[Federal Register Volume 75, Number 186 (Monday, September 27, 2010)]
[Proposed Rules]
[Pages 59160-59167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24137]
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NUCLEAR REGULATORY COMMISSION
10 CFR Chapter I
[NRC-2009-0279]
Radiation Protection Regulations and Guidance; Public Meetings
and Request for Comments
AGENCY: U.S. Nuclear Regulatory Commission (NRC).
ACTION: Notice of Public Meeting and Request for Comment.
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SUMMARY: The NRC is conducting a series of public meetings, in the
format of facilitated roundtable workshops, to solicit early public
input on major issues associated with potential updates to NRC's
radiation protection regulations and guidance in light of
recommendations presented in the International Commission on
Radiological Protection (ICRP) Publication 103 (2007). To aid in that
process, the NRC is requesting comments on the issues discussed in this
notice. The NRC has not initiated rulemaking on this subject, and is
seeking early input and views on the benefits and impacts of options to
be considered before making any decision on whether to proceed with a
rulemaking. Each meeting will include a panel of participants, selected
in a convening process to represent the
[[Page 59161]]
diversity of stakeholders for these issues, including the various uses
of radioactive materials licensed by the NRC. In addition to the panel,
the NRC is encouraging observation and participation by all interested
individuals. The meeting agenda will specifically include opportunities
for viewpoints to be expressed from individuals in attendance who are
not members of the panel. The NRC plans to transcribe the meetings.
DATES: Comments on this notice should be submitted by January 31, 2011.
Comments received after this date will be considered if it is practical
to do so, but the NRC is able to assure consideration only for comments
received on or before this date.
Public Meeting Dates: The NRC will take public comments on the
issues raised in this notice at a series of three 2-day public meetings
that will be held during the weeks of October 25, 2010 (Washington,
DC); November 1, 2010 (Los Angeles, California) and November 8, 2010
(Houston, Texas). The meeting in Washington DC will also include a
third day of discussions, focused more specifically on the issues
associated with power reactor licensees, as described in Section IV of
this notice. Specific locations and dates will be announced on the NRC
public Web site at http://www.nrc.gov/public-involve/public-meetings/index.cfm. Please refer to the SUPPLEMENTARY INFORMATION section for
additional information.
ADDRESSES: Members of the public are invited and encouraged to submit
comments by any of the following methods:
1. Mail to Cindy Bladey, Chief, Rules, Announcements and Directives
Branch, Office of Administration, Mail Stop 5B01M, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001; or
2. Electronically at http://www.regulations.gov.
Comments will be made available to the public in their entirety.
Because your comments will not be edited to remove any identifying or
contact information, the NRC cautions you against including any
information in your submission that you do not want to be publicly
disclosed.
The NRC requests that any party soliciting or aggregating comments
received from other persons for submission to the NRC inform those
persons that the NRC will not edit their comments to remove any
identifying or contact information, and therefore, they should not
include any information in their comments that they do not want
publicly disclosed.
You can access publicly available documents related to this notice
using the following methods:
Regulations.gov: Documents related to this notice, including public
comments, are accessible at http://www.regulations.gov.
NRC's Public Document Room (PDR): The public may examine and have
copied for a fee, publicly available documents at the NRC's PDR, Public
File Area O-1F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland.
NRC's Agencywide Document Access and Management System (ADAMS):
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this
site, the public can gain entry into ADAMS, which provides text and
image files of NRC's public documents. If you do not have access to
ADAMS or if there are problems in accessing the documents located in
ADAMS, contact the PDR Reference staff at 1-800-397-4209, 301-415-4737
or by e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Dr. Kimyata Morgan Butler, Office of
Federal and State Materials and Environmental Management Programs,
telephone (301) 415-0733, e-mail [email protected] or Dr.
Donald Cool, Office of Federal and State Materials and Environmental
Management Programs, telephone (301) 415-6347, e-mail
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Regulations issued by the U.S. Nuclear Regulatory Commission (NRC)
are found in Chapter I of Title 10, ``Energy,'' of the Code of Federal
Regulations (10 CFR). Chapter I is divided into Parts 1 through 199,
which contain requirements that are binding for all individuals and
entities that possess, use, or store nuclear materials or operate
nuclear facilities under the NRC's jurisdiction. Of these, the
regulations that are most relevant to the subject of this notice are
contained in 10 CFR Part 20, ``Standards for Protection Against
Radiation,'' and 10 CFR Part 50, ``Domestic Licensing of Production,
and Utilization Facilities.'' Through the existing compatibility
criteria, the NRC Agreement States have certain requirements that are
essentially identical to 10 CFR Part 20 for their licensees. Additional
requirements, specific to particular uses or classes of facilities, are
found in other portions of the regulations. For example, 10 CFR Part
35, ``Medical Use of Byproduct Material,'' contains requirements
related to medical use of radioactive material. Other portions of the
regulations also may contain radiation protection criteria, and cross
references to 10 CFR Part 20.
ICRP Publication 103 contains the latest in a series of revised
international recommendations for radiation protection. Earlier
recommendations of the ICRP concerning radiation protection were
contained in ICRP Publication 2 (1959), ICRP Publication 26 (1977), and
ICRP Publication 60 (1990). On December 18, 2008, the NRC staff
provided a Policy Issue Notation Vote Paper (SECY-08-0197) to the
Commission which presented the regulatory options of moving, or not
moving, towards a greater degree of alignment between NRC's current
radiation protection regulatory framework and the recommendations
contained in ICRP Publication 103. In a Staff Requirements Memorandum
(SRM) dated April 2, 2009, the Commission approved the staff's
recommendation to immediately begin engagement with stakeholders and
interested parties to ascertain the benefits, burdens, and potential
stakeholder impacts if updates are made to NRC's radiation protection
regulations and guidance in order to achieve greater alignment with the
recommendations in ICRP Publication 103. This notice and series of
public meetings are part of the NRC staff's ongoing engagement process.
II. Request for Written and Electronic Comments and Plans for a Public
Meeting
The NRC is soliciting comments on the technical issues and options,
as presented in Sections III and IV of this notice. Comments may be
submitted either in writing or electronically as indicated under the
ADDRESSES heading. In addition, the NRC is holding a series of three
public meetings, in the format of facilitated roundtable workshops, to
be held during the weeks of October 25, 2010 (Washington, DC); November
1, 2010 (Los Angeles, California); and November 8, 2010 (Houston,
Texas). Specific locations and dates will be announced on the NRC
public Web site at http://www.nrc.gov/public-involve/public-meetings/index.cfm.
Sections III and IV provide background and topics of discussion on
the major issues that will be the subject of the public meetings.
During the public meetings, the NRC will conduct roundtable panel
discussions, with a panel of participants, selected in a convening
process to represent the
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diversity of stakeholders for these issues, including the various uses
of radioactive materials licensed by the NRC. The meeting agenda will
specifically include opportunities for viewpoints to be expressed from
individuals in attendance who are not members of the panel. While all
roundtable meetings will feature a discussion of technical issues and
options for all types of licensed use of radioactive materials, as
described in Section III of this notice, each meeting will have some
degree of focus on particular types of licensed activity. The
Washington, DC roundtable meeting will include a power reactor-focused
session on the third day of the workshop, which will focus on issues
described in Section IV of this notice. The roundtable meeting to be
held in Los Angeles, California is intended to have additional medical
use participation and the roundtable meeting held in Houston, Texas is
intended to have additional industrial applications-focused (industrial
radiography, well logging, etc.) participation. However, all interested
stakeholders are encouraged to attend and participate in any of the
three workshops, including representatives from the university,
research, manufacturer and distributors, and other sectors that use
radioactive materials.
In addition to inviting public comments on the issues presented in
Sections III and IV of this notice, the NRC is also requesting specific
comments from potentially impacted industries. In Section III, the NRC
is soliciting comments related to: (1) Information on the projected
costs and benefits resulting from consideration of the factors
described in Sections III; (2) operational data on radiation exposures
from various licensee groups; (3) whether the presented issues are
addressed comprehensively; and (4) whether other options should be
considered. In Section IV, the NRC is requesting comments from the
nuclear power industry, and other stakeholders, specifically on
operational considerations and costs and benefits to the industry
increasing alignment of 10 CFR Part 50, Appendix I design objectives
with the recommendations of ICRP Publication 103. The Commission
believes that stakeholder comments will help to identify and quantify
the potential impact of these proposed changes and will assist the NRC
as potential regulatory action(s) are developed. Based on the comments
received, the Commission will then be in a better position to evaluate
whether to proceed with the development of a proposed rulemaking. If
the Commission decides to proceed with a proposed rulemaking,
additional information will be published in the Federal Register for
public review and comment.
III. NRC Staff-Identified Technical Issues and Options Associated With
the Potential Revision of NRC's Radiation Protection Regulations and
Guidance
Introduction
Section A of the following discussion presents background
information and describes some general considerations concerning
potential revisions to NRC's radiation protection regulations, as
identified by NRC staff. Section B discusses the various issues and
options that need to be assessed before commencing regulatory
activities related to initiating rulemaking to change current radiation
protection regulations. All public feedback will be used in developing
an options paper for Commission consideration in late 2011.
A. Background
The Commission believes that the current NRC regulatory framework
continues to provide adequate protection of health and safety of
workers, the public, and the environment. From a safety regulation
perspective, ICRP Publication 103 proposes measures that may be seen as
going beyond what is needed to provide adequate protection. In order to
ensure that the NRC is well informed of all the benefits and burdens
associated with further alignment of NRC's current radiation protection
regulations with ICRP Publication 103, the NRC is actively soliciting
stakeholders' input to further clarify the issues, options, benefits,
impacts, and/or burdens associated with making changes to the current
NRC radiation protection regulations. These efforts include
interactions with the public, the nuclear industry, the medical
community, the radioactive materials community, States, and other
Federal agencies (i.e., EPA, DOE, OSHA, etc.). The staff wishes to
continue these interactions with more detailed stakeholder discussions
during this series of facilitated roundtable workshops. The agenda for
each workshop will feature the list of NRC staff-identified technical
options and issues (described below) that are potential areas for
revision of 10 CFR Part 20 in light of the recommendations contained in
ICRP Publication 103. In addition, stakeholders and interested parties
may introduce other options, issues, and information for the NRC's
consideration.
The current NRC radiation protection framework, taken as a whole,
is a collection based on three different generations of international
radiation protection guidelines. 10 CFR Part 20 is based upon the 1977
recommendations contained in ICRP Publication 26, and the scientific
information contained in ICRP Publication 30. In addition, 10 CFR Part
20 contains certain requirements based on recommendations and materials
provided by the U.S. National Council on Radiation Protection and
Measurements. Some other NRC requirements, including those for 10 CFR
Part 50 Appendix I, are based on the older recommendations from 1959
contained in ICRP Publication 2. Certain licensees, as provided in
specific license conditions, are implementing the more recent
recommendations from 1990 in ICRP Publication 60 and subsequent
publications updating the scientific information. The situation in
other agencies of the Federal Government is similarly diverse, with
requirements and guidance values based on all three previous
generations of ICRP recommendations.
The recommendations in ICRP Publication 103 continue to be based on
the fundamental principles of justification of exposures, optimization
of protection, and limitation of dose. ICRP Publication 103
consolidates recommendations from ICRP Publication 60 and subsequent
publications using a better integrated approach to radiation protection
and in dealing with various types of radiation exposures. Among others
things, exposures are divided into three fundamental exposure
situations, planned exposure situations, existing exposure situations,
and emergency exposure situations. Planned exposure situations include
licensed activities where planning and controls are in place before the
exposure is permitted. In each exposure situation, ICRP has placed an
increased emphasis on the optimization of protection for such types of
exposure situations. NRC regulations in 10 CFR Parts 20 and 50 are part
of requirements in the United States for planned exposure situations,
as described by the ICRP.
B. Issues and Options for Discussion
The following format is used in the presentation of the issues that
follow. Each issue is assigned a number, a short title, regulatory
options, and a list of questions. These issues, options, and questions
are not meant to be a complete or final list, but are intended
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to initiate discussion. Interested stakeholders are welcome to
recommend additions, deletions, or modifications of the key issues for
consideration and propose implementation considerations. These issues
and options will serve as the basis for discussion at the public
meetings. Meeting participants, and those wishing to make comments, are
strongly encouraged to read more about this effort at http://www.nrc.gov/about-nrc/regulatory/rulemaking/opt-revise.html.
Issue No. 1: Effective Dose and Numerical Values
Currently, 10 CFR Part 20 expresses the sum of internal and
external exposures to an individual as the total effective dose
equivalent (TEDE). In particular, the Commission amended the
definitions in 10 CFR 20.1003 and 50.2 (72 FR 68058; December 4, 2007)
to clarify the definition of TEDE to mean the sum of the effective dose
equivalent (for external exposures) and the committed effective dose
equivalent (for internal exposures). This action was made effective on
February 15, 2008 (72 FR 72233; December 20, 2007). The revised
definition of TEDE allows a licensee to substitute ``effective dose
equivalent'' for ``deep dose equivalent'' (DDE) for external exposures,
when calculated using a method found satisfactory to the Commission.
Regulatory Guide 8.40 ``Methods for Measuring Effective Dose Equivalent
from External Exposure'' recently updated and consolidated the guidance
available on acceptable methods for calculation of effective dose. A
conforming change was made to 10 CFR 20.1201(c) to clarify the
determination of occupational radiation dose for adults. The rule
change is consistent with the current recommendations of the ICRP.
The staff is considering whether it is appropriate to adopt current
ICRP terminology and methodology throughout 10 CFR Part 20 and other
portions of the regulations, by using the term TED instead of the term
TEDE. ICRP publications no longer use the term TEDE or committed
effective dose equivalent. The updated terminology has been associated
with changes to various weighting factors within the calculation, but
the underlying conceptual approach has remained the same.
Another area of consideration is changing the radiation protection
weighting factors and numerical values. The weighting factors for
tissues (WT) and types of radiation (WR) are
currently specified in 10 CFR Part 20 in the definitions section, and
are based on the recommendations in ICRP Publication 26. ICRP
Publication 103 recommendations provide new values for both quantities.
Revising values for Annual Limits on Intake (ALI) and Derived Air
Concentrations (DAC) is also an area of consideration. At this time,
the ICRP is still in the process of developing a new set of dose
coefficients, which will incorporate the revised radiation and tissue
weighting factors and account for the latest biophysical models. The
ICRP has indicated that the first volume of these new dose coefficients
is expected in late 2011, although the publication of the complete set
for occupational exposure and public exposure is not expected before
2014.
In considering Issue No. 1, the staff has identified two main
issues and options that should be considered and discussed relative to
effective dose and numerical values:
Issue No. 1.1: Clarifying Effective Dose Methodology and Assessing
Implications for Licensee Compliance With Dose Limits and Changes to
Terminology
NRC staff wants to clarify, as stated above, that the revised
definition of TEDE allows a licensee to substitute EDE for deep dose
equivalent (DDE) for external exposures and that a conforming change
was made to 10 CFR 20.1201(c) to clarify the determination of
occupational radiation dose for adults. The issue of terminology goes
beyond the simple introduction of a new term. Some of the NRC
regulations continue to be based on older radiation protection
approaches, and if these approaches are changed, then a question would
be whether to make a change in the existing terminology of 10 CFR Part
20, or to the current terminology used worldwide. See Section IV for
particular considerations in the power reactor community.
In consideration of the potential changes to terminology, the
following three options should be considered:
Options: 1.1a: No change in the current terminology (terminology
remains TEDE).
1.1b: Change the current regulation to align with the current
ICRP Publication.
103: Express as Total Effective Dose.
1c: Allow use of either term.
Questions: Q1.1-1: In terms of implementing the recently changed
methodology for applying TEDE, are there any potential impacts on
the ability to comply with the options for dose limits (DDE vs.
TED)?
Q1.1-2: What are the anticipated impacts on records and reports?
Issue No. 1.2: Numerical Values and Weighting Factors
ICRP Publication 103 provided updated tissue and radiation
weighting factors (WT, WR). In addition, the ICRP
is in the process of revising the dose coefficients based on new
values, models, and decay data. The weighting factors currently used in
10 CFR Part 20 date from 1977, and the corresponding ALI and DAC values
are presented in 10 CFR Part 20 Appendix B. The NRC staff also notes
that the EPA is currently examining the values presented in Federal
Guidance Reports 11 and 13, and is considering an update of these
values. The difference between the ICRP values and the EPA values stems
primarily from the use of a U.S. population cancer incidence and
mortality analysis, instead of an average set of cancer incidence and
mortality values for a worldwide population. In discussion with
stakeholders to date, the majority have been generally in favor of
updating the scientific information. However, no specific information
related to potential impacts has been presented.
The following are options and questions are related to this issue:
Options: 1.2a: No change.
1.2b: Change the current regulation to align with the current
ICRP Publication.
103: Update to new values, models, and radionuclide decay data.
Questions: Q1.2-1: Are there any foreseen impacts of the timing
(2014) of making changes to the current numerical values and
weighting factors? Should NRC consider moving forward with a more
limited set of radionuclides that would be available more quickly,
and make subsequent amendments to add additional values as they are
published by the ICRP?
Q1.2-2: Should the NRC use the values developed by the EPA,
which will be based on a US population, instead of the ICRP values,
which are based on a more diverse world population?
Issue No. 2: Occupational Dose Limits
The occupational dose limit of 10 rem (100 mSv) over 5 years, with
a maximum of 5 rem (50 mSv) in any one year, recommended by ICRP in
1990, was not incorporated into the last revision of 10 CFR Part 20
because the recommendations were not available during the public
comment period for the proposed rule. The ICRP recommendations have now
been adopted, in some form, by the International Atomic Energy Agency
in their International Basic Safety Standards (BSS), and by most of the
other countries in the world. In some countries, the limits are as
recommended by the ICRP. In other cases, the national authorities have
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chosen to require a single 2 rem (20 mSv) limit for occupational
exposure. In the discussions with stakeholders that have already taken
place, the occupational dose limits issue has also included discussion
of the relationship between the limits, and any proposal related to
establishing constraints for occupational exposure (see Issue No. 4).
The NRC staff is aware from stakeholder interactions that there are
significant global or trans-boundary considerations that are important
to some licensees which would argue in favor of changes in the dose
limits. The staff is also aware that many other licensees wish to leave
the current NRC regulations as they are. Factors identified have
included potential impacts to licensees who have occupationally exposed
individuals who are currently receiving exposures in excess of 2 rem
(20 mSv) in a year.
The NRC staff has identified the following three options for
changes to NRC's occupational dose limits:
Options: 2.a: No change. Allow the dose limit to remain at 5 rem
(50 mSv) per year.
2.b: Change the current regulation to align with the current
ICRP Publication 103: 10 rem (100 mSv) over 5 years, with a maximum
of 5 rem (50 mSv) in any one year.
2.c: Change the current regulation to align with the approach
adopted by some other countries: yearly dose limit of 2 rem (20
mSv).
Questions: Q2-1: Are there any significant anticipated impacts
in assessing and retaining dose histories for each individual in
order to comply with a multi-year average?
Q2-2: Are there any anticipated implementation impacts expected
if the dose limit is decreased?
Q2-3: Is there any information about the actual dose
distributions for industrial and medical licensees? What are the
trends for this data? Are the data available to share with the NRC?
Q2-4: For the medical industry, are there any potential impacts
on patient care?
Issue No. 3: Doses to Special Populations
Issue No. 3.1: Dose Limits for Embryo/Fetus of a Declared Pregnant
Worker
The limits for the embryo/fetus of a declared pregnant worker are
specified in 10 CFR 20.1208. Currently, the dose limit to the embryo/
fetus of a declared pregnant worker is 0.5 rem (5 mSv) for the
gestation period with 0.05 rem (0.5 mSv) additional dose during the
gestation period if the dose to the embryo/fetus has already exceeded
0.5 rem (5 mSv) at the time of declaration. The current requirements
are based on the recommendations available in ICRP Publication 26. The
ICRP recommendations now state that protection should be provided that
is generally equivalent to that provided to a member of the public.
Thus, the ICRP has now recommended a simplified approach, which is 100
mrem (1 mSv) after the declaration of pregnancy.
In the discussions with stakeholders that have already taken place,
many stakeholders have indicated that the ICRP proposal would not cause
any issues. However, the NRC staff is also aware of some licensee
segments, such as Nuclear Pharmacy licensees, where the change could
result in an impact. To date, specific information and supporting data
on impacts have not been received.
The NRC staff identified the following three options for the dose
limit to an embryo/fetus of a declared pregnant worker:
Options: 3.a: No change. Continue with the dose limit of 0.5 rem
(5 mSv) per year.
3.b: Change the current regulation to align with the current
ICRP Publication 103: 100 mrem (1 mSv) after the declaration of
pregnancy. 3.c: Change the current regulation to another single
value after declaration: For example, 0.05 rem (.5 mSv) after
declaration, the provision of the current rule if a dose of 0.5 rem
(5 mSv) has already been exceeded at the time of declaration of the
pregnancy.
Questions: Q3-1: Are there any significant anticipated impacts
associated with reducing the dose limit to the embryo/fetus of a
declared pregnant woman, including operational impacts?
Q3-2: Are there any anticipated implementation impacts on record
keeping?
Q3-3: Is there a reduction in burden in assessment and record
keeping if the ICRP recommendation is considered for adoption?
Q3-4: Are there technological implementation issues, such as
limits of detection, which would make adoption of the ICRP
recommendation difficult in certain circumstances?
Q3-5: Is there data on actual dose distributions to the embryo/
fetus of a declared pregnant worker? What are the trends for this
data? Is this data available to share with the NRC?
Issue No. 3.2: Dose Limits for Members of the Public, Alternative
Provisions for 500 mrem (5 mSv)
In addition to the dose to the embryo/fetus of a declared pregnant
female, stakeholders have asked about the implementation of the ICRP
recommendations to sensitive populations. In particular, stakeholders
have noted that the ICRP recommendations have stated that, although the
dose limits for members of the public continue to provide flexibility
for doses greater than 100 mrem (1 mSv) in certain limited
circumstances, sensitive populations such as young children should not
be allowed to receive doses greater than the dose limits. This leads to
an issue regarding the public dose limits that the NRC staff has not
previously solicited comments.
The current NRC public dose limits in 10 CFR 20.1301 contain a
provision that allows for licensees to apply for a limited application
of a dose limit up to 500 mrem (5 mSv). In consideration of the ICRP's
latest set of recommendations, the following options have been
identified:
Options: 3.2-a: No change. Continue to allow a dose limit of 0.5
rem (5 mSv) per year, applicable only upon specific approval of a
licensee request.
3.2-b: Change the current regulation to limit the applicability
of the provision to situations in which sensitive populations are
not receiving the exposure.
3.2-c: Clarify in guidance that the NRC will require licensees
to demonstrate that sensitive populations are not included in any
proposals for alternative public dose limits.
Questions: Q3.2-1: Are there any significant anticipated impacts
associated with limiting the applicability of alternative public
dose limits?
Q3.2-2: Are these impacts the same for the options of a rule
change, or for changes to guidance?
Q3.2-3: Is there data available about the actual use of the
alternative dose criteria? Is this data available to share with the
NRC?
Issue No. 4: Incorporation of Dose Constraints
One of the most significant recommendations made in ICRP
Publication 103 was the increased emphasis on the use of constraints
and reference levels as part of the process of optimization of
protection for all exposure situations. Licensees are currently
required by 10 CFR 20.1101 to use sound radiation protection principles
to achieve occupational doses and doses to members of the public that
are `As Low As Is Reasonably Achievable (ALARA). The term,
``constraint,'' is already included in the definitions of 10 CFR Part
20. A constraint, as currently defined, is a value at which licensee
actions are required. Many licensees are generally familiar with the
concept of constraints, although the term may be unfamiliar, because
the concept is very similar to the use of various types of planning
values (such as self-imposed administrative limits) in their programs
to ensure that the dose limits are not exceeded. Thus, many established
radiation protection programs already incorporate this concept, at
least to some degree. The ICRP recommendations indicate that the
constraint is the starting point for optimization, serving as an upper
bound on the annual dose for members of the public, or an
occupationally exposed individual, should receive from the
[[Page 59165]]
planned operation of any controlled source of radiation. ICRP has
stated that constraints are not to be considered as limits. In the
discussions with stakeholders that have already taken place, many
stakeholders have asked questions about the concept of constraints, the
relationship of constraints to limits, and the relationship between
possible changes to the limits and the use of constraints. In the
current NRC regulatory structure, a constraint is defined as a level at
which a licensee action is required. This provision is applied to
airborne effluents from non-reactor facilities, and the actions are to
evaluate the situation, develop actions to return effluents levels to
less than the constraint, and provide a report to the NRC. Thus, as
presently used in the regulations, an effluent release in excess of the
numerical value of the constraint is not a violation. A violation only
occurs if actions are not implemented in response to the situation.
This approach is similar to the description presented by the ICRP,
where a dose in excess of the constraint would not be seen as a
violation, but as a point when reevaluation of the planning and
implementation of the optimization ALARA program is needed.
A number of stakeholders have expressed an interest in exploring
the implications of using the mandatory application of constraints as a
mechanism to achieve the same level of protection as a change in dose
limits, while retaining some flexibility on the part of the licensee to
examine and control their own programs. The NRC staff is interested in
continuing to explore these proposals and their implications from
various groups of licensees.
NRC staff has identified three options for the incorporation of
dose constraints to NRC's radiation protection framework:
Options: 4.a: No change. Do not incorporate the use of
constraints into NRC's radiation protection framework.
4.b: Change the current regulation to specify that licensees
establish and use constraints as part of their radiation protection
program and the implementation of the ALARA requirement.
4.c: In addition to requiring the establishment and use of
constraints, require that the licensee use a numeric value that does
not exceed some specified value. One such value for occupational
exposure could be the 2 rem (20 mSv) per year level.
Questions: Q4-1: Are there any significant anticipated benefits
and impacts associated with imposing the use of constraints in a
licensee's radiation protection program?
Q4-2: Are there any anticipated implementation impacts on
inspection, compliance, and reporting anticipated?
Q4-3: What relationship should a constraint have to the dose
limit, if any?
Q4-4: Is a requirement to establish and use constraints an
appropriate, or inappropriate, insertion of a regulatory
requirement?
Q4-5: How familiar are you with the use and implementation of
constraints or planning values in a radiation protection program?
Q4-6: Are constraints (planning values) used in your current
licensed activities, and if so, can you share insights on the use of
these constraints?
IV. NRC Staff-Identified Technical Issues and Options Associated With
the Possible Revision of 10 CFR Part 50, Appendix I Regulations and
Guidance
Section A of the following discussion presents background
information and describes general considerations concerning potential
revisions to NRC regulations controlling radioactive liquid and gaseous
effluent releases in the environment, as identified by NRC staff. The
regulations are contained in Appendix I to 10 CFR Part 50, ``Numerical
Guides for Design Objectives and Limiting Conditions for Operation to
Meet the Criterion `As Low as is Reasonably Achievable' for Radioactive
Material in Light-Water-Cooled Nuclear Power Reactor Effluents.''
Section B discusses the various issues and options that need to be
assessed before initiating any regulatory activities leading to a
rulemaking proposing to align the dosimetry basis, current dose
terminology, and dose calculation methods of 10 CFR Part 50, Appendix I
design objectives with the recommendations of ICRP Publication 103.
A. Background
In 1975, the NRC adopted the ALARA principle in regulating
radioactive liquid and gaseous effluent releases from nuclear power
plants. Radioactive liquid and gaseous effluents are controlled under
10 CFR Part 20, 10 CFR Parts 50.34a and 50.36a, and Appendix I to 10
CFR Part 50. 10 CFR Part 50, Appendix I contains provisions to ensure
that gaseous and liquid radioactive effluents released in unrestricted
areas and doses to members of the public are ALARA. These requirements
are based on dosimetry concepts issued in 1959 as ICRP Publication 2.
This approach was consistent with the version of Part 20 in effect
prior to 1991, but is no longer consistent with current 10 CFR Part 20.
The revision under consideration may propose the adoption of the
radiation protection framework recommended by ICRP Publication 103.
This NRC staff is considering the approach in parallel with the
consideration of changes to 10 CFR Part 20 so that the resulting
requirements can be consistent.
The Commission believes that the current NRC regulatory framework
of 10 CFR Part 50, Appendix I, and reactor oversight program continues
to ensure that gaseous and liquid radioactive effluents released in
unrestricted areas and doses to members of the public are ALARA. The
alignment of 10 CFR Part 50, Appendix I regulations and design
objectives with ICRP Publication 103 recommendations would not be
intended to change the design objective criteria and regulatory
guidance used by the nuclear power industry in demonstrating compliance
with these requirements.
B. Issues and Options for Discussion
Issue No. 1: Proposed Revision to the Basis of 10 CFR Part 50, Appendix
I Design Objectives
Currently, the design objectives of 10 CFR Part 50, Appendix I, and
associated guidance documents, are still based on ICRP Publication 2
dosimetry concepts, which include dose to the whole body and to
critical organs. The ICRP Publication 26 and ICRP Publication 103
recommendations moved to a more risk-based approach, and expressed the
dose limits as TEDE, a sum of external and internal radiation
exposures. Currently, nuclear power plant licensees must apply two
different methodologies in calculating doses, one in determining
compliance with the requirements of 10 CFR Part 50, Appendix I, and
another in calculating doses to members of the public under 10 CFR Part
20. The intent of a possible revision is to align and improve 10 CFR
Part 50, Appendix I regulations and guidance by incorporating current
developments in radiation protection principles and advances in
radiation dosimetry that have occurred since the issuance of ICRP
Publication 2, over 50 years ago, and promulgation of 10 CFR Part 50
and Appendix I in 1975.
The staff has identified three main issues and options that should
be considered and discussed relative to alignment with more recent
recommendation:
Options: 1.a: Leave the basis of 10 CFR Part 50, Appendix I
design objectives as is and continue to apply the requirement under
existing NRC guidance and industry practices. This approach argues
that there is no necessary connection between 10 CFR Part 50,
Appendix I design objectives and 10 CFR Part 20 dose limits to the
public, given that 10 CFR Part 50, Appendix I is not a
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radiation protection standard under 10 CFR Parts 50.34a. The 10 CFR
Part 50, Appendix I design objectives are an ``ALARA design basis''
requirement. If the numerical guides for design objectives and ALARA
provisions of 10 CFR Part 50, Appendix I are met, it constitutes a
demonstration that effluent releases and associated doses to the
public are ALARA and no additional efforts are required to reduce
radioactive effluent releases. As a result, it could be argued that
there is no need to link the two. This approach would result in
minor revisions to supporting NRC guidance. The revision would
require that a few regulatory guides, currently as draft, be
finalized and re-issued as final.
1.b: Align dose definitions and quantities of 10 CFR Part 50,
Appendix I criteria with the ICPR 103 recommendations, in parallel
with any changes made to 10 CFR Part 20. This approach argues that
there is a benefit in aligning the basis of 10 CFR Part 50, Appendix
I design objectives with 10 CFR Part 20, as updated to ICRP
Publication 103 recommendations. This approach would ensure a
consistent application of regulatory criteria between 10 CFR Part 20
and 10 CFR Part 50. Such a revision could offer the opportunity to
standardize the process to a common regulatory basis in calculating
doses. This approach would result in significant revisions to
supporting NRC guidance, including key regulatory guides, NUREG
documents, and computer codes.
1.c: Align dose definitions and quantities of 10 CFR Part 50,
Appendix I design objectives with the current framework of 10 CFR
Part 20 based on ICRP Publication 26. This approach has the same
goal as option 1.2, and is offered as an option if the NRC decides
to not update 10 CFR Part 20. As before, this approach would ensure
a consistent application of regulatory criteria between 10 CFR Part
20 and 10 CFR Part 50. The revision would result in standardization
to a common but still outdated regulatory dosimetry basis and method
in calculating doses. This approach would result in significant
revisions to supporting NRC guidance, including key regulatory
guides, regulatory guides (NUREG) documents, and computer codes.
Questions: Q1-1: What are the benefits and impacts of each
option identified above? Is there a preferred ranking of the
options?
Q1-2: What is the scope of operational impacts and costs in
updating programs and procedures given a revision of 10 CFR Part 50,
Appendix I design objectives and NRC guidance? Identify specific
types of impacts that the NRC should consider in implementing a
revision of 10 CFR Part 50, Appendix I design objectives and NRC
guidance to ICRP Publication 103 recommendations.
Q1-3: Are there estimates available for the costs to revise
operational programs, implementing procedures, computer codes, and
personnel training for a typical pressurized water reactor (PWR) and
boiling water reactor (BWR) power plant or for a generic power
plant? Is there an estimate of the aggregate cost for the operating
fleet of nuclear power reactors?
Q1-4: Should the NRC combine both 10 CFR Part 20 and 10 CFR Part
50, Appendix I updates into one rulemaking effort, or consider two
parallel rulemaking efforts with the implementation of the revised
rules synchronized to a common implementation date when all
regulatory conforming changes and revisions of implementing guidance
are completed for 10 CFR Part 20 and 10 CFR Part 50, Appendix I?
Issue No. 2: Voluntary or Required Implementation of Revised 10 CFR
Part 50, Appendix I Regulations
This issue examines the different possibilities for implementation
of a possible revision for existing licensee facilities. Voluntary
implementation should not pose any backfitting considerations under the
Backfit Rule (10 CFR 50.109). However, the staff would need to address
the potential impacts on the reactor inspection program for those
plants and new applicants that would voluntarily implement the revised
regulations.
Options: 2.a: No change. Leave the current requirements and
guidance intact for all currently licensed and operating plants
under Parts 50 and 52.
2.b. Make the implementation of new requirements voluntary for
all currently licensed and operating plants under Parts 50 and 52
using a separate set of revised 10 CFR Part 50, Appendix I
regulations and guidance.
2.c. Require the implementation of revised 10 CFR Part 50,
Appendix I regulations and guidance for all operating plants and
applicants over time with a mandated common implementation date.
Questions: Q2-1: If 10 CFR Part 50, Appendix I was revised,
should the NRC make the implementation of the revised requirements
voluntary or mandatory on all nuclear power plant licensees?
Q2-2: If 10 CFR Part 50, Appendix I were revised and became
mandatory, what should be the duration of the implementation phase
for power plant licensees, e.g., 2, 4, or 6 years?
Issue No. 3: Approaches and Considerations in Revising 10 CFR Part 50,
Appendix Regulations
In addition to the possible update of dosimetric concepts and
methods, there are a number of additional areas within 10 CFR Part 50
Appendix I which could be considered for possible revision and update.
The staff is examining a tiered set of options, reflecting increasing
levels of complexity of the update, with the scope of the revision
ultimately depending on the chosen option on how to proceed with the
revisions, whether the implementation is mandated or voluntary, and
taking full considerations of impacts on regulations and guidance.
Options: 3.a: Limited Scope Revision--Besides specific revisions
to the regulations, target only those elements of the guidance
dealing with dose conversion factors and, if necessary, directly
supporting radiological parameters, such as specific adjustments to
the basis of dose conversion factors, based on ICRP Publication 103
or ICRP Publications 26 and 30. The balance of the technical
guidance and default values of other parameters would remain as
stated in current regulatory guides. The revision would identify
changes to computer codes using new dose conversion factors based on
ICRP Publication 103 or ICRP Publications 26 and 30 recommendations.
3.b: Expanded Scope Revision--In addition to the above, the
basis of specific parameters used in dose calculations would be
evaluated, and an assessment would identify the need to update or
retain specific default values. Such parameters, for example, would
include human food or animal consumption rates, bio-accumulation
factors, shore-line width factors, agricultural productivity rates,
usage and time factors for exposed individuals, etc. The revision
would also identify changes to computer codes using new dose
conversion factors based on ICRP Publication 103 or ICRP
Publications 26 and 30 recommendations.
3.c: Full Scope Revision--This approach would consider a full
review of the guidance, including a complete update of models
addressing liquid and gaseous treatment options and development of
radiological effluent source terms, atmospheric and aquatic
dispersion, and environmental transport using the current literature
and industry standards. The review would assess model assumptions,
parameters (as partly described above), and their default values.
The revision would identify changes to computer codes, modeling
assumptions and parameters, and apply new dose conversion factors
based on ICRP Publication 103 or ICRP Publications 26 and 30
recommendations.
Questions: Q3-1: Which option should the NRC apply in aligning
10 CFR Part 50, Appendix I regulations with ICRP Publication 103 if
10 CFR Part 20 were revised, or with ICRP Publications 26 and 30 if
10 CFR Part 20 were not revised?
Q3-2: What are the impacts and benefits in the implementation of
revised 10 CFR Part 50, Appendix I regulations that the NRC should
consider?
Q3-3: If significant impacts in the implementation of revised 10
CFR Part 50, Appendix I regulations are envisioned, what types of
issues should the NRC evaluate and consider in revising 10 CFR Part
50, Appendix I regulations?
Issue No. 4: Scope of Revisions to 10 CFR Part 50, Appendix I
Regulations
At this time, the NRC assumes that any proposed revision to 10 CFR
Part 50, Appendix I will be multi-fold. One aspect involves conforming
changes in ensuring that the nomenclature used in defining doses and
dosimetric quantities, as described in Issue 1 above. The
implementation of conforming changes in regulations and guidance is
expected to be a relatively simple process, once all nomenclatures and
definitions have been finalized and
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integrated in a revised 10 CFR Part 20. However, some challenges are
expected in modifying some of the regulatory provisions of Appendix I
to 10 CFR Part 50. The following identifies specific provisions of
Appendix I to 10 CFR Part 50 and 10 CFR Part 20 regulations that may
need to be reviewed and updated, as warranted:
Provisions: 4.1: Numerical design objectives of 10 CFR Part 50,
Appendix I for liquid and gaseous effluents--The revision would
retain the current numerical dose criteria, but would redefine doses
as effective dose (ED) or TED for consistency with ICRP Publication
103 dosimetry concepts in a revised 10 CFR Part 20, or as TEDE with
the current 10 CFR Part 20 (ICRP Publications 26 and 30) if 10 CFR
Part 20 were not realigned with ICRP Publication 103. The update
would necessitate a revision of dose calculation methods described
in Regulatory Guide 1.109 and associated computer codes.
4.2: Organ numerical design objectives of 10 CFR Part 50,
Appendix I for liquid and gaseous effluents--The revision would
assess whether there is still a need to report doses separately for
organs since this would not be necessary if ICRP Publication 103 or
ICRP Publications 26 and 30 were adopted. The assessment would
consider the provisions of Sections II and III of Appendix I to 10
CFR Part 50 on doses associated with radioiodine in situations where
releases might be dominated by the presence of noble gases and
radioiodine, resulting in potentially significant skin and thyroid
doses. The assessment would also consider the need to revise the
scope of thyroid dose contributors to include radionuclides present
as vapor (tritium) and gases (e.g., 14C in inorganic and organic
forms) in addition to radioiodine and particulates.
4.3: Annual gamma and beta air dose for gaseous effluents--The
gamma and beta dose criteria characterize an absorbed dose rate in
air, expressed in mrad/year, while the balance of the design
objectives are expressed in mrem/year for the total body and organs.
The revision would assess the need to still report gamma and beta
absorbed air dose results based on a review of historical gaseous
effluent releases and doses from operating PWR and BWR plants. The
revision might consider dropping that requirement altogether, or
alternatively, converting the design objective to an ED or TED dose
for a receptor assumed to be located at the site boundary.
4.4: Light-Water-Cooled Reactor Provisions of Appendix I to 10
CFR Part 50--The revision would consider whether there is a need to
expand current regulatory provisions for design certifications and
new reactor applications involving other types of reactor
technologies. Such new technologies might include new types of
reactor fuels and modular reactor technologies, e.g., high
temperature gas-cooled reactors, molten-salt or lead-cooled
reactors, and breeder reactors.
4.5: Compliance with Requirements for ``Licensed Operation''
under 10 CFR Part 20--The revision would consider the need to expand
provisions describing compliance requirements for ``licensed
operation'' for sites with two or more licensed entities
contributing to and radiation exposures to a single offsite dose
receptor under Parts 20.1301(a)(1) and 20.1302(a) and (b). The
expanded provisions would identify acceptable methods in the
regulation or guidance for apportioning radioactive effluent
releases and doses between two or more licensed entities. The
discussion would also consider compliance with EPA regulations of 40
CFR Part 190 as implemented under 10 CFR Part 20.1301(e).
Questions: Q4-1: Given the above summary descriptions of the
provisions of 10 CFR Part 50, Appendix I that might be considered
for possible revision, should the NRC evaluate all provisions
described above, or focus instead only on those necessary to align
10 CFR Part 50, Appendix I regulations with ICRP Publication 103 if
10 CFR Part 20 were revised, or with ICRP Publication 26 and 30 if
10 CFR Part 20 were not revised?
Q4-2: Given the above, are there any significant impacts in the
implementation of revised 10 CFR Part 50, Appendix I regulations
that the NRC should consider if it were to proceed with a
rulemaking?
Q4-3: If significant impacts in the implementation of revised 10
CFR Part 50, Appendix I regulations are envisioned, what types of
issues should the NRC evaluate and consider in revising 10 CFR Part
50, Appendix I regulations?
Dated at Rockville, Maryland, this 20th day of September, 2010.
For the Nuclear Regulatory Commission.
Mark Thaggard,
Deputy Director, Division of Intergovernmental Liaison and Rulemaking,
Office of Federal and State Materials and Environmental Management
Program.
[FR Doc. 2010-24137 Filed 9-24-10; 8:45 am]
BILLING CODE 7590-01-P