg]- 37.7 [deg]C/90.5[deg]-99.8 [deg]F, that is a reason to 
believe that the individual may have altered or substituted the 
specimen, and another specimen shall be collected under direct 
observation of a same gender collection site person and both specimens 
shall be forwarded to the laboratory for testing. An individual may 
volunteer to have his or her oral temperature taken to provide evidence 
to counter the reason to believe the individual may have altered or 
substituted the specimen caused by the specimen's temperature falling 
outside the prescribed range.
    (15) Immediately after a urine specimen is collected, the collection 
site person shall also inspect the specimen to determine its

[[Page 454]]

color and look for any signs of contaminants. Any unusual findings shall 
be noted in the permanent record book.
    (16) All urine specimens suspected of being adulterated or found to 
be diluted shall be forwarded to the laboratory for testing.
    (17) Whenever there is reason to believe that a particular 
individual may alter or substitute the urine specimen to be provided, a 
second specimen shall be obtained as soon as possible under the direct 
observation of a same gender collection site person. Where appropriate, 
measures will be taken to prevent additional hydration.
    (18) Alcohol breath tests shall be delayed at least 15 minutes if 
any source of mouth alcohol (e.g., breath fresheners) or any other 
substances are ingested (e.g., eating, smoking, regurgitation of stomach 
contents from vomiting or burping). The collection site person shall 
ensure that each breath specimen taken comes from the end, rather than 
the beginning, of the breath expiration. For each screening test, two 
breath specimens shall be collected from each individual no less than 
two minutes apart and no more than 10 minutes apart. The test results 
shall be considered accurate if the result of each measurement is within 
plus or minus 10 percent of the average of the two measurements. If the 
two tests do not agree, the breath tests shall be repeated on another 
evidential-grade breath analysis device. Confirmatory testing is 
accomplished by repeating the above procedure on another evidential-
grade breath analysis device.
    (19) If the alcohol breath tests indicates that the individual is 
positive for a BAC at or above the 0.04 percent cut-off level, the 
individual may request a confirmatory blood test, at his or her 
discretion. All vacuum tube and needle assemblies used for blood 
collection shall be factory-sterilized. The collection site person shall 
ensure that they remain properly sealed until used. Antiseptic swabbing 
of the skin shall be performed with a nonethanol antiseptic. Sterile 
procedures shall be followed when drawing blood and transferring the 
blood to a storage container; in addition, the container must be sterile 
and sealed.
    (20) Both the individual being tested and the collection site person 
shall keep urine and blood specimens in view at all times prior to their 
being sealed and labeled. If a urine specimen is split (as described in 
Section 2.7(j)) and if any specimen is transferred to a second 
container, the collection site person shall request the individual to 
observe the splitting of the urine sample or the transfer of the 
specimen and the placement of the tamperevident seal over the container 
caps and down the sides of the containers.
    (21) The collection site person and the individual shall be present 
at the same time during procedures outlined in paragraphs (h) through 
(j) of this section.
    (22) The collection site person shall place securely on each 
container an identification label which contains the date, the 
individual's specimen number, and any other identification information 
provided or required by the drug testing program. If separate from the 
labels, the tamperevident seals shall also be applied.
    (23) The individual shall initial the identification labels on the 
specimen containers for the purpose of certifying that it is the 
specimen collected from him or her.
    (i) The individual shall be asked to read and sign a statement on 
either the chain-of-custody form or in the permanent record book 
certifying that the specimens identified as having been collected from 
him or her are in fact the specimen he or she provided.
    (ii) The individual shall be provided an opportunity to set forth on 
the urine chain-of-custody form information concerning medications taken 
or administered in the past 30 days.
    (24) The collection site person shall enter in the permanent record 
book all information identifying the specimens. The collection site 
person shall sign the permanent record book next to the identifying 
information.
    (25) A higher level supervisor in the drug testing program shall 
review and concur in advance with any decision by a collection site 
person to obtain a urine specimen under the direct observation of a same 
gender collection site person based on a reason to believe that the 
individual may alter or substitute the specimen to be provided.
    (26) The collection site person shall complete the chain-of-custody 
forms for both the aliquot and the split sample, if collected, and shall 
certify proper completion of the collection.
    (27) The specimens and chain-of-custody forms are now ready for 
transfer to the laboratory or the licensee's testing facility. If the 
specimens are not immediately prepared for shipment, they shall be 
appropriately safeguarded during temporary storage.
    (28) While any part of the above chain-of-custody procedures is 
being performed, it is essential that the specimens and custody 
documents be under the control of the involved collection site person. 
The collection site person shall not leave the collection site in the 
interval between presentation of the specimen by the individual and 
securement of the samples with identifying labels bearing the 
individual's specimen identification numbers and seals initialled by the 
individual. If the involved collection site person leaves his or her 
work station momentarily, the specimens and chain-of-custody forms shall 
be taken with him or her or shall be secured. If the collection site 
person is leaving for an extended period of time, the specimens shall be 
packaged for transfer to the laboratory before he or she leaves the 
site.

[[Page 455]]

    (h) ``Collection Control.'' To the maximum extent possible, 
collection site personnel shall keep the individual's specimen 
containers within sight both before and after the individual has 
urinated or provided a breath or blood sample. After the specimen is 
collected and whenever urine specimens are split, they shall be properly 
sealed and labeled. A chain-of-custody form shall be used for 
maintaining control and accountability of each specimen from the point 
of collection to final disposition of the specimen. The date and purpose 
shall be documented on the chain-of-custody form each time a specimen is 
handled or transferred, and every individual in the chain of custody 
shall be identified. Every effort shall be made to minimize the number 
of persons handling specimens.
    (i) ``Transportation to Laboratory or Testing Facility.'' Collection 
site personnel shall arrange to transfer the collected specimens to the 
drug testing laboratory or licensee testing facility. To transfer 
specimens off-site for initial screening and for a second screen and 
confirmatory analysis of presumptive positive specimens and for 
transferring suspect specimens to a laboratory for analysis under 
special processing [Section 2.7(d)], the specimens shall be placed in 
containers designed to minimize the possibility of damage during 
shipment (e.g., specimen boxes, padded mailers, or bulk shipping 
containers with that capability) and those containers shall be securely 
sealed to eliminate the possibility of undetected tampering. On the tape 
sealing the container, the collection site person shall sign and enter 
the date specimens were sealed in the containers for shipment. The 
collection site personnel shall ensure that the chain-of-custody 
documentation is attached to each container sealed for shipment to the 
drug testing laboratory.
    (j) ``Failure to Cooperate.'' If the individual refuses to cooperate 
with the urine collection or breath analysis process (e.g., refusal to 
provide a complete specimen, complete paperwork, initial specimen), then 
the collection site person shall inform the Medical Review Officer and 
shall document the non-cooperation in the permanent record book and on 
the specimen custody and control form. The Medical Review Officer shall 
report the failure to cooperate to the appropriate management. The 
provision of blood specimens for use to confirm a positive breath test 
for alcohol shall be entirely voluntary, at the individual's discretion. 
In the absence of a voluntary blood test the second positive breath test 
shall be considered a confirmed positive.

                 2.5. HHS-certified Laboratory Personnel

    (a) ``Day-to-Day Management of the HHS-certified Laboratories.''
    (1) The HHS-certified laboratory shall have a qualified individual 
to assume professional, organizational, educational, and administrative 
responsibility for the laboratories' drug testing facilities.
    (2) This individual shall have documented scientific qualifications 
in analytical forensic toxicology. Minimum qualifications are:
    (i) Certification as a laboratory director by the appropriate State 
in forensic or clinical laboratory toxicology; or
    (ii) A Ph.D. 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 (i), (ii), and (iii) above, 
minimum qualifications also require:
    (A) Appropriate experience in analytical forensic toxicology 
including experience with the analysis of biological material for drugs 
of abuse; and
    (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 
which qualify the individual as an expert witness in forensic 
toxicology.
    (3) This individual shall be engaged in and responsible for the day-
to-day management of the testing laboratory even where another 
individual has overall responsibility for an entire multispecialty 
laboratory.
    (4) This individual shall be responsible for ensuring that there are 
enough personnel with adequate training and experience to supervise and 
conduct the work of their testing laboratories. He or she shall assure 
the continued competency of laboratory personnel by documenting their 
inservice training, reviewing their work performance, and verifying 
their skills.
    (5) This individual shall be responsible for the laboratory's having 
a procedure manual which is complete, up-to-date, available for 
personnel performing tests, and followed by those personnel. The 
procedure manual shall be reviewed, signed, and dated by this 
responsible individual whenever procedures are first placed into use or 
changed or when a new individual assumes responsibility for management 
of the laboratory. Copies of all procedures and dates on which they are 
in effect shall be maintained. (Specific contents of the procedure 
manual are described in Section 2.7(0) of this appendix).
    (6) This individual shall be responsible for maintaining a quality 
assurance program to assure the proper performance and reporting of all 
test results; for maintaining acceptable analytical performance for all 
controls

[[Page 456]]

and standards; for maintaining quality control testing; and for assuring 
and documenting the validity, reliability, accuracy, precision, and 
performance characteristics of each test and test system.
    (7) This individual shall be responsible for taking all remedial 
actions necessary to maintain satisfactory operation and performance of 
the laboratory in response to quality control systems not being within 
performance specifications, errors in result reporting or in 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) ``Test Validation.'' The laboratory's urine drug testing 
facility shall have a qualified individual(s) who reviews all pertinent 
data and quality control results in order to attest to the validity of 
the laboratory's test reports. A laboratory may designate more than one 
person to perform this function. This individual(s) may be any employee 
who is qualified to be responsible for day-to-day management or 
operation of the drug testing laboratory.
    (c) ``Day-to-Day Operations and Supervision of Analysts.'' The 
laboratory's urine drug testing facility shall have an individual to be 
responsible for day-to-day operations and to supervise the technical 
analysts. This individual(s) shall have at least a bachelor's degree in 
the chemical or biological sciences or medical technology or equivalent. 
He or she shall have training and experience in the theory and practice 
of the procedures used in the laboratory, resulting in his or her 
thorough understanding of quality control practices and procedures; the 
review, interpretation, and reporting of test results; maintenance of 
chain-of-custody; and proper remedial actions to be taken in response to 
test systems being out of control limits or detecting aberrant test or 
quality control results.
    (d) ``Other Personnel.'' Other technicians or nontechnical staff 
shall have the necessary training and skills for the tasks assigned.
    (e) ``Training.'' The laboratory's testing program shall make 
available continuing education programs to meet the needs of laboratory 
personnel.
    (f) ``Files.'' Laboratory personnel files shall include: 
r[eacute]sum[eacute] of training and experience; certification or 
license, if any; references; job descriptions; records of performance 
evaluation and advancement; incident reports; and results of tests which 
establish employee competency for the position he or she holds, such as 
a test for color blindness, if appropriate.

                 2.6 Licensee Testing Facility Personnel

    (a) ``Day-to-Day Management of Operations.'' Any licensee testing 
facility shall have an individual to be responsible for day-to-day 
operations and to supervise the testing technicians. This individual(s) 
shall have at least a bachelor's degree in the chemical or biological 
sciences or medical technology or equivalent. He or she shall have 
training and experience in the theory and practice of the procedures 
used in the licensee testing facility, resulting in his or her 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 detecting aberrant test or quality 
control results.
    (b) ``Other Personnel.'' Other technicians or nontechnical staff 
shall have the necessary training and skills for the tasks assigned.
    (c) ``Files.'' Licensees' testing facility personnel files shall 
include: r[eacute]sum[eacute] of training and experience; certification 
or license, if any; references; job descriptions; records of performance 
evaluation and advancement; incident reports; results of tests which 
establish employee competency for the position he or she holds, such as 
a test for color blindness, if appropriate and appropriate data to 
support determinations of honesty and integrity conducted in accordance 
with Section 2.3 of this appendix.

         2.7 Laboratory and Testing Facility Analysis Procedures

    (a) ``Security and Chain-of-Custody.''
    (1) HHS-certified drug testing laboratories and any licensee testing 
facility shall be secure at all times. They 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 to areas where records and split samples are 
stored. Access to these secured areas shall be limited to specifically 
authorized individuals whose authorization is documented. All authorized 
visitors and maintenance and service personnel shall be escorted at all 
times in the HHS-certified laboratory and in the licensee's testing 
facility. Documentation of individuals accessing these areas, dates, and 
times of entry and purpose of entry must be maintained.
    (2) Laboratories and testing facilities shall use chain-of-custody 
procedures to maintain control and accountability of specimens from 
receipt through completion of testing, reporting of results, during 
storage, and continuing until final disposition of specimens. The date 
and purpose shall be documented on an appropriate chain-of-custody form 
each time a specimen is handled or transferred, and every individual in 
the chain shall be

[[Page 457]]

identified. Accordingly, authorized technicians shall be responsible for 
each urine specimen or aliquot in their possession and shall sign and 
complete chain-of-custody forms for those specimens or aliquots as they 
are received.
    (b) ``Receiving.''
    (1) When a shipment of specimens is received, laboratory and 
licensee's testing facility personnel shall inspect each package for 
evidence of possible tampering and compare information on specimen 
containers within each package to the information on the accompanying 
chain-of-custody forms. Any direct evidence of tampering or 
discrepancies in the information on specimen containers and the 
licensee's chain-of-custody forms attached to the shipment shall be 
reported within 24 hours to the licensee, in the case of HHS-certified 
laboratories, and shall be noted on the laboratory's chain-of-custody 
form which shall accompany the specimens while they are in the 
laboratory's possession. Indications of tampering with specimens at a 
testing facility operated by a licensee shall be reported within 8 hours 
to senior licensee management.
    (2) Specimen containers will normally be retained within the 
laboratory's or testing facility's accession area until all analyses 
have been completed. Aliquots and the chain-of-custody forms shall be 
used by laboratory or testing facility personnel for conducting initial 
and confirmatory tests, as appropriate.
    (c) ``Short-Term Refrigerated Storage.'' Specimens that do not 
receive an initial test within 7 days of arrival at the laboratory or 
are not shipped within 6 hours from the licensee's testing facility and 
any retained split samples shall be placed in secure refrigeration 
units. Temperatures shall not exceed 6 [deg]C. Emergency power equipment 
shall be available in case of prolonged power failure.
    (d) ``Specimen Processing.'' Urine specimens identified as 
presumptive positive by a licensee's testing facility shall be shipped 
to an HHS-certified laboratory for testing. Laboratory facilities for 
drug testing will normally process urine specimens by grouping them into 
batches. The number of specimens in each batch may vary significantly 
depending on the size of the laboratory and its workload. When 
conducting either initial or confirmatory tests at either the licensee's 
testing facility or an HHS-certified laboratory, every batch shall 
contain an appropriate number of standards for calibrating the 
instrumentation and a minimum of 10 percent controls. Both quality 
control and blind performance test samples shall appear as ordinary 
samples to laboratory analysts. Special processing may be conducted to 
analyze specimens suspected of being adulterated or diluted (including 
hydration). Any evidence of adulteration or dilution, and any detected 
trace amounts of drugs or metabolites, shall be reported to the Medical 
Review Officer.
    (e) ``Preliminary Initial Test.''
    (1) For the analysis of urine specimens, any preliminary test 
performed by a licensee's testing facility and the initial screening 
test performed by a HHS-certified laboratory shall use an immunoassay 
which meets the requirements of the Food and Drug Administration for 
commercial distribution. The initial test of breath for alcohol 
performed at the collection site shall use a breath measurement device 
which meets the requirements of Section 2.7(o)(3). The following initial 
cut-off levels shall be used when screening specimens to determine 
whether they are negative for the indicated substances:

    Initial test cut-off level (ng/ml)

Marijuana metabolites................................................100
Cocaine metabolites..................................................300
Opiate metabolites..................................................300*
Phencyclidine.........................................................25
Amphetamines.......................................................1,000
Alcohol........................................................0.04% BAC
    *25 ng/ml is immunoassay specific for free morphine.

In addition, licensees may specify more stringent cutoff levels. Results 
shall be reported for both levels in such cases.

    (2) The list of substances to be tested and the cut-off levels are 
subject to change by the NRC in response to industry experience and 
changes to the HHS Guidelines made by the Department of Health and Human 
Services as advances in technology, additional experience, or other 
considerations warrant the inclusion of additional substances and other 
concentration levels.
    (f) ``Confirmatory Test.''
    (1) Specimens which test negative as a result of this second 
screening shall be reported as negative to the licensee and will not be 
subject to any further testing unless special processing of the specimen 
is desired because adulteration or dilution is suspected.
    (2) All urine samples identified as presumptive positive on the 
screening test performed by a HHS-certified laboratory shall be 
confirmed using gas chromatography/mass spectrometry (GC/MS) techniques 
at the cut-off values listed in this paragraph for each drug, and at the 
cut-off values required by the licensee's unique program, where 
differences exist. All confirmations shall be by quantitative analysis. 
Concentrations which exceed the linear region of the standard curve 
shall be documented in the laboratory record as ``greater than highest 
standard curve value.''

    Confirmatory test cut-off level (ng/ml)

Marijuana metabolite.................................................15*
Cocaine metabolite.................................................150**
Opiates:
 Morphine............................................................300

[[Page 458]]

 Codeine.............................................................300
Phencyclidine.........................................................25
Amphetamines:
 Amphetamine.........................................................500
 Methamphetamine.....................................................500
Alcohol........................................................0.04% BAC

    *Delta-9-tetrahydrocannabinol-9-carboxylic acid.
    **Benzoylecgonine.

    In addition, licensees may specify more stringent cut-off levels. 
Results shall be reported for both levels in such cases.
    (3) The analytic procedure for confirmatory analysis of blood 
specimens voluntarily provided by individuals testing positive for 
alcohol on a breath test shall be gas chromatography analysis.
    (4) The list of substances to be tested and the cut-off levels are 
subject to change by the NRC in response to industry experience and 
changes to the HHS Guidelines made by the Department of Health and Human 
Services as advances in technology, additional experience, or other 
considerations warrant the inclusion of additional substances and other 
concentration levels.
    (5) Confirmatory tests for opiates shall include a test for 6-
monoacetylmorphine (MAM) if the screening test is presumptive positive 
for morphine.
    (g) ``Reporting Results.''
    (1) The HHS-certified laboratory shall report test results to the 
licensee's Medical Review Officer within 5 working days after receipt of 
the specimen by the laboratory. Before any test result is reported (the 
results of initial tests, confirmatory tests, or quality control data), 
it shall be reviewed and the test certified as an accurate report by the 
responsible individual at the laboratory. The report shall identify the 
substances tested for, whether positive or negative, the cut-off(s) for 
each, the specimen number assigned by the licensee, and the drug testing 
laboratory specimen identification number. The results (positive and 
negative) for all specimens submitted at the same time to the laboratory 
shall be reported back to the Medical Review Officer at the same time 
when possible.
    (2) The HHS-certified laboratory and any licensee testing facility 
shall report as negative all specimens, except suspect specimens being 
analyzed under special processing, which are negative on the initial 
test or negative on the confirmatory test. Specimens testing positive on 
the confirmatory analysis shall be reported positive for a specific 
substance. Except as provided in Sec. 26.24(d), presumptive positive 
results of preliminary testing at the licensee's testing facility will 
not be reported to licensee management.
    (3) The Medical Review Officer may routinely obtain from the HHS-
certified laboratory, and the laboratory shall provide, quantitation of 
test results. The Medical Review Officer may only disclose quantitation 
of test results for an individual to licensee management, if required in 
an appeals process, or to the individual under the provisions of Section 
3.2. (This does not preclude the provision of program performance data 
under the provisions of 10 CFR 26.71(d).) Quantitation of negative tests 
for urine specimens shall not be disclosed, except where deemed 
appropriate by the Medical Review Officer for proper disposition of the 
results of tests of suspect specimens. Alcohol quantitation for a blood 
specimen shall be provided to licensee management with the Medical 
Review Officer's evaluation.
    (4) The laboratory may transmit results to the Medical Review 
Officer by various electronic means (e.g., teleprinters, facsimile, or 
computer) in a manner designed to ensure confidentiality of the 
information. Results may not be provided verbally by telephone from HHS-
certified laboratory personnel to the Medical Review Officer. The HHS-
certified laboratory must ensure the security of the data transmission 
and limit access to any data transmission, storage, and retrieval 
system.
    (5) The laboratory shall send only to the Medical Review Officer a 
certified copy of the original chain-of-custody form signed by the 
individual responsible for day-to-day management of the drug testing 
laboratory or the individual responsible for attesting to the validity 
of the test reports and attached to which shall be a copy of the test 
report.
    (6) The HHS-certified laboratory and the licensee's testing facility 
shall provide to the licensee official responsible for coordination of 
the fitness-for-duty program a monthly statistical summary of urinalysis 
and blood testing and shall not include in the summary any personal 
identifying information. Initial test data from the licensee's testing 
facility and the HHS-certified laboratory, and confirmation data from 
HHS-certified laboratories shall be included for test results reported 
within that month. Normally this summary shall be forwarded from HHS-
certified laboratories by registered or certified mail and from the 
licensee's testing facility not more than 14 calendar days after the end 
of the month covered by the summary. The summary shall contain the 
following information:
    (i) Initial Testing:
    (A) Number of specimens received;
    (B) Number of specimens reported out; and
    (C) Number of specimens screened positive for:

Marijuana metabolites
Cocaine metabolites
Opiate metabolites
Phencyclidine
Amphetamines
Alcohol

    (ii) Confirmatory Testing:

[[Page 459]]

    (A) Number of specimens received for confirmation;
    (B) Number of specimens confirmed positive for:

Marijuana metabolite
Cocaine metabolite
Morphine, codeine
Phencyclidine
Amphetamine
Methamphetamine
Alcohol

    (7) The statistics shall be presented for both the cut-off levels in 
these guidelines and any more stringent cut-off levels which licensees 
may specify. The HHS-certified laboratory and the licensee's testing 
facility shall make available quantitative results for all samples 
tested when requested by the NRC or the licensee for which the 
laboratory is performing drug testing services.
    (8) Unless otherwise instructed by the licensee in writing, all 
records pertaining to a given urine or blood specimen shall be retained 
by the HHS-certified drug testing laboratory and the licensee's testing 
facility for a minimum of 2 years.
    (h) ``Long-Term Storage.'' Long-term frozen storage (-20 [deg]C or 
less) ensures that positive urine specimens will be available for any 
necessary retest during administrative or disciplinary proceedings. 
Unless otherwise authorized in writing by the licensee, HHS-certified 
laboratories shall retain and place in properly secured long-term frozen 
storage for a minimum of 1 year all specimens confirmed positive. Within 
this 1-year period a licensee or the NRC may request the laboratory to 
retain the specimen for an additional period of time, but if no such 
request is received, the laboratory may discard the specimen after the 
end of 1 year, except that the laboratory shall be required to maintain 
any specimens under legal challenge for an indefinite period. Any split 
samples retained by the licensee shall be transferred into long-term 
storage upon determination by the Medical Review Officer that the 
specimen has a confirmed positive test.
    (i) ``Retesting Specimens.'' Because some analytes deteriorate or 
are lost during freezing and/or storage, quantitation for a retest is 
not subject to a specific cut-off requirement but must provide data 
sufficient to confirm the presence of the drug or metabolite.
    (j) ``Split Samples.'' Urine specimens may be split, at the 
licensee's discretion, into two parts at the collection site. One half 
of such samples (hereafter called the aliquot) shall be analyzed by the 
licensee's testing facility or the HHS-certified laboratory for the 
licensee's purposes as described in this appendix. The other half of the 
sample (hereafter called the split sample) may be withheld from transfer 
to the laboratory, sealed, and stored in a secure manner by the licensee 
until the aliquot has been determined to be negative or until the 
positive result of a screening test has been confirmed. As soon as the 
aliquot has tested negative, the split sample in storage may be 
destroyed. If the aliquot tests positive by confirmatory testing, then, 
at the tested individual's request, the split sample may be forwarded on 
that day to another HHS-certified laboratory that did not test the 
aliquot. The chain-of-custody and testing procedures to which the split 
sample is subject, shall be the same as those used to test the initial 
aliquot and shall meet the standards for retesting specimens [Section 
2.7(i)]. The quantitative results of any second testing process shall be 
made available to the Medical Review Officer and to the individual 
tested.
    (k) ``Subcontracting.'' HHS-certified laboratories shall not 
subcontract and shall perform all work with their own personnel and 
equipment unless otherwise authorized by the licensee. The laboratory 
must be capable of performing testing of the five classes of drugs 
(marijuana, cocaine, opiates, phencyclidine, and amphetamines) and of 
whole blood and confirmatory GC/MS methods specified in these 
guidelines.
    (l) ``Laboratory Facilities.''
    (1) HHS-certified laboratories shall comply with applicable 
provisions of any State licensure requirements.
    (2) HHS-certified laboratories shall have the capability, at the 
same laboratory premises, of performing initial tests for each drug and 
drug metabolite for which service is offered, and for performing 
confirmatory tests for alcohol and for each drug and drug metabolite for 
which service is offered. Any licensee testing facilities shall have the 
capability, at the same premises, of performing initial screening tests 
for each drug and drug metabolite for which testing is conducted. Breath 
tests for alcohol may be performed at the collection site.
    (m) ``Inspections.'' The NRC and any licensee utilizing an HHS-
certified laboratory shall reserve the right to inspect the laboratory 
at any time. Licensee contracts with HHS-certified laboratories for drug 
testing and alcohol confirmatory testing, as well as contracts for 
collection site services, shall permit the NRC and the licensee to 
conduct unannounced inspections. In addition, prior to the award of a 
contract, the licensee shall carry out pre-award inspections and 
evaluation of the procedural aspects of the laboratory's drug testing 
operation. The NRC shall reserve the right to inspect a licensee's 
testing facility at any time.
    (n) ``Documentation.'' HHS-certified laboratories and the licensee's 
testing facility shall maintain and make available for at least 2 years 
documentation of all aspects of the testing process. This 2-year period 
may be extended upon written notification by the NRC or by any licensee 
for which laboratory

[[Page 460]]

services are being provided. The required documentation shall include 
personnel files on all individuals authorized to have access to 
specimens; chain-of-custody documents; quality assurance/quality control 
records; procedure manuals; all test data (including calibration curves 
and any calculations used in determining test results); reports; 
performance records on performance testing; performance on certification 
inspections; and hard copies of computer-generated data. The HHS-
certified laboratory and the licensee's testing facility shall be 
required to maintain documents for any specimen under legal challenge 
for an indefinite period.
    (o) ``Additional Requirements for HHS-certified Laboratories and 
Licensee's Testing Facilities.''
    (1) ``Procedure manual.'' Each laboratory and licensee's testing 
facility shall have a procedure manual which includes the principles of 
each test, preparation of reagents, standards and controls, calibration 
procedures, derivation of results, linearity of methods, sensitivity of 
the methods, cutoff values, mechanisms for reporting results, controls, 
criteria for unacceptable specimens and results, remedial actions to be 
taken when the test systems are outside of acceptable limits, reagents 
and expiration dates, and references. Copies of all procedures and dates 
on which they are in effect shall be maintained as part of the manual. 
Superseded material must be retained for three years.
    (2) ``Standards and controls.'' HHS-certified laboratory standards 
shall be prepared with pure drug standards which are properly labeled as 
to content and concentration. The standards shall be labeled with the 
following dates: when received; when prepared or opened; when placed in 
service; and expiration date.
    (3) ``Instruments and equipment.''
    (i) Volumetric pipettes and measuring devices shall be certified for 
accuracy or be checked by gravimetric, colorimetric, or other 
verification procedure. Automatic pipettes and dilutors shall be checked 
for accuracy and reproducibility before being placed in service and 
checked periodically thereafter.
    (ii) Alcohol breath analysis equipment shall be an evidental-grade 
breath alcohol analysis device of a brand and model that conforms to 
National Highway Traffic Safety Administration (NHTSA) standards (49 FR 
48855) and to any applicable State statutes.
    (iii) There shall be written procedures for instrument set-up and 
normal operation, a schedule for checking critical operating 
characteristics for all instruments, tolerance limits for acceptable 
function checks, and instructions for major troubleshooting and repair. 
Records shall be available on preventive maintenance.
    (4) ``Remedial actions.'' There shall be written procedures for the 
actions to be taken when systems are out of acceptable limits or errors 
are detected. There shall be documentation that these procedures are 
followed and that all necessary corrective actions are taken. There 
shall also be in place systems to verify all stages of testing and 
reporting and documentation that these procedures are followed.
    (5) ``Personnel available to testify at proceedings.'' The 
licensee's testing facility and HHS-certified laboratory shall have 
qualified personnel available to testify in an administrative or 
disciplinary proceeding against an individual when that proceeding is 
based on positive breath analysis or urinalysis results reported by the 
licensee's testing facility or the HHS-certified laboratory.

                2.8 Quality Assurance and Quality Control

    (a) ``General.'' HHS-certified laboratories and the licensee's 
testing facility shall have a quality assurance program which 
encompasses all aspects of the testing process including but not limited 
to specimen acquisition, chain-of-custody, security, reporting of 
results, initial and confirmatory testing, and validation of analytical 
procedures. Quality assurance procedures shall be designed, implemented, 
and reviewed to monitor the conduct of each step of the process of 
testing for drugs.
    (b) ``Licensee's Testing Facility Quality Control Requirements for 
Initial Tests.'' Because all positive preliminary tests for drugs are 
forwarded to an HHS-certified laboratory for screening and confirmatory 
testing when appropriate, the NRC does not require licensees to assess 
their testing facility's false positive rates for drugs. To ensure that 
the rate of false negative tests is kept to the minimum that the 
immunoassay technology supports, licensees shall process blind 
performance test specimens and submit a sampling of specimens screened 
as negative from every test run to the HHS-certified laboratory. In 
addition, the manufacturer-required performance tests of the breath 
analysis equipment used by the licensee shall be conducted as set forth 
in the manufacturer's specifications.
    (c) ``Laboratory Quality Control Requirements for Initial Tests at 
HHS-Certified Laboratories.'' Each analytical run of specimens to be 
screened shall include:
    (1) Urine specimens certified to contain no drug;
    (2) Urine specimens fortified with known standards; and
    (3) Positive controls with the drug or metabolite at or near the 
threshold (cut-off).
    In addition, with each batch of samples, a sufficient number of 
standards shall be included to ensure and document the linearity

[[Page 461]]

of the assay method over time in the concentration area of the cut-off. 
After acceptable values are obtained for the known standards, those 
values will be used to calculate sample data. Implementation of 
procedures to ensure that carryover does not contaminate the testing of 
an individual's specimen shall be documented. A minimum of 10 percent of 
all test samples shall be quality control specimens. Laboratory quality 
control samples, prepared from spiked urine samples of determined 
concentration, shall be included in the run and should appear as normal 
samples to laboratory analysts. One percent of each run, with a minimum 
of at least one sample, shall be the laboratory's own quality control 
samples.
    (d) ``Laboratory Quality Control Requirements for Confirmation 
Tests.'' Each analytical run of specimens to be confirmed shall include:
    (1) Urine specimens certified to contain no drug;
    (2) Urine specimens fortified with known standards; and
    (3) Positive controls with the drug or metabolite at or near the 
threshold (cut-off).
    The linearity and precision of the method shall be periodically 
documented. Implementation of procedures to ensure that carryover does 
not contaminate the testing of an individual's specimen shall also be 
documented.
    (e) ``Licensee Blind Performance Test Procedures.''
    (1) Licensees shall purchase chemical testing services only from 
laboratories certified by DHHS or a DHHS-recognized certification 
program in accordance with the HHS Guidelines. Laboratory participation 
is encouraged in other performance testing surveys by which the 
laboratory's performance is compared with peers and reference 
laboratories.
    (2) During the initial 90-day period of any new drug testing 
program, each licensee shall submit blind performance test specimens to 
each HHS-certified laboratory it contracts within the amount of at least 
50 percent of the total number of samples submitted (up to a maximum of 
500 samples) and thereafter a minimum of 10 percent of all samples (to a 
maximum of 250) submitted per quarter.
    (3) Approximately 80 percent of the blind performance test samples 
shall be blank (i.e., certified to contain no drug) and the remaining 
samples shall be positive for one or more drugs per sample in a 
distribution such that all the drugs to be tested are included in 
approximately equal frequencies of challenge. The positive samples shall 
be spiked only with those drugs for which the licensee is testing.
    (4) The licensee shall investigate, or shall refer to DHHS for 
investigation, any unsatisfactory performance testing result, and based 
on this investigation, the laboratory shall take action to correct the 
cause of the unsatisfactory performance test result. A record shall be 
made of the investigative findings and the corrective action taken by 
the laboratory, and that record shall be dated and signed by the 
individuals responsible for the day-to-day management and operation of 
the HHS-certified laboratory. Then the licensee shall send the document 
to the NRC as a report of the unsatisfactory performance testing 
incident within 30 days. The NRC shall ensure notification of the 
finding to DHHS.
    (5) Should a false positive error occur on a blind performance test 
specimen and the error is determined to be an administrative error 
(clerical, sample mixup, etc.), the licensee shall promptly notify the 
NRC. The licensees shall require the laboratory to take corrective 
action to minimize the occurrence of the particular error in the future; 
and, if there is reason to believe the error could have been systematic, 
the licensee may also require review and reanalysis of previously run 
specimens.
    (6) Should a false positive error occur on a blind performance test 
specimen and the error is determined to be a technical or methodological 
error, the licensee shall instruct the laboratory to submit to them all 
quality control data from the batch of specimens which included the 
false positive specimen. In addition, the licensee shall require the 
laboratory to retest all specimens analyzed positive for that drug or 
metabolite from the time of final resolution of the error back to the 
time of the last satisfactory performance test cycle. This retesting 
shall be documented by a statement signed by the individual responsible 
for day-to-day management of the laboratory's substance testing program. 
The licensee and the NRC may require an on-site review of the laboratory 
which may be conducted unannounced during any hours of operation of the 
laboratory. Based on information provided by the NRC, DHHS has the 
option of revoking or suspending the laboratory's certification or 
recommending that no further action be taken if the case is one of less 
serious error in which corrective action has already been taken, thus 
reasonably assuring that the error will not occur again.

                   2.9 Reporting and Review of Results

    (a) ``Medical Review Officer shall review results.'' An essential 
part of the licensees' testing programs is the final review of results. 
A positive test result does not automatically identify a nuclear power 
plant worker as having used substances in violation of the NRC's 
regulations or the licensee's company policies. An individual with a 
detailed knowledge of possible alternate medical explanations is 
essential to the review of results. This review shall be performed by 
the Medical Review Officer prior

[[Page 462]]

to the transmission of results to licensee management officials.
    (b) ``Medical Review Officer--qualifications and responsibilities.'' 
The Medical Review Officer shall be a licensed physician with knowledge 
of substance abuse disorders and may be a licensee or contract employee. 
The role of the Medical Review Officer is to review and interpret 
positive test results obtained through the licensee's testing program. 
In carrying out this responsibility, the Medical Review Officer shall 
examine alternate medical explanations for any positive test result 
(this does not include confirmation of blood alcohol levels obtained 
through the use of a breath alcohol anaylsis device). This action could 
include conducting a medical interview with the individual, review of 
the individual's medical history, or review of any other relevant 
biomedical factors. The Medical Review Officer shall review all medical 
records made available by the tested individual when a confirmed 
positive test could have resulted from legally prescribed medication. 
The Medical Review Officer shall not consider the results of tests that 
are not obtained or processed in accordance with these Guidelines, 
although he or she may consider the results of tests on split samples in 
making his or her determination, as long as those split samples have 
been stored and tested in accordance with the procedures described in 
these Guidelines.
    (c) ``Positive Test Results.'' Prior to making a final decision to 
verify a positive test result, the Medical Review Officer shall give the 
individual an opportunity to discuss the test result with him or her. 
Following verification of a positive test result, the Medical Review 
Officer shall, as provided in the licensee's policy, notify the 
applicable employee assistance program and the licensee's management 
official empowered to recommend or take administrative action (or the 
official's designated agent).
    (d) ``Verification for opiates; review for prescription 
medication.'' Before the Medical Review Officer verifies a confirmed 
positive result and the licensee takes action for opiates, he or she 
shall determine that there is clinical evidence--in addition to the 
urine test--of unauthorized use of any opium, opiate, or opium 
derivative (e.g., morphine/codeine). Clinical signs of abuse include 
recent needle tracks or behavioral and psychological signs of acute 
opiate intoxication or withdrawal. This requirement does not apply if 
the GC/MS confirmation testing for opiates confirms the presence of 6-
monoacetylmorphine. For other drugs that are commonly prescribed or 
commonly included in over-the-counter preparations (e.g., 
benzodiazepines in the first case, barbiturates in the second) and that 
are listed in the licensee's panel of substances to be tested, the 
Medical Review Officer shall also determine whether there is clinical 
evidence--in addition to the urine test--of unauthorized use of any of 
these substances or their derivatives.
    (e) ``Reanalysis authorized.'' Should any question arise as to the 
accuracy or validity of a positive test result, only the Medical Review 
Officer is authorized to order a reanalysis of the original sample and 
such retests are authorized only at laboratories certified by DHHS. The 
Medical Review Officer shall authorize a reanalysis of the original 
aliquot on timely request of the individual tested, and shall also 
authorize an analysis of any sample stored by the licensee.
    (f) ``Results consistent with responsible substance use.'' If the 
Medical Review Officer determines that there is a legitimate medical 
explanation for the positive test result and that use of the substance 
identified through testing in the manner and at the dosage prescribed 
does not reflect a lack of reliability and is unlikely to create on-the-
job impairment, the Medical Review Officer shall report the test result 
to the licensee as negative.
    (g) ``Result scientifically insufficient.'' Additionally, the 
Medical Review Officer, based on review of inspection reports, quality 
control data, multiple samples, and other pertinent results, may 
determine that the result is scientifically insufficient for further 
action and declare the test specimen negative. In this situation, the 
Medical Review Officer may request reanalysis of the original sample 
before making this decision. (The Medical Review Officer may request 
that reanalysis be performed by the same laboratory or, that an aliquot 
of the original specimen be sent for reanalysis to an alternate 
laboratory which is certified in accordance with the HHS Guidelines.) 
The licensee's testing facility and the HHS-certified laboratory shall 
assist in this review process as requested by the Medical Review Officer 
by making available the individual(s) responsible for day-to-day 
management of the licensee's test facility, of 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 licensee. The licensee shall 
maintain records that summarize any negative findings based on 
scientific insufficiency and shall make them available to the NRC on 
request, but shall not include any personal identifying information in 
such reports.

                     Subpart C--Employee Protection

                   3.1 Protection of Employee Records

    Licensee contracts with HHS certified laboratories and procedures 
for the licensee's testing facility shall require that test

[[Page 463]]

records be maintained in confidence, as provided in 10 CFR 26.29. 
Records shall be maintained and used with the highest regard for 
individual privacy.

   3.2 Individual Access to Test and Laboratory Certification Results

    Any individual who is the subject of a drug or alcohol test under 
this part shall, upon written request, have access to any records 
relating to his or her tests and any records relating to the results of 
any relevant laboratory certification, review, or revocation-of-
certification proceedings.

  Subpart D--Certification of Laboratories Engaged in Chemical Testing

                 4.1 Use of DHHS-certified laboratories

    (a) Licensees subject to this part and their contractors shall use 
only laboratories certified under the DHHS ``Mandatory Guidelines for 
Federal Workplace Drug Testing Programs'', Subpart C--``Certification of 
Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' (53 
FR 11970, 11986-11989) dated April 11, 1988, and subsequent amendments 
thereto for screening and confirmatory testing except for initial 
screening tests at a licensee's testing facility conducted in accordance 
with 10 CFR 26.24(d). Information concerning the current certification 
status of laboratories is available from: The Office of Workplace 
Initiatives, National Institute on Drug Abuse, 5600 Fishers Lane, 
Rockville, Maryland 20857.
    (b) Licensees or their contractors may use only HHS-certified 
laboratories that agree to follow the same rigorous chemical testing, 
quality control, and chain-of-custody procedures when testing for more 
stringent cut-off levels as may be specified by licensees for the 
classes of drugs identified in this part, for analysis of blood 
specimens for alcohol, and for any other substances included in 
licensees' drug panels.

[54 FR 24494, June 7, 1989, as amended at 56 FR 41927, Aug. 26, 1991; 58 
FR 31470, June 3, 1993]



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.
30.16 Resins containing scandium-46 and designed for sand-consolidation 
          in oil wells.
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.

                                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.
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.
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

[[Page 464]]

          need for an emergency plan for responding to a release.

Appendix A to Part 30--Criteria Relating to Use of Financial Tests and 
          Parent 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: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 
954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 
2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201 as amended, 202, 
206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); 
sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
    Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 
5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 954, as 
amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 
Stat. 955 (42 U.S.C. 2237).

                           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.

    Except 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 pursuant to the regulations in this 
chapter.

[30 FR 8185, June 26, 1965, as amended at 43 FR 6921, Feb. 17, 1978]



Sec. 30.4  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 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 any radioactive material (except special 
nuclear material) yielded in or made radioactive by exposure to the 
radiation incident to the process of producing or utilizing special 
nuclear material;
    Commencement of construction means any clearing of land, excavation, 
or other substantial action that would adversely affect the natural 
environment of a site but does not include changes desirable for the 
temporary use of the

[[Page 465]]

land for public recreational uses, necessary borings to determine site 
characteristics or other preconstruction monitoring to establish 
background information related to the suitability of a site or to the 
protection of environmental values.
    Commission means the Nuclear Regulatory Commission and its duly 
authorized representatives;
    Curie means that amount of radioactive material which disintegrates 
at the rate of 37 billion atoms per second;
    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.
    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).
    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;
    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

[[Page 466]]

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.
    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 Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



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 
36 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/eie.html, by calling (301) 415-6030, by e-mail to 
[email protected], or by writing the Office of Information Services, U.S. 
Nuclear Regulatory Commission, Washington,

[[Page 467]]

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.
    (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 to 
persons exempt pursuant 10 CFR 32.11 through 32.26.
    (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, Maine, Massachusetts, New Jersey, 
Pennsylvania, 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, 475 
Allendale Road, King of Prussia, Pennsylvania 19406-1415; where e-mail 
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: Virginia, West Virginia, 
Puerto Rico, and the Virgin Islands. All mailed or hand-delivered 
inquiries, communications, and applications for a new license or an 
amendment, 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 II, Material 
Licensing/Inspection Branch, Sam Nunn Atlanta Federal Center, Suite 
23T85, 61 Forsyth Street, SW, Atlanta, GA 30303-8931; where e-mail is 
appropriate it should be addressed to [email protected].
    (iii) Region III. The regional licensing program involves all 
Federal facilities in the region and non-Federal licensees in the 
following Region III non-Agreement States: Indiana, Michigan, Minnesota, 
Missouri, Ohio, and Wisconsin. All mailed or hand-delivered inquiries, 
communications, and applications for a new license or an amendment, 
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, 
801 Warrenville Road, Lisle, Illinois 60532-4351; where e-mail is 
appropriate it should be addressed to [email protected].
    (iv) Region IV. The regional licensing program involves all Federal 
facilities in the region and non-Federal licensees in the following 
Region IV non-Agreement States and a territory: Alaska, Hawaii, Montana, 
Oklahoma, South Dakota, Wyoming, and Guam. All mailed or hand-delivered 
inquiries,

[[Page 468]]

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, Material Radiation Protection 
Section, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011-4005; 
where e-mail is appropriate it should be addressed to 
[email protected].

[48 FR 16031, Apr. 14, 1983]

    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 on GPO Access.



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.
    (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 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

[[Page 469]]

discipline for legitimate reasons or from adverse action dictated by 
nonprohibited considerations.
    (e)(1) Each specific licensee, each applicant for a specific 
license, and each general licensee subject to part 19 shall prominently 
post the revision of NRC Form 3, ``Notice to Employees,'' referenced in 
10 CFR 19.11(c).
    (2) The posting of NRC Form 3 must be at locations sufficient to 
permit employees protected by this section to observe a copy on the way 
to or from their place of work. Premises must be posted not later than 
30 days after an application is docketed and remain posted while the 
application is pending before the Commission, during the term of the 
license, and for 30 days following license termination.
    (3) Copies of NRC Form 3 may be obtained by writing to the Regional 
Administrator of the appropriate U.S. Nuclear Regulatory Commission 
Regional Office listed in appendix D to part 20 of this chapter, by 
calling (301) 415-5877, via e-mail to [email protected], or by visiting the 
NRC's Web site at http://www.nrc.gov and selecting forms from the index 
found on the home page.
    (f) No agreement affecting the compensation, terms, conditions, or 
privileges of employment, including an agreement to settle a complaint 
filed by an employee with the Department of Labor pursuant to section 
211 of the Energy Reorganization Act of 1974, as amended, may contain 
any provision which would prohibit, restrict, or otherwise discourage an 
employee from participating in protected activity as defined in 
paragraph (a)(1) of this section including, but not limited to, 
providing information to the NRC or to his or her employer on potential 
violations or other matters within NRC's regulatory responsibilities.

[58 FR 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]



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.
    (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, 30.37, and 30.38, 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.

[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]



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

[[Page 470]]

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]

                               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

[[Page 471]]

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 36 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.

[37 FR 3985, Feb. 25, 1972, as amended at 43 FR 6921, Feb. 17, 1978; 52 
FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993]



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 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 
in an agreement State 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, 32, 33, 34, 36 and 39 of this chapter to the extent that he 
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 an agreement State, the Commission, or the Atomic 
Energy 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 pursuant to 
Sec. 32.11 of this

[[Page 472]]

chapter or the general license provided in Sec. 150.20 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]



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.
    (2) Lock illuminators containing not more than 15 millicuries of 
tritium or not more than 2 millicuries of promethium 147 installed in 
automobile locks. The levels of radiation from each lock illuminator 
containing promethium 147 will not exceed 1 millirad per hour at 1 
centimeter from any surface when measured through 50 milligrams per 
square centimeter of absorber.
    (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.
    (4) Automobile shift quadrants containing not more than 25 
millicuries of tritium.
    (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.
    (6) Thermostat dials and pointers containing not more than 25 
millicuries of tritium per thermostat.
    (7) [Reserved]
    (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.

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

[[Page 473]]

    (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) Spark gap irradiators containing not more than 1 microcurie of 
cobalt-60 per spark gap irradiator for use in electrically ignited fuel 
oil burners having a firing rate of at least 3 gallons per hour (11.4 
liters per hour).
    (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. 
30.16, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 30.16  Resins containing scandium-46 and designed for 
sand-consolidation in oil wells.

    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 synthetic 
plastic resins containing scandium-46 which are designed for sand-
consolidation in oil wells, and which have been manufactured or 
initially transferred for sale or distribution, in accordance with a 
specific license issued pursuant to Sec. 32.17 of this chapter or 
equivalent regulations of an agreement State. The exemption in this 
section does not authorize the manufacture or initial transfer for sale 
or distribution of any resins containing scandium-46.

[32 FR 4241, Mar. 18, 1967, as amended at 43 FR 6921, Feb. 17, 1978; 52 
FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993]



Sec. 30.18  Exempt quantities.

    (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 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 
prior to September 25, 1971 under the general license then provided in 
Sec. 31.4 of this chapter 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 of this chapter to the extent that such person possesses, 
uses, transfers, or owns such 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

[[Page 474]]

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.

[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]



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 self-
luminous products containing tritium, krypton-85, or promethium-147, or 
to transfer such products for use pursuant to paragraph (a) of this 
section, should apply for a license pursuant to Sec. 32.22 of this 
chapter, which license states that the product may be transferred by the 
licensee to persons exempt from the regulations pursuant to paragraph 
(a) of this section or equivalent regulations of an Agreement State.
    (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]



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 20 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 life or property from fires and airborne hazards, and 
manufactured, processed, produced, or initially transferred in 
accordance with a specific license issued pursuant to Sec. 32.26 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 gas 
and aerosol detectors containing byproduct material, or to initially 
transfer such products for use pursuant to paragraph (a) of this 
section, should apply for a license pursuant to Sec. 32.26 of this 
chapter, which license states that the product may be initially 
transferred by the licensee to persons exempt from the regulations 
pursuant to paragraph (a) of this section or equivalent regulations of 
an Agreement State.

[34 FR 6653, Apr. 18, 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]



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

[[Page 475]]

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]

                                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]



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) 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--
    (1) Identify the source or device by manufacturer and model number 
as registered with the Commission under Sec. 32.210 of this chapter or 
with an Agreement State; or
    (2) Contain the information identified in Sec. 32.210(c).
    (h) As provided by Sec. 30.35, certain applications for specific 
licenses filed under this part and parts 32 through 35 of this chapter 
must contain a proposed decommissioning funding plan or a certification 
of financial assurance

[[Page 476]]

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.
---------------------------------------------------------------------------

    (ix) Information to be communicated. A brief description of the 
types of information on facility status, radioactive releases, and 
recommended protective

[[Page 477]]

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.

[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]



Sec. 30.33  General requirements for issuance of specific licenses.

    (a) An application for a specific license will be approved if:
    (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 36 and 39; 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 
Commission determines will significantly affect the quality of the 
environment, the Director of Nuclear Material Safety and Safeguards or 
his designee, before commencement of construction of the plant or 
facility in which the activity will be conducted, on the basis of 
information filed and evaluations made pursuant to subpart A of part 51 
of this chapter, has concluded, after weighing the environmental, 
economic, technical, and other benefits against environmental costs and 
considering available alternatives, that the action called for is the 
issuance of the proposed license, with any appropriate conditions to 
protect environmental values. Commencement of construction prior to such 
conclusion shall be

[[Page 478]]

grounds for denial of a license to receive and possess byproduct 
material in such plant or facility. As used in this paragraph the term 
``commencement of construction'' means any clearing of land, excavation, 
or other substantial action that would adversely affect the environment 
of a site. The term does not mean site exploration, necessary roads for 
site exploration, borings to determine foundation conditions, or other 
preconstruction monitoring or testing to establish background 
information related to the suitability of the site or the protection of 
environmental values.
    (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]



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) 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.
    (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 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.

[[Page 479]]

    (g) Each licensee preparing technetium-99m radiopharmaceuticals from 
molybdenum-99/technetium-99m generators shall test the generator eluates 
for molybdenum-99 breakthrough in accordance with Sec. 35.204 of this 
chapter. The licensee shall record the results of each test and retain 
each record for three 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(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.
    (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.

[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]



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 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.

[[Page 480]]

    (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.
    (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).
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) Each decommissioning funding plan must contain a cost estimate 
for decommissioning and 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. Cost estimates must be adjusted at 
intervals not to exceed 3 years. The decommissioning funding plan must 
also contain a certification by the licensee that financial assurance 
for decommissioning has been provided in the amount of the cost estimate 
for decommissioning and a signed original of the financial instrument 
obtained to satisfy the requirements of paragraph (f) of this section.
    (f) Financial assurance for decommissioning must be provided by one 
or more of the following methods:

[[Page 481]]

    (1) Prepayment. Prepayment is the deposit prior to the start of 
operation into an account segregated from licensee assets and outside 
the licensee's administrative control of cash or liquid assets such that 
the amount of funds would be sufficient to pay decommissioning costs. 
Prepayment may be in the form of a trust, escrow account, government 
fund, certificate of deposit, or deposit of government securities.
    (2) A surety method, insurance, or other guarantee method. These 
methods guarantee that decommissioning costs will be paid. A surety 
method may be in the form of a surety bond, letter of credit, or line of 
credit. A parent company guarantee of funds for decommissioning costs 
based on a financial test may be used if the guarantee and test are as 
contained in appendix A to this part. A parent company guarantee may not 
be used in combination with other financial methods to satisfy the 
requirements of this section. For commercial corporations that issue 
bonds, a guarantee of funds by the applicant or licensee for 
decommissioning costs based on a financial test may be used if the 
guarantee and test are as contained in appendix C to 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. A 
guarantee by the applicant or licensee may not be used in combination 
with any other financial methods used to satisfy the requirements of 
this section or in any situation where the applicant or licensee has a 
parent company holding majority control of the voting stock of the 
company. Any surety method or insurance used to provide financial 
assurance for decommissioning must contain the following conditions:
    (i) The surety method or insurance must be open-ended or, if written 
for a specified term, such as five years, must be renewed automatically 
unless 90 days or more prior to the renewal date, the 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 or insurance, the value of which 
may decrease by the amount being accumulated in the sinking fund. An 
external sinking fund is a fund established and maintained by setting 
aside funds periodically in an account segregated from licensee assets 
and outside the 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 may 
be in the form of a trust, escrow account, government fund, certificate 
of deposit, or deposit of government securities. The surety or insurance 
provisions must be as stated in paragraph (f)(2) of this section.
    (4) In the case of Federal, State, or local government licensees, a 
statement of intent containing a cost estimate for decommissioning or an 
amount based on the table in paragraph (d) of this section, and 
indicating that funds for decommissioning will be obtained when 
necessary.
    (5) When a government entity is assuming custody and ownership of a 
site, an arrangement that is deemed acceptable by such government 
entity.

[[Page 482]]

    (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 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.

[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]



Sec. 30.36  Expiration and termination of licenses and decommissioning 
of sites and separate buildings or outdoor areas.

    (a)(1) Except as provided in paragraph (a)(2) of this section, 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 (or, for those licenses subject to 
paragraph (a)(2) of this section, 30 days before the deemed expiration 
date in that paragraph). If an application for renewal has been filed at 
least 30 days before the expiration date stated in the existing license 
(or, for those licenses subject to paragraph (a)(2) of this section, 30 
days before the deemed expiration date in that paragraph), the existing 
license expires at the end of the day on which the Commission makes a

[[Page 483]]

final determination to deny the renewal application or, if the 
determination states an expiration date, the expiration date stated in 
the determination.
    (2) Each specific license that has an expiration date after July 1, 
1995, and is not one of the licenses described in paragraph (a)(3) of 
this section, shall be deemed to have an expiration date that is five 
years after the expiration date stated in the current license.
    (3) The following specific licenses are not subject to, or otherwise 
affected by, the provisions of paragraph (a)(2) of this section:
    (i) Specific licenses for which, on February 15, 1996, an evaluation 
or an emergency plan is required in accordance with Sec. 30.32(i);
    (ii) Specific licenses whose holders are subject to the financial 
assurance requirements specified in 10 CFR 30.35, and on February 15, 
1996, the holders either:
    (A) Have not submitted a decommissioning funding plan or 
certification of financial assurance for decommissioning; or
    (B) Have not received written notice that the decommissioning 
funding plan or certification of financial assurance for decommissioning 
is acceptable;
    (iii) Specific licenses whose holders are listed in the SDMP List 
published in NUREG 1444, Supplement 1 (November 1995);
    (iv) Specific licenses whose issuance, amendment, or renewal, as of 
February 15, 1996, is not a categorical exclusion under 10 CFR 
51.22(c)(14) and, therefore, need an environmental assessment or 
environmental impact statement pursuant to subpart A of part 51 of this 
chapter;
    (v) Specific licenses whose holders have not had at least one NRC 
inspection of licensed activities before February 15, 1996;
    (vi) Specific licenses whose holders, as the result of the most 
recent NRC inspection of licensed activities conducted before February 
15, 1996, have been:
    (A) Cited for a Severity Level I, II, or III violation in a Notice 
of Violation;
    (B) Subject to an Order issued by the NRC; or
    (C) Subject to a Confirmatory Action Letter issued by the NRC.
    (vii) Specific licenses with expiration dates before July 1, 1995, 
for which the holders have submitted applications for renewal under 10 
CFR 30.37 of this part.
    (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

[[Page 484]]

    (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 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

[[Page 485]]

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, ground-water treatment 
activities, monitored natural ground-water 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.

[[Page 486]]

    (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]



Sec. 30.37  Application for renewal of licenses.

    (a) Application for renewal of a specific license must be filed on 
NRC Form 313 and in accordance with Sec. 30.32.
    (b) If any licensee granted the extension described in 10 CFR 
30.36(a)(2) has a currently pending renewal application for the extended 
license, that application will be considered withdrawn by the licensee 
and any renewal fees paid by the licensee for that application will be 
refunded.

[59 FR 36035, July 15, 1994, as amended at 61 FR 1114, Jan. 16, 1996; 66 
FR 64738, Dec. 14, 2001]



Sec. 30.38  Application for amendment of licenses.

    Applications for amendment of a license shall be filed on Form NRC-
313 in accordance with Sec. 30.32 and shall specify the respects in 
which the licensee desires its license to be amended and the grounds for 
the amendment.

[49 FR 19625, May 9, 1984]



Sec. 30.39  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. 30.33 and parts 32 through 36 and 39 of this chapter.

[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. 30.41  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;
    (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,

[[Page 487]]

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;
    (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;

[[Page 488]]

    (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 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

[[Page 489]]

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.
    (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 by 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 of the NRC's 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

[[Page 490]]

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]

                               Enforcement



Sec. 30.61  Modification and revocation of licenses.

    (a) The terms and conditions of each license issued pursuant to the 
regulations in this part and parts 31 through 35 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 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 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 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 an opportunity to demonstrate or 
achieve compliance with all lawful requirements.

[30 FR 8185, June 26, 1965, as amended at 35 FR 11460, July 17, 1970; 43 
FR 6922, Feb. 17, 1978]



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,

[[Page 491]]

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, 30.16, 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]

                                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.................  .......................  3x10-4
                                       Sb 124.................  .......................  2x10-4
                                       Sb 125.................  .......................  1x10-3
Argon (18)...........................  A 37...................  1x10-3.................
                                       A 41...................  4x10-7.................
Arsenic (33).........................  As 73..................  .......................  5x10-3
                                       As 74..................  .......................  5x10-4
                                       As 76..................  .......................  2x10-4
                                       As 77..................  .......................  8x10-4
Barium (56)..........................  Ba 131.................  .......................  2x10-3
                                       Ba 140.................  .......................  3x10-4
Beryllium (4)........................  Be 7...................  .......................  2x10-2
Bismuth (83).........................  Bi 206.................  .......................  4x10-4
Bromine (35).........................  Br 82..................  4x10-7.................  3x10-3
Cadmium (48).........................  Cd 109.................  .......................  2x10-3
                                       Cd 115m................  .......................  3x10-4
                                       Cd 115.................  .......................  3x10-4
Calcium (20).........................  Ca 45..................  .......................  9x10-5
                                       Ca 47..................  .......................  5x10-4
Carbon (6)...........................  C 14...................  1x10-6.................  8x10-3
Cerium (58)..........................  Ce 141.................  .......................  9x10-4
                                       Ce 143.................  .......................  4x10-4
                                       Ce 144.................  .......................  1x10-4
Cesium (55)..........................  Cs 131.................  .......................  2x10-2
                                       Cs 134m................  .......................  6x10-2
                                       Cs 134.................  .......................  9x10-5
Chlorine (17)........................  Cl 38..................  9x10-7.................  4x10-3
Chromium (24)........................  Cr 51..................  .......................  2x10-2
Cobalt (27)..........................  Co 57..................  .......................  5x10-3
                                       Co 58..................  .......................  1x10-3
                                       Co 60..................  .......................  5x10-4
Copper (29)..........................  Cu 64..................  .......................  3x10-3
Dysprosium (66)......................  Dy 165.................  .......................  4x10-3
                                       Dy 166.................  .......................  4x10-4
Erbium (68)..........................  Er 169.................  .......................  9x10-4
                                       Er 171.................  .......................  1x10-3
Europium (63)........................  Eu 152.................  .......................  6x10-4
                                       (T/2=9.2 Hrs)..........
                                       Eu 155.................  .......................  2x10-3
Fluorine (9).........................  F 18...................  2x10-6.................  8x10-3
Gadolinium (64)......................  Gd 153.................  .......................  2x10-3
                                       Gd 159.................  .......................  8x10-4
Gallium (31).........................  Ga 72..................  .......................  4x10-4
Germanium (32).......................  Ge 71..................  .......................  2x10-2
Gold (79)............................  Au 196.................  .......................  2x10-3
                                       Au 198.................  .......................  5x10-4
                                       Au 199.................  .......................  2x10-3
Hafnium (72).........................  Hf 181.................  .......................  7x10-4
Hydrogen (1).........................  H 3....................  5x10-6.................  3x10-2
Indium (49)..........................  In 113m................  .......................  1x10-2
                                       In 114m................  .......................  2x10-4
Iodine (53)..........................  I 126..................  3x10-9.................  2x10-5
                                       I 131..................  3x10-9.................  2x10-5
                                       I 132..................  8x10-8.................  6x10-4

[[Page 492]]

 
                                       I 133..................  1x10-8.................  7x10-5
                                       I 134..................  2x10-7.................  1x10-3
Iridium (77).........................  Ir 190.................  .......................  2x10-3
                                       Ir 192.................  .......................  4x10-4
                                       Ir 194.................  .......................  3x10-4
Iron (26)............................  Fe 55..................  .......................  8x10-3
                                       Fe 59..................  .......................  6x10-4
Krypton (36).........................  Kr 85m.................  1x10-6.................
                                       Kr 85..................  3x10-6.................
Lanthanum (57).......................  La 140.................  .......................  2x10-4
Lead (82)............................  Pb 203.................  .......................  4x10-3
Lutetium (71)........................  Lu 177.................  .......................  1x10-3
Manganese (25).......................  Mn 52..................  .......................  3x10-4
                                       Mn 54..................  .......................  1x10-3
                                       Mn 56..................  .......................  1x10-3
Mercury (80).........................  Hg 197m................  .......................  2x10-3
                                       Hg 197.................  .......................  3x10-3
                                       Hg 203.................  .......................  2x10-4
Molybdenum (42)......................  Mo 99..................  .......................  2x10-3
Neodymium (60).......................  Nd 147.................  .......................  6x10-4
                                       Nd 149.................  .......................  3x10-3
Nickel (28)..........................  Ni 65..................  .......................  1x10-3
Niobium (Columbium) (41).............  Nb 95..................  .......................  1x10-3
                                       Nb 97..................  .......................  9x10-3
Osmium (76)..........................  Os 185.................  .......................  7x10-4
                                       Os 191m................  .......................  3x10-2
                                       Os 191.................  .......................  2x10-3
                                       Os 193.................  .......................  6x10-4
Palladium (46).......................  Pd 103.................  .......................  3x10-3
                                       Pd 109.................  .......................  9x10-4
Phosphorus (15)......................  P 32...................  .......................  2x10-4
Platinum (78)........................  Pt 191.................  .......................  1x10-3
                                       Pt 193m................  .......................  1x10-2
                                       Pt 197m................  .......................  1x10-2
                                       Pt 197.................  .......................  1x10-3
Potassium (19).......................  K 42...................  .......................  3x10-3
Praseodymium (59)....................  Pr 142.................  .......................  3x10-4
                                       Pr 143.................  .......................  5x10-4
Promethium (61)......................  Pm 147.................  .......................  2x10-3
                                       Pm 149.................  .......................  4x10-4
Rhenium (75).........................  Re 183.................  .......................  6x10-3
                                       Re 186.................  .......................  9x10-4
                                       Re 188.................  .......................  6x10-4
Rhodium (45).........................  Rh 103m................  .......................  1x10-1
                                       Rh 105.................  .......................  1x10-3
Rubidium (37)........................  Rb 86..................  .......................  7x10-4
Ruthenium (44).......................  Ru 97..................  .......................  4x10-4
                                       Ru 103.................  .......................  8x10-4
                                       Ru 105.................  .......................  1x10-3
                                       Ru 106.................  .......................  1x10-4
Samarium (62)........................  Sm 153.................  .......................  8x10-4
Scandium (21)........................  Sc 46..................  .......................  4x10-4
                                       Sc 47..................  .......................  9x10-4
                                       Sc 48..................  .......................  3x10-4
Selenium (34)........................  Se 75..................  .......................  3x10-3
Silicon (14).........................  Si 31..................  .......................  9x10-3
Silver (47)..........................  Ag 105.................  .......................  1x10-3
                                       Ag 110m................  .......................  3x10-4
                                       Ag 111.................  .......................  4x10-4
Sodium (11)..........................  Na 24..................  .......................  2x10-3
Strontium (38).......................  Sr 85..................  .......................  1x10-4
                                       Sr 89..................  .......................  1x10-4
                                       Sr 91..................  .......................  7x10-4
                                       Sr 92..................  .......................  7x10-4
Sulfur (16)..........................  S 35...................  9x10-8.................  6x10-4
Tantalum (73)........................  Ta 182.................  .......................  4x10-4
Technetium (43)......................  Tc 96m.................  .......................  1x10-1
                                       Tc 96..................  .......................  1x10-3
Tellurium (52).......................  Te 125m................  .......................  2x10-3

[[Page 493]]

 
                                       Te 127m................  .......................  6x10-4
                                       Te 127.................  .......................  3x10-3
                                       Te 129m................  .......................  3x10-4
                                       Te 131m................  .......................  6x10-4
                                       Te 132.................  .......................  3x10-4
Terbium (65).........................  Tb 160.................  .......................  4x10-4
Thallium (81)........................  Tl 200.................  .......................  4x10-3
                                       Tl 201.................  .......................  3x10-3
                                       Tl 202.................  .......................  1x10-3
                                       Tl 204.................  .......................  1x10-3
Thulium (69).........................  Tm 170.................  .......................  5x10-4
                                       Tm 171.................  .......................  5x10-3
Tin (50).............................  Sn 113.................  .......................  9x10-4
                                       Sn 125.................  .......................  2x10-4
Tungsten (Wolfram) (74)..............  W 181..................  .......................  4x10-3
                                       W 187..................  .......................  7x10-4
Vanadium (23)........................  V 48...................  .......................  3x10-4
Xenon (54)...........................  Xe 131m................  4x10-6.................
                                       Xe 133.................  3x10-6.................
                                       Xe 135.................  1x10-6.................
Ytterbium (70).......................  Yb 175.................  .......................  1x10-3
Yttrium (39).........................  Y 90...................  .......................  2x10-4
                                       Y 91m..................  .......................  3x10-2
                                       Y 91...................  .......................  3x10-4
                                       Y 92...................  .......................  6x10-4
                                       Y 93...................  .......................  3x10-4
Zinc (30)............................  Zn 65..................  .......................  1x10-3
                                       Zn 69m.................  .......................  7x10-4
                                       Zn 69..................  .......................  2x10-2
Zirconium (40).......................  Zr 95..................  .......................  6x10-4
                                       Zr 97..................  .......................  2x10-4
Beta and/or gamma emitting byproduct   .......................  1x10-10................  1x10-6
 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.
Note 1: 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.
Note 2: 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 131 (Cs 131)........................................        1,000

[[Page 494]]

 
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 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 72 (Ga 72).........................................           10
Germanium 71 (Ge 71).......................................          100
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 113m (In 113m)......................................          100
Indium 114m (In 114m)......................................           10
Indium 115m (In 115m)......................................          100
Indium 115 (In 115)........................................           10
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 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
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
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 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 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 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

[[Page 495]]

 
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]



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
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
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]

 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

[[Page 496]]

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:
    1. The parent company must have:
    (i) Two of the following three ratios: A ratio of total liabilities 
to 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 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 (Tangible net worth 
shall be calculated to exclude the net book value of the nuclear 
unit(s)); and
    (iii) Tangible net worth of at least $10 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.
    2. The parent company must have:
    (i) A current rating for its most recent bond issuance of AAA, AA, 
A, or BBB as issued by Standard and Poor's or Aaa, Aa, A, or Baa as 
issued by Moody's; and
    (ii) Tangible net worth each 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 (Tangible net worth shall be calculated 
to exclude the net book value of the nuclear unit(s)); and
    (iii) Tangible net worth of at least $10 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 
have compared 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. In connection with that procedure the licensee 
shall inform 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 
repeat the passage of the test 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 such 
alternative financial assurance 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.
    D. If a trust is 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

[[Page 497]]

whose trust operations are regulated and examined by a Federal or State 
agency.

[53 FR 24046, June 27, 1988, as amended at 63 FR 50479, Sept. 22, 1998]

  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
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

[[Page 498]]

 
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]

 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 
following criteria:
    (1) Tangible net worth at least 10 times the total current 
decommissioning cost estimate for the total of all facilities or parts 
thereof (or the current amount required if certification is used), or, 
for a power reactor licensee, 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 
reactor units or parts thereof (Tangible net worth shall be calculated 
to exclude the net book value of the nuclear unit(s)).
    (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 for the total of all facilities or parts 
thereof (or the current amount required if certification is used), or, 
for a power reactor licensee, 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 
reactor units or parts thereof.
    (3) A current rating for its most recent bond issuance of AAA, AA, 
or A as issued by Standard and Poors (S&P), or Aaa, Aa, or A as issued 
by Moodys.
    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 have 
compared the data used by the company in the financial test which is 
derived from the independently audited, yearend financial statements for 
the latest fiscal year, with the amounts in such

[[Page 499]]

financial statement. In connection with that procedure, the licensee 
shall inform NRC within 90 days of any matters coming to the attention 
of the auditor that 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 repeat 
passage of the test 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.
    E. 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 
Poors or Moodys, the licensee will provide notice in writing of such 
fact to the Commission within 20 days after publication of the change by 
the rating service. If the licensee's most recent bond issuance ceases 
to be rated in any category of A or above by both Standard and Poors and 
Moodys, 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 set up and fund a trust in the amount of 
the current cost estimates for decommissioning.

[58 FR 68730, Dec. 29, 1993; 59 FR 1618, Jan. 12, 1994, as amended at 63 
FR 50479, Sept. 22, 1998]

 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 the following 
criteria:
    (1) Tangible net worth greater than $10 million, or at least 10 
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 company is responsible as self-
guaranteeing licensee and as parent-guarantor.
    (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 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 have 
compared the data used by the company in the financial test, which is 
required to be derived from the independently audited year end financial 
statement based on United States generally accepted accounting practices 
for the latest fiscal year, with the amounts in such financial 
statement. In connection with that procedure, the licensee shall inform 
NRC within 90 days of any matters that may cause the auditor to believe 
that the data specified in

[[Page 500]]

the financial test should be adjusted and that the company no longer 
passes the test.
    (2) After the initial financial test, the company must repeat 
passage of the test 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 set up and fund a trust in the amount of 
the current cost estimates for decommissioning.

[63 FR 29542, June 1, 1998]

 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 as issued by Standard and Poors (S&P) or Aaa, 
Aa, or A as issued by Moodys.
    (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 as issued by Standard and Poors (S&P) or Aaa, 
Aa, or A as issued by Moodys.
    (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 have 
compared the data used by the licensee in the financial test, which is 
required to be derived from the independently audited year end financial

[[Page 501]]

statements, based on United States generally accepted accounting 
practices, for the latest fiscal year, with the amounts in such 
financial statement. In connection with that procedure, the licensee 
shall inform NRC within 90 days of any matters coming to the attention 
of the auditor that 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 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.

                           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 set up and fund a trust in 
the amount of the current cost estimates for decommissioning.
    E. 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 
Poors or Moodys, the licensee shall provide notice in writing of such 
fact to the Commission within 20 days after publication of the change by 
the rating service.

[63 FR 29542, June 1, 1998]



PART 31_GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL--Table of 
Contents




Sec.
31.1 Purpose and scope.
31.2 Terms and conditions.
31.3 Certain devices and equipment.
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 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.
31.11 General license for use of byproduct material for certain in vitro 
          clinical or laboratory testing.
31.12 Maintenance of records.
31.13 Violations.
31.14 Criminal penalties.

    Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended 
(42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat. 1242, 
as amended,1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 Stat. 2750 (44 
U.S.C. 3504 note).



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

[[Page 502]]

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  Certain devices and equipment.

    A general license is hereby issued to transfer, receive, acquire, 
own, possess and use byproduct material incorporated in the following 
devices or equipment which have been manufactured, tested and labeled by 
the manufacturer in accordance with the specifications contained in a 
specific license issued to him by the Commission.
    (a) Static elimination device. Devices designed for use as static 
eliminators which contain, as a sealed source or sources, byproduct 
material consisting of a total of not more than 500 microcuries of 
polonium 210 per device.
    (b)-(c) [Reserved]
    (d) Ion generating tube. Devices designed for ionization of air 
which contain, as a sealed source or sources, byproduct material 
consisting of a total of not more than 500 microcuries of polonium 210 
per device or of a total of not more than 50 millicuries of hydrogen 3 
(tritium) per device.

[30 FR 8189, June 26, 1965, as amended at 34 FR 6652, Apr. 18, 1969; 35 
FR 3982, Mar. 3, 1970]



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, and 31.11.
    (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]



Sec. 31.5  Certain detecting, measuring, gauging, or controlling devices 
and certain devices for producing light or an ionized atmosphere.\2\

    (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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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--
    (i) A specific license issued under Sec. 32.51 of this chapter; or
    (ii) An equivalent specific license issued by an Agreement State.
    (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

[[Page 503]]

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 furnished to the Director 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, 
``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;

[[Page 504]]

    (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 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.
    (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. 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 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.
    (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 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.
    (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 MBq (10 mCi) 
of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of 
cobalt-60, or 37 MBq (1 mCi) 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

[[Page 505]]

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 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 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]



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

[[Page 506]]

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]



Sec. 31.8  Americium-241 in the form of calibration or reference sources.

    (a) A general license is hereby issued to those persons listed below 
to own, receive, acquire, possess, use and transfer, in accordance with 
the provisions of paragraphs (b) and (c) of this section, americium-241 
in the form of calibration or reference sources:
    (1) Any person in a non-Agreement State who holds a specific license 
issued pursuant to this chapter which authorizes him to receive, 
possess, use and transfer byproduct material, source material, or 
special nuclear material; and
    (2) Any Government agency, as defined in Sec. 30.4(g) of this 
chapter, which holds a specific license issued pursuant to 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 pursuant to 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.
    (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 pursuant 
to this general license:
    (1) Shall not possess at any one time, at any one location of 
storage or use, more than 5 microcuries of americium-241 in such 
sources:

[[Page 507]]

    (2) Shall not receive, possess, use or transfer such source unless 
the source, or the storage container, bears a label which includes the 
following statement or a substantially similar statement which contains 
the information called for in the following statement: \1\
---------------------------------------------------------------------------

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

    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. DO 
              NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

________________________________________________________________________
(Name of manufacturer or initial transferor)

    (3) Shall not transfer, abandon, or dispose of such source except by 
transfer to a person authorized by a license pursuant to this chapter or 
from an Agreement State to receive the source.
    (4) Shall store such source, except when the source is being used, 
in a closed container adequately designed and constructed to contain 
americium-241 which might otherwise escape during storage.
    (5) Shall not use such source for any purpose other than the 
calibration of radiation detectors or the standardization of other 
sources.
    (d) This general license does not authorize the manufacture or 
import of calibration or reference sources containing americium-241.
    (e) This general license does not authorize the export of 
calibration or reference sources containing americium-241.

[30 FR 8189, June 26, 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 40767, Aug. 16, 1991]



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.

[[Page 508]]

    (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 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.
    (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 of Nuclear Material Safety and Safeguards, by an appropriate 
method listed in Sec. 30.6(a), 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, pursuant 
to 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, and/or iron-59 in excess of 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

[[Page 509]]

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 that authorizes 
manufacture and distribution of iodine-125, iodine-131, carbon-14, 
hydrogen-3 (tritium), selenium-75, iron-59, or Mock Iodine-125 for 
distribution to persons generally licensed by the Agreement State.
    (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 
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 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 on GPO Access.



Sec. 31.12  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]



Sec. 31.13  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

[[Page 510]]

    (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. 31.14  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 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, 31.3, 31.4, 31.9, 31.13, and 31.14.

[57 FR 55073, Nov. 24, 1992]



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.
32.17 Resins containing scandium-46 and designed for sand-consolidation 
          in oil wells: Requirements for license to manufacture, or 
          initially transfer for sale or distribution.
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.
32.40 Schedule A--Prototype tests for automobile lock illuminators.

                   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.

[[Page 511]]

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: 
          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.
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.
32.101 Schedule B--prototype tests for luminous safety devices for use 
          in aircraft.
32.102 Schedule C--prototype tests for calibration or reference sources 
          containing americium-241.
32.103 Schedule D--prototype tests for ice detection devices containing 
          strontium 90.

              Subpart C_Quality Control Sampling Procedures

32.110 Acceptance sampling procedures under certain specific licenses.

                  Subpart D_Specifically Licensed Items

32.210 Registration of product information.

                          Subpart E_Violations

32.301 Violations.
32.303 Criminal penalties.

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as 
amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as 
amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 
note).

    Source: 30 FR 8192, June 26, 1965, unless otherwise noted.



Sec. 32.1  Purpose and scope.

    (a) 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:
    (1) Persons exempted from the licensing requirements of part 30 of 
this chapter, or
    (2) Persons generally licensed under part 31 or 35 of this chapter.

This part also prescribes certain regulations governing holders of these 
licenses. In addition, 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 the 
licensee or another and regulations governing holders of such licenses. 
Further, this part describes procedures and prescribes requirements for 
the issuance of certificates of registration (coverning radiation safety 
information about a product) to manufacturers or initial transferors of 
sealed source or devices containing sealed sources which are to be used 
by persons specifically licensed under part 30 of this chapter or 
equivalent regulations of an Agreement State.
    (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.

[30 FR 8192, June 26, 1965, as amended at 52 FR 27786, July 24, 1987; 63 
FR 1896, Jan. 13, 1998]



Sec. 32.2  Definitions.

    As used in this part:
    (a) 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.
    (b) Lot Tolerance Percent Defective means, expressed in percent 
defective, the poorest quality in an individual inspection lot that 
should be accepted.

[34 FR 6653, Apr. 18, 1969, as amended at 39 FR 22129, June 20, 1974]

[[Page 512]]



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, 32.17, 
32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27, 
32.29, 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, and 32.210.
    (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]



                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;
    (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

[[Page 513]]

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]



Sec. 32.12  Same: Records and material transfer reports.

    (a) Each person licensed under Sec. 32.11 shall maintain records of 
transfer of material and file a report with the Director of Nuclear 
Material Safety and Safeguards by an appropriate method listed in Sec. 
30.6(a) of this chapter. A copy of the report must be sent to the 
appropriate NRC Regional Office listed in appendix D to part 20 of this 
chapter.
    (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 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) The licensee shall file the report within 30 days following:
    (1) Five years after filing the preceding report; or
    (2) Filing an application for renewal of the license under Sec. 
30.37; or
    (3) Notifying the Commission under Sec. 30.34(f) of the licensee's 
decision to permanently discontinue activities authorized under the 
license issued under Sec. 32.11.
    (d) The report must cover the period between the filing of the 
preceding report and the occurrence specified in paragraphs (c) (1), 
(2), or (3) of this section. If no transfers of byproduct material have 
been made under Sec. 32.11 during the reporting period, the report 
shall so indicate.
    (e) The licensee shall maintain the record of a transfer for a 
period of one year after the event is included in a report to the 
Commission.

[48 FR 12333, Mar. 24, 1983; 48 FR 14863, Apr. 6, 1983, as amended at 68 
FR 58804, Oct. 10, 2003]



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 pursuant to Sec. 32.11 or the general license provided in Sec. 
150.20 of this chapter.

[30 FR 8192, June 26, 1965]



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) Procedures for and results of prototype testing to demonstrate 
that the 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) Quality control procedures to be followed in the fabrication of 
production lots of the product and the quality

[[Page 514]]

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 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:
    (1) 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.
    (2) For automobile lock illuminators, the product has been subjected 
to and meets the requirements of the prototype tests prescribed by Sec. 
32.40, schedule A.

[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]



Sec. 32.15  Same: Quality assurance, prohibition of transfer, and 
labeling.

    (a) Each person licensed under Sec. 32.14 shall:
    (1) Maintain quality assurance practices in the manufacture of the 
part or product, or the installation of the part into the product;
    (2) Subject inspection lots to such testing as may be required as a 
condition of the license issued under Sec. 32.14 taking a random sample 
of the size required by the tables in Sec. 32.110, and for Lot 
Tolerance Percent Defective of 5.0 percent, accept or reject inspection 
lots in accordance with the directions of Sec. 32.110; and
    (3) Visually inspect each unit, except electron tubes containing 
byproduct material, in inspection lots. Any unit which has an observable 
physical defect that could affect containment of the byproduct material 
shall be considered as a defective unit.
    (b) An application for a license or for amendment of a license may 
include a description of procedures proposed as alternatives to those 
prescribed by paragraph (a)(2) of this section, and proposed criteria 
for acceptance under those procedures. The Commission will approve the 
proposed alternative procedures if the applicant demonstrates that the 
operating characteristic curve or confidence interval estimate for the 
alternative procedures provides a Lot Tolerance Percent Defective of 5.0 
percent at the consumer's risk of 0.10.
    (c) 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 which has been tested and found defective 
under the criteria and procedures specified in the license issued under 
Sec. 32.14, unless the defective units have been repaired or reworked 
and have then met such criteria as may be required as a condition of the 
license issued under Sec. 32.14; or
    (2) Any inspection lot which has been rejected as a result of the 
procedures in Sec. 32.110 or alternative procedures in paragraph (b) of 
this section, unless the defective units have been sorted and removed or 
have been repaired or reworked and have then met such criteria as may be 
required as a condition of the license issued under Sec. 32.14.
    (d) 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.

[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]

[[Page 515]]



Sec. 32.16  Certain items containing byproduct material: Records and 
reports of transfer.

    (a) Each person licensed under Sec. 32.14 or Sec. 32.17 shall 
maintain records of all transfers of nuclear material and file a report 
with the Director of Nuclear Material Safety and Safeguards by an 
appropriate method listed in Sec. 30.6(a) of this chapter, with a copy 
to the appropriate NRC Regional Office listed in appendix D to part 20 
of this chapter.
    (b) The report must include the following information on items 
transferred to other persons for use under Sec. 30.15 or Sec. 30.16 of 
this chapter or equivalent regulations of an Agreement State:
    (1) A description or identification of the type of each product;
    (2) For each radionuclide in each type of product, the total 
quantity of the radionuclide; and
    (3) The number of units of each type of product transferred during 
the reporting period.
    (c) The licensee shall file the report within 30 days after:
    (1) Five years after filing the preceding report; or
    (2) Filing an application for renewal of the license under Sec. 
30.37; or
    (3) Notifying the Commission under Sec. 30.34(f) of the licensee's 
decision to permanently discontinue activities authorized under the 
license issued under Sec. 32.14 or Sec. 32.17.
    (d) The report must cover the period between the filing of the 
preceding report and the occurrence specified in paragraphs (c) (1), 
(2), or (3) of this section. If no transfers of byproduct material have 
been made under Sec. 32.14 or Sec. 32.17 during the reporting period, 
the report must so indicate.
    (e) The licensee shall maintain the record of a transfer for a 
period of one year after the event is included in a report to the 
Commission.

[48 FR 12333, Mar. 24, 1983; 48 FR 23383, May 25, 1983, as amended at 68 
FR 58804, Oct. 10, 2003]



Sec. 32.17  Resins containing scandium-46 and designed for 
sand-consolidation in oil wells: Requirements for license to manufacture, 
or initially transfer for sale or distribution.

    An application for a specific license to manufacture, or initially 
transfer for sale or distribution, synthetic plastic resins containing 
scandium-46 for use pursuant to Sec. 30.16 of this chapter will be 
approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec. 30.33 of this chapter;
    (b) The product is designed to be used only for sand-consolidation 
in oil wells;
    (c) The applicant submits the following information:
    (1) The general description of the product to be manufactured or 
initially transferred.
    (2) A description of control procedures to be used to assure that 
the concentration of scandium-46 in the final product at the time of 
distribution will not exceed 1.4x10-3 microcurie/milliliter.
    (d) Each container of such product will bear a durable, legible 
lable approved by the Commission, which contains the following 
information:
    (1) The product name;
    (2) A statement that the product contains radioactive scandium and 
is designed and manufactured only for sand-consolidation in oil wells;
    (3) Instructions necessary for proper use; and
    (4) The manufacturer's name.

[32 FR 4241, Mar. 18, 1967, as amended by 38 FR 29314, Oct. 24, 1973; 43 
FR 6922, Feb. 17, 1978]



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)

[[Page 516]]

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 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 of this part 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 and quantities of byproduct 
material transferred. The licensee shall maintain the record of a 
transfer for a period of one year after the event is included in a 
summary report to the Commission.
    (b) The licensee shall file a summary report stating the total 
quantity of each isotope transferred under the specific license with the 
Director of Nuclear Material Safety and Safeguards by an appropriate 
method listed in Sec. 30.6(a) of this chapter, with a copy to the 
appropriate NRC Regional Office listed in appendix D to part 20 of this 
chapter.
    (c) The licensee shall file the summary report within 30 days 
following:
    (1) Five years after filing the preceding report; or
    (2) Filing an application for renewal of the license under Sec. 
30.37; or
    (3) Notifying the Commission under Sec. 30.34(f) of the licensee's 
decision to

[[Page 517]]

permanently discontinue activities authorized under the license issued 
under Sec. 32.18.
    (d) The report must cover the period between the filing of the 
preceding report and the occurrences specified in paragraph (c) (1), 
(2), or (3) of this section. If no transfers of byproduct material have 
been made under Sec. 32.18 during the reporting period, the report must 
so indicate.

[48 FR 12333, Mar. 24, 1983, as amended at 68 FR 58804, Oct. 10, 2003]



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

[[Page 518]]

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, 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.
    (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]



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

[[Page 519]]

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 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 and file reports with the Director of Nuclear 
Material Safety and Safeguards, by an appropriate method listed in Sec. 
30.6(a), with copies to the appropriate NRC Regional Office listed in 
appendix D to part 20 of this chapter.
    (1) The report must include the following information on products 
transferred to other persons for use under Sec. 30.19 of this chapter 
or equivalent regulations of an Agreement State:
    (i) A description or identification of the type of each product;
    (ii) For each radionuclide in each type of product, the total 
quantity of the radionuclide; and
    (iii) The number of units of each type of product transferred during 
the reporting period.
    (2) The licensee shall file the report within 30 days following:

[[Page 520]]

    (i) Five years after filing the preceding report; or
    (ii) Filing an application for renewal of the license under Sec. 
30.37; or
    (iii) Notifying the Commission under Sec. 30.34(f) of the 
licensee's decision to permanently discontinue activities authorized 
under the license issued under Sec. 32.22.
    (3) The report must cover the period between the filing of the 
preceding report and the occurrences specified in paragraphs (c)(2)(i), 
(ii), or (iii) of this section. If no transfers of byproduct material 
have been made under Sec. 32.22 during the reporting period, the report 
must so indicate.
    (4) The licensee shall maintain the record of a transfer for a 
period of one year after the event 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]



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 life or property from fires and airborne hazards, or 
to initially transfer such products for use pursuant to 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;
    (13) The estimated external radiation doses and dose commitments 
relevant to the safety criteria in Sec. 32.27 and the basis for such 
estimates;

[[Page 521]]

    (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.

[34 FR 6653, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 
FR 38342, June 9, 1980]



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:
    (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

[[Page 522]]

    (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 and file a report with the Director of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555, with copies to the appropriate NRC Regional Office 
listed in appendix D of part 20 of this chapter.
    (1) The report must include the following information on products 
transfered to other persons for use under Sec. 30.20 of this chapter or 
equivalent regulations of an Agreement State:
    (i) A description or identification of the type of each product;
    (ii) For each radionuclide in each type of product, the total 
quantity of the radionuclide; and
    (iii) The number of units of each type of product transferred during 
the reporting period.
    (2) The licensee shall file the report within 30 days following:
    (i) Five years after filing the preceding report; or
    (ii) Filing an application for renewal of the license under Sec. 
30.37; or
    (iii) Notifying the Commission under Sec. 30.34(f) of the 
licensee's decision to permanently discontinue activities authorized 
pursuant to the license issued under Sec. 32.26.
    (3) The report must cover the period between the filing of the 
preceding report and the occurrences specified in paragraphs (c)(2) (i), 
(ii), or (iii) of this section. If no transfers of byproduct material 
have been made under Sec. 32.26 during the reporting period, the report 
must so indicate.
    (4) The licensee shall maintain the record of a transfer for a 
period of one year after the event 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]



Sec. 32.40  Schedule A--Prototype tests for automobile lock illuminators.

    An applicant for a license pursuant to Sec. 32.14 to install lock 
illuminators into automobile locks, or to initially transfer lock 
illuminators in automobile locks for use pursuant to Sec. 30.15 of this 
chapter shall conduct the following prototype tests on each of five 
prototype devices, consisting of the automobile lock with the installed 
illuminator in the following order:
    (a) The device shall be subjected to 100 hours of accelerated 
weathering in a suitable weathering machine which simulates the most 
severe conditions of normal use;
    (b) The device shall be dropped upon a concrete or iron surface in a 
3-foot free gravitational fall, or shall be subjected to an equivalent 
treatment in a test device simulating such a fall. The drop test shall 
be repeated 100 times from random orientations;
    (c) The device shall be attached to a vibratory fixture and vibrated 
at a rate of not less than 26 cycles per second and a vibration 
acceleration of not less than 2 G for a period of not less than 1 hour;
    (d) On completion of the foregoing tests, the device shall be 
immersed in 30 inches of water for 24 hours and shall show no visible 
evidence of water entry into the lock illuminator. Absolute pressure of 
the air above the water

[[Page 523]]

shall then be reduced to 1 inch of mercury. Lowered pressure shall be 
maintained for 1 minute or until air bubbles cease to be given off by 
the water, whichever is the longer. Pressure shall then be increased to 
normal atmospheric pressure. Any evidence of bubbles emanating from 
within the lock illuminator, or water entering the lock illuminator, 
shall be considered leakage;
    (e) After each of the tests prescribed by this section, each device 
shall be examined for evidence of physical damage and for loss of 
tritium or promethium-147. Any evidence of damage to or failure of any 
device which could affect the containment of the tritium or promethium-
147 in such devices shall be cause for rejection of the design on which 
such prototype devices were constructed or manufactured if the damage or 
failure is attributable to design defect. Loss of tritium or promethium-
147 from each tested device shall be measured both by sampling the 
immersion test water used in paragraph (d) of this section and by wiping 
with filter paper the entire accessible area of the lock illuminator. 
Measurements of tritium or promethium-147 shall be made in an apparatus 
calibrated to measure tritium or promethium-147, as appropriate. If more 
than 0.1 percent of the original amount of tritium or promethium-147 in 
the device is found in the immersion test water of the test in paragraph 
(d) of this section, or if more than 2,200 disintegrations per minute of 
tritium or promethium-147 on the filter paper is measured after any of 
the tests in paragraphs (a) to (d) of this section the device shall be 
rejected.

[30 FR 8192, June 26, 1965, as amended at 31 FR 5317, Apr. 2, 1966; 43 
FR 6923, Feb. 17, 1978]



                   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);
    (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.


[[Page 524]]


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

    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.
    (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 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]



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

[[Page 525]]

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 of Nuclear Material 
Safety and Safeguards, ATTN: GLTS, by an appropriate method listed in 
Sec. 30.6(a), 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 
report must be submitted on a quarterly basis 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.

[[Page 526]]

    (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, 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.

[[Page 527]]

    (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]



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) Any quality control procedures proposed as alternatives to those 
prescribed by 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) The device has been subjected to and has satisfactorily passed 
the prototype tests prescribed by Sec. 32.101, Schedule B, of this 
part.

[30 FR 8192, June 26, 1965, as amended at 33 FR 6463, Apr. 27, 1968; 43 
FR 6923, Feb. 17, 1978]



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

[[Page 528]]

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 which has an observable physical defect 
that could affect containment of the tritium or promethium-147.
    (b) Each person licensed under Sec. 32.53 shall take a random 
sample of the size required by the table in Sec. 32.110 for Lot 
Tolerance Percent Defective of 5.0 percent from each inspection lot, and 
shall subject each unit in the sample to the following tests:
    (1) Each device shall be immersed in 30 inches of water for 24 hours 
and shall show no visible evidence of water entry. Absolute pressure of 
the air above the water shall then be reduced to 1 inch of mercury. 
Lowered pressure shall be maintained for 1 minute or until air bubbles 
cease to be given off by the water, whichever is the longer. Pressure 
shall then be increased to normal atmospheric pressure. Any device which 
leaks as evidenced by bubbles emanating from within the device, or water 
entering the device, shall be considered as a defective unit.
    (2) The immersion test water from the preceding test in paragraph 
(b)(1) of this section shall be measured for tritium or promethium-147 
content by an apparatus that has been calibrated to measure tritium or 
promethium-147, as appropriate. If more than 0.1 percent of the original 
amount of tritium or promethium-147 in any device is found to have 
leaked into the immersion test water, the leaking device shall be 
considered as a defective unit.
    (3) The levels of radiation from each device containing promethium-
147 shall be measured. Any device which has a radiation level in excess 
of 0.5 millirad per hour at 10 centimeters from any surface when 
measured through 50 milligrams per square centimeter of absorber, shall 
be considered as a defective unit.
    (c) An application for a license or for amendment of a license may 
include a description of procedures proposed as alternatives to those 
prescribed by paragraph (b) of this section, and proposed criteria for 
acceptance under those procedures. The Commission will approve the 
proposed alternative procedures if the applicant demonstrates that:
    (1) They will consider defective any sampled device which has a 
leakage rate exceeding 0.1 percent of the original quantity of tritium 
or promethium 147 in any 24-hour period; and
    (2) The operating characteristic curve or confidence interval 
estimate for the alternative procedures provides

[[Page 529]]

a Lot Tolerance Percent Defective of 5.0 percent at the consumer's risk 
of 0.10.
    (d) No person licensed under Sec. 32.53 shall transfer to persons 
generally licensed under Sec. 31.7 of this chapter:
    (1) Any luminous safety device which has been tested and found 
defective under the criteria and procedures specified in this section, 
unless the defective units have been repaired or reworked and have then 
met the tests set out in paragraph (b) of this section; or
    (2) Any inspection lot which has been rejected as a result of the 
procedures in Sec. 32.110 or alternative procedures in paragraph (c) of 
this section, unless the defective units have been sorted and removed or 
have been repaired or reworked and have then met the tests set out in 
paragraph (b) of this section.

[30 FR 8192, June 26, 1965, as amended at 39 FR 22129, June 20, 1974; 39 
FR 26397, July 19, 1974]



Sec. 32.56  Same: Material transfer reports.

    Each person licensed under Sec. 32.53 shall file an annual report 
with the Director of Nuclear Material Safety and Safeguards, by an 
appropriate method listed in Sec. 30.6(a) of this chapter, which report 
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.

[60 FR 3737, Jan. 19, 1995, as amended at 68 FR 58805, Oct. 10, 2003]



Sec. 32.57  Calibration or reference sources containing americium-241: 
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, 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 
in the source;
    (2) Details of construction and design;
    (3) Details of the method of incorporation and binding of the 
americium-241 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, to demonstrate that the americium-241 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.
    (d) The Commission determines, with respect to any type of source 
containing more than 0.005 microcurie of americium-241, that:
    (1) The method of incorporation and binding of the americium-241 in 
the source is such that the americium-241 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 
the prototype tests prescribed by Sec. 32.102, Schedule C, of this 
part.

[30 FR 8192, June 26, 1965, as amended at 43 FR 6923, Feb. 17, 1978]



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

[[Page 530]]

relative to safe use and storage of the source and shall include the 
following statement or a substantially similar statement which contains 
the information called for in the following statement: \1\
---------------------------------------------------------------------------

    \1\ Sources licensed under Sec. 32.57 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 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. DO 
              NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

________________________________________________________________________
Name of manufacturer or initial transferor)

(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))

[30 FR 8192, June 26, 1965, as amended at 40 FR 8786, Mar. 3, 1975; 43 
FR 6923, Feb. 17, 1978]



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 0.1 microcurie of americium-241 
prior to transferring the source to a general licensee under Sec. 31.8 
of this chapter. This test shall be performed by wiping the entire 
radioactive surface of the source with a filter paper with the 
application of moderate finger pressure. The radioactivity on the paper 
shall be measured by using radiation detection instrumentation capable 
of detecting 0.005 microcurie of americium-241. If any such test 
discloses more than 0.005 microcurie of radioactive material, the source 
shall be deemed to be leaking or losing americium-241 and shall not be 
transferred to a general licensee under Sec. 31.8 of this chapter.

[30 FR 8192, June 26, 1965]



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 531]]

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) The device has been subjected to and has satisfactorily passed 
the prototype tests prescribed by Sec. 32.103; and
    (5) Quality control procedures have been established to satisfy the 
requirements of Sec. 32.62.

[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]



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 take a random 
sample of the size required by the table in Sec. 32.110 for Lot 
Tolerance Percent Defective of 5.0 percent from each inspection lot, and 
shall subject each unit in the sample to the following tests:
    (1) Each device shall be immersed in 30 inches of water for 24 hours 
and shall show no visible evidence of physical contact between the water 
and the strontium-90. Absolute pressure of the air above the water shall 
then be reduced to 1 inch of mercury. Lowered pressure shall be 
maintained for 1 minute or until air bubbles cease to be given off by 
the water, whichever is the longer. Pressure shall then be increased to 
normal atmospheric pressure. Any device which leaks, as evidenced by 
physical contact between the water and the strontium-90, shall be 
considered as a defective unit.
    (2) The immersion test water from the preceding test in paragraph 
(c)(1) of this section shall be measured for radioactive material. If 
the amount of radioactive material in the immersion test water is 
greater than 0.1 percent of the original amount of strontium-90 in any 
device, the device shall be considered as a defective unit.
    (d) An application for a license or for amendment of a license may 
include a description of procedures proposed as alternatives to those 
prescribed by paragraph (c) of this section, and proposed criteria for 
acceptance under those procedures. The Commission will approve the 
proposed alternative procedures if the applicant demonstrates that:
    (1) They will consider defective any sampled device which has a 
leakage rate exceeding 0.1 percent of the original quantity of 
strontium-90 in any 24-hour period; and
    (2) The operating characteristic curve or confidence interval 
estimate for the alternative procedures provides a Lot Tolerance Percent 
Defective of 5.0 percent at the consumer's risk of 0.10.
    (e) No person licensed under Sec. 32.61 shall transfer to persons 
generally licensed under Sec. 31.10 of this chapter:
    (1) Any device which has been tested and found defective under the 
criteria and procedures specified in this Sec. 32.62 unless the 
defective units have been repaired or reworked and then met the tests 
set out in paragraph (c) of this section; or

[[Page 532]]

    (2) Any inspection lot which has been rejected as a result of the 
procedures in Sec. 32.110 or alternative procedures in paragraph (d) of 
this section, unless the defective units have been sorted and removed or 
have been repaired or reworked and have then met the tests set out in 
paragraph (c) of this section.

[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]



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.
    (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 10 microcuries of iodine-131, iodine-125, selenium-75, or carbon-
14; 50 microcuries of hydrogen-3 (tritium); or 20 microcuries of iron-
59; or Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-
129 and 0.005 microcurie of americium-241 each; 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 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]



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

[[Page 533]]

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 or licensed with the U.S. Food and Drug 
Administration (FDA) as a drug manufacturer;
    (ii) Registered or licensed with a state agency as a drug 
manufacturer;
    (iii) Licensed as a pharmacy by a State Board of Pharmacy; or
    (iv) Operating as a nuclear pharmacy within a Federal medical 
institution.
    (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.
    (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 10 CFR 
35.55(b) or, prior to October 25, 2004, 10 CFR 35.980(b) and 35.59 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 10 CFR 35.2) as an 
authorized nuclear pharmacist if the individual is identified as of 
December 2, 1994, as an ``authorized user'' on a nuclear pharmacy 
license issued by the Commission under this part.
    (5) Shall provide to the Commission a copy of each individual's 
certification by the Board of Pharmaceutical Specialties, the Commission 
or Agreement State license, or the permit issued by a licensee of broad 
scope, and a copy of the state pharmacy licensure or registration, no 
later than 30 days after the date that the licensee allows, pursuant to 
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:

[[Page 534]]

    (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]



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 pursuant to part 35 of this chapter for use as a calibration or 
reference source or for the uses listed in Sec. Sec. 35.400, 35.500, 
and 35.600 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.
    (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 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;

[[Page 535]]

    (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]



Sec. 32.101  Schedule B--prototype tests for luminous safety devices 
for use in aircraft.

    An applicant for a license pursuant to Sec. 32.53 shall conduct 
prototype tests on each of five prototype luminous safety devices for 
use in aircraft as follows:
    (a) Temperature-altitude test. The device shall be placed in a test 
chamber as it would be used in service. A temperature-altitude condition 
schedule shall be followed as outlined in the following steps:

    Step 1. The internal temperature of the test chamber shall be 
reduced to -62 [deg]C. (-80 [deg]F.) and the device shall be maintained 
for at least 1 hour at this temperature at atmospheric pressure.
    Step 2. The internal temperature of the test chamber shall be raised 
to -54 [deg]C. (-65 [deg]F.) and maintained until the temperature of the 
device has stabilized at -54 [deg]C. at atmospheric pressure.
    Step 3. The atmospheric pressure of the chamber shall be reduced to 
83 millimeters of mercury absolute pressure while the chamber 
temperature is maintained at -54 [deg]C.
    Step 4. The internal temperature of the chamber shall be raised to -
10 [deg]C. (+14 [deg]F.) and maintained until the temperature of the 
device has stabilized at -10 [deg]C., and the internal pressure of the 
chamber shall then be adjusted to atmospheric pressure. The test chamber 
door shall then be opened in order that frost will form on the device, 
and shall remain open until the frost has melted but not long enough to 
allow the moisture to evaporate. The door shall then be closed.
    Step 5. The internal temperature of the chamber shall be raised to 
+85 [deg]C. (185 [deg]F.) at atmospheric pressure. The temperature of 
the device shall be stabilized at +85 [deg]C. and maintained for 2 
hours. The device shall then be visually inspected to determine the 
extent of any deterioration.
    Step 6. The chamber temperature shall be reduced to +71 [deg]C. (160 
[deg]F.) at atmospheric pressure. The temperature of the device shall be 
stabilized at +71 [deg]C. for a period of 30 minutes.
    Step 7. The chamber temperature shall be reduced to +55 [deg]C. (130 
[deg]F.) at atmospheric pressure. The temperature of the device shall be 
stabilized at this temperature for a period of 4 hours.
    Step 8. The internal temperature of the chamber shall be reduced to 
+30 [deg]C. (86 [deg]F.) and the pressure to 138 millimeters of mercury 
absolute pressure and stabilized. The device shall be maintained under 
these conditions for a period of 4 hours.
    Step 9. The temperature of the test chamber shall be raised to +35 
[deg]C. (95 [deg]F.) and the pressure reduced to 83 millimeters of 
mercury absolute pressure and stabilized. The device shall be maintained 
under these conditions for a period of 30 minutes.
    Step 10. The internal pressure of the chamber shall be maintained at 
83 millimeters of mercury absolute pressure and the temperature reduced 
to +20 [deg]C. (68 [deg]F.) and stabilized. The device shall be 
maintained under these conditions for a period of 4 hours.

    (b) Vibration tests. This procedure applies to items of equipment 
(including vibration isolating assemblies) intended to be mounted 
directly on the structure of aircraft powered by reciprocating, 
turbojet, or turbo-propeller engines or to be mounted directly on gas-
turbine engines. The device shall be mounted on an apparatus dynamically 
similar to the most severe conditions likely to be encountered in normal 
use. At the end of the test period, the device shall be inspected 
thoroughly for possible damage. Vibration tests shall be conducted under 
both resonant and cycling conditions according to the following 
Vibration Test Schedule (Table I):

[[Page 536]]



                    Vibration Test Schedule--Table I
              [Times shown refer to one axis of vibration]
------------------------------------------------------------------------
                                                   Vibration   Vibration
                                      Vibration     at 160      at -65
                                       at room      [deg]F.   [deg]F. (-
                Type                 temperature      (71         54
                                      (minutes)    [deg]C.)    [deg]C.)
                                                   (minutes)   (minutes)
------------------------------------------------------------------------
Resonance..........................           60          15          15
Cycling............................           60          15          15
------------------------------------------------------------------------

    (1) Determination of resonance frequency. Individual resonance 
frequency surveys shall be conducted by applying vibration to each 
device along each of any set of three mutually perpendicular axes and 
varying the frequency of applied vibration slowly through a range of 
frequencies from 5 cycles per second to 500 cycles per second with the 
double amplitude of the vibration not exceeding that shown in Figure 1 
for the related frequency.
    (2) Resonance tests. The device shall be vibrated at the determined 
resonance frequency for each axis of vibration for the periods and 
temperature conditions shown in table I and with the applied double 
amplitude specified in Figure 1 for that resonance frequency. When more 
than one resonant frequency is encountered with vibration applied along 
any one axis, the test period may be accomplished at the most severe 
resonance or the period may be divided among the resonant frequencies, 
whichever is considered most likely to produce failure. When resonant 
frequencies are not apparent within the specified frequency range, the 
specimen shall be vibrated for periods twice as long as those shown for 
resonance in table I at a frequency of 55 cycles per second and an 
applied double amplitude of 0.060 inch.

[[Page 537]]

[GRAPHIC] [TIFF OMITTED] TC02OC91.056

    (3) Cycling. Devices to be mounted only on vibration isolators shall 
be tested by applying vibration along each of three mutually 
perpendicular axes of the device with an applied double amplitude of 
0.060 inch and the frequency cycling between 10 and 55 cycles per second 
in 1-minute cycles for the periods and temperature conditions shown in 
table I. Devices to be installed in aircraft without vibration isolators 
shall be tested by applying vibration along each of three mutually 
perpendicular axes of the device with an applied double amplitude of 
0.036 inch or an applied acceleration of 10G, whichever is the limiting 
value, and the frequency cycling between 10 and 500 cycles per second in 
15-minute cycles for the periods and temperature conditions shown in 
table I.

[[Page 538]]

    (c) Accelerated weathering tests. The device shall be subjected to 
100 hours of accelerated weathering in a suitable weathering machine. 
Panels of Corex D glass shall surround the arc to cut off the 
ultraviolet radiation below a wave-length of 2,700 angstroms. The light 
of the carbon arcs shall fall directly on the face of the device. The 
temperature at the sample shall be maintained at 50 [deg]C. plus or 
minus 3 [deg]C. Temperature measurements shall be made with a black 
panel thermometer.
    (d) Shock test. The device shall be dropped upon a concrete or iron 
surface in a 3-foot free gravitational fall, or shall be subjected to 
equivalent treatment in a test device simulating such a free fall. The 
drop test shall be repeated 100 times from random orientations.
    (e) Hermetic seal and waterproof test. On completion of all other 
tests prescribed by this section, the device shall be immersed in 30 
inches of water for 24 hours and shall show no visible evidence of water 
entry. Absolute pressure of the air above the water shall then be 
reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 
minute or until air bubbles cease to be given off by the water, 
whichever is the longer. Pressure shall then be increased to normal 
atmospheric pressure. Any evidence of bubbles emanating from within the 
device, or water entering the device, shall be considered leakage.
    (f) Observations. After each of the tests prescribed by this 
section, each device shall be examined for evidence of physical damage 
and for loss of tritium or promethium-147. Any evidence of damage to or 
failure of any device which could affect containment of the tritium or 
promethium-147 shall be cause for rejection of the design if the damage 
or failure is attributable to a design defect. Loss of tritium or 
promethium-147 from each tested device shall be measured 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 amount of tritium or promethium-
147 in the water used in the hermetic seal and waterproof test 
prescribed by test paragraph (e) of this section shall also be measured. 
Measurements shall be made in an apparatus calibrated to measure tritium 
or promethium-147, as appropriate. The detection on the filter paper of 
more than 2,200 disintegrations per minute of tritium or promethium-147 
per 100 square centimeters of surface wiped or in the water of more than 
0.1 percent of the original amount of tritium or promethium-147 in any 
device shall be cause for rejection of the tested device.

[30 FR 8192, June 26, 1965]



Sec. 32.102  Schedule C--prototype tests for calibration or reference 
sources containing americium-241.

    An applicant for a license pursuant to Sec. 32.57 shall, for any 
type of source which is designed to contain more than 0.005 microcurie 
of americium-241, conduct prototype tests, in the order listed, on each 
of five prototypes of such source, which contains more than 0.005 
microcurie of americium-241, as follows:
    (a) Initial measurement. The quantity of radioactive material 
deposited on the source shall be measured by direct counting of the 
source.
    (b) Dry wipe test. The entire radioactive surface of the source 
shall be wiped with filter paper with the application of moderate finger 
pressure. Removal of radioactive material from the source shall be 
determined by measuring the radioactivity on the filter paper or by 
direct measurement of the radioactivity on the source following the dry 
wipe.
    (c) Wet wipe test. The entire radioactive surface of the source 
shall be wiped with filter paper, moistened with water, with the 
application of moderate finger pressure. Removal of radioactive material 
from the source shall be determined by measuring the radioactivity on 
the filter paper after it has dried or by direct measurement of the 
radioactivity on the source following the wet wipe.
    (d) Water soak test. The source shall be immersed in water at room 
temperature for a period of 24 consecutive hours. The source shall then 
be removed from the water. Removal of radioactive material from the 
source shall be determined by direct measurement of the radioactivity on 
the source

[[Page 539]]

after it has dried or by measuring the radioactivity in the residue 
obtained by evaporation of the water in which the source was immersed.
    (e) Dry wipe test. On completion of the preceding test in this 
section, the dry wipe test described in paragraph (b) of this section 
shall be repeated.
    (f) Observations. Removal of more than 0.005 microcurie of 
radioactivity in any test prescribed by this section shall be cause for 
rejection of the source design. Results of prototype tests submitted to 
the Commission shall be given in terms of radioactivity in microcuries 
and percent of removal from the total amount of radioactive material 
deposited on the source.

[30 FR 8192, June 26, 1965, as amended at 31 FR 15145, Dec. 2, 1966]



Sec. 32.103  Schedule D--prototype tests for ice detection devices 
containing strontium-90.

    An applicant for a license pursuant to Sec. 32.61 shall conduct 
prototype tests on each of five prototype ice detection devices as 
follows:
    (a) Temperature-altitude test. The device shall be placed in a test 
chamber as it would be used in service. A temperature-altitude condition 
schedule shall be followed as outlined in Step 1 through Step 10 of 
Sec. 32.101(a).
    (b) Vibration tests. The device shall be subjected to vibration 
tests as set forth in Sec. 32.101(b).
    (c) Shock test. The device shall be subjected to shock test as set 
forth in Sec. 32.101(d).
    (d) Hermetic seal and waterproof test. On completion of all other 
tests prescribed by this section, the device shall be immersed in 30 
inches of water for 24 hours and shall show no visible evidence of 
physical contact between the water and the strontium-90. Absolute 
pressure of the air above the water shall then be reduced to 1 inch of 
mercury. Lowered pressure shall be maintained for 1 minute or until air 
bubbles cease to be given off by the water, whichever is the longer. 
Pressure shall then be increased to normal atmospheric pressure. Any 
visible evidence of physical contact between the water and the 
strontium-90 shall be considered leakage.
    (e) Observations. After each of the tests prescribed by this 
section, each device shall be examined for evidence of physical damage 
and for loss of strontium-90. Any evidence of leakage or damage to or 
failure of any device which could affect containment of the strontium-90 
shall be cause for rejection of the design if the damage or failure is 
attributable to a design defect. Loss of strontium-90 from each tested 
device shall be measured 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 amount of strontium-90 in the water used in the 
hermetic seal and waterproof test prescribed in paragraph (d) of this 
section shall also be measured. The detection on the filter paper of 
more than 2,200 disintegrations per minute of strontium-90 per 100 
square centimeters of surface wiped or in the water of more than 0.1 
percent of the original amount of strontium-90 in any device, shall be 
cause for rejection of the tested device.

[30 FR 9906, Aug. 10, 1965]



              Subpart C_Quality Control Sampling Procedures



Sec. 32.110  Acceptance sampling procedures under certain specific 
licenses.

    (a) A random sample shall be taken from each inspection lot of 
devices licensed under Sec. Sec. 32.14, 32.53, or 32.61 of this part 
for which testing is required pursuant to Sec. Sec. 32.15, 32.55, or 
32.62 in accordance with the appropriate Sampling Table in this section 
determined by the designated Lot Tolerance Percent Defective. If the 
number of defectives in the sample does not exceed the acceptance number 
in the appropriate Sampling Table in this section, the lot shall be 
accepted. If the number of defectives in the sample exceeds the 
acceptance number in the appropriate Sampling Table in this section, the 
entire inspection lot shall be rejected.
    (b) Single sampling tables for Lot Tolerance Percent Defective:
    (1) Lot Tolerance Percent Defective 0.5 percent:

[[Page 540]]



------------------------------------------------------------------------
                                                    Sample    Acceptance
                    Lot size                         size         No.
------------------------------------------------------------------------
1 to 180........................................         All           0
181 to 210......................................         180           0
211 to 250......................................         210           0
251 to 300......................................         240           0
301 to 400......................................         275           0
401 to 500......................................         300           0
501 to 600......................................         320           0
601 to 800......................................         350           0
801 to 1,000....................................         365           0
1,001 to 2,000..................................         410           0
2,001 to 3,000..................................         430           0
3,001 to 4,000..................................         440           0
4,001 to 5,000..................................         445           0
5,001 to 7,000..................................         450           0
7,001 to 10,000.................................         455           0
10,001 to 20,000................................         460           0
20,001 to 50,000................................         775           1
50,001 to 100,000...............................         780           1
------------------------------------------------------------------------

    (2) Lot Tolerance Percent Defective 1.0 percent:

------------------------------------------------------------------------
                                                    Sample    Acceptance
                    Lot size                         size         No.
------------------------------------------------------------------------
1 to 120........................................         All           0
121 to 150......................................         120           0
151 to 200......................................         140           0
201 to 300......................................         165           0
301 to 400......................................         175           0
401 to 500......................................         180           0
501 to 600......................................         190           0
601 to 800......................................         200           0
801 to 1,000....................................         205           0
1,001 to 3,000..................................         220           0
3,001 to 5,000..................................         225           0
5,001 to 10,000.................................         230           0
10,001 to 100,000...............................         390           1
------------------------------------------------------------------------

    (3) Lot Tolerance Percent Defective 2.0 percent:

------------------------------------------------------------------------
                                                    Sample    Acceptance
                    Lot size                         size         No.
------------------------------------------------------------------------
1 to 75.........................................         All           0
76 to 100.......................................          70           0
101 to 200......................................          85           0
201 to 300......................................          95           0
301 to 400......................................         100           0
401 to 600......................................         105           0
601 to 800......................................         110           0
801 to 4,000....................................         115           0
4,001 to 10,000.................................         195           1
10,001 to 100,000...............................         200           1
------------------------------------------------------------------------

    (4) Lot Tolerance Percent Defective 3.0 percent:

------------------------------------------------------------------------
                                                    Sample    Acceptance
                    Lot size                         size         No.
------------------------------------------------------------------------
1 to 40.........................................         All           0
41 to 55........................................          40           0
56 to 100.......................................          55           0
101 to 200......................................          65           0
201 to 500......................................          70           0
501 to 3,000....................................          75           0
3,001 to 100,000................................         130           1
------------------------------------------------------------------------

    (5) Lot Tolerance Percent Defective 4.0 percent:

------------------------------------------------------------------------
                                                    Sample    Acceptance
                    Lot size                         size         No.
------------------------------------------------------------------------
1 to 35.........................................         All           0
36 to 50........................................          34           0
51 to 100.......................................          44           0
101 to 200......................................          50           0
201 to 2,000....................................          55           0
2,001 to 100,000................................          95           1
------------------------------------------------------------------------

    (6) Lot Tolerance Percent Defective 5.0 percent:

------------------------------------------------------------------------
                                                    Sample    Acceptance
                    Lot size                         size         No.
------------------------------------------------------------------------
1 to 30.........................................         All           0
31 to 50........................................          30           0
51 to 100.......................................          37           0
101 to 200......................................          40           0
201 to 300......................................          43           0
301 to 400......................................          44           0
401 to 2,000....................................          45           0
2,001 to 100,000................................          75           1
------------------------------------------------------------------------

    (7) Lot Tolerance Percent Defective 7.0 percent:

------------------------------------------------------------------------
                                                    Sample    Acceptance
                    Lot size                         size         No.
------------------------------------------------------------------------
1 to 25.........................................         All           0
26 to 50........................................          24           0
51 to 100.......................................          28           0
101 to 200......................................          30           0
201 to 300......................................          31           0
301 to 800......................................          32           0
801 to 1,000....................................          33           0
1,001 to 100,000................................          55           1
------------------------------------------------------------------------

    (8) Lot Tolerance Percent Defective 10.0 percent:

------------------------------------------------------------------------
                                                    Sample    Acceptance
                    Lot size                         size         No.
------------------------------------------------------------------------
1 to 20.........................................         All           0
21 to 50........................................          17           0
51 to 100.......................................          20           0
101 to 200......................................          22           0
201 to 800......................................          23           0
801 to 100,000..................................          39           1
------------------------------------------------------------------------


[39 FR 22130, June 20, 1974]



                  Subpart D_Specifically Licensed Items



Sec. 32.210  Registration of product information.

    (a) Any manufacturer or initial distributor of a sealed source or 
device containing a sealed source whose product is intended for use 
under a specific license may submit a request to NRC

[[Page 541]]

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, Materials Safety and Inspection 
Branch, 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.
    (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.
    (f) The person submitting the request for evaluation and 
registration of safety information about the product shall 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.

[52 FR 27786, July 24, 1987, as amended at 60 FR 24551, May 9, 1995; 68 
FR 58805, Oct. 10, 2003]



                          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, 32.17, 32.18, 32.22, 32.23, 
32.24, 32.26, 32.27, 32.28, 32.51, 32.53, 32.57, 32.61, 32.71, 32.74, 
32.301, and 32.303.

[57 FR 55073, Nov. 24, 1992, as amended at 59 FR 61781, Dec. 2, 1994]

[[Page 542]]



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: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as 
amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as 
amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (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 part 30 of this chapter apply to applications and licenses 
subject to this part.



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 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

[[Page 543]]

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
    (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;

[[Page 544]]

    (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 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;

[[Page 545]]

    (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]

                                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
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-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

[[Page 546]]

 
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
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-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
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]



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

[[Page 547]]

          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.

                         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: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as 
amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as 
amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 
note). Section 34.45 also issued under sec. 206, 88 Stat. 1246 (42 
U.S.C. 5846).

    Source: 62 FR 28963, May 28, 1997, unless otherwise noted.



                      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 10 parts 19, 
20, 21, 30, 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.



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.

[[Page 548]]

    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.)
    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.

[[Page 549]]

    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 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, 34.53, 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.

[[Page 550]]

    (2) [Reserved]

[62 FR 52186, Oct. 6, 1997]



                 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 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.

[[Page 551]]



                           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., 1430 Broadway, New York, 
New York 10018 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 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.''

[[Page 552]]

    (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 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]



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

[[Page 553]]

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 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 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

[[Page 554]]

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]



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 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

[[Page 555]]

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 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

[[Page 556]]

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 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.

[[Page 557]]

    (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 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]



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;

[[Page 558]]

    (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.



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.

[[Page 559]]

    (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 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

[[Page 560]]

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 
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,

[[Page 561]]

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 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;

[[Page 562]]

    (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, Division of Industrial and Medical 
Nuclear Safety, 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:
    (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(a)(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]



                          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.

[[Page 563]]

    (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.

            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;
    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

[[Page 564]]

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.
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 concentration.
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.

[[Page 565]]

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.
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.

Subpart I [Reserved]

             Subpart J_Training and Experience Requirements

35.900 Radiation Safety Officer.
35.910 Training for uptake, dilution, and excretion studies.
35.920 Training for imaging and localization studies.
35.930 Training for therapeutic use of unsealed byproduct material.
35.932 Training for treatment of hyperthyroidism.
35.934 Training for treatment of thyroid carcinoma.
35.940 Training for use of brachytherapy sources.
35.941 Training for ophthalmic use of strontium-90.
35.950 Training for use of sealed sources for diagnosis.
35.960 Training for use of therapeutic medical devices.
35.961 Training for an authorized medical physicist.
35.980 Training for an authorized nuclear pharmacist.
35.981 Training for experienced nuclear pharmacists.

  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 concentrations.

[[Page 566]]

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.

                          Subpart N_Enforcement

35.4001 Violations.
35.4002 Criminal penalties.

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as 
amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as 
amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 
note).

    Source: 67 FR 20370, Apr. 24, 2002, unless otherwise noted.



                      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 
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, 71, 170, and 171 of this chapter apply to applicants and 
licensees subject to this part unless specifically exempted.



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, 
before October 24, 2005, meets the requirements in Sec. Sec. 35.961(a), 
or (b), 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, 
before October 24, 2005, meets the requirements in Sec. Sec. 35.980(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;

[[Page 567]]

    (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, before October 24, 2005, meets the requirements in 
Sec. Sec. 35.910(a), 35.920(a), 35.930(a), 35.940(a), 35.950(a), or 
35.960(a) and 35.59; 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.
    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).
    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), but less than 12 gray

[[Page 568]]

(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.
    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--
    (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, before October 24, 2005, Sec. Sec. 35.900(a) 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

[[Page 569]]

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]



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 570]]

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 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, 35.900, 35.910, 35.920, 35.930, 35.940, 35.950, 
35.960, 35.961, 35.980, 35.981, 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 70 FR 16361, Mar. 30, 2005]



Sec. 35.10  Implementation.

    (a) A licensee shall implement the provisions in this part on or 
before October 24, 2002, with the exception of the requirements listed 
in paragraph (b) of this section.
    (b) A licensee shall implement the training requirements in 
Sec. Sec. 35.50(a) and (e), 35.51(a) and (c), 35.55(a) and (b)(1)(i), 
35.59, 35.190(a) and (c)(1), 35.290(a) and (c)(1), 35.390(a) and (b)(1), 
35.392(a), 35.394(a), 35.396(b) and (c), 35.490(a), 35.590(a), and 
35.690(a) and (c) on or before October 25, 2005. A licensee shall 
implement the requirement in Sec. 35.14(a) to provide to the Commission 
a copy of written attestation(s), signed by a preceptor, on or before 
October 25, 2005.
    (c) Prior to October 25, 2005, a licensee shall satisfy the training 
requirements of this part for a Radiation Safety Officer, an authorized 
medical physicist, an authorized nuclear pharmacist, or an authorized 
user by complying with either:
    (1) The appropriate training requirements in subpart J; or
    (2) The appropriate training requirements in subpart B or subparts D 
through H.
    (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 69 FR 55737, Sept. 16, 2004; 
70 FR 16361, Mar. 30, 2005]



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 paragraphs (b)(1) or (b)(2) 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

[[Page 571]]

under the supervision of an authorized nuclear pharmacist or authorized 
user as provided in Sec. 35.27, unless prohibited by license condition.



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.
    (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]



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 that is not 
authorized on the licensee's current license issued under this part;
    (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), 35.690(a), 35.910(a), 35.920(a), 
35.930(a) and 35.390(b)(1)(ii)(G), 35.392, 35.394, 35.940(a), 35.950(a), 
or 35.960(a) and 35.690(c);
    (2) For an authorized nuclear pharmacist, an individual who meets 
the requirements in Sec. Sec. 35.55(a) or 35.980(a) and 35.59;
    (3) For an authorized medical physicist, an individual who meets the 
requirements in Sec. Sec. 35.59 and 35.51(a) and (c); or Sec. Sec. 
35.59 and 35.961(a) or (b);
    (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

[[Page 572]]

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.
    (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, except for areas of use where byproduct 
material is used only in accordance with either Sec. 35.100 or Sec. 
35.200;
    (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; 67 FR 62872, Oct. 9, 2002, as amended at 70 
FR 16361, Mar. 30, 2005]



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, or the permit issued by a Commission 
master material license broad scope permittee 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's mailing address changes;
    (3) 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
    (4) 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.
    (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]



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)(4) regarding additions to or 
changes in 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.
    (g) The provisions of Sec. 35.49(a).

[[Page 573]]



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 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

[[Page 574]]

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.



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 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;

[[Page 575]]

    (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]



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 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. 35.600.
    (c) A licensee shall retain a copy of the procedures required under 
paragraph (a) in accordance with Sec. 35.2041.



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 noncommercially transferred from a 
Part 35 licensee; or
    (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.



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

[[Page 576]]

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 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. 35.290, 35.390, or, 
before October 24, 2005, Sec. Sec. 35.920, or 35.930; 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-(ii)
    (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

[[Page 577]]

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) 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]



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 for authorized 
users in Sec. Sec. 35.490 or 35.690, or, before October 24, 2005, 
authorized users who meet the requirements in Sec. Sec. 35.940 or 
35.960; 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

[[Page 578]]

    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c) and (a)(1) 
and (2), or (b)(1) 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. 35.51, or, before October 
24, 2005, Sec. 35.961, 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 68 
FR 19324, Apr. 21, 2003; 69 FR 55737, Sept. 16, 2004; 70 FR 16362, Mar. 
30, 2005]



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 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

[[Page 579]]

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]



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.
    (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.

[70 FR 16363, Mar. 30, 2005]



Sec. 35.59  Recentness of training.

    The training and experience specified in Subparts B, D, E, F, G, H, 
and J 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.



                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--

[[Page 580]]

    (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.
    (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 a manufacturer or 
preparer licensed under Sec. 32.72 of this chapter 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.



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, 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.



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

[[Page 581]]

    (2) Test the source for leakage at intervals not to exceed 6 months 
or at 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\ 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

[[Page 582]]

    (2) Information on the potential consequences, if any, of failure to 
follow the guidance.
    (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]



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 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.



  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 a manufacturer or preparer licensed under Sec. 
32.72 of this chapter or equivalent Agreement State requirements; or
    (b) 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, before October 24, 2005, Sec. 35.920; 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

[[Page 583]]

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; 
69 FR 55738, Sept. 16, 2004; 70 FR 16363, Mar. 30, 2005]



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 that includes the topics listed in paragraphs 
(c)(1)(i) and (c)(1)(ii) 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, 
before October 24, 2005, Sec. Sec. 35.910, 35.920, or 35.930, 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. 35.190, 35.290, 35.390, or, 
before October 24, 2005, Sec. Sec. 35.910, 35.920, or 35.930, 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. 35.190, 35.290, 
or 35.390, or, before October 24, 2005, Sec. Sec. 35.910, 35.920, or 
35.930, 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. 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]

[[Page 584]]



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 a manufacturer or preparer licensed under Sec. 
32.72 of this chapter or equivalent Agreement State requirements; or
    (b) 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, before October 24, 2005, Sec. 35.920; 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; 
69 FR 55738, Sept. 16, 2004; 70 FR 16363, Mar. 30, 2005]



Sec. 35.204  Permissible molybdenum-99 concentration.

    (a) A licensee may not administer to humans a radiopharmaceutical 
that contains more than 0.15 kilobecquerel of molybdenum-99 per 
megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per 
millicurie of technetium-99m).
    (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) If a licensee is required to measure the molybdenum-99 
concentration, the licensee shall retain a record of each measurement in 
accordance with Sec. 35.2204.



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 uptake, dilution, and 
excretion studies that includes the topics listed in paragraphs 
(c)(1)(i) and (c)(1)(ii) 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, before October 24, 2005, 
Sec. 35.920, 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--

[[Page 585]]

    (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. 35.290, or 35.290(c)(1)(ii)(G) 
and 35.390, or, before October 24, 2005, Sec. 35.920, 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. 35.290 or 
35.390 and 35.290(c)(1)(ii)(G), or, before October 24, 2005, Sec. 
35.920, 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 68 FR 19324, Apr. 21, 2003; 
69 FR 55738, Sept. 16, 2004; 70 FR 16364, Mar. 30, 2005]



    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 a manufacturer or preparer licensed under Sec. 
32.72 of this chapter or equivalent Agreement State requirements; or
    (b) 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, before October 
24, 2005, Sec. 35.920; 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; 
69 FR 55738, Sept. 16, 2004]



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--

[[Page 586]]

    (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 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--

[[Page 587]]

    (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. 35.390, or, before October 24, 2005, 
Sec. 35.930, or equivalent Agreement State requirements. A supervising 
authorized user, who meets the requirements in Sec. 35.390(b) or, 
before October 24, 2005, Sec. 35.930(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 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. 35.390, or, before October 24, 2005, Sec. 35.930, 
or equivalent Agreement State requirements. The preceptor authorized 
user, who meets the requirements in Sec. 35.390(b), or, before October 
24, 2005, Sec. 35.930(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 19325, Apr. 21, 2003; 
68 FR 75389, Dec. 31, 2003; 69 FR 55738, Sept. 16, 2004; 70 FR 16364, 
Mar. 30, 2005]



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

[[Page 588]]

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. Sec. 35.390(a), 35.390(b) for 
uses listed in Sec. 35.390(b)(1)(ii)(G)(1) or (2), Sec. 35.394, or, 
before October 24, 2005, Sec. Sec. 35.930, 35.932, or 35.934, 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. 35.390(a), 35.390(b), 35.392, 
35.394, or, before October 24, 2005, Sec. Sec. 35.930, 35.932, or 
35.934, 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)(1) or (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. 35.390, 35.392, or 35.394, or, before October 24, 2005, 
Sec. Sec. 35.930, 35.932, or 35.934, 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. 35.390(b)(1)(ii)(G)(1) or (2).

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19325, Apr. 21, 2003; 
68 FR 75389, Dec. 31, 2003; 69 FR 55738, Sept. 16, 2004; 70 FR 16364, 
Mar. 30, 2005]



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. Sec. 35.390(a), 35.390(b) for 
uses listed in Sec. 35.390(b)(1)(ii)(G)(2), or, before October 24, 
2005, Sec. Sec. 35.930 or 35.934, or equivalent Agreement State 
requirements; or
    (c)(1) Has successfully completed 80 hours of classroom and 
laboratory

[[Page 589]]

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. 35.390(a), 35.390(b), 35.394, 
or, before October 24, 2005, Sec. Sec. 35.930 or 35.934, 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;
    (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. 35.390 or 35.394, or, before October 24, 2005, Sec. Sec. 
35.930 or 35.934, 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 19325, Apr. 21, 2003; 
68 FR 75389, Dec. 31, 2003; 69 FR 55739, Sept. 16, 2004; 70 FR 16365, 
Mar. 30, 2005]



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 or, before October 24, 2005, Sec. 35.930 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 or 35.690, or, 
before October 24, 2005, Sec. Sec. 35.940 or 35.960, 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, or, before October 24, 2005, 
Sec. Sec. 35.940 or 35.960; and who meets the requirements in paragraph 
(d) of this section.
    (d)(1) Has successfully completed 80 hours of classroom and 
laboratory 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

[[Page 590]]

    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec. 35.390 or 35.396, or, before 
October 24, 2005, Sec. 35.930, 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. Sec. 35.390 or 35.930 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. 35.390, 35.396, 
or, before October 24, 2005, Sec. 35.930, or equivalent Agreement State 
requirements. A preceptor authorized user, who meets the requirements in 
Sec. 35.390, or, before October 24, 2005, Sec. 35.930, 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]



                     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.



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 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

[[Page 591]]

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 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.

[[Page 592]]

    (b) A licensee shall 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 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. 35.490, or, before 
October 24, 2005, Sec. 35.940, 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. 35.490, or, before October 24, 2005, Sec. 35.940, 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

[[Page 593]]

    (3) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. 35.490, or, before 
October 24, 2005, Sec. 35.940, or equivalent Agreement State 
requirements, that the individual has satisfactorily completed the 
requirements in paragraphs (a)(1), or (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 68 FR 19325, Apr. 21, 2003; 
69 FR 55739, Sept. 16, 2004; 70 FR 16366, Mar. 30, 2005]



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, before October 24, 
2005, Sec. Sec. 35.940 or 35.941, 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. 35.490 or 
35.491, or, before October 24, 2005, Sec. Sec. 35.940 or 35.941, or 
equivalent Agreement State requirements, that the individual has 
satisfactorily completed the requirements in paragraphs (a) and (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; 
69 FR 55739, Sept. 16, 2004; 70 FR 16366, Mar. 30, 2005]



                 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.



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]

[[Page 594]]



 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 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 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.

[[Page 595]]

    (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.



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.
    (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.

[[Page 596]]

    (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-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;

[[Page 597]]

    (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 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

[[Page 598]]

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.
    (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

[[Page 599]]

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 
(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-

[[Page 600]]

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
    (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 
afterloader 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.

[[Page 601]]

    (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.



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

[[Page 602]]

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. 35.690, or, before 
October 24, 2005, Sec. 35.960, 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
    (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. 35.690, or, before October 24, 2005, Sec. 35.960, 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 paragraphs (a)(1) or (b)(1) 
and (b)(2), and (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. 35.690, or, before October 24, 2005, Sec. 35.960, 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 68 FR 19326, Apr. 21, 2003; 
69 FR 55739, Sept. 16, 2004; 70 FR 16366, Mar. 30, 2005]

Subpart I [Reserved]



             Subpart J_Training and Experience Requirements



Sec. 35.900  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 the--

[[Page 603]]

    (1) American Board of Health Physics in Comprehensive Health 
Physics;
    (2) American Board of Radiology;
    (3) American Board of Nuclear Medicine;
    (4) American Board of Science in Nuclear Medicine;
    (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy;
    (6) American Board of Medical Physics in radiation oncology physics;
    (7) Royal College of Physicians and Surgeons of Canada in nuclear 
medicine;
    (8) American Osteopathic Board of Radiology; or
    (9) American Osteopathic Board of Nuclear Medicine; or
    (b) Has had classroom and laboratory training and experience as 
follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Radiation biology; and
    (v) Radiopharmaceutical chemistry; and
    (2) One year of full time experience as a radiation safety 
technologist at a medical institution under the supervision of the 
individual identified as the Radiation Safety Officer on a Commission or 
Agreement State license that authorizes the medical use of byproduct 
material; or
    (c) Is an authorized user identified on the licensee's license.



Sec. 35.910  Training for uptake, dilution, and excretion studies.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a radiopharmaceutical in Sec. 35.100(a) to be a 
physician who--
    (a) Is certified in--
    (1) Nuclear medicine by the American Board of Nuclear Medicine;
    (2) Diagnostic radiology by the American Board of Radiology;
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology;
    (4) Nuclear medicine by the Royal College of Physicians and Surgeons 
of Canada; or
    (5) American Osteopathic Board of Nuclear Medicine in nuclear 
medicine; or
    (b) Has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of prepared 
radiopharmaceuticals, and supervised clinical experience as follows--
    (1) 40 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Radiation biology; and
    (v) Radiopharmaceutical chemistry; and
    (2) 20 hours of supervised clinical experience under the supervision 
of an authorized user and that includes--
    (i) Examining patients or human research subjects and reviewing 
their case histories to determine their suitability for radioisotope 
diagnosis, limitations, or contraindications;
    (ii) Selecting the suitable radiopharmaceuticals and calculating and 
measuring the dosages;
    (iii) Administering dosages to patients or human research subjects 
and using syringe radiation shields;
    (iv) Collaborating with the authorized user in the interpretation of 
radioisotope test results; and
    (v) Patient or human research subject follow up; or
    (c) Has successfully completed a 6-month training program in nuclear 
medicine as part of a training program that has been approved by the 
Accreditation Council for Graduate Medical Education and that included 
classroom and laboratory training, work experience, and supervised 
clinical experience in all the topics identified in paragraph (b) of 
this section.



Sec. 35.920  Training for imaging and localization studies.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a radiopharmaceutical, generator, or reagent kit in 
Sec. 35.200(a) to be a physician who--
    (a) Is certified in--
    (1) Nuclear medicine by the American Board of Nuclear Medicine;

[[Page 604]]

    (2) Diagnostic radiology by the American Board of Radiology;
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology;
    (4) Nuclear medicine by the Royal College of Physicians and Surgeons 
of Canada; or
    (5) American Osteopathic Board of Nuclear Medicine in nuclear 
medicine; or
    (b) Has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of prepared 
radiopharmaceuticals, generators, and reagent kits, supervised work 
experience, and supervised clinical experience as follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Radiopharmaceutical chemistry; and
    (v) Radiation biology; and
    (2) 500 hours of supervised work experience under the supervision of 
an authorized user that includes--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Calibrating dose calibrators and diagnostic instruments and 
performing checks for proper operation of survey meters;
    (iii) Calculating and safely preparing patient or human research 
subject dosages;
    (iv) Using administrative controls to prevent the medical event of 
byproduct material;
    (v) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (vi) Eluting technetium-99m from generator systems, measuring and 
testing the eluate for molybdenum-99 and alumina contamination, and 
processing the eluate with reagent kits to prepare technetium-99m 
labeled radiopharmaceuticals; and
    (3) 500 hours of supervised clinical experience under the 
supervision of an authorized user that includes--
    (i) Examining patients or human research subjects and reviewing 
their case histories to determine their suitability for radioisotope 
diagnosis, limitations, or contraindications;
    (ii) Selecting the suitable radiopharmaceuticals and calculating and 
measuring the dosages;
    (iii) Administering dosages to patients or human research subjects 
and using syringe radiation shields;
    (iv) Collaborating with the authorized user in the interpretation of 
radioisotope test results; and
    (v) Patient or human research subject follow up; or
    (c) Has successfully completed a 6-month training program in nuclear 
medicine that has been approved by the Accreditation Council for 
Graduate Medical Education and that included classroom and laboratory 
training, work experience, and supervised clinical experience in all the 
topics identified in paragraph (b) of this section.



Sec. 35.930  Training for therapeutic use of unsealed byproduct material.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of radiopharmaceuticals in Sec. 35.300 to be a 
physician who--
    (a) Is certified by--
    (1) The American Board of Nuclear Medicine;
    (2) The American Board of Radiology in radiology, therapeutic 
radiology, or radiation oncology;
    (3) The Royal College of Physicians and Surgeons of Canada in 
nuclear medicine; or
    (4) The American Osteopathic Board of Radiology after 1984; or
    (b) Has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of therapeutic 
radiopharmaceuticals, and supervised clinical experience as follows--
    (1) 80 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology; and

[[Page 605]]

    (2) Supervised clinical experience under the supervision of an 
authorized user at a medical institution that includes--
    (i) Use of iodine-131 for diagnosis of thyroid function and the 
treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; 
and
    (ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 
individuals.



Sec. 35.932  Training for treatment of hyperthyroidism.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of only iodine-131 for the treatment of hyperthyroidism 
to be a physician with special experience in thyroid disease who has had 
classroom and laboratory training in basic radioisotope handling 
techniques applicable to the use of iodine-131 for treating 
hyperthyroidism, and supervised clinical experience as follows--
    (a) 80 hours of classroom and laboratory training that includes--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection,
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology; and
    (b) Supervised clinical experience under the supervision of an 
authorized user that includes the use of iodine-131 for diagnosis of 
thyroid function, and the treatment of hyperthyroidism in 10 
individuals.



Sec. 35.934  Training for treatment of thyroid carcinoma.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of only iodine-131 for the treatment of thyroid 
carcinoma to be a physician with special experience in thyroid disease 
who has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of iodine-131 for treating 
thyroid carcinoma, and supervised clinical experience as follows--
    (a) 80 hours of classroom and laboratory training that includes--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection;
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology; and
    (b) Supervised clinical experience under the supervision of an 
authorized user that includes the use of iodine-131 for the treatment of 
thyroid carcinoma in 3 individuals.



Sec. 35.940  Training for use of brachytherapy sources.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a brachytherapy source listed in Sec. 35.400 for 
therapy to be a physician who--
    (a) Is certified in--
    (1) Radiology, therapeutic radiology, or radiation oncology by the 
American Board of Radiology;
    (2) Radiation oncology by the American Osteopathic Board of 
Radiology;
    (3) Radiology, with specialization in radiotherapy, as a British 
``Fellow of the Faculty of Radiology'' or ``Fellow of the Royal College 
of Radiology''; or
    (4) Therapeutic radiology by the Canadian Royal College of 
Physicians and Surgeons; or
    (b) Is in the active practice of therapeutic radiology, has had 
classroom and laboratory training in radioisotope handling techniques 
applicable to the therapeutic use of brachytherapy sources, supervised 
work experience, and supervised clinical experience as follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology;
    (2) 500 hours of supervised work experience under the supervision of 
an authorized user at a medical institution that includes--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Checking survey meters for proper operation;
    (iii) Preparing, implanting, and removing sealed sources;
    (iv) Maintaining running inventories of material on hand;

[[Page 606]]

    (v) Using administrative controls to prevent a medical event 
involving byproduct material; and
    (vi) Using emergency procedures to control byproduct material; and
    (3) Three years of supervised clinical experience that includes one 
year in a formal training program approved by the Residency Review 
Committee for Radiology of the Accreditation Council for Graduate 
Medical Education or the Committee on Postdoctoral Training of the 
American Osteopathic Association, and an additional two years of 
clinical experience in therapeutic radiology under the supervision of an 
authorized user at a medical institution that includes--
    (i) Examining individuals and reviewing their case histories to 
determine their suitability for brachytherapy treatment, and any 
limitations or contraindications;
    (ii) Selecting the proper brachytherapy sources and dose and method 
of administration;
    (iii) Calculating the dose; and
    (iv) Post-administration follow up and review of case histories in 
collaboration with the authorized user.



Sec. 35.941  Training for ophthalmic use of strontium-90.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of only strontium-90 for ophthalmic radiotherapy to be a 
physician who is in the active practice of therapeutic radiology or 
ophthalmology, and has had classroom and laboratory training in basic 
radioisotope handling techniques applicable to the use of strontium-90 
for ophthalmic radiotherapy, and a period of supervised clinical 
training in ophthalmic radiotherapy as follows--
    (a) 24 hours of classroom and laboratory training that includes--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection;
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology;
    (b) Supervised clinical training in ophthalmic radiotherapy under 
the supervision of an authorized user at a medical institution that 
includes the use of strontium-90 for the ophthalmic treatment of five 
individuals that includes--
    (1) Examination of each individual to be treated;
    (2) Calculation of the dose to be administered;
    (3) Administration of the dose; and
    (4) Follow up and review of each individual's case history.



Sec. 35.950  Training for use of sealed sources for diagnosis.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a sealed source in a device listed in Sec. 35.500 to 
be a physician, dentist, or podiatrist who--
    (a) Is certified in--
    (1) Radiology, diagnostic radiology, therapeutic radiology, or 
radiation oncology by the American Board of Radiology;
    (2) Nuclear medicine by the American Board of Nuclear Medicine;
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology; or
    (4) Nuclear medicine by the Royal College of Physicians and Surgeons 
of Canada; or
    (b) Has had 8 hours of classroom and laboratory training in basic 
radioisotope handling techniques specifically applicable to the use of 
the device that includes--
    (1) Radiation physics, mathematics pertaining to the use and 
measurement of radioactivity, and instrumentation;
    (2) Radiation biology;
    (3) Radiation protection; and
    (4) Training in the use of the device for the uses requested.



Sec. 35.960  Training for use of therapeutic medical devices.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a sealed source listed in Sec. 35.600 to be a 
physician who--
    (a) Is certified in--
    (1) Radiology, therapeutic radiology, or radiation oncology by the 
American Board of Radiology;
    (2) Radiation oncology by the American Osteopathic Board of 
Radiology;
    (3) Radiology, with specialization in radiotherapy, as a British 
``Fellow of the Faculty of Radiology'' or ``Fellow of the Royal College 
of Radiology''; or

[[Page 607]]

    (4) Therapeutic radiology by the Canadian Royal College of 
Physicians and Surgeons; or
    (b) Is in the active practice of therapeutic radiology, and has had 
classroom and laboratory training in basic radioisotope techniques 
applicable to the use of a sealed source in a therapeutic medical 
device, supervised work experience, and supervised clinical experience 
as follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology;
    (2) 500 hours of supervised work experience under the supervision of 
an authorized user at a medical institution that includes--
    (i) Review of the full calibration measurements and periodic spot-
checks;
    (ii) Preparing treatment plans and calculating treatment times;
    (iii) Using administrative controls to prevent medical events;
    (iv) Implementing emergency procedures to be followed in the event 
of the abnormal operation of the medical device or console; and
    (v) Checking and using survey meters; and
    (3) Three years of supervised clinical experience that includes one 
year in a formal training program approved by the Residency Review 
Committee for Radiology of the Accreditation Council for Graduate 
Medical Education or the Committee on Postdoctoral Training of the 
American Osteopathic Association and an additional two years of clinical 
experience in therapeutic radiology under the supervision of an 
authorized user at a medical institution that includes--
    (i) Examining individuals and reviewing their case histories to 
determine their suitability for teletherapy, remote afterloader, or 
gamma stereotactic radiosurgery treatment, and any limitations or 
contraindications;
    (ii) Selecting the proper dose and how it is to be administered;
    (iii) Calculating the doses and collaborating with the authorized 
user in the review of patients' or human research subjects' progress and 
consideration of the need to modify originally prescribed doses as 
warranted by patients' or human research subjects' reaction to 
radiation; and
    (iv) Post-administration follow up and review of case histories.



Sec. 35.961  Training for authorized medical physicist.

    The licensee shall require the authorized medical physicist to be an 
individual who--
    (a) Is certified by the American Board of Radiology in--
    (1) Therapeutic radiological physics;
    (2) Roentgen ray and gamma ray physics;
    (3) X-ray and radium physics; or
    (4) Radiological physics; or
    (b) Is certified by the American Board of Medical Physics in 
radiation oncology physics; or
    (c) Holds a master's or doctor's degree in physics, biophysics, 
radiological physics, or health physics, and has completed 1 year of 
full time training in therapeutic radiological physics and an additional 
year of full time work experience under the supervision of a medical 
physicist at a medical institution that includes the tasks listed in 
Sec. Sec. 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644, 35.645 
and 35.652, as applicable.



Sec. 35.980  Training for an authorized nuclear pharmacist.

    The licensee shall require the authorized nuclear pharmacist to be a 
pharmacist who--
    (a) Has current board certification as a nuclear pharmacist by the 
Board of Pharmaceutical Specialties; or
    (b)(1) Has completed 700 hours in a structured educational program 
consisting of both--
    (i) Didactic 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

[[Page 608]]

    (E) Radiation biology; and
    (ii) Supervised experience in a nuclear pharmacy involving the 
following--
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of dose 
calibrators, 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 mistakes in the 
administration of byproduct material;
    (E) Using procedures to prevent or minimize contamination and using 
proper decontamination procedures; and
    (2) Has obtained written attestation, signed by a preceptor 
authorized nuclear pharmacist, that the above training has been 
satisfactorily completed and that the individual has achieved a level of 
competency sufficient to independently operate a nuclear pharmacy.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16367, Mar. 30, 2005]



Sec. 35.981  Training for experienced nuclear pharmacists.

    A licensee may apply for and must receive a license amendment 
identifying an experienced nuclear pharmacist as an authorized nuclear 
pharmacist before it allows this individual to work as an authorized 
nuclear pharmacist. A pharmacist who has completed a structured 
educational program as specified in Sec. 35.980(b)(1) before December 
2, 1994, and who is working in a nuclear pharmacy would qualify as an 
experienced nuclear pharmacist. An experienced nuclear pharmacist need 
not comply with the requirements for a preceptor statement (Sec. 
35.980(b)(2)) and recentness of training (Sec. 35.59) to qualify as an 
authorized nuclear pharmacist.



  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.



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

[[Page 609]]

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 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

[[Page 610]]

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 the individual who performed 
the survey.



Sec. 35.2204  Records of molybdenum-99 concentrations.

    A licensee shall maintain a record of the molybdenum-99 
concentration tests required by Sec. 35.204(b) for 3 years. The record 
must include, 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.



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.



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

[[Page 611]]

source and the instruments used to calibrate the source;
    (3) The source output or activity;
    (4) The source positioning accuracy within the applicators; and
    (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;

[[Page 612]]

    (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 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;

[[Page 613]]

    (4) Notations indicating the operability of each entrance door 
electrical interlock, radiation monitors, source exposure indicator 
lights, viewing and intercom system, applicators, source 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.



                            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 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.

[[Page 614]]

    (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) 951-0550.
---------------------------------------------------------------------------

    (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]



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

[[Page 615]]

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.
    (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), 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.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 58805, Oct. 10, 2003]



                          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;

[[Page 616]]

    (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 Start 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.
36.83 Reports.

                          Subpart F_Enforcement

36.91 Violations.
36.93 Criminal penalties.

    Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 
954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 
2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 
206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

    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

[[Page 617]]

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, 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.



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).
    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.

[[Page 618]]

    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.



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. 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 3150-0158.
    (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. 30.33 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

[[Page 619]]

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 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.



Sec. 36.15  Start of construction.

    The applicant may not begin construction of a new irradiator prior 
to the submission to NRC of both an application for a license for the 
irradiator and the fee required by Sec. 170.31. As used in this 
section, the term ``construction'' includes the construction of any 
portion of the permanent irradiator structure on the site but does not 
include: Engineering and design work, purchase of a site, site surveys 
or soil testing, site preparation, site excavation, construction of 
warehouse or auxiliary structures, and other similar tasks. 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, as amended, and rules, regulations, and orders issued under the 
Act.



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;

[[Page 620]]

    (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 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.

[[Page 621]]

    (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 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.

[[Page 622]]

    (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. 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

[[Page 623]]

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.
    (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

[[Page 624]]

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 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:

[[Page 625]]

    (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;
    (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;

[[Page 626]]

    (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;
    (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

[[Page 627]]

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 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.

[[Page 628]]

    (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).
    (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

[[Page 629]]

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-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]

[[Page 630]]



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.
    (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 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.

[[Page 631]]

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.

                          Subpart F_Exemptions

39.91 Applications for exemptions.

                          Subpart G_Enforcement

39.101 Violations.
39.103 Criminal penalties.

    Authority: Secs. 53, 57, 62, 63, 65, 69, 81, 82, 161, 182, 183, 186, 
68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 955, as amended, 
sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2073, 2077, 2092, 2093, 
2095, 2099, 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (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, 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.



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.

[[Page 632]]

    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.
    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.

[[Page 633]]

    (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.



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. 70.33 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.



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.

[[Page 634]]

    (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 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

[[Page 635]]

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]



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

[[Page 636]]

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 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--

[[Page 637]]

    (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 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

[[Page 638]]

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 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.

[[Page 639]]

    (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:
    (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

[[Page 640]]

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. 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.

[[Page 641]]

    (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 FR8234, 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;
    (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

[[Page 642]]

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 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.

[[Page 643]]

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]
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.

                    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: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 Stat. 
932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2), 83, 84, 
Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 83 Stat. 444, 
as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 
2114, 2201, 2232, 2233, 2236, 2282); sec. 274, Pub. L. 86-373, 73 Stat. 
688 (42 U.S.C. 2021); secs. 201, as amended, 202, 206, 88 Stat. 1242, as 
amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 275, 92 Stat. 
3021, as amended by Pub. L. 97-415, 96 Stat. 2067 (42 U.S.C. 2022); sec. 
193, 104 Stat. 2835, as amended by Pub. L. 104-134, 110 Stat. 1321, 
1321-349 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 
note).
    Section 40.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 (42 U.S.C. 5851). Section 40.31(g) also issued under sec. 122, 68 
Stat. 939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184, 68 
Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued under 
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

    Source: 26 FR 284, Jan. 14, 1961, unless otherwise noted.

                           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,

[[Page 644]]

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 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.

[[Page 645]]

    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 11 of the Act shall have 
the same meaning when used in the regulations in this part.
    Commencement of construction means any clearing of land, excavation, 
or other substantial action that would adversely affect the natural 
environment of a site but does not include changes desirable for the 
temporary use of the land for public recreational uses, necessary 
borings to determine site characteristics or other preconstruction 
monitoring to establish background information related to the 
suitability of a site or to the protection of environmental values.
    Commission means the Nuclear Regulatory Commission or its duly 
authorized representatives.
    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 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.

[[Page 646]]

    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.
    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 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.
    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.

[[Page 647]]

    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 on GPO Access.



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 of Nuclear 
Security, Office of Nuclear Security and Incident Response, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001.
    (2) By hand delivery to the 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/eie.html, by calling (301) 415-6030, by e-mail to 
[email protected], or by writing the Office of Information Services, 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.
    (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 to 
persons exempt pursuant to 10 CFR 32.11 through 32.26.
    (v) New uses or techniques for use of byproduct, source, or special 
nuclear material.
    (vi) Uranium enrichment facilities.
    (2) Submission--(i) Region I. The regional licensing program 
involves all Federal facilities in the region and non-Federal licensees 
in the following Region I non-Agreement States and the District of 
Columbia: Connecticut, Delaware, Maine, Massachusetts, New Jersey, 
Pennsylvania, and Vermont. All mailed or hand-delivered inquiries, 
communications, and applications for a new license or an amendment or 
renewal of an existing license specified in paragraph (b)(1) of this 
section must use the following address: U.S. Nuclear Regulatory 
Commission, Region I, 475

[[Page 648]]

Allendale Road, King of Prussia, Pennsylvania 19406-1415; where e-mail 
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: Virginia, West Virginia, 
Puerto Rico, and the Virgin Islands. All mailed or hand-delivered 
inquiries, communications, and applications for a new license or an 
amendment or renewal of an existing license specified in paragraph 
(b)(1) of this section must use the following address: U.S. Nuclear 
Regulatory Commission, Region II Material Licensing/Inspection Branch, 
Sam Nunn Atlanta Federal Center, Suite 23T85, 61 Forsyth Street, 
Atlanta, Georgia 30303-8931; where e-mail is appropriate it should be 
addressed to [email protected].
    (iii) Region III. The regional licensing program involves all 
Federal facilities in the region and non-Federal licensees in the 
following Region III non-Agreement States: Indiana, Michigan, Minnesota, 
Missouri, Ohio, and Wisconsin. All mailed or hand-delivered inquiries, 
communications, and applications for a new license or an amendment or 
renewal of an existing license specified in paragraph (b)(1) of this 
section must use the following address: U.S. Nuclear Regulatory 
Commission, Region III, Material Licensing Section, 801 Warrenville 
Road, Lisle, Illinois 60532-4351; where e-mail is appropriate it should 
be addressed to [email protected].
    (iv) Region IV. The regional licensing program involves all Federal 
facilities in the region and non-Federal licensees in the following 
Region IV non-Agreement States and a territory: Alaska, Hawaii, Montana, 
Oklahoma, South Dakota, Wyoming, and Guam. All mailed or hand-delivered 
inquiries, communications, and applications for a new license or an 
amendment or renewal of an existing license specified in paragraph 
(b)(1) of this section must use the following address: U.S. Nuclear 
Regulatory Commission, Region IV, Material Radiation Protection Section, 
611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011-4005; where e-
mail is appropriate it should be addressed to 
[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 on GPO Access.



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

[[Page 649]]

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 
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 or applicant.
    (3) Other enforcement action.
    (d) Actions taken by an employer, or others, which adversely affect 
an employee may be predicated upon nondiscriminatory grounds. The 
prohibition applies when the adverse action occurs because the employee 
has engaged in protected activities. An employee's engagement in 
protected activities does not automatically render him or her immune 
from discharge or discipline for legitimate reasons or from adverse 
action dictated by nonprohibited considerations.
    (e)(1) Each specific licensee, each applicant for a specific 
license, and each general licensee subject to part 19 shall prominently 
post the revision of NRC Form 3, ``Notice to Employees'', referenced in 
10 CFR 19.11(c).
    (2) The posting of NRC Form 3 must be at locations sufficient to 
permit employees protected by this section to observe a copy on the way 
to or from their place of work. Premises must be posted not later than 
30 days after an application is docketed and remain posted while the 
application is pending before the Commission, during the term of the 
license, and for 30 days following license termination.
    (3) Copies of NRC Form 3 may be obtained by writing to the Regional 
Administrator of the appropriate U.S. Nuclear Regulatory Commission 
Regional Office listed in appendix D to part 20 of this chapter, by 
calling (301) 415-5877, via e-mail to [email protected], or by visiting the 
NRC's Web site at http://www.nrc.gov and selecting forms from the index 
found on the home page.
    (f) No agreement affecting the compensation, terms, conditions, or 
privileges of employment, including an agreement to settle a complaint 
filed by an employee with the Department of Labor pursuant to section 
211 of the Energy Reorganization Act of 1974, 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]



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

[[Page 650]]

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, 40.23, 40.25, 40.26, 40.27, 40.31, 
40.35, 40.36, 40.41, 40.42, 40.43, 40.44, 40.51, 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, Form N-71 is approved under control number 3150-
0056.
    (3) In Sec. 40.42, NRC Form 314 is approved under control number 
3150-0028.
    (4) In Sec. 40.64, DOE/NRC Form 741 is approved under control 
number 3150-0003.

[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]



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

[[Page 651]]

    (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]

                               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 include byproduct 
material 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

[[Page 652]]

specific license, such person shall not refine or process such ore.
    (c) Any person is exempt from the regulation 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:
    (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, 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 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) The counterweights are manufactured in accordance with a 
specific license issued by the Commission or the Atomic Energy 
Commission authorizing distribution by the licensee pursuant to this 
paragraph;
    (ii) 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) (ii) and (iii) 
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.
---------------------------------------------------------------------------

    (iii) Each counterweight is durably and legibly labeled or marked 
with the identification of the manufacturer, and the statement: 
``Unauthorized Alterations Prohibited''; \2\ and
    (iv) 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.
    (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 contained in finished optical lenses, provided that each 
lens does not contain more than 30 percent

[[Page 653]]

by weight of thorium; and that the exemption contained in this 
subparagraph shall not be deemed to authorize either:
    (i) The shaping, grinding or polishing of such lens or manufacturing 
processes other than the assembly of such lens into optical systems and 
devices without any alteration of the lens; or
    (ii) The receipt, possession, use, transfer, or of 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.
    (d) 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 uranium 
contained in detector heads for use in fire detection units, provided 
that each detector head contains not more than 0.005 microcurie of 
uranium. The exemption in this paragraph does not authorize the 
manufacture of any detector head containing uranium.

[26 FR 284, Jan. 14, 1961]

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



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 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,

[[Page 654]]

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 use and transfer not 
more than fifteen (15) pounds of source material at any one time for 
research, development, educational, commercial or operational purposes. 
A person authorized to use or transfer source material, pursuant to this 
general license, may not receive more than a total of 150 pounds of 
source material in any one calendar year.
    (b) Persons who receive, possess, use, or transfer source material 
pursuant to the general license issued in paragraph (a) of this section 
are exempt from the provisions of parts 19, 20, and 21, of this chapter 
to the extent that such receipt, possession, use or transfer are within 
the terms of such general license: Provided, however, That this 
exemption shall not be deemed to apply to any such person who is also in 
possession of source material under a specific license issued pursuant 
to this part.
    (c) Persons who receive, possess, use or transfer source material 
pursuant to the general license in paragraph (a) of this section are 
prohibited from administering source material, or the radiation 
therefrom, either externally or internally, to human beings except as 
may be authorized by NRC in a specific license.

[26 FR 284, Jan. 14, 1961, as amended at 38 FR 22221, Aug. 17, 1973; 42 
FR 28896, June 6, 1977; 45 FR 55420, Aug. 20, 1980]



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, Division of Nuclear 
Security, 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.
    (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, Division of Nuclear 
Security 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 Nuclear 
Security 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 Nuclear Security at (301) 415-6828.

[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]

[[Page 655]]



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 of the NRC's 
Division of Industrial and Medical Nuclear Safety, 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 Form NRC 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 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, Division of Industrial and Medical 
Nuclear Safety, 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 Form NRC 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,

[[Page 656]]

Division of Industrial and Medical Nuclear Safety, 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]



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 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, 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]



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

[[Page 657]]

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 ground water 
characterization and any necessary ground water 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 ground water restoration. Ground 
water 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 
ground water restoration, the licensee shall assess the need to modify 
the LTSP and report results to the 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 ground water monitoring if required, appropriate constituent 
concentration limits for ground water, 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

[[Page 658]]

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]



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 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 ground water 
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 ground water monitoring if required, appropriate constituent 
concentration limits for ground water, 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;

[[Page 659]]

    (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]

                          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

[[Page 660]]

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) In response to a written request by the Commission, an applicant 
for a license to possess and use source material in a uranium 
hexafluoride production plant or a fuel fabrication plant and any other 
applicant for a license to possess and use more than one effective 
kilogram of source material (except for ore processing, as defined in 
Sec. 75.4(o) of this chapter) shall file with the Commission the 
installation information described in Sec. 75.11 of this chapter, on 
Form N-71. The applicant shall also permit verification of this 
installation information by the International Atomic Energy Agency and 
take other action as may be necessary to implement the US/IAEA 
Safeguards Agreement, in the manner set forth Sec. 75.6 and Sec. Sec. 
75.11 through 75.14 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 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

[[Page 661]]

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.
    (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

[[Page 662]]

applicant's provisions for liability insurance.

[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]



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 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 
Commission determines will significantly affect the quality of the 
environment, the Director of Nuclear Material Safety and Safeguards or 
his designee, before commencement of construction of the plant or 
facility in which the activity will be conducted, on the basis of 
information filed and evaluations made pursuant to subpart A of part 51 
of this chapter, has concluded, after weighing the environmental, 
economic, technical and other benefits against environmental costs and 
considering available alternatives, that the action called for is the 
issuance of the proposed license, with any appropriate conditions to 
protect environmental values. Commencement of construction prior to this 
conclusion is grounds for denial of a license to possess and use source 
and byproduct material in the plant or facility. As used in this 
paragraph, the term ``commencement of construction'' means any clearing 
of land, excavation, or other substantial action that would adversely 
affect the environment of a site. The term does not mean site 
exploration, roads necessary for site exploration, borings to determine 
foundation conditions, or other preconstruction monitoring or testing to 
establish background information related to the suitability of the site 
or the protection of environmental values.
    (f) The applicant satisfies any applicable special requirements 
contained in Sec. 40.34.
    (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]



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,

[[Page 663]]

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 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 of the 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

[[Page 664]]

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 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(i) 
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 of the 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]



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

[[Page 665]]

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 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.
    (d) Each decommissioning funding plan must contain a cost estimate 
for decommissioning and 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. Cost estimates must be adjusted at 
intervals not to exceed 3 years. The decommissioning funding plan must 
also contain a certification by the licensee that financial assurance 
for decommissioning has been provided in the amount of the cost estimate 
for decommissioning and a signed original of the financial instrument 
obtained to satisfy the requirements of paragraph (e) of this section.
    (e) Financial assurance for decommissioning must be provided by one 
or more of the following methods:
    (1) Prepayment. Prepayment is the deposit prior to the start of 
operation into an account segregated from licensee assets and outside 
the licensee's administrative control of cash or liquid assets such that 
the amount of funds would be sufficient to pay decommissioning costs. 
Prepayment may be in the form of a trust, escrow account, government 
fund, certificate of deposit, or deposit of government securities.
    (2) A surety method, insurance, or other guarantee method. These 
methods guarantee that decommissioning costs will be paid. A surety 
method may be in the form of a surety bond, letter of credit, or line of 
credit. A parent company guarantee of funds for decommissioning costs 
based on a financial test may be used if the guarantee and test are as 
contained in appendix A to part 30. A parent company guarantee may not 
be used in combination with other financial methods to satisfy the 
requirements of this section. For commercial corporations that issue 
bonds, a guarantee of funds by the applicant or licensee for 
decommissioning costs based on a financial test may be used if the 
guarantee and test are as contained in appendix C to part 30. For 
commercial companies that do not issue bonds, a guarantee of funds by 
the applicant or licensee for decommissioning costs may be used if the 
guarantee and test are as contained in appendix D to part 30. For 
nonprofit entities, such as colleges, universities, and nonprofit 
hospitals, a guarantee of funds by the applicant or licensee may be used 
if the guarantee and test are as contained in appendix E to part 30. A 
guarantee by the applicant or licensee may not be used in combination 
with any other financial methods used to satisfy the requirements of 
this section or in any situation where the applicant or licensee has a 
parent company holding majority control of the voting stock of

[[Page 666]]

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 or insurance, the value of which 
may decrease by the amount being accumulated in the sinking fund. An 
external sinking fund is a fund established and maintained by setting 
aside funds periodically in an account segregated from licensee assets 
and outside the 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 may 
be in the form of a trust, escrow account, government fund, certificate 
of deposit, or deposit of government securities. The surety or insurance 
provision 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. 
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,

[[Page 667]]

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.

[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]



Sec. 40.38  Ineligibility of certain applicants.

    A license may not be issued to the Corporation if the Commission 
determines that:
    (a) The Corporation is owned, controlled, or dominated by an alien, 
a foreign corporation, or a foreign government; or
    (b) The issuance of such a license would be inimical to--
    (1) The common defense and security of the United States; or
    (2) The maintenance of a reliable and economical domestic source of 
enrichment services.

[62 FR 6669, Feb. 12, 1997]

                                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.

[[Page 668]]

    (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.

[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]



Sec. 40.42  Expiration and termination of licenses and decommissioning 
of sites and separate buildings or outdoor areas.

    (a)(1) Except as provided in paragraph (a)(2) of this section, 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 before the expiration 
date stated in the existing license (or, for those licenses subject to 
paragraph (a)(2) of this section, 30 days before the deemed expiration 
date in that paragraph). If an application for renewal has been filed at 
least 30 days before the expiration date stated in the existing license 
(or, for those licenses subject to paragraph (a)(2) of this section, 30 
days before the deemed expiration date in that paragraph), 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.
    (2) Each specific license that has an expiration date after July 1, 
1995, and is not one of the licenses described in paragraph (a)(3) of 
this section, shall be deemed to have an expiration date that is five 
years after the expiration date stated in the current license.
    (3) The following specific licenses are not subject to, or otherwise 
affected by, the provisions of paragraph (a)(2) of this section:
    (i) Specific licenses for which, on February 15, 1996, an evaluation 
or an emergency plan is required in accordance with Sec. 40.31(j);
    (ii) Specific licenses whose holders are subject to the financial 
assurance requirements specified in 10 CFR 40.36, and on February 15, 
1996, the holders either:
    (A) Have not submitted a decommissioning funding plan nor 
certification of financial assurance for decommissioning; or
    (B) Have not received written notice that the decommissioning 
funding plan or certification of financial assurance for decommissioning 
is acceptable;
    (iii) Specific licenses whose holders are listed in the SDMP List 
published in NUREG 1444, Supplement 1 (November 1995);
    (iv) Specific licenses whose issuance, amendment, or renewal, as of 
February 15, 1996, is not a categorical exclusion under 10 CFR 
51.22(c)(14) and, therefore, need an environmental assessment or 
environmental impact statement pursuant to subpart A of part 51 of this 
chapter;
    (v) Specific licenses whose holders have not had at least one NRC 
inspection of licensed activities before February 15, 1996;
    (vi) Specific licenses whose holders, as the result of the most 
recent NRC inspection of licensed activities conducted before February 
15, 1996, have been:
    (A) Cited for a Severity Level I, II, or III violation in a Notice 
of Violation;
    (B) Subject to an Order issued by the NRC; or

[[Page 669]]

    (C) Subject to a CAL issued by the NRC.
    (vii) Specific licenses with expiration dates before July 1, 1995, 
for which the holders have submitted applications for renewal under 10 
CFR 40.43 of this part.
    (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:
    (i) Procedures would involve techniques not applied routinely during 
cleanup or maintenance operations;

[[Page 670]]

    (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, ground-water treatment 
activities, monitored natural ground-water 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 671]]

    (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]



Sec. 40.43  Renewal of licenses.

    (a) Application for renewal of a specific license must be filed on 
NRC Form 313 and in accordance with Sec. 40.31.
    (b) If any licensee granted the extension described in 10 CFR 
40.42(a)(2) has a currently pending renewal application for the extended 
license, that application will be considered to be withdrawn by the 
licensee and any renewal fees paid by the licensee for that application 
will be refunded.

[59 FR 36037, July 15, 1994, as amended at 61 FR 1114, Jan. 16, 1996; 62 
FR 52187, Oct. 6, 1997]



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.

    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,

[[Page 672]]

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.

                       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]

                    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

[[Page 673]]

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
    (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

[[Page 674]]

    (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 or 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 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

[[Page 675]]

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]



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;
    (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 1 kilogram or more or who imports or exports 1 
kilogram of uranium or thorium source material shall complete a Nuclear 
Material Transaction Report in computer-readable format in accordance 
with instructions (NUREG/BR-0006 and NMMSS Report D-24, ``Personal 
Computer Data Input for NRC Licensees''). Copies of the instructions may 
be obtained either by writing the U.S. Nuclear Regulatory Commission, 
Division of Nuclear Security, Office of Nuclear Security and Incident 
Response, Washington, DC 20555-0001, by e-mail to [email protected], 
or by calling (301) 415-6828. Each licensee who transfers the material 
shall submit a Nuclear Material Transaction Report in computer-readable 
format in accordance with 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 which has been 
previously submitted in paper form.
    (b) Except as specified in paragraphs (d) and (e) of this section, 
each licensee authorized to possess at any one time and location more 
than 1,000 kilograms of uranium or thorium, or any combination of 
uranium or thorium, shall submit to the Commission within 30 days after 
September 30 of each year or with the licensee's material status reports 
on special nuclear material filed under part 72 or 74, 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 (NUREG/BR-0007), and include the Reporting 
Identification Symbol (RIS) assigned by the Commission to the licensee. 
Copies of the reporting instructions may be obtained either by writing 
to the U.S. Nuclear Regulatory Commission, Division of Nuclear Security, 
Office of Nuclear Security and Incident Response, Washington, DC 20555-
0001, by e-mail to [email protected], or by calling (301) 415-6828.

[[Page 676]]

    (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. A copy of the written followup notification 
should also be made to the Director, Division of Nuclear Security, 
Office of Nuclear Security and Incident Response, by an appropriate 
method listed in Sec. 40.5.
    (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. A copy of the written followup notification 
shall also be sent to: ATTN: Document Control Desk, Director, Division 
of Nuclear Security, Office of Nuclear Security and Incident Response, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
    (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]



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 of the Office of Nuclear Material Safety 
and Safeguards, using an appropriate method listed in Sec. 40.5, with a 
copy to the appropriate NRC Regional Office shown in appendix D to part 
20 of this chapter; which 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

[[Page 677]]

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]



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, Division of Nuclear Security, 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 
Division of Nuclear Safety, 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 Division of Nuclear Safety, Office of Nuclear Security 
and Incident Response at (301) 816-5100.

[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]



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, Division of Nuclear Security, 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 Division of Nuclear Security by 
telephone at (301) 816-5100 when the shipment is received in the 
receiving facility.
    (d) A licensee who needs to amend a notification may do so by 
telephoning the Division of Nuclear Security 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]

[[Page 678]]

                 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, 
40.71, 40.81, and 40.82.

[57 FR 55075, Nov. 24, 1992]

  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-

[[Page 679]]

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 ground water 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 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 ground-
water 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

[[Page 680]]

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).
    Ground water means water below the land surface in a zone of 
saturation. For purposes of this appendix, ground water 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 ground-water 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 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

[[Page 681]]

and isolation of contaminants from ground-water 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 ground-water 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 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 ( or

[[Page 682]]

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 ground-water 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. Ground-water monitoring to comply with these standards is 
required by Criterion 7A.
    5A(1)--The primary ground-water 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, ground water, 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, ground water, 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 prevent the migration of any 
hazardous constituents into ground water 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 ground water 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 ground 
water 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.

[[Page 683]]

    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 ground-water protection standard: 
Hazardous constituents entering the ground water 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 
ground water. The point of compliance must be selected to provide prompt 
indication of ground-water 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 ground 
water 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 ground water 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 ground-water 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 ground water and the direction of ground-water 
flow;
    (iv) The proximity and withdrawal rates of ground-water users;
    (v) The current and future uses of ground water in the area;
    (vi) The existing quality of ground water, including other sources 
of contamination and their cumulative impact on the ground-water 
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 ground water, and the direction of 
ground-water 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.
    5B(4)--In making any determinations under paragraphs 5B(3) and 5B(6) 
of this criterion about the use of ground water 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--

[[Page 684]]

    (a) The Commission approved background concentration of that 
constituent in the ground water;
    (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 ground-water 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 ground water and the direction of ground-water 
flow;
    (iv) The proximity and withdrawal rates of ground-water users;
    (v) The current and future uses of ground water in the area;
    (vi) The existing quality of ground water, including other sources 
of contamination and their cumulative impact on the ground-water 
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 ground water, and the direction of 
ground-water 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 Ground-Water 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)...............................................
  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 ground-water 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

[[Page 685]]

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 ground water to the concentration limits set as 
standards. The licensee's proposed program must address removing the 
hazardous constituents that have entered the ground water 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 ground water 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 ground-water protection standard. The 
Commission will determine when the licensee may terminate corrective 
action measures based on data from the ground-water monitoring program 
and other information that provide reasonable assurance that the ground-
water protection standard will not be exceeded.
    5E--In developing and conducting ground-water 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 ground-water 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 ground-water 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 ground-water quality. The specific 
seepage control and ground-water 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 ground water. The 
information gathered on boreholes must 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 
ground water 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

[[Page 686]]

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 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

[[Page 687]]

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 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 ground-water 
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

[[Page 688]]

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 
ground-water 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 ground-water 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 ground water 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 
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

[[Page 689]]

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, 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 is 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--Financial surety arrangements must be established by 
each mill operator prior to 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 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. 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 surety must also cover the payment of the 
charge for long-term surveillance and control required by Criterion 10. 
In establishing specific surety arrangements, the licensee's cost 
estimates must take into account total costs that would be incurred if 
an independent contractor were hired to perform the decommissioning and 
reclamation work. In order 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 
such 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. The licensees'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. The amount of surety liability 
should be adjusted to recognize any increases or decreases resulting 
from inflation, changes in engineering plans, activities performed, and 
any other conditions affecting costs. 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.
    This will yield a surety that is 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 period of time (e.g., 5 years) yet which must be 
automatically renewed unless the surety notifies the beneficiary (the 
Commission or the State regulatory agency) and the principal (the 
licensee) some reasonable time (e.g., 90 days) prior to 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 period of time to allow at 
least 60 days for the regulatory agency to collect.
    Proof of forfeiture must not be necessary to collect the surety so 
that in the event that the licensee could not provide an acceptable 
replacement surety within the required time, the surety shall be 
automatically collected prior to its expiration. The conditions 
described above 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:

[[Page 690]]

    (a) Surety bonds;
    (b) Cash deposits;
    (c) Certificates of deposits;
    (d) Deposits of government securities;
    (e) Irrevocable letters or lines of credit; and
    (f) Combinations of the above or such other types of arrangements as 
may be approved by the Commission. However, 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 since 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.
    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

[[Page 691]]

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 ground-water 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 ground water. 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)
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)

[[Page 692]]

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)
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-)

[[Page 693]]

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\)
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)

[[Page 694]]

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)
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-)

[[Page 695]]

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)-)
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-)

[[Page 696]]

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]



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.
50.11 Exceptions and exemptions from licensing requirements.
50.12 Specific exemptions.
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, Form, Contents, Ineligibility of Certain 
                               Applicants

50.30 Filing of applications for licenses; 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 and Construction Permits

50.40 Common standards.
50.41 Additional standards for class 104 licenses.
50.42 Additional standards for class 103 licenses.
50.43 Additional standards and provisions affecting class 103 licenses 
          for commercial power.
50.44 Combustible gas control for nuclear power reactors.
50.45 Standards for construction permits.
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.
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.

[[Page 697]]

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.
50.62 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 Installation information and verification.

     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 or construction 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 and construction 
          permits 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.
50.120 Training and qualification of nuclear power plant personnel.

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 
          Facility Construction Permits
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--Standardization of Design; Manufacture of Nuclear 
          Power Reactors; Construction and Operation of Nuclear Power 
          Reactors Manufactured Pursuant to Commission License

[[Page 698]]

Appendix N to Part 50--Standardization of Nuclear Power Plant Designs: 
          Licenses To Construct and Operate Nuclear Power Reactors of 
          Duplicate Design at Multiple Sites
Appendix O to Part 50--Standardization of Design: Staff Review of 
          Standard Designs
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: Secs. 102, 103, 104, 161, 182, 183, 186, 189, 68 Stat. 
936, 937, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 
444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 
2236, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as 
amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 
2750 (44 U.S.C. 3504 note). Section 50.7 also issued under Pub. L. 95-
601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5841). Section 50.10 also issued 
under secs. 101, 185, 68 Stat. 955, as amended (42 U.S.C. 2131, 2235); 
sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 
50.54(dd), and 50.103 also issued under sec. 108, 68 Stat. 939, as 
amended (42 U.S.C. 2138).
    Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 185, 
68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a and Appendix Q 
also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 
4332). Sections 50.34 and 50.54 also issued under sec. 204, 88 Stat. 
1245 (42 U.S.C. 5844). Sections 50.58, 50.91, and 50.92 also issued 
under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also 
issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Sections 50.80--
50.81 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 
2234). Appendix F also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 
2237).

    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, 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).
    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

[[Page 699]]

    (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.
    By-product material means any radioactive material (except special 
nuclear material) yielded in or made radioactive by exposure to the 
radiation incident to the process of producing or utilizing special 
nuclear material.
    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/
cm2).
    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

[[Page 700]]

    (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 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

[[Page 701]]

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 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.
    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.

[[Page 702]]

    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 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.
    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,
    (iii) The reactor coolant system safety and relief valves.

[[Page 703]]


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 704]]

    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 deep-
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 any nuclear reactor other than one 
designed or used primarily for the formation of plutonium or U-233.
    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 on GPO Access.



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/eie.html, by 
calling (301) 415-6030, by e-mail at [email protected], or by writing the 
Office of Information Services, 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

[[Page 705]]

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 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

[[Page 706]]

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 
Information Services, Nuclear Regulatory Commission, Washington, DC 
20555-0001, telephone (301) 415-7233, e-mail [email protected].

[68 FR 58808, Oct. 10, 2003]



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 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

[[Page 707]]

    (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 
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 or applicant.
    (3) Other enforcement action.

[[Page 708]]

    (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(c). 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, by 
calling (301) 415-5877, via e-mail to [email protected], or by visiting the 
NRC's Web site at http://www.nrc.gov and selecting forms from the index 
found on the home page.
    (f) No agreement affecting the compensation, terms, conditions, or 
privileges of employment, including an agreement to settle a complaint 
filed by an employee with the Department of Labor pursuant to section 
211 of the Energy Reorganization Act of 1974, as amended, may contain 
any provision which would prohibit, restrict, or otherwise discourage an 
employee from participating in protected activity as defined in 
paragraph (a)(1) of this section including, but not limited to, 
providing information to the NRC or to his or her employer on potential 
violations or other matters within NRC's regulatory responsibilities.

[58 FR 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]



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. 50.30, 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, 50.62, 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, 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 is approved under control number 3150-
0056.

[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]



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

[[Page 709]]

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.

    (a) Except as provided in Sec. 50.11, 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.
    (b) No person shall begin the construction of a production or 
utilization facility on a site on which the facility is to be operated 
until a construction permit has been issued. As used in this paragraph, 
the term ``construction'' shall be deemed to include pouring the 
foundation for, or the installation of, any portion of the permanent 
facility on the site, but does not include:
    (1) Site exploration, site excavation, preparation of the site for 
construction of the facility, including the driving of piles, and 
construction of roadways, railroad spurs, and transmission lines;
    (2) Procurement or manufacture of components of the facility;
    (3) Construction of non-nuclear facilities (such as turbogenerators 
and turbine buildings) and temporary buildings (such as construction 
equipment storage sheds) for use in connection with the construction of 
the facility; and
    (4) With respect to production or utilization facilities, other than 
testing facilities, required to be licensed pursuant to section 104a or 
section 104c of the Act, the construction of buildings which will be 
used for activities other than operation of a facility and which may 
also be used to house a facility. (For example, the construction of a 
college laboratory building with space for installation of a training 
reactor is not affected by this paragraph. This paragraph does not apply 
to production or utilization facilities subject to paragraph (c) of this 
section.
    (c) Notwithstanding the provisions of paragraph (b) of this section, 
and subject to paragraphs (d) and (e) of this section, no person shall 
effect commencement of construction of a production or utilization 
facility subject to the provisions of Sec. 51.20(b) of this chapter on 
a site on which the facility is to be operated until a construction 
permit has been issued. As used in this paragraph, the term 
``commencement of construction'' means any clearing of land, excavation 
or other substantial action that would adversely affect the environment 
of a site, but does not mean:
    (1) Changes desirable for the temporary use of the land for public 
recreational uses, necessary borings to determine foundation conditions 
or other preconstruction monitoring to establish background information 
related to the suitability of the site or to the protection of 
environmental values;
    (2) Procurement or manufacture of components of the facility; and
    (3) With respect to production or utilization facilities, other than 
testing facilities, required to be licensed pursuant to section 104a or 
section 104c of the Act, the construction of buildings which will be 
used for activities other than operation of a facility and which may 
also be used to house a facility. (For example, the construction of a 
college laboratory building with space for installation of a training 
reactor is not affected by this paragraph.)
    (d)(1) Each person subject to the provisions of paragraph (c) of 
this section, who is, on March 21, 1972, conducting activities permitted 
pursuant to paragraph (b) of this section in effect prior to March 21, 
1972, may furnish to the Commission within 30 days after March 21, 1972 
or such later date as may be approved by the Commission upon good

[[Page 710]]

cause shown, a written statement of any reasons, with supporting factual 
submission, why, with reference to the factors stated in paragraph 
(d)(2) of this section, the activities should be continued, pending the 
issuance of a construction permit, notwithstanding the provisions of 
paragraph (c) of this section. If such written statement has been 
submitted, within the time specified, such activities may continue to be 
conducted pending Commission action pursuant to paragraph (d)(2) of this 
section.
    (2) Upon submission of a statement of reasons pursuant to paragraph 
(d)(1) of this section the Commission may authorize the continued 
conduct of activities permitted by paragraph (b) of this section in 
effect prior to March 21, 1972, upon consideration and balancing of the 
following factors:
    (i) Whether continuation of the activities will give rise to a 
significant adverse impact on the environment and the nature and extent 
of such impact, if any;
    (ii) Whether redress of any adverse environmental impact from 
continuation of the activities can reasonably be effected should such 
redress be necessary;
    (iii) Whether continuation of the activities would foreclose 
subsequent adoption of alternatives; and
    (iv) The effect of delay in conducting such activities on the public 
interest, including the power needs to be served 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.
    (3) Activities permitted to be continued pursuant to this paragraph 
(d) shall be conducted in such a manner as will minimize or reduce their 
environmental impact.
    (e)(1) The Director of Nuclear Reactor Regulation may authorize an 
applicant for a construction permit for a utilization facility which is 
subject to Sec. 51.20(b) of this chapter, and is of the type specified 
in Sec. 50.21(b) (2) or (3) or Sec. 50.22 or is a testing facility to 
conduct the following activities: (i) Preparation of the site for 
construction of the facility (including such activities as clearing, 
grading, construction of temporary access roads and borrow areas); (ii) 
installation of temporary construction support facilities (including 
such items as warehouse and shop facilities, utilities, concrete mixing 
plants, docking and unloading facilities, and construction support 
buildings); (iii) excavation for facility structures; (iv) construction 
of service facilities (including such facilities as roadways, paving, 
railroad spurs, fencing, exterior utility and lighting systems, 
transmission lines, and sanitary sewerage treatment facilities); and (v) 
the construction of structures, systems and components which do not 
prevent or mitigate the consequences of postulated accidents that could 
cause undue risk to the health and safety of the public. No such 
authorization shall be granted unless the staff has completed a final 
environmental impact statement on the issuance of the construction 
permit as required by subpart A of part 51 of this chapter.
    (2) Such an authorization shall be granted only after the presiding 
officer in the proceeding on the construction permit application (i) has 
made all the findings required by Sec. Sec. 51.104(b) and 51.105 of 
this chapter to be made prior to issuance of the construction permit for 
the facility, and (ii) has determined that, based upon the available 
information and review to date, there is reasonable assurance that the 
proposed site is a suitable location for a reactor of the general size 
and type proposed from the standpoint of radiological health and safety 
considerations under the Act and rules and regulations promulgated by 
the Commission pursuant thereto.
    (3)(i) The Director of Nuclear Reactor Regulation may authorize an 
applicant for a construction permit for a utilization facility which is 
subject to Sec. 51.20(b) of this chapter, and is of the type specified 
in Sec. 50.21(b) (2) or (3) or Sec. 50.22 or is a testing facility to 
conduct, in addition to the activities described in paragraph (e)(1) of 
this section, the installation of structural foundations, including any 
necessary subsurface preparation, for structures, systems and components 
which prevent or mitigate the consequences of postulated accidents that 
could cause undue

[[Page 711]]

risk to the health and safety of the public.
    (ii) Such an authorization, which may be combined with the 
authorization described in paragraph (e)(1) of this section, or may be 
granted at a later time, shall be granted only after the presiding 
officer in the proceeding on the construction permit application has, in 
addition to making the findings and determinations required by paragraph 
(e)(2) of this section, determined that there are no unresolved safety 
issues relating to the additional activities that may be authorized 
pursuant to this paragraph that would constitute good cause for 
withholding authorization.
    (4) Any activities undertaken pursuant to an authorization granted 
under this paragraph shall be entirely at the risk of the applicant and, 
except as to matters determined under paragraphs (e)(2) and (e)(3)(ii), 
the grant of the authorization shall have no bearing on the issuance of 
a construction permit with respect to the requirements of the Act, and 
rules, regulations, or orders promulgated pursuant thereto.

[21 FR 355, Jan. 19, 1956, as amended at 25 FR 8712, Sept. 9, 1960; 33 
FR 2381, Jan. 31, 1968; 35 FR 11460, July 7, 1970; 37 FR 5748, Mar. 21, 
1972; 39 FR 14508, Apr. 24, 1974; 39 FR 26279, July 18, 1974; 39 FR 
33202, Sept. 16, 1974; 43 FR 6924, Feb. 17, 1978; 49 FR 9403, Mar. 12, 
1984]



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 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

[[Page 712]]

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;
    (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

[[Page 713]]

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 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 prior to the issuance of a license 
if the application is otherwise acceptable, and will be converted upon 
due completion of the facility and Commission action into a license as 
provided in Sec. 50.56 of this part. A construction permit for the 
alteration of a production or utilization facility will be issued prior 
to the issuance of an amendment of a license, if the application for 
amendment is otherwise acceptable, as provided in Sec. 50.91.

[21 FR 355, June 19, 1956, as amended at 35 FR 11461, July 17, 1970]

  Applications for Licenses, Form, Contents, Ineligibility of Certain 
                               Applicants



Sec. 50.30  Filing of application for licenses; oath or affirmation.

    (a) Serving of applications. (1) Each filing of an application for a 
license to construct and/or operate a production or utilization facility 
(including amendments to the applications) must be submitted to the U.S. 
Nuclear Regulatory Commission in accordance with Sec. 50.4.
    (2) The applicant shall maintain the capability to generate 
additional copies of the general information and the

[[Page 714]]

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, or the Director, 
Office of Nuclear Material Safety and Safeguards, as appropriate.
    (3) Each applicant shall, upon notification by the Atomic Safety and 
Licensing Board appointed to conduct the public hearing required by the 
Atomic Energy Act for the issuance of a construction permit, 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. In addition, at that time the applicant shall serve a copy of the 
updated application on the Atomic Safety and Licensing Appeal Panel. 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.
    (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 
facility for public inspection and copying.
    (6) The serving of copies required by this section must not occur 
until the application has been docketed pursuant to Sec. 2.101(a) of 
this chapter. Copies must be submitted to the Commission, as specified 
in Sec. 50.4, to enable 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 license, including 
whenever appropriate a construction 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 production or utilization 
facility license, including, whenever appropriate, a construction 
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 or operating license, 
except as provided in Sec. 170.21 of this chapter.
    (f) Environmental report. An application for a construction permit 
or an operating license for a nuclear power reactor, testing facility, 
fuel reprocessing plant, or such other production or utilization 
facility whose construction or operation may be determined by the 
Commission to have a significant impact on the environment shall be 
accompanied by any Environmental Report required pursuant to 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]

[[Page 715]]



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, 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) Each application for a construction permit or an operating 
license submitted by a newly-formed entity organized for the primary 
purpose of constructing 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) Its 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.

[[Page 716]]

    (4) 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 for a nuclear 
power reactor, 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) \3\, as well as the plans of State 
governments wholly or partially within the ingestion pathway EPZ.\4\ 
Generally, the plume exposure pathway 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.
---------------------------------------------------------------------------

    \3\ 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.
    \4\ 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 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 for a production 
or utilization facility, 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.
    (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]



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.

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

[[Page 717]]

    (1) Stationary power reactor applicants for a construction permit 
pursuant to this part, or a design certification or combined license 
pursuant to part 52 of this chapter 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 pursuant to this part or a design 
certification or combined license pursuant to part 52 of this chapter, 
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 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.
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    (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.

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[[Page 718]]

    (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 this paragraph (a)(1)(i), in support of the application for 
a construction permit, or a design approval.
    (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:
    (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.
---------------------------------------------------------------------------

    (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

[[Page 719]]

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 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 pursuant to this part, or 
a design certification or combined license pursuant to part 52 of this 
chapter, 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.
    (b) Final safety analysis report. Each application for a license to 
operate a facility 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.

[[Page 720]]

    (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.
    (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 pursuant to this part, or 
a design certification or combined license pursuant to part 52 of this 
chapter, 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 
prior to 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 pursuant to this part, or 
a combined license pursuant to part 52 of this chapter, shall provide a 
description and safety assessment of the site and of the facility as in 
Sec. 50.34(a)(1)(ii) of this part. However, for either an operating 
license applicant or holder whose construction permit was issued prior 
to 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.
    (c) Each application for a license to operate a production or 
utilization facility must include a physical security plan. The plan 
must describe how the applicant will meet the requirements of part 73 
(and part 11 of this chapter, if applicable, including the 
identification and description of jobs as required by Sec. 11.11(a), at 
the proposed facility). The plan must list tests, inspections, audits, 
and other means to be used to demonstrate compliance with the 
requirements of 10 CFR parts 11 and 73, if applicable.
    (d) Safeguards contingency plan. Each application for a license to 
operate a production or utilization facility that

[[Page 721]]

will be subject to Sec. Sec. 73.50, 73.55, or Sec. 73.60 of this 
chapter must include a licensee safeguards contingency plan in 
accordance with the criteria set forth in appendix C to 10 CFR part 73. 
The safeguards contingency plan shall include plans for dealing with 
threats, thefts, and radiological sabotage, as defined in part 73 of 
this chapter, relating to the special nuclear material and nuclear 
facilities licensed under this chapter and in the applicant's possession 
and control. Each application for such a license shall include the first 
four categories of information contained in the applicant's safeguards 
contingency plan. (The first four categories of information as set forth 
in appendix C to 10 CFR part 73 are Background, Generic Planning Base, 
Licensee Planning Base, and Responsibility Matrix. The fifth category of 
information, Procedures, does not have to be submitted for approval.) 
\9\
---------------------------------------------------------------------------

    \9\ A physical security plan that contains all the information 
required in both Sec. 73.55 and appendix C to part 73 satisfies the 
requirement for a contingency plan.
---------------------------------------------------------------------------

    (e) Each applicant for a license to operate a production or 
utilization facility, who prepares a physical security plan, a 
safeguards contingency plan, or a guard qualification and training 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, as appropriate.
    (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 
rule applies only 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, if issued, will be that number whose start of 
manufacture, as defined in the license application, can practically 
begin within a ten-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 five 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 rule. 
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 the manufacturing license may be considered 
in the manufacturing license proceeding.
    (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 such studies are factored into the final 
design of the facility. All studies shall be completed no later than two 
years following issuance of the construction permit or manufacturing 
license. \10\
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    \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.
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    (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):

[[Page 722]]

    (A) A simplified AFWS reliability analysis using event-tree and 
fault-tree logic techniques.
    (B) A design review of AFWS.
    (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

[[Page 723]]

the requirements of (f)(2)(ix) of this section.
    (C) For the selected system, preliminary design descriptions of 
equipment, function, and layout.
    (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)
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    \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-

[[Page 724]]

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 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

[[Page 725]]

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; (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)

[[Page 726]]

    (iv) Provide one or more dedicated containment penetrations, 
equivalent 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, Subsubarticle 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 Subsubarticle 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, Subsubarticle 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, 
Subsubarticle 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)

[[Page 727]]

    (g) Combustible gas control. All applicants for a reactor 
construction permit or operating license under this part, and all 
applicants for a reactor design approval, design certification, or 
license under part 52 of this chapter, whose application was 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, manufacturing licenses, and preliminary or final 
design approvals for standard plants 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 prior to 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.

[33 FR 18612, Dec. 17, 1968]

    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 on GPO Access.



Sec. 50.34a  Design objectives for equipment to control releases of 
radioactive material in effluents--nuclear power reactors.

    (a) An application for a permit to construct a nuclear power reactor 
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 
utilization 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 permit to construct a nuclear power 
reactor shall include:
    (1) A description of the preliminary design of equipment to be 
installed pursuant to paragraph (a) of this section;
    (2) An estimate of:

[[Page 728]]

    (i) The quantity of each of the principal radio-nuclides expected to 
be released annually to unrestricted areas in liquid effluents produced 
during normal reactor operations; and
    (ii) The quantity of each of the principal radio-nuclides 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 a license to operate a nuclear power 
reactor 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, pursuant to 
paragraph (a) of this section; an (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.

[35 FR 18387, Dec. 3, 1970, as amended at 40 FR 58847, Dec. 19, 1975; 61 
FR 65172, Dec. 11, 1996]



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.
    (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

[[Page 729]]

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) 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.
    (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 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.

[[Page 730]]

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, 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.

[[Page 731]]

    (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 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]



Sec. 50.36a  Technical specifications on effluents from nuclear power 
reactors.

    (a) In order 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 will include technical specifications that, in 
addition to

[[Page 732]]

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 licensee 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 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]



Sec. 50.36b  Environmental conditions.

    Each license authorizing operation of a production or utilization 
facility, 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) 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 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 and 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.

[61 FR 39299, July 29, 1996]



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 or construction permit, the applicant shall agree 
in writing that it will not

[[Page 733]]

permit any individual to have access to or any facility to possess 
Restricted Data or classified National Security Information until the 
individual and/or facility has been approved for such access under the 
provisions of 10 CFR parts 25 and/or 95. The agreement of the applicant 
in this regard shall be deemed part of the license or construction 
permit, whether so stated therein or not.

[62 FR 17690, Apr. 11, 1997]



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.

             Standards for Licenses and Construction Permits



Sec. 50.40  Common standards.

    In determining that a license will be issued to an applicant, the 
Commission will be guided by the following considerations:
    (a) 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, and that the health and safety of the public will not be endangered.
    (b) The applicant 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.
    (c) The issuance of a 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 part 51 have been 
satisfied.

[21 FR 355, Jan. 19, 1956, as amended at 36 FR 12731, July 7, 1971; 49 
FR 9404, Mar. 12, 1984; 49 FR 35753, Sept. 12, 1984]



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) An application for a class 104 operating license as to which a 
person who intervened or sought by timely written notice to the 
Commission to intervene in the construction permit proceeding for the 
facility to obtain a determination of antitrust considerations or to 
advance a jurisdictional basis for such determination has requested an 
antitrust review under section 105 of the Act within 25 days after the 
date of publication in the Federal Register of notice of filing of the 
application for an operating license or December 19, 1970, whichever is 
later, is also subject to the provisions of Sec. 50.42(b).

[21 FR 355, Jan. 19, 1956, as amended at 35 FR 19660, Dec. 29, 1970]



Sec. 50.42  Additional standards for class 103 licenses.

    In determining whether a class 103 license will be issued to an 
applicant,

[[Page 734]]

the Commission will, in addition to applying the standards set forth in 
Sec. 50.40, be guided by the following considerations:
    (a) The proposed activities will serve a useful purpose 
proportionate to the quantities of special nuclear material or source 
material to be utilized.
    (b) Due account will be taken of the advice provided by the Attorney 
General, under subsection 105c of the Act, and to any evidence that may 
be provided during any proceedings in connection with the antitrust 
aspects of the application for a construction permit or the facility's 
initial operating license.
    (1) For this purpose, the Commission will promptly transmit to the 
Attorney General a copy of the construction permit application or 
initial operating license application. The Commission will request any 
advice as the Attorney General considers appropriate in regard to the 
finding to be made by the Commission as to whether the proposed license 
would create or maintain a situation inconsistent with the antitrust 
laws, as specified in subsection 105a of the Act. This requirement will 
not apply--
    (i) With respect to the types of class 103 licenses which the 
Commission, with the approval of the Attorney general, may determine 
would not significantly affect the applicant's activities under the 
antitrust laws; and
    (ii) To an application for an initial license to operate a 
production or utilization facility for which a class 103 construction 
permit was issued unless the Commission, after consultation with the 
Attorney General, determines such review is advisable on the ground that 
significant changes have occurred subsequent to the previous review by 
the Attorney General and the Commission.
    (2) The Commission will publish any advice it receives from the 
Attorney General in the Federal Register. After considering the 
antitrust aspects of the application for a construction permit or 
initial operating license, the Commission, if it finds that the 
construction permit or initial operating license to be issued or 
continued, would create or maintain a situation inconsistent with the 
antitrust laws specified subsection 105a of the Act, will consider, in 
determining whether a construction permit or initial operating license 
should be issued or continued, other factors the Commission considers 
necessary to protect the public interest, including the need for power 
in the affected area.\1\
---------------------------------------------------------------------------

    \1\ As permitted by subsection 105c(8) of the Act, with respect to 
proceedings in which an application for a construction permit was filed 
prior to Dec. 19, 1970, and proceedings in which a written request for 
antitrust review of an application for an operating license to be issued 
under section 104b has been made by a person who intervened or sought by 
timely written notice to the Atomic Energy Commission to intervene in 
the construction permit proceeding for the facility to obtain a 
determination of antitrust considerations or to advance a jurisdictional 
basis for such determination within 25 days after the date of 
publication in the Federal Register of notice of filing of the 
application for an operating license or Dec. 19, 1970, whichever is 
later, the Commission may issue a construction permit or operating 
license in advance of consideration of, and findings with respect to the 
antitrust aspects of the application, provided that the permit or 
license so issued contains the condition specified in Sec. 50.55b.

[21 FR 355, Jan. 19, 1956, as amended at 35 FR 11461, July 17, 1970; 35 
FR 19660, Dec. 29, 1970; 65 FR 44660, July 19, 2000]



Sec. 50.43  Additional standards and provisions affecting class 103 
licenses for commercial power.

    In addition to applying the standards set forth in Sec. Sec. 50.40 
and 50.42, in the case of a class 103 license for a facility for the 
generation of commercial power:
    (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

[[Page 735]]

weeks after the last notice is published in the Federal Register.
    (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 herein 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 license for the construction and operation of a utilization facility 
for the primary purpose of producing electric energy for disposition for 
ultimate public consumption.

[21 FR 355, Jan. 19, 1956, as amended at 35 FR 19660, Dec. 29, 1970; 63 
FR 50480, Sept. 22, 1998]



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 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.

[[Page 736]]

    (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 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

[[Page 737]]

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 health and safety and common defense and security.

[68 FR 54141, Sept. 16, 2003]



Sec. 50.45  Standards for construction permits.

    An applicant for a license or an amendment of a 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.



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

[[Page 738]]

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 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 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 licensee 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. If the change or error is signficant, 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.
    (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

[[Page 739]]

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.
    (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]



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) 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.

[[Page 740]]

    (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 near-site 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.
    (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. Guidelines for the choice of 
protective actions during an emergency, consistent with Federal 
guidance, are developed and in place, and

[[Page 741]]

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 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

[[Page 742]]

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 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 near-site 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.

[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]



Sec. 50.48  Fire protection.

    (a)(1) Each operating nuclear power plant 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;

[[Page 743]]

    (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.
    (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, 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

[[Page 744]]

    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 
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

[[Page 745]]

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]



Sec. 50.49  Environmental qualification of electric equipment important 
to safety for nuclear power plants.

    (a) Each holder of or an applicant for a license for a nuclear power 
plant, other than a nuclear power plant for which the certifications 
required under Sec. 50.82(a)(1) have been submitted, shall establish a 
program for qualifying the electric equipment defined in paragraph (b) 
of this section.
    (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;
    (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 
Printing Office by calling 202-275-2060 or by writing to the U.S. 
Government Printing 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

[[Page 746]]

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 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

[[Page 747]]

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 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

[[Page 748]]

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]

   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 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.

    Whether stated therein or not, the following shall be deemed 
conditions in every license issued:
    (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, pursuant to Sec. 50.34(b)(6)(ii) of this part, the 
quality assurance program described or referenced in the Safety Analysis 
Report, including changes to that report.
    (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.

[[Page 749]]

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 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,

[[Page 750]]

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.
    (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 three months after issuance of an operating license, 
the licensee shall have in effect an operator requalification program 
which 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:

[[Page 751]]

    (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.

    (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. 
50.82(a)(1) 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 effecting the actions and decisions contained in the 
Responsibility Matrix of the safeguards contingency plan. The licensee 
may make no change which would decrease the effectiveness of a security 
plan, or guard training and qualification plan, prepared pursuant to 
Sec. 50.34(c) 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 pursuant to Sec. 50.34(d) or part 73 of this 
chapter, as applicable, without prior

[[Page 752]]

approval of the Commission. A licensee desiring to make such a change 
shall submit an application for an amendment to the licensee's license 
pursuant to 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 three years from the date of 
the change, and shall submit, as specified in Sec. 50.4, a report 
containing a description of each change within two 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 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
    (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) A licensee authorized to possess and operate a nuclear power 
reactor shall follow and maintain in effect emergency plans which meet 
the standards in Sec. 50.47(b) and the requirements in appendix E of 
this part. A licensee authorized to possess and/or operate a research 
reactor or a fuel facility shall follow and maintain in effect emergency 
plans which meet the requirements in appendix E to this part. The 
licensee shall retain the emergency plan and each change that decreases 
the effectiveness of the plan as a record until the Commission 
terminates the license for the nuclear power reactor. The nuclear power 
reactor licensee may make changes to these plans without Commission 
approval only if the changes do not decrease the effectiveness of the 
plans and the plans, as changed, continue to meet the standards of Sec. 
50.47(b) and the requirements of appendix E to this part. The research 
reactor and/or the fuel facility licensee may make changes to these 
plans without Commission approval only if these changes do not decrease 
the effectiveness of the plans and the plans, as changed, continue to 
meet the requirements of appendix E to this part. This nuclear power 
reactor, research reactor, or fuel facility licensee shall retain a 
record of each change to the emergency plan made without prior 
Commission approval for a period of three years from the date of the 
change. Proposed changes that decrease the effectiveness of the approved 
emergency plans may not be implemented without application to and 
approval by the Commission. The licensee shall submit, as specified in 
Sec. 50.4, a report of each proposed change for approval. If a change 
is made without approval, the licensee shall submit, as specified in 
Sec. 50.4, a report of each change within 30 days after the change is 
made.

[[Page 753]]

    (r) Each licensee who is authorized to possess and/or operate a 
research or test reactor facility with an authorized power level greater 
than or equal to 2 MW thermal, under a licensee of the type specified in 
Sec. 50.21(c), shall submit emergency plans complying with 10 CFR part 
50, appendix E, to the Director of the Office of Nuclear Reactor 
Regulation for approval by September 7, 1982. Each licensee who is 
authorized to possess and/or operate a research or test reactor facility 
with an authorized power level less than 2 MW thermal, under a license 
of the type specified in Sec. 50.21(c), shall submit emergency plans 
complying with 10 CFR part 50, appendix E, to the Director of the Office 
of Nuclear Reactor Regulation for approval by November 3, 1982.
    (s)(1) Each licensee who is authorized to possess and/or operate a 
nuclear power reactor shall submit to NRC within 60 days of the 
effective date of this amendment the radiological emergency response 
plans of State and local governmental entities in the United States that 
are wholly or partially within a plume exposure pathway EPZ, as well as 
the plans of State governments wholly or partially within an ingestion 
pathway EPZ. \1, 2\ These plans must be forwarded to the Director of 
Nuclear Reactor Regulation, by appropriate method listed in Sec. 50.4, 
with a copy to the Administrator of the appropriate NRC regional office. 
Generally, the plume exposure pathway 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 for 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 EPZ shall focus on such actions as are appropriate 
to protect the food ingestion pathway.
---------------------------------------------------------------------------

    \1\ 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.
    \2\ 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.
---------------------------------------------------------------------------

    (2)(i) For operating power reactors, the licensee, State, and local 
emergency response plans shall be implemented by April 1, 1981, except 
as provided in section IV.D.3 of appendix E to this part.
    (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

[[Page 754]]

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) Within 60 days after the effective date of this amendment, each 
nuclear power reactor licensee shall submit to the NRC plans for coping 
with emergencies that meet standards in Sec. 50.47(b) and the 
requirements of appendix E to this part.
    (v) Each licensee subject to the requirements of part 73 of this 
chapter shall ensure that physical security, safeguards contingency and 
guard qualification and training plans and other related Safeguards 
Information are protected against unauthorized disclosure in accordance 
with the requirements of Sec. 73.21 of this chapter, as appropriate.
    (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 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

[[Page 755]]

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 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

[[Page 756]]

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 
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;

[[Page 757]]

    (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.

[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 on GPO Access.



Sec. 50.55  Conditions of construction permits.

    Each construction permit shall be subject to the following terms and 
conditions:
    (a) The 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 permit shall expire and 
all rights thereunder shall be forfeited: Provided, however, That 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

[[Page 758]]

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) Each individual, corporation, partnership, or other entity 
holding a facility construction permit subject to this part 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 paragraph (e)(1)(ii) 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.
    (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)(7) 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 is informed as soon 
as practicable, and, in all cases, within the 5 working days after 
completion of the evaluation described in paragraph (e)(1)(i) or 
(e)(1)(ii) of this section, if the construction of a facility or 
activity, or a basic component supplied for such facility or activity--
    (A) 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 a substantial safety hazard,
    (B) Contains a defect, or
    (C) Undergoes any significant breakdown in any portion of the 
quality assurance program conducted pursuant to the requirements of 
appendix B to 10 CFR part 50 which could have produced a defect in a 
basic component. Such 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 or installation.
    (2) The holder of a facility construction permit subject to this 
part who obtains information reasonably indicating that the facility 
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 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)(7) of this section.
    (3) The holder of a facility construction permit subject to this 
part who obtains information reasonably indicating the existence of any 
defect found in construction or any defect found in the final design of 
a facility as approved and released for construction must notify the 
Commission of the defect through a director or responsible officer or 
designated person as discussed in paragraph (e)(7) of this section.
    (4) The holder of a facility construction permit subject to this 
part who obtains information reasonably indicating that the quality 
assurance program has undergone any significant breakdown discussed in 
paragraph (e)(1)(ii)(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)(7) of this section.
    (5) The notification requirements of paragraphs (e)(2), (e)(3), and 
(e)(4) of this section 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 or construction 
permit. Evaluation of potential defects and

[[Page 759]]

failures to comply and reporting of defects and failures to comply under 
this section satisfies the construction permit 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 of this chapter 
to report defects, and failures to comply associated with substantial 
safety hazards under section 206 of the Energy Reorganization Act of 
1974.
    (6) The notification required by paragraphs (e)(2), (e)(3), and 
(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 two days following receipt of 
information by the director or responsible corporate officer under 
paragraph (e)(1)(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)(1)(ii).
    (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)(1)(iii) of this section, on the identification of a defect 
or failure to comply.
    (7) 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.
    (8) The written notification required by paragraph (e)(6)(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 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 all the components in use at 
the facility 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 other entities.
    (9) The holder of a construction permit 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 basic component.
    (ii) Retain evaluations of all deviations and failures to comply for 
a minimum of five years.
    (iii) Maintaining records in accordance with this section satisfies 
the construction permit holders recordkeeping obligations under part 21 
of this chapter. The recordkeeping obligations of responsible officers 
and directors under part 21 of this chapter are met by recordkeeping in 
accordance with this section.
    (10) The requirements of this Sec. 50.55(e) are satisfied when the 
defect or failure

[[Page 760]]

to comply associated with a substantial safety hazard has been 
previously reported under part 21 of this chapter or under Sec. 73.71 
of this chapter under Sec. 50.55(e) or Sec. 50.73 of this part. For 
holders of construction permits issued prior to 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.
    (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 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.

[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]



Sec. 50.55a  Codes and standards.

    Each operating license for a boiling or pressurized water-cooled 
nuclear power facility is subject to the conditions in paragraphs (f) 
and (g) of this section and each construction permit for a utilization 
facility is subject to the following conditions in addition to those 
specified in Sec. 50.55.

[[Page 761]]

    (a)(1) Structures, systems, and components must be designed, 
fabricated, erected, constructed, tested, and inspected to quality 
standards commensurate with the importance of the safety function to be 
performed.
    (2) Systems and components of boiling and pressurized water-cooled 
nuclear power reactors must meet the requirements of the ASME Boiler and 
Pressure Vessel Code specified in paragraphs (b), (c), (d), (e), (f), 
and (g) of this section. Protection systems of nuclear power reactors of 
all types must meet the requirements specified in paragraph (h) of this 
section.
    (3) Proposed alternatives to the requirements of paragraphs (c), 
(d), (e), (f), (g), and (h) of this section or portions thereof may be 
used when authorized by the Director of the Office of Nuclear Reactor 
Regulation. The applicant shall demonstrate that:
    (i) The proposed alternatives would provide an acceptable level of 
quality and safety, or
    (ii) 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.
    (b) The ASME Boiler and Pressure Vessel Code and the ASME Code for 
Operation and Maintenance of Nuclear Power Plants, which are referenced 
in paragraphs (b)(1), (b)(2), and (b)(3) of this section, were approved 
for incorporation by reference by the Director of the Office of the 
Federal Register pursuant to 5 U.S.C. 552(a) and 1 CFR part 51. NRC 
Regulatory Guide 1.84, Revision 33, ``Design, Fabrication, and Materials 
Code Case Acceptability, ASME Section III'' (August 2005); NRC 
Regulatory Guide 1.147 (Revision 0-February 1981), including Revision 1 
through Revision 14 (August 2005), ``Inservice Inspection Code Case 
Acceptability, ASME Section XI, Division 1''; and Regulatory Guide 
1.192, ``Operation and Maintenance Code Case Acceptability, ASME OM 
Code'' (June 2003), have been approved for incorporation by reference by 
the Director of the Office of the Federal Register pursuant to 5 U.S.C. 
552(a) and 1 CFR part 51. These regulatory guides list ASME Code cases 
which the NRC has approved in accordance with the requirements in 
paragraphs (b)(4), (b)(5), and (b)(6). Copies of the ASME Boiler and 
Pressure Vessel Code and the ASME Code for Operation and Maintenance of 
Nuclear Power Plants may be purchased from the American Society of 
Mechanical Engineers, Three Park Avenue, New York, NY 10016. Single 
copies of NRC Regulatory Guides 1.84, Revision 33; 1.147, Revision 14; 
and 1.192 may be obtained free of charge by writing the Reproduction and 
Distribution Services Section, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; or by fax to 301-415-2289; or by e-mail to 
[email protected]. Copies of the ASME Codes and NRC Regulatory Guides 
incorporated by reference in this section may be inspected at the NRC 
Technical Library, Two White Flint North, 11545 Rockville Pike, 
Rockville, MD 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.
    (1) As used in this section, references to Section III of the ASME 
Boiler and Pressure Vessel Code refer to Section III, and include the 
1963 Edition through 1973 Winter Addenda, and the 1974 Edition (Division 
1) through the 2003 Addenda (Division 1), subject to the following 
limitations and modifications:
    (i) Section III Materials. When applying the 1992 Edition of Section 
III, licensees must apply the 1992 Edition with the 1992 Addenda of 
Section II of the ASME Boiler and Pressure Vessel Code.
    (ii) Weld leg dimensions. When applying the 1989 Addenda through the 
latest edition and addenda incorporated by reference in paragraph (b)(1) 
of this section, licensees may not apply paragraph NB-3683.4(c)(1), the 
footnote to circumferential fillet welded and socket welded joints in 
Figure NC-3673.2(b)-1 that permit a socket weld leg dimension to be less 
than 1.09 of the nominal wall thickness of the pipe or the footnote to 
circumferential fillet welded and socket welded joints in figure ND-
3673.2(b)-1 that permit a socket weld leg dimension to be less than 1.09 
of the nominal wall thickness of the pipe.

[[Page 762]]

    (iii) Seismic design. Licensees may use Articles NB-3200, NB-3600, 
NC-3600, and ND-3600 up to and including the 1993 Addenda, subject to 
the limitation specified in paragraph (b)(1)(ii) of this section. 
Licensees may not use these Articles in the 1994 Addenda through the 
latest edition and addenda incorporated by reference in paragraph (b)(1) 
of this section.
    (iv) 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 Facilities,'' 1986 Edition 
through the 1992 Edition, are acceptable for use provided that the 
edition and addenda of NQA-1 specified in NCA-4000 is used in 
conjunction with the administrative, quality, and technical provisions 
contained in the edition and addenda of Section III being used.
    (v) Independence of inspection. Licensees may not apply NCA-
4134.10(a) of Section III, 1995 Edition through the latest edition and 
addenda incorporated by reference in paragraph (b)(1) of this section.
    (vi) 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 (b)(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 component to reach temperatures exceeding 
900 [deg]F.
    (2) As used in this section, references to Section XI of the ASME 
Boiler and Pressure Vessel Code refer to Section XI, and include the 
1970 Edition through the 1976 Winter Addenda, and the 1977 Edition 
(Division 1) through the 2003 Addenda (Division 1), subject to the 
following limitations and modifications:\10\
    (i) Limitations on specific editions and addenda. When applying the 
1974 Edition, only the addenda through the Summer 1975 Addenda may be 
used. When applying the 1977 Edition, all of the addenda through the 
Summer 1978 Addenda must also be used. Addenda and editions subsequent 
to the Summer 1978 Addenda, that are incorporated by reference in 
paragraph (b)(2) of this section are not affected by these limitations.
    (ii) 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 Code in the 1974 Edition and 
addenda through the Summer 1975 Addenda or other requirements the 
Commission may adopt.
    (iii) Steam generator tubing (modifies Article IWB-2000). If the 
technical specifications of a nuclear power plant include surveillance 
requirements for steam generators different than those in Article IWB-
2000, the inservice inspection program for steam generator tubing is 
governed by the requirements in the technical specifications.
    (iv) Pressure-retaining welds in ASME Code Class 2 piping (applies 
to Tables IWC-2520 or IWC-2520-1, Category C-F). (A) Appropriate Code 
Class 2 pipe welds in Residual Heat Removal Systems, Emergency Core 
Cooling Systems, and Containment Heat Removal Systems, must be examined. 
When applying editions and addenda up to the 1983 Edition through the 
Summer 1983 Addenda of section XI of the ASME Code, the extent of 
examination for these systems must be determined by the requirements of 
paragraph IWC-1220, Table IWC-2520 Category C-F and C-G, and paragraph 
IWC-2411 in the 1974 Edition and Addenda through the Summer 1975 
Addenda.
    (B) For a nuclear power plant whose application for a construction 
permit was docketed prior to July 1, 1978, when applying editions and 
addenda up to the 1983 Edition through the Summer 1983 Addenda of 
section XI of the ASME Code, the extent of examination for Code Class 2 
pipe welds may be determined by the requirements of paragraph IWC-1220, 
Table IWC-2520 Category C-F and C-G and paragraph IWC-2411 in the 1974 
Edition and Addenda through the Summer 1975 Addenda of Section XI of the 
ASME Code or other

[[Page 763]]

requirements the Commission may adopt.
    (v) Evaluation procedures and acceptance criteria for austenitic 
piping (applies to IWB-3640). When applying the Winter 1983 Addenda and 
Winter 1984 Addenda, the rules of paragraph IWB-3640 may be used for all 
applications permitted in that paragraph, except those associated with 
submerged arc welds (SAW) or shielded metal arc welds (SMAW). For SAW or 
SMAW, use paragraph IWB-3640, as modified by the Winter 1985 Addenda.
    (vi) Effective edition and addenda of Subsection IWE and Subsection 
IWL, Section XI. Licensees 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 modified and supplemented by the requirements in 
paragraphs (b)(2)(viii) and (b)(2)(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 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 (b)(3) of this section.
    (viii) Examination of concrete containments. Licensees applying 
Subsection IWL, 1992 Edition with the 1992 Addenda, shall apply 
paragraphs (b)(2)(viii)(A) through (b)(2)(viii)(E) of this section. 
Licensees applying Subsection IWL, 1995 Edition with the 1996 Addenda, 
shall apply paragraphs (b)(2)(viii)(A), (b)(2)(viii)(D)(3), and 
(b)(2)(viii)(E) of this section. Licensees applying Subsection IWL, 1998 
Edition through the 2000 Addenda shall apply paragraphs (b)(2)(viii)(E) 
and (b)(2)(viii)(F) of this section. Licensees applying Subsection IWL, 
2001 Edition through the latest edition and addenda incorporated by 
reference in paragraph (b)(2) of this section, shall apply paragraphs 
(b)(2)(viii)(E) through (b)(2)(viii)(G) of this section.
    (A) 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) When evaluation of consecutive surveillances of prestressing 
forces for the same tendon or tendons in a group indicates a trend of 
prestress loss such that the tendon force(s) would be less than the 
minimum design prestress requirements before the next inspection 
interval, an evaluation must be performed and reported in the 
Engineering Evaluation Report as prescribed in IWL-3300.
    (C) When the elongation corresponding to a specific load (adjusted 
for effective wires or strands) during retensioning 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) The licensee shall 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;
    (3) Grease leakage is detected during general visual examination of 
the containment surface.
    (E) For Class CC applications, the licensee shall evaluate the 
acceptability of inaccessible areas when conditions exist in accessible 
areas that could indicate the presence of or result in degradation to 
such inaccessible areas. For each inaccessible area identified,

[[Page 764]]

the licensee shall 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) 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) 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.
    (ix) Examination of metal containments and the liners of concrete 
containments. Licensees applying Subsection IWE, 1992 Edition with the 
1992 Addenda, or the 1995 Edition with the 1996 Addenda, shall satisfy 
the requirements of paragraphs (b)(2)(ix)(A) through (b)(2)(ix)(E) of 
this section. Licensees applying Subsection IWE, 1998 Edition through 
the latest edition and addenda incorporated by reference in paragraph 
(b)(2) of this section, shall satisfy the requirements of paragraphs 
(b)(2)(ix)(A), (b)(2)(ix)(B), and (b)(2)(ix)(F) through (b)(2)(ix)(I) of 
this section.
    (A) For Class MC applications, the licensee shall evaluate the 
acceptability of inaccessible areas when conditions exist in accessible 
areas that could indicate the presence of or result in degradation to 
such inaccessible areas. For each inaccessible area identified, the 
licensee shall provide the following in the ISI Summary Report as 
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.
    (B) When performing remotely the visual examinations required by 
Subsection IWE, the maximum direct examination distance specified in 
Table IWA-2210-1 may be extended and the minimum illumination 
requirements specified in Table IWA-2210-1 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) The examinations specified in Examination Category E-B, Pressure 
Retaining Welds, and Examination Category E-F, Pressure Retaining 
Dissimilar Metal Welds, are optional.
    (D) Section 50.55a(b)(2)(ix)(D) may be used as an alternative to the 
requirements of IWE-2430.
    (1) 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 which 
exceeds acceptance standards, the licensee shall provide the following 
in the ISI Summary Report required by IWA-6000:
    (i) A description of each flaw or area, including the extent of 
degradation, and the conditions that led to the degradation;
    (ii) The acceptability of each flaw or area, and the need for 
additional examinations to verify that similar degradation does not 
exist in similar components, and;
    (iii) A description of necessary corrective actions.
    (2) The number and type of additional examinations to ensure 
detection of similar degradation in similar components.
    (E) A general visual examination as required by Subsection IWE must 
be performed once each period.
    (F) 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 shall 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) The VT-3 examination method must be used to conduct the 
examinations in Items E1.12 and E1.20 of Table

[[Page 765]]

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) 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) 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.
    (x) Quality Assurance. When applying Section XI editions and addenda 
later than the 1989 Edition, the requirements of NQA-1, ``Quality 
Assurance Requirements for Nuclear Facilities,'' 1979 Addenda through 
the 1989 Edition, are acceptable as permitted by IWA-1400 of Section XI, 
if the licensee uses its 10 CFR Part 50, Appendix B, quality assurance 
program, in conjunction with Section XI requirements. Commitments 
contained in the licensee's quality assurance program description that 
are more stringent than those contained in NQA-1 must govern Section XI 
activities. Further, where NQA-1 and Section XI do not address the 
commitments contained in the licensee's Appendix B quality assurance 
program description, the commitments must be applied to Section XI 
activities.
    (xi) Class 1 piping. Licensees may not apply IWB-1220, ``Components 
Exempt from Examination,'' of Section XI, 1989 Addenda through the 
latest edition and addenda incorporated by reference in paragraph (b)(2) 
of this section, and shall apply IWB-1220, 1989 Edition.
    (xii) 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 (b)(2) of this section, 
are not approved for use on irradiated material.
    (xiii) Mechanical clamping devices. Licensees may use the provisions 
of Code Case N-523-1, ``Mechanical Clamping Devices for Class 2 and 3 
Piping.'' Licensee choosing to apply Code Case N-523-1 shall apply all 
of its provisions.
    (xiv) Appendix VIII personnel qualification. All personnel qualified 
for performing ultrasonic examinations in accordance with Appendix VIII 
shall 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 (b)(2) 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) Appendix VIII specimen set and qualification requirements. The 
following provisions may be used to modify implementation of Appendix 
VIII of Section XI, 1995 Edition through the 2001 Edition. Licensees 
choosing to apply these provisions shall apply all of the following 
provisions under this paragraph except for those in Sec. 
50.55a(b)(2)(xv)(F) which are optional.
    (A) When applying Supplements 2, 3, and 10 to Appendix VIII, the 
following examination coverage criteria requirements must be used:

[[Page 766]]

    (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 may be used to perform examinations from either side of 
the weld.
    (B) The following provisions 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 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) When applying Supplement 4 to Appendix VIII, the following 
provisions 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 
shall 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) The following provisions 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 
which 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) When applying Supplement 6 to Appendix VIII, the following 
provisions 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

[[Page 767]]

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) The following provisions 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 shall apply all of the provisions of Supplements 4 and 6 
including the following provisions:
    (1) For detection and sizing, the total number of flaws must be at 
least 10. A minimum of 5 flaws shall 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) When applying Supplement 4 to Appendix VIII, Supplement 6 to 
Appendix VIII, or combined Supplement 4 and Supplement 6 qualification, 
the following additional provisions 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), shall 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 Sec. 
50.55a(b)(2)(xv)(G)(1) 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 
provisions of Sec. 50.55a(b)(2)(xv)(G)(2) are met.
    (H) 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 shall be demonstrated with cracks. Flaws in 
nozzles with bore diameters equal to or less than 4 inches may be 
notches.
    (I) When applying Supplement 5, Paragraph (a), to Appendix VIII, the 
following provision must be used in calculating the number of 
permissible false calls:
    (1) 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) When performing nozzle-to-vessel weld examinations, the 
following provisions 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 provisions are required to

[[Page 768]]

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 either 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 Sec. 
50.55a(b)(2)(xv)(K)(1)(i) must be included in the test set. The length 
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 Sec. 
50.55a(b)(2)(xv)(E)(3).
    (iii) For depth sizing, a minimum of four flaws as in Sec. 
50.55a(b)(2)(xv)(K)(1)(i) 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 Sec. Sec. 50.55a(b)(2)(xv)(C)(1), 
50.55a(b)(2)(xv)(E)(1), and 50.55a(b)(2)(xv)(F)(3).
    (2) For examination of reactor pressure vessel nozzle-to-vessel 
welds conducted from the inside of the vessel,
    (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 modified by Sec. Sec. 50.55a(b)(2)(xv)(B) and 
50.55a(b)(2)(xv)(C).
    (ii) When the examination volume defined in Sec. 
50.55a(b)(2)(xv)(K)(2)(i) 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 
Sec. 50.55a(b)(2)(xv)(K)(1).
    (iii) The remainder of the examination volume not covered by Sec. 
50.55a(b)(2)(xv)(K)(2)(ii) or a combination of Sec. 
50.55a(b)(2)(xv)(K)(2)(i) and Sec. 50.55a(b)(2)(xv)(K)(2)(ii), must be 
examined from the nozzle bore using a procedure and personnel qualified 
in accordance with Sec. 50.55a(b)(2)(xv)(K)(1), or from the vessel 
shell using a procedure and personnel qualified for single sided 
examination in accordance with Supplement 6 to Appendix VIII, as 
modified by Sec. Sec. 50.55a(b)(2)(xv)(D), 50.55a(b)(2)(xv)(E), 
50.55a(b)(2)(xv)(F), and 50.55a(b)(2)(xv)(G).
    (3) For examination of reactor pressure vessel nozzle-to-shell welds 
conducted from the outside of the vessel,
    (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 modified by Sec. Sec. 
50.55a(b)(2)(xv)(B) and 50.55a(b)(2)(xv)(C), for examinations performed 
in the radial direction, and Supplement 5 to Appendix VIII, as modified 
by Sec. 50.55a(b)(2)(xv)(J), for examinations performed in the 
circumferential direction.
    (ii) The examination volume not addressed by Sec. 
50.55a(b)(2)(xv)(K)(3)(i) 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 
modified by Sec. Sec. 50.55a(b)(2)(xv)(D), 50.55a(b)(2)(xv)(E), 
50.55a(b)(2)(xv)(F), and 50.55a(b)(2)(xv)(G).

[[Page 769]]

    (4) Table VIII-S7-1, ``Flaw Locations and Orientations,'' Supplement 
7 to Appendix VIII, is modified as follows:

                        Table VIII-S7-1--Modified
------------------------------------------------------------------------
                     Flaw Locations and Orientations
-------------------------------------------------------------------------
                                                Parallel   Perpendicular
                                                 to weld      to weld
------------------------------------------------------------------------
Inner 15 percent.............................          X             X
OD Surface...................................          X   .............
Subsurface...................................          X   .............
------------------------------------------------------------------------

    (L) As a modification 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) 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) Appendix VIII single side ferritic vessel and piping and 
stainless steel piping examination.
    (A) 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 modified by this 
paragraph and Sec. Sec. 50.55a(b)(2)(xv) (B) through (G), on specimens 
containing flaws with non-optimum sound energy reflecting 
characteristics or flaws similar to those in the vessel being examined.
    (B) 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 
modified by this paragraph and Sec. 50.55a(b)(2)(xv)(A).
    (xvii) 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) Certification of NDE personnel. (A) Level I and II 
nondestructive examination personnel shall 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 (b)(2) of this section.
    (B) Paragraph IWA-2316 of the 1998 Edition through the latest 
edition and addenda incorporated by reference in paragraph (b)(2) of 
this section, may only be used to qualify personnel that observe for 
leakage during system leakage and hydrostatic tests conducted in 
accordance with IWA-5211(a) and (b), 1998 Edition through the latest 
edition and addenda incorporated by reference in paragraph (b)(2) of 
this section.
    (C) When qualifying visual examination personnel for VT-3 visual 
examinations under paragraph IWA-2317 of the 1998 Edition through the 
latest edition and addenda incorporated by reference in paragraph (b)(2) 
of this section, the proficiency of the training must be demonstrated by 
administering an initial qualification examination and administering 
subsequent examinations on a 3-year interval.
    (xix) Substitution of alternative methods. The provisions for the 
substitution of alternative examination methods, a combination of 
methods, or newly developed techniques in the 1997 Addenda of IWA-2240 
must be applied. The provisions in IWA-2240, 1998 Edition through the 
latest edition and addenda incorporated by reference in paragraph (b)(2) 
of this section, are not approved for use. The provisions in IWA-
4520(c), 1997 Addenda through the latest edition and addenda 
incorporated by reference in paragraph (b)(2) of this section, allowing 
the substitution of alternative examination methods, a combination of 
methods, or newly developed techniques for the methods specified in the 
Construction Code are not approved for use.

[[Page 770]]

    (xx) System leakage tests. When performing system leakage tests in 
accordance IWA-5213(a), 1997 through 2002 Addenda, a 10-minute hold time 
after attaining test pressure is required for Class 2 and Class 3 
components that are not in use during normal operating conditions, and 
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.
    (xxi) Table IWB-2500-1 examination requirements. (A) 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) in the 1998 Edition must 
be applied when using the 1999 Addenda through the latest edition and 
addenda incorporated by reference in paragraph (b)(2) of this section. A 
visual examination with enhanced magnification that has a resolution 
sensitivity to detect a 1-mil width wire or crack, utilizing the 
allowable flaw length criteria in Table IWB-3512-1, 1997 Addenda through 
the latest edition and addenda incorporated by reference in paragraph 
(b)(2) of this section, may be performed in place of an ultrasonic 
examination.
    (B) The provisions of Table IWB-2500-1, Examination Category B-G-2, 
Item B7.80, that are in the 1995 Edition are applicable only to reused 
bolting when using the 1997 Addenda through the latest edition and 
addenda incorporated by reference in paragraph (b)(2) of this section.
    (xxii) 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 (b)(2) of 
this section, that allow use of an ultrasonic examination method is 
prohibited.
    (xxiii) 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 latest 
edition and addenda incorporated by reference in paragraph (b)(2) of 
this section are prohibited.
    (xxiv) 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 latest edition and addenda 
incorporated by reference in paragraph (b)(2) of this section, is 
prohibited.
    (xxv) 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 (b)(2) of this section are 
prohibited.
    (xxvi) 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 (b)(2) of 
this section.
    (xxvii) Removal of Insulation. When performing visual examinations 
in accordance with IWA-5242 of Section XI, 2003 Addenda through the 
latest edition and addenda incorporated by reference in paragraph (b)(2) 
of the 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.
    (3) As used in this section, references to the OM Code refer to the 
ASME Code for Operation and Maintenance of Nuclear Power Plants, and 
include the 1995 Edition through the 2003 Addenda subject to the 
following limitations and modifications:
    (i) Quality Assurance. When applying editions and addenda of the OM 
Code, the requirements of NQA-1, ``Quality Assurance Requirements for 
Nuclear Facilities,'' 1979 Addenda, are acceptable as permitted by ISTA 
1.4 of the 1995 Edition through 1997 Addenda or ISTA-1500 of the 1998 
Edition through the latest edition and addenda incorporated by reference 
in paragraph (b)(3) of this section, provided the licensee

[[Page 771]]

uses its 10 CFR Part 50, Appendix B, quality assurance program in 
conjunction with the OM Code requirements. Commitments contained in the 
licensee's quality assurance program description that are more stringent 
than those contained in NQA-1 govern OM Code activities. If NQA-1 and 
the OM Code do not address the commitments contained in the licensee's 
Appendix B quality assurance program description, the commitments must 
be applied to OM Code activities.
    (ii) Motor-Operated Valve testing. Licensees shall comply with the 
provisions for testing motor-operated valves in 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 (b)(3) of this section, and shall establish a program to 
ensure that motor-operated valves continue to be capable of performing 
their design basis safety functions.
    (iii) [Reserved]
    (iv) Appendix II. Licensees applying Appendix II, ``Check Valve 
Condition Monitoring Program,'' of the OM Code, 1995 Edition with the 
1996 and 1997 Addenda, shall satisfy the requirements of (b)(3)(iv)(A), 
(b)(3)(iv)(B), and (b)(3)(iv)(C) of this section. Licensees applying 
Appendix II, 1998 Edition through the 2002 Addenda, shall satisfy the 
requirements of (b)(3)(iv)(A), (b)(3)(iv)(B), and (b)(3)(iv)(D) of this 
section.
    (A) Valve opening and closing functions must be demonstrated when 
flow testing or examination methods (nonintrusive, or disassembly and 
inspection) are used;
    (B) 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) 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) The provisions of ISTC-3510, ISTC-3520, and ISTC-3540 in 
addition to ISTC-5221 must be implemented if the Appendix II condition 
monitoring program is discontinued.
    (v) Subsection ISTD. Article IWF-5000, ``Inservice Inspection 
Requirements for Snubbers,'' of the ASME BPV Code, Section XI, provides 
inservice inspection requirements for examinations and tests of snubbers 
at nuclear power plants. Licensees may use Subsection ISTD, ``Inservice 
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 (b)(3) of this section, 
in place of the requirements for snubbers in 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.
    (vi) Exercise interval for manual valves. Manual valves must be 
exercised on a 2-year interval rather that the 5-year interval specified 
in paragraph ISTC-3540 of the 1999 Addenda through the latest edition 
and addenda incorporated by reference in paragraph (b)(3) of this 
section, provided that adverse conditions do not require more frequent 
testing.
    (4) Design, Fabrication, and Materials Code Cases. Licensees may 
apply the ASME Boiler and Pressure Vessel Code cases listed in NRC 
Regulatory Guide 1.84, Revision 33, without prior NRC approval subject 
to the following:
    (i) When an applicant or licensee initially applies a listed Code 
case, the applicant or licensee shall apply the most recent version of 
that Code case incorporated by reference in this paragraph.
    (ii) If an applicant or licensee has previously applied a Code case 
and a later version of the Code case is incorporated by reference in 
this paragraph, 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 772]]

    (iii) 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) Inservice Inspection Code Cases. Licensees may apply the ASME 
Boiler and Pressure Vessel Code cases listed in Regulatory Guide 1.147 
through Revision 14, without prior NRC approval subject to the 
following:
    (i) When a licensee initially applies a listed Code case, the 
licensee shall apply the most recent version of that Code case 
incorporated by reference in this paragraph.
    (ii) If a licensee has previously applied a Code case and a later 
version of the Code case is incorporated by reference in this paragraph, 
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.
    (iii) 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 Regulatory Guide 1.147. Any Code case listed as 
annulled in any Revision of Regulatory Guide 1.147 which a licensee has 
applied prior to it being listed as annulled, may continue to be applied 
by that licensee to the end of the 120-month interval in which the Code 
case was implemented.
    (6) Operation and Maintenance of Nuclear Power Plants Code Cases. 
Licensees may apply the ASME Operation and Maintenance Nuclear Power 
Plants Code cases listed in Regulatory Guide 1.192 without prior NRC 
approval subject to the following:
    (i) When a licensee initially applies a listed Code case, the 
licensee shall apply the most recent version of that Code case 
incorporated by reference in this paragraph.
    (ii) If a licensee has previously applied a Code case and a later 
version of the Code case is incorporated by reference in this paragraph, 
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.
    (iii) 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 Regulatory Guide 1.192. If a licensee has applied 
a listed Code case that is later listed as annulled in 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. (1) Components which are part 
of the reactor coolant pressure boundary must meet the requirements for 
Class 1 components in Section III \4,5\ of the ASME Boiler and Pressure 
Vessel Code, except as provided in paragraphs (c)(2), (c)(3), and (c)(4) 
of this section.
---------------------------------------------------------------------------

    See footnotes at end of section.
---------------------------------------------------------------------------

    (2) Components which 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:
    (i) 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) 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) The Code edition, addenda, and optional ASME Code cases to be 
applied to components of the reactor

[[Page 773]]

coolant pressure boundary must be determined by the provisions of 
paragraph NCA-1140, Subsection NCA of Section III of the ASME Boiler and 
Pressure Vessel Code, but--
    (i) the edition and addenda applied to a component must be those 
which are incorporated by reference in paragraph (b)(1) of this section,
    (ii) the ASME Code provisions applied to the pressure vessel may be 
dated no earlier than the Summer 1972 Addenda of the 1971 edition,
    (iii) 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) 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 (b) of this section.
    (4) 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 component at the time of issuance of the construction permit.
    (d) Quality Group B components. (1) For a nuclear power plant whose 
application for a construction permit is docketed after May 14, 1984 
components classified Quality Group B \9\ must meet the requirements for 
Class 2 Components in Section III of the ASME Boiler and Pressure Vessel 
Code.
    (2) 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 must be determined by the rules of paragraph NCA-1140, 
Subsection NCA of Section III of the ASME Boiler and Pressure Vessel 
Code, but--
    (i) the edition and addenda must be those which are incorporated by 
reference in paragraph (b)(1) of this section,
    (ii) the ASME Code provisions applied to the systems and components 
may be dated no earlier than the 1980 Edition, and
    (iii) The optional Code cases must be those listed in the NRC 
Regulatory Guide 1.84 that is incorporated by reference in paragraph (b) 
of this section.
    (e) Quality Group C components. (1) For a nuclear power plant whose 
application for a construction permit is docketed after May 14, 1984 
components classified Quality Group C \9\ must meet the requirements for 
Class 3 components in Section III of the ASME Boiler and Pressure Vessel 
Code.
    (2) 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 Boiler and Pressure Vessel 
Code, but--
    (i) the edition and addenda must be those which are incorporated by 
reference in paragraph (b)(1) of this section,
    (ii) the ASME Code provisions applied to the systems and components 
may be dated no earlier than the 1980 Edition, and
    (iii) The optional Code cases must be those listed in NRC Regulatory 
Guide 1.84 that is incorporated by reference in paragraph (b) of this 
section.
    (f) Inservice testing requirements. Requirements for inservice 
inspection of Class 1, Class 2, Class 3, Class MC, and Class CC 
components (including their supports) are located in Sec. 50.55a(g).
    (1) 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 (f)(5) 
of this section to the extent practical. Pumps and valves which are part 
of the reactor coolant pressure boundary must meet the requirements 
applicable to components which 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 Boiler and Pressure Vessel or OM Code) must meet the 
test requirements applicable to components which are classified as ASME 
Code Class 2 or Class 3.

[[Page 774]]

    (2) 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 which are classified as ASME Code 
Class 1 and Class 2 must be designed and be 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 Boiler and 
Pressure Vessel Code incorporated by reference in paragraph (b) of this 
section (or the optional ASME Code cases listed in NRC Regulatory Guide 
1.147, through Revision 14, or 1.192 that are incorporated by reference 
in paragraph (b) of this section) in effect six 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 which are incorporated by reference in paragraph (b) of 
this section (or the optional ASME Code cases listed in NRC Regulatory 
Guide 1.147, through Revision 14, or 1.192 that are incorporated by 
reference in paragraph (b) of this section), subject to the applicable 
limitations and modifications listed therein.
    (3) For a boiling or pressurized water-cooled nuclear power facility 
whose construction permit was issued on or after July 1, 1974:
    (i)-(ii) [Reserved]
    (iii)(A) Pumps and valves, in facilities whose construction permit 
was issued before November 22, 1999, which are classified as ASME Code 
Class 1 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 Boiler and Pressure Vessel Code incorporated by reference 
in paragraph (b) of this section (or the optional ASME Code cases listed 
in NRC Regulatory Guide 1.147, through Revision 14, or 1.192 that are 
incorporated by reference in paragraph (b) of this section) applied to 
the construction of the particular pump or valve or the Summer 1973 
Addenda, whichever is later.
    (B) Pumps and valves, in facilities whose construction permit is 
issued on or after November 22, 1999, which are classified as ASME Code 
Class 1 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 editions and addenda of the ASME OM 
Code (or the optional ASME Code cases listed in NRC Regulatory Guide 
1.192 that is incorporated by reference in paragraph (b) of this 
section) referenced in paragraph (b)(3) of this section at the time the 
construction permit is issued.
    (iv)(A) Pumps and valves, in facilities whose construction permit 
was issued before November 22, 1999, which are classified as ASME 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 Boiler and Pressure Vessel Code incorporated by 
reference in paragraph (b) of this section (or the optional ASME Code 
cases listed in NRC Regulatory Guide 1.147, through Revision 14, that 
are incorporated by reference in paragraph (b) of this section) applied 
to the construction of the particular pump or valve or the Summer 1973 
Addenda, whichever is later.
    (v) All pumps and valves may meet the test requirements set forth in 
subsequent editions of codes and addenda or portions thereof which are 
incorporated by reference in paragraph (b) of this section, subject to 
the limitations and modifications listed in paragraph (b) of this 
section.
    (4) Throughout the service life of a boiling or pressurized water-
cooled nuclear power facility, pumps and valves which are classified as 
ASME Code Class 1, Class 2 and Class 3 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 (f)(3) of this section and 
that are incorporated by reference in paragraph (b) of this section, to 
the extent practical within the limitations of design, geometry and 
materials of construction of the components.

[[Page 775]]

    (i) 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 Code incorporated by reference in 
paragraph (b) of this section on the date 12 months before the date of 
issuance of the operating license (or the optional ASME Code cases 
listed in NRC Regulatory Guide 1.192 that is incorporated by reference 
in paragraph (b) of this section), subject to the limitations and 
modifications listed in paragraph (b) of this section.
    (ii) 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 Code incorporated by reference in 
paragraph (b) 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, through Revision 14, or 1.192 that are incorporated by 
reference in paragraph (b) of this section), subject to the limitations 
and modifications listed in paragraph (b) of this section.
    (iii) [Reserved]
    (iv) Inservice tests of pumps and valves may meet the requirements 
set forth in subsequent editions and addenda that are incorporated by 
reference in paragraph (b) of this section, subject to the limitations 
and modifications 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.
    (5)(i) 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) If a revised inservice test program for a facility conflicts 
with the technical specification for the facility, the licensee shall 
apply to the Commission for amendment of the technical specifications to 
conform the technical specification to the revised program. The licensee 
shall 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) If the licensee has determined that conformance with certain 
code requirements is impractical for its facility, the licensee shall 
notify the Commission and submit, as specified in Sec. 50.4, 
information to support the determination.
    (iv) 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 demonstrated to 
the satisfaction of the Commission not later than 12 months after the 
expiration of the initial 120-month period of operation from start of 
facility commercial operation and each subsequent 120-month period of 
operation during which the test is determined to be impractical.
    (6)(i) 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 is authorized by law and will not endanger life or 
property or the common defense and security and is 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) 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) Inservice inspection requirements. Requirements for inservice 
testing of Class 1, Class 2, and Class 3 pumps and valves are located in 
Sec. 50.55a(f).
    (1) 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 which are 
part of the reactor

[[Page 776]]

coolant pressure boundary and their supports must meet the requirements 
applicable to components which 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 which 
are classified as ASME Code Class 2 or Class 3.
    (2) 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 (including supports) which are 
classified as ASME Code Class 1 and Class 2 must be designed and be 
provided with access to enable the performance of inservice examination 
of such components (including supports) and must meet the preservice 
examination requirements set forth in editions and addenda of Section XI 
of the ASME Boiler and Pressure Vessel Code incorporated by reference in 
paragraph (b) of this section (or the optional ASME Code cases listed in 
NRC Regulatory Guide 1.147, through Revision 14, that are incorporated 
by reference in paragraph (b) of this section) in effect six months 
before the date of issuance of the construction permit. The components 
(including supports) may meet the requirements set forth in subsequent 
editions and addenda of this Code which are incorporated by reference in 
paragraph (b) of this section (or the optional ASME Code cases listed in 
NRC Regulatory Guide 1.147, through Revision 14, that are incorporated 
by reference in paragraph (b) of this section), subject to the 
applicable limitations and modifications.
    (3) For a boiling or pressurized water-cooled nuclear power facility 
whose construction permit was issued on or after July 1, 1974:
    (i) Components (including supports) which are classified as ASME 
Code Class 1 must be designed and be provided with access to enable the 
performance of inservice examination of these components and must meet 
the preservice examination requirements set forth in the editions and 
addenda of Section XI of the ASME Boiler and Pressure Vessel Code 
incorporated by reference in paragraph (b) of this section (or the 
optional ASME Code cases listed in NRC Regulatory Guide 1.147, through 
Revision 14, that are incorporated by reference in paragraph (b) of this 
section) applied to the construction of the particular component.
    (ii) Components which are classified as ASME Code Class 2 and Class 
3 and supports for components which are classified as ASME Code Class 1, 
Class 2, and Class 3 must be designed and be provided with access to 
enable the performance of inservice examination of these components and 
must meet the preservice examination requirements set forth in the 
editions and addenda of Section XI of the ASME Boiler and Pressure 
Vessel Code incorporated by reference in paragraph (b) of this section 
(or the optional ASME Code cases listed in NRC Regulatory Guide 1.147, 
through Revision 14, that are incorporated by reference in paragraph (b) 
of this section) applied to the construction of the particular 
component.
    (iii)-(iv) [Reserved]
    (v) All components (including supports) may meet the requirements 
set forth in subsequent editions of codes and addenda or portions 
thereof which are incorporated by reference in paragraph (b) of this 
section, subject to the limitations and modifications listed therein.
    (4) Throughout the service life of a boiling or pressurized water-
cooled nuclear power facility, components (including supports) which 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 of the 
ASME Boiler and Pressure Vessel Code and Addenda that become effective 
subsequent to editions specified in paragraphs (g)(2) and (g)(3) of this 
section and that are incorporated by reference in paragraph (b) of this 
section, to the extent practical within the limitations of design, 
geometry and materials of construction of the components. Components 
which are classified as Class MC pressure retaining components and their 
integral attachments, and components which 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,

[[Page 777]]

set forth in Section XI of the ASME Boiler and Pressure Vessel Code and 
Addenda that are incorporated by reference in paragraph (b) of this 
section, subject to the limitation listed in paragraph (b)(2)(vi) of 
this section and the modifications listed in paragraphs (b)(2)(viii) and 
(b)(2)(ix) of this section, to the extent practical within the 
limitation of design, geometry and materials of construction of the 
components.
    (i) Inservice examinations 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 Code 
incorporated by reference in paragraph (b) of this section on the date 
12 months before the date of issuance of the operating license (or the 
optional ASME Code cases listed in NRC Regulatory Guide 1.147, through 
Revision 14, that are incorporated by reference in paragraph (b) of this 
section), subject to the limitations and modifications listed in 
paragraph (b) of this section.
    (ii) 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 Code 
incorporated by reference in paragraph (b) 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, through Revision 
14, that are incorporated by reference in paragraph (b) of this 
section), subject to the limitations and modifications listed in 
paragraph (b) of this section.
    (iii) 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) 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 (b) of this section, 
subject to the limitations and modifications 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) For a boiling or pressurized water-cooled nuclear power facility 
whose construction permit was issued after January 1, 1956:
    (A) Metal containment pressure retaining components and their 
integral attachments must meet the inservice inspection, repair, and 
replacement requirements applicable to components which are classified 
as ASME Code Class MC;
    (B) Metallic shell and penetration liners which are pressure 
retaining components and their integral attachments in concrete 
containments must meet the inservice inspection, repair, and replacement 
requirements applicable to components which are classified as ASME Code 
Class MC; and
    (C) Concrete containment pressure retaining components and their 
integral attachments, and the post-tensioning systems of concrete 
containments must meet the inservice inspection, repair, and replacement 
requirements applicable to components which are classified as ASME Code 
Class CC.
    (5)(i) 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.
---------------------------------------------------------------------------

    See footnotes at end of section.
---------------------------------------------------------------------------

    (ii) If a revised inservice inspection program for a facility 
conflicts with the technical specification for the facility, the 
licensee shall apply to the Commission for amendment of the technical 
specifications to conform the technical specification to the revised 
program. The licensee shall 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) If the licensee has determined that conformance with certain 
code requirements is impractical for its facility, the licensee shall 
notify the Commission and submit, as specified in

[[Page 778]]

Sec. 50.4, information to support the determinations.
    (iv) Where an examination requirement by the code or addenda is 
determined to be impractical by the licensee and is not included in the 
revised inservice inspection program as permitted by paragraph (g)(4) of 
this section, the basis for this determination must be demonstrated to 
the satisfaction of the Commission not later than 12 months after the 
expiration of the initial 120-month period of operation from start of 
facility commercial operation and each subsequent 120-month period of 
operation during which the examination is determined to be impractical.
    (6)(i) The Commission will evaluate determinations 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 is authorized by law and will not endanger 
life or property or the common defense and security and is 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) 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) Augmented examination of reactor vessel.
    (1) All previously granted reliefs under Sec. 50.55a to licensees 
for the extent of volumetric examination of reactor vessel shell welds 
specified in Item B1.10 of Examination Category B-A, ``Pressure 
Retaining Welds in Reactor Vessel,'' in Table IWB-2500-1 of subsection 
IWB in applicable edition and addenda of section XI, Division 1, of the 
ASME Boiler and Pressure Vessel Code, during the inservice inspection 
interval in effect on September 8, 1992 are hereby revoked, subject to 
the specific modification in Sec. 50.55a(g)(6)(ii)(A)(3)(iv) for 
licensees that defer the augmented examination in accordance with Sec. 
50.55a(g)(6)(ii)(A)(3).
    (2) All licensees shall augment their reactor vessel examination by 
implementing once, as part of the inservice inspection interval in 
effect on September 8, 1992, the examination requirements for reactor 
vessel shell welds specified in Item B1.10 of Examination Category B-A, 
``Pressure Retaining Welds in Reactor Vessel,'' in Table IWB-2500-1 of 
subsection IWB of the 1989 Edition of section XI, Division 1, of the 
ASME Boiler and Pressure Vessel Code, subject to the conditions 
specified in Sec. 50.55a(g)(6)(ii)(A) (3) and (4). The augmented 
examination, when not deferred in accordance with the provisions of 
Sec. 50.55a(g)(6)(ii)(A)(3), shall be performed in accordance with the 
related procedures specified in the section XI edition and addenda 
applicable to the inservice inspection interval in effect on September 
8, 1992, and may be used as a substitute for the reactor vessel shell 
weld examination scheduled for implementation during the inservice 
inspection interval in effect on September 8, 1992. For the purpose of 
this augmented examination, ``essentially 100% as used in Table IWB-
2500-1 means more than 90 percent of the examination volume of each 
weld, where the reduction in coverage is due to interference by another 
component, or part geometry.
    (3) Licensees with fewer than 40 months remaining in the inservice 
inspection interval in effect on September 8, 1992 may defer the 
augmented reactor vessel examination specified in Sec. 
50.55a(g)(6)(ii)(A)(2) to the first period of the next inspection 
interval under the following conditions:
    (i) The deferred augmented examination may not be used as a 
substitute for the reactor vessel shell weld examination scheduled for 
implementation during the inservice inspection interval in effect on 
September 8, 1992.
    (ii) The deferred augmented examination may be used as a substitute 
for the reactor vessel shell weld examination normally scheduled for the 
inspection interval in which the deferred examination is performed.
    (iii) If the deferred augmented examination is used as a substitute 
for the normally scheduled reactor vessel shell weld examination, 
subsequent reactor vessel shell weld examinations must be

[[Page 779]]

performed during the first period of successive inspection intervals.
    (iv) Licensees that defer the augmented examination, as permitted 
herein, may retain all previously granted reliefs that otherwise would 
be revoked by Sec. 50.55a(g)(6)(ii)(A)(1) for the inservice inspection 
interval in effect on September 8, 1992.
    (v) Licensees with fewer than 40 months remaining in the inservice 
inspection interval in effect on September 8, 1992 may extend that 
interval in accordance with the provisions of section XI (1989 Edition) 
IWA-2430(d) for the purpose of implementing the augmented examination 
during that interval.
    (vi) The deferred augmented examination shall be performed in 
accordance with the related procedures specified in the section XI 
edition and addenda applicable to the inspection interval in which the 
augmented examination is performed.
    (4) The requirement for augmented examination of the reactor vessel 
may be satisfied by an examination of essentially 100 percent of the 
reactor vessel shell welds specified in Sec. 50.55a(g)(6)(ii)(A)(2) 
that has been completed, or is scheduled for implementation with a 
written commitment, or is required by Sec. 50.55a(g)(4)(i), during the 
inservice inspection interval in effect on September 8, 1992.
    (5) Licensees that make a determination that they are unable to 
completely satisfy the requirements for the augmented reactor vessel 
shell weld examination specified in Sec. 50.55a(g)(6)(ii)(A) shall 
submit information to the Commission to support the determination and 
shall propose an alternative to the examination requirements that would 
provide an acceptable level of quality and safety. The licensee may use 
the proposed alternative when authorized by the Director of the Office 
of Nuclear Reactor Regulation.
    (B) Licensees do not have to submit to the NRC staff for approval of 
their containment inservice inspection programs which were developed to 
satisfy the requirements of Subsection IWE and Subsection IWL with 
specified modifications and limitations. The program elements and the 
required documentation must be maintained on site for audit.
    (C) 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 Boiler and Pressure Vessel 
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 Boiler and 
Pressure Vessel 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 Boiler and Pressure Vessel Code.
    (h) Protection and safety systems. (1) IEEE Std. 603-1991, including 
the correction sheet dated January 30, 1995, which is referenced in 
paragraphs (h)(2) and (h)(3) of this section, is approved for 
incorporation by reference by the Director of the Office of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. Copies of 
IEEE Std. 603-1991 may be purchased from the Institute of Electrical and 
Electronics Engineers Service Center, 445 Hoes Lane, Piscataway, NJ 
08855. The standard is also available for inspection at the NRC Library, 
11545 Rockville Pike, Rockville, Md; 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 IEEE Std. 279, which is referenced in paragraph (h)(2) of 
this section, was approved for incorporation by reference by the 
Director of the Office of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR Part 51. Copies of IEEE Std. 279 are also 
available as indicated for IEEE Std. 603-1991.
    (2) Protection systems. For nuclear power plants with construction 
permits issued after January 1, 1971, but before

[[Page 780]]

May 13, 1999, protection systems must meet the requirements stated in 
either IEEE Std. 279, ``Criteria for Protection Systems for Nuclear 
Power Generating Stations,'' or in IEEE Std. 603-1991, ``Criteria for 
Safety Systems for Nuclear Power Generating Stations,'' and the 
correction sheet dated January 30, 1995. For nuclear 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 
preliminary and final design approvals (10 CFR Part 52, Appendix O), 
design certifications, and construction permits, operating licenses and 
combined licenses that do not reference a final design approval or 
design certification, must meet the requirements for safety systems in 
IEEE Std. 603-1991 and the correction sheet dated January 30, 1995.

    Footnotes to Sec. 50.55a:
    1-3 [Reserved]
    \4\ 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 (b) 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 (b) of this section.
    \5\ 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.
    6-8 [Reserved]
    \9\ Guidance for quality group classifications of components which 
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.''
    \10\ Supplemental inservice inspection requirements for reactor 
vessel pressure heads have been imposed by Order EA-03-09 issued to 
licensees of pressurized water reactors. The NRC expects to develop 
revised supplemental inspection requirements, based in part upon a 
review of the initial implementation of the order, and will determine 
the need for incorporating the revised inspection requirements into 10 
CFR 50.55a by rulemaking.

[36 FR 11424, June 12, 1971]

    Editorial Note: For Federal Register citations affecting Sec. 
50.55a, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



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]



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:
    (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

[[Page 781]]

    (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, 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.

[[Page 782]]

    (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, 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) Applicability. This section applies to each holder of a license 
authorizing operation of a production or utilization

[[Page 783]]

facility, 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 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, a report 
containing a brief description of any changes, tests, and experiments, 
including a summary of the evaluation of each. A report must be 
submitted at intervals not to exceed 24 months.
    (3) The records of changes in the facility must be maintained until 
the termination of a license issued pursuant to this part or the 
termination of a license issued pursuant to 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]

[[Page 784]]



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.
    (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, other than a 
nuclear power reactor facility for which the certifications required 
under Sec. 50.82(a)(1) have been submitted, the licensee shall have 
projected values of RTPTS, accepted by the NRC, for each 
reactor vessel beltline material for the EOL fluence of the material. 
The assessment of RTPTS must use the calculation procedures 
given in paragraph (c)(1) of this section, except as provided 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

[[Page 785]]

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 prior to the expiration of the operating 
license, 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 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.

[[Page 786]]

    (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 (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

[[Page 787]]

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.
[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. 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,

[[Page 788]]

Office of Nuclear Reactor Regulation, 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
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]



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

[[Page 789]]

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 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. 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.

[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]



Sec. 50.63  Loss of all alternating current power.

    (a) Requirements. (1) Each light-water-cooled nuclear power plant 
licensed to operate 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

[[Page 790]]

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 the effective date of this amendment, the licensee shall submit 
the information defined below to the Director by 270 days after the date 
of license issuance.
    (i) A proposed station blackout duration to be used in determining 
compliance with paragraph (a) of this section, 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

[[Page 791]]

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]



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 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

[[Page 792]]

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 a license to operate a nuclear power plant 
under Sec. Sec. 50.21(b) or 50.22 shall monitor the performance or 
condition of structures, systems, or components, against licensee-
established goals, in a manner sufficient to provide reasonable 
assurance that such structures, systems, and components, as defined in 
paragraph (b), are capable of fulfilling their intended functions. Such 
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 nuclear power plant for which the licensee has submitted 
the certifications specified in Sec. 50.82(a)(1), this section only 
shall 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 such 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.

[[Page 793]]

    (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]

    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 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

[[Page 794]]

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.
    (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)

[[Page 795]]

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 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.

[[Page 796]]

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 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:

[[Page 797]]

    (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).



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\ 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

[[Page 798]]

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 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).

[63 FR 63130, Nov. 12, 1998]



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.

[[Page 799]]

    (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 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

[[Page 800]]

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 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

[[Page 801]]

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).
    (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 licensee and each holder of a construction 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 as may 
be necessary to effectuate the purposes of the Act, including section 
105 of the Act.
    (b)(1) Each licensee and each holder of a construction permit shall 
upon request by the Director, Office of Nuclear Reactor Regulation, 
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 
pursuant to part 50, the space provided shall be adequate to accommodate 
a full-time inspector, a part-time secretary and transient NRC personnel 
and will be generally commensurate with other office facilities at the 
site. A space of 250 square feet either within the site's office complex 
or in an office trailer or other on site space is suggested as a guide. 
For sites containing multiple 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 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 meaures 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]

[[Page 802]]



Sec. 50.71  Maintenance of records, making of reports.

    (a) Each licensee and each holder of a construction 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 rules, regulations, and orders of the Commission in 
effectuating the purposes of the Act, including section 105 of the Act. 
Reports must be submitted in accordance with Sec. 50.4.
    (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.
    (c) Records that are required by the regulations in this part, 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.
    (d)(1) Records which must be maintained pursuant to this part 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 of 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 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 pursuant 
to the provisions of Sec. 50.21 or Sec. 50.22 of this part 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 operating 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 
licensee or prepared by the 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 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) of this part; and all analyses of 
new safety issues performed by or on behalf of the licensee at 
Commission request. The updated information shall be appropriately 
located within the update to the FSAR.
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    \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

[[Page 803]]

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.
    (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) The provisions of this section apply to nuclear power reactor 
licensees that have submitted the certification of permanent cessation 
of operations required under Sec. 50.82(a)(1)(i). 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.

[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]

    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. 50.21(b) or Sec. 50.22 of this part 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 rectors 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

[[Page 804]]

(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.
    (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-

[[Page 805]]

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 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]



Sec. 50.73  Licensee event report system.

    (a) Reportable events. (1) The holder of an operating license 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 three 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.

[[Page 806]]

    (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
    (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

[[Page 807]]

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 (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

[[Page 808]]

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.
    (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]



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;

[[Page 809]]

    (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, 
reasonable assurance consists of a series of steps as provided in 
paragraphs (b), (c), (e), and (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, by other agencies to establish rates.
    (b) Each power reactor applicant for or holder of an operating 
license 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) of this part.
    (1) 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.
    (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 use 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.
    (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:
    (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

[[Page 810]]

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 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

[[Page 811]]

(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, letter of credit, 
or line 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.
    (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

[[Page 812]]

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(ies) 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.
    (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. 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 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. 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 has already closed (before the end of its licensed 
life), or for plants involved in mergers or acquisitions shall submit 
this report annually.
    (2) 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.
    (3) 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.
    (4) 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

[[Page 813]]

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 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

[[Page 814]]

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, or the 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 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, or the Director, Office of Nuclear Material Safety and 
Safeguards, as applicable, within the notice period; and
    (iv) Except for withdrawals being made under 10 CFR 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, or the 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, or the 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 10 CFR 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 10 CFR 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

[[Page 815]]

a disbursement or payment has been given the Director, Office of Nuclear 
Reactor Regulation, or the 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, or the 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 10 CFR 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]



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  Installation information and verification.

    Each holder of a construction permit shall, if requested by the 
Commission, submit installation information on Form N-71, permit 
verification thereof by the International Atomic Energy Agency, and take 
such other action as may be necessary to implement the US/IAEA 
Safeguards Agreement, in the manner set forth in Sec. Sec. 75.6 and 
75.11 through 75.14 of this chapter.

[49 FR 19627, May 9, 1984]

[[Page 816]]

     Transfers of Licenses--Creditors' Rights--Surrender of Licenses



Sec. 50.80  Transfer of licenses.

    (a) No license for a production or utilization facility, 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 shall give its consent in writing.
    (b) An application for transfer of a license shall include 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 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. 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 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]



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 or construction permit which 
may be issued by the Commission with regard to the 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

[[Page 817]]

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.

[26 FR 9546, Oct. 10, 1961, as amended at 32 FR 2562, Feb. 7, 1967]



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 report must include a description of the planned 
decommissioning activities along with a schedule for their 
accomplishment, an estimate of expected costs, and 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.
    (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.

[[Page 818]]

    (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.
    (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.

[[Page 819]]

    (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--
    (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

[[Page 820]]

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]



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

[[Page 821]]

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 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 or construction permit.

    Whenever a holder of a license or construction permit desires to 
amend the license (including the Technical Specifications incorporated 
into the license) or permit, application for an amendment must be filed 
with the Commission, as specified in Sec. 50.4, fully describing the 
changes desired, and following as far as applicable, the form prescribed 
for original applications.

[64 FR 53614, Oct. 4, 1999]

    Effective Date Note: See 64 FR 53582, Oct. 4, 1999, for 
effectiveness of Sec. 50.90.



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 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 thirty (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.

[[Page 822]]

    (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 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;

[[Page 823]]

    (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 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]



Sec. 50.92  Issuance of amendment.

    (a) In determining whether an amendment to a license or construction 
permit will be issued to the applicant, the Commission will be guided by 
the considerations which govern the issuance of initial licenses or 
construction 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. If the amendment involves a significant hazards 
consideration, the Commission will give notice of its proposed action 
(1) pursuant to Sec. 2.105 of this chapter before acting thereon and 
(2) as soon as

[[Page 824]]

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).
    (c) The Commission may make a final determination, pursuant to the 
procedures in Sec. 50.91, that a proposed amendment to an operating 
license for a facility licensed under Sec. 50.21(b) or Sec. 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]

    Revocation, Suspension, Modification, Amendment of Licenses and 
      Construction Permits, Emergency Operations by the Commission



Sec. 50.100  Revocation, suspension, modification of licenses and 
construction permits for cause.

    A license or construction permit may be revoked, suspended, or 
modified, in whole or in part, for any material false statement in the 
application for license or in the supplemental or other statement of 
fact required of the applicant; or because of conditions revealed by the 
application for license or statement of fact or any report, record, 
inspection, or other means, which would warrant the Commission to refuse 
to grant a license on an original application (other than those relating 
to Sec. Sec. 50.51, 50.42(a), and 50.43(b) of this part); or for 
failure to construct or operate a facility in accordance with the terms 
of the construction permit or license, provided that failure to make 
timely completion of the proposed construction or alteration of a 
facility under a construction permit 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, or 
order of the Commission.



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 825]]

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 rules 
or the imposition of a regulatory staff position interpreting the 
Commission rules 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; or
    (ii) Six months before the date of docketing of the operating 
license application for the facility for facilities having construction 
permits issued before October 21, 1985; or
    (iii) The date of issuance of the operating license for the facility 
for facilities having operating licenses; or
    (iv) The date of issuance of the design approval under appendix M, 
N, or O of part 52.
    (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 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.

[[Page 826]]

    (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]

                               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--
    (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,

[[Page 827]]

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]



Sec. 50.120  Training and qualification of nuclear power plant personnel.

    (a) Applicability. The requirements of this section apply to each 
applicant for (applicant) and each holder of an operating license 
(licensee) for a nuclear power plant of the type specified in Sec. 
50.21(b) or Sec. 50.22.
    (b) Requirements. (1) Each nuclear power plant applicant, by 
November 22, 1993 or 18 months prior to fuel load, whichever is later, 
and each nuclear power plant licensee, by November 22, 1993 shall 
establish, implement, and maintain a training program derived from a 
systems approach to training as defined in 10 CFR 55.4. The training 
program 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.
    (2) 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 so as 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.

[58 FR 21912, Apr. 26, 1993; 58 FR 39092, July 21, 1993]

 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
  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

[[Page 828]]

 
  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

    Pursuant to the provisions of Sec. 50.34, an application for a 
construction permit 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 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.

[[Page 829]]

    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, 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.

[[Page 830]]

    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, 
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

[[Page 831]]

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 certifications under part 52 of this chapter who 
apply on or after January 10, 1997, applicants for and holders of 
combined licenses under part 52 of this chapter who do not reference a 
standard design 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 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

[[Page 832]]

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 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)

[[Page 833]]

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.
    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,

[[Page 834]]

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 
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

[[Page 835]]

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 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]

[[Page 836]]

  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. 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, 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 therefor. The authority and 
duties of persons and organizations performing activities affecting the 
safety-related functions of structures, 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 (a) assuring that an appropriate quality assurance program is 
established and effectively executed and (b) verifying, such as by 
checking, auditing, and inspection, 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. Such persons and organizations performing 
quality assurance functions shall report to a management level such that 
this 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 this 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 such levels of management as may be 
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. These criteria will also be used for guidance in 
evaluating the adequacy of quality assurance programs in use by holders 
of construction permits and operating 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

[[Page 837]]

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 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.

[[Page 838]]

       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, 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.

[[Page 839]]

               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.

                              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 3210D, Jan. 20, 1975]

   Appendix C to Part 50--A Guide for the Financial Data and Related 
Information Required To Establish Financial Qualifications for Facility 
                          Construction Permits

                           General Information

    This appendix is intended to apprise applicants for licenses to 
construct 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 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 such information is pertinent to 
establishing the applicant's financial ability to construct the proposed 
facility.
    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

[[Page 840]]

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

    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 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

    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.

[[Page 841]]

                     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 is required by Sec. 50.71(b) to file its annual 
financial report with the Commission at the time of issuance thereof. 
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 Commiasion 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]

                    Appendix D to Part 50 [Reserved]

     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

    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.
    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 report and submitted as part of the final safety analysis 
report.
    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 as necessary will be 
determined on a case-by-case basis.\2\
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    \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.
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    Notwithstanding the above paragraphs, in the case of an operating 
license authorizing only fuel loading and/or low power operations up to 
5% 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.

               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.

[[Page 842]]

    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.
    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 
of the near-site emergency operations facility in assessing information, 
recommending protective action, and disseminating information to the 
public.

                  III. The Final Safety Analysis Report

    The Final Safety Analysis Report 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 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

    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 radiation 
emergencies, assessment action, activation of emergency organization, 
notification procedures, emergency facilities and equipment, training, 
maintaining emergency preparedness, and recovery. In addition, the 
emergency response plans submitted by an applicant for a nuclear power 
reactor operating license shall contain information needed to 
demonstrate compliance with the standards described in Sec. 50.47(b), 
and they will be evaluated against those standards. The nuclear power 
reactor operating license applicant shall also provide an analysis of 
the time required to evacuate and for taking other protective actions 
for various sectors and distances within the plume exposure pathway EPZ 
for transient and permanent populations.

                             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 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 on 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

[[Page 843]]

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. Identification of, and assistance expected from, appropriate 
State, local, and Federal agencies with responsibilities for coping with 
emergencies.
    8. Identification of the State and/or local officials responsible 
for planning for, ordering, and controlling appropriate protective 
actions, including evacuations when necessary.

                          B. Assessment Actions

    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 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. These 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. A revision to an emergency action level 
must be approved by the NRC before implementation if:
    (1) The licensee is changing from one emergency action level scheme 
to another emergency action level scheme (e.g., a change from an 
emergency action level scheme based on NUREG-0654 to a scheme based upon 
NUMARC/NESP-007 or NEI-99-01);
    (2) The licensee is proposing an alternate method for complying with 
the regulations; or
    (3) The emergency action level revision decreases the effectiveness 
of the emergency plan.
    A licensee shall submit each request for NRC approval of the 
proposed emergency action level change as specified in Sec. 50.4. If a 
licensee makes a change to an EAL that does not require NRC approval, 
the licensee shall submit, as specified in Sec. 50.4, a report of each 
change made within 30 days after the change is made.

                 C. Activation of Emergency Organization

    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.

                       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. \1\
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    \1\ See footnote 1 to section I.
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    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

[[Page 844]]

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 State/local officials 
have the capability to make a public notification decision promptly on 
being informed by the licensee of an emergency condition. By February 1, 
1982, 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 four-month period in 10 CFR 50.54(s)(2) for the 
correction of emergency plan deficiencies shall not apply to the initial 
installation of this public notification system that is required by 
February 1, 1982. The four-month period will apply to correction of 
deficiencies identified during the initial installation and testing of 
the prompt public notification systems as well as those deficiencies 
discovered thereafter. The design objective of the prompt public 
notification system shall be to have the capability to essentially 
complete the initial notification of the public within the plume 
exposure pathway EPZ within about 15 minutes. The use of this 
notification capability will range from immediate 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 State 
and local governmental officials to make a judgment whether or not to 
activate the public notification system. Where there is a decision to 
activate the notification system, the State and local officials will 
determine whether to activate the entire notification system 
simultaneously or in a graduated or staged manner. The responsibility 
for activating such a public notification system shall remain with the 
appropriate governmental authorities.

                  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 the services of physicians and other medical 
personnel qualified to handle radiation emergencies on-site;
    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 licensee onsite technical support center and a licensee near-
site emergency operations facility from which effective direction can be 
given and effective control can be exercised during an emergency;
    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 near-site 
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 near-site 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 radiation 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 
radiation 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:

[[Page 845]]

    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 
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.
---------------------------------------------------------------------------

    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. This exercise shall be conducted 
within two years before the issuance of the first operating license for 
full power (one authorizing operation above 5% of rated 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 one year prior to issuance of an operating 
licensee for full power, an exercise which tests the licensee's onsite 
emergency plans shall be conducted within one year before issuance of an 
operating license for full power. This exercise need not have State or 
local government participation.
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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.
---------------------------------------------------------------------------

    b. Each licensee at each site shall conduct an exercise of its 
onsite emergency plan every 2 years. 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, protective action decisionmaking, and 
plant system repair and corrective actions. 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 
would have the opportunity to resolve problems (success paths) rather 
than have controllers intervene, and the drills could focus on onsite 
training objectives.
    c. Offsite plans for each site shall be exercised biennially with 
full participation by each offsite authority having a role under the 
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 2 years and shall, at least, partially participate \5\ in 
other offsite plan exercises in this period.
    If two different licensees whose licensed facilities are located 
either on the same site or on adjacent, contiguous sites, and that share 
most of the elements defining co-located licensees,\6\ each licensee 
shall:

[[Page 846]]

    (1) Conduct an exercise biennially of its onsite emergency plan; and
    (2) Participate quadrennially in an offsite biennial full or partial 
participation exercise; and
    (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.
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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.
    \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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    d. A State should fully participate in the ingestion pathway portion 
of exercises at least once every six years. In States with more than one 
site, the State 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 find reasonable assurance that adequate 
protective measures can be taken in the event of a radiological 
emergency. 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 training, including exercises, shall provide for formal 
critiques in order to identify weak or deficient areas that need 
correction. Any weaknesses or deficiencies that are identified shall 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 10 CFR 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.

                  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.

                       V. Implementing Procedures

    No less than 180 days prior to the scheduled issuance of an 
operating license for a nuclear power reactor or a license to possess 
nuclear material the applicant's detailed implementing procedures for 
its emergency plan shall be submitted to the Commission as specified in 
Sec. 50.4. Licensees who are authorized to operate a nuclear power 
facility shall submit any changes to the emergency plan or procedures to 
the Commission, as specified in Sec. 50.4, within 30 days of such 
changes.

                   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

[[Page 847]]

this case, appropriate isolation devices would be required at these 
interfaces. \7\ The data points, identified in the following parameters 
will be transmitted:
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    \7\ See 10 CFR 50.55a(h) Protection Systems.
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    (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 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.
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    \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.
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    \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.
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    \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]

[[Page 848]]

      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 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]

         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

[[Page 849]]

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).
    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, 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 analyses must be supplemented in a manner approved by the 
Director, Office of Nuclear Reactor Regulation, 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, 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

[[Page 850]]

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, 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 
incorporated by reference into Sec. 50.55a(b)(2) at the time the 
analysis is submitted.
---------------------------------------------------------------------------

    \1\ Defined in ASTM E 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.

   2. Pressure-Temperature Limits and Minimum Temperature Requirements

    a. Pressure-temperature limits and minimum temperature requirements 
for the reactor vessel are given in table 3, 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 3, 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 3 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 3 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 3, 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.

[[Page 851]]



                 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..........   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

[[Page 852]]

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, 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.
    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.

                       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]

   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 permit to construct a nuclear power reactor 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.
    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.
    Sec. II. Guides on design objectives for light-water-cooled nuclear 
power reactors licensed under 10 CFR part 50. The guides on design 
objectives set forth in this section may be

[[Page 853]]

used by an applicant for a permit to construct a light-water-cooled 
nuclear power reactor as guidance in meeting the requirements of Sec. 
50.34a(a). 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 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.
    Sec. 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

[[Page 854]]

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.
    Sec. IV. Guides on technical specifications for limiting conditions 
for operation for light-water-cooled nuclear power reactors licensed 
under 10 CFR part 50. The guides on limiting conditions for operation 
for light-water-cooled nuclear power reactors set forth below may be 
used by an applicant for a license to operate a light-water-cooled 
nuclear power reactor or a licensee who has submitted a certification of 
permanent cessation of operations under Sec. 50.82(a)(1) 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.

[[Page 855]]

    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).
    Sec. 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 permit 
to construct a light-water-cooled nuclear power reactor.
    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 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

[[Page 856]]

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.
    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]

 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 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 such 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(v), and serves as an essentially leak-tight 
barrier against the uncontrolled release of radioactivity to the 
environment.

[[Page 857]]

    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-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.
    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

[[Page 858]]

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 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.

[[Page 859]]

    (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.
    (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\
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    \2\ Such inservice inspections are required by Sec. 50.55a.
---------------------------------------------------------------------------

    (b) Permissible periods for testing. The performance of Type A tests 
shall be limited

[[Page 860]]

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 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

[[Page 861]]

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.

                             I. Introduction

    One of the conditions required of all operating 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

[[Page 862]]

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 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 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 below) to the Director of the Office 
of Nuclear Reactor Regulation.
    3. The regulatory guide or other implementation document used by a 
licensee, or applicant for an operating license, 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]

              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.

[[Page 863]]

    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 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

[[Page 864]]

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 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

[[Page 865]]

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 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

[[Page 866]]

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.

          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 7x7 fuel assembly

[[Page 867]]

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-
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 7x7 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]

                    Appendix L to Part 50 [Reserved]

Appendix M to Part 50--Standardization of Design; Manufacture of Nuclear 
  Power Reactors; Construction and Operation of Nuclear Power Reactors 
               Manufactured Pursuant to Commission License

    Section 101 of the Atomic Energy Act of 1954, as amended, and Sec. 
50.10 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 the 
part require the issuance of a construction permit by the Commission 
before commencement of construction of a production or utilization 
facility, and the issuance of an operating license before operation of 
the facility. The provisions of this part relating to the facility 
licensing process are, in general, predicated on the assumption that the 
facility will be assembled and constructed on the site at which it is to 
be operated. In those circumstances, both facility design and site-
related issues can be considered in the initial, construction permit 
stage of the licensing process.

[[Page 868]]

    However, under the Atomic Energy Act, a license may be sought and 
issued authorizing the manufacture of facilities but not their 
construction and installation at the sites on which the facilities are 
to be operated. Prior to the ``commencement of construction'', as 
defined in Sec. 50.10(c), of a facility (manufactured pursuant to such 
a Commission license) on the site at which it is to operate--that is 
preparation of the site and installation of the facility--a construction 
permit that, among other things, reflects approval of the site on which 
the facility is to be operated, must be issued by the Commission. This 
appendix sets out the particular requirements and provisions applicable 
to such situations where nuclear power reactors to be manufactured 
pursuant to a Commission license and subsequently installed at the site 
pursuant to a Commission construction permit, are of the type described 
in Sec. 50.22. It thus codifies one approach to the standardization of 
nuclear power reactors.
    1. Except as otherwise specified in this appendix or as the context 
otherwise indicates, the provisions in this part applicable to 
construction permits, including the requirement in Sec. 50.58 for 
review of the application by the Advisory Committee on Reactor 
Safeguards and the holding of a public hearing, apply in context, with 
respect to matters of radiological health and safety, environmental 
protection, and the common defense and security, to licenses pursuant to 
this appendix M to manufacture nuclear power reactors (manufacturing 
licenses) to be operated at sites not identified in the license 
application.
    2. An application for a manufacturing license pursuant to this 
appendix M must be submitted, as specified in Sec. 50.4, and meet all 
the requirements of Sec. Sec. 50.34(a) (1)-(9) and 50.34a (a) and (b), 
except that the preliminary safety analysis report shall be designated 
as a ``design report'' and any required information or analyses relating 
to site matters shall be predicated on postulated site parameters which 
must be specified in the application. The application must also include 
information pertaining to design features of the proposed reactor(s) 
that affect plans for coping with emergencies in the operation of the 
reactor(s).
    3. An applicant for a manufacturing license pursuant to this 
appendix M shall submit with his application an environmental report as 
required of applicants for construction permits in accordance with 
subpart A of part 51 of this chapter, provided, however, that such 
report shall be directed at the manufacture of the reactor(s) at the 
manufacturing site; and, in general terms, at the construction and 
operation of the reactor(s) at a hypothetical site or sites having 
characteristics that fall within the postulated site parameters. The 
related draft and final environmental impact statement prepared by the 
Commission's regulatory staff will be similarly directed.
    4. (a) Sections 50.10 (b) and (c), 50.12(b), 50.23, 50.30(d), 
50.34(a)(10), 50.34a(c), 50.35 (a) and (c), 50.40(a), 50.45, 50.55(d), 
50.56, and appendix J do not apply to manufacturing licenses. Appendices 
E and H apply to manufacturing licenses only to the extent that the 
requirements of these appendixes involve facility design features.
    (b) The financial information submitted pursuant to Sec. 50.33(f) 
and appendix C shall be directed at a demonstration of the financial 
qualifications of the applicant for the manufacturing license to carry 
out the manufacturing activity for which the license is sought.
    5. The Commission may issue a license to manufacture one or more 
nuclear power reactors to be operated at sites not identified in the 
license application if the Commission finds that:
    (a) The applicant has described the proposed design of and the site 
parameters postulated for the reactor(s), 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.
    (b) Such further technical or design information as may be required 
to complete the design report and which can reasonably be left for later 
consideration, will be supplied in a supplement to the design report.
    (c) 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
    (d) On the basis of the foregoing, there is reasonable assurance 
that (i) such safety questions will be satisfactorily resolved before 
any of the proposed nuclear power reactor(s) are removed from the 
manufacturing site and (ii) taking into consideration the site criteria 
contained in part 100 of this chapter, the proposed reactor(s) can be 
constructed and operated at sites having characteristics that fall 
within the site parameters postulated for the design of the reactor(s) 
without undue risk to the health and safety of the public.
    (e) The applicant is technically and financially qualified to design 
and manufacture the proposed nuclear power reactor(s).
    (f) The issuance of a license to the applicant will not be inimical 
to the common defense and security or to the health and safety of the 
public.
    (g) On the basis of the evaluations and analyses of the 
environmental effects of the proposed action required by subpart A of 
part 51 of this chapter and paragraph 3 of

[[Page 869]]

this appendix, the action called for is the issuance of the license.
    Note: When an applicant has supplied initially all of the technical 
information required to complete the application, including the final 
design of the reactor(s), the findings required for the issuance of the 
license will be appropriately modified to reflect that fact.
    6. Each manufacturing license issued pursuant to this appendix will 
specify the number of nuclear power reactors authorized to be 
manufactured and the latest date for the completion of the manufacture 
of all such reactors. Upon good cause shown, the Commission will extend 
such completion date for a reasonable period of time.
    7. The holder of a manufacturing license issued pursuant to this 
appendix M shall submit to the Commission the final design of the 
nuclear power reactor(s) covered by the license as soon as such design 
has been completed. Such submittal shall be in the form of an 
application for amendment of the manufacturing license.
    8. The prohibition in Sec. 50.10(c) against commencement of 
construction of a production or utilization facility prior to issuance 
of a construction permit applies to the transport of a nuclear power 
reactor(s) manufactured pursuant to a license issued pursuant to this 
appendix from the manufacturing facility to the site at which the 
reactor(s) will be installed and operated. In addition, such nuclear 
power reactor(s) shall not be removed from the manufacturing site until 
the final design of the reactor(s) has been approved by the Commission 
in accordance with paragraph 7.
    9. An application for a permit to construct a nuclear power 
reactor(s) which is the subject of an application for a manufacturing 
license pursuant to this appendix M need not contain such information or 
analyses as have previously been submitted to the Commission in 
connection with the application for a manufacturing license, but shall 
contain, in addition to the information and analyses otherwise required 
by Sec. Sec. 50.34(a) and 50.34a, sufficient information to demonstrate 
that the site on which the reactor(s) is to be operated falls within the 
postulated site parameters specified in the relevant manufacturing 
license application.
    10. The Commission may issue a permit to construct a nuclear power 
reactor(s) which is the subject of an application for a manufacturing 
license pursuant to this appendix M if the Commission (a) finds that the 
site on which the reactor is to be operated falls within the postulated 
site parameters specified in the relevant application for a 
manufacturing license and (b) makes the findings otherwise required by 
this part. In no event will a construction permit be issued until the 
relevant manufacturing license has been issued.
    11. An operating license for a nuclear power reactor(s) that has 
been manufactured under a Commission license issued pursuant to this 
appendix M may be issued by the Commission pursuant to Sec. 50.57 and 
subpart A of part 51 of this chapter except that the Commission shall 
find, pursuant to Sec. 50.57(a)(1), that construction of the reactor(s) 
has been substantially completed in conformity with both the 
manufacturing license and the construction permit and the applications 
therefor, as amended, and the provisions of the Act, and the rules and 
regulations of the Commission. Notwithstanding the other provisions of 
this paragraph, no application for an operating license for a nuclear 
power reactor(s) that has been manufactured under a Commission license 
issued pursuant to this appendix M will be docketed until the 
application for an amendment to the relevant manufacturing license 
required by paragraph 7 has been docketed.
    12. In making the findings required by this part for the issuance of 
a construction permit or an operating license for a nuclear power 
reactor(s) that has been manufactured under a Commission license issued 
pursuant to this appendix, or an amendment to such a manufacturing 
license, construction permit, or operating license, the Commission will 
treat as resolved those matters which have been resolved at an earlier 
stage of the licensing process, unless there exists significant new 
information that substantially affects the conclusion(s) reached at the 
earlier stage or other good cause.

[38 FR 30253, Nov. 2, 1973, as amended at 49 FR 9404, Mar. 12, 1984; 49 
FR 35754, Sept. 12, 1984; 50 FR 18853, May 3, 1985; 51 FR 40311, Nov. 6, 
1986]

 Appendix N to Part 50--Standardization of Nuclear Power Plant Designs: 
 Licenses To Construct and Operate Nuclear Power Reactors of Duplicate 
                        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,

[[Page 870]]

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, 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]

   Appendix O to Part 50--Standardization of Design: Staff Review of 
                            Standard Designs

    This appendix sets out procedures for the filing, staff review and 
referral to the Advisory Committee on Reactor Safeguards of standard 
designs for a nuclear power reactor of the type described in Sec. 50.22 
or major portions thereof.
    1. Any person may submit a proposed preliminary or final standard 
design for a nuclear power reactor of the type described in Sec. 50.22 
to the regulatory staff for its review. Such a submittal may consist of 
either the preliminary or final design for the entire reactor facility 
or the preliminary or final design of major portions thereof.
    2. The submittal for review of the standard design 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.
    3. The submittal for review of the standard design shall include the 
information described in Sec. 50.33(a) through (d) and the applicable 
technical information required by Sec. Sec. 50.34 (a) and (b), as 
appropriate, and 50.34a (other than that required by Sec. Sec. 50.34(a) 
(6) and (10), 50.34(b)(1), (6)(i), (ii), (iv), and (v) and 50.34(b) (7) 
and (8)). The submittal shall also include a description, analysis and 
evaluation of the interfaces between the submitted design and the 
balance of the nuclear power plant. With respect to the requirements of 
Sec. Sec. 50.34(a)(1), the submittal for review of a standard design 
shall include the site parameters postulated for the design, and an 
analysis and evaluation of the design in terms of such postulated site 
parameters. The information submitted pursuant to Sec. 50.34(a)(7) 
shall be limited to the quality assurance program to be applied to the 
design, procurement and fabrication of the structures, systems, and 
components for which design review has been requested and the 
information submitted pursuant to Sec. 50.34(a)(9) shall be limited to 
the qualifications of the person submitting the standard design to 
design the reactor or major portion thereof. The submittal shall also 
include information pertaining to design features that affect plans for 
coping with emergencies in the operation of the reactor or major portion 
thereof.
    4. Once the regulatory staff has initiated a technical review of a 
submittal under this appendix, the submittal will be referred to the 
Advisory Committee on Reactor Safeguards (ACRS) for a review and report.
    5. Upon completion of their review of a submittal under this 
appendix, the NRC regulatory staff shall publish in the Federal Register 
a determination as to whether or not the preliminary or final design is 
acceptable, subject to such conditions as may be appropriate, and make 
available at the NRC Web site, http://www.nrc.gov, an analysis of the 
design in the form of a report. An approved design shall be utilized by 
and relied upon by the regulatory staff and the ACRS in their review of 
any individual facility license application which incorporates by 
reference a design approved in accordance with this paragraph unless 
there exists significant new information which substantially affects the 
earlier determination or other good cause.
    6. The determination and report by the regulatory staff shall not 
constitute a commitment to issue a permit or license, or in any way 
affect the authority of the Commission, Atomic Safety and Licensing 
Appeal Panel, Atomic Safety and Licensing Panel, and other presiding 
officers in any proceeding under subpart G of part 2 of this chapter.

[[Page 871]]

    7. The Commission may, on its own initiative or in response to a 
petition for rule making, approve the design in a rulemaking proceeding 
and in that event, the approved design will be subject to challenge only 
as provided in Sec. 2.758 of this chapter. An environmental impact 
statement may be prepared for such a rule making action in accordance 
with Sec. Sec. 51.20(b)(13) and 51.85 of this chapter. If an 
environmental impact statement is prepared, the Commission may require 
the petitioner for rulemaking to submit information to the Commission to 
aid the Commission in the preparation of the environmental impact 
statement.
    8. Information requests to the approval holder regarding an approved 
design shall be evaluated 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 evaluation performed by the NRC staff shall be in accordance 
with 10 CFR 50.54(f) and shall be approved by the Executive Director for 
Operations or his or her designee prior to issuance of the request.

[40 FR 2977, Jan. 17, 1975, as amended at 49 FR 9405, Mar. 12, 1984; 50 
FR 38112, Sept. 20, 1985; 51 FR 40311, Nov. 6, 1986; 64 FR 48952, Sept. 
9, 1999]

                    Appendix P to Part 50 [Reserved]

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

[[Page 872]]

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.
    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]

    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 873]]

 
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 874]]

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 875]]

    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 of 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 876]]

    (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 877]]

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 878]]

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 879]]

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]

Appendix S to Part 50--Earthquake Engineering Criteria for Nuclear Power 
                                 Plants

                           General Information

    This appendix applies to applicants for a design certification or 
combined license pursuant to part 52 of this chapter or a construction 
permit or operating license pursuant to part 50 of this chapter on or 
after January 10, 1997. However, for either an operating license 
applicant or holder whose construction permit was issued prior to 
January 10, 1997, the earthquake engineering criteria in Section VI of 
appendix A to 10 CFR part 100 continues to apply.

                             I. Introduction

    (a) Each applicant for a construction permit, operating license, 
design certification, or combined license is required by Sec. 50.34 
(a)(12), (b)(10), 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 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.

[[Page 880]]

                                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 pursuant to 
subpart C of part 52 of this chapter.
    Design Certification means a Commission approval, issued pursuant to 
subpart B of part 52 of this chapter, of a standard design for a nuclear 
power facility. A design so approved may be referred to as a ``certified 
standard design.''
    The 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.
    A 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.
    The Safe Shutdown Earthquake Ground Motion (SSE) is the vibratory 
ground motion for which certain structures, systems, and components must 
be designed to remain functional.
    The 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 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

[[Page 881]]

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]


[[Page 883]]



                              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.

  Material Approved for Incorporation by Reference
  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 885]]

            Material Approved for Incorporation by Reference

                     (Revised as of January 1, 2006)

  The Director of the Federal Register has approved under 5 U.S.C. 
552(a) and 1 CFR Part 51 the incorporation by reference of the following 
publications. This list contains only those incorporations by reference 
effective as of the revision date of this volume. Incorporations by 
reference found within a regulation are effective upon the effective 
date of that regulation. For more information on incorporation by 
reference, see the preliminary pages of this volume.


10 CFR (PARTS 1-50)

NUCLEAR REGULATORY COMMISSION
Each of the following documents is available for                  10 CFR
  inspection at the Nuclear Regulatory 
  Commission's Library, 11545 Rockville Pike, 
  Rockville, MD 20852-2738. The individual 
  documents are available through the sources 
  listed below..


American Association of Physicists in Medicine

  335 E. 45th St., New York, NY 10017
Scientific Committee on Radiation Dosimetry of the             35.632(d)
  American Association of Physicists in Medicine, 
  Physics in Medicine and Biology, Volume 16, No. 
  3, 1971, 379-396.
Task Group 21 of the Radiation Therapy Committee,              35.632(d)
  Medical Physics, Vol. 10, No. 6, 1983, pp. 741-
  771; and Volume 11, No. 2, 1984, p. 213.


American National Standards Institute

  25 West 43rd Street, Fourth floor, New York, NY 
  10036 Telephone: (212) 642-4900
ASA B31.1 1955 Ed., American Standard Code for                    50.55a
  Pressure Piping.
USAS B31.1.0 1967 Ed., Addenda A, B & C, U.S.A.                   50.55a
  Standard Code for Pressure Piping.
USAS B31.7 1969 Ed., Addenda A, B & C, U.S.A.                     50.55a
  Standard Code for Pressure Piping.
ANSI N432-1980 Radiological Safety for the Design                  34.20
  and Construction of Apparatus for Gamma 
  Radiography (published as NBS Handbook 136, 
  issued January 1981).
ANSI N45.4-1972 Leakage Rate Testing of                Part 50, App. J, 
  Containment Structures for Nuclear Reactors,                 III.A.3.a
  March 16, 1972.


American Nuclear Society

  555 North Kensington Ave., La Grange Park, IL 
  60525
Proposed American Nuclear Society Standard--Decay      Part 50, App. K, 
  Energy Release Rates Following Shutdown of                       I.A.4
  Uranium Fueled Thermal Reactors, Approved by 
  Subcommittee ANS-5, ANS Standards Committee, 
  Oct. 1971.


American Society of Mechanical Engineers

  Three Park Avenue, New York, New York 10016
ASME Boiler and Pressure Vessel Code Section III,                 50.55a
  1963 Edition: Addenda Summer 64; Winter 64.
1965 Edition: Addenda Summer 65; Winter 65; Summer                50.55a
66; Winter 66; Summer 67; Winter 67.
[[Page 886]]

1968 Edition: Addenda Summer 68; Winter 68; Summer                50.55a
  69; Winter 69; Summer 70; Winter 70.
1971 Edition: Addenda Summer 71; Winter 71; Summer                50.55a
  72; Winter 72; Summer 73; Winter 73.
  ASME Boiler and Pressure Vessel Code Section 
    III, Division 1
1974 Edition: Addenda Summer 74; Winter 74; Summer                50.55a
  75; Winter 75; Summer 76; Winter 76.
1977 Edition: Addenda Summer 77; Winter 77; Summer                50.55a
  78; Winter 78; Summer 79; Winter 79.
1980 Edition: Addenda Summer 80;..................                50.55a
1981 Edition: Addenda Winter 1981.................                50.55a
1983 Edition: Addenda Summer 83; Winter 83; Summer                50.55a
  84; Winter 84; Summer 85; Winter 85.
1986 Edition: 1986, 1987 and 1988 Addenda.........                50.55a
1989 Edition......................................                50.55a
ASME Boiler and Pressure Vessel Code, Section III,                50.55a
  Division 1, 1989 Addenda, 1990 Addenda, 1992 
  Edition, 1992 Addenda, 1993 Addenda, 1994 
  Addenda, 1995 Edition, 1995 Addenda, 1996 
  Addenda.
ASME Boiler and Pressure Vessel Code, Section III,                50.55a
  Division 1, 1997 Addenda, 1998 Edition, 1999 
  Addenda and 2000 Addenda.
ASME Boiler and Pressure Vessel Code, Section III,                50.55a
  Division 1, 2001 Edition, 2002 and 2003 Addenda.
ASME Boiler and Pressure Vessel Code Section III,                  50.34
  1980 Edition: Subarticle CC-3720, Division 2.
Subarticle NE-3220................................                 50.34
ASME Boiler and Pressure Vessel Code Section XI,                  50.55a
  Division 1, 1970 Edition: Addenda Winter 70.
1971 Edition: Addenda Summer 71; Winter 71; Summer                50.55a
  72; Winter 72; Summer 73; Winter 73.
1974 Edition: Addenda Summer 74; Winter 74; Summer                50.55a
  75; Winter 75; Summer 76; Winter 76.
1977 Edition: Addenda Summer 77; Winter 77; Summer                50.55a
  78; Winter 78; Summer 79; Winter 79.
1980 Edition: Addenda Winter 80...................                50.55a
1981 Edition: Addenda Winter 81; Winter 82........                50.55a
1983 Edition: Addenda Summer 83; Winter 83; Summer                50.55a
  84; Winter 84; Summer 85; Winter 85.
1986 Edition: 1986, 1987 and 1988 Addenda.........                50.55a
1989 Edition......................................                50.55a
ASME Boiler and Pressure Vessel Code, Section XI,                 50.55a
  Division 1, 1989 Addenda, 1991 Addenda, 1992 
  Edition, 1992 Addenda, 1993 Addenda, 1994 
  Addenda, 1995 Edition, 1996 Addenda.
ASME Boiler and Pressure Vessel Code, Section XI,                 50.55a
  Division 1, 1997 Addenda, 1998 Edition, 1999 
  Addenda, and 2000 Addenda.
ASME Boiler and Pressure Vessel Code, Section XI,                 50.55a
  Division 1, 2001 Edition, 2002 and 2003 Addenda.
ASME Code for Operation and Maintenace of Nuclear                 50.55a
  Power Plants (OM Code) 1995 Edition, 1996 
  Addenda.
ASME Code for Operation and Maintenace of Nuclear                 50.55a
  Power Plants (OM Code) 1997 Addenda, 1998 
  Edition, 1999 Addenda and 2000 Addenda.
ASME Code for Operation and Maintenace of Nuclear                 50.55a
Power Plants (OM Code) 2002 and 2003 Addenda.
[[Page 887]]

Draft ASME Code for Pumps and Valves for Nuclear                  50.55a
  Power, dated Nov. 1968 and 1 addenda dated Mar. 
  1970.
F. J. Moody, Maximum Flow Rate of a Single             Part 50, App. K, 
  Component, Two-Phase Mixture, Journal of Heat                 I.C.1.b.
  Transfer, Trans American Society of Mechanical 
  Engineers, 87, No. 1, Feb. 1965.


American Society for Testing Materials

  100 Barr Harbor Drive, West Conshohocken, PA 
  19428-2959, Telephone (610) 832-9585, FAX (610) 
  832-9555
ASTM E 185-73, E 185-79 and E 185-82 Standard         Part 50, App. H, I
  Recommended Practice for Surveillance Tests for 
  Nuclear Reactor Vessels.


Commerce Department, National Technical Information Service

  5285 Port Royal Rd., Springfield, VA 22161
Baker-Just, Studies of Metal Water Reactions at        Part 50, App. K, 
  High Temperatures, III. Experimental and                         I.A.5
  Theoretical Studies of the Zirconium-Water 
  Reaction, ANL-6548, page 7, May 1962.
PWR FLECHT (Full Length Emergency Cooling Heat         Part 50, App. K, 
  Transfer) Final Report, Westinghouse Report                      I.D.5
  WCAP-7665, Apr. 1971.


General Electric Co.

  Nuclear Energy Business Group, Technical Support 
  Services, MC-211, 175 Curtner Ave., San Jose, CA 
  95125
Loss-of-Coolant Accident and Emergency Core            Part 50, App. K, 
  Cooling Models for GE Boiling Water Reactors, GE               I.D.7.c
  Report NEDO-10329, Apr. 1971.


Institute of Electrical and Electronic Engineers

  IEEE Service Center, 445 Hoes Lane, P.O. Box 
  1331, Piscataway, NJ 08855-1331
IEEE-279 Criteria for Protection Systems for                   50.55a(h)
  Nuclear Generating Stations, dated Aug. 30, 1968 
  and June 3, 1971.
IEEE Std. 603-1991, Standard Criteria for Safety               50.55a(h)
  Systems for Nuclear Power Generating Stations, 
  including correction sheet dated January 30, 
  1995.
IEEE 803-1983 Recommended Practices for Unique                     50.73
  Identification in Power Plants and Related 
  Facilities--Principles and Definitions.


National Fire Protection Association

  NFPA Customer Service Department, 1 Batterymarch 
  Park, P.O. Box 9101, Quincy, MA 02269-9101
NFPA Standard 805: Performance-Based Standard for                  50.48
  Fire Protection for Light Water Reactor Electric 
  Generating Plants, 2001 Edition.


U.S. Nuclear Regulatory Commission

  NRC Library, Two White Flint North, 11545 
  Rockville Pike, Rockville, MD 20852-2738
NRC Regulatory Guide 1.147 (Revision 0): Inservice             50.55a(b)
  Inspection Code Case Acceptability ASME Section 
  XI Division 1, including Revisions 1 through 14. 
  (Date of original issue: February 1981; Date of 
  Revision 14: August 2005).
NRC Regulatory Guide 1.84, Design, Fabrication,                50.55a(b)
  and Materials Code Case Acceptability, ASME 
  Section III, Revision 33, dated August 2005.
NRC Regulatory Guide 1.192, Operation and                      50.55a(b)
  Maintenance Code Case Acceptability, ASME OM 
  Code, dated June 2003.

[[Page 889]]



                    Table of CFR Titles and Chapters




                     (Revised as of January 1, 2006)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
        IV  Miscellaneous Agencies (Parts 400--500)

                    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 100-199)
        II  Office of Management and Budget Circulars and Guidance 
                (200-299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements [Reserved]


                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--99)

                   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)
         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 (Part 2100)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)

[[Page 890]]

        XV  Office of Administration, Executive Office of the 
                President (Parts 2500--2599)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Part 3201)
     XXIII  Department of Energy (Part 3301)
      XXIV  Federal Energy Regulatory Commission (Part 3401)
       XXV  Department of the Interior (Part 3501)
      XXVI  Department of Defense (Part 3601)
    XXVIII  Department of Justice (Part 3801)
      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 (Part 4301)
      XXXV  Office of Personnel Management (Part 4501)
        XL  Interstate Commerce Commission (Part 5001)
       XLI  Commodity Futures Trading Commission (Part 5101)
      XLII  Department of Labor (Part 5201)
     XLIII  National Science Foundation (Part 5301)
       XLV  Department of Health and Human Services (Part 5501)
      XLVI  Postal Rate Commission (Part 5601)
     XLVII  Federal Trade Commission (Part 5701)
    XLVIII  Nuclear Regulatory Commission (Part 5801)
         L  Department of Transportation (Part 6001)
       LII  Export-Import Bank of the United States (Part 6201)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Part 6401)
        LV  National Endowment for the Arts (Part 6501)
       LVI  National Endowment for the Humanities (Part 6601)
      LVII  General Services Administration (Part 6701)
     LVIII  Board of Governors of the Federal Reserve System (Part 
                6801)
       LIX  National Aeronautics and Space Administration (Part 
                6901)
        LX  United States Postal Service (Part 7001)
       LXI  National Labor Relations Board (Part 7101)
      LXII  Equal Employment Opportunity Commission (Part 7201)
     LXIII  Inter-American Foundation (Part 7301)
       LXV  Department of Housing and Urban Development (Part 
                7501)
      LXVI  National Archives and Records Administration (Part 
                7601)
     LXVII  Institute of Museum and Library Services (Part 7701)
      LXIX  Tennessee Valley Authority (Part 7901)
      LXXI  Consumer Product Safety Commission (Part 8101)
    LXXIII  Department of Agriculture (Part 8301)
     LXXIV  Federal Mine Safety and Health Review Commission (Part 
                8401)
     LXXVI  Federal Retirement Thrift Investment Board (Part 8601)

[[Page 891]]

    LXXVII  Office of Management and Budget (Part 8701)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Part 
                9701)
      XCIX  Department of Defense Human Resources Management and 
                Labor Relations Systems (Department of Defense--
                Office of Personnel Management) (Part 9901)

                      Title 6--Homeland Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 0--99)

                         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)
        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)

[[Page 892]]

     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)
      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  Cooperative State Research, Education, and Extension 
                Service, Department of 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)

                    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)

[[Page 893]]

                           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 1303--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Part 1800)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)

                      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  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        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)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
      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, Department of 
                Commerce (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board, 
                Department of Commerce (Parts 500--599)

[[Page 894]]

                    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--499)
         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  Technology Administration, Department of Commerce 
                (Parts 1100--1199)
      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)

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

[[Page 895]]

             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  Bureau of 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  Bureau of Immigration and Customs Enforcement, 
                Department of Homeland Security (Parts 400--599)

                     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)
        IV  Employees Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Employment Standards Administration, 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, 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)

[[Page 896]]

                      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 Regulations (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)
       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)
        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)

[[Page 897]]

        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)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           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--799)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900)
        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 (Part 1200)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--899)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)

[[Page 898]]

        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)
        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)

[[Page 899]]

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Minerals Management Service, Department of the 
                Interior (Parts 200--299)
       III  Board of Surface Mining and Reclamation Appeals, 
                Department of the Interior (Parts 300--399)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)

                 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)
      VIII  Office of International Investment, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)

                      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)
     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)

[[Page 900]]

    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 (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)
        IV  Office of Vocational and Adult Education, Department 
                of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599)
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
        XI  National Institute for Literacy (Parts 1100--1199)
            Subtitle C--Regulations Relating to Education
       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)
       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 (Part 1501)

[[Page 901]]

       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  Copyright Office, Library of Congress (Parts 200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                301--399)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--499)
         V  Under Secretary for Technology, Department of Commerce 
                (Parts 500--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--99)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Rate 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)

          Title 41--Public Contracts and Property Management

            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)
            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)

[[Page 902]]

       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)
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System
       201  Federal Information Resources Management Regulation 
                (Parts 201-1--201-99) [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)
       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)
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--499)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   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 200--499)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10010)

             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)

[[Page 903]]

                       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)
         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)
         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  Office of Human Development Services, 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 on Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Part 2301)
      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)

[[Page 904]]

        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)

           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  United States 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)
        35  [Reserved]
        44  Federal Emergency Management Agency (Parts 4400--4499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)

[[Page 905]]

        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399)
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  General Services Administration Board of Contract 
                Appeals (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       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, Department of 
                Transportation (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499)
       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)

[[Page 906]]

        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)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR

[[Page 907]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of January 1, 2006)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Committee of the Federal Register  1, I
Advanced Research Projects Agency                 32, I
Advisory Council on Historic Preservation         36, VIII
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development, United      22, II
     States
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department                            5, LXXIII
  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
  Cooperative State Research, Education, and      7, XXXIV
       Extension Service
  Economic Research Service                       7, XXXVII
  Energy, Office of                               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
  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                              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
Appalachian Regional Commission                   5, IX

[[Page 908]]

Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Army Department                                   32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
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
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X
Civil Rights, Commission on                       45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce Department                               44, IV
  Census Bureau                                   15, I
  Economic Affairs, Under Secretary               37, V
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Fishery Conservation and Management             50, VI
  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
  National Marine Fisheries Service               50, II, IV, VI
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Telecommunications and Information     15, XXIII; 47, III
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Productivity, Technology and Innovation,        37, IV
       Assistant Secretary for
  Secretary of Commerce, Office of                15, Subtitle A
  Technology, Under Secretary for                 37, V
  Technology Administration                       15, XI
  Technology Policy, Assistant Secretary for      37, IV
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 Product Safety Commission                5, LXXI; 16, II
Cooperative State Research, Education, and        7, XXXIV
     Extension Service
Copyright Office                                  37, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    28, VIII
     for the District of Columbia
Customs and Border Protection Bureau              19, I
Defense Acquisition Regulations System            48, 2
Defense Contract Audit Agency                     32, I

[[Page 909]]

Defense Department                                5, XXVI; 32, Subtitle A; 
                                                  40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  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
  Federal Acquisition Regulation                  48, 1
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 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
District of Columbia, Court Services and          28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Under Secretary                 37, V
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office 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
  Vocational and Adult Education, Office of       34, IV
Educational Research and Improvement, Office of   34, VII
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 Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             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                   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
  Administration, Office of                       5, XV
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                5, III, LXXVII; 14, VI; 
                                                  48, 99
  National Drug Control Policy, Office of         21, III

[[Page 910]]

  National Security Council                       32, XXI; 47, 2
  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           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                       11, I
Federal Emergency Management Agency               44, I
  Federal Acquisition Regulation                  48, 44
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 Board                     12, IX
Federal Labor Relations Authority, and General    5, XIV; 22, XIV
     Counsel of the Federal Labor Relations 
     Authority
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
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Fishery Conservation and Management               50, VI
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 911]]

  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
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          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
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Human Development Services, Office of           45, XIII
  Indian Health Service                           25, V; 42, I
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  6, I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection Bureau            19, I
  Federal Emergency Management Agency             44, I
  Immigration and Customs Enforcement Bureau      19, IV
  Immigration and Naturalization                  8, I
  Transportation Security Administration          49, XII
Housing and Urban Development, Department of      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
Human Development Services, Office of             45, XIII
Immigration and Customs Enforcement Bureau        19, IV
Immigration and Naturalization                    8, I
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V; 42, I
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII

[[Page 912]]

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
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior Department
  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
  Minerals Management Service                     30, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            43, Subtitle A
  Surface Mining and Reclamation Appeals, Board   30, III
       of
  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 Fishing and Related Activities      50, III
International Investment, Office of               31, VIII
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
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                                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
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  5, XLII
  Benefits Review Board                           20, VII
  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
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I

[[Page 913]]

  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
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII
  Copyright Office                                37, II
  Copyright Royalty Board                         37, III
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
Micronesian Status Negotiations, Office for       32, XXVII
Mine Safety and Health Administration             30, I
Minerals Management Service                       30, II
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
National Aeronautics and Space Administration     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   45, XII, XXV
National Archives and Records Administration      5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Bureau of Standards                      15, II
National Capital Planning Commission              1, IV
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National Council on Disability                    34, XII
National Counterintelligence Center               32, XVIII
National Credit Union Administration              12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           21, III
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Standards and Technology    15, II
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV, VI
National Mediation Board                          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                       5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI
National Security Council and Office of Science   47, II
     and Technology Policy
National Telecommunications and Information       15, XXIII; 47, III
     Administration
National Transportation Safety Board              49, VIII
National Weather Service                          15, IX
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV

[[Page 914]]

Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Offices of Independent Counsel                    28, VI
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                                       22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 45, VIII
  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 Rate 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
Procurement and Property Management, Office of    7, XXXII
Productivity, Technology and Innovation,          37, IV
     Assistant Secretary
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
Regional Action Planning Commissions              13, V
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
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                17, II
Selective Service System                          32, XVI
Small Business Administration                     13, I
Smithsonian Institution                           36, V
Social Security Administration                    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                                  22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining and Reclamation Appeals, Board of  30, III
Surface Mining Reclamation and Enforcement,       30, VII
   Office of
[[Page 915]]

Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Technology Administration                         15, XI
Technology Policy, Assistant Secretary for        37, IV
Technology, Under Secretary for                   37, V
Tennessee Valley Authority                        5, LXIX; 18, XIII
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     5, L
  Commercial Space Transportation                 14, III
  Contract Appeals, Board of                      48, 63
  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; 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
  Surface Transportation Board                    49, X
  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                               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 Bureau            19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Law Enforcement Training Center         31, VII
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  International Investment, Office of             31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  Thrift Supervision, Office of                   12, V
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
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       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
Vocational and Adult Education, Office of         34, IV
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I
World Agricultural Outlook Board                  7, XXXVIII

[[Page 917]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations that were 
made by documents published in the Federal Register since January 1, 
2001, 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 and parts as well as 
sections for revisions.
For the period before January 1, 2001, see the ``List of CFR Sections 
Affected, 1949-1963, 1964-1972, 1973-1985, and 1986-2000'' published in 
11 separate volumes.

                                  2001

10 CFR
                                                                   66 FR
                                                                    Page
Chapter I
2 Technical correction.............................................33013
2.101 (f)(1) and (5) revised.......................................55787
2.103 (a) revised..................................................55787
2.104 (e) revised..................................................55787
2.105 (a)(5) revised...............................................55787
2.106 (c) revised..................................................55787
2.714 (d) revised..................................................55788
2.1001 Amended..............................................29465, 55788
2.1003 (a) introductory text, (2) introductory text and (xv) 
        revised....................................................29465
2.1009 (b) revised.................................................29466
2.1010 (a)(2) revised..............................................29466
2.1011 (b), (c)(3) and (4) revised; (c)(6) and (7) added...........29466
2.1012 (a) revised.................................................29466
2.1013 (a)(2) and (c)(1) revised...................................55788
2.1014 (a)(1) introductory text and (a)(4) introductory text 
        revised....................................................55788
2.1021 (a) introductory text revised...............................55788
2.1023 (a) introductory text revised...............................55789
5 Appendix A added...................................................709
9.35 (a)(1) revised................................................22907
19.2 Revised.......................................................55789
19.3 Amended.......................................................55789
19.20 Revised......................................................55789
20.1002 Revised....................................................55789
20.1003 Amended....................................................55789
20.1401 (a) revised................................................55789
20.2001 (a)(1) and (b)(5) revised..................................55789
20.2103 (b)(3) amended.............................................64737
20.2201 (c) amended................................................64738
20.2206 (a)(4) revised.............................................55789
21.2 (a) revised...................................................55790
21.3 Amended.......................................................55790
21.21 (d)(1)(i) and (ii) revised...................................55790
30.11 (b) added....................................................51838
    (c) revised....................................................55790
30.37 (a) amended..................................................64738
32.21 (a)(2) amended...............................................64738
34.47 Regulation at 65 FR 63751 confirmed...........................1573
34.53 Amended......................................................64738
34.83 Regulation at 65 FR 63752 confirmed...........................1573
36.55 Regulation at 65 FR 63752 confirmed...........................1573
36.81 Regulation at 65 FR 63752 confirmed...........................1573
39.65 Regulation at 65 FR 63752 confirmed...........................1573
40.14 (c) revised..................................................55790
40.42 (j)(2), (k)(3)(i) and (ii) amended...........................64738
50 Authority citation revised......................................64738
50.47 (b)(10) revised...............................................5440
50.49 (b)(2) amended...............................................64738
50.55a (b)(2)(xv)(C)(1)............................................16391
50.59 (b) amended..................................................64738

                                  2002

10 CFR
                                                                   67 FR
                                                                    Page
Chapter I
1.3 (a) amended....................................................67097
1.5 Revised........................................................67097
    Corrected......................................................70835
1.5 (b)(2) amended.................................................77652

[[Page 918]]

1.11--1.47 (Subpart B) undesignated center heading removed.........67097
1.30 Redesignated as 1.35..........................................67097
1.32(b) Amended.....................................................3585
1.35 Redesignated from 1.30........................................67097
2 Technical correction..............................................3263
    Authority citation revised.....................................57089
    Regulation at 67 FR 57089 withdrawn............................72091
2.4 Amended........................................................67098
2.101 (g)(1) introductory text amended.............................67098
2.206 (a) amended..................................................57089
    Regulation at 67 FR 57089 withdrawn............................72091
2.701 (a)(1) amended...............................................67098
2.714 (d) revised..................................................20885
2.802 (a) revised; (b) introductory text amended...................57089
    Regulation at 67 FR 57089 withdrawn............................72091
4 Authority citation revised.......................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
4.5 Revised........................................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
4.570 (c) revised..................................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
7.1 (d) revised; (e)(1), (2) and (i) added.........................79838
7.2 Amended........................................................67098
    Corrected......................................................70835
    Revised........................................................79839
7.5 Revised........................................................79840
7.6 Revised........................................................79840
7.7 (a)(3) and (b)(2) revised......................................79840
7.8 Revised........................................................79841
7.9 Revised........................................................79841
7.10 (a), (b)(5), (6), (7) and (c)(2) revised......................79841
7.11 Revised.......................................................79841
7.12 (a), (c), and (e) revised; (f) added..........................79841
7.13 (c) revised...................................................79842
7.14 Revised.......................................................79842
7.15 Revised.......................................................79842
7.16 (b) amended...................................................79842
7.17 Revised.......................................................79842
7.18 Revised.......................................................79843
7.19 Revised.......................................................79843
7.20 Revised.......................................................79843
9 Authority citation revised.......................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
9.6 Added..........................................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
9.21 (b) revised...................................................67098
9.23 (b) amended...................................................57090
    (a)(1) introductory text revised...............................67098
    Regulation at 67 FR 57090 withdrawn............................72091
9.29 (a) amended...................................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
9.35 (b) introductory text revised.................................67098
9.41 (a)(2) revised................................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
9.53 (a) revised; (b) amended......................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
9.65 (b) amended...................................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
9.66 (b) amended...................................................57090
    Regulation at 67 FR 57090 withdrawn............................72091
9.67 (a) amended...................................................57091
    Regulation at 67 FR 57091 withdrawn............................72091
11 Authority citation revised......................................57091
    Regulation at 67 FR 57091 withdrawn............................72091
11.15 (a)(1) amended...............................................57091
    Regulation at 67 FR 57091 withdrawn............................72091
15 Authority citation revised...............................30318, 57091
    Regulation at 67 FR 57091 withdrawn............................72091
15.1 (a)(1) and (3) revised; (c) added.............................30318
15.2 Amended.......................................................30318
15.3 Revised.......................................................57091
    Regulation at 67 FR 57091 withdrawn............................72091
15.5 (b)(4) and (5) revised; (b)(7) added..........................30318
15.7 (a) and (b) revised...........................................30318
15.8 Added.........................................................30319
15.9 Heading and (a) revised.......................................30319
15.11 Heading, (a) and (b) revised.................................30319
15.20 Added........................................................30319
15.21 (a)(5), (6), (b) introductory text, (3)(ii), (iii) and (vi) 
        revised; (a)(7) and (e) added..............................30319

[[Page 919]]

15.23 Heading and (a) revised......................................30319
15.26 (a)(3) removed; (a)(4) and (5) redesignated as (a)(3) and 
        (4); heading, (a)(2), new (3) and (4) revised..............30319
15.29 Revised......................................................30320
15.32 Revised......................................................30320
15.33 Revised......................................................30320
15.35 (b), (c) introductory text and (1) revised...................30322
15.37 (a) and (b) revised; (l) added...............................30322
15.39 Revised......................................................30322
15.41 Revised......................................................30322
15.43 (c) and (d) revised..........................................30322
15.45 Revised......................................................30322
15.49 Added........................................................30322
15.51 Revised......................................................30323
15.53 Revised......................................................30323
15.55 Revised......................................................30323
15.57 Revised......................................................30323
15.59 Revised......................................................30323
15.60 Added........................................................30323
15.61 Revised......................................................30324
15.65 Revised......................................................30324
15.67 Revised......................................................30324
16 Authority citation revised......................................57507
16.1 (b)(2) removed; (b)(3) and (4) redesignated as (b)(2) and 
        (3); (d) revised; (f) added................................57507
16.3 Amended.......................................................57507
16.7 (b)(3) and (6) revised........................................57508
16.8 Added.........................................................57508
16.9 (b)(2) revised................................................57508
16.13 Revised......................................................57508
16.15 Heading revised..............................................57509
16.23 Revised......................................................57509
19 Technical correction.............................................3263
    Authority citation revised.....................................57091
    Regulation at 67 FR 57091 withdrawn............................72091
19.5 Revised.......................................................67098
19.11 (c)(2) revised...............................................57091
    Regulation at 67 FR 57091 withdrawn............................72091
19.17 (a) amended...........................................57091, 77652
    Regulation at 67 FR 57091 withdrawn............................72091
20 Technical correction.............................................3263
    Authority citation revised.....................................57092
    Regulation at 67 FR 57092 withdrawn............................72091
20.1002 Revised....................................................20370
    Corrected......................................................62872
    Amended........................................................77652
20.1003 Amended.............................................16304, 20370
    Corrected......................................................62872
20.1007 Revised....................................................57092
    Regulation at 67 FR 57092 withdrawn............................72091
20.1009 (b) revised; (OMB numbers).................................67099
20.1201 (a)(2) introductory text, (ii) and (c) revised.............16304
20.1301 (a) introductory text and (1) revised; (c) through (e) 
        redesignated as (d) through (f); new (c) added.............20370
    (a)(1) corrected...............................................62872
20.1703 (c)(5) introductory text and (i) amended...................77652
20.2201 (a)(2)(ii) amended..........................................3585
20.2203 (d) Revised................................................57092
    Regulation at 67 FR 57092 withdrawn............................72091
20.2206 (c) revised................................................57092
    Regulation at 67 FR 57092 withdrawn............................72091
20 Appendix D revised..............................................57092
    Appendix D amended......................................67099, 77652
    Appendix G amended.............................................57092
21 Technical correction.............................................3263
    Authority citation revised.....................................57092
    Regulation at 67 FR 57092 withdrawn............................72091
21.5 Revised.......................................................57092
    Regulation at 67 FR 57092 withdrawn............................72091
21.21 (a)(2), (d)(1) and (2) amended...............................77652
25 Authority citation revised......................................57093
    Regulation at 67 FR 57093 withdrawn............................72091
25.9 Revised.......................................................57093
    Regulation at 67 FR 57093 withdrawn............................72091
26 Policy statement................................................66311
    Authority citation revised.....................................67099
26.8 (b) revised; (OMB numbers)....................................67099
30 Technical correction.............................................3263
    Authority citation revised.....................................57093
    Regulation at 67 FR 57093 withdrawn............................72091
30.6 (a)(1), (2) and (b) introductory text revised; (a)(3) added; 
        (b)(2)(i) through (iv) amended.............................57093
    Regulation at 67 FR 57093 withdrawn............................72091
30.7 (e)(3) revised................................................57094

[[Page 920]]

    Regulation at 67 FR 57094 withdrawn............................72091
30.8 (b) revised; (OMB numbers)....................................67099
30.50 (c)(2) amended...............................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
30.55 (c) amended..................................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
31 Authority citation revised......................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
31.4 (b) revised; (OMB numbers)....................................67099
31.5 (c)(8)(ii) introductory text, (9)(i) introductory text and 
        (11) amended...............................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
31.11 (b)(1) revised...............................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
31.12 (a) revised..................................................57094
32 Authority citation revised......................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
32.12 (a) revised..................................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
32.16 (a) revised..................................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
32.20 (b) revised..................................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
32.25 (c) introductory text revised................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
32.52 (a) introductory text amended................................57094
    Regulation at 67 FR 57094 withdrawn............................72091
32.56 Amended......................................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
32.72 (b)(1) amended...............................................20370
    Corrected......................................................62872
    (b)(2)(iii) amended............................................77652
32.74 (a) introductory text and (3) amended........................20370
32.210 (b) revised.................................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
33.8 (c)(2), (3) and (4) removed...................................67099
34 Authority citation revised......................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
34.27 (d) amended...........................................57095, 77652
    Regulation at 67 FR 57095 withdrawn............................72091
34.43 (a)(1) amended...............................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
34.101 (a) amended..................................................3585
    (a) introductory text revised..................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
35 Revised.........................................................20370
    Authority citation revised.....................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
35.6 (c) corrected.................................................62872
35.12 (c)(1)(i) corrected..........................................62872
35.13 (b)(1), (2) and (3) corrected................................62872
35.14 (b) introductory text and (c) revised........................57095
    Regulation at 67 FR 57095 withdrawn............................72091
35.40 (a) corrected................................................62872
35.51 (b)(1) corrected.............................................62872
35.59 (e)(2) revised...............................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
39 Authority citation revised......................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
39.8 (b) revised; (OMB numbers)....................................67099
39.63 (h) amended..................................................77652
39.77 (a) revised..................................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
40 Technical correction.............................................3263
    Authority citation revised.....................................57095
    Regulation at 67 FR 57095 withdrawn............................72091
40.5 (a)(1), (2) and (b) introductory text revised; (a)(3) added; 
        (b)(2)(i) through (iv) amended.............................57096
    Regulation at 67 FR 57096 withdrawn............................72091
40.7 (e)(3) revised................................................57096
    Regulation at 67 FR 57096 withdrawn............................72091
40.23 (b)(1) amended...............................................57096
    Regulation at 67 FR 57096 withdrawn............................72091

[[Page 921]]

40.25 (c)(1) introductory text amended.............................57096
    Regulation at 67 FR 57096 withdrawn............................72091
40.35 (e)(1) and (f) amended.......................................57096
    Regulation at 67 FR 57096 withdrawn............................72091
40.60 (c)(2) introductory text amended.............................57096
    Regulation at 67 FR 57096 withdrawn............................72091
40.64 (a), (b) and (c) amended.....................................57096
    Regulation at 67 FR 57096 withdrawn............................72091
40.65 (a)(1) amended...............................................57097
    Regulation at 67 FR 57097 withdrawn............................72091
40.66 (a) amended..................................................57097
    Regulation at 67 FR 57097 withdrawn............................72091
40.67 (a) amended..................................................57097
    Regulation at 67 FR 57097 withdrawn............................72091
50 Authority citation revised...............................57097, 67099
    Technical correction...........................................64033
    Regulation at 67 FR 57097 withdrawn............................72091
50.4 Revised.......................................................57097
    Regulation at 67 FR 57097 withdrawn............................72091
50.7 (e)(2) revised................................................57098
    Regulation at 67 FR 57098 withdrawn............................72091
50.8 (b) revised; (OMB numbers)....................................67099
50.30 (a)(2) revised...............................................57098
    Regulation at 67 FR 57098 withdrawn............................72091
50.54 (s)(1) amended...............................................57099
    Regulation at 67 FR 57099 withdrawn............................72091
50.55 (e)(6)(ii) revised...........................................57099
    Regulation at 67 FR 57099 withdrawn............................72091
50.55a (b)(2)(xv)(G)(4) and (g)(6)(ii)(B)(1) through (4) removed; 
        (g)(6)(ii)(B)(5) redesignated as (g)(6)(ii)(B); (b)(1) 
        introductory text, (ii), (iii), (v), (2) introductory 
        text, (vi), (viii) introductory text, (ix) introductory 
        text, (xi), (xiv), (xv) introductory text, (A), (K)(1)(i), 
        (xvii), (3) introductory text, (ii), (iii) introductory 
        text, (iv) introductory text, new (g)(6)(ii)(B) and (C)(1) 
        revised; (b)(2)(viii)(F), (ix)(F) through (I), (xii), 
        (xv), (M), (vviii) through (xxi), (3)(iv)(D), (vi) and 
        (g)(6)(ii)(C)(2) added; interim............................60539
50.74 Introductory text revised....................................57099
    Regulation at 67 FR 57099 withdrawn............................72091
50.75 (e)(1) introductory text, (i) and (ii) revised; (h) added....78350

                                  2003

10 CFR
                                                                   68 FR
                                                                    Page
Chapter I
1.5 Amended........................................................75389
1.19 Amended.......................................................75389
2 Authority citation revised.......................................58798
2.206 (a) amended..................................................58799
2.790 (a) introductory text, (b)(1), (4)(ii) and (c) revised; (e) 
        redesignated as (f); (b) introductory text and new (e) 
        added......................................................18842
2.802 (a) revised; (b) introductory text amended...................58799
2.1201 (a)(4) added................................................19726
4 Heading and authority citation revised...........................51344
    Authority citation revised.....................................58799
4.3 Introductory text amended......................................51344
4.4 (f) and (h) amended; (g) revised...............................51344
    (g)(2)(ii) revised.............................................75389
4.5 Revised........................................................58799
4.12 (a) introductory text amended.................................51344
4.13 (a) amended...................................................51344
4.21 (a) and (b) amended...........................................51344
    (b) amended....................................................75389
4.22 Amended; heading revised......................................51344
4.24 (b) revised...................................................51344
4.32 (b) amended...................................................51344
4.34 Amended.......................................................51344

[[Page 922]]

4.51 (a)(4) amended................................................51344
4.64 Amended.......................................................51344
4.74 Amended.......................................................51344
4.91 Introductory text amended.....................................51344
4.121 (a), (b)(1)(v), (2), (3)(ii), (4)(i), (c) and (d) amended....51345
4.122 (a), (c)(8) and (d) amended..................................51345
4.123 (a), (c) introductory text and (1) amended...................51345
4.126 Amended; heading revised.....................................51345
4.127 (a) heading revised; (a), (b) and (d)(3) amended.............51345
4.231 (a), (c)(3)(i) and (ii) amended..............................51345
4.232 (a) amended..................................................51345
4.313 Introductory text amended....................................51345
4.321 Amended......................................................51345
4.334 (a)(2) amended...............................................51345
4.336 (c)(2) amended...............................................51345
4.338 (c) amended..................................................51345
4.339 (b)(2) amended...............................................51345
4.341 (b), (c) and (d) amended.....................................51345
4.570 (c) revised..................................................58799
9 Authority citation revised.......................................58799
9.6 Added..........................................................58800
9.23 (b) introductory text amended.................................58800
9.29 (a) amended...................................................58800
9.41 (a)(2) revised................................................58800
9.53 (a) revised; (b) amended......................................58800
9.54 (b) amended...................................................58800
9.65 (b) amended...................................................58800
9.66 (b) amended...................................................58800
9.67 (a) amended...................................................58800
11 Authority citation revised......................................58800
11.15 (a)(1) amended...............................................58800
    (e) revised....................................................62511
    (e)(2) table corrected.........................................65765
15 Authority citation revised......................................58801
15.3 Revised.......................................................58801
19 Authority citation revised......................................58801
19.11 (c)(2) revised...............................................58801
19.17 (a) amended..................................................58801
19.32 Amended......................................................75389
20 Authority citation revised......................................58801
20.1007 Revised....................................................58801
20.1401 (a) and (c) revised........................................19726
20.2203 (b)(2) revised [Editorial Note:Due to a pagination 
        anomaly, this document, which published March 25, 2003, 
        shares the same Federal Register page number as a 
        Presidential Executive Order published on March 24, 2003] 
                                                                   14308
    Regulation at 68 FR 14308 eff. date confirmed..................27903
    (d) revised....................................................58802
20.2206 (c) revised................................................58802
20 Appendix D revised; Appendix G amended..........................58802
21 Authority citation revised......................................58802
21.5 Revised.......................................................58802
25 Authority citation revised......................................58803
25.9 Revised.......................................................58803
25.17 (f) revised..................................................62512
25 Appendix A revised..............................................62512
    Appendix A corrected...........................................65765
30 Authority citation revised......................................58803
30.6 (a)(1), (2) and (b) introductory text revised; (a)(3) added; 
        (b)(2)(i) through (iv) amended.............................58803
30.7 (e)(3) revised................................................58803
30.32 (a) amended..................................................58804
30.35 (a), (c)(2), (d) and (e) revised; (c)(5) added...............57335
30.50 (c)(2) introductory text amended.............................58804
30.55 (c) amended..................................................58804
31 Authority citation revised......................................58804
31.5 (c)(8)(ii) introductory text revised; (c)(9)(i) introductory 
        text and (11) amended......................................58804
31.11 (b)(1) revised...............................................58804
32 Authority citation revised......................................58804
32.12 (a) revised..................................................58804
32.16 (a) revised..................................................58804
32.20 (b) revised..................................................58804
32.25 (c) introductory text revised................................58804
32.52 (a) introductory text amended................................58805
32.56 Amended......................................................58805
32.210 (b) revised.................................................58805
33 Authority citation revised......................................58805
33.12 Revised......................................................58805
34 Authority citation revised......................................58805
34.11 Revised......................................................58805
34.27 (d) amended..................................................58805
34.43 (a)(1) amended...............................................58805
34.101 (a) introductory text revised...............................58805

[[Page 923]]

35 Regulation at 68 FR 19321 eff. date confirmed...................35534
    Authority citation revised.....................................58805
35.2 Amended.......................................................19324
35.14 (b) introductory text and (c) revised........................58805
35.40 Amended......................................................75389
35.51 (b)(2) amended...............................................19324
35.100 (b) revised.................................................19324
35.190 (b), (c)(1)(ii) introductory text and (2) revised...........19324
35.200 (b) revised.................................................19324
35.290 (b), (c)(1)(ii) introductory text and (2) revised...........19324
35.300 (b) revised.................................................19324
35.310 (a)(5) revised..............................................19324
35.315 (b) revised.................................................19325
35.390 (b)(1)(ii) introductory text and (2) revised................19325
    (b) amended....................................................75389
35.392 (b), (c)(2) introductory text and (3) revised...............19325
    Introductory text and (c) amended..............................75389
35.394 (b), (c)(2) introductory text and (3) revised...............19325
    Introductory text and (c) amended..............................75389
35.432 (b) revised.................................................19325
35.490 (b)(1)(ii) introductory text, (2) and (3) revised...........19325
35.491 (a), (b)(2) introductory text and (3) revised...............19326
35.630 (a)(1) revised..............................................19326
35.690 (b)(1)(ii) introductory text, (2) and (3) revised...........19326
35.2432 (b)(5) revised.............................................19326
35.3045 (d) introductory text revised..............................58805
35.3047 (d) introductory text revised..............................58805
35.3067 Amended....................................................58805
39 Authority citation revised......................................58806
39.55 Revised......................................................75390
39.77 (a) revised..................................................58806
40 Authority citation revised......................................58806
40.4 Amended.......................................................10364
    Regulation at 10364 eff. date confirmed........................25281
40.5 (a)(1), (2) and (b) introductory text revised; (a)(3) added; 
        (b)(2)(i) through (iv) amended.............................58806
40.7 (e)(3) revised................................................58806
40.23 (b)(1), (2)(ix), (c) and (d) revised.........................58806
40.25 (c)(1) introductory text amended.............................58807
40.31 (a) amended..................................................58807
40.35 (e)(1) and (f) amended.......................................58807
40.36 (b)(2), (c)(2) and (d) revised...............................57336
40.42 (l) revised..................................................75390
40.60 (c)(2) introductory text amended.............................58807
40.64 (a) and (b) revised..........................................10364
    Regulation at 10364 eff. date confirmed........................25281
    (a) and (b) amended; (c) revised...............................58807
40.65 (a)(1) amended...............................................58807
40.66 (a) amended..................................................58808
40.67 (a) amended..................................................58808
50 Authority citation revised......................................58808
50.2 Amended.......................................................19727
50.4 Revised.......................................................58808
50.7 (e)(2) revised................................................58809
50.8 (b) revised...................................................19727
50.30 (a)(2) revised...............................................58809
50.34 (a)(4) revised; (g) redesignated as (h); new (g) added.......54141
50.44 Revised......................................................54141
50.46a Added.......................................................54141
50.54 (s)(1) amended...............................................58809
50.55 (e)(6)(ii) revised...........................................58809
50.55a (b) Introductory text, (c)(3) introductory text, (iv), 
        (d)(2) introductory text, (iii), (e)(2) introductory text, 
        (iii), (f)(2), (3)(iii)(A), (B), (iv)(A), (B), (4)(i), 
        (ii), (g)(2), (3)(i), (ii), (4)(i) and (ii) revised; 
        (b)(4), (5) and (6) added; Footnote 6 removed..............40475
50.74 Introductory text revised....................................58809
50.75 (e)(1)(ii) revised...........................................12571
    (g)(4) added...................................................19727
    (e)(1)(i), (ii), (h)(1)(i)(A), (B) and (iv) amended; (h)(2) 
revised; (h)(5) added..............................................65388
50.82 (a)(9)(ii)(H) added; (a)(11)(ii) revised.....................19727
50.83 Added........................................................19727
50 Appendix L amended..............................................58810
    Appendix H amended.............................................75390

                                  2004

10 CFR
                                                                   69 FR
                                                                    Page
Title 10 Nomenclature change.......................................18803

[[Page 924]]

Chapter I
0--199 (Chapter I) Policy statement................................29187
1.25 (g) revised....................................................2233
2 Authority citation revised........................................2233
2.2 Revised.........................................................2233
2.3 Revised.........................................................2233
2.4 Amended.........................................................2233
2.100 Revised.......................................................2234
2.101 (a)(3)(ii), (b), (f)(1) and (g)(2) revised....................2234
2.102 (d)(3) revised................................................2235
2.103 Heading and (a) revised.......................................2235
2.104 (e) revised...................................................2235
2.105 (a)(5) and (6) revised........................................2235
2.106 (c) revised...................................................2235
2.107 (a) revised...................................................2236
2.108 (c) revised...................................................2236
2.110 (a)(1) revised................................................2236
2.205 (j) revised..................................................62394
2.206 (c)(3) added..................................................2236
    (a) amended....................................................41749
2.300--2.390 (Subpart C) Added......................................2236
2.402 (b) revised...................................................2256
2.405 Revised.......................................................2256
2.604 (b) and (c) revised...........................................2256
2.606 (a) revised...................................................2256
2.700--2.713 (Subpart G) Revised....................................2256
2.901 Revised.......................................................2264
2.902 (e) revised...................................................2264
2.1000 Revised......................................................2264
2.1001 Amended...............................................2264, 32848
2.1003 (a) introductory text revised................................2264
    (a) introductory text and (1) revised; (e) added...............32848
2.1005 (i) added...................................................32848
2.1006 (a) revised..................................................2265
2.1010 (e) revised..................................................2265
2.1012 (b) revised..................................................2265
    (a) revised....................................................32848
2.1013 (a)(1), (2), (b) and (c)(1) revised..........................2265
    (a)(2) and (c)(1) revised......................................32849
2.1014 Removed......................................................2265
2.1015 (b) and (d) revised..........................................2265
2.1016 Removed......................................................2266
2.1018 (a)(1)(v), (c), (f)(3) and (g) revised.......................2266
2.1019 (j) removed..................................................2266
2.1021 (a) introductory text revised................................2266
2.1022 (a) introductory text and (1) revised........................2266
2.1023 (a) and (b)(2) revised.......................................2266
2.1026 (b)(1) revised...............................................2266
2.1027 Revised......................................................2266
2.1103 Revised......................................................2266
2.1109 (a)(1) and (c) revised.......................................2267
2.1111 Removed......................................................2267
2.1113 (a) revised; (b) redesignated as (c); new (b) added..........2267
2.1117 Revised......................................................2267
2.1119 Added........................................................2267
2.1200--2.1213 (Subpart L) Revised..................................2267
2.1300 Revised......................................................2270
2.1306 Removed......................................................2270
2.1307 Removed......................................................2270
2.1308 Revised......................................................2270
2.1312 Removed......................................................2270
2.1313 Removed......................................................2270
2.1314 Removed......................................................2270
2.1315 (a) revised..................................................2270
2.1317 Removed......................................................2270
2.1318 Removed......................................................2270
2.1321 (a) revised..................................................2271
2.1322 (a)(1) revised...............................................2271
2.1323 (d) revised..................................................2271
2.1326 Removed......................................................2271
2.1328 Removed......................................................2271
2.1329 Removed......................................................2271
2.1330 Removed......................................................2271
2.1331 (b) revised..................................................2271
2.1400--2.1407 (Subpart N) Added....................................2271
2.1500--2.1509 (Subpart O) Added....................................2273
2 Appendix A removed................................................2274
    Appendix D revised..............................................2275
    Appendix D corrected...........................................25997
19.3 Amended.......................................................76600
25 Authority citation revised......................................74952
25.3 Revised; eff. 2-28-05.........................................74952
25.5 Amended; eff. 2-28-05.........................................74952
25.17 (a) revised; eff. 2-28-05....................................74953
25.37 (b) revised; eff. 2-28-05....................................74953
34 Authority citation revised......................................76600
35.2 Amended.......................................................55737
35.10 (b) and (c) introductory text revised........................55737
35.51 (b)(2) revised...............................................55737
35.100 (b)(2) revised..............................................55738
35.190 (b), (c)(1)(ii) introductory text and (2) revised...........55738
35.200 (b)(2) revised..............................................55738
35.290 (b), (c)(1)(ii) introductory text and (2) revised...........55738
35.300 (b)(2) revised..............................................55738
35.390 (b)(1)(ii) introductory text and (2) revised................55738
35.392 (b), (c)(2) introductory text and (3) revised...............55738

[[Page 925]]

35.394 (b), (c)(2) introductory text and (3) revised...............55739
35.490 (b)(1)(ii) introductory text, (2) and (3) revised...........55739
35.491 (a) and (b)(3) revised......................................55739
35.690 (b)(1)(ii) introductory text, (2) and (3) revised...........55739
40.66 (b)(5) and (c) revised.......................................76600
40.67 (a) amended; (c) and (d) revised.............................76600
50.8 (b) revised...................................................68046
50.33 (f)(2) revised................................................4448
50.48 (c) added; (f) introductory text revised.....................33550
50.55a (b)(1) introductory text, (ii), (2) introductory text, 
        (viii) introductory text, (ix) introductory text, (xiii), 
        (xiv), (xv) introductory text, (C)(1), (xvii), (xx), (b) 
        introductory text, (i) and (iv) introductory text amended; 
        (b)(1)(vi), (2)(viii)(G) and (xxii) through (xxvii) added; 
        (b)(2)(xv)(J) and (3)(iii) removed.........................58819
50.57 (c) revised...................................................2275
50.69 Added........................................................68047
50.75 Regulation at 68 FR 65388 confirmed...........................5268
50.76 Added.........................................................4448
50.91 Introductory text, (a)(4) and (6)(v) revised..................2276

                                  2005

10 CFR
                                                                   70 FR
                                                                    Page
Chapter I
0--199 (Ch. I) Policy statement....................................51581
    Nomenclature change............................................69421
1.3 (c) revised....................................................69421
1.5 (b)(2) and (3) revised.........................................69421
1.32 (b) revised...................................................69421
1.33 Revised.......................................................69422
1.34 (d) revised...................................................69422
1.35 Revised.......................................................69422
1.41 Heading and introductory text revised.........................69422
1.43 Revised.......................................................69422
1.46 Added.........................................................69422
2 Authority citation revised.......................................61886
2.101 (a-1)(5) and (e) removed; (f) and (g) redesignated as (e) 
        and (f); (a)(5), (a-1) introductory text and (c) revised 
                                                                   61887
2.102 (d) removed..................................................61887
2.104 Footnote 4 and (d)(3) removed; (d)(4) redesignated as 
        (d)(3); (d) introductory text, (1) and (2) revised.........61887
2.105 (e)(2) revised; (f) removed..................................61887
2.332 (a) introductory text, (2) and (b) revised...................20461
2.334 Revised......................................................20461
2.402 (a) revised..................................................61887
2 Appendix B added.................................................20462
9.8 (b) revised....................................................34306
9.13 Amended.......................................................34306
9.21 (c)(5) and (6) revised........................................34306
9.23 (a)(1)(ii) and (b) introductory text revised..................34306
9.25 (g) and (h) revised...........................................34306
9.27 (a) revised...................................................34307
9.28 Added.........................................................34307
9.29 Revised.......................................................34307
9.35 (d) revised...................................................34308
9.40 (f) revised...................................................34308
9.43 (d) revised...................................................34308
9.53 (b) revised...................................................34308
9.54 (a)(1) revised................................................34309
9.61 (c) introductory text, (1) introductory text and (i) revised 
                                                                   34309
9.62 Revised.......................................................34309
9.65 (b) revised...................................................34309
9.66 (b) revised...................................................34309
9.67 (a) revised...................................................34309
9.85 Revised.......................................................34309
9.95 Revised.......................................................34309
10 Nomenclature changes............................................30897
25 Authority citation revised......................................32227
25.3 Regulation at 69 FR 74952 withdrawn............................8921
    Revised........................................................32227
25.5 Regulation at 69 FR 74952 withdrawn............................8921
    Amended........................................................32227
25.17 Regulation at 69 FR 74953 withdrawn...........................8921
    (a) revised....................................................32227
25.37 Regulation at 69 FR 74953 withdrawn...........................8921
    (b) revised....................................................32227
30.34 (i) added.....................................................2009
35.2 Amended.......................................................16361
35.8 (b) revised (OMB numbers).....................................16361
35.10 (b) revised..................................................16361
35.13 (b)(1) and (3) revised.......................................16361
35.14 (a) revised..................................................16361
35.50 (a), (b)(1)(i) introductory text, (ii)(G) and (c) revised; 
        (b)(2) removed; (d) and (e) added..........................16361

[[Page 926]]

35.51 (a) and (b) revised; (c) added...............................16362
35.55 (a), (b)(1)(i) introductory text and (2) revised.............16362
35.57 Revised......................................................16363
35.75 (a) footnote 1 amended.......................................16363
35.100 (b)(2) revised..............................................16363
35.190 (a), (c)(1) introductory text, (ii)(B) and (2) revised......16363
35.200 (b)(2) revised..............................................16363
35.290 (a), (b), (c)(1) introductory text, (ii) introductory text, 
        (B) and (2) revised........................................16364
35.390 (a), (b)(1) introductory text, (ii) introductory text, (B), 
        (G)(1), (3), (4) and (2) revised; (b)(1)(ii)(F) removed....16364
35.392 (a), (c)(2)(ii) and (3) revised.............................16364
35.394 (a), (c)(2)(ii) and (3) revised.............................16365
35.396 Added.......................................................16365
35.490 (a), (b)(2) and (3) revised.................................16366
35.491 (b)(3) revised..............................................16366
35.590 (a) and (b) revised; (c) added..............................16366
35.690 (a), (b)(2) and (3) revised; (c) added......................16366
35.980 (b)(2) revised..............................................16367
50 Appendix E amended...............................................3599
    Actions on petitions...........................................52893
50 Authority citation revised......................................61887
50.8 (b) revised...................................................61887
50.33a Removed.....................................................61888
50.55a (b)(2)(xxi)(C) removed; (b) introductory text, (4) 
        introductory text, (5) introductory text, (f)(2), 
        (3)(iii)(A), (iv)(A), (4)(ii), (g)(2), (3)(i), (ii), 
        (4)(i) and (ii) revised....................................56812
50.80 (b) revised..................................................61888
50 Appendix L removed; Appendix N amended..........................61888


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