[Federal Register Volume 91, Number 134 (Wednesday, July 15, 2026)]
[Proposed Rules]
[Pages 43456-43504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-14208]
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Vol. 91
Wednesday,
No. 134
July 15, 2026
Part II
Nuclear Regulatory Commission
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10 CFR Parts 19, 20, 34, et al.
Reforming and Modernizing the NRC's Radiation Protection Framework;
Proposed Rule
Federal Register / Vol. 91 , No. 134 / Wednesday, July 15, 2026 /
Proposed Rules
[[Page 43456]]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 19, 20, 34, 35, 40, 50, 53, 61, 71, and 72
[NRC-2025-1140]
RIN 3150-AL47
Reforming and Modernizing the NRC's Radiation Protection
Framework
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations that govern its standards for protection against
radiation. These proposed revisions would address section 5(b) of
Executive Order 14300, ``Ordering the Reform of the Nuclear Regulatory
Commission,'' and would reflect the NRC's experience and other
developments in the field of radiation protection since the NRC's last
major revisions to these standards in 1991. In addition, the NRC is
issuing for public comment draft implementing guidance.
DATES: Comments must be submitted electronically using https://www.regulations.gov by 11:59 p.m. Eastern Time on August 31, 2026.
ADDRESSES: Submit your comments, identified by Docket ID NRC-2025-1140,
at https://www.regulations.gov. If your material cannot be submitted
using https://www.regulations.gov, call or email the individual 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-2025-1140. 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: Caylee Kenny, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; telephone: 301-415-7150; email:
[email protected].
SUPPLEMENTARY INFORMATION:
Executive Summary
A. Need for the Regulatory Action
The NRC is proposing revisions to its Standards for Protection
Against Radiation to address section 5(b) of Executive Order (E.O.)
14300 and to support national policy objectives stated therein. The
revisions to the NRC's Standards for Protection Against Radiation
reflect the agency's reconsideration of its use of the linear no-
threshold (LNT) model for assessing health effects from radiation
exposure and its application of the ``as low as is reasonably
achievable'' (ALARA) principle that is predicated on LNT. Additionally,
the proposed revisions reflect the agency's consideration of shifting
to a regulatory framework that uses predominately determinate radiation
limits to protect from deterministic and stochastic health effects of
radiation exposure. The intent of these revisions is twofold and
directed at enabling the safe use of nuclear technology while
maintaining reasonable assurance of adequate protection from the health
effects of radiation exposure and reflecting on several decades of
experience since the last major revisions to the NRC's Standards for
Protection Against Radiation. In particular, as further discussed
below, the proposed revisions would (1) address unnecessary
conservatism and excessive subjectivity in regulatory requirements as
they relate to protection from very low doses of radiation, and (2)
apply the NRC's considerable regulatory experience to incorporate
flexibility and acceptable alternatives in the regulations while
maintaining reasonable assurance of adequate protection from the health
effects of radiation exposure.
The NRC has determined that certain aspects of its radiation
protection standards allow for excessive subjectivity that leads to
overly conservative assessments, and thus, are in tension with the
NRC's Principles of Good Regulation (see SECY-25-0031, ``Mission
Statement Implementation Guidance'' (ML25106A351)), in particular, the
``Efficiency,'' ``Clarity,'' and ``Reliability'' principles. Therefore,
the NRC is proposing changes to its regulations and guidance to reduce
subjectivity and unnecessary burden on applicants and licensees and to
increase flexibility associated with the licensing and use of nuclear
technology while maintaining reasonable assurance of adequate
protection of public health and safety. Specifically, the NRC has
determined that the LNT model may lead to conservative implementation
of radiation protection measures at low doses. Consequently, the NRC
proposes to remove references to the ALARA principle, which rests on
the LNT model's assessment of risks from very low doses of radiation,
from its regulations; instead, the NRC would apply a less-subjective,
graded approach to managing doses below regulatory limits.
Since the proposed changes would predominantly affect regulations
in title 10 of the Code of Federal Regulations (10 CFR) part 20,
``Standards for Protection Against Radiation,'' they would impact all
categories of NRC licensees, and, to the extent that the affected
regulations are required for an adequate and compatible Agreement State
program, these proposed changes would impact Agreement States. In
addition, the proposed changes would support the safe use and
deployment of nuclear technologies while continuing to maintain
reasonable assurance of adequate protection of individuals and are
founded on a holistic consideration of the NRC's regulatory experience
and the current state of science using a weight of scientific evidence
decision-making approach, as described in E.O. 14303, ``Restoring Gold
Standard Science.''
B. Major Provisions
Major provisions of the proposed rule are the following:
1. Remove ALARA requirements from the regulations in 10 CFR Chapter
I, and apply a graded approach to dose management framework that
involves determinate thresholds for radiation protection, methods for
dose management, and acceptable dosimetry methods.
2. Establish a process, called the planned occupational dose limit
extension, whereby individuals can exceed certain annual occupational
dose limits as long as certain actions are taken and the resultant
doses are maintained below multiyear limitations.
3. Introduce a reporting threshold for required monitoring results
related to occupational dose limits.
4. Replace unplanned overexposure reporting criteria for public and
occupational effective dose limits with a 5-year dose assessment.
5. Allow for variances in public dose limits and/or accessible dose
rates on a case-by-case basis, with the implementation of adequate
controls.
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6. Enable the optional use of modern dose modeling/calculation
methods.
7. Apply a 10-rem design-basis accident acceptance criterion to
consequence analyses in Regulatory Guide (RG) 1.183 and retire the use
of the ``well-within'' and ``small fraction of'' standards.
8. Allow licensees to use NRC-approved devices for respiratory
protection and certain deviations for these devices without separate
licensing actions.
9. Introduce revised threshold/constraint for control of
radiological effluents to ensure ample margin with the public dose
limit and support of environmental policy objectives, while providing a
burden reduction and flexibilities for licensees.
C. Costs and Benefits
The NRC prepared a draft regulatory analysis to determine the
expected quantitative costs and benefits of this proposed rule, as well
as qualitative factors to be considered in the NRC's rulemaking
decision. The draft analysis concluded that the proposed rule would
result in net cost savings to the industry, Agreement State regulators
and the NRC. The key findings of the analysis related to the proposed
changes are as follows:
Cost savings to the industry of approximately $9.53
million/year at a 7 percent discount rate.
Cost savings to the Agreement State regulators of
approximately $244,000/year at a 7 percent discount rate.
Cost savings to the NRC of approximately $704,000/year at
a 7 percent discount rate.
The draft regulatory analysis also includes a qualitative
discussion of factors that were not quantifiable, including precise
cost savings and benefits, if the NRC adopts the rule.
The draft regulatory analysis finds that this proposed rule
provides cost savings while maintaining exposure to ionizing radiation
within safe limits.
For more information, please refer to the draft regulatory analysis
cited in the Availability of Documents section.
Table of Contents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
B. Submitting Comments
II. Executive Order 14300: Ordering the Reform of the Nuclear
Regulatory Commission
III. Background
IV. Discussion
V. Specific Requests for Comments
VI. Availability of Guidance
VII. National Environmental Policy Act
VIII. Regulatory Flexibility Certification
IX. Regulatory Analysis
X. Backfitting and Issue Finality
XI. Cumulative Effects of Regulation
XII. Plain Writing
XIII. Paperwork Reduction Act
XIV. Coordination With NRC Agreement States
XV. Compatibility of Agreement State Regulations
XVI. Voluntary Consensus Standards
XVII. Incorporation by Reference--Reasonable Availability to
Interested Parties
XVIII. 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
XIX. Availability of Documents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2025-1140 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-2025-1140.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Search.'' For
problems with ADAMS, please contact the NRC's Public Document Room
(PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email
to [email protected]. For the convenience of the reader,
instructions about obtaining materials referenced in this document are
provided in the ``Availability of Documents'' section.
NRC's PDR: The PDR, where you may examine and order copies
of publicly available documents, is open by appointment. To make an
appointment to visit the PDR, please send an email to
[email protected] or call 1-800-397-4209 or 301-415-4737, between 8
a.m. and 4 p.m. Eastern Time, Monday through Friday, except Federal
holidays.
Public Meeting: The NRC will conduct a public meeting to
describe the proposed amendments and answer questions from the public
on this 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.
B. Submitting Comments
Comments must be submitted using https://www.regulations.gov by
11:59 p.m. Eastern Time on August 31, 2026. Please include Docket ID
NRC-2025-1140 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, ``Ordering the Reform of the Nuclear Regulatory
Commission,'' which requires the NRC to take a number of actions to
help provide the American people with safe, abundant nuclear energy.
Section 2, ``Policy,'' of E.O. 14300 sets forth the policy of the
United States to (a) reestablish the United States as the global leader
in nuclear energy; (b) facilitate increased deployment of new nuclear
reactor technologies; (c) facilitate the expansion of American nuclear
energy capacity from approximately 100 gigawatts (GW) in 2024 to 400 GW
by 2050; (d) employ emerging technologies to safely accelerate the
modeling, simulation, testing, and approval of new reactor designs; (e)
support the continued operation of, and facilitate appropriate
operational extensions for, the current
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nuclear fleet, as well as the reactivation of prematurely shuttered or
partially completed nuclear facilities; and (f) maintain the United
States' leading reputation for nuclear safety. Section 5, ``Reforming
and Modernizing the NRC's Regulations,'' 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 addresses section 5(b) of E.O. 14300, which
requires the NRC to ``reconsider reliance on the linear no-threshold
(LNT) model for radiation exposure and the `as low as reasonably
achievable' standard, which is predicated on LNT,'' and states, ``[i]n
reconsidering those limits, the NRC shall specifically consider
adopting determinate radiation limits.'' A fulsome explanation of how
this rulemaking addresses section 5(b) of E.O. 14300 is provided next.
III. Background
Introduction
The NRC is proposing revisions to its standards for protection
against radiation to address section 5(b) of Executive Order (E.O.)
14300, ``Ordering the Reform of the Nuclear Regulatory Commission,'' to
support the national policy objectives stated in that E.O. and to
improve the regulation of the civilian nuclear energy industry,
consistent with the aims of the Accelerating Deployment of Versatile,
Advanced Nuclear for Clean Energy Act of 2024 (ADVANCE Act). All NRC
licensees are subject to the NRC's radiation protection requirements
set forth in title 10 of the Code of Federal Regulations (10 CFR) part
20, ``Standards for Protection Against Radiation.'' These requirements
are designed to protect both members of the public and occupational
workers from harm that could be caused by exposure to radiation
resulting from a licensee's use of radioactive materials. The proposed
revisions to the NRC's standards for protection against radiation
reflect the agency's reconsideration, based on current scientific
knowledge and regulatory experience, of its use of the linear no-
threshold (LNT) model for assessing health effects from radiation
exposure and its use of the ``as low as is reasonably achievable''
(ALARA) principle that is predicated on the LNT model. Additionally,
the proposed revisions reflect the agency's consideration of shifting
to a regulatory framework that uses predominately determinate radiation
limits to protect from deterministic and stochastic health effects of
radiation exposure. These proposed revisions are twofold and reflect
the NRC's several decades of experience since the last major revisions
to 10 CFR part 20 and would enable the safe use of nuclear technology
while maintaining reasonable assurance of adequate protection from the
health effects of radiation exposure. Specifically, the proposed
revisions would (1) address unnecessary conservatism and excessive
subjectivity associated with regulatory requirements as they relate to
protection from very low doses of radiation, and (2) incorporate
flexibility and acceptable alternatives in the regulations.
At present, there are several factors, such as global competition
in the development of advanced, energy-intensive technologies like
artificial intelligence, that--combined with a national emergency in
energy production as described in E.O. 14156, ``Declaring a National
Energy Emergency''--demand urgent action by the NRC to ensure that the
NRC continues to enable the safe use of nuclear technology while
maintaining reasonable assurance of adequate protection of the public
health and safety. Historically, when establishing or revising its
standards for protection against radiation, the NRC, as well as its
predecessor, the Atomic Energy Commission (AEC), has stated that the
standards are subject to change, considering factors such as the
development of new scientific knowledge or further regulatory
experience (see 22 FR 549, Jan 29, 1957 and 56 FR 23360, May 21, 1991).
As a result of its consideration of current scientific knowledge
and regulatory experience, the NRC has determined that certain aspects
of its standards for protection against radiation allow for excessive
subjectivity that leads to overly cautious assessments regarding
radiological risk and methods to mitigate that risk, and that some
aspects of the standards are susceptible to selective or inconsistent
enforcement. Such an outcome is inconsistent with the NRC's Principles
of Good Regulation, in particular, the ``Efficiency,'' ``Clarity,'' and
``Reliability'' principles. Specifically, correcting over-conservatisms
in the NRC's regulatory framework would help ensure that the NRC's
regulatory activities are consistent with the degree of risk reduction
achieved, and increasing objectivity would help ensure that regulated
entities and the public are more readily able to understand NRC
requirements and plan activities accordingly. Moreover, a more
objective regulatory framework would contribute to increasing
accountability for the NRC in fairly administering its radiation
protection standards and lend stability to nuclear regulation.
Therefore, the NRC is proposing changes to its regulations and guidance
that reduce subjectivity in the implementation and enforcement of the
NRC's regulations, reduce unnecessary burden on licensees, and increase
flexibility associated with the licensing and use of nuclear
technology, all while maintaining reasonable assurance of adequate
protection of the public health and safety.
Since the proposed changes would predominantly affect regulations
in 10 CFR part 20, they would apply to all categories of NRC licensees.
To the extent that the affected regulations must be adopted for an
Agreement State to maintain an adequate and compatible Agreement State
program, these proposed changes would impact Agreement States. The
proposed changes would support the safe use and deployment of nuclear
technologies while continuing to maintain reasonable assurance of
adequate protection of individuals. The proposed changes are based on a
comprehensive evaluation of the NRC's regulatory experience and the
current state of scientific knowledge using a weight of scientific
evidence decision-making approach, as described in E.O. 14303,
``Restoring Gold Standard Science.''
Radiation Protection Standards
Current Standards for Protection Against Radiation
The NRC's standards for protection against radiation in 10 CFR part
20 were last significantly revised in 1991 (56 FR 23360, May 21, 1991),
with minor revisions being implemented since that time. For example,
the NRC introduced changes in areas such as license termination
criteria and respiratory protection in 1997 (62 FR 39058, July 21,
1997) and 1999 (64 FR 54543, October 7, 1999), respectively. In short,
the 1991 revisions culminated with the Commission adopting, with some
exceptions, the 1977 recommendations from International Commission on
Radiation Protection (ICRP) Publication 26. These revisions marked a
significant departure from the approach to radiation protection that
the NRC and its predecessor, the AEC, had followed since the 1950s. The
most significant technical change was the adoption of the concept of
``effective'' dose, a concept that uses a series of correction factors
to translate the risk associated with any type of radiation exposure to
a dose as if it were given to the entire body. Effective dose is
particularly
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important for predicting and limiting the stochastic effects of
radiation exposure (i.e., health effects, such as cancer, whose
occurrence is random in nature). As described in the proposed rule for
the 1991 revisions of 10 CFR part 20 (51 FR 1092, May 21, 1991), prior
to those revisions, regulatory limits were derived from implicit
judgements on health effects associated with the use of licensed
materials; but in the 1991 revisions, these limits were derived from an
increased understanding of the risk of health effects from radiation
exposure. For example, the 1991 revisions set the occupational limit
for stochastic effects such that the risk of a worker dying from cancer
that resulted from occupational exposure to radiation was roughly
equivalent to the mortality risk experienced by workers in industries
not involving radiation exposures.
As described in the NRC's 1991 final rule, the radiation protection
standards were revised based on the following key assumptions: (1)
within the range of exposure conditions usually encountered in
radiation work, there is a linear relationship, without threshold,
between dose and the probability of stochastic health effects (such as
latent cancer and genetic effects) occurring; (2) the severity of each
type of stochastic health effect is independent of dose; and (3)
nonstochastic radiation-induced health effects (i.e., health effects
whose occurrence is not random in nature, but rather is based on
exceeding an empirically determined threshold dose) can be prevented by
limiting exposures so that doses are below the thresholds for their
induction. The first and second assumptions imply that the potential
health risk associated with radiation exposure is proportional to the
dose received and that there is an incremental health risk associated
with even small doses. Additionally, the second assumption implies that
the severity of a stochastic health effect is not related to the
radiation dose received by an individual. Finally, the third assumption
implies that there are some health effects for which there is a
threshold, meaning that the health effect does not occur if the dose to
an individual remains below that threshold value. For such
nonstochastic effects (now known as tissue effects), determinate limits
are appropriate because the threshold for the effects can be reliably
established through observation or experimentation, and thus, a limit
can be established below which the effect would not occur.
As it relates to stochastic effects, when the NRC issued its 1991
revisions, the Commission observed, based on studies available at the
time, that ``there is an increased incidence of certain cancers
associated with radiation exposure at high doses and high dose rates.
However, whether these effects occur at very low doses and, if they
occur, whether their occurrence is linearly proportional to dose are
not firmly established.'' Therefore, the NRC determined that as a
policy matter, in the absence of convincing evidence that there is a
dose threshold or that the health effects of low levels of radiation
are fully understood, the LNT model for cancers and genetic effects was
appropriate for formulating radiation protection standards and planning
radiation protection programs.
Developments in Radiation Protection Relevant to the NRC's Radiation
Protection Regulatory Framework
ICRP Publication 26
The ICRP is an independent organization of members in all fields of
radiation protection. It publishes recommendations and guidance
regarding radiation protection.
In ICRP Publication 26, the ICRP provided its 1977 recommendations.
This was a watershed event in the field of radiation protection. Prior
to these recommendations, much of radiation protection was based on
limiting the external exposure to individuals and limiting the amount
of intake of radioactive materials to radionuclide-specific maximum
concentration levels. With the 1977 recommendations, the ICRP
introduced the distinction between stochastic health effects and
nonstochastic health effects, and it also introduced several new
quantities for measuring radiation dose (i.e., equivalent dose and
effective dose). Thereafter, the primary focus of radiation protection
became protection from those effects that show a threshold and thus
whose occurrences are not random in nature (i.e., nonstochastic, or
tissue, effects) and protection from those effects that do not show a
threshold and whose occurrence is random in nature (i.e., stochastic
effects), as opposed to the older approach that essentially focused on
protection from internal and external exposures. In ICRP Publication
26, to assess the level of risk, the health effects of internal and
external exposures were combined into the concept of effective doses, a
quantity that is weighted for types of radiation and organs irradiated,
as applicable. This system was largely adopted by the NRC in its 1991
revisions to 10 CFR part 20 and has served as the basis for the NRC's
radiation protection regulatory framework ever since.
ICRP Publication 60
At the time that the NRC was developing its 1991 revisions to 10
CFR part 20, the ICRP was in the process of revising its 1977
recommendations. This culminated with the issuance of ICRP Publication
60 in which the ICRP introduced several refinements to the 1977 methods
for calculating doses and recommended revised limits for members of the
public and occupationally exposed individuals. As it pertains to the
recommended public dose limits, the ICRP initially published its new
recommendations in 1985. During the development of its 1991 revisions
to 10 CFR part 20, which occurred throughout the 1980s, the NRC
integrated the new ICRP recommendations for exposure of members of the
public into the 1991 rule.
With regard to the occupational dose limit for stochastic effects,
the ICRP reduced its recommended limit from 5 rem/year (50 mSv/year) to
2 rem/year (20 mSv/year) averaged over 5 years, not to exceed 5 rem (50
mSv) in any single year. The NRC decided not to follow this
recommendation in the 1991 rule for exposure of workers, based on the
NRC's regulatory experience. With ICRP Publication 60, the ICRP also
introduced changes to several quantities that are significant to
dosimetry calculations. For example, the radiation weighting factor was
introduced to replace the quality factor in the conversion of absorbed
dose to equivalent dose (called dose equivalent in ICRP Publication
26). This change improved the accuracy of calculations because, rather
than calculating the biological effects at a given point in an organ as
was done with the quality factor, the radiation weighting factor
provides values that are averaged over an entire organ. Additionally,
several subsequent supporting publications for ICRP Publication 60
(e.g., ICRP Publication 67) sought to improve the biokinetic models
used to calculate doses and to provide updated derived limits, like
annual limits on intake and radionuclide-specific dose conversion
factors.
ICRP Publication 103
The most recent updates to the ICRP's comprehensive recommendations
for a system of radiological protection, as of 2026, are contained in
ICRP Publication 103, published in 2007. In ICRP Publication 103, the
ICRP maintained its recommended dose limits and maintained
justification, limitation, and optimization as the fundamental
principles of radiation protection.
[[Page 43460]]
Additionally, the ICRP updated its recommended tissue weighting factors
and its recommended methodology for accounting for detrimental impacts
on overall health, and it provided a framework for demonstrating
radiological protection of the environment. The NRC has not
incorporated the recommendations in ICRP Publication 103 as
requirements into its regulations; however, as explained in the
sections describing the proposed regulations at Sec. 20.1010 and at
Appendix H to 10 CFR part 20, the NRC proposes in this rulemaking to
allow applicants and licensees to use dosimetry modeling approaches
that differ from those underlying the current 10 CFR part 20, including
those that result from ICRP Publication 103.
NCRP 180 and Commentaries 26 and 27
The National Council on Radiation Protection and Measurements
(NCRP) is a technical organization dedicated to the development of
recommendations that pertain to public policy involving radiation
protection. The NCRP holds a Congressional Charter under Public Law 88-
376 to support radiation protection by providing independent analysis,
information, and recommendations.
The NCRP's latest major set of recommendations for managing
exposure to ionizing radiation is provided in NCRP 180, published in
2018. NCRP 180 is largely consistent with the recommendations in ICRP
Publication 103 and reflects advances in the understanding of the
biological effects of ionizing radiation that have accrued since the
NCRP published its last major set of recommendations in 1993. In NCRP
180, the NCRP concluded that the consensus understanding of radiation
effects has not changed in a way that significantly impacts recommended
numeric protection criteria from the 1990s--which are consistent with
the NRC's current regulations--except potentially in the case of dose
to the lens of the eye. Specifically, the NCRP recognized that there is
a growing body of evidence that health effects to the lens of the eye
may occur at lower dose levels than previously estimated, potentially
impacting currently accepted threshold values. Additionally, the NCRP
observed that some research indicates that vision-impairing cataracts
might be better characterized as a stochastic health effect rather than
a tissue effect (i.e., a nonstochastic effect that is subject to a
threshold). On this topic, NCRP Commentary 26 (2016) recognizes that
available data does not yet support a quantitative estimate of a new
threshold value.
Separately, the current observations from the ICRP, in ICRP
Publication 118, concluded that a nominal threshold of 50 rad (0.5 Gy)
for the lens of the eye is appropriate. NCRP Commentary 26 provides
updated guidance on radiation dose limits for the lens of the eye,
reflecting new scientific evidence on cataract formation at lower
doses. The commentary recommends reducing the occupational dose limit
for the lens of the eye from 15 rem/year (150 mSv/year) to 5 rem/year
(50 mSv/year). This recommendation aligns with international
recommendations, including those from the ICRP. However, at the time of
this rulemaking, these findings are preliminary and the recommendations
are conservative in nature, especially when considering that the
current annual limit on dose to the lens of the eye is already less
than half of the new nominal threshold observed by the ICRP. Further
research in this area may merit reconsideration of the current
occupational dose limit for the lens of the eye in the future.
Recent Rulemaking Activity Pertaining to 10 CFR Part 20
In April 2002, the NRC staff commenced an effort to update 10 CFR
part 20 to align with what would become the ICRP Publication 103
recommendations. With SECY-01-0148, ``Processes for Revision of 10 CFR
part 20 Regarding Adoption of ICRP Recommendations on Occupational Dose
Limits and Dosimetric Models and Parameters'' (ML011580363), the staff
presented the Commission with options and recommendations for agency
action in response to radiation protection-related information that had
been developed since the last major revisions to 10 part 20 in 1991. In
response, the Commission directed the staff to coordinate with other
Federal agencies to ensure that a coherent approach would be applied to
the use of updated radiation protection-related information and to
monitor the work of the ICRP as it develops what would become ICRP
Publication 103.
In December 2008, after the release of ICRP Publication 103, the
NRC staff, in SECY-08-0197, ``Options to Revise Radiation Protection
Regulations and Guidance with Respect to the 2007 Recommendations of
the International Commission on Radiological Protection''
(ML091310193), recommended that the NRC's radiation protection
framework be amended to align with ICRP Publication 103. As part of
that recommendation, the staff observed that rulemaking would not begin
immediately because information required for developing the technical
basis for the rulemaking and the regulatory analysis was not available
at the time. In response, the Commission directed the staff to
``immediately begin engagement with stakeholders and interested parties
to initiate development of the technical basis for possible revision of
the NRC's radiation protection regulations, as appropriate and where
scientifically justified, to achieve greater alignment with the 2007
recommendations of the [ICRP] contained in ICRP Publication 103.''
In April 2012, after much stakeholder engagement regarding
potential changes to the NRC's radiation protection regulatory
framework, the NRC staff, in SECY-12-0064, ``Recommendations for Policy
and Technical Direction to Revise Radiation Protection Regulations and
Guidance'' (ML121020108), communicated to the Commission policy
recommendations and the technical basis for revisions to that
framework. In response, the Commission approved the development of a
regulatory basis for the revision of 10 CFR part 20 and 10 CFR part 50,
Appendix I to align those regulations with the most recent methodology
and terminology for dose assessment. However, the Commission
disapproved the staff recommendations to develop a basis for reducing
the limit on occupational total effective dose equivalent and to
eliminate the use of traditional units in favor of International System
of Units (SI) for radiological measurement. The Commission also
directed the staff to continue discussions with stakeholders regarding
dose limits for the lens of the eye and for the embryo/fetus. Finally,
the Commission directed the staff to continue discussions with
stakeholders on alternative approaches regarding radiological
protection for individuals at or near the dose limit.
Subsequently, in July 2014, the NRC staff published an advance
notice of proposed rulemaking (ANPR) (79 FR 43284, July 25, 2014) to
obtain input on its proposed approach to the rulemaking. In response to
the ANPR, the NRC received 90 individual comments and about 3,000 form
letters. The staff assessed that most of the comments were not
supportive of the revision to 10 CFR part 20 in large part because of
doubts regarding the safety benefits of the proposed changes when
weighed against the costs of implementing the proposed changes.
Finally, in December 2016, as described in SECY-16-0009,
``Recommendations Resulting from the Integrated Prioritization and Re-
Baselining of Agency Activities'' (ML16028A189), and its accompanying
[[Page 43461]]
Federal Register notice (81 FR 95410), as part of an agencywide
reprioritization initiative, the NRC discontinued this rulemaking
activity--having concluded that, ``the current NRC regulatory framework
continues to provide adequate protection of the health and safety of
workers, the public, and the environment.''
Petition for Rulemaking Regarding the Linear No-Threshold Model and
Standards for Protection Against Radiation
In February 2015, the NRC received three petitions for rulemaking
(PRMs) requesting that the NRC amend 10 CFR part 20 to discontinue the
use of the LNT model as the primary scientific basis for the NRC's
radiation protection standards. The NRC published a Federal Register
notice docketing the PRMs (80 FR 35870, June 23, 2015) and requested
public comments. The PRMs sought several specific changes to the
regulations, such as the increase of the occupational dose limit from 5
rem to 10 rem; the removal of the concept of ALARA based on the
assertion that radiation exposure is beneficial at low doses; the
increase of the public dose limit so that it would match the proposed
occupational dose limit; and the ending of the use of lower dose limits
for pregnant women, an embryo/fetus, and children under 18 years of
age.
Upon consideration of the PRMs and associated comments from the
public and other governmental agencies and the relevant positions of
authoritative scientific bodies, the NRC denied the PRMs. In its denial
(86 FR 45923, August 17, 2021), the NRC reviewed the scientific basis
for its current regulatory framework and the relevant recent research
in the area. A key basis asserted by the PRMs was the concept of
hormesis (i.e., that low doses of radiation are beneficial to humans),
and that, because of this, the NRC's regulatory framework should be
revised to reflect the beneficial nature of low dose exposures for
workers and members of the public.
The NRC ultimately denied the PRMs, noting, ``There is scientific
uncertainty and no compelling evidence as to whether the hormesis
concept is valid for application to radiation protection requirements.
None of the national and international authoritative scientific
advisory bodies . . . support the hormesis concept as a regulatory
model for radiation protection'' (86 FR 45923). With respect to the
argument in the PRMs that the concept of ALARA should be removed from
the NRC's regulations, the NRC described the intended implementation of
ALARA as involving the concept of reasonableness (i.e., ``making `every
reasonable effort' to implement ALARA . . . to the `extent practical'
''). Notwithstanding public comments regarding the PRMs, which argued
that the NRC's implementation of ALARA has led to excessive costs to
licensees and has inhibited the growth and innovation of the nuclear
sector, the denial explained that compliance with the ALARA requirement
is based on whether the licensee has incorporated reasonable measures
to track and, if necessary, to reduce exposures--not whether exposures
and doses represent an absolute minimum or whether the licensee has
used all possible methods to reduce exposures.
While this description of the ALARA requirement remains true today,
the NRC recognizes that there have been challenges in the
implementation of the ALARA requirement, namely a lack of clarity of
when dose reduction is deemed sufficient, excessive subjectivity, and
susceptibility for selective or inconsistent enforcement. For example,
there is wide variance within the U.S. nuclear industry in how much a
given licensee is willing to spend to reduce radiation exposure and
regulatory experience indicates that, in general, these industry-
determined benchmarks significantly exceed the value promulgated by the
NRC in NUREG-1530. Accordingly, the direction in section 5(b) of E.O.
14300 provides an opportunity for the Commission to correct the
implementation issues associated with ALARA, consistent with the
``Efficiency,'' ``Clarity,'' and ``Reliability'' principles of the
NRC's Principles of Good Regulation.
NRC Response to E.O. 14300 Section 5(b)
The NRC considers its current standards for protection against
radiation to be science-based to the extent that adequate methods and
analyses have been applied in the works that have been referenced in
the development of the NRC's regulations and guidance. However, as has
been known for many decades, the uncertainty associated with dosimetric
models and methods increases significantly in the low dose range. This
is largely because these models and methods rely in part on
extrapolations from high-dose and high-dose-rate data as the primary
basis for estimation of radiation-related risk at low doses. Such
extrapolations of epidemiological data do not fully account for what is
known to be a complex, and likely adaptive, cellular response to doses
in the low dose range--which includes levels common to NRC-licensed
activities--thus, a degree of scientific judgement is used to account
for these effects.
Difficulties with using epidemiological data to estimate radiation-
related risk at low doses can be attributed to multiple factors. For
example, there is difficulty in conducting epidemiological studies with
sufficient statistical power to control for confounding factors such as
lifestyle choices (e.g., smoking and diet) and population health in
order to distinguish between cancers caused by very low level radiation
and the large baseline cancer rate to which humans are subjected. For
example, Table 12-4 of the BEIR VII Phase 2 report shows that 20
percent of the U.S. population is expected to die from solid cancers
(i.e., excluding blood cancers like leukemia). This large baseline
cancer rate essentially introduces a signal-to-noise problem with the
``signal,'' or the fatal cancers from very low doses of radiation, are
masked by the large ``noise,'' from the baseline fatal cancer rate.
From a radiobiological perspective, there are unknowns involving
cellular defense mechanisms and how these mechanisms modify the long-
term health effects of radiation exposure. The scientific community has
sought to address these uncertainties in part by adjusting the slope of
the linear approximation of the dose-response relationship through the
use of a dose and dose rate effectiveness factor (DDREF). However, the
appropriate value of the DDREF is itself subject to uncertainty and is
the result of scientific judgement. More importantly, the
implementation of the DDREF has not had a practical impact on
recommended radiation limits or upon curtailing practices that seek to
reduce radiation risk by minimizing exposures even to very low doses.
Thus, while the methods used to establish the basis for the NRC's
radiation protection standards are sound, and while these standards are
protective of the public health and safety, there are uncertainties
associated with the methods and resulting recommendations within
consensus-based standards, including their exact degree of
conservatism. Regulatory experience, though, has demonstrated that the
primary issue is not the standards themselves, but their
implementation. For example, those standards that go beyond what is
necessary for reasonable assurance of adequate protection and that can
be interpreted as requiring continuous dose reductions even to very low
doses of radiation have often been applied
[[Page 43462]]
without a reasonable stopping point. In these instances, the radiation
protection standards have led to outcomes that are overly conservative.
As a practical matter, such over conservatism can significantly
undervalue the benefits of activities when compared to their risks,
sometimes at great economic costs or stifling of innovation.
Reconsideration of LNT and ALARA
The LNT model of radiation protection has led to confusion
regarding the risks associated with low doses of radiation exposure and
to unintended consequences as it relates to the costs associated with
radiation protection at levels common to NRC-licensed activities. This
model is used to account for the stochastic nature of some radiogenic
health effects. It combines knowledge from epidemiological data from
atomic bomb survivors and other cohorts and radiobiological research
results to establish a relationship between the amount of radiation
dose that a human receives and the health outcome, in particular
cancer. The ICRP describes how epidemiological data from high doses are
used to predict risk at very low doses:
The LNT model receives considerable, although not decisive,
support from epidemiological studies of radiation-related cancer
risk, in the same sense that the risk of mortality and morbidity
from all solid cancers combined in the LSS [Life Span Study] is
proportional to radiation dose down to about 100 mGy [10,000 mrad],
below which statistical variation in baseline risk, as well as small
and uncontrollable biases, increasingly tend to obscure evidence
concerning any radiation-related risk. This uncertainty is the main
reason why it is generally impossible to determine, on
epidemiological grounds alone, that there is, or is not, an
increased risk of cancer associated with radiation exposures of the
order of a few tens of mSv [1 mSv = 100 mrem] and below. Risk
estimates for such exposures are obtained through the use of
mathematical models that assume a simple relationship, e.g., linear,
linear-quadratic, or linear with a dose and dose rate effectiveness
factor (DDREF) between risk at higher doses, where epidemiological
data tend to be informative, and at doses so low that direct
epidemiological observation is uninformative (ICRP Publication 103,
paragraph A179).
The radiation dose response relationship is commonly accepted to be
linear with changes in slope at lower doses, represented by the DDREF,
indicating less health impact per unit dose at lower doses. To date, no
threshold has been established in this model, meaning that as the dose
decreases to zero, the corresponding risk follows proportionally to
zero. However, this lack of a threshold and the proportional
relationship between dose and health response are commonly distilled to
mean that even the lowest dose will increase the risk of cancer. While
this conclusion is technically consistent with the LNT model, it is
overly simplistic and leads to confusion because it discounts the
effect of known biological responses to cellular upsets and the margins
of error associated with slope factors and cancer coefficients that, at
low levels of dose, include zero health effects as a possibility.
The NRC recognizes that the quantitative estimation of health risk
at very low doses presents longstanding scientific challenges. The NRC
acknowledges that advances in radiobiology have identified mechanisms
such as DNA damage response and repair, dose-rate effects, and adaptive
cellular responses that complicate simple linear extrapolation.
However, the NRC finds that no consensus-supported, regulation-ready
alternative model to the LNT model exists at this time. In the absence
of such a suitable replacement, the NRC has taken this opportunity to
address the LNT model's inherent limitations by carefully examining its
unintended impact on ALARA practices.
Because of the LNT model's limitations in the very low dose region
of the model (sometimes referred to as linear to zero), the radiation
protection community has taken a layered precautionary approach,
traditionally seeking to minimize radiation exposure in order to
minimize the risk of stochastic health effects. Initially, the intent
of this practice was to reduce dose ``as low as practicable,'' as
described in ICRP Publication 1, the 1959 ``Recommendations of the
International Commission on Radiological Protection.'' Subsequently, it
was recast to emphasize reasonable approaches to dose reduction, first
as ``as low as is reasonably achievable'' and then as the present-day
practice of ``optimization.'' However, regulatory experience
corroborates the observations in E.O. 14300 regarding the negative
consequences of relying on subjective interpretations of reasonableness
as it relates to risks from and protective measures for very low doses
of radiation. The root of the matter is that there is a difference
between eliminating all risks and recognizing when a risk exists but is
extremely small, or even within the margin of error that includes zero
risk, and that further risk reduction is not reasonable.
The ALARA principle is an outgrowth of applying the LNT model. That
is, because the LNT model does not recognize a threshold below which
stochastic health effects do not occur, there is an implication that
dose should be minimized to also minimize the risk of health effects.
However, properly understood, the ALARA principle recognizes that,
unless all dose is eliminated, some risk may remain but that the level
of that risk should be balanced by the reasonableness of further dose
reduction measures. In contrast, over-conservatism in the application
of the LNT model at very low doses combined with the potential for
enforcement action for noncompliance renders implementation of the
model susceptible to rote attempts at dose reduction rather than an
approach tempered by a measured consideration of the reasonableness of
those reductions. In essence, the reasonableness test that is supposed
to be inherent to ALARA-related decision-making has gradually become an
expectation that if a means of dose reduction is available, regardless
of its reasonableness in relation to the total dose and the amount of
reduction, it should be applied without further consideration. In
practice, this has at times resulted in significant economic costs and
operational and licensing inefficiencies without commensurate public
health and safety gains.
This seemingly singular focus on minimizing the risk associated
with very low doses is at odds with the long-standing radiation
protection recommendations that established these principles in the
first place. Notably, as far back as 1977, the ICRP observed that in
the choice of alternative practices, radiation risk estimates should be
used only with great caution and with explicit recognition of the
possibility that the actual risk at low doses may be lower than that
implied by a deliberately cautious assumption of linear proportionality
of risk with dose.
As observed in E.O. 14300, the ALARA principle as used in the NRC's
regulations has lost its intended focus on reasonableness. Instead, as
a practical matter, its unbalanced application may very well contribute
to more societal harm than the potential harm from the extremely low
levels of radiation typical of NRC-licensed activities by hindering the
consideration of nuclear technology for energy production and other
uses. Therefore, while the NRC recognizes that there is insufficient
evidence to refute the use of the LNT model when considering the
stochastic health effects of radiation exposure, it also recognizes
that the NRC's implementation of the ALARA principle as part of its use
of the LNT model--in particular, the nonthreshold
[[Page 43463]]
aspect of the model--has led to regulatory burden that is not
commensurate with the resulting public health and safety benefit and
that is not consistent with the original intent of the ALARA principle.
In light of the foregoing, one purpose of this rulemaking is to
restore to the NRC's regulations the original intent of the ALARA
principle, which is to ensure that dose reductions below the dose
limits are only required to the extent that they are reasonable and are
supportive of compliance with those dose limits. The NRC proposes to do
this by retiring the use of ALARA terminology in the NRC's regulations;
utilizing selected aspects of the linear dose response model in favor
of a strict adherence to the LNT model and its emphasis on the lack of
a threshold for stochastic effects; and defining required dose
management practices below dose limits, which will enable clearer and
more objective decision-making regarding dose situations typical of
NRC-licensed activities. Stated another way, the NRC proposes to
continue to use the linear dose response model, as it continues to be
the most appropriate model upon which to base a radiation protection
framework; however, the NRC proposes to also detail how licensees
should apply a graded approach to dose management to ensure clarity in
how doses below the dose limits are to be controlled.
Through this rulemaking, the NRC proposes a complete
discontinuation of the use of ALARA terminology in its regulations and
guidance. The NRC has concluded that simply issuing a clarification of
the intent of the ALARA principle would not be effective in achieving
an enduring resolution of the issues associated with the NRC's current
implementation of the ALARA principle. As previously discussed, the
NRC's current implementation of the ALARA principle allows for
excessive subjectivity in the expectations for dose reduction measures,
oftentimes resulting in overly conservative outcomes. The proposed rule
changes seek to minimize the subjectivity associated with radiation
safety decision-making at the low doses typical of NRC-licensed
activities. However, these rule changes will not require any changes to
licensees' current practices; instead, the rule changes would clarify
what is required for compliance but would not preclude licensees from
choosing to do more. Therefore, in addition to providing dose limits
that are sufficient for the adequate protection of workers and the
public, the NRC's regulations would include requirements that are
triggered at dose levels below those dose limits to ensure that the
dose limits are not exceeded and that radiological hazards are
adequately surveyed and controlled. These dose levels would be the
basis for a graded approach to dose management.
With the recognition that the NRC's radiation protection regulatory
framework is conservative as described previously, the NRC intends as
an additional purpose of this proposed rulemaking to provide additional
flexibility and to remove from its regulations overly cautious
requirements pertaining to radiological matters. Combined with the
proposed retirement of the term ALARA, the proposed changes that would
enable licensee flexibility would support the NRC's mission statement
by enabling the development of nuclear energy in the United States
while maintaining reasonable assurance of adequate protection.
For example, the NRC proposes to reduce certain reporting
requirements for radiological monitoring and certain exposure
situations in excess of limits. Additionally, the NRC proposes to allow
licensees to use dosimetry methods that differ from the systems that
serve as the basis for certain provisions in the regulations without
needing an approved exemption from those regulations. This proposed
change would allow licensees to use modern approaches to dosimetry
without incurring the burden and costs of an exemption request.
As it relates to public dose limits, the proposed changes would
allow applicants and licensees to apply for higher limits for members
of the public who enter the controlled area of a facility and to apply
for higher limits for members of the public at large. The controlled
area of a facility is defined in 10 CFR 20.1003 as ``an area, outside
of a restricted area but inside the site boundary, access to which can
be limited by the licensee for any reason.'' In essence, the controlled
area is land that a licensee (or applicant) owns or leases (or will own
or lease during the period of the license) and thus where it can
legally control occupancy and impose other radiation protection
measures, as necessary. Regarding occupational dose limits, the
proposed changes would allow licensees to manage occupational doses
using a multi-year average dose within acceptable limits without having
to implement burdensome provisions associated with planned special
exposures when managing the dose limits on an annual basis alone. And,
again, these proposed changes would not affect current licensees that
desire to continue using their existing practices. These proposed
changes are described in greater detail in Section IV.
In accordance with accepted practice in the field of radiation
protection, the NRC would continue to emphasize the fundamental
radiation protection principles of justification, limitation, and
optimization as the guideposts within its radiation protection
regulatory framework. However, consistent with International Atomic
Energy Agency (IAEA) General Safety Requirements Part 3 (GSR Part 3),
``Radiation Protection and Safety of Radiation Sources: International
Basic Safety Standards''--which provides internationally accepted
standards to ensure the protection of people and the environment--under
the revisions proposed by this rule, compliance with the NRC's
regulations would be taken as evidence of the application of those
principles in the United States. Specifically, the principle of
justification--ensuring that decisions resulting in radiation exposure
do more good than harm--is satisfied by the NRC's enacting legislation,
NRC regulations, and the licensing process, which ensures that licensed
activities are conducted for the general welfare of the American public
as authorized by law. The principle of limitation--the regulatory body
establishing and enforcing dose limits--is satisfied by the dose limits
in the radiation protection standards reflected in the NRC's
regulations. These limits continue to be sufficient to provide
reasonable assurance of adequate protection of the public health and
safety and the graded approach to dose management requirement proposed
in this rulemaking ensures that these limits are not exceeded. The
principle of optimization--the process for ensuring that the likelihood
and magnitude of exposures and the number of individuals exposed are as
low as reasonably achievable, with economic, societal, and
environmental factors taken into account--is satisfied by licensees
complying with the precautionary requirements in the NRC's regulations,
and, as applicable, applying prescribed practices when doses are below
regulatory limits to maintain doses within those limits. To minimize
subjectivity in implementing the principle of optimization and to avoid
the overly cautious practices that resulted from the NRC's previous use
of the term ALARA throughout its regulations and guidance, the NRC
proposes to provide implementation guidance for a graded approach to
dose management below regulatory limits.
[[Page 43464]]
This approach would ensure that the risk of stochastic effects is
adequately controlled by ensuring that regulatory dose limits are not
exceeded.
In sum, with this rulemaking, the NRC proposes to use the linear
dose response model as a partial basis for its regulations and guidance
but would remove from its practices the excessive conservatisms and
potential for disproportionate enforcement that result from the LNT
model and its emphasis on the lack of a threshold for stochastic
effects. This is consistent with the NRC's continued determination that
the dose limits are sufficient to provide reasonable assurance of
adequate protection of the public health and safety.
Consideration of Determinate Dose Limits
As part of its response to E.O. 14300 section 5(b), the NRC
considered whether to propose shifting its radiation protection
regulatory framework to be based on a set of determinate dose limits.
Determinate dose limits currently exist in the NRC's regulations for
nonstochastic effects (tissue effects) because research has revealed
that these effects do not occur below a threshold dose value. Thus, a
regulatory dose limit can be derived from this threshold dose value by
adding margin to the threshold value, and there would be high
confidence that no health effects would occur should doses remain
within that limit. Such is the case, for example, with the skin dose
limit in 10 CFR 20.1201(a)(2)(ii).
Theoretically, a radiation protection regulatory framework based on
determinate limits, for both nonstochastic and stochastic effects,
could essentially apply a ``go/no-go'' regulatory approach that would
deemphasize radiation protection precautions in lieu of verifications
that a licensee is maintaining dose values below the applicable dose
limit. In order to move to such a regulatory framework, a basis would
be required to establish determinate dose limits for stochastic health
effects.
At present, there is no scientific consensus establishing a
threshold below which stochastic health effects do not occur. As
described in SECY-12-0064, as it relates to stochastic effects, ``It is
unlikely there might be a threshold level of exposure below which
biological response does not occur. Such a threshold could only occur
if DNA repair processes were totally effective in that dose range or if
a single radiation track were unable to produce an effect. The cellular
processes such as apoptosis and cellular differentiation that can
protect against later phases of tumorigenesis are judged to be
efficient but can be bypassed; there is no reason to believe that those
defenses act differently on spontaneous and radiation-induced tumors or
have specific dose dependencies.''
Additionally, more recent analysis of datasets focusing on lower
doses levels (i.e., 10 rem or less) in ``Issues in Interpreting
Epidemiologic Studies of Populations Exposed to Low-Dose, High-Energy
Photon Radiation'' (2020), concludes that the totality of scientific
evidence suggests that even if a threshold for stochastic health
effects existed it would not be higher than 1 rem, which is
significantly below the current occupational dose limit of 5 rem per
year for stochastic health effects. Such analyses reflect the evolving
understanding of stochastic health effects and indicate challenges with
establishing a defensible determinate threshold for these types of
effects.
Furthermore, as described in ICRP Publication 103 and supporting
publications such as ICRP Publication 118, ``ICRP Statement on Tissue
Reactions/Early and Late Effects of Radiation in Normal Tissues and
Organs--Threshold Doses for Tissue Reactions in a Radiation Protection
Context,'' there is growing evidence that other health effects such as
cataracts may show stochastic behavior, or that the threshold for the
effect, if one exists, is lower than originally understood. Therefore,
the NRC, after consideration of the available information, concludes
that establishing a determinate regulatory dose limit for both
stochastic and nonstochastic health effects and adopting a
corresponding ``go/no-go'' regulatory approach is not currently
supported by scientific evidence.
Accordingly, the NRC reaffirms its position that the linear dose
response model is the most appropriate available consensus model for
formulating radiation protection standards and planning radiation
protection programs. However, to address deficiencies in the
implementation of that model in its current radiation protection
regulatory framework, the NRC proposes to provide clarity and increased
objectivity to radiation protection decisions by identifying a series
of threshold doses that guide actions below the stochastic dose limits.
This graded approach to dose management below stochastic dose limits is
aligned with the NRC's overall risk-informed approach to regulation.
The general purpose of this approach is to ensure that the NRC's
radiation protection regulatory framework remains in harmony with
scientific consensus while being responsive to the observations in E.O.
14300 regarding the deficiencies associated with the LNT model and the
implementation of the ALARA principle in the United States. The graded
approach to dose management is described further in Section IV.
Summary of NRC Response to E.O. 14300 Section 5(b)
In summary, as directed by E.O. 14300 section 5(b), the NRC is
reconsidering its use of the LNT model and its use of the ALARA
principle. The NRC recognizes that there are limitations to the
accuracy of the LNT model at very low doses, however, the NRC has also
not identified a suitable alternative model. Nevertheless, it may be
possible to improve how the NRC addresses the inherent limitations of
the LNT model. Therefore, the NRC is proposing changes to how the LNT
model is implemented in its regulations and guidance. These changes, as
proposed in this rulemaking, are intended to minimize subjectivity
regarding radiation protection at low doses and to make sure that the
required management of dose below regulatory dose limits is subject to
a more objective reasonableness standard.
Additionally, the NRC considered the use of determinate dose limits
for stochastic health effects and determined that the scientific
understanding of stochastic health effects does not support the
establishment of such limits at this time. Instead, consistent with the
original intent of the ALARA principle, the changes proposed in this
rulemaking would adopt a graded approach to dose management by
identifying a series of dose-based levels that would guide radiation
protection decisions below regulatory dose limits.
Further, the NRC is proposing several changes to its regulations to
enable flexibility and to remove overly cautious requirements, which
would support the E.O. 14300 objective of enabling the development of
nuclear energy in the United States while maintaining reasonable
assurance of adequate protection. The changes proposed as part of this
rulemaking would apply regulatory experience and licensee feedback on
operational challenges to address key deficiencies in the application
of the NRC's current radiation protection standards, while remaining
consistent with the current scientific understanding of the health
effects of radiation exposure. These changes would represent a
rebaselining of applicable regulations and guidance to reduce the
subjectivity that has developed over time in the implementation of the
NRC's radiation
[[Page 43465]]
protection standards with the intent of achieving the original aims of
the ALARA principle; specifically, ensuring that the management of dose
below applicable dose limits is subject to an objective reasonableness
standard that uses sound radiation protection principles.
Should these changes be implemented, the NRC determined that prior
licensing decisions--including environmental reviews, license
amendments, and approvals--that involved ALARA would remain valid
because of their inherently conservative nature (i.e., because of the
prior implementation of the ALARA principle, they would be at least as
protective as the proposed revised regulations). This is true because
compliance with regulatory dose limits is sufficient to provide
reasonable assurance of adequate protection for individuals and ALARA
practices seek to establish reasonable margin to the limits and limit
the overall risk of health effects that are stochastic in nature.
Moreover, the proposed regulatory changes define what is reasonable in
order to remove subjectivity on the part of licensees--so if licensees
had come to these conclusions on their own, the NRC could have accepted
their approaches as being commensurate with the ALARA principle at the
time.
Additionally, the proposed changes are designed such that existing
radiation protection programs that are compliant with the current
requirements would be compliant with the proposed new requirements.
Accordingly, the proposed changes would not affect current licensees
that desire to continue using their existing programs.
Finally, the NRC determined that the proposed changes would
maintain a radiation protection regulatory framework that is in harmony
with the United States' commitments to the international community. For
example, both Article 15 of the Convention on Nuclear Safety (CNS) and
GSR Part 3, which serves as a standard for how countries can meet their
obligations under the CNS, include the ALARA principle, with the latter
discussing ALARA in its description of the concept of optimization. The
graded approach to dose management proposed in this rulemaking meets
the description of optimization in Requirement 11 of GSR Part 3 and,
therefore, also satisfies CNS Article 15. As explained in this
rulemaking, the NRC is proposing to remove references to the ALARA
principle in its regulations and guidance in order to definitively move
away from overly conservative practices that have developed over time
in the name of ALARA and, through strictly applying the concept of
optimization, return to the original intent of the ALARA principle.
IV. Discussion
Description of Proposed Changes to the Regulations
Definitions
The NRC is proposing to remove the definition of ``ALARA'' because
that term would no longer be used within the NRC's radiation protection
regulatory framework. In its place, the proposed rule would add the
term ``graded approach to dose management.'' This term would be defined
as an approach whereby progressively increasing radiation protection
measures are required as prospective, or actual, radiation doses exceed
determinate dose thresholds to provide reasonable assurance that the
applicable regulatory limit is not exceeded. This definition reflects
the NRC's determination that its regulatory dose limits are sufficient
to provide reasonable assurance of adequate protection of the public
health and safety and that the proposed graded approach to dose
management requirement ensures that these limits are not exceeded.
The graded approach to dose management serves the purpose of
ensuring that dose limits are not exceeded in large part by relying on
existing precautionary regulatory requirements (e.g., radiation worker
training, radiological monitoring, signage and posting) to control
doses below the limits. Additionally, the graded approach to dose
management entails that as doses increase and become closer to the dose
limits (i.e., at specified determinate thresholds), increasingly more
rigorous radiation protection measures would be required to ensure that
the dose limits are not exceeded. NRC guidance would provide one
acceptable means for establishing a graded approach to dose management,
including appropriate determinate thresholds and corresponding
radiation protection measures (e.g., shielding, additional work
planning) that are considered reasonable for the circumstances.
As discussed further in this document, the NRC is also proposing to
allow the use of alternative dosimetry methods as reflected in new
proposed sections of its regulations, specifically, 10 CFR 20.1010 and
the associated Appendix H to 10 CFR part 20. This change necessitates
that several clarifying statements be added to the definitions section
of 10 CFR part 20 (e.g., to the definition of airborne radioactivity
area) and to other applicable sections of part 20 to account for the
potential that a licensee might use alternative methods and/or
alternative derived operational values such as annual limits on
intakes, labeling criteria, and derived air concentrations.
Additionally, the term ``dosimetry method (or system)'' and its
definition is proposed to be added as described later in this section.
With the proposed allowance of alternative dosimetry methods, the NRC
determined that it would also be necessary to provide definitions for
certain terms related to dosimetry concepts that have been introduced
as part of modern methodologies (e.g., ICRP Publication 60). Therefore,
the terms ``committed effective dose'', ``committed equivalent dose'',
``effective dose'', ``equivalent dose'', ``radiation weighting
factor'', and ``total effective dose'' and their definitions are
proposed to be added to 10 CFR 20.1003.
A key difference between the dosimetry methods currently
incorporated in the NRC's regulations and the newer, alternative
dosimetry methods proposed to be allowed as part of this rulemaking
involves a distinction between the quality factor and the radiation
weighting factor. In using a radiation weighting factor to convert from
an absorbed dose to an equivalent dose, the newer, alternative
dosimetry methods more accurately capture the health effect on entire
organs versus at a single point in the organ as is done when the
quality factor is used to develop dose equivalent. Therefore, while the
dosimetry methods currently incorporated in the NRC's regulations
remain acceptable, the NRC is proposing to include the potential for
licensees to use newer, alternative dosimetry methods.
The definitions for the terms ``nonstochastic effect'' and
``stochastic effect'' are proposed to be revised to reflect updated
scientific understanding and to align the NRC definition with the
Department of Energy (DOE) definition, respectively. The definition for
the term ``nonstochastic effect'' would be amended to include the
alternative term ``tissue effect'' to reflect modern terminology and to
delete cataracts as an example of the effect in consideration of recent
research that indicates that this health effect may be stochastic in
nature. The definition for the term ``stochastic effect'' would be
amended to be consistent with the DOE definition for the term in 10 CFR
835.2, which, in turn, closely matches the definition in ICRP
Publication 103.
[[Page 43466]]
Additionally, the definition for the term ``Quarter'' is proposed
to be revised to correct a typo; the word ``consecutive'' in this
definition is currently misspelled.
Units of Radiation Dose
The NRC is proposing to add language to Sec. 20.1004 to account
for the potential that, with the proposed addition of the option to use
alternative dosimetry methods, licensees and applicants may determine
values of equivalent dose/dose equivalent and total effective dose
equivalent/total effective dose and effective dose equivalent/effective
dose using different dosimetry systems. As stated in paragraph 31 of
ICRP Publication 60:
It is appropriate to treat as additive the weighted quantities
used by the [ICRP] but assessed at different times, despite the use
of different values of weighting factors. The [ICRP] does not
recommend that any attempt be made to correct earlier values. It is
also appropriate to add values of dose equivalent to equivalent dose
and values of effective dose equivalent to effective dose without
any adjustments. If values of weighting factors other than those
recommended by the [ICRP] are used, this fact should be clearly
stated, and the values should be explicitly given when the
quantities are introduced. These weighted quantities should not be
added to the [ICRP's] quantities.
The proposed new Sec. 20.1004(e)(3) would address the possibility
that a licensee or applicant may apply a custom dosimetry system with
the approval of the NRC, which would be required to include provisions,
and supporting justification, for tracking dosimetric quantities
similar to the approach that is described in paragraph 31 of ICRP
Publication 60.
Alternative Dosimetry Methods
The proposed rulemaking would define the term ``dosimetry method
(or system)'' as ``an approach for calculating the biological effects
of ionizing radiation exposure in humans. The approach provides a
repeatable method of converting from fundamental knowledge of
radioactive decay to biological effects, typically through modeling and
a series of conversion and correction factors for types of radiation
emitted and interactions with tissues, organs, and the environment.''
Dosimetry methods are essential to radiation protection because they
provide the tools necessary to translate how the physical phenomenon of
the energy imparted by radioactive decay results in an impact and
potential hazard to public health and safety.
The current radiation protection standards in 10 CFR part 20 use
dosimetry methods that are based, with some exceptions, on ICRP
Publication 26 (and supporting publications like ICRP Publication 30),
which contains the 1977 recommendations of the ICRP. Other NRC
regulations and certain license conditions make use of different
dosimetry methods. For example, the requirements for technical
specifications regarding effluents from nuclear power reactors at 10
CFR 50.36a apply dosimetry methods established in ICRP Publication 1.
Additionally, some licensees have applied for NRC approval to use
derived limits that are based on more recent dosimetry methods, in
particular with respect to internal dose calculations of inhaled
radionuclides. The NRC has approved the use of those methods on a case-
by-case basis, concluding that their use provides reasonable assurance
of adequate protection of the health and safety of workers and the
public and complies with applicable regulatory requirements.
Through a proposed new regulation and a proposed new associated
appendix, Sec. 20.1010 and Appendix H to 10 CFR part 20, respectively,
the proposed rulemaking would give licensees and applicants the option
to voluntarily use specific, alternative, dosimetry methods, without
requiring a separate, case-by-case NRC review and approval, to
demonstrate compliance with the NRC's radiation protection standards in
10 CFR part 20.
The NRC determined that allowing the use of alternative dosimetry
methods based on specific, identified publications would offer
flexibility to licensees and applicants, increase efficiency in
licensing, operations, and the administration of radiation protection
programs, and bring the NRC's radiation protection regulatory framework
more in line with current recommendations, while maintaining reasonable
assurance of adequate protection of the public health and safety. The
NRC determined that this change would maintain the effectiveness of its
radiation protection regulatory framework because the specific,
alternative, dosimetry methods that would be preapproved for use are
appropriate for the scope of activities subject to 10 CFR part 20, are
technically adequate and have been published by expert, standards-
setting organizations, and provide sufficient transparency regarding
associated assumptions and uncertainties. The use of dosimetry methods
other than these specific methods would still require case-by-case
review and approval by the NRC, and acceptability criteria for requests
to use such methods are proposed to be added to the NRC's regulations
to streamline that process.
To these ends, the proposed new regulation, Sec. 20.1010, would
reference a listing of generically approved alternative dosimetry
methods in a proposed new Appendix H to 10 CFR part 20, and it would
also provide the criteria for the NRC's approval of a method that is
not listed in Appendix H. The methods proposed for inclusion in
Appendix H have been promulgated primarily by the ICRP, but the listing
of generically approved methods would also include methods published by
other consensus-setting organizations. Finally, Appendix H would list
the conditions, if any, on the use of these generically approved
methods. In the future, the NRC expects to update Appendix H as
appropriate, including as more methods become available.
The application of alternative dosimetry methods should be
described and controlled within a licensee's radiation protection
program, as is required by the existing regulation at Sec. 20.2102,
such that dose assessments can be evaluated and, if necessary,
reconstructed by a knowledgeable third party (e.g., NRC inspector).
These programs should ensure that dosimetric quantities are determined
in accordance with relevant standards and, once determined, are summed
in accordance with the proposed regulation at Sec. 20.1004(e)(3).
Documents Incorporated by Reference for Proposed Sec. 20.1010 and
Appendix H to 10 CFR Part 20
Reasonable availability of documents--As part of this rulemaking,
the NRC is proposing to incorporate by reference (IBR) documents from
the American National Standards Institute/American Nuclear Society
(ANSI/ANS) and the International Commission on Radiological Protection
(ICRP). Upon approval from the Office of the Federal Register, the
documents will be available for inspection at the NRC. Contact the NRC
at NRC Technical Library, Two White Flint North, 11545 Rockville Pike,
Rockville, Maryland 20852; telephone: 301-415-7000; email:
[email protected]. Material from ANSI/ANS is available for
purchase from the ANSI website: https://webstore.ansi.org/. Material
from the ICRP is available to the public for free viewing online at the
ICRP publication website: https://www.icrp.org/page.asp?id=5.
IBR Summaries--The NRC is proposing to IBR the following documents
into proposed Appendix H to 10 CFR part 20 for use as
[[Page 43467]]
preapproved alternative dosimetry methods per proposed Sec. 20.1010:
ANSI/ANS, 2020. Photon and Neutron Fluence-to-Dose Conversion
Coefficients. ANSI/ANS-6.1.1-2020. La Grange Park, IL: American Nuclear
Society--ANSI-ANS 6.1.1-2020 (reaffirmed 2025) provides coefficients
for converting photon and neutron particle fluence to effective dose
based on ICRP Publication 116 data. Separate data are used for cranial
and caudal irradiation geometries. Effective dose conversion
coefficients are provided in tabular form for incident monoenergetic
photons having energies from 10 keV to 10 GeV and for neutrons with
energies from 0.001 eV to 10 GeV. Finally, an analytical model is
provided for evaluating exposures to both photon and neutron fields in
the form of a fourth order polynomial with tabulated numerical
coefficients corresponding to exposure geometry and energy.
ICRP, 1990. Age-dependent Doses to Members of the Public from
Intake of Radionuclides--Part 1. ICRP Publication 56. Ann. ICRP 20
(2)--ICRP Publication 56 provides an analytical framework for
calculating age-dependent committed dose equivalents and effective dose
equivalents to members of the public from ingestion and inhalation of
radionuclides. The framework incorporates biokinetic and dosimetric
models that account for physiological differences from infancy through
adulthood and applies the dose calculation methods consistent with ICRP
Publications 26 and 30. This report provides organ-specific dose
coefficients for 18 radionuclides across six age groups (3 months, 1,
5, 10, and 15 years, and adult) using age-specific anatomical data
(e.g., organ masses, bone surface areas) and biokinetic parameters
(e.g., gastrointestinal absorption fractions, retention half-times,
tissue distribution). ICRP Publication 56 is the first in a series of
five reports that also includes ICRP Publications 67, 69, 71, and 72
that provides radionuclide-specific, age-dependent, dose coefficients
for members of the public.
ICRP, 1993. Age-dependent Doses to Members of the Public from
Intake of Radionuclides--Part 2 Ingestion Dose Coefficients. ICRP
Publication 67. Ann. ICRP 23 (3-4)--ICRP Publication 67 is part two of
a series of five reports (i.e., ICRP Publications 56, 67, 69, 71, and
72) that provides radionuclide-specific, age-dependent, ingestion and
inhalation dose coefficients for members of the public. This report
provides ingestion dose coefficients for 13 radionuclides using the
framework described in ICRP Publication 56, but with tissue weighting
factors from ICRP Publication 60. Additionally, the report updates age-
specific, biokinetic models for the alkaline earth elements, lead, and
selected transuranic radionuclides for incorporation of ICRP
Publication 60 tissue weighting factors and methods and updated
understanding of human biokinetics, as applicable. Lastly, the report
provides recalculated ingestion dose coefficients for the radioisotopes
covered by ICRP Publication 56 using the ICRP Publication 60 tissue
weighting factors and methods.
ICRP, 1994. Dose Coefficients for Intakes of Radionuclides by
Workers. ICRP Publication 68. Ann. ICRP 24 (4)--ICRP Publication 68
provides dose coefficients for occupational intakes--inhalation and
ingestion--of radionuclides, that applied the tissue and radiation
weighting factors from ICRP Publication 60. The report incorporates the
revised Human Respiratory Tract Model from ICRP Publication 66 and
updated systemic biokinetic models in ICRP Publications 56 and 67.
Additionally, the report addresses excretion pathways, gastrointestinal
tract modeling, and provides effective dose rates for inert gases and
soluble/reactive vapors.
ICRP, 1995. Age-dependent Doses to Members of the Public from
Intake of Radionuclides--Part 3 Ingestion Dose Coefficients. ICRP
Publication 69. Ann. ICRP 25 (1)--ICRP Publication 69 is part three of
a series of five reports (i.e., ICRP Publications 56, 67, 69, 71, and
72) that provides radionuclide-specific, age-dependent, ingestion and
inhalation dose coefficients for members of the public. This report
provides ingestion dose coefficients for five radionuclides not covered
in ICRP Publication 67.
ICRP, 1995. Age-dependent Doses to Members of the Public from
Intake of Radionuclides--Part 4 Inhalation Dose Coefficients. ICRP
Publication 71. Ann. ICRP 25 (3-4)--ICRP Publication 71 is part four of
a series of five reports (i.e., ICRP Publications 56, 67, 69, 71, and
72) that provides radionuclide-specific, age-dependent, ingestion and
inhalation dose coefficients for members of the public. This report
provides inhalation dose coefficients for the radionuclides covered in
ICRP Publications 56, 67, and 69 and for calcium and curium.
Additionally, the report provides biokinetic models for calcium,
curium, and decay products for selected radionuclides. Finally, the
report provides an approach for determining absorption types in cases
where material-specific, absorption type is not known.
ICRP, 1995. Age-dependent Doses to Members of the Public from
Intake of Radionuclides--Part 5 Compilation of Ingestion and Inhalation
Coefficients. ICRP Publication 72. Ann. ICRP 26 (1)--ICRP Publication
72 is part five of a series of five reports (i.e., ICRP Publications
56, 67, 69, 71, and 72) that provides radionuclide-specific, age-
dependent, ingestion and inhalation dose coefficients for members of
the public. This report provides a compilation of age-dependent
committed effective dose coefficients for members of the public from
intakes by ingestion and inhalation of the 31 elements covered in ICRP
Publications 56, 67, 69, and 71, as well as for the 60 elements covered
in ICRP Publication 68 for workers.
ICRP, 2010. Conversion Coefficients for Radiological Protection
Quantities for External Radiation Exposures. ICRP Publication 116. Ann.
ICRP 40(2-5)--ICRP Publication 116 provides fluence-to-dose conversion
coefficients for effective dose and organ absorbed doses from external
radiation exposures, based on ICRP Publication 103 recommendations and
using official computational phantoms representing the Reference Adult
Male and Reference Adult Female. The report covers a broad range of
radiation types and various irradiation geometries and includes
coefficients for organ-specific doses, eye lens, skin, and skeletal
tissues. The report includes annexes with extensive tabulated
coefficients, dose-response functions, and guidance for aircraft crew
dosimetry.
ICRP, 2015. Occupational Intakes of Radionuclides: Part 1. ICRP
Publication 130. Ann. ICRP 44(2)--ICRP Publication 130 provides an
introduction to a series of reports that include information for
calculating doses from occupational intakes of radionuclides. This
report includes sections on control of occupational exposures,
biokinetic models (including a revision to the human respiratory tract
model that was published in ICRP Publication 66), dosimetric models,
monitoring methods and programs, and general aspects of retrospective
dose assessment. ICRP Publication 130 is part one of a series of five
reports that also includes ICRP Publications 134, 137, 141, and 151
that provides dose coefficients for occupational intakes of
radionuclides by inhalation and ingestion. This information in this
series of reports was meant to replace the dose coefficients for
occupational dose calculations found in ICRP Publications 30 and 68 by
implementing the ICRP's recommendations in ICRP Publication 103.
ICRP, 2016. Occupational Intakes of Radionuclides: Part 2. ICRP
Publication
[[Page 43468]]
134. Ann. ICRP 45(\3/4\), 1-352--ICRP Publication 134 is part two of a
series of five reports (i.e., ICRP Publications 130, 134, 137, 141, and
151) that provides dose coefficients for occupational intakes of
radionuclides by inhalation and ingestion. As part of this report
series, the ICRP published an electronic database (available at https://www.icrp.org/) that contains a comprehensive set of committed
effective and equivalent dose coefficients, committed effective dose
per content functions, and reference bioassay functions that apply to
scenarios involving inhalation, ingestion, and direct input to blood.
This report provides data on several individual elements and their
radioisotopes, including information on chemical forms encountered in
an occupational setting, decay information, and reference parameter
values for input into biokinetic models. Additionally, this report
provides several corrections that are applicable to ICRP Publication
130.
ICRP, 2017. Occupational Intakes of Radionuclides: Part 3. ICRP
Publication 137. Ann. ICRP 46(\3/4\)--ICRP Publication 137 is part
three of a series of five reports (i.e., ICRP Publications 130, 134,
137, 141, and 151) that provides dose coefficients for occupational
intakes of radionuclides by inhalation and ingestion. As part of this
report series, the ICRP published an electronic database that contains
a comprehensive set of committed effective and equivalent dose
coefficients, committed effective dose per content functions, and
reference bioassay functions that apply to scenarios involving
inhalation, ingestion, and direct input to blood. This report provides
data on several individual elements and their radioisotopes, including
information on chemical forms encountered in an occupational setting,
decay information, and reference parameter values for input into
biokinetic models. Additionally, this report provides background
information for dosimetry of radon progeny and dose coefficients in the
electronic database referenced above.
ICRP, 2019. Occupational Intakes of Radionuclides: Part 4. ICRP
Publication 141. Ann. ICRP 48(\2/3\)--ICRP Publication 141 is part four
of a series of five reports (i.e., ICRP Publications 130, 134, 137,
141, and 151) that provides dose coefficients for occupational intakes
of radionuclides by inhalation and ingestion. As part of this report
series, the ICRP published an electronic database that contains a
comprehensive set of committed effective and equivalent dose
coefficients, committed effective dose per content functions, and
reference bioassay functions that apply to scenarios involving
inhalation, ingestion, and direct input to blood. This report provides
data on several individual elements and their radioisotopes, including
information on chemical forms encountered in an occupational setting,
decay information, and reference parameter values for input into
biokinetic models. Additionally, this report provides several
corrections that are applicable to ICRP Publication 137.
ICRP, 2020. Dose Coefficients for External Exposures to
Environmental Sources. ICRP Publication 144. Ann. ICRP 49(2)--ICRP
Publication 144 provides the technical basis for the calculation of
external dose-rate coefficients for environmental exposure of members
of the public, as well as a tabulation of coefficients. The
calculations include modeling of environmental radiation fields,
computation of organ and effective dose-rate coefficients for exposures
to monoenergetic photons and electrons, and the use of these data to
calculate dose-rate coefficients. The report provides tables of dose-
rate coefficients for selected radionuclides for use in determining
external doses from submersion in water, submersion in air (1 meter
above ground), and for radionuclides distributed at a depth of 0.5 g/
cm\2\ in soil. The supplementary material that accompanies the report
provides external dose-rate coefficients for 1,252 radionuclides of the
97 elements whose decay information is provided in ICRP Publication
107. Additionally, this report provides dosimetry information for the
skeleton and the skin.
ICRP, 2022. Occupational Intakes of Radionuclides: Part 5. ICRP
Publication 151. Ann. ICRP 51(1-2)--ICRP Publication 151 is part five
of a series of five reports (i.e., ICRP Publications 130, 134, 137,
141, and 151) that provides dose coefficients for occupational intakes
of radionuclides by inhalation and ingestion. As part of this report
series, the ICRP published an electronic database that contains a
comprehensive set of committed effective and equivalent dose
coefficients, committed effective dose per content functions, and
reference bioassay functions that apply to scenarios involving
inhalation, ingestion, and direct input to blood. This report provides
data on several individual elements and their radioisotopes, including
information on chemical forms encountered in an occupational setting,
decay information, and reference parameter values for input into
biokinetic models. Additionally, this report provides effective dose
rate coefficients for several radionuclides that apply to the
submersion exposure pathway of occupationally exposed individuals, and
it provides a description of how the contribution to dose from progeny
is accounted for in this series of reports.
References to the ALARA Principle
As part of this rulemaking, the NRC is proposing to remove
references to the ALARA principle from its regulations and guidance.
While the implementation of the ALARA principle based on the NRC's
current regulatory language has generally led to low overall radiation
doses, over time it has also resulted in overly cautious dose reduction
efforts beyond what are reasonable and lacking clear alignment with
actual risk or benefit. As E.O.14300 observes, implementing the ALARA
principle in this manner has resulted in over-conservatism likely to
the detriment of nuclear technology development because it leads to an
overemphasis on the reduction of risks that the state-of-knowledge
identifies as being minimal. The ALARA principle has also been
superseded by the concept of optimization in the system of radiation
protection recommended by the ICRP. As discussed previously in this
document, in response to E.O. 14300, the NRC reconsidered the use of
the ALARA principle in its regulations and determined that in order to
return to the original intent of the ALARA principle and to align with
the more recent concept of optimization, the appropriate approach would
be to replace the ALARA principle with a requirement for a graded
approach to dose management. To this end, the NRC proposes to remove
all instances of the term ALARA from its regulations and to specify
that the original intent of the ALARA principle will be achieved
through the use of a new graded approach to dose management.
The concept of optimization is defined in the 2022 IAEA Nuclear
Safety and Security Glossary as, ``The process of determining what
level of protection and safety would result in the magnitude of
individual doses, the number of individuals (workers and members of the
public) subject to exposure and the likelihood of exposure being as low
as reasonably achievable, economic and social factors being taken into
account (ALARA).'' Requirement 11 of the IAEA's GSR-3 states that,
``The government or the regulatory body shall establish and enforce
requirements for the optimization of protection and
[[Page 43469]]
safety, and registrants and licensees shall ensure that protection and
safety is optimized.'' Further details regarding the regulatory body's
responsibilities pertaining to optimization include establishing
requirements for optimization, requiring documentation addressing
optimization, and the administration of constraints (or thresholds) on
dose, or risk, as appropriate. The 2022 IAEA Nuclear Safety and
Security Glossary describes the purpose of constraints as boundaries in
defining the range of options in optimization.
As discussed previously in this notice, in order to address the
problems of subjectivity and over-conservatism that were introduced
over time through the implementation of the references to the ALARA
principle throughout the NRC's regulations, the NRC proposes removing
these references and replacing them with a requirement for a graded
approach to dose management, which would essentially be an application
of the concept of optimization that, below the dose limits, relies on
various existing regulatory requirements as well as licensees'
individual radiation protection programs to manage dose. NRC guidance
would provide an acceptable approach for this. The graded approach to
dose management would rely on a series of threshold doses below the
regulatory dose limits and dose management actions to be taken at each
threshold dose. These threshold doses and dose management actions would
generally correspond to existing requirements in 10 CFR part 20 or
other regulations and, therefore, should already be incorporated within
the radiation protection programs of existing licensees to a degree
``commensurate with the scope and extent of licensed activities'' as is
currently required by Sec. 20.1101.
For any occupational exposure scenario, compliance with 10 CFR part
20 would provide both optimization and reasonable assurance of adequate
protection from radiation exposure up to and including planned special
exposure events and the proposed planned occupational dose limit
extensions. For example, licensees are required to conduct surveys,
control access to certain areas, store material appropriately, and use
signs, postings, and labels to warn workers of radiological hazards.
These provisions are in effect for the full spectrum of radiological
hazards that a licensee could encounter during the course of its
licensed activities, and thus, these provisions form the first set of
dose management actions below the regulatory dose limits that would be
credited as part of a graded approach to dose management.
Under a graded approach to dose management, additional dose
management actions would apply as radiological hazards increase and
move closer to the applicable regulatory dose limit. The dose levels
corresponding to dose management actions are threshold doses in that
they represent determinate boundaries above which a specific action is
required and below which they are inapplicable (i.e., there is no
subjectivity to when a specific dose management action should be
taken). Examples of these progressively increasing, threshold doses for
occupational exposure are: expected doses of 100 mrem/year, 500 mrem/
year, and 5 rem/year. Specifically, above an expected dose of 100 mrem/
year, licensees are required to provide instructions to workers (i.e.,
radiation worker training) per 10 CFR 19.12; above an expected dose of
500 mrem/year, or, more specifically, 10 percent of the applicable
limit, licensees are required to monitor doses to individual workers
per 10 CFR 20.1502; and above an expected dose of 5 rem/year (i.e., the
regulatory dose limit), licensees can exercise the proposed new planned
occupational dose limit extension of Sec. 20.1205 or the existing
planned special exposure process of Sec. 20.1206, if the situation
requires higher dose.
The NRC is developing guidance to further explain and provide
acceptable approaches for implementing the graded approach to dose
management, including alternative radiation protection measures not
already set out in the NRC's regulations that would help ensure that
dose limits are not exceeded. The NRC's guidance would explain that it
would be acceptable for radiation protection measures under the graded
approach to dose management to be supported by a comparison of the cost
of the radiation protection measure (e.g., shielding, additional
workers, robotics) to a reasonably calculated cost-basis of an averted
person-rem. The proposed guidance would provide that one example of a
reasonable cost-basis standard is provided in NUREG-1530,
``Reassessment of NRC's Dollar Per Person-Rem Conversion Factor
Policy.'' Specifically, in that guidance document, the NRC establishes
the cost of an averted person-rem by multiplying a value of a
statistical life coefficient--a factor that corresponds to society's
willingness-to-pay for small reductions in a particular mortality
risk--by a cancer mortality risk coefficient. The nominal cost of an
averted person-rem under this standard is $5,200 (in 2014 dollars).
Taken together, this means that it would be acceptable for considering
under the graded approach to dose management whether additional
radiation protection measures are reasonable based on a need to spend
$5,200 to avoid a person-rem of exposure. Consequently, if a radiation
protection measure were more costly than that, the licensee would have
an acceptable cost-justified basis for not implementing the measure and
instead accruing the dose as long as that dose is within the regulatory
dose limits or, if applicable, the licensee complies with the
provisions regarding planned occupational dose limit extensions or
planned special exposures. In this manner the graded approach to dose
management would maintain occupational dose below the regulatory dose
limits while replacing the subjectivity of the current ALARA-based
regulations with objective cost-benefit analyses. This guidance would
be issued subsequent to this rulemaking as part of the NRC's planned
two-phased approach to issuing guidance associated with this
rulemaking, see Section VI, ``Availability of Guidance,'' for more
information.
As part of this rulemaking, the NRC also proposes to require a
graded approach to dose management with respect to public dose in place
of the existing implementation of the ALARA principle. The objective is
to maintain a layered protective approach to potential public dose as a
precautionary measure. Public dose differs from occupational exposure
in several key respects. First, the dose to individual members of the
public is generally calculated based on an exposure scenario, whereas
occupationally exposed individuals are usually monitored. For example,
with respect to nuclear power plant effluents, the member of the public
is assumed to be a hypothetical maximally exposed individual who
represents the maximum exposure regarding food consumption, occupancy,
and other usage in the vicinity of the plant site. Another example is
that for a waiting room in a medical facility, the facility may conduct
area monitoring and assume conservative occupancy of the waiting room.
Another difference between public dose and occupational dose is that
the dose limit itself is much lower for the public than for
occupationally exposed individuals (i.e., 100 mrem/year vs. 5,000 mrem/
year, respectively), and the public dose limit represents a very low
level of risk. Specifically, as described in Table 12-4 of the BEIR VII
report, the average lifetime risk of dying from cancer is 20 percent,
and a lifetime (i.e., 70 years) of
[[Page 43470]]
exposure at the public dose limit of 100 mrem/year would conservatively
result in an addition of only 0.35 percent to that average lifetime
risk. Importantly, the public dose limit is based on the risk of cancer
mortality to a large population that is assumed to be exposed at the
full limit for a lifetime. However, as just mentioned in the nuclear
power plant effluent and medical waiting room examples, in practice,
licensees calculate bounding doses to smaller subsets of the population
and use the parameters in those calculations to control doses (e.g.,
reducing effluents from power plants or installing shielding around
medical equipment). This means that the actual dose to the average
member of the public from NRC licensed activities is assuredly below
the limit, and thus, that that individual faces an even smaller risk
than the already small risk that is assumed by a lifetime of exposure
at the limit.
Because of these inherent conservatisms, the NRC would explain in
guidance that one acceptable way of managing dose below the public dose
limit--which management would be required under the proposed new graded
approach to dose management--is to perform cost-benefit analyses using
the assumptions of NUREG-1530, or equivalent assumptions, for any doses
to members of the public that are projected to be greater than or equal
to 25 percent of the public dose limit (i.e., 25 mrem/year). In
addition, this approach to managing public dose would also be
acceptable because the existing precautions in 10 CFR part 20 (e.g.,
waste disposal regulations in subpart K) or other regulations intended
to limit public dose (e.g., 10 CFR 50.36a) are sufficient to manage
doses to the public within the public dose limits as required by Sec.
20.1101. Stated another way, the assumptions in the calculation of
public dose and in the public dose limit itself, in combination with
already-existing NRC requirements related to dose management, make it
so that it is acceptable to comply with the proposed new graded
approach to dose management by not analyzing projected public doses
below 25 mrem/year and by performing a cost-benefit analysis for
projected public doses greater than or equal to 25 mrem/year. This
approach would essentially reestablish the original intent of the ALARA
principle of minimizing dose below limits to the extent that doing so
is reasonably achievable and would ensure that dose limits are not
exceeded. Again, as with the implementation of the proposed new graded
approach to dose management for occupational dose, whereas the NRC's
proposed guidance provides one way by which a licensee can satisfy that
requirement for public dose, licensees may propose other ways to
satisfy the requirement.
Effluents
The NRC's regulations include requirements for maintaining control
over the release of radioactive material to the environment during
normal reactor operations. For example, under Sec. 50.34a and Sec.
50.36a, the NRC requires nuclear power plant licensees to include in
their facilities measures to control radiological effluents to the
environment--including via monitoring and control systems--and to have
in their licenses technical specifications to control the release of
effluents. For power reactors, Appendix I to 10 CFR part 50 provides
numerical design objectives regarding effluents. These design
objectives are translated into performance criteria that are reflected
in plant-specific technical specifications. In these requirements,
effluents are quantified using the calculated dose that a member of the
public would receive when exposed to the effluents under limiting
conditions, i.e., the hypothetical maximally exposed individual who
represents the maximum exposure regarding food consumption, occupancy,
and other usage in the vicinity of the plant site.
A similar requirement regarding air emissions for licensees not
subject to Sec. 50.34a and Sec. 50.36a is provided in Sec.
20.1101(d). These requirements were added to the NRC's regulations to
provide design objectives and constraints to ensure that radioactive
effluents (and thus the resulting public doses) would be maintained
consistent with the ALARA principle. Additionally, the NRC has used
these types of regulations to meet environmental protection-related
obligations under the Clean Air Act (CAA) and to demonstrate compliance
with the environmental protection standards for nuclear power
operations under 40 CFR part 190. In NUREG-0543, the NRC describes how
a licensee would be in compliance with the dose-based requirement in 40
CFR part 190, if the licensee maintains effluents below the numerical
criteria of Appendix I to 10 CFR part 50.
In the context of the CAA, the NRC has historically worked with the
U.S. Environmental Protection Agency (EPA) to develop effluent
standards that are sufficiently low to support EPA determinations and
to ensure that NRC licensees are not subjected to redundant regulation
from multiple agencies (see, e.g., 42 FR 2858, 54 FR 51654, and 61 FR
65120). As part of the development of the current air emissions
constraint in Sec. 20.1101(d), the NRC ensured that the value of that
constraint would be such that the Administrator of the EPA could
determine that the constraint provided ``ample margin of safety,'' as
is required under Section 112(d)(9) of the CAA. This ``ample margin''
determination is explained in the proposed and final rules that
promulgated the National Emissions Standards for Hazardous Pollutants
(NESHAPs) for radionuclides (54 FR 9612 and 54 FR 51654, respectively).
EPA supported its determination that the NRC's regulations would
satisfy the ``ample margin'' statutory requirement with studies of air
emissions from NRC and Agreement State licensees. In total, these
studies considered air emissions from 412 facilities on an annualized
basis. EPA found that air emissions from most facilities do not result
in doses exceeding 1 mrem/year with a small percentage of facilities
approaching, but none exceeding, 10 mrem/year.
As part of its response to E.O. 14300, the NRC reconsidered risk
analyses that are based on the LNT model and the implementation of the
ALARA principle, as described elsewhere in this proposed rule. As it
pertains to doses to members of the public, the NRC maintains that
there is reasonable assurance that public health and safety is
adequately protected at all doses below the NRC's current regulatory
dose limit of 100 mrem/year. Dose reduction below this limit in and of
itself is not necessary for ensuring the public health and safety;
instead, as clarified by this proposed rulemaking, dose reduction
serves the purpose of ensuring that ample margin exists to the
regulatory dose limit and thus ensures that the limit is not exceeded.
Regarding the contribution of effluents to public dose, this margin to
the dose limit is maintained by the requirements in the NRC's
regulations that pertain to the monitoring and control of effluents and
by licensees' actions to manage dose, which could include performing
cost-benefit analyses to support decision making on additional measures
for controlling doses below the dose limits.
Accordingly, the NRC is proposing revisions to radionuclide
emissions standards in 10 CFR 50.34a, 10 CFR 50.36a, 10 CFR part 50
Appendix I, and 10 CFR 20.1101(d) because it has determined that they
are excessively cautious and overly burdensome. Specifically, the NRC
is proposing to increase its radionuclide emissions standards from the
current regulatory constraint in 10 CFR 20.1101(d) of 10 mrem per year
to 25 mrem per year. The
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NRC's position is that this would remove excess conservatisms while
continuing to provide an adequate basis to EPA that the NRC's
regulatory framework provides ``ample margin of safety to protect the
public health'' under section 112(d)(9) of the CAA. To illustrate, in
its proposed NESHAP rule for radionuclides, the EPA characterized the
maximum lifetime risk of fatal cancer from natural background radiation
from all sources, including naturally occurring radon, as approximately
1x10-2, or 1 case per 100 people. Using a current, widely
accepted, and likely conservative cancer risk coefficient of
5x10-4 per rem (see NCRP 180, Section 4.1), an individual
receiving a dose of 10 mrem per year, the current regulatory constraint
in 10 CFR 20.1101(d), for 70 years would experience an excess fatal
cancer risk of 3.5x10-4, or about 0.04 cases per 100 people.
If the dose to that individual were raised to 25 mrem per year, the
proposed new regulatory constraint, for 70 years, the individual would
experience an excess fatal cancer risk of 8.7x10-4, or about
0.09 cases per 100 people. When compared to the baseline lifetime risk
of fatal cancer of approximately 0.2 (e.g., as provided in Table 12-4
of the BEIR VII report), or 20 cases per 100 people, the risks of these
environmental levels of radiation exposure, at both 10 mrem per year
and 25 mrem per year, are a small fraction and well below the 100 mrem
per year public dose limit.
In addition to reconsidering its current radionuclide emissions
standards through a risk perspective, the uncertainties associated with
risk estimates based on extrapolations from high-dose and high-dose-
rate data provide additional support for the NRC's position that its
proposed increase to its radionuclide emissions standards would remove
excess conservatisms while still providing reasonable assurance of
adequate protection of the public health and safety and would also
continue to support EPA's determination that the NRC's standards
provide an ample margin of safety under the CAA. Adjustments in the
slope of the dose response curve, such as is done with the DDREF, are
helpful in the extrapolation of high-dose/high-dose-rate data to low
doses; however, there is subjectivity and potential conservatism
associated with this adjustment. Additionally, there is evidence for
adaptive cellular response, which would mitigate the health effects of
exposures at low doses, especially those resulting from effluents. The
NRC determined that these uncertainties were undervalued in the
establishment of the radionuclide emissions standards that the NRC
currently uses.
The NRC's proposed approach to the regulation of effluents would
involve allowing licensees to continue using the existing effluent
constraints of 10 mrem per year or allowing licensees to use a new
constraint of 25 mrem per year TEDE or TED, as applicable. Regardless
of the constraint used by a licensee, if the licensee demonstrates that
its effluents are below the 25 mrem per year level, it would only be
required to collect and retain effluent data on an annual basis and in
a format that can be inspected by the NRC. If a licensee releases
effluents greater than or equal to the 25 mrem per year constraint,
that licensee would be required to collect and retain effluent data and
submit relevant reports to the NRC on an annual basis until levels are
returned to below the 25 mrem per year constraint. Additionally, such a
licensee would be required to evaluate and consider implementing cost-
justified corrective actions to restore effluent levels to below the 25
mrem per year constraint. NRC guidance would provide that one
acceptable method for performing this evaluation would be to use the
dollar per person rem value from NUREG-1530. If a cost analysis
demonstrates that corrective actions are not justified, the licensee
could propose a new constraint that would support continued operations
in a cost-justified manner, but this new constraint would be required
to be below the public dose limit. A similar approach would be taken
during the licensing of a new facility, i.e., a constraint higher than
the regulatory constraint, but lower than the public dose limit, could
be proposed as needed to support operations in a cost-justified manner.
These changes are being proposed to Sec. Sec. 20.1101(d), 50.34a, and
50.36a and to appendix I to 10 CFR part 50. To avoid disruptions to
existing licensees, the NRC is proposing these changes such that
existing effluent programs will remain compliant with the NRC's
requirements, as amended, and that licensees can adopt changes on a
voluntary basis.
The NRC understands that its radionuclide emissions constraint
relates to EPA's ample margin determination under section 112(d)(9) of
the CAA. According to CAA section 112(d)(9), the EPA must consult with
NRC prior to a new or revised ample margin determination. The NRC's
proposed position is that the proposed change to its radionuclide
emissions constraint could continue to provide an adequate basis to EPA
for such a determination.
Additionally, the NRC is proposing to revise paragraph C of Section
IV of Appendix I to 10 CFR part 50 to add ``Sec. 52.110'' to the
applicability of the provisions in that paragraph. This is an editorial
change to make paragraph C consistent with the applicability specified
in the introductory paragraph of Section IV.
Planned Occupational Dose Limit Extension
In the NRC's current regulations, planned special exposures (PSEs)
(see 10 CFR 20.1206) allow occupationally exposed individuals to
receive doses in excess of the applicable limit to a maximum of twice
the applicable limit in one year, provided that certain criteria are
met (e.g., documentation tracking lifetime dose and remaining bank of
PSE-dose). There is a cap on PSE-dose of five times the applicable
limit over the lifetime of an individual. To ensure compliance with
this lifetime cap, a licensee must ascertain the lifetime exposure
history of an individual prior to conducting a PSE of that individual.
Additionally, a PSE is viewed as a tool to be used only during
exceptional circumstances. As such, PSEs involve additional reporting
and recordkeeping requirements when compared to routine occupational
exposures. Since the NRC added the regulations allowing for PSEs in the
1991 revisions to 10 CFR part 20, PSEs have not been used by licensees,
as demonstrated through a lack of reports having been submitted to the
NRC per Sec. 20.2204.
The NRC has determined that the administrative burden associated
with PSEs (e.g., determination of lifetime exposure histories and
additional reporting requirements) combined with the characterization
of a PSE as a tool to be used only in exceptional circumstances is not
commensurate with the radiological risk involved with exposures at
occupational levels. Additionally, the increased administrative burden
associated with PSEs likely dissuades licensees from viewing PSEs as a
viable option for occupational dose management. Given this background
and to enable flexibility in the balancing of occupational exposure
with operational needs, the NRC is proposing to codify in 10 CFR
20.1205 a new process for allowing workers to receive doses in excess
of applicable annual limits: the planned occupational dose limit
extension (DLE). This optional process would make available to
licensees a method to manage a justified, pre-planned exceedance of
annual occupational limits for workers, provided that an
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adequate decision-making process is applied to support its use and that
the overall dose is limited within specified multi-year average values
and annual limits are limited to twice the applicable limit. Although
the NRC is also maintaining the current PSE process in its regulations,
the proposed new planned occupational DLE would be less burdensome for
licensees to implement while still maintaining occupational doses, and
thus the underlying risk, within acceptable values.
The proposed new planned occupational DLE would allow licensees to
access, in the current year, occupational dose that was not given to a
worker in previous years. Dose limits generally serve two purposes: (1)
to avoid nonstochastic/deterministic effects, also called tissue
effects, and (2) to manage stochastic risk to an acceptable level.
Nonstochastic/deterministic effects, or tissue reactions, are effects
that are only seen once a threshold is exceeded and their severity is
dependent upon the dose received. Protraction of dose reduces the risk
of nonstochastic/deterministic effects especially at doses below the
threshold because the body is able to heal the biological damage
resulting from the dose received. Stochastic effects are random in
nature; they are not subject to a threshold and the severity of the
health effect is independent of the dose received. Currently accepted
models assume that for stochastic effects the likelihood/risk of an
adverse health effect occurring increases proportionately with dose.
Each of the NRC's occupational dose limits functions to limit the risk
of adverse health effects associated with radiation exposure to levels
that have been determined to be acceptable for routine occupational
situations.
Occupationally exposed individuals rarely approach even small
fractions of applicable dose limits (see NUREG-0713) because of
licensees' existing dose management efforts, which are generally
founded on ALARA practices. In general, the fact that the risk from
radiation exposure has been made negligible because of these dose
management efforts is a net benefit. However, it is likely that these
measures have resulted from overly conservative decision-making.
Additionally, some licensees use locally developed administrative
limits to maintain margin to occupational dose limits. Occasionally,
normally during maintenance periods, licensees may encounter the need
for workers to be exposed to doses in excess of annual limits but still
within the standards for protecting against the health effects of
radiation exposure (e.g., long-term averages with respect to lifetime
doses). In these cases, in part to avoid the added burden of PSE use,
licensees employ additional measures (e.g., shielding) or use
additional workers to spread out the dose so as to maintain individual
doses below limits. However, these actions may increase the cost and
the time associated with the work in a manner that is not commensurate
with the risk associated with the dose.
To encourage more reasonable decision-making regarding doses at
levels corresponding to occupational exposures, consistent with the
original intent of the ALARA principle and the proposed graded approach
to dose management, the NRC is proposing to add to its regulations the
planned occupational DLE process to allow licensees to periodically
exceed applicable dose limits for an individual worker provided that
certain criteria are met. The NRC proposes to define the dose allowed
for a planned occupational dose limit extension as the occupational
exposure that was unused by the individual over the most recent 5-year
period. For example, for the TEDE limit of Sec. 20.1201(a)(1), this
would mean the dose available is equal to the product of 5 years and 5
rem TEDE, totaling 25 rem TEDE, minus the actual annual TEDE received
by the individual in the current year and the preceding 4 years. A
similar approach can be used to determine the allowable dose for a
planned occupation dose limit extension of the deterministic limits,
with the exception of the lens dose limit. Licensees would be able to
apply this allowable dose, or ``retrospective dose,'' up to a total
dose of twice the applicable annual dose limit in the current year.
Thus, the annual limit for the planned occupational dose limit
extension would be consistent with the dose that is allowed through the
planned special exposure, with the exception of lens dose.
The safety basis for the proposed new planned occupational dose
limit extension process relies on the fact that annual dose limits are
derived with the intent to limit total lifetime exposure to an
individual worker and to preclude deterministic effects. However,
because total lifetime exposure is not a practical value to measure,
radiation protection standards prescribe annual stochastic limits that
are essentially fractionated lifetime totals. Therefore, the annual
stochastic limits in and of themselves should not be viewed as
demarcations of safety or thresholds above which health effects are
expected. Instead, they are regulatory tools to manage the long-term
risks of exposure. As such, these limits can safely be exceeded to a
certain extent in the short-term, provided that long-term doses
continue to be controlled adequately. When an occupationally exposed
individual receives an annual dose below the annual limit, that
individual is experiencing a smaller risk than was originally assumed
to be acceptable for a radiation worker in developing the annual dose
limits. In general, this is a positive outcome, primarily because of
the corresponding reduction in risk that is associated with reductions
in dose inherent to the statistical nature of stochastic effects.
However, this also means that there often exists unused retrospective
dose that could be safely used, provided that an adequate decision-
making process is applied to support its use and that the overall dose
is limited within specified multi-year average values. Deterministic
effects would not result from the planned occupational dose limit
extension process because those effects are only seen when certain
thresholds are exceeded, and the restrictions on the planned
occupational dose limit extension process would maintain doses below
those thresholds.
The proposed new planned occupational dose limit extension process,
as described in Sec. 20.1205, would allow a licensee to authorize an
individual worker to receive a dose in excess of annual occupational
dose limits provided that (1) the licensee does not authorize a dose
that would cause the individual to receive twice the applicable annual
dose limit in a year, and (2) sufficient retrospective dose is
available to the individual. This process would also entail limitations
and reporting and recordkeeping requirements. For example, approval of
a planned occupational dose limit extension for an adult worker must be
in writing before the exposure occurs; the individual must be informed
of the purpose of the planned operation, estimated doses and their
associated risks, and measures taken to manage doses; and the licensee
must determine the occupational exposure of the individual during the
current and preceding four years (see 10 CFR 20.1205). Furthermore,
declared pregnant women and minors would not be allowed to participate
in planned occupational dose limit extensions. Additionally, because of
the uncertainty associated with the health risks of lens dose, as
discussed previously in this document, the NRC has decided to exclude
exceeding the annual lens dose limit from the proposed new planned
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occupational dose limit extension process; however, licensees could
still use the current PSE process, which will remain in the NRC's
regulations (including the required lifetime dose determination), in
situations that involve a need to exceed the annual lens dose limit.
Finally, the requirement to implement a graded approach to dose
management would also apply to the management of the doses received
during planned occupational dose limit extensions such that unnecessary
occupational exposure would be avoided and radiation protection
practices would be employed commensurate with the risks involved.
Public Dose Limits
The NRC is not proposing to change its current public dose limit,
which is 100 mrem per year. The NRC considered several recommendations
to change the public dose limit. As described previously, the 2015 PRMs
requested an increase in the public dose limit based, in part, on the
assertion that radiation exposure is beneficial. Additionally, the
Idaho National Laboratory--a U.S. National Laboratory dedicated to
energy research and development--recently suggested in a public report
(``Reevaluation of Radiation Protection Standards for Workers and the
Public Based on Current Scientific Evidence,'' INL/RPT-25-85463,
Revision 0, July 2025) that the public dose limit be raised, in part,
to increase public acceptance of radiation exposure.
The NRC regulates the civilian use of radioactive materials in a
manner that provides reasonable assurance of adequate protection of the
public health and safety. Although the current public dose limit is
sufficient to provide reasonable assurance of adequate protection of
the public health and safety, the NRC understands that it is a generic
limit and, thus, may be overly conservative in certain, specific
circumstances. The NRC also recognizes that a number of factors may
weigh in favor of allowing a higher public dose limit on a case-by-case
basis when such conservatisms are specifically identified and accounted
for, including why such an allowance would remain protective of the
public health and safety. As discussed previously, in response to E.O.
14300 section 5(b), the NRC reexamined its approach to radiation
protection and recognizes that there are inherent limitations in the
LNT model, particularly at low doses, that could be better addressed in
the NRC's rules. One example is the decision in the NRC's 1991
rulemaking to disallow exceptions to the public dose limit for new
applicants. Upon reexamination, such a limitation is not needed for
reasonable assurance of adequate protection of public health and safety
and is also inconsistent with the principles of the E.O.s discussed in
this document concerning enabling the use of nuclear power,
particularly in light of the declared energy emergency in E.O. 14156.
Taken together, these factors weigh in favor of the NRC reconsidering
whether exceptions to the generic public dose limit of 100 mrem per
year may be allowed. Therefore, although it is not proposing to change
its current public dose limit or define specific exceptions to that
limit, the NRC is proposing revisions to the regulations in Sec.
20.1301 that would allow a licensee or an applicant to request
alternative public dose limits on a sufficiently supported, case-by-
case basis.
First, in Sec. 20.1301(b), the NRC is proposing a path to enable a
licensee or applicant to request prior NRC authorization for a public
dose limit in excess of 100 mrem per year for members of the public who
have access to controlled areas. Such requests may be on a generic
basis (e.g., for a design). A controlled area, as defined in Sec.
20.1003, is an area, outside of a restricted area but inside the site
boundary, to which access can be limited by the licensee for any
reason. The NRC's current regulations extend the public dose limit to
all areas within the site boundary. However, this approach may be
excessively restrictive if dose is appropriately managed in the
controlled areas. This is because members of the public do not maintain
a lifetime of continuous occupancy in spaces within the controlled area
boundary of licensed facilities. Instead, members of the public
typically access these spaces on a temporary basis for such non-
occupational-exposure purposes as tours, awaiting for or accompanying
those receiving medical treatments, or work activities separate from
those of the facility like making deliveries to/from the facility.
Further, it is reasonable to assume that the majority of these
individuals will be adults and that the time of exposure of any
children will be small when compared to the lifetime of exposure that
is considered when determining acceptable risks for stochastic health
effects.
Therefore, the NRC is proposing to amend its regulations to provide
that, as long as a licensee or applicant establishes appropriate dose
management measures (e.g., signage, information briefings and area
monitoring to ensure compliance with the proposed higher annual dose
limit), a higher public dose limit within the controlled area may be
approved on a case-by-case basis. The NRC's case-by-case review would
consider such things as the likely cumulative exposure of a member of
the public under the proposed new dose limit given the time that the
member of the public is expected to be within the controlled area and
the effectiveness of the proposed dose management measures.
Second, in Sec. 20.1301(d), the NRC is proposing to remove
references to ALARA, to remove the upper limit on the annual dose limit
for a member of the public that may be requested (which is currently
set at 500 mrem per year), and to specify the information that is
required in an application by a licensee or applicant for prior NRC
authorization, on a case-by-case basis, for a public dose limit in
excess of 100 mrem per year. The regulation at Sec. 20.1301(d) was
originally intended to provide a process for facilities existing at the
time of the regulatory changes implemented in 1991 that found it
difficult to meet the then newly enacted public dose limit of 100 mrem
per year (see 56 FR 23360). However, the NRC now proposes to clarify
that any licensee or applicant can apply for a higher public dose limit
by providing the information required by the regulation, which the NRC
will review on a case-by-case basis. Specifically, such an application
must: (1) demonstrate the need for and the expected duration of
operations in excess of the public dose limit; (2) describe the
licensee's program to assess and control dose within the proposed
higher limit; and (3) provide a supporting basis for the proposed
higher limit, including why it remains protective of the public health
and safety. Such a request for a higher public dose limit for the
unrestricted area would require a more detailed analysis than a request
for a higher public dose limit for the controlled area because of the
lack of control that a licensee can exert over the unrestricted area
and the presumably larger population that could potentially be subject
to the proposed higher doses. Because of the statistical nature of
stochastic health effects, the larger the population that receives a
given dose, the larger the potential health impact. Therefore, it is
likely that the NRC would generally reserve approvals for higher public
dose limits that are limited in duration and/or demonstrated to have
limited population impacts.
In their applications, in order to demonstrate that the requested
higher public dose limit remains protective of the public health and
safety, licensees and applicants could apply the critical
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group or representative person concepts described in ICRP Publication
101, and earlier ICRP references, to perform prospective dose
assessments. Determinate or probabilistic assessments, or a combination
of both, could be used to support the request. Habit data and
physiological characteristics should be representative of the affected
population and not overly conservative in terms of assumptions.
Additionally, licensees and applicants may consider the use of dose
constraints, additional environmental monitoring, and land use censuses
as part of their programs to assess and control dose within the
proposed higher dose limits.
In addition to the proposed changes to allow requests for NRC
authorization, on a case-by-case basis, for higher public dose limits
in the controlled area and in the unrestricted area, the NRC is
proposing two other changes to the requirements at Sec. 20.1301: (1)
changes to the limits that apply to caregivers of patients who cannot
be released, and (2) deletion of the short-term dose rate limit for
external sources in the unrestricted area.
First, the NRC is proposing to allow higher doses to members of the
public who visit and/or care for medical patients who cannot be
released under the provisions of Sec. 35.75. Limits that apply to
patient release are contained in 10 CFR part 35. The NRC has long
permitted a member of the public to receive up to 500 mrem at the
Authorized User's (AU) discretion under Sec. 20.1301(c). Additionally,
the NRC has approved several exemptions to this regulation as described
in Regulatory Issue Summary (RIS) 2006-18, ``Requesting Exemption from
the Public Dose Limits for Certain Caregivers of Hospital Patients.''
These exemptions allowed a caregiver to receive up to 2 rem, by
default, with the flexibility to increase that amount if it was too low
for a particular case. Similar to these previously issued exemptions,
the NRC proposes to revise Sec. 20.1301(c) to include a 2-rem limit
for a caregiver and a 500-mrem limit for a non-caregiver member of the
public per administration regimen. These limits are independent of the
patient release regulations in 10 CFR 35.75, and doses accrued by
caregivers or non-caregiver members of the public from exposure to a
patient prior to release do not contribute to the patient's release
evaluation. The guidance in RIS 2006-18 and the exemption process
remain available to licensees should they desire to pursue
authorization, on a case-by-case basis, to exceed the proposed new 2-
rem limit for caregivers.
Amending the regulations to allow caregivers to receive up to 2 rem
without a licensee requesting and having approved an exemption
increases licensee flexibility, reduces regulatory cost and burden, and
enables licensees to provide more timely care to patients while
maintaining the public health and safety. The justification for the
higher limit to the caregiver (i.e., 2 rem instead of 100 mrem) is that
it is beneficial, or possibly essential, to the wellbeing of the
patient for caregivers to have access to the patient and may,
therefore, be considered an element of the patient's medical treatment.
Caregivers are usually members of the patient's family or someone close
to the family or the patient. Caregivers receive no financial
compensation for the comfort or support that they provide a patient and
knowingly consent to being exposed above the public dose limit.
Additionally, the higher dose limit is temporary and would not
significantly impact the caregiver's lifetime fatal cancer risk.
Similarly, the justification for the higher limit to the non-caregiver
(i.e., 500 mrem instead of 100 mrem) is that the higher dose limit is
temporary and would not significantly impact the individual's lifetime
fatal cancer risk. A non-caregiver being exposed in a situation
relevant to Sec. 20.1301(c) is likely also a family member or a friend
of the patient, thus their access to the patient provides relief during
medical treatment. In ICRP Publication 60--which provided the ICRP's
first set of comprehensive recommendations after the recommended public
dose limit was changed to its current value--the ICRP stated in
paragraph 192 that, ``Since the detriment is a function of the
accumulation of dose over many years, it would be unduly restrictive to
require the controls to be related rigidly to annual dose limits. Some
flexibility in the limits is desirable.'' Accordingly, with this
proposed rulemaking the NRC is proposing to exercise this flexibility
as it relates to patient care.
Second, the NRC is proposing to delete the short-term dose rate
limit in the unrestricted area of 0.002 rem in any hour in Sec.
20.1301(b) because it serves no safety purpose that is not already
achieved by the public dose limit of 100 mrem per year. This is because
a member of the public could receive the full 100 mrem annual public
dose instantaneously and this fact in and of itself would have minimal
safety impact. The actual concern in such a hypothetical case would be
that a source that could provide such a high dose rate would most
assuredly result in an exceedance of the annual public dose limit in a
short period of time and it is that exceedance that would require
appropriate corrective actions and not the exceedance of any rate limit
in receiving the dose. Licensees can voluntarily include short-term
dose rate limits within their radiation protection programs for the
purposes of dose management or to facilitate investigations of abnormal
conditions; however, these are not necessary in addition to the annual
public dose limit for the protection of the public health and safety.
Therefore, the NRC is proposing to delete Sec. 20.1301(a)(2) and the
provision in Sec. 20.1302(b)(2)(ii) that references 2 mrem in an hour.
License Termination Criteria
The NRC is proposing to revise the license termination criteria in
10 CFR part 20 subpart E to make conforming changes based on the
discontinuation of the use of ALARA terminology in the NRC's
regulations and guidance. Specifically, the NRC is removing the terms
``as low as reasonably achievable'' and ``ALARA'' from subpart E and
replacing them, as appropriate. As explained previously in this
document, the NRC's regulations and guidance would continue to use
justification and optimization analyses to satisfy the original intent
of the ALARA principle of, in this instance, reducing residual
radioactivity to levels where further reductions would not be justified
for both unrestricted and restricted use. The NRC intends for licensees
to continue providing a combination of qualitative and quantitative
analyses consistent with the guidance in NUREG-1757, volume 2, appendix
N to satisfy the requirement to justify such reductions in residual
radioactivity.
Additionally, the NRC is proposing to include a reference to Sec.
20.1406(c) to its radiological criteria for unrestricted use at Sec.
20.1402 to emphasize that the reduction in residual radioactivity may
be justified by actions already taken by the licensee to minimize
contamination. For example, licensees may be able to take credit for
performing dismantlement and remediation activities in a way that
minimizes the introduction of contamination to the environment in the
analysis to demonstrate that further reductions are not justified. The
NRC's proposed reference to this requirement would provide additional
flexibility in the justification analysis required to comply with the
proposed radiological criteria for unrestricted and restricted use.
With respect to restricted use, under Sec. 20.1403 and Sec.
20.1404, the NRC is proposing to increase clarity for licensees to
demonstrate compliance with the proposed requirement that
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further reductions in residual radioactivity necessary to comply with
the provisions of Sec. 20.1402 would not be justified. Currently,
licensees must demonstrate that such reductions either would result in
net public, or environmental harm or are consistent with ALARA. The NRC
is proposing to introduce significantly more clarity by updating the
requirement to include an explicit option to provide a cost-benefit
analysis.
Finally, the NRC is making the language in 10 CFR part 20 subpart E
consistent by using the broader term ``traffic accidents'' throughout
instead of sometimes using the narrower term ``deaths from
transportation accidents.'' The term ``traffic accidents'' encompasses
the term ``deaths from transportation accidents.''
Respiratory Protection
The NRC is proposing to make changes to its respiratory protection
regulations to enable more efficient authorizations of respiratory
equipment and their use. Currently, licensees are required to obtain
individual authorization from the NRC in order to: (1) use respiratory
equipment that has not been authorized by the National Institute for
Occupational Safety and Health (NIOSH), and (2) use assigned protection
factors (APFs) in excess of those specified in 10 CFR part 20. Through
this rulemaking, a licensee would be allowed instead to reference
approvals that the NRC has already issued to other licensees to use
non-NIOSH certified equipment and/or to exceed the APFs in 10 CFR part
20; provided that the conditions in the safety evaluations used by the
NRC to justify such approvals are applicable to that licensee.
Effectively, this would mean that the NRC would only have to review and
approve the use of new equipment or APFs once, and subsequent licensees
could avail themselves of those approvals to the extent that they apply
in their cases. This change would facilitate the use of modern
equipment while minimizing risk and administrative burden because
regulatory experience has shown that these reviews have not
significantly differed once a precedent is established. In cases where
the conditions of prior approvals would not apply or where licensee use
of the equipment would not be within the scope of what the NRC
considered in its safety evaluation, the licensee would have to
individually apply for authorization as the regulations currently
require.
Doses Received by a Member of the Public Due to Byproduct Material
Administered for Medical Purposes
The NRC is proposing changes to 10 CFR part 35 regarding the
release of patients who have been administered byproduct material. The
first proposed change would add to 10 CFR 35.2 the definitions of
``caregiver'' and ``administration regimen.'' The proposed definition
of ``caregiver'' is an adult who provides the patient with support or
comfort for non-commercial gains following administration of byproduct
material. The proposed definition of ``administration regimen'' is the
course of administrations of a given radiopharmaceutical or
brachytherapy source as intended by the authorized user. The second
proposed change would amend 10 CFR 35.75 to add a provision to allow a
consenting caregiver, who has been educated on the risks of radiation
exposure, to receive up to 5 rem (i.e., the occupation dose limit of 10
CFR 20.1201) per patient administration regimen. The dose limit to the
general public would remain at 0.5 rem; however, the rule would be
revised to specify that this limit is per administration regimen
instead of per release. The third proposed change would amend 10 CFR
35.2075 to remove the requirement to keep records of dose evaluations
for individual releases that meet certain criteria. Instead, the
proposed change would require licensees to develop, implement, and
maintain a written procedure for ensuring that a member of the public
is not likely to exceed the established limits. The licensee would be
required to retain this procedure for the duration of the license.
Additionally, the proposed change would remove the requirement to
document each instance where instructions are given to a breastfeeding
patient.
In 2002, the NRC adopted the current dose-based criteria used in 10
CFR 35.75. At that time, the patient release framework was developed to
address brachytherapy implants and single administration therapies
(e.g., I-131 therapy for conditions of the thyroid). Also at that time,
other applications of byproduct material use in medicine did not
involve quantities that would warrant concern regarding the release of
patients. The medical landscape has evolved substantially since the
current 10 CFR 35.75 was put in place. Namely, radiopharmaceuticals are
increasingly being administered over a series of administrations as a
matter of protocol, instead of all at once. With the proposed changes
to 10 CFR 35.75, the NRC intends to adapt its patient release framework
to better address the evolving use of byproduct material in medicine.
While the limit for dose received by an individual member of the public
is 0.5 rem per patient administration regimen, the NRC is proposing to
introduce flexibility through the identification of a caregiver, who is
eligible to receive up to the occupational dose limit (i.e., 5 rem) per
patient administration regimen. Individuals identified as caregivers
(e.g., spouses, parents) are likely to receive the most dose as a
result of a given patient release due to high duration or close contact
activities, such as co-sleeping. Other members of the public are
unlikely to receive a dose on the same order of magnitude as these
potential caregivers. This is reflected in DG-8061 (the proposed
revision 2 to Regulatory Guide (RG) 8.39) by using an assumed occupancy
factor of 0.25 at 1 meter for a general member of the public (also
referred to as a bystander) and an assumed occupancy factor of 1 at 1
meter for a caregiver in the tables provided. RG 8.39 contains
additional information regarding patient-specific calculations for
added flexibility, including lower occupancies for both caregivers and
other members of the public.
The NRC is also proposing to change the recordkeeping requirements
for patient release outlined in 10 CFR 35.2075 to better align with
common practice. Most patients are likely to fall into certain
categories that a licensee has previously determined to be compliant
with release in accordance with 10 CFR 35.75. It is unnecessarily
burdensome for licensees to retain the bases of release for individual
patients who are released in such a way. As such, the NRC is proposing
to instead require licensees to develop, implement, and maintain a
written procedure for releasing patients in accordance with 10 CFR
35.75. The NRC is also proposing to remove the requirement to
individually document when a breastfeeding patient has been given
instructions following administration of byproduct material. The
procedures required by the proposed 10 CFR 35.75 should detail the
process for ensuring compliance for all patients who have been
administered byproduct material, including situations where licensees
provide instructions to patients who are breastfeeding. This change is
intended to alleviate the burden associated with prescriptive
recordkeeping requirements and to instead focus on the need to maintain
a robust patient release program that enables the treatment of
[[Page 43476]]
patients while protecting members of the public.
For patients who cannot be released under 10 CFR 35.75, the NRC is
proposing to amend 10 CFR 20.1301 to incorporate into that rule
flexibilities introduced in RIS 2006-18. The proposed changes to 10 CFR
20.1301(c) would permit licensees, without having to apply for an
exemption, to allow a caregiver, newly defined in the proposed changes
to 10 CFR part 35, to receive up to 2 rem while providing care to a
patient who cannot be released under 10 CFR 35.75. Any receipt of dose
in excess of 2 rem would still require an application for an exemption
and case-by-case prior approval by the NRC.
In 2002, the NRC amended 10 CFR part 20 to allow some visitors of
patients who cannot be released under 10 CFR 35.75 to receive up to 500
mrem. At that time, the NRC acknowledged that, because visitors are
often family members or close friends of patients, there is a
substantial benefit that outweighs the risk of additional exposure.
However, as the medical use of byproduct material has changed, it has
come to the NRC's attention that a limit of 500 mrem is insufficient
and overly cautious for some situations. While RIS 2006-18 does not set
a maximum dose for which a licensee may apply for an exemption, 2 rem
is the established initial dose limit for the outlined exemption. The
NRC has already deemed a limit of 2 rem adequately protective for
situations where a caregiver is necessary while a patient is
hospitalized, provided that the licensee justifies the use of the
exemption. The proposed rule would therefore eliminate the need for
licensees to apply for an exemption for caregiver doses up to 2 rem.
For caregiver doses in excess of 2 rem, licensees may still refer to
RIS 2006-18. Note that caregiver doses received prior to the patient's
release do not contribute to the 5 rem allowed by 10 CFR 35.75
following release. Finally, the proposed update to 10 CFR 20.2107 would
require licensees to retain a record of the justification for a
caregiver's dose for three years following the exposure.
Industrial Radiography
The NRC is proposing to remove from 10 CFR part 34 the definition
of the term ``ALARA'' in Sec. 34.3 and the prescriptive list of the
radiation safety officer (RSO) responsibilities in Sec. 34.42(c),
which includes the term ``ALARA.'' Removing this term is consistent
with the other changes being made as part of this rulemaking and
removing the RSO responsibilities is consistent with other similar
descriptions of requirements for RSOs. Licensees would continue to be
able to look to guidance in NUREG-1556, volume 2, for more detailed
information regarding the responsibilities of an RSO for industrial
radiography.
Uniform Waste Manifest Forms
The NRC is also proposing changes to 10 CFR part 20 appendix G to
provide additional clarity and flexibility on how the information
requested on the Uniform Waste Manifest forms (NRC Forms 540 and 540A,
541 and 541A, and 542 and 542A) could be provided. The proposed changes
would clarify that the Manifest does not need to include these NRC
forms themselves as long as the Manifest reflects the information
requested on the applicable NRC forms. Other proposed changes would
remove language specifying when NRC Form 540 must physically accompany
a shipment and would instead reference Department of Transportation
(DOT) regulations. This change would ensure that the NRC's regulations
are consistent with the DOT's regulations, including potential future
changes to the DOT's regulations. The remaining proposed changes would
add clarity and correct minor grammatical errors.
Clarifying Changes to Appendix A to 10 CFR Part 40
The NRC is proposing a change to the introduction section of
Appendix A to 10 CFR part 40. The purpose of this change would be to
clarify that the use of the phrase ``as low as is reasonably
achievable'' in Appendix A has the same meaning as in EPA's generally
applicable standards in 40 CFR part 192, which is different than how
NRC has traditionally used ALARA. In this context, the use of the
phrase ``as low as reasonably achievable'' is focused on the technical
practicability of corrective actions. The remaining proposed changes to
Appendix A are consistent with the proposed changes to 10 CFR part 20
in that they would require licensees to manage dose within the
applicable limits and would require that practicable dose reduction
measures be taken. The proposed changes would remove any language that
implies that further dose reduction is required. In this context, the
phrase ``as low as reasonably achievable'' will remain in Appendix A,
Criterion 5B(6) to conform to EPA's generally applicable standards in
40 CFR part 192.
Conforming Changes to 10 CFR Parts 50, 61, 71, and 72
This proposed rule would also include additional conforming changes
to align with the removal of references to ALARA. This includes the
removal of a reference to ALARA in 10 CFR 50.66 and in 10 CFR 71.78.
Additionally, removals of references to ALARA are proposed in 10 CFR
part 72, specifically in Sec. Sec. 72.3, 72.24, 72.44, 72.104, and
72.126. The changes proposed to Sec. 72.44(d)(3) are conforming
changes to align with the proposed changes to effluent reporting
requirements in 10 CFR 50.34a, which are discussed in the previous
section entitled ``Effluents.''
Finally, the NRC is proposing to revise the public dose limits in
10 CFR part 61 to make conforming changes based on the discontinuation
of the use of ALARA terminology in the NRC's regulations and guidance.
Specifically, the NRC is proposing to remove the terms ``as low as
reasonably achievable'' and ``ALARA'' from subpart C, ``Performance
Objectives.''
Conforming Changes to 10 CFR Part 53
The changes proposed in this rulemaking necessitate conforming
changes to the recently issued 10 CFR part 53. In general, these
changes serve two purposes. First, they acknowledge that licensees may
potentially use dosimetry systems that provide results in terms of
total effective dose, as opposed to total effective dose equivalent.
Second, they provide the additional flexibility that is being included
in the proposed changes to the NRC's overall radiation protection
regulatory framework based on the agency's reconsideration of its use
of the LNT model and its application of the ALARA principle.
The regulations at Sec. 53.210, Sec. 53.425, and Sec. 53.530 are
proposed to be revised to add reference to total effective dose to the
units for dose-based criteria. Additionally, footnote 1 to Sec. 53.210
is proposed to be revised to delete ``TEDE'' as the designation of the
type of effective dose is not central to the purpose of the footnote,
rather the magnitude of the dose is. The requirements at Sec. 53.850
are proposed to be revised to change ``limiting'' to ``controlling'' to
be consistent with the intent of effluent monitoring and control
measures. Additionally, Sec. 53.850(b)(2) is proposed to be revised to
remove reference to the ``Annual Radiological Environmental Operating
and Radioactive Effluent Release Reports,'' in lieu of a more
generalized requirement for an effluent program to retain records and
develop reporting criteria. This change conforms to changes being
proposed in this rulemaking for radiological effluent monitoring and
control through revisions to Sec. 50.34a, Sec. 50.36a, and
[[Page 43477]]
Appendix I to 10 CFR part 50. Lastly, Sec. 53.1645(a) is proposed to
be revised to add a process that conforms to the framework being
proposed in this rulemaking for the monitoring and control of
radiological effluents.
Updates to Design Basis Accident Dose-Based Acceptance Criteria
The NRC has historically used dose-based acceptance criteria when
evaluating certain aspects of licensee safety assessments associated
with applications for new reactors (e.g., Sec. 50.34(a)(1)). Some of
these safety assessments end up forming part of the current licensing
basis of the facility after the NRC issues its license. Specifically,
some of the accidents that are analyzed in these safety assessments are
used to set the design basis of plant equipment to ensure public health
and safety. These accidents are known as ``design basis accidents.''
Once incorporated into the current licensing basis, the assumptions,
methodology, and equipment (including structures, systems, and
components) are controlled as required by licensing-related regulations
(e.g., Sec. 50.90, Sec. 50.59). The NRC has established dose-based
acceptance criteria that recognize that certain design basis accidents
have a higher assumed frequency of occurrence than others. To maintain
the balance provided by the risk triplet--whereby changes in likelihood
of occurrence of an accident may be offset by changes in consequences
in order to control the risk of an event--the NRC has historically
assigned a lower dose-based criteria value (i.e., lower consequence)
for accidents that are more likely to occur. In NRC guidance documents
(e.g., Branch Technical Positions and the Standard Review Plan in
NUREG-0800) this approach is evidenced through the use of ``well
within,'' or ``a small fraction of'' terminology in reference to
fractions of the dose-based acceptance criteria used to evaluate the
consequences of the maximum hypothetical accident described in Footnote
3 of Sec. 50.34.
Historically, the NRC has interpreted the term ``well within'' to
mean 25 percent of the dose resulting from a maximum hypothetical
accident (or 6.3 rem) and the term ``small fraction of'' to mean 10
percent of the dose resulting from a maximum hypothetical accident (or
2.5 rem). This approach is implemented in Table 7 in RG 1.183, Revision
1, ``Alternative Radiological Source Terms for Evaluating Design Basis
Accidents at Nuclear Power Reactors,'' dated October 2023
(ML23082A305), but the practice can be observed in other guidance, such
as Branch Technical Positions and the Standard Review Plan in NUREG-
0800.
With this rulemaking, the NRC is proposing to adopt a single, dose-
based acceptance criterion of 10 rem TEDE for design basis accidents
that currently use criteria derived from fractions of the maximum
hypothetical accident criterion of 25 rem TEDE. With this change the
NRC will stop using the ``well within'' and ``small fraction of''
qualitative designations and their corresponding numerical values and
instead use 10 rem TEDE. This new, dose-based acceptance criterion
would apply at locations that are evaluated for radiological
consequences (i.e., exclusion area boundary and low population zone).
Regulatory experience indicates that significant applicant, licensee,
and NRC staff resources are expended in evaluating the results of these
analyses, to include assumptions and plant configurations that support
conclusions that the dose criteria are met. Additionally, licensees may
encounter situations where equipment that has been determined as being
necessary to satisfy the existing dose-based criteria becomes
inoperable, sometimes necessitating emergent licensing actions to
continue plant operations. These outcomes are not consistent with the
safety significance of conservatively calculated doses on the order of
2.5 rem and 6.3 rem resulting from analyses of postulated events that
have a very low probability of occurrence. This regulatory experience,
combined with the knowledge that deterministic health effects do not
occur below 10 rem and that there is a reasonably likelihood that
stochastic health effects below 10 rem have been overestimated,
supports this proposal.
To implement this proposal, the NRC would revise Table 7 in RG
1.183. This guidance would be issued subsequent to this rulemaking as
part of the NRC's planned two-phased approach to issuing guidance
associated with this rulemaking, see Section VI, ``Availability of
Guidance,'' for more information. Additional guidance documents
identified by the NRC will be updated on a timeline separate from the
rulemaking schedule.
V. Specific Requests for Comments
The NRC is seeking advice and recommendations from the public on
the proposed rule. The NRC is particularly interested in comments and
supporting rationale from the public on the following:
Question 1: The NRC is seeking input from the public on the
proposed rule. The NRC is interested in comments and supporting
rationale from the public regarding the implementation of proposed 10
CFR 20.1301(b), which would allow licensees and applicants to request
higher dose limits for members of the public who access the controlled
area, as defined in 10 CFR part 20. As explained in the proposed rule,
the NRC would review these requests on a case-by-case basis and would
provide individual approvals if the NRC determined that there was
reasonable assurance of adequate protection of public health and
safety.
(A) As it pertains to the proposed process of case-by-case reviews
of requests for higher annual dose limits to members of the public who
access the controlled area,
i. Would a performance-based method be an acceptable means of
justifying such requests? For example, a performance-based method could
rely on an integrated analysis of relevant factors (e.g., radiological
hazards, occupancy, and access conditions) to demonstrate that members
of the public are unlikely to receive doses exceeding the annual public
dose limit in 10 CFR 20.1301(a).
ii. Under an applicant driven, case-by-case analysis, how should
NRC evaluate applicant requested justifications?
iii. What factors should the NRC consider in evaluating these
requests (e.g., health risks, duration of entry, proximity to
population centers, demographics, accessibility to the controlled area,
national security, energy reliability, undue hardship, cost
considerations), and how should these factors be prioritized?
iv. Similar to other protective measures (i.e., such as postings
for high voltages at electrical substations), what measures would be
appropriate to provide notice and protection to members of the public
in such cases including any special subgroups such as transient
workers, minors, pregnant or breast feeding women, etc.?
(B) Alternatively, or in addition to the previously discussed case-
by-case review and approval process, should the NRC increase the annual
public dose limit of 10 CFR 20.1301(a) within the controlled area?
i. What dose management measures would be appropriate in such
cases?
ii. Additionally, would it be sufficient for these dose management
actions to be implemented through a licensee's radiation protection
program, which is required by 10 CFR 20.1101, and verified through NRC
inspection?
iii. Finally, under such an option, what should the annual dose
limit be for members of the public who access the controlled area under
these circumstances?
[[Page 43478]]
Question 2: What are the expected benefits (e.g., simplified
design/construction, costs, operational efficiency) and drawbacks
(e.g., additional dose management and controls, periodic monitoring of
population, stronger access controls) of allowing higher annual dose
limits to members of the public who access the controlled area and, in
limited circumstances, outside the site boundary? What specific use
cases are expected to leverage these flexibilities and what operational
or design benefits are anticipated for these use cases if the
flexibilities are adopted? Please provide quantitative information and
description of use cases to the extent possible; however, qualitative
assessments would be useful, as well.
Question 3: The NRC requests comments and supporting rationale on
proposed 10 CFR 20.1301(d), which would allow licensees and applicants
to request, on a case-by-case basis, higher public dose limits than
those in 10 CFR 20.1301(a) when there is reasonable assurance of
adequate protection of public health and safety.
(A) What factors should the NRC consider when evaluating these
requests (e.g., dose control measures, health risks, proximity to
population centers, demographics, land ownership, national security,
energy reliability, cost considerations), and how should these factors
be prioritized?
(B) Are there scientific considerations the NRC should take into
account when reviewing requests for increased dose limits on a case-by-
case basis? Quantitative or qualitative information is useful.
(C) Based on practical use cases and consistent with the NRC's
intent for the flexibility in 10 CFR 20.1301(d), as described in the
preamble, the NRC seeks input on the advantages and disadvantages of
public dose limit flexibility allowed through 10 CFR 20.1301(d) and
potential qualitative or quantitative limits on flexibility in guidance
or regulatory text that the NRC should consider. Are there any
practical use cases that would be challenged by a limitation on the
flexibility allowed in 10 CFR 20.1301(d)?
Question 4: The NRC proposes to introduce the concept of the
caregiver in the patient visit and release-related regulations in parts
20 and 35, respectively. This will enable people who are essential to
the care and well-being of patients receiving radiopharmaceutical
treatments to willingly receive higher doses than members of the
general public, if needed. As part of this regulatory change, while the
NRC is maintaining the dose limit to members of the public from patient
release at 500 mrem, the NRC proposes to revise the basis for
calculating doses to members of the public from per-administration to
per-regimen. What are the advantages and disadvantages of using a per-
regimen basis for patient release determinations? Would this approach
create any barriers to treatment access? Alternatively, should the NRC
retain a per-administration basis for members of the public but apply a
per-regimen basis for caregivers? Please provide quantitative
information to the extent possible; however, qualitative assessments
would be useful, as well.
Question 5: The NRC proposes to increase its radionuclide emissions
standards from the current regulatory constraint in 10 CFR 20.1101(d)
of 10 mrem per year to 25 mrem per year; this change would also be
extended to the criteria in 10 CFR part 50, Appendix I. If a licensee
releases effluents greater than or equal to the 25 mrem per year
constraint, that licensee would be required to submit relevant reports
to the NRC on an annual basis until levels are returned to below the 25
mrem per year constraint. Additionally, such a licensee would be
required to evaluate and consider implementing cost-justified
corrective actions to restore effluent levels to below the 25 mrem per
year constraint. The NRC is seeking input from the public on the
following related to the proposed changes to effluent constraints and
reporting requirements:
Are there alternative approaches the NRC should consider, such as
increasing the constraint while retaining existing reporting practices?
What are the potential advantages or disadvantages of these alternative
approaches?
Question 6: If the public dose limit in 10 CFR 20.1301(a) were
increased, what level would be appropriate and why? What would be the
advantages and disadvantages of such a change? Please provide the
technical basis for your response, including quantitative or
qualitative information supporting that basis.
VI. Availability of Guidance
The NRC is issuing draft guidance for implementation of the
proposed requirements in this rulemaking in two phases. Three guidance
documents will be issued for public comment at the same time as this
notice. Additional guidance documents will be issued for public comment
following the publication of the proposed rule. The draft guidance
documents issued for comment concurrently with this proposed rule are
available in ADAMS as described in the ``Availability of Documents''
section. When finalized, the documents will provide stakeholders with
guidance for implementing the final requirements contemplated by this
proposed rule. You may submit comments on the draft regulatory guidance
by the methods outlined in the ADDRESSES section of this document.
Additional guidance documents identified by the NRC will be updated on
a timeline separate from the rulemaking schedule.
VII. National Environmental Policy Act
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A of 10 CFR part 51, ``Environmental Protection Regulations for
Domestic Licensing and Related Regulatory Functions,'' that this
proposed rule, if adopted, would not be a major Federal action
significantly affecting the quality of the human environment, and an
environmental impact statement is not required. The bases for this
determination are documented in the draft environmental assessment,
listed under the ``Availability of Documents'' section and incorporated
by reference in this proposed rule. As explained in the draft
environmental assessment, the implementation of the proposed rule
described in this Federal Register notice would not have a significant
environmental impact. Public comments on the draft environmental
assessment may be submitted to the NRC as indicated under the ADDRESSES
section of this document.
VIII. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission certifies that this rule, if adopted, will not
have a significant economic impact on a substantial number of small
entities. Therefore, in accordance with section 605(b), the NRC is not
preparing a regulatory flexibility certification analysis. The rule
will in fact apply to the many small entities that are among the NRC
licensees, applicants, and petitioners for rulemaking, but it will
impose no new burden on those small entities. To the contrary, as noted
in the regulatory analysis section of this notice, the agency's
expectation is that the rule will reduce burden.
IX. Regulatory Analysis
The NRC has prepared a draft regulatory analysis on this proposed
rule. The analysis examines the costs
[[Page 43479]]
and benefits of the alternatives considered by the NRC. The NRC
requests public comment on the draft regulatory analysis. The draft
regulatory analysis is available as indicated in the ``Availability of
Documents'' section of this document. Comments on the draft regulatory
analysis may be submitted to the NRC as indicated under the ADDRESSES
section of this document.
X. Backfitting and Issue Finality
The NRC has determined that the backfitting provisions in 10 CFR
parts 50, 53, 70, 72, and 76 and the issue finality provisions in 10
CFR part 52 are not implicated by this proposed rule. While the
proposed changes would predominantly affect regulations in 10 CFR part
20 and would thus impact all categories of NRC licensees, including
those entities within the scope of backfitting or issue finality
provisions, none of the proposed revisions in this rulemaking would
constitute backfitting or affect issue finality. Each proposed
amendment in this rulemaking is either in the form of a voluntary
relaxation or the addition of an alternative option for compliance with
applicable NRC regulations. For example, while the NRC is proposing to
discontinue the use of ALARA terminology in its regulations and
guidance and introduce a graded approach to dose management in its
place, a licensee would not be required to modify or add to its
operating procedures because compliance with regulations implementing
the current ALARA terminology would also be sufficient to satisfy the
revised regulations implementing the graded approach to dose
management. Therefore, because the NRC would not be imposing new or
revised requirements on an applicable entity, the NRC has determined
that the proposed revisions would not constitute backfitting as defined
in 10 CFR parts 50, 53, 70, 72, and 76 or affect the issue finality of
an existing approval issued under 10 CFR part 52.
XI. 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 deregulatory 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.
XII. 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.
XIII. Paperwork Reduction Act
This proposed rule contains new or amended collections of
information subject to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq). This proposed rule has been submitted to the Office of
Management and Budget for review and approval of the information
collections. The proposed changes to 10 CFR parts 19, 40, 61, and 71 do
not contain any new or amended collections of information subject to
the Paperwork Reduction Act of 1995.
Type of submission, new or revision: New.
The title of the information collection: Reforming and Modernizing
the NRC's Radiation Protection Framework.
The form number if applicable: None.
How often the collection is required or requested: Once, on
occasion, annually. Under the proposed rule, information collections
would be generally required on occasion, such as when certain
applications are submitted to the NRC for review, and when exposures
occur that require a report. Certain reports, such as ones specifying
the quantity of principal radionuclides released, would be required at
least once per year. Recordkeeping requirements would mandate that some
records be retained for three to five years, while others are to be
maintained for the duration of a license, depending on the specific
regulation. Forms and other reports would be submitted at the time of
specific events.
Who will be required or asked to respond: NRC licensees under parts
20, 34, 35, 50, 53, or 72.
An estimate of the number of annual responses:
10 CFR part 20:-45.0 (-162.0 reporting responses + 99.0 recordkeepers +
18.0 third-party disclosures)
10 CFR part 34:-594.0 (0.0 reporting responses + -594.0 recordkeepers +
0.0 third-party disclosures)
10 CFR part 35: 7,650.0 (0.0 reporting responses + 3,825.0
recordkeepers + 3,825.0 third-party disclosures)
10 CFR part 50: 300.0 (150.0 reporting responses + 150.0 recordkeepers
+ 0.0 third-party disclosures)
10 CFR part 53: 0.0 (0.0 reporting responses + 0.0 recordkeepers + 0.0
third-party disclosures)
10 CFR part 72: 170.0 (85.0 reporting responses + 85.0 recordkeepers +
0.0 third-party disclosures)
The estimated number of annual respondents:
10 CFR part 20: 99 Respondents
10 CFR part 34: 0 Respondents
10 CFR part 35: 3,825 Respondents
10 CFR part 50: 150 Respondents
10 CFR part 53: 0 Respondents
10 CFR part 72: 85 Respondents
An estimate of the total number of hours needed annually to comply
with the information collection requirement or request:
10 CFR part 20:-2,070.0
10 CFR part 34:-33,264.0
10 CFR part 35:-1,963.5
10 CFR part 50: 0.0
10 CFR part 53: 0.0
10 CFR part 72: 0.0
Abstract:The NRC is proposing to amend its regulations that govern
its standards for protection against radiation. The revisions reflect
the agency's reconsideration of its use of the LNT model for assessing
health effects from radiation exposure and its application of the ALARA
principle that is predicated on the LNT model. The proposed rule would
reflect the NRC's experience and other developments in the field of
radiation protection since the NRC's last major revisions to these
standards in 1991.
The proposed rule covers diverse topics, which result in
recordkeeping and reporting requirements related to instruction to
workers, radiation protection requirements, industrial radiography,
medical use of byproduct material, source material licensing, and
storage and transportation of radioactive material.
In addition to the new information collections in the proposed
regulations,
[[Page 43480]]
this proposed rule would result in amended requirements for NRC Forms
540/540A, 541/541A, and 542/542A. These forms are used on a nationwide
basis to reflect the minimum safety-related information for a low-level
radioactive waste shipment as required by Federal and State reporting
requirements for the safe transportation and disposal of low-level
radioactive waste. The rulemaking would not make any changes to the
forms themselves. The rulemaking would make the use of the forms
optional as long as respondents provide the same information as
required in the forms using a different format.
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 answer.
2. Is the estimate of the burden of the proposed information
collection accurate? Please explain your answer.
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected? Please explain your answer.
4. How can the burden of the proposed information collection on
respondents be minimized, including the use of automated collection
techniques or other forms of information technology?
A copy of the 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
submissions related to the OMB clearance package by searching on
https://www.regulations.gov under Docket ID NRC-2025-1140.
You may submit comments on any aspect of this 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-2025-1140.
Submit comments by August 14, 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.
XIV. Coordination With NRC Agreement States
On February 11, 2026, the NRC held a government-to-government
meeting with the Agreement States regarding this rulemaking. On
February 12, 2026, the rule was shared with the Standing Committee for
Compatibility.
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 Agreement State Policy Statement, a program
element means any component or function of a radiation control
regulatory program, including regulations and other legally binding
requirements imposed on regulated persons, which contributes to
implementation of that program.
Compatibility Category A are those program elements that include
basic radiation protection standards and scientific terms and
definitions that are necessary to understand radiation protection
concepts. Compatibility Category A program elements adopted by an
Agreement State should be essentially identical to those of the NRC to
provide uniformity in the regulation of agreement material on a
nationwide basis.
Compatibility Category B pertains to a limited number of program
elements that cross jurisdictional boundaries and should be addressed
to ensure uniformity of regulation on a nationwide basis. For
Compatibility Category B, the Agreement State program element shall be
essentially identical to that of NRC.
Compatibility Category C are those program elements that are
important for an Agreement State to have in order to avoid conflict,
duplication, gaps, or other conditions that would jeopardize an orderly
pattern in the regulation of agreement material on a national basis. An
Agreement State program shall embody the essential objectives of the
Category C program elements. Under Category C, Agreement State program
elements may be more restrictive than NRC program elements; however,
they should not be so restrictive as to prohibit a practice authorized
by the Atomic Energy Act of 1954 (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.
The proposed rule is a matter of compatibility between the NRC and
the Agreement States, thereby providing consistency among Agreement
State and NRC requirements.
The NRC is proposing to assign Category A to following new
definitions in 10 CFR part 20: Committed effective dose'', ``Committed
equivalent dose'', ``Dosimetry method (or system)'', ``Effective
dose'', ``Equivalent dose'', ``Graded approach to dose
[[Page 43481]]
management'', ``Planned occupational dose limit extension'',
``Radiation weighting factor'', and ``Total Effective Dose.'' These
definitions are necessary to understand radiation protection concepts.
Next, the NRC is proposing to change the compatibility category of
10 CFR 20.1101(b) from Category H&S to Category A. The regulatory
history of the rationale for the H&S designation is scant as 10 CFR
20.1101(b), originally issued as 10 CFR 20.1, did not address Agreement
State compatibility and adequacy categories because it predated the
Agreement State Policy Statement. As the NRC clarified Agreement State
categories with the issuance and subsequent updates to the Agreement
State Policy Statement, 10 CFR 20.1101(b) was assigned the H&S
Category. 10 CFR 20.1101(b), at its heart, ensures that licensees
operate their radiation protection program in a manner that ensures
compliance with dose limits. The Agreement State Policy Statement
provides that Category A, ``includes basic radiation protection
standards that encompass dose limits, concentration, and release limits
related to radiation protection in [10 CFR part 20], that are generally
applicable.'' As such, the NRC is proposing to change the compatibility
category of 10 CFR 20.1101(b) because it relates closely to radiation
protection standards. Additionally, the proposed graded approach to
dose management in revised 10 CFR 20.1101(b) is a critical piece of the
overall regulatory framework that ensures that the dose limits in 10
CFR part 20 are not exceeded.
With this proposed change in compatibility category, Agreement
States would be required to revise their equivalent 10 CFR 20.1101(b)
regulation to be essentially identical to the NRC's and remove the
ALARA requirement. Given this proposed required revision to the ALARA
requirement, Agreement States would also remove ALARA references from
their equivalent regulations to avoid conflicts, duplications, gaps,
and to ensure an orderly pattern in the regulation of agreement
material on a nationwide basis. However, the NRC is not proposing to
change the compatibility or adequacy category of every regulation where
references to ALARA should be removed. To assist states, the following
is a non-exhaustive list of those regulations with references to ALARA
where Agreement States would be required to either remove their
equivalent regulation entirely (e.g., the definition of ALARA), or
remove the reference to ALARA in a regulation that is otherwise
Category H&S, C, or D (i.e., those regulations not already required to
be essentially identical with the NRC):
1. Remove 20.1003, ALARA definition (previously Category A; this
proposed rule would remove this definition entirely)
2. 20.1402 (previously Category C; note that the NRC is proposing to
revise this designation for certain licensees)
3. 20.1403(a) (previously Category C; note that the NRC is proposing to
revise this designation for certain licensees)
4 20.1403(e) (previously Category C; note that the NRC is proposing to
revise this designation for certain licensees)
5. 20.1404(a)(3) (previously Category C; note that the NRC is proposing
to revise this designation for certain licensees) 20.1601(f) (Category
H&S)
6. 20.1702 (Category H&S)
7. 20.1704(a) (Category D)
8. 20.2002 (Category D)
9. 20.2105 (Category D)
10. 20.2203(a)(2)(vi) (Category C)
11. 20.2203(b)(iv) (Category C)
12. Remove 34.3, ALARA definition (previously Category A; this proposed
rule would remove this definition entirely)
13. Remove 34.42(c) (previously Category D; this proposed rule would
remove this definition entirely)
14. 35.75(b) (Category C)
The NRC is also proposing revisions to remove references to ALARA
in 10 CFR 71.87(i), which is compatibility Category B. The NRC is not
proposing to change the compatibility category for that regulation.
Thus, Agreement States would be required to ensure that their
equivalent regulations be essentially identical to the NRC's proposed
revisions in 10 CFR 71.87(i) and, therefore, remove references to ALARA
in said regulation.
The NRC recognizes that the removal of ALARA references is not as
straightforward in 10 CFR part 20 subpart E (10 CFR 20.1402,
20.1403(a), 20.1403(e), 20.1404(a)(3), 20.1601(f)). The compatibility
categories of these sections remain Category C except for certain
licensees as noted in the Table below. The essential objective of 10
CFR part 20 subpart E still remains to provide a licensee with a
pathway to terminate its license for unrestricted or restricted use.
This rulemaking clarifies that the essential objective also includes
that residual radioactivity be managed within the applicable limit and
not be required to be managed significantly below that limit. Thus,
while Agreement States would be required to remove references to ALARA
in 10 CFR part 20 subpart E, and the other sections referenced above,
to prevent a disorderly pattern of regulation nationwide, Agreement
States have flexibility in revising their regulations to be consistent
with the clarified essential objectives of 10 CFR part 20 subpart E.
For ease and consistency, the NRC encourages Agreement States to follow
NRC's model in revising 10 CFR part 20 subpart E.
The NRC is also proposing changing the compatibility category for
10 CFR 20.1101(d) from Category C to Category A. 10 CFR 20.1101(d)
provides standards for air emissions of radioactive material to the
environment, other than Radon-222, for licensees other than those
subject to 10 CFR 50.34a (i.e., power reactors). In 1996, the NRC
issued this requirement to provide assurance to the U.S. Environmental
Protection Agency (EPA) that future emissions from NRC licensees (other
than power reactors, which were addressed separately) would not exceed
dose levels that the EPA had determined would provide an ample margin
of safety under Section 112(d)(9) of the Clean Air Act (CAA) (42 U.S.C.
7412(d)(9); 61 FR 65120, December 10, 1996). The 1996 rulemaking thus
provided EPA a basis upon which to rescind its own CAA regulations for
NRC licensed facilities and Agreement State licensees, thereby
relieving these licensees from unnecessary dual regulation.
Notably, in the 1996 rulemaking, the Federal Register notice stated
that the new 10 CFR 20.1101(d) codified ``numerical values for NRC's
application of ALARA guidelines for radioactive air emissions from its
licensees, other than power reactors.'' However, with this proposed
rule, the NRC is replacing ALARA with a graded approach to dose
management in revised 10 CFR 20.1101(b), which the NRC is proposing to
assign a compatibility category A. This graded dose management approach
consists of regulatory requirements and guidance that ensure that the
applicable dose limit is not exceeded. In the proposed rule, the
revised 20.1101(d) emissions standards would no longer be implemented
by numerical criteria for the application of ALARA guidelines, but
instead the emissions standards would be an integral part of the
proposed graded approach to dose management in 10 CFR 20.1101(b).
While the CAA does not preclude a state from adopting more
restrictive emissions standards for radionuclides, Agreement State
programs must be adequate and compatible with the
[[Page 43482]]
NRC's program under the AEA. Per the Agreement State Policy Statement,
compatibility category A includes those requirements such as ``basic
radiation protection standards that encompass dose limits,
concentration, and release limits related to radiation protection [10
CFR part 20].'' Given that the emissions standards in proposed 10 CFR
20.1101(d) serve an integral purpose in ensuring that the dose limits
referred to in the revised 20.1101(b) are not exceeded and that the NRC
is proposing to designate 10 CFR 20.1101(b) as Category A, 10 CFR
20.1101(d) would also be most appropriately categorized as Category A.
Those portions of the provision that address areas reserved to the NRC,
e.g., 10 CFR part 50.34a and 10 CFR 53.260, are designated as a
Compatibility Category NRC. A State should not adopt provisions that
would confer regulatory authority to the State in an area of exclusive
NRC jurisdiction pursuant to the Act, 10 CFR 8.4, 10 CFR part 150, and
other Federal laws, regulations, or provisions.
As indicated above, the NRC is proposing to change the
compatibility category of the license termination criteria in 10 CFR
part 20 subpart E (10 CFR 20.1402, 20.1403(a), 20.1403(e),
20.1404(a)(3), 20.1601(f)) only for certain licensees. Specifically,
the NRC is proposing to change the compatibility category of these
regulations from Category C to Category B for licensees recovering
source material from any mineral resources (includes rare earths and
other critical minerals as defined in 90 FR 41591) that are processed
primarily for purposes other than obtaining the source material
content. Similarly, the NRC is proposing to change the compatibility
category for the license termination criteria for the domestic milling
of uranium in 10 CFR part 40, Appendix A for Criterion 5 and Criterion
6 from Category C to Category B. Under the Agreement State Policy
Statement, Category B ``pertains to a limited number of program
elements that cross jurisdictional boundaries and that should be
addressed to ensure uniformity of regulation on a nationwide basis.''
In Management Directive 5.9, ``Adequacy and Compatibility of Program
Elements for Agreement State Programs,'' the NRC defines ``cross
jurisdictional'' with respect to Category B as ``a practice or licensed
activity that necessitates identical requirements to ensure an orderly
regulatory pattern for the use and regulation of agreement material
between all Agreement States and NRC jurisdictions.''
On January 29, 2025, the President issued E.O. 14156, ``Declaring a
National Energy Emergency.'' That E.O. declares a national energy
emergency and instructs heads of agencies to ``identify and exercise
lawful emergency and other authorities available to facilitate the
identification, leasing, siting, production, transportation, refining,
and generation of domestic energy resources.'' On that same day, the
President also issued E.O 14154, ``Unleashing American Energy.'' That
E.O sets forth several United States policies, including ``to protect
the United States's economic and national security and military
preparedness by ensuring that an abundant supply of reliable energy is
readily accessible in every State and territory of the Nation.''
Subsequently, on May 23, 2025, the President issued E.O. 14299,
``Deploying Advanced Nuclear Reactor Technologies for National
Security,'' which discusses the national security aspects of the need
for additional nuclear energy nationwide.
The domestic extraction of some critical minerals, which are
established by the U.S. Geological Survey in coordination with
responsible agencies and departments, in part to protect national
security, may involve the recovery of source material and require
licensing by the NRC or an Agreement State. E.O. 14154 speaks directly
to the importance of critical minerals in establishing a United States
policy ``to establish our position as the leading producer and
processor of non-fuel minerals, including rare earth minerals, which
will create jobs and prosperity at home, strengthen supply chains for
the United States and its allies, and reduce the global influence of
malign and adversarial states.''
Consistent with the direction of the previously discussed E.O.s as
well as the National Materials and Minerals Policy, Research and
Development Act of 1980, which ensures the stable supply of materials
necessary to maintain national security, this activity necessitates
identical requirements to ensure an orderly regulatory pattern for the
use and regulation of material between all Agreement States and NRC
jurisdictions. The proposed change in compatibility category for these
licensees will ensure uniformity for license termination nationwide
since the domestic extraction of critical minerals is important for
national security.
Similarly, the NRC is proposing to change the compatibility
category of 10 CFR part 40, Appendix A for Criterion 5 and Criterion 6
from Category C to Category B. These criteria in 10 CFR part 40,
Appendix A contain the groundwater and stabilization and control of
material requirements that must be achieved prior to license
termination of uranium mills. Criterion 5 establishes applicable
groundwater protection standards during operations and prior to the end
of closure. Criterion 6 establishes additional requirements for the
stabilization and control of material prior to the end of closure. The
domestic milling of uranium is an essential part of the nuclear fuel
cycle and, therefore, important to national security, consistent with
the direction of the previously discussed E.O.s. As uranium milling
occurs in multiple jurisdictions, it is important for a consistent
approach and understanding of license termination criteria nationwide.
Further, a consistent approach is essential to the overall regulatory
framework for domestic uranium milling and, therefore, important to the
development and growth of domestic uranium milling and to national
security, consistent with the direction of the previously discussed
E.O.s. Accordingly, the NRC is proposing changing Criterion 5 and
Criterion 6 in 10 CFR part 40, Appendix A to Category B as the activity
necessitates identical requirements to ensure an orderly regulatory
pattern for the use and regulation of material between all Agreement
States and NRC jurisdictions.
Importantly, the NRC is not proposing that the license termination
criteria for this subset of licensees are matters relating to common
defense and security such that they would be exclusively regulated by
the NRC. Rather, the national security considerations and
Administration's priorities expressed in the above E.O.s underpin the
NRC's proposal to designate these activities as Category B, for the
identified licensees, as a practice or licensed activity that
necessitates identical requirements to ensure an orderly regulatory
pattern for the use and regulation of agreement material between all
Agreement States and NRC jurisdictions. The NRC recognizes the
challenges Agreement States may have in implementing different
compatibility categories based on the type of licensed activity and
will work with the States on implementation.
For newly proposed 10 CFR 20.1010 and the associated 10 CFR part
20, Appendix H, the NRC is proposing to assign Compatibility Category
B. The proposed new regulation, Sec. 20.1010, would reference a
listing of generically approved alternative dosimetry methods in a
proposed new Appendix H to 10 CFR part 20, and it would also provide
the criteria for the NRC's approval of a method that is not listed in
Appendix H.
[[Page 43483]]
The NRC is proposing to assign these regulations Category B because the
use of dosimetry methods is cross-jurisdictional and the uniformity of
approved alternatives is necessary to ensure an orderly regulatory
pattern for the use and regulation of material between all Agreement
States and NRC jurisdictions.
Next, the NRC is proposing to change the compatibility category of
10 CFR 20.1301(d) from Category C to Category A. Currently, 10 CFR
20.1301(d) allows a licensee or applicant to apply for prior NRC
authorization to operate in excess of the public dose limit (i.e., 100
mrem) for an individual member of the public, up to 500 mrem, and
specifies the information the entity should provide in this
application. The proposed revision to 10 CFR 20.1301(d) would remove
the 500 mrem upper limit. This change does not affect the ability for
Agreement States to approve an optional upper public dose limit
consistent with past practices. With the removal of that upper limit
and the regulation tied to the public dose limit of 100 mrem, the NRC
proposes designating the regulation Compatibility Category A,
consistent with the designation for the public dose limit.
For the newly proposed 10 CFR 20.1205, which concerns a new process
for allowing workers to receive occupational doses in excess of
applicable annual limits, the NRC is proposing to assign Compatibility
Category A. As explained above, this optional process in the newly
proposed 10 CFR 20.1205 would allow licensees to periodically exceed
annual occupational dose limits for workers, provided that an adequate
decision-making process is applied to support its use and that the
overall dose is limited within specified multi-year average values. The
proposed approach would allow for dose averaging across several years
to demonstrate compliance with occupational dose limits. Similar to 10
CFR 20.1301(d) for the public dose limit, 10 CFR 20.1205 allows
licensees flexibility with respect to the occupational dose limit.
Thus, the NRC proposes designating 10 CFR 20.1205 as Category A,
consistent with the designation for the occupational dose limit itself
and the similar proposed designation for 10 CFR 20.1301(d) for the
public dose limit flexibility. Moreover, in order to protect radiation
workers' ability to work in different jurisdictions within the same
calendar year when utilizing this provision, it is necessary for all
jurisdictions to have the same flexibility built into their
regulations.
With respect to 10 CFR part 35, the NRC is proposing to assign
compatibility Category B to the new definitions for ``Caregiver'' and
``Administration regimen'' as well as the revised 10 CFR 35.75(b)
regarding the dose limits for patient release, which means that these
requirements have cross-jurisdictional boundaries implications.
Agreement States' requirements should be essentially identical to those
of the NRC so that there are consistent standards for patient release
requirements between the NRC and the Agreement States.
Since the 2002 adoption of the current dose-based criteria in 10
CFR 35.75, the treatment and release of patients with byproduct
materials have undergone a number of significant changes with regard to
the doses and administrative regimens of therapeutic radioisotopes
used, treatment modalities, and the treatment and release of patient at
regional treatment centers that require patients to travel in multiple
jurisdictions. These changes require consistent standards to ensure
equivalent levels of protection. For example, an increasing number of
therapeutic radiopharmaceuticals are being delivered over the course of
multiple administrations. Safe implementation of the proposed revision
to 10 CFR 35.75(b) relies on consistent application of release
considerations over the course of the entire administration regimen,
which could be delivered in multiple jurisdictions.
The compatibility (A, B, C, D, and NRC) and adequacy (H&S)
categories are designated in the following tables:
Adequacy and Compatibility Table for 10 CFR Part 19
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
19.12.................... Amend................ Instruction to C.................. C.
workers.
19.13.................... Amend................ Notifications and C.................. C.
reports to
individuals.
----------------------------------------------------------------------------------------------------------------
Adequacy and Compatibility Table for 10 CFR Part 20
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
20.1003.................. Amend................ Definition--Airborne A.................. A.
radioactivity area.
20.1003.................. Delete............... Definition--ALARA... A..................
20.1003.................. Amend................ Definition--Annual A.................. A.
limit on intake.
20.1003.................. Amend................ Definition--Committe A.................. A.
d Dose Equivalent.
20.1003.................. New.................. Definition--Committe ................... A.
d equivalent dose.
20.1003.................. Amend................ Definition--Committe A.................. A.
d effective dose
equivalent.
20.1003.................. New.................. Definition--Committe ................... A.
d effective dose.
20.1003.................. Amend................ Definition--Derived A.................. A.
air concentration.
20.1003.................. Amend................ Definition--Dose or D.................. D.
radiation dose.
20.1003.................. Amend................ Definition--Dose A.................. A.
equivalent.
20.1003.................. New.................. Definition--Dosimetr ................... A.
y method (or
system).
20.1003.................. New.................. Definition--Effectiv ................... A.
e dose.
20.1003.................. Amend................ Definition--Effectiv A.................. A.
e dose equivalent.
20.1003.................. New.................. Definition--Equivale ................... A.
nt Dose.
20.1003.................. New.................. Definition--Graded ................... A.
approach to dose
management.
20.1003.................. Amend................ Definition--License. D.................. D.
20.1003.................. Amend................ Definition--Nonstoch A.................. A.
astic effect.
20.1003.................. Amend................ Definition--Planned D.................. D.
special exposure.
[[Page 43484]]
20.1003.................. New.................. Definition--Planned ................... A.
occupational dose
limit extension.
20.1003.................. New.................. Definition--Radiatio ................... A.
n weighting factor.
20.1003.................. Amend................ Definition--Stochast A.................. A.
ic effects.
20.1003.................. New.................. Definition--Total ................... A.
effective dose.
20.1003.................. Amend................ Definition--Weightin A.................. A.
g factor.
20.1004.................. Amend................ Units of radiation A.................. A.
dose.
20.1010.................. New.................. Dosimetry methods... ................... B.
20.1101(a) and (c)....... Amend................ Radiation protection H&S................ H&S.
programs.
20.1101(b)............... Amend................ Radiation protection H&S................ A.
programs.
20.1101(d)............... Amend................ Radiation protection C.................. A, except portions
programs. of these
provisions are
designated as NRC
(Those portions of
the provision that
address areas
reserved to the
NRC, e.g., 10 CFR
Parts 50.34a and
53.260 are
designated as a
Compatibility
Category NRC).
20.1201.................. Amend................ Occupational dose A.................. A.
limits for adults.
20.1202.................. Amend................ Compliance with A.................. A.
requirements for
summation of
external and
internal doses.
20.1204.................. Amend................ Determination of A.................. A.
internal exposure.
20.1205.................. New.................. Planned occupational ................... A.
dose limit
extension.
20.1206.................. Amend................ Planned special D.................. D.
exposures.
20.1301(a), (b), (c)..... Amend................ Dose limits for A.................. A.
individual members
of the public.
20.1301(d)............... Amend................ Dose limits for C.................. A.
individual members
of the public.
20.1302(b)............... Amend................ Compliance with dose H&S................ H&S.
limits for
individual members
of the public.
20.1302(c)............... Amend................ Compliance with dose D.................. D.
limits for
individual members
of the public.
20.1402.................. Amend................ Radiological C.................. B--for source
criteria for material recovered
unrestricted use. from any mineral
resources
processed
primarily for
purposes other
than obtaining the
source material
content.
C--for all other
Agreement State
licensed
activities.*
20.1403.................. Amend................ Criteria for license C.................. B--for source
termination under material recovered
restricted from any mineral
conditions. resources
processed
primarily for
purposes other
than obtaining the
source material
content.
C--for all other
Agreement State
licensed
activities.*
20.1404.................. Amend................ Alternate criteria C.................. B--for source
for license material recovered
termination. from any mineral
resources
processed
primarily for
purposes other
than obtaining the
source material
content.
C--for all other
Agreement State
licensed
activities.*
20.1405.................. Amend................ Public notification C.................. C.
and public
participation.
20.1502.................. Amend................ Conditions requiring H&S................ H&S.
individual
monitoring of
external and
internal
occupational dose.
20.1601(f)............... Amend................ Control of access to H&S................ H&S.
high radiation
areas.
20.1702.................. Amend................ Use of other H&S................ H&S.
controls.
20.1703.................. Amend................ Use of individual H&S................ H&S.
respiratory
protection
equipment.
20.1704.................. Amend................ Further restrictions D.................. D.
on the use of
respiratory
protection
equipment.
20.1705.................. Amend................ Application for use B.................. B.
of higher assigned
protection factors.
20.1905(b)............... Amend................ Exceptions to A.................. A.
labeling
requirements.
20.2002.................. Amend................ Method for obtaining D.................. D.
approval of
proposed disposal
procedures.
20.2003 (a)(2)&(a)(3).... Amend................ Disposal by release A.................. A.
into sanitary
sewerage.
20.2004.................. Amend................ Treatment or D.................. D.
disposal by
incineration.
20.2101.................. Amend................ General provisions.. C.................. C.
20.2104.................. Amend................ Determination of D or H&S (for D or H&S (for
prior occupational States who adopt States who adopt
dose. planned special planned special
exposure). exposure.
20.2105.................. Amend................ Records of planned D.................. D.
special exposures.
20.2106(a)............... Amend................ Records of C.................. C.
individual
monitoring results.
20.2107.................. Amend................ Records of dose to D.................. D.
individual members
of the public.
20.2202(e)............... Amend................ Notification of D.................. D.
incidents.
[[Page 43485]]
20.2203(a), (b).......... Amend................ Reports of C.................. C.
exposures,
radiation levels,
and concentrations
of radioactive
material exceeding
the constraints or
limits.
Appendix G............... Amend................ Requirements for Low- B.................. B.
level radioactive
waste intended for
disposal at land
disposal facilities
and manifests.
App. G I................. Amend................ Manifest............ B.................. B.
App. G I................. New.................. Definition--Carrier. ................... B.
App. G I................. Delete............... Definition--Computer B..................
readable medium.
App. G I................. Amend................ Definition--EPA B.................. B.
identification
number.
App. G I................. Amend................ Definition--High B.................. B.
integrity container.
App. G I................. Amend................ Definition--NRC B.................. B.
Forms 540, 540A,
541, 541A, 542, and
542A.
App. G I................. Amend................ Definition--Shipping B.................. B.
paper.
App. G I................. Amend................ Definition--Uniform B.................. B.
Low-Level
Radioactive Waste
Manifest.
App. G III.A............. Amend................ Control and Tracking B.................. B.
App. G III.B............. Amend................ Control and Tracking B.................. B.
App. G III.C............. Amend................ Control and Tracking B.................. B.
App. G III.D............. Amend................ Control and Tracking B.................. B.
Appendix H............... New.................. Alternative ................... B.
Dosimetry Methods
Acceptable for Use
to Demonstrate
Compliance with
NRC's Standards for
Protection Against
Radiation.
----------------------------------------------------------------------------------------------------------------
* Consistent with 10 CFR 20.1401(a), the criteria in 10 CFR part 20, subpart E do not apply to uranium and
thorium recovery facilities already subject to appendix A to 10 CFR part 40 or the uranium solution extraction
facilities.
Adequacy and Compatibility Table for 10 CFR Part 34
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
34.3..................... Delete............... Definitions--ALARA.. [A]................
34.42(c), (d)............ Delete............... Radiation Safety D..................
Officer for
industrial
radiography.
----------------------------------------------------------------------------------------------------------------
Adequacy and Compatibility Table for 10 CFR Part 35
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
35.2..................... New.................. Definitions--Adminis ................... B.
tration Regimen.
35.2..................... New.................. Definitions--Caregiv ................... B.
er.
35.75(a)................. Revised.............. Release of C.................. C.
individuals
containing unsealed
byproduct material
or implants
containing
byproduct material.
35.75(b)................. Amend................ Release of C.................. B.
individuals
containing unsealed
byproduct material
or implants
containing
byproduct material.
35.75(c)................. Amend................ Release of C.................. C.
individuals
containing unsealed
byproduct material
or implants
containing
byproduct material.
35.75(d)................. Amend................ Release of D.................. D.
individuals
containing unsealed
byproduct material
or implants
containing
byproduct material.
35.2075.................. Amend................ Records of the D.................. D.
release of
individuals
containing unsealed
byproduct material
or implants
containing
byproduct material.
----------------------------------------------------------------------------------------------------------------
[[Page 43486]]
Adequacy and Compatibility Table for 10 CFR Part 40
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
Appendix A............... Amend................ Criteria Relating to Definitions--A for Definitions--A for
the Operation of States with States with
Uranium Mills and authority to authority to
the Disposition of regulate uranium regulate uranium
Tailings or Wastes mill activities mill activities
Produced by the (11e.(2) byproduct (11e.(2) byproduct
Extraction or material). material).
Concentration of Criterion 11A.thru Criterion 5 and 6
Source Material F and Criterion 12 are B--for States
From Ores Processed are NRC.. with authority to
Primarily for Their All of the regulate uranium
Source Material remaining portions mill activities.
Content. of the section are D--States without
C--for States with authority.
authority to Criterion 11A. thru
regulate uranium F and Criterion 12
mill activities.. are NRC.
D--States without All of the
authority.. remaining portions
of the section are
C--for States with
authority to
regulate uranium
mill activities.
D--States without
authority.
----------------------------------------------------------------------------------------------------------------
Adequacy and Compatibility Table for 10 CFR Part 61
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
61.41.................... Amend................ Protection of the A.................. A.
general population
from releases of
radioactivity.
61.43.................... Amend................ Protection of H&S................ H&S.
individuals during
operations.
----------------------------------------------------------------------------------------------------------------
Adequacy and Compatibility Table for 10 CFR Part 71
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
71.87.................... Amend................ Routine [B]................ [B].
determinations.
----------------------------------------------------------------------------------------------------------------
The NRC invites comment on the compatibility category designations
in the proposed rule and suggests that commenters refer to Management
Directive 5.9, ``Adequacy and Compatibility of Program Elements for
Agreement State Programs,'' and its Handbook for more information. The
NRC notes that, like the rule text, the compatibility category
designations can change between the proposed rule and final rule, based
on comments received and NRC decisions regarding the final rule. The
NRC encourages anyone interested in commenting on the compatibility
category designations in any manner to do so during the comment period.
XVI. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995,
Public Law 104-113, requires that Federal agencies use technical
standards that are developed or adopted by voluntary consensus
standards bodies unless the use of such a standard is inconsistent with
applicable law or otherwise impractical. In this proposed rule, the NRC
is proposing to amend its regulations that govern its standards for
protection against radiation. The amendments reflect the agency's
reconsideration of its use of the LNT model for assessing health
effects from radiation exposure and its application of the ALARA
principle that is predicated on the LNT model. The proposed rule would
reflect the NRC's experience and other developments in the field of
radiation protection since the NRC's last major revisions to these
standards in 1991. As part of the proposed rule, the NRC would
discontinue the use of ALARA terminology in its regulations and
guidance and would use a graded approach to dose management in its
place.
The proposed rule would give licensees the option to voluntarily
use alternative dosimetry methods to demonstrate compliance with NRC
regulations in 10 CFR part 20 without separate NRC approval through a
new regulation, Sec. 20.1010, and its associated Appendix H. The NRC
has determined that allowing the use of dosimetry methods based on
specific, identified publications will offer flexibility to licensees
and applicants, increase efficiency in licensing, operations, and
administration of radiation protection programs, and bring the NRC's
radiation protection framework more in line with current
recommendations, while still retaining reasonable assurance of adequate
protection of the public health and safety. The NRC determined that
this change would maintain the effectiveness of the radiation
protection regulatory framework because the alternative dosimetry
methods that would be preapproved for use are appropriate for the scope
of activities subject to 10 CFR part 20, are technically adequate and
have been published by expert, standards-setting organizations, and
provide sufficient transparency regarding associated assumptions and
uncertainties. Accordingly, the proposed new regulation, Sec. 20.1010,
would reference a listing of preapproved alternative dosimetry methods
in proposed new Appendix H and it would also provide the criteria for
the NRC approval of a method not listed in Appendix H. The methods to
be included in Appendix H have been promulgated primarily by the ICRP,
but the listing of approved methods also includes other methods
published by consensus-setting organizations. In the future, the NRC
expects to update Appendix H as appropriate, including as more methods
become available.
In this proposed rule, the NRC is proposing to incorporate by
reference the following voluntary consensus standards from the American
National Standards Institute/American Nuclear Society (ANSI/ANS) and
the
[[Page 43487]]
International Commission on Radiological Protection (ICRP):
1. ANSI/ANS-6.1.1-2020--ANSI/ANS, 2020. Photon and Neutron Fluence-
to-Dose Conversion Coefficients. ANSI/ANS-6.1.1-2020. La Grange Park,
IL: American Nuclear Society.
2. ICRP Publication 56--ICRP, 1990. Age-dependent Doses to Members
of the Public from Intake of Radionuclides--Part 1. ICRP Publication
56. Ann. ICRP 20 (2).
3. ICRP Publication 67--ICRP, 1993. Age-dependent Doses to Members
of the Public from Intake of Radionuclides--Part 2 Ingestion Dose
Coefficients. ICRP Publication 67. Ann. ICRP 23 (3-4).
4. ICRP Publication 68--ICRP, 1994. Dose Coefficients for Intakes
of Radionuclides by Workers. ICRP Publication 68. Ann. ICRP 24 (4).
5. ICRP Publication 69--ICRP, 1995. Age-dependent Doses to Members
of the Public from Intake of Radionuclides--Part 3 Ingestion Dose
Coefficients. ICRP Publication 69. Ann. ICRP 25 (1).
6. ICRP Publication 71--ICRP, 1995. Age-dependent Doses to Members
of the Public from Intake of Radionuclides--Part 4 Inhalation Dose
Coefficients. ICRP Publication 71. Ann. ICRP 25 (3-4).
7. ICRP Publication 72--ICRP, 1995. Age-dependent Doses to Members
of the Public from Intake of Radionuclides--Part 5 Compilation of
Ingestion and Inhalation Coefficients. ICRP Publication 72. Ann. ICRP
26 (1).
8. ICRP Publication 116--ICRP, 2010. Conversion Coefficients for
Radiological Protection Quantities for External Radiation Exposures.
ICRP Publication 116. Ann. ICRP 40 (2-5).
9. ICRP Publication 130--ICRP, 2015. Occupational Intakes of
Radionuclides: Part 1. ICRP Publication 130. Ann. ICRP 44(2).
10. ICRP Publication 134--ICRP, 2016. Occupational Intakes of
Radionuclides: Part 2. ICRP Publication 134. Ann. ICRP 45(\3/4\), 1-
352.
11. ICRP Publication 137--ICRP, 2017. Occupational Intakes of
Radionuclides: Part 3. ICRP Publication 137. Ann. ICRP 46(\3/4\).
12. ICRP Publication 141--ICRP, 2019. Occupational Intakes of
Radionuclides: Part 4. ICRP Publication 141. Ann. ICRP 48(\2/3\).
13. ICRP Publication 144--ICRP, 2020. Dose Coefficients for
External Exposures to Environmental Sources. ICRP Publication 144. Ann.
ICRP 49(2).
14. ICRP Publication 151--ICRP, 2022. Occupational Intakes of
Radionuclides: Part 5. ICRP Publication 151. Ann. ICRP 51(1-2).
The NRC invites comment on the applicability and use of other
standards.
XVII. Incorporation by Reference--Reasonable Availability to Interested
Parties
The NRC proposes to incorporate by reference. As described in the
``Background'' and ``Discussion'' sections of this document, these
materials contain standards.
The NRC is required by law to obtain approval for incorporation by
reference from the Office of the Federal Register (OFR). The OFR's
requirements for incorporation by reference are set forth in 1 CFR part
51. On November 7, 2014, the OFR adopted changes to its regulations
governing incorporation by reference (79 FR 66267). The OFR regulations
require an agency to include in a proposed rule a discussion of the
ways that the materials the agency proposes to incorporate by reference
are reasonably available to interested parties or how it worked to make
those materials reasonably available to interested parties. The
discussion in this section complies with the requirement for proposed
rules as set forth in 1 CFR 51.5(a)(1).
The NRC considers ``interested parties'' to include all potential
NRC stakeholders, not only the individuals and entities regulated or
otherwise subject to the NRC's regulatory oversight. These NRC
stakeholders are not a homogenous group but vary with respect to the
considerations for determining reasonable availability. Therefore, the
NRC distinguishes between different classes of interested parties for
the purposes of determining whether the material is ``reasonably
available.'' The NRC considers the following to be classes of
interested parties in NRC rulemakings with regard to the material to be
incorporated by reference:
1. Individuals and small entities regulated or otherwise subject to
the NRC's regulatory oversight (this class also includes applicants and
potential applicants for licenses and other NRC regulatory approvals)
and who are subject to the material to be incorporated by reference by
rulemaking. In this context, ``small entities'' has the same meaning as
a ``small entity'' under 10 CFR 2.810.
2. Large entities otherwise subject to the NRC's regulatory
oversight (this class also includes applicants and potential applicants
for licenses and other NRC regulatory approvals) and who are subject to
the material to be incorporated by reference by rulemaking. In this
context, ``large entities'' are those that do not qualify as a ``small
entity'' under 10 CFR 2.810.
3. Non-governmental organizations with institutional interests in
the matters regulated by the NRC.
4. Other Federal agencies, States, and local governmental bodies
(within the meaning of 10 CFR 2.315(c)).
5. Federally-recognized and State-recognized Indian Tribes.
6. Members of the public (i.e., individual, unaffiliated members of
the public who are not regulated or otherwise subject to the NRC's
regulatory oversight) who may wish to gain access to the materials that
the NRC proposes to incorporate by reference by rulemaking in order to
participate in the rulemaking process.
ICRP documents are publicly available and may be found by
contacting International Commission on Radiological Protection, 350
Albert Street Suite 410, Ottawa, Ontario, K1R 1A4, Canada or online at
https://www.icrp.org/index.asp.
Interested parties may purchase a copy of the ANSI/ANS material
from ANSI/ANS at American National Standards Institute/American Nuclear
Society (ANSI/ANS): ATTN Standards, 555 N Kensington Avenue, La Grange
Park, IL 60526, or at the ANSI website, https://webstore.ansi.org/. The
purchase price for the material is $97.
For the class of interested parties constituting members of the
public who wish to gain access to the materials to be incorporated by
reference in order to participate in the rulemaking, the NRC recognizes
that the cost may be so high that the materials could be regarded as
not reasonably available for purposes of commenting on this proposed
rule, despite the NRC's actions to make the materials available at the
NRC's PDR. Accordingly, the NRC requested that ANSI/ANS consider
enhancing public access to these materials during the public comment
period. On February 11, 2026, ANSI/ANS agreed to make the material
available online in a read-only electronic access format during the
public comment period. Therefore, the one ANSI/ANS document that the
NRC proposes to incorporate by reference in this rulemaking is
available in read-only format at the ANSI/ANS website, https://www.ans.org/standards/nprm/.
In addition, as described in Section XIX of this document,
documents related to this proposed rule are available online in the
NRC's ADAMS Public Documents Collection at https://www.nrc.gov/reading-rm/adams.html.
The materials are available to all interested parties in multiple
ways and in a manner consistent with their interest in this proposed
rule. Therefore,
[[Page 43488]]
the NRC concludes that the materials the NRC proposes to incorporate by
reference in this proposed rule are reasonably available to all
interested parties.
XVIII. Executive Orders
The following are Executive orders that are related to this
proposed rule:
A. Executive Order 12866: Regulatory Planning and Review (as Amended by
Executive Order 14215, Ensuring Accountability for All Agencies)
The Office of Information and Regulatory Affairs (OIRA) has
determined that this proposed rule is a significant regulatory action.
Accordingly, the NRC submitted this proposed rule to OIRA for review.
The NRC is required to conduct an economic analysis in accordance with
section 6(a)(3)(B) of E.O. 12866. More can be found in Section IX 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 IX of this document, ``Regulatory
Analysis.''
D. Executive Order 14267: Reducing Anti-Competitive Regulatory Barriers
E.O. 14267 requires the NRC to identify anti-competitive
regulations for recission or modification. The NRC identified Sec.
20.1101 because of the burden imposed by the NRC's implementation of
the ALARA standard. The proposed modification of this and related
regulations supports the objectives of E.O. 14267 by modifying
regulatory requirements that could ``create unnecessary barriers to
entry for new market participants'' or ``limit competition between
competing entities or have the effect of limiting competition between
competing entities.''
E. Executive Order 14270: Zero-Based Regulatory Budgeting To Unleash
American Energy
E.O. 14270 requires the NRC to insert a conditional sunset date
into all new or amended NRC regulations provided the regulations are
(1) promulgated under the Atomic Energy Act of 1954, as amended (AEA),
the Energy Reorganization Act of 1974, as amended (ERA), and the
Nuclear Waste Policy Act of 1982, as amended (NWPA); (2) not
statutorily required; and (3) not part of the NRC's permitting regime.
The NRC determined that the regulatory changes proposed in this rule
are part of the NRC's permitting regime authorized by the AEA, ERA, or
NWPA. Therefore, the NRC views this rulemaking to be outside the scope
of E.O. 14270 and did not insert conditional sunset dates for the
regulatory changes in this proposed rule.
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 Atomic Energy Act of 1954, as amended (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 parts 19, 20, 34, 35, 40, 50, 53,
61, 71, and 72 under one or more of Sections 161b, 161i, or 161o of the
AEA, except as noted in Sec. Sec. 19.40(b), 20.2402(b), 34.123(b),
35.4002(b), 40.82(b), 50.111(b), 53.9010(b), 61.84(b), 71.100(b), and
72.86(b). The applicability of criminal penalties to regulations in
parts 19, 20, 34, 35, 40, 50, 53, 61, 71, and 72 is set forth in
Sec. Sec. 19.40, 20.2402, 34.123, 35.4002, 40.82, 50.111, 53.9010,
61.84, 71.100, and 72.86. Willful violations of the 10 CFR parts 19,
20, 34, 35, 40, 50, 53, 61, 71, and 72 regulations, other than those
listed in Sec. Sec. 19.40(b), 20.2402(b), 34.123(b), 35.4002(b),
40.82(b), 50.111(b), 53.9010(b), 61.84(b), 71.100(b), and 72.86(b)
(including as updated by this proposed rule), would be subject to
criminal enforcement.
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./web link/
Document Federal Register citation
------------------------------------------------------------------------
Rule Related Documents
------------------------------------------------------------------------
Draft Environmental Assessment for the ML26180A026.
Proposed Rule--Executive Order 14300:
Reforming and Modernizing the NRC's
Radiation Protection Framework, July
13, 2026.
Draft Regulatory Analysis for the ML26180A025.
Proposed Rule--Executive Order 14300:
Reforming and Modernizing the NRC's
Radiation Protection Framework, July
13, 2026.
Draft Supporting Statement for the ML25337A399.
Proposed Rule--Executive Order 14300:
Reforming and Modernizing the NRC's
Radiation Protection Framework, July
13, 2026.
Proposed Rule--Burden Table for ML26007A106.
Reforming and Modernizing the NRC's
Radiation Protection Framework, July
13, 2026.
Unofficial Redline for the Proposed ML26180A027.
Rule--Executive Order 14300: Reforming
and Modernizing the NRC's Radiation
Protection Framework, July 13, 2026.
------------------------------------------------------------------------
LNT/ALARA Related Documents
------------------------------------------------------------------------
Title 10--Atomic Energy, Chapter I-- 22 FR 549.
Atomic Energy Commission, Part 20--
``Standards for Protection Against
Radiation,'' January 29, 1957.
Title 40--Protection of Environment, 42 FR 2858.
Chapter I--Environmental Protection
Agency, Subchapter F--Radiation
Protection Programs, [FRL 659-6], Part
190--``Environmental Radiation
Protection Standards for Nuclear Power
Operations,'' January 13, 1977.
[[Page 43489]]
Proposed Rule, ``Standards for 51 FR 1092.
Protection Against Radiation;
Republication,'' January 9, 1986.
Proposed Rule and Notice of Public 54 FR 9612.
Hearing, ``National Emission Standards
for Hazardous Air Pollutants;
Regulation of Radionuclides,'' March 7,
1989.
Final Rule and Notice of 54 FR 51654.
Reconsideration, ``National Emission
Standards for Hazardous Air Pollutants;
Radionuclides,'' December 15, 1989.
Final Rule, ``Standards for Protection 56 FR 23360.
Against Radiation,'' May 21, 1991.
Executive Order 12866, ``Regulatory 58 FR 51735.
Planning and Review,'' October 4, 1993.
Final Rule, ``Resolution of Dual 61 FR 65120.
Regulation of Airborne Effluents of
Radioactive Materials; Clean Air Act,''
December 10, 1996.
Final Rule, ``Radiological Criteria for 62 FR 39058.
License Termination,'' July 21, 1997.
``Plain Language in Government 63 FR 31885.
Writing,'' June 10, 1998.
Final Rule, ``Respiratory Protection and 64 FR 54543.
Controls to Restrict Internal
Exposures,'' October 7, 1999.
Advanced Notice of Proposed Rulemaking, 79 FR 43284.
``Radiation Protection,'' July 25, 2014.
``Incorporation by Reference,'' November 79 FR 66267.
7, 2014.
Petition for Rulemaking; Notice of 80 FR 35870.
Docketing and Request for Comment,
``Linear No-Threshold Model and
Standards for Protection Against
Radiation,'' June 23, 2015.
``Rulemaking Activities Being 81 FR 95410.
Discontinued by the NRC,'' December 28,
2016.
``Agreement State Program Policy 82 FR 48535.
Statement,'' October 18, 2017.
``Linear No-Threshold Model and 86 FR 45923.
Standards for Protection Against
Radiation,'' August 17, 2021.
Executive Order 14154, ``Unleashing 90 FR 8353.
American Energy,'' January 29, 2025.
Executive Order 14156, ``Declaring a 90 FR 8433.
National Energy Emergency,'' 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 14300, ``Ordering the 90 FR 22587.
Reform of the Nuclear Regulatory
Commission,'' May 29, 2025.
Executive Order 14303, ``Restoring Gold 90 FR 22601.
Standard Science,'' May 29, 2025.
``2025 Draft List of Critical 90 FR 41591.
Minerals,'' August 26, 2025.
International Atomic Energy Agency https://www.iaea.org/
(IAEA) Nuclear Safety and Security publications/15236/iaea-
Glossary. nuclear-safety-and-security-
glossary#.
NUREG-0713, Volume 45, ``Occupational ML25191A324.
Radiation Exposure at Commercial
Nuclear Power Reactors and Other
Facilities,'' July 2025.
NUREG-1530, Revision 1, ``Reassessment ML22053A025.
of NRC's Dollar Per Person-Rem
Conversion Factor Policy,'' February
2022.
NUREG-1556, Vol 2, Rev. 1, ``Program- ML16062A091.
Specific Guidance About Industrial
Radiography Licenses,'' February 2016.
NUREG-1757, Vol 2, Rev. 2, ML22194A859.
``Consolidated Decommissioning
Guidance: Characterization, Survey, and
Determination of Radiological
Criteria,'' July 2022.
Regulatory Issue Summary (RIS) 2006-18, ML061940204.
``Requesting Exemption from the Public
Dose Limits for Certain Caregivers of
Hospital Patients,'' August 31, 2006.
SECY-01-0148, ``Processes for Revision ML011580363.
of 10 CFR Part 20 Regarding Adoption of
ICRP Recommendations on Occupational
Dose Limits and Dosimetric Models and
Parameters,'' August 2, 2001.
SECY-08-0197, ``Options to Revise ML091310193.
Radiation Protection Regulations and
Guidance with Respect to the 2007
Recommendations of the International
Commission on Radiological
Protection,'' December 18, 2008.
SECY-12-0064, ``Recommendations for ML121020108.
Policy and Technical Direction to
Revise Radiation Protection Regulations
and Guidance,'' April 25, 2012.
SECY-16-0009, ``Recommendations ML16028A189.
Resulting from the Integrated
Prioritization and Re-Baselining of
Agency Activities,'' January 31, 2016.
IAEA Nuclear Safety and Security https://www.iaea.org/
Glossary, ``Terminology Used in Nuclear publications/15236/iaea-
Safety, Nuclear Security, Radiation nuclear-safety-and-security-
Protection and Emergency Preparedness glossary.
and Response, 2022 (Interim) Edition.
Journal of the National Cancer Institute https://pmc.ncbi.nlm.nih.gov/
Monographs (JNCI) Monographs, Gilbert articles/PMC7355296/, https://
et al, ``Issues in Interpreting doi.org/10.1093/
Epidemiologic Studies of Populations jncimonographs/lgaa004.
Exposed to Low-Dose, High-Energy Photon
Radiation,'' July 13, 2020.
National Academies of Sciences, https://doi.org/10.17226/
Engineering, and Medicine, ``Health 11340.
Risks from Exposure to Low Levels of
Ionizing Radiation: BEIR VII Phase 2,''
2006.
------------------------------------------------------------------------
Documents Relating to Incorporation by Reference
------------------------------------------------------------------------
ICRP Publication Database............... https://www.icrp.org/.
[[Page 43490]]
ICRP Publication 1--ICRP, 1959. https://www.icrp.org/
Recommendations of the International publication.asp?id=ICRP%20Pub
Commission on Radiological Protection. lication%201.
Now known as ICRP Publication 1.
Pergamon Press, New York.
ICRP Publication 26--ICRP, 1977. https://www.icrp.org/
Recommendations of the ICRP. ICRP publication.asp?id=icrp%20pub
Publication 26. Ann. ICRP 1 (3). lication%2026.
ICRP Publication 30--ICRP, 1979. Limits https://www.icrp.org/
for Intakes of Radionuclides by publication.asp?id=ICRP%20Pub
Workers. ICRP Publication 30 (Part 1). lication%2030%20(Part%201).
Ann. ICRP 2 (3-4).
ICRP Publication 56--ICRP, 1990. Age- https://www.icrp.org/
dependent Doses to Members of the publication.asp?id=ICRP%20Pub
Public from Intake of Radionuclides-- lication%2056.
Part 1. ICRP Publication 56. Ann. ICRP
20 (2).
ICRP Publication 60--ICRP, 1991. 1990 https://www.icrp.org/
Recommendations of the International publication.asp?id=icrp%20pub
Commission on Radiological Protection. lication%2060.
ICRP Publication 60. Ann. ICRP 21 (1-3).
ICRP Publication 67--ICRP, 1993. Age- https://www.icrp.org/
dependent Doses to Members of the publication.asp?id=ICRP%20Pub
Public from Intake of Radionuclides-- lication%2067.
Part 2 Ingestion Dose Coefficients.
ICRP Publication 67. Ann. ICRP 23 (3-4).
ICRP Publication 68--ICRP, 1994. Dose https://www.icrp.org/
Coefficients for Intakes of publication.asp?id=ICRP%20Pub
Radionuclides by Workers. ICRP lication%2068.
Publication 68. Ann. ICRP 24 (4).
ICRP Publication 69--ICRP, 1995. Age- https://www.icrp.org/
dependent Doses to Members of the publication.asp?id=ICRP%20Pub
Public from Intake of Radionuclides-- lication%2069.
Part 3 Ingestion Dose Coefficients.
ICRP Publication 69. Ann. ICRP 25 (1).
ICRP Publication 71--ICRP, 1995. Age- https://www.icrp.org/
dependent Doses to Members of the publication.asp?id=ICRP%20Pub
Public from Intake of Radionuclides-- lication%2071.
Part 4 Inhalation Dose Coefficients.
ICRP Publication 71. Ann. ICRP 25 (3-4).
ICRP Publication 72--ICRP, 1995. Age- https://www.icrp.org/
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Person for the Purpose of the Radiation lication%20101a.
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Publication 101a. Ann. ICRP 36 (3).
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2007 Recommendations of the publication.asp?id=ICRP%20Pub
International Commission on lication%20103.
Radiological Protection. ICRP
Publication 103. Ann. ICRP 37 (2-4).
ICRP Publication 109--ICRP, 2009. https://www.icrp.org/
Application of the Commission's publication.asp?id=icrp%20pub
Recommendations for the Protection of lication%20109.
People in Emergency Exposure
Situations. ICRP Publication 109. Ann.
ICRP 39 (1).
ICRP Publication 116--ICRP, 2010. https://www.icrp.org/
Conversion Coefficients for publication.asp?id=icrp%20pub
Radiological Protection Quantities for lication%20116.
External Radiation Exposures. ICRP
Publication 116. Ann. ICRP 40(2-5).
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Statement on Tissue Reactions/Early and publication.asp?id=icrp%20pub
Late Effects of Radiation in Normal lication%20118.
Tissues and Organs--Threshold Doses for
Tissue Reactions in a Radiation
Protection Context. ICRP Publication
118. Ann. ICRP 41(\1/2\).
ICRP Publication 130--ICRP, 2015. https://www.icrp.org/
Occupational Intakes of Radionuclides: publication.asp?id=icrp%20pub
Part 1. ICRP Publication 130. Ann. ICRP lication%20130.
44(2).
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Occupational Intakes of Radionuclides: publication.asp?id=icrp%20pub
Part 2. ICRP Publication 134. Ann. ICRP lication%20134.
45(\3/4\), 1-352.
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Occupational Intakes of Radionuclides: publication.asp?id=icrp%20pub
Part 3. ICRP Publication 137. Ann. ICRP lication%20137.
46(\3/4\).
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Occupational Intakes of Radionuclides: publication.asp?id=icrp%20pub
Part 4. ICRP Publication 141. Ann. ICRP lication%20141.
48(\2/3\).
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Coefficients for External Exposures to publication.asp?id=icrp%20pub
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144. Ann. ICRP 49(2).
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Occupational Intakes of Radionuclides: publication.asp?id=icrp%20pub
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51(1-2).
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United States, 2018.
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Radiation Dose Limits for the Lens of commentaries/commentary-no-26-
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eye-2016/.
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Protection, 2018. epidemiologic-studies-for-the-
linear-nonthreshold-model-and-
radiation-protection-2018/.
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(GSR-3), ``Radiation Protection and lations%20RIDP/
Safety of Radiation Sources: GSR%20Part%203.pdf.
International Basic Safety Standards,''
October 23, 1956.
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Neutron Fluence-to-Dose Conversion nprm/.
Coefficients,'' September 10, 2020.
------------------------------------------------------------------------
Guidance Documents
------------------------------------------------------------------------
DG-8063 (draft Regulatory Guide 8.18, ML25294A723.
Rev. 3), ``Information Relevant to
Radiation Dose Management at Medical
Institutions,'' July 9, 2026.
[[Page 43491]]
DG-8064 (draft Regulatory Guide 8.37, ML25321A656.
Rev. 1), ``Effluent Release Program for
Materials Facilities,'' July 9, 2026.
DG-8067 (draft Regulatory Guide 8.31, ML26034C423.
Rev. 2), ``Information Relevant to the
Development of Radiation Protection
Programs at Uranium Recovery
Facilities,'' July 9, 2026.
------------------------------------------------------------------------
Additional References
------------------------------------------------------------------------
SECY-25-0031, ``Mission Statement ML25106A351.
Implementation Guidance,'' May 16, 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-2025-1140. 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-2025-1140); (2) click
the ``Subscribe'' link; and (3) enter an email address and click on the
``Subscribe'' link.
List of Subjects
10 CFR Part 19
Criminal penalties, Environmental protection, Nuclear Energy,
Nuclear materials, Nuclear power plants and reactors, Occupational
safety and health, Penalties, Radiation protection, Reporting and
recordkeeping requirements, Sex discrimination.
10 CFR Part 20
Byproduct material, Criminal penalties, Hazardous waste,
Incorporation by reference; Licensed material, Nuclear energy, Nuclear
materials, Nuclear power plants and reactors, Occupational safety and
health, Packaging and containers, Penalties, Radiation protection,
Reporting and recordkeeping requirements, Source material, Special
nuclear material, Waste manifest.
10 CFR Part 34
Criminal penalties, Incorporation by reference, Manpower training
programs, Occupational safety and health, Packaging and containers,
Penalties, Radiation protection, Radiography, Reporting and
recordkeeping requirements, Scientific equipment, Security measures, X-
rays.
10 CFR Part 35
Biologics, Byproduct material, Criminal penalties, Drugs, Health
facilities, Health professions, Labeling, Medical devices, Nuclear
energy, Nuclear materials, Occupational safety and health, Penalties,
Radiation protection, Reporting and recordkeeping requirements.
10 CFR Part 40
Criminal penalties, Exports, Government contracts, Hazardous
materials transportation, Hazardous waste, Nuclear energy, Nuclear
materials, Penalties, Reporting and recordkeeping requirements, Source
material, Uranium, Whistleblowing.
10 CFR Part 50
Administrative practice and procedure, Antitrust, Backfitting,
Classified information, Criminal penalties, Education, Emergency
planning, Fire prevention, Fire protection, Intergovernmental
relations, Nuclear power plants and reactors, Penalties, Radiation
protection, Reactor siting criteria, Reporting and recordkeeping
requirements, Whistleblowing.
10 CFR Part 53
Administrative practice and procedure, Antitrust, Backfitting,
Construction permit, Combined license, Classified information, Criminal
penalties, Early site permit, Emergency planning, Fees, Fire
prevention, Fire protection, Inspection, Intergovernmental relations,
Limited work authorization, Manufacturing license, Nuclear power plants
and reactors, Operating license, Penalties, Prototype, Radiation
protection, Reactor siting criteria, Reporting and recordkeeping
requirements, Standard design, Standard design certification, Training
programs.
10 CFR Part 61
Criminal penalties, Hazardous waste, Indians, Intergovernmental
relations, Low- level waste, Nuclear energy, Nuclear materials,
Penalties, Reporting and recordkeeping requirements, Waste treatment
and disposal, Whistleblowing. protection of the general population from
releases of radioactivity, Protection of individuals during operations.
10 CFR Part 71
Criminal penalties, Hazardous materials transportation,
Intergovernmental relations, Nuclear materials, Packaging and
containers, Penalties, Radioactive materials, Reporting and
recordkeeping requirements.
10 CFR Part 72
Administrative practice and procedure, Hazardous waste, Indians,
Intergovernmental relations, Nuclear energy, Penalties, Radiation
protection, Reporting and recordkeeping requirements, Security
measures, Spent fuel, Whistleblowing.
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 adopt the following amendments to 10 CFR parts 19, 20, 34, 35, 40,
50, 53, 61, 71, and 72:
PART 19--NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION
AND INVESTIGATIONS
0
1. The authority citation for part 19 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 53, 63, 81, 103,
104, 161, 223, 234, 1701 (42 U.S.C. 2073, 2093, 2111, 2133, 2134,
2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs.
201, 211, 401 (42 U.S.C. 5841, 5851, 5891); 44 U.S.C. 3504 note.
0
2. In Sec. 19.12, revise paragraphs (a) introductory text and (a)(2)
to read as follows:
Sec. 19.12 Instruction to workers.
(a) All individuals who in the course of employment are likely to
receive in a year an occupational dose in excess of the limit for
individual members of the public in Sec. 20.1301(a)(1) of this chapter
shall be--
(1) * * *
(2) Instructed in the health protection problems associated with
exposure to radiation and/or radioactive material, in precautions or
procedures to manage
[[Page 43492]]
dose, and in the purposes and functions of protective devices employed;
* * * * *
0
3. In Sec. 19.13, revise paragraph (b)(1) to read as follows:
Sec. 19.13 Notifications and reports to individuals.
* * * * *
(b) * * *
(1) The individual's occupational dose exceeds the limit for
individual members of the public in Sec. 20.1301(a)(1) of this
chapter; or
* * * * *
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
0
4. The authority citation for part 20 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 53, 63, 65, 81,
103, 104, 161,170H, 182, 186, 223, 234, 274, 1701 (42 U.S.C. 2014,
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2210h, 2232, 2236, 2273,
2282, 2021, 2297f); Energy Reorganization Act of 1974, secs. 201,
202 (42 U.S.C. 5841, 5842); Low-Level Radioactive Waste Policy
Amendments Act of 1985, sec. 2 (42 U.S.C. 2021b); 44 U.S.C. 3504
note.
0
5. In Sec. 20.1003,
(a) Revise the definitions of ``Airborne radioactivity area'',
``Annual limit on intake'', ``Committed dose equivalent'', ``Committed
effective dose equivalent'', ``Derived air concentration'', ``Dose or
radiation dose'', ``Dose equivalent'', ``Effective dose equivalent'',
``License'', ``Nonstochastic effect'', ``Quarter'', ``Stochastic
effects'', and ``Weighting factor'';
(b) Add, in alphabetical order, definitions for ``Committed
effective dose'', ``Committed equivalent dose'', ``Dosimetry method (or
system)'', ``Effective dose'', ``Equivalent dose'', ``Graded approach
to dose management'', ``Planned occupational dose limit extension'',
``Radiation weighting factor'', and ``Total Effective Dose''; and
(c) Remove the definition for the term ``ALARA''.
The additions and revisions read as follows:
Sec. 20.1003 Definitions.
* * * * *
Airborne radioactivity area means a room, enclosure, or area in
which airborne radioactive materials, composed wholly or partly of
licensed material, exist in concentrations--
(1) In excess of the derived air concentrations (DACs) specified in
appendix B, to Sec. Sec. 20.1001-20.2402, or as developed using
alternative dosimetry methods pursuant to Sec. 20.1010, or
(2) To such a degree that an individual present in the area without
respiratory protective equipment could exceed, during the hours an
individual is present in a week, an intake of 0.6 percent of the annual
limit on intake (ALI) or 12 DAC-hours.
* * * * *
Annual limit on intake (ALI) means the derived limit for the amount
of radioactive material taken into the body of an adult worker by
inhalation or ingestion in a year. ALI is the smaller value of intake
of a given radionuclide in a year by the reference man that would
result in a committed effective dose equivalent of 5 rems (0.05 Sv) or
a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ
or tissue. (ALI values for intake by ingestion and by inhalation of
selected radionuclides are given in table 1, columns 1 and 2, of
appendix B to Sec. Sec. 20.1001-20.2402; alternatively, licensees can
develop ALI values using alternative dosimetry methods pursuant to
Sec. 20.1010).
* * * * *
Committed dose equivalent (HT,Q,50) means the dose
equivalent to organs or tissues of reference (T) that will be received
from an intake of radioactive material by an individual during the 50-
year period following the intake.
* * * * *
Committed effective dose (Et) is the sum of the products
of the weighting factors applicable to each of the body organs or
tissues that are irradiated and the committed equivalent dose to these
organs or tissues (Et = [Sigma] wT
HT,t).
* * * * *
Committed effective dose equivalent (HE,50) is the sum
of the products of the weighting factors applicable to each of the body
organs or tissues that are irradiated and the committed dose equivalent
to these organs or tissues (HE,50 = [Sigma] wT
HT,Q,50).
* * * * *
Committed equivalent dose (HT,t) means the equivalent
dose to organs or tissues of reference (T) that will be received from
an intake of radioactive material by an individual during the years (t)
period following the intake. ``t'' is 50 years for adults and 70 years
for minors.
* * * * *
Derived air concentration (DAC) means the concentration of a given
radionuclide in air which, if breathed by the reference man for a
working year of 2,000 hours under conditions of light work (inhalation
rate 1.2 cubic meters of air per hour), results in an intake of one
ALI. DAC values are given in table 1, column 3, of appendix B to
Sec. Sec. 20.1001-20.2402; alternatively, licensees can develop DAC
values using alternative dosimetry methods pursuant to Sec. 20.1010.
* * * * *
Dose or radiation dose is a generic term that means absorbed dose,
dose equivalent, effective dose equivalent, committed dose equivalent,
committed effective dose equivalent, committed equivalent dose,
committed effective dose, total effective dose equivalent, effective
dose, or total effective dose, as defined in other paragraphs of this
section.
Dose equivalent (HT,Q) means the product of the absorbed
dose in tissue, quality factor, and all other necessary modifying
factors at the location of interest. The units of dose equivalent are
the rem and sievert (Sv).
Dosimetry method (or system) means an approach for calculating the
biological effects of ionizing radiation exposure in humans. The
approach provides a repeatable method of converting from fundamental
knowledge of radioactive decay to biological effects, typically through
modeling and a series of conversion and correction factors for types of
radiation emitted and interactions with tissues, organs, and the
environment.
* * * * *
Effective dose (E) is the sum of the products of the equivalent
dose (HT) to a tissue or organ and the tissue weighting
factor for that tissue or organ (wT). The sum is performed
over all the specified organs and tissues involved and includes
equivalent doses from external sources and equivalent doses (committed)
for intakes of radionuclides (E = [Sigma] wT HT).
Effective dose is applicable only to stochastic effects and the tissue
weighting factors were developed for a reference population of equal
numbers of both males and females and a wide range of ages.
Effective dose equivalent (HE) is the sum of the
products of the dose equivalent to the organ or tissue
(HT,Q) and the weighting factors (wT) applicable
to each of the body organs or tissues that are irradiated
(HE = [Sigma] wT HT,Q).
* * * * *
Equivalent dose (HT) is the product of the absorbed dose
averaged over a tissue or organ and the radiation weighting factor for
the radiation under consideration; therefore, it is an absorbed dose
that is weighted for the radiation quality of interest. The equivalent
dose term was introduced in International Commission on Radiological
Protection Publication 60
[[Page 43493]]
to differentiate dose equivalent, which depends on the quality factor
for weighting, from a new weighted absorbed dose value, which depends
on the radiation weighting factor (wR). The units of
equivalent dose are the rem and sievert (Sv).
* * * * *
Graded approach to dose management means an approach whereby
progressively increasing radiation protection measures are required as
prospective, or actual, radiation doses exceed determinate thresholds
to provide reasonable assurance that the applicable regulatory limit is
not exceeded.
* * * * *
License means a license issued under the regulations in parts 30
through 36, 39, 40, 50, 52, 53, 60, 61, 63, 70, or 72 of this chapter.
* * * * *
Nonstochastic effect (also called a deterministic effect or tissue
effect) means a health effect, the severity of which varies with the
dose and for which a threshold is believed to exist.
* * * * *
Planned occupational dose limit extension means a planned exposure
to radiation in addition to the annual occupational dose limits that
utilizes unused occupational dose allowances from previous years. Such
exposure must be limited so that the total occupational dose received
by the individual for the current year and the preceding four years
does not exceed limits prescribed in this part.
* * * * *
Quarter means a period of time equal to one-fourth of the year
observed by the licensee (approximately 13 consecutive weeks),
providing that the beginning of the first quarter in a year coincides
with the starting date of the year and that no day is omitted or
duplicated in consecutive quarters.
* * * * *
Radiation weighting factor (wR) is a modifying factor
that represents the type and energy of the radiation incident on the
body or, when sources are within the body, the type and energy emitted
by the source.
* * * * *
Stochastic effects means malignant disease and heritable effects
for which the probability of an effect occurring, but not its severity,
is regarded as a function of dose without threshold, for radiation
protection purposes.
* * * * *
Total Effective Dose (TED) means the sum of the effective dose (for
external exposures) and the committed effective dose (for internal
exposures). Values of TEDE and TED can be added (e.g., for the purpose
of long-term dose tracking) when using different dosimetry systems,
provided they are developed in accordance with dosimetry methods or
systems as defined in this part.
* * * * *
Weighting factor wT, for an organ or tissue (T) is the
proportion of the risk of stochastic effects resulting from irradiation
of that organ or tissue to the total risk of stochastic effects when
the whole body is irradiated uniformly. Licensees can obtain
wT values using alternative dosimetry methods pursuant to
Sec. 20.1010. For calculating the effective dose equivalent, the
values of wT are:
* * * * *
0
6. In Sec. 20.1004, add paragraphs (d) and (e) to read as follows:
Sec. 20.1004 Units of radiation dose.
* * * * *
(d) In cases where a licensee or applicant uses alternative
dosimetry methods pursuant to Sec. 20.1010, the applicable conversion
factors between absorbed dose and equivalent dose may be determined
using the standards in appendix H or methods approved through Sec.
20.1010(b).
(e) Dosimetric quantities that are determined using different
dosimetry methods can be added as follows--
(1) Values of equivalent dose and dose equivalent that are
determined using different dosimetry methods are additive provided that
the methods used in their determination are applied as intended.
(2) Values of total effective dose equivalent/effective dose
equivalent and total effective dose/effective dose that are determined
using different dosimetry methods are additive provided that the
methods used in their determination are applied as intended.
(3) Notwithstanding Sec. 20.1004(e)(1) and Sec. 20.1004(e)(2),
where a licensee or applicant uses weighting factors (i.e.,
wR or wT) that differ from those published by the
International Commission on Radiological Protection for a particular
dosimetry method, the resulting quantities are not additive to values
that are determined using International Commission on Radiological
Protection methods. In these cases, these resulting dosimetric
quantities are subject to the conditions, including those on
additivity, as specified in the corresponding NRC approval of that
dosimetry method.
0
7. Add Sec. 20.1010 to subpart A to read as follows:
Sec. 20.1010 Alternative dosimetry methods.
The regulations in this part are largely based on dosimetry methods
that implement the recommendations of International Commission on
Radiological Protection Publication 26 and supporting documents (e.g.,
International Commission on Radiological Protection Publication 30).
(a) A licensee or applicant may use alternative dosimetry methods,
including assumptions (e.g., aerosol size distribution, solubility
class, density, and chemical forms), dose conversion factors, and
tissue and radiation weighting factors, to demonstrate compliance with
the dose limits in subparts C and D, as well as other dose-based
requirements and criteria in this part, and to develop derived limits
such as ALIs and DACs. Unless otherwise approved by the NRC per
paragraph (b), alternative dosimetry methods must be consistent with
one or more of the standards incorporated by reference and listed in
appendix H to part 20.
(b) A licensee or applicant may apply for NRC authorization to use
an alternative dosimetry method not listed in appendix H to part 20.
The licensee or applicant shall include the following information in
this application--
(1) Justification that the proposed method is appropriate for, or
applicable to, the intended use;
(2) Description of the technical adequacy of the proposed method,
for example, as supported by peer-reviewed research or consensus-based
standards; and
(3) Demonstration that the proposed method provides transparency
regarding assumptions and uncertainties such that a knowledgeable third
party could apply the method and obtain results similar to those
obtained by the licensee or applicant.
0
8. In Sec. 20.1101, revise paragraphs (b) through (d) to read as
follows:
Sec. 20.1101 Radiation protection programs.
* * * * *
(b) The licensee shall use procedures, engineering controls, and a
graded approach to dose management based upon sound radiation
protection principles to maintain occupational doses and doses to
members of the public within the limits specified in this part.
(c) The licensee shall periodically review the radiation protection
program content and implementation.
(d) Notwithstanding the requirements in Sec. 20.1301 of this part,
a constraint on air emissions of radioactive material to the
environment, excluding Radon-222 and its daughters, shall be
established by licensees other than those subject to
[[Page 43494]]
Sec. 50.34a or Sec. 53.260 of this chapter, such that the individual
member of the public likely to receive the highest dose will not be
expected to receive a total effective dose equivalent in excess of 25
mrem (0.25 mSv) per year from these emissions. If a licensee subject to
this requirement exceeds this dose constraint, the licensee shall
report the exceedance as provided in Sec. 20.2203 and promptly take
appropriate corrective action to ensure against recurrence. A licensee
or applicant may request prior NRC authorization to establish a higher
constraint, provided that the proposed constraint provides an ample
margin of safety to protect public health.
0
9. Revise and republish Sec. 20.1201(a) through (d) to read as
follows:
Sec. 20.1201 Occupational dose limits for adults.
(a) The licensee shall control the occupational dose to individual
adults, except for planned occupational dose limit extensions under
Sec. 20.1205 and planned special exposures under Sec. 20.1206, to the
following dose limits.
(1) An annual limit, which is the more limiting of--
(i) The total effective dose equivalent being equal to 5 rems (0.05
Sv); or
(ii) The sum of the deep-dose equivalent and the committed dose
equivalent to any individual organ or tissue other than the lens of the
eye being equal to 50 rems (0.5 Sv).
(2) The annual limits to the lens of the eye, to the skin of the
whole body, and to the skin of the extremities, which are:
(i) A lens dose equivalent of 15 rems (0.15 Sv), and
(ii) A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of
the whole body or to the skin of any extremity.
(b) Doses received in excess of the annual limits, with the
exception of doses received under Sec. 20.1205, including doses
received during accidents, emergencies, and planned special exposures,
must be subtracted from the limits for planned special exposures that
the individual may receive during the current year (see Sec.
20.1206(e)(1)) and during the individual's lifetime (see Sec.
20.1206(e)(2)).
(c) When the external exposure is determined by measurement with an
external personal monitoring device, the deep-dose equivalent must be
used in place of the effective dose equivalent, unless the effective
dose equivalent is determined by a dosimetry method approved by the NRC
or by an alternative dosimetry method pursuant to Sec. 20.1010. The
assigned deep-dose equivalent must be for the part of the body
receiving the highest exposure. The assigned shallow-dose equivalent
must be the dose averaged over the contiguous 10 square centimeters of
skin receiving the highest exposure. The deep-dose equivalent, lens-
dose equivalent, and shallow-dose equivalent may be assessed from
surveys or other radiation measurements for the purpose of
demonstrating compliance with the occupational dose limits, if the
individual monitoring device was not in the region of highest potential
exposure, or the results of individual monitoring are unavailable.
(d) Derived air concentration (DAC) and annual limit on intake
(ALI) values are presented in table 1 of appendix B to part 20 and may
be used to determine the individual's dose (see Sec. 20.2106) and to
demonstrate compliance with the occupational dose limits.
Alternatively, the licensee may use alternative dosimetry methods to
demonstrate compliance with the occupational dose limits (see Sec.
20.1010).
* * * * *
0
10. In Sec. 20.1202, revise footnote 1 to read as follows:
Sec. 20.1202 Compliance with requirements for summation of external
and internal doses.
* * * * *
\[1]\ An organ or tissue is deemed to be significantly
irradiated if, for that organ or tissue, the product of the
weighting factor, wT, and the committed dose equivalent,
HT,Q,50, per unit intake is greater than 10 percent of
the maximum weighted value of HT,Q,50, (i.e.,
wT HT,Q,50) per unit intake for any organ or
tissue.
0
11. In Sec. 20.1204, revise paragraphs (c)(2) and (3), (e)(1), and
(h)(2), to read as follows:
Sec. 20.1204 Determination of internal exposure.
* * * * *
(c) * * *
(2) Upon prior approval of the Commission or consistent with the
use of alternative dosimetry methods to demonstrate compliance with
dose limits as allowed by Sec. 20.1010, adjust the DAC or ALI values
to reflect the actual physical and chemical characteristics of airborne
radioactive material (e.g., aerosol size distribution or density); and
(3) If applicable, separately assess the contribution of fractional
intakes of different solubility classes (e.g., Class D, W, or Y
compounds of a given radionuclide (see appendix B to part 20)) to the
committed effective dose equivalent.
* * * * *
(e) * * *
(1) The sum of the ratios of the concentration to the appropriate
DAC value (e.g., D, W, Y) from appendix B to part 20, or as determined
using an alternative dosimetry method as allowed by Sec. 20.1010, for
each radionuclide in the mixture; or
* * * * *
(h) * * *
(2) When the ALI (and the associated DAC) is determined by the
nonstochastic organ dose limit of 50 rem (0.5 Sv), the licensee may, as
a simplifying assumption, use the stochastic ALIs to determine
committed effective dose equivalent. However, if the licensee uses the
stochastic ALIs, the licensee must also demonstrate that the limit in
Sec. 20.1201(a)(1)(ii) is met. Table 1 of appendix B to part 20 lists
stochastic ALIs, even when the limiting ALI and DAC is governed by the
nonstochastic organ dose limit of 50 rem (0.5 Sv). In cases where a
licensee is using an alternative dosimetry method pursuant to Sec.
20.1010, that licensee can develop the stochastic ALI to use for the
purposes of this paragraph.
0
12. Add section Sec. 20.1205 to subpart C to read as follows:
Sec. 20.1205 Planned occupational dose limit extension.
A licensee may authorize a worker that is not a declared pregnant
woman or a minor to receive occupational doses in excess of the limits
specified in Sec. 20.1201 provided that each of the following
conditions is satisfied--
(a) The licensee (and employer if the employer is not the licensee)
authorizes the planned occupational dose limit extension, in writing,
before the dose limit specified in Sec. 20.1201 is exceeded.
(b) Before a planned occupational dose limit extension, the
licensee ensures that the individuals involved are--
(1) Informed of the purpose of the planned operation;
(2) Informed of the estimated doses and associated potential risks
and estimated radiation levels or other conditions that might be
involved in performing the task; and
(3) Instructed in the measures to be taken to manage doses
considering other risks that may be present.
(c) Prior to permitting an individual to participate in a planned
occupational dose limit extension, the licensee ascertains prior
occupational doses as required by Sec. 20.2104(b) during the current
year and the preceding four years for each individual involved.
(d) The licensee does not authorize a planned occupational dose
limit extension that would cause an
[[Page 43495]]
individual to receive a dose from all occupational exposures in excess
of--
(1) Five times the numerical limits in Sec. 20.1201(a)(1) and
Sec. 20.1201(a)(2)(ii) over the current year and the preceding four
years;
(2) Twice the numerical limits in Sec. 20.1201(a)(1) and Sec.
20.1201(a)(2)(ii) in any one year; and
(3) A lens dose equivalent of 15 rem (0.15 Sv) in any one year.
(e) The licensee maintains records of the conduct of a planned
occupational dose limit extension in accordance with Sec. 20.2105.
(f) The dose from planned occupational dose limit extensions is not
to be considered in controlling future occupational dose of the
individual under Sec. 20.1201(a) but is to be included in evaluations
required by Sec. Sec. 20.1205 (c) and (d) and 20.1206 (d) and (e).
0
13. In Sec. 20.1206, revise paragraph (c)(3) to read as follows:
Sec. 20.1206 Planned special exposures.
* * * * *
(c) * * *
(3) Instructed in the measures to be taken to manage doses
considering other risks that may be present.
* * * * *
0
14. In Sec. 20.1301, revise paragraph (a)(1), remove and reserve
paragraph (a)(2), and revise paragraphs (b) through (d) to read as
follows:
Sec. 20.1301 Dose limits for individual members of the public.
(a) * * *
(1) The total effective dose equivalent to individual members of
the public from the licensed operation, or any other source of
radiation under the control of a licensee, does not exceed 0.1 rem (1
mSv) in a year, exclusive of the dose contributions from background
radiation, from any medical administration the individual has received,
from exposure to individuals administered radioactive material and
released under Sec. 35.75, from voluntary participation in medical
research programs, and from the licensee's disposal of radioactive
material into sanitary sewerage in accordance with Sec. 20.2003.
(2) [Reserved]
(b) If the licensee permits members of the public to have access to
controlled areas, the limits for members of the public continue to
apply to those individuals. Alternatively, a licensee or applicant may
request prior NRC authorization for an annual dose limit in excess of
0.1 rem (1 mSv) for members of the public who have access to controlled
areas, provided that dose is appropriately managed.
(c) Notwithstanding paragraph (a)(1) of this section, a licensee
may permit members of the public to visit an individual who cannot be
released, under Sec. 35.75, to receive a radiation dose in excess of
0.1 rem (1 mSv) if--
(1) The radiation dose received is not likely to exceed either--
(i) 0.5 rem (5 mSv) for a member of the public who is not a
caregiver per administration regimen; or
(ii) 2 rem (20 mSv) for a caregiver, as defined in 10 CFR part 35,
per administration regimen; and
(2) The authorized user, as defined in 10 CFR part 35, has
determined before the visit that it is appropriate.
(d) A licensee or applicant may apply for prior NRC authorization
to operate with an annual dose limit for an individual member of the
public in excess of 0.1 rem (1 mSv). The licensee or applicant shall
include the following information in this application:
(1) Demonstration of the need for and the expected duration of
operations in excess of the limit in paragraph (a) of this section;
(2) Description of the licensee's program to assess and control
dose within the proposed dose limit for an individual member of the
public; and
(3) The proposed dose limit for an individual member of the public
and its supporting basis, including why it remains protective of the
public health and safety.
* * * * *
0
15. In Sec. 20.1302, revise paragraph (b)(2) and remove and reserve
paragraph (c) to read as follows:
Sec. 20.1302 Compliance with dose limits for individual members of
the public.
* * * * *
(b) * * *
(1) * * *
(2) Demonstrating that--
(i) The annual average concentrations of radioactive material
released in gaseous and liquid effluents at the boundary of the
unrestricted area do not exceed the values specified in table 2 of
appendix B to part 20 or as developed using alternative dosimetry
methods pursuant to Sec. 20.1010; and
(ii) If an individual were continuously present in an unrestricted
area, the dose from external sources would not exceed 0.05 rem (0.5
mSv) in a year.
(c) [Reserved]
0
16. Revise Sec. 20.1402 to read as follows:
Sec. 20.1402 Radiological criteria for unrestricted use.
A site will be considered acceptable for unrestricted use if the
residual radioactivity that is distinguishable from background
radiation results in a TEDE to the average member of the critical group
that does not exceed 25 mrem (0.25 mSv) per year, including that from
groundwater sources of drinking water, and, consistent with Sec.
20.1406(c), the residual radioactivity has been reduced to levels where
further reductions would not be justified when considering any
detriments, such as traffic accidents, expected to potentially result
from decontamination and waste disposal.
0
17. In Sec. 20.1403, revise paragraph (a) and revise and republish
paragraph (e) to read as follows:
Sec. 20.1403 Criteria for license termination under restricted
conditions.
* * * * *
(a) The licensee can demonstrate that further reductions in
residual radioactivity necessary to comply with the provisions of Sec.
20.1402 would not be justified when considering any detriments, such as
traffic accidents, expected to potentially result from decontamination
and waste disposal; would result in net public or environmental harm;
or would not be justified through a cost-benefit analysis;
* * * * *
(e) Residual radioactivity at the site has been reduced so that if
the institutional controls were no longer in effect, there is
reasonable assurance that the TEDE from residual radioactivity
distinguishable from background to the average member of the critical
group would not exceed either--
(1) 100 mrem (1 mSv) per year provided that the licensee--
Demonstrates that further reductions in residual radioactivity
would not be justified when considering any detriments, such as traffic
accidents, expected to potentially result from decontamination and
waste disposal; or
(2) 500 mrem (5 mSv) per year provided that the licensee--
(i) Demonstrates that further reductions in residual radioactivity
necessary to comply with the 100 mrem/y (1 mSv/y) value of paragraph
(e)(1) of this section are not technically achievable, would be
prohibitively expensive, or would result in net public or environmental
harm;
(ii) Makes provisions for durable institutional controls;
(iii) Provides sufficient financial assurance to enable a
responsible government entity or independent third party, including a
governmental custodian of a site, both to carry out periodic rechecks
of the site no less frequently than every 5 years to assure that the
institutional controls remain in place as necessary to meet the
criteria of
[[Page 43496]]
Sec. 20.1403(b) and to assume and carry out responsibilities for any
necessary control and maintenance of those controls. Acceptable
financial assurance mechanisms are those in paragraph (c) of this
section.
0
18. In Sec. 20.1404, revise and republish paragraphs (a)(1) through
(a)(4) to read as follows:
Sec. 20.1404 Alternate criteria for license termination.
(a) * * *
(1) Provides assurance that public health and safety would continue
to be protected by submitting an analysis demonstrating that it is
unlikely that the dose from all man-made sources combined, other than
medical, would be more than 100 mrem/y (1 mSv/y);
(2) Has employed to the extent practical restrictions on site use
according to the provisions of Sec. 20.1403 in minimizing exposures at
the site;
(3) Demonstrates that further reductions in residual radioactivity
would not be justified when considering any detriments, such as traffic
accidents, expected to potentially result from decontamination and
waste disposal;
(4) Has submitted a decommissioning plan or License Termination
Plan (LTP) to the Commission indicating the licensee's intent to
decommission in accordance with Sec. Sec. 30.36(d), 40.42(d), 50.82(a)
and (b), subpart G of part 53, 70.38(d), or 72.54 of this chapter, and
specifying that the licensee proposes to decommission by use of
alternate criteria. The licensee shall document in the decommissioning
plan or LTP how the advice of individuals and institutions in the
community who may be affected by the decommissioning has been sought
and addressed, as appropriate, following analysis of that advice. In
seeking such advice, the licensee shall provide for:
(i) Participation by representatives of a broad cross section of
community interests who may be affected by the decommissioning;
(ii) An opportunity for a comprehensive, collective discussion on
the issues by the participants represented; and
(iii) A publicly available summary of the results of all such
discussions, including a description of the individual viewpoints of
the participants on the issues and the extent of agreement and
disagreement on the issues; and
* * * * *
0
19. In Sec. 20.1405, revise paragraph (b) to read as follows:
Sec. 20.1405 Public notification and public participation.
* * * * *
(b) Publish a notice in the Federal Register and in a forum, such
as local newspapers, letters to State or local organizations, or other
appropriate forum, that is readily accessible to individuals in the
vicinity of the site, and solicit comments from affected parties.
0
20. In Sec. 20.1502, revise introductory text and paragraphs (a)(4)
and (b)(1) to read as follows:
Sec. 20.1502 Conditions requiring individual monitoring of external
and internal occupational dose.
Each licensee shall monitor exposures to radiation and radioactive
material at levels sufficient to demonstrate compliance with the
occupational dose limits of this part.
(a) * * *
(4) Individuals entering a high or very high radiation area. These
individuals shall be monitored for external occupational dose, unless
any of the conditions of Sec. 20.1502(b) apply, in which case they
shall be monitored for both external and internal occupational dose.
(b) * * *
(1) Adults likely to receive, in 1 year, an intake in excess of 10
percent of the applicable ALI(s) in table 1, columns 1 and 2, of
appendix B to Sec. Sec. 20.1001-20.2402 or as developed using
alternative dosimetry methods pursuant to Sec. 20.1010;
* * * * *
Sec. 20.1601 [Amended]
0
21. In Sec. 20.1601(f), remove the text ``ALARA''.
0
22. Revise and republish Sec. 20.1702 to read as follows:
Sec. 20.1702 Use of other controls.
(a) When it is not practical to apply process or other engineering
controls to control the concentrations of radioactive material in the
air to values below those that define an airborne radioactivity area,
the licensee shall increase monitoring and limit intakes by one or more
of the following means--
(1) Control of access;
(2) Limitation of exposure times;
(3) Use of respiratory protection equipment; or
(4) Other controls.
(b) If the licensee performs an analysis to determine whether or
not respirators should be used, the licensee may consider safety
factors other than radiological factors. The licensee should also
consider the impact of respirator use on workers' industrial health and
safety.
0
23. In Sec. 20.1703, revise paragraph (b) to read as follows:
Sec. 20.1703 Use of individual respiratory protection equipment.
* * * * *
(b) If the licensee wishes to use equipment that has not been
tested or certified by NIOSH, or for which there is no schedule for
testing or certification, the licensee shall submit an application to
the NRC for authorized use of this equipment except as provided in this
part. The application must include evidence that the material and
performance characteristics of the equipment are capable of providing
the proposed degree of protection under anticipated conditions of use.
This must be demonstrated either by licensee testing or on the basis of
reliable test information. The use of equipment that has not been
tested or certified by NIOSH, but has previously been approved for use
by the NRC, does not require an application and its approval as
described in this paragraph, provided that the licensee maintains an
evaluation to demonstrate that the bases for the previous NRC
approval--as documented in the applicable safety evaluation--are
applicable to the licensee's facility.
* * * * *
Sec. 20.1704 [Amended]
0
24. In Sec. 20.1704(a), remove the text ``ALARA'' and add in its
place, ``within the requirements of this part''.
0
25. In Sec. 20.1705, add paragraph (c) to read as follows:
Sec. 20.1705 Application for use of higher assigned protection
factors.
* * * * *
(c) The use of higher assigned protection factors that have
previously been approved for use by the Commission does not require an
application and its approval as described in this section, provided
that the licensee maintains an evaluation to demonstrate that the bases
for the previous Commission approval--as documented in the applicable
safety evaluation--are applicable to the licensee's facility.
0
26. In Sec. 20.1905, revise paragraph (b) to read as follows:
Sec. 20.1905 Exemptions to labeling requirements.
* * * * *
(b) Containers holding licensed material in concentrations less
than those specified in table 3 of appendix B to part 20 or
concentrations derived using alternative dosimetry methods pursuant to
Sec. 20.1010; or
* * * * *
[[Page 43497]]
Sec. 20.2002 [Amended]
0
27. In Sec. 20.2002(d), remove the text ``ALARA and''.
0
28. In Sec. 20.2003, revise paragraphs (a)(2) and (a)(3)(i) to read as
follows:
Sec. 20.2003 Disposal by release into sanitary sewerage.
(a) * * *
(1) * * *
(2) The quantity of licensed or other radioactive material that the
licensee releases into the sewer in 1 month divided by the average
monthly volume of water released into the sewer by the licensee does
not exceed the concentration listed in table 3 of appendix B to part 20
or concentrations derived using alternative dosimetry methods pursuant
to Sec. 20.1010; and
(3) * * *
(i) The licensee shall determine the fraction of the limiting
concentration in table 3 of appendix B to part 20, or the limiting
concentrations derived using alternative dosimetry methods pursuant to
Sec. 20.1010, represented by discharges into sanitary sewerage by
dividing the actual monthly average concentration of each radionuclide
released by the licensee into the sewer by the applicable limiting
concentration; and
* * * * *
Sec. 20.2004 [Amended]
0
29. In Sec. 20.2004, remove from the first sentence in paragraph
(b)(1) the text ``the requirements of appendix I to part 50 of this
chapter and''.
Sec. 20.2101 [Amended]
0
30. In Sec. 20.2101, remove from paragraph (c) the text ``Not
withstanding'' and replace with ``Notwithstanding''.
0
31. In Sec. 20.2104, revise paragraphs (b) and (e)(2) to read as
follows:
Sec. 20.2104 Determination of prior occupational dose.
* * * * *
(b) Prior to permitting an individual to participate in a planned
occupational dose limit extension or a planned special exposure, the
licensee shall determine--
(1) For a planned occupational dose limit extension--
(i) Prior occupational doses during the current year and the
preceding four years that correspond to the applicable limits in Sec.
20.1205(d) for each individual involved.
(2) For a planned special exposure--
(i) The internal and external doses from all previous planned
special exposures; and
(ii) All doses in excess of the limits (including doses received
during accidents and emergencies) received during the lifetime of the
individual.
* * * * *
(e) * * *
(2) That the individual is not available for planned occupational
dose limit extensions, if records for the current year and the
preceding four years are not complete, and planned special exposures.
* * * * *
0
32. In Sec. 20.2105:
0
a. Revise the section heading and paragraphs (a)(5) and (6);
0
b. Redesignate paragraph (b) as paragraph (c); and
0
c. Add a new paragraph (b).
The revisions and addition read as follows:
Sec. 20.2105 Records of planned occupational dose limit extensions
and planned special exposures.
(a) * * *
(1) * * *
(5) How doses were managed; and
(6) The doses received by individuals involved in the planned
special exposure.
(b) For each use of the provisions of Sec. 20.1205 for planned
occupational dose limit extensions, the licensee shall maintain records
that describe the circumstances requiring the extension of occupational
dose limits, how doses were managed, and the doses received by
individuals involved in the planned occupational dose limit extension.
0
33. In Sec. 20.2106, revise paragraph (a) introductory text and
paragraphs (a)(5) through (7) to read as follows:
Sec. 20.2106 Records of individual monitoring results.
(a) Recordkeeping requirement. Each licensee shall maintain records
of doses received by individuals for whom monitoring was required
pursuant to Sec. 20.1502 and records of doses received during planned
occupational dose limit extensions, planned special exposures,
accidents, and emergency conditions. These records \[5]\ must include,
when applicable--
(1) * * *
(5) The total effective dose equivalent when required by Sec.
20.1202;
(6) The total of the deep-dose equivalent and the committed dose to
the organ receiving the highest total dose; and
(7) In cases where monitoring was required pursuant to Sec.
20.1502, but the dose received did not exceed 10 percent of the
applicable monitoring criteria, the licensee may, instead of recording
the numerical value of the dose received, annotate that an occupational
dose was received but did not exceed the criteria for recording.
* * * * *
\[5]\ Assessments of dose equivalent and records made using
units in effect before the licensee's adoption of this part need not
be changed.
0
34. In Sec. 20.2107, add paragraphs (c) and (d) to read as follows:
Sec. 20.2107 Records of dose to individual members of the public.
* * * * *
(c) The licensee shall retain a record of the justification for the
dose received by a caregiver as described in Sec. 20.1301(c)(1)(ii).
(d) The licensee shall retain the records required by paragraph (c)
of this section for 3 years after the final date of the allowed
exposure.
0
35. In Sec. 20.2202, revise paragraph (e) to read as follows:
Sec. 20.2202 Notification of incidents.
* * * * *
(e) The provisions of this section do not include doses that result
from planned occupational dose limit extensions or from planned special
exposures that are within the limits for planned special exposures, and
that are reported under Sec. 20.2204.
0
36. In Sec. 20.2203:
0
a. revise and republish paragraph (a)(2) and
0
b. remove the text ``ALARA'' from paragraph (b)(iv).
The revision reads as follows:
Sec. 20.2203 Reports of exposures, radiation levels, and
concentrations of radioactive material exceeding the constraints or
limits.
(a) * * *
(1) * * *
(2) Doses in excess of any of the following:
(i) The occupational dose limits for adults in Sec. 20.1201 unless
they are exceeded pursuant to Sec. 20.1205 or Sec. 20.1206; except
that reporting of unplanned exceedances of the limit in
20.1201(a)(1)(i) is required only if the total effective dose
equivalent for the current year and the preceding four years exceeds 25
rem; or
(ii) The occupational dose limits for a minor in Sec. 20.1207; or
(iii) The limits for an embryo/fetus of a declared pregnant woman
in Sec. 20.1208; or
(iv) The limits for an individual member of the public in Sec.
20.1301, except that reporting of exceedances of the limit in Sec.
20.1301(a) is required only if the total dose to a single individual
for the current year and the preceding four years exceeds 500 mrem; or
(v) Any applicable limit in the license; or
[[Page 43498]]
(vi) The constraints for air emissions established under Sec.
20.1101(d); or
(vii) The applicable dose limit for a planned occupational dose
limit extension in Sec. 20.1205(c); or
(viii) The applicable dose limit for a planned special exposure in
Sec. 20.1206(e); or
* * * * *
0
37. In appendix G to 10 CFR part 20:
0
a. Revise and republish the introductory paragraphs to Section I; add a
definition for ``Carrier''; remove the definition for ``Computer
readable medium''; and revise the definitions for ``EPA identification
number'', ``High integrity container'', ``NRC Forms 540, 540A, 541,
541A, 542, and 542A'', ``Shipping paper'', and ``Uniform Low-Level
Radioactive Waste Manifest or uniform manifest'';
0
b. Revise paragraph III.A.6, paragraph III.B.4, paragraph III.C.7, and
paragraph III.D.2.; and
0
c. Amend paragraph III.E.1. to remove the text ``or receipt'' and add,
in its place, ``of receipt''.
The revisions read as follows:
Appendix G to Part 20--Requirements for Transfers of Low-Level
Radioactive Waste Intended for Disposal at Licensed Land Disposal
Facilities and Manifests
I. Manifest
A waste generator, collector, or processor who transports, or
offers for transportation, low-level radioactive waste intended for
ultimate disposal at a licensed low-level radioactive waste land
disposal facility must prepare a Manifest (OMB Control Numbers 3150-
0164,-0165, and-0166) reflecting information requested on applicable
NRC Forms 540 (Uniform Low-Level Radioactive Waste Manifest
(Shipping Paper)) and 541 (Uniform Low-Level Radioactive Waste
Manifest (Container and Waste Description)) and, if necessary, on an
applicable NRC Form 542 (Uniform Low-Level Radioactive Waste
Manifest (Manifest Index and Regional Compact Tabulation)). The
Manifest does not need to use these NRC Forms themselves as long as
the Manifest reflects the information requested on the applicable
NRC Forms. References to NRC Forms 540, 540A, 541, 541A, 542, and
542A in this appendix refer to either the NRC Form(s) or any other
document(s) reflecting the information requested on the NRC Form(s)
(e.g., licensee-generated versions of the NRC Forms).
Upon agreement between shipper and consignee, NRC Forms 540 and
540A, 541 and 541A, and 542 and 542A may be completed, signed,
transmitted, and stored in electronic media with the capability for
producing legible, accurate, and complete records on the respective
forms. NRC Forms 540 and 540A must be transmitted to the carrier in
accordance with regulations of the Department of Transportation
(DOT).
Licensees are not required by NRC to comply with the manifesting
requirements of this part when they ship:
(a) LLW for processing and expect its return (i.e., for storage
under their license) prior to disposal at a licensed land disposal
facility;
(b) LLW that is being returned to the licensee who is the
``waste generator'' or ``generator,'' as defined in this part; or
(c) Radioactively contaminated material to a ``waste processor''
that becomes the processor's ``residual waste.''
For guidance in completing these forms, refer to the
instructions that accompany the forms. Copies of manifests required
by this appendix may be legible carbon copies, photocopies, computer
printouts, or electronic copies that reproduce the data of the
uniform manifest.
NRC Forms 540, 540A, 541, 541A, 542 and 542A, and the
accompanying instructions, in hard copy, may be obtained by writing
or calling the Office of the Chief Information Officer, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301)
415-5877, or by visiting the NRC's website at http://www.nrc.gov and
selecting forms from the index found on the home page.
This appendix includes information requirements of the DOT, as
codified in 49 CFR parts 172, 174, 175, 176, and 177. Information on
hazardous, medical, or other waste, required to meet Environmental
Protection Agency (EPA) regulations, as codified in 40 CFR parts
259, 261, or elsewhere, is not addressed in this section. However,
any forms required by the EPA must accompany the Uniform Low-Level
Radioactive Waste Manifest required by this chapter.
As used in this appendix, the following definitions apply:
Carrier means a person who transports passengers or property in
commerce by rail car, aircraft, motor vehicle, or vessel.
* * * * *
EPA identification number means the number received by a carrier
following application to the Administrator of EPA as required by 40
CFR part 263.
* * * * *
High integrity container (HIC) means a container commonly
designed to meet the structural stability requirements of Sec.
61.56 of this chapter, and to meet DOT requirements for a Type A
package.
* * * * *
NRC Forms 540, 540A, 541, 541A, 542, and 542A mean either the
NRC Form(s) or any other document(s) reflecting the information
requested on the NRC Form(s) (e.g., licensee-generated or Agreement
State-generated versions of the NRC Forms).
* * * * *
Shipping paper means NRC Form 540 and, if required, NRC Form
540A which includes the information required by DOT regulations.
* * * * *
Uniform Low-Level Radioactive Waste Manifest or uniform manifest
means the combination of NRC Forms 540, 541, and, if necessary, 542,
and their respective continuation sheets as needed.
* * * * *
III. Control and Tracking
A. * * *
6. If required by regulations of the DOT, physically include NRC
Form 540 (and NRC Form 540A, if required) with the shipment
regardless of the option chosen in paragraph A.5 of this section;
* * * * *
B. * * *
4. If required by regulations of the DOT, physically include NRC
Form 540 (and NRC Form 540A, if required) with the shipment
regardless of the option chosen in paragraph B.3 of this section;
* * * * *
C. * * *
7. If required by regulations of the DOT, physically include NRC
Form 540 (and NRC Form 540A, if required) with the shipment
regardless of the option chosen in paragraph C.6 of this section;
* * * * *
D. * * *
2. Maintain copies of or electronically store all completed
manifests and electronically store the information required by 10
CFR 61.80(l) until the Commission terminates the license; and
* * * * *
0
38. Add new appendix H to part 20 to read as follows:
Appendix H to Part 20--Alternative Dosimetry Methods Acceptable for Use
To Demonstrate Compliance With NRC's Standards for Protection Against
Radiation
(a) Material incorporated by reference. The material listed in
this appendix for developing alternative dosimetry methods is
incorporated by reference into Sec. 20.1010 with the approval of
the Director of the Office of the Federal Register under 5 U.S.C.
552(a) 1 CFR part 51. All approved material is available for
inspection at the Nuclear Regulatory Commission (NRC) and at the
National Archives Records Administration (NARA). Contact the NRC at
NRC Technical Library, Two White Flint North, 11545 Rockville Pike,
Rockville, Maryland 20852; telephone: 301-415-7000; email:
[email protected]. For information on the availability of
this material at NARA, visit https://www.archives.gov/federal-register/cfr/ibr-locations.html or email [email protected]. The
material may also be obtained from the following sources:
(1) American National Standards Institute/American Nuclear
Society (ANSI/ANS), ATTN Standards, 555 N Kensington Avenue, La
Grange Park, IL 60526; https://webstore.ansi.org/.
(i) ANSI/ANS-6.1.1-2020, ``Photon and Neutron Fluence-to-Dose
Conversion Coefficients.'' IBR approved for Sec. 20.1010(a).
(ii) Reserved
(2) International Commission on Radiological Protection (ICRP),
350 Albert Street Suite 410, Ottawa, Ontario, K1R 1A4, Canada;
https://www.icrp.org/index.asp.
[[Page 43499]]
(i) ICRP Publication 56--ICRP, 1990. ``Age-dependent Doses to
Members of the Public from Intake of Radionuclides--Part 1.'' ICRP
Publication 56. Ann. ICRP 20 (2). IBR approved for Sec. 20.1010(a).
(ii) ICRP Publication 67--ICRP, 1993. ``Age-dependent Doses to
Members of the Public from Intake of Radionuclides--Part 2 Ingestion
Dose Coefficients.'' ICRP Publication 67. Ann. ICRP 23 (3-4). IBR
approved for Sec. 20.1010(a).
(iii) ICRP Publication 68--ICRP, 1994. ``Dose Coefficients for
Intakes of Radionuclides by Workers.'' ICRP Publication 68. Ann.
ICRP 24 (4). IBR approved for Sec. 20.1010(a).
(iv) ICRP Publication 69--ICRP, 1995. ``Age-dependent Doses to
Members of the Public from Intake of Radionuclides--Part 3 Ingestion
Dose Coefficients.'' ICRP Publication 69. Ann. ICRP 25 (1). IBR
approved for Sec. 20.1010(a).
(v) ICRP Publication 71--ICRP, 1995. ``Age-dependent Doses to
Members of the Public from Intake of Radionuclides--Part 4
Inhalation Dose Coefficients.'' ICRP Publication 71. Ann. ICRP 25
(3-4). IBR approved for Sec. 20.1010(a).
(vi) ICRP Publication 72--ICRP, 1995. ``Age-dependent Doses to
Members of the Public from Intake of Radionuclides--Part 5
Compilation of Ingestion and Inhalation Coefficients.'' ICRP
Publication 72. Ann. ICRP 26 (1). IBR approved for Sec. 20.1010(a).
(vii) ICRP Publication 116--ICRP, 2010. ``Conversion
Coefficients for Radiological Protection Quantities for External
Radiation Exposures.'' ICRP Publication 116. Ann. ICRP 40(2-5). IBR
approved for Sec. 20.1010(a).
(viii) ICRP Publication 130--ICRP, 2015. ``Occupational Intakes
of Radionuclides: Part 1.'' ICRP Publication 130. Ann. ICRP 44(2).
IBR approved for Sec. 20.1010(a).
(ix) ICRP Publication 134--ICRP, 2016. ``Occupational Intakes of
Radionuclides: Part 2.'' ICRP Publication 134. Ann. ICRP 45(\3/4\),
1-352. IBR approved for Sec. 20.1010(a).
(x) ICRP Publication 137--ICRP, 2017. ``Occupational Intakes of
Radionuclides: Part 3.'' ICRP Publication 137. Ann. ICRP 46(\3/4\).
IBR approved for Sec. 20.1010(a).
(xi) ICRP Publication 141--ICRP, 2019. ``Occupational Intakes of
Radionuclides: Part 4.'' ICRP Publication 141. Ann. ICRP 48(\2/3\).
IBR approved for Sec. 20.1010(a).
(xii) ICRP Publication 144--ICRP, 2020. ``Dose Coefficients for
External Exposures to Environmental Sources.'' ICRP Publication 144.
Ann. ICRP 49(2). IBR approved for Sec. 20.1010(a).
(xiii) ICRP Publication 151--ICRP, 2022. ``Occupational Intakes
of Radionuclides: Part 5.'' ICRP Publication 151. Ann. ICRP 51(1-2).
IBR approved for Sec. 20.1010(a).
(b) Conditions. Per Sec. 20.1010(a), unless otherwise approved
by the NRC, alternative dosimetry methods must be consistent with
one or more of the standards listed in paragraph (a), subject to the
following conditions:
(1) American National Standards Institute/American Nuclear
Society (ANSI/ANS)--
(i) ANSI/ANS-6.1.1-2020--No conditions.
(2) International Commission on Radiological Protection (ICRP)--
(i) ICRP Publication 56--Only the following sections may be used
as alternative dosimetry methods: Glossary, Section I Chapters 1-3,
Section II Chapters 1-12, and Annexes A-B.
(ii) ICRP Publication 67--Only the following sections may be
used as alternative dosimetry methods: Glossary, Introduction,
Computation of Age-Dependent Effective Dose Coefficients, Chapters
1-13, and Appendices A-C.
(iii) ICRP Publication 68--Only the following sections may be
used as alternative dosimetry methods: Glossary, Chapters 1-6 and 8,
and Annexes A-F.
(iv) ICRP Publication 69--Only the following sections may be
used as alternative dosimetry methods: Glossary, Introduction,
Computation of Age-Dependent Effective Dose Coefficients, and
Chapters 1-5.
(v) ICRP Publication 71--Only the following sections may be used
as alternative dosimetry methods: Glossary, Chapters 1-5, and
Annexes A-D.
(vi) ICRP Publication 72--Only the following sections may be
used as alternative dosimetry methods: Glossary, Chapters 1-5, and
Annexes A-B.
(vii) ICRP Publication 116--Only the following sections may be
used as alternative dosimetry methods: Chapters 1-5, Annexes A-J,
and Supplementary Material.
(viii) ICRP Publication 130--Only the following sections may be
used as alternative dosimetry methods: Glossary, Chapter 1, Chapter
3, Section 6.5, and Chapter 7.
(ix) ICRP Publication 134--Only the following sections may be
used as alternative dosimetry methods: Chapters 1-15.
(x) ICRP Publication 137--Only the following sections may be
used as alternative dosimetry methods: Chapters 1-15, Annex A.
(xi) ICRP Publication 141--Only the following sections may be
used as alternative dosimetry methods: Chapters 1-28.
(xii) ICRP Publication 144--Only the following sections may be
used as alternative dosimetry methods: Chapters 2-9, Annexes A-C,
and Supplementary Material.
(xiii) ICRP Publication 151--Only the following sections may be
used as alternative dosimetry methods: Chapters 1-39, Annexes A-B.
PART 34--LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY
REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
0
39. The authority citation for part 34 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182,
183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273,
2282, 2021); Energy Reorganization Act of 1974, secs. 201, 206 (42
U.S.C. 5841, 5846); 44 U.S.C. 3504 note.
Sec. 34.3 [Amended].
0
40. In Sec. 34.3, the definition for ``ALARA'' is removed.
Sec. 34.42 [Amended].
0
41. In Sec. 34.42, remove paragraphs (c) and (d).
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
0
42. The authority citation for part 35 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182,
183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273,
2282, 2021); Energy Reorganization Act of 1974, secs. 201, 206 (42
U.S.C. 5841, 5846); 44 U.S.C. 3504 note.
0
43. In Sec. 35.2, add in alphabetical order definitions for
``Administration regimen'' and ``Caregiver''.
Sec. 35.2 Definitions.
* * * * *
Administration regimen means the course of administrations of a
given radiopharmaceutical or brachytherapy source as intended by the
authorized user.
* * * * *
Caregiver means an adult who provides the patient with support or
comfort for non-commercial gains following administration of byproduct
material.
* * * * *
0
44. Revise and republish Sec. 35.75 to read as follows:
Sec. 35.75 Release of individuals containing byproduct material.
(a) A licensee shall develop, implement, and maintain a written
procedure to authorize release in accordance with paragraphs (b) and
(c) of this section.
(b) A licensee may authorize the release from its control of any
individual who has been administered byproduct material if--
(1) the licensee has written consent from the released individual
or, as necessary, the released individual's parent or guardian, and, if
applicable, the released individual's caregiver; and in situations
involving a caregiver, the released individual or, as necessary, the
released individual's parent or guardian, and the released individual's
caregiver have been instructed on the radiation risks to the caregiver
and methods to manage exposure to the caregiver if the total effective
dose equivalent to the caregiver is likely to exceed 5 mSv (0.5 rem)
and is not likely to exceed 50 mSv (5 rem) per patient administration
regimen.
(2) the total effective dose equivalent to any other individual who
is not a caregiver from exposure to the released individual is not
likely to exceed 5 mSv (0.5 rem) per patient administration regimen.\1\
(c) A licensee shall provide the released individual or, as
necessary, the released individual's parent or guardian,
[[Page 43500]]
with instructions, including written instructions, on actions
recommended to reduce contamination and maintain doses to other
individuals below the limits in paragraphs (b)(1) and (b)(2) of this
section if the total effective dose equivalent to any other individual,
including a caregiver, is likely to exceed 1 mSv (0.1 rem). If the
total effective dose equivalent to a nursing infant or child could
exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-
feeding, the instructions must also include--
(1) Guidance on the interruption or discontinuation of breast-
feeding; and
(2) Information on the potential consequences, if any, of failure
to follow the guidance.
(d) A licensee shall maintain a record of the written procedure(s)
used for authorizing the release of individuals containing byproduct
material in accordance with Sec. 35.2075(a).
\1\ The current revision of Regulatory Guide 8.39, ``Release of
Patients Administered Radioactive Material,'' describes methods for
calculating doses to caregivers and other individuals.
0
45. Revise and republish Sec. 35.2075 to read as follows:
Sec. 35.2075 Records of procedures used for release of individuals
containing byproduct material.
(a) A licensee shall retain a copy of the procedure(s) required by
Sec. 35.75(a) for the duration of the license.
PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL
0
46. The authority citation for part 40 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 62, 63, 64, 65, 69,
81, 83, 84, 122, 161, 181, 182, 183, 184, 186, 187, 193, 223, 234,
274, 275 (42 U.S.C. 2092, 2093, 2094, 2095, 2099, 2111, 2113, 2114,
2152, 2201, 2231, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282,
2021, 2022); Energy Reorganization Act of 1974, secs. 201, 202, 206,
211 (42 U.S.C. 5841, 5842, 5846, 5851); Uranium Mill Tailings
Radiation Control Act of 1978, sec. 104 (42 U.S.C. 7914); 44 U.S.C.
3504 note.
0
47. Amend Appendix A to 10 CFR part 40:
0
a. In the Introduction, revise the first and fifth paragraphs;
0
b. In Section I, Technical Criteria, Criterion 6, paragraph (6), revise
the undesignated second paragraph; and
0
c. In Section I, Technical Criteria, Criterion 8, revise the first
paragraph.
The revisions read as follows:
Appendix A to Part 40--Criteria Relating to the Operation of Uranium
Mills and the Disposition of Tailings or Wastes Produced by the
Extraction or Concentration of Source Material From Ores Processed
Primarily for Their Source Material Content
Introduction. Every applicant for a license to possess and use
source material in conjunction with uranium or thorium milling, or
byproduct material at sites formerly associated with such milling,
is required by the provisions of Sec. 40.31(h) to include in a
license application proposed specifications relating to milling
operations and the disposition of tailings or wastes resulting from
such milling activities. This appendix establishes technical,
financial, ownership, and long-term site surveillance criteria
relating to the siting, operation, decontamination, decommissioning,
and reclamation of mills and tailings or waste systems and sites at
which such mills and systems are located. As used in this appendix,
the term ``as low as is reasonably achievable'' has the same meaning
as in 40 CFR part 192.
* * * * *
All site specific licensing decisions based on the criteria in
this appendix or alternatives proposed by licensees or applicants
will take into account the risk to the public health and safety and
the environment with due consideration to the economic costs
involved and any other factors the Commission determines to be
appropriate. In implementing this appendix, the Commission will
consider ``practicable'' and ``reasonably achievable'' as equivalent
terms. Decisions involving these terms will take into account the
state of technology, and the economics of improvements in relation
to benefits to the public health and safety, and other societal and
socioeconomic considerations, and in relation to the utilization of
atomic energy in the public interest.
* * * * *
I. Technical Criteria
* * * * *
Criterion 6--
(6) * * *
Byproduct material containing concentrations of radionuclides
other than radium in soil, and surface activity on remaining
structures, must not result in a total effective dose equivalent
(TEDE) exceeding the dose from cleanup of radium contaminated soil
to the above standard (benchmark dose). If more than one residual
radionuclide is present in the same 100-square-meter area, the sum
of the ratios for each radionuclide of concentration present to the
concentration limit will not exceed ``1'' (unity). A calculation of
the potential peak annual TEDE within 1000 years to the average
member of the critical group that would result from applying the
radium standard (not including radon) on the site must be submitted
for approval. The use of decommissioning plans with benchmark doses
that exceed 100 mrem/yr requires the approval of the Commission
after consideration of the recommendation of the NRC staff. This
requirement for dose criteria does not apply to sites that have
decommissioning plans for soil and structures approved before June
11, 1999.
* * * * *
Criterion 8--Milling operations must be conducted so that all
airborne effluent releases are managed primarily by use of emission
controls. Institutional controls, such as extending the site
boundary and exclusion area, may be employed to ensure that offsite
exposure limits are met, but only after all practicable measures
have been taken to control emissions at the source. Notwithstanding
the existence of individual dose standards, strict control of
emissions is necessary to assure that population exposures are
managed to the extent reasonably achievable and to avoid site
contamination. The greatest potential sources of offsite radiation
exposure (aside from radon exposure) are dusting from dry surfaces
of the tailings disposal area not covered by tailings solution and
emissions from yellowcake drying and packaging operations. During
operations and prior to closure, radiation doses from radon
emissions from surface impoundments of uranium or thorium byproduct
materials must be managed to the extent reasonably achievable.
* * * * *
PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION
FACILITIES
0
48. The authority citation for part 50 is revised to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 101, 102, 103,
104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186,
187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135,
2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236,
2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs.
201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste
Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National
Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504
note; ADVANCE Act of 2024, sec. 301 (42 U.S.C. 2133 note).
0
49. In Sec. 50.34, revise paragraphs (a)(1)(ii)(D)(1) and (2), and
paragraph (f)(2)(xv) to read as follows:
Sec. 50.34 Contents of applications; technical information.
(a) * * *
(1) * * *
(ii) * * *
(D) * * *
(1) An individual located at any point on the boundary of the
exclusion area for any 2-hour period following the onset of the
postulated fission product release, would not receive a radiation dose
in excess of 25 rem \4\ total effective dose equivalent (TEDE), or
total effective dose (TED), as applicable.
(2) An individual located at any point on the outer boundary of the
low
[[Page 43501]]
population zone, who is exposed to the radioactive cloud resulting from
the postulated fission product release (during the entire period of its
passage) would not receive a radiation dose in excess of 25 rem total
effective dose equivalent (TEDE), or total effective dose (TED), as
applicable.
* * * * *
* * * * *
(f) * * *
(2) * * *
(xv) Provide a capability for containment purging/venting designed
to minimize the purging time in consideration of the occupational dose
limits set forth in part 20 of this chapter. Provide and demonstrate
high assurance that the purge system will reliably isolate under
accident conditions. (II.E.4.4)
* * * * *
\4\ A whole body dose of 25 rem has been stated to correspond
numerically to the once in a lifetime accidental or emergency dose
for radiation workers which, according to NCRP recommendations at
the time could be disregarded in the determination of their
radiation exposure status (see NBS Handbook 69 dated June 5, 1959).
However, its use is not intended to imply that this number
constitutes an acceptable limit for an emergency dose to the public
under accident conditions. Rather, this dose value has been set
forth in this section as a reference value, which can be used in the
evaluation of plant design features with respect to postulated
reactor accidents, in order to assure that such designs provide
assurance of low risk of public exposure to radiation, in the event
of such accidents.
* * * * *
0
50. In Sec. 50.34a, revise paragraphs (a), (d)(1), and (e)(1) to read
as follows:
Sec. 50.34a Design objectives for equipment to control releases of
radioactive material in effluents--nuclear power reactors.
(a) An application for a construction permit shall include a
description of the preliminary design of equipment to be installed to
maintain control over radioactive materials in gaseous and liquid
effluents produced during normal reactor operations, including
anticipated operational occurrences. In addition to the information
required under paragraph (b) of this section, the application shall
identify the design objectives, and the means to be employed, for
adequate control of radioactive materials in effluents to unrestricted
areas.\1\ The guides set out in appendix I to this part provide
acceptable design objectives; alternative design objectives approved by
the NRC are also acceptable. The guides in appendix I are not to be
construed as radiation protection standards.
(d) * * *
(1) A description of the equipment and procedures for the control
of gaseous and liquid effluents and for the maintenance and use of
equipment installed in radioactive waste systems, under paragraph (a)
of this section, and the design objectives, and the means to be
employed, for adequate control of radioactive materials in effluents to
unrestricted areas; \1\ and
(e) * * *
(1) A description of the equipment for the control of gaseous and
liquid effluents and for the maintenance and use of equipment installed
in radioactive waste systems, under paragraph (a) of this section, and
the design objectives, and the means to be employed, for adequate
control of radioactive materials in effluents to unrestricted
areas;\[1]\ and
* * * * *
\[1]\ In the case of an application filed before [EFFECTIVE DATE
OF FINAL RULE], the application may instead identify the design
objectives, and the means to be employed, that are based on keeping
levels of radioactive materials in effluents to unrestricted areas
as low as is reasonably achievable. The term ``as low as is
reasonably achievable'' as used in this footnote means as low as is
reasonably achievable taking into account the state of technology,
and the economics of improvements in relation to benefits to the
public health and safety and other societal and socioeconomic
considerations, and in relation to the use of atomic energy in the
public interest. The guides set out in Sections I through V of
appendix I to this part provide acceptable design objectives for
this approach.
0
51. Revise and republish Sec. 50.36a to read as follows:
Sec. 50.36a Technical specifications on effluents from nuclear power
reactors.
(a) To maintain adequate control of releases of radioactive
materials to unrestricted areas during normal conditions, including
anticipated operational occurrences, each license authorizing operation
of a nuclear power reactor and each application for a design
certification or a manufacturing license will include technical
specifications that, in addition to requiring compliance with
applicable provisions of Sec. 20.1301 of this chapter, require that:
(1) Operating procedures developed pursuant to Sec. 50.34a(c)(1)
for the control of effluents be established and followed and that the
equipment installed in radioactive waste systems, pursuant to Sec.
50.34a(c)(1), be maintained and used. The licensee shall retain the
operating procedures in effect as a record until the Commission
terminates the license and shall retain each superseded revision of the
procedures for 3 years from the date it was superseded.
(2) The holder of either an operating license under this part or a
combined license under part 52 after the Commission has made the
finding under Sec. 52.103(g) of this chapter for a nuclear power
reactor using the technical specifications must develop and maintain a
report, or reports, that specifies the quantity of each of the
principal radionuclides released to unrestricted areas in liquid and in
gaseous effluents and the results of the surveillance and monitoring
program required by paragraph (a)(3) during the previous 12 months. The
time between the development of the reports must be no longer than 12
months. The report, or reports, must include any information as may be
required by the Commission to estimate maximum potential annual
radiation doses to the public resulting from effluent releases, or to
independently verify results. The report, or reports, must be
maintained as records as specified in Sec. 50.71(c). The technical
specifications required by paragraph (a) of this section shall include
requirements for when such a report, or reports, must be submitted to
the Commission as specified in Sec. 50.4. On the basis of these
reports and any additional information the Commission may obtain from
the licensee or others, the Commission may require the licensee to take
action as the Commission deems appropriate.
(3) Each licensee subject to paragraph (a)(2) of this section must
establish an appropriate surveillance and monitoring program to:
(i) Provide data on quantities of radioactive material released in
liquid and gaseous effluents to assure that the provisions of paragraph
(a) of this section are met;
(ii) Provide data on measurable levels of radiation and radioactive
materials in the environment to evaluate the relationship between
quantities of radioactive material released in effluents and resultant
radiation doses to individuals from principal pathways of exposure; and
(iii) Identify changes in the use of unrestricted areas (e.g., for
agricultural purposes) sufficient to evaluate the effectiveness of and
enable modifications, if necessary, to monitoring programs for
evaluating doses to individuals from principal pathways of exposure.
(b) In establishing and implementing the technical specifications
described in paragraph (a) of this section, the licensee shall include
limiting conditions for operation such that adequate opportunity is
available for
[[Page 43502]]
licensee action and NRC notification prior to exceeding applicable
limits. The guides set out in appendix I to this part provide one
acceptable approach for meeting the requirements of this paragraph;
alternative approaches approved by the NRC are also acceptable.
(c) If the data collected by the surveillance and monitoring
program described in paragraph (a)(3) of this section or by other
monitoring programs show that the relationship between the quantities
of radioactive material released in liquid and gaseous effluents and
the dose to individuals in unrestricted areas is significantly
different from that assumed in the calculations used to determine
design objectives pursuant to Sec. 50.34a, the Commission may modify
the quantities in the technical specifications defining the limiting
conditions in a license to operate a nuclear power reactor or a license
whose holder has submitted a certification of permanent cessation of
operations under Sec. 50.82(a)(1).
0
52. In Sec. 50.66, revise paragraph (b)(1)(iii) to read as follows.
Sec. 50.66 Requirements for thermal annealing of the reactor
pressure vessel.
* * * * *
(b) * * *
(1) * * *
(iii) The methods, including heat source, instrumentation and
procedures proposed for performing the thermal annealing. This shall
include any special precautions necessary to maintain occupational
exposure within the limits set forth in part 20 of this chapter.
* * * * *
0
53. In Appendix I to part 50:
0
a. Revise the title of Appendix I;
0
b. In Section IV, revise paragraph C; and
0
c. Add Section VI.
The revisions and addition read as follows:
Appendix I to Part 50--Acceptable Design Objectives and Limiting
Conditions for Operation To Maintain Adequate Control of Radioactive
Material in Nuclear Power Reactor Effluents
* * * * *
Section IV
* * * * *
C. If the data collected by the surveillance and monitoring
program described in paragraph B of Section III or by other
monitoring programs show that the relationship between the
quantities of radioactive material released in liquid and gaseous
effluents and the dose to individuals in unrestricted areas is
significantly different from that assumed in the calculations used
to determine design objectives pursuant to Sections II and III, the
Commission may modify the quantities in the technical specifications
defining the limiting conditions in a license to operate a light-
water-cooled nuclear power reactor or a license whose holder has
submitted a certification of permanent cessation of operations under
Sec. 50.82(a)(1) or Sec. 52.110.
* * * * *
Section VI. Alternative acceptable design objectives and
limiting conditions for operation to maintain adequate control of
radioactive material in nuclear power reactor effluents.
This section provides an alternative acceptable to the NRC to
the approach described in Sections I-V of this appendix for
establishing technical specifications under Sec. 50.36a to maintain
adequate control of releases of radioactive materials to
unrestricted areas during normal conditions, including anticipated
operational occurrences.
A. The design objective for adequate control of radioactive
material in effluents is that the calculated total quantity of all
radioactive material above background to be released from each
nuclear power reactor to the unrestricted area will not result in an
estimated total effective dose equivalent, or total effective dose,
as applicable, of more than 25 mrem per year.
B.
1. Licensees may use the methods described in Section III and
associated guidance to demonstrate conformity with the design
objective of Section VI.A. Alternatively, licensees may use the
guides in Section VI.C to demonstrate conformity with the design
objective of Section VI.A.
2. In demonstrating conformity with the design objective of
Section VI.A, a licensee may use alternative dosimetry methods as
described in Sec. 20.1010.
3. In establishing technical specifications pursuant to Sec.
50.36a, licensees can use administrative controls per Sec.
50.36(c)(5) to describe general aspects of the program to maintain
adequate control of releases of radioactive materials to
unrestricted areas during normal conditions, including anticipated
operational occurrence, and to describe implementation of the
recordkeeping and reporting requirements of Sec. 50.36a(a)(2).
Additional details, including controls for specific equipment,
applicability statements, actions, and surveillance requirements can
be maintained in licensee-controlled documents whose configuration
would be managed with an administrative control per Sec.
50.36(c)(5).
C. The guides on technical specifications for limiting
conditions for operation or administrative controls for nuclear
power reactors set forth below may be used by an applicant for an
operating license under this part or a design certification,
manufacturing license or combined license under part 52 of this
chapter, or by a licensee who has submitted a certification of
permanent cessation of operations under Sec. 50.82(a)(1) or Sec.
52.110 of this chapter, as guidance in developing technical
specifications pursuant to Sec. 50.36a(a) to adequately control
releases of radioactive materials in effluents to unrestricted
areas.
1. If the quantity of radioactive material actually released in
effluents to unrestricted areas from a nuclear power reactor during
any calendar quarter is such that the resulting radiation exposure,
calculated on the same basis as the respective design objective
exposure, would exceed one-half the design objective in Section
VI.A, the holder of an operating license or combined license shall:
(a) Make an investigation to identify the causes for such
release rates;
(b) Define and initiate a program of corrective action; and
(c) Record these actions in the appropriate annual report that
is required by Sec. 50.36a(a)(2).
2. If the quantity of radioactive material actually released in
effluents to unrestricted areas from a nuclear power reactor during
any calendar quarter is such that the resulting radiation exposure,
calculated on the same basis as the respective design objective
exposure, would exceed the design objective in Section VI.A, the
licensee shall complete the actions of paragraph VI.C.1 and submit
the annual report that is required by Sec. 50.36a(a)(2) to the
Commission at the conclusion of the monitored year as specified in
Sec. 50.4. The licensee shall continue to submit annual reports to
the Commission until the report after conformity with the design
objective of Section VI.A is restored.
3. The surveillance and monitoring program required by Sec.
50.36a(a)(3) shall include administrative controls that:
(a) Provide data and controls on the quantities of radioactive
material released in liquid and gaseous effluents to assure that the
design objective of Section VI.A is met;
(b) Provide data on measurable levels of radiation and
radioactive materials in the environment to evaluate the
relationship between quantities of radioactive material released in
effluents and resultant radiation doses to individuals from
principal pathways of exposure; and
(c) Identify changes in the use of unrestricted areas (e.g., for
agricultural purposes) to permit modifications in monitoring
programs for evaluating doses to individuals from principal pathways
of exposure.
(d) Ensure proper use and maintenance of equipment used to
monitor and control releases of radioactive materials to
unrestricted areas during normal conditions, including anticipated
operational occurrences.
4. If the data developed in the surveillance and monitoring
program described in Sec. 50.36a(a)(3) or from other monitoring
programs show that the relationship between the quantities of
radioactive material released in liquid and gaseous effluents and
the dose to individuals in unrestricted areas is significantly
different from that assumed in the calculations used to determine
design objectives pursuant to Section VI.A, the Commission may
modify the quantities in the technical specifications defining the
limiting conditions in a license to operate a nuclear power reactor
or a license whose holder has submitted a certification of permanent
cessation of operations under Sec. 50.82(a)(1).
[[Page 43503]]
PART 53--RISK-INFORMED, TECHNOLOGY-INCLUSIVE REGULATORY FRAMEWORK
FOR ADVANCED REACTORS
0
54. The authority citation for part 53 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 101, 103, 108,
122, 147, 161, 181, 182, 183, 184, 185, 186, 187, 189, 223, 234 (42
U.S.C. 2014, 2131, 2132, 2133, 2134, 2135, 2138, 2152, 2167, 2169,
2201, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2239, 2273, 2282);
Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42
U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982,
sec. 306 (42 U.S.C. 10226); National Environmental Policy Act of
1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note; Pub. L. 115-439, 132
Stat. 5571.
0
55. In Sec. 53.210, revise paragraphs (a) and (b) and footnote 1 to
read as follows:
Sec. 53.210 Safety criteria for design-basis accidents.
* * * * *
(a) An individual located at any point on the boundary of the
exclusion area for any 2-hour period following the onset of the
postulated fission product release would not receive a radiation dose
in excess of 25 rem (250 millisieverts) total effective dose equivalent
(TEDE), or total effective dose (TED), as applicable; and
(b) An individual located at any point on the outer boundary of the
low-population zone who is exposed to the radioactive cloud resulting
from the postulated fission product release (during the entire period
of its passage) would not receive a radiation dose in excess of 25 rem
(250millisieverts) TEDE, or TED, as applicable.\1\
\1\ The use of 25 rem is not intended to imply that this number
constitutes an acceptable limit for an emergency dose to the public
under accident conditions. Rather, this dose value has been set
forth in this section as a reference value, which can be used in the
evaluation of plant design features with respect to postulated
reactor accidents, to assure that these designs provide assurance of
low risk of public exposure to radiation, in the event of an
accident.
0
56. In Sec. 53.530, revise paragraphs (a)(1) and (2) to read as
follows:
Sec. 53.530 Population-related considerations.
* * * * *
(a) * * *
(1) An individual located at any point on the boundary of the
exclusion area for any 2-hour period following the onset of the
postulated fission product release would not receive a radiation dose
in excess of 25 rem (250 millisieverts) total effective dose
equivalent, or total effective dose, as applicable.
(2) An individual located at any point on the outer boundary of the
low-population zone who is exposed to the radioactive cloud resulting
from the postulated fission product release (during the entire period
of its passage) would not receive a radiation dose in excess of 25 rem
(250 millisieverts) total effective dose equivalent, or total effective
dose, as applicable.
* * * * *
0
57. In Sec. 53.850, revise paragraphs (a) and (b)(2) to read as
follows:
Sec. 53.850 Radiation protection.
(a) Each holder of an OL or COL under this part must develop,
implement, and maintain a Radiation Protection Program for operations
that is commensurate with the scope and extent of licensed activities
under this part and includes measures for controlling and monitoring
radioactive plant effluents and controlling and monitoring the dose to
individuals working with radioactive materials in accordance with 10
CFR part 20 of this chapter.
(b) * * *
(2) Contain the radioactive effluent controls and radiological
environmental monitoring activities, and descriptions of the
information that should be included in the report, or reports, required
by Sec. 53.1645.
* * * * *
0
58. In Sec. 53.1645, revise paragraph (a) and remove and reserve
paragraph (b) to read as follows:
Sec. 53.1645 Reports of radiation exposure to members of the public.
(a) Each holder of an OL, and each holder of a COL after the
Commission has made the finding under Sec. 53.1452(g), must develop
and maintain a report, or reports, that specifies the quantity of each
of the principal radionuclides released to unrestricted areas in liquid
and in gaseous effluents and the results of the control and monitoring
program required by Sec. Sec. 53.850(a) and 53.850(b) during the
previous 12 months. The time between the development of the reports
must be no longer than 12 months. The report, or reports, must include
any information as may be required by the Commission to estimate
maximum potential annual radiation doses to the public resulting from
effluent releases, or to independently verify results. The report, or
reports, must be maintained as records as specified in Sec. 53.1620.
The program required by Sec. Sec. 53.850(a) and 53.850(b) shall
include requirements for when such a report, or reports, must be
submitted to the Commission as specified in Sec. 53.040. On the basis
of these reports and any additional information the Commission may
obtain from the licensee or others, the Commission may require the
licensee to take action as the Commission deems appropriate.
(b) [Reserved].
PART 61--LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE
WASTE
0
59. The authority citation for part 61 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 53, 57, 62, 63, 65,
81, 161, 181,182, 183, 223, 234 (42 U.S.C. 2073, 2077, 2092, 2093,
2095, 2111, 2201, 2231, 2232,2233, 2273, 2282); Energy
Reorganization Act of 1974, secs. 201, 206, 211 (42 U.S.C.5841,
5846, 5851); Low-Level Radioactive Waste Policy Amendments Act of
1985, sec.2 (42 U.S.C. 2021b); 44 U.S.C. 3504 note.
Sec. 61.41 [Amended].
0
60. In Sec. 61.41 the last sentence is removed.
Sec. 61.43 [Amended].
0
61. In Sec. 61.43, the last sentence is removed.
PART 71--PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL
0
62. The authority citation for part 71 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 53, 57, 62, 63, 81,
161, 182, 183, 223, 234, 1701 (42 U.S.C. 2073, 2077, 2092, 2093,
2111, 2201, 2232, 2233, 2273, 2282, 2297f); Energy Reorganization
Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846,
5851); Nuclear Waste Policy Act of 1982, sec. 180 (42 U.S.C. 10175);
44 U.S.C. 3504 note.
Section 71.97 also issued under Sec. 301, Pub. L. 96-295, 94
Stat. 789 (42 U.S.C. 5841 note).
0
63. In Sec. 71.87, revise paragraph (i) to read as follows:
Sec. 71.87 Routine determinations.
* * * * *
(i) The level of non-fixed (removable) radioactive contamination on
the external surfaces of each package offered for shipment is within
the limits specified in DOT regulations in 49 CFR 173.443;
* * * * *
[[Page 43504]]
PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF
SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-
RELATED GREATER THAN CLASS C WASTE
0
64. The authority citation for part 72 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63,
65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42
U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e,
2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy
Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C.
5841, 5842, 5846, 5851); National Environmental Policy Act of 1969
(42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a),
132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C.
10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168,
10198(a)); 44 U.S.C. 3504 note.
Sec. 72.3 [Amended]
0
65. In Sec. 72.3, the definition for ``As low as is reasonably
achievable (ALARA)'' is removed.
0
66. In Sec. 72.24, revise paragraph (e) and paragraph (l) introductory
text to read as follows:
Sec. 72.24 Contents of application: Technical information
* * * * *
(e) The means for maintaining occupational radiation exposures
within the limits given in part 20 of this chapter.
* * * * *
(l) A description of the equipment to be installed to maintain
control over radioactive materials in gaseous and liquid effluents
produced during normal operations and expected operational occurrences.
The description must identify the design objectives and the means to be
used for keeping levels of radioactive material in effluents to the
environment within the exposure criteria stated in Sec. 72.104. The
description must include:
* * * * *
0
67. In Sec. 72.44, revise paragraph (d) introductory text and
paragraph (d)(3) to read as follows:
Sec. 72.44 License conditions.
* * * * *
(d) Each license authorizing the receipt, handling, and storage of
spent fuel, high-level radioactive waste, and/or reactor-related GTCC
waste under this part must include technical specifications that, in
addition to stating the limits on the release of radioactive materials
for compliance with limits of part 20 of this chapter, require:
* * * * *
(3) An annual report, or reports, be developed and maintained
specifying the quantity of each of the principal radionuclides released
to the environment in liquid and in gaseous effluents during the
previous 12 months. The time between the development of the reports
must be no longer than 12 months. The report, or reports, must include
any information as may be required by the Commission to estimate
maximum potential annual radiation doses to the public resulting from
effluent releases, or to independently verify results. The report, or
reports, must be maintained as records until termination of the
license. The technical specifications required by paragraph (d) of this
section shall include requirements for when such a report, or reports,
must be submitted to the Commission as specified in Sec. 72.4. On the
basis of these reports and any additional information that the
Commission may obtain from the licensee or others, the Commission may
require the licensee to take action as the Commission deems
appropriate.
* * * * *
0
68. In Sec. 72.104, revise paragraphs (b) and (c) and add (d) to read
as follows:
Sec. 72.104 Criteria for radioactive materials in effluents and
direct radiation from an ISFSI or MRS.
* * * * *
(b) Operational restrictions must be established to meet direct
radiation levels associated with ISFSI or MRS operations.
(c) Operational restrictions must be established for radioactive
materials in effluents and direct radiation levels associated with
ISFSI or MRS operations to meet the criteria given in paragraph (a) of
this section.
(d) Licensees may use alternative dosimetry methods, per Sec.
20.1010 of this chapter, to demonstrate compliance with criteria that
are equivalent to the criteria given in paragraph (a) of this section.
In these cases, the applicable criterion is 0.25 mSv (25 mrem) total
effective dose equivalent, or total effective dose, as applicable.
0
69. In Sec. 72.126, revise paragraph (d) to read as follows:
Sec. 72.126 Criteria for radiological protection.
* * * * *
(d) Effluent control. The ISFSI or MRS must be designed to provide
means for managing the release of radioactive materials in effluents
during normal operations and controlling the release of radioactive
materials under accident conditions. Analyses must be made to show that
releases to the general environment during normal operations and
anticipated occurrences will be within the exposure criteria given in
Sec. 72.104. Analyses of design basis accidents must be made to show
that releases to the general environment will be within the exposure
criteria given in Sec. 72.106. Systems designed to monitor the release
of radioactive materials must have means for calibration and testing
their operability.
Dated: July 13, 2026.
For the Nuclear Regulatory Commission.
Jody Martin,
Secretary of the Commission.
[FR Doc. 2026-14208 Filed 7-14-26; 8:45 am]
BILLING CODE 7590-01-P