[Federal Register Volume 91, Number 95 (Monday, May 18, 2026)]
[Proposed Rules]
[Pages 28916-28954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-09877]
[[Page 28915]]
Vol. 91
Monday,
No. 95
May 18, 2026
Part V
Nuclear Regulatory Commission
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10 CFR Parts 30, 31, 32, et al.
Modernizing NRC Regulations for Byproduct Material Use; Proposed Rule
Federal Register / Vol. 91, No. 95 / Monday, May 18, 2026 / Proposed
Rules
[[Page 28916]]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 31, 32, 34, 39, 40, 70 and 150
[NRC-2025-1205]
RIN 3150-AL49
Modernizing NRC Regulations for Byproduct Material Use
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations for the licensing of byproduct material, some
source material, and some special nuclear material. The NRC's goal in
amending these regulations is to modernize the safe, effective, and
efficient use of licensed material. This action would reduce the burden
of the NRC's licensing process, eliminate the need for certain
exemptions from existing regulations, and eliminate unnecessary
requirements. The NRC is seeking public comment on this proposed rule
and draft interim guidance.
DATES: Comments must be submitted electronically using https://www.regulations.gov by 11:59 p.m. eastern time on July 2, 2026.
ADDRESSES: Submit your comments, identified by Docket ID NRC-2025-1205,
at https://www.regulations.gov. If your material cannot be submitted
using https://www.regulations.gov, call or email the individuals listed
in the FOR FURTHER INFORMATION CONTACT section of this document for
alternate instructions.
Do not include any personally identifiable information (such as
name, address, or other contact information) or confidential business
information that you do not want publicly disclosed. All comments are
public records; they are publicly displayed exactly as received, and
will not be deleted, modified, or redacted. Comments may be submitted
anonymously.
Follow the search instructions on https://www.regulations.gov to
view public comments.
You can read a plain language description of this proposed rule at
https://www.regulations.gov/docket/NRC-2025-1205. For additional
direction on obtaining information and submitting comments, see
``Obtaining Information and Submitting Comments'' in the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Amy McKenna, U.S. Nuclear Regulatory
Commission, Washington DC 20555-0001, Office of Nuclear Material Safety
and Safeguards email: [email protected].
SUPPLEMENTARY INFORMATION:
Executive Summary
A. Need for Regulatory Action
On May 23, 2025, President Trump signed Executive Order (E.O.)
14300, ``Ordering the Reform of the Nuclear Regulatory Commission.''
E.O. 14300 requires the NRC to undertake a review and wholesale
revision of its regulations and guidance documents, after which it must
issue notices of proposed rulemaking by February 23, 2026. Final rules
and guidance to conclude the revision process must be issued no later
than November 23, 2026. In accordance with E.O. 14300 the NRC
identified changes across title 10 of the Code of Federal Regulations
(10 CFR) parts 30, 31, 32, 34, 39, 40, 70, and 150. These changes would
yield significant efficiencies and reduce regulatory burden for
licensees, NRC, and Agreement States while upholding our shared
commitment to public safety.
B. Major Provisions
Major provisions of this proposed rule include the following
changes:
Revised the table of radionuclide activity values used for
determining decommissioning financial assurance (DFA) for sealed and
unsealed radioactive materials.
Established a new class of general licenses (GLs), called
standard general licenses (SGLs), to address anti-competitive barriers.
Streamlined requirements for the distribution of exempt
byproduct material and source material.
Established distribution pathways for microsources.
Revised the definition of consortium to address anti-
competitive barriers.
Revised administrative requirements for industrial
Radiography to reduce anti-competitive barriers and modernized the
radiography regulations.
Modernized well logging regulations.
Streamlined requirements for Agreement State Licensees in
10 CFR part 150.
C. Costs and Benefits
The NRC prepared a draft regulatory analysis to determine the
expected quantitative costs and benefits of this proposed rule, as well
as qualitative factors to be considered in the NRC's rulemaking
decision. The conclusion of the analysis is that this proposed rule and
associated guidance would result in net savings to Industry, Agreement
States, and the NRC of $2,987,000 using a 7-percent discount rate.
The draft regulatory analysis also considers, in a qualitative
fashion, regulatory efficiency, and public confidence. This rulemaking
will reduce the effort that applicants and licensees would need to
expend to generate exemption requests and consider alternative means to
accomplish the goals of current regulation. This rulemaking
demonstrates the NRC's ability to effectively regulate applicants and
licensees, including appropriate responses to statutory requirements.
The regulatory analysis is available as indicated in Section XVII,
``Availability of Documents,'' of this document.
Table of Contents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
B. Submitting Comments
II. Executive Order 14300: Ordering the Reform of the Nuclear
Regulatory Commission
III. Background
IV. Discussion
V. Specific Requests for Comments
VI. Initial Regulatory Flexibility Certification
VII. Regulatory Analysis
VIII. Backfitting and Issue Finality
IX. Cumulative Effects of Regulation
X. Plain Writing
XI. Environmental Assessment
XII. Paperwork Reduction Act Statement
XIII. Coordination With NRC Agreement States
XIV. Compatibility of Agreement State Regulations
XV. Coordination With the Advisory Committee on the Medical Uses of
Isotopes
XVI. Voluntary Consensus Standards
XVII. Availability of Guidance
XVIII. Executive Orders
XIV. Availability of Documents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2025-1205 when contacting the NRC
about the availability of information for this action. You may obtain
publicly available information related to this action by any of the
following methods:
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-1205.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Search.'' For
problems
[[Page 28917]]
with ADAMS, please contact the NRC's Public Document Room (PDR)
reference staff at 1-800-397-4209, at 301-415-4737, or by email to
[email protected]. For the convenience of the reader, instructions
about obtaining materials referenced in this document are provided in
the ``Availability of Documents'' section.
NRC's PDR: The PDR, where you may examine and order copies
of publicly available documents, is open by appointment. To make an
appointment to visit the PDR, please send an email to
[email protected] or call 1-800-397-4209 or 301-415-4737, between 8
a.m. and 4 p.m. eastern time, Monday through Friday, except Federal
holidays.
Public Meeting: The NRC may conduct a public meeting to
describe the proposed amendments and answer questions from the public
on the proposed rule. If the NRC determines it will hold a public
meeting, NRC will publish a notice of the location, time, and agenda of
the meeting on the NRC's public meeting website within 10 calendar days
of the meeting. Stakeholders should monitor the NRC's public meeting
website for information about the public meeting at: https://www.nrc.gov/public-involve/public-meetings/index.cfm.
B. Submitting Comments
Comments must be submitted electronically using https://www.regulations.gov no later than 11:59 p.m. eastern time on July 2,
2026. Please include Docket ID NRC-2025-1205 in your comment
submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at
https://www.regulations.gov as well as enter the comment submissions
into ADAMS. The NRC does not routinely edit comment submissions to
remove identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Executive Order 14300: Ordering the Reform of the Nuclear
Regulatory Commission
On May 23, 2025, President Donald J. Trump signed E.O. 14300,
``Ordering the Reform of the Nuclear Regulatory Commission.'' Section
5, ``Reforming and Modernizing the NRC's Regulations,'' requires the
NRC to undertake a review and wholesale revision of its regulations and
guidance documents as guided by the policies set forth in section 2 of
the E.O. This rulemaking addresses section 5, which requires the NRC to
``undertake a review and wholesale revision of its regulations and
guidance documents.''
III. Background
Within the National Materials Program, the NRC regulates the use of
byproduct material, source material, and special nuclear material in
quantities not sufficient to form a critical mass for a variety of uses
as authorized by Sections 53, 63, and 81 of the Atomic Energy Act of
1954, as amended (AEA) and pursuant to 10 CFR parts 19, 20, 30, 31, 32,
33, 34, 35, 36, 39, 40, 70 and 150. For the purposes of this document,
``byproduct material,'' ``source material,'' and ``special nuclear
material'' describe three broad categories of radioactive material
regulated under the AEA: (1) radioactive material created, made
radioactive, or generated as waste from nuclear processes (byproduct
material); (2) naturally occurring uranium and thorium (source
material); and (3) processed or enriched nuclear materials used for
reactor fuel or other applications (special nuclear material). These
categories are defined in NRC regulations, Sec. Sec. Sec. 30.4, 40.4,
70.4. These materials have many different uses, including use in
industrial radiography, moisture-density gauges, medical applications,
and well logging. Currently, the NRC has approximately 2,700 active
specific licenses for the use and possession of byproduct, source, and
certain quantities of special nuclear material. The applicable NRC
regulations and specific license conditions establish the requirements
for the safe handling, use, and storage of these materials. The NRC
inspects facilities to ensure compliance with regulations and takes
action when violations occur. The public also uses exempt quantities of
byproduct material and source material in consumer products such as
smoke detectors, static eliminators and self-luminous products.
Under Section 274b of the AEA, States can enter into Agreements
with the NRC that allow States to assume, and the NRC to discontinue,
regulatory authority over byproduct, source, and small quantities of
special nuclear material. Known as Agreement States, these States can
then regulate byproduct, source, and certain quantities of special
nuclear materials that are covered in the Agreement, using their own
legislation, regulations, or other legally binding provisions. The NRC
enters into an Agreement if the Commission finds the State program
adequate to protect public health and safety and compatible with the
NRC's regulatory program. The NRC ensures that an Agreement State
program remains adequate and compatible through periodic review and
assessment under the Integrated Materials Performance Evaluation
Program (IMPEP). There are currently 40 Agreement States, which
regulate approximately 20,000 materials licensees.
In response to several recent E.O.s, including E.O. 14300, the NRC
identified requirements within 10 CFR parts 30, 31, 32, 34, 39, 40, and
150 that could be revised, deleted, or modified in order to meet the
E.O. objectives. The following sections provide background information
on the affected parts. Section IV of this document provides discussion
on the specific proposed changes for each of the affected parts.
A. Part 30 Reducing Anti-Competitive Barriers in Consortium Definition
The NRC is proposing to revise its definition of consortium to
remove the anti-competitive barrier limitation that a positron emission
tomography (PET) radionuclide production facility must be in the same
geographical area as the medical use licensee to be considered a
consortium. The limitation that the PET production facility had to be
located in the same geographical area as the medical use licensee
severely limited licensees from locating their PET radionuclide
production facility in the most cost-effective location and was based
primarily on the short half-life of PET radionuclides, making distant
transport impracticable.
B. Part 30 Modernizing Appendix B and Part 70 Quantities of Licensed
Material Used To Assess Financial Assurance for Decommissioning
The NRC is proposing to revise the table of radionuclide activity
values used for determining decommissioning financial assurance (DFA)
for sealed and unsealed radioactive materials. The proposed rule would
revise the current table in appendix B, ``Quantities of Licensed
Material Requiring Labeling,'' to 10 CFR part 30, ``Rules of General
[[Page 28918]]
Applicability to Domestic Licensing of Byproduct Material,'' by
replacing its applicable values from the table in appendix C,
``Quantities of Licensed Material Requiring Labeling,'' to 10 CFR part
20, ``Standards for Protection against Radiation.'' This would add
radionuclides not currently listed in appendix B to 10 CFR part 30,
including radionuclides associated with industrial technologies and
current and emerging medical uses. These changes would generally reduce
DFA requirements for most licensees and eliminate the need for certain
exemptions. In addition, the NRC would remove all radionuclides with a
half-life of 120 days or less from the appendix, since these
radionuclides are not considered when developing DFA, and amend the
title of the table to ``Quantities of Licensed Material Used to Assess
Financial Assurance for Decommissioning,'' to more accurately reflect
its current use for DFA. The default values would remain at their
current values. The NRC is proposing to revise Sec. 70.25 to match the
proposed changes to appendix B to part 30.
C. Part 31 Creating New Classes of General Licenses and Modernization
of Current Classes of General Licenses
The NRC is proposing to establish a new class of general licenses
(GLs), called standard general licenses (SGLs), to address anti-
competitive barriers. The proposed framework would permit GLs for
portable gauges, additional fixed gauges, a subset of diagnostic
medical uses, additional analytical instruments, and additional in
vitro testing. The SGLs would be granted by regulation, and requires
submission of a registration, fee, and certification of understanding.
Proposed rule language, found in Sec. Sec. 31.13 through 31.18, is
based on standard license conditions and essential standard commitments
related to programs necessary for radiological safety and security.
Conforming changes are proposed in other parts of 10 CFR parts 30 and
32 to ensure radioactive materials can be distributed to and from the
standard general licensees. The SGL pathway would create a second
option for licensing such that entities could select between a SGL or a
specific license for certain activities. The specific license pathway
for entities wishing to conduct activities in a non-standard manner or
outside of the normal conditions would be preserved so as to not limit
flexibility. However, licensees could select the lower regulatory
burden standard general licensing pathway if they are able to conduct
activities within the framework of the SGL for their specified
activity.
Additionally, the NRC is proposing to amend requirements in 10 CFR
part 31, ``General Domestic Licenses For Byproduct Material,'' to
permit electronic transmission of registrations for Sec. 31.5
registerable devices, harmonize holding periods with decommissioning
timelines in Sec. 30.36, align physical inventory frequencies with
equivalent physical inventory limits for specific licenses, and
harmonize in vitro test vial limits with labeling limits in 10 CFR part
20.
D. Parts 32 and 40 Reducing Reporting Requirements for Consumer
Products Containing Small Quantities of Radioactive Material
The NRC is proposing to amend several regulations governing the
distribution of exempt byproduct material and source material. This
proposed rule would eliminate the requirements under 10 CFR part 32,
``Specific Domestic Licenses to Manufacture or Transfer Certain Items
Containing Byproduct Material,'' and 10 CFR part 40, ``Domestic
Licensing of Source Material,'' that require licensees to submit an
annual report of transfers to the NRC. The elimination of these
requirements would reduce the licensee's burden of preparing and
providing records and would reduce the burden of the NRC to collect,
manage, and store the reports while still remaining protective of
public health and safety given that the NRC will still maintain access
to the information.
E. Part 32 Expanding Distribution Pathways for Microsources
The NRC is proposing to amend requirements in Sec. 32.72 to
include microsources, such as radioactive microspheres, within its
scope, which would allow commercial radiopharmacies to prepare and
distribute these materials. The proposed rule would expand eligibility
to any applicant legally authorized under applicable Federal or State
law to manufacture, compound, prepare, or distribute radioactive drugs
or medical devices, providing flexibility for future distribution
pathways authorized by the U.S. Food and Drug Administration (FDA) or
State regulatory bodies. In addition, the NRC is proposing to revise
Sec. 32.74 to clarify that it may also be used to distribute
microsources and authorize distribution to any licensee authorized to
use the source or device under 10 CFR part 35, ``Medical Use of
Byproduct Material,'' without limitation to specific subparts. These
changes would allow for smooth distribution of microsources to medical
use licensees.
F. Part 34 Reducing Anti-Competitive Barriers and Administrative
Requirements for Industrial Radiography
The NRC is proposing to amend the requirements associated with
industrial radiography operations in 10 CFR part 34, ``Licenses for
Industrial Radiography and Radiation Safety Requirements for Industrial
Radiographic Operations.'' These revisions to the proposed rule would
address anti-competitive barriers due to overly prescriptive
performance requirements for industrial radiography equipment, provide
clarity regarding ambiguous language in the two-person rule, and reduce
or remove administrative and obsolete requirements. These proposed
changes would reduce the regulatory burden on licensees and applicants
by reducing or eliminating administrative requirements for
recordkeeping and notifications. Additionally, revisions to the
performance requirements for industrial radiography equipment would
remove the need to meet the requirements in American National Standards
Institute (ANSI) N432-1980, ``Radiological Safety for the Design and
Construction of Apparatus for Gamma Radiography'' and replace them with
requirements to register the device in accordance with Sec. 32.320 of
this section. These changes will ensure that radiation safety is
maintained while reducing anti-competitive regulatory barriers and
allowing for innovation in the design of radiography equipment.
G. Part 39 Modernizing Well Logging Regulations
The NRC is proposing to amend the rules associated with well
logging in 10 CFR part 39, ``Licenses and Radiation Safety Requirements
for Well Logging.'' These revisions to the proposed rule would remove
or modify redundant and unnecessary regulations regarding the use of
nuclear material in well logging operations that support the oil and
gas exploration industry. The proposed rule would revise leak testing
requirements to allow for the sealed source leak testing frequency in
accordance with the Sealed Source and Device Registration (SSDR),
extend the survey meter calibration frequency in Sec. 39.33 from 6
months to 12 months, and eliminate unnecessary notifications. These
changes would reduce the regulatory burden on licensees by reducing or
eliminating administrative requirements and notifications while
maintaining safety.
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H. Part 150 Modernizing Requirements for Agreement State Licensees in
Part 150
The NRC is proposing to amend the rules in 10 CFR part 150,
``Exemptions and Continued Regulatory Authority in Agreement States and
in Offshore Waters Under Section 274,'' to remove the requirement for
Agreement State licensees using special nuclear material of low
strategic significance to meet the physical protection requirements in
10 CFR part 73, ``Physical Protection of Plants and Materials.'' Forty
years of operational experience has demonstrated that this material is
adequately secured under the Agreement State oversight. Additionally,
the NRC is proposing to amend the requirements in Sec. 150.20 to
reduce the amount of time an Agreement State licensee has to file for
reciprocity before initiation of work activities in an NRC
jurisdiction, eliminate the need to notify the NRC of location changes
for work in offshore waters, and allow SGLs to be recognized by the NRC
for the purposes of reciprocity. This action would reduce
administrative burden on the applicant and the NRC while maintaining
safety.
IV. Discussion
The NRC, as directed in E.O. 14300, Section 5, undertook a review
of its regulations of the use of byproduct, source, and special nuclear
material. The NRC's goal in its review was to identify in its
regulations areas that could be modernized while ensuring the continued
safe, effective, and efficient use of byproduct material. The NRC has
identified changes which would yield significant efficiencies and
reduce regulatory burden for licensees, NRC, and Agreement States while
upholding our shared commitment to public safety. These actions would
reduce the burden of the NRC's licensing process, eliminate the need
for certain exemptions from existing regulations, and eliminate
unnecessary requirements
Each section presents information on a different part impacted by
the proposed rule, detailing what action the NRC is proposing and whom
the action affects and how.
The NRC prepared an unofficial redline strikeout version of the
proposed changes to regulatory text that is intended to help the reader
identify the proposed changes. The unofficial redline strikeout version
of the proposed rule is publicly available and is listed in the
``Availability of Documents'' section.
Part 30 Reducing Anti-Competitive Barriers in Consortium Definition
On October 1, 2007, the NRC published a final rule (72 FR 55864) to
amend 10 CFR part 30 to implement provisions of the Energy Policy Act
of 2005 (EPAct). The amendments included a revision to Sec. 30.4 to
add a definition for the term ``consortium.'' Under the definition in
10 CFR 30.4, a consortium was an association of medical use licensees
and a PET radionuclide production facility located at an educational
institution, Federal facility, or noncommercial medical facility ``in
the same geographical area'' that jointly own or share the operation
and maintenance costs of the facility. The rule provided regulatory
relief to consortia engaged in the noncommercial production and
distribution of PET radionuclides for medical use, including
authorization for noncommercial transfers under Sec. 30.32(j) without
requiring a separate distribution license under Sec. 32.72. The
geographical limitation was included due to the short half-lives of PET
radionuclides, such as fluorine-18 (1.8 hours) and carbon-11 (20
minutes), which require rapid production and delivery to ensure timely
medical use. However, there was no safety reason provided for the
limitation and it was based on the supply chain difficulties associated
with short-lived radionuclides. While some changes in the medical use
of byproduct material have introduced longer lived PET radionuclides
into use, such as copper-64 (12.7 hours), the NRC has determined that
licensees and regulators have found the phrase ``geographical area''
lacks clarity as to when consortium relief applies. In addition,
requiring the PET production facility to be located in the same
geographic area, when safe transfer of PET radionuclides can occur
following all other applicable requirements, unnecessarily inhibits
licensees' ability to establish or participate in cost-effective,
collaborative PET radionuclide production arrangements.
The NRC proposes a revision to Sec. 30.4 to change the definition
for the term ``consortium.'' The definition would support the
regulation of accelerator-produced radioactive materials, including PET
radionuclides used in medical imaging. Under the proposed definition, a
consortium would be an association of medical use licensees and a PET
radionuclide production facility that jointly own or share in the
operation and maintenance cost of the PET radionuclide production
facility that produces PET radionuclides for use in radioactive drugs
within the consortium for noncommercial distribution among its
associated members for medical use. The proposed rule would remove the
requirement to be in the same geographical area and would provide
regulatory relief to consortia engaged in the noncommercial production
and distribution of PET radionuclides for medical use, including
authorization for noncommercial transfers under Sec. 30.32(j) without
requiring a separate distribution license under Sec. 32.72.
Part 30 Modernizing Appendix B and Part 70 Quantities of Licensed
Material Used To Assess Financial Assurance for Decommissioning
Decommissioning financial assurance is a guarantee or other
financial agreement provided by a licensee to ensure that sufficient
funds are available to complete decommissioning activities in a safe
and timely manner. The NRC's regulations in Sec. Sec. 30.35 and 70.25,
``Financial assurance and recordkeeping for decommissioning,'' provide
tables of required funds that need to be saved by each licensee. These
regulations rely on the values provided in appendix B to 10 CFR part 30
when determining the amount of DFA required for unsealed and sealed
byproduct material and unsealed special nuclear material. As noted in
Sec. Sec. 30.35(a)(1) and 70.25(a)(2), a decommissioning funding plan
(DFP) must be submitted when unsealed radionuclide activities exceed 1
x 10\5\ times the applicable quantities listed in appendix B to 10 CFR
part 30 and fixed amounts of DFA are required when unsealed
radionuclide activities exceed 1 x 10\3\ times the applicable
quantities listed in that appendix B to part 30. Individuals with
licenses authorizing the possession and use of sealed sources or plated
foils at quantities 1 x 10\12\ times the values in appendix B to 10 CFR
part 30 must also submit DFPs and fixed amounts of DFA are required
when radionuclide activities in sealed sources or plated foils exceed 1
x 10\10\ times the applicable quantities listed in appendix B to part
30. The potentially affected licensees are those authorized to possess
licensed materials above these limits.
Appendix B to 10 CFR part 30 includes default possession values for
radionuclides not specifically listed. The default possession values
are equal to the lowest values listed in appendix B to 10 CFR part 30
for specific alpha, beta, and gamma-emitting radionuclides. Use of the
default values may result in licensees needing more DFA than is
warranted based on the risk to public health and safety. For example, a
licensee possessing more
[[Page 28920]]
than 0.1 millicurie (mCi) but less than 1 mCi of an unsealed non-alpha-
emitting isotope, would be required under Sec. 30.35(d) to provide
$225,000 in DFA. To possess more than 1 mCi of the non-alpha-emitting
isotope, a licensee would be required to provide $1,125,000 in DFA, and
a DFP would be required to possess more than 10 mCi. However, if the
NRC revised appendix B to 10 CFR part 30 to adopt the values in
appendix C to 10 CFR part 20, the minimum possession threshold for DFA
or a DFP would increase 100-fold for accelerator-produced radioactive
material (NARM) isotopes germanium (Ge)-68, gold-195, and sodium-22.
Therefore, the application of the current generic default possession
values creates a regulatory burden by requiring licensees to provide
decommissioning funding that is not commensurate with the risk of
isotope-specific possession values.
In a petition for rulemaking (PRM) docketed as PRM-30-66, the
Organization of Agreement States (OAS) requested that the NRC provide
specific possession values for naturally occurring and NARM
radionuclides that are not currently listed in appendix B to 10 CFR
part 30 so that licensees using these isotopes, especially medical
licensees, would not have to apply the appendix's default values to
calculate decommissioning funding requirements. The OAS stated that
patient health and safety are being compromised due to delays in
licensing important diagnostic and therapeutic products that use
radionuclides not listed in appendix B to 10 CFR part 30, and that
these licensing obstacles could discourage the development of new
medical and industrial applications. The OAS also suggested that,
rather than issuing exemptions on a case-by-case basis, the more
appropriate way to address the inconsistency in appendix B to 10 CFR
part 30 is to amend the regulation to add appropriate radionuclides and
their corresponding activities.
The NRC is proposing to update appendix B to 10 CFR part 30,
``Quantities of Licensed Material Requiring Labeling,'' with
radionuclides and values from appendix C to 10 CFR part 20,
``Quantities of Licensed Material Requiring Labeling'' for values that
are equal to or higher than the current default value in appendix B to
10 CFR part 30. This would add radionuclides not currently listed in
appendix B to 10 CFR part 30, including radionuclides associated with
industrial technologies and current and emerging medical uses.
The proposed revisions to the list of radionuclides in appendix B
to 10 CFR part 30 would align with the NRC's regulatory authority under
the EPAct. The EPAct amended the definition of byproduct material to
include NARM radionuclides and provided the NRC authority over this new
category of byproduct material. Germanium (Ge)-68 and gallium (Ga)-68,
radionuclide generators are of particular concern to those in the
medical field since Ge-68 is not listed in appendix B to 10 CFR part 30
and the default values resulted in overly conservative decommissioning
financial assurance requirements. In the report, ``Germanium-68 (Ge-68)
Decommissioning Funding Plan (DFP) Final Report,'' dated August 12,
2015, the Advisory Committee on the Medical Uses of Isotopes (ACMUI)
concluded that the restrictive aspects of a DFP for Ge-68/Ga-68
generators that arise from the current 10 CFR part 30 regulations were
preventing or deterring the use of promising Ga-68 diagnostic imaging
agents for patients and recommended that the NRC address the DFP
concerns relative to Ge-68/Ga-68 generators through rulemaking. The NRC
has granted a limited number of exemptions for licensees that use Ge-
68/Ga-68 generators under certain conditions. These exemptions were
approved in advance of this rulemaking. By providing a regulatory
solution through rulemaking, the NRC would create a more stable
regulatory framework for applicants, licensees, and regulators. In
cases where the values in appendix C to 10 CFR part 20 are lower than
the values currently listed in appendix B to 10 CFR part 30, the NRC
proposes maintaining the current values in appendix B to 10 CFR part
30. This means the values listed in appendix B to part 30 would align
with the majority of values listed in appendix C to part 20 except for
americium-241, cadmium-109, plutonium-239, uranium-233, uranium-234,
uranium-235, zirconium-93, the default value for any alpha-emitting
radionuclide not listed or mixtures of alpha emitters of unknown
composition, and the default value for any radionuclide other than
alpha emitting radionuclides not listed or mixtures of beta emitters of
unknown composition which would remain at their current values.
Each of the values that would remain at their current values are a
factor of 10 higher than what is listed in appendix C to 10 CFR part
20. If the values for these radionuclides were adopted from appendix C
to 10 CFR part 20, then the values would decrease, and several
licensees would become subject to DFA requirements. This would result
in an undue burden to this population of licensees in obtaining DFA or
requesting an exemption from the requirements. Since implementing DFA
requirements in 1988, the NRC has not identified any instance where a
licensee with these radionuclides has had insufficient DFA or any
negative safety consequences because of insufficient DFA.
Because there is no safety related reason to decrease any values
listed in appendix B to 10 CFR part 30, the NRC proposes maintaining
status quo for the values for americium-241, cadmium-109, plutonium-
239, uranium-233, uranium-234, uranium-235, zirconium-93, the default
value for any alpha-emitting radionuclide not listed or mixtures of
alpha emitters of unknown composition, and the default value for any
radionuclide other than alpha emitting radionuclides not listed or
mixtures of beta emitters of unknown composition in appendix B to 10
CFR part 30. The default values in appendix B to 10 CFR part 30 remain
at their current values. These changes will either reduce or not affect
the amount of DFA required for licensees, depending on the mixture of
radionuclides the licensee possesses.
Finally, the NRC would remove all radionuclides with a half-life of
120 days or less from the updated appendix B to 10 CFR part 30 because
these radionuclides are not considered when developing DFA.
Additionally, the NRC is also proposing a revision to Sec. 70.25(a)(2)
and (b) to specify unsealed special nuclear material ``of half-life
greater than 120 days.'' NRC experience shows that short-lived
radionuclides do not require major decommissioning efforts, as
radionuclides with half-lives of 120 days or less naturally decay to
negligible levels within a few years.
This rulemaking also includes changing the title to appendix B to
10 CFR part 30 to clarify the intent and purpose of the appendix.
Appendix B to 10 CFR part 30 is used solely for the purpose of
calculating the required amounts of DFA. Therefore, this proposed rule
would change the title of appendix B to 10 CFR part 30 from
``Quantities of Licensed Material Requiring Labeling'' to ``Quantities
of Licensed Material Used to Assess Financial Assurance for
Decommissioning.''
These proposed revisions address the changes requested in PRM-30-66
from the OAS requesting that the NRC conduct rulemaking to provide an
expeditious solution to the DFA concerns of applicants and licensees
who currently use, or plan to use, the unlisted NARM radionuclides,
especially in the diagnosis and treatment of diseases.
[[Page 28921]]
Under current requirements, licensees may choose to submit either a
DFP under Sec. 30.35(e) or a certification that financial assurance
for decommissioning has been provided in the amount prescribed by Sec.
30.35(d). Although medical licensees generally possess smaller
quantities of radioactive material than major nuclear facilities and
typically use certifications under Sec. 30.35(d), they may possess
unsealed radionuclides with half-lives greater than 120 days and thus
could develop facility-specific decommissioning cost estimates in
accordance with Sec. 30.35(e). While the review and approval of DFPs
under Sec. 30.35(e) could be resource intensive for both the applicant
or licensee and the regulatory agency, some licensees might find the
submission of a DFP more cost effective than the certification of
financial assurance for decommissioning using DFA values based on the
default radionuclide threshold values in appendix B to 10 CFR part 30.
The proposed changes to radionuclide values in appendix B to 10 CFR
part 30 would decrease, or maintain, the amount required for
decommissioning financial assurance for an individual NRC 10 CFR part
30 licensee. After evaluating the impact of the proposed provisions on
their decommissioning financial assurance mechanism, a licensee may be
required to make revisions that lead to additional costs. However, the
NRC expects that most 10 CFR part 30 licensees would benefit from these
changes. This was demonstrated both by the petition that initiated the
rulemaking and by the public responses to the draft regulatory basis
supporting a rulemaking on decommissioning financial assurance for
sealed and unsealed radioactive materials (87 FR 25157).
NRC licensees under subpart H of 10 CFR part 70, as required by
Sec. 70.25(b) must submit DFPs. The changes to appendix B to 10 CFR
part 30 would not impact 10 CFR part 70 licensees, as their possession
quantities exceed the threshold identified in Sec. 70.25(d).
Under the proposed rule all affected licensees would be required to
review the updated appendix B to 10 CFR part 30 to determine whether
changes are needed. Licensees that no longer require DFA or a DFP or
could decrease their DFA, could do so voluntarily at their discretion
after the effective date of the rule. Licensees would need to request
NRC approval when making any changes to their DFAs or DFPs. For
licensees where no change is required, the NRC would verify compliance
during triannual reviews and as part of routine inspection activities.
Part 31 Creating New Classes of General Licenses and Modernization of
Current Classes of General Licenses
A. Standard General Licenses (SGL)
Consistent with its authority under the AEA, the NRC may issue
general or specific licenses for the use of byproduct, source, and
certain quantities of special nuclear material. A specific license is
issued to a named entity after the filing of an application with the
Commission. Additionally, amendments to specific licenses are required
when a variety of changes occur. In the case of applications and
amendments, the NRC and licensee engage in back and forth communication
until a licensing basis is solidified and documented in a licensing
document. Specific licenses cover a wide range of activities of
byproduct material and have a variety of associated risk profiles. Some
activities are conducted in a standard method across the industry,
while others are conducted in a non-uniform manner. The specific
licenses for standard operations use consistent license authorizations
and conditions, such that, these specific licenses appear almost
identical across the industry with the exception of individuals named
on the license and the locations authorized by the license. For
example, the majority of specifically licensed portable gauge licensees
operate under the same license conditions and have the same license
commitments. The burden associated with applying for a specific license
and maintaining a specific license is unnecessarily high for low risk,
standard operations when the specific license follows the standard
format.
A GL is issued by regulation and grants authority to entities
conducting the activities specified in the regulation issuing the GL.
Requirements for general licensees appear in the regulations and are
designed to be commensurate with the specific activities covered by the
GL. A GL is effective without the need for a user to file an
application with the Commission or the issuance of a licensing document
to a particular person. However, certain GLs may require registration
with the Commission. Under 10 CFR part 31, the Commission grants GLs
for certain uses of byproduct material and provides the requirements
associated with these GLs. This regulatory framework has proven to be
effective and a low burden for many low risk, standard activities.
The NRC is proposing to create a new class of GLs within subpart C
of 10 CFR part 31 for a subset of low-risk activities that are
currently specifically licensed, including fixed gauging, portable
gauging, certain medical uses, certain analytical equipment uses, and
certain in vitro testing uses. The impacted groups would be permitted
to choose between two licensing pathways. An SGL would require
submission of a registration, fee, and certification of understanding
for five types of technology. The NRC is proposing that each type of
technology has requirements codified in a separate regulation. For
example, the NRC is proposing requirements for a Standard General
License for Certain Fixed Gauging in Sec. 31.14, a Standard General
License for Portable Gauging in Sec. 31.15, a Standard General License
for Certain Medical Uses in Sec. 31.16, a Standard General License for
Certain Analytical Equipment Including Electron Capture Detectors, X-
Ray Fluorescence Devices, and Ion Generators in Sec. 31.17, and a
Standard General License for Certain In Vitro Testing in Sec. 31.18.
The NRC is proposing administrative requirements, such as notifications
and decommissioning, applicable to each of the SGLs in Sec. 31.13.
The proposed rule language is based on standard license conditions
and essential standard commitments related to programs necessary for
radiological safety and security. The standard license conditions and
essential standard commitments were derived from risk significant
elements of NUREG-1556, ``Consolidated Guidance About Materials
Licenses''. Elements taken from program specific NUREG-1556 Volumes and
codified in the rule come from the ``Response from Applicants''
sections of NUREG-1556 and revolve around establishing programs,
processes, and procedures to safely conduct licensed activities. These
sections are tied to regulatory requirements in 10 CFR that are general
in nature so NUREG-1556 provides methodologies to meet the general
requirements for the safe conduct of licensed activities.
The proposed rule language requires, by reference, compliance with
applicable regulations found in other applicable parts of 10 CFR to
ensure the new general licensees comply with all applicable provisions
that they are currently subject to by their specific licenses. In
addition, the NRC is proposing inventory limitations in Sec. 31.13(c)
that would prohibit a single general licensee from aggregation of
materials requiring implementation of requirements contained in 10 CFR
part 37, materials requiring a decommissioning plan or financial
assurance, and materials requiring an emergency plan. The GLs would not
be
[[Page 28922]]
subject to any requirements beyond what is currently required to obtain
a specific license. Under this proposed rule, entities would still have
the flexibility to choose to obtain a specific license.
The NRC is proposing conforming changes in other parts of 10 CFR to
ensure radioactive materials can be distributed to and from the new
GLs. Conforming changes include: the definition of principal activities
in Sec. 30.4, addition of SGLs to Sec. 30.6, addition of SGLs in
Sec. 30.34(h)(1), addition of SGLs to Sec. 30.35(g), addition of SGLs
to Sec. 30.41(d)(1), addition of Standard General License for Certain
Medical Uses to Sec. 32.72(a), addition of Standard General License
for Certain Medical Uses to Sec. 32.74(a), and addition of SGLs in
Sec. 150.20.
Overall, the SGL pathway would reduce the burden on the licensee as
well as the NRC while maintaining adequate safety, security, and
oversight of these licensed activities. The current licensing pathway
would exist as it does today, so no impact may be observed to licensees
who chose to remain specifically licensed. However, licensees could
select the SGL pathway if they are able to conduct activities within
the framework of the SGL for their specified activity. The SGL option
would have a lower application fee, lower annual fee, and would
eliminate the need to submit licensing correspondence such as amendment
requests. Instead of amendments, a notification process would be used
for specified program changes. The SGLs would be subject to an
inspection program that is equivalent to the inspection for the same
specifically licensed activities. As part of the NRC's response to the
ADVANCE Act of 2024, the NRC is reviewing current inspection programs
including the frequency of inspection conducted under Inspection Manual
Chapter 2800, ``Materials Inspection Program''.
B. Current Classes of General Licenses--10 CFR 31.5 Licensees
General licenses in Sec. 31.5 currently authorize use of certain
devices. The NRC is proposing changes to these requirements to reduce
burden while maintaining protection of public health and safety.
Currently, registrations for generally licensed devices as required
by Sec. 31.5(c)(14) must be submitted to the Commission by mail.
However, most entities subject to this requirement use electronic
communications as their primary communication method. The NRC is
proposing to amend Sec. 31.5(c)(14) to add electronic communication
methods, such as email, as permitted communication methods.
Additionally, the NRC is proposing to add a mailing address that is
compatible for signature required correspondence should an entity wish
to send their registration as signature required.
Currently, Sec. 31.5(c)(15) permits general licensees to hold
devices for a period of no longer than 2 years. The term hold is used
to describe a licensee's action of keeping a device in its possession
that is no longer in use and no longer planned to be used; this is
typically the period where a device is out of service prior to disposal
of the device. This has shown to be constraining to business operations
since entities may need to hold devices for longer than 2 years. For
example, an entity may take a device out of service with the intention
of disposing of it. However, it may take longer than 2 years to solicit
bids for disposal, obtain a contract, and complete the disposal. The
NRC is proposing to amend Sec. 31.5(c)(15) to revise the holding
period for GLs from 2 years to 36 months. Additionally, holding periods
for generally licensed devices are based on decommissioning time
periods for many types of specific licensees. Currently, the time
period in Sec. 30.36(d) and Sec. 31.5(c)(15) is 2 years. However, as
part of its response to E.O. 14300, the NRC is considering increasing
this time period to 3 years.
Currently, Sec. 31.5(c)(15) requires general licensees to perform
quarterly physical inventory on devices that are placed on standby. The
term standby is used to describe a licensee's action of keeping a
device in their possession that they plan to return to service and use
in the future. However, the regulatory framework for sealed sources
that have fewer inherent safety features require physical inventories
every 6 months. For example, sealed sources possessed by medical
licensees are subject to Sec. 35.67 which requires physical
inventories of sealed sources at a semi-annual periodicity. Similarly,
licensed materials in well-logging activities are subject to Sec.
39.37 which requires physical inventories of licensed material at a
semi-annual periodicity. Additionally, the majority of sealed sources
possessed by specific licensees are subject to semi-annual physical
inventories through license conditions based on the applicable volume
of the NUREG-1556 series, ``Consolidated Guidance About Materials
Licenses.'' A quarterly physical inventory is overly burdensome and
restrictive in comparison to the Commission's holistic regulatory
framework related to physical inventories. The NRC is proposing to
amend Sec. 31.5(c)(15) to change the physical inventory frequency from
quarterly to semi-annually for devices on standby. By changing the
periodicity to semi-annually, the NRC would ensure consistent
requirements are imposed across various licensee populations in regard
to physical inventory requirements. Specifically, the risk profile for
generally licensed devices is lower than the risk profile for
specifically licensed devices for which a semi-annual inventory is
required for sealed sources. Since the inception of the generally
licensed device program in the 1970s, the NRC has obtained sufficient
operating experience to demonstrate that this population of licensees
generally has adequate material control and accountability such that
quarterly inventories are not necessary.
These changes would affect entities required to register devices
under Sec. 31.5. Affected entities currently include holders of
certain generally licensed devices. The changes would provide
flexibility to the communication methods permitted, which increase
efficiency, and save entities the cost of mailing physical copies.
Additionally, the changes to holding periods would provide flexibility
to entities by allowing them to hold devices for a longer time period
before disposal is required, should the time period for decommissioning
increase. Finally, the change to physical inventories would reduce the
number of times per year that an entity must conduct a physical
inventory of their generally licensed devices. This would cut the time
spent on physical inventories in half.
C. Current Classes of General Licenses--10 CFR 31.11 Licensees
Currently, Sec. 31.11(a) limits the total activity per vial for in
vitro clinical or laboratory testing for certain persons, including
physicians. The limit for carbon-14 is 10 microcuries, the limit for
hydrogen-3 is 50 microcuries, the limit for selenium-75 is 10
microcuries, and the limit for cobalt-57 is 10 microcuries. Meanwhile,
10 CFR part 20 only requires labeling for quantities that are above
these activities. Specifically, 10 CFR part 20 appendix C requires
labeling for carbon-14 at 100 microcuries, hydrogen-3 at 1,000
microcuries, selenium-75 at 100 microcuries, and cobalt-57 at 100
microcuries. Additionally, Sec. 30.71 Schedule B provides exempt
quantity thresholds that are higher than the GL limits. Specifically,
Sec. 30.71 Schedule B states the exempt quantity limit for carbon-14
is 100 microcuries, hydrogen-3 is 1,000 microcuries, selenium-75 is
[[Page 28923]]
10 microcuries, and cobalt-57 is 100 microcuries. The conflict between
exempt quantities in Sec. 30.71 Schedule B and the values in Sec.
31.11(a) pose an unclear regulatory framework for entities working with
quantities above the vial limit, but below the exempt quantity limit.
The NRC is proposing to amend Sec. 31.11(a) to increase the
prepackaged unit limit from 10 microcuries to 100 microcuries for
carbon-14, from 50 microcuries to 1,000 microcuries for hydrogen-3,
from 10 microcuries to 100 microcuries for selenium-75, and from 10
microcuries to 100 microcuries for cobalt-57.
The proposed change would affect entities that are currently
required to obtain a specific license for in vitro testing to use
prepackaged units above the current limits and instead would allow
entities to handle prepackaged units with higher activity under a GL.
Additionally, it would provide clarity to the licensee community since
the current limits in Sec. 31.11 for carbon-14, hydrogen-3, selenium-
75, and cobalt-57 are below the exempt quantity limits in 10 CFR part
30 Schedule B or below the limits requiring labeling in 10 CFR part 20
appendix C.
Finally, physician is currently defined in Sec. Sec. 30.4 and
35.2. With various rulemakings in progress to meet the requirements of
E.O. 14300, divergent definitions across the byproduct material
regulatory framework could emerge if the definition in 10 CFR part 35
is revised without also revising the definition in 10 CFR part 30 in
parallel. The NRC is proposing conforming changes in Sec. 30.4 to
remove the definition of physician as it is already defined in 10 CFR
part 35 and not used in 10 CFR part 30. This would increase regulatory
clarity and ensure one single definition is present within the NRC's
byproduct material regulatory framework.
Part 32 and 40 Reducing Reporting Requirements for Consumer Products
Containing Small Quantities of Radioactive Material
In this rulemaking, the NRC is proposing to remove certain
reporting requirements, while still requiring the information be
maintained and available for review by the NRC, to ensure regulatory
requirements are commensurate with risk and information needs. On March
24, 1983, the NRC published a final rule (48 FR 12331) to amend 10 CFR
part 32. The amendments to 10 CFR part 32 included modifications to the
reporting and recordkeeping requirements for licensees authorized to
distribute consumer products containing small quantities of byproduct
material (exempt items). Prior to this change, these regulations
required licensees to submit an annual report to the NRC specifying the
total quantity of byproduct material transferred to each type of
consumer product and the total number of each product transferred
during the reporting period. An annual report was required even if a
licensee made no transfers during the reporting period. Under the rule,
licensees were required to submit a report every five years, or at the
time of application for renewal of the specific license, or at the time
the licensee notifies the NRC that it is discontinuing distribution of
these consumer products.
On October 16, 2007, the NRC published a final rule (72 FR 58473)
to amend 10 CFR part 32, changing the reporting requirements back to an
annual basis and to include details on what information should be
included in the report. The rationale provided in the 2007 final rule
was that changing back to annual reporting cycle, instead of a 5-year-
cycle, would provide timely information for the NRC to fully determine
the products and amount of byproduct material distributed annually
which impacted the efforts of developing the NUREG-1717, ``Systematic
Radiological Assessment of Exemptions for Source and Byproduct
Materials,'' and contributed to uncertainties in the results.
With respect to source material, on May 29, 2013, the NRC published
a final rule (78 FR 32310) to amend 10 CFR part 40. The amendment
required licensees to obtain a specific license rather than be
permitted to operate under a GL. The amendment also included conditions
for the initial distributor such as requirements for reporting and
recordkeeping. The rule required that initial distributors of products
used under an exemption in Sec. 40.13(c) submit a report of transfer
each year, following the same practice as consumer products distributed
under 10 CFR part 32.
Since 2013, the NRC has not received complete or timely information
regarding products and materials containing byproduct material and
source material distributed for use under exemptions from licensing,
despite the annual reporting frequency required under the 2007 and 2013
final rules. While the reevaluation of the reporting requirements
suggested that annual reporting and additional information to be
provided would improve inefficiencies in data collection, these issues
have not been resolved. Licensees have not provided information clearly
and consistently. There are also programmatic implementation issues in
the collection, management, and storage of these reports. The intent of
the information was to have readily available data to assess public
exposure to radiation from these products and inform the Commission on
the extent of distribution, if needed. However, this information, while
useful, has been seldomly used. The NRC maintains the same access to
the data by requesting information from the licensee when the need
arises, instead of requesting a formal report to be submitted annually.
Furthermore, the NRC has decades of data that can be used to support
gaps in assessing public dose.
The NRC is proposing updating the regulations in Sec. Sec. 32.12,
32.16, 32.20, 32.25(c), 32.29(c), and 32.32(c) to remove the annual
reporting requirements. With this proposed change, licensees would be
required to maintain the records of transfer per the record retention
policy in Sec. 30.51 and make the information available to the NRC
upon request.
The elimination of the reporting requirements would reduce the
licensee's burden of preparing and providing records and would reduce
the burden of the NRC to collect, manage, and store the reports while
still remaining protective of public health and safety given that the
NRC will still maintain access to the information. This change would
also be applicable to exempt products under 10 CFR part 40 and the
required reporting under Sec. 40.53(c). For exempt products under 10
CFR part 40, records would need to be maintained in accordance with
Sec. 40.61 and made available to the NRC upon request.
This proposed change would affect specific licensees who maintain a
license under Sec. Sec. 32.11, 32.14, 32.22, 32.26, 32.30, and 40.52
for distribution of consumer products under 10 CFR part 30 or 10 CFR
part 40. Licensees would no longer have to submit an annual report to
the NRC. Record retention policy would follow the regulations in
Sec. Sec. 30.51 and 40.61, for byproduct and source material
respectively. This would allow the NRC to have access to information
when needed, while at the same time reducing the burden on licenses in
preparing and submitting the reports. Requesting the information when
needed may introduce some burden due to unscheduled data collection,
but it would be outweighed by the reduction in burden of annually
preparing, submitting, and maintaining the records of the report on an
annual basis.
[[Page 28924]]
Part 32 Expanding Distribution Pathways for Microsources
The NRC regulates the distribution of byproduct material for
medical use under 10 CFR part 32. Specifically, Sec. 32.72 governs the
commercial distribution of radioactive drugs, while Sec. 32.74 governs
the distribution of sources and devices containing byproduct material.
However, recent developments in clinical practice have highlighted the
need to allow both distribution pathways to be available to
microsources, which include radioactive microspheres used for
intravascular brachytherapy. The proposed amendments to 10 CFR part 32
in this rulemaking would allow additional authorizations for the
preparation and distribution of radioactive microspheres.
Microspheres are regulated by the FDA as medical devices and they
are not considered radioactive drugs. As such, manufacturing,
preparation and transfer of microsources is not addressed under Sec.
32.72 and must be authorized under Sec. 32.74, even though the
radiation safety considerations between microsources and radioactive
drugs are similar. This requirement has become a burden following the
implementation of United States Pharmacopeia (USP) General Chapter
<825>, which included standards for the preparation, compounding,
dispensing, and repackaging for radioactive microspheres similar to
radiopharmaceuticals.
The USP sets quality, purity, strength, and identity standards for
medicines, food ingredients, and dietary supplements used in the United
States. USP standards are enforceable by the FDA and State Boards of
Pharmacy. As such, USP standards are widely adopted in healthcare and
pharmaceutical practice. USP <825> requires that sterile radioactive
microspheres be prepared in International Organization of
Standardization (ISO) Class 5 environments if they are to be used more
than one hour after puncture. To comply with these requirements and
accommodate patient-specific treatment schedules, medical use licensees
have increasingly relied on commercial radiopharmacies to prepare and
distribute patient-ready doses of microspheres. As radiopharmacies
historically focused their activities on radioactive drugs, they are
licensed under Sec. 32.72. However, the current regulatory framework
does not authorize commercial radiopharmacies for preparing and
distributing microspheres under Sec. 32.72.
The proposed rule would revise Sec. 32.72 to include microsources
within its scope, which would allow commercial radiopharmacies that are
licensed under this provision to prepare and distribute microspheres.
In addition, the proposed rule would expand those who can use the Sec.
32.72 pathway to any applicant who is legally authorized, under
applicable Federal or State law, to manufacture, compound, prepare, or
distribute radioactive drugs or medical devices to allow flexibility
for future pathways allowed by states or the FDA to distribute
radioactive drugs and medical devices safely.
The NRC is also proposing to revise Sec. 32.74 to provide
provisions specific to microsources, including microspheres. The
revised language ensures clarity that licensees can use either Sec.
32.72 or Sec. 32.74 to distribute microsources. The amendments to
Sec. 32.74 also clarify that the regulation allows distribution to any
licensee authorized to use the source or device under 10 CFR part 35
and does not limit distribution to specific types of medical facilities
listed under specific subparts to avoid unnecessary limitations. A
conforming change to Sec. 30.32 would be made based on the changes in
the structure of Sec. 32.72.
These changes are intended to reduce regulatory burden and improve
clarity for regulators and, radiopharmacy licensees, medical device
manufacturing licensees, and medical licensees. By allowing both
Sec. Sec. 32.72 and 32.74 to serve as licensing pathways for the
distribution of microsources, the NRC is allowing licensees to select
the most appropriate regulatory framework based on their business model
and operational needs. This flexibility supports compliance with USP
<825>, enables timely access to microspheres for patient care, and
maintains public health and safety.
Part 34 Reducing Anti-Competitive Barriers and Administrative
Requirements for Industrial Radiography
The NRC's regulations in 10 CFR part 34 establish the specific
requirements for industrial radiography. The proposed changes to 10 CFR
part 34 in this rulemaking aim to provide greater flexibly in the use
of codes and standards, clarify the two-person rule; and update
prescriptive administrative requirements to allow for a more
performance-based approach, while continuing to ensure the protection
of public health and safety.
Current NRC regulations in Sec. 34.20(a)(1) require that
radiographic equipment meet the standards in ANSI N432-1980,
``Radiological Safety for the Design and Construction of Apparatus for
Gamma Radiography.'' ANSI N432 was incorporated into NRC regulations on
January 10, 1990 (55 FR 843) because manufacturers of radiography
equipment were not all consistently using ANSI N432, nor were they
uniformly or fully implementing the performance criteria intended to
improve radiation safety for workers. However, ANSI N432 has been
superseded by ANSI N43.9-1991, ``For Gamma Radiography--Specifications
for Design and Testing of Apparatus.'' Additionally, other applicable
industry standards have also been developed. Pursuant to the SSDR
program in Sec. 32.210, radiographic exposure devices, source
assemblies, and sealed sources are evaluated using accepted industry
standards 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. The NRC is removing requirements
that incorporate specific standards to stay current with the industry
as these standards may become obsolete or superseded. The proposed rule
would remove the prescriptive and outdated reference to ANSI N432-1980
and instead require that radiography devices, source assemblies, and
sealed sources be evaluated and registered in the SSDR. Additionally,
since Sec. 34.20 also discusses associated equipment that is not
evaluated under the SSDR, the proposed rule would also require that
this equipment meets the manufacturers' specifications and
instructions. Manufacturer specifications include design elements and
criteria necessary for the safe function of the associated equipment.
This change will conform Sec. 34.20 with Sec. 32.210 while continuing
to ensure that radiography licensees use and maintain the radiography
device, sealed source, and associated equipment in accordance with the
industry standards and manufacturer requirements it was designed to
meet. The removal of the incorporation by reference of an industry
standard will also prevent this requirement from becoming superseded
and needing to be revised in the future. Further Sec. 34.20(a)(2) will
remain to provide a pathway for licensees to use alternative standards
on a case-by-case basis. Finally, NRC is proposing a conforming change
to Sec. 34.3 to define SSDR for 10 CFR part 34. These changes will
ensure that radiation safety is maintained while reducing anti-
competitive regulatory barriers and allowing for innovation in the
design of radiography equipment.
[[Page 28925]]
On May 28, 1997, the NRC issued Sec. 34.41(a) ``Licenses for
Industrial Radiography and Radiation Safety Requirements for Industrial
Radiographic Operations,'' commonly called ``the two-person rule,''
which requires a second qualified individual (radiographer or
radiographer's assistant) to be present during industrial radiography
operations at temporary jobsites (TJS) (62 FR 28948). The purpose of
the second individual is to provide immediate assistance when required
and to prevent unauthorized entry into the restricted area.
Prior to 2021, the NRC had consistently interpreted Sec. 34.41(a)
to require both the radiographer and the second qualified individual to
maintain direct observation when radiographic operations are being
conducted at a TJS. Through operating experience, this interpretation
was found to be unnecessary to protect public health and safety, and on
June 1, 2021, the NRC reinterpreted the requirement (86 FR 29173).
Since 2021, NRC has interpreted Sec. 34.41(a) such that the
requirements contained in the sentence, ``[t]he additional qualified
individual shall observe the operation and be capable of providing
immediate assistance to prevent unauthorized entry'' are met if the
second qualified individual is in sufficiently close proximity to the
operation and sufficiently aware of the ongoing activities to be able
to provide assistance or take charge when necessary and to prevent
unauthorized entry. The second individual may perform other tasks
nearby so long as they are cognizant of the site-specific circumstances
when radiographic operations are in progress. In 2021, the NRC also
determined that this interpretation makes Sec. 34.41(a) consistent
with the requirement in Sec. 34.51 that at least one of the two
individuals present at a TJS must ``maintain direct observation of the
operation,'' the NRC discontinued planned rulemaking after determining
that the reinterpretation resolved the issues raised in PRM-34-6 which
requested that 10 CFR part 34 clarify requirements related to the
responsibilities of the second individual required to be present during
radiographic operations.
The proposed rule would combine the requirements in Sec. 34.51
into Sec. 34.41(a) to create a single, concise requirement regarding
the availability and surveillance responsibilities of the qualified
individuals performing industrial radiography at TJSs. This change
seeks to eliminate ambiguity, allowing for technological innovation in
the implementation of the requirement, all while maintaining the
integrity of the performance requirements. Combining Sec. 34.41 and
Sec. 34.51 into a single simplified requirement enhances regulatory
clarity by plainly aligning the requirement with the reinterpretation
from 2021.
Part 34 of 10 CFR currently contains obsolete and overly
prescriptive administrative requirements dating from its last
significant revision in 1997 (62 FR 28948). Many of these requirements
are not consistent with the NRC's modern and performance-based approach
to oversight. For example, the operational history of Sec. 34.101(c),
which requires notification when work activities at a TJS exceed 180
days, is unnecessary because the information is collected during
routine inspections and does not provide value to the NRC's performance
based oversight program. The proposed rule would also reduce
administrative burden on licensees by reducing the record keeping
requirements in Sec. 34.89(b) to remove duplicative records and by
eliminating the notification requirement in Sec. 34.101(c) which
required licensees to notify the appropriate NRC Regional Office prior
to exceeding 180 days at a TJS in a calendar year. The notification
requirement can be eliminated because it can be reviewed through the
routine inspection program.
The proposed rule would align leak testing requirements in Sec.
34.27(c) with the SSDR. The sealed source leak testing frequency in the
SSDR is based on the specifications of the sealed source specific to
the design of the device for which it is used. This proposed change
could reduce administrative burden on radiography licensees while
ensuring that radiation safety is maintained and the leak testing
frequency used is specific to the source model.
The proposed changes would further streamline 10 CFR part 34 by
removing the obsolete legacy requirements related to previous rules
that are no longer applicable and that were put in place to allow
legacy incorporation for certain requirements in Sec. Sec.
34.13(b)(2), 34.27(e), 34.41(d), 34.43(a)(2),(h), and (i).
The proposed revisions to 10 CFR part 34 would affect industrial
radiographic license holders. The changes would reduce the
administrative burden on license holders and the changes to streamline
and clarify which would enable greater comprehension of the rule and
increased compliance. Additionally, the changes to Sec. 34.20 would
allow greater flexibility to industrial radiography equipment
manufacturers by removing the overly prescriptive performance design
criteria that the equipment must currently meet.
Part 39 Modernizing Well Logging Regulations
The NRC is proposing to streamline 10 CFR part 39 to by amending
requirements related to instrument calibration intervals (Sec.
39.33(c)(1)), leakage testing for each sealed source (Sec.
39.35(c)(1)) and certain notification requirements.
Current NRC regulations in Sec. 39.33(c)(1) require that the
licensee shall have each radiation survey instrument calibrated at
intervals not to exceed 6 months and after instrument servicing. The
proposed rule would extend this frequency from 6 months to 12 months to
be consistent with other regulations regarding the calibration of
survey instruments found in 10 CFR parts 35 and 36. It is necessary
that well logging licensees use equipment that has been calibrated to
ensure accuracy of radiation emitted and associated radiation detection
practices, however, this should be consistent with other regulations.
This would ensure that radiation safety is maintained while decreasing
administrative and financial burden on the licensee.
The NRC regulations in Sec. 39.35(c)(1) require that each sealed
source (except an energy compensation source (ECS)) must be tested for
leakage at intervals not to exceed six months. However, other parts of
this chapter allow for leak tests to be conducted at frequency outlined
in the SSDR, which may list periods longer than six months. The
proposed rule would align the leak testing provisions in other parts of
NRC regulations and would be consistent with the intervals approved by
the NRC or an Agreement State on the SSDR. It is necessary that well
logging licensees ensure sealed sources are not leaking; however, this
should be consistent with the source design specifications of the SSDR.
This would ensure that radiation safety is maintained, and the leak
testing frequency used is specific to the source model while reducing
administrative and financial burden on the licensee.
Current NRC regulations in Sec. 39.77(c)(1) require that the
licensee shall notify the appropriate NRC Regional Office by telephone
of the circumstances that resulted in the inability to retrieve the
source and obtain NRC approval to implement abandonment procedures.
These procedures are reviewed and approved by the NRC during the
licensing process. The proposed rule would reduce administrative burden
on applicants and licensees by eliminating
[[Page 28926]]
the notification requirement in Sec. 39.77(c)(1). The notification
requirement can be eliminated because it is not needed for the licensee
to implement operating and emergency procedures for abandonment that
have already been approved by the NRC during the licensing process. The
NRC's approval is for the licensee to implement the procedures that
were approved during licensing, which is unnecessary, because the NRC's
approval at the time of notification does not change the previously
approved procedures. The removal of Sec. 39.77(c)(1) would eliminate
the notification and duplicative approval process for implementing
abandonment procedures.
Part 150 Modernizing Requirements for Agreement State Licensees in Part
150
The proposed changes 10 CFR part 150 concern (1) regulation of
special nuclear material of low strategic significance (SNM-LSS), and
(2) reciprocity, which allows the NRC to recognize Agreement State
licenses in certain circumstances, and vice versa.
First, consistent with Section 274 of the AEA, Agreement States may
assume regulatory authority over SNM in quantities not sufficient to
form a critical mass, including SNM-LSS. SNM-LSS includes gram
quantities of plutonium or uranium-233 or uranium-235, or certain
combinations of the three. These materials are used in research or in
the manufacture of certain radiation detectors. Currently, there are 10
Agreement State licensees that possess SNM of low strategic
significance (SNM-LSS). While otherwise Agreement State licensees, the
NRC reserved regulation over SNM-LSS under its common defense and
security authority. Thus, Agreement State licensees possessing SNM-LSS
must follow Sec. 73.67 pursuant to Sec. 150.14.
Prior to 2023, the NRC had not exercised any oversight over
Agreement State licensees for compliance with Sec. 73.67. On March 6,
2023, a Temporary Instruction (TI) 2800/044,``Assessment of Physical
Protection Requirements under Sec. 150.14 For Agreement State Licensee
Processing, Using, or Transporting Special Nuclear Material of Low
Strategic Significance,'' was issued to evaluate, through inspection,
whether Agreement State licensees had adequate physical protection
processes and procedures in place for the possession, use, and
transport of SNM-LSS consistent with the requirements of Sec. 73.67.
The NRC inspectors identified, through TI 2800/044 inspections, that
Agreement State licensees in possession of SNM-LSS store the material
in secure areas where other radioactive materials are stored.
Considering the low safety and security significance of SNM-LSS and the
results of TI 2800/044 inspections, the NRC determined that security
requirements in Sec. 20.1801 ``Security of stored material'' and Sec.
20.1802 ``Control of material not in storage'' are adequate to secure
SNM-LSS.
The current regulatory approach for SNM-LSS Agreement State
licensees means that these licensees are subject to oversight by both
the NRC and their Agreement State regulator (NRC currently oversees
physical protection of SNM-LSS and the Agreement State oversees control
of radiation hazards associated with the SNM to ensure adequate
protection of public health and safety). In addition, the NRC does not
have a pathway to recover inspection costs from these Agreement State
licensees and the additional cost for these inspections is shouldered
by NRC licensees.
The proposed rule would delete Sec. 150.14, which requires
Agreement State licensees that possess SNM-LSS to meet the physical
protection requirements in Sec. 73.67. The deletion of Sec. 150.14
would affect Agreement State licensees possessing SNM-LSS by removing
the requirement to implement the physical protection requirements in
Sec. 73.67. Under this change, the NRC would no longer have oversight
of SNM-LSS in Agreement States and the Agreement States would continue
to maintain oversight of the security of this material under their
current programs based on security requirements found in 10 CFR part
20. There would also be a minimal resource savings for the NRC by no
longer having regulatory oversight of this requirement.
The proposed rule also addresses reciprocity, which is the NRC's
recognition of Agreement State licenses for work performed in areas of
NRC jurisdiction, without the licensee having to obtain a specific
license from the NRC. Under reciprocity, the NRC grants a GL to
Agreement State licensees for work in NRC jurisdiction for periods not
exceeding 180 days in a calendar year (except for activities performed
in offshore waters which does not have a time period limit). The
provisions in Sec. 150.20 require a specific license from an Agreement
State as the basis for the GL to be granted. Areas of NRC jurisdiction
include non-Agreement States, areas of exclusive Federal jurisdiction,
and offshore waters. The term reciprocity is also used in Agreement
States to identify Agreement State recognition of an NRC license and
licenses from other Agreement States for work performed in their
jurisdiction. Some types of activities conducted under reciprocity
include radiography, portable gauge use, well logging, leak testing,
and calibration.
Activities conducted by Agreement State licensees in an NRC
jurisdiction must meet the GL provisions of Sec. 150.20, ``Recognition
of Agreement State Licenses.'' Pursuant to this provision, prior to
engaging in licensed activities an agreement state licensee must
provide an NRC Form 241 ``Report of Proposed Activities in Non-
Agreement States,'' a copy of its Agreement State specific license, and
the appropriate fee as prescribed in Sec. 170.31. Currently, Agreement
State licensees provide these materials at least 3 days before engaging
in an activity for the first time in a calendar year. Additionally,
Agreement State licensees must file an amended NRC Form 241 to request
approval for changes in work locations, radioactive materials, or work
activities different from the initial request. Work performed under
reciprocity is limited to 180 days in any calendar year, except for
offshore activities, which are authorized for an unlimited period in
the year. The NRC has published guidance in NUREG-1556, Volume 19,
``Guidance for Agreement State Licensees About NRC Form 241 ``Report of
Proposed Activities in Non-Agreement States, Areas of Exclusive Federal
Jurisdiction, or Offshore Waters.''
Between 2020 and 2024, the NRC annually processed on average 180
initial reciprocity filings and 1,386 amended reciprocity filings. Most
initial reciprocity requests create a significant workload on NRC
regional staff to review and approve the requests within the three-day
time window. The majority of, if not all, reciprocity initial
applications are approved. Additionally, there is an administrative
burden on the licensee to ensure timely filing for initial reciprocity
and ensure that amended forms are filed when required (i.e., changes in
work location, radioactive material, or different work activities).
The information collected on NRC Form 241 provides the NRC an
opportunity for oversight including the conduct of inspections. The NRC
conducts approximately 21 of these inspections each year. Each year,
NRC staff processes hundreds of reciprocity amendments related to
offshore work, mostly for changes in location. Due to logistical
challenges and expense required to perform inspections offshore, the
NRC has not performed
[[Page 28927]]
any inspection of offshore work in several years.
The NRC is proposing to revise Sec. 150.20(b)(1) to reduce the
notification time for submitting an initial reciprocity filling from
three days before engaging in an activity to the day of the activity.
The revision would also delete Sec. 150.20(b)(1)(i)-(iii), which
currently allows for submittals with less than three days for emergent
reasons, as it would be superfluous. The proposed revisions to Sec.
150.20(b)(1) would allow licensees greater flexibility in scheduling
licensed activities that require reciprocity with minimal impact on
public health and safety. This change would affect Agreement State
licensees performing work in areas of exclusive Federal jurisdiction by
reducing the administrative burden to file for reciprocity prior to
conducting work activities. Specifically, for reciprocity submitted
less than three days prior to engaging in the initial work activities,
Agreement State licensees would no longer be required to provide
additional justification regarding the emergent nature of the work.
For amended reciprocity filings pursuant to Sec. 150.20(b)(2), the
proposed revisions would remove the requirement that Agreement State
licensees engaging in activities offshore amend the NRC Form 241 for
changes in work locations. This proposed change would affect Agreement
State licensees working in offshore waters by significantly decreasing
the number of amended NRC Form 241s submitted. Correspondingly, this
change would also lessen the administrative burden on NRC staff by
reducing the number of NRC Form 241s that are required to be processed.
Finally, to allow SGLs from Agreement States to be recognized by
the NRC for the purposes of reciprocity, the proposed rule would revise
Sec. Sec. 150.20(a)(1), 150.20(a)(2), 150.20(b), 150.20(b)(1), and
150.20(b)(5) to include SGLs from Agreement States in addition to
specific licenses throughout the requirement. These changes would allow
Agreement State licensees, that have been granted an SGL, to work in
NRC jurisdiction for up to 180 days without obtaining a specific
license or SGL from the NRC. This would ensure that SGLs are not
precluded from the ability to use the provisions of Sec. 150.20 which
would ensure parity between businesses conducting similar licensed
activities but operating under a standard general licensees or specific
license.
V. Specific Requests for Comments
The NRC is seeking feedback from the public on the proposed rule.
We are particularly interested in comments and supporting rationale
from the public on the following:
The NRC is seeking comments on how many persons that
currently possess a specific license for portable gauge activities,
fixed gauge activities, limited medical uses, analytical equipment
uses, and in vitro testing would transition to a SGL that is described
in the changes to 10 CFR part 31 subpart C. The NRC is also seeking
comments on the costs and the benefits of the new SGL. Please provide a
basis for your response.
The NRC is seeking comments on possible impacts to small
entities. The regulations in Sec. 2.810, ``NRC size standards,''
provide specific size standards to determine whether a licensee
qualifies as a small entity in its regulatory programs.
As part of the wholesale review of regulations the NRC
reviewed all reporting and notification requirements that reside within
10 CFR parts 30-39. The NRC is proposing changes to some of these
requirements as part of this rulemaking. During the review, the NRC
considered revising notification and reporting requirements in Sec.
30.50(b)(2) to exclude the reporting for certain circumstances that
fixed gauge licensees may encounter. This requirement currently
requires a 24-hour notification and a 30-day written report for a
variety of incidents including when a fixed gauge shutter is found to
be inoperable and stuck in the open position. During the review, the
NRC considered whether the reporting of fixed gauges with stuck
shutters in the open position, when the open position is the normal
operating mode, and the stuck position has been found by the licensee
to pose no radiation hazard to workers, the public, or the environment
was necessary. The NRC considered exploring whether it could issue a
generic communication to exclude these events by reinterpreting what is
meant in Sec. 30.50(b)(2)(ii) by ``the equipment is required to be
available and operable when it is disabled or fails to function.''
Alternatively, the NRC considered revising Sec. 30.50 to provide the
exclusion for these circumstances related to fixed gauges. Ultimately,
the NRC determined that the impacts to the wide range of circumstances
that are reported under Sec. 30.50 warrants further review to ensure
all consequences are understood. The NRC is seeking comments on whether
inoperable fixed gauges that operate with open shutters but have
shutters stuck in the open position, that pose no radiation hazard,
warrant reporting and notification to the NRC. If reporting and
notifications are warranted, the NRC is seeking comments on the
appropriate timeline and content of the reports and notifications.
Additionally, the NRC is seeking comments on what criteria, related to
fixed gauges with stuck shutters, should be included to determine
whether a hazard to the workers, the public, or the environment exists
as a result of the stuck shutter. Please provide a basis for your
response. Finally, the NRC is seeking comments on all event reporting
and notification requirements in 10 CFR parts 30-34, 39, 40, and 150
related to the burden, content, and required timeframe associated with
each report or notification. Please provide a basis for your response.
VI. Initial Regulatory Flexibility Analysis
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission certifies that this rule, if adopted, would not
have a significant economic impact on a substantial number of small
entities. Therefore, in accordance with section 605(b), the NRC is not
preparing a regulatory flexibility certification analysis. This
proposed rule would affect a small number of ``small entities'' as
defined by the Regulatory Flexibility Act or the size standards
established by the NRC (Sec. 2.810), but it would not be a significant
impact.
Any small entity subject to this regulation that determines,
because of its size, it is likely to bear a disproportionate adverse
economic impact should notify the Commission of this opinion in a
comment that indicates--
(a) The licensee's size and how the proposed regulation would
impose a significant economic burden on the licensee as compared to the
economic burden on a larger licensee;
(b) How the proposed regulations could be modified to take into
account the licensee's differing needs or capabilities;
(c) The benefits that would accrue or the detriments that would be
avoided if the proposed regulations were modified as suggested by the
licensee;
(d) How the proposed regulation, as modified, would more closely
equalize the impact of NRC regulations or create more equal access to
the benefits of Federal programs as opposed to providing special
advantages to any individual or group; and
(e) How the proposed regulation, as modified, would still
adequately protect public health and safety.
Comments should be submitted as indicated under the ADDRESSES
caption.
[[Page 28928]]
VII. Regulatory Analysis
A. Introduction
The NRC has prepared a draft regulatory analysis on this proposed
rule. The analysis examines the costs and benefits of the alternatives
considered by the NRC. The NRC has preliminarily determined that the
proposed action in this rule is expected to reduce regulatory burden
and generate cost savings for licensees, the NRC and the Agreement
States, when compared to the no-action alternative. The NRC requests
public comment on the draft regulatory analysis. Comments on the draft
regulatory analysis may be submitted to the NRC as indicated under the
ADDRESSES caption of this document.
B. Identification and Preliminary Analysis of Alternative Approaches
The NRC identified two alternatives for this action: (1) no action
(i.e., maintaining the status quo regulatory baseline), and (2) the
proposed rulemaking to revise language for the licensing of byproduct
material.
The assessment of total costs and benefits discussed previously
leads the NRC to the conclusion that the proposed rule, if implemented,
would result in quantifiable net cost savings for industry, the NRC and
Agreement States. In addition, the NRC concludes that the rule provides
nonquantified benefits of regulatory clarity and improved consistency
in the regulatory program. The proposed rule is also responsive to
stakeholder feedback and aligns with E.O. 14300.
VIII. Backfitting and Issue Finality
The NRC has determined that this proposed rule would not constitute
backfitting as that term is defined in the NRC's backfitting provisions
in Sec. Sec. 50.109, 70.76, 72.62, and 76.76, all titled
``Backfitting,'' or affect the issue finality of an approval issued
under 10 CFR part 52, ``Licenses, Certifications, and Approvals for
Nuclear Power Plants.'' The proposed amendments would not include any
provisions that would impose new or modified requirements on existing
licensees, applicants, or certificate holders that are within the scope
of a backfitting or issue finality provision. The proposed changes
would not inextricably affect activities of licensees that are within
the scope of the backfitting or issue finality provisions.
Additionally, 10 CFR part 70 licensees within the scope of Sec. 70.76
would not be impacted by this proposed rule. Each of these licensees is
already required to submit a site-specific financial assurance plan
because their authorized possession limits already exceed the proposed
table values. For these reasons, the proposed rule would not meet the
definition of ``backfitting'' under Sec. 50.109, Sec. 70.76, Sec.
72.62, or Sec. 76.76, or affect the issue finality of an approval
issued under 10 CFR part 52.
This proposed rule also includes the draft guidance documents
described in section XIV, ``Availability of Guidance,'' These documents
if finalized, would not constitute backfitting as defined in Sec.
50.109, Sec. 70.76, Sec. 72.62, or Sec. 76.76 or affect the issue
finality of any approval issued under 10 CFR part 52 because the
guidance would not inextricably affect activities of licensees that are
within the scope of the backfitting or issue finality provisions. The
guidance would not impose new or modified requirements on existing
licensees, applicants, or certificate holders that are within the scope
of a backfitting or issue finality provision.
IX. Cumulative Effects of Regulation
The NRC seeks to minimize potential negative consequences resulting
from the cumulative effects of regulation (CER). The NRC believes that
the de-regulatory impacts of this rulemaking activity are unlikely to
cause implementation challenges for stakeholders. In addition, during
the pendency of this rulemaking, the NRC is deprioritizing issuance of
regulatory actions that might influence the implementation date for the
new rule requirements (e.g., orders, generic communications, license
amendment requests, and inspection findings of a generic nature).
To fully understand any potential CER implications that could
result from this rulemaking, the NRC is asking the following questions.
Response to these questions is voluntary and any input will be
considered during development of the final rule.
1. The NRC is proposing an effective date that will be 30 days
after the date of publication of a final rule. Does this provide
sufficient time to implement the proposed requirements? Please provide
a rationale for your response.
2. Are there unintended consequences related to this rulemaking and
how should they be addressed? Please provide a rationale for your
response.
3. Please comment on the NRC's cost and benefit estimates in the
regulatory analysis that supports this proposed rule.
X. Plain Writing
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, and well-organized
manner. The NRC has written this document to be consistent with the
Plain Writing Act as well as the Presidential Memorandum, ``Plain
Language in Government Writing,'' published June 10, 1998 (63 FR
31883). The NRC requests comment on this document with respect to the
clarity and effectiveness of the language used.
XI. Environmental Assessment
A. Introduction
The NRC has prepared this environmental assessment (EA) of the
proposed rule amending regulations for byproduct, source, and special
nuclear material use to determine the significance of the environmental
effects of the proposed agency action in accordance with the National
Environmental Policy Act of 1969, as amended (NEPA) and the NRC's NEPA
implementing regulations in 10 CFR part 51, ``Environmental Protection
Regulations for Domestic Licensing and Related Regulatory Functions.''
As explained below, the NRC has preliminarily determined that the
proposed agency action to modernize the NRC regulations for byproduct,
source, and special nuclear material use would have no significant
effect on the quality of the human environment.
B. Environmental Impacts of the Proposed Action
The proposed action would amend multiple NRC regulations in 10 CFR
parts 30, 31, 32, 34, 39, 40, 70, and 150 regarding licensed material
use. Conforming changes would also be made to guidance consistent with
the changes to regulations. Table B-1 lists the sections of the
regulations that would be updated and the affected guidance documents.
[[Page 28929]]
Table B-1 Regulation Under the Proposed Modernizing NRC Regulations for Byproduct Material Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rulemaking Regulations Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Modernizing NRC Regulations for 30.4, 30.6, 30.32, 30.34, 30.35, 30.41, Appendix B to Part 30, 31.5, 31.11, 31.13 Interim Staff Guidance.
Byproduct Material Use. (new), 31.14 (new), 31.15 (new), 31.16 (new), 31.17 (new), 31.18 (new), 32.12,
32.16, 32.20, 32.25, 32.29, 32.32, 32.72, 32.74, 34.3, 34.13, 34.20, 34.23, 34.27,
34.33, 34.41, 34.43, 34.51, 34.89, 34.101, 39.33, 39.35, 39.77, 40.53, 70.25,
150.14, 150.20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conforming changes are administrative actions with no physical
environmental effect and provide for the appropriate administrative and
regulatory framework for byproduct material use under 10 CFR. An
example would be adding a reference to a newly created subsection in an
existing regulation. Most of the amendments to NRC regulations in the
proposed rule occur within the affected regulation. The proposed rule
includes conforming changes to NRC regulations in 10 CFR parts 30, 32,
and 34.
B.1 Rule Amendments Addressed Under Categorical Exclusion
The NRC has determined that some of the changes to the regulations
identified in this proposed rule meet the criteria for categorical
exclusion under Sec. 51.22, ``Categorical Exclusions.'' Categorical
exclusions provide a mechanism to identify Federal actions that
normally do not have a significant environmental effect on the human
environment and for which neither an EA nor environmental impact
statement is normally required. This ensures that resources are not
expended on the environmental analysis of proposed actions that do not
present the potential for significant environmental effects. Rule
amendments with applicable categorical exclusions are presented in
Table B-2 below and no further NEPA analysis is required.
These proposed rule amendments belong to categories of actions
which the Commission, by rule or regulation, has declared to be a
categorical exclusion, after first finding that the category of actions
do not individually or cumulatively have a significant effect on the
human environment. In reviewing list of regulations in Table B-1, the
NRC staff have determined that several of the rule amendments under
consideration are actions eligible for categorical exclusion under
Sec. 51.22(a)(1) or Sec. 51.22(a)(3). The following rulemaking
actions meet the criterion for categorical exclusion under Sec.
51.22(a)(1) or Sec. 51.22(a)(3):
Table B-2 Rule Amendments Covered by Categorical Exclusion
----------------------------------------------------------------------------------------------------------------
Categorical
Rule amendments Exclusion Reason
----------------------------------------------------------------------------------------------------------------
30.4; 30.6; 30.32; 30.41 31.5; 31 subparts A, Sec. Actions that are administrative, procedural, or
B, D and E. 34.3, 34.13; 34.20; 34.23; 34.27; 51.22(a)(1) solely financial in nature, including examples
34.33; 34.43; 34.89; 34.101; 39.33; 39.35; (iv) and (vi). Example (iv): issuance of or
39.77. changes to administrative procedures or
requirements. Example (vi): the proposed
amendments are also corrective or of a minor or
nonpolicy nature, and do not substantially
modify existing regulations.
30.34, 30.35; 32.12; 32.16; 32.20; 32.25; Sec. Actions that are administrative, procedural, or
32.29; 32.32; 40.53; 70.25. 51.22(a)(1) solely financial in nature, including Example
(ii): issuance of or changes to recordkeeping
or reporting requirements.
----------------------------------------------------------------------------------------------------------------
These proposed rule amendments clarify NRC regulations and would
not change radiation protection and emergency preparedness requirements
while continuing to provide reasonable assurance of adequate protection
of public health and safety.
B.2 Rule Amendments Requiring Environmental Assessment
The NRC also evaluated rule amendments that have the potential to
affect the human environment and determined that the proposed agency
action (rulemaking) would not have a significant environmental effect.
These rule amendments would clarify NRC regulations, would not change
existing radiation protection and emergency preparedness requirements
or overall risk, would continue to provide reasonable assurance of
adequate protection of public health and safety, and would result in no
new or different environmental effects. The following table presents
the basis for why these proposed rule amendments would have no
significant environmental effects.
[[Page 28930]]
Table B-3 Basis for No Significant Environmental Effects Determination for Rule Amendments Not Covered by a
Categorical Exclusion
----------------------------------------------------------------------------------------------------------------
Rule amendments Basis for no significant environmental effects
----------------------------------------------------------------------------------------------------------------
Part 30, Appendix B......................... These proposed amendments would replace the current values in
appendix B with applicable values from the table in appendix C,
``Quantities of Licensed Material Requiring Labeling,'' to 10 CFR
part 20, ``Standards for Protection against Radiation.'' They
also add radionuclides not currently listed in appendix B to 10
CFR part 30, including radionuclides associated with industrial
technologies and current and emerging medical uses. The proposed
changes would also remove all radionuclides with a half-life of
120 days or less from the appendix, since these radionuclides are
not considered when developing decommissioning financial
assurance, and amends the title of the table to ``Quantities of
Licensed Material Used to Assess Financial Assurance for
Decommissioning,'' to more accurately reflect its current use for
financial assurance during decommissioning. These changes will
either reduce or not affect the amount of DFA required for
licensees, depending on the mixture of radionuclides the licensee
possesses and would have no different environmental effects.
Thus, this regulatory change would have no significant effect on
the quality of the human environment.
31.11....................................... Amendments would allow entities to handle vials for in vitro
testing with higher activity under a general license. This change
would align limits for carbon-14, hydrogen-3, selenium-75, and
cobalt-57 with the exempt quantity limits in 10 CFR part 30 and
labelling requirements in appendix C to 10 CFR part 20. The
limits in Sec. 31.11 have not been updated since their initial
issuance in 1968 and the amendments would bring Sec. 31.11 in
step with current regulatory limits in 10 CFR parts 20 and 30.
Given that the amendments would align with other existing
requirements in 10 CFR parts 20 and 30, the amendments would have
no significantly different environmental effects than those
evaluated for 10 CFR part 20, and, thus, would have no
significant effect on the quality of the human environment.
Subpart C--Standard General Licenses: New The amendments to this subpart would establish a new regulatory
regulations 31.13 through 31.18. program and grant standard general licenses in accordance with
specific conditions. Each technology would have its own standard
general license requirements codified in separate regulations,
including:
Sec. 31.14: Certain Fixed Gauging;
Sec. 31.15: Portable Gauging;
Sec. 31.16: Certain Medical Uses;
Sec. 31.17: Certain Analytical Equipment Including
Electron Capture Detectors, X-Ray Fluorescence Devices, and Ion
Generators; and
Sec. 31.18: Certain In Vitro Testing.
These amendments propose a new class of general licenses for some
low risk standardized operations that are currently specifically
licensed, and all of the specifically licensed activities are
currently categorically excluded. Because the NRC previously
concluded that these activities do not individually or
cumulatively have a significant effect on the human environment,
no additional analysis is needed. Additionally, these amendments
do not authorize any activities not included in 10 CFR part 30.
32.72; 32.74................................ The proposed amendments to Sec. 32.72, commercial distribution
of radioactive drugs for medical use under 10 CFR part 35, would
be expanded to include microsources (e.g., microspheres) allowing
radiopharmacies to prepare and distribute these materials.
Proposed amendments would also provide flexibility for future
distribution authorized by the U.S. Food and Drug Administration
(FDA) or State regulatory bodies. In addition, proposed
amendments to Sec. 32.74 would clarify the distribution of
sources and devices containing byproduct material. These two
changes would ensure that manufacturers and commercial
radiopharmacies can be licensed to distribute microsources in a
manner consistent with NRC safety requirements and FDA
classifications, while minimizing burden on radiopharmacy and
medical use licensees. These changes are administrative and
procedural and would not authorize any site-specific action on
the part of the NRC or licensee. Licensees and applicants would
need to request and receive separate regulatory approval before
preparing and distributing microsources. Consequently, this
rulemaking provides the basis for any procedure granting the
license but does not, by its own operation, provide a license for
preparation or distribution activities, but rather applicants
must comply with the relevant NRC or Agreement State regulations
before they can receive a license. Therefore, this rulemaking
will not result in any physical impacts to the environment, and
the NRC has determined that the action would result in no
significant environmental impacts.
34.41; 34.51................................ These proposed amendments would combine the requirements in Sec.
34.51 with requirements in Sec. 34.41(a), commonly called ``the
two-person rule,'' ``Licenses for Industrial Radiography and
Radiation Safety Requirements for Industrial Radiographic
Operations'' and eliminate Sec. 34.51. The regulation requires
a second qualified individual (radiographer or radiographer's
assistant) to be present during industrial radiography operations
at temporary jobsites. The revision eliminates ambiguity,
allowing for technological innovation in the implementation of
the requirement, all while maintaining the integrity of the
performance requirements. This action does not alter any the
substantive activities under Sec. 34.41(a), and would have no
significantly different environmental impacts than those
evaluated for Sec. 34.41(a), and, thus, would have no
significant effect on the quality of the human environment.
----------------------------------------------------------------------------------------------------------------
These proposed rule amendments would modernize existing NRC
regulations while ensuring the continued safe, effective, and efficient
use of byproduct material to provide reasonable assurance of adequate
protection of public health and safety. As noted in Table B-3, these
amendments either consist of administrative and procedural changes, or
would have no significantly different environmental effects than those
in the current regulatory framework. The table also provides rationale
supporting the conclusion that these proposed rule amendments would not
result in any significant environmental effects.
C. Summary of the Environmental Impacts of the Proposed Action
Implementation of the proposed rule would result in no physical
changes to the environment, and, therefore, the NRC has determined that
this proposed agency action would not have a significant effect on the
quality of the human environment. Proposed rule amendments include
changes that: (1) are administrative in application and matters of
procedure, (2) clarify record keeping and reporting requirements, and
(3) would provide an equivalent level of safety and security as current
NRC regulations.
In addition, the proposed rule would not affect any threatened or
endangered
[[Page 28931]]
species or historic properties, as no physical changes to the human
environment would occur as a result of this proposed agency action.
Accordingly, the NRC finds that the proposed rulemaking would have no
significant environmental impact.
D. Environmental Impacts of the Alternative to the Proposed Agency
Action
Under the no-action alternative (i.e., the status quo), NRC
regulations would remain unchanged. As stated in section B of this
draft EA, the proposed rule would not have a significant effect on the
quality of the human environment. Therefore, the no action alternative
and the proposed agency action (i.e., proposed rulemaking) would have
the same environmental effect, although there would be costs
attributable to reviewing the environmental effects of exemption and
license amendment requests under the no action alternative. Licensees
would continue to comply with existing NRC regulations or request
regulatory relief (exemption) from the regulations. The NRC would
continue to evaluate the environmental effects of exemption and license
amendment requests. The averted costs (benefits) of the rulemaking
would not occur. The Regulatory Analysis for the proposed rule provides
information about the costs and benefits of the no action alternative
and the proposed agency action (ADAMS Accession No. ML26125A393).
E. Agencies and Persons Consulted
The NRC developed the proposed rule and is requesting public
comment on this draft EA. The agency will consider comments received on
the docket as it develops the final rule and the final EA. The NRC will
issue the final EA when it publishes the final rule. The proposed rule
is one step in the rulemaking process.
As discussed in section B, the proposed rule provisions would not
have a significant effect on the quality of the human environment. For
this reason, the proposed rulemaking would not impact threatened or
endangered species or critical habitat, and the NRC has determined that
section 7 consultation under the Endangered Species Act of 1973, as
amended, is not necessary. The proposed regulatory changes do not
involve any ground disturbing activities or visual effects that would
adversely affect historic properties. Therefore, the NRC has determined
that consultation is not required under section 106 of the National
Historic Preservation Act of 1966, as amended.
F. Draft Finding of No Significant Environmental Impacts
The NRC has prepared this EA to determine the environmental effects
of the proposed agency action (i.e., a rulemaking to update NRC
regulations). Proposed rule amendments are primarily administrative or
procedural in nature and thus would not have any physical environmental
effect. As explained in the EA, the NRC has determined the proposed
rulemaking would not change radiation protection and emergency
preparedness requirements or overall risk, would continue to provide
reasonable assurance of adequate protection of public health and
safety, and would result in no new or different environmental effects.
Therefore, the NRC concludes that the proposed regulatory changes would
not have a significant effect on the quality of the human environment.
Based on this conclusion, the NRC finds the proposed agency action
would have no significant environmental impact. Accordingly, the NRC
has determined there is no need to prepare an environmental impact
statement.
Concurrent with the publication of this proposed rule, the NRC has
sent a copy of the draft EA and this proposed rule to every State
Liaison Officer and has requested comments.
XII. Paperwork Reduction Act Statement
This proposed rule contains new or amended collections of
information subject to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq). This proposed rule has been submitted to the Office of
Management and Budget for review and approval of the information
collections.
Type of submission: New.
The title of the information collection: Modernizing NRC
Regulations for Byproduct Material Use.
The form number if applicable: NRC Forms 241, 313, 483, and 1003.
How often the collection is required or requested: Once, on
occasion, and annually.
Who will be required or asked to respond: Applicants and licensees
licensed to use byproduct, source, and special material.
An estimate of the number of annual responses:
10 CFR part 30: 570 (423 reporting responses + 147 recordkeepers)
10 CFR part 31: 1,449 (354 reporting responses + 1,095 recordkeepers)
10 CFR part 32: -109 (-109 reporting responses + 0 recordkeepers)
10 CFR part 34: -577 (-29 reporting responses + -548 recordkeepers)
10 CFR part 39: -8 (-8 reporting responses + 0 recordkeepers)
10 CFR part 40: -27 (-27 reporting responses + 0 recordkeepers)
NRC Form 241: -425 (-425 reporting responses + 0 recordkeepers)
NRC Form 313: -398 (-398 reporting responses + 0 recordkeepers)
NRC Form 483: 60 (60 reporting responses + 0 recordkeepers)
NRC Form 1003: 1,289 (1,289 reporting responses + 0 recordkeepers)
Total: 2,221 (1,528 reporting responses + 693 recordkeepers)
The estimated number of annual respondents:
10 CFR part 30: 423 respondents
10 CFR part 31: 1,095 respondents
10 CFR part 32: -109 respondents
10 CFR part 34: -548 respondents
10 CFR part 39: -2 respondents
10 CFR part 40: -27 respondents
NRC Form 241: -25 respondents
NRC Form 313: -398 respondents
Form 483: 60 respondents
NRC Form 1003: 398 respondents
Total: 897 unique respondents to the requirements in this proposed rule
An estimate of the total number of hours needed annually to comply
with the information collection requirement or request:
10 CFR part 30: 23,736.6 (23,590 reporting + 146.6 recordkeeping)
10 CFR part 31: 1,490.3 (118.55 reporting + 1,371.8 recordkeeping)
10 CFR part 32: -34.55 (-34.5 reporting + 0 recordkeeping)
10 CFR part 34 -288.5 (-14.5 reporting + -274 recordkeeping)
10 CFR part 39: -4 (-4 reporting + 0 recordkeeping)
10 CFR part 40: -13.5 (-13.5 reporting + 0 recordkeeping)
NRC Form 241: -106.3 (-106.3 reporting + 0 recordkeeping)
NRC Form 313: -1,711.4 (-1,711.4 reporting + 0 recordkeeping)
NRC Form 483: -10.2 (-10.2 reporting + 0 recordkeeping)
NRC Form 1003: 881.55 (881.5 reporting + 0 recordkeeping)
Total: 23,960.4 (22,716.2 reporting + 1,244.4 recordkeeping)
Abstract: The NRC is proposing to amend its regulations to
modernize the safe, effective, and efficient use of byproduct, source,
and special nuclear material. This action would reduce licensing burden
and the need for exemptions from existing regulations; address other
deregulatory issues deemed relevant by the NRC; and support the NRC's
Principles of Good Regulation, including openness, clarity, and
reliability. This effort is consistent with, and implements direction
in, the Accelerating Deployment of Versatile,
[[Page 28932]]
Advanced Nuclear for Clean Energy Act of 2024 (ADVANCE Act), and
recently issued E.O. 14300, ``Ordering the Reform of the Nuclear
Regulatory Commission.''
The proposed rule covers a wide range of topics, including the
following that would result in a reduction in recordkeeping and
reporting requirements:
Establishing a low burden class of standard GLs.
Revising the decommissioning financial assurance tables.
Addressing anti-competitive barriers.
Reducing reporting of distribution to exempt persons.
Removing or modifying redundant and unnecessary
regulations.
Reducing the burden for filing amended NRC Form 241's for
work activities conducted in offshore waters.
This information collection includes burden reduction associated
with revised information collection in 10 CFR parts 30, 31, 32, 34, 39,
40, and Forms 241, 483, and 313. It also includes burden associated
with new information collection in proposed 10 CFR part 31 and proposed
NRC Form 1003 that would create a low burden licensing option for
licensees currently licensed under 10 CFR part 30 who use NRC Form 313.
The NRC is seeking public comment on the potential impact of the
information collections contained in this proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility? Please explain your response.
2. Is the estimate of the burden of the proposed information
collection accurate? Please explain your response.
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected? Please explain your response.
4. How can the burden of the proposed information collection on
respondents be minimized, including the use of automated collection
techniques or other forms of information technology?
A copy of the Office of Management and Budget (OMB) clearance
package and proposed rule are available in the ``Availability of
Documents'' section of this document or may be viewed free of charge by
contacting the NRC's Public Document Room reference staff at 1-800-397-
4209, at 301-415-4737, or by email to [email protected]. You may
obtain information and comment on submissions related to the OMB
clearance package by searching on https://www.regulations.gov under
Docket ID NRC-2025-1205.
You may submit comments on any aspect of these proposed information
collection(s), including suggestions for reducing the burden and on the
above issues, by the following method:
Federal rulemaking website: Go to https://www.regulations.gov and
search for Docket ID NRC-2025-1205.
Submit comments by June 17, 2026. Comments received after this date
will be considered if it is practical to do so, but the NRC staff is
able to ensure consideration only for comments received on or before
this date.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless the document requesting
or requiring the collection displays a currently valid OMB control
number.
XIII. Coordination With NRC Agreement States
On September 3, 2025, the NRC held a Government-to-Government
meeting with the OAS to discuss this rulemaking. The rulemaking working
group that prepared this proposed rule also included representatives
from OAS. Comments from the Agreement States were taken into
consideration during the development of this proposed rule.
XIV. Compatibility of Agreement State Regulations
On the basis of the ``Agreement State Program Policy Statement''
approved by the Commission on October 2, 2017, and published in the
Federal Register (82 FR 48535; October 18, 2017), NRC program elements
can be placed into six categories (A, B, C, D, NRC, or health and
safety (H&S)) to form the basis for evaluating and classifying the
program elements. Under the Policy Statement, a program element means
any component or function of a radiation control regulatory program,
including regulations and other legally binding requirements imposed on
regulated persons, which contributes to implementation of that program.
Compatibility Category A are those program elements that include
basic radiation protection standards and scientific terms and
definitions that are necessary to understand radiation protection
concepts. Compatibility Category A program elements adopted by an
Agreement State should be essentially identical to those of the NRC to
provide uniformity in the regulation of agreement material on a
nationwide basis.
Compatibility Category B pertains to a limited number of program
elements that cross jurisdictional boundaries and should be addressed
to ensure uniformity of regulation on a nationwide basis. For
Compatibility Category B, the Agreement State program element shall be
essentially identical to that of NRC.
Compatibility Category C are those program elements that are
important for an Agreement State to have in order to avoid conflict,
duplication, gaps, or other conditions that would jeopardize an orderly
pattern in the regulation of agreement material on a national basis. An
Agreement State program shall embody the essential objectives of the
Category C program elements. Under Category C, Agreement State program
elements may be more restrictive than NRC program elements; however,
they should not be so restrictive as to prohibit a practice authorized
by the AEA, as amended, and in the national interest without an
adequate public health and safety or environmental basis related to
radiation protection.
Compatibility Category D are those program elements that do not
meet any of the criteria of Category A, B, or C, above, and are not
required to be adopted by Agreement States for purposes of
compatibility. An Agreement State has the flexibility to adopt and
implement program elements within the State's jurisdiction that are not
addressed by the NRC or that are not required for compatibility (i.e.,
Compatibility Category D). However, such program elements of an
Agreement State relating to agreement material shall (1) not create
conflicts, duplications, gaps, or other conditions that would
jeopardize an orderly pattern in the regulation of agreement material
on a nationwide basis; (2) not preclude a practice authorized by the
AEA and in the national interest; and (3) not preclude the ability of
the NRC to evaluate the effectiveness of Agreement State programs for
agreement material with respect to protection of public health and
safety.
Compatibility Category NRC are those program elements that address
areas of regulation that cannot be relinquished to the Agreement States
under the AEA, or provisions of 10 CFR. The NRC maintains regulatory
authority over these program elements and the Agreement States must not
adopt these NRC program elements. However, an Agreement State may
inform its licensees of these NRC requirements through a mechanism
under the State's administrative procedure laws, as long
[[Page 28933]]
as the State adopts these provisions solely for the purposes of
notification, and does not exercise any regulatory authority as a
result.
Category H&S program elements embody the basic health and safety
aspects of the NRC's program elements. Although H&S program elements
are not required for purposes of compatibility, they do have particular
health and safety significance. The Agreement State must adopt the
essential objectives of such program elements to maintain an adequate
program.
This proposed rule is a matter of compatibility between the NRC and
the Agreement States, thereby providing consistency among Agreement
State and NRC requirements. In this proposed rule, the NRC is not
proposing to change the compatibility categories for requirements that
are being amended. Therefore, for any requirements that are currently
designated as Compatibility A or B, States would have to amend their
rules to be essentially identical to the amended rule language.
However, for requirements that are designated as Compatibility C or
Category H&S, States may not necessarily have to revise their rules so
long as their current rule meets the essential objective for the
amended requirement. For instance, the essential objective for Sec.
150.20, is for Agreement States to provide reciprocal recognition of a
specific license issued by the NRC or another Agreement State. However,
proposed changes to Sec. 150.20 include permitting SGLs to be used for
the basis of reciprocal recognition. The NRC is proposing that the
Compatibility Category of Sec. 150.20 remain Category C, but to
continue to meet the essential objective for the amended requirement,
all Agreement States would be required to provide reciprocal
recognition of a specific license or SGL issued by the NRC or another
Agreement State. The State would have flexibility in the administration
and requirements for reciprocity and would not need to revise their
current program to remain compatible with the proposed revision to
Sec. 150.20.
The NRC is also proposing to remove requirements in Sec. Sec.
34.20(d) and (e), 34.41(d), 34.43(a)(2), 34.43(h) and (i), 34.51,
34.101(c), and 39.77(c)(1). Except for 34.20(e), these requirements
pertain to grandfathering and duplicative requirements and, as such,
Agreement States are not required to also remove those regulations;
Agreement States keeping their equivalent to the listed regulations
(except for Sec. 34.20(e)) would not lead to a disorderly pattern of
regulation on a nationwide basis. However, Agreement States should
remove their equivalent to Sec. 34.20(e) to remove superseded
standards and requirements. Failure to remove this would result in gaps
and conflicts between programs in the National Materials Program that
would negatively impact the uniformity of regulation on a nationwide
basis because only radiographic equipment that meets the appropriate
standards and requirements can used by licensees.
In developing the new SGL pathway, the NRC recognizes that
Agreement States may not want to adopt the new subpart C of 10 CFR part
31, and it would therefore not be required for purposes of
compatibility. For States that choose to adopt this pathway, some of
the requirements would be required for either compatibility or H&S
purposes. To ensure that transferors of devices and byproduct material
are permitted to transfer materials to an SGL, the requirement in Sec.
30.41(d)(1) is being revised.
The NRC is proposing that the Compatibility Category of Sec. 30.41
remain Category C, but the NRC is proposing to clarify that to meet the
essential objective for the amended requirement, all Agreement States
must ensure that a validated SGL is an acceptable method of
verification for Sec. 30.41(c). Since a validated SGL is a
verification method for transferring byproduct material under Sec.
30.41(d), the requirement in Sec. 31.13(a)(2), regarding issuing the
validated SGL, is proposed to be designated as Compatibility Category C
for Agreement States that adopt the SGL pathway. To meet the essential
objective for Sec. 31.13(a)(2), an Agreement State would need to issue
a document validating an SGL. The SGL pathway codifies the minimum
legally binding requirements needed to ensure health and safety that
are required to obtain a specific license into the regulations, and it
is therefore necessary that the State meet the essential objective for
those requirements that have been designated as Compatibility Category
C.
Provisions specifying the specific sealed sources and devices that
are permitted under the SGL pathway are based on the SSDR use codes and
have a proposed designation of Compatibility Category B since there is
need for consistency across jurisdictions when using SSDRs for
licensing purposes. The SGL for Certain Medical Uses includes an
exhaustive list of the radionuclides authorized pursuant to
31.16(a)(2). Because 31.16(a)(2) is proposed to be designated
Compatibility Category C, Agreement States would have the flexibility
to permit other radionuclides than those authorized under the SGL to be
used. However, authorizing additional radionuclides such as PET or
generators other than Molybdenum-99/technetium-99m generators would not
meet the essential objective for this requirement as these
radionuclides or uses require additional licensing requirements to
ensure an adequate level of safety. Administrative requirements, such
as recordkeeping, are not required for purposes of compatibility and
would be Compatibility Category D.
The proposed compatibility (A, B, C, D, and NRC) and adequacy (H&S)
categories are designated in the following table.
Adequacy and Compatibility Table
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
Part 30
----------------------------------------------------------------------------------------------------------------
30.4........................... Amend............ Definitions--Consortiu C................ C.
m.
30.4........................... Remove........... Definitions--Physician D................
30.4........................... Amend............ Definitions--Principal D................ D.
activities.
30.6(b)(1)..................... Amend............ Communications........ D................ D.
30.32(j)(2).................... Amend............ Application for B................ B.
specific licenses.
[[Page 28934]]
30.34(h)(1).................... Amend............ Terms and conditions H&S.............. H&S.
of licenses. Note--the
reference to 10
CFR 31 subpart C
should only be
included by
States that
adopt Standard
General
Licenses.
30.35(g)....................... Amend............ Financial assurance H&S.............. H&S.
and recordkeeping for Note--the
decommissioning. reference to 10
CFR 31 subpart C
should only be
included by
States that
adopt Standard
General
Licenses.
30.41(d)(1).................... Amend............ Transfer of byproduct C................ C.
material.
Appendix B..................... Amend............ Appendix B--Quantities B................ B.
of Licensed Material
Used to Assess
Financial Assurance
for Decommissioning.
----------------------------------------------------------------------------------------------------------------
Part 31
----------------------------------------------------------------------------------------------------------------
31.5(c)(14).................... Amend............ Certain detecting, C................ C.
measuring, gauging,
or controlling
devices and certain
devices for producing
light or an ionized
atmosphere.
31.5(c)(15).................... Amend............ Certain detecting, C................ C.
measuring, gauging,
or controlling
devices and certain
devices for producing
light or an ionized
atmosphere.
31.11(a)(3), (4), (6), & (8)... Amend............ General license for D................ D.
use of byproduct
material for certain
in vitro clinical or
laboratory testing.
31.13(a) & (b), except (a)(2).. New.............. Standard General ................. D.
License Requirements.
31.13(a)(2).................... New.............. Requirements.......... ................. C--for States
that authorize
Standard General
Licenses.
D--for States who
don't.
31.13(c) & (d)................. New.............. Standard General ................. C--for States
License Requirements. that authorize
Standard General
Licenses.
D--for States who
don't.
31.13(e)....................... New.............. Standard General ................. NRC.
License Requirements.
31.13(f)-(h)................... New.............. Standard General ................. H&S--for States
License Requirements. that authorize
Standard General
Licenses.
D--for States who
don't.
31.14 except (a)(2), New.............. Standard General ................. C--for States
(c)(2)(ii), (c)(3)(ii), License for Certain that authorize
(c)(6)(i), (c)(6)(iii), Fixed Gauging. Standard General
(c)(7)(ii), (c)(8)(ii), Licenses.
(c)(9)(i) & (c)(10)(ii). D--for States who
don't.
Note--States
should not
incorporate
references to
Federal
Government
agencies.
31.14(a)(2).................... New.............. Standard General ................. B--for States
License for Certain that authorize
Fixed Gauging. Standard General
Licenses.
D--for States who
don't.
31.14(c)(2)(ii), (c)(3)(ii), New.............. Standard General ................. D.
(c)(6)(iii), (c)(7)(ii), License for Certain
(c)(8)(ii), (c)(9)(i) & Fixed Gauging.
(c)(10)(ii).
31.14(c)(6)(i)................. New.............. Standard General ................. H&S
License for Certain
Fixed Gauging.
31.15 except (a)(2), New.............. Standard General ................. C--for States
(a)(3)(iii), (c)(2)(ii), License for Portable that authorize
(c)(3)(ii), (c)(5)(iii), Gauging. Standard General
(c)(7)(ii), (c)(8)(i). Licenses.
D--for States who
don't.
Note--States
should not
incorporate
references to
Federal
Government.
Reference to NRC
Form 1003 is
Compatibility D.
31.15(a)(2).................... New.............. Standard General ................. B--for States
License for Portable that authorize
Gauging. Standard General
Licenses.
D--for States who
don't.
31.15(a)(3)(iii), (c)(2)(ii), New.............. Standard General ................. D.
(c)(3)(ii), (c)(5)(iii), License for Portable
(c)(7)(ii), (c)(8)(i). Gauging.
[[Page 28935]]
31.16 except (c)(1)(iii), New.............. Standard General ................. C--for States
(c)(2)(iii), (c)(4)(iii), License for Certain that authorize
(c)(5)(iii), (c)(6)(iv). Medical Uses. Standard General
Licenses.
D--for States who
don't.
Note--States
should not
incorporate
references to
Federal
Government.
31.16(c)(1)(iii), (c)(2)(iii), New.............. Standard General ................. D.
(c)(4)(iii), (c)(5)(iii), License for Certain
(c)(6)(iv). Medical Uses.
31.17 except (a)(2), New.............. Standard General ................. C--for States
(a)(3)(iii), (c)(2)(ii), License for Certain that authorize
(c)(4)(ii), (c)(5)(i) & Analytical Equipment Standard General
(c)(6)(ii). Including Electron Licenses.
Capture Detectors, X- D--for States who
Ray Fluorescence don't.
Devices, and Ion Note--States
Generators. should not
incorporate
references to
Federal
Government.
Reference to NRC
Form 1003 is
Compatibility D.
31.17(a)(2).................... New.............. Standard General ................. B--for States
License for Certain that authorize
Analytical Equipment Standard General
Including Electron Licenses.
Capture Detectors, X- D--for States who
Ray Fluorescence don't.
Devices, and Ion
Generators.
31.17(a)(3)(iii), (c)(2)(ii), New.............. Standard General ................. D.
(c)(4)(ii), (c)(5)(i) & License for Certain
(c)(6)(ii). Analytical Equipment
Including Electron
Capture Detectors, X-
Ray Fluorescence
Devices, and Ion
Generators.
31.18 except (c)(1)(ii), New.............. Standard General ................. C--for States
(c)(2)(ii), (c)(4)(iii), License for Certain that authorize
(c)(5)(iii), (c)(6)(ii)-(iii). In Vitro Testing. Standard General
Licenses.
D--for States who
don't.
31.18 (c)(1)(ii), (c)(2)(ii), New.............. Standard General ................. D.
(c)(4)(iii), (c)(5)(iii), License for Certain
(c)(6)(ii)-(iii). In Vitro Testing.
----------------------------------------------------------------------------------------------------------------
Part 32
----------------------------------------------------------------------------------------------------------------
32.12.......................... Amend............ Same: Records and NRC.............. NRC.
material transfer
reports.
32.16.......................... Amend............ Certain items NRC.............. NRC.
containing byproduct
material: Records and
reports of transfer.
32.20.......................... Amend............ Same: Records and NRC.............. NRC.
material transfer
reports.
32.25.......................... Amend............ Conditions of licenses NRC.............. NRC.
issued underSec.
32.22: Quality
control, labeling,
and reports of
transfer.
32.29.......................... Amend............ Conditions of licenses NRC.............. NRC.
issued underSec.
32.26: Quality
control, labeling,
and reports of
transfer.
32.32.......................... Amend............ Conditions of licenses NRC.............. NRC.
issued underSec.
32.30: Quality
control, labeling,
and reports of
transfer.
32.72.......................... Amend............ Manufacture, B................ B.
preparation, or
transfer for
commercial
distribution of
radioactive drugs
containing byproduct
material for medical
use under Part 35.
32.74.......................... Amend............ Manufacture and B................ B.
distribution of
sources or devices
containing byproduct
material for medical
use.
----------------------------------------------------------------------------------------------------------------
Part 34
----------------------------------------------------------------------------------------------------------------
34.3........................... New.............. Definitions--Sealed ................. [D].
Source and Device
Registry.
34.13.......................... Amend............ Specific license for C................ C.
industrial
radiography.
34.20(a)(1) & (c).............. Amend............ Performance B................ B.
requirements for
industrial
radiography equipment.
34.20(a)(2).................... Amend............ Performance D................ D.
requirements for
industrial
radiography equipment.
34.20(d) & (e)................. Remove........... Performance B................
requirements for
industrial
radiography equipment.
34.23.......................... Amend............ Locking of B................ B.
radiographic exposure
devices, storage
containers and source
changers.
34.27(c)(1) & (e).............. Amend............ Leak testing and C................ C.
replacement of sealed
sources.
34.33.......................... Amend............ Permanent radiographic H&S.............. H&S.
installations.
[[Page 28936]]
34.41(a)....................... Amend............ Conducting industrial C................ C.
radiographic
operations.
34.41(d)....................... Remove........... Conducting industrial D................
radiographic
operations.
34.43(a)(1).................... Amend............ Training.............. B................ B.
34.43(a)(2).................... Remove........... Training.............. D................
34.43(h) & (i)................. Remove........... Training.............. B................
34.51.......................... Remove........... Surveillance.......... C................ Note--requirement
moved to
34.41(a).
34.89(b)....................... Amend............ Location of documents C................ C.
and records.
34.101(c)...................... Remove........... Notifications......... C................
----------------------------------------------------------------------------------------------------------------
Part 39
----------------------------------------------------------------------------------------------------------------
39.33(c)....................... Amend............ Radiation detection C................ C.
instruments.
39.35(c)....................... Amend............ Leak testing of sealed C................ C.
sources.
39.77(c)(1).................... Remove........... Notification of C................
incidents:
abandonment
procedures for
irretrievable sources.
----------------------------------------------------------------------------------------------------------------
Part 40
----------------------------------------------------------------------------------------------------------------
40.53(c)....................... Amend............ Conditions for NRC.............. NRC.
licenses issued for
initial transfer of
certain items
containing source
material: Quality
control, labeling,
and records.
----------------------------------------------------------------------------------------------------------------
Part 70
----------------------------------------------------------------------------------------------------------------
70.25(a)(2).................... Amend............ Financial Assurance NRC.............. NRC.
and Recordkeeping for
Decommissioning.
70.25(b)....................... Amend............ Financial Assurance H&S.............. H&S.
and Recordkeeping for
Decommissioning.
----------------------------------------------------------------------------------------------------------------
Part 150
----------------------------------------------------------------------------------------------------------------
150.14......................... Remove........... Commission regulatory NRC..............
authority for
physical protection..
150.20......................... Amend............ Recognition of C................ C.
Agreement State Note--States
licenses.. should not
incorporate
references to
offshore waters.
----------------------------------------------------------------------------------------------------------------
Please Note: The bracket ``[ ]'' around a compatibility category
designation means that the section may have been adopted elsewhere in a
State's rules and it is not necessary to adopt it again.
XV. Coordination With the Advisory Committee on the Medical Uses of
Isotopes
The ACMUI established a subcommittee to review and comment on the
draft proposed rule. The subcommittee will make its recommendations to
the full committee on this proposed rule at a publicly held
teleconference during the public comment period.
XVI. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995,
Public Law 104-113, requires that Federal agencies use technical
standards that are developed or adopted by voluntary consensus
standards bodies unless the use of such a standard is inconsistent with
applicable law or otherwise impractical. The NRC's goals in amending
these regulations are to modernize the safe, effective, and efficient
use of byproduct material. This action would reduce licensing burden
and the need for exemptions from existing regulations and address other
deregulatory issues deemed relevant by the NRC. This action does not
constitute the establishment of a standard that contains generally
applicable requirements.
XVII. Availability of Guidance
The NRC expects to update NUREG-1556 series ``Consolidated Guidance
About Materials Licenses'', NUREG 1757, Volume 1, ``Consolidated
Decommissioning Guidance,'' various Inspection Procedures, and certain
Inspection Manual Chapters to make changes to conform with this
rulemaking effort. To support an accelerated development schedule for
this proposed rule, the updates will be made in a future revision of
the guidance, rather than concurrently with this rulemaking. However,
for the new SGL program that is proposed in 10 CFR part 31 subpart C,
the NRC has drafted interim guidance to aid licensees and the NRC in
implementation of the new licensing option. The NRC has also drafted
interim staff guidance to address the revised reciprocity requirements
in Sec. 150.20, using a Frequently Asked Questions format. The interim
guidance will be added to the NRC's public website. You may submit
comments on the draft interim guidance by the methods outlined in the
ADDRESSES section of this document
XVIII. Executive Orders
The following are Executive orders that are related to this
proposed rule:
A. Executive Order 12866: Regulatory Planning and Review (as Amended by
Executive Order 14215, Ensuring Accountability for All Agencies)
The Office of Information and Regulatory Affairs (OIRA) has
determined that this proposed rule is a
[[Page 28937]]
significant regulatory action. Accordingly, the NRC submitted this
proposed rule to OIRA for review. The NRC is required to conduct an
economic analysis in accordance with section 6(a)(3)(B) of E.O. 12866.
More can be found in Section VII, of this document, ``Regulatory
Analysis.''
B. Executive Order 14154: Unleashing American Energy
NRC has examined this proposed rule and has determined that it is
consistent with the policies and directives outlined in E.O. 14154.
C. Executive Order 14192: Unleashing Prosperity Through Deregulation
This action is tentatively determined to be a deregulatory action
as defined by E.O. 14192. Details on the estimated costs of this
proposed rule can be found in Section VII, of this document,
``Regulatory Analysis.''
D. Executive Order 14267: Reducing Anti-Competitive Regulatory Barriers
E.O. 14267 requires the NRC to identify anti-competitive
regulations for recission or modification. It also serves an important
regulatory goal. The NRC identified Sec. 30.4 because this regulation
creates a barrier to market participation by creating artificial
barriers to facility location related to consortiums and PET
radionuclide production. In addition, NRC identified Sec. 34.20(a)(1)
because this regulation creates a barrier to market participation by
limiting the universe of acceptable radiography designs. The NRC
identified 10 CFR part 31 because this regulation creates a barrier to
market participation by increasing the compliance requirements on all
market participants. The proposed changes to 10 CFR part 31 support the
objectives of E.O. 14267 by adding standard general licensing pathway
and thereby expanding the scope of general licenses for byproduct
material to include additional devices and more activities.
E. Executive Order 14270: Zero-Based Regulatory Budgeting To Unleash
American Energy
E.O. 14270, ``Zero-Based Regulatory Budgeting to Unleash American
Energy,'' requires the NRC to insert a conditional sunset date into all
new or amended NRC regulations provided the regulations are (1)
promulgated under the Atomic Energy Act of 1954, as amended (AEA), the
Energy Reorganization Act of 1974, as amended (ERA), and the Nuclear
Waste Policy Act of 1982, as amended (NWPA); (2) not statutorily
required; and (3) not part of the NRC's permitting regime. The NRC
determined that the regulatory changes proposed in this rule are
required because they would be necessary for providing reasonable
assurance of adequate protection of public health and safety and
provide for the common defense and security, and would be part of the
NRC's permitting regime authorized by the AEA. Therefore, the NRC views
this rulemaking to be outside the scope of E.O. 14270 and did not
insert conditional sunset dates for the regulatory changes in this
proposed rule.
XIX. Availability of Documents
The documents identified in the following table are available to
interested persons through one or more of the following methods, as
indicated.
------------------------------------------------------------------------
ADAMS accession No./
Document web link/Federal
Register citation
------------------------------------------------------------------------
Interim Staff Guidance Reciprocity.............. ML25316A025.
Office Of Nuclear Material Safety and Safeguards ML25316A026.
Interim Staff Guidance NMSS-ISG-04 Guidance for
the Implementation of 10CFRPart31 Subpart C
Standard General Licenses.
Final rule, ``Requirements for Expanded 72 FR 55864.
Definition of Byproduct Material,'' dated
October 1, 2007.
Final rule, ``Exemptions From Licensing, General 72 FR 58473.
Licenses, and Distribution of Byproduct
Material: Licensing and Reporting
Requirements,'' dated October 16, 2007.
Final rule, ``Standards for Protection Against 58 FR 67657.
Radiation; Removal of Expired Material,'' dated
December 22, 1993.
Decommissioning Financial Assurance Requirements ML21235A480.
for Sealed and Unsealed Radioactive Materials--
Regulatory Basis.
PRM-30-66 Petition for Rulemaking, Revision of ML17173A063.
10 CFR 30 Appendix B, April 14, 2017.
SECY-23-0062, Enclosure 1--Proposed Rule Federal ML23010A171.
Register Notice for Decommissioning Financial
Assurance for Sealed and Unsealed Radioactive
Materials, July 24, 2023.
Final rule, ``Distribution of Source Material to 78 FR 32310.
Exempt Persons and to General Licensees and
Revision of General License Exemptions,'' dated
May 29, 2013.
Final rule, ``Safety Requirements for Industrial 55 FR 843.
Radiographic Equipment,'' dated January 10,
1990.
Final rule, ``Licenses for Industrial 62 FR 28948.
Radiography and Radiation Safety Requirements
for Industrial Radiographic Operations,'' dated
May 28, 1997.
Notification of interpretation, ``Industrial 86 FR 29173.
Radiographic Operations and Training,'' dated
June 1, 2021.
Final rule, ``Licenses and Radiation Safety 65 FR 20345.
Requirements for Well Logging,'' dated April
17, 2000.
Final rule, ``Consumer Products Containing Small 48 FR 12331.
Quantities of Radioactive Material; Modified
Reporting and Recordkeeping Requirements,''
dated March 24, 1983..
PRM-30-66, ``Request of the Organization of ML17173A063.
Agreement States for the NRC to Amend Appendix
B, `Quantities of Licensed Material Requiring
Labeling,' '' dated April 14, 2017.
PRM-34-6, ``Petition for Rulemaking on behalf of ML053190112.
the Organization of Agreement States (AOS),
Barbara Hamrick to amend 10 CFR part 34,''
dated November 3, 2005.
NUREG-1556, ``Consolidated Guidance About https://www.nrc.gov/
Materials Licenses''. reading-rm/doc-
collections/nuregs/
staff/sr1556/index.
NUREG-1717, ``Systematic Radiological Assessment ML011980433 (Package).
of Exemptions for Source and Byproduct
Materials,'' June 2001.
NUREG-1757, ``Consolidated Decommissioning ML063000243.
Guidance,'' Volume 1, Revision 2, September
2006.
Regulatory Analysis for the Proposed Rule-- ML26125A393.
Modernizing NRC Regulations for Byproduct
Material Use.
Redline Strikeout Document--Proposed Rule-- ML25323A157 (Package).
Modernizing NRC Regulations for Byproduct
Material Use.
Revision to policy statement, ``Agreement State 82 FR 48535.
Program Policy Statement; Correction,'' dated
October 18, 2017.
Regulatory basis; request for comment, 87 FR 25157.
``Decommissioning Financial Assurance for
Sealed and Unsealed Radioactive Materials,''
dated April 28, 2022.
Executive Order 12866, ``Regulatory Planning and 58 FR 51735.
Review,'' October 4, 1993.
Executive Order 14154, ``Unleashing American 90 FR 8353.
Energy,'' January 29, 2025.
[[Page 28938]]
Executive Order 14192, ``Unleashing Prosperity 90 FR 9065.
Through Deregulation,'' February 6, 2025.
Executive Order 14270, ``Zero-Based Regulatory 90 FR 15643.
Budgeting To Unleash American Energy,'' April
15, 2025.
Burden Tables Modernizing Regulations for ML25323A164.
Byproduct Material use.
Supporting Statement Modernizing Regulations for ML25322A158.
Byproduct Material Use.
Presidential Memorandum, ``Plain Language in 63 FR 31885.
Government Writing,'' dated June 10, 1998.
------------------------------------------------------------------------
The NRC may post materials related to this document, including
public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2025-1205. In addition, the
Federal rulemaking website allows members of the public to receive
alerts when changes or additions occur in a docket folder. To
subscribe: (1) navigate to the docket folder (NRC-2025-1205); (2) click
the ``Subscribe'' link; and (3) enter an email address and click on the
``Subscribe'' link.
List of Subjects
10 CFR Part 30
Byproduct material, Criminal penalties, Government contracts,
Intergovernmental relations, Isotopes, Nuclear energy, Nuclear
materials, Penalties, Radiation protection, Reporting and recordkeeping
requirements, Whistleblowing.
10 CFR Part 31
Byproduct material, Criminal penalties, Labeling, Nuclear energy,
Nuclear materials, Packaging and containers, Penalties, Radiation
protection, Reporting and recordkeeping requirements, Scientific
equipment.
10 CFR Part 32
Byproduct material, Criminal penalties, Labeling, Nuclear energy,
Nuclear materials, Radiation protection, Reporting and recordkeeping
requirements.
10 CFR Part 34
Criminal penalties, Manpower training programs, Occupational safety
and health, Packaging and containers, Penalties, Radiation protection,
Radiography, Reporting and recordkeeping requirements, Scientific
equipment, Security measures, X-rays.
10 CFR Part 39
Byproduct material, Criminal penalties, Labeling, Nuclear energy,
Nuclear material, Occupational safety and health, Oil and gas
exploration--well logging, Penalties, Radiation protection, Reporting
and recordkeeping requirements, Scientific equipment, Security
measures, Source material, Special nuclear material.
10 CFR Part 40
Criminal penalties, Exports, Government contracts, Hazardous
materials transportation, Hazardous waste, Nuclear energy, Nuclear
materials, Penalties, Reporting and recordkeeping requirements, Source
material, Uranium, Whistleblowing.
10 CFR Part 70
Classified information, Criminal penalties, Emergency medical
services, Hazardous materials transportation, Material control and
accounting, Nuclear energy, Nuclear materials, Packaging and
containers, Penalties, Radiation protection, Reporting and
recordkeeping requirements, Scientific equipment, Security measures,
Special nuclear material, Whistleblowing.
10 CFR Part 150
Criminal penalties, Hazardous materials transportation,
Intergovernmental relations, Nuclear energy, Nuclear materials,
Penalties, Reporting and recordkeeping requirements, Security measures,
Source material, Special nuclear material.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing
to amend 10 CFR parts 30, 31, 32, 34, 39, 40, 70 and 150:
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
0
1. The authority citation for part 30 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 82, 161, 181, 182, 183,
186, 223, 234 (42 U.S.C. 2111, 2112, 2201, 2231, 2232, 2233, 2236,
2273, 2282); Energy Reorganization Act secs. 201, 202, 206 (42
U.S.C. 5841, 5842, 5846); Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-
58, 119 Stat. 549 (2005).
Section 30.7 also issued under Energy Reorganization Act sec.
211, Pub. L. 95-601, sec. 10, as amended by Pub. L. 102-486, sec.
2902 (42 U.S.C. 5851). Section 30.34(b) also issued under Atomic
Energy Act sec. 184 (42 U.S.C. 2234). Section 30.61 also issued
under Atomic Energy Act sec. 187 (42 U.S.C. 2237).
0
2. In Sec. 30.4, remove the definition of ``Physician'' and revise the
definitions of ``Consortium'' and ``Principle activities'' to read as
follows:
Sec. 30.4 Definitions.
* * * * *
Consortium means an association of medical use licensees and a PET
radionuclide production facility that jointly own or share in the
operation and maintenance cost of the PET radionuclide production
facility that produces PET radionuclides for use in producing
radioactive drugs within the consortium for noncommercial distributions
among its associated members for medical use. The PET radionuclide
production facility within the consortium must be located at an
educational institution or a Federal facility or a medical facility.
* * * * *
Principal activities, as used in this part and part 31 of this
chapter, 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.
* * * * *
0
3. In Sec. 30.6, revise paragraph (b)(1) to read as follows:
Sec. 30.6 Communications.
* * * * *
(b) * * *
(1) The delegated licensing program includes authority to issue,
renew, amend, cancel, modify, suspend, or revoke licenses for nuclear
materials issued, and validate standard general license registrations,
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:
* * * * *
0
4. In Sec. 30.32, revise paragraph (j)(2) to read as follows:
[[Page 28939]]
Sec. 30.32 Application for specific licenses.
* * * * *
(j) * * *
(2) Evidence that the applicant is qualified to produce radioactive
drugs for medical use by meeting one of the criteria in Sec. 32.72(a)
of this chapter.
* * * * *
0
5. In Sec. 30.34, revise paragraph (h)(1) to read as follows:
Sec. 30.34 Terms and conditions of licenses.
* * * * *
(h) * * *
(1) Each general licensee that is required to register by Sec.
31.5(c)(13) or part 31 subpart C in accordance with Sec. 31.13 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:
* * * * *
0
6. In Sec. 30.35, revise paragraph (g) introductory text to read as
follows:
Sec. 30.35 Financial assurance and recordkeeping for decommissioning.
* * * * *
(g) Each person licensed under this part, part 31 subpart C of this
chapter, 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--
* * * * *
0
7. In Sec. 30.41, revise paragraph (d)(1) to read as follows:
Sec. 30.41 Transfer of byproduct material.
* * * * *
(d) * * *
(1) The transferor may have in his possession, and read, a current
copy of the transferee's specific license, validated standard general
license, or registration certificate;
* * * * *
0
8. Revise appendix B to 10 CFR part 30 to read as follows:
Appendix B--Quantities of Licensed Material Used To Assess
Financial Assurance for Decommissioning
------------------------------------------------------------------------
Material Microcuries
------------------------------------------------------------------------
Aluminum-26............................... 10
Americium-241............................. 0.01
Antimony-125.............................. 100
Argon-39.................................. 1,000
Barium-133................................ 100
Berkelium-249............................. 0.1
Beryllium-10.............................. 1
Bismuth-207............................... 10
Bismuth-210m.............................. 0.1
Cadmium-109............................... 10
Cadmium-113m.............................. 0.1
Cadmium-113............................... 100
Calcium-41................................ 100
Calcium-45................................ 100
Californium-248........................... 0.01
Carbon-14................................. 100
Cerium-139................................ 100
Cerium-144................................ 1
Cesium-134................................ 10
Cesium-135................................ 100
Cesium-137................................ 10
Chlorine-36............................... 10
Cobalt-57................................. 100
Cobalt-60................................. 1
Curium-242................................ 0.01
Dysprosium-159............................ 100
Europium-150.............................. 1
Europium-152.............................. 1
Europium-154.............................. 1
Europium-155.............................. 10
Gadolinium-151............................ 10
Gadolinium-152............................ 100
Gadolinium-153............................ 10
Germanium-68.............................. 10
Gold-195.................................. 10
Hafnium-172............................... 1
Hafnium-178m.............................. 0.1
Hafnium-182............................... 0.1
Holmium-166m.............................. 1
Hydrogen-3................................ 1,000
Indium-115................................ 100
Iodine-129................................ 1
Iridium-194m.............................. 10
Iron-55................................... 100
Iron-60................................... 1
Krypton-81................................ 1,000
Krypton-85................................ 1,000
Lanthanum-137............................. 10
Lanthanum-138............................. 100
Lead-202.................................. 10
Lead-205.................................. 100
Lutetium-173.............................. 10
Lutetium-174m............................. 10
Lutetium-174.............................. 10
Lutetium-176.............................. 100
Lutetium-177m............................. 10
Manganese-53.............................. 1,000
Manganese-54.............................. 100
Mercury-194............................... 1
Molybdenum-93............................. 10
Neptunium-235............................. 100
Nickel-59................................. 100
Nickel-63................................. 100
Niobium-93m............................... 10
Niobium-94................................ 1
Osmium-194................................ 1
Palladium-107............................. 10
Platinum-193.............................. 1,000
Plutonium-239............................. 0.01
Polonium-210.............................. 0.1
Potassium-40.............................. 100
Promethium-143............................ 100
Promethium-144............................ 10
Promethium-145............................ 10
Promethium-146............................ 1
Promethium-147............................ 10
Radium-226................................ 0.1
Radium-228................................ 0.1
Rhenium-184m.............................. 10
Rhenium-186m.............................. 10
Rhenium-187............................... 1,000
Rhodium-101............................... 10
Rhodium-102m.............................. 10
Rhodium-102............................... 10
Rubidium-87............................... 100
Ruthenium-106............................. 1
Samarium-145.............................. 100
Samarium-146.............................. 1
Samarium-147.............................. 100
Samarium-151.............................. 10
Selenium-79............................... 100
Silicon-32................................ 1
Silver-108m............................... 1
Silver-100m............................... 10
Sodium-22................................. 10
Strontium-90.............................. 0.1
Tantalum-179.............................. 100
Technetium-97............................. 1,000
Technetium-98............................. 10
Technetium-99............................. 100
Tellurium-121m............................ 10
Tellurium-123............................. 100
Terbium-157............................... 10
Terbium-158............................... 1
Thallium-204.............................. 100
Thorium-232............................... 100
Thorium-natural \1\....................... 100
Thulium-170............................... 10
Thulium-171............................... 10
Tin-119m.................................. 100
Tin-121m.................................. 100
Tin-123................................... 10
Tin-126................................... 10
Titanium-44............................... 1
Tungsten-181.............................. 1,000
Uranium-233............................... 0.01
Uranium-234............................... 0.01
Uranium-235............................... 0.01
Uranium-238............................... 100
Uranium-natural \2\....................... 100
Vanadium-49............................... 1,000
Zinc-65................................... 10
Zirconium-93.............................. 10
Any alpha-emitting radionuclide not listed 0.01
above or mixtures of alpha emitters of
unknown composition.
Any radionuclide other than alpha emitting 0.1
radionuclides 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.
* * * * *
[[Page 28940]]
PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL
0
9. The authority citation for part 31 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 183, 223, 234 (42
U.S.C. 2111, 2201, 2233, 2273, 2282); Energy Reorganization Act
secs. 201, 202 (42 U.S.C. 5841, 5842); Government Paperwork
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C.
2014, 2021, 2021b, 2111).
0
10. Add subpart A, before Sec. 31.1 to read as follows:
PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL
Subpart A--General Information
Sec. 31.1 Purpose and scope.
* * * * *
0
11. In Sec. 31.4, revise paragraph (b) and add paragraph (c)(2) to
read as follows:
Sec. 31.4 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 31.5, 31.8, 31.11, 31.12, 31.13, 31.14,
31.15, 31.16, 31.17, and 31.18.
(c) * * *
(2) In Sec. 31.13, NRC Form 1003 is approved under control number
3150-XXXX.
* * * * *
0
12. Add subpart B, before Sec. 31.5, and revise paragraphs (c)(14) and
(15) to read as follows:
Subpart B--General Licenses
Sec. 31.5 Certain detecting, measuring, gauging, or controlling
devices and certain devices for producing light or an ionized
atmosphere.\[2]\
* * * * *
c. * * *
(14) Shall report changes to the mailing address for the location
of use (including change in name of general licensee) within 30 days of
the effective date of the change by electronic submission such as
Electronic Information Exchange, email to [email protected], or CD-
ROM; via mail to the Director, Office of Nuclear Material Safety and
Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001 for mail where a signature is not required; or via mail
to the Director, Office of Nuclear Material Safety and Safeguards,
ATTN: GLTS, U.S. Nuclear Regulatory Commission, 11555 Rockville Pike,
Rockville, MD 20852-2738 for signature required correspondence. For a
portable device, a report of address change is only required for a
change in the device's primary place of storage. 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 website
at https://www.nrc.gov/site-help/e-submittals.html; by email to
[email protected]; or by writing the Office of the Chief
Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001. The guidance discusses, among other topics, the formats the
NRC can accept, the use of electronic signatures, and the treatment of
nonpublic information.
(15) May not hold devices that are not in use for longer than 36
months. 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 36 month time limit if the general
licensee performs semi-annually physical inventories of these devices
while they are in standby.
0
13. In Sec. 31.11, revise paragraphs (a)(3), (a)(4), (a)(6) and (a)(8)
to read as follows:
Sec. 31.11 General license for use of byproduct material for certain
in vitro clinical or laboratory testing.
(a) * * *
(1) * * *
(3) Carbon-14, in units not exceeding 100 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 1000 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) * * *
(6) Selenium-75, in units not exceeding 100 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) * * *
(8) Cobalt-57, in units not exceeding 100 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.
* * * * *
0
14. Add subpart C, consisting of Sec. Sec. 31.13 through 31.18, to
read as follows:
Subpart C--Standard General Licenses
31.13 Standard General License Requirements.
31.14 Standard General License for Certain Fixed Gauging.
31.15 Standard General License for Portable Gauging.
31.16 Standard General License for Certain Medical Uses.
31.17 Standard General License for Certain Analytical Equipment
Including Electron Capture Detectors, X-Ray Fluorescence Devices,
and Ion Generators.
31.18 Standard General License for Certain In Vitro Testing.
Subpart C--Standard General Licenses
Sec. 31.13 Standard General License Requirements.
(a) Any person, as defined in Sec. 30.4 of this chapter, engaging
in standard general license activities described in Sec. 31.14-31.18
of this part, shall:
(1) At least 30 calendar days prior to acquiring, receiving
possessing, using, or transferring byproduct material, file a submittal
containing an NRC Form 1003, with the Commission using a communication
method defined in Sec. 30.6(a) of this chapter;
(2) Receive from the Commission, a validated standard general
license in the form of a copy of NRC Form 1003 with a registration
number assigned; and
(3) Pay the appropriate fee as prescribed in Sec. 170.31 of this
chapter. No fee will be required to accompany an amendment of a
standard general license, except as provided in Sec. 170.31 of this
chapter.
(b) A standard general licensee under this subpart shall:
(1) Limit the number of locations of use to no more than five
locations of use, excluding temporary job sites as permitted by the
standard general licenses in Sec. 31.15 and Sec. 31.17 of this part.
(2) File a submittal containing an NRC Form 1003, with the
Commission using a communication method defined in Sec. 30.6(a) of
this chapter, at least 30 calendar days prior to the effective date
[[Page 28941]]
of any of the following changes to the most recently validated NRC Form
1003: the licensee's direct ownership, controlling ownership of the
licensed activities, name of the licensee, location of use addresses,
mailing address, Radiation Safety Officer, or materials.
(i) If licensed activities are transferred or assigned to a
different ownership, 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: 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 Records required by Sec.
20.2103(b)(4) of this chapter.
(3) Pay an annual fee as prescribed in Sec. 171.16 of this
chapter.
(c) A person licensed under this subpart shall restrict the
possession of licensed material:
(1) To a total quantity below unity for the radionuclides listed in
10 CFR part 37 appendix A, calculated using the Category 2 activity
thresholds specified in the table, according to 10 CFR part 37 appendix
A;
(2) To quantities below the minimum limits for unsealed and/or
sealed material as specified in Sec. 30.35(d) of this chapter for
which decommissioning financial assurance is required; and
(3) To quantities below the limits specified in Sec. 30.72 of this
chapter, in the form of unsealed material and foil or plated sources,
above which, consideration of the need for an emergency plan for
responding to a release of licensed material is required.
(d) A person licensed under this subpart shall not abandon
byproduct material.
(e) A person licensed under this subpart shall not export the
byproduct material except in accordance with part 110 of this chapter.
(f)(1) Within 60 days of the occurrence of any of the following,
each licensee shall provide notification to the Commission by filing a
submittal containing an NRC Form 1003 with the Commission using a
communication method defined in Sec. 30.6(a) of this chapter any of
the following and indicate which approach under paragraph (f)(2) of
this section the licensee intends to pursue:
(i) The licensee has decided to permanently cease principal
activities, 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 Commission
requirements, or
(ii) No principal activities under the license have been conducted
for a period of 36 months, or
(iii) No principal activities have been conducted for a period of
36 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.
(2) When notification is made pursuant to paragraph (f)(1) of this
section, the licensee must--
(i) Within 45 days, submit a request to delay initiation of
decommissioning activities consistent with paragraph (g) of this
section, or
(ii) Immediately 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
(iii) Within 12 months, submit a decommissioning plan, if required
by paragraph (f)(3) of this section, and begin decommissioning upon
approval of that plan.
(3)(i) A decommissioning plan must be submitted 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 cases
described in Sec. 30.36(g)(1)(i)-(iv).
(ii) The Commission may approve an alternate schedule for submittal
of a decommissioning plan required pursuant to paragraph (f)(2) 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.
(iii) Procedures such as those listed in paragraph (f)(3)(i) of
this section with potential health and safety impacts may not be
carried out prior to approval of the decommissioning plan.
(iv) The proposed decommissioning plan for the site or separate
building or outdoor area must include the information listed in Sec.
30.36 (g)(4)(i)-(vi):
(v) 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.
(4) 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.
(5) 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.
(6) As the final step in decommissioning, the licensee shall--
(i) Certify the disposition of all licensed material, including
accumulated wastes, by filing a submittal containing an NRC Form 1003,
with the Commission using a communication method defined in Sec.
30.6(a) of this chapter; and
(ii) 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--
(A) 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
(B) Specify the survey instrument(s) used and certify that each
instrument is properly calibrated and tested.
(g) The Commission may grant a request to extend the time periods
established in paragraph (f). The schedule for decommissioning set
forth in paragraph (f) of this section may not commence until the
Commission has made a determination on the request. The request must
include the following:
(1) Discussion of the business need for continued possession or
authorization of licensed material or how the request is otherwise in
the public interest.
(2) Discussion of the health and safety plan that will be in effect
during the extension period.
(3) Discussion of the current decommissioning cost estimate and the
potential for increased decommissioning costs if an extension of the
time period is approved.
[[Page 28942]]
(4) A timeframe for which principal activities will resume, which
shall not exceed 36 months from the date that principal activities
ceased at the site, separate building, or outdoor area, as provided for
in (f)(1)(ii) and (f)(1)(iii) of this section.
(5) A commitment that, should principal activities not resume
within the timeframe specified in paragraph (g)(4), the licensee shall
submit provide notification to the NRC consistent with paragraph (f) of
this section.
(h) A licensee shall terminate a standard general license with the
Commission by filing a submittal containing an NRC Form 1003, with the
Commission using a communication method defined in Sec. 30.6(a) of
this chapter. The standard general license will be terminated by
written notice to the licensee when the Commission determines that:
(i) Byproduct material has been properly disposed;
(ii) Reasonable effort has been made to eliminate residual
radioactive contamination, if present; and
(iii)(A) A radiation survey has been performed which demonstrates
that the premises are suitable for unrestricted release in accordance
with the criteria for decommissioning in 10 CFR part 20, subpart E; or
(B) Other information submitted by the licensee is sufficient to
demonstrate that the premises are suitable for unrestricted release in
accordance with the criteria for decommissioning in 10 CFR part 20,
subpart E.
(iv) Records required by Sec. 30.51 (d) and (f) of this chapter
have been received.
Sec. 31.14 Standard General License for Certain Fixed Gauging.
(a)(1) Provided that the provisions of paragraph (b) of this
section have been met, 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 byproduct material contained in devices
designed and manufactured for the purpose of detecting, measuring,
gauging or controlling thickness, density, level, interface location,
or qualitative or quantitative chemical composition in accordance with
the provisions of paragraph (c) of this section.
(2)(i) The provisions of paragraph (a)(1) of this section apply to
byproduct material contained in devices which are registered in the
Sealed Source and Device Registry with the Commission under Sec.
32.210, as defined in Sec. 32.2 of this chapter, or with an Agreement
State, with the principle use codes D--gamma gauges or E--beta gauges.
(ii) The provisions of paragraph (a)(1) of this section apply to
the use specifically licensed devices that are distributed in
accordance with Sec. 30.41 of this chapter.
(3) The provisions of paragraph (a)(1) of this section apply for
use of these materials at fixed locations listed on the most recent NRC
Form 1003 provided to the Commission in accordance with Sec. 31.13 of
this part.
(4) The provisions of paragraph (a)(1) of this section do not
authorize the manufacture, initial transfer or distribution, or import
of devices containing byproduct material.
(b)(1) The general licenses provided in this section are subject to
all the provisions of the Act, now or hereafter in effect, and to all
applicable rules, regulations, and orders of the Commission including
the provisions of Sec. Sec. 30.7, 30.8, 30.9, 30.10, 30.11, 30.31,
30.34, 30.35, 30.41, 30.50 through 30.64 of this chapter; Sec. Sec.
31.1 through 31.4 of this part; Sec. Sec. 31.21 through 31.23 of this
part; and to the provisions of 10 CFR parts 19, 20, 21, and 71.
(2) Any person engaging in activities under the general licenses
provided in this section need not comply with Sec. 30.34(b) of this
chapter.
(3) In addition, any person engaging in activities under the
general licenses provided in this section shall comply with the
requirements in Sec. 31.13 of this part.
(c) A licensee shall --
(1)(i) Limit the use of sealed sources to those registered either
with Commission under Sec. 32.210 of this chapter or with an Agreement
State.
(ii) Ensure sealed sources are incorporated in compatible devices,
by manufacturer and model, and limited to use as specified in the
Sealed Source and Device Registry for the devices manufacturer and
model.
(iii) Ensure the activity of byproduct material in sealed sources
is limited to the activity listed in the Sealed Source and Device
Registry for the associated devices manufacturer and model.
(2)(i) Appoint and designate, in writing, a radiation safety
officer 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.
(ii) Maintain a record of an individual's training and experience,
and appointment as the Radiation Safety Officer for 5 years following
their last day in the role.
(3)(i) Designate, in writing, individuals to work as authorized
users, who have sufficient training and experience to use and supervise
the use of licensed materials. Additionally, Licensee staff engaged in
leak test sample collection, on-off mechanism testing, and routine
maintenance shall be trained on the licensee's procedures and the
manufacturer's written recommendations and instructions for the
relevant activities.
(ii) Maintain the designation and record of the individuals'
training and experience for 5 years after the individuals last works as
an Authorized User for the licensee.
(4) Ensure licensed materials authorized by paragraph (a) of this
section are used by, or under the supervision of, individuals who have
been designated as authorized users by paragraph (c)(3) of this
section.
(5)(i) Operate each device containing byproduct material within the
manufacturer's specified temperature and environmental limits such that
shielding and shutter mechanisms of the source holder are not
comprised.
(ii) Ensure sealed sources containing licensed material are not
opened and sources are not removed from source holders.
(iii) Ensure only the gauge manufacturer, distributor, or other
person authorized by the Commission or an Agreement State will perform
nonroutine maintenance such as installation, initial radiation survey,
repair and maintenance of radiological safety components, relocation,
replacement, alignment, removal from service, and disposal of sealed
sources.
(6)(i) Prepare an evaluation demonstrating that unmonitored
individuals are not likely to receive a radiation dose in excess of the
limits in Sec. 20.1502 of this chapter; or
(ii) Develop, implement, and maintain a program for individual
monitoring of external and internal occupational dose in accordance
with Sec. 20.1502 of this chapter.
(iii) maintain records of the evaluation described in (6)(i) for 3
years following the last use of licensed material by unmonitored
individuals.
(iv) maintain records of individual monitoring results in
accordance with Sec. 20.2106 of this chapter.
(7)(i) Ensure any radiation detection instruments used to perform
on-off
[[Page 28943]]
mechanism tests and surveys required by this part, 10 CFR part 20, and
10 CFR part 30 are appropriate for the isotopes and activities present
and meet the requirements of Sec. 20.1501 of this chapter.
(ii) Ensure the instruments used for required surveys are
calibrated at least annually by a person licensed by the Commission or
an Agreement State to perform instrument calibration services.
(iii) Maintain a record of the calibration 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.
(8)(i) Conduct physical inventories every 6 months to account for
all sealed sources and/or devices received and possessed under the
license.
(ii) Maintain records of inventories for 3 years from the date of
each inventory, and shall include the radionuclides, quantities,
manufacturer's name and model numbers, and the date of the inventory.
(9) Ensure sealed sources and detector cells are tested for leakage
periodically.
(i)The licensee shall keep a record of leak test results in units
of becquerels (microcuries) and retain the record for inspection by the
Commission for 3 years after the leak test is performed. The final leak
test record performed prior to the sealed source or detector cell being
transferred or disposed of shall be retained until the license is
terminated. Records must also show the dates of performance and the
names of persons performing testing.
(ii) Ensure leak tests are performed by an organization licensed by
the NRC or an Agreement State to provide leak testing services to other
licensees; or by using a leak test sample collection kit supplied by an
organization licensed by the NRC or an Agreement State to provide leak
test kits and/or sample analysis services to other licensees and
according to the kit supplier's instructions. The leak test sample must
be taken from the nearest accessible point to the sealed source or
detector cell where contamination might accumulate. The leak test
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 is performed by persons
specifically licensed by the U.S. Nuclear Regulatory Commission or an
Agreement State to perform such services.
(iii)(A) Ensure each sealed source, except sealed sources and
detector cells designed to primarily emit alpha particles, are tested
at intervals specified either in the certificate of registration issued
by the U.S. Nuclear Regulatory Commission under Sec. 32.210 of this
chapter or by an Agreement State. In the absence of a registration
certificate, sealed sources or detector cell shall be tested for
leakage and/or contamination at intervals not to exceed 6 months, or at
such other intervals as specified.
(B) Ensure sealed sources and detector cells designed to primarily
emit alpha particles are tested for leakage and/or contamination at
intervals not to exceed 3 months.
(C) Ensure that, in the absence of a certificate from a transferor
indicating that a leak test has been made within the intervals
specified in the certificate of registration issued by the Commission
under Sec. 32.210 of this chapter or by an Agreement State, prior to
the transfer, a sealed source or detector cell received from another
person not be put into use until tested and the test results received.
(iv)(A) Ensure that, if the test conducted pursuant to paragraphs
(i) and (ii) of this section reveals the presence of 185 becquerels
(0.005 microcuries) or more of removable contamination, a report shall
be filed with the Commission in accordance with Sec. 30.50(c)(2) of
this chapter, and the source shall be removed immediately from service
and decontaminated, repaired, or disposed of in accordance with
Commission regulations.
(B) 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.
(v) Exempt the following sealed sources and detector cells from the
periodic leak test requirements set out in paragraphs (i) through (iv)
of this section:
(A) Hydrogen-3 (tritium) sources;
(B) Sources containing licensed material with a half-life of 30
days or less;
(C) sources containing licensed material in gaseous form;
(D) Sources of beta- or gamma-emitting radioactive material with an
activity of 3.7 MBq [100 microcuries] or less; and
(E) Sources of alpha- or neutron-emitting radioactive material with
an activity of 0.37 MBq [10 microcuries] or less.
(F) Sealed sources if they are in storage and are not being used.
However, when they are removed from storage for use or transferred to
another person and have not been tested within the required leak test
interval, they shall be tested before use or transfer. No source shall
be stored for a period of more than 10 years without being tested for
leakage and/or contamination.
(10)(i) Test each gauge for the proper operation of the on-off
mechanism (shutter) and indicator, if any, at intervals not to exceed 6
months. This requirement does not apply to gauges that are in storage
with the shutter mechanism is in the locked position.
(ii) Maintain on-off mechanism test records for 3 years. The record
must include the model and serial number of the device, the date of the
test, the results of the test, and the name of the individual who
performed the test.
(11) Develop, implement, and maintain procedures for routine
maintenance of gauges according to each manufacturer's or distributor's
written recommendations and instructions.
(12) Develop, implement, and maintain operating, emergency, and
security procedures that meet the requirements of Sec. Sec.
19.11(a)(3), 20.1101, 20.1801-1802, 20.2201-2203, 2207, 21.21, and
30.50 of this chapter.
Sec. 31.15 Standard General License for Portable Gauging.
(a)(1) Provided that the provisions of paragraph (b) of this
section have been met, 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, byproduct material contained in devices
designed and manufactured for the purpose of measuring the physical
properties of materials in accordance with the provisions of paragraph
(c) of this section.
(2)(i)The provisions of paragraph (a)(1) of this section apply to
byproduct material contained in devices which are registered in the
Sealed Source and Device Registry with the Commission under Sec.
32.210 of this chapter, as defined in Sec. 32.2 of this chapter, or
with an Agreement State, with the principle use codes G--Portable
Moisture Density Gauges.
(ii) The provisions of paragraph (a)(1) of this section apply to
the use of specifically licensed devices that are distributed in
accordance with Sec. 30.41 of this chapter.
[[Page 28944]]
(3)(i) The provisions of paragraph (a)(1) of this section authorize
use, possession and storage of licensed materials at fixed locations
listed on the most recent NRC Form 1003 provided to the Commission in
accordance with Sec. 31.13 of this part; and
(ii) Use, possession and storage of licensed materials at temporary
job sites of the licensee anywhere in the United States where the U.S.
Nuclear Regulatory Commission maintains jurisdiction for regulating the
use of licensed material, including areas of exclusive Federal
jurisdiction within Agreement States. If the jurisdiction status of a
Federal facility within an Agreement State is unknown, the licensee
shall contact the Federal agency controlling the job site in question
to determine whether the proposed job site is an area of exclusive
Federal jurisdiction.
(iii) Authorization for use of radioactive materials at job sites
in Agreement States in areas not under exclusive Federal jurisdiction
is not provided under this general license and shall be obtained from
the appropriate State regulatory agency.
(4) The provisions of paragraph (a)(1) of this section do not
authorize the manufacture, initial transfer or distribution, or import
of devices containing byproduct material
(b)(1)The general licenses provided in this section are subject to
all the provisions of the Act, now or hereafter in effect, and to all
applicable rules, regulations, and orders of the Commission including
the provisions of Sec. Sec. 30.7,30.8, 30.9, 30.10, 30.11, 30.31,
30.34, 30.35, 30.41, 30.50 through 30.64 of this chapter; Sec. Sec.
31.1 through 31.4 of this part; Sec. Sec. 31.21 through 31.23 of this
part; and to the provisions of 10 CFR parts 19, 20, 21, and 71.
(2) Any person engaging in activities under the general licenses
provided in this section need not comply with Sec. 30.34(b) of this
chapter.
(3) In addition, any person engaging in activities under the
general licenses provided in this section shall comply with the
requirements in Sec. 31.13 of this part.
(c) The licensee shall--
(1)(i) Limit the use of sealed sources to those registered either
with Commission under Sec. 32.210 of this chapter or with an Agreement
State.
(ii) Ensure sealed sources are incorporated in compatible devices,
by manufacturer and model, and limited to use as specified in the
Sealed Source and Device Registry for the devices manufacturer and
model.
(iii) Ensure the activity of byproduct material in sealed sources
is limited to the activity listed in the Sealed Source and Device
Registry for the associated devices manufacturer and model.
(2)(i) Appoint and designate, in writing, a radiation safety
officer 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.
(ii) Maintain a record of an individual's training and experience,
and appointment as the Radiation Safety Officer for 5 years following
their last day in the role.
(3)(i) Designate, in writing, individuals to work as authorized
users, who have completed a portable gauge safety course for users and
hands-on training in the use of portable gauges.
(ii) Maintain the designation and record of the individual's
training and experience for 5 years after the individual last works as
an Authorized User for the licensee.
(4) Ensure licensed materials authorized by paragraph (a) of this
section are used by, or under the supervision of, individuals who have
been designated as authorized users by paragraph (c)(3) of this
section.
(5)(i) Prepare an evaluation demonstrating that unmonitored
individuals are not likely to receive a radiation dose in excess of the
limits in Sec. 20.1502 of this chapter; or
(ii) Develop, implement, and maintain a program for individual
monitoring of external and internal occupational dose in accordance
with Sec. 20.1502 of this chapter.
(iii) maintain records of the evaluation described in (5)(i) for 3
years following the last use of licensed material by unmonitored
individuals.
(iv) maintain records of individual monitoring results in
accordance with Sec. 20.2106 of this chapter.
(6)(i) Possess and use, or have access to and use, a radiation
detection instrument for surveys required by parts 20 and 71 of this
chapter.
(ii) Ensure the instruments used for required surveys are
calibrated at least annually by a person licensed by the Commission or
an Agreement State to perform instrument calibration services.
(7)(i) Develop, implement, and maintain procedures for ensuring
accountability of licensed materials at all times.
(ii) Conduct Physical inventories every 6 months to account for all
sealed sources and/or devices received and possessed under the license.
(iii) Maintain records of inventories for 3 years from the date of
each inventory, and shall include the radionuclides, quantities,
manufacturer's name and model numbers, and the date of the inventory.
(8) Ensure sealed sources are tested for leakage periodically.
(i) The licensee shall keep a record of leak test results in units
of becquerels (microcuries) and retain the record for inspection by the
Commission for 3 years after the leak test is performed. The final leak
test record performed prior to the sealed source being transferred or
disposed of shall be retained until the license is terminated. Records
must also show the dates of performance and the names of persons
performing testing.
(ii) Ensure leak tests are performed by an organization licensed by
the NRC or an Agreement State to provide leak testing services to other
licensees; or by using a leak test sample collection kit supplied by an
organization licensed by the NRC or an Agreement State to provide leak
test kits and/or sample analysis services to other licensees and
according to the kit supplier's instructions. The leak test sample must
be taken from the nearest accessible point to the sealed source where
contamination might accumulate. The leak test 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 is performed by persons specifically
licensed by the U.S. Nuclear Regulatory Commission or an Agreement
State to perform such services.
(iii)(A) Ensure each sealed source, except sealed sources designed
to primarily emit alpha particles, are tested at intervals specified
either in the certificate of registration issued by the U.S. Nuclear
Regulatory Commission under Sec. 32.210 of this chapter or by an
Agreement State. In the absence of a registration certificate, sealed
sources shall be tested for leakage and/or contamination at intervals
not to exceed 6 months, or at such other intervals as specified.
(B) Ensure sealed sources designed to primarily emit alpha
particles are tested for leakage and/or contamination at intervals not
to exceed 3 months.
(C) Ensure, that in the absence of a certificate from a transferor
indicating that a leak test has been made within the intervals
specified in the certificate
[[Page 28945]]
of registration issued by the Commission under Sec. 32.210 of this
chapter or by an Agreement State, prior to the transfer, a sealed
source received from another person not be put into use until tested
and the test results received.
(iv)(A) Ensure, that if the test conducted pursuant to paragraphs
(i) and (ii) of this section reveals the presence of 185 becquerels
(0.005 microcuries) or more of removable contamination, a report shall
be filed with the Commission in accordance with Sec. 30.50(c)(2) of
this chapter, and the source shall be removed immediately from service
and decontaminated, repaired, or disposed of in accordance with
Commission regulations.
(B) 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.
(v) Exempt the following sealed sources from the periodic leak test
requirements set out in paragraphs (i) through (iv) of this section:
(A) Hydrogen-3 (tritium) sources;
(B) Sources containing licensed material with a half-life of 30
days or less;
(C) sources containing licensed material in gaseous form;
(D) Sources of beta- or gamma-emitting radioactive material with an
activity of 3.7 MBq [100 microcuries] or less; and
(E) Sources of alpha- or neutron-emitting radioactive material with
an activity of 0.37 MBq [10 microcuries] or less.
(F) Sealed sources if they are in storage and are not being used.
However, when they are removed from storage for use or transferred to
another person, and have not been tested within the required leak test
interval, they shall be tested before use or transfer. No source shall
be stored for a period of more than 10 years without being tested for
leakage and/or contamination.
(9) Develop, implement, and maintain procedures for routine
maintenance of gauges according to each manufacturer's or distributor's
written recommendations and instructions.
(10) Develop, implement, and maintain operating, emergency, and
security procedures that meet the requirements of Sec. Sec. 20.1101,
20.1801 through 1802, 20.2201 through 2203, 30.34, and 30.50 of this
chapter.
Sec. 31.16 Standard General License for Certain Medical Uses.
(a)(1) Provided that the provisions of paragraph (b) of this
section have been met, 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 manufacture, produce,
acquire, receive, possess, prepare, use, or transfer, byproduct
material for certain medical uses in accordance with the provisions of
paragraph (c) of this section.
(2) The provisions of paragraph (a)(1) of this section apply for
use of:
(i) Unsealed gallium-67, indium-111, iodine-123, iodine-125,
iodine-131), technetium-99m, thallium-201, and xenon-133 for uptake,
dilution, excretion, imaging, and localization studies for which a
written directive is not required for medical uses as described in
Sec. Sec. 35.100 and 35.200 of this chapter;
(ii) Molybdenum-99/technetium-99m generators to prepare
radiopharmaceuticals for medical uses as described in Sec. Sec. 35.100
and 35.200 of this chapter; and
(iii) Calibration, transmission, and reference sources for uses as
described in Sec. 35.65 of this chapter.
(3)(i) The provisions of paragraph (a)(1) of this section do not
apply for use of unsealed byproduct material for mobile medical
services as defined in Sec. 35.2.
(ii) The provisions of paragraph (a)(2)(iii) do not apply for use
of sources for medical use as defined in Sec. 35.2 of this chapter
including with the requirements Sec. 35.500 of this chapter.
(4) The provisions of paragraph (a)(1) of this section apply for
use of these materials at fixed locations listed on the most recent NRC
Form 1003 provided to the Commission in accordance with Sec. 31.13 of
this part.
(b)(1)The general licenses provided in this section are subject to
all the provisions of the Act, now or hereafter in effect, and to all
applicable rules, regulations, and orders of the Commission including
the provisions of Sec. Sec. 30.7, 30.8, 30.9, 30.10, 30.11, 30.31,
30.34, 30.35, 30.41, 30.50 through 30.64 of this chapter; Sec. Sec.
31.1 through 31.4 of this part; Sec. Sec. 31.21 through 31.23 of this
part; and to the provisions of 10 CFR parts 19, 20, 21, 35 with the
exceptions provided in paragraph (b)(2) of this section, and 10 CFR
part 71.
(2) Any person engaging in activities under the general licenses
provided in this section need not comply with Sec. 30.34(b) of this
chapter and Sec. Sec. 35.11, 35.12, 35.13, 35.14, 35.18, 35.24(a)-(b),
and 35.24(d),of this chapter.
(3) In addition, any person engaging in activities under the
general licenses provided in this section shall comply with the
requirements in Sec. 31.13 of this part.
(c) A licensee shall--
(1)(i) Designate, in writing, an individual to work as the
Radiation Safety Officer, as defined in 10 CFR 35.2 who meets the
training and experience requirements in Sec. 35.50 of this chapter to
be responsible for implementing the radiation protection program.
(ii) Ensure the individual working as Radiation Safety Officer
meets the training, experience and criteria established in Sec. 35.59
of this chapter.
(iii) Maintain the designation and record of the individual's
training and experience for 5 years after the individual last works as
a Radiation Safety Officer for the licensee.
(iv) For the time period described in Sec. 35.24(c) of this
chapter, a licensee may permit an individual qualified to be a
Radiation Safety Officer, under Sec. Sec. 35.50 and 35.59 of this
chapter, to function as a temporary Radiation Safety Officer and to
perform the functions of a Radiation Safety Officer, as provided in
Sec. 35.24(g) of this chapter, if the licensee takes the actions
required in paragraphs (2)(i)-(iii) of this paragraph and the required
actions in Sec. Sec. 35.24(e), 35.24(g), and 35.24(h) of this chapter
and notifies the Commission in accordance with Sec. 31.13 of this
chapter.
(2)(i) Designate, in writing, individuals to work as authorized
users, as defined in Sec. 35.2 of this chapter who meet the training
and experience requirements in Sec. 35.190 of this chapter for Sec.
35.100 activities Sec. 35.290 of this chapter for Sec. 35.200
activities.
(ii) Ensure individuals working as authorized users meet the
training, experience and criteria established in Sec. 35.59 of this
chapter.
(iii) Maintain the designation and record of the individual's
training and experience for 5 years after the individual last works as
an Authorized User for the licensee.
(3) Ensure licensed materials authorized by paragraph (a) of this
section are used by, or under the supervision of, individuals who have
been designated as authorized users by paragraph (c)(2) of this
section.
(4)(i) Prepare an evaluation demonstrating that unmonitored
individuals are not likely to receive a radiation dose in excess of the
limits in Sec. 20.1502 of this chapter; or
(ii) Develop, implement, and maintain a program for individual
monitoring of external and internal occupational dose
[[Page 28946]]
in accordance with Sec. 20.1502 of this chapter.
(iii) maintain records of the evaluation described in (4)(i) for 3
years following the last use of licensed material by unmonitored
individuals.
(iv) maintain records of individual monitoring results in
accordance with Sec. 20.2106 of this chapter.
(5)(i) Ensure any radiation detection instruments used to perform
surveys required by this part, 10 CFR parts 20, 30, 35, and 71 are
appropriate for the isotopes and activities present and meet the
requirements of Sec. 20.1501 of this chapter.
(ii) Ensure the instruments used for required surveys are
calibrated at least annually by a person licensed by the Commission or
an Agreement State to perform instrument calibration services.
(iii) Maintain a record of the calibrations 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.
(6)(i) Develop, implement, and maintain written procedures for
sealed-source leak testing that meet the requirements of Sec. 35.67 of
this chapter; or
(ii) Ensure leak test sample collection and analysis is performed
by an organization authorized by the Commission or an Agreement State
to provide leak testing services to other licensees; or
(iii) Use a leak test sample collection kit supplied by an
organization licensed by the Commission or an Agreement State to
provide leak test kits or sample analysis services to other licensees
and according to the instructions provided in the leak test sample
collection kit;
(iv) Maintain records of leak testing in accordance with Sec.
35.2067(a) of this chapter.
(7) Develop, implement, and maintain written procedures for safe
use of unsealed byproduct material that meet the requirements of
Sec. Sec. 20.1101 and 20.1201 of this chapter.
(8) Develop, implement, and maintain written procedures for safe
response to spills of licensed material in accordance with Sec.
20.1101 of this chapter.
(9) Develop, implement, and maintain written procedures for area
surveys in accordance with Sec. 20.1101 of this chapter that meet the
requirements of Sec. Sec. 20.1501 and 35.70 of this chapter.
(10) Develop, implement, and maintain written procedures for
licensed material accountability and control to ensure that: license
possession limits are not exceeded; licensed material in storage is
secured from unauthorized access or removal; licensed material not in
storage is maintained under constant surveillance and control; records
of receipt (either from the licensee's own production operations or
from another licensee), transfer, and disposal of licensed material,
are maintained.
(11) Develop, implement, and maintain written procedures for a
program for training required under Sec. 19.12 of this chapter for
each group of workers, including (i) topics covered, (ii)
qualifications of the instructors, (iii) method of training, (iv)
method for assessing the success of the training, (v) initial training,
and (vi) annual refresher training.
(12) Develop, implement, and maintain written waste disposal
procedures for licensed material in accordance with Sec. 20.1101 of
this chapter, that also meet the requirements of the applicable section
of 10 CFR part 20, subpart K, and of Sec. 35.92 of this chapter.
Sec. 31.17 Standard General License for Certain Analytical Equipment
Including Electron Capture Detectors, X-Ray Fluorescence Devices, and
Ion Generators.
(a)(1) Provided that the provisions of paragraph (b) of this
section have been met, 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, byproduct material contained in devices
designed and manufactured for the purpose of detecting, measuring, or
qualitatively or quantitatively assessing chemical composition, or for
producing an ionized atmosphere in accordance with the provisions of
paragraph (c) of this section.
(2)(i) The provisions of paragraph (a)(1) of this section apply to
byproduct material contained in devices which are registered in the
Sealed Source and Device Registry with the Commission under Sec.
32.210 of this chapter, as defined in Sec. 32.2 of this chapter, or
with an Agreement State, with the principle use codes N--Ion
Generators, Chromatography, or U--X-Ray Fluorescence.
(ii) The provisions of paragraph (a)(1) of this section apply to
the use of specifically licensed devices that are distributed in
accordance with Sec. 30.41 of this chapter.
(3)(i) The provisions of paragraph (a)(1) of this section authorize
use, possession and storage of licensed materials at fixed locations
listed on the most recent NRC Form 1003 provided to the Commission in
accordance with Sec. 31.13 of this part; and
(ii) Temporary job sites of the licensee anywhere in the United
States where the U.S. Nuclear Regulatory Commission maintains
jurisdiction for regulating the use of licensed material, including
areas of exclusive Federal jurisdiction within Agreement States. If the
jurisdiction status of a Federal facility within an Agreement State is
unknown, the licensee shall contact the Federal agency controlling the
job site in question to determine whether the proposed job site is an
area of exclusive Federal jurisdiction.
(iii) Authorization for use of radioactive materials at job sites
in Agreement States in areas not under exclusive Federal jurisdiction
is not provided under this general license, and shall be obtained from
the appropriate State regulatory agency.
(4) The provisions of paragraph (a)(1) of this section do not
authorize the manufacture, initial transfer or distribution, or import
of devices containing byproduct material.
(b)(1)The general licenses provided in this section are subject to
all the provisions of the Act, now or hereafter in effect, and to all
applicable rules, regulations, and orders of the Commission including
the provisions of Sec. Sec. 30.7, 30.8, 30.9, 30.10, 30.11, 30.31,
30.34, 30.35, 30.41, 30.50 through 30.64 of this chapter; Sec. Sec.
31.1 through 31.4 of this part; Sec. Sec. 31.21 through 31.23 of this
part; and to the provisions of 10 CFR parts 19, 20, 21, and 71.
(2) Any person engaging in activities under the general licenses
provided in this section need not comply with Sec. 30.34(b) of this
chapter.
(3) In addition, any person engaging in activities under the
general licenses provided in this section shall comply with the
requirements in Sec. 31.13 of this chapter.
(c) A licensee shall--
(1)(i) Limit the use of sealed sources to those registered either
with Commission under Sec. 32.210 of this chapter or with an Agreement
State.
(ii) Ensure sealed sources are incorporated in compatible devices,
by manufacturer and model, and limited to use as specified in the
Sealed Source and Device Registry for the devices manufacturer and
model.
(iii) Ensure the activity of byproduct material in sealed sources
is limited to the activity listed in the Sealed Source and Device
Registry for the associated devices manufacturer and model.
(2)(i) Appoint and designate, in writing, a radiation safety
officer responsible for having knowledge of the appropriate regulations
and
[[Page 28947]]
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.
(ii) Maintain a record of an individual's training, and appointment
as the Radiation Safety Officer for 5 years following their last day in
the role.
(3)(i) Ensure detector cells containing a titanium tritide foil or
scandium tritide foil are only used in conjunction with a properly
operating temperature control mechanism that prevents the foil
temperature from exceeding that specified in the certificate of
registration issued by the U.S. Nuclear Regulatory Commission pursuant
to Sec. 32.210 of this chapter or equivalent regulations from an
Agreement State.
(ii) Ensure when in use, detector cells containing a titanium
tritide foil or scandium tritide foil are vented to the outside.
(iii) Ensure sealed sources, source rods, foil sources, or detector
cells containing licensed material are not opened or sources removed
from source holders or detached from source rods, or foil sources
removed from detector cells.
(iv) Except for maintaining labeling as required by 10 CFR part 20
or 10 CFR part 71, the licensee shall not make any changes in the
sealed source, device, or source-device combination that would alter
the description or specifications as indicated in the respective
certificate of registration issued either by the U.S. Nuclear
Regulatory Commission pursuant to Sec. 32.210 of this chapter or by an
Agreement State.
(v) Ensure maintenance, repair, cleaning, replacement, and disposal
of foils contained in detector cells or of sealed sources is performed
only by the device manufacturer or other persons specifically
authorized by the U.S. Nuclear Regulatory Commission or an Agreement
State to perform such services.
(4)(i) Conduct Physical inventories every 6 months to account for
all sealed sources and/or devices received and possessed under the
license.
(ii) Maintain records of inventories for 3 years from the date of
each inventory, and shall include the radionuclides, quantities,
manufacturer's name and model numbers, and the date of the inventory.
(5) Ensure sealed sources and plated foil sources are tested for
leakage periodically.
(i) The licensee shall keep a record of leak test results in units
of becquerels (microcuries) and retain the record for inspection by the
Commission for 3 years after the leak test is performed. The final leak
test record performed prior to the sealed source or foil plated source
being transferred or disposed of shall be retained until the license is
terminated. Records must also show the dates of performance and the
names of persons performing testing.
(ii) Ensure leak tests are performed by an organization licensed by
the NRC or an Agreement State to provide leak testing services to other
licensees; or by using a leak test sample collection kit supplied by an
organization licensed by the NRC or an Agreement State to provide leak
test kits and/or sample analysis services to other licensees and
according to the kit supplier's instructions. The leak test sample must
be taken from the nearest accessible point to the sealed source or
plated foil sources where contamination might accumulate. The leak test
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 is performed by persons
specifically licensed by the U.S. Nuclear Regulatory Commission or an
Agreement State to perform such services.
(iii)(A) Ensure each sealed source, except sealed sources and
plated foil sources designed to primarily emit alpha particles, are
tested at intervals specified either in the certificate of registration
issued by the U.S. Nuclear Regulatory Commission under Sec. 32.210 of
this chapter or by an Agreement State. In the absence of a registration
certificate, sealed sources or foil plated source shall be tested for
leakage and/or contamination at intervals not to exceed 6 months, or at
such other intervals as specified.
(B) Ensure sealed sources and plated foil sources designed to
primarily emit alpha particles are tested for leakage and/or
contamination at intervals not to exceed 3 months.
(C) Ensure, that in the absence of a certificate from a transferor
indicating that a leak test has been made within the intervals
specified in the certificate of registration issued by the Commission
under Sec. 32.210 of this chapter or by an Agreement State, prior to
the transfer, a sealed source or plated foil sources received from
another person not be put into use until tested and the test results
received.
(iv)(A) Ensure, that if the test conducted pursuant to paragraphs
(i) and (ii) of this section reveals the presence of 185 becquerels
(0.005 microcuries) or more of removable contamination, a report shall
be filed with the Commission in accordance with Sec. 30.50(c)(2) of
this chapter, and the source shall be removed immediately from service
and decontaminated, repaired, or disposed of in accordance with
Commission regulations.
(B) 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.
(v) Exempt the following sealed sources and plated foil sources
from the periodic leak test requirements set out in paragraphs (i)
through (iv) of this section:
(A) Hydrogen-3 (tritium) sources;
(B) Sources containing licensed material with a half-life of 30
days or less;
(C) sources containing licensed material in gaseous form;
(D) Sources of beta- or gamma-emitting radioactive material with an
activity of 3.7 MBq [100 microcuries] or less; and
(E) Sources of alpha- or neutron-emitting radioactive material with
an activity of 0.37 MBq [10 microcuries] or less.
(F) Sealed sources if they are in storage and are not being used.
However, when they are removed from storage for use or transferred to
another person, and have not been tested within the required leak test
interval, they shall be tested before use or transfer. No source shall
be stored for a period of more than 10 years without being tested for
leakage and/or contamination.
(6)(i) Test each analytical instrument, as applicable, for the
proper operation of the on-off mechanism (shutter) and indicator, if
any, at intervals not to exceed 6 months. This requirement does not
apply to analytical instruments that are in storage with the shutter
lock mechanism is in the locked position.
(ii) Maintain on-off mechanism test records for 3 years. The record
must include the model and serial number of the device, the date of the
test, the results of the test, and the name of the individual who
performed the test.
Sec. 31.18 Standard General License for Certain In Vitro Testing.
(a)(1) Provided that the provisions of paragraph (b) of this
section have been met, a general license is hereby issued
[[Page 28948]]
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, byproduct material for certain in vitro
clinical or laboratory test in accordance with the provisions of
paragraph (c) of this section.
(2) The provisions of paragraph (a)(1) of this section apply for
use of materials listed in Sec. 31.11(a)(1)-(8) of this part.
(3) The provisions of paragraph (a)(1) of this section do not apply
for use of licensed materials in or on humans.
(4) The provisions of paragraph (a)(1) of this section do not
authorize the use of licensed material in field applications where
radioactivity is released.
(5) The provisions of paragraph (a)(1) of this section apply for
use of these materials at fixed locations listed on the most recent NRC
Form 1003 provided to the Commission in accordance with Sec. 31.13 of
this part.
(b)(1) The general licenses provided in this section are subject to
all the provisions of the Act, now or hereafter in effect, and to all
applicable rules, regulations, and orders of the Commission including
the provisions of Sec. Sec. 30.7, 30.8, 30.9, 30.10, 30.11, 30.31,
30.34, 30.35, 30.41, 30.50 through 30.64 of this chapter; Sec. Sec.
31.1 through 31.4 of this part; Sec. Sec. 31.21 through 31.23 of this
part; and to the provisions of 10 CFR parts 19, 20, 21, and 71.
(2) Any person engaging in activities under the general licenses
provided in this section need not comply with Sec. 30.34(b) of this
chapter or Sec. 31.11 of this part.
(3) In addition, any person engaging in activities under the
general licenses provided in this section shall comply with the
requirements in Sec. 31.13 of this part.
(c) A licensee shall--
(1)(i) Appoint and designate, in writing, a radiation safety
officer 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.
(ii) Maintain a record of an individual's training and experience,
and appointment as the Radiation Safety Officer for 5 years following
their last day in the role.
(2)(i) Designate, in writing, individuals to work as authorized
users, who have sufficient training and experience to use and supervise
the use of licensed materials.
(ii) Maintain the designation and record of the individuals'
training and experience for 5 years after the individuals last works as
an Authorized User for the licensee.
(3) Ensure licensed materials authorized by paragraph (a) of this
section are used by, or under the supervision of, individuals who have
been designated as authorized users by paragraph (c)(3) of this
section.
(4)(i) Prepare an evaluation demonstrating that unmonitored
individuals are not likely to receive a radiation dose in excess of the
limits in Sec. 20.1502 of this chapter; or
(ii) Develop, implement, and maintain a program for individual
monitoring of external and internal occupational dose in accordance
with Sec. 20.1502 of this chapter.
(iii) maintain records of the evaluation described in (5)(i) for 3
years following the last use of licensed material by unmonitored
individuals.
(iv) maintain records of individual monitoring results in
accordance with Sec. 20.2106 of this chapter.
(5)(i) Ensure any radiation detection instruments used to perform
surveys required by this part, 10 CFR parts 20, 30, and 71 are
appropriate for the isotopes and activities present and meet the
requirements of Sec. 20.1501 of this chapter.
(ii) Ensure the instruments used for required surveys are
calibrated at least annually by a person licensed by the Commission or
an Agreement State to perform instrument calibration services.
(iii) Maintain a record of the calibrations 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.
(6)(i) Dispose of radioactive waste in accordance with 10 CFR part
20.
(ii) Where appropriate, hold radioactive material with a physical
half-life of less than or equal to 275 days for decay-in-storage before
disposal in ordinary trash provided:
(A) Before disposal as ordinary trash, the waste shall be surveyed
at the container surface with the appropriate survey instrument set on
its most sensitive scale and with no interposed shielding to determine
that its radioactivity cannot be distinguished from background. All
radiation labels shall be removed or obliterated, 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 record of each such disposal permitted under this license
requirement shall be retained for 3 years. The record must include the
date of disposal, the date on which the byproduct material was placed
in storage, the radionuclides disposed, the survey instrument used, the
background dose rate, the dose rate measured at the surface of each
waste container, and the name of the individual who performed the
disposal.
(iii) Waste from in vitro kits, except mock I-125, that are
generally licensed under Sec. 31.11 of this part are exempt from waste
disposal regulations in 10 CFR part 20, as set forth in Sec. 31.11(f).
Radioactive labels shall be defaced or removed. There is no need to
keep any record of release or make any measurement.
(7) Develop, implement, and maintain written procedures for safe
use of unsealed byproduct material that meet the requirements of
Sec. Sec. 20.1101 and 20.1201 of this chapter.
(8) Develop, implement, and maintain written procedures for safe
response to spills of licensed material in accordance with Sec.
20.1101 of this chapter.
(9) Develop, implement, and maintain written procedures for area
surveys in accordance with Sec. 20.1101 of this chapter that meet the
requirements of Sec. 20.1501 of this chapter.
(10) Develop, implement, and maintain written procedures for
licensed material accountability and control to ensure that: license
possession limits are not exceeded; licensed material in storage is
secured from unauthorized access or removal; licensed material not in
storage is maintained under constant surveillance and control; records
of receipt (either from the licensee's own production operations or
from another licensee), transfer, and disposal of licensed material,
are maintained.
(11) Develop, implement, and maintain written procedures for a
program for training required under Sec. 19.12 of this chapter for
each group of workers, including (i) topics covered, (ii)
qualifications of the instructors, (iii) method of training, (iv)
method for assessing the success of the training, (v) initial training,
and (vi) annual refresher training.
(12) Develop, implement, and maintain written waste disposal
procedures for licensed material in accordance with Sec. 20.1101 of
this chapter, that also meet the requirements of the applicable section
of 10 CFR part 20, subpart K.
[[Page 28949]]
Sec. 31.19-31.20 [Reserved]
0
15. Add subpart D, before Sec. 31.21 to read as follows:
Subpart D--Records
Sec. 31.21 Maintenance of records.
* * * * *
0
16. Add subpart E, before Sec. 31.22 to read as follows:
Subpart E--Enforcement
Sec. 31.22 Violations.
* * * * *
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
0
17. The authority citation for part 32 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201 (42 U.S.C. 5841); Government Paperwork
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C.
2014, 2021, 2021b, 2111).
0
18. Revise and republish Sec. 32.12 to read as follows:
Sec. 32.12 Same: Records of material transfer.
(a) Each person licensed under Sec. 32.11 shall maintain records
of transfer of byproduct material identifying, by name and address,
each person to whom byproduct material is transferred for use under
Sec. 30.14 of this chapter or the equivalent regulations of an
Agreement State and stating the kinds, quantities, and physical form of
byproduct material transferred.
(b) The record must identify the:
(1) Type and quantity of each product or material into which
byproduct material has been introduced by calendar year, if applicable;
(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 maintain the record of a transfer in
accordance with Sec. 30.51.
0
19. Revise and republish Sec. 32.16 to read as follows:
Sec. 32.16 Certain items containing byproduct material: Records of
transfer.
(a) Each person licensed under Sec. 32.14 shall maintain records
of all transfers of byproduct identifying, by name and address, each
person to whom byproduct material is transferred for use under Sec.
30.15 of this chapter or the equivalent regulations of an Agreement
State and stating the kinds, quantities, and physical form of byproduct
material transferred.
(b) The record must include the following information:
(1) A description or identification of the type of each product and
the model number(s), if applicable;
(2) For each radionuclide in each type of product and each model
number, if applicable, the total quantity of the radionuclide; and
(3) The number of units of each type of product transferred by
calendar year and model number, if applicable;
(c) The licensee shall maintain the record of a transfer in
accordance with Sec. 30.51.
0
20. Revise and republish Sec. 32.20 to read as follows:
Sec. 32.20 Same: Records of material transfer.
(a) Each person licensed under Sec. 32.18 shall maintain records
of transfer of material identifying, by name and address, each person
to whom byproduct material is transferred for use under Sec. 30.18 of
this chapter or the equivalent regulations of an Agreement State and
stating the kinds, quantities, and physical form of byproduct material
transferred.
(b) The record must include the following information:
(1) For each radionuclide in each physical form, the record shall
indicate the total quantity of each radionuclide and the physical form,
transferred under the specific license.
(c) The licensee shall maintain the record of a transfer in
accordance with Sec. 30.51 of this chapter.
0
21. Revise and republish Sec. 32.25 to read as follows:
Sec. 32.25 Conditions of licenses issued under Sec. 32.22: Quality
control, labeling, and records 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) Each person licensed under Sec. 32.22 shall maintain records
of transfer of material identifying, by name and address, each person
to whom byproduct material is transferred for use under Sec. 30.19 of
this chapter or the equivalent regulations of an Agreement State and
stating the kinds, quantities, and physical form of byproduct material
transferred.
(1) The record must include the following information:
(i) A description or identification of the type of each product and
the model number(s);
(ii) For each radionuclide in each type of product and each model
number, the total quantity of the radionuclide; and
(iii) The number of units of each type of product transferred by
calendar year and model number, if applicable.
(b) The licensee shall maintain the record of a transfer in
accordance with Sec. 30.51.
0
22. Revise and republish Sec. 32.29 to read as follows:
Sec. 32.29 Conditions of licenses issued under Sec. 32.26: Quality
control, labeling, and records 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
(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
[[Page 28950]]
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) Each person licensed under Sec. 32.26 shall maintain records
of transfer of material identifying, by name and address, each person
to whom byproduct material is transferred for use under Sec. 30.20 of
this chapter or the equivalent regulations of an Agreement State and
stating the kinds, quantities, and physical form of byproduct material
transferred.
(1) The record must include the following information:
(i) A description or identification of the type of each product and
the model number(s);
(ii) For each radionuclide in each type of product and each model
number, the total quantity of the radionuclide; and
(iii) The number of units of each type of product transferred by
calendar year and model number, if applicable.
(d) The licensee shall maintain the record of a transfer in
accordance with Sec. 30.51.
0
23. Revise and republish Sec. 32.32 to read as follows:
Sec. 32.32 Conditions of licenses issued under Sec. 32.30: Quality
control, labeling, and records of transfer.
Each person licensed under Sec. 32.30 shall:
(a) Carry out adequate control procedures in the manufacture of the
device to ensure that each production lot meets the quality control
standards approved by the Commission;
(b) Label or mark each device and its point-of-sale package so
that:
(1) Each item has a durable, legible, readily visible label or
marking on the external surface of the device containing:
(i) The following statement: ``CONTAINS RADIOACTIVE MATERIAL'';
(ii) The name of the radionuclide(s) and quantity(ies) of activity;
(iii) An identification of the person licensed under Sec. 32.30 to
transfer the device for use under Sec. 30.22 of this chapter or
equivalent regulations of an Agreement State; and
(iv) Instructions and precautions necessary to assure safe
installation, operation, and servicing of the device (documents such as
operating and service manuals may be identified in the label and used
to provide this information).
(2) The external surface of the point-of-sale package has a
legible, readily visible label or marking containing:
(i) The name of the radionuclide and quantity of activity;
(ii) An identification of the person licensed under Sec. 32.30 to
transfer the device for use under Sec. 30.22 of this chapter or
equivalent regulations of an Agreement State; and
(iii) The following or a substantially similar statement: ``THIS
DEVICE CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN
COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN
10 CFR 32.31. THE PURCHASER IS EXEMPT FROM ANY REGULATORY
REQUIREMENTS.''
(3) Each device and point-of-sale package contains such other
information as may be required by the Commission; and
(c) Each person licensed under Sec. 32.30 shall maintain records
of transfer of material identifying, by name and address, each person
to whom byproduct material is transferred for use under Sec. 30.22 of
this chapter or the equivalent regulations of an Agreement State and
stating the kinds, quantities, and physical form of byproduct material
transferred.
(1) The record must include the following information:
(i) A description or identification of the type of each product and
the model number(s);
(ii) For each radionuclide in each type of product and each model
number, the total quantity of the radionuclide; and
(iii) The number of units of each type of product transferred by
calendar year and model number, if applicable.
(d) The licensee shall maintain the record of a transfer in
accordance with Sec. 30.51.
0
24. Revise and republish Sec. 32.72 to read as follows:
Sec. 32.72 Manufacture, preparation, or transfer for commercial
distribution of radioactive drugs or preparation or transfer for
commercial distribution microsources 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, or to
prepare or transfer for commercial distribution microsources containing
byproduct material for use by persons authorized pursuant to part 35 of
this chapter or Sec. 31.16 will be approved if:
(1) The applicant satisfies the general requirements specified in
Sec. 30.33 of this chapter;
(2) The applicant submits evidence that it is legally authorized,
under applicable Federal or State law, to manufacture, compound,
prepare, or distribute radioactive drugs or medical devices, including
those regulated under 21 CFR part 207, 21 CFR part 212, or 21 CFR part
820, as applicable;
(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 or microsources;
and the shielding provided by the packaging to show it is appropriate
for the safe handling and storage of the radioactive drugs or
microsources by medical use licensees; and
(4) The applicant commits to 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
radioactive drugs or microsources 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, microsource, or its abbreviation; and
the quantity of radioactivity at a specified date and time. For
radioactive drugs or microsources 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 or microsources 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, and
(iii) A label is affixed in accordance with the Sealed Source and
Device Registry, as applicable.
(b) A licensee that meets the requirements of paragraph (a)(2) and
is licensed as a pharmacy by a State Board of Pharmacy or that is
operating as a nuclear pharmacy within a Federal medical institution:
(1) May prepare radioactive drugs or microsources for medical use,
as defined in Sec. 35.2 of this chapter, provided that the radioactive
drug or microsources are 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 Sec. 35.27 of this chapter.
(2) May allow a pharmacist to work as an authorized nuclear
pharmacist if:
[[Page 28951]]
(i) This individual qualifies as an authorized nuclear pharmacist
as defined in Sec. 35.2 of this chapter;
(ii) This individual meets the requirements specified in Sec.
35.55(b) and 35.59 of this chapter, and the licensee has received an
approved license amendment identifying this individual as an authorized
nuclear pharmacist; or
(iii) This individual is designated as an authorized nuclear
pharmacist in accordance with paragraph (b)(4) of this section.
(3) The actions authorized in paragraphs (b)(1) and (b)(2) of this
section are permitted in spite of more restrictive language in license
conditions.
(4) May designate a pharmacist (as defined in Sec. 35.2 of this
chapter) as an authorized nuclear pharmacist if:
(i) The individual was a nuclear pharmacist preparing only
radioactive drugs or microsources containing accelerator-produced
radioactive material; and
(ii) The individual practiced at a pharmacy at a Government agency
or Federally recognized Indian Tribe before November 30, 2007, or at
all other pharmacies before August 8, 2009, or an earlier date as
noticed by the NRC.
(5) Shall provide to the Commission:
(i) A copy of each individual's certification by a specialty board
whose certification process has been recognized by the Commission or an
Agreement State as specified in Sec. 35.55(a) of this chapter; or
(ii) The Commission or Agreement State license, or
(iii) Commission master materials licensee permit, or
(iv) The permit issued by a licensee or Commission master materials
permittee of broad scope or the authorization from a commercial nuclear
pharmacy authorized to list its own authorized nuclear pharmacist, or
(v) Documentation that only accelerator-produced radioactive
materials were used in the practice of nuclear pharmacy at a Government
agency or Federally recognized Indian Tribe before November 30, 2007,
or at all other locations of use before August 8, 2009, or an earlier
date as noticed by the NRC; and
(vi) A copy of the State pharmacy licensure or registration, no
later than 30 days after the date that the licensee allows, under
paragraphs (b)(2)(i) and (b)(2)(iii) of this section, the individual to
work as an authorized nuclear pharmacist.
(c) A licensee shall possess and use instrumentation to measure the
radioactivity of radioactive drugs and microsources. 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 or microsources prior to transfer
for commercial distribution. In addition, the licensee shall:
(1) Perform tests before initial use, periodically, and following
repair, on each instrument for accuracy, linearity, and geometry
dependence, as appropriate for the use of the instrument; and make
adjustments when necessary; and
(2) Check each instrument for constancy and proper operation at the
beginning of each day of use.
(d) A licensee shall satisfy the labeling requirements in paragraph
(a)(4) of this section.
(e) Nothing in this section relieves the licensee from complying
with applicable FDA, other Federal, and State requirements governing
radioactive drugs or microsources.
0
25. In Sec. 32.74, revise section heading, paragraphs (a) introductory
text, (a)(2) introductory text, (a)(2)(ii), (a)(2)(viii), (a)(3) and
(b)(1) to read as follows:
Sec. 32.74 Manufacture and distribution of sources, microsources, or
devices containing byproduct material for medical use.
(a) An application for a specific license to manufacture and
distribute sources, microsources, or devices containing byproduct
material to persons licensed under part 35 of this chapter or Sec.
31.16 of this chapter for use as a calibration, transmission, or
reference source or for the medical uses listed in part 35 of this
chapter will be approved if:
(1) * * *
(2) The applicant submits sufficient information regarding each
type of source, or device pertinent to an evaluation of its radiation
safety, including:
(i) * * *
(ii) Details of design and construction of the source, or device;
* * * * *
(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, 35.600,
35.700, and 35.1000 of this chapter as appropriate, and to persons who
hold an equivalent license issued by an Agreement State.
* * * * *
(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.
PART 34--LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY
REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
0
26. The authority citation for part 34 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201 (42 U.S.C. 5841); Government Paperwork
Elimination Act sec. 1704, (44 U.S.C. 3504 note). Atomic Energy Act
of 2005 sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C.
2014, 2021, 2021b, 2111)
Section 34.45 also issued under Energy Reorganization Act sec. 206
(42 U.S.C. 5846).
0
27. In Sec. 34.3, add in alphabetical order the definition for Sealed
Source and Device Registry to read as follows:
* * * * *
Sealed Source and Device Registry means the national registry that
contains all the registration certificates, generated by both the NRC
and the Agreement States, that summarize the radiation safety
information for the sealed sources and devices and describe the
licensing and use conditions approved for the product.
* * * * *
0
28. In Sec. 34.13, revise paragraph (b) and remove paragraphs (b)(1)
and (b)(2). The revision reads as follows:
[[Page 28952]]
Sec. 34.13 Specific license for industrial radiography.
* * * * *
(b) The applicant submits an adequate program for training
radiographers and radiographers' assistants that meets the requirements
of Sec. 34.43. A license applicant need not describe its initial
training and examination program for radiographers in the subjects
outlined in Sec. 34.43(g).
* * * * *
Sec. 34.20 [Amended]
0
29. Amend Sec. 34.20 by:
0
a. Revising paragraphs (a)(1) and (a)(2);
0
b. Removing paragraph (c)(8) and redesigning paragraph (c)(9) as
paragraph (c)(8); and
0
d. Removing paragraphs (d) and (e).
The revisions read as follows:
Sec. 34.20 Performance requirements for industrial radiography
equipment.
* * * * *
(a) * * *
(1) Each radiographic exposure device, source assembly or sealed
source must have been evaluated by the NRC or an Agreement State and
registered in the Sealed Source and Device Registry, and all associated
equipment must meet the manufactures' specifications and instructions.
(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 requirements referenced
in paragraph (a)(1) of this section.
* * * * *
Sec. 34.23 [Amended]
0
30. In Sec. 34.23, in paragraph (a) remove the phrase ``Sec. 34.51''
and add in its place the phrase ``Sec. 34.41''.
Sec. 34.27 [Amended]
0
31. Amend Sec. 34.27 by:
0
a. In the first sentence of (c)(1), add the phrase ``or at other
intervals approved by the Commission or an Agreement State in the
Sealed Source and Device Registry'', after the phrase ``6 months'';
0
b. In paragraph (e), removing the phrase ``Licensees will have until
June 27, 1998, to comply with the DU leak-testing requirements of this
paragraph''.
Sec. 34.33 [Amended]
0
32. In Sec. 34.33, in paragraph (b) remove the phrase ``Sec. 34.51''
and add in its place the phrase ``Sec. 34.41''.
0
33. Revise and republish Sec. 34.41 to read as follows:
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).
Radiography may not be performed if only one qualified individual is
present.
(1) During each radiographic operation either the radiographer or
the other qualified individual present 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.
(2) The second individual present must be in sufficiently close
proximity to the radiographic operation and sufficiently aware of the
ongoing activities to be able to provide immediate assistance when
necessary and to prevent unauthorized entry.
(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.
0
34. Amend Sec. 34.43 by:
0
a. Revising paragraph (a) and removing paragraphs (a)(1) and (2); and
0
b. Removing paragraphs (h) and (i).
The revision reads as follows:
Sec. 34.43 Training.
(a) The licensee may not permit any individual to act as a
radiographer until the individual 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.)
* * * * *
Sec. 34.51 [Reserved]
0
35. Remove and reserve Sec. 34.51.
0
36. In Sec. 34.89, revise paragraph (b) to read as follows:
Sec. 34.89 Location of documents and records.
* * * * *
(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) Utilization records for each radiographic exposure device
dispatched from that location as required by Sec. 34.71.
(3) Records of alarm system and entrance control checks required by
Sec. 34.75, if applicable;
(4) Records of direct reading dosimeters such as pocket dosimeter
and/or electronic personal dosimeters readings as required by Sec.
34.83;
(5) Current operating and emergency procedures required by Sec.
34.81;
(6) Evidence of the latest calibration of the radiation survey
instruments in use at the site, as required by Sec. 34.65;
(7) 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;
(8) Latest survey records required by Sec. 34.85;
(9) The shipping papers for the transportation of radioactive
materials required by Sec. 71.5 of this chapter; and
(10) 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.
* * * * *
Sec. 34.101 [Amended]
0
37. In Sec. 34.101, remove and reserve paragraph (c).
PART 39--LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL
LOGGING
0
38. The authority citation for part 39 continues to read as follows:
Authority: Atomic Energy Act secs. 53, 57, 62, 63, 65, 69, 81,
82, 161, 181, 182, 183, 186, 223, 234 (42 U.S.C. 2073, 2077, 2092,
2093, 2095, 2099, 2111, 2112, 2201, 2231, 2232, 2233, 2236, 2273,
2282); Energy Reorganization Act secs. 201, 202, 206 (42 U.S.C.
5841, 5842, 5846); Government Paperwork Elimination Act sec. 1704
(44 U.S.C. 3504 note).
Sec. 39.33 [Amended]
0
39. In Sec. 39.33, in paragraph (c)(1), remove the phrase ``6 months''
and add in its place the phrase ``12 months''.
0
40. In Sec. 39.35, revise paragraph (c)(1) to read as follows:
[[Page 28953]]
Sec. 39.35 Leak testing of sealed sources.
* * * * *
(c) Each sealed source (except an energy compensation source (ECS))
must be tested 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. In the absence of a certificate from
a transferor that a test has been made within the 6 months or at other
intervals approved by the Commission or an Agreement State in the
Sealed Source and Device Registry before the transfer, the sealed
source may not be used until tested.
* * * * *
0
41. In Sec. 39.77, remove paragraph (c)(1) and redesignate paragraphs
(c)(2) and (c)(3) as paragraphs (c)(1) and (c)(2).
PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL
0
42. The authority citation for part 40 continues to read as follows:
Authority: Atomic Energy Act secs. 11(e)(2), 62, 63, 64, 65,
81, 161, 181, 182, 183, 186, 193, 223, 234, 274, 275 (42 U.S.C.
2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2231,
2232, 2233, 2236, 2243, 2273, 2282, 2021, 2022); Energy
Reorganization Act secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846);
Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504
note); Energy Policy Act of 2005, Public Law 109-59, 119 Stat. 594
(2005).
Section 40.7 also issued under Energy Reorganization Act sec. 211,
Public Law 95-601, sec. 10, as amended by Public Law 102-486, sec. 2902
(42 U.S.C. 5851). Section 40.31(g) also issued under Atomic Energy Act
sec. 122 (42 U.S.C. 2152). Section 40.46 also issued under Atomic
Energy Act sec. 184 (42 U.S.C. 2234). Section 40.71 also issued under
Atomic Energy Act sec. 187 (42 U.S.C. 2237).
0
43. Revise and republish Sec. 40.53 to read as follows:
Sec. 40.53 Conditions for licenses issued for initial transfer of
certain items containing source material: Quality control, labeling,
and records.
(a) Each person licensed under Sec. 40.52 shall ensure that the
quantities or concentrations of source material do not exceed any
applicable limit in Sec. 40.13(c).
(b) Each person licensed under Sec. 40.52 shall ensure that each
product is labeled as provided in the specific exemption under Sec.
40.13(c) and as required by their license. Those distributing products
to be used under Sec. 40.13(c)(1)(i) and (iii) or equivalent
regulations of an Agreement State shall provide radiation safety
precautions and instructions relating to handling, use, and storage of
these products as specified in the license.
(c)(1) Each person licensed under Sec. 40.52 shall maintain record
of transfer.
(2) The record must clearly identify the specific licensee
preparing the record and include the license number of the specific
licensee and indicate that the products are transferred for use under
Sec. 40.13(c), giving the specific paragraph designation, or
equivalent regulations of an Agreement State.
(3) The record must include the following information on products
transferred to other persons for use under Sec. 40.13(c) or equivalent
regulations of an Agreement State:
(i) A description or identification of the type of each product and
the model number(s), if applicable;
(ii) For each type of source material in each type of product and
each model number, if applicable, the total quantity of the source
material; and
(iii) The number of units of each type of product transferred by
calendar year and model number, if applicable.
(4) The licensee shall maintain the record of a transfer and all
information concerning transfers in accordance with Sec. 40.61.
PART 70--DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL
0
44. The authority citation for part 70 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 51, 53, 57(d), 108,
122, 161, 182, 183, 184, 186, 187, 193, 223, 234, 274, 1701 (42
U.S.C. 2071, 2073, 2077(d), 2138, 2152, 2201, 2232, 2233, 2234,
2236, 2237, 2243, 2273, 2282, 2021, 2297f); Energy Reorganization
Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846,
5851); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C.
10155, 10161); 44 U.S.C. 3504 note.
Sec. 70.25 [Amended]
0
45. Amend Sec. 70.25 by:
0
a. In paragraph (a)(2), remove the phrase ``unsealed special nuclear
material'' and add in its place the phrase ``unsealed special nuclear
material of half-life greater than 120 days and''; and
0
b. In paragraph (b) introductory text, remove the phrase ``unsealed
special nuclear material'' and add in its place the phrase ``unsealed
special nuclear material of half-life greater than 120 days''.
PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274
0
46. The authority citation for part 150 continues to read as follows:
Authority: Atomic Energy Act sec. 161, 181, 223, 234 (42 U.S.C.
2201, 2021, 2231, 2273, 2282); Energy Reorganization Act sec. 201
(42 U.S.C. 5841); Government Paperwork Elimination Act sec. 1704 (44
U.S.C. 3504 note); Energy Policy Act of 2005, Public Law 109-58, 119
Stat. 594 (2005).
Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued
under Atomic Energy Act secs. 11e(2), 81, 83, 84 (42 U.S.C.
2014e(2), 2111, 2113, 2114). Section 150.14 also issued under Atomic
Energy Act sec. 53 (42 U.S.C. 2073). Section 150.15 also issued
under Nuclear Waste Policy Act secs. 135 (42 U.S.C. 10155). Section
150.17a also issued under Atomic Energy Act sec. 122 (42 U.S.C.
2152). Section 150.30 also issued under Atomic Energy Act sec. 234
(42 U.S.C. 2282).
Sec. 150.14 [Reserved]
0
47. Remove and reserve Sec. 150.14.
0
48. Revise and republish Sec. 150.20 to read as follows:
Sec. 150.20 Recognition of Agreement State licenses.
(a)
(1) Provided that the provisions of paragraph (b) of this section
have been met, any person who holds a specific license or a standard
general license from an Agreement State, where the licensee maintains
an office for directing the licensed activity and retaining radiation
safety records, is granted a general license to conduct the same
activity in--
(i) Non-Agreement States;
(ii) Areas of Exclusive Federal jurisdiction within Agreement
States; and
(iii) Offshore waters.
(2) The provisions of paragraph (a)(1) of this section do not apply
if the specific Agreement State license or Agreement State standard
general license limits the authorized activity to a specific
installation or location.
(b) Notwithstanding any provision to the contrary in any specific
license issued by an Agreement State or standard general license
granted by an Agreement State to a person engaging in activities in a
non-Agreement State, in an area of exclusive Federal jurisdiction
within an Agreement State, or in offshore waters under the general
licenses provided in this section, the general licenses provided in
this section are subject to all the provisions of the Act, now or
hereafter in effect, and to all applicable rules, regulations, and
orders of the Commission including the provisions of Sec. Sec. 30.7(a)
through (f), 30.9, 30.10, 30.34, 30.41, and 30.51 through 30.63 of this
chapter; Sec. Sec. 40.7(a) through (f), 40.9, 40.10, 40.41, 40.51,
40.61 through 40.63, 40.71, and 40.81 of this chapter; Sec. Sec.
70.7(a) through (f), 70.9, 70.10, 70.32, 70.42, 70.52, 70.55, 70.56,
70.60 through 70.62 of this chapter;
[[Page 28954]]
Sec. Sec. 74.11, 74.15, and 74.19 of this chapter; and to the
provisions of 10 CFR parts 19, 20 and 71 and subparts C through H of
part 34, Sec. Sec. 39.15 and 39.31 through 39.77 of this chapter. In
addition, any person engaging in activities in non-Agreement States, in
areas of exclusive Federal jurisdiction within Agreement States, or in
offshore waters under the general licenses provided in this section:
(1) Shall, no later than the day of engaging in each activity for
the first time in a calendar year, file a submittal containing an NRC
Form 241, ``Report of Proposed Activities in Non-Agreement States,'' a
copy of its Agreement State specific license or a copy of its validated
Agreement State standard general license, and the appropriate fee as
prescribed in Sec. 170.31 of this chapter with the Regional
Administrator of the U.S. Nuclear Regulatory Commission Regional Office
listed on the NRC Form 241 and in appendix D to part 20 of this chapter
for the Region in which the Agreement State that issued the license is
located.
(2) Shall file an amended NRC Form 241 for changes in work
locations except for activities performed offshore, radioactive
material, or work activities different from the information contained
on the initial NRC Form 241.
(3) Shall not, in any non-Agreement State, in an area of exclusive
Federal jurisdiction within an Agreement State, or in offshore waters,
transfer or dispose of radioactive material possessed or used under the
general licenses provided in this section, except by transfer to a
person who is specifically licensed by the Commission to receive this
material.
(4) Shall not, under the general license concerning activities in
non-Agreement States or in areas of exclusive Federal jurisdiction
within Agreement States, possess or use radioactive materials, or
engage in the activities authorized in paragraph (a) of this section,
for more than 180 days in any calendar year, except that the general
license in paragraph (a) of this section concerning activities in
offshore waters authorizes that person to possess or use radioactive
materials, or engage in the activities authorized, for an unlimited
period of time.
(5) Shall comply with all terms and conditions of the specific
license issued by an Agreement State, or as applicable, comply with the
terms and conditions of the standard general license granted by an
Agreement State, except such terms or conditions as are contrary to the
requirements of this section.
Dated: May 14, 2026.
For the Nuclear Regulatory Commission.
Carrie Safford,
Secretary of the Commission.
[FR Doc. 2026-09877 Filed 5-15-26; 8:45 am]
BILLING CODE 7590-01-P