[Federal Register Volume 91, Number 142 (Monday, July 27, 2026)]
[Proposed Rules]
[Pages 47042-47100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-15080]
[[Page 47041]]
Vol. 91
Monday,
No. 142
July 27, 2026
Part II
Nuclear Regulatory Commission
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10 CFR Part 35
Reducing Barriers to Medical Use Licensing; Proposed Rule
Federal Register / Vol. 91, No. 142 / Monday, July 27, 2026 /
Proposed Rules
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[NRC-2025-1237]
RIN 3150-AL50
Reducing Barriers to Medical Use Licensing
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule and guidance; request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations to reduce barriers to medical use licensing. This
proposed rule responds to Executive Order 14300, ``Ordering the Reform
of the Nuclear Regulatory Commission,'' which requires the NRC to
conduct a review and wholesale revision of its regulations. This
proposed rule, if adopted, would reduce overly prescriptive
regulations, increase flexibility, and modernize radiation safety
practices for the medical use of byproduct material. It also would
enable more efficient and predictable licensing for emerging medical
technologies and reduce unnecessary burden in training and experience
requirements for medical authorized users. The NRC is revising guidance
for this proposed rule. This proposed rule also would incorporate minor
editorial corrections.
DATES: Comments must be submitted electronically using https://www.regulations.gov by 11:59 p.m. eastern time on September 10, 2026.
ADDRESSES: Submit your comments, identified by Docket ID NRC-2025-1237,
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-2025-1237. 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: Irene Wu, Office of Nuclear Material
Safety and Safeguards, telephone: 301-415-1951, email: [email protected]
and Katie Tapp, Office of Nuclear Material Safety and Safeguards,
telephone: 301-415-0236, email: [email protected]. Both are staff
of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
EXECUTIVE SUMMARY
A. Need for Regulatory Action
On May 23, 2025, President Donald J. Trump signed Executive Order
(E.O.) 14300, ``Ordering the Reform of the Nuclear Regulatory
Commission.'' E.O. 14300 directs the NRC to conduct a comprehensive
review and wholesale revision of its regulations and guidance documents
in alignment with objectives outlined in section 2 of the E.O. This
rulemaking addresses section 5 of the E.O., focusing on the regulations
in title 10 of the Code of Federal Regulations (10 CFR) part 35,
``Medical Use of Byproduct Material,'' and guidance documents related
to the medical use of byproduct material. The proposed changes would
facilitate the licensing of innovative technologies while maintaining
the NRC's commitment to public health and safety. The proposed changes
also aim to improve efficiency, reduce regulatory burden, and ease
administrative burden for the NRC, Agreement States, licensees, and
individuals or entities that seek medical use licenses.
B. Major Provisions
The major provisions of this proposed rule include the following:
1. Broadening the definition of ``physician'' to include foreign-
trained individuals as long as they are licensed by a State or
Territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico to prescribe drugs in the practice
medicine.
2. Replacing the recentness in training requirement (within 7
years) with a performance-based continuing education model and removing
specific work experience requirements for generator systems due to
changes in industry practice.
3. Eliminating the requirement for license amendments to add
authorized users for diagnostic uses, allowing licensees to approve and
document these users internally due to the lower risk of these non-
therapeutic uses.
4. Removing prescriptive training hours requirements for physicians
who have received significant radiation safety and clinical training
during the completion of a clinical radiation specialty residency,
while retaining the alternative board certification and cross-
qualification pathways.
5. Updating work experience categories for ``oral'' and
``parenteral'' administration of any radioactive drug requiring a
written directive, allowing flexibility for future
radiopharmaceuticals.
6. Moving specialty board certification approval requirements to a
new section for clarity and regulatory efficiency, removing specific
accrediting body references in residency training requirements, and
clarifying that required work experience may be supervised by an
authorized user at an NRC or Agreement State licensed medical facility.
7. Codifying provisions for emerging medical technologies (EMTs)
currently licensed under subpart K of 10 CFR part 35, by establishing
clear licensing pathways, training and experience requirements, and
performance-based safety criteria. The EMTs include modern gamma
stereotactic radiosurgery (GSR) devices, ophthalmic source/applicator
devices, generators, and microsources.
8. Establishing clear requirements for rubidium-82 (Rb-82)
generators, including codified definitions for breakthrough,
calibration flexibility for dynamic systems, and updated licensing and
training provisions to codify enforcement guidance.
9. Removing the written directive requirement for diagnostic
administrations of sodium iodide I-131, aligning regulatory oversight
with current clinical practice and other diagnostic administrations
with comparable risk.
10. Refining written directive and medical event reporting
requirements to exclude events caused by emergent patient conditions or
real-time clinical decisions, while preserving reporting for events
with potential safety significance, such as those involving equipment
defects or unintended harm, reducing unnecessary burden and improving
regulatory clarity.
11. Refining embryo/fetus dose reporting requirements to exclude
cases where pregnancy could not reasonably be determined prior to
administration, aligning oversight with clinical realities and reducing
unnecessary reporting.
12. Expanding decay-in-storage eligibility by increasing the
allowable
[[Page 47043]]
half-life from 120 to 275 days, enabling safe, cost-effective onsite
disposal of longer-lived materials like lutetium-177 metastable (Lu-
177m) and cobalt-57 (Co-57).
13. Eliminating the license amendment requirement for human subject
research already approved by an Institutional Review Board (IRB) and
covered under existing medical use authorizations, streamlining
research initiation while maintaining safety and ethical oversight.
14. Removing duplicative and prescriptive requirements for mobile
medical services, aligning them with general radiation safety
regulations and providing licensees greater flexibility without
compromising protection of patients, workers, or the public.
15. Extending the temporary Radiation Safety Officer (RSO) duration
and refining Radiation Safety Committee (RSC) requirements to reflect
current clinical practice, reduce administrative burden, and focus
oversight on higher-risk therapeutic uses requiring written directives.
16. Removing outdated and redundant provisions across 10 CFR part
35, including prescriptive mobile medical survey requirements, obsolete
waiver clauses, and recordkeeping requirements, to modernize the
regulatory framework.
C. Costs and Benefits
This proposed rule is considered a deregulatory action and is
expected to reduce barriers to medical use licensing by enabling more
efficient and predictable licensing, increasing flexibility, and easing
administrative burden for the NRC, Agreement States, licensees and
individuals or entities that seek medical use licenses. Over the 5-year
analysis period (2027-2031), the proposed revisions are estimated to
generate net savings of $39.1 million (savings minus costs),
undiscounted. Using 2024 as the base year, the net present value (NPV)
of these net savings is $35.6 million, discounted at 3 percent, or
$31.7 million, discounted at 7 percent. The licensees, accounting for
the largest share of net savings, would save about $30.5 million over 5
years, undiscounted, with an NPV of $27.8 million discounted at 3
percent, or $24.8 million discounted at 7 percent. Overall, the
projected annualized cost savings would be $7.2 million discounted at 3
percent, or $6.4 million discounted at 7 percent. Although this
proposed rule would reduce barriers to medical-use licensing (including
new technologies) and generate net savings, some costs would still be
incurred over the 5-year period, primarily due to small increases in
recordkeeping requirements from the proposed new regulations for new
technologies and aligning with other modalities contained in 10 CFR
part 35, as well as implementation costs. The additional recordkeeping
costs, which represent operational costs for licensees, are estimated
at $2.4 million (undiscounted), $2.2 million (discounted at 3 percent),
and $2.0 million (discounted at 7 percent) over this 5-year period.
Implementation costs for both NRC and industry stakeholders are
estimated at about $2.9 million (undiscounted), $2.8 million
(discounted at 3 percent), and $2.7 million (discounted at 7 percent).
When compared with the projected savings, the operational (expanded
recordkeeping requirements) costs account for a small share, about 6
percent of the projected net savings.
For more information, please see the regulatory analysis included
later in this notice.
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
A. Training and Experience
B. Emerging Medical Technologies
C. Rubidium-82 Generators
D. Written Directives for Diagnostic Sodium Iodide I-131
E. Reductions in Event Reporting
F. Decay-in-Storage
IV. Discussion
A. Training and Experience
B. Emerging Medical Technologies
C. Rubidium-82 Generators
D. Other Topics
V. Specific Requests for Comments
VI. Regulatory Flexibility Certification
VII. Regulatory Analysis
A. Need for the Rule
B. Analytical Framework
C. Estimated Costs and Savings of This Proposed Rule
D. Rulemaking and Implementation Costs
VIII. Backfitting and Issue Finality
IX. Cumulative Effects of Regulation
X. Plain Writing
XI. National Environmental Policy Act
A. Introduction
B. Environmental Impacts of the Proposed Agency Action
C. Summary of the Environmental Impacts of the Proposed Agency
Action
D. Environmental Impacts of the Alternative to the Proposed
Agency Action
E. Agencies and Persons Consulted
F. Draft Finding of No Significant Impact
XII. Paperwork Reduction Act
XIII. Executive Orders
A. Executive Order 12866: Regulatory Planning and Review (as
Amended by Executive Order 14215, Ensuring Accountability for All
Agencies)
B. Executive Order 14154: Unleashing American Energy
C. Executive Order 14192: Unleashing Prosperity Through
Deregulation
D. Executive Order 14267: Reducing Anti-Competitive Regulatory
Barriers
E. Executive Order 14270: Zero-Based Regulatory Budgeting To
Unleash American Energy
F. Executive Order 14294: Fighting Overcriminalization in
Federal Regulations
XIV. Coordination With NRC Agreement States
XV. Compatibility of Agreement State Regulations
XVI. Coordination With the Advisory Committee on the Medical Uses of
Isotopes
XVII. Voluntary Consensus Standards
XVIII. Availability of Guidance
XIX. Availability of Documents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2025-1237 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-2025-1237.
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 ``Begin ADAMS Public Search.''
For problems 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.
Public Meeting: The NRC plans to conduct a public meeting
to describe the proposed amendments and answer questions from the
public on the proposed rule. The 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.
NRC's PDR: The PDR, where you may examine and order copies
of publicly available documents, is open
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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.
B. Submitting Comments
Comments must be submitted electronically using https://www.regulations.gov no later than 11:59 p.m. eastern time on September
10, 2026. Please include Docket ID NRC-2025-1237 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 Executive Order
(E.O.) 14300. 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 with a focus on the regulations and guidance documents
pertaining to the medical use of byproduct material.
III. Background
Since 1946, physicians have used byproduct material in the
diagnosis, treatment, and research of medical conditions. Over the
decades, the medical use of byproduct material has evolved
significantly, driven by advances in isotopes, procedural complexity,
and medical technologies. Today, more than 20 million patients undergo
procedures involving byproduct material each year in the United States,
a number expected to grow as new medical devices and
radiopharmaceuticals are developed, researched, and approved by the
U.S. Food and Drug Administration (FDA).
As part of its ongoing efforts to modernize the regulatory
framework in accordance with E.O. 14300, the NRC has reviewed its
regulations governing the medical use of byproduct material under 10
CFR part 35. This review has led the NRC to propose changes to the
training and experience requirements to ensure they are risk-informed,
reduce unnecessary burden on physicians who already receive substantial
radiation safety training as part of their medical education, and
enhance regulatory clarity. In addition, the NRC proposes to codify
certain well-established EMTs and regulatory provisions specific to the
use of Rb-82 generators. The NRC uses ``well-established EMTs'' to
refer to EMTs with extensive operating experience and widespread
clinical use, for which licensing and training practices are stable and
supported by NRC and Agreement State experience. In selecting EMTs for
codification, the NRC prioritized those with the most extensive history
and highest levels of use and with performance-based safety criteria
that can be standardized in 10 CFR part 35. These updates aim to
improve efficiency and predictability in licensing and oversight. The
proposed changes also seek to eliminate outdated or unnecessarily
burdensome requirements, allow for flexibility to facilitate licensing
of innovative devices and medical uses, align regulations with current
clinical practices, and improve clarity for licensees. Nothing in this
proposed rule would relieve licensees from complying with applicable
FDA, Federal, or State requirements or National Institutes of Health
grant compliance obligations related to the use of radioactive drugs or
devices. These proposed changes are detailed in Section IV,
``Discussion,'' of this document.
Several key topics addressed in this proposed rule benefit from
additional context and relevant background information, as provided in
the following sections.
A. Training and Experience
The training and experience requirements in 10 CFR part 35 are
designed to ensure that individuals authorized to use byproduct
material in medical applications possess the necessary knowledge,
skills, and competencies to ensure radiation safety. The regulations in
10 CFR part 35 include provisions related to the training and
experience of physicians who use or supervise the medical use of
byproduct material, known as authorized users (AUs). The AU training
and experience requirements in 10 CFR part 35 have evolved over time in
response to changes in medical practice, stakeholder input, and broader
shifts in medical education. The current framework includes
requirements for classroom and laboratory training and supervised work
experience that requires a prescriptive number of hours for all AUs,
regardless of whether they completed residency training in a clinical
radiation specialty. This is in addition to the individual (1) being a
physician licensed to prescribe drugs in the practice of medicine by
their respective State or Territory of the United States, the District
of Columbia, or the Commonwealth of Puerto Rico; (2) either having
obtained written attestation that they are able to independently
fulfill the radiation safety-related duties as an AU for the medical
uses authorized, or having received board certification from a board
recognized by the NRC or an Agreement State; and (3), in some cases,
having obtained device-specific training. 10 CFR part 35 also contains
training and experience requirements for other individuals important to
radiation safety, including authorized medical physicists (AMPs),
authorized nuclear pharmacists (ANPs), and RSOs.
The NRC last made significant revisions to the training and
experience requirements in 2002 and 2005. Since then, stakeholders have
raised concerns about the impact of these requirements, particularly
the prescriptive number of hours required for unsealed use of byproduct
material for therapy contained in Sec. 35.390, ``Training for use of
unsealed byproduct material for which a written directive is
required.'' From 2015 to 2016, both the NRC staff and the Advisory
Committee on the Medical Uses of Isotopes (ACMUI) independently
reviewed the training and experience requirements for medical uses
authorized under Sec. 35.300, ``Use of unsealed byproduct material for
which a written directive is required.'' In its March 2016 report, the
ACMUI concluded that no changes to the 700-hour requirement were
warranted at that time as they found no evidence that the requirement
adversely affected patient access. However, the ACMUI recommended
forming a subcommittee to periodically review the training and
experience requirements and make recommendations as needed.
In 2016, the ACMUI established a subcommittee to review the
training and experience requirements across all modalities regulated
under 10 CFR part
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35, beginning with Sec. 35.300. In its September 2016 status report,
the subcommittee identified several drivers for reevaluation, including
ongoing stakeholder concerns about access to radiopharmaceuticals, the
development of new radiopharmaceuticals since the 2002 rulemaking, and
a shift in medical education from hour-based to competency-based
training models.
The subcommittee's draft interim report, discussed in a public
meeting on March 1, 2018, expressed concern about the declining number
of nuclear medicine physicians and the potential long-term implications
for patient access. While the subcommittee acknowledged the difficulty
in quantifying the impact of this trend, it noted the absence of data
suggesting a surplus of AUs and emphasized the need to consider future
workforce needs.
In response to these ongoing concerns, the Commission issued Staff
Requirements Memorandum (SRM)-M170817 on August 17, 2017, directing the
NRC staff to evaluate whether tailored training and experience
requirements should be established for different categories of
radiopharmaceuticals, how those categories should be defined (e.g., by
risk or delivery method), and whether training and experience
requirements should be based on hours or competency. The staff's
initial evaluation was documented in SECY-18-0084, ``Staff Evaluation
of Training and Experience Requirements for Administering Different
Categories of Radiopharmaceuticals.'' In that paper, the staff
concluded that additional stakeholder outreach was needed.
Following further engagement with stakeholders, including the ACMUI
and Agreement States, the NRC staff submitted SECY-20-0005,
``Rulemaking Plan for Training and Experience Requirements for Unsealed
Byproduct Material (10 CFR part 35),'' to the Commission on January 13,
2020. On January 27, 2022, the Commission issued SRM-SECY-20-0005,
maintaining the existing training and experience requirements and
directing staff to continue to obtain stakeholder input on training and
experience requirements for EMTs as part of the broader rulemaking
effort to update 10 CFR part 35.
At the time E.O. 14300 was issued on May 23, 2025, the NRC staff
was actively evaluating training and experience requirements for Rb-82
generators and EMTs. The E.O. directed the NRC to undertake a
comprehensive review and modernization of its regulations, including
those governing the medical use of byproduct material. The proposed
changes to training and experience in this rulemaking are in response
to the E.O. and build upon the historical evolution of the training and
experience requirements and the extensive body of stakeholder feedback
and Commission direction developed over the past two decades.
Specifically, this proposed rulemaking removes prescriptive hours
for physicians who have received significant radiation safety and
clinical training over years of a clinical radiation specialty
residency. In addition, it proposes to remove the requirement for
diagnostic AUs to be listed on a license and removes outdated training
topics and requirements associated with arbitrary dates of when
physicians last received training, allowing licensees to focus training
and experience on topics more relevant to clinical practice. Finally,
the NRC proposes changes to the training and experience requirements'
organization for all authorized individuals (i.e., AUs, AMPs, ANPs, and
RSOs) to enhance regulatory clarity.
B. Emerging Medical Technologies
In 2002, the NRC added subpart K, ``Other Medical Uses of Byproduct
Material or Radiation from Byproduct Material,'' (Sec. 35.1000) to 10
CFR part 35 to provide a flexible regulatory framework for licensing
new or existing EMTs that do not fit within the existing subparts of 10
CFR part 35. The regulations in Sec. 35.1000 define the process to
obtain a license or license amendment for EMTs. EMTs often require
unique provisions for training and experience, facility and equipment
specifications, or other safety-related considerations that are not
addressed in the existing 10 CFR part 35 subparts (subparts D through
H). As a result, the NRC and Agreement States evaluate each EMT on a
case-by-case basis to determine the specific risks associated with the
EMT and any additional regulatory requirements needed for its medical
use and may develop model- and vendor-specific licensing guidance to
support consistent and safe licensing and use.
Licensing guidance for EMTs is developed with input from the ACMUI,
vendors, and regulatory staff, and includes general licensing
considerations, radiation safety protocols, and training and experience
expectations for individuals authorized to use the technology. While
not binding, licensing guidance for EMTs provides applicants with an
acceptable means to satisfy the requirements for a license for the EMT.
Applicants who commit to following the EMT licensing guidance may have
those commitments incorporated as license conditions. Alternatively,
applicants may propose other sets of regulations and specific
conditions to use the EMT that become binding through license
conditions in accordance with Sec. 35.1000.
Since 2002, the NRC and Agreement States have licensed at least 18
EMTs under subpart K, including microspheres, GSR units, photon-
emitting teletherapy systems, radiopharmaceutical generator systems,
and ophthalmic applicator sources and devices. While subpart K offers a
quick path for licensing EMTs with unique radiation safety needs as
they are being introduced, continued licensing of well-established EMTs
under subpart K offers limited regulatory benefit and can lead to
inconsistencies and lack of clarity, as subpart K relies on guidance
and the incorporation of license conditions rather than codified rules.
This approach also places a resource burden on regulators due to
frequent updates of EMT-specific guidance.
On June 27, 2023, the NRC published an associated regulatory basis
document, ``Rubidium-82 Generators, Emerging Technologies, and Other
Medical Use of Byproduct Material Regulatory Basis Document,'' for
public comment. The majority of the comments were in favor of
incorporating well-established EMTs into the main body of 10 CFR part
35. However, to meet the timeline established in E.O. 14300 for
publishing this proposed rule, the scope of EMTs addressed in this
proposal has been narrowed to focus on some well-established
technologies with the most extensive history and highest levels of use,
such as modern GSR devices, ophthalmic source/applicator devices,
generators, and microsources. Uses and EMTs not included in this
rulemaking include intravascular brachytherapy systems, liquid and
diffusing brachytherapy sources and devices, and radioactive seed
localization. While these technologies currently remain licensed under
Sec. 35.1000, and they may be incorporated into the main body of 10
CFR part 35 in a future rulemaking depending on NRC and industry need
and available resources.
C. Rubidium-82 Generators
Rb-82 generators produce Rb-82 chloride, a positron-emitting
radiopharmaceutical used for cardiac imaging. These generators differ
from other generators licensed under Sec. 35.200, ``Use of unsealed
byproduct material for imaging and localization studies for which a
written directive is not required,'' due to the short 75
[[Page 47046]]
second half-life of Rb-82 and the generator's automated elution and
direct patient infusion. Because of both the short half-life and direct
infusion after elution, as well as the absence of nationally recognized
standards or specific instrument calibration procedures, Rb-82
generator licensees are unable to calibrate instruments or measure
dosage prior to administration. As such, these licensees are unable to
meet the requirements in Sec. 35.60, ``Possession, use, and
calibration of instruments used to measure the activity of unsealed
byproduct material,'' for the calibration of radiation detector
instruments associated with medical use, or Sec. 35.63,
``Determination of dosages of unsealed byproduct material for medical
use,'' to determine the activity of each dosage administered before
medical use. In recognition of these challenges, the NRC issued
Enforcement Guidance Memorandum (EGM) 13-003, ``Interim Guidance for
Dispositioning Violations Involving 10 CFR 35.60 and 10 CFR 35.63 for
the Calibration of Instrumentation to Measure the Activity of Rubidium-
82 and the Determination of Rubidium-82 Patient Dosages,'' dated April
18, 2013, to provide interim enforcement discretion for licensees that
are unable to fully comply with the applicable calibration and dosage
determination requirements. This EGM remains in effect today and
continues to provide temporary regulatory relief. Like for EMTs, the
majority of public comments received on the June 27, 2023, regulatory
basis document were in favor of resolving the Rb-82 generator
compliance issue by rulemaking.
D. Written Directives for Diagnostic Sodium Iodide I-131
A written directive is the AU's written order for administration of
byproduct material or radiation from byproduct material to a specific
patient or human research subject. Section 35.40, ``Written
directives,'' establishes requirements for which medical uses of
byproduct material require written directives. Under the current
regulations, a written directive is required for diagnostic
administrations of sodium iodide I-131 in quantities greater than 1.11
megabecquerels (30 microcuries), even when the administration is solely
for diagnostic purposes. This is the only diagnostic use that currently
requires a written directive; all other uses requiring a written
directive are therapeutic in nature and are subject to more stringent
requirements commensurate with their higher risk. Because diagnostic
sodium iodide I-131 currently requires a written directive, it is
licensed under subpart E of 10 CFR part 35, which otherwise applies
exclusively to therapeutic uses. In contrast, all other diagnostic uses
of unsealed byproduct material are regulated under subpart D of 10 CFR
part 35, which does not require a written directive and reflects the
lower risk associated with diagnostic procedures.
The requirement for a written directive for diagnostic sodium
iodide I-131 was established by rule on April 24, 2002. At that time,
the radiation safety considerations associated with the diagnostic use
of millicurie quantities of sodium iodide I-131 were considered to be
more similar to therapeutic uses than to other diagnostic procedures,
such as those involving technetium-99m (Tc-99m). However, the practice
of nuclear medicine has evolved significantly since 2002. On October 1,
2007, the NRC published a final rule to amend 10 CFR part 35 to
implement provisions of the Energy Policy Act of 2005 requiring the NRC
to license medical use of accelerator-produced radioactive material,
including positron emission tomography (PET) (72 FR 55864). This
introduced diagnostic procedures involving higher radiation exposure
risk and more complex safety considerations. As a result, the relative
risk profile of diagnostic sodium iodide I-131 use has shifted.
Today, diagnostic sodium iodide I-131 is typically administered in
unit dosages, often in capsule form, rather than as liquid preparations
compounded onsite. This change has reduced the radiation safety risks
associated with handling and administering radioactive material.
Additionally, the training and expertise of diagnostic nuclear medicine
staff have increased in parallel with the broader use of PET and other
advanced imaging modalities. These developments have brought radiation
safety considerations for diagnostic sodium iodide I-131 in line with
those of other diagnostic procedures regulated under subpart D of 10
CFR part 35. There are also now over 50 years of operating experience
using diagnostic dosages of sodium iodide I-131, contributing to a
better understanding of diagnostic sodium iodide I-131 and safety
considerations surrounding its use. For the foregoing reasons, this
proposed rule would remove the requirement that diagnostic sodium
iodide I-131 administrations need a written directive, moving its
authorization from subpart E to subpart D of 10 CFR part 35.
E. Reductions in Event Reporting
Sections 35.3045, ``Report and notification of a medical event,''
and 35.3047, ``Report and notification of a dose to an embryo/fetus or
a nursing child,'' establish the criteria for reporting medical events
and dose to embryo/fetus from the administration of byproduct material
or radiation from byproduct material. These events represent unintended
deviations from the AU's planned administration of radioactive
materials that may result in doses exceeding specified thresholds.
Medical event reporting is consistent with item number 3 in the NRC's
risk-informed, performance-based Medical Use Policy Statement, which
states the NRC will, when justified by the risk to patients, regulate
the radiation safety of patients primarily to assure the use of
radionuclides is in accordance with the physician's directions. These
reports enable the NRC to investigate safety concerns, ensure
corrective actions are taken at a licensee level, and take action such
as providing communication to the industry or working with the
manufacturer and the FDA to prevent recurrence at the national level.
The NRC first required reporting of medical use errors, then termed
``misadministrations,'' in 1980. In 2002, the NRC comprehensively
revised 10 CFR part 35, renaming ``misadministrations'' as ``medical
events'' and refining the reporting criteria to focus on outcomes with
potential radiation safety significance. The revised rule introduced a
dose-based threshold to exclude events associated with most diagnostic
procedures from reporting, recognizing their low risk. Despite these
improvements, stakeholders have raised concerns that the current
criteria may still result in the reporting of events that do not
reflect licensee error, such as those caused by emergent patient
conditions (e.g., vascular spasms or seizures) or real-time clinical
decisions made in the interest of patient care. The NRC is proposing
changes to medical event reporting requirements to avoid unnecessary
reporting of these events while maintaining oversight of significant
occurrences that could impact radiation safety.
F. Decay-in-Storage
On April 24, 2002, Sec. 35.92, ``Decay-in-storage,'' was revised
to allow medical licensees to dispose of short-lived radioactive waste
``without regard to its radioactivity'' once they can confirm the waste
has become indistinguishable from background. This provides medical
licensees with a practical and cost-
[[Page 47047]]
effective option for managing short-lived radioactive waste commonly
used in medicine while avoiding triggering additional regulatory
requirements under the Environmental Protection Agency's hazardous
waste rules (40 CFR part 261), and the Department of Transportation's
transportation regulations (49 CFR parts 171-178), which would
otherwise apply if the waste retained measurable radioactivity. If
licensees would prefer to dispose of waste sooner, they can continue to
use disposal pathways available to all licensees in 10 CFR part 20,
subpart K. The NRC is proposing a change to this rule to reflect the
increasing use of longer-lived medical isotopes, such as Lu-177m, in
clinical practice. Expanding the eligibility for decay-in-storage
disposal would reduce waste disposal costs while maintaining safety.
IV. Discussion
This discussion section has been divided into multiple sections
(Training and Experience, Emerging Medical Technologies, Rubidium-82
Generators, and Other Topics) and subsections to better present
information on the major topics impacted by this proposed rule. Each
section will discuss what action the NRC is proposing, why the action
is being proposed, and who 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 changes. The NRC is providing the unofficial redline as a
reader tool only. Comments on the rule text should be made in this
proposed rule.
A. Training and Experience
1. Flexible Physician Training Pathways
The current definition of physician in Sec. 35.2, ``Definitions,''
means a medical doctor (MD) or doctor of osteopathy (DO) licensed by a
State or Territory of the United States, the District of Columbia, or
the Commonwealth of Puerto Rico to prescribe drugs in the practice of
medicine. The NRC is proposing to change this definition to remove the
specific requirement for the individual to be an MD or DO. This change
is intended to expand eligibility for foreign-trained physicians whose
primary medical qualifications may not be titled MD or DO, but who are
fully licensed to practice medicine in the United States, to become
AUs. AUs must still meet the training and experience requirements in
the applicable subparts of 10 CFR part 35.
In addition, the NRC is proposing to remove from regulations the
listing of specific accrediting bodies for residency programs under the
training and experience requirements for AU physicians in Sec. Sec.
35.190. 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, and 35.690.
Over time, both residency programs and their accrediting bodies have
evolved to incorporate NRC requirements into their curricula. As a
result, the NRC no longer finds it necessary to specify accrediting
bodies in the regulations. Under this proposed rule, the residency
programs would be required to include the proposed classroom and work
experience topics to ensure that physicians receive training as part of
a structured educational program. This approach allows for greater
flexibility by permitting any accredited program, regardless of the
accrediting body, to qualify, provided it includes the specified
training topics.
2. Physician Residency Pathways
The NRC is proposing to revise its regulations to recognize the
structured and comprehensive nature of accredited residency programs in
certain medical specialties that inherently include radiation safety
training and experience as part of the clinical specialty.
Specifically, the NRC proposes to remove the prescriptive requirements
in Sec. Sec. 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490,
and 35.690 for specific numbers of classroom, laboratory, and work
experience hours for physicians who have completed residency training
in specialties where radiation safety and the clinical use of byproduct
material are inherently integrated into the curriculum. This proposed
change acknowledges that the depth and scope of training provided in
these accredited residency programs are tailored to the clinical
application of byproduct materials. The NRC believes that successful
completion of such a residency program along with written attestation
from a preceptor or residency program director, provides sufficient
assurance of an individual's competency to serve as an AU, without the
need for fixed hour requirements.
To implement this change, the NRC is proposing to add a residency-
based training and work experience pathway for the medical use of
unsealed byproduct material in Sec. Sec. 35.190, 35.290, 35.390,
35.392, 35.394, and 35.396. This new pathway would apply to Sec. Sec.
35.190 (Training for uptake, dilution, and excretion studies), 35.290
(Training for imaging and localization studies), 35.390, and 35.396
(Training for the parenteral administration of unsealed byproduct
material requiring a written directive), where current regulations do
not explicitly reference residency training. For Sec. Sec. 35.490
(Training for use of manual brachytherapy sources) and 35.690 (Training
for use of remote afterloader units, teletherapy units, and GSR units),
no new pathway would be created as the regulations already require
completion of a residency. For all applicable sections, the NRC would
remove the prescriptive hour requirements for classroom, laboratory,
and work experience for individuals who have completed an accredited
residency in specified specialties. This change would not amend the
topics that must be covered for classroom and laboratory training and
work experience that must be completed in a structured educational
program. The topics listed in the regulations are essential to ensuring
radiation safety. Individuals completing a residency-based pathway
would still need to receive training and experience in all required
topic areas during their residency. The written attestation from a
preceptor or residency program director should confirm that the
individual has completed the required training and experience as
required and is able to independently fulfill the radiation safety-
related duties as an AU for the medical use the individual is
requesting.
The NRC would retain the NRC-approved specialty board pathway and
alternate pathway with specified hours for individuals who have not
completed residency training in specialties identified in regulations.
Finally, the proposed regulations would retain the equivalent
qualification pathways where an AU who is qualified for Sec. 35.290
also is qualified for Sec. 35.190, an AU who is qualified for Sec.
35.390 also is qualified for Sec. Sec. 35.290 and 35.190, and an AU
who is qualified for 35.490 also is qualified for Sec. 35.491,
``Training for ophthalmic use of strontium-90.''
3. Device and Use Specific Training
Currently, Sec. Sec. 35.300, 35.392, 35.394, 35.396, and 35.491
require physicians to complete a prescribed number of cases to qualify
as an AU. This fixed case requirement does not allow flexibility for
physicians who can complete the required work experience and
demonstrate the knowledge and competency in radiation safety-related
duties through other means than a prescriptive number of cases for the
medical use for which they are requesting AU status.
This proposed rule would replace the specified number of cases to
qualify as an AU in the NRC's regulations with a requirement that the
physician receive sufficient experience in casework during either their
residency or the
[[Page 47048]]
required training and experience hours for the medical use in question.
This experience must be sufficient for the supervising AU to evaluate
and document the physician's competency in independently performing
radiation safety-related duties for the requested medical use. This
proposed change would allow flexibility based on the needs of the
physician to ensure they have the knowledge necessary to ensure
radiation safety for the patient, public, other workers, and themselves
for their requested medical use.
In addition, Sec. Sec. 35.300, 35.392, 35.394, and 35.396
currently state that the physician must have experience in
administering dosages of radioactive drugs in their respective
categories. However, the physical act of administering dosages of
radioactive drugs is a practice of medicine and is not always performed
by the physician seeking AU status. The purpose of training and
experience for AUs is to ensure radiation safety rather than medical
competency; this proposed rule revises this requirement to focus on
preparing written directives and observing or performing the
administration of dosages. While the AUs do not need to physically
perform the administration, they must participate in the entire
process, gaining experience in all required topics, to ensure they can
independently perform all radiation safety-related duties for the
medical use for which they are requesting AU status.
In addition, currently, Sec. 35.59, ``Recentness of training,''
requires individuals to demonstrate related continuing education and
experience if their required training and experience was obtained more
than 7 years prior to the date of application. However, as the medical
use of byproduct material continues to evolve at a quick pace,
particularly with the expansion of radiopharmaceutical therapies,
experience gained even a few years ago does not ensure that authorized
individuals, such as AUs, possess current training or experience in the
specific uses for which they are applying. In many cases, the uses for
which individuals were originally trained differ significantly from
current or emerging practices.
Inadequate training of staff, including AUs, before treating the
first patient has been identified as a root cause of a significant
number of events, including those described in NRC Information Notice
2024-04, ``Recent Medical Events involving Administration of
Therapeutic Radiopharmaceuticals.'' Similarly, as documented in
Information Notice 2019-07, ``Methods to Prevent Medical Events,'' NRC
staff determined that several additional medical events were linked to
insufficient training following the introduction of new equipment or
software. The ACMUI has also concluded that many medical events involve
users who perform treatments infrequently and recommended refresher
training for AUs. These findings underscore the need for a performance-
based continuing education requirement to ensure that authorized
individuals maintain current knowledge and skills as practices and
technologies evolve, particularly as the NRC proposes to remove the
outdated recentness requirement in Sec. 35.59.
The ACMUI and other stakeholders have recommended that licensees
receive additional application-specific training for existing and
future EMTs. This includes the potential for future radiopharmaceutical
therapies to be licensed under 10 CFR part 35, subpart H. Stakeholders
also have expressed concern that the current Sec. 35.59 lacks clarity
regarding what constitutes acceptable training and experience to meet
the recentness requirement. This has led to uncertainty about what
documentation should be submitted with license applications. To address
these concerns, the NRC this proposed rule would revise Sec. 35.59 to
remove the prescriptive requirement to demonstrate recent training and
experience at the time of application and would introduce a
performance-based continuing education requirement. This would ensure
authorized individuals maintain the necessary education and experience
to support radiation safety and regulatory compliance for the uses they
are authorized.
Recognizing the differing risk profiles between diagnostic and
therapeutic uses, the NRC is proposing a change that would require AUs
for diagnostic uses to maintain education or experience in the type of
use. For uses requiring a written directive, AUs must maintain
education and experience in the specific source, microsource, device,
or radioactive drug. This proposed rule also would require instruction
on changes to applicable regulations, license conditions, and the
licensee's written radiation protection and written directive
procedures. This is particularly important because AUs are responsible
for supervising others under Sec. 35.27, ``Supervision,'' and ensuring
safe use of byproduct material. As part of this performance-based
approach, licensees would no longer be required to submit documentation
of recent training and experience with a license application. Instead,
a new recordkeeping requirement would be added in a new section, Sec.
35.2059, ``Records of continuing education and training,'' to ensure
that licensees maintain appropriate documentation of continuing
education and experience.
The NRC also is proposing to remove the specific work experience
requirement for eluting generator systems, measuring and testing the
eluate for radionuclidic purity, and processing the eluate with reagent
kits to prepare labeled radioactive drugs. Changes in industry practice
have resulted in a limited number of generators in use at medical
facilities, creating challenges for AU trainees to meet this portion of
the experience requirement. The NRC believes that the classroom portion
of the requirements for the chemistry of byproduct material could
adequately cover the topics previously addressed through hands-on
experience. This change would provide the necessary radiation safety
information as an alternative to direct work experience.
4. Authorized User Approval for Non-Therapeutic Uses of Unsealed
Byproduct Material
The NRC is proposing to amend its regulations to eliminate the
requirement for licensees to submit a license amendment before allowing
an individual to serve as an AU for medical uses authorized under Sec.
35.100, ``Use of unsealed byproduct material for uptake, dilution, and
excretion studies for which a written directive is not required,'' or
Sec. 35.200, ``Use of unsealed byproduct material for imaging and
localization studies for which a written directive is not required.''
Under this proposed rule, licensees would be permitted to approve
individuals as AUs for these non-therapeutic uses of unsealed byproduct
material without prior NRC review and approval, provided the individual
meets the applicable training and experience requirements specified in
subpart D. Licensees would be required to maintain documentation of
their internal review and approval process, including verification that
the individual satisfies the relevant training and experience criteria.
This documentation would be subject to NRC inspection.
This proposed change reflects the NRC's risk-informed, performance-
based regulatory approach and acknowledges that the medical uses
authorized under Sec. Sec. 35.100 and 35.200, such as diagnostic
imaging and localization studies, do not require a written directive
and are considered lower-risk activities. By removing the license
amendment
[[Page 47049]]
requirement for these uses, the NRC aims to reduce unnecessary
regulatory burden on licensees while maintaining appropriate oversight.
The approval of AUs for these uses would be evaluated as part of the
NRC's routine inspection program, ensuring AUs have the necessary
training and experience to support radiation safety without requiring
pre-approval through the licensing process.
5. Training and Experience Categories of Therapeutic Uses of Unsealed
Byproduct Material
The NRC is proposing to amend Sec. Sec. 35.390(b)(1)(ii)(G) and
35.14(a) to remove the prescriptive requirement that individuals
seeking AU status must have experience with both low-dose (less than or
equal to 1.22 gigabecquerels or 33 millicuries) and high-dose (greater
than 1.22 gigabecquerels or 33 millicuries) oral administrations of
sodium iodide I-131. Under the current regulation, applicants must
document a minimum of three cases in each of these two categories. This
rigid structure may not reflect the evolving landscape of
radiopharmaceuticals. The proposed change would consolidate these two
categories into a single, broader category: oral administration of any
radioactive drug for which a written directive is required. This
proposed revision eliminates the specific dose-based thresholds for
sodium iodide I-131 and instead focuses on the route of administration
and the requirement for a written directive. This approach is more
risk-informed and performance-based. This proposed change preserves the
integrity of the training and experience requirements while allowing
for greater flexibility in how those requirements are met. It also
would ensure that the regulation remains adaptable to future
developments in radiopharmaceuticals that may be administered orally
and require a written directive. This proposed amendment would only
apply to the categories in Sec. 35.390 for physicians seeking full
authorization and does not remove or change the existing work
experience requirements for those who desire the limited scope pathway
provided in Sec. Sec. 35.392, ``Training for the oral administration
of sodium iodide I-131 requiring a written directive in quantities less
than or equal to 1.22 gigabecquerels (33 millicuries),'' and 35.394,
``Training for the oral administration of sodium iodide I-131 requiring
a written directive in quantities greater than 1.22 gigabecquerels (33
millicuries).'' These limited pathways would remain available for
physicians who seek authorization for these specific uses without
completing the training and experience requirements for all therapeutic
uses of unsealed byproduct material authorized under Sec. 35.390.
The NRC also is proposing to remove unnecessary limitations in the
current Sec. 35.390(b)(1)(ii)(G)(3), which requires AU applicants to
have work experience with a radionuclide that is primarily used for its
electron emission, beta radiation characteristics, alpha radiation
characteristics, or photon energy of less than 150 kilo-electron volt
(keV). This proposed rule would amend Sec. 35.390(b)(1)(ii)(G)(2) to
require parenteral administration of any radioactive drug for which a
written directive is required, replacing the removed requirement with a
broader, more flexible requirement while still ensuring safety. This
proposed change would allow training involving any future
radiopharmaceuticals delivered by a parenteral route to be included
under this regulation. These revisions provide flexibility for future
individuals seeking AU status while ensuring such individuals continue
to demonstrate the foundational knowledge and clinical experience
necessary to support radiation safety. In conjunction with the proposed
changes to Sec. 35.59, these updates also would ensure that
individuals maintain current knowledge specific to the uses they are
authorized to perform.
6. Authorized User Pathway To Become a Radiation Safety Officer
Under the current regulations, Sec. 35.50(c)(3) allows physicians
to be simultaneously approved as both the RSO and AU on a new medical
use license or permit, provided they also meet the requirements of
Sec. 35.50(d). The NRC is proposing to amend this regulation to allow
individuals to seek this pathway on an existing license or permit.
There is no safety basis for limiting this pathway solely to new
licenses or permits, and this change would provide greater flexibility
for an AU to become an RSO on a license at any time without
compromising safety.
7. Regulatory Clarification of Training and Experience Regulations
To improve clarity, the NRC is proposing to restructure the
training and experience requirements in 10 CFR part 35 by consolidating
the specialty board certification approval process into a new section,
Sec. 35.58, ``Specialty board certification approval.'' Currently, the
specialty board certification requirements for AUs, RSOs, AMPs, and
ANPs are embedded within multiple subparts throughout 10 CFR part 35.
When a licensee is reviewing the requirements needed to complete a
licensing application for approval as an AU, the requirements of a
specialty board certification process is not needed to support the
application. Therefore, the NRC is proposing a separation to clarify
the training and experience requirements for AUs and to simplify the
approval process for specialty boards.
The proposed amendment moves the specialty board approval process
from Sec. Sec. 35.50(a), 35.51(a), 35.55(a), 35.190(a), 35.290(a),
35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a) to
proposed new Sec. 35.58.
In addition, this proposed rule would clarify that work experience
required under each subpart may be obtained under the supervision of an
AU at a medical facility authorized to use byproduct materials under
that subpart. Under the proposed change, licensees would not be
required to verify the training and experience of supervising
individuals, as they are already authorized to use the material. This
regulatory change would clarify who can supervise required work
experience.
B. Emerging Medical Technologies
1. Expansion of Medical Use Generators
The NRC is proposing amendments to 10 CFR part 35 to modernize and
expand the regulatory framework for medical use generators. Currently,
Sec. 35.204, ``Permissible molybdenum-99, strontium-82, and strontium-
85 concentrations,'' provides specific concentration limits for parent
radionuclides for molybdenum-99 (Mo-99)/Tc-99m and Rb-82 generators to
limit such exposure, but provides no such limit for Germanium-68/
Gallium-68 (Ge-68/Ga-68) generators or flexibility for other new or
emerging generators. In addition, generator regulations are contained
within subpart D, which are limited to diagnostic uses. As a result of
this narrow regulatory framework, generator systems such as the Ge-68/
Ga-68 generators have been regulated under Sec. 35.1000. Additionally,
the current regulatory requirements for breakthrough testing and
effluent limits are prescriptive and located within the diagnostic
subpart, which would not be appropriate for future therapeutic
applications. As generator technologies become more common and new
therapeutic generators are developed, reliance on Sec. 35.1000 would
create unnecessary delays in licensing and implementation because each
new generator type would need to undergo case-by-case review and
approval under
[[Page 47050]]
the EMT review process rather than following a standardized regulatory
pathway.
To address these issues, the NRC is proposing to revise and expand
the regulatory provisions applicable to medical use generators to
accommodate both diagnostic and therapeutic applications and to reduce
reliance on Sec. 35.1000 for licensing new generator systems.
Specifically, the NRC is proposing to--
a. Revise Sec. 35.2 to add a definition for ``breakthrough'' to
reflect current industry practices and terminology.
b. Move generator breakthrough testing requirements contained in
Sec. Sec. 35.204 and 35.2204, ``Records of molybdenum-99, strontium-
82, and strontium-85 concentrations,'' to new sections Sec. Sec.
35.93, ``Permissible concentrations for generator-produced
radionuclides,'' and 35.2093, ``Records of generator breakthrough
testing,'' respectively. The proposed new Sec. 35.93 would be located
in subpart C (General Technical Requirements) as opposed to subpart D
(Unsealed Byproduct Material--Written Directive Not Required) where the
current generator breakthrough testing requirements in Sec. 35.204 are
contained. This move would support the anticipated licensing of
therapeutic generators, which may not fall under the current scope of
subpart D. In addition, the proposed Sec. 35.93 would remove
prescriptive requirements limited to specific generators and replace
them with a more flexible approach that allows licensees to develop and
implement written procedures to define acceptable breakthrough limits
and testing frequencies that are consistent with generator labeling as
set forth in its FDA product approval or nationally recognized
standards. To ensure safety and regulatory alignment, the proposed
changes would require that the limits and testing frequency be
consistent with generator labeling as set forth in its FDA product
approval or nationally recognized standards, such as those published by
the United States Pharmacopeia (USP). These proposed changes align with
the current recommendations outlined in the Sec. 35.1000 licensing
guidance for the Ge-68/Ga-68 generators and would ensure that
breakthrough testing practices remain current with evolving safety and
performance standards and allow flexibility for emerging generators.
These proposed changes also would allow licensing of emerging
generators without further rulemaking or a separate case-by-case
licensing evaluation and guidance development under Sec. 35.1000.
c. Include a requirement in Sec. 35.93(a)(2) that licensees must
ensure individuals using generator systems have received operational
and safety training specific to the generator model. This codifies
expectations that were previously addressed only in guidance (e.g.,
EGM-13-003), and expands them to apply to all radionuclide generators,
not just rubidium-based generator systems, enhancing regulatory clarity
and stability. In addition, Sec. 35.93(b) would require that licensees
provide instruction in their generator procedures to individuals
involved in generator use, particularly when procedures are first
implemented or significantly changed. Because the NRC is proposing to
require training on the specific generator model and procedures being
used, the NRC is also able to propose the removal of broader training
and experience requirements for all physicians seeking authorization
under Sec. 35.200 described above. This approach is informed by
operational experience, where untrained users used the wrong eluant
without understanding the associated risks leading to generator
breakthrough events and unnecessary radiation exposure to patients.
Ensuring that users are trained on the specific systems they operate
mitigates these risks. Overall, this proposed change would represent a
significant reduction in regulatory burden, particularly since most
physicians do not directly use or supervise generator systems in
clinical settings, while still maintaining a high standard of safety in
generator operation. Proposed conforming changes also would be made to
the associated recordkeeping requirement contained in Sec. 35.2310,
``Records of safety instruction,'' to add the proposed new Sec. 35.93.
d. Similar to Sec. 35.204, the proposed Sec. 35.93(a)(3) would
prohibit the administration of generator eluate to patients or human
research subjects if breakthrough measurements exceed the licensee's
established limits. Section 35.93(c) would retain the requirement to
report any such exceedance at the time of generator elution, but
reference new proposed Sec. 35.3093, ``Report and notification for an
eluate exceeding breakthrough limits,'' instead of Sec. 35.3204,
``Report and notification for an eluate exceeding permissible
molybdenum-99, strontium-82, and strontium-85 concentrations.'' Section
35.93(d) would require licensees to retain records of each breakthrough
test in accordance with Sec. 35.2093, replacing the previous reference
to Sec. 35.2204.
e. Confirming changes would be made to information collections
contained in Sec. 35.8, ``Information collection requirements: OMB
approval,'' and recordkeeping requirements would be moved from Sec.
35.2204 to Sec. 35.2093.
These proposed changes are intended to remove the need for
licensing emerging generators under Sec. 35.1000 in order to increase
licensing efficiency, eliminate unnecessary prescriptiveness, align
regulatory requirements with current standards, and ensure that the
NRC's regulations remain adaptable to future innovations. By relocating
generator requirements out of the diagnostic subpart and into a more
general framework, the NRC aims to facilitate broader adoption of
generator-based technologies commensurate with the NRC's role in
maintaining appropriate oversight and safety assurance.
2. Ophthalmic Applicator Sources and Devices
The NRC is proposing to amend subpart F to replace references to
``strontium-90 sources'' with ``beta-emitting sources,'' to reflect the
broader range of beta-emitting isotopes that may be used in superficial
ophthalmic treatments and remove the outdated assumption that only
strontium-90 (Sr-90) is applicable. The proposed revised language would
ensure that the regulation remains relevant as new technologies and
isotopes are introduced into clinical use, reducing reliance on Sec.
35.1000 licensing, such as what is currently done for the NeoVista
Inc's Epi-Rad90 Sr-90 Ophthalmic System and Liberty Vision (LV)
Yttrium-90 (Y-90) Disc and iWand[supreg], by allowing these
technologies to be licensed under subpart F instead. While Sec.
35.400, ``Use of sources for manual brachytherapy,'' allows AUs who
meet training and experience requirements under Sec. 35.490 to
currently use beta-emitting sources for superficial ophthalmic
procedures, these proposed amendments would reduce training and
experience criteria contained in Sec. 35.491 for superficial
ophthalmic procedures for all beta-emitting sources. These amendments
aim to modernize regulatory language, support innovation in treatment
methods, and align with the NRC's risk-informed, performance-based
regulatory framework.
Specifically, the NRC is proposing to amend Sec. 35.491 to
modernize and clarify the training and experience requirements for
physicians authorized for superficial beta emitter ophthalmic
treatments, currently licensed under Sec. 35.1000, and any new
innovative superficial ophthalmic treatments. The section title would
be amended to read, ``Training for superficial ophthalmic use of beta-
emitting sources,'' and
[[Page 47051]]
references to ``strontium-90'' would be replaced with ``beta-emitting
sources,'' recognizing that ophthalmic radiotherapy may involve a
broader range of isotopes.
As the proposed amendment would allow use of a broader range of
isotopes instead of just one, the NRC is proposing to introduce device-
specific training for the applicable AUs authorized via Sec. Sec.
35.490 and 35.491. The applicable AUs would be able to satisfy this
training either through a vendor-provided program for new users or
through supervised instruction by an AU or AMP authorized to use the
same device. This aligns with the current recommendations outlined in
the Sec. 35.1000 licensing guidance for Liberty Vision, ensuring that
AUs are not only trained in radiation safety and clinical application
but also are proficient in the specific operational and safety features
of the device they will use.
In addition, confirming changes would be made to expand Sec.
35.433, ``Strontium-90 sources for ophthalmic treatments,'' to allow
for any beta-emitting source, not just Sr-90, to be used for ophthalmic
treatments. This proposed rule also would make conforming changes to
the recordkeeping requirement in Sec. 35.2433, ``Records of decay of
strontium-90 sources for ophthalmic treatments,'' to reflect the
broader terminology, requiring licensees to retain records of the
activity of each beta-emitting source. This proposed change does not
alter the intent or scope of the recordkeeping requirement but instead
updates the terminology to reflect current and future clinical
practices.
3. Remote Afterloader, Teletherapy, and Gamma Stereotactic Radiosurgery
Subpart H of 10 CFR part 35 establishes requirements for the use of
sealed sources in photon-emitting remote afterloader units, teletherapy
units, and GSR units. These requirements were originally developed
based on the operational characteristics of the devices available at
the time. For example, regulations for GSR units were developed in 2002
and calibration and spot check regulations contained in Sec. Sec.
35.635, ``Full calibration measurements on gamma stereotactic
radiosurgery units,'' and 35.645, ``Periodic spot-checks for gamma
stereotactic radiosurgery units,'' were based on the NRC's review of
units and clinical practice used in 1995. In 1995, the units used
stationary sources, helmet collimators that needed to be changed
manually, trunnions, and head frames drilled into the skull. However,
the evolution of medical technology has introduced new units with
design and engineering elements that make their operation significantly
different than these previous units, resulting in their inability to be
licensed under 10 CFR part 35 subpart H. As a result, modern GSR units
are currently licensed under Sec. 35.1000.
To support licensing these units under Sec. 35.1000, the NRC
developed several licensing guidance documents, including for Akesis
Galaxy Rti, Leksell Gamma Knife[supreg] PerfexionTM, Leksell
Gamma Knife[supreg] IconTM, Elekta Esprit, Xcision[supreg]
GammaPodTM, and ViewRayTM System for Radiation
Therapy. In addition, the NRC expects more EMTs would be licensed under
Sec. 35.1000 if subpart H to 10 CFR part 35 is not changed. As
licensing under subpart K can increase burden on licensees and
regulators and lead to inconsistencies, this proposed rule would
eliminate the need to use subpart K for licensing for modern GSR units.
In addition, the NRC is proposing additional amendments to support the
broader goals of E.O.s 14300 and 14267 to align regulations with
current clinical practices and reduce unnecessary requirements that may
limit innovation.
To reduce unnecessary regulatory burdens that may hinder
innovation, the NRC is proposing to amend:
a. Section 35.2 to include a definition for ``gamma stereotactic
radiosurgery'' and revise the existing definition of ``teletherapy.''
These changes are part of a broader initiative to modernize and clarify
terminology used in 10 CFR part 35, improve consistency in regulatory
language, and better reflect current clinical practices and medical
community standards;
b. Section 35.610(a)(1) to allow flexibility in securing either the
console or its keys, rather than requiring both, while still
maintaining the requirement to secure the unit and treatment room when
not in use; and
c. Sections 35.615(a) and (b) to remove the prescriptive
requirement for a physical door to control access, while preserving the
requirement that access to each treatment room entrance must be
controlled using an electronic interlock.
These proposed changes preserve the core safety principles of the
current regulations while allowing for alternative, modern mechanisms
to ensure therapeutic units remain secure and controlled.
As GSR technology advances, the differences between units impacting
radiation safety are increasing. With the proposal to allow more unit
types to be licensed under subpart H, it is essential that AUs,
operators, and calibrators receive training specific to the units they
will use. To address this, the NRC is proposing to amend Sec.
35.610(d)(1) to require vendor-provided operational and safety training
for all individuals who will operate or calibrate the unit, including
the AU, prior to the first use of a new or upgraded unit. Unlike
traditional units for which subpart H was originally written, modern
units may incorporate various types of immobilization devices, and in
the event of an emergency, it is critical that responders are trained
to safely release a patient from the specific device in use. Therefore,
the NRC is proposing to revise Sec. 35.610(e) to add a requirement to
ensure emergency training includes instruction on the specific
immobilization devices used with the unit. These amendments would
ensure safety is maintained while subpart H is expanded to include
different types of units, minimizing the need for future subpart K
licensing.
GSR units have advanced along with their safety systems, which help
ensure patients are treated accurately and as prescribed. This
advancement is detailed in the ACMUI subcommittee report titled
``Physical Presence Requirements for the Leksell Gamma Knife[supreg]
IconTM.'' Currently, Sec. 35.615(f)(3) requires both an AU
and an AMP to be physically present throughout the entire GSR
treatment. However, due to the enhanced safety features of modern GSR
units, the NRC is proposing to reduce this physical presence
requirement by amending Sec. 35.615(f)(3), now proposed Sec.
35.615(e)(3):
a. The AU and AMP would still be required to be physically present
at the initiation of treatment to ensure proper setup and confirm that
the patient receives the intended dose to the correct location.
b. After initiation, the AU may leave the treatment area but must
remain immediately available in case of an emergency or treatment
interruption that requires a medical decision.
c. Given the high dose rates involved in GSR treatments, the AMP
would still be required to remain physically present during the
continuation of treatment.
d. The licensee would have the flexibility to designate other
appropriate personnel to be physically present to respond to
emergencies and remove the patient from the radiation field if
necessary.
e. In the event of an unexpected interruption, both the AU and the
AMP would be required to evaluate the situation before treatment re-
initiation.
This proposed amendment reduces the amount of time the AU must be
physically present during GSR
[[Page 47052]]
treatments compared to both current regulations and licensing
conditions described in Sec. 35.1000 licensing guidance documents,
reflecting the reliability of modern safety systems. Additionally, the
proposed amendment does not require the AU to return in the event of an
unexpected interruption. However, to ensure treatments are delivered
according to the treatment plan and written directive, the AU must
evaluate the situation before the operator resumes treatment. Overall,
this proposed amendment reduces prescriptive requirements regarding the
AU's location while maintaining safety as qualified personnel remain
available to respond to emergencies and unexpected conditions.
To allow modern and future radiation therapy units, including GSRs,
to be licensed under 10 CFR part 35, subpart H, the NRC is proposing to
modify or remove prescriptive spot check and full calibration
requirements. These proposed changes would eliminate outdated,
redundant, or overly prescriptive provisions, better accommodate modern
equipment designs, and align with the NRC's risk-informed, performance-
based regulatory framework.
Specifically, for GSRs, the NRC is proposing to amend the following
full calibration requirements contained within Sec. 35.635:
a. Remove all references to helmet factors in paragraphs (a)(3) and
throughout (b). These references are obsolete because newer GSR
technologies do not rely on physical helmets or use integrated
collimation systems. Removing all references to helmet factors
eliminates unnecessary specificity that no longer reflects current
practice and equipment design.
b. Revise paragraph (a)(2)(iii) to include collimation components
in required post-repair calibrations aligning with the current
recommendations outlined in Sec. 35.1000 licensing guidance for modern
GSR units. The current language limits the calibration trigger to
repairs involving source removal or source assembly components. This
proposed rule includes ``major repair of component(s) associated with
the source assembly or collimation,'' ensuring calibrations are
conducted when critical components that affect dose distribution are
modified. This clarification improves regulatory clarity without
increasing burden.
c. Replace outdated and device-specific calibration checks in
paragraph (b) with a more performance-based set of criteria. The list
includes references to obsolete components (e.g., helmet microswitches,
trunnion centricity) that are no longer applicable to modern units. The
proposed revised calibration elements focus on broad system functions
such as accuracy of positioning, localization, attenuation, and
collimation devices; isocenter coincidence; timer linearity and on-off
error; function of system interlocks; and availability of backup power
systems. These revisions would provide licensees with greater
flexibility in meeting calibration requirements, while aligning with
the current recommendations outlined in Sec. 35.1000 licensing
guidance for modern GSR units.
d. Add a requirement for full calibration to verify the operability
and availability of emergency response equipment required under Sec.
35.610. This change would account for modern and future gamma
stereotactic radiosurgery (GSR) units, which incorporate varied
emergency response equipment that licensees must ensure is available
and operational to respond in the event of an emergency, such as a
stuck shutter. Although rare, such events have been reported to the NRC
and resulted in sources continuing to be exposed following treatment
where licensees have had to use emergency equipment. This requirement
would not be expected to increase burden because licensees are already
required to have emergency response equipment operational and available
to implement emergency procedures specified in Sec. 35.610 and perform
full calibration of the unit in accordance with Sec. 35.635.
Next, the NRC is proposing to amend Sec. 35.645 to eliminate
redundant and overly prescriptive requirements for periodic spot-checks
of GSR units that are already addressed through nationally recognized
standards or manufacturer protocols. Specifically, the NRC is proposing
to--
a. Remove prescriptive specific spot checks for the GSR units
contained in Sec. 35.645(c)(1)-(2) and (d)(1)-(6), such as helmet
microswitches, trunnion centricity, emergency timing circuits, and
intercom systems. The prescriptive list of outdated requirements for
modern GSR units would be replaced with a performance-based approach
allowing licensees to follow written procedures established by the AMP
and to rely on nationally recognized standards or NRC-accepted
manufacturer instructions. NRC-accepted manufacturer instructions would
be listed on the NRC's medical use toolkit on the emerging medical
technology page after the NRC confirms the instructions to check the
necessary systems and components as required per regulation and contain
clear tolerance limits for licensee use. This change provides
flexibility while maintaining safety and quality assurance.
b. Restructure Sec. 35.645 to clearly define the frequency of
required spot checks, aligning with the current recommendations
outlined in Sec. 35.1000 licensing guidance for modern GSR units.
c. Revise the current Sec. 35.645(e) into proposed Sec. Sec.
35.645(d) and (e) to permit the licensee to continue using the unit,
provided that any system or device identified as not functioning
properly is not used for treatment. The requirement in Sec. 35.645(e)
that a licensee must not use a unit if a malfunction is found in a
system necessary for treatment would be retained.
d. For remote afterloader units, the NRC is proposing to amend
Sec. 35.643 to eliminate redundant and overly prescriptive
requirements for periodic spot-checks that are already addressed
through nationally recognized protocols or NRC-accepted manufacturer
procedures. These changes are intended to streamline regulatory
requirements, reduce unnecessary burden on licensees, and align with
the NRC's risk-informed, performance-based regulatory framework.
Specifically, the NRC is proposing to remove prescriptive specific spot
checks for the high dose rate (HDR) units contained in Sec.
35.643(d)(1)-(8), such as electrical interlocks, source exposure
indicator lights, viewing and intercom systems, emergency response
equipment, and computer clock settings. These requirements would be
replaced with a performance-based approach allowing licensees to follow
written procedures established by the AMP and to rely on nationally
recognized standards or NRC-accepted manufacturer instructions, as
described in Sec. 35.643(b). NRC-accepted manufacturer instructions
would be listed on the NRC's medical use toolkit on the EMT page after
NRC confirms the instructions contain procedures and acceptable
tolerance limits for necessary spot checks and calibrations. This shift
would align required checks with standards and allow licensees to use
innovative or emerging technologies while maintaining safety.
As very few teletherapy units currently exist in the U.S., the NRC
is not proposing additional changes to remove prescriptive spot-check
or full calibration requirements for these units, as was done for HDR
and GSR. However, for consistency with the updates to HDR and GSR
regulations, the NRC is proposing to amend spot check requirements
contained within Sec. Sec. 35.632(d) for teletherapy units. This
amendment would allow licensees to
[[Page 47053]]
follow NRC-approved manufacturer procedures in the absence of
nationally recognized protocols if a new teletherapy unit is developed.
4. Establishment of Subpart I for Microsource Brachytherapy
The NRC is proposing to establish a dedicated regulatory framework
for microsource brachytherapy by developing a new subpart I under 10
CFR part 35 and making other conforming changes. These changes are
intended to incorporate microsources, such as Y-90 microspheres, into
traditional medical-use subparts in a way that reflects their unique
characteristics. Due to microspheres' unique characteristics, they are
currently licensed under Sec. 35.1000. To support licensing these
units under subpart K, the NRC developed two licensing guidance
documents for 3 types of microspheres, TheraSphere[supreg], SIR-
Spheres[supreg], and Eye90[supreg]. The use of microspheres for
permanent implant manual brachytherapy has grown significantly over the
past two decades, and the NRC anticipates continued growth and
innovation in this area, including the development of new microsource
systems. This proposed rule would eliminate the need to use subpart K
for licensing microspheres, while still ensuring proper radiation
safety oversight.
The new subpart I of 10 CFR part 35 mirrors the structure of
existing subparts F and H but specific requirements would be tailored
to the specific operational and safety considerations of microsource
brachytherapy based on current licensing conditions contained in Sec.
35.1000 licensing guidance to include microsources. The NRC is
proposing to amend Sec. 35.2 to add definitions for ``microsource,''
``microsource brachytherapy,'' and ``shunting,'' and revise the
definition of ``prescribed dosage'' to include microsources. Adding
these definitions is part of a broader effort to modernize and clarify
terminology used in 10 CFR part 35 to improve consistency in regulatory
language and better reflect current clinical practices and medical
community standards.
The NRC is proposing to amend written directive requirements in
Sec. 35.40 to include microsource brachytherapy. Specifically, the
proposed amendments would--
a. Revise Sec. 35.40(b)(5) to explicitly include ``microsource
brachytherapy'' alongside permanent manual brachytherapy, ensuring that
written directives for microsource treatments document the treatment
site, radionuclide, and either total source strength or prescribed
dosage before administration.
b. Update Sec. Sec. 35.40(a)(2) and (b)(5) to include microsource
brachytherapy with manual brachytherapy to allow changes to the written
directive after administration but before the patient leaves the post-
treatment recovery area.
c. Modernize terminology to reflect current clinical practice,
replacing ``permanent implant brachytherapy'' with ``permanent manual
or microsource brachytherapy,'' and allowing for documentation of
either total source strength, prescribed dosage, or administered
activity, which is particularly relevant for microsphere therapies.
Additionally, the proposed subpart I would introduce the following
provisions:
a. Section 35.700 would establish the conditions under which
microsources may be used, including sourcing from licensed
manufacturers or use under an FDA-accepted investigational device
exemption (IDE). This provision would ensure that microsources are
obtained and used in a manner consistent with existing safety and
quality standards.
b. Section 35.710 would outline safety procedures and instruction
requirements. Specifically, Sec. 35.710(a) would mandate that
microsource administration devices be used in accordance with the
Sealed Source and Device Registry, consistent with current licensing
guidance. In addition, Sec. 35.710(b) would require licensees to
develop, implement, and maintain written procedures for responding to
abnormal situations (e.g., spills, equipment failures, or emergent
conditions that could affect the administration of microsources). This
is a new requirement that is not currently addressed in the current
Sec. 35.1000 microsphere licensing guidance and which is not expected
to increase regulatory burden. The addition would be necessary for
safety to ensure that applicants have documented procedures to manage
abnormal situations that may periodically occur during microsource use,
enhancing safety and preparedness and reducing risk. Section 35.710(c)
also would require initial operational and safety training for
individuals handling microsources, including training provided by the
manufacturer or certified trainers, in line with current Sec. 35.1000
licensing guidance. Further, to align with regulations in other
subparts for other therapeutic modalities that may involve patients who
cannot be released under Sec. 35.75, radiation safety instructions are
proposed to be added for personnel caring for such patients or human
research subjects in Sec. 35.710(d). These instructions emphasize
patient control, contamination prevention, and emergency response. This
change is not expected to increase the burden for current yttrium-90
microsphere licensees, as patients are typically released under current
clinical practice. However, it is essential to ensure personnel have
clear and consistent safety instructions in the event that future
microsource administrations require inpatient care. Recordkeeping
requirements are proposed to be added for training and procedures to
ensure accountability and compliance.
c. Proposed new Sec. 35.790 would define the training and
experience requirements for AUs of microsources in line with current
Sec. 35.1000 licensing guidance and changes described in Section
IV.A., ``Training and Experience,'' of this document. Specifically, the
proposed amendment would require:
i. Completion of a diagnostic and interventional radiology
residency, along with classroom and laboratory training in radiation
safety fundamentals.
ii. Supervised clinical experience involving at least three
microsource cases, including hands-on work with ordering, preparing,
administering, and evaluating treatments. Unlike the proposed changes
that remove specific case requirements for unsealed byproduct material
and superficial ophthalmic use of beta-emitting sources, this proposed
rule retains a minimum of three microsource cases currently contained
in the Sec. 35.1000 licensing guidance for Y-90 microspheres and is
being retained to ensure practitioners have sufficient experience to
maintain safety given the continued high number of reported events and
the unique delivery systems used for each microsource type.
iii. Written attestation from a qualified preceptor or residency
program director confirming the individual's readiness to independently
perform radiation safety duties.
Alternatively, prior authorization under Sec. 35.390, 35.396, or
35.490 with supplemental microsource-specific training and attestation
would meet the training and experience requirement. The addition of
Sec. 35.396 would allow for additional physicians to be licensed based
on their prior training and experience under Sec. 35.396, reducing
burden from past Sec. 35.1000 licensing guidance recommendations.
a. The regulations in Sec. 35.2310 would establish the
recordkeeping requirements for safety instruction provided under
Sec. Sec. 35.93, 35.310,
[[Page 47054]]
35.410, 35.610, and now also Sec. 35.710, which would address safety
procedures for microsource brachytherapy systems. This revision would
expand the scope of required records to include operational and safety
instruction related to microsource use. The update would align
microsource recordkeeping requirements for operational and safety
instructions with the other therapeutic technologies contained in 10
CFR part 35.
b. The regulations in Sec. 35.2710 is a proposed new section that
would establish the recordkeeping requirements associated with safety
procedures and instruction for microsource use. This section would
ensure that licensees maintain documentation of written procedures for
managing abnormal situations involving microsource administration,
aligning microsource recordkeeping requirement for procedures with
other modalities contained in 10 CFR part 35 while adding minimal
burden. The NRC is proposing these requirements to support
accountability and reinforce safe clinical practice in the use of
microsource brachytherapy systems.
5. Increasing Flexibility for Safety Precautions Regarding Exposure
From Patients
The NRC is proposing to amend its regulations to reduce regulatory
burden and increase flexibility for licensees in managing patients or
human research subjects who cannot be released under Sec. 35.75.
Specifically, the NRC is proposing to combine safety precautions from
individual modality subparts into a new section, Sec. 35.76 contained
in subpart C, which would be applicable to all uses. By combining the
safety precautions, licensees would have flexibility to house
individuals who cannot be released under Sec. 35.75 in the same room,
regardless of whether they received the same type of administration.
This change would allow, for example, a patient who received
radiopharmaceutical administration under subpart E to be roomed with a
patient who received microsource administration under subpart I,
provided the licensee can do so in accordance with 10 CFR part 20 dose
limits. This would increase flexibility in patient management and
facility use without compromising radiation safety.
The NRC is also proposing to revise the requirement that patients
receiving unsealed byproduct material must have a private sanitary
facility. This proposed rule would instead require that such patients
have access to a sanitary facility used only by individuals who have
received similar administrations, without leaving the controlled area.
This change would support more efficient facility design and use while
maintaining adequate protection against contamination and exposure in
uncontrolled areas.
6. Reduce Barriers for Innovative Emerging Medical Technologies
The NRC is proposing amendments to 10 CFR part 35 to reduce
regulatory barriers that may delay or discourage the adoption of
innovative EMTs. These changes are part of a broader initiative to
modernize the medical use regulations and ensure they remain risk-
informed, performance-based, and adaptable to technological
advancements.
One set of proposed changes addresses the calibration of dose
calibrators and survey instruments. Specifically, Sec. 35.60(c) would
be amended to permit licensees to submit written calibration procedures
for NRC approval in cases where the instrumentation required under
paragraph (a) cannot be calibrated using nationally recognized
standards or the manufacturer's instructions. This revision would
facilitate the use of innovative instrumentation for emerging and novel
radioisotopes in medical applications without the need for licensing
under subpart K or exemption as current licensees must calibrate these
instruments using nationally recognized standards or manufacturer
instructions. The NRC would evaluate the submitted procedures to
determine whether they achieve calibration tolerances comparable to
those established in nationally recognized standards. Conforming
changes would be made to Sec. Sec. 35.12(b)(2) and (c)(2). This
approach is intended to support the safe and effective use of new
technologies in nuclear medicine while reducing regulatory barriers
that may hinder medical research and the development of future clinical
applications involving byproduct material.
Similarly, the proposed revision to Sec. 35.61 would reduce the
prescriptiveness of survey instrument calibration requirements,
allowing licensees greater flexibility to tailor calibration methods to
the energy characteristics of new isotopes. Specifically, the proposed
amendments would:
a. Revise Sec. 35.61(a)(1) to require calibration of survey
instruments for the radiation type and energy range measured, rather
than specifying calibration of all scales up to 10 mSv (1000 mrem) per
hour. This change would provide licensees with greater flexibility
while ensuring that instruments are appropriately calibrated for their
intended use.
b. Additionally, the requirement in Sec. 35.61(a)(2) to calibrate
two separate readings on each scale or decade would be removed, as it
is overly prescriptive and not necessary to ensure accurate instrument
performance. The requirement to conspicuously note the date of
calibration on the instrument, currently in Sec. 35.61(a)(3), would be
retained as Sec. 35.61(a)(2).
The NRC also is proposing to revise Sec. 35.604, ``Surveys of
patients and human research subjects treated with a remote afterloader
unit,'' to remove the term ``portable'' from the description of survey
instruments. This change would accommodate the use of innovative
detection technologies, provided they meet performance and calibration
requirements. The revised language would continue to ensure that
radiation sources are properly surveyed and returned to a shielded
position before the end of the procedure, while allowing licensees to
adopt newer technologies within existing regulatory framework.
Another proposed change clarifies the licensing pathway for manual
brachytherapy sources. Under current regulations, subpart F governs the
use of sealed sources in manual brachytherapy, but the term ``implant''
in Sec. Sec. 35.404(a) and (b), and 35.2404, ``Records of surveys
after source implant and removal,'' has led to confusion regarding
whether topically administered sources could be licensed under this
subpart. The proposed revisions would clarify that manual brachytherapy
sources both topically and inserted within a patient or human research
subject are subject to subpart F. This clarification would streamline
the licensing process for treatments such as those for skin cancers or
post-surgical sites and ensure that licensees can efficiently implement
innovative brachytherapy devices without compromising safety.
7. Other Regulatory Clarifications and Implementation Changes for
Emerging Medical Technologies
The NRC is proposing amendments to certain regulatory requirements
in 10 CFR part 35 to clarify the intent and application of several
regulatory provisions related to the medical use of byproduct material.
These clarifications are part of the NRC's broader effort to ensure
that its regulations remain clear, risk-informed, and aligned with
current clinical practices, particularly as new technologies emerge and
evolve.
[[Page 47055]]
One area of focus is Sec. Sec. 35.57(b)(4) and 35.1000(c), which
address the continued use of medical technologies initially licensed
under subpart K. As these technologies become well established and are
incorporated into traditional subparts of 10 CFR part 35, the NRC seeks
to ensure that licensees and AUs do not need to reapply for approval to
continue using them. The proposed changes would establish a clear
regulatory pathway to preserve existing authorizations when a Sec.
35.1000 use transitions into a standard subpart use, thereby reducing
administrative burden and supporting continuity of care.
The NRC also is proposing to revise Sec. 35.27(a)(1) to replace
the phrase ``written directive procedures'' with ``procedures for
administrations requiring a written directive.'' This change would
align the language with Sec. 35.41, ``Procedures for administrations
requiring a written directive,'' and clarify that the regulation
applies to the implementation of the written directive, not to the
physician's clinical decision-making process. The proposed revision
reinforces the NRC's intent to ensure that licensees have procedures in
place to verify that the medical use of byproduct material is
administered in accordance with the physician's instructions, as
documented in the written directive.
Additionally, the NRC is proposing to revise Sec. 35.41(b)(4) to
remove prescriptive language that limits the applicability of the
requirement for verifying computer-generated dose calculations to
specific subparts such as Sec. 35.600 or Sec. 35.1000. This proposed
change broadly applies to any modality that uses computer-generated
dose calculations, regardless of the subpart under which it is
licensed. The proposed revision would ensure that the requirement
applies broadly, without inadvertently triggering subpart K licensing
for modalities that adopt these technologies in the future.
Together, these proposed changes are intended to clarify regulatory
intent, reduce unnecessary burden, support the safe and efficient
adoption of EMTs, and ensure that the NRC's medical use regulations
remain flexible, forward-looking, and focused on safety outcomes.
C. Rubidium-82 Generators
The proposed revision would include amendments to 10 CFR part 35,
subpart A, ``General Information,'' subpart B, ``General Administrative
Requirements,'' subpart C, ``General Technical Requirements,'' and
subpart D, ``Unsealed Byproduct Material--Written Directive Not
Required,'' to resolve outstanding regulatory issues regarding the use
of Rb-82 generators that are currently dispositioned through use of
enforcement discretion as described in EGM 13-003. To continue
regulating Rb-82 generators without the need for enforcement discretion
and without impacting safety, changes would be necessary to allow for
the currently accepted methods for calibration of radiation detectors
in a dynamic mode and to address dosage measurements for Rb-82
generators. These criteria are currently implemented under EGM 13-003
and remain in effect today. The proposed amendments would codify these
requirements into regulation, eliminating the need for ongoing
enforcement discretion while maintaining the same safety basis. The NRC
is proposing to revise Sec. 35.63 to address longstanding challenges
associated with determining the activity of radiopharmaceutical dosages
in certain clinical scenarios, particularly those involving short-lived
isotopes administered via direct infusion systems, which cannot meet
the regulations for measuring patient dosages before administration.
1. Specifically, the title of Sec. 35.63 would be revised from
``Determination of dosages of unsealed byproduct material for medical
use'' to ``Determination of dosages for medical use'' to reflect the
broader applicability of the section. Paragraph (a) to Sec. 35.63
would be amended to exempt incremental administrations that meet the
criteria in new paragraph (e) from the requirement to determine and
record the activity of each dosage before medical use.
2. Paragraphs (b) and (c), which describe acceptable methods for
determining the activity of unit and non-unit dosages, respectively,
would be retained but revised to clarify that they do not apply to
incremental administrations that meet the criteria in paragraph (e).
3. A new paragraph (d) would be added to allow licensees to
determine and record the activity of each incremental dosage
administered from a direct infusion system using either a calibrated
instrument that is part of the system or a combination of measurement
and mathematical calculations.
4. Paragraph (e) would establish specific criteria under which
incremental administrations may be performed using direct infusion
systems. These criteria include: (1) the administered radioisotope must
have a half-life of less than three minutes; (2) a written directive
must not be required (for diagnostic use, a written directive would not
be required because these administrations involve very short-lived
isotopes delivered in small quantities through automated systems,
making pre-administration measurement impractical and risk minimal);
(3) the radioisotope must be administered directly from the generator
or system without additional preparation steps; and (4) the
administration must follow the manufacturer's guidelines and
procedures. These provisions are designed to accommodate the unique
characteristics of isotopes such as Rb-82, which cannot be practically
measured before administration using traditional methods due to rapid
decay and automated delivery systems.
5. The existing dosage deviation limit in paragraph (d) would be
redesignated as paragraph (f) and retained without change, as would the
recordkeeping requirement in paragraph (e), which would become
paragraph (g). These proposed changes would accommodate the unique
characteristics of isotopes such as Rb-82, which cannot be practically
measured prior to administration using traditional methods, while
maintaining adequate assurance that patients receive the prescribed
dosage.
To address direct measurements allowed under the proposed addition
of Sec. 35.63(d), Sec. 35.60(d) would be added to require licensees
to test the infusion pump flow rate and radiation detectors used by
developing, implementing, and maintaining written test procedures.
These tests would continue to be required at least every 12 months to
ensure continued accuracy and reliability of the infusion systems and
associated detectors over time and following any repair that could
affect calibration in accordance with EGM 13-003 and the proposed new
Sec. 35.60(e). Conforming changes would be made in Sec. Sec. 35.60(f)
and 35.2060, ``Records of calibrations of instruments used to measure
the activity of unsealed byproduct material,'' to ensure licensees
retain a copy of procedures used to verify the infusion pump flow rate.
These criteria, with the exception of the proposed record keeping
requirements for testing procedures under Sec. 35.2060(b), are
currently implemented under EGM 13-003 and remain in effect today. The
new recordkeeping requirement would ensure traceability and regulatory
oversight by documenting not only test results but also the approved
methods used to obtain those results, while adding minimal burden. This
would close a gap in current rules, align with best practices for
quality assurance, and
[[Page 47056]]
provide inspectors confidence that testing was performed under
validated procedures rather than improvised practices.
D. Other Topics
1. Written Directives for Diagnostic Sodium Iodide I-131
The NRC is proposing to amend Sec. 35.40 to remove the requirement
that a written directive be prepared for diagnostic administrations of
sodium iodide I-131. Currently only diagnostic administrations of
sodium iodide I-131 in quantities greater than 1.11 megabecquerels (30
microcuries) require a written directive. This proposed change would
reclassify these diagnostic uses under the licensing framework of 10
CFR part 35, subpart D, which governs diagnostic uses of unsealed
byproduct material that do not require a written directive. To support
this change, Sec. Sec. 35.100 and 35.200 would be revised to remove
the introductory clause referencing Sec. 35.40(b) as a limiting
condition. The revision would ensure consistency with the updated
written directive requirements in Sec. 35.40.
This revision also would reflect the evolution of clinical practice
and radiation safety standards in diagnostic nuclear medicine. In the
past decade, only one reported medical event involved a diagnostic
administration of sodium iodide I-131 at a dosage level requiring a
written directive. This event occurred because the licensee failed to
complete the written directive before administration, even though the
patient received the correct prescribed dosage. In contrast, there have
been three medical events in the same period where patients scheduled
for diagnostic administration of sodium iodide I-123 received the wrong
radionuclide. Additionally, two older events (both more than 5 years
ago) involved patients prescribed doses below the threshold requiring a
written directive who instead received higher-than-intended doses of
sodium iodide I-131. These examples show that diagnostic
administrations of sodium iodide I-131 at dosage levels requiring a
written directive have a risk profile comparable to other diagnostic
administrations that do not require a written directive. By removing
the written directive requirement for these diagnostic administrations,
licensees would still be required to report any medical event that
occurs, maintaining appropriate safety oversight while eliminating the
unnecessary requirement.
2. Reductions in Event Reporting
The NRC is proposing to amend Sec. 35.3045(a) to exclude requiring
licensees to report events that result from emergent patient conditions
that prevent completion of administration as planned. In addition, the
NRC is proposing to add a definition of emergent patient conditions to
Sec. 35.2 to clarify that emergent patient conditions are unexpected
developments or acute changes in patients' condition, such as vascular
spasm or seizure, that occur during the administration which cause a
deviation from the planned administration. To ensure the NRC takes
appropriate actions to reduce occurrence of significant events, the NRC
is also proposing to amend Sec. 35.3045(b) to require reporting of an
event under this proposed exclusion if the event is expected to cause
unintended permanent functional damage to an organ or physiological
system, as determined by a physician. This clarification does not
introduce a new reporting category; rather, it aligns emergent patient
condition events with existing requirements for events caused by
actions of patients, known as patient intervention. This proposed
change would be expected to reduce reporting burden by approximately
nine events per year while ensuring the NRC is still notified of
significant events that could cause unintended significant harm to
patients. The proposed changes are intended to reduce unnecessary
reporting burden; improve clarity; better align the rule with a risk-
informed, performance-based regulatory framework; and continue to
ensure significant events that result in unintended permanent
functional damage are reported.
In addition, the NRC is proposing to amend Sec. 35.40(a)(2) to
allow AUs to revise the written directive during administration for all
brachytherapy procedures, except for high dose-rate (HDR) remote
afterloader treatments, provided the changes are documented and signed
by the AU within 24 hours of the procedure. This change would provide
clarity that licensees may use the post-administration portion of the
written directive when determining whether a medical event occurred and
allows AUs to approve real-time adjustments based on the medical needs
of the patient, consistent with their medical judgment. This includes
adjusting the written directive if stasis occurs during administration,
consistent with the current Y-90 microsphere licensing guidance.
However, to ensure leaks or defects in administration device or
supplies are reported, the NRC is proposing to add Sec. 35.3045(a)(3)
to require reporting if the total dose or dosage delivered differs from
the prescribed dose or dosage defined on the written directive before
administration by 20 percent, as caused by a leak or defect in
administration device or supplies, unless the event resulted from
patient intervention or an emergent patient condition. This would
ensure the NRC can take appropriate action to prevent reoccurrence of
similar events.
Section 35.3047 requires licensees to report any dose to an embryo/
fetus that is greater than 50 mSv (5 rem) dose equivalent that is a
result of an administration of byproduct material or radiation from
byproduct material to a pregnant individual unless the dose to the
embryo/fetus was specifically approved, in advance, by the AU. Over the
years, this has resulted in licensees reporting events where they made
reasonable effort to determine pregnancy status but due to early
gestational age or other medical conditions of the patient, they were
unable to determine the patient's pregnancy status at the time of
administration. Because this is a medical issue and there is no action
for the NRC to take in these events, the NRC is proposing to amend the
regulation to add Sec. 35.3047(a)(2) to exclude requiring licensees to
report these events when they made a reasonable effort to determine
pregnancy status, but pregnancy could not be reasonably excluded prior
to the administration by the licensee.
The NRC has determined that the proposed revisions to Sec. 35.3045
would maintain adequate protection of public health and safety while
improving the utility, clarity, and clinical relevance of medical event
reporting. By focusing reporting requirements on events that may
indicate a breakdown in safety controls, such as those caused by
equipment defects or procedural errors, the rule continues to support
the NRC's oversight mission while reducing unnecessary administrative
burden on licensees.
3. Expanding Use of Decay-in-Storage
The NRC is proposing to amend Sec. 35.92 to increase the allowable
physical half-life for byproduct material eligible for decay-in-storage
from 120 days to 275 days. This change would allow licensees to use
decay-in-storage for longer-lived materials, such as Lu-177m, which is
becoming more prevalent in medical facilities as new lutetium-177 (Lu-
177) radiopharmaceuticals receive FDA approval. In addition, this
amendment
[[Page 47057]]
would enable licensees to retain Co-57 flood sources for decay-in-
storage as operational experience has demonstrated licensees can store
these sources safely.
This proposed amendment would reduce unnecessary disposal costs and
regulatory burden for medical licensees while maintaining public health
and safety. Under the current rule, licensees must dispose of Lu-177
waste as low-level radioactive waste if it contains Lu-177m, even if
the licensee has the space and shielding to safely store the material
until it decays to background levels. As medical licensees already
maintain secure, shielded storage areas for decay-in-storage, this
proposed change would not require new infrastructure or introduce new
risks. The proposed change supports the NRC's risk-informed,
performance-based regulatory approach by focusing regulatory
requirements on materials that pose a greater hazard, while allowing
flexibility for low-risk materials.
4. Reduction in License Amendments for Human Subject Research
Under Sec. 35.6(c), licensees currently must seek a license
amendment for certain proposed research involving humans even if they
are licensed for the type of medical use involved and the research is
approved by an institutional review board (IRB). This duplicative
requirement has led to delays in research and increased administrative
workload for both licensees and the NRC. Therefore, the NRC is
proposing to amend Sec. 35.6 to eliminate the requirement for
licensees to submit a license amendment before conducting research
involving human subjects, provided the licensee is already authorized
for the medical use of byproduct material and has obtained IRB approval
and informed consent from the research subject. Conforming changes also
would be made to Sec. 35.8 as the proposed change would reduce the
need for a licensing amendment request. By removing the requirement for
an unnecessary license amendment application, the NRC would facilitate
timely and efficient research without compromising safety or ethical
standards.
5. Reduce Duplication Requirements for Mobile Medical Services
The NRC is proposing to amend regulations specific to mobile
medical services contained in Sec. 35.80 to eliminate prescriptive
requirements that are redundant to regulations contained in 10 CFR part
20 and other sections of 10 CFR part 35. These changes would ensure
regulations for mobile medical licensees are aligned with survey
requirements in 10 CFR part 20, and consistent with requirements for
transfer of byproduct material for other 10 CFR part 30 licensees. In
addition, these proposed changes would reduce unnecessary limitations
on licensees and align with the NRC's risk-informed, performance-based
regulatory framework.
Specifically, the proposed amendments would remove the following
provisions:
a. Section 35.80(a)(2), which requires licensees to check
instruments used to measure the activity of byproduct material before
use at a client's address. This requirement is overly prescriptive and
redundant with Sec. 35.60, which requires that all licensees possess
and calibrate instruments used to measure activity of unsealed
byproduct material and microsources before administration in accordance
with specific requirements. Because Sec. 35.60 provides reasonable
assurance that patients receive prescribed dosages for both mobile and
non-mobile medical licensees, Sec. 35.80(a)(2) is unnecessary.
b. Section 35.80(a)(3), which requires licensees to check survey
instruments for proper operation with a dedicated check source before
use at each client's address. This is a standard health physics
practice and is already encompassed by the broader requirement in Sec.
20.1501(c) to perform adequate radiation surveys that are necessary to
ensure compliance with radiation safety regulations contained in 10 CFR
part 20 and are reasonable under the circumstances to evaluate the
magnitude and extent of radiation levels, concentrations or quantities
of residual radioactivity, and the potential radiological hazards of
the radiation levels and residual radioactivity detected. The removal
of this provision would eliminate unnecessary regulatory specificity
and clarify that there are not different requirements for mobile
medical licensees versus non-mobile medical licensees who can also
transport survey instruments to different sites.
c. Section 35.80(a)(4), which requires licensees to survey all
areas of use to ensure compliance with 10 CFR part 20 before leaving
the client's address. Removing this provision would align regulations
for mobile medical licensees with regulations for other 10 CFR part 30
licensees who have temporary job sites and would avoid duplicative
regulation with Sec. 20.1501 while ensuring radiation safety.
d. Section 35.80(b), which prohibits the delivery of byproduct
material to a client unless the client is licensed to receive it.
Section 20.1802 requires licensees to control and maintain constant
surveillance of licensed material that is in a controlled or
unrestricted area and that is not in storage, which would already
preclude a mobile medical licensee from delivery of byproduct material
to a client unless they would be able to safely secure it or the client
has a license. Therefore, retaining this provision in Sec. 35.80 is
unnecessary.
Conforming changes are being proposed to remove associated survey
records as currently required in Sec. 35.2080(b). The proposed
amendments would not introduce new risks or reduce the level of
protection for workers, patients, or the public. Rather, they would
remove outdated or duplicative requirements and provide licensees with
greater flexibility in how they meet existing performance-based
requirements, consistent with their capabilities.
6. Expand Temporary Radiation Safety Officer and Changes to Radiation
Safety Committee
Section 35.24 outlines the authority and responsibilities for
licensees' radiation protection programs, including requirements for
RSOs and RSCs. The NRC is proposing to revise Sec. 35.24 to increase
the allowable service period for temporary RSOs and to revise the
required composition and applicability of RSCs to better reflect
current clinical practices. This change would reduce regulatory burden
on medical use licensees while maintaining appropriate oversight of
radiation safety programs.
First, the NRC proposes to amend Sec. 35.24(c) to extend the
allowable duration for a qualified individual to serve as a temporary
RSO from 60 days to 120 days per calendar year. Under the current rule,
licensees may allow a qualified individual to act as a temporary RSO
for up to 60 days without submitting a license amendment. However, the
NRC has found that this timeframe is often insufficient for licensees
to recruit, hire, and onboard a permanent RSO, particularly in
specialized or rural medical settings. Extending the temporary RSO
period to 120 days would provide licensees with greater flexibility
during staffing transitions or extended absences, reduce the need for
license amendments, and support continuity of oversight and safety by
avoiding the need to designate multiple RSOs during a transition
period.
Second, the NRC proposes to revise Sec. 35.24(f) to clarify that
an RSC is only required if a licensee is authorized for
[[Page 47058]]
two or more different types of uses or units that require written
directives. This change would provide clarity that diagnostic uses,
which are generally lower risk and do not require written directives,
do not trigger the requirement to establish an RSC. In addition, this
section would be amended as a conforming change to add subpart I and to
clarify that EMTs that require a written directive must be included
when a licensee is determining if an RSC is needed. This revision
aligns with the NRC's risk-informed approach by focusing regulatory
oversight on higher-risk therapeutic uses.
Finally, the NRC proposes to revise the required composition of the
RSC by removing the requirement to include a representative of the
nursing service. The current rule specifies that the RSC must include
an AU for each type of use, the RSO, a representative of management,
and a representative of the nursing service. However, in modern medical
practice, patients receiving therapeutic byproduct material are often
treated on an outpatient basis and are not under the care of nursing
staff. As a result, the nursing representative is frequently not
involved in the radiation safety aspects of treatment. Removing this
requirement would reduce administrative burden on licensees while
preserving the core safety oversight functions of the RSC. Licensees
may still choose to include a nursing representative or any other
clinical staff member on the RSC at their discretion.
These proposed changes are consistent with the NRC's ongoing
efforts to modernize its medical use regulations, reduce unnecessary
regulatory burden, and align requirements with current clinical
practice. The NRC has determined that these proposed amendments would
not introduce new risks and would maintain adequate protection of
public health and safety for workers, patients, and the public, while
providing greater flexibility and clarity.
7. Removal of Redundant Regulations and Addition of Implementation
Clauses
As part of the larger response to E.O. 14300, the NRC reviewed 10
CFR part 35 in its entirety to remove redundant regulations. As a
result of this review, the NRC is proposing to remove Sec. 35.5
because maintenance of records is already required by Sec. 30.51,
which applies to 10 CFR part 35 licensees.
In addition, the NRC reviewed 10 CFR part 35 to remove outdated
regulations related to implementation of previous rulemakings. On
October 1, 2007, the NRC published a final rule to amend 10 CFR part 35
to implement provisions of the Energy Policy Act of 2005 requiring that
the NRC license the medical use of accelerator-produced radioactive
material or discrete sources of radium-226 (72 FR 55864). In Sec. Sec.
35.10(a) and 35.11(c)(1) and (2), the NRC regulations provide waivers
for certain entities using this material from requiring a specific
license until the entity submitted a medical use license application.
As these waivers had end dates of no later than August 8, 2009, for
Sec. 35.10(a); December 1, 2008, for Sec. 35.11(c)(1); and August 7,
2009, for Sec. 35.11(c)(2), these paragraphs are outdated and would be
removed. In addition, the clause ``on or after October 24, 2002,''
regarding calibration measurements of brachytherapy sources in Sec.
35.432, is outdated and also would be removed.
V. Specific Requests for Comments
The NRC is seeking advice and recommendations from the public on
this proposed rule. The NRC is particularly interested in comments and
supporting rationale from the public on the following:
1. The NRC is proposing to revise the definition of ``teletherapy''
in Sec. 35.2 to clarify that it refers to external beams of ionizing
radiation are delivered from an external source without stereotactic
guidance. However, the NRC is also considering removing the specific
reference to stereotactic guidance or adding additional clarifying
language to further expand the definition. As such, the NRC is seeking
comments on examples of teletherapy uses and whether the NRC would need
to further revise the definition of teletherapy to ensure these
teletherapy uses are included. Please provide the basis for your
response.
2. As part of this rulemaking package, the NRC has developed
guidance to clarify that the physical presence of an AU for the medical
use of byproduct is not required under Sec. 35.11(b)(1). 10 CFR
35.11(b)(1) permits licensees to allow individuals who are not AUs to
perform certain tasks under the supervision of an AU who is named on
the license or permit. As indicated, the NRC has developed guidance to
clarify that there is no requirement regarding the location of the AU
during the use. The current compatibility category of Sec. 35.11(b) is
category C, allowing Agreement States to be more restrictive and
potentially require the physical presence of an AU. The NRC has
received concerns from industry stakeholders that Sec. 35.11(b) raises
transboundary concerns as medical networks have grown and many cross
state lines, such that the regulation should be compatibility category
B. In addition, the industry stakeholders have expressed concerns that
requiring an AU to be physically present or within a specified location
of the medical use limits access to treatments in rural areas. As such,
the NRC is considering changing this regulation to be compatibility
category B. The NRC is requesting specific comments on the appropriate
compatibility category for Sec. 35.11(b).
3. The NRC is proposing to establish specific criteria in Sec.
35.63 to allow incremental administrations to be performed using direct
infusion systems, including a criterion that calls for the administered
radioisotope to have a half-life of less than three minutes. These
provisions are designed to accommodate the unique characteristics of
isotopes such as Rb-82, which cannot be practically measured using
traditional methods due to their rapid decay and automated delivery
systems. The NRC is seeking feedback on whether the proposed three-
minute timeframe is appropriate or if a higher threshold would be
beneficial for a current or expected future medical use and if so, what
length half-life would be appropriate (for example, 5 minutes or 10
minutes). Please provide the basis for your response.
4. The NRC is proposing to change Sec. 35.92(a) to allow licensees
to hold byproduct material with a physical half-life of less than or
equal to 275 days, instead of 120 days, to allow licensees to hold Lu-
177m and Co-57 flood sources for decay-in-storage. The NRC is seeking
feedback on whether an even longer half-life limit would be beneficial
for medical use in this context. Specifically, the NRC is considering
increasing the physical half-life beyond 275 days if there is a
radioisotope used in medicine that could benefit from such an increase
without causing a significant increase in risk. Please comment on
whether increasing the half-life limit beyond 275 days would provide a
meaningful benefit to medical licensees. If you believe a longer limit
would be appropriate, indicate what specific half-life (for example,
300 days or 365 days) you recommend and explain the medical use which
would benefit from your recommendation. In addition, describe any
safety or operational considerations the NRC should evaluate if the
limit is extended further.
5. The NRC is proposing to change the definition of ``physician''
in Sec. 35.2 to expand eligibility for individuals to become AUs. This
change is intended to
[[Page 47059]]
allow those who meet training and experience requirements and are fully
licensed to practice medicine in the United States, but whose primary
medical qualification is not titled MD or DO, such as foreign-trained
physicians, to be eligible to become AUs. The NRC is considering
whether the clause specific to prescribing drugs should be removed or
additional qualifying language should be added to this definition in
the final rule. In particular, the NRC is seeking feedback on whether
removing additional language or adding additional qualifying language,
such as ``fully licensed to practice medicine independently,'' is
needed in this definition to ensure individuals defined as physicians
have adequate training and experience to perform tasks allowed under 10
CFR part 35. Please provide the basis for your response.
6. The NRC is proposing to remove the requirement for a written
directive for a diagnostic administration of sodium iodide I-131 in
quantities greater than 1.11 megabecquerels (30 microcuries). The
requirement was historically established to reduce the potential for
unintended thyroid irradiation associated with irreversible thyroid
uptake and to help prevent wrong-patient or wrong-procedure
administrations. The NRC is seeking feedback on whether eliminating
this written directive requirement could raise any safety concerns or
otherwise affect patient protection beyond risks associated with
diagnostic administrations. In particular, the NRC seeks input on
whether current clinical practices of patient identification, procedure
verification, and pregnancy screening provide sufficient assurance that
diagnostic administration of sodium iodide I-131 are performed safely
without the need for a written directive. The NRC is also seeking
feedback on whether the removal of this requirement would reduce
unnecessary administrative burden on licensees while maintaining
adequate protection of patients. Please provide the technical or
operational basis for your response, including any relevant experience,
data, examples from clinical practices, or information on current
institutional practices used to verify patient identity and the
intended procedure.
7. The NRC is proposing to remove prescriptive requirements for
specific numbers of classroom and laboratory training hours and work
experience hours for physicians who have completed residency training
in specialties where radiation safety and the clinical use of byproduct
material are inherently integrated into the curriculum. This proposed
rule identifies diagnostic radiology, nuclear medicine, and radiation
oncology as specialties that would not need to complete these
prescriptive training hours for training related to uptake, dilution,
excretion, imaging, and localization studies. The NRC is seeking
feedback on whether these residency programs do and would continue to
include sufficient training in these areas, without the prescriptive
hour requirements, as the NRC considers whether to remove or maintain
the current requirements.
8. In addition, the NRC is proposing to keep the current training
hours requirements for physicians who completed fellowship but is
considering removing these training hours requirements provided the
fellowship curriculum sufficiently integrates radiation safety and the
clinical use of byproduct material to ensure the physician can
independently fulfill radiation safety-related duties as an AU for
medical use. Thus, the NRC is seeking feedback on whether any
fellowship curriculum sufficiently integrates radiation safety and the
clinical use of byproduct material to ensure the physician can
independently fulfill radiation safety-related duties as an AU for
medical use, and on any potential considerations of including
fellowship training in addition to residency training for meeting the
training and experience requirements in subparts D through H of 10 CFR
part 35. Please provide the basis for your response.
VI. Regulatory Flexibility Analysis
The Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), requires
that agencies consider the impact of their rulemakings on small
entities and, consistent with applicable statutes, consider
alternatives to minimize these impacts on the businesses,
organizations, and government jurisdictions to which they apply. An
agency must prepare an Initial Regulatory Flexibility Analysis unless
it determines and certifies that a rule, if promulgated, would not have
a significant economic impact on a substantial number of small
entities. Because the NRC has not made such a certification for this
proposed rule, the NRC has prepared this analysis in accordance with 5
U.S.C. 603.
The NRC has established standards for determining which of its
licensees qualify as small entities pursuant to 10 CFR 2.810, ``NRC
size standards.'' These standards include an $8 million receipts-based
threshold and related employee-based criteria. Approximately 30 percent
of 4,250 NRC and Agreement State licensees (or about 1,275 licensees)
qualify as small entities. This percentage is derived from the small-
entity distribution used in the NRC's annual fee rule (91 FR 36470;
June 16, 2026) and is applied here as a general indicator of the
proportion of licensees that may qualify as small entities.
The Small Business Regulatory Enforcement Fairness Act requires
that the NRC prepare a written compliance guide to assist small
entities in complying with each rule for which a regulatory flexibility
analysis is prepared. The proposed rule includes both deregulatory
provisions and several new or revised recordkeeping requirements. These
include updates associated with continuing education, documentation for
emerging medical technologies, Rb-82 generator activities, expanded
decay in storage provisions, and revised Radiation Safety Committee
applicability. As discussed in Sections VII, ``Regulatory Analysis,''
these requirements apply to different subsets of licensees, and
together represent a small portion of the overall amendments.
As shown in table 25, licensees would incur approximately $3.8
million in total costs over the five-year analysis period when
discounted at 7 percent, consisting of about $1.8 million in
implementation costs and about $2.0 million in recordkeeping costs.
Applying the NRC's 30-percent small-entity proportion, small entities
would experience approximately $1.1 million of this total, or about
$0.5 million in implementation costs and $0.6 million in recordkeeping
costs, discounted at 7 percent. Based on 1,275 small entities, this
equates to roughly $430 to $470 per small entity over five years, or
about $90 per year. These impacts are minimal.
Likewise, the estimated annual small-entity burden, discounted at 7
percent, would be $0.2 million, consisting of about $0.1 million in
implementation burden and about $0.1 million in recordkeeping burden.
Because the individual recordkeeping provisions apply to different
subsets of licensees, the number of affected small entities varies by
requirement.
The NRC is seeking public comment on the potential impact of this
proposed rule on small entities. The NRC particularly desires comment
from licensees who qualify as small businesses, specifically as to how
the proposed regulation will affect them and how the regulation may be
tiered or otherwise modified to impose less stringent requirements on
small entities while still adequately protecting the public health and
safety and common defense and security. Comments on how
[[Page 47060]]
the regulation could be modified to take into account the differing
needs of small entities should specifically discuss:
(a) The size of the business and how the proposed regulation would
result in a significant economic burden upon it as compared to a larger
organization in the same business community;
(b) How the proposed regulation could be further modified to take
into account the business's differing needs or capabilities;
(c) The benefits that would accrue, or the detriments that would be
avoided, if the proposed regulation was modified as suggested by the
commenter;
(d) How the proposed regulation, as modified, would more closely
equalize the impact of NRC regulations as opposed to providing special
advantages to any individuals or groups; and
(e) How the proposed regulation, as modified, would still
adequately protect the public health and safety and common defense and
security.
Comments should be submitted as indicated under the ADDRESSES
caption.
VII. Regulatory Analysis
This regulatory analysis is prepared in accordance with E.O. 12866,
``Regulatory Planning and Review,'' and E.O. 14215, ``Ensuring
Accountability for All Agencies.'' E.O. 14215 requires independent
agencies, such as the NRC, to comply with E.O. 12866 and submit
significant actions for Office of Information and Regulatory Affairs
(OIRA) review. The analysis assesses the costs and savings of the
alternatives considered by the NRC and concludes that the proposed
deregulation 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 baseline. The
regulatory analysis is detailed in the following paragraphs of this
document. Comments on the analysis may be submitted to the NRC as
indicated under the ADDRESSES caption of this document.
A. Need for the Rule
The NRC was created by Congress in 1974 to ensure the safe use of
radioactive materials for beneficial civilian purposes while protecting
people and the environment. The NRC protects public health and safety
and advances the Nation's common defense and security by enabling the
safe and secure use and deployment of civilian nuclear energy
technologies and radioactive materials through efficient and reliable
licensing, oversight, and regulation for the benefit of society and the
environment. From an economic perspective, common defense and national
security are public goods for which the markets cannot maximize net
benefits, and markets alone can sometimes create unintended impacts to
public health and safety. Consistent with its statutory authority, the
NRC provides reasonable assurance of adequate protection of public
health and safety.
Section 5 of E.O. 14300 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 is
part of the NRC's response to the direction in section 5 of the E.O.
because, in conducting the wholesale review of its regulations, the NRC
reexamined the regulations pertaining to the use of certain nuclear
material without a license and determined--based on past experience and
practice--such uses can be expanded. Rulemaking is the most effective
way to achieve this. Licensees may amend their current license for
additional radionuclides; however, such amendments impose a cost on
licensees and regulators without a proportionate benefit to public
health and safety. Expanding the use of certain nuclear material
without the need for a license also cannot be accomplished through
guidance, as such guidance would conflict with the existing regulatory
text. Therefore, amending the NRC's regulations is the most effective
way to make this deregulatory change for all intended exempt uses.
B. Analytical Framework
This analysis uses current regulations under 10 CFR part 35 as the
no-action baseline (Alternative 1), evaluates the changes proposed in
this rule as the regulatory alternative (Alternative 2), and estimates
the costs and savings of this proposed rule's implementation.
Alternative 2 would revise 10 CFR part 35 to reduce barriers to medical
use licensing and address E.O. 14300, section 5, by improving
efficiency, predictability, and flexibility, while easing
administrative burdens for the NRC, Agreement States, licensees, and
applicants. The proposed changes include administrative updates,
clarifications, and streamlined requirements that reduce redundancies
and support the licensing of innovative technologies, all while
maintaining the NRC's commitment to public health and safety.
To estimate the regulatory impact of the proposed changes, the NRC
used input from agency subject matter experts, data from three related
agency information collection requests approved by the Office of
Management and Budget (OMB),\1\ through OIRA, and other supporting
documents as listed under Section XIX., ``Availability of Documents,''
of this document. Specifically, tables 2, 3, 4, and 7 and tables 9
through 23 rely on current OMB-approved information collection requests
included in the paperwork reduction package supporting this proposed
rule. Tables 5, 6, and 8 rely on prior NRC regulatory basis analysis
listed in the ``Availability of Documents'' section of this document.
In all cases, the quantitative and qualitative input used in the
analysis were informed by the agency subject matter experts. Where
possible, the NRC provides quantitative estimates based on available
data. Where data are not available, the NRC relies on judgment from
agency subject matter experts to approximate the impact and the level
of effort involved. The analysis then monetizes the estimated time
impacts for NRC staff, Agreement State staff, and licensees involved in
medical use licensing activities. Monetized impacts are calculated by
multiplying the estimated labor hours spent by (1) licensees to comply
with regulatory requirements and (2) NRC and Agreement State staff to
review submissions by the applicable wage rates. Because the monetized
impacts are directly proportional to both labor time and wage rates,
any change in these inputs would result in a corresponding change in
the estimated values. For the NRC staff, the NRC uses its own internal
labor rate of $158 per hour.\2\ As shown in table 1, wage rates for
licensees and Agreement State staff are derived from U.S. Bureau of
Labor Statistics (BLS) \3\ and adjusted using NRC's standard 2.4
multiplier to account for fringe benefits and overhead costs.
---------------------------------------------------------------------------
\1\ OMB Control Numbers 3150-0010, 3150-0120, and 3150-0178.
\2\ This NRC labor rate differs from those developed under the
agency's license fee recovery program (10 CFR part 170, ``Fees for
Facilities, Materials, Import and Export Licenses, and Other
Regulatory Services under the Atomic Energy Act of 1954, as
Amended''). NRC labor rates for fee recovery purposes are
appropriately designed for full-cost recovery of the services
rendered and thus include nonincremental costs (e.g., overhead,
administrative, and logistical support costs). https://www.nrc.gov/about-nrc/regulatory/rulemaking/regulatory-analysis.
\3\ U.S. Bureau of Labor Statistics, Occupational Employment and
Wage Statistics, National Industry-Specific Occupational Employment
and Wage Statistics, May 2024.
[[Page 47061]]
Table 1--Wage Rates Used in the Analysis
[2024 U.S. dollars]
----------------------------------------------------------------------------------------------------------------
Fully loaded
hourly mean
Standard occupational Position title Hourly mean NRC wage (mean
classification wage multiplier wage rate *
2.4)
----------------------------------------------------------------------------------------------------------------
Licensees: Wage rates for training and experience requirements
----------------------------------------------------------------------------------------------------------------
29-0000............................ Healthcare Practitioners $52.85 2.4 $126.84
and Technical Occupations.
29-1210............................ Physicians................. 133.01 2.4 319.22
29-1224............................ Radiologists............... 176.61 2.4 423.86
-----------------------------------------------
Blended mean wage.............. ........................... .............. .............. 289.98
----------------------------------------------------------------------------------------------------------------
Licensees: Wage rates for EMT, Rb-82 generators, and other related topics requirements
----------------------------------------------------------------------------------------------------------------
19-2099............................ Physical Scientists, All 47.40 2.4 113.76
Other.
19-2012............................ Physicists................. 107.97 2.4 259.13
19-5011............................ Occupational Health and 42.64 2.4 102.34
Safety Specialists.
19-5012............................ Occupational Health and 28.71 2.4 68.90
Safety Technicians.
29-0000............................ Healthcare Practitioners 52.85 2.4 126.84
and Technical Occupations.
29-1210............................ Physicians................. 133.01 2.4 319.22
29-1224............................ Radiologists............... 176.61 2.4 423.86
43-0000............................ Office and Administrative 22.77 2.4 54.65
Support Occupations.
43-1011............................ First-Line Supervisors of 32.02 2.4 76.85
Office and Administrative
Support Workers.
-----------------------------------------------
Blended mean wage.............. ........................... .............. .............. 171.73
29-1140............................ Registered Nurses.......... 47.21 2.4 113.30
----------------------------------------------------------------------------------------------------------------
Licensees: Wage rates for written directives for diagnostic sodium iodide I-131 requirements
----------------------------------------------------------------------------------------------------------------
29-2033............................ Nuclear Medicine 47.98 2.4 115.15
Technologists.
29-1224............................ Radiologists............... 176.61 2.4 423.86
-----------------------------------------------
Blended mean wage.............. ........................... .............. .............. 269.51
----------------------------------------------------------------------------------------------------------------
Licensees: Wage rates for event reporting requirements
----------------------------------------------------------------------------------------------------------------
19-2012............................ Physicists................. 107.97 2.4 259.13
29-0000............................ Healthcare Practitioners 52.85 2.4 126.84
and Technical Occupations.
29-1210............................ Physicians................. 133.01 2.4 319.22
29-1224............................ Radiologists............... 176.61 2.4 423.86
-----------------------------------------------
Blended mean wage.............. ........................... .............. .............. 282.26
----------------------------------------------------------------------------------------------------------------
Licensees: Wage rates for use of decay in storage
----------------------------------------------------------------------------------------------------------------
29-0000............................ Healthcare Practitioners 52.85 2.4 126.84
and Technical Occupations.
----------------------------------------------------------------------------------------------------------------
For all licensees: Average wage rate
----------------------------------------------------------------------------------------------------------------
Blended mean wage.............. ........................... .............. .............. 228.06
----------------------------------------------------------------------------------------------------------------
Agreement State: Wage rates
----------------------------------------------------------------------------------------------------------------
11-3031............................ Financial Managers......... 64.45 2.4 154.68
17-2081............................ Environmental Engineers.... 48.66 2.4 116.78
19-5010............................ Occupational Health and 37.24 2.4 89.38
Safety Specialists and
Technicians.
23-1011............................ Lawyers.................... 57.44 2.4 137.86
-----------------------------------------------
Blended mean wage.............. ........................... .............. .............. 124.67
----------------------------------------------------------------------------------------------------------------
All costs and cost savings are expressed in 2024 dollars. The
analysis covers a 5-year period, which provides a reasonable basis for
projecting licensee activities. In accordance with OMB Circular A-4,
the staff used NPV calculations to estimate the value of future cost
savings in constant 2024 dollars, the most recent year for which
complete annual data are available. NPV analysis allows for the
comparison of costs and benefits that occur at different points in time
by discounting them to a common base year. Consistent with OMB
guidance, the analysis applies real discount rates of 3 percent and 7
percent. The 3-percent rate reflects the social rate of time preference
and approximates the real return on long-term government debt. The 7-
percent rate reflects the opportunity cost of capital and approximates
the average pretax real rate of return on private-sector investments.
The sign convention
[[Page 47062]]
used in this analysis is that savings associated with Alternative 2 are
positive, while costs are negative. Negative values are shown in
parentheses (e.g., negative $500 is displayed as ($500)).
The resulting estimates and underlying calculations are presented
in the subsequent sections.
C. Estimated Costs and Savings of This Proposed Rule
The estimated undiscounted costs and savings for major provisions
are outlined in this section. These include updates to training and
experience requirements, incorporation of certain well-established
EMTs, revisions to requirements for the use of Rb-82 generators to
codify existing enforcement guidance and provide regulatory clarity,
changes to other requirements in different areas of medical use, and
costs associated with implementing the rule.
1. Training and Experience
As discussed in Sections III.A and IV.A, ``Training and
Experience,'' the proposed changes would modernize and streamline the
training and experience requirements for physician AUs. Most physician
AUs undergo comprehensive residency programs that include radiation
safety as part of the nature of the program that equips them with the
necessary knowledge to ensure they can independently fulfill the
radiation safety-related duties as an AU for medical use. By removing
outdated and prescriptive topics from the regulations, the NRC seeks to
reduce unnecessary administrative burdens for applicants while ensuring
AUs are adequately prepared for their roles. Past experience has shown
that many applicants submit incomplete or inadequate information, which
results in additional time needed by the NRC, Agreement States, and
applicants to resolve these issues. Because this proposed rule would
reduce the complexity of training and experience criteria, it is
expected that it would shorten licensing processing times and reduce
the need to track incomplete information, some of which would no longer
be required. Retaining preceptor statements for non-board-certified
individuals and providing alternative pathways would ensure each
physician has a pathway to become an AU while ensuring they have the
knowledge to independently fulfill radiation safety duties. Finally,
changing the definition of physician to include a path for foreign
trained medical doctors would remove anti-competitive barriers.
These proposed changes to the training and experience requirements
in 10 CFR part 35 would reduce ongoing NRC and Agreement State
licensing resources in reviewing and approving requests from applicants
and reduce licensee burden in developing license applications to add
authorized individuals. Overall, these changes are designed to enhance
licensing efficiency and reduce unnecessary burdens, while ensuring
that AUs have sufficient training to ensure radiation safety in the
medical use of byproduct material.
In addition, by removing the license amendment requirement for
certain diagnostic uses of unsealed byproduct material, the NRC aims to
reduce unnecessary regulatory burden on licensees while maintaining
appropriate oversight. The approval of AUs for these uses would be
evaluated as part of the NRC's routine inspection program, ensuring AUs
have the necessary training and experience to support radiation safety
without requiring pre-approval through the licensing process. As shown
in table 2, these proposed changes are expected to reduce paperwork and
administrative costs, yielding a reduction of 4,208 hours (or $1.2
million, undiscounted) for the licensees per year.
Table 2--Averted Costs From Pre-Approval Through the Licensing Process
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
number of
Type amended and Responses per Burden hours Total burden Fully loaded Annual cost
renewed licensee per response hours reduced wage rate savings
applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amendments: Authorized user approval for non-therapeutic uses of unsealed byproduct material
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................ 70 1 4.50 315 $289.98 $91,342
Agreement State licensees............................ 525 1 4.50 2,363 289.98 685,068
--------------------------------------------------------------------------------------------------------------------------------------------------------
Renewal: Authorized user approval for non-therapeutic uses of unsealed byproduct material
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................ 40 1 4.50 180 289.98 52,196
Agreement State licensees............................ 300 1 4.50 1,350 289.98 391,468
--------------------------------------------------------------------------------------------------
Total............................................ ................. .............. .............. 4,208 .............. 1,220,074
--------------------------------------------------------------------------------------------------------------------------------------------------------
This proposed rule also would reduce unnecessary burden by
eliminating outdated and overly broad training and experience
requirements for physicians. Instead of mandating individuals provide
documentation at time of licensing that they had training or experience
within 7 years in uses and administrations that may no longer be
relevant or practiced, sometimes in types of use they never will see in
practice, the NRC is proposing to streamline requirements to focus
solely on the procedures that licensees actively perform, ensuring more
efficient and targeted preparation. These proposed changes are expected
to reduce paperwork and associated administrative costs related to
training and experience requirements. Under the current requirements,
licensees must report the information listed in NRC forms 313 and 313a,
by either using these forms or their own format, to document training
and experience details. The proposed amendments would streamline
reportable data by reducing the number of data fields and clarifying
what information must be reported, which is expected to lessen burden.
These proposed changes would reduce reporting time by an estimated 1.25
hours per submission. Of this reduction, 0.25 hours comes from less
time spent reporting on the recentness of training. The remaining
savings result from other burden reductions related to training and
experience requirements, excluding the diagnostic AU category
[[Page 47063]]
previously shown in table 2. Overall, these proposed changes would
yield a saving of 8,177 hours (or $2.4 million, undiscounted) for the
licensees per year, as shown in table 3.
Table 3--Averted Costs From Outdated and Broad Training Requirements
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Reduction in
Type licensee Responses per burden hours Total burden Fully loaded wage Annual cost
respondents licensee per response hours reduced rate savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
New license applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees..................................... 32 1 1.25 40 $289.98 $11,599
Agreement State licensees......................... 240 1 1.25 300 289.98 86,993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amendments
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees..................................... 640 1 1.25 800 289.98 231,981
Agreement State licensees......................... 4,800 1 1.25 6,000 289.98 1,739,856
--------------------------------------------------------------------------------------------------------------------------------------------------------
Renewals
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees..................................... 122 1 1.00 122 289.98 35,377
Agreement State licensees......................... 915 1 1.00 915 289.98 265,328
-----------------------------------------------------------------------------------------------------
Total......................................... .............. .............. .............. 8,177 ................. 2,371,134
--------------------------------------------------------------------------------------------------------------------------------------------------------
Currently, Sec. 35.59 requires individuals to demonstrate related
continuing education and experience if their required training and
experience was obtained more than 7 years prior to the date of
application. This proposed rule would replace this prescriptive
licensing requirement that may not align with uses the physician plans
to perform with a performance-based continuing education requirement
that ensures authorized individuals maintain the necessary education
and experience to support radiation safety and regulatory compliance
for the uses they are authorized to perform. Although licensees would
incur an increase in recordkeeping cost, it is necessary to ensure
physicians have necessary education and experience to support radiation
safety and regulatory compliance for the uses they are authorized to
perform to ensure safety while decreasing costs overall. As shown in
table 4, the recordkeeping burden would increase by 1,063 hours (or
$308,100, undiscounted) per year for licensees.
Table 4--Additional Costs From Recordkeeping Requirements
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase in
Type number of Records per Burden hours Total burden Fully loaded Annual cost
recordkeepers licensee per record hours increase wage rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees......................................... 500 5 0.05 125.0 $289.98 ($36,247)
Agreement State licensees............................. 3,750 5 0.05 937.5 289.98 (271,853)
-------------------------------------------------------------------------------------------------
Total............................................. ............... .............. .............. 1,062.5 .............. (308,100)
--------------------------------------------------------------------------------------------------------------------------------------------------------
The NRC recognizes that, to realize these ongoing savings,
licensees and training providers may need to update continuing
education programs and revise recordkeeping practices to reflect the
new requirements. The NRC has included an estimate for these activities
within the overall implementation costs presented in table 24.
2. Emerging Medical Technologies
As discussed in Sections III.B. and IV.B, ``Emerging Medical
Technologies,'' this proposed rule would codify provisions for 13 EMTs,
by establishing clear licensing pathways, defined training and
experience requirements, and performance-based safety criteria.
Codifying these provisions would reduce reliance on EMT-specific
guidance and eliminate the recurring burden associated with application
reviews and guidance updates. Based on data presented in the regulatory
basis, the NRC estimated measurable burden reductions would occur for
well-established EMTs across the NRC, Agreement States, and licensees.
Due to the timeline established in E.O. 14300 for publishing this
proposed rule, the scope of EMTs addressed in this proposed rule has
been narrowed to focus on those with the most extensive history and
highest levels of use. In addition, the proposed regulations have been
updated to align with the NRC's efforts to reduce burden by
establishing performance-based requirements compared to current
recommendations contained in licensing guidance where possible. To
assess burden, the NRC used data from the regulatory basis for the EMTs
listed. For EMTs not included in the regulatory basis, the NRC applied
the same methodology from the regulatory basis to the updated EMT list,
to ensure consistency. The regulatory basis originally presented
cumulative burden estimates over a 15-year period, which the NRC
converted to annual estimates for purposes of this regulatory
[[Page 47064]]
analysis. As shown in table 5, the NRC estimates that 12,867 hours of
burden related to EMT licensing guidance would be eliminated on an
annual basis across the NRC, Agreement States, and licensees. This
total includes 724 hours for NRC licensing staff, 10,380 hours for
Agreement States to review and process EMT-related licensing actions,
and 1,763 hours for licensees to prepare and submit applications and
amendments per year.
Table 5--Averted Time Spent on EMT-Related Licensing Actions
[NRC, agreement states and licensees]
----------------------------------------------------------------------------------------------------------------
Agreement
EMTs NRC states Licensees
----------------------------------------------------------------------------------------------------------------
Time spent on submission and review of license applications and amendments in hours per year
----------------------------------------------------------------------------------------------------------------
Ge-68/Ga-68 Pharmaceutical Grade Generators..................... 5 76 10
NeoVista, Inc.'s Epi-Rad90 (Sr-90) Ophthalmic System............ 12 171 23
ViewRay System for Radiation Therapy............................ 6 86 11
LV Liberty Vision Y-90 Disc and Ophthalmic System............... 7 105 14
Gamma Knife--Elekta Esprit...................................... 11 162 22
Akesis Galaxy RTi............................................... 11 162 22
Eye90 Microspheres.............................................. 64 914 122
Gamma Knife--Perfexion.......................................... 9 133 18
GammaPod........................................................ 5 76 10
Masep Infini.................................................... 12 171 23
Sirtex Microspheres............................................. 389 5,562 744
Nordion Microspheres............................................ 193 2,762 744
-----------------------------------------------
Total hours................................................. 724 10,380 1,763
----------------------------------------------------------------------------------------------------------------
In addition to this burden reduction, the NRC would save 437 hours
for licensing guidance development. As shown in table 6, the aggregate
annual savings for the NRC, Agreement States, and licensees would be
13,304 hours (or $1.8 million, undiscounted). These estimated burden
reductions reflect reduced staff time associated with licensing reviews
license amendment processing, and related administrative and guidance-
development activities for EMTs.
Table 6--Averted Costs From EMT-Related Licensing Actions
[NRC, agreement states and licensees]
----------------------------------------------------------------------------------------------------------------
Fully loaded Annual cost
Entities and activities Averted hours wage rate savings
----------------------------------------------------------------------------------------------------------------
NRC: EMT licensing guidance cost................................ 437 $158.00 $68,993
NRC: Review of EMT license applications and amendments.......... 724 158.00 114,392
Agreement States: Review of EMT license applications and 10,380 124.67 1,294,116
amendments.....................................................
Licensees: Submission of EMT license applications and amendments 1,763 171.73 302,756
-----------------------------------------------
Total....................................................... 13,304 .............. 1,780,258
----------------------------------------------------------------------------------------------------------------
Licensees would benefit from the proposed change to codify
provisions that reduce reliance on EMT-specific guidance and eliminate
the recurring burden associated with application reviews and guidance
updates. Specifically:
Proposed changes that would align with recommended EMT-
specific guidance are not expected to impose additional burdens on
licensees. The NRC staff determined that no incremental costs are
anticipated, and costs for these changes were not included.
Proposed changes to Sec. 35.60 would allow licensees to
use instrumentation that cannot be calibrated according to nationally
recognized standards or the manufacturer's instructions. This
flexibility is optional and intended to support future innovations, but
it is not expected to be used at this time. The NRC subject matter
experts determined that no incremental costs are anticipated, and costs
for these changes were not included.
Proposed changes in Sec. 35.41(b)(4) would require
licensees to verify computer-generated dose calculations are
transferred into a console correctly for all therapeutic uses, not just
those authorized by Sec. Sec. 35.600 and 35.1000. This proposed
regulation would not be required for new modalities at this time as
they do not currently use computer-driven consoles. The intent of this
proposed regulation is to reduce future licensing costs associated with
subpart K of 10 CFR part 35 licensing for innovative and emerging
medical technologies; NRC subject matter experts determined that cost
cannot be estimated at this time because none of these technologies are
currently in use.
Proposed changes in Sec. 35.635(b)(6) would require
licensees to determine the operability and availability of emergency
response equipment in their full calibration. This requirement is not
expected to increase burden because licensees are already required to
have emergency response equipment operational and available to
implement emergency procedures specified in Sec. 35.610 and perform
full calibration of the unit in accordance with Sec. 35.635.
Although the proposed changes to the NRC's microsource regulations
would introduce an additional burden on licensees, these changes are
intended to make these regulations more flexible and better accommodate
both current and future microsource use. The proposed changes that
align with
[[Page 47065]]
current Sec. 35.1000 licensing guidance criteria and the additional
requirement contained in Sec. 35.710(d), which would require radiation
safety instructions for personnel caring for such patients or human
research subjects who cannot be released in accordance with Sec.
35.75, are not expected to increase the burden. Current Y-90
microsphere regulations allow licensees to release patients under Sec.
35.75 following administration; however, it is uncertain if future
microsource administrations could require inpatient care. This proposed
rule would require licensees to keep records of safety instructions and
develop and maintain procedures for responding to abnormal situations,
such as microsource spills, equipment failures, and emergent conditions
that may occur during use. Licensees would incur a small increase in
costs due to this requirement, but these procedures are necessary to
ensure the safe use of microsources. As shown in table 7, the
recordkeeping burden associated with this proposed requirement would
increase by 183 hours (or $31,427, undiscounted) per year for
licensees.
Table 7--Costs From Recordkeeping Requirements on EMTs
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase in
Type number of Records per Burden hours Total burden Fully loaded Annual cost
recordkeepers licensee per record hours increase wage rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amended requirements: Maintain a record of safety instructions
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees.......................................... 40 1 0.1 4.0 $171.73 ($687)
Agreement State licensees.............................. 300 1 0.1 30.0 171.73 (5,152)
--------------------------------------------------------------------------------------------------------------------------------------------------------
New requirements: Maintain a copy of each procedure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amended record maintained.............................. 35 1 0.5 17.5 171.73 (3,005)
Agreement State licensees.............................. 263 1 0.5 131.5 171.73 (22,582)
------------------------------------------------------------------------------------------------
Total.............................................. ............... .............. .............. 183.0 .............. (31,427)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Impacts related to EMT training requirements have already been
accounted for in Section VII.B.1, ``Training and Experience,'' of this
document.
3. Rubidium-82 Generators
As discussed in Sections III.C. and IV.C, ``Rubidium-82
Generators,'' of this document, this proposed rule would establish
formal requirements for Rb-82 generators, including calibration
flexibility for radiation detector instrumentation in dynamic use mode
and updated licensing and training provisions to replace reliance on
enforcement guidance. The proposed regulations are consistent with the
criteria required to use enforcement discretion as described in EGM 13-
003. Eliminating reliance on enforcement guidance would remove the
recurring burden associated with enforcement discretion activities,
such as, review of exemption requests and inspections associated with
Rb-82 generators. The NRC converted the data presented in the
regulatory basis, cumulative burden estimates over a 15-year period,
into annual estimates for purposes of this regulatory analysis. As
shown in table 8, the NRC estimates 3,145 burden hours (or $435,699,
undiscounted) related to enforcement guidance activities would be
eliminated on an annual basis across the NRC, Agreement States, and
licensees under this proposed rule. These estimated burden reductions
reflect reduced staff time associated with licensing, inspection,
exemption review, and related administrative activities that would have
supported the use of enforcement guidance for Rb-82 generators.
Table 8--Averted Costs From Rb-82 Generators Enforcement Guidance
[NRC, agreement states and licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enforcement discretion cases Inspections
Entities ---------------------------------------------------------------- Total burden Fully loaded Annual cost
Number Hours Number Hours hours reduced wage rate savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC..................................... 11 36 8.5 6 447 $158.00 $70,626
Agreement States........................ 49.5 36 76.5 4 2,088 124.67 260,319
Licensees............................... 55 8 85 2 610 171.73 104,754
---------------------------------------------------------------------------------------------------------------
Total............................... .............. .............. .............. .............. 3,145 .............. 435,699
--------------------------------------------------------------------------------------------------------------------------------------------------------
Licensees would incur a small increase in costs due to the
recordkeeping requirements associated with this proposed rule change
but would benefit and save costs overall from the proposed codification
of EGM-13-003. As shown in table 9, the recordkeeping burden would
increase by 253 hours (or $43,499, undiscounted) per year for
licensees.
[[Page 47066]]
Table 9--Costs From Recordkeeping Requirements on Rb-82 Generators
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase in
Type number of Records per Burden hours Total burden Fully loaded Annual cost
recordkeepers licensee per record hours increase wage rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amended requirements: Maintain a record of each instrument calibration and test
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 5 255 0.02 25.5 $171.73 ($4,379)
Agreement State licensees............................... 38 255 0.02 193.8 171.73 (33,281)
--------------------------------------------------------------------------------------------------------------------------------------------------------
New requirements: Retain a copy of each procedure
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 40 1 0.10 4.0 171.73 (687)
Agreement State licensees............................... 300 1 0.10 30.0 171.73 (5,152)
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 253.3 .............. (43,499)
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. Other Topics
The proposed amendments discussed in this section seek to modify
existing requirements in several areas of 10 CFR part 35, including
those governing written directives, decay-in-storage requirements,
medical event reporting criteria, and other provisions. These changes
are intended to reduce regulatory burden, increase flexibility, and
modernize radiation safety practices for the medical use of byproduct
material.
a. Written Directives for Diagnostic Sodium Iodide I-131
The proposed changes to Sec. 35.40 would remove the requirement
that a written directive be prepared for diagnostic administrations of
sodium iodide I-131 in quantities greater than 1.11 megabecquerels (30
microcuries). As a result, physicians would no longer need to prepare a
written directive prior to these diagnostic administrations and
licensees would no longer need to develop, implement, and maintain
written procedures in accordance with Sec. 35.41 to use this
administration. In addition, physicians who do not perform any other
administrations requiring a written directive besides diagnostic
administrations of sodium iodide I-131 in quantities greater than 1.11
megabecquerels (30 microcuries) would be able to receive AU status
under subpart D. This would reduce the training and experience needed
for these physicians to be able to provide this administration as
discussed Section VII.A of this document.
As shown in table 10, these proposed changes are expected to reduce
paperwork and other administrative costs. A decrease of 15 records per
licensee and a one-hour decrease in burden per procedure is estimated
to save 6,323 hours (or $1.7 million, undiscounted) annually for
licensees performing reporting and recordkeeping for the NRC and
Agreement States.
Table 10--Averted Costs From Written Directives for Diagnostic Sodium Iodide I-131
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records Burden hours
Type Number of reduced per reduced per Burden hours Total burden Fully loaded Annual cost
licensees licensee response per record hours wage rate savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................... 425 15 .............. 0.05 319 $269.51 $85,906
Agreement State licensees............... 3,188 15 .............. 0.05 2,391 269.51 644,394
--------------------------------------------------------------------------------------------------------------------------------------------------------
Following procedure
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................... 425 .............. 1 .............. 425 269.51 114,541
Agreement State licensees............... 3,188 .............. 1 .............. 3,188 269.51 859,192
---------------------------------------------------------------------------------------------------------------
Total............................... 7,226 .............. .............. .............. 6,323 .............. 1,704,032
--------------------------------------------------------------------------------------------------------------------------------------------------------
b. Reductions in Event Reporting
The NRC is proposing to amend Sec. 35.3045(a) to exclude requiring
licensees to report events that result from emergent patient conditions
that prevent completion of administration as planned unless the
administration results or would result in damage as described in Sec.
35.3045(b). In addition, NRC is proposing to amend Sec. 35.40 to allow
AUs for microsources to modify written directives after administration.
To ensure the NRC continues to receive reports of leaks or defects in
administration devices or supplies which can impact multiple licensees
in a short time period, the NRC is proposing to add Sec.
35.3045(a)(3). This addition would require reporting when such a leak
or defect causes the total dose or dosage delivered to differ from the
prescribed dose or dosage specified in the pre-administration portion
of the written directive, unless the event results from patient
intervention or an emergent patient condition. The cumulative result of
these proposed changes would reduce the number of medical events, which
would reduce burden in reporting these events to the
[[Page 47067]]
NRC or Agreement States as well as the required notification to the
patient and referring physician. As shown in table 11, these proposed
changes are expected to reduce paperwork burden, resulting in estimated
annual savings of about 117 hours (or $33,025, undiscounted) per year
for licensees.
Table 11--Averted Costs From Medical Event Reporting
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
Type number of Responses per Burden hours Total burden Fully loaded Annual cost
licensees licensee per response hours wage rate savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification by telephone to the NRC within 15 days of the discovery of the medical event
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 1 1 0.50 0.50 $282.26 $141
Agreement State licensees............................... 8 1 0.50 4 282.26 1,129
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written report to the NRC within 15 days of the discovery of the medical event
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 1 1 8 8 282.26 2,258
Agreement State licensees............................... 8 1 8 64 282.26 18,065
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annotated copy of the medical event report
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 1 1 0.50 0.50 282.26 141
Agreement State licensees............................... 8 1 0.50 4 282.26 1,129
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of medical events to referring physician and individual within 24 hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 1 2 2 4 282.26 1,129
Agreement State licensees............................... 8 2 2 32 282.26 9,032
-----------------------------------------------------------------------------------------------
Combined Total...................................... .............. .............. .............. 117 .............. 33,025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additionally, the NRC is proposing to amend the regulation to add
Sec. 35.3047(a)(2) to exclude reporting of exposure to an embryo/fetus
if the licensee made a reasonable effort to determine pregnancy status,
but pregnancy could not be reasonably excluded prior to the
administration by the licensee. As shown in table 12, the projected
reductions related to these events are expected to result in a reduced
burden of about 28 hours (or $7,903, undiscounted) per year for
licensees.
Table 12--Averted Costs From Medical Event Reporting
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
Type number of Responses per Burden hours Total burden Fully loaded Annual cost
licensees licensee per response hours wage rate savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification by telephone to the NRC Operations Center no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing
child
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 1 1 0.50 0.50 $282.26 $141
Agreement State licensees............................... 7 1 0.50 3.50 282.26 988
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written report to the NRC Regional Office no later than 15 days after discovery of a dose to the embryo/fetus or nursing child
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 1 1 0.50 0.50 282.26 141
Agreement State licensees............................... 7 1 0.50 3.50 282.26 988
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification to referring physicians and to the pregnant individual or mother no later than 24 hours after discovery of an event
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 1 1 2 2 282.26 565
Agreement State licensees............................... 7 1 2 14 282.26 3,952
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annotated copy of the event report
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 1 1 0.50 0.50 282.26 141
Agreement State licensees............................... 7 1 0.50 3.50 282.26 988
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 28 .............. 7,903
--------------------------------------------------------------------------------------------------------------------------------------------------------
In addition, both these changes would reduce burden to both the NRC
and Agreement States as it would reduce reactive inspection follow-ups
that occur when the NRC receives a medical or fetal/embryo event. As
shown in table 13, the projected reduction related to these events
would reduce burden by 48 hours per year for the NRC and 120
[[Page 47068]]
hours per year for Agreement States. There are also savings on travel
and lodging costs for NRC inspectors, with estimated savings of about
$800 for each inspection event (or $1,600 per year). For Agreement
States, savings on travel and lodging costs are expected to be minimal
because most inspection sites are nearby. The combined savings for both
the NRC and Agreement States are $25,274, undiscounted, per year.
Table 13--Averted Costs From Medical Event Follow-Ups
[NRC and agreement states]
----------------------------------------------------------------------------------------------------------------
Reduction in
number of Burden hours Total burden Fully loaded Annual cost
Entity reactive per inspector hours reduced wage rate savings
inspections
----------------------------------------------------------------------------------------------------------------
NRC............................. 2 24 48 $158.00 $7,584
Travel and lodging.......... 1,600
Agreement State................. 15 8 120 124.67 14,961
-------------------------------------------------------------------------------
Total................... .............. .............. 168 .............. 25,274
----------------------------------------------------------------------------------------------------------------
In addition, the NRC requires Agreement States to submit reports to
the Nuclear Material Events Database (NMED) each time a qualifying
medical event occurs at one of their licensee's facilities within their
state. With this proposed rule, the number of respondents would
decrease resulting in a reduction in reporting obligations to the NRC.
As shown in table 14, the projected savings are expected to result in a
reduced burden of about 145 hours (or $18,129, undiscounted) per year
for Agreement States.
Table 14--Averted Costs From NMED Reporting
[Agreement states]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
agreement Responses per Burden hours Total burden Fully loaded Annual cost
Requirements state licensee licensee per response hours reduced wage rate savings
respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nuclear Material Event Report (Routine Significance).... 8 10.77 1.50 129.24 $124.67 $16,113
Nuclear Material Event Report (Higher Significance)..... 7 0.77 3.00 16.17 124.67 2,016
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 145.41 .............. 18,129
--------------------------------------------------------------------------------------------------------------------------------------------------------
c. Expanding Use of Decay in Storage
The NRC is proposing to amend Sec. 35.92 to increase the allowable
physical half-life for byproduct material eligible for decay-in-storage
(DIS) from 120 days to 275 days. This proposed change would allow
licensees to use DIS for longer-lived materials, such as Lu-177m, which
is becoming more prevalent in medical facilities as new Lu-177
radiopharmaceuticals receive FDA approval. By allowing these materials
to decay on-site until they are no longer radioactive, rather than
requiring disposal as radioactive waste under subpart K of 10 CFR part
20, the proposed amendment would reduce waste disposal costs for
licensees. NRC staff has determined this would likely result in fewer
low level waste shipments overall, reducing costs associated with
packaging, transportation, and disposal fees for the licensees. As
shown in table 15, these reductions are estimated to yield annual
undiscounted savings of $584,800 for licensees. This value is subject
to the use of Lu-177 containing Lu-177m by licensees and savings may
vary due to differences in licensee-specific practices.
Table 15--Averted Costs From Low Level Wate Shipments
[Licensees]
----------------------------------------------------------------------------------------------------------------
Reduction in
number of Amount of Cost per pound Annual cost
Type waste waste (pound) of waste savings
shipments
----------------------------------------------------------------------------------------------------------------
NRC licensees................................... 86 100 $8.00 $68,800
Agreement State licensees....................... 645 100 8.00 516,000
---------------------------------------------------------------
Total....................................... .............. .............. .............. 584,800
----------------------------------------------------------------------------------------------------------------
Most licensees that would benefit from this proposed change already
operate a DIS program for isotopes with half-lives of 120 days or less
and maintain dedicated secured space that complies with regulatory
requirements.
[[Page 47069]]
However, with this proposed rule change, additional onsite storage may
be needed to hold waste from materials with longer half-lives for
licensees who opt into expanded DIS rather than continue disposal under
current regulations. NRC staff believe most licensees would choose DIS
because it is expected to cost less than disposal under current
regulations, resulting in potential savings for those who opt in.
Although the NRC staff assume that these activities would result in
minor costs for facility expansion or operational adjustments, there is
uncertainty regarding potential cost impacts because detailed
information on licensees' existing storage setup and waste-handling
procedures is not available. Additionally, licensees would incur a
small increase in costs due to recordkeeping requirements associated
with the extended storage period. As shown in table 16, the
recordkeeping burden would increase by 833 hours (or $105,658,
undiscounted) per year for licensees.
Table 16--Additional Costs From Recordkeeping Requirements on Storage
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase in
Type number of Records per Burden hours Total burden Fully loaded Annual cost
recordkeepers licensee per record hours wage rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees.............................................. 86 57 0.02 98.0 $126.84 ($12,435)
Agreement State licensees.................................. 645 57 0.02 735.3 126.84 (93,265)
--------------------------------------------------------------------------------------------
Total.................................................. .............. .............. .............. 833.3 .............. (105,701)
--------------------------------------------------------------------------------------------------------------------------------------------------------
d. Reduction in License Amendments for Human Subject Research
The NRC is proposing to amend Sec. 35.6 to eliminate the
requirement for licensees to submit a license amendment before
conducting research involving human subjects, provided the licensee is
already authorized for the medical use of byproduct material and has
obtained IRB approval and informed consent from the research subject.
This would reduce the number of license amendments required. As shown
in table 17, the estimated reduction related to the elimination of
research application information is expected to result in a reduced
burden of 204 hours (or $35,033, undiscounted) per year for licensees.
Table 17--Averted Costs from Research Application Information
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
Type number of Responses per Burden hours Total burden Fully loaded Annual cost
licensees licensee per response hours wage rate savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 6 1 4 24 $171.73 $4,121
Agreement State licensees............................... 45 1 4 180 171.73 30,911
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 204 .............. 35,033
--------------------------------------------------------------------------------------------------------------------------------------------------------
In addition, this change would reduce burden to both the NRC and
Agreement States as it would reduce license amendment review time. This
proposed change would reduce the burden on both the NRC and Agreement
States by decreasing the time needed to review license amendments. As
shown in table 15, these reductions are estimated to yield annual
undiscounted savings of $584,800 for both the NRC and Agreement States.
Table 18--Averted Costs on Reviewing License Amendments Related to Research
[NRC and agreement states]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
number of Responses per Burden hours Total burden Fully loaded Annual cost
Entity license licensee per response hours wage rate savings
reviews
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC..................................................... 6 1 8 48 $158.00 $7,584
Agreement State......................................... 45 1 8 360 124.67 44,883
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 408 .............. 52,467
--------------------------------------------------------------------------------------------------------------------------------------------------------
e. Reduce Duplication Requirements for Mobile Medical Services
The NRC is proposing to amend regulations specific to mobile
medical services contained in Sec. 35.80 to eliminate prescriptive
requirements that are redundant to regulations contained in 10 CFR part
20 and other sections of 10 CFR part 35. Conforming changes are being
proposed to remove associated survey records as currently required in
Sec. 35.2080(b). As shown in table 19, these proposed changes are
expected to reduce recordkeeping requirements, resulting in estimated
annual savings of about 426 hours (or $73,156, undiscounted) per year
for licensees.
[[Page 47070]]
Table 19--Averted Costs From Mobile Medical Services
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
Type number of Responses per Burden hours Total burden Fully loaded Annual cost
recordkeepers licensee per response hours wage rate savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 25 20 0.10 50 $171.73 $8,586
Agreement State licensees............................... 188 20 0.10 376 171.73 64,570
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 426 .............. 73,156
--------------------------------------------------------------------------------------------------------------------------------------------------------
f. Expand Temporary Radiation Safety Officer and Changes to Radiation
Safety Committee
The NRC proposes to amend Sec. 35.24(c) to extend the allowable
duration for a qualified individual to serve as a temporary RSO from 60
days to 120 days per calendar year. This would reduce the number of
license amendments required. As shown in table 20, these proposed
changes are expected to reduce paperwork burden, resulting in estimated
annual savings of about 18 hours ($2,919, undiscounted) per year for
licensees.
Table 20--Averted Costs From Extending Allowable Duration for RSO
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
number of Responses per Burden hours Total burden Fully loaded Annual cost
Type license licensee per response hours wage rate savings
amendments
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 2 1 1 2 $171.73 $343
Agreement State licensees............................... 15 1 1 15 171.73 2,576
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 17 .............. 2,919
--------------------------------------------------------------------------------------------------------------------------------------------------------
Similarly, the NRC and Agreement States would realize an estimated
annual savings of 17 hours (or $2,186, undiscounted) per year for
reduced requirements regarding reviewing and processing RSOs. This
reduction is based on eliminating two RSO reviews per year for the NRC
(at 1 hour per review) and 15 RSO reviews per year for the Agreement
States (at 1 hour per review), as shown in table 21.
Table 21--Averted Costs From Reduced RSO Reviews
[NRC and agreement]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction in
number of
Entity license Responses per Burden hours Total burden Fully loaded Annual cost
amendments to licensee per response hours wage rate savings
review
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC..................................................... 2 1 1 2 $158.00 $316
Agreement State......................................... 15 1 1 15 124.67 1,870
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 17 .............. 2,186
--------------------------------------------------------------------------------------------------------------------------------------------------------
In addition, the NRC proposes to revise the requirements to the RSC
contained in Sec. 35.24(f). First, with the addition of microsources,
this proposed rule is updated to include subpart I and K and clarifies
that an RSC is only required if a licensee is authorized for two or
more different types of uses or units that require written directives.
As shown in table 22, the projected increase in burden is estimated at
42.5 hours (or $7,298, undiscounted) annually for licensees. This
estimate is based on expanded reporting requirements due to the
inclusion of microsources under subparts I and K of 10 CFR part 35.
Table 22--Averted Costs From RSC Requirements
[Licensees]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase in
Type number of Responses per Burden hours Total burden Fully loaded Annual cost
respondents licensee per response hours wage rate savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRC licensees........................................... 10 1 0.5 5.0 $171.73 $859
Agreement State licensees............................... 75 1 0.5 37.5 171.73 6,440
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 42.5 .............. 7,298
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47071]]
In addition, this proposed rule would remove the requirements for a
representative of the nursing service to be part of an RSC. This would
reduce an average of 4 hours of a nurse's time for all licensees who
are required to have an RSC. As shown in table 23, this elimination is
estimated to yield 4,640 hours savings (or $525,731, undiscounted)
annually for licensees.
Table 23--Averted Costs From Nursing Service
[Licensees]
----------------------------------------------------------------------------------------------------------------
Reduction of
nursing Nurse's time Total burden Fully loaded Annual cost
Type service under in hours hours wage rate savings
RSC
----------------------------------------------------------------------------------------------------------------
NRC licensees................... 232 4 928 $113.30 $105,146
Agreement State licensees....... 928 4 3,712 113.30 420,584
-------------------------------------------------------------------------------
Total....................... .............. .............. 4,640 .............. 525,731
----------------------------------------------------------------------------------------------------------------
D. Rulemaking and Implementation Costs
For the purposes of this analysis, rulemaking costs consist of non-
recurring expenses incurred by the NRC to complete the rulemaking
process and transition to compliance with the final requirements.
Implementation costs consist of non-recurring expenses incurred by the
NRC, Agreement States, and affected licensees to transition to
compliance with the final rule, including updates to guidance,
procedures, and internal processes. Proposed provisions that would
result in recurring costs are discussed in Sections VII.B.1 through
VII.B.4 of this document and are therefore not included in this
section. The NRC would incur about 1,000 hours of effort (or $158,000,
undiscounted) to implement this rule, if finalized.
Agreement States would need to assess compatibility with the NRC's
final rule, update state regulations and procedures as necessary, and
inform affected licensees. While the rule is deregulatory, existing
stringent requirements remain consistent with safety mandates. The NRC
estimates that, if this proposed rule were to become final, Agreement
States implementing this rule with respect to EMTs and Rb-82
generators, would incur an estimated cost of $760,000, undiscounted, as
they would need to update their regulatory framework to reflect changes
introduced by the NRC's final rule and ensure compatibility for
licensing and oversight of these technologies. This effort ensures
compliance with compatibility standards and provides the necessary
authority for Agreement States to issue licenses for EMTs and Rb-82
generators. For the other changes associated with this proposed rule,
because the effect of the rule would be deregulatory, the more
stringent requirements currently required by Agreement States would be
consistent with the mandate to adequately administer safety
regulations. However, Agreement States would be likely to expend
resources to amend state regulations and guidance documents to be
consistent with this rule, if finalized. The NRC staff did not quantify
these costs due to the expectation that the costs would be minor
relative to the net benefits and are difficult to quantify.
Licensees and industry stakeholders would need to update compliance
programs and internal procedures on the new requirements, if finalized.
Because this would be a deregulatory rule, the implementation burden
would be minimal and occur only during the initial period. The largest
implementation burden would come from the revision to Sec. 35.59 to
replace the prescriptive recentness of training and experience
requirement with a performance-based continuing education requirement.
On average, each licensee is anticipated to spend 2 hours on
implementation activities with licensees that have a greater number of
AUs requiring more time than those with fewer AUs. In addition, there
may be some implementation burden associated with appropriate licensees
establishing a process to authorize diagnostic AUs without submitting a
license amendment. However, this burden is expected to be small because
licensees already maintain a process for preparing license applications
to demonstrate that these individuals meet the authorized user training
and experience requirements; the only change is that this information
would no longer need to be submitted to the NRC. The remaining
implementation burden would be relatively minor or would occur during
the licensing process and due to the deregulatory action of the rule,
would result in net burden reduction as already reflected above. As
shown in table 24, the licensees implementing this rule would incur
about 8,500 hours of effort, or an estimated cost of $1.9 million,
undiscounted.
Table 24--Implementation Costs
[Licensees]
----------------------------------------------------------------------------------------------------------------
Estimated hours
Type Number of to implement Total hours Fully loaded One-time cost
licensees rule wage rate
----------------------------------------------------------------------------------------------------------------
NRC licensees.................. 500 2 1,000 $228.06 ($228,063)
Agreement State licensees...... 3,750 2 7,500 228.06 (1,710,474)
--------------------------------------------------------------------------------
Total...................... .............. ............... 8,500 .............. (1,938,537)
----------------------------------------------------------------------------------------------------------------
[[Page 47072]]
Summary of Costs, Cost Savings, and Net Cost Savings
Overall, this proposed rule is considered a deregulatory action and
would be expected to reduce barriers to medical use licensing by
enabling more efficient and predictable licensing, increasing
flexibility, and easing administrative burden for the NRC, Agreement
States, licensees, and individuals or entities that seek medical use
licenses. Over the 5-year analysis period (2027-2031), the proposed
revisions are estimated to generate net savings of $39.1 million
(savings minus costs), undiscounted. As shown in table 25, the NPV of
these net savings would be $35.6 million, discounted at 3 percent, or
$31.7 million, discounted at 7 percent. The projected annualized cost
savings would be $7.2 million discounted at 3 percent, or $6.4 million
discounted at 7 percent. Although this proposed rule would reduce
barriers to medical use licensing and generate savings, some costs
would still be incurred over the 5-year period, primarily due to
expanded recordkeeping requirements and implementation costs. The
additional recordkeeping costs, which represent operational costs for
licensees, are estimated at $2.4 million (undiscounted), $2.2 million
(discounted at 3 percent), and $2.0 million (discounted at 7 percent)
over this 5-year period. Implementation costs for both NRC and industry
stakeholders are estimated at about $2.9 million (undiscounted), $2.8
million (discounted at 3 percent), and $2.7 million (discounted at 7
percent). The combined implementation and compliance costs for both NRC
and industry stakeholders, as well as expanded recordkeeping
requirements in some areas for licensees, are estimated at about $5.3
million (undiscounted), $5.0 million (discounted at 3 percent), and
$4.7 million (discounted at 7 percent).
The licensees, accounting for the largest share of net cost
savings, would save about $30.5 million over the 5-year analysis
horizon, undiscounted, with an NPV of $27.8 million discounted at 3
percent, or $24.8 million discounted at 7 percent. The Agreement States
would realize net cost savings of about $7.4 million over 5 years,
undiscounted, with an NPV of $6.7 million discounted at 3 percent, or
$6.0 million discounted at 7 percent. During the same period, the NRC
would save about $1.2 million over 5 years, undiscounted, with an NPV
of $1.1 million discounted at 3 percent, or $964,000 discounted at 7
percent.
The annualized costs are approximately $970,000 per year at a 3
percent discount rate, and $865,000 per year at a 7 percent discount
rate. The annualized cost savings are approximately $8.1 million per
year at a 3 percent discount rate, and $7.2 million per year at a 7
percent discount rate. Therefore, the annualized net cost savings are
estimated at $7.2 million per year at a 3 percent discount rate and
$6.4 million per year at a 7 percent discount rate.
Table 25--Total 5-Year Costs, Savings, and Net Savings
[NRC, agreement states and licensees] \4\
----------------------------------------------------------------------------------------------------------------
Costs (2024 dollars)
Attribute --------------------------------------------------------------------
Undiscounted 3% NPV 7% NPV
----------------------------------------------------------------------------------------------------------------
NRC Total.................................. $158,000 $153,000 $148,000
Agreement States Total..................... 760,000 738,000 710,000
Licensee Total............................. 4,382,000 4,120,000 3,816,000
Net........................................ 5,300,000 5,012,000 4,674,000
Annualized................................. 970,000 865,000
--------------------------------------------------------------------
Cost Savings (2024 Dollars)
--------------------------------------------------------------------
NRC Total.................................. (1,355,000) (1,242,000) (1,112,000)
Agreement States Total..................... (8,171,000) (7,485,000) (6,701,000)
Licensee Total............................. (34,863,000) (31,933,000) (28,589,000)
Net........................................ (44,390,000) (40,659,000) (36,402,000)
Annualized................................. (8,125,000) (7,247,000)
Net Cost Savings (2024 Dollars)
--------------------------------------------------------------------
Net NRC.................................... (1,197,000) (1,089,000) (964,000)
Net Agreement States....................... (7,411,000) (6,747,000) (5,991,000)
Net Licensees.............................. (30,481,000) (27,813,000) (24,773,000)
Net Total.................................. (39,089,000) (35,649,000) (31,728,000)
Annualized Net............................. ................. (7,155,000) (6,382,000)
--------------------------------------------------------------------
Qualitative Factors........................ Regulatory Clarity, Predictability, Flexibility, and Promoting
Technological Advances
----------------------------------------------------------------------------------------------------------------
In addition to the quantified savings, the NRC notes that this
proposed rule would be expected to provide qualitative benefits to
medical use licensees by enhancing regulatory clarity and
predictability. By consolidating and modernizing requirements, the rule
reduces ambiguity that has historically led to inconsistent
interpretations and delays. Clearer, performance-based standards for
training, experience, and emerging technologies will foster greater
confidence in compliance and reduce the need for repeated consultations
with regulators. This improved transparency would support a more
streamlined licensing process and strengthen trust between licensees
and regulators.
---------------------------------------------------------------------------
\4\ Values rounded to the nearest 1,000 dollars.
---------------------------------------------------------------------------
This proposed rule also promotes innovation and adaptability in
medical use licensing. Codifying pathways for emerging medical
technologies and updating requirements for generator systems ensures
that licensees can adopt new devices and therapies without prolonged
reliance on case-by-case guidance. This forward-looking approach
positions the regulatory framework to accommodate future
[[Page 47073]]
advancements in nuclear medicine, reducing barriers that could
otherwise slow patient access to cutting-edge treatments. These
benefits extend beyond cost savings by creating an environment that
encourages technological progress while maintaining safety.
Finally, updates to training and experience requirements would
allow licensees to receive authorization more quickly for future users
and uses under Sec. 35.300, which is critical given the anticipated
growth in therapeutic radiopharmaceuticals. By recognizing accredited
residency programs and introducing continuing education provisions, the
rule aligns regulatory expectations with modern medical education
practices. This flexibility helps address workforce challenges and
supports timely onboarding of qualified practitioners, ensuring that
patients benefit from expanded access to specialized care without
unnecessary administrative delays.
VIII. Backfitting and Issue Finality
The NRC's backfitting provisions (which are found in the
regulations at Sec. Sec. 50.109, 70.76, 72.62, and 76.76) and issue
finality provisions of 10 CFR part 52 do not apply to this rule. The
regulations in 10 CFR part 35 do not contain a backfitting provision,
and this rulemaking would not impact activities authorized by 10 CFR
parts 50, 52, 70, 72, or 76. As a result, this rulemaking would not
constitute ``backfitting'' as defined in 10 CFR chapter I or otherwise
affect the issue finality of a 10 CFR part 52 approval.
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
31885). The NRC requests comment on this document with respect to the
clarity and effectiveness of the language used.
XI. National Environmental Policy Act
A. Introduction
The NRC has prepared this environmental assessment (EA) of this
proposed rule amending regulations to reduce barriers to medical use
licensing 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 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 determined that the proposed agency
action to modernize NRC regulations for medical use licensing would
have no significant effect on the quality of the human environment.
B. Environmental Impacts of the Proposed Agency Action
Proposed rule changes would occur in 10 CFR part 35. Conforming
changes would be made to guidance at a later date consistent with
changes to regulations. Table 26 lists the sections of the regulations
being changed and affected guidance.
Table 26--Regulations and Guidance Under Consideration in the Reducing
Barriers to Medical Use Licensing Rulemaking
------------------------------------------------------------------------
Regulations Guidance
------------------------------------------------------------------------
35.2, 35.5, 35.6, 35.8, 35.10, 35.11, 35.12, NUREG-1556, Volume 9.
35.13, 35.14, 35.24, 35.27, 35.40, 35.41,
35.50, 35.51, 35.55, 35.57, 35.58, 35.59,
35.60, 35.61, 35.63, 35.67, 35.69, 35.70,
35.76, 35.80, 35.92, 35.93, 35.100, 35.190,
35.200, 35.204, 35.290, 35.315, 35.390, 35.392,
35.394, 35.396, 35.404, 35.415, 35.432, 35.433,
35.490, 35.491, 35.590, 35.604, 35.610, 35.615,
35.632, 35.633, 35.635, 35.643, 35.645, 35.690,
35.700, 35.710, 35.790, 35.1000, 35.2059,
35.2060, 35.2063, 35.2080, 35.2093, 35.2204,
35.2310, 35.2404, 35.2406, 35.2433, 35.2642,
35.2643, 35.2645, 35.2710, 35.3045, 35.3047,
35.3093, 35.3204.
------------------------------------------------------------------------
Conforming changes are administrative actions with no physical
environmental effect and provide for the appropriate administrative and
regulatory framework for byproduct material use under title 10 of the
CFR. An example would be adding a reference to a newly created
subsection in an existing regulation. All amendments to NRC regulations
in this proposed rule occur within the affected regulation.
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 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 environmental assessment 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 27 and no further NEPA analysis is required.
These proposed rule amendments belong to categories of actions that
the
[[Page 47074]]
Commission, by rule or regulation, has declared to be a categorical
exclusion, after first finding that the actions within the category do
not individually or cumulatively have a significant effect on the human
environment. In reviewing the list of regulations in table 26, the NRC
staff have determined that several of the rule amendments are actions
eligible for categorical exclusion under Sec. 51.22(a)(1) or (2).
Examples of eligible actions include amendments to the regulations in
this chapter that are corrective or of a minor or nonpolicy nature and
do not substantially modify existing regulations, and actions on
petitions for rulemaking relating to these amendments. Additional
examples of eligible actions include amendments to 10 CFR part 35,
which include the issuance of or changes to procedures for filing and
reviewing applications, recordkeeping or reporting requirements, and
administrative procedures or requirements. Actions under Sec.
51.22(a)(2) include the issuance of or changes to education, training,
experience, qualification or other employment suitability requirements.
The following rulemaking actions meet the criterion for categorical
exclusion under Sec. 51.22(a)(1) or (2):
Table 27--Rule Amendments Covered by Categorical Exclusion
----------------------------------------------------------------------------------------------------------------
Rule amendments Categorical exclusion Reason
----------------------------------------------------------------------------------------------------------------
35.6; 35.12; 35.13.................... Sec. 51.22(a)(1)..... Example (i). Amendments are administrative,
procedural, or solely financial in nature.
They would amend procedures for filing and
reviewing applications.
35.5; 35.8; 35.14; 35.40; 35.2060; Sec. 51.22(a)(1)..... Example (ii). Amends recordkeeping or reporting
35.2063; 35.2080; 35.2093; 35.2204; requirements.
35.2310; 35.2406; 35.2642; 35.2643;
35.2645; 35.2710; 35.3045; 35.3047;
35.3093; 35.3204.
35.2; 35.10; 35.11; 35.27; 35.41; Sec. 51.22(a)(1)..... Examples (iv) and (vi). Amendments are
35.60; 35.61; 35.63; 35.67; 35.69; administrative, corrective or of a minor or
35.70; 35.76; 35.80; 35.93; 35.100; nonpolicy nature, and do not substantially
35.200; 35.204; 35.315; 35.404; modify existing regulations. Amendments would
35.415; 35.432; 35.604; 35.615; be procedural--taking place in an office
35.632; 35.633; 35.635; 35.643; setting, relying on paper or electronic (e.g.,
35.645; 35.700; 35.710; 35.2404. computer) screen to demonstrate compliance
with revised regulations. Amendments would
modernize and clarify terminology used in 10
CFR part 35, improve consistency in regulatory
language, and better reflect current clinical
practices and medical community standards.
Amendments do not authorize any site-specific
action on the part of the NRC or licensee.
35.24; 35.50; 35.51; 35.55; 35.57; Sec. 51.22(a)(2)..... Amends education, training, experience,
35.58; 35.59; 35.190; 35.290; 35.390; qualification, or other employment suitability
35.392; 35.394; 35.396; 35.433; requirements.
35.490; 35.491; 35.590; 35.610;
35.690; 35.790; 35.2059; 35.2433.
----------------------------------------------------------------------------------------------------------------
These proposed rule amendments include administrative and
procedural changes--taking place in an office setting, relying on paper
or electronic (e.g., computer) screen to demonstrate compliance with
revised regulations, and would not authorize any site-specific action
on the part of the NRC or licensee. They 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.
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.
Table 28--Basis for No Significant Environmental Effects Determination
for Rule Amendments Not Covered by a Categorical Exclusion
------------------------------------------------------------------------
Basis for no significant environmental
Rule amendments effects
------------------------------------------------------------------------
35.92 Decay-in-storage....... Proposed amendment would increase the
half-life from 120 to 275 days for decay-
in-storage, which would reduce costs for
medical licensees who have been required
to dispose of Lu-177 waste as low level
waste when they have space to safely
store it. Expanding the scope of
radioisotopes for which licensees are
permitted to use decay-in-storage would
not have any significant environmental
effect because Sec. 35.92 requires
licensees to store the waste until its
radioactivity cannot be distinguished
from background.
------------------------------------------------------------------------
These proposed rule amendments would modernize existing NRC
regulations while ensuring the continued safe, effective, and efficient
medical use licensing to provide reasonable assurance of adequate
protection of public health and safety. As noted in table 28, these
amendments consist of administrative and procedural changes and would
not authorize any site-specific action on the part of the NRC or
licensee. Implementation of these amendments would have no
significantly different environmental effects than those from the
current regulatory framework.
[[Page 47075]]
C. Summary of the Environmental Impacts of the Proposed Agency Action
Implementation of this rule, if finalized, would result in no
physical changes to the environment, and, therefore, the NRC has
determined that this proposed agency action will not have a significant
effect on the quality of the human environment. Proposed rule
amendments are administrative in application, matters of procedure,
clarify record keeping and reporting requirements, and would provide an
equivalent level of safety and security as current NRC regulations.
Since no physical changes would occur in the human environment, the
proposed agency action (rulemaking) would not affect any threatened or
endangered species or historic properties. Accordingly, the NRC finds
that this proposed rulemaking would have no significant environmental
impact.
D. Environmental Impacts of the Alternative to the Proposed Agency
Action
Under the no-action alternative (the status quo), NRC regulations
would remain unchanged. As stated in Section B of this EA, this
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 (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 this proposed rule provides information about
the costs and benefits of the no-action alternative and the proposed
agency action, as discussed in Section VII., of this document,
``Regulatory Analysis.''
E. Agencies and Persons Consulted
The NRC is requesting public comment on this draft EA. Comments on
this draft EA may be submitted to the NRC as indicated under the
ADDRESSES caption of this document. The NRC will consider public
comments in the development of the final rule, EA, and finding of no
significant impact. The NRC will issue the final EA when it publishes
the final rule. This proposed rule is one step in the rulemaking
process.
As discussed in Section B of this EA, these proposed rule
provisions would not have a significant effect on the quality of the
human environment. For this reason, this proposed rule 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. These 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 Impact
The NRC has prepared this EA to determine the environmental effects
of the proposed agency action (rulemaking). 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 this 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 has
determined there is no need to prepare an environmental impact
statement. Accordingly, the NRC finds the proposed agency action would
have no significant environmental impact. This environmental assessment
and finding of no significant impact can be tracked with identification
number NEPA ID EAXX-429-00-000-1770620320.
XII. Paperwork Reduction Act
This proposed rule contains new and 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: Reducing Barriers to
Medical Use Licensing.
OMB Approval Number(s): 3150-0010, 3150-0120, and 3150-0178.
The form number if applicable: NRC Form 313A (RSO), 313A (AMP),
313A (ANP), 313A (AUD), 313A (AUT), 313A (AUS), 313A (AUM).
How often the collection is required or requested: Some information
must be submitted once at application or amendment (e.g., NRC Form 313,
training attestations, procedures), while other collections are
required on a recurring basis, such as continuing education and
experience documentation (preceding first use), annual or periodic
instrument calibrations and spot-checks (every 12 months, monthly, or
before each use), semi-annual inventories, daily or per-use surveys,
and periodic safety instructions (initially and annually). Most records
must be kept for three years (e.g., instrument calibrations, safety
instructions, dosages, spot-checks, generator breakthrough tests,
mobile medical service letters), while some records (such as activity
records for beta-emitting ophthalmic sources) must be retained for the
life of the source, and certain procedures or authorizations must be
retained for the duration of the license or until superseded by updated
records.
Who will be required or asked to respond: Applicants and licensees
who use byproduct materials for medical uses.
An estimate of the number of annual responses:
10 CFR part 35: 4,360 (-122 reporting responses + 4,500 recordkeepers +
-18 third party disclosure responses)
Form 313 and Form 313A Series: -990 (-990 reporting responses + 0
recordkeepers + 0 third party disclosure responses)
NMED: -92 (-92 reporting responses + 0 recordkeepers + 0 third party
disclosure responses)
The estimated number of annual respondents:
10 CFR part 35: 4,369 respondents
Form 313 and Form 313A Series: -990 respondents
NMED: -15 respondents
An estimate of the total number of hours needed annually to comply
with the information collection requirement or request:
10 CFR part 35: -220 (-334 reporting + 150 recordkeeping + -36 third
party disclosure responses)
Form 313 and Form 313A Series: -12,915 (-12,915 reporting + 0
recordkeeping + 0 third party disclosure responses)
[[Page 47076]]
NMED: -145 (-145 reporting + 0 recordkeeping + 0 third party disclosure
responses)
Abstract:
The NRC is proposing to amend its regulations to reduce barriers to
medical use licensing. This proposed rule would reduce overly
prescriptive requirements, increase regulatory flexibility, and
modernize radiation safety practices for the medical use of byproduct
material. It also would enable more efficient and predictable licensing
for emerging medical technologies and reduce unnecessary burden
associated with training and experience requirements for medical
authorized users. This effort is consistent with, and implements, the
direction in Executive Order 14300, ``Ordering the Reform of the
Nuclear Regulatory Commission,'' which directs the NRC to conduct a
comprehensive review and revision of its regulations.
This proposed rule addresses a wide range of topics, including the
following areas that result in new or revised recordkeeping and
reporting requirements involving:
Research applications,
Applications,
Temporary RSOs,
Instrument calibrations,
Medical events,
Dose to an embryo/fetus or a nursing child,
Generator elutions,
Radiation Safety Committees,
Mobile medical services,
Radiation safety,
Continuing education,
Decay-in-storage,
Permissible concentrations for generator-produced
radionuclides,
Microsource brachytherapy, and
Safety precautions for patients not eligible for release.
This supporting statement includes the burden associated with new
and revised information collections in 10 CFR part 35, the Nuclear
Material Events Database (NMED), and NRC Forms 313A (RSO), 313A (AMP),
313A (ANP), 313A (AUD), 313A (AUT), and 313A (AUS). It also includes
burden associated with new information collection in proposed Form 313A
(AUM).
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? Please explain
your response.
A copy of the 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-2025-1237.
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-2025-1237.
Submit comments by August 26, 2026.
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. 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 significant regulatory action
under section 3(f) of E.O. 12866; though not economically significant
under section 3(f)(1). 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
The 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 rescission or modification. The NRC identified the
definition of physician listed in Sec. 35.2 because the regulation
creates a barrier to market participation by limiting the pool of
eligible employees to work in this role. The proposed modification of
the regulation supports the objectives of E.O. 14267 by removing
regulatory requirements that could create unnecessary barriers to entry
for new market participants. In addition, the NRC identified that
training and qualification requirements contained in 10 CFR part 35
create a barrier to entry and restrict the flexibility of training
pathways by favoring existing qualification certifying organizations
and specialty boards. The proposed modification of the regulation to
expand flexible training options supports the objectives of E.O. 14267
by removing unnecessary barriers to entry for new market participants.
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 (AEA), the Energy
Reorganization Act of 1974, as amended (ERA), or the Nuclear Waste
Policy Act of 1982, as amended; (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
[[Page 47077]]
outside the scope of E.O. 14270 and did not insert conditional sunset
dates for the regulatory changes in this proposed rule.
F. Executive Order 14294: Fighting Overcriminalization in Federal
Regulations
This proposed rule includes Federal regulations that, if adopted,
would be enforceable by criminal penalty, as authorized by section 223
of the AEA. Therefore, per E.O. 14294, those regulations constitute
``criminal regulatory offenses.''
For the purposes of section 223 of the AEA, the NRC is issuing this
proposed rule that would amend 10 CFR part 35 under one or more of
sections 161b, 161i, or 161o of the AEA, except as noted in Sec.
35.4002(b). The applicability of criminal penalties to regulations in
10 CFR part 35 is set forth in Sec. 35.4002(a). Willful violations of
the 10 CFR part 35 regulations, other than those listed in Sec.
35.4002(b), would be subject to criminal enforcement.
XIV. Coordination With NRC Agreement States
The working group that prepared this proposed rule included a
representative from the Organization of Agreement States. Comments from
the Agreement States representative were taken into consideration
during the development of this proposed rule.
XV. 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.
Program elements in Compatibility Category C include 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 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. For amended and redesignated requirements,
the NRC is not proposing any changes to the current compatibility
designations for those requirements. However, for Sec. 35.300, which
would not be revised as part of this proposed rulemaking, the NRC is
proposing to change its compatibility designation as it was identified
to have been erroneously assigned as Category B the last time the
section was revised. Since Sec. 35.300 does not have cross
jurisdictional impacts, the NRC is proposing the compatibility category
revert to its original designation of Category H&S (67 FR 20250; April
24, 2002). There are also several requirements pertaining to outdated
regulations needed for implementation of previous rulemakings and
duplicative requirements being removed. Agreement States are
encouraged, but not required to, also remove those regulations.
Agreement States keeping their equivalent to those outdated and
duplicative requirements would not lead to a disorderly pattern of
regulation on a nationwide basis.
The compatibility (A, B, C, D, and NRC) and adequacy (H&S)
categories are designated in the following table:
[[Page 47078]]
Adequacy and Compatibility Table
----------------------------------------------------------------------------------------------------------------
Adequacy or compatibility
Section Change Subject -----------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
35.2..................... Amend................ Definition: B.................. B.
Authorized user.
35.2..................... New.................. Definition: ................... D.
Breakthrough.
35.2..................... New.................. Definition: Emergent ................... H&S.
patient condition.
35.2..................... New.................. Definition: Gamma ................... D.
stereotactic
radiosurgery.
35.2..................... Amend................ Definition: Manual D.................. D.
brachytherapy.
35.2..................... New.................. Definition: ................... D.
Microsource.
35.2..................... New.................. Definition: ................... D.
Microsource
brachytherapy.
35.2..................... Amend................ Definition: D.................. D.
Physician.
35.2..................... Amend................ Definition: C.................. C.
Prescribed dosage.
35.2..................... New.................. Definition: Shunting ................... H&S.
35.2..................... Remove............... Definition: D..................
Stereotactic
radiosurgery.
35.2..................... Amend................ Definition: D.................. D.
Teletherapy.
35.5..................... Remove............... Maintenance of D..................
records.
35.6(b).................. Amend................ Provisions for the C.................. C.
protection of human
research subjects.
35.6(c).................. Remove............... Provisions for the C..................
protection of human
research subjects.
35.6(d).................. Redesignate.......... Provisions for the C.................. C.
protection of human
research subjects.
35.8(b).................. Amend................ Information D.................. D.
collection
requirements: OMB
approval.
35.10(a)................. Remove............... Implementation...... D..................
35.11(a)................. Amend................ License required.... C.................. C.
35.11(c)................. Remove............... License required.... NRC/D..............
35.12(b) & (c)(2)........ Amend................ Application for D.................. D.
license, amendment,
or renewal.
35.13(a)................. Remove............... License amendments.. NRC/D..............
35.13(b) & (h)........... Amend................ License amendments.. D.................. D.
35.14(a)(1)(ii).......... Amend................ Notifications....... D.................. D.
35.24(c)................. Amend................ Authority and D.................. D.
responsibilities
for the radiation
protection program.
35.24(f)................. Amend................ Authority and H&S................ H&S.
responsibilities
for the radiation
protection program.
35.24(g)(3) & (4)........ Amend................ Authority and H&S................ H&S.
responsibilities
for the radiation
protection program.
35.24(g)(5).............. New.................. Authority and ................... H&S.
responsibilities
for the radiation
protection program.
35.27(a)(1).............. Amend................ Supervision......... H&S................ H&S.
35.40(a) & (b)........... Amend................ Written directives.. H&S................ H&S.
35.40(d)................. Amend................ Written directives.. D.................. D.
35.41(b)................. Amend................ Procedures for H&S................ H&S.
administrations
requiring a written
directive.
35.50(a)(c).............. Amend/Redesignate.... Training for B.................. B.
radiation safety
officer and
associate radiation
safety officer.
35.51(a)(b).............. Amend/Redesignate.... Training for an B.................. B.
authorized medical
physicist.
35.55(a)(b).............. Amend/Redesignate.... Training for an B.................. B.
authorized nuclear
pharmacist.
35.57(b)(4).............. New.................. Training for ................... B.
experienced
Radiation Safety
Officer,
teletherapy or
medical physicist,
authorized user,
nuclear pharmacist,
and authorized
nuclear pharmacist.
35.58.................... New.................. Specialty board ................... B.
certification
approval.
35.59.................... Amended in its Continuing education ................... B.
entirety.
35.60(a) & (b)........... Amend................ Possession, use, and H&S................ H&S.
calibration of
instruments used to
measure the
activity of
unsealed byproduct
material and
microsources.
35.60(c), (d) & (e)...... New.................. Possession, use, and ................... H&S.
calibration of
instruments used to
measure the
activity of
unsealed byproduct
material and
microsources.
35.60(f)................. Amend/Redesignate Possession, use, and D.................. D.
(previously calibration of
35.60(c)). instruments used to
measure the
activity of
unsealed byproduct
material and
microsources.
35.61(a)(1).............. Amend................ Calibration of H&S................ H&S.
survey instruments.
35.61(a)(2).............. Redesignate.......... Calibration of D.................. D.
survey instruments.
35.63(a), (b), (c)....... Amend................ Determination of H&S................ H&S.
dosages for medical
use.
35.63(d) & (e)........... New.................. Determination of ................... H&S.
dosages for medical
use.
35.63(f)................. Redesignate Determination of H&S................ H&S.
(previously dosages for medical
35.63(d)). use.
[[Page 47079]]
35.63(g)................. Amend/Redesignate Determination of D.................. D.
(previously dosages for medical
35.63(e)). use.
35.67(b) & (g)........... Amend................ Requirements for H&S................ H&S.
possession of
sealed sources and
brachytherapy
sources.
35.69.................... Amend................ Labeling of vials H&S................ H&S.
and syringes.
35.70(a)................. Amend................ Surveys for ambient H&S................ H&S.
radiation exposure
rate.
35.76.................... New.................. Safety precautions ................... H&S.
for individuals not
eligible for
release under Sec.
35.75.
35.80(a)(2)(4), (b), & Remove............... Provision of mobile H&S/D..............
(c). medical service.
35.92(a)................. Amend................ Decay-in-storage.... H&S--for those H&S--for those
States which States which
authorize this authorize this
activity D for activity D for
States that do not. States that do
not.
35.93(a) & (b)........... Amend/Redesignate Permissible H&S................ H&S.
(previously concentrations for
35.204(a)). generatorproduced
radionuclides.
35.93(b)................. New.................. Permissible ................... H&S.
concentrations for
generatorproduced
radionuclides.
35.93(c)................. Amend/Redesignate Permissible H&S................ H&S.
(previously concentrations for
35.204(b)). generatorproduced
radionuclides.
35.93(d)................. Amend/Redesignate Permissible D.................. D.
(previously concentrations for
35.204(c)). generatorproduced
radionuclides.
35.93(e)................. New.................. Permissible ................... D.
concentrations for
generatorproduced
radionuclides.
35.100................... Amend................ Use of unsealed H&S................ H&S.
byproduct material
for uptake,
dilution, and
excretion studies
for which a written
directive is not
required.
35.190................... Amend/Redesignate.... Training for uptake, B.................. B.
dilution, and
excretion studies.
35.200................... Amend................ Use of unsealed H&S................ H&S.
byproduct material
for imaging and
localization
studies.
35.204................... Remove............... Permissible H&S/D..............
molybdenum-99,
strontium-82, and
strontium-85
concentrations.
35.290................... Amend/Redesignate.... Training for imaging B.................. B.
and localization
studies.
35.300................... Category designation Use of unsealed B.................. H&S.
change. byproduct material
for which a written
directive is
required.
35.315................... Remove............... Safety precautions.. H&S................
35.390................... Amend/Redesignate.... Training for use of B.................. B.
unsealed byproduct
material for which
a written directive
is required.
35.392................... Amend/Redesignate.... Training for the B.................. B.
oral administration
of sodium iodide I-
131 requiring a
written directive
in quantities less
than or equal to
1.22 gigabecquerels
(33 millicuries).
35.394................... Amend/Redesignate.... Training for the B.................. B.
oral administration
of sodium iodide I-
131 requiring a
written directive
in quantities
greater than 1.22
gigabecquerels (33
millicuries).
35.396................... Amend/Redesignate.... Training for the B.................. B.
parenteral
administration of
unsealed byproduct
material requiring
a written directive.
35.404(a) & (b).......... Amend................ Surveys after source H&S................ H&S.
implant and removal.
35.415(a) & (c).......... Remove............... Safety precautions.. H&S................
35.415................... Redesignate Safety precautions.. H&S................ H&S.
(previously
35.415(b)).
35.432(a)................ Amend................ Calibration H&S................ H&S.
measurements of
brachytherapy
sources.
35.433(a)................ Amend................ Decay of strontium- B.................. B.
90 sources for
ophthalmic
treatments.
35.433(b)(1)............. Amend................ Decay of strontium- H&S................ H&S.
90 sources for
ophthalmic
treatments.
35.433(c)................ Amend................ Decay of strontium- D.................. D.
90 sources for
ophthalmic
treatments.
35.490(a) & (b).......... Amend/Redesignate.... Training for use of B.................. B.
manual
brachytherapy
sources.
[[Page 47080]]
35.490(c)................ New.................. Training for use of ................... B.
manual
brachytherapy
sources.
35.491(a) & (b).......... Amend................ Training for B.................. B.
ophthalmic use of
strontium-90.
35.491(c)................ New.................. Training for ................... B.
ophthalmic use of
strontium-90.
35.590................... Amend/Redesignate.... Training for use of B.................. B.
sealed sources and
medical devices for
diagnosis.
35.604(a)................ Amend................ Surveys of patients H&S................ H&S.
and human research
subjects treated
with a remote
afterloader unit.
35.610(a)(1), (d)(1) & Amend................ Safety procedures H&S................ H&S.
(e). and instructions
for remote
afterloader units,
teletherapy units,
and gamma
stereotactic
radiosurgery units.
35.615................... Amend................ Safety precautions H&S................ H&S.
for remote
afterloader units,
teletherapy units,
and gamma
stereotactic
radiosurgery units.
35.632(a), (c), (d) & (e) Amend................ Full calibration H&S................ H&S.
measurements on
teletherapy units.
35.632(g)................ Amend................ Full calibration D.................. D.
measurements on
teletherapy units.
35.633(a), (c), (d), (e), Amend................ Full calibration H&S................ H&S.
(g). measurements on
remote afterloader
units.
35.633(i)................ Amend................ Full calibration D.................. D.
measurements on
remote afterloader
units.
35.635(a)(e)............. Amend................ Full calibration H&S................ H&S.
measurements on
gamma stereotactic
radiosurgery units.
35.635(g)................ Amend................ Full calibration D.................. D.
measurements on
gamma stereotactic
radiosurgery units.
35.643(a)(e)............. Amend................ Periodic spotchecks H&S................ H&S.
for remote
afterloader units.
35.643(f)................ Amend................ Periodic spotchecks D.................. D.
for remote
afterloader units.
35.645(a)-(e)............ Amend/Redesignate.... Periodic spotchecks H&S................ H&S.
for gamma
stereotactic
radiosurgery units.
35.645(f)................ Amend/Redesignate Periodic spotchecks D.................. D.
(previously for gamma
35.645(g)). stereotactic
radiosurgery units.
35.690................... Amend/Redesignate.... Training for use of B.................. B.
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
35.700................... New.................. Use of microsources ................... H&S.
for microsource
brachytherapy.
35.710(a)................ New.................. Safety procedures ................... C.
and instruction.
35.710(b)(d) & (f)....... New.................. Safety procedures ................... H&S.
and instruction.
35.710(e)................ New.................. Safety procedures ................... D.
and instruction.
35.790................... New.................. Training for use of ................... B.
microsources.
35.1000.................. Amend................ Other medical uses D.................. D.
of byproduct
material or
radiation from
byproduct material.
35.2059.................. New.................. Records of ................... D.
Continuing
Education and
Training.
35.2060.................. Amend................ Records of D.................. D.
calibrations of
instruments used to
measure the
activity of
unsealed byproduct
material.
35.2063.................. Amend................ Records of dosages D.................. D.
for medical use.
35.2080(b)............... Remove............... Records of mobile D..................
medical services.
35.2093.................. Amend/Redesignate Records of generator D.................. D.
(previously 35.2204). breakthrough
testing.
35.2204.................. Remove............... Records of D..................
molybdenum-99,
strontium-82, and
strontium-85
concentrations.
35.2310.................. Amend................ Records of safety D.................. D.
instruction.
35.2404.................. Amend................ Records of surveys D.................. D.
after source
administration and
removal.
35.2406.................. Amend................ Records of D.................. D.
brachytherapy
sealed source
accountability.
35.2433.................. Amend................ Records of decay of D.................. D.
betaemitting
sources for
ophthalmic
treatments.
35.2642.................. Amend................ Records of periodic D.................. D.
spotchecks for
teletherapy units.
35.2643.................. Amend................ Records of periodic D.................. D.
spotchecks for
remote afterloader
units.
[[Page 47081]]
35.2645.................. Amend................ Records of periodic D.................. D.
spotchecks for
gamma stereotactic
radiosurgery units.
35.2710.................. New.................. Records of safety ................... D.
procedures and
instruction.
35.3045.................. Amend................ Report and C.................. C.
notification of a
medical event.
35.3047(a)(1) & (2)...... New/Redesignate...... Report and ................... C.
notification of a
dose to an embryo/
fetus or a nursing
child.
35.3093.................. New.................. Report and ................... C.
notification for an
eluate exceeding
breakthrough limits.
35.3204.................. Remove (has been Report and C..................
incorporated into notification for an
35.3093). eluate exceeding
permissible
molybdenum-99,
strontium-82, and
strontium-85
concentrations.
----------------------------------------------------------------------------------------------------------------
XVI. 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 on
this proposed rule at a publicly held teleconference with the full
committee during the public comment period.
XVII. 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. In this proposed rule, the NRC
would revise the NRC requirements in 10 CFR part 35 to reduce overly
prescriptive regulations, increase flexibility, and modernize radiation
safety practices for the medical use of byproduct material. This action
also would enable more efficient and predictable licensing for emerging
medical technologies and reduce unnecessary burden in training and
experience requirements for medical authorized users. This action does
not constitute the establishment of a standard that contains generally
applicable requirements.
XVIII. Availability of Guidance
The NRC expects to update NUREG-1556, Volume 9, ``Consolidated
Guidance About Materials Licenses: Program-Specific Guidance About
Medical Use Licenses,'' 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. The NRC is
issuing interim guidance, in the form of frequently asked questions,
for implementation of the requirements in this rulemaking, as
finalized. The draft guidance is available in ADAMS under Accession No.
ML26167A223 and in the docket for this proposed rule (NRC-2025-1237).
You may submit comments on the draft regulatory guidance by the methods
outlined in the ADDRESSES section of this document.
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./Federal
Document Register citation
------------------------------------------------------------------------
Proposed Rule: Reducing Barriers to ML26167A223.
Medical Use Licensing--Frequently Asked
Questions, July 2026.
Unofficial Redline of the NRC's Proposed ML25349A081.
Rule: Reducing Barriers to Medical Use
Licensing, July 2026.
Proposed Rule Supporting Statement, ML25349A079.
``Reducing Barriers to Medical Use
Licensing''.
Proposed Rule: Reducing Barriers to ML25349A082.
Medical Use Licensing Burden Tables.
NRC Form 313A (RSO), Radiation Safety ML26064A071.
Officer or Associate Radiation Safety
Officer, Training, Experience and
Preceptor Attestation.
NRC Form 313A (ANP), Authorized Nuclear ML26065A073.
Pharmacist, Training, Experience and
Preceptor Attestation.
NRC Form 313A (AMP), Authorized Medical ML26065A074.
Physicist or Ophthalmic Physicist,
Training, Experience and Preceptor
Attestation.
NRC Form 313A (AUT), Authorized User ML26078A320.
Training, Experience and Preceptor
Attestation (for uses defined under
35.300).
NRC Form 313A (AUS), Authorized User ML26078A321.
Training, Experience and Preceptor
Attestation (for uses defined under
35.400 and 35.600).
NRC Form 313A (AUD), Authorized User ML26084A017.
Training, Experience and Preceptor
Attestation (for uses defined under
35.100, 35.200, and 35.500).
NRC Form 313A (AUM), Authorized User ML26085A524.
Training, Experience and Preceptor
Attestation (for uses defined under
35.700).
Final Rule--Medical Use of Byproduct 67 FR 20250.
Material, April 24, 2002.
Final Rule--Medical Use of Byproduct 70 FR 16336.
Material--Recognition of Specialty
Boards, March 30, 2005.
Final Rule--Requirements for Expanded 72 FR 55864.
Definition of Byproduct Material,
October 1, 2007.
[[Page 47082]]
NRC Information Notice 2024-04, Recent ML24138A129.
Medical Events involving Administration
of Therapeutic Radiopharmaceuticals,
August 9, 2024.
NRC Information Notice 2019-07, Methods ML19240A450.
to Prevent Medical Events, August 26,
2019.
ACMUI Subcommittee on Patient ML20097F476.
Intervention Report, Final Report,
April 6, 2020.
ACMUI Subcommittee on Training & ML16089A271.
Experience for Authorized Users of
Alpha and Beta Emitters under 10 CFR
35.390, Final Report, March 16, 2016.
ACMUI Standing Subcommittee on Training ML17066A442.
and Experience Requirements, Status
Report, September 16, 2016.
ACMUI Subcommittee on Training and ML18051A725.
Experience Requirements for All
Modalities, Interim Report, February
19, 2018.
ACMUI Subcommittee on Training and ML25177A059.
Experience, Final Report, April 7, 2025.
Policy Statement--Medical Use of 65 FR 47654.
Byproduct Material Policy Statement,
August 3, 2000.
Final Rule--Misadministration Reporting 45 FR 31701.
Requirements, May 14, 1980.
SRM-M170817M--Affirmation Session, 10:30 ML17229B284.
A.M., Thursday, August 17, 2017,
Commissioners' Conference Room, One
White Flint North, Rockville, Maryland
(Open to Public Attendance).
SECY-18-0084, Staff Evaluation of ML18135A276 (Package).
Training and Experience Requirements
for Administering Different Categories
of Radiopharmaceuticals in Response to
SRM-M170817, August 28, 2018.
SECY-20-0005, Rulemaking Plan for ML19217A318 (Package).
Training and Experience Requirements
for Unsealed Byproduct Material (10 CFR
Part 35), January 13, 2020.
SRM-SECY-20-0005, Rulemaking Plan for ML22027A519.
Training and Experience Requirements
for Unsealed Byproduct Material (10 CFR
Part 35), January 27, 2022.
Regulatory Basis--Rubidium-82 88 FR 42654.
Generators, Emerging Technologies, and
Other Medical Use of Byproduct
Material, July 3, 2023.
Regulatory Basis--Rubidium-82 ML23122A356.
Generators, Emerging Technologies, and
Other Medical Use of Byproduct
Material, June 2023.
Enforcement Guidance Memorandum--Interim ML13101A318.
Guidance for Dispositioning Violations
Involving 10 CFR 35.60 and 10 CFR 35.63
for the Calibration of Instrumentation
to Measure the Activity of Rubidium-82
and the Determination of Rubidium-82
Patient Dosages, EGM-13-003, April 18,
2013.
ACMUI Subcommittee on Training and ML25084A178.
Experience for All Modalities, Draft
Report, March 10, 2025.
Agreement State Program Policy 82 FR 48535.
Statement, October 18, 2017.
Consolidated Guidance About Materials ML19256C219.
Licenses: Program-Specific Guidance
About Medical Use Licenses, Final
Report (NUREG-1556, Volume 9, Revision
3), September 2019.
SECY-21-0013, Rulemaking Plan to ML20261H562.
Establish Requirements for Rubidium-82
Generators and Emerging Medical
Technologies, February 9, 2021.
ACMUI Subcommittee on ``Physical ML18071A413.
Presence Requirements for the Leksell
Gamma Knife[supreg] Icon\TM\,'' Final
Report, February 27, 2018.
Final Rule--Fee Schedules; Fee Recovery 91 FR 36470.
for Fiscal Year 2026, June 16, 2026.
Presidential Memorandum, ``Plain 63 FR 31885.
Language in Government Writing,'' June
10, 1998.
NRC Website: Regulatory Analysis........ https://www.nrc.gov/about-nrc/regulatory/rulemaking/regulatory-analysis.
Executive Order 12866, ``Regulatory 58 FR 51735.
Planning and Review,'' October 4, 1993.
Executive Order 14154, ``Unleashing 90 FR 8353.
American Energy,'' January 29, 2025.
Executive Order 14192, ``Unleashing 90 FR 9065.
Prosperity Through Deregulation,''
February 6, 2025.
Executive Order 14215, ``Ensuring 90 FR 10447.
Accountability for All Agencies,''
February 24, 2025.
Executive Order 14267, ``Reducing Anti- 90 FR 15629.
Competitive Regulatory Barriers,''
April 15, 2025.
Executive Order 14270, ``Zero-Based 90 FR 15643.
Regulatory Budgeting to Unleash
American Energy,'' April 15, 2025.
Executive Order 14294, ``Fighting 90 FR 20363.
Overcriminalization in Federal
Regulations,'' May 14, 2025.
Executive Order 14300, ``Ordering the 90 FR 22587.
Reform of the Nuclear Regulatory
Commission,'' May 29, 2025.
------------------------------------------------------------------------
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-2025-1237. 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-2025-1237); (2) click
the ``Subscribe'' button; and (3) enter an email address and click on
the ``Subscribe'' button.
List of Subjects in 10 CFR Part 35
Biologics, Byproduct material, Criminal penalties, Drugs, Health
facilities, Health professions, Labeling, Medical devices, Nuclear
energy, Nuclear materials, Occupational safety and health, Penalties,
Radiation
[[Page 47083]]
protection, Reporting and recordkeeping requirements.
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 part 35.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
0
1. The authority citation for part 35 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282, 2021);
Energy Reorganization Act sec. 201, 206 (42 U.S.C. 5841, 5846); 44
U.S.C. 3504 note.
0
2. In Sec. 35.2:
0
a. Revise the definition for ``Authorized user'';
0
b. Add in alphabetical order the definitions for ``Breakthrough'',
``Emergent patient condition'', and ``Gamma stereotactic
radiosurgery'';
0
c. Revise the definition for ``Manual brachytherapy'';
0
d. Add in alphabetical order the definitions for ``Microsource'' and
``Microsource brachytherapy'';
0
e. Revise the definitions for ``Physician'' and ``Prescribed dosage'';
0
f. Add in alphabetical order the definition for ``Shunting'';
0
g. Remove the definition for ``Stereotactic radiosurgery''; and
0
h. Revise the definition for ``Teletherapy''.
The revisions and additions read as follows:
Sec. 35.2 Definitions.
* * * * *
Authorized user means a physician, dentist, or podiatrist who--
(1) Meets the requirements in Sec. Sec. 35.59 and 35.190, 35.290,
35.390(b), 35.392(b), 35.394(b), 35.490(b), 35.590(b), or 35.690(b); or
(2) Is identified as an authorized user on--
(i) A Commission or Agreement State license that authorizes the
medical use of byproduct material;
(ii) A permit issued by a Commission master material licensee that
is authorized to permit the medical use of byproduct material;
(iii) A permit issued by a Commission or Agreement State specific
licensee of broad scope that is authorized to permit the medical use of
byproduct material; or
(iv) A permit issued by a Commission master material license broad
scope permittee that is authorized to permit the medical use of
byproduct material.
* * * * *
Breakthrough, as used in this part, means the unintended presence
of the parent radionuclide impurity, expressed as a percentage of the
total activity of the intended daughter radionuclide, at the time of
elution.
* * * * *
Emergent patient condition means an unexpected development or acute
change in a patient's condition that occurs during the administration
which causes a deviation from the planned administration.
* * * * *
Gamma stereotactic radiosurgery, as used in this part, means a
method of radiation therapy in which collimated external beams of
ionizing radiation are delivered from an external source to a patient
or human research subject using stereotactic guidance to deliver a
localized therapeutic dose to a treatment site.
* * * * *
Manual brachytherapy, as used in this part, means a type of
brachytherapy, other than microsource brachytherapy, in which the
brachytherapy sources (e.g., seeds, ribbons, and embedded mesh) are
manually placed topically on or inserted either into the body cavities
that are in close proximity to a treatment site or directly into the
tissue volume.
* * * * *
Microsource means inert solid microspheres or microparticles
containing radioactive material and dispersed in a carrier solution
designed to deliver targeted therapeutic dose to a treatment site.
Microsource brachytherapy means a type of brachytherapy in which
microsources are administered through parenteral methods, to deliver
targeted therapeutic dose to a treatment site. Microsource
brachytherapy is not a form of manual brachytherapy.
* * * * *
Physician means an individual licensed by a State or Territory of
the United States, the District of Columbia, or the Commonwealth of
Puerto Rico to prescribe drugs in the practice of medicine.
* * * * *
Prescribed dosage means the specified activity or range of activity
of unsealed byproduct material or microsource as documented--
(1) In a written directive; or
(2) In accordance with the directions of the authorized user for
procedures performed pursuant to Sec. Sec. 35.100 and 35.200.
* * * * *
Shunting means blood flow through pathway or bypass due to patient
vasculature causing microsources to flow to an unwanted location.
* * * * *
Teletherapy, as used in this part, means a method of radiation
therapy in which collimated external beams of ionizing radiation are
delivered from an external source to a patient or human research
subject without stereotactic guidance to deliver a therapeutic dose to
a treatment site.
* * * * *
Sec. 35.5 [Removed and Reserved]
0
3. Remove and reserve Sec. 35.5.
0
4. Revise Sec. 35.6 to read as follows:
Sec. 35.6 Provisions for the protection of human research subjects.
* * * * *
(b) Before conducting research, the licensee must--
(1) Obtain review and approval of the research from an
``Institutional Review Board,'' as defined and described in the Federal
Policy for the Protection of Human Subjects (Federal Policy); and
(2) Obtain ``informed consent,'' as defined and described in the
Federal Policy, from the human research subject.
(c) Nothing in this section relieves licensees from complying with
the other requirements in this part.
0
5. In Sec. 35.8:
0
a. Remove the reference ``3501et seq.'' and add in its place the
reference ``3501 et seq.'' wherever it appears; and
0
b. Revise paragraph (b).
The revision reads as follows:
Sec. 35.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 35.12, 35.13, 35.14, 35.19, 35.24,
35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.59, 35.60, 35.61,
35.63, 35.67, 35.69, 35.70, 35.75, 35.76, 35.80, 35.92, 35.93, 35.190,
35.204, 35.290, 35.310, 35.315, 35.390, 35.392, 35.394, 35.396, 35.404,
35.406, 35.410, 35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604,
35.605, 35.610, 35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643,
35.645, 35.647, 35.652, 35.655, 35.690, 35.710, 35.1000, 35.2024,
35.2026, 35.2040, 35.2041, 35.2059, 35.2060, 35.2061, 35.2063, 35.2067,
35.2070, 35.2075, 35.2080, 35.2092, 35.2093, 35.2310, 35.2404, 35.2406,
35.2432, 35.2433, 35.2605, 35.2610, 35.2630, 35.2632, 35.2642,
[[Page 47084]]
35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 35.2710, 35.3045, 35.3047,
35.3067, and 35.3093.
Sec. 35.10 [Amended]
0
6. In Sec. 35.10, remove and reserve paragraph (a).
0
7. In Sec. 35.11:
0
a. Revise and republish paragraph (a); and
0
b. Remove and reserve paragraph (c).
The revisions read as follows:
Sec. 35.11 License required.
(a) A person may manufacture, produce, acquire, receive, possess,
prepare, use, or transfer byproduct material for medical use only in
accordance with a specific license issued by the Commission or an
Agreement State, or as allowed in paragraph (b) of this section.
* * * * *
0
8. In Sec. 35.12, revise and republish paragraphs (b) through (d) to
read as follows:
Sec. 35.12 Application for license, amendment, or renewal.
* * * * *
(b) An application for a license for medical use of byproduct
material must be made by--
(1) Filing an original NRC Form 313, ``Application for Material
License,'' that includes the facility diagram, equipment, and training
and experience qualifications of the Radiation Safety Officer,
Associate Radiation Safety Officer(s), authorized user(s), authorized
medical physicist(s), ophthalmic physicist(s), and authorized nuclear
pharmacist(s); and
(2) Submitting procedures required by Sec. Sec. 35.60, 35.610,
35.642, 35.643, and 35.645, as applicable.
(c) A request for a license amendment or renewal must be made by--
(1) Submitting an original of either--
(i) NRC Form 313, ``Application for Material License''; or
(ii) A letter containing all information required by NRC Form 313;
and
(2) Submitting procedures required by Sec. Sec. 35.60, 35.610,
35.642, 35.643, and 35.645, as applicable.
(d) In addition to the requirements in paragraphs (b) and (c) of
this section, an application for a license or amendment for medical use
of byproduct material as described in Sec. 35.1000 must also include:
(1) Any additional aspects of the medical use of the material that
are applicable to radiation safety that are not addressed in, or differ
from, subparts A through C, L, and M of this part;
(2) Identification of and commitment to follow the applicable
radiation safety program requirements in subparts D through I of this
part that are appropriate for the specific Sec. 35.1000 medical use;
(3) Any additional specific information on--
(i) Radiation safety precautions and instructions;
(ii) Methodology for measurement of dosages or doses to be
administered to patients or human research subjects; and
(iii) Calibration, maintenance, and repair of instruments and
equipment necessary for radiation safety; and
(4) Any other information requested by the Commission in its review
of the application.
* * * * *
0
9. In Sec. 35.13:
0
a. Revise the introductory text to Sec. 35.13;
0
b. Remove and reserve paragraph (a);
0
c. Revise the introductory text to paragraph (b) and paragraph (b)(1);
0
d. Revise paragraph (f) by removing the references ``or Sec. 35.200''
and adding in its place the references to ``or 35.200'' wherever it may
appear; and
0
e. Revise paragraph (h).
The revisions read as follows:
Sec. 35.13 License amendments.
A licensee must apply for and must receive a license amendment--
* * * * *
(b) Before it permits anyone to work as an authorized user for
medical use of byproduct material as described in Sec. Sec. 35.300,
35.400, 35.600, 35.700, and 35.1000, authorized medical physicist,
ophthalmic physicist, or authorized nuclear pharmacist under the
license, except--
(1) For an authorized user, an individual who meets the
requirements in Sec. Sec. 35.59 and 35.390(b), 35.392(b), 35.394(b),
35.490(b), 35.590(b), and 35.690(b);
* * * * *
(f) Before it adds to or changes the areas of use identified in the
application or on the license, including areas used in accordance with
either Sec. 35.100 or 35.200 if the change includes addition or
relocation of either an area where PET radionuclides are produced or a
PET radioactive drug delivery line from the PET radionuclide/PET
radioactive drug production area. Other areas of use where byproduct
material is used only in accordance with either Sec. 35.100 or 35.200
are exempt;
* * * * *
(h) Before it revises procedures required by Sec. Sec. 35.60,
35.610, 35.642, 35.643, 35.645, and 35.710, as applicable, where such
revision reduces radiation safety; and
* * * * *
Sec. 35.14 [Amended]
0
10. In Sec. 35.14:
0
a. In paragraph (a)(1)(ii), remove the reference ``Sec.
35.390(b)(1)(ii)(G)'' and add in its place the reference ``Sec.
35.390(a)(2)(ii)(G)''; and
0
b. In paragraph (b)(5), remove the reference ``Sec. 35.200'' and add
in its place the reference ``35.200''.
0
11. In Sec. 35.24:
0
a. Remove the time period ``60 days'' and add in its place the time
period ``120 days'' wherever it may appear; and
0
b. Revise paragraphs (a)(3), (f), and (g).
The addition and revision read as follows:
Sec. 35.24 Authority and responsibilities for the radiation
protection program.
(a) * * *
(3) Radiation protection program changes that do not require a
license amendment and are permitted under Sec. 35.26.
* * * * *
(f) Licensees that are authorized for two or more different types
of uses of byproduct material under subparts E, F, H, I, and K of this
part which require a written directive, or two or more types of units
under subpart H of this part, must establish a Radiation Safety
Committee to oversee all uses of byproduct material permitted by the
license. The Committee must include an authorized user of each type of
use permitted by the license, the Radiation Safety Officer, and a
representative of management who is neither an authorized user nor a
Radiation Safety Officer. The Committee may include other members the
licensee considers appropriate.
(g) A licensee must provide the Radiation Safety Officer sufficient
authority, organizational freedom, time, resources, and management
prerogative, to--
(1) Identify radiation safety problems;
(2) Initiate, recommend, or provide corrective actions;
(3) Stop unsafe operations;
(4) Verify implementation of corrective actions; and
(5) Verify the training and experience of an individual meets Sec.
35.190 prior to authorizing use under Sec. Sec. 35.100 and 35.290
prior to authorizing use under Sec. 35.200.
* * * * *
0
12. In Sec. 35.27, revise paragraph (a)(1) to read as follows:
Sec. 35.27 Supervision.
(a) * * *
[[Page 47085]]
(1) In addition to the requirements in Sec. 19.12 of this chapter,
instruct the supervised individual in the licensee's written radiation
protection procedures, procedures for administrations requiring a
written directive, regulations of this chapter, and license conditions
with respect to the use of byproduct material; and
* * * * *
0
13. In Sec. 35.40, revise and republish paragraphs (a), (b), and (d)
to read as follows:
Sec. 35.40 Written directives.
(a) A written directive must be dated and signed by an authorized
user before the administration of any therapeutic dosage of unsealed
byproduct material or any therapeutic dose of radiation from byproduct
material.
(1) If, because of the emergent nature of the patient's condition,
a delay in order to provide a written directive would jeopardize the
patient's health, an oral directive is acceptable. The information
contained in the oral directive must be documented as soon as possible
in writing in the patient's record. A written directive must be
prepared within 48 hours of the oral directive.
(2) After administration, the portion of the written directive
described in (5)(ii) and (6)(ii) of this part must be signed and dated
by an authorized user within 24 hours if the treatment site, total
source strength, dose or activity administered changes.
(b) The written directive must contain the patient or human
research subject's name and the following information--
(1) For an administration of a therapeutic dosage of unsealed
byproduct material: the radioactive drug, dosage, and route of
administration;
(2) For gamma stereotactic radiosurgery: the total dose for each
treatment site(s); dose per fraction and the number of fractions for
treatment plan with multiple fractions; and geometry settings;
(3) For teletherapy: the total dose, dose per fraction, number of
fractions, and treatment site;
(4) For high dose-rate remote afterloading brachytherapy: The
radionuclide, treatment site, dose per fraction, number of fractions,
and total dose;
(5) For permanent manual or microsource brachytherapy:
(i) Before administration: The treatment site, the radionuclide,
and the total source strength or prescribed dosage; and
(ii) After administration but before the patient leaves the post-
treatment recovery area: The treatment site, the number of sources and
total source strength or activity administered, and the date; or
(6) For all other brachytherapy, including low, medium, and pulsed
dose-rate remote afterloaders:
(i) Before administration: The treatment site, radionuclide, and
dose; and
(ii) After administration but before completion of the procedure:
The treatment site; number of sources; total source strength and
exposure time (or the total dose); and date.
* * * * *
(d) The licensee must retain a copy of the written directive in
accordance with Sec. 35.2040.
0
14. In Sec. 35.41, revise the introductory text to paragraph (b) and
paragraphs (b)(4) and (6) to read as follows:
Sec. 35.41 Procedures for administrations requiring a written
directive.
* * * * *
(b) At a minimum, the procedures required by this section must
address the following items that are applicable to the licensee's use
of byproduct material--
* * * * *
(4) Verifying that any computer-generated dose calculations are
correctly transferred into the consoles of therapeutic medical units;
* * * * *
(6) Determining, for permanent manual brachytherapy, within 60
calendar days from the date the administration was performed, the total
source strength administered outside of the treatment site compared to
the total source strength documented in the post-administration portion
of the written directive, unless a written justification of patient
unavailability is documented.
* * * * *
0
15. In Sec. 35.50:
0
a. Remove paragraph (a) and redesignate paragraphs (b) and (c) as
paragraphs (a) and (b), respectively;
0
b. In newly redesignated paragraph (a)(2), remove the reference
``paragraphs (b)(1) and (d) of this section'' and add in its place the
reference ``paragraphs (a)(1) and (d) of this section'';
0
c. Revise newly redesignated paragraphs (b)(1) and (3);
0
d. Add new paragraph (c); and
0
e. Revise paragraph (d).
The revisions and additions read as follows:
Sec. 35.50 Training for Radiation Safety Officer and Associate
Radiation Safety Officer.
* * * * *
(b)(1) Is a medical physicist who has been certified by a specialty
board whose certification process has been recognized by the Commission
or an Agreement State under Sec. 35.58(l), has experience with the
radiation safety aspects of similar types of use of byproduct material
for which the licensee seeks the approval of the individual as
Radiation Safety Officer or an Associate Radiation Safety Officer, and
meets the requirements in paragraph (d) of this section; or
* * * * *
(3) Has experience with the radiation safety aspects of types of
use of byproduct material for which the individual is seeking approval
both as the Radiation Safety Officer and the authorized user on the
same medical use license or medical use permit issued by a Commission
master material licensee. The individual must also meet the
requirements in paragraph (d) of this section; or
(c) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(k); and
(d) Has training in radiation safety, regulatory issues, and
emergency procedures for the types of use for which a licensee seeks
approval. This training requirement may be satisfied by completing
training that is supervised by a Radiation Safety Officer, an Associate
Radiation Safety Officer, authorized medical physicist, authorized
nuclear pharmacist, or authorized user, as appropriate, who is
authorized for the type(s) of use for which the licensee is seeking
approval.
* * * * *
0
16. In Sec. 35.51:
0
a. Remove paragraph (a) and redesignate paragraph (b) as paragraph (a);
0
b. Revise newly redesignated paragraph (a)(2); and
0
c. Add new paragraph (b).
The revision and addition read as follows:
Sec. 35.51 Training for an authorized medical physicist.
* * * * *
(a) * * *
(2) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) and (c)
of this section, and is able to independently fulfill the radiation
safety-related duties as an authorized medical physicist for each type
of therapeutic medical unit for which the individual is requesting
authorized medical physicist status. The written attestation must be
signed by a preceptor authorized medical physicist who meets the
requirements in Sec. 35.51,
[[Page 47086]]
35.57, or equivalent Agreement State requirements for an authorized
medical physicist for each type of therapeutic medical unit for which
the individual is requesting authorized medical physicist status; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(l); and
* * * * *
0
17. In Sec. 35.55:
0
a. Remove paragraph (a) and redesignate paragraph (b) as paragraph (a);
0
b. Revise newly redesignated paragraph (a)(2); and
0
c. Add new paragraph (b).
The revision and addition read as follows:
Sec. 35.55 Training for an authorized nuclear pharmacist.
* * * * *
(a) * * *
(2) Has obtained written attestation, signed by a preceptor
authorized nuclear pharmacist, that the individual has satisfactorily
completed the requirements in paragraph (a)(1) of this section and is
able to independently fulfill the radiation safety-related duties as an
authorized nuclear pharmacist; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(m).
0
18. In Sec. 35.57:
0
a. In paragraph (a)(1), remove the phrase ``Sec. 35.50, Sec. 35.51,
or Sec. 35.55, respectively, except the Radiation Safety Officers and
authorized medical physicists identified in this paragraph must meet
the training requirements in Sec. 35.50(d) or Sec. 35.51(c)'' and add
in its place the phrase ``Sec. 35.50, 35.51, or 35.55, respectively,
except the Radiation Safety Officers and authorized medical physicists
identified in this paragraph must meet the training requirements in
Sec. 35.50(d) or 35.51(c)'';
0
b. In paragraph (a)(4), remove the phrase ``the training requirements
of Sec. 35.50, Sec. 35.51 or Sec. 35.55'' and add in its place the
phrase ``the training requirements of Sec. 35.50, 35.51 or 35.55'';
0
c. Revise paragraph (b)(2)(i);
0
d. In paragraph (b)(2)(iii), remove the reference ``Sec. 35.600'' and
add in its place the reference ``35.600''; and
0
e. Add paragraph (b)(4).
The addition and revisions read as follows:
Sec. 35.57 Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized medical physicist,
authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
* * * * *
(b) * * *
(2) * * *
(i) For uses authorized under Sec. 35.100 or 35.200, a physician
who was certified on or before October 24, 2005, in nuclear medicine by
the American Board of Nuclear Medicine; diagnostic radiology by the
American Board of Radiology; diagnostic radiology or radiology by the
American Osteopathic Board of Radiology; nuclear medicine by the Royal
College of Physicians and Surgeons of Canada; or American Osteopathic
Board of Nuclear Medicine in nuclear medicine;
* * * * *
(4) Physicians identified as authorized users for the medical use
of byproduct material under Sec. 35.1000 on a license issued by the
Commission or an Agreement State, a permit issued by a Commission
master material licensee, a permit issued by a Commission or an
Agreement State broad scope licensee, or a permit issued in accordance
with a Commission master material broad scope license on or before
[DATE 30 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER], need not comply with the training requirements for
which the physician was authorized, as follows:
(i) For uses authorized under Sec. 35.400 for ophthalmic
treatments, need not comply with training requirements of Sec. 35.491
except for device-specific training under Sec. 35.491(c) for any
devices for which they were not authorized prior to this date.
(ii) For uses authorized under Sec. 35.600, need not comply with
training requirements under Sec. 35.690 except for device-specific
training under Sec. 35.690(c) for any devices for which they were not
authorized prior to this date; and
(iii) For uses authorized under Sec. 35.700, need not comply with
training requirements of Sec. 35.790 except for microsource training
under Sec. 35.790(c) for any microsources for which they were not
authorized prior to this date.
* * * * *
0
19. Add Sec. 35.58 to read as follows:
Sec. 35.58 Specialty board certification approval.
The names of board certification that have been recognized by the
Commission or an Agreement State to confirm a physician has adequate
training and experience for medical use of byproduct material are
posted on the NRC's Medical Uses Licensee Toolkit web page.
(a) To have its certification process recognized for unsealed
byproduct material uses authorized under Sec. 35.100, a specialty
board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program
as described in Sec. 35.190(a)(1); or
(2) Successfully complete 60 hours of training and experience as
described in Sec. 35.190(a)(2); and
(3) Pass an examination, administered by diplomates of the
specialty board, that assesses knowledge and competence in radiation
safety, radionuclide handling, and quality control.
(b) To have its certification process recognized for unsealed
byproduct material uses authorized under Sec. 35.200, a specialty
board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program
as described in Sec. 35.290(a)(1); or
(2) Successfully complete 700 hours of training and experience as
described in Sec. 35.290(a)(2); and
(3) Pass an examination, administered by diplomates of the
specialty board, that assesses knowledge and competence in radiation
safety, radionuclide handling, and quality control.
(c) To have its certification process recognized for unsealed
byproduct material uses authorized under Sec. 35.300, a specialty
board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program
in nuclear medicine or radiation oncology as described in Sec.
35.390(a)(1); or
(2) Successfully complete an accredited residency training program
in a related medical specialty and complete 700 hours of training and
experience as described in Sec. 35.390(a)(2); and
(3) Pass an examination, administered by diplomates of the
specialty board, which tests knowledge and competence in radiation
safety, radionuclide handling, quality assurance, and clinical use of
unsealed byproduct material for which a written directive is required.
(d) To have its certification process recognized under Sec. 35.300
for oral administration of sodium iodide I-131 requiring a written
directive in quantities less than or equal to 1.22 gigabecquerels (33
millicuries), a specialty board must require all candidates for
certification to:
(1) Successfully complete an accredited residency training program
in nuclear medicine or radiation oncology as described in Sec.
35.392(a)(1); or
(2) Successfully complete an accredited residency training program
[[Page 47087]]
in a related medical specialty and complete 80 hours of training and
experience as described in Sec. 35.392(a)(2)(i) through (a)(2)(ii)(E);
and
(3) Pass an examination, administered by diplomates of the
specialty board, which tests knowledge and competence in radiation
safety, radionuclide handling, quality assurance, and clinical use of
unsealed byproduct material for which a written directive is required.
(e) To have its certification process recognized under Sec. 35.300
for oral administration of sodium iodide I-131 requiring a written
directive in quantities greater than 1.22 gigabecquerels (33
millicuries), a specialty board must require all candidates for
certification to:
(1) Successfully complete an accredited residency training program
in nuclear medicine or radiation oncology as described in Sec.
35.394(a)(1); or
(2) Successfully complete an accredited residency training program
in a related medical specialty and complete 80 hours of training and
experience as described in Sec. 35.394(a)(2)(i) through (a)(2)(ii)(E);
and
(3) Pass an examination, administered by diplomates of the
specialty board, which tests knowledge and competence in radiation
safety, radionuclide handling, quality assurance, and clinical use of
unsealed byproduct material for which a written directive is required.
(f) To have its certification process recognized for unsealed
byproduct material uses authorized under Sec. 35.300 for parenteral
administration requiring a written directive, a specialty board must
require all candidates for certification to:
(1) Successfully complete an accredited residency training program
in nuclear medicine or radiation oncology as described in Sec.
35.396(a)(1); or
(2) Successfully complete an accredited residency training program
in a related medical specialty and complete 80 hours of training and
experience as described in Sec. 35.396(a)(2)(i) through (a)(2)(ii)(E);
and
(3) Pass an examination, administered by diplomates of the
specialty board, which tests knowledge and competence in radiation
safety, radionuclide handling, quality assurance, and clinical use of
unsealed byproduct material for which a written directive is required.
(g) To have its certification process recognized for unsealed
byproduct material uses authorized under Sec. 35.400, a specialty
board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program
in radiation oncology and training and experience as described in Sec.
35.490(a)(1) and (2); and
(2) Pass an examination, administered by diplomates of the
specialty board, that tests knowledge and competence in radiation
safety, radionuclide handling, treatment planning, quality assurance,
and clinical use of manual brachytherapy;
(h) To have its certification process recognized for unsealed
byproduct material uses authorized under Sec. 35.500, a specialty
board must require all candidates for certification to obtain training
and experience described in Sec. 35.590.
(i) To have its certification process recognized for unsealed
byproduct material uses authorized under Sec. 35.600, a specialty
board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program
in radiation oncology and training and experience as described in Sec.
35.690(a)(1) and (2); and
(2) Pass an examination, administered by diplomates of the
specialty board, which tests knowledge and competence in radiation
safety, radionuclide handling, treatment planning, quality assurance,
and clinical use of stereotactic radiosurgery, remote afterloaders and
external beam therapy;
(j) [Reserved]
(k) To have its certification process recognized for individuals
fulfilling the responsibilities of the Radiation Safety Officer or an
individual's assigned duties and tasks as an Associate Radiation Safety
Officer, a specialty board must require all candidates for
certification to:
(1)
(i) Hold a bachelor's or graduate degree from an accredited college
or university in physical science or engineering or biological science
with a minimum of 20 college credits in physical science;
(ii) Have 5 or more years of professional experience in health
physics (graduate training may be substituted for no more than 2 years
of the required experience) including at least 3 years in applied
health physics; and
(iii) Pass an examination administered by diplomates of the
specialty board, which evaluates knowledge and competence in radiation
physics and instrumentation, radiation protection, mathematics
pertaining to the use and measurement of radioactivity, radiation
biology, and radiation dosimetry; or
(2)
(i) Hold a master's or doctor's degree in physics, medical physics,
other physical science, engineering, or applied mathematics from an
accredited college or university;
(ii) Have 2 years of full-time practical training and/or supervised
experience in medical physics--
(A) Under the supervision of a medical physicist who is certified
in medical physics by a specialty board recognized by the Commission or
an Agreement State; or
(B) In clinical nuclear medicine facilities providing diagnostic or
therapeutic services under the direction of physicians who meet the
requirements for authorized users in Sec. 35.57, 35.290, or 35.390;
and
(iii) Pass an examination, administered by diplomates of the
specialty board, that assesses knowledge and competence in clinical
diagnostic radiological or nuclear medicine physics and in radiation
safety;
(l) To have its certification process recognized for individuals
fulfilling the responsibilities of an authorized medical physicist, a
specialty board must require all candidates for certification to:
(1) Hold a master's or doctor's degree in physics, medical physics,
other physical science, engineering, or applied mathematics from an
accredited college or university;
(2) Have 2 years of full-time practical training and/or supervised
experience in medical physics--
(i) Under the supervision of a medical physicist who is certified
in medical physics by a specialty board whose certification process has
been recognized under this section by the Commission or an Agreement
State; or
(ii) In clinical radiation facilities providing high-energy,
external beam therapy (photons and electrons with energies greater than
or equal to 1 million electron volts) and brachytherapy services under
the direction of physicians who meet the requirements in Sec. 35.57,
35.490, or 35.690; and
(3) Pass an examination, administered by diplomates of the
specialty board, that assesses knowledge and competence in clinical
radiation therapy, radiation safety, calibration, quality assurance,
and treatment planning for external beam therapy, brachytherapy, and
stereotactic radiosurgery;
(m) To have its certification process recognized for individuals
fulfilling the responsibilities of an authorized nuclear pharmacist, a
specialty board must require all candidates for certification to:
(1) Have graduated from a pharmacy program accredited by the
Accreditation
[[Page 47088]]
Council for Pharmacy Education (ACPE) (previously named the American
Council on Pharmaceutical Education) or have passed the Foreign
Pharmacy Graduate Examination Committee (FPGEC) examination;
(2) Hold a current, active license to practice pharmacy;
(3) Provide evidence of having acquired at least 4000 hours of
training/experience in nuclear pharmacy practice. Academic training may
be substituted for no more than 2000 hours of the required training and
experience; and
(4) Pass an examination in nuclear pharmacy administered by
diplomates of the specialty board, that assesses knowledge and
competency in procurement, compounding, quality assurance, dispensing,
distribution, health and safety, radiation safety, provision of
information and consultation, monitoring patient outcomes, and research
and development.
0
20. Revise and republish Sec. 35.59 to read as follows:
Sec. 35.59 Continuing education.
(a) The licensee must ensure an authorized user has continuing
education and experience preceding the medical use of a source,
microsource, device, or radioactive drug for administrations requiring
a written directive. This must include, at a minimum--
(1) Education or experience in the administration of the source,
microsource, device, or radioactive drug within the 7 years preceding
administration; and
(2) Instruction on the regulations and licensee's written radiation
protection procedures, written directive procedures, and license
conditions with respect to the use.
(b) The licensee must ensure an authorized user has continuing
education and experience preceding the medical use of a source, device,
or radioactive drug for administrations not requiring a written
directive. This must include, at a minimum--
(1) Education or experience in the type of use within the 7 years
preceding administration; and
(2) Instruction on the regulations and licensee's written radiation
protection procedures and license conditions with respect to the use.
(c) The training and experience specified in subpart B for
Radiation Safety Officers, Associate Radiation Safety Officers,
Authorized Medical Physicist, and Authorized Nuclear Pharmacists of
this part must have been obtained within the 7 years preceding the date
of use or the individual must have had related continuing education and
experience since the required training and experience was completed.
(d) The licensee must retain a record of individuals' continuing
education and experience and instruction required by paragraphs (a),
(b), and (c) in accordance with Sec. 35.2059.
0
21. Revise and republish Sec. 35.60 to read as follows:
Sec. 35.60 Possession, use, and calibration of instruments used to
measure the activity of unsealed byproduct material and microsources.
(a) For direct measurements performed in accordance with Sec.
35.63, a licensee must possess and use instrumentation to measure the
activity of unsealed byproduct material and microsources before it is
administered to each patient or human research subject.
(b) A licensee must calibrate the instrumentation required in
paragraph (a) of this section in accordance with nationally recognized
standards or the manufacturer's instructions.
(c) Except for direct measurement described in paragraph (d) of
this section, if instrumentation required in paragraph (a) cannot be
calibrated in accordance with nationally recognized standards or the
manufacturer's instructions required in paragraph (b), the licensee
must submit written procedures for approval used to calibrate the
instrumentation required in paragraph (a) of this section.
(d) For direct measurements performed in accordance with Sec.
35.63(d), if radiation detector instrumentation cannot be calibrated in
dynamic use mode in accordance with paragraph (b) of this section, a
licensee must develop, implement, and maintain written test procedures
to ensure that--
(1) The infusion pump flow rate is consistent and accurate; and
(2) The radiation detector meets the manufacturer's specifications.
(e) A licensee must perform the tests required in paragraph (d) of
this section at least every 12 months and following repair that affects
the calibration.
(f) A licensee must retain a record of each instrument calibration,
test, and procedure required by this section in accordance with Sec.
35.2060.
0
22. In Sec. 35.61:
0
a. Revise paragraph (a)(1); and
0
b. Remove paragraph (a)(2) and redesignate paragraph (a)(3) as
paragraph (a)(2).
The revision reads as follows:
Sec. 35.61 Calibration of survey instruments.
* * * * *
(a) * * *
(1) Calibrate for the radiation type and energy range measured; and
* * * * *
0
23. Revise and republish Sec. 35.63 to read as follows:
Sec. 35.63 Determination of dosages for medical use.
(a) A licensee must determine and record the activity of each
dosage before medical use of unsealed byproduct material and
microsources, except for incremental administrations that meet the
criteria in paragraph (d) of this section.
(b) For a unit dosage, this determination must be made by--
(1) Direct measurement of radioactivity; or
(2) A decay correction, based on the activity or activity
concentration determined by--
(i) A manufacturer or preparer licensed under Sec. 32.72 or
distributor licensed under Sec. 32.74 of this chapter or equivalent
Agreement State requirements; or
(ii) An NRC or Agreement State licensee for use in research in
accordance with a Radioactive Drug Research Committee-approved protocol
or an Investigational New Drug (IND) protocol accepted by FDA; or
(iii) A PET radioactive drug producer and except for incremental
administrations that meet the criteria in paragraph (d) of this
section, licensed under Sec. 30.32(j) of this chapter or equivalent
Agreement State requirements.
(c) For other than unit dosages, this determination must be made
by--
(1) Direct measurement of radioactivity;
(2) Combination of measurement of radioactivity and mathematical
calculations; or
(3) Combination of volumetric measurements and mathematical
calculations, based on the radioactivity measurement made by:
(i) A manufacturer or preparer licensed under Sec. 32.72 of this
chapter or equivalent Agreement State requirements; or
(ii) A PET radioactive drug producer licensed under Sec. 30.32(j)
of this chapter or equivalent Agreement State requirements.
(d) For incremental administrations from a direct infusion system
that meet the criteria in paragraph (e) of this section, a licensee
must determine and record the activity of each administered dosage by--
(1) Measurement of radioactivity using a calibrated instrument that
is part of the direct infusion system or
[[Page 47089]]
(2) A combination of measurement of radioactivity and mathematical
calculations.
(e) A licensee may perform incremental administrations as direct
infusions only when the following criteria are met--
(1) The administered radioisotope has a half-life of less than
three minutes.
(2) A written directive is not required.
(3) The radioisotope is administered through direct infusion from
the generator or system without additional preparation steps.
(4) The administration is performed in accordance with the
manufacturer's guidelines and procedures.
(f) Unless otherwise directed by the authorized user, a licensee
may not use a dosage if the dosage does not fall within the prescribed
dosage range or if the dosage differs from the prescribed dosage by
more than 20 percent.
(g) A licensee must retain a record of the dosage determination
required by this section in accordance with Sec. 35.2063.
0
24. In Sec. 35.67, revise the introductory text to paragraph (b)
paragraph (g) to read as follows:
Sec. 35.67 Requirements for possession of sealed sources and
brachytherapy sources.
* * * * *
(b) A licensee in possession of a sealed source, excluding
microsources, must--
* * * * *
(g) A licensee in possession of sealed sources or brachytherapy
sources, except for gamma stereotactic radiosurgery sources and
microsources, must conduct a semi-annual physical inventory of all such
sources in its possession. The licensee must retain each inventory
record in accordance with Sec. 35.2067(b).
0
25. Revise Sec. 35.69 to read as follows:
Sec. 35.69 Labeling of vials and syringes.
Each syringe and vial that contains unsealed byproduct material
must be labeled to identify the radioactive drug, microsource, or
device. Each syringe shield and vial shield must also be labeled unless
the label on the syringe or vial is visible when shielded.
0
26. In Sec. 35.70, revise paragraph (a) to read as follows:
Sec. 35.70 Surveys of ambient radiation exposure rate.
(a) In addition to the surveys required by Part 20 of this chapter,
a licensee must survey with a radiation detection survey instrument at
the end of each day of use in all restricted areas and after each use
in all non-restricted areas. A licensee must survey all areas where
unsealed byproduct material or microsources requiring a written
directive was prepared for use or administered.
* * * * *
0
27. Add Sec. 35.76 to read as follows:
Sec. 35.76 Safety precautions for individuals not eligible for
release under Sec. 35.75.
(a) For each patient or human research subject who cannot be
released under Sec. 35.75, a licensee must:
(1) Maintain the individual in a private room or in a room with
another individual who also received such administration and cannot be
released under Sec. 35.75.
(2) For administrations involving unsealed byproduct material or
microsources:
(i) Provide access for the individual, without leaving the
controlled area, to a sanitary facility used only by individuals who
have received such administrations; and
(ii) Handle contaminated materials and items removed from the room
as radioactive waste, as appropriate; and
(3) Visibly post the individual's room with a ``Radioactive
Materials'' sign; and
(4) Note on the door or in the individual's chart the location and
duration visitors may stay in the patient's or human research subject's
room.
(b) A licensee must notify the Radiation Safety Officer, or his or
her designee, and an authorized user for the type of administration, as
soon as possible if the patient or human research subject has a medical
emergency or dies.
0
28. Revise and republish Sec. 35.80 to read as follows:
Sec. 35.80 Provision of mobile medical service.
A licensee providing mobile medical service must obtain a letter
signed by the management of each client for which services are rendered
that permits the use of byproduct material at the client's address and
clearly delineates the authority and responsibility of the licensee and
the client, and retain this letter in accordance with Sec. 35.2080.
Sec. 35.92 [Amended]
0
29. In Sec. 35.92, in the introductory text to paragraph (a), remove
the time period ``120 days'' and add in its place the time period ``275
days''.
0
30. Add Sec. 35.93 to read as follows:
Sec. 35.93 Permissible concentrations for generator-produced
radionuclides.
(a) A licensee that uses a radionuclide generator for preparing a
radiopharmaceutical must:
(1) Develop, implement, and maintain written procedures to define
acceptable breakthrough limits and breakthrough testing frequency
consistent with manufacturer's generator labeling as set forth in its
FDA product approval or nationally recognized standard.
(2) Prior to the first use for preparation of radioactive drugs of
a new generator or existing generator with an upgrade that affects the
operation and safety, provide operational and safety training to
measure and test the eluate for breakthrough to all individuals who
will elute the generator and training to process the eluate with
reagent kits to all individuals who prepare radioactive drugs; and
(3) Not administer an eluate to patients or human research subjects
if the breakthrough measurements exceed the limits established in
paragraph (a) of this section.
(b) In addition to the requirements of Sec. 19.12 of this chapter,
the licensee must initially or when there are significant changes to
the licensee's procedures, provide instruction in the licensee's
procedures identified in paragraph (a) of this section to individuals
involved in the use of generator systems, as appropriate to the
individual's assigned duties.
(c) The licensee must report any measurement that exceeds the
limits in paragraph (a) of this section at the time of generator
elution, in accordance with Sec. 35.3093.
(d) The licensee must retain a record of each breakthrough test in
accordance with Sec. 35.2093.
(e) A licensee must retain a record of individuals receiving
instruction required by paragraphs (a) and (b) of this section, in
accordance with Sec. 35.2310.
0
31. In Sec. 35.100, revise the section heading and the introductory
text to read as follows:
Sec. 35.100 Use of unsealed byproduct material for uptake, dilution,
and excretion studies.
A licensee may use any unsealed byproduct material prepared for
medical use for uptake, dilution, or excretion studies that is--
* * * * *
0
32. Revise and republish Sec. 35.190 to read as follows:
Sec. 35.190 Training for uptake, dilution, and excretion studies.
Except as provided in Sec. 35.57, the licensee must require an
authorized user of unsealed byproduct material for the uses authorized
under Sec. 35.100 to be a physician who--
(a)(1) Has successfully completed a minimum of 3 years of residency
[[Page 47090]]
training in a nuclear medicine, diagnostic radiology, or radiation
oncology accredited program which includes training and experience
topic areas as described in Sec. 35.190(a)(2); or
(2) Has completed 60 hours of training and experience, including a
minimum of 8 hours of classroom and laboratory training, in basic
radionuclide handling techniques applicable to the medical use of
unsealed byproduct material for uptake, dilution, and excretion
studies. The training and experience must include, at a minimum--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.100 or equivalent
Agreement State requirements, at a medical facility. The work
experience must involve--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to
determine the activity of dosages and performing checks for proper
operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely
and using proper decontamination procedures; and
(F) Administering dosages of radioactive drugs to patients or human
research subjects; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (a)(1) or (2) of
this section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized
under Sec. 35.100. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.190, 35.290, or 35.390, or equivalent Agreement State
requirements; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.190, 35.290, or 35.390, or equivalent
Agreement State requirements, and concurs with the attestation provided
by the residency program director. The residency training program must
be accredited and must include training and experience specified in the
topic areas in paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(a); or
(c) Is an authorized user under Sec. 35.290, 35.390, 35.396, or
equivalent Agreement State requirements.
0
33. In Sec. 35.200, revise the section heading and the introductory
text to read as follows:
Sec. 35.200 Use of unsealed byproduct material for imaging and
localization studies.
A licensee may use any unsealed byproduct material prepared for
medical use for imaging and localization studies that is--
* * * * *
Sec. 35.204 [Amended]
0
34. Remove Sec. 35.204.
0
35. Revise and republish Sec. 35.290 to read as follows:
Sec. 35.290 Training for imaging and localization studies.
Except as provided in Sec. 35.57, the licensee must require an
authorized user of unsealed byproduct material for the uses authorized
under Sec. 35.200 to be a physician who--
(a)(1) Has successfully completed a minimum of 3 years of residency
training in a nuclear medicine, diagnostic radiology, or radiation
oncology accredited program which includes training and experience
topic areas as described in Sec. 35.290(a)(2); or
(2) Has completed 700 hours of training and experience, including a
minimum of 80 hours of classroom and laboratory training, in basic
radionuclide handling techniques applicable to the medical use of
unsealed byproduct material for imaging and localization studies. The
training and experience must include, at a minimum--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use;
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.200 or equivalent
Agreement State requirements, at a medical facility. The work
experience must involve--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to
determine the activity of dosages and performing checks for proper
operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of unsealed byproduct material;
(E) Using procedures to safely contain spilled radioactive material
and using proper decontamination procedures; and
(F) Administering dosages of radioactive drugs to patients or human
research subjects; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (a)(1) or (2) of
this section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized
under Sec. Sec. 35.100 and 35.200. The attestation must be obtained
from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.290, or 35.390, or equivalent Agreement State requirements;
or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.290, or 35.390, or equivalent Agreement
State requirements, and concurs with the attestation provided by the
residency program director. The residency training program must be
accredited and must include training and experience specified in the
topic areas in paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(b); or
(c) Is an authorized user under Sec. 35.390, 35.396, or equivalent
Agreement State requirements.
Sec. 35.315 [Removed and Reserved]
0
36. Remove and reserve Sec. 35.315.
0
37. Revise and republish Sec. 35.390 to read as follows:
[[Page 47091]]
Sec. 35.390 Training for use of unsealed byproduct material for
which a written directive is required.
Except as provided in Sec. 35.57, the licensee must require an
authorized user of unsealed byproduct material for the uses authorized
under Sec. 35.300 to be a physician who--
(a)(1) Has successfully completed a minimum of 3 years of
accredited residency training in a nuclear medicine or radiation
oncology which includes training and experience topics as described in
Sec. 35.390(a)(2); or
(2) Has completed 700 hours of training and experience, including a
minimum of 200 hours of classroom and laboratory training, in basic
radionuclide handling techniques applicable to the medical use of
unsealed byproduct material requiring a written directive. The training
and experience must include, at a minimum--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.300 or equivalent
Agreement State requirements, at a medical facility. A supervising
authorized user must have experience in administering dosages in the
same dosage category or categories (i.e., Sec. 35.390(a)(2)(ii)(G)) as
the individual requesting authorized user status. The work experience
must involve--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to
determine the activity of dosages, and performing checks for proper
operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely
and using proper decontamination procedures;
(F) [Reserved]
(G) Preparing written directives and observing or performing
administration of dosages of radioactive drugs to patients or human
research subjects from the two categories in this paragraph under the
supervision of an authorized user for the use. Radioactive drugs
containing radionuclides in categories not included in this paragraph
are regulated under Sec. 35.1000. This supervised work experience must
involve sufficient experience in each of the following categories to
allow the supervising authorized user to evaluate the individual's
ability to independently perform radiation safety related duties for
the medical use for which the individual is requesting authorized user
status--
(1) Oral administration of any radioactive drug for which a written
directive is required;
(2) Parenteral administration of any radioactive drug for which a
written directive is required; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (a)(1) or (2) of
this section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized
under Sec. 35.300 for which the individual is requesting authorized
user status. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.390, or equivalent Agreement State requirements and has
experience in administering dosages in the same dosage category or
categories as the individual requesting authorized user status; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.390, or equivalent Agreement State
requirements, has experience in administering dosages in the same
dosage category or categories as the individual requesting authorized
user status, and concurs with the attestation provided by the residency
program director. The residency training program must be accredited and
must include training and experience specified in the topic areas in
paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(c).
0
38. Revise and republish Sec. 35.392 to read as follows:
Sec. 35.392 Training for the oral administration of sodium iodide I-
131 requiring a written directive in quantities less than or equal to
1.22 gigabecquerels (33 millicuries).
Except as provided in Sec. 35.57, the licensee must require an
authorized user for the oral administration of sodium iodide I-131
requiring a written directive in quantities less than or equal to 1.22
Gigabecquerels (33 millicuries), to be a physician who--
(a)(1) Has successfully completed a minimum of 3 years of residency
training in a nuclear medicine or radiation oncology accredited program
which includes training and experience topic areas as described in
Sec. 35.392(a)(2); or
(2) Has completed training and experience, including 80 hours of
classroom and laboratory training, in basic radionuclide handling
techniques applicable to the medical use of sodium iodide I-131 for
procedures requiring a written directive. The training and experience
must include, at a minimum--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.300, or equivalent
Agreement State requirements, for oral administration of sodium iodide
I-131 in quantities less than or equal to 1.22 gigabecquerels (33
millicuries) at a medical facility. A supervising authorized user who
meets the requirements in Sec. 35.390(a)(2) must also have experience
in administering dosages as specified in Sec. 35.390(a)(2)(ii)(G)(1).
The work experience must involve--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to
determine the activity of dosages and performing checks for proper
operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(E) Using procedures to contain spilled byproduct material safely
and
[[Page 47092]]
using proper decontamination procedures; and
(F) Preparing written directives and observing or performing
administration of dosages of radioactive drugs to patients or human
research subjects for the oral administration of less than or equal to
1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 under the
supervision of an authorized user for the use. This supervised work
experience must involve sufficient experience to allow the supervising
authorized user to evaluate the individual's ability to independently
perform radiation safety related duties for the medical use for which
the individual is requesting authorized user status; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) or (2)
of this section and is able to independently fulfill the radiation
safety-related duties as an authorized user for oral administration of
less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium
iodide I-131 for medical uses authorized under Sec. 35.300. The
attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.390, 35.392, 35.394, or equivalent Agreement State
requirements and has experience in administering dosages as specified
in Sec. 35.390(a)(2)(ii)(G)(1); or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.390, 35.392, 35.394, or equivalent
Agreement State requirements, has experience in administering dosages
as specified in Sec. 35.390(a)(2)(ii)(G)(1), and concurs with the
attestation provided by the residency program director. The residency
training program must be accredited and must include training and
experience specified in the topic areas in paragraph (a)(2) of this
section; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(d).
0
39. Revise and republish Sec. 35.394 to read as follows:
Sec. 35.394 Training for the oral administration of sodium iodide I-
131 requiring a written directive in quantities greater than 1.22
gigabecquerels (33 millicuries).
Except as provided in Sec. 35.57, the licensee must require an
authorized user for the oral administration of sodium iodide I-131
requiring a written directive in quantities greater than 1.22
Gigabecquerels (33 millicuries), to be a physician who--
(a)(1) Has successfully completed a minimum of 3 years of residency
training in a nuclear medicine or radiation oncology accredited program
which includes training and experience topic areas as described in
Sec. 35.394(a)(2); or
(2) Has completed training and experience, including 80 hours of
classroom and laboratory training, in basic radionuclide handling
techniques applicable to the medical use of sodium iodide I-131 for
procedures requiring a written directive. The training and experience
must include, at a minimum--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation on protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.300, or equivalent
Agreement State requirements, for oral administration of sodium iodide
I-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)
at a medical facility. A supervising authorized user who meets the
requirements in Sec. 35.390(b) must also have experience in
administering dosages as specified in Sec. 35.390(a)(2)(ii)(G)(1). The
work experience must involve--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to
determine the activity of dosages and performing checks for proper
operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(E) Using procedures to contain spilled byproduct material safely
and using proper decontamination procedures; and
(F) Preparing written directives and observing or performing
administration of dosages of radioactive drugs to patients or human
research subjects for the oral administration of greater than 1.22
gigabecquerels (33 millicuries) of sodium iodide I-131 under the
supervision of an authorized user for the use. This supervised work
experience must involve sufficient experience to allow the supervising
authorized user to evaluate the individual's ability to independently
perform radiation safety related duties for the medical use for which
the individual is requesting authorized user status; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) or (2)
of this section and is able to independently fulfill the radiation
safety-related duties as an authorized user for oral administration of
greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-
131 for medical uses authorized under Sec. 35.300. The attestation
must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.390, 35.394, or equivalent Agreement State requirements, and
has experience in administering dosages as specified in Sec.
35.390(a)(2)(ii)(G)(1); or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.390, 35.394, or equivalent Agreement
State requirements, has experience in administering dosages as
specified in Sec. 35.390(a)(2)(ii)(G)(1), and concurs with the
attestation provided by the residency program director. The residency
training program must be accredited and must include training and
experience specified in the topic areas in paragraph (a)(2) of this
section; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(e).
0
40. Revise and republish Sec. 35.396 to read as follows:
Sec. 35.396 Training for the parenteral administration of unsealed
byproduct material requiring a written directive.
Except as provided in Sec. 35.57, the licensee must require an
authorized user for the parenteral administration requiring a written
directive, to be a physician who--
(a)(1) Has successfully completed a minimum of 3 years of residency
training in a nuclear medicine or radiation oncology accredited program
which includes training and experience topic areas as described in
Sec. 35.396(a)(2); or
(2) Has completed training and experience, including 80 hours of
classroom and laboratory training,
[[Page 47093]]
applicable to the medical use of the parenteral administration of
unsealed byproduct material requiring a written directive listed in
Sec. 35.390(a)(2)(ii)(G)(2). The training must include, at a minimum--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.300, or equivalent
Agreement State requirements, for parenteral administrations at a
medical facility. A supervising authorized user who meets the
requirements in Sec. 35.390(a)(2) must also have experience in
administering dosages as specified in Sec. Sec.
35.390(a)(2)(ii)(G)(2). The work experience must involve--
(A) Ordering, receiving, and unpacking radioactive materials
safely, and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to
determine the activity of dosages, and performing checks for proper
operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely,
and using proper decontamination procedures; and
(F) Preparing written directives and observing or performing
administration of dosages of radioactive drugs to patients or human
research subjects for the parenteral administration of unsealed
byproduct material under the supervision of an authorized user for the
use. This supervised work experience must involve sufficient experience
to allow the supervising authorized user to evaluate the individual's
ability to independently perform radiation safety related duties for
the medical use for which the individual is requesting authorized user
status; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) or (2)
of this section and is able to independently fulfill the radiation
safety-related duties as an authorized user for the parenteral
administration of unsealed byproduct material requiring a written
directive. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.390, 35.396, or equivalent Agreement State requirements. A
preceptor authorized user who meets the requirements in Sec. 35.390,
35.396, or equivalent Agreement State requirements, must have
experience in administering dosages in the same category or categories
as the individual requesting authorized user status; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.390, 35.396, or equivalent Agreement
State requirements, has experience in administering dosages in the same
dosage category or categories as the individual requesting authorized
user status, and concurs with the attestation provided by the residency
program director. The residency training program must be accredited and
must include training and experience specified in the topic areas in
paragraph (a)(2) of this section; or
(b) Is an authorized user under Sec. 35.390 for uses listed in
Sec. 35.390(a)(2)(ii)(G)(2), or equivalent Agreement State
requirements; or
(c) Is an authorized user under Sec. 35.490, 35.690, or equivalent
Agreement State requirements, and who meets the requirements in
paragraph (a)(2) of this section; or
(d) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(f).
0
41. In Sec. 35.404, revise the section heading, and revise and
republish paragraphs (a) and (b) to read as follows:
Sec. 35.404 Surveys after source administration and removal.
(a) Immediately after administering sources, topically or inserted
within a patient or a human research subject, the licensee must conduct
a survey to locate and account for all sources that have not been
administered.
(b) Immediately after removing the last temporary source from a
patient or a human research subject, the licensee must make a survey of
the patient or the human research subject with a radiation detection
survey instrument to confirm that all sources have been removed.
* * * * *
0
42. Revise Sec. 35.415 to read as follows:
Sec. 35.415 Safety precautions.
A licensee must have applicable emergency response equipment
available near each treatment room to respond to a source--
(1) Dislodged from the patient; and
(2) Lodged within the patient following removal of the source
applicators.
Sec. 35.432 [Amended]
0
43. In Sec. 35.432:
0
a. In the introductory text to paragraph (a), remove the phrase ``on or
after October 24, 2002''; and
0
b. In paragraph (a)(3), remove the reference ``(a)(2)'' and add in its
place the reference ``(2)''.
0
44. In Sec. 35.433, revise the section heading, and revise and
republish the introductory text to paragraph (a) and paragraphs (b)(1)
and (c).
The revisions read as follows:
Sec. 35.433 Beta-emitting sources for ophthalmic treatments.
(a) Licensees who use beta-emitting sources for ophthalmic
treatments must ensure that certain activities as specified in
paragraph (b) of this section are performed by either:
* * * * *
(b) * * *
(1) Calculate the activity of each beta-emitting source that is
used to determine the treatment times for ophthalmic treatments. The
decay must be based on the activity determined under Sec. 35.432; and
* * * * *
(c) Licensees must retain a record of the activity of each beta-
emitting source in accordance with Sec. 35.2433.
0
45. Revise Sec. 35.490 to read as follows:
Sec. 35.490 Training for use of manual brachytherapy sources.
Except as provided in Sec. 35.57, the licensee must require an
authorized user of a manual brachytherapy source for the uses
authorized under Sec. 35.400 to be a physician who--
(a)(1) Has successfully completed a minimum of 3 years of residency
training in a radiation oncology accredited program, and
(2) Has completed a structured educational program in basic
radionuclide handling techniques applicable to the use of manual
brachytherapy sources that includes--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity; and
(D) Radiation biology; and
[[Page 47094]]
(ii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.400, or equivalent
Agreement State requirements, at a medical facility. The work
experience must involve--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Checking survey meters for proper operation;
(C) Preparing, implanting, and removing brachytherapy sources;
(D) Maintaining running inventories of material on hand;
(E) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(F) Using emergency procedures to control byproduct material; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) and (2)
of this section and is able to independently fulfill the radiation
safety-related duties as an authorized user of manual brachytherapy
sources for the medical uses authorized under Sec. 35.400. The
attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.490, or equivalent Agreement State requirements; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.490, or equivalent Agreement State
requirements, and concurs with the attestation provided by the
residency program director. The residency training program must be
accredited and must include training and experience specified in
paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(g).
(c) For authorized use of beta-emitting sources for superficial
ophthalmic radiotherapy, has received training required in Sec.
35.491(c) of this part.
0
46. Revise and republish Sec. 35.491 to read as follows:
Sec. 35.491 Training for superficial ophthalmic use of beta-emitting
sources.
Except as provided in Sec. 35.57, the licensee must require the
authorized user of beta-emitting sources for superficial ophthalmic
radiotherapy to be a physician who--
(a)
(1) Has completed training and experience, including 24 hours of
classroom and laboratory training, in basic radionuclide handling
techniques applicable to the medical use of beta-emitting sources for
superficial ophthalmic radiotherapy. The training and experience must
include, at a minimum--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity; and
(D) Radiation biology; and
(ii) Supervised clinical training in superficial ophthalmic
radiotherapy under the supervision of an authorized user at a medical
institution, clinic, or private practice that includes the use of beta-
emitting sources for the superficial ophthalmic treatment. This
supervised work experience must involve sufficient experience to allow
the supervising authorized user to evaluate the individual's ability to
independently perform radiation safety related duties for the medical
use for which the individual is requesting authorized user status. This
supervised clinical training must involve--
(A) Examination of each individual to be treated;
(B) Calculation of the dose to be administered;
(C) Administration of the dose; and
(D) Follow up and review of each individual's case history; and
(2) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. 35.57, 35.490,
35.491, or equivalent Agreement State requirements, that the individual
has satisfactorily completed the requirements in paragraph (a) of this
section and is able to independently fulfill the radiation safety-
related duties as an authorized user of beta-emitting sources for
superficial ophthalmic use; or
(b) Is an authorized user under Sec. 35.490, or equivalent
Agreement State requirements; and
(c) Has received training in device operation, safety procedures,
and clinical use of the device. This training requirement may be
satisfied by completing a training program provided by the vendor for
new users or by receiving training supervised by an authorized user or
authorized medical physicist, as appropriate, who is authorized for use
of the same device for which the individual is seeking authorization.
0
47. Revise and republish Sec. 35.590 to read as follows:
Sec. 35.590 Training for use of sealed sources and medical devices
for diagnosis.
Except as provided in Sec. 35.57, the licensee must require the
authorized user of a diagnostic sealed source or a device authorized
under Sec. 35.500 to be a physician, dentist, or podiatrist who--
(a) Has completed 8 hours of classroom and laboratory training in
basic radionuclide handling techniques specifically applicable to the
use of the device. The training must include--
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of
radioactivity; and
(4) Radiation biology; or
(b) Is an authorized user for uses listed in Sec. 35.200 or
equivalent Agreement State requirements; or
(c) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(h); and
(d) Has completed training in the use of the device for the uses
requested.
Sec. 35.604 [Amended]
0
48. In Sec. 35.604, in paragraph (a), remove the word ``portable''
from the phrase ``portable radiation detection survey instrument''.
0
49. In Sec. 35.610, revise paragraphs (a)(1), (d)(1), and (e) to read
as follows:
Sec. 35.610 Safety procedures and instructions for remote
afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units.
(a) * * *
(1) Secure the unit, the console or the console keys, and the
treatment room when not in use or unattended;
* * * * *
(d) (1) Prior to the first use for patient treatment of a new unit
or an existing unit with a manufacturer upgrade that affects the
operation and safety of the unit, a licensee must ensure that vendor
operational and safety training is provided to all individuals who will
operate or calibrate the unit, and the authorized user. The vendor
operational and safety training must be provided by the device
manufacturer or by an individual certified y the device manufacturer to
provide the operational and safety training.
* * * * *
(e) A licensee must ensure that operators, authorized medical
physicists, and authorized users participate in drills of the emergency
procedures, prior to first use of a unit, type of immobilization
device, or revised procedure, and at least annually.
* * * * *
0
50. Revise Sec. 35.615 to read as follows:
[[Page 47095]]
Sec. 35.615 Safety precautions for remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units.
(a) A licensee must control access to each entrance to the
treatment room with an electrical interlock system that will--
(1) Prevent the operator from initiating the treatment cycle unless
each treatment room entrance door is secured;
(2) Cause the source(s) to be shielded in case of unauthorized
entry or interlock interruption; and
(3) Prevent the source(s) from being exposed following an interlock
interruption until the electrical interlock system is restored and
access is controlled to each entrance and the source(s) on-off control
is reset at the console.
(b) A licensee must require any individual entering the treatment
room to assure, through the use of appropriate radiation monitors, that
radiation levels have returned to ambient levels.
(c) Except for low-dose remote afterloader units, a licensee must
construct or equip each treatment room with viewing and intercom
systems to permit continuous observation of the patient or the human
research subject from the treatment console during irradiation.
(d) For licensed activities where sources are placed within the
patient's or human research subject's body, a licensee must only
conduct treatments which allow for expeditious removal of a decoupled
or jammed source.
(e) In addition to the requirements specified in paragraphs (a)
through (e) of this section, a licensee must--
(1) For medium dose-rate and pulsed dose-rate remote afterloader
units, require--
(i) An authorized medical physicist and either an authorized user
or a physician, under the supervision of an authorized user, who has
been trained in the operation and emergency response for the unit to be
physically present during the initiation of all patient treatments
involving the unit; and
(ii) An authorized medical physicist and either an authorized user
or an individual, under the supervision of an authorized user, who has
been trained to remove the source applicator(s) in the event of an
emergency involving the unit, to be immediately available during
continuation of all patient treatments involving the unit.
(2) For high dose-rate remote afterloader units, require--
(i) An authorized user and an authorized medical physicist to be
physically present during the initiation of all patient treatments
involving the unit; and
(ii) An authorized medical physicist and either an authorized user
or a physician, under the supervision of an authorized user, who has
been trained in the operation and emergency response for the unit, to
be physically present during continuation of all patient treatments
involving the unit.
(3) For gamma stereotactic radiosurgery units, require--
(i) An authorized user and an authorized medical physicist to be
physically present during the initiation of all patient treatments;
(ii) An authorized user to be immediately available during
continuation of patient treatments;
(iii) An authorized medical physicist and appropriate staff who are
trained in emergency response and are necessary in accordance with
written procedures pursuant to Sec. 35.610(a)(4) to be physically
present for the continuation of treatment; and
(iv) If there is an unexpected interruption of treatment requiring
operator re-initiation, an authorized user and authorized medical
physicist will evaluate the situation to ensure treatment is being
delivered in accordance with the treatment plan and written directive
prior to re-initiation of the treatment.
(4) Notify the Radiation Safety Officer, or his/her designee, and
an authorized user as soon as possible if the patient or human research
subject has a medical emergency or dies.
(f) A licensee must have applicable emergency response equipment
available near each treatment room to respond to a source--
(1) Remaining in the unshielded position; or
(2) Lodged within the patient following completion of the
treatment.
0
51. In Sec. 35.632, revise paragraphs (a), (c) through (e), and (g) to
read as follows:
Sec. 35.632 Full calibration measurements on teletherapy units.
(a) A licensee authorized to use a teletherapy unit for medical use
must perform full calibration measurements on each teletherapy unit--
* * * * *
(c) A licensee must use the dosimetry system described in Sec.
35.630(a) to measure the output for one set of exposure conditions. The
remaining radiation measurements required in paragraph (b)(1) of this
section may be made using a dosimetry system that indicates relative
dose rates.
(d) A licensee must make full calibration measurements required by
paragraph (a) of this section in accordance with published protocols
accepted by nationally recognized bodies. In absence of such protocols,
a licensee must make full calibration measurements required by
paragraph (a) in accordance with NRC-approved or Agreement State-
approved manufacturer procedures.
(e) A licensee must mathematically correct the outputs determined
in paragraph (b)(1) of this section for physical decay for intervals
not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at
intervals consistent with 1 percent decay for all other nuclides.
* * * * *
(g) A licensee must retain a record of each calibration in
accordance with Sec. 35.2632.
0
52. In Sec. 35.633, revise paragraphs (a), (c) through (e), (g), and
(i) to read as follows:
Sec. 35.633 Full calibration measurements on remote afterloader
units.
(a) A licensee authorized to use a remote afterloader unit for
medical use must perform full calibration measurements on each unit--
* * * * *
(c) A licensee must use the dosimetry system described in Sec.
35.630(a) to measure the output.
(d) A licensee must make full calibration measurements required by
paragraph (a) of this section in accordance with published protocols
accepted by nationally recognized bodies. In absence of such protocols,
a licensee must make full calibration measurements required by
paragraph (a) of this section in accordance with NRC-approved or
Agreement State-approved manufacturer procedures.
(e) In addition to the requirements for full calibrations for low
dose-rate remote afterloader units in paragraph (b) of this section, a
licensee must perform an autoradiograph of the source(s) to verify
inventory and source(s) arrangement at intervals not exceeding 1
quarter.
* * * * *
(g) A licensee must mathematically correct the outputs determined
in paragraph (b)(1) of this section for physical decay at intervals
consistent with 1 percent physical decay.
* * * * *
(i) A licensee must retain a record of each calibration in
accordance with Sec. 35.2632.
0
53. In Sec. 35.635, revise paragraphs (a) through (e) and (g) to read
as follows:
[[Page 47096]]
Sec. 35.635 Full calibration measurements on gamma stereotactic
radiosurgery units.
(a) A licensee authorized to use a gamma stereotactic radiosurgery
unit for medical use must perform full calibration measurements on each
unit--
* * * * *
(2) * * *
(iii) Following any repair of the gamma stereotactic radiosurgery
unit that includes removal of the source(s) or major repair of
component(s) associated with the source assembly or collimation; and
(3) At intervals not exceeding 1 year.
(b) To satisfy the requirement of paragraph (a) of this section,
full calibration measurements must include determination of--
(1) The output within 3 percent;
(2) Condition, function, and accuracy of source(s), collimator(s),
and treatment couch positioning and localizing, attenuation, and
collimation devices;
(3) Isocenter coincidence;
(4) Timer accuracy and linearity over the range of use;
(5) On-off error;
(6) The operability and availability of retraction devices and
emergency response equipment required per procedures required in Sec.
35.610;
(7) System interlocks necessary to ensure pause in treatment in
abnormal operations;
(8) Emergency timing circuits;
(9) The operability and availability of backup power devices or
systems; and
(10) Operability of source(s), collimator(s), and treatment couch
movement during treatment, as applicable.
(c) A licensee must use the dosimetry system described in Sec.
35.630(a) to measure the output for one set of exposure conditions. The
remaining radiation measurements required in paragraph (b)(1) of this
section may be made using a dosimetry system that indicates relative
dose rates.
(d) A licensee must make full calibration measurements required by
paragraph (a) of this section in accordance with published protocols
accepted by nationally recognized bodies. In absence of such protocols,
licensee must make full calibration measurements required by paragraph
(a) in accordance with NRC-approved or Agreement State-approved
manufacturer procedures.
(e) A licensee must mathematically correct the outputs determined
in paragraph (b)(1) of this section at intervals not exceeding 1 month
for cobalt-60 and at intervals consistent with 1 percent physical decay
for all other radionuclides.
* * * * *
(g) A licensee must retain a record of each calibration in
accordance with Sec. 35.2632.
0
54. Revise and republish Sec. 35.643 to read as follows:
Sec. 35.643 Periodic spot-checks for remote afterloader units.
(a) A licensee authorized to use a remote afterloader unit for
medical use must perform spot-checks of each remote afterloader
facility and on each unit--
(1) Before the first use of a high dose-rate, medium dose-rate, or
pulsed dose-rate remote afterloader unit on a given day;
(2) Before each patient treatment with a low dose-rate remote
afterloader unit; and
(3) After each source installation.
(b) A licensee must perform the measurements required by paragraph
(a) of this section in accordance with written procedures established
by the authorized medical physicist and in accordance with:
(1) Nationally recognized standards or published protocols accepted
by nationally recognized bodies; or
(2) Manufacturer instructions accepted by the NRC, if nationally
recognized standards or published protocols accepted by nationally
recognized bodies do not exist.
(c) A licensee must have the authorized medical physicist review
the results of each spot-check within 15 days. The authorized medical
physicist must notify the licensee as soon as possible in writing of
the results of each spot-check.
(d) To satisfy the requirements of paragraph (a) of this section,
spot-checks must, at a minimum, verify the performance of the following
systems and functions:
(1) Emergency and safety systems;
(2) Computer systems controlling source output and timing; and
(3) Dosimetric and geometry accuracy.
(e) If the results of the checks required in paragraph (d) of this
section indicate the malfunction of any system, a licensee must lock
the control console in the off position and not use the unit except as
may be necessary to repair, replace, or check the malfunctioning
system.
(f) A licensee must retain a record of each check required by
paragraph (d) of this section and a copy of the procedures required by
paragraph (b) of this section in accordance with Sec. 35.2643.
0
55.. Revise and republish Sec. 35.645 to read as follows:
Sec. 35.645 Periodic spot-checks for gamma stereotactic radiosurgery
units.
(a) A licensee authorized to use a gamma stereotactic radiosurgery
unit for medical use must perform spot-checks of each gamma
stereotactic radiosurgery facility and on each unit in accordance with
written procedures established by the authorized medical physicist
and--
(1) Nationally recognized standards or published protocols accepted
by nationally recognized bodies, or
(2) Manufacturer instructions accepted by the NRC, if nationally
recognized standards or published protocols accepted by nationally
recognized bodies do not exist.
(b) To satisfy the requirement of paragraph (a) of this section,
spot-checks must--
(1) Before each patient use, confirm patient immobilization devices
and localization systems, and any adaptors, are functional and fit
appropriately.
(2) Before the first use of the unit on a given day and after each
source installations:
(i) Verify systems and components that provide for safe termination
of treatment and prevention of exposure to individuals other than the
patient, and ensure that real-time monitoring and communication during
administration are functional;
(ii) Confirm date and time of computer systems necessary for
operation are correct; and
(3) On a monthly basis, spot-checks must verify:
(i) Systems and components to ensure accurate image guidance, as
applicable, and geometric and dosimetry accuracy; and
(ii) Output for one typical set of operating conditions measured
with the dosimetry system described in Sec. 35.630(b) is within range
specified by the procedure required in paragraph (a) of this section.
(c) Have the authorized medical physicist review the results of
each spot-check within 15 days. The authorized medical physicist must
notify the licensee as soon as possible in writing of the results of
each spot-check.
(d) A licensee must not use a system or device for medical use if
the system is identified in paragraph (b)(1) of this section as not
functioning appropriately.
(e) If the results of the checks required in paragraphs (b)(2) and
(3) of this section indicate the malfunction of any system, a licensee
must lock the control console in the off position and not use the unit
except as may be necessary to repair, replace, or check the
malfunctioning system.
[[Page 47097]]
(f) A licensee must retain a record of each check required by
paragraph (b) and a copy of the procedures required by paragraph (b) of
this section in accordance with Sec. 35.2645.
0
56. Revise and republish Sec. 35.690 to read as follows:
Sec. 35.690 Training for use of remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units.
Except as provided in Sec. 35.57, the licensee must require an
authorized user of a sealed source for a use authorized under Sec.
35.600 to be a physician who--
(a)(1) Has successfully completed a minimum of 3 years of residency
training in a radiation oncology accredited program; and
(2) Has completed a structured educational program in basic
radionuclide techniques applicable to the use of a sealed source in a
therapeutic medical unit that includes--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity; and
(D) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.600 or equivalent
Agreement State requirements, at a medical facility, involving--
(A) Reviewing full calibration measurements and periodic spot-
checks;
(B) Preparing treatment plans and calculating treatment doses and
times;
(C) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(D) Implementing emergency procedures to be followed in the event
of the abnormal operation of the medical unit or console;
(E) Checking and using survey meters; and
(F) Selecting the proper dose and how it is to be administered; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) and (2)
and (c) of this section; and is able to independently fulfill the
radiation safety-related duties as an authorized user of each type of
therapeutic medical unit for which the individual is requesting
authorized user status. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.690, or equivalent Agreement State requirements for the
type(s) of therapeutic medical unit for which the individual is
requesting authorized user status; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.690, or equivalent Agreement State
requirements, for the type(s) of therapeutic medical unit for which the
individual is requesting authorized user status, and concurs with the
attestation provided by the residency program director. The residency
training program must be accredited and must include training and
experience specified in paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification
process has been recognized under Sec. 35.58(i); and
* * * * *
Sec. Sec. 35.700 through 35.799 [Designated as Subpart I of 10 CFR
Part 35]
0
57. Designate Sec. Sec. 35.700 through 35.799 as subpart I and add a
heading for newly created subpart I to read as follows:
Subpart I--Microsource Brachytherapy
0
58. Add Sec. 35.700 to read as follows:
Sec. 35.700 Use of microsources for microsource brachytherapy.
A licensee must only use microsources:
(a) Obtained from a manufacturer or preparer licensed under Sec.
32.72 or 32.74 of this chapter or equivalent Agreement State
requirements; or
(b) In research to deliver therapeutic doses for medical use in
accordance with an active Investigational Device Exemption (IDE)
application accepted by the U.S. Food and Drug Administration provided
the requirements of Sec. 35.49(a) are met.
0
59. Add Sec. 35.710 to read as follows:
Sec. 35.710 Safety procedures and instruction.
(a) Microsource administration devices that use microsources for
brachytherapy and are listed in the Sealed Source and Device Registry
must be used in accordance with radiation safety conditions and
limitations described in the Sealed Source and Device Registry.
(b) A licensee must develop, implement, and maintain written
procedures for responding to abnormal situations including microsource
spills, equipment failures, and emergent conditions that affect the
administration of microsources.
(c)(1) Prior to the first use for patient treatment of a new type
of microsource or an existing type with a manufacturer upgrade to the
delivery kit that affects the operation and safety of administration, a
licensee must ensure that operational and safety training is provided
to all individuals who operate the system and authorized user.
(2) A licensee must provide operational and safety instructions
initially to all individuals who prepare or transfer microsources for
administration and operate the unit at the facility, as appropriate to
the individual's assigned duties. The instructions must include
instruction in--
(i) The procedures identified in Sec. 35.41; and
(ii) The operating procedures for the unit.
(d) In addition to the requirements of Sec. 19.12, a licensee must
provide radiation safety instruction, initially, and at least annually,
to personnel caring for patients or human research subjects that cannot
be released under Sec. 35.75. To satisfy this requirement, the
instruction must be commensurate with the duties of the personnel and
include--
(1) Patient or human research subject control;
(2) Visitor control, including--
(i) Routine visitation to hospitalized individuals in accordance
with Sec. 20.1301(a)(1) of this chapter; and
(ii) Visitation authorized in accordance with Sec. 20.1301(c) of
this chapter;
(1) Contamination control;
(2) Waste control; and
(3) Notification of the Radiation Safety Officer, or his or her
designee, and an authorized user if the patient or the human research
subject has a medical emergency or dies.
(e) A licensee must retain a record of individuals receiving
instruction required by paragraphs (c) and (d) of this section, in
accordance with Sec. 35.2310.
(f) A licensee must retain a copy of the procedures required by
paragraph (b) of this section in accordance with Sec. 35.2710.
0
60. Add Sec. 35.790 to read as follows:
Sec. 35.790 Training for use of microsources.
Except as provided in Sec. 35.57, the licensee must require an
authorized user of microsources authorized under Sec. 35.700 to be a
physician who--
(a)(1) Has successfully completed a minimum of 3 years of residency
training in diagnostic radiology and 1 year of interventional radiology
in a residency or fellowship program(s), and
[[Page 47098]]
(2) Has completed the training and experience requirements that
include--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity; and
(D) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user
at a medical facility that is authorized to use byproduct materials in
Sec. 35.700, or training provided by a microsource manufacturer. The
work experience or training must involve--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to
determine the activity of microsource doses and performing checks for
proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages; and
(D) Using procedures to contain spilled microsources safely using
decontamination procedures; and
(iii) Work experience, under the supervision of an authorized user
for the use of byproduct materials under Sec. 35.700 or equivalent
Agreement State requirements, at a medical facility. The work
experience must involve--
(A) Using administrative controls to prevent a medical event
involving the use of byproduct material; and
(B) Preparing written directives and observing or performing
administration of microsource brachytherapy; and
(C) Evaluation of patient or research subject's treatments to
determine whether the administered dosage was in accordance with the
written directive or if a medical event occurred; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) and (2);
and is able to independently fulfill the radiation safety-related
duties as an authorized user for microsource brachytherapy. The
attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.790, or equivalent Agreement State requirements; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.790, or equivalent Agreement State
requirements and concurs with the attestation provided by the residency
program director. The residency training program must be accredited and
must include training and experience specified in paragraph (a)(2) of
this section; or
(b) [Reserved]
(c) Is an authorized user under Sec. 35.390, 35.396, 35.490, or
equivalent Agreement State requirements, and
(d)(1) Has received training and work experience in device
operation, safety procedures, and clinical use for the type(s) of
microsource for which authorization is sought. This training must
include three hands on cases including work experience as described in
paragraphs (a)(2)(ii) and (iii) for the type of microsource for which
authorization is sought. This training requirement may be satisfied by
satisfactory completion of a training program provided by the vendor
for new users or by receiving training supervised by an authorized user
who is authorized for the type(s) of microsources for which the
individual is seeking authorization, and
(2) Has obtained written attestation that the individual has
satisfactorily completed these requirements.
The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in Sec.
35.57, 35.790, or equivalent Agreement State requirements for the
type(s) of microsources for which the individual is requesting
authorized status; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.790, or equivalent Agreement State
requirements, for the type(s) of microsources for which the individual
is requesting authorized status, and concurs with the attestation
provided by the residency program director. The residency training
program must be accredited and must include training and experience
specified in paragraph (d)(1) of this section.
Subpart J [Reserved]
0
61. Reserve subpart J.
0
62. Revise Sec. 35.1000 to read as follows:
Sec. 35.1000 Other medical uses of byproduct material or radiation
from byproduct material.
(a) A licensee may use byproduct material or a radiation source
approved for medical use which is not specifically addressed in
subparts D through I of this part if--
(1) The applicant or licensee has submitted the information
required by Sec. 35.12(b) through (d); and
(2) The applicant or licensee has received written approval from
the Commission in a license or license amendment and uses the material
in accordance with the regulations and specific conditions the
Commission considers necessary for the medical use of the material.
(b) A licensee may use byproduct material or a radiation source
approved for medical use in accordance with the written approval from
the Commission in a license or license amendment if the licensee
obtained approval under Sec. 35.1000 prior to [DATE 30 DAYS AFTER DATE
OF PUBLICATION OF THE FINAL RULE IN THE Federal Register].
0
63. Add Sec. 35.2059 to read as follows:
Sec. 35.2059 Records of continuing education and training.
A licensee must maintain a record of continuing education and
training required by Sec. 35.59 until the individual is no longer
authorized for medical use or listed on the license. The record must
include a list of the topics covered, the date of the training, and the
name(s) of the individual(s) who provided the training.
0
64. Revise and republish Sec. 35.2060 to read as follows:
Sec. 35.2060 Records of calibrations of instruments used to measure
the activity of unsealed byproduct material and microsources.
(a) A licensee must maintain a record of each instrument
calibration and test required by Sec. 35.60 for 3 years. The records
must include the model and serial number of the instrument, if
applicable; the date of, the results of, and the name of the individual
who performed each calibration and test.
(b) A licensee must retain a copy of each procedure required by
Sec. 35.60(d) until the licensee no longer possesses the instrument.
0
65. In Sec. 35.2063, revise the section heading and paragraph (a) to
read as follows:
Sec. 35.2063 Records of dosages for medical use.
(a) A licensee must maintain a record of dosage determinations
required by Sec. 35.63 for 3 years.
* * * * *
0
66. Revise Sec. 35.2080 to read as follows:
Sec. 35.2080 Records of mobile medical services.
A licensee must retain a copy of each letter that permits the use
of byproduct
[[Page 47099]]
material at a client's address, as required by Sec. 35.80(a)(1). Each
letter must clearly delineate the authority and responsibility of the
licensee and the client and must be retained for 3 years after the last
provision of service.
0
67. Add Sec. 35.2093 to read as follows:
Sec. 35.2093 Records of generator breakthrough testing.
A licensee must maintain a record of results of the breakthrough
tests required by Sec. 35.93(a) for 3 years. The record must include
the eluate concentrations of the parent and daughter, the time and date
of the measurement, and the name of the individual who made the
measurement.
Sec. 35.2204 [Removed and Reserved]
0
68. Remove and reserve Sec. 35.2204.
0
69. Revise Sec. 35.2310 to read as follows:
Sec. 35.2310 Records of safety instruction.
A licensee must maintain a record of safety instructions required
by Sec. Sec. 35.93, 35.310, and 35.410 and the operational and safety
instructions required by Sec. 35.610 and Sec. 35.710 for 3 years. The
record must include a list of the topics covered, the date of the
instruction, the name(s) of the attendee(s), and the name(s) of the
individual(s) who provided the instruction.
0
79. In Sec. 35.2404, revise the section heading and the first sentence
in the section to read as follows:
Sec. 35.2404 Records of surveys after source administration and
removal.
A licensee must maintain a record of the surveys required by
Sec. Sec. 35.404 and 35.604 for 3 years. * * *
0
71. In Sec. 35.2406, revise the section heading, paragraph (a), and
the introductory text to paragraphs (b) and (c) to read as follows:
Sec. 35.2406 Records of manual brachytherapy source accountability.
(a) A licensee must maintain a record of brachytherapy source
accountability required by Sec. 35.406 for 3 years.
(b) For temporary manual brachytherapy sources, the record must
include--
* * * * *
(c) For permanent manual brachytherapy sources, the record must
include--
* * * * *
0
72. In Sec. 35.2433, revise the section heading and paragraph (a) to
read as follows:
Sec. 35.2433 Records of decay of beta-emitting sources for ophthalmic
treatments.
(a) A licensee must maintain a record of the activity of a beta-
emitting source required by Sec. 35.433 for the life of the source.
* * * * *
Sec. 35.2642 [Amended]
0
73. In Sec. 35.2642:
0
a. In paragraph (a), remove the word ``shall'' and add in its place the
word ``
0
must'';
b. In paragraph (b)(9), remove the word ``signature'' and add in
its place the phrase ``dated signature''; and
0
c. In paragraph (c), remove the word ``shall'' and add in its place the
word ``must''.
0
74. Revise and republish Sec. 35.2643 to read as follows:
Sec. 35.2643 Records of periodic spot-checks for remote afterloader
units.
(a) A licensee must retain a record of each periodic spot-check for
remote afterloader units required by Sec. 35.643 for 3 years.
(b) The record must include, as applicable--
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for
the remote afterloader unit and source;
(3) The equipment and systems checked, including--
(i) Emergency and safety systems;
(ii) Computer systems controlling source output and timing; and
(iii) Dosimetric and geometric accuracy.
(4) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who
reviewed the record of the spot-check.
(c) A licensee must retain a copy of the procedures required by
Sec. 35.643(b) until the licensee no longer possesses the remote
afterloader unit.
0
75. Revise and republish Sec. 35.2645 to read as follows:
Sec. 35.2645 Records of periodic spot-checks for gamma stereotactic
radiosurgery units.
(a) A licensee must retain a record of each periodic spot-check for
gamma stereotactic radiosurgery units required by Sec. 35.645 for 3
years.
(b) The record must include--
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for
the gamma stereotactic radiosurgery unit and the instrument used to
measure the output of the unit;
(3) The systems and components checked, including--
(i) Patient immobilization devices and localization systems;
(ii) Emergency and safety systems;
(iii) Real-time monitoring and communication systems;
(iv) Computer systems necessary for operation (including date and
time settings); and
(v) Image guidance;
(4) The calculated on-off error;
(5) A determination of trunnion centricity;
(6) The difference between the anticipated output and the measured
output;
(7) An assessment of source output against computer calculations;
(8) Notations indicating the operability of radiation monitors,
helmet microswitches, emergency timing circuits, emergency off buttons,
electrical interlocks, source exposure indicator lights, viewing and
intercom systems, timer termination, treatment table retraction
mechanism, and stereotactic frames and localizing devices (trunnions);
and
(9) The name of the individual who performed the periodic spot-
check and the dated signature of the authorized medical physicist who
reviewed the record of the spot-check.
(c) A licensee must retain a copy of the procedures required by
Sec. 35.645(b) until the licensee no longer possesses the gamma
stereotactic radiosurgery unit.
0
76. Add Sec. 35.2710 to read as follows:
Sec. 35.2710 Records of safety procedures and instruction.
A licensee must retain a copy of the procedures required by Sec.
35.710(b) until the licensee is no longer authorized for the type of
microsource.
0
77. In Sec. 35.3045:
0
a. Revise paragraphs (a) and (b);
0
b. In paragraph (c), redesignate footnote 3 as footnote 1.
The revisions read as follows:
Sec. 35.3045 Report and notification of a medical event.
(a) A licensee must report any event as a medical event, except for
an event that results from patient intervention or emergent patient
condition that prevents completion of administration as planned, in
which--
(1) The administration of byproduct material or radiation from
byproduct material, except permanent manual or microsource
brachytherapy, results in--
* * * * *
(2) For permanent manual or microsource brachytherapy, the
administration of byproduct material or radiation from byproduct
material (excluding sources that were implanted in the correct site but
migrated outside the treatment site or microsources administered at the
correct site but shunted to a site other than the treatment site if
shunting was evaluated
[[Page 47100]]
in accordance with the manufacturer's instructions as set forth in its
FDA product approval prior to administration) that results in--
(i) The total source strength or activity administered differing by
20 percent or more from the total source strength or activity
documented in the post-implantation portion of the written directive;
(ii) The total source strength or activity administered outside of
the treatment site exceeding 20 percent of the total source strength or
activity documented in the post-implantation portion of the written
directive; or
(iii) An administration that includes any of the following:
(A) The wrong radionuclide;
(B) The wrong individual or human research subject;
(C) Sealed source(s) implanted directly into a location
discontiguous from the treatment site, as documented in the post-
implantation portion of the written directive;
(D) A leaking sealed source resulting in a dose that exceeds 0.5 Sv
(50 rem) to an organ or tissue; or
(3) The total dose or dosage that exceeds or results in a dose that
exceeds 0.5 Sv (50 rem) to an organ or tissue delivered and differs
from the prescribed dose or dosage defined on the written directive
before administration by 20 percent caused by a leak or defect in
administration device or supplies.
(b) A licensee must report any event resulting from patient
intervention or emergent patient condition in which the administration
of byproduct material or radiation from byproduct material results or
will result in unintended permanent functional damage to an organ or a
physiological system, as determined by a physician.
* * * * *
0
78. In Sec. 35.3047, revise paragraph (a) to read as follows:
Sec. 35.3047 Report and notification of a dose to an embryo/fetus or
a nursing child.
(a) A licensee must report any dose to an embryo/fetus that is
greater than 50 mSv (5 rem) dose equivalent that is a result of an
administration of byproduct material or radiation from byproduct
material to a pregnant individual unless;
(1) The dose to the embryo/fetus was specifically approved, in
advance, by the authorized user, or
(2) The licensee made a reasonable effort to determine pregnancy
status but pregnancy could not be reasonably excluded prior to the
administration by the licensee.
* * * * *
0
79. Add Sec. 35.3093 to read as follows:
Sec. 35.3093 Report and notification for an eluate exceeding
breakthrough limits.
(a) The licensee must notify by telephone the NRC Operations Center
and the distributor of the generator within 7 calendar days after
discovery that an eluate exceeded the permissible concentration listed
in Sec. 35.93(a) at the time of generator elution. The telephone
report to the NRC must include the manufacturer, model number, and
serial number (or lot number) of the generator; the results of the
measurement; the date of the measurement; whether dosages were
administered to patients or human research subjects; when the
distributor was notified; and the action taken.
(b) By an appropriate method listed in Sec. 30.6(a) of this
chapter, the licensee must submit a written report to the appropriate
NRC Regional Office listed in Sec. 30.6 of this chapter within 30
calendar days after discovery of an eluate exceeding the permissible
concentration at the time of generator elution. The written report must
include the action taken by the licensee; the patient dose assessment;
the methodology used to make this dose assessment if the eluate was
administered to patients or human research subjects; and the probable
cause and an assessment of failure in the licensee's equipment,
procedures or training that contributed to the excessive readings if an
error occurred in the licensee's breakthrough determination; and the
information in the telephone report as required by paragraph (a) of
this section.
Sec. 35.3204 [Removed and Reserved]
0
80. Remove and reserve Sec. 35.3204.
For the Nuclear Regulatory Commission.
Dated: July 23, 2026.
Jody Martin,
Secretary of the Commission.
[FR Doc. 2026-15080 Filed 7-24-26; 8:45 am]
BILLING CODE 7590-01-P